2008k home train-the-trainer manual

2008KBringing Home Therapy ExcellenceFresenius Medical Care


HHDTrain-the-Trainer Manual2008K@home Hemodialysis Delivery System

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1 P/N 490167 Rev A 2008K@home hemodialysis system Train-the-Trainer Manual

2008K@home Hemodialysis Delivery System

Train-the-Trainer Manual © Copyright 2011, Fresenius USA, Inc.—All Rights Reserved

This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius Medical Care.

Fresenius, Fresenius Medical Care, the triangle logo, 2008, PURISTERIL, and success@home are trademarks of Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. Hemastix® is a registered trademark of Miles, Inc. All other trademarks are the property of their respective owners.

TABLE OF CONTENTS Section 1 – Introducing the FMCNA 2008K@home™ Hemodialysis System ............... 3 Section 2 – Home Requirements ................................................................................... 5 Section 3 – Preparing for Dialysis .................................................................................. 8 Section 4 – Access for Dialysis ...................................................................................... 9 Section 5 – 2008K@home System Overview ............................................................... 10 Section 6 – 2008K@home Software Overview ............................................................ 17 Section 7 – Getting Started .......................................................................................... 19 Section 8 – Entering the Prescription ........................................................................... 21 Section 9 – Machine Setup .......................................................................................... 24 Section 10 – Preparing Your Dialysate ......................................................................... 25 Section 11 – Testing your 2008K@home Machine (Tx Setup) ..................................... 27 Section 12 – Setting Up the Arterial Lines: Screen 1 (Tx Setup) ................................. 28 Section 13 – Arterial Lines: Screen 2 (Tx Setup) ........................................................ 30 Section 14 – Venous Bloodline (Tx Setup) ................................................................... 31 Section 15 – Priming Blood Side (Tx Setup) ................................................................ 32 Section 16 – Prime Dialysate Side: Screen 1 (Tx Setup) ............................................ 33 Section 17 – Prime Dialysate Side: Screen 2 (Tx Setup) ............................................ 34 Section 18 – Entering Tx Parameters (Tx Setup) ......................................................... 35 Section 19 – Starting your Treatment (Tx Connect) ..................................................... 36


Section 20 – Flush Saline (Tx Connect) ....................................................................... 38 Section 21 – Connect Bloodlines (Tx Connect) ............................................................ 39 Section 22 – Start Treatment (Tx Connect) .................................................................. 40 Section 23 – Monitoring the Treatment (Home Screen) ............................................... 42 Section 24 – Ending the Treatment .............................................................................. 43 Section 25 – Check Saline (Tx End)............................................................................. 44 Section 26 – Return Blood (Tx End) ............................................................................. 45 Section 27 – Disconnect (Tx End) ................................................................................ 47 Section 28 – Emptying (Tx End) ................................................................................... 48 Section 29 – Cleansing (Tx End) .................................................................................. 49 Section 30 – Troubleshooting Alarms ........................................................................... 52 Section 31 – Troubleshooting Specific Blood Alarms and Dialysate Alarms ............... 54 Section 32 – Potential Problems During Dialysis ......................................................... 64 Section 33 – Returning the Blood Manually – Handcranking ....................................... 65 Section 34 – Potential Problems During Dialysis ......................................................... 67 Section 35 – Replacing the Diasafe Plus Filter ............................................................ 68 Section 36 – Overview of Warnings and Cautions ....................................................... 69 Section 37 – Servicing the Fresenius 2008K@home Machine ..................................... 73 APPENDIX A – GLOSSARY OF TERMS ...................................................................... 74 APPENDIX B – HEMODIALYSIS BASIC TRAINING .................................................... 86 APPENDIX C – VITAL SIGN CHECK AND RECORDING ............................................ 88 APPENDIX D – INTRADIALYTIC COMPLICATIONS ................................................... 94 APPENDIX E – INFECTION CONTROL ....................................................................... 95 APPENDIX F – VASCULAR ACCESS CARE ............................................................... 98

HOW YOUR ACCESS WORKS ................................................................................ 98 PREPARING YOUR ACCESS .................................................................................. 98 CANNULATE AND SECURE YOUR VASCULAR ACCESS ................................... 101 VASCULAR ACCESS CARE ................................................................................... 102

APPENDIX G – COMPETENCY CHECKLIST ............................................................ 104


Section 1 – Introducing the FMCNA 2008K@home™ Hemodialysis System The Learning Theory Train-the-Trainer section should be used in conjunction with this training section to introduce the trainer to learning techniques and theory that are applicable to the successful training of 2008K@home hemodialysis system users. This section provides an overview of the main learning concepts that must be taught to potential users of the 2008K@home hemodialysis system and should be used in conjunction with the 2008K@home User’s Guide. This Train-the-Trainer section is intended to help the trainer teach safe and effective use of the 2008K@home hemodialysis machine in the home setting. This includes a thorough discussion of all warnings and cautions contained in the user’s guide, a thorough review of all alarms and troubleshooting procedures and recommendations for competence demonstrations to be completed by the trainee. For each topic, we will review the main concepts, key terms, recommended return demonstrations and critical warnings that are integral to the training of home operators. This is supported by the Competency Check List (Appendix G). It is recommended that each item on the competency checklist is included as a return demonstration during the training period. Please remember that the suggested trainer-led learning activities listed in this section are only a guide. You will want to develop your own activities based on your experience, the information you have learned reading the Learning Theory Train-the-Trainer, and on your trainee’s ability level and learning style. Refer to the 2008K@home User’s Guide for definitions of terms and for a more complete description of each of these topics.

Implementation Overview Of primary importance to the success of home dialysis treatments using the 2008K@home hemodialysis system, is the suitability of home dialysis for the patient’s lifestyle, environment, and achievement of prescription goals. The patient’s nephrologist must certify that the patient is a candidate for home hemodialysis training. It is recommended that each trainer assess the patient in conjunction with the patient’s nephrologist to confirm their suitability for home dialysis. In addition, trainers should complete and document (if not already in the patient’s chart), a patient learning assessment to determine primary language for verbal and written communication, level of literacy, potential visual impairment particularly color differentiation, hearing impairment and manual dexterity. The patient’s training session should be adapted to meet the learner’s educational needs. The main learning concepts, key terms and recommended return demonstrations listed in this manual are guidelines for teaching strategies which require individualization to meet specific patient requirements. After completing the above assessments, a mutually agreed upon training schedule should be established. In general it is anticipated that training for home hemodialysis will take approximately 4-8 weeks. Please refer to the appropriate sections of the 2008K@home User’s Guide to review each procedure, definitions of individual terms, and warnings prior to each training session.

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Goals and Objectives After the successful completion of a four to eight week training period, the patient and care partner should demonstrate the competency to perform safe and effective dialysis at home. The patient and care partner should:

• Understand and perform hemodialysis treatments safely without supervision. • Demonstrate the appropriate action to be taken during possible emergencies. • Understand how to obtain assistance for any technical or medical problems. • Understand and explain the prescribed diet and medication therapies. • Demonstrate blood work draws and processing. • Demonstrate medication administration. • Understand that all elements of the dialysis treatment, including medication, diet, and

blood work, are under the order of the physician. • Understand normal renal function, the effects of end stage renal disease, and the effects

of the hemodialysis treatment. A more complete listing is contained in the Competency Checklist (Appendix G) Goals and objectives form the foundation for learning activities, and assessment measures. Review the objectives with the patient and care partner so that they may see how the material is related to their training and recognize them as being important.


Section 2 – Home Requirements Safe operation of the Fresenius 2008K@home hemodialysis machine in the home setting requires that the home have sufficient electricity, water, water quality, water pressure and drainage capacity (sewers) for proper machine operations. The power, water and other environmental factors must be evaluated and certified by a qualified technician prior to the installation of the Fresenius 2008K@home machine (see sample checklist from the user’s guide below). Table 1. Home Evaluation Checklist Note: A qualified person from your clinic must fill out this or a similar form. He or she should come to your home in person to check it over.

TYPE OF HOME: □ House □ Apartment □ Mobile Home □ Nursing Home □ Retirement Home Other: _______________ COMMUNITY ENVIRONMENT: □ # of occupants: ________ □ Room shared w/ another occupant □ Urban □ Rural □ Local Hospital: ______________________ □ Approximate miles From home to hospital: __________ □ Approximate miles from Home to unit: ___________ WATER SYSTEM: □ City □ Well □ Spring

SEWAGE SYSTEM: □ City □ Septic □ Leach Bed □ Trash Service □ Other: _________________ □ # of bathrooms: _________ □ Bathroom ______ft. to bed. □ Condition of shower head ELECTRICAL: □ 3-Prong outlets (single phase, three-conductor type receptacle and a ground fault interrupter at 120 Volts, 15 Amps, 60 Hz) □ Outlet near bed COOLING: □ A/C: Central/Window Units □ Fans: Type _____________ □ Duct System: Ceiling/Floor □ Other: ______________ HEATING: □ Electrical □ Gas □ Solar □ Wood stove □ Other: _________________

Failure to properly assess and ensure the reliable availability of electricity and water can result in patient injury. For this reason the user’s guide includes the following contraindication:

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Contraindications (When this machine should not be used) The 2008K@home machine is contraindicated for use in a home setting where there is inadequate water supply or inadequate water pressure. In other words, you cannot use the 2008K@home machine in your home if you do not have a constant water supply with good pressure. Your water pressure must be at least 20 psi and no more than 105 psi. Your water temperature must be at least 10°C (50°F) and no higher than 25°C (77°F). Home Hemodialysis Training In order to provide home dialysis training for home hemodialysis, the facility must be approved and certified by the Centers for Medicare and Medicaid Services (CMS) meeting all State and Federal program requirements as applicable. Training for home dialysis must be provided by a qualified registered nurse who meets the following minimum requirements:

1. Current licensure in the State in which he or she is employed. 2. Current licensure in the State where home visits or contact with patients via telephone

occurs. 3. A minimum of 12 months experience providing nursing care. 4. Additionally the Home Training Nurse is required to have a minimum of 3 months of

experience working as a nurse in the specific modality (hemodialysis or peritoneal dialysis) for which the nurse will provide patient/caregiver training.1

The qualified registered nurse is responsible for providing major portion of the home dialysis training, and for oversight and coordination of the Home Training Program.

Home Operator Training Requirements At the completion of the training program the patient and/or caregiver must successfully demonstrate competency in clinical and technical procedures and self care management, and also successfully complete a written final exam. The qualified home training Registered Nurse must validate the patient’s and/or caregiver competency including evaluating the patient’s comprehension and skills, utilizing a skills checklist (see Competency Checklist, Appendix G). These requirements must be met prior to the patient/caregiver being certified to perform home dialysis independently. Home dialysis training for the patient and/or caregiver must be individualized to the needs of the home dialysis patient/training candidate, and tailored to their level of understanding. Special attention must be provided to ensure patients’ comprehension and ability to perform and master each of the required tasks. The patient and/or caregiver may be trained in a small group or individually over a sufficient time and in a setting that facilitates learning and understanding. At a minimum, suggested content areas that must be mastered as part of home dialysis training include:

1 Refer to V Tag 685 of the CMS Interpretive Guidelines.


1. The nature and management of ESRD 2. Specific (step-by-step) instructions on using the prescribed patient equipment. Specific

emphasis should be placed upon proper set-up, input of treatment parameters, initiation of a treatment, performance of a hemodialysis treatment, understanding and proper management of alerts and alarms, termination of the hemodialysis treatment and proper machine cleansing and maintenance.

3. Specific (step-by-step) instructions in home dialysis procedures for home hemodialysis to facilitate adequate dialysis as prescribed by the patient’s physician

4. Training in proper storage and administration of erythrocyte stimulating agents (ESA’s), if applicable

5. Training in proper storage, preparation and administration of other physician ordered medications in the home environment

6. Detecting, managing and reporting potential dialysis complications, including water treatment problems as applicable.

7. When and how to contact support personnel. It must be emphasized that patients are not authorized to repair the machine and must contact an authorized person. Failure to follow these instructions can result in patient injury.

8. Availability of support services and how to access and use these resources 9. Self-monitoring of health status including recording and reporting of health status

information 10. Completing and presenting home dialysis documentation including treatment sheets,

and technical logs to the facility for monthly review by their physician and home hemodialysis care team

11. Handling medical and non-medical emergencies 12. Infection control precautions including disposal of biohazard waste

The facility is responsible to ensure that training must be documented in the patient medical record and must include evidence of patient/caregiver demonstrated competence in performing the home dialysis procedures.


Section 3 – Preparing for Dialysis Main learning concepts: Performing home hemodialysis is not only about being able to operate the hemodialysis machine. There are a number of medical concepts that must be reviewed and taught to home operators. These include teaching a basic understanding of simple infection control techniques, documenting treatment data, monitoring vital signs, and calculating fluid goal. Review common blood work that may be prescribed. Stress the significance of time, friction and quantity of cleanser. Discuss use of hand sanitizers (alcohol based cleansers) as needed. Key Terms: Hand washing, Sterile and clean techniques, monitoring and documenting vital signs and weight, Checking blood work, Approved hand cleanser, Paper towels Recommended return demonstrations: At the end of this section the patient will be able to:

1. Contrast sterile from clean technique 2. Monitor and document vital signs and weight 3. Explain the importance of thorough hand washing and demonstrate the skill 4. Discuss preferred use of paper towels as an infection control measure 5. Restate facility established blood work protocols for blood draws, maintaining specimen

integrity and review of specimen results Critical warnings, cautions and notes:

• Warning: Failure to use sterile and clean techniques can result in severe injury or death.

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Section 4 – Access for Dialysis Vascular access cannulation and care are central to performing hemodialysis. Comfort and success with cannulation is key to successful home hemodialysis. It is anticipated that this subject will be stressed throughout the 4-8 week training period. Main learning concepts: Please also refer to Appendix F, Vascular Access Care. Discuss central venous catheters, arterio-venous (AV) fistulas, and grafts. Review the signs or symptoms of access complications, access clotting, and access infection. Train on stepladder and buttonhole techniques as per the policy of the facility and physician order. Review rules for good access care and cannulation. Verbalize how to assess the dialysis access. Describe visual assessment of access. Note possible access abnormalities such as signs of infection, bruising, or aneurysms. Stress importance of visual inspection and palpation of the thrill for the entire length of the access. If the patient will utilize a catheter for dialysis, educate the patient throughout these pathways according to the specific facility policy and procedure for catheter care. Discuss needle removal and hemostasis including that insufficient pressure may lead to prolonged bleeding while excessive pressure can lead to access clotting. Key Terms: Types of access used for hemodialysis, access care and complications, cannulation, Redness/edema/bruising, Infection/abscess Infiltration, Gauze and band aids Sharps container, AV fistula, AV graft, dialysis catheter, Povidone iodine solution, isopropyl alcohol, or other approved cleanser Recommended return demonstrations: At the end of this section the patient will be able to demonstrate appropriate care of their access and access cannulation techniques including:

1. Evaluating access thrill and bruit 2. Identifying supplies needed to clean the access 3. Identifying the parts of the fistula needle including wings, protective needle guard,

needle bevel, needle back eye, anti-stick needle protector, and tubing cap 4. Restating the steps of cannulation 5. Preparing the access for cannulation 6. Explaining the process of access monitoring during the treatment 7. Listing post treatment access steps including needle disposal and securing of access

site 8. Showing a positive commitment to self care

Critical warnings, cautions and notes:

• Warning: Problems with your vascular access must be reported immediately to your physician.

• Warning: Failure to properly care for your access may result in injury or death.

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Section 5 – 2008K@home System Overview 1. Indication for Use & General Warnings Main learning concepts: The learner must be familiarized with the 2008K@home User’s Guide and the key indications for use, contraindications and general warnings relating to the 2008K@home hemodialysis machine Key Terms: User’s Guide, indications, contraindications, warnings Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Explain the structure and components of the user’s guide including the glossary 2. Identify symbols for alerts and warning and explain their meaning 3. Restate indications for use, contraindications to use and general warnings


• Please refer to the section on warnings, cautions and notes of this document. 2. Introduction to the 2008K@home hemodialysis machine and overview of its functionality Main learning concepts: It is important to familiarize the home operator with the layout of the 2008K@home hemodialysis machine. This includes a complete review of the basic machine components, control screens and safety features. This is discussed in detail in the 2008K@home User’s Guide section, “Meet Your 2008K@home Machine” Key terms: Explain the key features and parts of the 2008K@home machine including each of the components listed in the diagrams on page 12. These include the key components of the control panel, module compartment, and dialysate circuit section. Other key terms include the function keys on control panel, color coding of screen buttons, the main screen Status Box and Dialogue Box, arterial drip chamber holder and tubing guides, the blood pump, the heparin pump, the level detector module, the venous clamp, the concentrate connectors for bicarbonate and acid concentrate and the dialyzer quick-connectors and the shunt interlock. Discuss the blood circuit, the dialysate circuit, modules and control panel features. Please refer to the user’s guide and the glossary at the end of this manual as necessary for help in your explanations. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Confirm that the user’s guide section “Meet Your 2008K@home Machine” has been reviewed

2. Identify and demonstrate each portion of the machine including those named in the illustrations below

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3. Restate the function of the control panel and each screen, each of the keys and the color

coding of screen buttons 4. Explain the functional sections of the main screen including the Status Box and the

Dialogue Box 5. Discuss each component in the module section including the Arterial Drip Chamber,

Blood Pump, Heparin Pump, and Level Detector 6. Recognize the importance of the venous clamp and how to properly seat the venous

blood line in the clamp 7. Discuss the dialysate circuit 8. Differentiate between the red acid connector and the blue bicarbonate connector 9. Demonstrate the use of the concentrate connectors for bicarbonate and acid concentrate

and the handling of the dialyzer quick-connectors and the shunt interlock. Critical warnings, cautions and notes:

• Warning: The machine’s modules and internal hydraulics involve fluids. Fluid leaks may cause excess fluid removal from the patient. Correct the problem immediately or take the machine out of service. Spills can cause damage to carpeting and other surfaces. To contain such spills, the machine should be on a spill-tolerant surface. Spills can cause slips and falls; clean up spills immediately.

• Caution: Do not raise the level of the drip chamber so high that the transducer protector becomes wet. Wet transducer protectors must be replaced, as they will cause inaccurate readings and possibly serious injury or death. See “Clearing the Pressure Monitor Line” in the 2008K@home User’s Guide

• Note: The Power key does not interrupt electrical power to your machine. To disconnect completely, use the main power switch on the back or pull the power cord plug.


2008K@home Machine Front View


2008K@home Machine Rear View


Control Panel

Standard Module Setup

Machine Section

Treatment Section

Patient Section


Dialysate Circuit

Blue Bicarbonate Connector

Red Acid Connector

Fluid Sample

Line

Concentrate Jug Connector

Cap

Shunt Door

Dialyzer Quick-

Connecters

Shunt Interlock

Dialysate Supply Line

Flow Indicator


The 2008K@home User’s Guide features a foldout map of your machine called “Your K Map”: When a procedure references a location not shown, the operator can find the matching letter and location on “Your K Map” (inside front page of the user’s guide).


Section 6 – 2008K@home Software Overview Main learning concepts: The different types of touch screen buttons and their functions, non-clickable status of grayed-out buttons, flowchart at the top of dialysis procedure screens

Insert diagram explaining flowchart at top of screens

Key terms: In addition to reinforcing machine terminology add: grayed-out, touch (for buttons), press (for keys), progress bar graph, flowchart Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Explain the various types of buttons and which are selectable 2. Explain how to read the progress bar graph on various screens

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3. Explain how to read the flowchart along the top of the screen 4. Explain the alert sections of the display: Status Box and Dialogue Box


Section 7 – Getting Started Main learning concepts: Reinforce the benefits of home dialysis and use of the 2008K@home machine (easy to use Control Panel keys, and simple on-screen menus). Define the role of the trained operator, the role of the trained person who will observe the treatment, and the role of the trainer. Identify available resources of technical support. Provide the definition of heparin and its purpose, pharmacokinetics as it relates to dialysis and medication administration. Discuss the contraindications to the Blood Pressure Module, identification of the 4 attention boxes and the 7 other important machine symbols. Stress the importance of adherence to dialysis prescription. Compare and contrast hemodialysis to the functions of the renal system, introduce intradialytic complications, the clinic’s schedule for disinfecting and testing the water treatment system, piping, inlet lines, filters, concentrate feed containers, and the dialysate lines. Review ordering supplies provide an introduction to medical waste disposal. These overall concepts form the basis for further learning. It is recommended that they be reviewed on multiple occasions throughout training. Key terms: In addition to reinforcing machine terminology add: contraindications, hypovolemia, hypervolemia, hypertension, hypotension, hypothermia, hyperthermia, convulsions, seizures, dialysis dementia, electrolyte, hemorrhage, acidosis, alkalosis, hemolysis, pyrogenic, chemical, AAMI, aseptic technique, Your K Map, appendix, ultrafiltration, serum potassium, blood clotting time. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Discuss how fundamental hemodialysis procedures affect the body 2. Define aseptic technique 3. Describe available resources for technical and clinical support 4. Define roles and responsibilities of the registered nurse trainer, the trained operator and

trained partner 5. Explain the purpose and action of hemodialysis related medications 6. List contraindications to the Blood Pressure Module 7. Recognize the importance of adhering to the dialysis prescription 8. Restate the clinic’s schedule for disinfecting and testing the water treatment system,

piping, inlet lines, filters, concentrate feed containers, and the dialysate lines, ordering of supplies

9. Discuss potential intradialytic complications and their potential resolution 10. Restate appropriate medical waste procedures relating to home hemodialysis

Critical warnings, cautions and notes: Strict adherence to physician’s orders. AAMI standards for water, Following clinic’s schedule for disinfecting and testing the water treatment system, piping, inlet lines, filters, concentrate feed containers, and the dialysate lines. Discuss Needle Dislodgement and blood loss. Discuss how to monitor the access site, blood pressure, pulse, and general physical status so that the patient

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can learn to quickly react to any problem with the right solution. Discuss that the patient should not rely solely on machine alarms. Vigilance is key. Other important warnings include:

• Warning: The air detector alarm is a critical safety feature that alerts the user of potential air in the bloodline. You must properly place the venous drip chamber in its holder and set the proper blood/saline level in the venous drip chamber. Avoid overfilling. Failure to follow the instructions in this user’s guide can result in severe injury or death. Please contact your physician if you have any questions about the proper operation of the air detector or how to attach the venous bloodline. Repeated air detector alarms at the beginning of treatment may indicate improper placement of the venous drip chamber in its holder.

