cardiac monitor pm750 · pdf filethe standard telepatch cardiac monitor pm750 kit comes with...

TelePatch™ Cardiac Monitor PM750

USER MANUAL - UTM0000701-04D | January 06, 2017

TelePatch™

Cardiac Monitor PM750

User Manual INSTRUCTIONS FOR USE

TelePatch is intended for use as prescribed by a physician who wants to follow

cardiac activity. TelePatch is not intended for diagnostic use. A physician must

review and interpret ECG findings recorded during procedure.

Have a question or need assistance?

Call Medicomp Patient Support: 800-234-3278 ext. 2370


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Table of Contents

GETTING STARTED AND INTRODUCTION .................................................................................................... 5

Notices, Cautions, and Copyrights ............................................................................................................ 5

TelePatch Cardiac Monitor User Kit .......................................................................................................... 6

Contact Us ................................................................................................................................................. 9

ABOUT TELEPATCH CARDIAC MONITOR PM750 ......................................................................................... 9

INDICATIONS FOR USE .............................................................................................................................. 9

OVERVIEW ............................................................................................................................................... 10

SAFETY SPECIFICATIONS AND COMPLIANCE ............................................................................................. 10

Contraindication ..................................................................................................................................... 10

Safety Classification ................................................................................................................................ 10

Modifications .......................................................................................................................................... 10

Defibrillation ........................................................................................................................................... 10

System Safety .......................................................................................................................................... 10

COMPLIANCE .............................................................................................................................................. 11

Safety Classification ................................................................................................................................ 11

Radio Frequency Regulatory Compliance ............................................................................................... 11

BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION ....................................................................... 12

TELEPATCH SYSTEM OVERVIEW ................................................................................................................. 14

TelePatch Pendant Description ............................................................................................................... 16

.................................................................................................................................................................... 18

TelePatch Smartphone Description ........................................................................................................ 18

Accessories to the TelePatch System ...................................................................................................... 19

TelePatch Charger Cord ...................................................................................................................... 19

Connecting Charger Cord: Smartphone .............................................................................................. 21

TelePatch Battery Charger .................................................................................................................. 22

Connecting Charger Cord: Battery Charger ........................................................................................ 23

TelePatch Electrode Patch .................................................................................................................. 26

STANDARD PROCEDURE SET-UP ................................................................................................................ 28

Patient Preparation ................................................................................................................................. 29




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Step 1 - Identify Electrode Patch Site...................................................................................................... 29

Step 2 - Prepare the Skin ......................................................................................................................... 29

Step 3 - Electrode Patch Application ....................................................................................................... 30

Step 4 - Turn on Pendant and Connect ................................................................................................... 32

Step 5 - Starting the Smartphone ........................................................................................................... 34

Step 6 - Procedure Set Up ....................................................................................................................... 35

Step 7 - Procedure Settings ..................................................................................................................... 36

Pacemaker Settings ............................................................................................................................. 36

Protocol Setting................................................................................................................................... 37

Set Up .................................................................................................................................................. 38

Start Over ............................................................................................................................................ 38

Step 8 - Initial Procedure Screens ........................................................................................................... 39

Recording Symptoms: Standard TelePatch Procedure ........................................................................... 41

Manual Diary Entry ............................................................................................................................. 42

Audio Diary Entry ................................................................................................................................ 44

PROCEDURE SET-UP: Cable Cradle with Patient Cable ............................................................................ 44

Step 1 - Identify Electrode Sites .............................................................................................................. 44

Step 2 - Prepare the Skin ......................................................................................................................... 45

Step 3 - Snap on Electrodes and Set Up Cable Cradle............................................................................. 46

Step 4 - Start Pendant ............................................................................................................................. 48





Recording Symptoms: Cable Cradle Procedure ...................................................................................... 48

PROCEDURE SET-UP: Fingertip Electrodes ................................................................................................ 49

Step 1 - Start Pendant ............................................................................................................................. 49








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Recording Symptoms: Fingertip Electrode Procedure ............................................................................ 49

COMMON QUESTIONS ............................................................................................................................... 50

How Do I Wear TelePatch System: Electrode Patch and Pendant? ........................................................ 50

How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes? ........................................ 51

Can I Shower? ......................................................................................................................................... 51

Tip For During Shower ............................................................................................................................ 51

Tip For After Shower ............................................................................................................................... 51

Stress Loops ............................................................................................................................................ 52

EMERGENCY AND SUPPORT NUMBERS ..................................................................................................... 52

Call 911 .................................................................................................................................................... 52

PROCEDURE INFORMATION AND CAUTIONS ............................................................................................ 53

TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH ................................................................ 53

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH ........................... 53

TELEPATCH SYSTEM WHEN USING CABLE CRADLE ............................................................................. 54

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE .................................. 54

SMARTPHONE / HANDSET .................................................................................................................. 55

BATTERY CHARGER ............................................................................................................................. 55

PENDANT PRECAUTIONS ............................................................................................................................ 56

ADVERSE REACTIONS ................................................................................................................................. 56

MAINTENANCE ........................................................................................................................................... 57

Cleaning the TelePatch System ............................................................................................................... 57

VISUAL AND AUDIBLE INDICATORS ........................................................................................................... 57

Normal Performance Indicators ............................................................................................................. 57

Error Indicators ....................................................................................................................................... 58

TROUBLESHOOTING ................................................................................................................................... 59

Setup Details and Troubleshooting Overview ........................................................................................ 59

TelePatch System Hookup Testing Information ..................................................................................... 60

Quality Hookup Tests Overview .............................................................................................................. 60

The Setup/Normal Setting ...................................................................................................................... 60

Pacemakers ............................................................................................................................................. 60

Lead Position Test ................................................................................................................................... 61




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Skin Prep Results ..................................................................................................................................... 61

Error Displays .......................................................................................................................................... 61

Voltage Errors after Several Attempts .................................................................................................... 62

Lead Position Tests.................................................................................................................................. 62

Lead Test Error ........................................................................................................................................ 62

High/Low Voltage Notifications .............................................................................................................. 64

LOW VOLTAGE IN CHANNEL A ............................................................................................................ 64

LOW VOLTAGE IN CHANNEL B ............................................................................................................ 64

HIGH VOLTAGE IN CHANNEL A ............................................................................................................ 64

HIGH VOLTAGE IN CHANNEL B ............................................................................................................ 65

SAMPLE SCREEN WARNINGS ..................................................................................................................... 65

Screen Warnings ..................................................................................................................................... 65

Unable to find Pendant ........................................................................................................................... 65

Pendant is Turned Off ............................................................................................................................. 66

Procedure Has Ended .............................................................................................................................. 66

Start Procedure Exceptions ..................................................................................................................... 66

Selecting a Pendant ............................................................................................................................. 66

SAFE BATTERY USE AND DISPOSAL ............................................................................................................ 66

Safely Loading the Pendant Battery ........................................................................................................ 67

Battery Maintenance .............................................................................................................................. 69

Disposal of Rechargeable Lithium Ion Batteries ..................................................................................... 69

EXPLANATION OF MARKINGS .................................................................................................................... 69

EXPECTED LIFE ............................................................................................................................................ 71

PENDANT SPECIFICATIONS......................................................................................................................... 72

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ................................................ 73

Recommended separation distances between portable and mobile RF communications equipment and

the PM750 ................................................................................................................................................... 75




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GETTING STARTED AND INTRODUCTION

Notices, Cautions, and Copyrights

CAUTION: FEDERAL LAW RESTRICTS TELEPATCH CARDIAC MONITOR PM750 FOR SALE

BY, OR ON THE ORDER OF, A LICENSED MEDICAL PRACTITIONER. THE DATA

OBTAINED FROM THE PENDANT IS FOR THE REVIEW BY A PHYSICIAN. IT IS

RECOMMENDED THAT A PHYSICIAN OVERREAD THE RESULTS.

THIS TELEPATCH CARDIAC MONITOR PM750 IS NOT INTENDED FOR USE BY USERS WHO ARE

UNABLE TO ACTIVATE THE SYMPTOM BUTTON WHEN THEY ARE EXPERIENCING A SYMPTOM.

USERS SHOULD BE SUPERVISED IF UNABLE TO ACTIVATE THE SYMPTOM BUTTON ON THEIR

OWN.

TelePatch™ Cardiac Monitor PM750 is a product of Medicomp, Inc.

Medicomp, Inc. is the manufacturer and provider of TelePatch products and services. TelePatch

is a trademark of Medicomp, Inc. ©2016 Medicomp, Inc. All rights reserved.

COPYRIGHT MEDICOMP, INC. 2016 ALL RIGHTS RESERVED. NO PART OF THIS PUBLICATION MAY

BE REPRODUCED OR DISTRIBUTED IN ANY FORM OR BY MEANS WITHOUT PRIOR WRITTEN

PERMISSION FROM MEDICOMP, INC.




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TelePatch Cardiac Monitor User Kit

The standard TelePatch Cardiac Monitor PM750 kit comes with:

1. TelePatch Pendant

2. Electrode Patch with Cradle

3. Rechargeable Batteries

4. TelePatch Smartphone

5. Battery Charger

6. Charger Cord for both Smartphone and Battery Charger

7. Electrode Prep Pad

8. Quick Start Patient Guide

9. Survey Invitation

10. Return Envelope with Pre-paid Shipping Label

TelePatch Cardiac Monitor Kit




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TELEPATCH KIT CONTENTS

Item Quantity Picture

TelePatch Pendant 1

Electrode Patch with Cradle* 1 - 4

*Kit will have one or the other patch style, single or double is based on procedure prescribed by physician

Rechargeable Battery 2

TelePatch Smartphone* 1 *Holter procedures do not require a Smartphone




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Battery Charger 1

Charger Cord for Smartphone

and Battery Charger 1

Quick Start Patient Guide 1

Electrode Prep Pad 1

Survey Invitation 1

Return Envelope with Pre-paid Shipping Label 1

Legal Booklet 1 PICTURE TO BE ADDED

These items are not standard in TelePatch Kit. By physician request only

Cable Cradle 1

Cable 3-lead or 5-lead 1

Electrodes (3-5 per pouch) 1- 4

Breakaway Lanyard 1




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Contact Us

Contact Medicomp, Inc. for any issues concerning the TelePatch product such as: • General questions about our product • Product safety • Safe disposal of component parts • Return of product Contact information

Medicomp, Inc. 600 Atlantis Rd. Melbourne, FL, 32904 Website: www.medicompinc.com

Telephone: 800-23 HEART (800-234-3278) Fax: 321-676-2282 email: [email protected]

ABOUT TELEPATCH CARDIAC MONITOR PM750

INDICATIONS FOR USE

The TelePatch Cardiac Monitor PM750, is a pager-sized, handheld or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device is designated as Rx only, to be worn by infants to adults of all ages. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.




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The TelePatch Cardiac Monitor System

OVERVIEW

Users of the TelePatch System should be able to activate the Symptom button unassisted or be supervised and assisted. The TelePatch System can be worn by users weighing less than 10kg. TelePatch is intended for use as prescribed by a physician who wants to follow cardiac activity. A physician must review and interpret ECG findings recorded during procedure. The TelePatch System is not intended for diagnostic use.

SAFETY SPECIFICATIONS AND COMPLIANCE

Contraindication

There are no potential adverse effects of the TelePatch Cardiac Monitor, PM750 on health.

Safety Classification

In accordance with IEC 60601-1 Third Edition Am 1: 2012:

● This equipment is designed to be operated with one 3.7V 440mAh 1.62Wh lithium ion battery, and under no circumstances shall

power be supplied in any other manner.

● Type BF equipment.

● Rated for Continuous Operation.

● Ordinary Equipment. Enclosed equipment. The device is protected to IP55 as required by the standard.

● This equipment shall not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide, or

flammable cleaning agents.

● Equipment with an Applied Part, specifically designed for applications where a Conductive Connection is made to the Patient, but

not directly to the heart.

● The equipment requires no adjustment.

● Operating and Storage Humidity: 10% to 95%, non-condensing

● Operating Temperature: 0°C to 45°C (32°F to 284°F).

● Storage Temperature: -15°C to 60°C (5°F to 140°F).

● TelePatch System Shipment: Temperature limitation for shipment: -15°C to 60°C (5°F to 140°F).

● Atmospheric Pressure: Operating: 700 hPa to 1060 hPa; Storage/Transport: Not Applicable to TelePatch System

The equipment contains no user-serviceable parts. It shall be serviced only by Medicomp, Inc. Unauthorized repairs of the equipment will void

the warranty.

Modifications

For continued safety, equipment should not be modified in any manner and must be used only as indicated.

Defibrillation

The external parts of the equipment may provide a source of the defibrillation voltage if it is not removed from the patient during defibrillation.

Due to the small size of the unit and patient connectors, the cable or connector may break down and cause the defibrillation voltage to be

shunted and make it less effective for the patient. The unit and cable MUST be removed prior to defibrillation.

System Safety

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data

processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or

clause 16 of the 3Ed. of IEC 60601-1, respectively). Anybody connecting additional equipment to medical electrical equipment configures a




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medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn

to the fact that local laws take priority over the above mentioned requirements. If in doubt, consult your local representative or the technical

service department

WARNINGS

USE THE TELEPATCH SYSTEM ONLY WITH THE LEADS, ELECTRODES, AND ACCESSORIES RECOMMENDED BY MEDICOMP. USE OF

OTHER ACCESSORIES MAY ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE OR MAY RESULT IN STRONGER

ELECTROMAGNETIC EMISSIONS OR REDUCE THE ELECTROMAGNETIC IMMUNITY OF TELEPATCH CARDIAC MONITOR PM750

CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR CF APPLIED PARTS, INCLUDING NEUTRAL

ELECTRODE, SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING EARTH.

USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP WHILE THAT DEVICE IS TURNED ON. THE

OPERATION OF THESE PENDANTS INTERFERES WITH THE TELEPATCH’S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE

DEVICES SHOULD BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH.

DO NOT USE THE TELEPATCH IN COMBINATION WITH EXTERNAL CARDIAC DEFIBRILLATORS OR HIGH FREQUENCY SURGICAL

EQUIPMENT.

PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT CAN AFFECT MEDICAL ELECTRICAL EQUIPMENT. THIS PENDANT

SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT.

LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE TELEPATCH CARDIAC MONITOR BATTERY

COMPARTMENT.

LEAD FAILURES ARE DETECTED BY A 10 MV PEAK, 50% DUTY CYCLE RECTANGULAR PULSE, WHICH IS APPLIED TO EACH PATIENT

ELECTRODE CONNECTION THROUGH A 4.9MOHM RESISTOR AT A RATE OF 15 HZ WITH RESPECT TO THE SYSTEM GROUND.

THIS IS A PRESCRIBED MEDICAL DEVICE, NOT A TOY, INFANTS AND CHILDREN MUST BE SUPERVISED.

WARNING: CHOKING HAZARD – ADULT SUPERVISION REQUIRED

IN THE EVENT OF A DAMAGED PENDANT, DISCONTINUE USE AND CALL MEDICOMP PATIENT SUPPORT: 800-234-3278 EXT. 2370,

FOR RETURN AND REPLACEMENT.

COMPLIANCE

Safety Classification

In accordance with IEC 60601-1 Third Edition Am 1:2012 :

Conformance to Standards – non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B

Medicomp, Inc.’s Quality System conforms to 21 CFR 820 and ISO 13485:2003

Radio Frequency Regulatory Compliance

Conformance to Standards

Non-clinical testing demonstrated conformance to voluntary safety IEC 60601-1 and to IEC 60601-1-2-2001 Class B

Medicomp, Inc.’s Quality System conforms to 21 CFR 820 and ISO 13485:2003

This Pendant contains transmitter module FCC ID:

Model Name: TAS0000700

FCC ID: 2AGDTPM750

IC account number/IC company number: 21061-PM750

CAN ICES-3 (B)/NMB-3(B)”

This Pendant complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This Pendant may not cause

harmful interference, and (2) this Pendant must accept any interference received, including interference that may cause undesired operation.

Part 15 Clause 15.105

Note: This equipment has been tested and found to comply with the limits for a Class B digital Pendant, pursuant to part 15 of the FCC Rules.

These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates

uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference

to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does

cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is

encouraged to try to correct the interference by one or more of the following measures:

—Reorient or relocate the receiving antenna.

—Increase the separation between the equipment and receiver.

—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.




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—Consult the dealer or an experienced radio/TV technician for help.

Part 15 Clause 15.21

Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the

equipment

This Pendant complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this

Pendant may not cause interference, and (2) this Pendant must accept any interference, including interference that may cause undesired

operation of the Pendant.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux

deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage

radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. »

Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved

for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen

that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication.