• Warning: Repeated arterial and/or venous pressure alarms may mean poor blood flow

or access problems. If you have frequent alarms or a change in alarm patterns, you should call your clinic. Frequent movement can trigger the alarm. Patients should refrain from unnecessary movement during dialysis.

• Warning: The conductivity alarm is an important safety feature of your dialysis

treatment. You must fill your concentrate jugs to the top at the beginning of each treatment. During treatment you must keep your jugs full enough so you do not run low on concentrate. Failure to change your jugs when they run low will prevent you from receiving your prescribed dialysis and may lead to serious injury or death.

Instructions for general checks before starting a treatment: Review the machine requirements before starting a treatment including:

1. Check that the Reverse Osmosis (RO) unit is running and the water supply line is connected to the water inlet.

2. Check that the drain line is inserted into a drain with an air gap. 3. Check that the power cord is plugged into a grounded, GFI-protected electrical outlet,

and the main power switch on the back of your machine is in the ON position. 4. Check that the heater switch on the back of your machine is in the ON position. 5. Check that the acid concentrate line (red connector) is inserted tightly into the red acid

port. 6. Check that the bicarbonate concentrate line (blue connector) is inserted tightly into the

blue bicarb port. 7. Check that the dialysate supply line (blue quick-connector) and the dialysate return line

(red quick-connector) are both firmly snapped onto the matching color connectors of the shunt interlock.

8. Check that your machine has been recently disinfected, rinsed, tested for traces of disinfectant, and is ready to use.

9. Check that the emergency hand crank for the blood pump is readily available. 10. Check that all of your supplies are prepared.


Section 8 – Entering the Prescription

Main learning concepts: Restating the prescription parameters, identification of commonly used abbreviations within the prescription setting, how to change an incorrect entry, explain significance of 2X dialysate autoflow, mathematical addition exercises, identification of milliliters on fluid containers, impact of improper blood pressure cuff placement and use of the BP module, acceptable blood pressure and pulse range, and purpose of 24 hour clock (military time) vs. regular time. Stress the importance of mastery of the entire set-up process and procedures and emphasize the critical nature of correctly following their physicians prescription, how to use the My Treatment Parameters card (see next page), the My Treatment Procedures sheet, and the My Cleaning Procedures sheet.

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Key terms: Rx=prescription, parameter, conc=concentrate, Na+=sodium, dialysate flow, bicarbonate, syringe, heparin, bolus, inflation pressure, interval, dry weight, Tx=treatment, dry weight, maximum UF volume, 2X dialysate autoflow Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Set the prescription parameters 2. Identify commonly used abbreviations within the prescription setting 3. Explain significance of 2X dialysate autoflow 4. Demonstrate how to change an incorrect entry 5. Identify milliliters on fluid containers 6. Compute simple mathematical equations needed for machine input (or use calculator) 7. State their acceptable blood pressure and pulse range as determined by the physician 8. Compare military time with regular time


Critical warnings, cautions and notes: • Warning: Setting the dialysate flow to a rate that is too low can negatively affect

dialyzer clearance and reduce treatment effectiveness. If “2X” selects a flow rate below your prescribed rate, you may manually set the dialysate flow to the desired value. Using the wrong values could cause injury or death.

• Warning: Your doctor must prescribe each of the values in the “Rx Parameter” screen. Use the “My Treatment Parameters” sheet on page ii of the 2008K@home User’s Guide (P/N 490180). Using the wrong values could cause injury or death.

Instructions for entering the prescription:

1. Press Power key and touch the Rx Parameter button on the “Select Program” screen. 2. Touch the Conc button to enter “Select Concentrate” screen. 3. Use the Up/Down arrows to choose the prescribed concentrate. 4. Confirm selection with CONFIRM key. 5. Select each of the parameters (Na+, Dialysate Flow, Bicarbonate, Temperature) and

enter the prescribed parameters then confirm. 6. Touch Syringe button and enter prescribed syringe. 7. Select each of the parameters (Heparin Rate, Stop Heparin, Heparin Bolus) and enter

the prescribed parameters. 8. Touch Blood Pressure button and enter the prescribed alarm limits, Inflation Pressure,

and Interval then confirm. 9. Set the clock in the upper right corner of the “Blood Pressure” screen. 10. Select each of the parameters (Dry Weight, Tx Time, Max UF Vol) and enter the

prescribed parameters then confirm. 11. Touch Done button to complete entering prescription.


Section 9 – Machine Setup Main learning concepts: Organizing and gathering supplies in a logical and consistent manner, arranging for convenient access during setup, and checking the water system. Stress the importance of mastery of the entire set-up process and procedures. Key terms: Dialyzer, heparin, bloodlines, syringe, concentrate, and dialysis circuit. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Explain the steps for water system checks 2. Identify each needed supply for the hemodialysis treatment

Critical warnings: N/A Instructions for setup preparation:

1. Obtain all of your supplies and arrange for convenient access during setup. 2. Ensure that water system is running and has been checked according to manufacturer’s

specification. 3. Press Power key and check if the machine requires rinse or disinfection.

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Section 10 – Preparing Your Dialysate Main learning concepts: Properly mixing concentrates, identification of appropriate acid and bicarbonate connections, determining guidelines for sufficient concentrate throughout the treatment, confirming concentrate prescription, and describing opportunities for potential errors. Stress the importance of mastery of the entire set-up process and procedures and the critical role of dialysate in hemodialysis. Key terms: Red acid port, red acid connector, acid concentrate jug, blue bicarb port, blue bicarbonate connector, bicarbonate jug, acetate, pH, and conductivity.

Insert diagram of properly mixing concentrates Action Reason A. Fill the dialysate jug with the appropriate volume of RO water based upon the type of bicarbonate concentrate used.

A. Powdered concentrate will displace water so do not fill completely until powder has been added.

B. Add one packet of bicarbonate powder to the water.

B. Be sure not to spill powder anywhere but in the jug.

C. Place the cap assembly on the bicarbonate jug.

C. Capping the jug prevents spillage.

D. Mix the solution well by gently shaking the jug. Keep mixing until the powder is completely dissolved.

D. Twisting jug back and forth provides enough agitation to dissolve powder.

E. Once the bicarbonate is completely dissolved, add more RO water to the solution, to make the total volume for the type of concentrate used. Gently mix the solution.

E. The package will state the total volume in liters required to assure the proper dilution.

Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Demonstrate proper mixing of concentrates 2. Show appropriate acid and bicarbonate connections 3. Discern guidelines for sufficient concentrate throughout the treatment 4. Confirm concentrate prescription 5. Describe opportunities for potential errors 6. Explain critical role of dialysate in hemodialysis


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• Warning: Your jugs of acid and bicarbonate concentrates must match both your prescription and your machine settings. Make sure they are correct before connecting. Using the wrong concentrates may cause serious injury or death.

• Warning: When your machine has stabilized, test the conductivity and approximate pH of the dialysate with an independent device. Improper conductivity or pH may cause serious injury or death.

• Warning: Mix your bicarbonate according to your clinic’s instructions. Be sure the jugs contain enough concentrate for your whole treatment—fill your concentrate jugs all the way up to the top. If a jug runs out during treatment, a condition known as “air lock” may occur, causing conductivity problems.

Instructions for dialysate setup:

1. Remove red acid connector and touch the Dialysis screen-button 2. Check prescribed concentrate is listed and that Na+ and Bicarbonate settings are

correct. Press CONFIRM key. 3. Connect red acid connector to acid concentrate jug. Connect blue bicarbonate connector

to bicarbonate jug. Provide enough concentrate for a full treatment. 4. Touch the Done button to go to the next screen


Section 11 – Testing your 2008K@home Machine (Tx Setup) Main learning concepts: Purpose of testing the machine and frequency, how bar graph displays time remaining in testing, how the done button is grayed-out and not selectable during the test, explaining steps required to retest machine after failed test, explaining how the machine indicates a failed test, recognizing Diasafe Plus filter frequency of testing if applicable, and distinguishing two situations when a qualified technician is needed. Stress the importance of mastery of the entire set-up process and procedures and the critical nature of passing all safety checks. Key terms: Hydraulic system, Alarm system, grayed-out, test progress bar graph, and Status Box. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Explain testing the machine and testing frequency 2. Explain why the Done button is grayed out and how to read the test progress bar graph 3. Restate and explain the steps required to retest the machine after a failed test 4. Retell how the machine indicates a failed test 5. Distinguish two situations when a qualified technician is needed


• Warning: After you select and confirm the Start Test button, your machine will beep. This is a test of the audible alarm system; make certain that the sound occurs. If your machine fails any of these tests and the cause cannot be corrected, do not start your treatment. Contact your clinic immediately. Have your machine checked by a qualified technician to correct the problem.

Testing (Tx Setup) Instructions:

1. Touch Start Test and press CONFIRM to begin testing machine 2. When Status Box reads “Test Complete,” press RESET to clear message 3. Touch the Done button to go to the next screen 4. Explain steps required to retest machine after failed test

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Section 12 – Setting Up the Arterial Lines: Screen 1 (Tx Setup) Main learning concepts: Principles of aseptic technique during arterial line connection process. Explain components of the bloodline set and the functionality, explain importance of removing numbered tape only when instructed, explain the risk of kinked lines, arterial line, arterial access, arterial line clamp. Stress the importance of mastery of the entire set-up process and procedures.

Explain possible uses for bracket: • Hanging bloodlines if operator decides to remove them from

package early • Hanging patient end of arterial bloodline • Hanging saline line • Hanging blood pressure cuff

Key terms: Arterial drip chamber, blood pump, pump housing, transducer, transducer protector, aseptic technique, arterial pressure port, sterile, bracket, tape, and bloodline set.

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1. Explain components of the bloodline set and the functionality 2. Connect the patient end of the arterial line to the drain bag 3. Feed the pump segment into the pump 4. Connect an arterial line to a dialyzer 5. Discuss the risk of kinked lines


• Note: Do not remove the tape from your bloodlines until necessary to snap them into the machine.

• Note: A bracket is provided to help you organize your bloodlines during setup, if necessary.

Arterial Line – Screen 1 setup instructions:

1. Explain components of the bloodline set and the functionality. 2. Insert dialyzer into holder 3. Hang drain bag on posts 4. Snap arterial drip chamber into holder. 5. Remove Tape 1 and demonstrate feeding pump segment into pump:

a. Open blood pump door, press and hold Start/Stop key until blood pump stops (to align for placement of blood pump segment).

b. Firmly insert left side of pump segment into pump housing and make sure hard plastic piece is below housing.

c. Press and hold Start/Stop key until pump segment is fully loaded and blood pump stops.

6. Remove Tape 2 and connect arterial line to bottom of dialyzer. 7. Insert line into tubing guides and explain risk of kinked lines. 8. Touch the Done button to go to the next screen.


Section 13 – Arterial Lines: Screen 2 (Tx Setup) Main learning concepts: Stress the importance of mastery of the entire set-up process and procedures. Explain functionality of transducer protectors, and explain why wet transducers must be replaced. Key terms: Drain bag, transducer protector, red and blue recirc connector Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Show how to tighten the red and blue recirc connectors 2. Demonstrate opening and closing clamps 3. Manipulate saline bags as needed 4. Change a wet transducer protector 5. Restate aseptic technique


• Warning: Use a sterile transducer protector between your machine and each pressure monitor line so the transducers do not get wet. Wet transducer protectors must be replaced, as they will cause inaccurate pressure readings.

Arterial Line – Screen 2 setup instructions:

1. Connect patient end of arterial line to drain bag 2. Connect transducer protector to arterial pressure port and explain functionality of

transducer protectors. Show procedure to change wet TP. 3. Tighten the red and blue recirc connector 4. Close saline clamp 5. Hang saline bag 6. Remove Tape 3 and connect saline bag 7. Touch the Done button to go to the next screen

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Section 14 – Venous Bloodline (Tx Setup) Main learning concepts: Principles of aseptic technique during venous line connection. Stress the importance of mastery of the entire set-up process and procedures. Key terms: Venous chamber, sensor heads, Venous Clamp Optical Detector, tubing guides, medication clamps, and venous pressure port. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Discuss and review the blood circuit, venous blood lines, hemodialysis access and preventing kinks in the bloodlines

2. Restate aseptic technique 3. Complete all venous line connections follow venous line setup instructions 4. Explain functionality of optical detector 5. Explain the functionality of transducer protectors and explain why wet transducers must

be replaced. Critical warnings, cautions and notes:

• Warning: If the drip chamber contains a filter, make certain the filter is below the sensor heads.

• Warning: The level detector must be calibrated for the venous line model being used. Failure to do so may cause serious injury or death.

• Warning: The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.

Venous Line – setup instructions:

1. Roll venous chamber into holder; make sure the filter is below the sensor heads. 2. Insert line into Venous Clamp and Optical Detector. Explain functionality of both

components again. 3. Connect patient end of venous line to drain bag. 4. Remove Tape 4 and connect venous line to dialyzer. 5. Insert line into tubing guides. 6. Connect transducer protector to venous pressure port. 7. Close both medication clamps. 8. Touch Done button to go to the next screen.

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Section 15 – Priming Blood Side (Tx Setup) Main learning concepts: Utilizing “my treatment procedures sheet” to determine drip chamber level. How to set drip chamber level. How the Done button is grayed-out and not selectable during the priming process, How bar graph displays time remaining in priming process. Stress the importance of mastery of the entire set-up process and procedures. Key terms: Gravity prime, prime, heparin, heparin line clamp, and recirculated saline. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Demonstrate proper use and function of the level detector. 2. Review air detector alarms. 3. Stress the importance and function of the air detector and transducers protector.

Critical warnings, cautions and notes: Review wet transducer procedure.

• Warning: The Level Adjust on the Blood Pump module can only be used to raise the level in the arterial chamber. Do not press the Level Adjust key so long that the pressure transducer becomes wet. Wet transducer protectors must be replaced to avoid false pressure readings.

• Warning: Only use syringes prescribed by your doctor in the Heparin Pump module. Make sure that there is enough heparin for your entire treatment. Do not load the syringe beyond your prescribed amount.

• Warning: The heparin pump is to be used only under positive pressure conditions. Under negative pressure conditions, too much heparin may be infused.

• Caution: The syringe must be properly loaded for your machine to add heparin during treatment.

Prime Blood Side Instructions:

1. Prime heparin line, close heparin clamp, and insert your selected syringe. 2. Open saline line clamp. 3. Gravity prime arterial patient line to drain bag. 4. Close arterial patient line clamp. 5. Turn on the blood pump. 6. Set arterial drip chamber level using the arterial Level Up key on the Blood Pump. 7. Touch the Prime button and press CONFIRM twice to begin priming. 8. Touch Done button to go to the next screen.

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Section 16 – Prime Dialysate Side: Screen 1 (Tx Setup) Main learning concepts: Importance of testing dialysate for proper pH and conductivity, explain why it is necessary to use an independent meter to test the dialysate, explain what is residual disinfectant and why it is necessary to test for it. Key terms: Dialysate, conductivity, pH, independent device or meter, residual disinfectant Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Demonstrate how to take a dialysate sample for testing 2. Test the dialysate for conductivity using an independent meter 3. Enter the values displayed on the meter into the 2008K@home parameter-buttons on

the screen Critical warnings, cautions and notes:

• Warning: After testing the dialysate through independent means (e.g., using a conductivity meter and pH paper or meter), verify that the conductivity is reasonably close to the theoretical value (TCD) and the pH is between 6.9 and 7.6. The machine must also be free of residual disinfectant. If these conditions are not met, do not initiate dialysis.

• Note: If your conductivity or pH values are out of range, the Dialogue Box will alert you. Make sure that the value you entered matches your test reading. If the value is still out of range, take a new dialysate sample to test.

Dialysate Testing Instructions:

1. Verify the following: a. Dialysate lines on shunt b. Conductivity and temperature stabilized c. Independent meter is properly calibrated d. Patient has a clean, non-foam container for collection

2. Open shunt door and unsnap blue dialysate line 3. Rinse container and collect sample 4. Close shunt door 5. Open shunt door and snap blue dialysate line back on shunt. 6. Test dialysate with an independent device 7. Enter conductivity 8. Enter pH 9. Press the CONFIRM key 10. Touch the Done button to continue

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Section 17 – Prime Dialysate Side: Screen 2 (Tx Setup) Main learning concepts: Restate why dialyzer is rotated, purpose of recirculation, how to clear air from the dialyzer, how the done button is grayed-out and not selectable during the test and recirc, and emphasize the importance of clearing all air from the dialyzer and lines by priming to the end of the lines, how to read the test and recirc progress bar graph Key terms: Venous side of dialyzer, arterial side of dialyzer, shunt door, and shunt interlock. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Demonstrate “tight” connections 2. Demonstrate priming the tubing and dialyzer 3. State purpose of rotating the dialyzer 4. Identify correct connections and sequence of connections


• Warning: All quick-connectors must be tightly connected to prevent air from entering the dialysate circuit or dialysate leaks.

• Note: If all the air has not been cleared from your dialyzer, turn your dialyzer upside down and right side up again.

• Note: Make sure the saline has reached the end of the bloodline when priming. Prime Dialysate Side Instructions:

1. Rotate dialyzer. 2. Connect blue dialysate line to venous side of dialyzer and red dialysate line to arterial

side of dialyzer. 3. Close drain bag clamp 4. Open arterial patient line clamp. 5. Touch Recirc Saline and press CONFIRM to begin recirculation. 6. When recirculation is complete, touch Done button to go to the next screen.

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Section 18 – Entering Tx Parameters (Tx Setup) Main learning concepts: Mathematical addition exercises, identification of milliliters on fluid containers, impact of incorrect UF setting, conversion of pounds to kilograms, and the importance of following the physicians prescription. Discuss the concept of estimated dry weight and target weight. Stress the importance of mastery of the entire set-up process and procedures. Key terms: UF=ultrafiltration, kilograms, rinse back volume, and estimated dry weight. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Describe addition of rinse back volume to “Additional Volume” 2. Discuss impact of incorrect UF setting 3. Enter weight in kilograms 4. Explain concepts of estimated dry weight and target weight and importance of following

the physician’s prescription Critical warnings, cautions and notes: Review impact of incorrect mathematical equations

• Note: Your weight must be measured in kilograms. Enter Tx parameter Instructions:

1. To calculate a new UF goal, touch the UF Calculator button. a. Touch the Pre Weight button and enter your weight. b. Touch the Additional Volume button and enter amount. c. Press CONFIRM to confirm changes. d. Touch Done button to go to the next screen.

2. Explain units required for UF calculator and recommend scale with units in kg (not with lbs).

3. Review new UF goal and touch the Done button again to go to the next screen.

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Section 19 – Starting your Treatment (Tx Connect) Main learning concepts: Adherence to prescription and treatment procedures, aseptic technique, identification of critical checks prior to connecting for treatment, identification of milliliters on fluid containers, impact of improper blood pressure cuff placement and use of the BP module, and acceptable blood pressure and pulse range. Key terms: Ultrafiltration, aseptic, dialysate, kilogram, bypass mode, conductivity, pH, bolus, hemolysis, transducer, transmembrane pressure, dialysate flow rate, systolic pressure, and diastolic pressure. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Review and demonstrate connection of the acid and bicarbonate lines 2. Understand the rational for the emergency hand crank and demonstrate how to operate

it 3. Demonstrate how to test for traces of disinfectant 4. Perform simple mathematical addition exercises and calculate military time 5. Demonstrate how to properly fit the blood pressure cuff and use the blood pressure

module 6. Touch the Tx Connect button to move to the next set of on-screen instructions. 7. Independently initiate their treatment by cannulating their blood access, connecting their

bloodlines, and beginning their treatment 8. Explain when and why a transducer protector should be changed

Critical warnings, cautions and notes: The patient must demonstrate competency of the following machine checks prior to connecting for treatment:

• Check that the machine has passed all pressure and alarm tests. • Check that the dialysate is at proper temperature and conductivity. • Check that the dialysate is tested and free of traces of disinfectant. • Check that the machine’s bypass mode is functioning correctly by opening and

closing the shunt door and watching the float in the dialyzer line. • Warning: If any of the conditions listed above have not been met, you must correct

them before continuing with your treatment preparation. Failure to do so may cause serious injury or death.

• Warning: You must test the conductivity and approximate pH of the dialysate with an independent device before connecting for treatment. Improper conductivity or pH may cause serious injury or death.

The patient must restate the following warnings and explain reasoning behind each. If any of the safety checks described in Error! Reference source not found. failed and were not corrected, the patient must not start the treatment. Failure to do so may cause serious injury or death. Improper conductivity or pH may cause serious injury or death. Bloodlines and

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dialysate lines must be checked for leaks after the treatment has started. Access sites must be uncovered and monitored. Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury and death. Check all bloodlines for kinking as improper blood flow may cause hemolysis. Do not raise blood level so high in the arterial drip chamber that the transducer becomes wet. Keep fingers clear of the blood pump rotor when it is running. Serious injury may occur.

• Warning: If any of the conditions listed above have not been met, you must correct them before continuing with your treatment preparation. Failure to do so may cause serious injury or death.

• Warning: You must test the conductivity and approximate pH of the dialysate with an independent device before connecting for treatment. Improper conductivity or pH may cause serious injury or death.