Conformément à la réglementation d'Industrie Canada, le présent émetteur radio peut fonctionner avec une antenne d'un type et d'un gain

maximal (ou inférieur) approuvé pour l'émetteur par Industrie Canada. Dans le but de réduire les risques de brouillage radioélectrique à

l'intention des autres utilisateurs, il faut choisir le type d'antenne et son gain de sorte que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne

dépasse pas l'intensité nécessaire à l'établissement d'une communication satisfaisante.

BUTTONS, ICONS AND SCREEN INDICATOR DESCRIPTION

Below is a detailed description of TelePatch Icons and Screen Indicators.

USER GUIDE DESCRIPTIONS FOR SCREEN INDICATORS AND ICONS ARE FOR USE WITH THE

TELEPATCH SMARTPHONE APPLICATION ONLY AND NOT FOR NORMAL CELLULAR PHONE

USAGE.

TELEPATCH APPLICABLE BUTTONS

The Smartphone POWER Button

This is the Smartphone POWER button. It is located on the top, RIGHT side of the Smartphone.

Front View Side View




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The Pendant POWER Button

This is the Pendant POWER button. It is located on the FACE of the Pendant.

The Pendant Symptom Button

This is the Pendant Symptom button. It is located in the center of the FACE of the Pendant. Users push the Symptom* button to manually initiate the recording of symptoms that they may be experiencing. (*Symptom capture can also be initiated on the Smartphone)

The Smartphone Needs Charging Indicator

Smartphone will have red flashing LED at top of Smartphone when battery is low. This LED will stop flashing when plugged into the Charger Cord and Smartphone is charging.

The Smartphone Charged Light Indicator

There is no light indicator showing Smartphone is charging or full charged. Smartphone battery percentage will read 100%.

TELEPATCH APPLICABLE TOUCH KEYS - Smartphone

Start Procedure

Initiates procedure for the TelePatch system.

Symptom Button

Press when experiencing a symptom.

FREQUENT SCREEN ICONS AND INDICATORS

Cell Network Strength Icon




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3G Connectivity Icon

Bluetooth Connectivity Icon

The Smartphone Battery Strength Indicator

This is the Smartphone Battery Strength Indicator in percentages. This is located in the lower left corner of the Smartphone screen once Bluetooth communication has been set up. In this example, the Smartphone battery strength is 100 percent.

Pendant Battery Strength Indicator

This is the Pendant Battery Strength Indicator in percentages. This is located in the lower right corner of the Smartphone screen once Bluetooth communication has been set up. In this example, the Pendant battery strength is 40 percent.

The Bluetooth Communication Indicator

This is the Bluetooth communication Indicator. Once Procedure Setup has been completed and communication with the Pendant has been established, ' BT' will appear in the bottom left side of the Smartphone screen.

TELEPATCH SYSTEM OVERVIEW




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Below is a graphical overview of the TelePatch System. Detailed description of icons, buttons,

and screen indicators are in previous section.

KEY DESCRIPTIONS PROVIDED BELOW ARE FOR USE WITH THE TELEPATCH APPLICATION

ONLY. KEY DESCRIPTIONS ARE NOT INTENDED FOR NORMAL CELLULAR PHONE USAGE.

Front of TelePatch Pendant Back of TelePatch Pendant

Front of TelePatch Smartphone Back of TelePatch Smartphone

PENDANT AND SMARTPHONE PICTURED ARE NOT ACTUAL SIZE.




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TELEPATCH CARDIAC MONITOR DESCRIPTION

TelePatch Pendant Description

Below is an overview of the TelePatch Pendant, which is part of the TelePatch Cardiac Monitor

System. The TelePatch Pendant is very light-weight. It is a light gray, pager-sized ECG data

collecting Pendant.

The Pendant SYMPTOM Button

The TelePatch Pendant has a Symptom* button which is located in the center of the face of the

Pendant. (*Symptoms can also be initiated on the Smartphone screen). The Symptom button

has two raised bars so it can be distinguished from power button by touch.

The Pendant POWER Button

The Pendant POWER button is located on the face of the Pendant, below the Symptom button.




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Fingertip Electrode Accessory

The fingertip electrode is built into the TelePatch pendant. Fingertip electrodes are used when

the patient cannot tolerate wearing the Electrode Patch or individual electrode patches.

Fingertip electrode procedures should be performed only after consulting your physician.

Detailed directions about fingertip electrode procedures begin on page 49.

TelePatch Battery

Bottom and top views of the TelePatch lithium ion battery

TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the

battery well of the back of the TelePatch Pendant.




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THE RECHARGEABLE BATTERY PROVIDED WITH THE TELEPATCH SYSTEM IS NOT TO BE

DISCARDED IN HOUSEHOLD WASTE. IF A BATTERY GETS DAMAGED CONTACT MEDICOMP, INC.:

877-996-5553

TelePatch Pendant

Battery Well Battery properly inserted in Battery Well

Detailed directions to change and charge the battery properly are found on page 25 or page 68.

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY,

OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE

PENDANT BELOW THE SYMPTOM BUTTON.

TelePatch Smartphone Description

Below is an overview of the TelePatch

Smartphone, which is part of the

TelePatch System.




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Accessories to the TelePatch System

TelePatch Charger Cord

The TelePatch Charger Cord is compliant for use with the Smartphone and the Battery Charger.

Both are components of the TelePatch System. The Charger Cord is a two piece device:

MicroUSB Cable AC Power Supply

MicroUSB Cable SKN6430A / S13239-0403532

AC Power Supply SPN5504A / S004ASU0510085




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Details pertaining to pertinent electrical specifications are provided below.

MicroUSB cable

Connector type Micro-USB

AC Power Supply

INPUT 100-240V~ 50/60Hz 0.2A

OUTPUT 5.1V=850mA 13262-1109957

The TelePatch Charger Cord will replenish battery power when the Smartphone power or

Pendant Battery is depleted. When the Smartphone is turned on, the Smartphone battery

indicator lets users know when the battery life of the Smartphone and the Pendants Lithium Ion

Battery are depleting. Icons are displayed on the screen of the Smartphone.

For optimal performance from the Smartphone, it is recommended to plug the charger cord

into the Smartphone overnight until the Smartphone is fully charged. Instructions on charging

the Smartphone are on page 22 of this User Manual.

TelePatch Pendant Batteries will need to charge every seven (7) days on average. There are two

(2) lithium ion batteries in the TelePatch Kit, so the procedure will not be interrupted.

Instructions about how to charge the Pendant Battery can be found in the charging the

Batteries section of this User Manual.

How to attach USB Cable to AC Power Supply block:

Should the Charger Cord come apart or if the Charger Cord is in two pieces (the MicroUSB cable

and the Power Supply) when the TelePatch Kit is received, insert the USB connector into the

port on the power supply. Keep the two pieces connected for the duration of the procedure.




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SMARTPHONE AND BATTERY CHARGER ARE POWERED BY THE CHARGER CORD ONCE

CHARGER CORD IS PLUGGED IN TO SMARTPHONE OR BATTERY CHARGER AND THEN A

WALL OUTLET.

CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE OBJECTS AND

REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET EASILY, AS NEEDED.

Connecting Charger Cord: Smartphone

The port for the Charger Cord is located on the left side of the smartphone near the bottom

Charger properly inserted

Correct direction of charger head

Incorrect direction of charger head




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Connecting the Charger Cord to the Smartphone:

Take the end of the Charger Cord and insert it into the lower left side of the Smartphone as

displayed in the graphic. The side of the Charger Cord plug-in with the indented circle is the

correct way to insert in the Charger Cord into the Smartphone.

WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE POWER

OUTLET AND THE SMARTPHONE.

MAKE SURE WALL OUTLET IS NOT CONTROLLED BY A LIGHT SWITCH.

SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS PLUGGED

IN TO BOTH SMARTPHONE AND WALL OUTLET.

CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND


UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING

SMARTPHONE IN POCKET OR PURSE/BRIEFCASE. DO NOT WEAR THE SMARTPHONE

WHILE THE CHARGER IS ATTACHED TO THE SMARTPHONE.

TelePatch Battery Charger




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Battery Charger – Top Battery Charger - Bottom

TelePatch rechargeable batteries have an approximate seven (7) day life before needing to be

recharged. The TelePatch Kit has two (2) batteries, a Battery Charger and a Charger Cable (also

used to charge the Smartphone).

TelePatch Pendant batteries need to be changed when the Pendant indicates the battery is low

on power: the orange LED will blink continuously on the face of the Pendant, and the Pendant

will chirp every 4 minutes. The battery level can also be seen on the Smartphone screen.

Using the Charger Cord with the TelePatch Battery Charger

The TelePatch Battery Charger will replenish battery power when lithium ion battery power is

depleted. The same Charger Cord used to charge the Smartphone is used to power the Battery

Charger.

For optimal performance from the Battery Charger, it is recommended to plug the Charger Cord

into the Battery Charger and a wall outlet until the battery is fully charged. The indicator light

on the flat end of the charger, next to the Charger Cord outlet, is flashing orange while

charging, and steady green when fully charged. The Battery Charger will stop charging the

battery once fully charged.

Connecting Charger Cord: Battery Charger

● Place the Battery Charger on a flat, dry surface, near a wall outlet

● Plug Charger Cord into the corresponding outlet on the Battery Charger

● Plug the Charger Cord into the wall outlet




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Charger Cord properly inserted into Battery Charger

Correct direction of Charger Cord head

Incorrect direction of Charger Cord head

Charging a Battery in the Battery Charger

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. TO ENSURE

SAFE CHARGING AND MAXIMUM PERFORMANCE OVER THE LIFE OF THE PRODUCT ALWAYS

USE THE MEDICOMP PROVIDED CHARGER. DO NOT ATTEMPT TO CHARGE THE BATTERY ON

ANOTHER MANUFACTURER’S CHARGER.

Place a Battery from the TelePatch Kit into the Battery Charger, with the Medicomp

label facing up and the two small tabs into the notches

Slide the latch at the back of the Battery to the left, securing the battery in place. The

Battery is locked in place when the latch is below the BLUE lock icon




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Battery IS NOT locked in the charger Battery IS correctly locked into charger

A light at the end of the Battery Charger, next to the Charger Cord, will turn green when

the battery is fully charged.

Flashing Orange Light: Battery is charging Green Light: Battery is charged


BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS

PLUGGED IN TO BOTH BATTERY CHARGER AND WALL OUTLET.




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CHARGER CORD MUST NOT BE OBSTUCTED BY FURNITURE OR LARGE OBJECTS AND


THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL

BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN’T USED. TO

ENSURE OPTIMAL PERFORMANCE AND LIFETIME OF THE BATTERY PACK, PLEASE

FULLY CHARGE THE BATTERY AT LEAST ONCE EVERY 6 MONTHS REGARDLESS OF USE. IT IS

FURTHER RECOMMENDED THAT IF THE BATTERY HASN’T BEEN CHARGED MORE RECENTLY

THAN A MONTH AGO THAT IT BE FULLY CHARGED PRIOR TO THE START OF A PATIENT

PROCEDURE.

DO NOT STORE BATTERIES IN THE BATTERY CHARGER.

TelePatch Electrode Patch

Single Channel Electrode Patch with Cradle

Dual Channel Electrode Patch with Cradle

The TelePatch Pendant slides into the cradle on the Electrode Patch.

Placing Pendant into Electrode Patch cradle

● Slide Pendant into cradle with lock facing down into cradle.




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● The Pendant is correctly placed when it clicks into cradle

Single Channel Electrode Patch

Dual Channel Electrode Patch

Single Channel Electrode Patch supports modified lead II with reference right leg drive.

Dual Channel Electrode Patch supports Channel A modified lead II, Channel B modified

III and a reference electrode.

THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH

IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE.

MAKE SURE TO REMOVE THE TELEPATCH PENDANT FROM THE CRADLE BEFORE

DISCARDING THE ELECTRODE PATCH. THE PENDANT IS TO BE INSERTED IN CRADLE OF FRESH

ELECTRODE PATCH TO CONTINUE PROCEDURE.




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Description of Patch and Patch Packaging

Electrode Patch

Description Medical sensor electrode, Foam, 1.5” teardrop shape, wet gel

Gel Wet Gel 7% KCL

Gel Sponge Polyurethane (reticulated foam)

Substrate Polyester printed with black ink

Foam polyethylene foam with acrylic adhesive

Conductive Ink Ag/AgCl

Insulator Blue UV Dielectic

Release Liner Polystyrene (HIPS) with silicone release

Connector 5 Pin Housing

Packaging

Pouch

Material 25# Paper/7.2#LOPE/.0003 Foil/14# LDPE (minimum)

Dimensions 7”x11”

Pouch Contents

Printed Circuit Sensor

STANDARD PROCEDURE SET-UP

TelePatch Electrode Patch Procedure




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Patient Preparation

This section contains step-by-step instructions that describe how to prepare patient for a

TelePatch Cardiac Monitor procedure with the Electrode Patch. Follow the skin preparation

sequence as closely as possible. This will greatly enhance the ECG signal quality and optimize

analysis.

Patch Placement for the TelePatch Procedure

Step 1 - Identify Electrode Patch Site

Refer to the figure below for proper patch placement:

Dual Channel and Single Channel Electrode Patch Placement

Step 2 - Prepare the Skin

Because the Electrode Patch will be worn for up to seven (7) days, proper skin preparation is

important for the procedure. Good skin preparation means better ECG signal traces that, in

turn, are easier for the doctor to review and evaluate. In order to obtain the best ECG

recording, the following procedure is recommended for initial hookup:

1. Whenever possible, be in an upright sitting position. This may be useful if any setup

problems occur that concern the signal voltage.

2. Following the placement diagram, select sites that are flat. Avoid skin folds or creases,

irritated skin or scar tissue, and highly muscular areas.

3. If necessary, shave an area at the patch site slightly larger than the size of the Electrode

Patch.

4. If powder, lotion, sun block, etc. has been applied to the chest or if skin is excessively

oily, wash site with plain soap and water. Do not use a soap that contains lotion or oil.




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5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and

prepare skin for initial application.

The above skin prep procedure is only required at the beginning of the procedure, during

Smartphone initialization. Users will not be required to perform this type of preparation each

time they apply a new Electrode Patch. It is best for users to have freshly showered with plain

soap each time they apply new Electrode Patches (about every 7 days).

If patch has connectivity issues the skin can be lightly abraded each electrode site with a

rough wash cloth, or an abrasive pad.

Step 3 - Electrode Patch Application

Applying TelePatch Patch

● Prepare skin, as shown in Step 2.

● When ready to position Electrode Patch on skin, remove backing from Electrode Patch,

apply to chest, using placement in the illustration. This can be done before inserting

Pendant in the cradle or after.

● Press Electrode Patch firmly onto skin with fingers once correctly positioned on the left

side of chest (Below collarbone).

● Once it is firmly adhered to skin peel remaining white tabs on the patch so the whole

surface of the patch is adhered to skin.

THE MEDICOMP ECG ELECTRODE PATCH IS SINGLE USE, NON-STERILE, AND DISPOSABLE

AND IS TO BE USED ON INTACT (UNINJURED) SKIN.




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PRODUCT SHELF LIFE IN INTACT, ORIGINALLY SEALED PACKAGING IS 12 MONTHS.

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP

PROCEDURE INITATION ERRORS FROM OCCURRING.

CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR

CF APPLIED PARTS, INCLUDING NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER

CONDUCTIVE PARTS, INCLUDING EARTH.

Wearing TelePatch

● The Electrode Patch should stay in position about seven (7) days on average.

● The cradle on Electrode Patch holds the Pendant.

● Leave the Electrode Patch in place until it no longer remains adhered or as ordered by

physician.

● The Electrode Patch with the TelePatch Pendant in the cradle can be worn in shower

during procedure, pat dry with a towel once shower is complete.

● Do not go swimming while wearing Electrode Patch or Pendant during procedure.

● The Electrode Patch should be disposed of when changed for a fresh Electrode Patch or

at the completion of the procedure. For additional patches for your procedure contact

Medicomp Patient Care: 877-996-5553

DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR

SUBMERGED IN WATER DURING PROCEDURE.

THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED

FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH

ELECTRODE PATCH.

THE TELEPATCH ELECTRODE PATCH IS A SINGLE USE ITEM. ONCE THE ELECTRODE PATCH

IS REMOVED FROM THE SKIN IT SHOULD BE DISCARDED AS HOUSHOLD WASTE.




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Step 4 - Turn on Pendant and Connect

Insert a Battery into the Pendant Remove the Pendant from the TelePatch Kit. Hold the Pendant face down in hand or place on a flat surface. There is a well where the

Battery will be inserted. Insert the Battery into the opening, with the Medicomp label facing up and the two

small tabs into the notches, as pictured.