Section 20 – Flush Saline (Tx Connect) Main learning concepts: The purpose of performing a saline flush before the start of the treatment. How to properly flush the lines with saline. Explain how to verify the patient ends of the bloodlines have been flushed properly. Stress the importance of mastery of the entire set-up process and procedures. Key terms: Blood pump, gravity flush, arterial line, drain bag, saline bag, saline, level detector, level adjust, drip chamber, and venous clamp, recirculated saline. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Restate how to perform a saline flush and why it is done 2. Retell and stress what to do in the case of an air detector alarm and how to prevent

them Flush saline instructions:

1. Explain why saline is flushed before start of treatment. 2. Press the Start/Stop key on the Blood Pump module to stop blood pump. 3. Change saline bag. 4. Open drain bag clamp and gravity flush arterial line to drain bag. 5. Close clamp on patient end of arterial bloodline. 6. Start blood pump. 7. 300 ml saline into drain bag. 8. Stop blood pump. 9. Close saline, drain bag, and venous clamps. 10. Verify that line is flushed and set toggle-button to Yes, then CONFIRM. 11. Touch the Done button to go to the next screen.

Critical warnings, cautions and notes: Ensure that the level detector system has been tested before treatment is started. Make certain that there is enough saline in the bag for the entire treatment. Pay close attention to the saline bag level until 300 ml has been disposed into the drain bag. Ensure that the clamps are closed after 300 ml of saline has been drained.

• Warning: You must test the Level Detector system before treatment. To test your machine: Press the Down Level Adjust key to lower the fluid level in the venous drip chamber. Remove your machine from service if the blood pump does not stop and the Venous Clamp does not close. Press the Up Level Adjust key to raise the venous drip chamber level again.

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Section 21 – Connect Bloodlines (Tx Connect) Main learning concepts: Connection of the correct line segments to the correct section of the vascular access (arterial line to arterial access and venous line to venous access), and proper administration of heparin bolus, if prescribed. Key terms: Arterial line, arterial access, venous line, venous access, drain bag, heparin line, and heparin bolus Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Restate and demonstrate how to disconnect the arterial line from drain bag and connect to it to the arterial access and then disconnect the venous line from the drain bag and connect it to the venous access

2. Verbalize the purpose of heparin and administer the heparin bolus if prescribed by their physician.


• Warning: Check all bloodlines and dialysate lines for leaks after your treatment has started. Keep access sites uncovered and monitored. Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury and death. Machine alarms may not occur in every blood loss situation.

• Warning: Check all bloodlines for kinking. Improper blood flow may cause hemolysis of the blood.

• Warning: Infusing recirculated saline is not recommended. Use fresh, sterile saline, if required.

Flush saline instructions:

1. Remove Tape 5 2. Disconnect arterial line from Drain Bag and connect to arterial access 3. Remove Tape 6 4. Disconnect venous line from Drain Bag and connect to venous access 5. Open bloodline clamps at the patient ends of the arterial and venous bloodlines and

open both access line clamps 6. Open heparin line clamp 7. Infuse bolus if prescribed 8. Touch the Done button to go to the next screen.

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Section 22 – Start Treatment (Tx Connect) Main learning concepts: Initiating prescribed blood flow rate while monitoring tolerance of the vascular access, acceptable machine pressures (arterial, venous, and TMP) and any blood alarms. Initiating treatment. Calculating TMP using UF Rate displayed on “Home” screen and Dialyzer Coefficient or KUF from dialyzer instruction sheet. Key terms: Blood pump, Pump Speed, Tx Paused, Tx Running, Arterial Pressure, Venous Pressure, Transmembrane Pressure (TMP), KUF, dialyzer ultrafiltration coefficient. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Demonstrate how to begin their treatment by setting the blood pump speed and then starting the Blood Pump and slowly raising the speed to the prescribed blood flow rate

2. Turn on the Tx Clock (Tx Running) 3. Restate how to adjust the level of the arterial drip chamber 4. Explain importance of arterial, venous, and TMP pressure and associated alarm

windows 5. Explain importance of having enough concentrate for the entire treatment 6. Calculate approximate expected TMP using the following equation:


• Warning: The Level Adjust ( ) key can only raise the blood level in the arterial drip chamber. Do not raise the level so high that the transducer protector becomes wet. Wet transducer protectors must be replaced. Failure to do so may cause injury or death.

• Warning: Keep fingers clear of the blood pump rotor when it is running. Serious injury may occur.

• Warning: Check all bloodline connections for leaks after your treatment has started. Improper bloodline connections could cause blood loss and death. Keep your access site uncovered.

• Caution: If you run out of concentrates during treatment, turn the dialysate flow pumps off before replacing a jug. The pumps must be off to avoid drawing air into the system, as it can cause dialysate concentrate pump errors. To turn off dialysate flow in the dialysis “Home” screen: Touch the Dialysate Flow button to highlight it, and then use the Down Arrow ( ) key on the data entry keypad to set the button to “Off.” Press the CONFIRM key to confirm the selection. Turn dialysate flow back on to your prescribed rate when you resume treatment.

UF Rate

Dialyzer Coefficient or KUF = Approximate

Expected TMP

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• Warning: Dialysate leaks in the dialyzer will add to your ultrafiltration rate. Watch the system for fluid leaks. Stop your treatment if you cannot correct any fluid leak quickly. Failure to do so may cause serious injury or death.

• Warning: When blood flow is established, check the bloodlines for air. Air must not enter your access lines.

• Warning: The pressure changes from an access line separation or needle dislodgement may be too small for your machine to detect. All access sites and connections must be uncovered, properly, secured and checked regularly. Failure to do so may cause serious injury or death.

• Warning: After starting dialysis, calculate to see if the TMP corresponds to the dialyzer’s ultrafiltration coefficient (KUF). TMP must be closely monitored with the alarm limits. The TMP may not change substantially during UF errors when high permeable dialyzers are in use. A fluctuating TMP may indicate a leak in the dialysate side of the system. Some, but not all, UF errors can be checked by measuring the volumetric accuracy of the UF pump via the fluid sample port using a graduated cylinder. If the cause cannot be corrected quickly, discontinue treatment.

• Warning: After starting dialysis, calculate to see if the TMP corresponds to the dialyzer’s ultrafiltration coefficient (KUF). TMP must be closely monitored with the alarm limits. The TMP may not change substantially during UF errors when high permeable dialyzers are in use. A fluctuating TMP may indicate a leak in the dialysate side of the system. Some, but not all, UF errors can be checked by measuring the volumetric accuracy of the UF pump via the fluid sample port using a graduated cylinder. If the cause cannot be corrected quickly, discontinue treatment.

Starting the blood pump instructions:

1. Set the blood pump speed and turn the blood pump on. Gradually increase speed to prescribed blood flow rate.

2. Touch the Tx Paused button and press CONFIRM to start treatment (Tx Running) 3. Explain importance of arterial, venous, and TMP pressure and the associated alarm

windows 4. Touch the Done button to go to the “Home” screen


Section 23 – Monitoring the Treatment (Home Screen)

Main learning concepts: Monitoring arterial, venous, and TMP pressures, monitor Dialogue Box for most recent blood pressure and heart rate, and use of Screen Sleep button to darken screen like a screen saver. Key terms: Arterial Pressure, Venous Pressure, Transmembrane Pressure (TMP), Dialogue Box, and Screen Sleep button—Method to darken the display. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Identify important readings on the Dialysis Home Screen, including the transmembrane pressure (TMP), arterial and venous pressures, the blood pressure and the heart rate

2. Demonstrate how to darken the dialysis “Home” screen Critical warnings, cautions and notes:

• Warning: The values shown here are for example only. You must use the values prescribed by your doctor. If you use the wrong values, it may cause serious injury or death.

• Warning: Your dialysate flow must be monitored. The flow must be set to your prescribed flow rate. Without proper dialysate flow, your machine cannot remove enough waste from your blood. This may cause injury.

Monitoring the Treatment Instructions:

1. Explain how parameters can be adjusted on the “Home” screen, if required 2. Monitor the bloodline connections, arterial, venous, and TMP pressures; DO NOT allow

concentrates to run out during treatment 3. Measure and document patient’s vital signs according to home program protocol 4. Address Alarm and Warning messages without delay

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Section 24 – Ending the Treatment Main learning concepts: Adherence to prescription and treatment procedures Following correct sequence of actions when UF Goal is reached. Interpretation of machine indicators for end of treatment, preparing for appropriate bloodline disposal Key terms: UF Goal, Tx Time, fluid overload, Status Box, recirc connector, shunt door, shunt interlock Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize their understanding of how they know their treatment is completed and how to begin the end of treatment procedure


• Warning: The UF Goal Reached alert is an important feature of the 2008K@home hemodialysis machine. Reaching the prescribed UF Goal is important. If the patient does not reach their prescribed UF Goal, it may lead to fluid overload, serious injury and death.

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Section 25 – Check Saline (Tx End) Main learning concepts: Adherence to treatment procedures. Identification of correct fluid volume in a plastic bag using milliliters. Calculating the required amount of saline required to return the blood in the extracorporeal circuit based on the priming volume of the bloodlines and the dialyzer, identifying which clamps are used for the procedure. Replacing the saline bag if not enough fluid is left to complete blood return. Key terms: Saline, rinse back Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Evaluate the amount of saline left in the saline bag and determine if it is enough to rinse back the blood in the extracorporeal circuit. If not, demonstrate using aseptic technique, how to hang a fresh bag of saline.

Critical warnings, cautions and notes: Check saline bag for adequate volume and change if necessary. Check saline instructions:

1. Stop blood pump. 2. Check saline bag volume and change if necessary. 3. Close arterial clamps. 4. Close both saline line clamps. 5. Touch the Done button to go to the next screen.

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Section 26 – Return Blood (Tx End) Main learning concepts: Adherence to treatment procedures, maintaining aseptic technique, identifying which clamps are used for the procedure, and making secure connections to avoid leaks. Key terms: Arterial access line, patient end of the arterial line, recirc connector, and Optical Detector.


1. Restate and demonstrate the steps required to return their blood 2. Identify the sensor that detects blood remaining in the bloodline


• Warning: Check all bloodlines and dialysate lines for leaks. Keep access sites uncovered and monitored. Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury and death. Machine alarms may not occur in every blood loss situation.

Return blood instructions:

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1. Connect arterial line to red recirc connector 2. Open clamps R & A 3. Start blood pump to return blood 4. Touch the Done button to go to the next screen


Section 27 – Disconnect (Tx End) Main learning concepts: Adherence to procedures. Use aseptic technique when disconnecting from access and performing access care. Key terms: Venous patient line, venous access line, access site, and infection Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Restate and demonstrate how to disconnect the bloodlines from the blood access. Critical warnings, cautions and notes:

• Warning: You must wait until the blood pump is stopped before completing the disconnect (Tx End) steps.

Disconnect instructions:

1. After blood pump has stopped, close clamp on saline line 2. Close clamp on Arterial bloodline 3. Disconnect patient end of the venous line from the venous access line 4. Disconnect from access 5. When these steps are completed, touch the Done button to go to the next screen.

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Section 28 – Emptying (Tx End) Main learning concepts: Adherence to procedures. Key terms: Priming set, red and blue recirc connector, venous line, rotate dialyzer, shunt, and shunt interlock Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Restate and demonstrate the steps to complete the end of treatment procedures. Emptying instructions:

1. Disconnect the saline line and bag from the bloodlines. 2. Connect the arterial and venous lines together with the red and blue recirc connector. 3. Open the arterial and venous line clamps. 4. Rotate the dialyzer so the venous line is on top. 5. Open the shunt door, take the blue dialysate line off the dialyzer and connect the blue

dialysate connector to the shunt interlock. 6. Close the shunt door. 7. When the dialysate compartment is empty, touch the Done button to go to the next

screen. Critical warnings, cautions and notes:

• Caution: Do not forcefully pull the lines from your machine. Damage to your machine or its sensors may result. Open the pump door and press the Start/Stop key on the Blood Pump module (see Your K Map: ‘D’) to re-align the rotor so you can remove the bloodline more easily. Rotate the Optical Detector door open before taking the line from the Venous Clamp.

• Warning: Keep fingers clear of the blood pump rotor when it is running. Serious injury may occur.

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Section 29 – Cleansing (Tx End) Acid Clean and Heat Disinfect; Acid Clean, Chemical Disinfect and Rinse Main learning concepts: Difference between rinsing, cleaning and disinfecting the dialysis machine, difference between cleaning and disinfecting schedule, appropriate cleaning and disinfecting agents, preparation of dilute (1:100) bleach solutions, cleaning of the machine’s exterior, cleaning of the blood pressure cuff, transducer contamination policy, disinfection of the concentrate containers, explaining “Put connectors in chem”, explaining “Put Connectors to ports”, testing for negative bleach residual according to unit policy, explaining purpose of rinsing, cleaning and disinfecting. Key terms: Cleaning, disinfecting, acid clean, heat disinfection, rinsing, vinegar, rinse cycle, chemical disinfectant jug, rinse port, corrosive, and rotor Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize their understanding of the importance of cleaning their machine according to the procedures recommended by their clinic

2. Restate the types of cleaners that should and should not be used in and on their machine

3. Demonstrate how to return the connectors to the ports and put the red dialysate connector into the shunt, all with tight connections.

4. Restate and demonstrate how to clean the outside of the machine and the blood pressure cuff

5. Demonstrate an acid cleaning procedure and a heat disinfection procedure 6. Explains the importance of the bleach test strip being negative after a chemical

disinfection 7. Explain why the cleaning and disinfection screen prompt (pop-up) on the “Select

Program” screen would be displayed and how to clear the message. Critical warnings, cautions and notes:

• Warning: Your clinic must decide your cleaning procedures. Failure to follow your clinic’s procedures could lead to serious injury or death. Thoroughly cleaning the exterior of your 2008K@home machine after every treatment is critical to prevent the spread of bacteria and viruses like Hepatitis. Use surface cleaners in small amounts to avoid excess cleaner from getting into your machine. Rinse off cleaning solutions with a water-dampened cloth, especially if a corrosive cleaner such as bleach is used.

• Caution: Do not use foaming type cleansers or disinfectants containing quaternary ammonium compounds like N-alkyl (C12 – C18) dimethyl benzyl ammonium chloride. These chemicals attack the polycarbonate plastics used in your machine. Read the product labels and follow the instructions. Call Technical Services or your clinic if you have questions.

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• Warning: Bent or loose tubing guide posts can damage bloodlines. Replace rotor if necessary.

• Warning: Disinfect your machine immediately after your treatment if a blood leak alarm occurs.

• Warning: When chemicals are used inside your machine, it must be thoroughly rinsed and tested for remaining disinfectant before your next treatment. Your machine must be labeled with the chemical used and instructions to rinse and test for remaining chemicals. Rinsing your machine does not disinfect your machine. Acid cleaning does not disinfect the machine. Test your machine for remaining disinfectant before starting your treatment after a chemical disinfection.

• Warning: Do not come into contact with the steam from your machine’s vent during heat disinfection. Steam and machine parts affected by heat disinfection will be hot and can cause burns.

• Note: Your machine must be connected to an approved water source, the drain line connected to a drain, the dialysate supply lines on the shunt interlock with the shunt door closed, and the concentrate connectors tightly seated in their rinse ports to run these programs.

• Caution: Do not use chlorine solutions or high-temperature steam-cleaners on the blood pressure cuff. If using a chemical soak, test a small area of the cuff for possible staining. Rinse well to remove any remaining disinfectant. When machine washing, be sure that the hook and loop fasteners are connected so the hooks do not collect lint or other fibers. The fasteners can melt at temperatures above 132°C (325°F), when being ironed or pressed. Follow the manufacturer’s instructions.

Cleansing (Tx End) instructions:

1. Return red dialysate connector to shunt. 2. Discard bloodline circuit. 3. Return blue bicarbonate connector to port. 4. Return red concentrate connector to port. 5. Touch the Done button to go to the next screen.

Acid Clean and Heat Disinfect instructions:

1. Return acid and bicarb concentrate connectors to machine ports. The “Select Program” screen will appear.

2. Touch the Acid Clean button; the lines will be rinsed. 3. “Put connectors in chem” message will appear. Connect acid concentrate connector to

acid and bicarb connector to vinegar. 4. Press CONFIRM to start. 5. When completed, the message “Put Connectors to ports” will appear. Put acid and

bicarb connectors into respective ports and CONFIRM to exit. 6. Touch the Heat Disinfect button. 7. Machine will shut itself off when done if the “Off After Heat Disin” option is set in Service

Mode. If not, press CONFIRM and then press and hold POWER key to turn off machine after the heat disinfect.

Acid Clean, Chemical Disinfect and Rinse Instructions:

1. Return acid and bicarb concentrate connectors to machine ports. The “Select Program” screen will appear.

2. Touch the Acid Clean button; the lines will be rinsed.


3. “Put connectors in chem” message will appear. Connect acid concentrate connector to acid and bicarb connector to vinegar.

4. Press CONFIRM to start. 5. When completed, the message “Put Connectors to ports” will appear. Put acid and

bicarb connectors into respective ports and CONFIRM to exit. 6. Touch the Chemical/Rinse button. 7. “Put Red wand in chem.” message will appear. Connect acid concentrate connector to

disinfectant container (yellow connector bottle) and press CONFIRM. 8. When completed, the message “Return Connector in port” will appear. Return Acid

concentrate connector to machine port and machine will initiate a 15 minute mandatory rinse.

9. Test for negative bleach residual according to unit policy. DO NOT interrupt the mandatory rinse cycle. This MUST be completed. Press and hold POWER key to turn off machine once test for bleach is negative.


Section 30 – Troubleshooting Alarms Introduction: Your 2008K@home machine has an advanced system of features that work for your safety. Electronic sensors and diagnostic software constantly monitor your machine’s operation. When problems or possible problems are detected, your machine warns you with Status Box messages and, in some cases, audible alarms. Audible alarms are deactivated when dialyzer supply lines are on the shunt interlock and/or the Tx Clock is running, unless blood is sensed. Your 2008K@home machine may be set to silence all audible alarms until blood is sensed in the venous line. When selected, the audible alarms occur only if the dialysate lines are off the shunt interlock and the optical sensor in the level detector module senses blood. This option is set in Service Mode by a qualified technician and is selected by your clinic. Otherwise, alarms are always audible when dialysate lines are off the shunt interlock. During an alarm, the Status Box background turns bright red and an audible alarm sounds. The Help screen-button in the lower right corner of the display may flash if additional information on troubleshooting the problem is available. For alarm procedures, use the troubleshooting section of this manual and as listed in the user’s guide. Main learning concepts: Prioritizing alarms, what alarms indicate, correct order of response steps, troubleshooting alarms Key terms: Status Box, Dialogue Box, Blood Alarms, Dialysate Alarms, Other Alarms, Troubleshooting, Reset, Override, Mute, Help screen-button, alarm, alarm window, warning Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a blood alarm, demonstrating how to reset the alarm and adjust the alarm limits

2. Troubleshoot potential causes of the alarm and solutions by referring to the alarms troubleshooting section of the 2008K@home User’s Guide and/or using your machine’s built-in “Help” screen.

3. Verbalize understanding of the importance of promptly addressing the alarm and the potential consequences of not addressing it

Critical warnings, cautions and notes: All alarms need your immediate attention. Failure to do so may cause serious injury or death. Your machine may not alarm with all blood loss situations. Your access site must be uncovered, properly secured, and checked regularly throughout the dialysis treatment. Failure to do so may lead to excessive blood loss which can cause serious injury or death. You must correct the condition causing a blood alarm before clearing the alarm. Reacting to Alarms The Mute and Reset keys on the 2008K@home control panel are used in the course of handling most alarms:

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• Mute: Press the Mute key to silence an alarm for two minutes or until another alarm event occurs. The red light above the key illuminates when an alarm is muted.

• Reset: Press the Reset key to reset the machine after an alarm. Press and hold the Reset key for two seconds to spread the alarm window by 300 mm Hg for arterial and venous pressures and fully open the transmembrane (TMP) pressure window for 30 seconds. The light above the Reset key will not be on when the alarm window has been spread.

Types of Alarms There are three categories of alarms: 1. Blood Related Alarms Blood alarm events have the highest priority. When a blood alarm occurs:

• The blood pump stops. • The venous clamp on the level detector occludes. • The UF pump stops. • RTD stops

During a blood leak alarm, press and hold the RESET key for three seconds to override the alarm and keep the blood pump running for three minutes. The light above the RESET key will be on during an override. 2. Dialysate Related Alarms During a dialysate alarm (temperature or conductivity), the blood system continues to operate, but the dialysate is run through the machine instead of the dialyzer. This is called ‘bypass’ and can be observed by watching the float in the dialyzer supply line. During bypass, the float will remain still at the bottom of the flow indicator. Contrarily, a high or low flow error will not cause the machine to go into bypass. Dialysate alarms are self-resetting when the alarm condition is corrected. Temperature and conductivity alarms do not occur during the pure UF mode of sequential dialysis when there is no dialysate flow. 3. Other Alarms Other alarms may relate to machine parts like the heparin pump or UF pump, BPM, BVM, BTM, etc. Troubleshooting The 2008K@home User’s Guide contains a table of all alarms the machine’s software can detect. Your 2008K@home machine is also equipped with a 9-Volt battery that sounds an alarm if the power fails. The power failure procedure is contained in the Alarms and Troubleshooting section of the 2008K@home User’s Guide. Other potentially hazardous situations that may go undetected such as fluid spills/leaks or damage to the machine must be observed by the operator. Be sure to resolve all problems quickly.