Slide the latch at the back of the Battery to the left, securing the Battery in place

Battery is NOT secure in Pendant – unlocked Battery IS secure in Pendant - Locked

Turn the Pendant over, slide the Pendant into the Electrode Patch Cradle with the lock

facing down into the cradle. The Pendant is correctly placed when it clicks into the Electrode Patch Cradle.




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Turn the Pendant on:

Press and hold the power button on the face of the Pendant until the Pendant green LED flashes.

For a Holter procedure (24 hour to 96 hour)

o Press the Symptom button three (3) times

For all other procedures (7 day to 30 day) o The Pendant will initiate on its own. o If Pendant does not turn on its own, press Power button to turn on pendant

During the TelePatch Procedure:

Wear and Electrode Patch and TelePatch Pendant all day and all night. A physician will determine the duration of the TelePatch procedure. The Electrode Patch will stay in position for seven (7) days, on average. The Pendant should always be in the Electrode Patch Cradle. TelePatch Pendant and Electrode Patch can be worn in the shower and during exercise.

All regular activities can be enjoyed during a TelePatch procedure.

TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT.

PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS




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IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE ON/OFF BUTTON IS LOCATED ON THE FACE OF THE PENDANT.

THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD BE REMOVED

FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN THE CRADLE OF THE FRESH

ELECTRODE PATCH.

IMPORTANT NOTE: If setting up a 24 hour – 96 hour Holter procedure, the procedure set-up is

complete at this point. The Smartphone is not used with Holter procedures.

Step 5 - Starting the Smartphone

Before using the Smartphone:

Charge the Smartphone until it is fully powered. If it is not fully charged (low) a red LED will flash in the upper left corner of the face of the Smartphone.

Take the Smartphone and turn it on by pressing and holding the POWER button which is located in the upper right side of the Smartphone.

Wait for the Medicomp main screen to appear on the screen before continuing with standard procedure setup.

Tap “Start Procedure.”




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Medicomp TelePatch Smartphone Main Screen

Step 6 - Procedure Set Up

After identifying Electrode Patch site, preparing the skin, applying the Electrode Patch and, turning on the Pendant, turning on the Smartphone, the patient is now ready for 'Procedure Setup' with the TelePatch System. The steps are described below. After following the instructions on the patient preparation screen, which may have already been completed, the next step is to select the correct settings before starting a procedure.

Medicomp TelePatch Smartphone Patient Preparation Screen

Tap “OK”




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Step 7 - Procedure Settings

After following the instructions on the patient preparation screen, the next step is to select the correct settings before starting a procedure. Follow the instructions below on how to select the necessary procedure settings from the TelePatch System. The Procedure Setup screen will display the default settings, which are: Patient has Pacemaker = No Protocol = Standard Setup = Normal

Medicomp TelePatch Smartphone Procedure Set Up Screen

Choose “Accept Settings” or change settings from this screen. To accept default settings:

Tap “Accept Settings” OR to change settings:

Tap the setting to be changed

Pacemaker Settings

The following describes the steps and screens when 'Pacemaker' is selected as a setting. To select a setting for pacemakers:

Tap “No”

Tap option desired.

If the patient desires to change more settings, then repeat the steps above for Protocol




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and Setup.

After all the correct settings have been chosen.

Tap “Accept Settings”

If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the Smartphone displays a screen of QRS during the procedure setup. Then it will display the settings. Please select “Yes” to accept this step.

After all the correct settings have been chosen.

Tap “Accept Settings”

Pacemaker Setup Screens

For additional standard procedure setup instructions, go to patient preparation.

Protocol Setting

'Protocol' has three (3) sub-options. More information pertaining to those options is provided below.

Standard - “Standard” is the default for adult users.

Atrial Fib - Use “Atrial Fib” for users who have permanent Atrial Fibrillation.

Pediatric - Use “Pediatric” for users under 16 years of age. Users should check with child's Pediatrician to verify heart rate. The Pediatric protocol sets Normal Sinus Rhythm at 80-150bpm. To select a setting from protocol: To apply 'Protocol' as a setting:

Tap “Standard”

Tap desired Protocol

Press “Accept Settings”




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For additional standard procedure setup instructions, go to PATIENT PREPARATION.

THE TELEPATCH SYSTEM CAN BE USED FOR INFANTS WEIGHING LESS THAN 10KG.

“TEST”SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE SUPERVISION AND GUIDANCE OF A MEDICOMP CARDIAC MONITORING CENTER (CMC) TECHNICIAN. CALL THE CMC FOR GUIDANCE IN “TEST” MODE.

Set Up

All TelePatch systems will be shipped in “Normal” mode. There is therefore, no need to instruct users on how to select the “Normal” mode. The following instructions describe the steps and screens for selecting “Test” mode. To apply the “Test” mode: • Tap “Normal” • Tap “Test” on drop down menu If there are additional settings changes desired, repeat the steps above for Pacemaker and Protocol. After all the correct settings have been chosen, • Tap “Accept Settings” An example of a test result screen for the Skin Prep is provided below.

Skin Prep Test Result

For additional standard procedure setup instructions, go to PATIENT PREPARATION. If a mistake is made during the procedure setup process, the set up can Start Over.

“START OVER” WILL ERASE ALL PREVIOUS SETTING SELECTIONS IN ORDER TO START THE ENTIRE PROCEDURE SETTINGS PROCESS FROM THE VERY BEGINNING.

Start Over

• Tap “Start Over” button This will erase all previous setting selections in order to start the entire procedure settings




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process over from the very beginning.

Protocol: The protocol is an integral part of the auto capture capability. It may be defined as a set of guidelines that the ECG analysis algorithm uses in identifying clinically-significant events. For example, the normal heart rate in Standard protocol is 60-100 bpm.

Pediatric Protocol: this range is 80-150 bpm. Therefore, the TelePatch System would not trigger to generate recordings for heart-rate events of 140 bpm if the protocol had been set to Pediatric, but would trigger if it had been set to Standard.

For additional standard procedure setup instructions, go to PATIENT PREPARATION.

Step 8 - Initial Procedure Screens

After applying and accepting the procedure settings, the procedure will initialize.

Medicomp TelePatch Smartphone Scanning for TelePatch Pendant

The TelePatch system will first collect ECG data, then the ECG Data will appear on the screen for a short time, then the screen

Medicomp TelePatch Smartphone Initializing Procedure

Medicomp TelePatch Smartphone ECG Baseline Reading




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will display “Monitoring.”

'Monitoring' will be displayed the majority of the time during a procedure.

The Medicomp TelePatch Smartphone Monitoring Screen

The TelePatch procedure is now running.

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY, OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FACE OF THE PENDANT. DEPENDING ON THE SETTINGS, AND THE PATIENT PREPARATION, SOME INTERMITTENT CONFIRMATION AND/OR ERROR SCREENS MAY APPEAR DURING THE INITIALIZATION. PLEASE PERIODICALLY CHECK THE PENDANT AND/OR SMARTPHONE TO ENSURE THEY ARE BOTH IN MONITORING MODE. THIS MEANS THE PENDANT IS BLINKING BLUE LED

LIGHTS, AND THE SMARTPHONE DISPLAY STATES ‘MONITORING’.

THE TELEPATCH SYSTEM IS DESIGNED TO OPERATE IN ENVIRONMENTS THAT MAY EXPERIENCE TRANSIENT ELECTRICAL EVENTS LIKE ELECTROSTATIC DISCHARGE (ESD).

TELEPATCH IS DESIGNED TO BE RESISTANT TO SUCH EVENTS AND WILL TYPICALLY CONTINUE TO OPERATE NORMALLY. A SEVERE ESD EVENT MAY CAUSE THE DEVICE TO SHUT DOWN IN ORDER TO PROTECT THE MEMORY. IF A SHUTDOWN OCCURS, MANUALLY POWER THE DEVICE ON USING THE POWER BUTTON ON THE FRONT OF THE DEVICE. ONCE POWERED ON, TELEPATCH SHALL RESUME NORMAL OPERATION WITH NO LOSS OF FUNCTIONALITY OR INFORMATION.




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Best Practices for using the Smartphone and the Pendant Keep the Smartphone charged and turned on Keep Smartphone within 10’ of the Pendant during procedure Review how to record a SYMPTOM, make a Diary Entry Review how to charge the Smartphone daily Review how to change and charge the Pendant battery

Recording Symptoms: Standard TelePatch Procedure

When a Symptom is felt, or at other times as directed by your physician: Press the SYMPTOM button on the Pendant or on the Smartphone, to record heart’s

activity.

The SYMPTOM button on the Pendant has two raised bars so it can be easily located.

Press SYMPTOM on TelePatch Pendant

OR Press SYMPTOM on Smartphone

The TelePatch Smartphone will display Recording in Progress for 60 seconds The TelePatch Smartphone will light up with a message to make a Diary Entry




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How to Make a Diary Entry: It is important the prescribing physician to know when a symptom is felt and activity at the time the SYMPTOM button was pressed.

While “Recording in Progress” is displayed on the Smartphone, Diary options will be displayed

Manual Diary Entry Tap “Manual” Below the word Symptom Tap ”No

symptom selected” Choose a symptom from the list Tap “Save” Below the word “Location” Tap ”No

location selected” Choose a location from the list Tap “Save” Below the word “Activity” Tap” No

activity selected” Choose an activity from the list Tap “Save” From the Select Diary Options screen

(showing options picked) Tap “Save” The “Monitoring” display will return*

*The screen may return to “Recording in Progress”, Smartphone screen will return to “Monitoring” as soon as recording period is complete.




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Symptom Menu Location Menu Activity Menu

Select Diary Options Screen – Options chosen




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Audio Diary Entry Tap “Audio” Cleary state the symptom, location

where symptom occurred, and activity during symptom

Tap “Done” The “Monitoring” display will return*

*The screen may return to “Recording in Progress”, Smartphone screen will return to “Monitoring” as soon as recording period is complete.

PROCEDURE SET-UP: Cable Cradle with Patient Cable

If wearing TelePatch Cradle and Pendant with individual electrodes, start preparation here

Patient Preparation

This section contains step-by-step instructions that describe how to prepare TelePatch System

and skin for a TelePatch Cable Cradle with Cable procedure - (requires individual chest

electrode patch application). Please follow the skin preparation sequence as closely as possible.

This will greatly enhance the ECG signal quality and optimize analysis.

Electrode Placement for the TelePatch Procedure

Step 1 - Identify Electrode Sites

Leads V5/MCL5 and a modified Lead I are used with the TelePatch Cable Cradle procedure, two-

channel ambulatory monitoring. By convention in the symptom recording reports, V5 is

Channel A and the modified Lead I is Channel B. Refer to the figure below for proper electrode

placement:




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For women with large breasts, the following electrode positions are recommended:

Red in the left axillary line

Black in the right axillary line

This lead placement may eliminate potential skin prep problems and minimizes occurrences of

artifact.

Step 2 - Prepare the Skin

Individual electrodes may be worn for a few. In order to obtain the best ECG recording, the

following procedure is recommended for initial patient hookup:

1. Whenever possible, be in an upright sitting position. This may be useful if any setup

problems occur that concern the signal voltage.

2. Following the lead placement diagram, select sites that are flat and bony. Avoid skin

folds or creases, irritated skin or scar tissue, and highly muscular areas.

3. If necessary, shave an area at each electrode site slightly larger than the size of the

electrode.

3-Lead Wire Hook-Up 5-Lead Wire Hook-Up

A- WHITE A- WHITE

A+ / B+ RED A+ RED

B- BLACK B- BLACK

B+ BROWN

G GREEN




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4. If powder, lotion, sun block, etc. has been applied to the chest, or if skin is excessively

oily, wash each site with plain soap and water. Do not use a soap that contains lotion or

oil.

5. Skin-prep pads (found in alcohol prep-pad type packaging) can be used to clean and

prepare skin for initial application.

The above skin prep procedure is only required at the beginning of the procedure, during

Smartphone initialization. Users will not be required to perform this type of preparation each

time they re-locate electrodes. It is best for users to have freshly showered with plain soap each

time they apply new electrodes. When the Pendant is reconnected to the patient cable, the

unit performs a less restrictive setup.

If electrodes have connectivity issues the skin can be lightly abraded each electrode site

with a rough wash cloth, or an abrasive pad

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY HELP

PROCEDURE INITATION ERRORS FROM OCCURRING.

CONDUCTIVE PARTS OF ELECTRODES AND ASSOCIATED CONNECTORS FOR TYPE BF OR

CF APPLIED PARTS, INCLUDING NEUTRAL ELECTRODE, SHOULD NOT CONTACT OTHER

CONDUCTIVE PARTS, INCLUDING EARTH.

Step 3 - Snap on Electrodes and Set Up Cable Cradle

Locate the Cable Cradle, one battery, lead wires, envelope of electrodes and lanyard (optional).




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● Snap the wires onto the electrodes while they are still attached to the plastic backing.

● One by one, peel each electrode from the backing and apply it to the chest.

● Position the electrodes at the appropriate color-coded sites.

● If wearing cable cradle on lanyard, clip lanyard onto the loop at the top of cradle.

○ Cable Cradle may also be carried in pocket, be careful Cable remains connected

to Cable Cradle

● Hold flat plug at the end of electrodes cable and connect cable to the base of cradle into

the corresponding outlet.

● Place the lanyard over head to wear the cradle with cable attached

LANYARD IS NOT TO BE WORN WHILE SLEEPING.




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CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS.

PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY CABLE CRADLE WITH

PENDANT IN POCKET. THE BREAKAWAY LANYARD IS TO BE DISPOSED OF AS HOUSEHOLD WASTE FOLLOWING THE PROCEDURE.

WARNING: CHOKING HAZARD – ADULT SUPERVISION REQUIRED

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE LOADING BATTERIES,

OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE RIGHT SIDE OF THE

PENDANT.

Step 4 - Start Pendant

● Follow directions for starting Pendant on page 32


● Follow directions for starting Smartphone on page 35


● Follow directions for initiating procedure on page 35


● Follow directions for initial procedure set up on page 36


● Follow directions for completing procedure set up on page 39

Recording Symptoms: Cable Cradle Procedure

● Follow directions for Recording a Symptom on page 41

Procedure while wearing the Cable Cradle

● Wear the Cable Cradle and Pendant all day and all night - except when showering




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● The Cable Cradle can be worn on the included break-away lanyard or can be kept in pocket (make sure Cable stays firmly attached).

● The Cable Cradle and Pendant should go into a pocket of a nightshirt while sleeping ○ Do not wear the lanyard at night while sleeping

● The physician will tell you the duration of your procedure ● The Pendant should always be in the Cable Cradle, the Cable should remain plugged into

the Cable Cradle ● Enjoy all of your regular activities like exercise or gardening, while wearing the Pendant,

Cable Cradle and Cable ● DO NOT shower with the Cable Cradle and Cable

○ Turn off the Pendant by pressing the Power Button ○ Unsnap the cable heads from the electrodes ○ Leave Cable Cradle, Cable, Pendant (and lanyard) outside the shower ○ Electrodes may be worn in the shower - fresh electrodes may need to be

applied following the shower ● After showered and dry, place lanyard with Cable Cradle and Pendant back on, re-attach

electrodes, turn on Pendant

PROCEDURE SET-UP: Fingertip Electrodes

If using Fingertip Electrodes for procedure, start preparation here.

Step 1 - Start Pendant

● Follow directions for starting Pendant on page 32


● Follow directions for starting Smartphone on page 35


● Follow directions for initiating procedure on page 35


● Follow directions for initial procedure set up on page 36


● Follow directions for completing procedure set up on page 39

Recording Symptoms: Fingertip Electrode Procedure

When experiencing a symptom, or at other times as directed by physician,

● Remove the Pendant from pocket or cable cradle

● Press the SYMPTOM button on the Pendant or on the Smartphone




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● Place index fingers firmly on the Fingertip Electrodes (the silver-gray corners) on the top

edge of the Pendant for 30 seconds.

● Smartphone will display “Recording in Progress”, keep fingers on the Fingertip

Electrode corners until the Smartphone screen message says “Recording Complete”

● The Smartphone will light up and a message will remind user to make a Diary Entry.

○ See page 42 for instructions on making a Dairy entry

Procedure while using and Pendant and Fingertip Electrodes

Carry the Pendant all day and have it nearby at night.

Charge Smartphone daily.

The physician will determine the duration of the procedure.

Enjoy all regular activities like exercise or gardening, during procedure.

COMMON QUESTIONS

How Do I Wear TelePatch System: Electrode Patch and Pendant?