Section 31 – Troubleshooting Specific Blood Alarms and Dialysate Alarms 1. Air Detector Alarm Main learning concepts: Air is sensed by the ultrasound detector at the venous drip chamber, the status line populates with ‘Air Detector Alarm’ and the blood pump stops to prevent air from being delivered to the patient. Key terms: Status box, venous drip chamber, reset button, ultrasound detector, sensors, bloodline Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of an air detector alarm, demonstrating how to reset the alarm and adjust the alarm limits

2. Troubleshoot potential causes of the alarm and solutions by referring to the alarms troubleshooting section of the 2008K@home User’s Guide

3. Verbalizes understanding of the importance of promptly addressing the alarm and the potential consequences of not addressing it

Critical warnings, cautions and notes: Machine’s level detector module must be calibrated for the venous line being used. The machine is compatible with a number of venous lines, Follow instructions for adjusting the level in the venous drip chamber. Visually check that the venous clamp is capable of fully closing the model of bloodline you are using. Failure to do so may cause serious injury or death. The air detector alarm is a critical safety feature that alerts the user of potential air in the bloodline. You must properly place the venous drip chamber in its holder and set the proper blood/saline level in the venous drip chamber. Avoid overfilling. Please contact your physician if you have any questions about the proper operation of the air detector or how to attach the venous bloodline. 2. Blood Pump Stop Alarm Main learning concept: a stopped blood pump increases the risk of the dialyzer clotting that will result in blood loss and decreased adequacy Key Terms: blood pump door, blood pump segment, hand crank Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a blood pump stop alarm, demonstrating how to reset the alarm

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Critical warnings, cautions and notes: A sustained blood pump stoppage can contribute to a clotted extracorporeal system 3. Arterial Pressure Alarm - LOW Main learning concepts: the pressure inside the arterial drip chamber is below the set alarm limits indicating kinking, clotting or line obstruction, access spasms, occlusions at the tip of the needle caused by patient movement. Key Terms: Arterial drip chamber, access, blood pump, transducer protector, RESET key Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a low arterial pressure alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: Inadequate dialysis will result with decreased blood flow. 4. Arterial Pressure Alarm - HIGH Main learning concepts: The pressure inside the arterial drip chamber is above the set alarm limits indicating a potential problem with the access being able to deliver the blood flow as set on the blood pump or there may be kinking or clotting within the extracorporeal system Key Terms: Arterial drip chamber, access, blood pump, transducer protector, RESET key Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a high arterial pressure alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: Hemolysis can occur when the arterial pressure is indicating that the access cannot supply the blood required by the blood pump.


5. Venous Pressure Alarm – LOW Main learning concepts: Low pressure is detected in the venous drip chamber that may indicate a kink in the line that could result in hemolysis or a line separation that could introduce air into the system in addition to blood loss. Key Terms: Venous chamber, transducer protector, RESET Key Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a low venous pressure alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: If hemolysis occurs do not return hemolyzed blood to the patient. 6. Venous Pressure Alarm - HIGH Main learning concepts: High pressure is detected in the venous drip chamber that may indicate a kink in the line that could result in hemolysis or a line separation that could introduce air into the system in addition to blood loss. Key Terms: Venous drip chamber, transducer protector, RESET key Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a high venous pressure alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: In case of a line separation the patient could exsanguate (bleed to death) or receive an air emboli (air entering the blood vessels). These are very serious complications and may cause severe injury or death. 7. TMP Alarm - Low (toward or below 0) Main learning concepts: Transmembrane Pressure (TMP) is the difference in pressure between the filtrate and permeate sides of the dialyzer membrane. TMP = Dialysate Pressure – Venous Pressure


Key terms: TMP, ultrafiltration coefficient (KUF), dialysate pressure, Ultrafiltration rate, blood flow rate, dialysate flow rate, dialysate line filter screen, UF Goal Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a low TMP alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: To keep dialysate from moving into the bloodstream, blood compartment pressure must be equal to or greater than dialysate compartment pressure

• Warning: Verify that that the TMP corresponds to the ultrafiltration coefficient (KUF) of the dialyzer. TMP must be closely monitored with the alarm limits. The TMP may not change substantially during UF errors when high permeable dialyzers are in use. A fluctuating TMP may indicate a malfunction in the balancing system and could result in UF errors and/or serious injury. If unable to reset alarm, discontinue treatment and notify home training nurse and/or a qualified technician.

8. TMP Alarm - High (Toward 500) Main learning concepts: Transmembrane Pressure (TMP) is the difference in pressure between the filtrate and permeate sides of the dialyzer membrane. TMP = Dialysate Pressure – Venous Pressure and are dependent on the Ultrafiltration rate, ultrafiltration coefficient (KUF) of the dialyzer, and the blood and dialysate flow rate. Key Terms: TMP, ultrafiltration coefficient (KUF) dialysate pressure, ultrafiltration rate, blood flow rate, dialysate flow rate, dialysate line filter screen, UF Goal Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a high TMP alarm, demonstrating how to reset the alarm and adjust the alarm limits



Critical warnings, cautions and notes: To keep dialysate from moving into the bloodstream, blood compartment pressure must be equal to or greater than dialysate compartment pressure

• Warning: Verify that that the TMP corresponds to the ultrafiltration coefficient (KUF) of the dialyzer. TMP must be closely monitored with the alarm limits. The TMP may not change substantially during UF errors when high permeable dialyzers are in use. A fluctuating TMP may indicate a malfunction in the balancing system and could result in


UF errors and/or serious injury. If unable to reset alarm, discontinue treatment and notify home training nurse and/or a qualified technician.

9. Fill in One Hour Alarm Main learning concepts: Frequent fill programs may mean air is in the balancing system, some, but not all UF errors can be checked by measuring the volumetric accuracy of the UF pump via the fluid sample port. Key terms: Balancing, dialysate Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a fill in one hour alarm, demonstrating how to reset the alarm




• Warning: This alarm may indicate a leak in the hydraulic system. Check for loose connections or for air entering the system. Failure to correct this alarm could result in inadequate fluid removal. If unable to correct alarm, notify home training nurse and/or a qualified technician.

10. Blood Leak Alarm Main learning concepts: The blood leak detector has detected the presence of blood or air in the dialysate. This may be caused from an air leak especially at the connectors and the filter or a break in the fibers of the dialyzer. If this occurs, the patient could have major blood loss and/or the blood could be contaminated by the nonsterile dialysate. Key Terms: Blood leak detector, Hemastix Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a blood leak alarm, demonstrating how to reset the alarm



Critical warnings, cautions and notes: Positive blood leak can result in the patient blood coming in contact with nonsterile dialysate and could develop sepsis or hemolysis

• Warning: Follow facility’s blood leak policy. Reinfusing blood after a confirmed blood leak may result in sepsis. Failure to heed to a blood leak alarm could result in blood loss.


All alarms need your immediate attention. Failure to do so may result in serious injury or death.

11. Conductivity Alarm – Low Main learning concepts: Conductivity is the ability of a fluid to transfer electrical charge. It is a measure of ions in solution, the conductivity meter measures the electrolyte composition of dialysate to be sure it is within safe limits, a conductivity alarm Low, means the actual of measured conductivity has exceeded the low conductivity alarm limit and the machine is in bypass. Bypass is a safety feature that cuts off the flow of fresh dialysate to the dialyzer and shunts it to the drain. Bypass prevents unsafe dialysate from reaching the patient and causing harm. Key words: Bypass, conductivity, dialysate Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a low conductivity alarm, demonstrating how to reset the alarm



Critical warnings, cautions and notes: The conductivity alarm is an important safety feature of your dialysis treatment. You must fill your concentrate jugs to the top at the beginning of each treatment. During treatment you must keep your jugs full enough so you do not run low on concentrate. Failure to change your jugs when they run low will prevent you from receiving your prescribed dialysis and may lead to serious injury or death

• Warning: Check conductivity and approximate pH of the dialysate with an independent device prior to initiating treatment. Verify that the machine is set for the correct type of concentrates used. Improper dialysate composition could result in serious injury or death. Verify that the machine goes into bypass when this alarm occurs. See Alarms and Troubleshooting Section of the user’s guide. If unable to reset alarm, discontinue treatment and notify home training nurse and/or a qualified technician.

12. Conductivity Alarm – High Main learning concept: Conductivity is the ability of a fluid to transfer electrical charge. It is a measure of ions in solution, the conductivity meter measures the electrolyte composition of dialysate to be sure it is within safe limits, a conductivity alarm High, means the actual of measured conductivity has exceeded the high conductivity alarm limit and the machine is in bypass. Bypass is a safety feature that cuts off the flow of fresh dialysate to the dialyzer and shunts it to the drain. Bypass prevents unsafe dialysate from reaching the patient and causing harm. Key Terms: Bypass, conductivity


Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a high conductivity alarm, demonstrating how to reset the alarm




• Warning: The conductivity alarm is an important safety feature of your dialysis treatment. You must fill your concentrate jugs to the top at the beginning of each treatment. During treatment you must keep your jugs full enough so you do not run low on concentrate. Failure to change your jugs when they run low will prevent you from receiving your prescribed dialysis and may lead to serious injury or death

• Warning: Check conductivity and approximate pH of the dialysate with an independent device prior to initiating treatment. Verify that the machine is set for the correct type of concentrates used. Improper dialysate composition could result in serious injury or death. Verify that the machine goes into bypass when this alarm occurs. See Alarms and Troubleshooting Section of the 2008K@home User’s Guide. If unable to reset alarm, discontinue treatment and notify home training nurse and/or a qualified technician.

13. Temperature Alarm - High Main learning concepts: A temperature alarm indicates that the dialysate temperature is too high or too low. Dialysate that is too hot can cause hemolysis, Key terms: Hemolysis Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a high temperature alarm, demonstrating how to reset the alarm



Critical warnings, cautions and notes: Hemolysis of the blood in the dialyzer may occur if the dialysate temperature goes higher than 42 C. Dialysate temperatures must be maintained below this level, do not return hemolyzed blood.

• Warning: High dialysate temperature could result in patient discomfort, hypotension and/or hemolysis. Verify that the machine goes into bypass. Check that the machine is set to the prescribed temperature. Discontinue treatment if unable to maintain prescribed temperature and notify home training nurse and/or a qualified technician.


14. Temperature Alarm – Low Main learning concepts: A temperature alarm indicates that the dialysate temperature is too hot or too low. Too cool dialysate can cause patient discomfort and reduce the efficiency of the treatment Key terms: Dialysate Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a low temperature alarm, demonstrating how to reset the alarm



Critical warnings, cautions and notes: Frequent temperature or water flow alarms may indicate a problem with the water supply

• Warning: Low dialysate temperature could result in patient discomfort. Verify that the machine goes into bypass. Check that the machine is set to the prescribed temperature. Discontinue treatment if unable to reach prescribed temperature and notify home training nurse and/or a qualified technician.

15. Dialysate Flow Alarm Main learning concepts: Can cause the machine to go into bypass affecting the adequacy of the delivered dose of dialysis, potential for dialyzer clotting Key terms: Delivered dose of dialysis, dialyzer clotting Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a dialysate flow alarm, demonstrating how to reset the alarm



Critical warnings, cautions and notes: Frequent dialysate alarms will result in the patient not receiving their delivered dose of dialysis. Please contact your physician and a qualified service technician. 16. Heparin Pump Alarm

Main learning concepts: Heparin is a blood thinner (anticoagulant) used during dialysis so blood will flow freely through the extracorporeal circuit. The heparin pump consists of a syringe


holder, a piston and an electric motor used to continuously deliver precise amounts of heparin during dialysis. Key terms: Heparin, anticoagulant, extracorporeal circuit, syringe, piston Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Verbalize what to check and do in the event of a heparin pump alarm, demonstrating how to reset the alarm




• Warning: Only use syringes prescribed by your doctor in the Heparin Pump module. Make sure that there is enough heparin for your entire treatment. Do not load the syringe beyond your prescribed amount.

• Warning: The heparin pump is to be used only under positive pressure conditions. Under negative pressure conditions, too much heparin may be infused.

• Warning: You must select your prescribed syringe to accurately add heparin during the treatment.

• Caution: The syringe must be properly loaded for your machine to add heparin during treatment.

• Warning: If you do not enter a “Stop Heparin” value, the heparin pump will run at the selected rate until the syringe is empty or your treatment is over. The heparin pump should be monitored to make sure of proper heparin infusion.

17. Online PHT Failed Alarm

Main learning concepts: The online Pressure Holding Test (PHT) automatically checks the 2008K@home machine’s dialysate balancing system. The PHT runs only during dialysis when the dialyzer is connected. The online PHT runs about every 12 minutes regardless of other alarm conditions. During the test, the Status Box displays the message: “Running Online PHT.” The UF light above the UF on/off key also flashes. The test will run for about seven seconds as the balancing chamber runs through two cycles. During the test, your machine is in bypass mode and the TMP alarm limits are spread. If your machine fails an online PHT (pressure holding test), the Status Box displays the alarm message: “Online PHT Failed.” This alarm does not stop the blood pump. Key terms: online Pressure Holding Test, PHT, UF on/off key, balancing chambers, dialyzer, cycle Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:


1. Verbalize what to check and do in the event of an Online PHT Failed alarm, demonstrating how to reset the alarm

2. Troubleshoot potential causes of the alarm and solutions by referring to Chapter 6: Emergencies and Alarms and the alarms troubleshooting section of the 2008K@home User’s Guide



• Warning: If an online PHT failure recurs, you must stop your treatment and have a qualified technician test the hydraulics.

• Note: The online pressure holding test is not a substitute for the self-test. Do not begin dialysis until the self-test has been run.


Section 32 – Potential Problems During Dialysis Main learning concepts: This section is to provide a general guide to some treatment complications. Identifying and reporting clinical signs, symptoms or other problems is a crucial portion of training. This must be emphasized and stressed repeatedly. Review and discuss the signs, symptoms and response to potential treatment problems including chest pain and shortness of breath. Stress the importance of reporting any problems to the patient’s physician and home RN. Please refer to Appendix D for further information on complications of hemodialysis. Key terms: Hypotension, leg cramps, arrhythmias, seizure, air embolism, hemolysis, crenation, infiltration, blood loss, allergic reaction, steal syndrome, edema Recommended return demonstration: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to:

1. Describe signs and symptoms associated with common intradialytic complications and when these should be reported to the home dialysis nurse

2. Explain how to check for edema 3. Describe what to do to manage potential complications as described in Appendix D


• Warning: Failure to report potential problems or complications promptly to your physician can result in severe injury or death.

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Section 33 – Returning the Blood Manually – Handcranking Main learning concepts: During a power failure the blood pump stops and the venous clamp closes. The dialysate flow pump, heater, blood leak detector and level detector are non-functional. All machine lights go out and a steady, audible alarm will sound for seven minutes. The alarm cannot be silenced with the Mute key. The blood pump can be manually operated to immediately return the blood to the patient, or, if power is expected to return soon, to keep the blood in circulation. It is imperative that the learner familiarizes himself with the steps necessary to immediately return the blood manually or, if power is expected to return soon, to keep the blood in circulation. Reference the procedure noted in the user’s guide.

Key terms: Arterial access bloodline, arterial line, arterial line clamp, blood leak detector, blood pump, blood pump door, crank handle, detachable handle, dialysate flow pump, emergency hand crank, hand crank spindle, handle knob, heater, latch door, level detector, recirc

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connector, rotor, rotor latch, rotor latch slot, saline bag, venous bloodline, venous chamber, venous clamp. Recommended return demonstration: Locating emergency hand crank on back of machine, ensuring sufficient saline is available for rinseback of blood (equal to at least the priming volume), removing venous line from venous clamp (otherwise the line will remain clamped), closing arterial clamps, disconnecting arterial access bloodline, connecting arterial line to saline bag and opening clamps, opening latch door and flipping rotor latch outward, lining up hand crank with rotor, sliding hand crank into place, rotating hand crank six to ten revolutions per minute, disconnecting venous line when blood has returned. Critical warnings, cautions and notes:

• Caution: Do not forcefully pull the lines from the machine. Damage to machine or sensors may result.

• Note: As a precaution, the handle knob will detach from the crank if you attempt to turn the rotor in the wrong direction. An arrow stamped on the blood pump module, above the rotor, points in the correct clockwise direction of rotation.

• Warning: Carefully watch the venous chamber and bloodline for air intakes. Be sure no air enters the patient access/circulation.

• Warning: Keep fingers clear of the blood pump rotor when it is turning as serious injury may occur.

• Note: During power failure, the machine safety systems are inactive. All machine lights go out and a steady audible alarm will sound for seven minutes.


Section 34 – Potential Problems During Dialysis Main learning concepts: Testing of the Diasafe Plus Filter, how to perform the Pressure Holding Test (PHT), what to do if PHT fails. Key terms: Pressure Holding Test (PHT), Diasafe Test Recommended return demonstrations: The patient must demonstrate how to perform the Pressure Holding Test and verbalize troubleshooting for failed PHT test. Critical warnings, cautions and notes:

• Warning: If your machine fails any of the tests and the cause cannot be corrected, or if it fails later tests, it should not be used for treatment. Have your machine checked by a qualified technician to correct the problem.

• Warning: After replacing the Diasafe Plus filter, run a Heat Disinfect to disinfect your machine.

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Section 35 – Replacing the Diasafe Plus Filter Main learning concepts: Identification and purpose of the Diasafe Plus Filter, how and when to replace the filter. Key terms: Diasafe Plus Filter, ultra-pure dialysate Recommended return demonstrations: The patient must demonstrate the location of the Diasafe Plus Filter on the hemodialysis machine; demonstrate the removal of the old filter and subsequent replacement with a new filter. Critical warnings, cautions and notes:

• Warning: You must still routinely monitor the chemical and bacterial water quality. • Caution: Before inserting the new filter in your machine, remove the plastic tabs on the

Diasafe Plus filter inlet and outlet. The Diasafe Plus filter can only be used in Fresenius hemodialysis machines fitted with Diasafe Plus Diafix lock system kits.

Instructions for replacing the Diasafe plus filter:

1. Lift lock levers on the left side of the filter mount 2. Slide the old Diasafe Plus filter up and out 3. Fit the new Diasafe filter into the groove in the top of the mount. Slide the filter down until

it snaps into place 4. Push the lock levers down to lock the filter into the mount.

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Section 36 – Overview of Warnings and Cautions It is important that home operators are understand the warnings in the 2008K@home User’s Guide. These should be reviewed individually by the home training nurse. Failure to appropriately follow the warnings may result in patient injury or death. Some key warnings in the 2008K@home User’s Guide are listed below. A complete list of general warnings is included in the beginning of the user’s guide. Please refer to the user’s guide and review these warnings with patients as part of their training.

1. Machine Set-up: a. Warning: Make sure your machine is working correctly before beginning

your treatment. If you fail to respond to alarms, it may lead to serious injury or death.

b. Warning: You must properly match your concentrate type to your machine’s setup. Failure to do so may cause serious injury or death. Many different concentrate types are available for use in your machine. Concentrates contain various amounts of dextrose, potassium, calcium, sodium, chloride, magnesium, and bicarbonate.

c. Warning: Make sure your machine is working correctly before beginning your treatment. If you fail to respond to alarms, it may lead to serious injury or death.

d. Warning: Use of an acid concentrate intended for a 1:44 mix ratio in any 1:34 proportioning dialysate delivery machine may result in a dialysate solution with normal conductivity but without a physiological buffer (low pH). There will be no alarms in this event. Use of improper dialysate solutions may cause injury or death.

e. Warning: Your dialysate concentrate jugs must match the concentrate listed in the “Set up” screens. If you use the wrong dialysate solutions, it may cause serious injury or death. Fresenius Medical Care recommends using the concentrate containers provided with your machine to avoid mismatching containers.

f. Warning: Test the conductivity and approximate pH of the dialysate with an independent device before beginning treatment. Test it also when you change concentrates during your treatment. The wrong conductivity or pH may cause serious injury or death.

g. Warning: You must properly disinfect your machine and test for remaining disinfectant before every treatment day.

h. Warning: You must follow all local regulations covering the separation of devices in the water supply. In case of drain back up; you must maintain an air gap between your machine’s drain line and its drain.

i. Warning: Your machine’s Level Detector module must be calibrated for the venous line being used, your machine is compatible with a number of venous lines. Follow the instructions for adjusting the level in the venous drip chamber. Also, visually check that the Venous Clamp is capable of fully closing the model of bloodline you are using. Failure to do so may cause serious injury or death.

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j. Warning: Do not use your machine in the presence of flammable substances, like anesthetics, as it may cause explosions which may cause serious injury or death.

k. Warning: Do not use devices emitting strong electromagnetic radiation such as portable phones, radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment near your machine. Improper operation may result. Digital phones may be conditionally allowed. Discontinue use of any device if any interference is noted, such as false pressure readings that disappear when the external signal is removed.

l. Warning: You must use sterile transducer protectors between your machine and pressure monitor lines to prevent the transducers from getting wet. If transducer protectors become wet or contaminated with blood, they must be replaced. Wet transducers cause inaccurate pressure readings and may cause injury or death. Disinfect or replace associated parts. Clear monitor lines if they become wet.

m. Warning: Alarm limits for arterial and venous pressure monitoring, temperature, and conductivity must be maintained within safe physiological limits, prescribed by your doctor.

n. Warning: The air detector alarm is a critical safety feature that alerts the user of potential air in the bloodline. You must properly place the venous drip chamber in its holder and set the proper blood/saline level in the venous drip chamber. Avoid overfilling. Failure to follow the instructions in this user’s guide can result in severe injury or death. Please contact your physician if you have any questions about the proper operation of the air detector or how to attach the venous bloodline.

2. Proper hemodialysis prescription a. Warning: Your doctor must prescribe your entire hemodialysis treatment,

including all of the values listed on the “My Treatment Parameters” sheet. If you use the wrong values, it may cause serious injury or death. Do not use example values shown in machine pictures

b. Warning: Headaches and nausea can be caused by dehydration or too much volume removed during hemodialysis. You and your doctor must pay strict attention to the achievement of the prescribed dry weight.