The TelePatch Pendant is securely held in the Electrode Patch cradle, and won’t interfere with

day to day activities. Make sure the Symptom button (on the Pendant or Smartphone) is easily

accessible.




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How Do I Wear TelePatch System: Pendant, Cable Cradle With Electrodes?

You can wear the Cable Cradle on the breakaway Lanyard, or keep it in your pocket. Make sure

the cable stays plugged into the Cable Cradle at all times. When wearing Cable Cradle avoid

areas where the buttons might accidentally be pressed. At bedtime place Cable Cradle next to

you where its location is the most comfortable. Do not wear the Lanyard when sleeping.

Can I Shower?

When wearing the TelePatch Pendant with the Electrode Patch you can shower with the

Pendant and patch on. When done in the shower gently pat (not rub) the face of the patch and

the Pendant dry. You can remove the Pendant from the patch cradle if you would like to dry

behind the Pendant, then reinsert in the cradle immediately.

When wearing the Cable Cradle with cable DONOT wear the Cable Cradle or cable in the

shower.

1. Disconnect the cable from the Pendant and set the unit aside.

2. Unsnap the wires from electrodes. A diagram in the Patient Guide will help you to

replace them correctly when re-connecting.

Remove electrodes if skin is very irritated or if it has been 72 hours or more (per electrode

manufacturer's directive) since the last electrode change. If you don't need to remove the

electrodes, just make sure that water does not fall directly on them.

Tip For During Shower

The Electrode Patch and Pendant are water resistant. They will withstand brief periods in

contact with water – such as when showering. You can and should wear the Electrode Patch

and Pendant while showering but do not submerge or soak the devices in water.

If it is time to remove the electrodes, try removing them during your shower after they have

become thoroughly soaked with water. This will make removal easier.

Tip For After Shower

Please make sure to dry both the pendant and the plastic on the patch that holds the pendant

after getting wet.

If you are replacing Electrode Patch or single electrodes: After showering, determine where

electrode will be placed (refer to the diagram in the Patient Guide for placement) and dry your

skin well in those areas.




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If wearing the Cable Cradle with individual electrodes: Snap the wires onto the electrodes. Now,

carefully remove the back plastic cover from each electrode in turn and press the electrodes to

your skin so that complete contact is made with the adhesive backing. Plug the cable into the

Cable Cradle if it has been unplugged. Make sure the Pendant is turned on. The Smartphone

will resume receiving data from the Pendant.

Stress Loops

Stress Loops are only applicable to the TelePatch Cable Cradle procedure. Stress loops are

recommended. Two examples of stress loops are shown below.

Lead Wire Stress Loops

This is a good way to secure lead wires to prevent pulling, thus minimizing noise interference

during the procedure. Wear the Cable Cradle with the lanyard or keep the Cable Cradle in a

pocket.

EMERGENCY AND SUPPORT NUMBERS

Call 911

Below are instructions on how to call 911 from the Smartphone.

From the 'Monitoring' screen

Tap “Call Option”

Tap “Call 911”

Tap “YES“

• Hang up the call with the End Key




USER MANUAL - UTM0000701-04D | 01/06/2017 53

PROCEDURE INFORMATION AND CAUTIONS

TELEPATCH SYSTEM WHEN WEARING ELECTRODE PATCH

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY

HELP PROCEDURE INITIATION ERRORS FROM OCCURRING.

UNLESS OTHERWISE INSTRUCTED, WEAR THE TELEPATCH CONTINUOUSLY

DURING NORMAL DAILY ACTIVITIES.

TURN THE PENDANT ON BEFORE TAPPING “START PROCEDURE” ON THE

SMARTPHONE AS THE SMARTPHONE WILL IMMEDIATELY LAUNCH A PROCESS

THAT WILL START COMMUNICATION TO THE PENDANT VIA BLUETOOTH

TECHNOLOGY. IF THE PENDANT IS NOT TURNED ON AT THAT TIME, THE

SMARTPHONE WILL NOT BE ABLE TO IDENTIFY THE PENDANT

PENDANT BATTERY NEEDS TO BE CHANGED ABOUT EVERY SEVEN (7) DAYS

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE REMOVING AND

LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER

BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM

BUTTON.

HEAVY EXERCISE OR OTHER ACTIVITIES THAT EXPOSE THE TELEPATCH TO

MOISTURE CAN AFFECT PATCH ADHESION DURATION. IF A PATCH SELF-

REMOVES DUE TO EXERCISE OR ACTIVITY, CLEAN THE AREA AS NOTED IN THE

PATIENT GUIDE AND APPLY A NEW PATCH.

THE PENDANT AND BATTERY ARE NOT DISPOSABLE. THE PENDANT SHOULD

BE REMOVED FROM THE CRADLE ON THE ELECTRODE PATCH AND PLACED IN

THE CRADLE OF THE FRESH ELECTRODE PATCH, NOT DISCARDED WITH

REMOVED ELECTRODE PATCH.

THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE.

ONLY THE ELECTRODE PATCH SHOULD BE DISCARDED AFTER USE.

RETURN TELEPATCH PENDANT AND ALL COMPONENTS IN KIT PROVIDED, TO

MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE.

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND ELECTRODE PATCH

THE TELEPATCH PENDANT IS WATER RESISTANT. YOU CAN SHOWER WITH THE

TELEPATCH PENDANT AND ELECTRODE PATCH INTACT.

TELEPATCH PENDANT AND ELECTRODE PATCH ARE NOT WATERPROOF,

MEANING THE PENDANT COULD CEASE TO FUNCTION IF FULLY SUBMERGED IN

WATER FOR A PERIOD OF TIME. AVOID SWIMMING AND FULL SUBMERSION

INTO WATER, WHILE WEARING TELEPATCH.




USER MANUAL - UTM0000701-04D | 01/06/2017 54

REMOVE TELEPATCH PENDANT BEFORE SWIMMING. THE PATCH WILL NOT

REMAIN INTACT ON THE SKIN IF SUBMERGED IN WATER FOR AN EXTENDED

PERIOD OF TIME.

DO NOT WEAR ELECTRODE PATCH OR TELEPATCH PENDANT SWIMMING OR

SUBMERGED IN WATER DURING PROCEDURE.

TELEPATCH SYSTEM WHEN USING CABLE CRADLE

ALLOW 15 MINUTES FOR SKIN TO ABSORB THE ELECTRODE GEL, WHICH MAY

HELP PROCEDURE INITIATION ERRORS FROM OCCURRING.







LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER

BUTTON IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM

BUTTON.

IF WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL ELECTRODES

IT IS RECOMMENDED TO PLACE THE PENDANT IN A POCKET DURING EXERCISE

OR OTHER ACTIVITIES. IF INDIVIDUAL ELECTRODES SELF-REMOVE DURING

ACTIVITY, CLEAN THE AREAS AND APPLY NEW ELECTRODES. AVOID FULL

IMMERSION INTO WATER (POOLS, HOT TUBS, OPEN WATER SWIMMING).

BREAKAWAY LANYARD IS NOT TO BE WORN WHILE SLEEPING.

CHILDREN WEARING PENDANTS MUST BE SUPERVISED BY ADULTS.

PEOPLE WORKING WITH MACHINERY OR WORKING IN ENVIRONMENTS WHERE

LOOSE HANGING ROPE- LIKE OBJECTS CAN POSE A POTENTIAL THREAT OR

HARM TO THEMSELVES AND/OR THE MACHINERY ARE ADVISED TO CARRY

CABLE CRADLE WITH PENDANT IN POCKET.

THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER.

THE TELEPATCH PENDANT SHOULD NOT BE TREATED AS HOUSEHOLD WASTE.

THE INDIVIDUAL ELECTRODES SHOULD BE DISCARDED AFTER USE.

THE BREAKAWAY LANYARD SHOULD BE DISCARDED AFTER USE.

RETURN TELEPATCH PENDANT, AND ALL COMPONENTS IN KIT PROVIDED, TO

MEDICOMP, INC., USING THE INCLUDED POSTAGE PAID ENVELOPE.

SHOWERING OR SWIMMING WITH TELEPATCH SYSTEM AND CABLE CRADLE

THE CABLE CRADLE SHOULD NOT BE WORN IN THE SHOWER.