3. Hemodialysis treatment: a. Warning: Check all bloodlines for leaks after your treatment has started.

Keep access sites uncovered and monitored. Bad bloodline connections or needles coming out can result in blood loss, serious injury and death. Machine alarms may not occur in every blood loss situation.

b. Warning: Check that all lines and tubing are free of kinks to prevent damage to your blood (hemolysis).

c. Warning: You must use sterile transducer protectors between your machine and pressure monitor lines to prevent the transducers from getting wet. If transducer protectors become wet or contaminated with blood, they must be replaced. Wet transducers cause inaccurate pressure readings and may cause injury or death. Disinfect or replace associated parts. Clear monitor lines if they become wet.

d. Warning: Alarm limits for arterial and venous pressure monitoring, temperature, and conductivity must be maintained within safe physiological limits, prescribed by your doctor.

e. Warning: Check that all lines and tubing are free of kinks to prevent damage to your blood (hemolysis).


f. Warning: The “UF Goal Reached” alert is an important feature of your 2008K@home hemodialysis machine. Reaching your prescribed UF Goal is important. If you do not reach your prescribed UF Goal, it may lead to fluid overload, serious injury and death. The supervising nephrologist and care team is responsible for adequate training and supervisions of hemodialysis and volume removal.

g. Warning: The 2008K@home has not been cleared by the FDA for nocturnal use.

h. Warning: Hemolysis of the blood in the dialyzer may occur if the dialysate temperature goes higher than 42°C. Dialysate temperatures must be maintained below this level. Do not return hemolyzed blood.

i. Caution: System leaks may occur. Unattended operation of the machine (for example, during disinfection at night) may result in flooding and can cause property damage. Clean up spills immediately.

j. Note: Keep emergency supplies near your machine at all times. Include a flashlight in case of power failure. Check the flashlight regularly for fresh batteries

4. Alarms and alerts a. Note: Arterial, venous, and transmembrane pressure monitor alarm limits

are automatically set and delayed for pressure to stabilize, but conductivity and temperature alarm limits are calculated for the dialysate composition and may be somewhat adjusted by the operator.

b. Warning: Repeated acid pump alarms may mean acid pump failure. If repeated acid pump alarms occur, stop your treatment and contact a qualified technician. Failure to replace a failed acid pump could cause serious injury.

c. Warning: The “UF Goal Reached” alert is an important feature of your 2008K@home hemodialysis machine. Reaching your prescribed UF Goal is important. If you do not reach your prescribed UF Goal, it may lead to fluid overload, serious injury and death. The supervising nephrologist and care team is responsible for adequate training and supervisions of hemodialysis and volume removal.

d. Warning: The air detector alarm is a critical safety feature that alerts the user of potential air in the bloodline. You must properly place the venous drip chamber in its holder and set the proper blood/saline level in the venous drip chamber. Avoid overfilling. Failure to follow the instructions in the 2008K@home User’s Guide can result in severe injury or death. Please contact your physician if you have any questions about the proper operation of the air detector or how to attach the venous bloodline.

e. Warning: Repeated acid pump alarms may mean acid pump failure. If repeated acid pump alarms occur, stop your treatment and contact a qualified technician. Failure to replace a failed acid pump could cause serious injury.

f. Warning: Repeated arterial and/or venous pressure alarms may mean poor blood flow or access problems. If you have frequent alarms or a change in alarm patterns, you should call your clinic. Frequent movement can trigger the alarm. Patients should refrain from unnecessary movement during dialysis.

g. Warning: The conductivity alarm is an important safety feature of your dialysis treatment. You must fill your concentrate jugs to the top at the beginning of each treatment. During treatment you must keep your jugs full enough so you do not run low on concentrate. Failure to change your jugs


when they run low will prevent you from receiving your prescribed dialysis and may lead to serious injury or death.

h. Warning: Frequent temperature or water flow alarms may indicate a problem with the water supply. Call a qualified technician if you have these problems.

5. Machine maintenance a. Warning: Only qualified people from your clinic may use Service Mode. Do

not make any changes to your machine with Service Mode. If you enter the wrong options or values, you may cause serious injury or death.

b. Warning: The water used for hemodialysis must be periodically tested to demonstrate that it meets AAMI standards. Your water must meet all standards to keep dialysate quality. Monitor the water source regularly to detect changes in quality. These changes could have an unfavorable effect on you or your machine. Regularly check for chemicals such as chlorine and chloramines. These chemicals can harm dialysis patients.

c. Warning: Do not use the 2008K@home machine in your home if you do not have a constant water supply with good pressure. Your water pressure must be at least 20 psi and no more than 105 psi.

d. Warning: Never perform maintenance when a patient is connected to your machine. If possible, remove your machine from the treatment area when it is being serviced. Label your machine to make sure that it is not accidentally returned to use before the service work is completed. Disinfect and test your machine when service is done. Test the dialysate for acceptable conductivity and pH values before use.

e. Warning: Do not install the 9-Volt battery backwards in your machine, it will damage your “No Power” alarm.

f. Warning: Shock hazard. Do not remove machine covers. Refer servicing to qualified personnel. The electrical source must be single phase, three-conductor type provided with a hospital grade receptacle and a ground fault interrupter at 120 Volts, 15 Amps, 60 Hz. The proper polarity and ground integrity must be initially checked and maintained. Plug your machine directly into the electrical outlet; do not use extension cords or power strips.

g. Caution: Only qualified people authorized by your clinic’s medical director or by Fresenius Medical Care may assemble, install, adjust, or repair your machine.


Section 37 – Servicing the Fresenius 2008K@home Machine The Fresenius 2008K@home machine must be serviced only by authorized and trained personnel. It must be emphasized that patients are not authorized to repair the machine and must contact an authorized person. Failure to follow these instructions can result in patient injury. Patients should be instructed on the availability of support services and provided with instructions both verbally and in writing regarding how to access and use these resources. The 2008K@home User’s Guide includes the following information for contacting technical services: Call Technical Support If you have any questions, please call Fresenius Medical Care Technical Support anytime at (800) 227-2572.

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APPENDIX A – GLOSSARY OF TERMS AAMI – Association for the Advancement of Medical Instrumentation that develops voluntary standards for aspects of dialysis, including water treatment and dialyzer reprocessing. Access – A means to connect to the bloodstream for hemodialysis. Hemodialysis accesses include arteriovenous fistula (AVF), arteriovenous graft (AVG), and central venous catheters. Acid – A substance with a pH below 7.0 that is capable of donating a hydrogen ion ( H+) and is used in conjunction with bicarbonate to compose the dialysate bath. Acid Clean – A daily process when acid (vinegar) is rinsed through the acid and bicarbonate lines. Acid Concentrate Jug – Container used for storing acid concentrate. Acidosis – A pathologic condition resulting from accumulation of acid or depletion of the alkaline reserve (bicarbonate) content of the blood and body tissues, and characterized by an increase in hydrogen ion concentration (decrease in pH). Air Embolism – Occurs when air bubbles enter the bloodstream and are carried into a vessel small enough to be blocked by the air, where it acts like a clot, blocking the flow of blood. Alarm Window – The allowable range without activating alarms for the arterial, venous, and transmembrane pressures, and the dialysate temperature and conductivity during treatment. Movement of levels outside the window will trigger an alarm after a short delay. The conductivity alarm window is graphically represented in the “Dialysis Home” screen as the area located between the upper and lower alarm limits of the conductivity bar graph. The alarm window can be widened or narrowed, or shifted up or down within the hard limits. The temperature alarm window is ± 2°C of the set temperature value within the temperature hard limits (30°C to 41°C). The arterial and venous limit window width is also selectable. The position of the window is set automatically. Alkalosis – A pathological condition resulting from accumulation of bicarbonate and is characterized by a decrease in hydrogen ion concentration and increase in pH. Allergic Reaction – Local or general hypersensitivity reaction following contact with a specific allergen. Aneurism – a ballooning or bulging of a weak spot in a vessel. Aneurisms can occur if needles are inserted too often into the same small area of a fistula. Anticoagulant – Substance that delays or prevents coagulation of blood in the extracorporeal circuit during dialysis. Appendix – Additional material added to a manual. Arrhythmia – Irregular heart beat, rapid or slow pulse, palpitations caused by changes in the blood pH or electrolyte levels (potassium), hypotension or heart disease. Arterial Access – Route used to remove blood for hemodialysis.


Arterial Drip Chamber – Chamber within the extracorporeal circuit were arterial pressure is monitored. A bubble trap inside the drip chamber collects any air that enters the blood tubing. Arterial Drip Chamber Holder – Semicircular piece on the module that secures the arterial drip chamber in place Arterial Inflow – the flow of arterial blood into a fistula. Arterial Line – Part of the extracorporeal circuit that is involved with transporting the patient’s blood to the dialyzer. Arterial Line Clamp – Clamp positioned on the arterial blood line. Arterial Pressure Port – The pressure port houses a pressure transducer that monitors arterial tubing pressure. Arterial Side of Dialyzer – The end of the dialyzer where the patient’s blood enters to be dialyzed. Aseptic Technique – Series of steps necessary to prevent microbial contamination of patient or environment. Auto Flow Rate – A ratio of dialysate flow to blood flow based on the dialysis prescription, for example 2x dialysate auto flow with a blood flow of 400ml/min would be 800 ml/min. Back Pain – Pain located in the posterior regions of the trunk, including the thoracic, lumbar, sacral, or adjacent regions. Balancing Chambers – The hydraulic chambers inside your machine that control the volume of dialysate. The chambers make sure that the amount of fresh dialysate entering the dialysate flow is equal to the amount of used dialysate being drained. Base Na+ – The prescribed sodium level for the dialysate. The default Na+ value is carried over from the value displayed in the Na+ parameter-button in the “Rx Parameter” screen. Bicarbonate – A buffer used by the body to neutralize acids that form when the body breaks down protein and other foods. Bicarbonate Jug – Container used for storing bicarbonate. Biofilm – Biological residue from treatment that collects on machine drain lines. Bleeding – Escape of blood from a vessel. Blood Circuit – Component of the dialysis system that is enclosed within the arterial blood line, dialyzer fibers and the venous blood line. It is also referred to as the extracorporeal circuit. Blood Clotting Time – the time is takes for blood to clot. Blood Flow Rate – See blood pump speed. Blood Leak Detector – An alarm system that monitors used dialysate for blood or air that would indicate a leak in the dialyzer membrane. Blood Line Set – Part of the extracorporeal circuit that carries blood from the patient’s vascular access through the arterial needle or catheter port, to the dialyzer, and back to the patient through the venous needles or catheter port. There are two segments of


blood tubing: arterial (red connector colored) and the venous (blue connector colored). Other components of the blood tubing include patient connectors, dialyzer connectors, arterial and venous drip chambers, blood pump segment, heparin and saline infusion lines. Blood Pump – Part of the hemodialysis delivery system that moves the patient’s blood through the extracorporeal circuit at a fixed rate of speed when the blood pump segment is threaded between the pump head and the rollers. Blood Pump Door – Cover of the blood pump. Blood Pump Housing – Component that holds the blood pump rotor and tubing guides. Blood Pump Speed – Prescribed rate of blood programmed on the blood pump. Blood Sensed – The venous line runs through an Optical Detector above the Venous Clamp. When the clear bloodline tubing is opaque, your machine uses this “Blood Sensed” information for a number of alarms, informational messages, or warnings. Blue Bicarbonate Connector – Device used to connect to the bicarbonate jug. Blue Recirc Connector – Part of the extracorporeal circuit used when returning venous blood to the patient. Bolus – A relatively large, single dose. Bruit – The buzzing or swooshing sound caused by the high-pressure flow of blood through a patient’s fistula or graft. Button – Certain identified sites on the Touch Screen that, when touched, will cause a specific action by the software. Bypass Mode – Bypass mode occurs when the dialysate conductivity or temperature goes outside alarm limits. In bypass mode, valves inside your machine redirect the flow of dialysate to bypass the dialyzer internally until temperature and conductivity are back within acceptable limits. Cannulation – to insert fistula needles into a fistula or graft for dialysis. Caution – Statement that identifies conditions or actions that could result in damage to the machine. Chemical Rinse – The “Chemical/Rinse program disinfects your machine by rinsing it with water, chemical disinfectant, and water again. You should run a Chemical/Rinse weekly. Chemical Disinfect Jug – Container for bleach during the chemical rinse. Chest Pain – Pressure, burning, discomfort, or numbness in the chest. Clean Technique – Series of steps necessary to prevent contamination of patient or environment. It includes, but is not limited to, using clean gloves and hand washing. Clearance – The rate at which waste products in the blood are removed by dialysis. Coefficient – A numerical measure of a physical or chemical property that is constant for a system under specified conditions. Conc. – Abbreviation for “concentrate.”


Concentrate – One of two salt solutions (acid and bicarbonate) that are mixed together with purified water to form dialysate. Concentrate Connectors – Color-coded plastic connectors located on the front panel to connect acid and bicarbonate concentrates. The red connector is for acid concentrate and blue connector for bicarbonate concentrate. Conductivity – The ability of a fluid to transfer electrical charge as a measurement of ions in a solution. Conductivity Meter – Measures the electrolyte composition of dialysate to ensure it is within safe limits for use. Contraindication – Symptom, condition or circumstance that renders the use or a remedy or procedure inadvisable, usually because of a risk. Control Panel – Top front portion of the machine consisting of a touch screen, various keys and data entry keypads used to operate the 2008K@home machine. Convulsion – Violent involuntary contraction or series of contractions of voluntary muscles. Also known as seizure. Corrosive – Slow disintegration or wearing away of something by a destructive agent. Cramping – A sudden, involuntary, spasmodic muscular contraction causing severe pain, often occurring in the leg or shoulder. Painful muscle cramps often in the hands and feet may result from removal of too much fluid, changes in blood chemistry, especially sodium, low potassium levels and hypotension. Crenation – Conversion of normally round red blood cells into shriveled, irregularly shaped forms that occurs if the blood is exposed to a solution that is more concentrated than blood. Delivered Dose of Dialysis – The amount of clearance of urea expected to be completed following the dialysis prescription. Dialogue Box – Text box in the top right corner of the screen that shows patient information and instructs the operator for certain actions. Dialysate – Solution used to diffuse and clear waste from your bloodstream through the dialyzer. It consists of the acid and bicarbonate concentrates mixed together with purified water. Dialysate Circuit – Component of the dialysis system that is enclosed within the hydraulic system and the dialysate compartment (outside the fibers) of the dialyzer. Dialysate Flow Rate – A prescribed ml/min flow of the dialysate through the dialyzer. Dialysate Line Filter Screen – A small screen inside the dialysate connector to filter concentrate Dialysate Pressure – Pressure or force within the dialysate side of the dialysis system. It is used in conjunction with venous pressure to measure TMP (Transmembrane Pressure). Dialysis – The passage of a solute through a membrane. Dialysis Dementia – Deteriorative mental state that may occur during dialysis. Dialysis dementia can be caused by chronic exposure to aluminum salts.


Dialyzer – The device used to filter and diffuse waste from your bloodstream using semi-permeable membranes. Dialyzer Clotting – related to sustained blood pump alarms or less that required anticoagulation that caused the blood to clot in the dialyzer. Dialyzer Quick Connectors – Color-coded metal pieces to securely attach the dialyzer to the dialysate lines. The blue connector delivers fresh dialysate and is attached to the venous end of the dialyzer. The red connector sends spent dialysate to the rest of the hydraulic system and is attached to the arterial end of the dialyzer. Dialyzer Reaction – can be caused by a reaction to ethylene oxide or other chemicals in the system with symptoms occurring in the first 15 – 30 minutes of treatment that include itching, chest and or back pain, shortness of breath, hypotension, nausea and general discomfort. Dialyzer Ultrafiltration Coefficient – Ultrafiltration constant. The fixed amount of fluid a dialyzer will remove from the patient’s blood per hour at a specified pressure. A dialyzer’s ultrafiltration coefficient is included with its instructions. See also KUF. Diasafe Plus – A filter for your dialysis machine that filters the dialysate solution further, removing even the smallest bacteria and pyrogen to deliver ultra pure dialysate. Diasafe Test – A test to verify integrity of the Diasafe Plus filter. This is automatically performed after chemical disinfectant rinse. Diastolic Pressure – The lower blood pressure number of the two, it describes the blood’s pressure just before the next heartbeat. Diffusion – The movement of dissolved particles across a semi-permeable membrane from an area of higher solute concentration to an area of lower solute concentration. This process continues until the concentration of solutes on both sides of the membrane are equal. In dialysis, the diffusion process removes wastes from the blood. Dim button – Method to darken the display screen like a screen saver. Disequilibrium Syndrome – can occur when the BUN is removed much faster from the blood than from the brain, when disequilibrium occurs and the fluid moves into the brain cells causing swelling. The symptoms are headache, nausea, hypertension, restlessness, confusion, blurred vision and seizures. Disinfection – The process that destroys or slows the growth of harmful microbes. Display Screen – A viewing screen located in the middle of the control panel. Drain Bag – Device used when priming the dialyzer to collect saline. Drip Chamber – Used to collect air in the arterial and venous chambers. Dry Weight – Patient’s weight without excess fluid. Edema – Accumulation of an excessive amount of fluid in or around tissues or cells. Electrolytes – Ions or electrically charged molecules in the bloodstream that are needed for various functions in the body, including nerve cell transfer signals. Healthy kidneys maintain constant, healthy levels despite changes in exercise and diet. Electrolyte (Imbalance) Disturbance – is an abnormal change in the levels of electrolytes in the body, usually constituting a medical emergency. Severe or prolonged


electrolyte disturbance can lead to cardiac problems, neuronal malfunction, organ failure, and ultimately death. Estimated Dry Weight – See Dry Weight. Etiology – The science and study of the causes or origins of disease. Exsanguinate – To drain of blood. Febrile Reaction – Fever during dialysis, feeling cold, redness, swelling, tenderness, warmth for access or other site, caused by infection, contaminated dialyzer or bloodlines or too-cold dialysate. Fill Program – Occurs when the water level in the air separation chamber of the hydraulic system gets too low. To remove excessive air from the hydraulic system, your machine will normally go into a “Fill” program when the dialysate lines are first connected to the dialyzer, and the air within the dialyzer is being evacuated. If the “Fill” program runs repeatedly during operation it could mean a dialysate leak. Call a qualified technician if this problem occurs. Filtrate – A liquid that has passed through a filter. Flow Indicator – A clear tube in the dialyzer supply line that allows the operator to monitor dialysate flow. When dialysate flow is on, a small float inside the cylinder moves up and down in rhythm to the dialysate pump. When flow is off, the float sinks to the bottom of the cylinder. Fluid Overload – State of the patient when dry weight has not been reached, this can lead to congestive heart failure or pulmonary edema. GFI (Ground Fault Interrupter) – Device on special electrical outlets that protects against electrocution by interrupting current. The outlet faceplate has a “Test” and a “Reset” button. Gravity Prime – Method used to instill saline into the arterial patient end of the extracorporeal circuit. Hand Crank – Method used to return blood to the patient during a power failure, also know as Emergency Hand Crank, that utilizes the auxiliary blood pump crank handle inserted into the hand crank spindle on the blood pump and the blood is manually returned to the patient. Hard Limits – Unchangeable limits written in the software that define the maximum and minimum alarm window values for the arterial, venous, and transmembrane pressures, and the dialysate temperature and conductivity. Hard limits are not shown to the user. Headache – Pain in the cranial region that may occur as an isolated and benign symptom or as a manifestation of a wide variety of conditions. Heat Disinfection – The “Heat Disinfect program disinfects your machine by running hot water (over 80°C or 176°F) through it. You should run a Heat Disinfect at the end of every treatment day. Heater – A component in the machine that warms the water or dialysate to approximately body temperature during dialysis and to a set temperature during heat disinfection. Hemastix – Monitoring strip that identifies the presence of blood.


Hemodialysis – The procedure carried out by your machine that separates the waste products and excess water artificially from your blood by diffusion and ultrafiltration. Hemolysis – Rupture of red blood cells. This may be caused by hyponatremia (low blood sodium), dialysate that is too hot or too dilute (hypotonic), chloramines, copper, or nitrates in dialysate water, bleach in the dialysate, low dialysate conductivity, too-high arterial pressure or kinked blood tubing. Hemorrhage – Abnormal bleeding, either internal or external. Heparin – A chemical naturally found in the liver that prevents blood from clotting. Heparin Line Clamp – Clamp positioned on the heparin line. Heparin Pump – A component of the dialysis delivery system that delivers heparin at a prescribed rate. Hydraulic System – The lower third of the dialysis machine that houses the water/dialysate circuit and controls ultrafiltration. Hyperparathroidism – Primary hyperparathyroidism is a disorder of the parathyroid glands, also called parathyroids. "Primary" means this disorder originates in the parathyroids: One or more enlarged, overactive parathyroid glands secretes too much parathyroid hormone (PTH). In secondary hyperparathyroidism, a problem such as kidney failure causes the parathyroids to be overactive. Hypertension – Is high blood pressure, readings > 140 mm Hg systolic and 90 mm Hg diastolic pressure are considered high blood pressure. Can be related to fluid overload, patients missing their blood pressure medication, anxiety or disequilibrium syndrome. Hyperthermia – Abnormally high body temperature. Hypervolemia – Abnormally increased volume of circulating blood in the body. Hypotension – Is low blood pressure and occurs most often when too much fluid is removed during dialysis. Symptoms include sever muscle cramps, headache, feeling warm, restless, dizzy, faint or nauseated. Hypothermia – Abnormally low body temperature. Hypovolemia – Abnormally decreased volume of circulating blood in the body. Hypoxia – Clinical manifestation of respiratory distress consisting of a relatively complete absence of oxygen. Infection – Invasion and multiplication of microorganisms in body tissues, which may be clinically unapparent or result in local cellular injury. Infiltration – In dialysis, this is refers to the dislodgment of the fistula needle from the patient’s access and blood being injected into the surrounding tissues. Inflation Pressure – The amount of pressure in the blood pressure cuff when taking a blood pressure reading. Keys – Located on the Control Panel and on various modules, keys are used to enter numbers, confirm selections on the Touch Screen, and activate certain machine functions. Kilogram – Measure of weight, 2.2 lbs = 1 kg (kilogram).


KUF – Ultrafiltration constant. The fixed amount of fluid a dialyzer will remove from the patient’s blood per hour at a specified pressure. A dialyzer’s KUF is included with its instructions. See also Dialyzer Ultrafiltration Coefficient Level Adjust – Ability to raise the level within either the venous chamber or the arterial chamber. Level Detector Module – Component of the dialysis delivery systems that holds the venous drip chamber in place and utilizes an ultrasonic sensor to detect a deficiency in the fluid level within the venous drip chamber. Long Power Down – Turning off your machine for longer than two minutes. Certain information stored in machine memory is lost after two minutes and some treatment parameters are reset to their default settings. Power failures are not the same as long power downs, where treatment information is saved. See also Short Power Down and Power Failure Recovery. MAP (Mean Arterial Pressure) – The average pressure your blood vessels experience as your heart beats. Maximum UF Volume – Value set in service mode with the maximum value of 4000 ml/hour for fluid removal. Medication Clamps – Clamps on the medication administration lines. Meter Box – Box that displays screen-specific information like timers and dates. Military Time – Time measured in hours numbered to twenty-four (as 0100 or 2300) from one midnight to the next. For example, ‘00:00’ is midnight and ‘13:00’ is one o’clock PM. Module Compartment – Middle front section of the machine which houses the different modules such as the blood pump, heparin pump, level detector, etc. Nausea – An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Note – Advisory comments or recommendations regarding practices or procedures. Onesiteitis – Term used to describe the act of cannulating in the same small area of an access and can lead to aneurysm or pseudoaneurism development. Optical Detector – Located on the Level Detector module that senses whether or not the venous line is filled with blood. See also Blood Sensed. Osmosis – The movement of fluid across a semi-permeable membrane from an area of lower solute concentration (blood) to an area of higher solute concentration (dialysate) until the concentrations on both sides of the membrane are equal. Parameter-Button – A button on the Touch Screen that displays the changeable value it controls through software. Pathogenesis – The development of a disease or morbid condition. Permeate – To penetrate or pass through, as through a filter or the RO water that has already passed through a filter. pH – The hydrogen ion concentration of a solution. A solution with a pH above 7 is alkaline (base). A solution with a pH below 7 is an acid.


Phosphorus – is a nonmetallic element present in such foods as dairy products, meats, fish, nuts, chocolate and cola. Too much phosphorus in the blood can cause itching, secondary hyperparathroidism and bone disease. Piston – Sliding valve moving in a cylinder. Positive Pressure – Condition that exists when pressure inside the lines is greater than outside of the lines. If an opening occurs, air or fluid will flow out of the system. Potassium – A metallic element, and an important electrolyte in the human body. Levels of potassium that are too high or too low can cause illness or death in patients, levels must be kept within very tight limits. Power Failure Recovery – When power to your machine is lost, many dialysis parameters are automatically stored. They are recovered when the power is restored to your machine. Prescription – Directions written for the preparation and administration of a therapy. Pressure Holding Test (PHT) – Pressure Holding Tests test the integrity of the hydraulic system, which is necessary for accurate fluid balance and UF control. There are two types of pressure holding tests: One is an extensive PHT is activated from the “Test” or “Help” screens. The other is an Online Pressure Holding Test that is run automatically every 12 minutes during treatment. It lasts about seven seconds, depending on the dialysate flow rate (two cycles of the balancing chamber). Pressure Port – A tubing outlet on both the Blood Pump and Level Detector modules that connects to a pressure transducer and to the drip chambers. Pressure ports allow monitoring of the bloodline pressure. Prime – Procedure done before dialysis to remove air from the extracorporeal circuit to prepare the bloodlines and dialyzer ready for use by flushing them with saline. Pruritus (itching) – Severe itching on and off dialysis, red skin and crusting on the skin, caused by uremia, high blood phosphorus levels, calcium phosphate crystals under the skin or secondary to hyperparathyroidism. Pseudoaneurysm – A false aneurysm, a bulging pocket of blood around a graft. Can occur if a graft has been damaged by repeated punctures in the same area. Pump Housing – Channel around the blood pump where the blood pump segment of the bloodline is placed. Pure Ultrafiltration – A treatment option in which the ultrafiltration pump draws excess fluid from the patient while the dialysate flow is turned off. See also Sequential Ultra-filtration. Puristeril 340® – A chemical used to clean and disinfect the hydraulic system. Puristeril 340 is a registered trademark of Fresenius Medical Care. Pyrogen – A substance that causes fever. Recirc Connector – Part of the extracorporeal that is utilized when returning blood back to the patient. Recirculation – Process where saline is moved through the extracorporeal circuit prior to initiation of treatment to assist in the removal of air. Red Acid Connector – Device used to connect to the acid concentrate.


Reset Button – Button prompted to address alarms. Restless Leg Syndrome – Is a condition that is characterized by an irresistible urge to move one's body to stop uncomfortable or odd sensations. It most commonly affects the legs, but can also affect the arms or torso. Reverse Osmosis (RO) – A method for purifying water by forcing it through a semi-permeable membrane that prevents the passage of ions. Rinse Back Volume – Amount of saline required to rinse the patient’s blood back following completion of the dialysis treatment. Rinse Cycle (Rinsing) – The “Rinse” program may be run before each treatment, but it must be run after an acid clean. Rinse Port – Opening on the front of the machine where wand is inserted during the rinse cycle. RO – Abbreviation for “Reverse Osmosis.” Rotate Dialyzer – Process during the set up of the system when the user is prompted to ’flip’ the dialyzer 180 degrees. Rotor – The rotating part of an electronic or mechanical device. Rotor Latch – Metal piece on the front of the blood pump rotor used to attach the auxiliary blood pump crank when returning blood manually during a power failure. Rotor Latch Slot – Space on the blood pump rotor where the spindle of the auxiliary blood pump crank is inserted to return blood manually during a power failure. Rx – Abbreviation for “Prescription.” Saline Bag – Solution consisting of normal saline used to prime the bloodlines and to rinse the blood back after treatment. It is also used to expand plasma volume during a hypotensive episode or to relieve cramps. Screen-Button – Any of the buttons located in the row along the bottom of the Touch Screen. Screen-buttons are also on the left side of the “Rx Parameter” screen. Touching one of these buttons will display its screen. Seizure – Uncontrolled electrical activity in the brain, which may produce a physical convulsion, minor physical signs, thought disturbances, or a combination of symptoms Sensor heads – Ultrasonic devices that detect fluid level deficiency in the venous chamber. Sequential Dialysis – Two-stage form of dialysis treatment in which the first stage consists only of ultrafiltration. In the first stage, there is no dialysate flow while the ultrafiltration pump draws excess fluid from the patient. After the calculated amount of fluid has been drawn, usually a standard dialysis treatment, begins. Service Mode – A functional state of your machine that allows technicians to calibrate your machine or program various software features and options not accessible in Dialysis Mode. Short Power Down – Turning off the power with the Control Panel Power key for less than two minutes. Certain information stored in memory is only held for up to two


minutes—after that, it is erased. See also Long Power Down and Power Failure Recovery. Shunt Door – Opening to the device that connects the dialysate lines when not in use. Shunt Interlock – Located on the right side of your machine, it is the device that connects the dialysate lines when they are not in use. Audible alarms may be silenced when the dialysate supply lines are on the shunt (unless the Optical Detector senses blood). Sodium – Chief cation of the extracellular body fluids. Its salts are the most widely used in medicine. Physiologically the sodium ion plays a major role in blood pressure regulation, maintenance of fluid volume, and electrolyte balance. Status Box – The Status Box is located in the top, left corner of the Touch Screen. It displays various operational modes, warnings, alarms, or operator instructions. The Status Box background changes between three different colors to display your machine’s conditions. Steal Syndrome – Pain or weak pulse in affected limb caused by shunting of normal arterial blood supply through the access thus depriving distal extremity of needed oxygenation. Stenosis – The narrowing of a blood vessel. Stenosis slows the flow of blood and causes turbulence inside the vessel. Sterile – Free from living microorganisms. Stethoscope – A medical instrument for listening for sounds within the body. Syringe – Instrument used for injecting or withdrawing fluids. Systolic Pressure – The higher blood pressure number of the two, it is the blood’s pressure during a heartbeat. Temperature Alarm – Indicates that the dialysate temperature is too high or too low. Dialysate that is too high can cause hemolysis. Too cool dialysate can cause patient discomfort and reduce the efficiency of the treatment. Theoretical Conductivity (TCD) – The approximate conductivity of the dialysate based upon the concentrate type, and sodium and bicarbonate values entered in the “Dialysis Home” screen. TCD is measured in milliSiemens per centimeter (mS/cm) and is corrected to 25°C. Thrill – The vibration of blood flowing through the patient’s fistula or graft. It can be felt by touching the access. TMP (Transmembrane Pressure) – The difference in pressure between the filtrate and permeate sides of the dialyzer membrane. TMP = Dialysate Pressure – Venous Pressure. Transducer – An electronic sensor in your machine that reads the pressure inside the arterial and venous drip chambers. Transducers are connected to the drip chambers through pressure monitor lines. Transducer Protector – A small, disposable, plastic cap containing a hydrophobic paper filter that fits over each pressure port. Inserted between the pressure monitor line and the pressure port connection, it is used to prevent the transducer from becoming


wet or contaminated with blood. There are two transducer protectors for each connection: a disposable external TP that is to be replaced with each treatment and a second, internal TP that comes installed with the module. Tubing Guides – Components on the blood pump module to properly align the blood pump segment within the blood pump module. Tx – Abbreviation for “treatment.” Tx Clock – The amount of time remaining until the end of the treatment. The Tx Clock is viewable in the “Dialysis Home” screen as a pie chart button. Tx Paused – Indicator that treatment is paused. Tx Running – Indicator that dialysis is in progress. UF – Abbreviation for “Ultrafiltration.” UF Goal – Total amount of fluid to be removed during the treatment. Ultrafiltration – The process of drawing off excess fluid from the patient during treatment. Your machine’s hydraulic system is a closed system that uses a separate UF pump for greater measured accuracy. Ultrasonic Sensor – Used to sense fluid in the venous chamber. Urea – Dissolved protein waste product. User’s Guide – Set of instructions on the proper use of the 2008K@home machine. Venous Access – Route used to return dialyzed blood back to the patient. Venous Drip Chamber – Chamber within the extracorporeal circuit where venous pressure is monitored. A bubble trap inside the drip chamber collects any air that enters the blood tubing. Venous Line Clamp – Metal piece on the level detector module that clamps the venous line when there is a blood alarm to prevent blood from being delivered to the patient. Venous Outflow – The flow of blood leaving a fistula. Venous Pressure – The pressure within the venous drip chamber of the extracorporeal circuit. Venous Pressure Port – Opening on the level detector module to monitor venous pressure. Venous Side of Dialyzer – The end of the dialyzer returning the dialyzed blood back to the patient. Vinegar – Acid used for the Acid Rinse Cycle. Vomiting – The forcible expulsion of the contents of the stomach through the mouth. Warning – Statement that identifies conditions or actions that could result in personal injury or loss of life. Your K Map – Map for patient to navigate the 2008K@home machine’s modules and control panel.


APPENDIX B – HEMODIALYSIS BASIC TRAINING Introduction To Hemodialysis 1 The following is an introduction to home hemodialysis using the Fresenius 2008K@home machine. Being on dialysis probably makes you feel like you have less control over some aspects of your life. Things that you previously took for granted - like the food you ate or the amount of fluid that you drank - now require much more thought and consideration than they once did. Your decision to learn home hemodialysis will allow you to take a much more active role in your healthcare. Home hemodialysis will hopefully give you more freedom and control over your life. THE KIDNEYS AND HOW THEY WORK Your doctor has diagnosed you with chronic kidney disease (CKD), Stage 5 (end-stage renal disease). This means that your kidneys no longer function at a level necessary to sustain a state of wellness compatible with a long-term, good quality of life. There was a time when there was no treatment for CKD. The good news is that today, if you choose, there are several options available, including hemodialysis, to keep people with CKD healthy for a very long period of time. Kidneys are magnificent organs. They work 24 hours a day, 7 days a week, and 365 days a year. The kidneys are two bean-shaped organs located just above the waist. Each kidney is only about the size of a clenched fist. About every 2 minutes, all the blood in the body circulates through the kidneys. In healthy kidneys, tiny filters, called nephrons, remove excess fluid and impurities from the blood. These impurities are excreted as urine. When the kidneys are working properly, they perform many functions. Some of these functions are very obvious, like the production of urine. Others that are essential to a healthy life but less obvious include:

• Regulation of body chemistry, • Production of hormones that help regulate blood pressure and produce new red blood

cells • Cleansing your body of impurities, and • Balancing your body’s pH, to name just a few.

You probably were able to tell when your kidneys were starting to fail. Some of the symptoms may have included: always feeling tired, loss of appetite, severe itching, nausea, shortness of breath, and swelling in your face, hands, and ankles. Again, the good news is that with the proper treatment regimen, including dialysis, following your renal diet, and taking all your medications as prescribed, most of these symptoms can be minimized - you can hopefully regain a level of function that will let you participate in the lifestyle that you were accustomed to before your kidneys failed.


WHAT IS HEMODIALYSIS? The option you chose to manage your kidney disease is hemodialysis. During a hemodialysis treatment, your blood is continuously moved between your body and the hemodialysis system. Your blood is drawn into the system and passed through a dialyzer or “artificial kidney.” The dialyzer is sometimes called the “artificial kidney” because it performs three of the functions that healthy kidneys perform. The dialyzer:

• Removes the excess fluid that builds up in your body (cardiovascular system, tissues, and lungs) in between treatments

• Removes the toxins that build up in your body from the byproducts of the food you eat and from the normal breakdown and repair of muscle and tissue helps to readjust your body chemistry closer to “normal” values - things like your blood potassium, sodium, phosphorus, and acid base balance

How the Dialyzer Works The processes that occur inside the dialyzer are actually quite interesting. As your blood enters the top of the dialyzer, it is channeled into thousands of tiny fibers or “straws” that are the size of a human hair. The dialyzer fibers are surrounded by a solution called dialysate. Dialysate is made up of purified water and prescribed chemicals that help correct your body chemistry and carry away the waste products that come out of your blood. Even though the dialysate surrounds the fibers containing your blood, the blood and dialysate never come into direct contact with each other. The fibers are semipermeable - that is, they allow impurities to go out but keep the good things, like blood cells and proteins, in. The dialyzer’s semipermeable fibers allow excess fluid and impurities to move out of your blood and into the dialysate. The three processes that take place inside the dialyzer that make this happen are diffusion, osmosis, and ultrafiltration.


APPENDIX C – VITAL SIGN CHECK AND RECORDING

RECORDING YOUR VITAL SIGNS Taking and recording your vital signs are important steps in preparing for treatment. You will be asked to record your temperature, blood pressure, and pulse before, during, and after each treatment. You will be asked to record your weight before and after each treatment. All of this information will be documented on your treatment flowsheet and will become part of your treatment records. The flowsheet allows your doctor and your dialysis unit to track the progress of your treatments. Every dialysis unit has its own flowsheets. Your home training staff will give you copies of your unit-specific flowsheet and will train you on your unit’s procedures for recording your vital signs.

TAKING YOUR TEMPERATURE Taking and recording your temperature help you establish your normal temperature range. Your temperature will not be the same every time you take a reading. It is normal for your temperature to change slightly depending on the time of day, the medications you are taking, and your activity level. A normal temperature range for a healthy adult is 97.5º F to 99.5º F (36.4º C to 37.5º C). A normal temperature range for an older adult is 96.8º F to 99.5º F (36.0º C to 37.5º C).

High Temperature The oral temperature of dialysis patients can often be below the normal ranges for healthy adults and for older adults. Kidney disease and dialysis treatments can change the body’s normal fever response - your temperature reading could be on the high end of the normal range for a healthy adult but be a sign that you have an infection. Possible Causes

• Infection In Your Vascular Access • Cold Or Flu • Nausea Or Vomiting • Open Sores Or Wounds

Response Follow your clinic’s recommendations. They may include the following:

• Notify your home training staff if your temperature is above normal before you start treatment.

• Start medications as ordered by your doctor.


TAKING YOUR BLOOD PRESSURE What is Blood Pressure? Blood pressure is the force in the arteries when the heart beats and when the heart is at rest. Systolic Pressure is the measure of the highest pressure in an artery when your heart is pumping the blood to your body. Diastolic Pressure is the measure of the lowest pressure in the artery when your heart is at rest. Blood pressure is written with the systolic pressure first and the diastolic pressure second. A normal blood pressure reading for a healthy adult is around 120/80. Patients on dialysis may normally have higher or lower than normal blood pressures because of their kidney disease.

What is Hypertension? High blood pressure is called hypertension. Current guidelines define high blood pressure as a pressure greater than 130/90. Symptoms There are often no symptoms of high blood pressure, but symptoms can include headache, blurred vision, and flushing. Possible Causes of High Blood Pressure:

• Unusually High Stress • Failure To Take Blood Pressure Or Heart Medications As Ordered By Your Doctor • Greater Than Normal Weight Gain Between Treatments • Eating A Lot Of Salty Foods Between Treatments • Over-The-Counter Medications • Drinking Alcoholic Beverages


• Notify your home training staff or doctor if your blood pressure is above normal before you start treatment.

• Have a record of previous blood pressure readings available when you contact your home training staff or doctor.

• Have a list of your current medications (prescription and over-the-counter) available when you contact your home training staff or doctor. Let them know if you have missed or changed any of your medication doses in the past 48 hours.

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What is Hypotension? Low blood pressure is called hypotension. Current guidelines define low blood pressure as less than 90/50. Symptoms of Hypotension Signs and symptoms include: dizziness, sweating, feeling of illness/uneasiness/restlessness, ringing in the ears or decreased hearing, nausea, vomiting, change in level of alertness, chest pain or tightness, change in skin tone to pale, or seizures.


Possible Causes: • Incorrect dosage of blood pressure or heart medications • Removing too much fluid during treatment • Rapid change in position • Weight loss between treatments caused by nausea, • Vomiting, or diarrhea


• Notify your home training staff or doctor if your blood pressure is low before you start your treatment.

• Administer saline during treatment as needed. • Set the system to remove the minimal UFR. • Drink additional fluids before and during your treatment. • Have a record of previous blood pressure readings and a list of your current medications

(prescription and over-the-counter) available when you contact your home training staff or doctor. Let them know if you have missed or changed any of your medication doses in the past 48 hours.

Tips for Taking Your Blood Pressure

• Take your blood pressure in the same sitting position. • The cuff must fit correctly to your arm. A tight cuff can give a false high blood pressure

reading, and a large cuff can give a false low blood pressure reading. • If signs or symptoms of hypotension occur when you are sitting or lying down, don’t get

up. Call for help and treat the signs and symptoms of hypotension before you change position. If you are standing, sit down.

• If your first blood pressure check is high or low, wait for about 10 minutes and then take your blood pressure again. When you take your blood pressure the second time, make sure the cuff is placed directly on your skin and is positioned correctly on your arm.

• If you have questions about your blood pressure monitor – refer to the 2008K@home User’s Guide that you will use once your training is complete and you are at home.

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TAKING YOUR PULSE Your pulse rate measures your heart rate and rhythm. As your heart beats, it pushes blood through your body. If you put your finger over one of your arteries where it is close to your skin surface, such as on your wrist, you can feel a throb - this is your pulse. Pulse rate is measured by counting the number of beats per minute. A normal pulse rate is between 60 and 100 beats per minute. Your pulse rate may vary from minute to minute.

Rapid Pulse Rate Possible Causes

• Exercising • Stress • Fever • Pre-existing heart condition (tachycardia and atrial fibrillation)


• Notify your home training staff or doctor if your pulse measurement is above normal before you start treatment.

• Have a record of your previous pulse measurements and current medications (prescription and over-the counter) available when you call your home training staff or doctor.

• Let your home training staff or doctor know if you have missed or altered your medication in the past 48 hours.

• Inform your home training staff or doctor if you experience chest pain, dizziness, sweating, or weakness.

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Slow Pulse Rate Possible Causes

• Blood pressure or heart medications • Pre-existing heart condition (bradycardia and atrial fibrillation)


• Notify your home training staff or doctor if your pulse measurement is below normal before you start treatment.

• Have a record of your previous pulse measurements available as a reference for your home training staff or doctor.

• Have a list of your current medications (prescription and over the-counter) available when you call your home training staff or doctor.

• Inform your home training staff or doctor if you have missed or altered your medication in the past 48 hours.

• Inform your home training staff or doctor of any other symptoms you are experiencing such as chest pain, dizziness, sweating, or weakness.

TIPS FOR TAKING YOUR PULSE


• The most common place to feel the pulse is on your wrist over your radial artery. Move your fingertips around your wrist - stopping for a few seconds in each area to try to feel your pulse. Continue moving from area to area on your wrist until you find an area where you can easily feel your pulse.

• Try holding your arm pointing toward the floor -sometimes your pulse is easier to feel with your arm down than when your arm is pointing up.

• You can take your pulse over your vascular access. • Try changing the pressure of your fingertips on your wrist- try increasing the pressure

and decreasing the pressure by small amounts. • Be sure to count your pulse rate for 1 full minute. • If your pulse rate is low or high, rest for 10 minutes and take your pulse again.

PROCEDURE Taking Your Pulse STEP 1 Locate your radial artery on the inside of your wrist on the thumb side. STEP 2 Place two fingers of one hand over the radial artery on your opposite wrist. Don’t press too hard, just hard enough to feel your heartbeat. STEP 3 Count the heartbeat for 1 full minute - use a watch or a clock with a second hand for timing. STEP 4 The number of beats you counted in 1 minute equals your pulse rate. STEP 5 Skipped or irregular beats can occur if your heart rate is irregular. If the beats occur at an irregular interval, make a note that your pulse was irregular when entering your pulse rate on your flowsheet.

RECORDING YOUR WEIGHT The Fresenius 2008K@home machine requires that you enter your current weight on the user interface screen before every treatment. The system will use the weight you enter plus the additional volume you enter to calculate the fluid removal for your treatment. When your doctor and home training staff talk about weight, there are a few different terms they will use - pre weight, post weight, goal weight, additional volume, UF goal, and UF rate. Checking for Fluid Gain When weighing yourself, you may also be asked to check for fluid gain. Your home training staff might require you to check for edema (swelling). You can easily check for edema. Push down on the skin on your ankle with the fingertips of two fingers. Then release and watch to see if your skin indents and for how long it stays indented. If your skin indents, count the number of seconds it takes for the skin to come back up to normal position.

• Pre weight: your weight right before the dialysis treatment • Post weight: your weight at the end of the dialysis treatment (including any saline that

might be given after your blood has been rinsed back) • Goal weight: your weight if your kidneys were working normally - determined by your

doctor • UF Goal: is determined by subtracting your goal weight from your pre weight • UF Rate (UFR): the rate at which excess fluid can be removed during dialysis

High Pre Weight Possible Causes

• Drinking too much fluid in between treatments


• Wearing shoes when you normally weigh yourself without shoes - or wearing heavier shoes than normal

• Wearing heavier clothing than normal • Scale not level


• Verify that you are weighing yourself with the same amount of clothing and wearing the same type of shoes as normal.

• Verify that the scale is level. • Remove the maximum fluid your can tolerate in a single session - Ask your doctor if

there is a specific maximum amount of fluid you can remove in a single treatment. • Monitor your fluid gain closely between this treatment and the next, and try to reach your

goal weight in the next treatment.

Low Pre Weight Possible Causes

• Flu or a viral illness • Not wearing shoes when you usually weigh yourself with your shoes on • Wearing lighter clothing than normal • Scale not level • Loss of actual body weight


• Verify that you are weighing yourself with the same amount of clothing and wearing the same type of shoes as normal. Verify that the scale is level.

• Notify your home training staff. Set the UFR to remove the minimal amount of fluid allowed during your treatment.

• Drink additional fluids before and during treatment. • Administer additional saline during the treatment as needed.

Tips for Weighing Yourself

• Place the scale on a flat, level surface (carpeting or uneven flooring can cause inaccurate measurements).

• Keep the scale in the same place for taking both your pre- and post-dialysis weights. • Try to always measure your weight with about the same amount of clothing on and your

shoes off. This will prevent an inaccurate weight measurement. • It is important to weigh yourself in kilograms. Using units in kilograms makes fluid

conversions more accurate (1 kilogram in body weight is equal to 1 liter of fluid) (1 kilogram is equal to 2.2 pounds).

• Stand in the center of the scale pad and do not move until a stable weight is displayed on the scale.

• If your pre weight is unusually high or low, weigh yourself a second time to make sure the first reading was correct.

• Refer to the scale manufacturer’s instructions for information on calibrating or “zeroing” the scale to make sure the correct weight is displayed.

• If you have questions about your scale, refer to the user manual of the model that you will use once your training is complete and you are at home.


APPENDIX D – INTRADIALYTIC COMPLICATIONS Intradialytic complications of hemodialysis may occur frequently or infrequently and can be categorized according to severity. Below is a table which divides intradialytic complications into the categories of “serious” and “less serious”. It is the responsibility of the home hemodialysis trainer to review the below chart with the home hemodialysis patient and partner and discuss etiology (patient related factors, procedure related factors and others), pathogenesis, treatment and prevention. Comprehensive training materials addressing intradialytic complication etiology, pathogenesis, treatment and prevention are available at www.advancedrenaleducation.com. Please refer to the glossary for definition of terms. Warning: Patients who are experiencing intradialytic complications must be instructed to promptly discuss their complication(s) with the nephrologist in order for appropriate treatment to be executed.

Serious Less Serious Common Hypotension Headache

Dialyzer reaction Nausea/vomiting

Electrolyte disturbance Cramping Uncommon Hemolysis Restless leg syndrome

Febrile reaction Itching

Bleeding Chest/back pain

Seizures

Air embolism

Hypoxia

Arrhythmia

Dysequilibrium Syndrome


APPENDIX E – INFECTION CONTROL This section will teach you proper infection control procedures that should be followed while using the Fresenius 2008K@home machine. The objective of infection control is to prevent the spread of infection from patient to patient, caregiver to patient, or patient to caregiver. Keeping a clean environment is the responsibility of everyone using dialysis equipment. It is especially important for dialysis patients to practice infection control because they face an increased risk of infection. When learning about infection control, you will hear the following terms: Each dialysis unit has specific policies and procedures to limit the spread of infection during dialysis treatment. You will need to practice your unit-specific policies as well as the policies explained in the user’s guide. Important Definitions

• Sterile - to be completely free of germs • Clean - to be nearly free of germs, properly disinfected, and suitable for use in certain

parts of the treatment • Pathogen - any disease-producing agent, especially a virus, bacteria, or other

microorganism Aseptic Technique

• Aseptic technique refers to the practices that help reduce the risk of infection. The transfer of germs is prevented by keeping the number of germs to a minimum.

• Aseptic techniques include: • Removing or killing bacteria or viruses on hands and objects • Preventing direct contamination of materials and supplies • Using sterile products to maintain a sterile fluid pathway • Reducing the risk of exposure to patients and caregivers to potentially infectious blood

and tissue during treatment • Using clean nonsterile gloves when contact with bloodborne pathogens is possible

When to Use Aseptic Technique

• You must use aseptic technique when handling: • Blood-side disposables • Dialysate-side disposables • Your vascular access • Fistula needles • Sterile recirculation caps • Open ends of saline bags (when hanging and spiking) • Ends of the syringes


Maintaining a Sterile Fluid Pathway The blood tubing, fistula needles, recirculation caps, the open ends of the saline bags, and the syringes have sterile fluid pathways - that means that the inside of all tubing and connectors that carry and hold the blood or sterile fluids during treatment are sterile and must remain sterile. You can keep the ends of the tubing sterile by not touching them with your hands or allowing them to contact any surface. All Fresenius 2008K@home machine disposables must remain inside their packaging until you are ready to use them for a treatment. Universal Precautions Universal precautions is an approach to infection control that assumes that all human blood and body fluids are infectious. Using universal precautions when performing dialysis involves using “barriers” to prevent the exposure of caregivers to bloodborne pathogens from patients when a blood or body fluid exposure is likely to occur. Barriers used in standard universal precautions include:

• Fluid-resistant barrier gown • Clean, nonsterile gloves • Mask and eye protection or face shield

When to Use Universal Precautions You should use universal precautions when you begin and end treatment and any time you access the blood pathways (once blood has entered the system). Your home training staff will advise you on the universal precautions that you should follow when performing dialysis treatment at home. Warning Statements The following warning statements should be reviewed with each patient regarding the procedures that requires using aseptic technique or universal precautions.

• WARNING: Use aseptic technique when handling blood or dialysate tubing, treatment fluids, or connecting to the system to prevent and control the possibility of infection.

• WARNING: Universal precautions should be used during the use and maintenance of the Fresenius 2008K@home machine for dialysis treatment to reduce the risk of exposure to bloodborne pathogens.

HOW GERMS ARE SPREAD: PROPER HANDWASHING PROCEDURE Germs are invisible, and the spread of germs is invisible. Germs are very easily spread with your hands. Unwashed hands can quickly “touch contaminate” clean areas by moving the germs from a dirty area to a clean area. This can lead to the spread of infection and cause illness. As a dialysis patient, you face an increased risk of getting infections. There are also many viruses that patients on dialysis are especially susceptible to contracting. Handwashing is a simple, but important, step to take to help prevent spreading germs. Germs are always on your skin and on all items or surfaces you touch. By washing your hands correctly, you can remove many of the germs. Frequent and correct hand washing can easily and effectively reduce the spread of germs.


Correct Handwashing Procedure • STEP 1 Rinse your hands with warm water. • STEP 2 Lather your hands with soap, and rub your hands together vigorously. Scrub

your hands, in-between your fingers, and under your fingernails, for about 20 seconds. • STEP 3 Rinse your hands with warm water. Let the water run from the tips of your

fingers down to your hands. After you wash your hands, you must be very careful not to recontaminate your hands by touching any objects in the washroom.

• STEP 4 Leave the water running while you dry your hands with a clean towel. Use the towel to turn off the faucets on the sink.


APPENDIX F – VASCULAR ACCESS CARE

HOW YOUR ACCESS WORKS Your hemodialysis vascular access or “access,” allows your blood to reach the Fresenius 2008K@home machine for treatment. Your access will be either an arteriovenous fistula (also referred to as an “AVF”) or an arteriovenous graft (also referred to as an “AVG”) or possibly a tunneled dialysis catheter (referred to as “TDC”).

• A fistula is an access made by joining an artery and vein in your arm. • A graft is an access made by using a piece of soft tube to join an artery and vein in your

arm. • A catheter is a large plastic tube that is placed into a large vein in your neck or chest and

extends outside your body. How Your Access Works You will place needles into your fistula or graft at the beginning of each treatment. The needles are connected to the blood tubing (arterial and venous), and the blood tubing is connected to the Fresenius 2008K@home machine. Your blood will travel through the arterial tubing into the Fresenius 2008K@home machine, will be cleaned by the dialyzer, and then returned to your body through the venous tubing. Catheters can be directly connected to the blood tubing (arterial and venous) without the use of a needle. They however have a higher risk of infection because they directly connect the outside of your body to inside a large blood vessel leading to your heart.

PREPARING YOUR ACCESS • Step 1: Wash Your Hands and Your Vascular Access Site

o The first step in preparing your access is washing your hands and your vascular access site.

• Step 2: Put on Gloves o The second step in preparing your access is to put on gloves. You must use

aseptic technique when preparing your access and connecting to the Fresenius 2008K@home machine. This will help prevent bacteria on your skin’s surface from being pushed into your bloodstream by the needle.

• Step 3: Check Your Access Area o The third step in preparing your access is to check your access and the area

around your access. The steps for checking your access are slightly different for fistulas or grafts - please read the appropriate section for your type of access.


FISTULAS (AVF) LOOK

• Check the entire length of your fistula and old puncture sites for signs of infection. Specifically you should look for redness, swelling, drainage, tenderness, or bruises. It is normal for the buttonhole site to have a small scab.

• Check your vein to make sure it is healthy. You will need a 1-inch straight segment of vein to cannulate with the 1- inch fistula needle. You should look for a well-developed, main vein outflow of the fistula. Make sure there are no bulging vein areas. Bulging areas are aneurysm formations and must not be used for needle cannulation.

• Raise your vascular access arm. Your entire fistula should flatten and become soft. If your fistula does not flatten and stays enlarged, this means there is a narrowing in the vein (stenosis) somewhere between the area where your fistula was made and your heart. Notify your home training staff if you note this change in your fistula.

• Remember: if your gloves become contaminated (by touching your face, hair, furniture, the dialysis system, or any other surface), change your gloves immediately before proceeding.

LISTEN

• Using a stethoscope, listen for the bruit. The bruit is the low-pitched, continuous “swish-swish” sound you hear with the diastolic and systolic phases of your blood pressure. The bruit is strongest at the arterial inflow and weakens as you move your stethoscope up the vein.

• If the bruit has a high pitched, interrupted “swish-swish” sound, it may be an indication of stenosis, a narrowing within the fistula or in the vein leading all the way back to your heart.

• If you think that you may have a problem with your fistula, contact your home training staff for instructions.

FEEL

• Using your second and middle fingers, feel your fistula. Your fistula should feel soft and be easy to compress with your fingers. You should feel a buzzing sensation, which is called the thrill. The thrill is strongest at the arterial inflow and weakens as you move your fingers up the vein.

• If the thrill feels strong and pulse-like, and the vein is firm instead of soft, it may be an indication of stenosis. Feel the fistula for tenderness or warmth, which may indicate that you have an infection.

• If you are concerned that your fistula feels different than normal, contact your home training staff.


GRAFTS (AVG) LOOK

• Check the entire length of your graft and old puncture sites for signs of infection. Specifically you should look for redness, swelling, drainage, tenderness, or bruises.

• Inspect the graft to make sure it is healthy. You will need a 1-inch straight segment of graft to cannulate with the 1- inch fistula needle. You should look for a healthy graft that is well-defined and regular in shape. It will not contain any pseudoaneurysm formations (large bulging areas that cannot be used for cannulation).

LISTEN

• Using a stethoscope, listen for the bruit. The bruit is the low-pitched, continuous “swish-swish” sound you hear with the diastolic and systolic phases of your blood pressure. The bruit is strongest at the arterial inflow and weakens as you move your stethoscope up the graft.

• If the bruit has a high pitched, interrupted “swish-swish” sound, it may be an indication of stenosis, a narrowing within the graft or in the vein leading all the way back to your heart.

• If you think that you may have a problem with your graft, contact your home training staff for instructions.

FEEL

• Using your second and middle fingers, feel your graft. Your graft should feel round and smooth and free from dips or indentations on the surface. It should not feel soft or “mushy.” If your graft feels soft, this can be an indication of “onesiteitis” and lead to the formation of a pseudoaneurysm.

• You should feel a buzzing sensation, which is called the thrill. It is strongest at the arterial inflow and weakens as you feel the graft at the venous outflow.

• If the thrill feels strong and pulse-like, it could be a sign of stenosis. The change in the thrill can be felt over the area where the narrowing has occurred if it is within the body of the graft itself. If the narrowing is in the outflow vein, the entire graft will have a strong, pulse-like thrill.

• Feel the graft for tenderness or warmth, which may indicate that you have an infection. • If you are concerned that your graft feels different than normal, contact your home

training staff.

Tips for Preparing Your Access - Fistulas and Grafts • Never insert needles into an access that looks infected. Bacteria can quickly enter your

bloodstream through an infected access. Contact your home training staff or doctor immediately if you suspect an infection.

• A change in the sound of the bruit may indicate a problem. A decrease in the thrill or in the bruit should be immediately reported to your doctor and home training staff.

• You can evaluate your fistula or graft for Steal Syndrome. Your fistula or graft changes the normal blood flow to your hand, which can lead to Steal Syndrome. If your hands begin to hurt, become cold or blue, and the movement and sensation in your fingers is decreased, notify your home training staff.


CANNULATE AND SECURE YOUR VASCULAR ACCESS Once your access site has been carefully cleaned, you can insert your dialysis needle. Aseptic technique must be used for all needle insertions. Follow your unit-specific procedures for inserting needles. Review the procedure below for self-cannulation and securing your access, and discuss it with your home training staff. This procedure is included here as an example only. Your home training staff will provide you with unit-specific procedures for cannulating and securing your access. What Supplies Will I Need? Have the following supplies ready:

• Three alcohol prep pads • Two 10cc syringes with needles • Two pairs of gloves • Two fistula needles (size prescribed by your doctor) • One bandage • One roll transpore or micropore tape • One tourniquet (AVF’s only) • One underpad • Germicidal soap • Chloraprep applicator • Personal protection equipment (gown, eye protection, face shield, and gloves)

Cannulating and Securing Your Access

• STEP 1 Wash your hands and access area with germicidal soap and water. • STEP 2 Put on a pair of gloves and personal protection equipment. • STEP 3 Prepare the saline medication port on the I.V. bag with the alcohol prep pads,

and fill both of the syringes with 8 cc’s of normal saline solution. • STEP 4 Open the needle package and place it on a clean work area. • STEP 5 Attach the syringes to the end of each fistula needle tubing, but do not prime the

needles. • STEP 6 Place an underpad under your access arm. • STEP 7 Check the vascular access area for any signs or symptoms of infection. If the

thrill is not present or is weak, stop and notify your home training staff. • STEP 8 Clean the insertion site using aseptic technique and cleanser recommended by

your dialysis clinic. Using a back and forth motion, wet the treatment area for 30 seconds. Do not touch the site after it has been cleaned. (If you touch the site after it has been cleaned, you must reprep the site.)

• STEP 9 Take off your gloves and put on a new pair. • STEP 10 Apply a tourniquet to your arm above the insertion site. (You do not need a

tourniquet if you have a graft). • STEP 11 Anchor the vein or graft between the thumb and forefinger to prevent

movement. • STEP 12 Insert the needle, bevel-up, at a 45-degree angle for a graft or at a 35- (or less)

degree angle for a fistula. Advance the needle until blood is seen in the tubing and or a decrease in resistance is felt. Level the needle and advance into the vessel.

• STEP 13 Check for the blood flashback (you may need to release the needle clamp to see the blood flashback) and, if visible, pull back 1 to 5 cc’s of blood with the 10 cc syringe. Flush the needle with saline and clamp. The needle must pull back and flush with ease. If not, reposition the needle.


• STEP 14 Apply a bandage over the insertion site and tape down the needle. Repeat steps for second needle

VASCULAR ACCESS CARE Daily Care

• Check the skin over and around your access. Signs and symptoms of an access infection can include fever, skin redness, drainage, pain, or warmth to the touch over or surrounding the access. Report any signs or symptoms of an access infection to your home care staff.

• Check your access thrill two times per day. A decrease in the strength of the thrill could mean that the blood flow inside the access has clotted. Call your home care staff right away.

• To prevent blood flow from decreasing, do not wear tight jewelry or tight clothing over the access, and do not carry heavy items over your access arm.

Blood Flow Check: Thrill: The “thrill” is the buzzing or pulse you feel when you place your fingertips over your access. The pulse you feel is caused by the blood moving inside your access. Pre-Dialysis Care

• Check your access thrill. Report any changes before the access is used for treatment. • After the needles are inserted for treatment, ensure that the tape has not been wrapped

too tightly around your access (this will cause the thrill to decrease). • If you notice symptoms of infection, notify your home care staff before your access is

used for treatment. • Wash your access arm with soap and water. • Your arm should be “prepped” with a cleaning solution right before needles are inserted.

Post-Dialysis Care

• When the needles have been removed, hold direct pressure on the access site for at least 5-10 minutes. Wait until the skin and the hole in the vein have stopped bleeding before you place a dressing over the site. The access thrill should be present while you are holding your needle sites and after the bleeding has stopped.

• The dressing from the needle sites should be removed in the timeframe per facility protocol. Check your access for signs or symptoms of infection. Report any signs to your home care staff.

TUNNELED DIALYSIS CATHETER (TDC) A Tunneled Dialysis Catheter (TDC) can be an alternative form of a hemodialysis vascular access. The TDC is a large plastic tube that is placed into a large vein most commonly in the neck or shoulder area. The tube is divided into separate sides and the sides that are commonly colored coded red and blue. The red side or lumen is the arterial lumen. The blue side or lumen is the venous lumen. You will connect the TDC lumens (arterial and venous) to the blood tubing of the 2008K@home machine. Your blood will travel through the arterial tubing and on the 2008K@home machine, will be cleaned by the dialyzer, and then returned to you body through the venous tubing.


You will be carefully trained to open your TDC to make the connections to the blood tubing. Anytime the TDC has the clamps and caps opened, you can be at risk to get an infection. You will be trained to use the proper infection control techniques when using your TDC for dialysis treatment and changing the dressing over the catheter. Daily Care Dressing Check:

• Inspect the dressing to make sure it covers the TDC exit site. • Make sure the catheter clamps and caps are closed at all times. • If your dressing becomes wet or loose, refer to your unit specific instructions.

Pre-dialysis / Post-dialysis Care Infection Check:

• Your TDC site may not be visible through the dressing, so your exit sites should be checked with each dialysis treatment for any signs or symptom of infection by the dialysis care team.

• Report any fevers, night sweats, general weakness, nausea or a general feeling of malaise (discomfort, uneasiness). Infections can become severe in a short period of time if bacteria enters the blood stream through your TDC.

• You and your dialysis nurse should wear a surgical mask anytime your TDC has the dressing changed or the caps are removed for use. This prevents germs from entering the TDC area.

• Never let anyone use your TDC for any reason other than dialysis – without notifying your nephrologist first.

• The EMS and emergency room staff should not use the TDC to draw blood or give you IV fluids.

• If your TDC should move out of your vein or fall out of your skin, place direct pressure on the skin site with the palm of your hand and call for help.


APPENDIX G – COMPETENCY CHECKLIST Facility: Facility trainer:

Address: Student:

City: In-service specialist:

State: Zip: Date of training: Warning: The facility trainer or student must read and understand the user’s guide including all “Warnings” and “Cautions”

statement. Clamp Symbols on Setup Screens Training Competence

Check Comments

Patient Arterial Line from Machine

Patient Arterial Line from Access

Patient Venous Line from Machine

Patient Venous Line from Access

Saline Line

Clamp on Saline Line below the Saline Bag

Drain Bag

Medication Lines to the Drip Chambers

Heparin Line

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Indication for Use & General Warnings Training CompetenceCheck

Comments

1. Explain structure of user’s guide

2. Review indication for use

3. Review contraindications

4. Review general warnings and explain importance Overview of 2008K@home Machine System Training Competence

Check Comments

1. Show major components of Control Panel, Module Compartment, and Dialysate Circuit section

2. Explain function of keys on Control Panel 3. Show location of Arterial Drip Chamber Holder and Tubing

Guides

4. Explain keys, display, and components of the Blood Pump module

5. Demonstrate functionality of Heparin Pump module

6. Explain the keys and components of the Level Detector module - Stress the importance of the venous clamp

7. Show the handling of the concentrate connectors for bicarbonate and acid concentrate

8. Show the handling of the dialyzer quick-connectors and the shunt interlock

Overview of 2008K@home Machine Software Training Competence

Check Comments

1. Explain the various types of buttons and which are selectable 2. Explain how to read the progress bar graph on various

screens

3. Explain how to read the flowchart along the top of the screen 4. Explain alert sections of the display

- Status Box - Dialogue Box


Entering Prescription Training Competence

Check Comments

1. Press Power key and touch Rx Parameter on the “Select Program” screen

2. Touch Conc button to enter “Select Concentrate” screen 3. Use the Up/Down arrows to choose the prescribed

concentrate

4. Confirm selection with CONFIRM key 5. Select each of the parameters (Na+, Dialysate Flow,

Bicarbonate, Temperature) and enter the prescribed parameters

6. Touch Syringe button and enter prescribed syringe 7. Select each of the parameters (Heparin Rate, Stop Heparin,

Heparin Bolus) and enter the prescribed parameters

8. Touch Blood Pressure button and enter the prescribed alarm limits, Inflation Pressure, and Interval. Set clock time in upper right hand corner of screen.

9. Select each of the parameters (Dry Weight, Tx Time, Max UF Vol) and enter the prescribed parameters

10. Touch Done button to complete entering prescription Prepare for Setup Training Competence

Check Comments

1. Obtain all of your supplies and arrange for convenient access during setup

2. Ensure that water system is running and has been checked according to manufacturer’s specification

3. Press Power key and check if the machine requires rinse or disinfection


Setup Training Competence

Check Comments

1. Remove Acid Concentrate connector and touch Dialysis screen button

2. Check prescribed concentrate is listed and that Na+ and Bicarbonate settings are correct. Press CONFIRM key.

3. Press CONFIRM key and connect red acid connector to acid concentrate jug. Plug blue bicarbonate connector into bicarbonate jug. Provide enough concentrate for a full treatment.

4. Touch Done button to go to the next screen Testing (Tx Setup) Training Competence

Check Comments

1. Explain grayed-out Done button and test progress bar during test

2. Touch Start Test and press CONFIRM to begin testing machine

3. When Status Box reads “Test Complete,” press RESET to clear message

4. Touch Done button to go to the next screen

5. Explain steps required to retest machine after failed test Arterial Line – Screen 1 (Tx Setup) Training Competence

Check Comments

1. Explain components of the blood line set and the functionality

2. Insert dialyzer into holder

3. Hang Drain Bag on posts

4. Snap arterial drip chamber into holder


5. Remove Tape 1 and demonstrate feeding pump segment into pump

a. Open blood pump door, press and hold Start/Stop key until blood pump stops (to align for placement of blood pump segment)

b. Firmly insert left side of pump segment into pump housing and make sure hard plastic piece is below housing

c. Press and hold Start/Stop key until pump segment is fully loaded and blood pump stops

6. Remove Tape 2 and connect arterial line to bottom of dialyzer

7. Insert line into tubing guides and explain risk of kinked lines

8. Touch Done button to go to the next screen Arterial Line – Screen 2 (Tx Setup) Training Competence

Check Comments

1. Connect patient end of arterial line to drain bag

2. Connect transducer protector to arterial pressure port and explain functionality of transducer protectors. Show procedure to change wet TP.

3. Tighten the red and blue recirc connector

4. Close saline clamp

5. Hang Saline Bag

6. Remove Tape 3 and fully insert the priming spike into a bag of saline


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Venous Line (Tx Setup) Training Competence

Check Comments

1. Roll venous chamber into holder; make sure the filter is below the sensor heads

2. Insert line into Venous Clamp and Optical Detector. Explain functionality of both components again.

3. Connect patient end of venous line to drain bag

4. Remove Tape 4 and connect venous line to dialyzer

5. Insert line into tubing guides

6. Connect transducer protector to venous pressure port

7. Close all medication clamps

8. Touch Done button to go to the next screen Prime Blood Side (Tx Setup) Training Competence

Check Comments

1. Demonstrate proper use and function of the level detector

2. Review air detector alarms

3. Stress the importance and function of the air detector and transducers protector

4. Draw up heparin dose into prescribed syringe

5. Prime heparin line, insert your selected syringe, close clamp

6. Open saline line clamp

7. Gravity prime arterial patient line to drain bag

8. Close arterial patient line clamp

9. Turn on the blood pump

10. Touch the Prime button and press CONFIRM to begin priming

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11. Set arterial drip chamber level using the arterial Level Up key on the Blood Pump

12. Touch Done button to go to the next screen Prime Dialysate Side Screen 1 (Tx Setup) Training Competence

Check Comments

1. Verify the following: o Dialysate lines on shunt o Conductivity and temperature stabilized o Independent meter is properly calibrated o Patient has a clean, non-foam container for collection

2. Open shunt door and unsnap blue dialysate line

3. Rinse container and collect sample

4. Close shunt door

5. Open shunt door and snap blue dialysate line back on shunt.

6. Test dialysate with an independent device

7. Enter conductivity

8. Enter pH

9. Press CONFIRM to confirm selection

10. When recirculation is complete, touch Done button to go to the next screen


Prime Dialysate Side Screen 2 (Tx Setup) Training CompetenceCheck

Comments

11. Rotate dialyzer

12. Connect blue dialysate line to venous side of dialyzer and red dialysate line to arterial side of dialyzer

13. Close drain bag clamp and open arterial patient line clamp

14. Touch Recirc Saline and press CONFIRM to begin recirculation

15. When recirculation is complete, touch Done button to go to the next screen

Enter Treatment Parameter (Tx Setup) Training Competence

Check Comments

1. To calculate a new UF goal, touch the UF Calculator button a. Touch the Pre Weight button and enter your weight b. Touch Additional Volume and enter amount c. Press CONFIRM to confirm changes d. Touch Done button to go to the next screen

2. Explain units required for UF calculator and recommend scale with units in kg (not with lbs)

3. Review new UF goal and touch Done button to go to the next screen

Connecting for Treatment (Tx Connect) Training Competence

Check Comments

1. Check that machine has passed all pressure and alarm tests

2. Check that the dialysate is at proper temperature, conductivity, and pH

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3. Check that the dialysate is tested and free of traces of disinfectant

4. Check that machine’s bypass mode is functioning correctly by opening and closing the shunt door and watching the float in the dialyzer line

5. Explain use of integrated Blood Pressure Monitor and the proper placement of blood pressure cuff

6. Prepare vascular access. If prescribed, administer anticoagulant

7. Touch the Tx Connect button to begin connecting for treatment

Flush Saline (Tx Connect) Training Competence

Check Comments

1. Explain why saline is flushed before start of treatment

2. Press the Start/Stop key on the Blood Pump module to stop blood pump

3. Open clamp and gravity flush arterial line to drain bag

4. Close arterial patient clamp

5. Change saline bag

6. Start blood pump and run 300 ml saline into drain bag

7. Stop blood pump and close clamps

8. Verify that line is flushed and set toggle-button to Yes, then CONFIRM.


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Connect Blood Lines (Tx Connect) Training CompetenceCheck

Comments

1. Remove Tape 5

2. Disconnect arterial line from drain bag and connect to arterial access. Stress importance of tight connections.

3. Remove Tape 6

4. Disconnect venous line from drain bag and connect to venous access. Stress importance of tight connections.

5. Open clamps

6. Open heparin line clamp

7. Infuse bolus if prescribed


Start Treatment (Tx Connect) Training Competence

Check Comments

1. Set blood pump speed, turn the blood pump on, and gradually increase the speed to the prescribed blood flow rate

2. Touch the Tx Paused button and press CONFIRM to start treatment

3. Restate how to adjust the level of the arterial drip chamber

4. Explain importance of arterial, venous, and TMP pressure and associated alarm windows

5. Explain importance of having enough concentrate for the entire treatment

6. Calculate TMP


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Monitoring the Treatment (Home Screen) Training Competence

Check Comments

1. Explain how parameters can be adjusted on the home screen, if required

2. Monitor the bloodline connections, arterial, venous, and TMP pressures; DO NOT allow concentrates to run out during treatment

3. Measure and document patient’s vital signs according to home program protocol

4. Address Alarms and Cautions messages without delay End Treatment Training Competence

Check Comments

1. Wait for “UF Goal Reached” message at end of treatment then press RESET

2. Touch the Tx Running button and press CONFIRM to turn off the treatment clock (Tx Paused)

3. Touch the Tx End button to begin disconnection Check Saline (Tx End) Training Competence

Check Comments

1. Stop blood pump

2. Check saline bag volume and change if necessary

3. Close arterial clamps

4. Close clamps


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Return Blood (Tx End) Training CompetenceCheck

Comments

1. Connect arterial line to red recirc connector

2. Open clamps

3. Start blood pump to return blood

4. Touch Done button to go to the next screen Disconnect (Tx End) Training Competence

Check Comments

1. After the blood pump has stopped, close clamps

2. Close venous patient and access line clamps

3. Disconnect venous access line

4. Remove needles or perform catheter care according to home program protocol

5. Touch Done button to go to the next screen Emptying (Tx End) Training Competence

Check Comments

1. Disconnect priming set and attach venous line to blue recirc connector

2. Open clamps

3. Rotate dialyzer

4. Return the blue dialysate connector to shunt

5. Close shunt door to empty


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Cleansing (Tx End) Training Competence

Check Comments

1. Return red dialysate connector to shunt

2. Discard bloodline circuit

3. Return blue bicarbonate connector to port

4. Return red concentrate connector to port

5. Touch Done button to go to the “Select Program” screen Acid Clean and Heat Disinfect Training Competence

Check Comments

1. Explain why the cleaning and disinfection screen prompt (pop-up) on the “Select Program” screen would be displayed and how to clear the message.

2. Return acid and bicarb concentrate connectors to machine ports. The “Select Program” screen will appear

3. Touch the Acid Clean button; the lines will be rinsed

4. “Put Connectors in chem” message will appear. Connect acid concentrate connector to acid and bicarb connector to vinegar

5. Press CONFIRM to start

6. When completed, the message “Put Connectors to ports” will appear. Put acid and bicarb connectors into respective ports and CONFIRM to exit

7. Touch the Heat Disinfect button

8. Machine will shut itself off when done if the “Off After Heat Disin” option is set in Service Mode. If not, press CONFIRM and then press and hold POWER key to turn off machine after the heat disinfect


Acid Clean, Chemical Disinfect and Rinse Training CompetenceCheck

Comments

1. Return acid and bicarb concentrate connectors to machine ports. The “Select Program” screen will appear

2. Touch the Acid Clean button; the lines will be rinsed

3. “Put Connectors in chem” message will appear. Connect acid concentrate connector to acid and bicarb connector to vinegar

4. Press CONFIRM to start

5. When completed, the message “Put Connectors to ports” will appear. Put acid and bicarb connectors into respective ports and CONFIRM to exit

6. Touch the Chemical/Rinse button

7. “Put Red Con in Chemical” message will appear. Connect acid concentrate connector to disinfectant container (yellow connector bottle) and press CONFIRM

8. When completed, the message “Return red wand to port” will appear. Return Acid concentrate connector to machine port and machine will initiate a 15 minute mandatory rinse

9. Test for negative bleach residual according to unit policy. DO NOT interrupt the mandatory rinse cycle. This MUST be completed. Press and hold POWER key to turn off machine once test for bleach is negative

Troubleshooting – Air Detector Alarm Training Competence

Check Comments

1. Explain purpose of air detector 2. Review troubleshooting for air detector alarm

a. Venous Drip Chamber in holder with adequate level of solution?

b. Venous Drip Chamber position with filter below level detector sensors. Cover closed and latched?


c. Raise level by pressing and holding the key on level detector until the level of blood reaches acceptable level.

d. Are sensors clean? If not, clean with alcohol pad. e. Press RESET to reset the alarm f. If unable to reset alarm, have a qualified technician

recalibrate for the model bloodline used Troubleshooting – Blood Pump Stop Alarm Training Competence

Check Comments

1. Explain impact of stopped blood pump and risk of clotting 2. Review troubleshooting for blood pump stop alarm

a. Assure the Blood Pump door is properly closed. b. Check if the pump tubing segment is properly

positioned. Correct if necessary c. Press RESET to reset the alarm. d. Turn BFR to zero and slowly increase flow to

prescribed rate. e. If unable to resume BFR, replace the Blood Pump

Module and resume treatment. f. If Blood Pump Module is not functioning, hand crank

blood to the patient and call a qualified technician.

Troubleshooting – Arterial Pressure Alarm (LOW) Training Competence

Check Comments

1. Explain purpose of monitoring arterial pressure (LOW) and potential impact on patient’s access

2. Review troubleshooting for Arterial Pressure LOW alarm a. Check Arterial tubing for line kinks, clotting, or clamps.b. Check the access needle position and access clots. c. Is BFR too high? d. Arterial Transducer Protector dry and monitor line clear

and unclamped?


e. Press RESET to reset alarm. Press the RESET again and hold for 1 second to select new alarm limits.

f. It may be necessary to start the Blood Pump at a slow speed and gradually work up to desired rate.

g. If unable to reset alarm take machine out of service and call your qualified technician.

Troubleshooting – Arterial Pressure Alarm (HIGH) Training Competence

Check Comments

1. Explain purpose of monitoring Arterial Pressure (HIGH) 2. Explain how to prevent and detect a clotted system 3. Demonstrate how to exchange wet Transducer Protector 4. Explain importance of placing line into tubing guides to

prevent kinking

5. Review troubleshooting for Arterial Pressure HIGH alarm a. Check arterial and venous tubing for line kinks,

clotting, or clamps. b. Clotted kidney? c. Arterial Transducer Protector dry and monitor line clear

and unclamped? d. If wet, clear pressure line and replace Transducer

Protector if necessary. e. Press RESET to reset alarm. Press RESET again and

hold for 1 second to select new alarm limits. f. If unable to reset alarm take machine out of service

and call qualified technician.


Troubleshooting – Venous Pressure Alarm (LOW) Training CompetenceCheck

Comments

1. Explain purpose of monitoring Venous Pressure (LOW) 2. Explain risk of disconnected line or leaking connections 3. Explain importance of tight connections and securing lines at

patient’s access

4. Review troubleshooting for Venous Pressure LOW alarm a. Check for Venous line for loose connections, kinks,

clotting, or loose clamps. b. Check for a disconnected line or leaks. c. Venous Transducer Protector dry, monitor line clear

and unclamped. d. If wet, clear pressure line and replace Transducer

Protector if necessary. e. Press RESET to reset alarm. Press RESET again

and hold for 1 second to select new alarm limits. f. If unable to reset alarm take machine out of service



Troubleshooting – Venous Pressure Alarm (HIGH) Training CompetenceCheck

Comments

1. Explain purpose of monitoring Venous Pressure (HIGH)

2. Explain risk of kinked line

3. Demonstrate how to exchange wet Transducer Protector 4. Review troubleshooting for Venous Pressure HIGH alarm

a. Check Venous tubing for line kinks, clotting, or clampsb. Venous Transducer Protector dry, monitor line clear

and unclamped? c. Replace Transducer Protector if necessary. d. Venous line unclamped during operation. e. Check the needle for position and possible access

clots f. Press RESET to reset alarm. Press RESET again and

hold for 1 second to select new alarm limits. g. If condition persists, reduce blood flow rate. h. If unable to reset alarm take machine out of service



Troubleshooting – TMP Alarm (LOW) Training Competence

Check Comments

1. Explain purpose of monitoring TMP (LOW)

2. Explain risk of leakage in the dialysate circuit

3. Explain the purpose of Online PHT (pressure holding test) 4. Review troubleshooting for TMP LOW alarm

a. Venous Transducer Protector dry, monitor line clear and unclamped?

b. Replace Venous Transducer Protector if necessary. c. Check dialysate lines for kinks. d. Press RESET to reset alarm. Press RESET again

and hold for 1 second to select new alarm limits e. Check the dialysate line filter screen to make sure it is

clean. (on dialysate line behind machine) f. Clean dialysate line filter if necessary. g. Increasing the UF RATE by increasing the UF GOAL

can lower the TMP. Replace with NS as prescribed. h. If unable to reset alarm call qualified technician.


Troubleshooting – TMP Alarm (HIGH) Training Competence

Check Comments

1. Explain purpose of monitoring TMP (HIGH) 2. Explain how ultrafiltration rate, KUF of dialyzer, blood flow,

and dialysate flow can impact TMP

3. Review troubleshooting for TMP HIGH alarm a. Venous Transducer Protector dry and monitor line

clear and unclamped? b. Replace Venous Transducer Protector if necessary. c. Check dialysate lines for kinks. d. Check the dialysate line filter screen to make sure it is

clean. (on dialysate line behind machine) e. Press RESET to reset alarm. Press RESET again

and hold 1 second to select new alarm limits. f. If using a low dialyzer KUF coefficient, the UF GOAL

may need to be lowered. g. Reducing BFR can also be effective h. If unable to reset alarms call qualified technician.

Troubleshooting – 10 Fill in one Hour Alarm Training Competence

Check Comments

1. Explain purpose of Filling Programs to ensure accurate balancing

2. Review troubleshooting for “10 Fill in 1 Hour” alarm a. Check dialysate lines especially around connectors

and dialysate filter, for air entering machine and correct problem.

b. Press RESET to clear. c. If unable to reset:

i. Disconnect the dialysate lines ii. Cap dialysate ports of dialyzer iii. Return blood to patient iv. Call qualified technician.


Troubleshooting – Blood Leak Alarm Training Competence

Check Comments

1. Explain purpose of Blood Leak alarm 3. Review troubleshooting for Blood Leak alarm

a. Press RESET to reset. b. If unable to reset, press OVERRIDE to continue. c. Check dialysate for presence of blood with Hemastix. d. If negative, recheck with Hemastix from new

container. If negative after 3 checks, follow steps below:

i. Press OVERRIDE to run blood pump while trouble-shooting alarm.

ii. Check the dialysate lines air leaks especially at the connectors and the filter

iii. Press RESET to reset alarm. iv. If unable to reset the alarm, return patient’s

blood per unit’s Blood Leak procedure. v. Call qualified technician.

e. If Hemastix is positive for Blood Leak, proceed per facility’s dialyzer blood leak policy. If facility policy is to return patient’s blood, follow steps below:

i. Press RESET to reset all other blood flow alarms.

ii. Press OVERRIDE to enable blood pump to return patient’s blood per unit protocol.


Troubleshooting – Conductivity Alarm (LOW) Training Competence

Check Comments

1. Explain dialysate bypass function 2. Explain importance of sufficient concentrate for complete

treatments

3. Review troubleshooting for Conductivity LOW alarm a. Dialysate Flow ON? b. Correct concentrate selected in the “Dialysate

Composition and Conductivity Limits” screen c. Concentrate lines connected to correct concentrate d. Check for correct baseline Na+ and Bicarbonate

values displayed in “Dialysate Composition and Conductivity Limits” screen

e. The supply of concentrate is adequate f. Concentrate has been mixed properly g. Check that concentrate connectors are pulling

concentrate and tightly connected. If not, check for clogged filter screens in the connector handles, especially the bicarbonate connector

h. If unable to correct conductivity alarm, discontinue treatment and remove patient from the machine.

i. Perform an acid cleaning followed by a complete rinse cycle. Test machine operation. If conductivity alarm persists, take the machine out of service and call a qualified technician


Troubleshooting – Conductivity Alarm (HIGH) Training Competence

Check Comments

1. Review troubleshooting for Conductivity HIGH alarm a. Check for prescribed baseline Sodium and Bicarb. b. Check that concentrates are properly mixed and in

proper containers. Remix concentrates as needed. c. Allow 5 minutes for conductivity to reach prescribed

level and adjust conductivity alarm limits if needed. d. Replace the concentrates if appears fluid is being

pulled into machine but the conductivity remains high. e. After problem corrected, verify conductivity and pH

with an independent device. f. If unable to attain prescribed conductivity, discontinue

treatment and call qualified technician.

Troubleshooting – Temperature Alarm (HIGH) Training Competence

Check Comments

1. Explain importance of stable incoming water temperature 2. Review troubleshooting for Temperature HIGH alarm

a. Assure water is flowing to machine when turned ON. b. If Heat Disinfection just previously done, place

machine in rinse cycle to decrease temperature. c. Check the Temperature setting and readjust if needed

by touching Temperature and adjust with and arrows or numeric keypad.

d. Check water supply temperature for excess temperature and correct if needed.

e. If unable to attain proper dialysate temperature, discontinue treatment and call qualified technician.

f. DO NOT USE HEAT DISINFECTION CYCLE UNTIL REPAIRED.


Troubleshooting – Temperature Alarm (LOW) Training Competence

Check Comments

1. Review troubleshooting for Temperature LOW alarm a. Observe machine is in Dialysis mode with dialysate

flow ON. b. Check water supply to machine for excessively cold

temperature and correct. c. Check the Temperature Setting and adjust using the

and arrows or numeric keypad if needed. d. Check the heater switch on the back panel that it is in

the ON position. e. If unable to attain prescribed temperature, discontinue

treatment. f. Call qualified technician.

Troubleshooting – Dialysate Flow Alarm Training Competence

Check Comments

1. Review troubleshooting for Dialysate Flow alarm a. Check water supply into machine that it is on. b. Check water inlet line for kinks. c. Check that in-line water filter is clean. If clogged

change filter. d. If unable to attain proper dialysate flow, discontinue

treatment and call qualified technician.


Troubleshooting – Heparin Pump Alarm Training Competence

Check Comments

1. Review troubleshooting for Heparin Pump Flow alarm a. Check heparin line for clamps or kinks and correct. b. Check heparin syringe for adequate amount of

heparin and correct if needed. c. Ensure the correct type of syringe is loaded and

locked in place. d. To clear alarm, press RESET and restart heparin

pump. e. If alarm will not reset or continues to alarm

intermittently, alert a qualified technician.

Troubleshooting – Online PHT Failed Alarm Training Competence

Check Comments

2. Review troubleshooting for Online PHT Failed alarm a. Press RESET to clear the alarm. b. Check the machine for liquid leaks. c. Wait 12 minutes until the next test; if the alarm fails

again, take your machine out of service and alert a qualified technician


NOTES: ________________________________________________________________ ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Fresenius Medical Care North America • 2637 Shadelands Drive • Walnut Creek, CA 94598 • 1.800.227.2572

The FMCNA 2008K@home machine is indicated for acute or chronic dialysis treatment in a facility or in the home.In the home, a trained and qualified person as prescribed by a physician must observe the treatment. See the full labeling for

complete descriptions of instructions for use, warnings, hazards, contraindications, side effects, and precautions.

Fresenius Medical Care, the triangle logo, 2008, @ home logo and Diasafe are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies.

© 2011 Fresenius Medical Care North America. All rights reserved. P/N 490167 Rev A 05/2011



2008k home train-the-trainer manual

Documents

trainer manual section

home machine tx setup

home train

tx parameters tx setup

table of contents section

home requirements

home hemodialysis system

home system overview