WHEN WEARING TELEPATCH WITH A CABLE CRADLE AND INDIVIDUAL

ELECTRODES: BEFORE TAKING A SHOWER OR BATH, UNSNAP THE LEAD

WIRES FROM THE ELECTRODES (THAT ARE ATTACHED TO CHEST) REMOVE

THE CABLES, CABLE CRADLE AND LANYARD BEFORE ENTERING SHOWER..




USER MANUAL - UTM0000701-04D | 01/06/2017 55

WATER WILL NOT AFFECT THE INDIVIDUAL ELECTRODES; DO NOT REMOVE

THEM BEFORE SHOWERING IF THEY ARE STILL FIRMLY ATTACHED TO THE

SKIN. IF AN INDIVIDUAL ELECTRODE SELF-REMOVES IN SHOWER, PREPARE

THE AREAS AND APPLY NEW ELECTRODES.

IF SHOWERING WITH ELECTRODES, GENTLY PAT THEM DRY WITH A TOWEL

BEFORE RECONNECTING THE LEAD WIRES TO THE ELECTRODES

IF SWIMMING, REMOVE CABLE, CABLE CRADLE AND PENDANT BEFORE

SUBMERGING INTO WATER. USER MAY LEAVE ELECTRODES ON IF THEY ARE

STILL FIRMLY ATTACHED TO THE SKIN.

SMARTPHONE / HANDSET







CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE

OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET

EASILY, AS NEEDED.

SMARTPHONE IS POWERED BY THE CHARGER CORD ONCE CHARGER CORD IS

PLUGGED INTO BOTH SMARTPHONE AND WALL OUTLET.

WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE

POWER OUTLET AND THE SMARTPHONE.

UNPLUG THE CHARGER CORD FROM THE SMARTPHONE BEFORE PLACING

SMARTPHONE IN POCKET OR PURSE/BRIEFCASE.

DO NOT WEAR THE SMARTPHONE WHILE THE CHARGER IS ATTACHED TO THE

SMARTPHONE.

BATTERY CHARGER

BATTERY CHARGER IS POWERED BY THE CHARGER CORD ONCE CHARGER

CORD IS PLUGGED INTO BATTERY CHARGER AND THEN A WALL OUTLET.


CHARGER CORD MUST NOT BE OBSTRUCTED BY FURNITURE OR LARGE

OBJECTS AND REMAIN ACCESSIBLE TO DISCONNECT FROM WALL OUTLET

EASILY, AS NEEDED.

BATTERY CHARGER LIGHT WILL BE FLASHING AMBER OR ORANGE WHILE

BATTERY IS CHARGING.

BATTERY CHARGER LIGHT WILL BE GREEN WHEN BATTERY IS FULLY

CHARGED.

BATTERY CHARGER LIGHT MAY FLASH RED WHEN BATTERY IS NOT INSTALLED

IN CHARGER PROPERLY.




USER MANUAL - UTM0000701-04D | 01/06/2017 56

IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG,

VERIFY CHARGER CORD IS PLUGGED INTO BATTERY CHARGER AND WALL

PROPERLY.

IF BATTERY CHARGER HAS NO LIGHT INDICATION LIT NEXT TO CABLE PLUG,

VERIFY BATTERY IS PLACED IN CHARGER PROPERLY.

WHEN CHARGING IS COMPLETE, UNPLUG THE CHARGER CORD FROM THE

POWER OUTLET AND THE BATTERY CHARGER.

PENDANT PRECAUTIONS

CAUTION: Portable and mobile RF communications equipment can affect medical electrical

equipment. This Pendant should not be used adjacent to or stacked with other equipment in

accordance with the directions described in the Practice Reference Manual.

NOTE: EUT (PM750 Pendant) shuts down between +/-8 and 15kV Air Discharge. It is

recommended that you restart the device (wait 30 seconds after power down) upon occurrence

of this event.

WARNING: When using lead wires, they should not contact other conductive equipment or

electric ground, including earth.

Lead failures are detected by a 10 mV peak, 50% duty cycle rectangular pulse, which is

applied to each patient electrode connection through a 4.9Mohm resistor at a rate of 15

Hz with respect to the system ground.

This is a prescribed medical Pendant, not a toy; keep away from small children.

In the event of a damaged Pendant, discontinue use and call Medicomp Patient Support:

800-234-3278 ext. 2370, for return and replacement.

ADVERSE REACTIONS In the event of irritation worse than minor itching, to the Electrode Patch or individual

electrodes, consult your physician. Users may also contact Medicomp to discuss alternative,

Physicians must request change of procedure to Medicomp. Medicomp cannot authorize

change of patient procedure.

● Signs of significant irritation where the electrode patch is in contact with the skin.

● Any other unanticipated reaction to the adhesive or the electrode gel.




USER MANUAL - UTM0000701-04D | 01/06/2017 57

MAINTENANCE

Cleaning the TelePatch System

The TelePatch pendant may need to be cleaned if for any reason it becomes exposed to

biological materials, like body fluids or matter. The user should clean the TelePatch Monitoring

System in order to maintain optimal use and functionality.

Use a tissue, lightly moistened with alcohol or a hospital-grade cleanser such as Sporicidin –

(Do not saturate) - wipe off debris, dirt or other matter that may gather on either the

Smartphone or Pendant of the TelePatch System. If the Pendant has been dropped in a basin

water (i.e.: sink or toilet) and will not power back on, contact Customer Support for a

replacement.

VISUAL AND AUDIBLE INDICATORS

Normal Performance Indicators

Pendant Action Visual Indicator Audible Indicator

Pendant power up Green, blue, and orange lit simultaneously for 1.5 seconds.

Beep High-Low-High for 0.5 second per frequency while LEDs are lit.

Pendant ready to start procedure

Green LED blinks fast None

Procedure initiated: Press Symptom button 3 times (Holter Only)

Green LED solid for 1.5 seconds Beep High-Low-High for 0.5 second duration for each beep

Procedure initiated not in cradle: Press Symptom button 3 times (Holter procedure only)

Orange and blue blinks fast in unison

Beep 4 times in unison with LEDs

Procedure in progress: not in cradle

3 LED sections: continuous flashing

None

Pendant removed from 3 LED sections: continuous None




USER MANUAL - UTM0000701-04D | 01/06/2017 58

Cradle flashing

Pendant placed in cradle with procedure running BT OFF/Holter

Green LED: every 4 seconds Beep for 2 seconds before entering this mode for the first time

Symptom Button Press on cables or patch: Record Symptom

Green LED lit for 1 second Beep for 1 second

Symptom Recording Complete on Cables or Patch

“Recording Complete” message will be seen on screen of smartphone

None

Finger Tip Electrodes Start of Recording

Green LED 3 flashes 0.5 second each then Green LED lit for 1 second

Beep 3 times in unison with LED flashes then Beep for 1 second

Finger Tip Electrodes during Recording period

Green LED flashes during 32 second recording period

None

Finger Tip Electrode Recording complete

Green LED lit for 1 second Beep for 1 second

Pendant communicating with Smartphone

Blue LED: every 4 seconds None

Holter procedure end Green and blue blink alternately at 2Hz

None

Pendant power down All three LEDs simultaneously every 1.5 seconds

Beep 3 times in unison with lit LEDS.

Error Indicators

Pendant Action Visual Indicator Audible Indicator

Pendant configuration wrong Blink all three LEDs 5 times for 0.5 seconds every second

Beep 5 times in unison with lit LEDs

New Holter procedure power- up – running cradle and lead-

Green blinks twice and blue blinks once repetitively

None




USER MANUAL - UTM0000701-04D | 01/06/2017 59

on/lead-off tests.

New Holter procedure power-up, low main battery error detected.

Orange LED blinks fast None

RECORD button pressed, Pendant not in cradle

3 slow Green flashes, then Green LED flashing fast

3 beeps then none

RECORD button pressed while Pendant creating a recording

Green LED Flash Long beep

Early low main battery warning

Orange LED blink 1 per second

Beep 1 second duration every 4 minutes

Late low main battery warning

Orange LED blink 3 times per second

Beep 1 second duration every 30 seconds

TROUBLESHOOTING

Setup Details and Troubleshooting Overview

This section helps resolve any problems that may be encountered while you are setting up the

TelePatch. Reduce the likelihood of seeing errors by making sure fresh Electrode Patch or fresh

individual electrodes are used, as appropriate, the cable is in good condition and securely

connected to the Cable Cradle, and care has been taken to perform the recommended skin

preparation.

Some problems are unavoidable due to a patient's particular heart condition or the unexpected

failure of a component. However, these cases are infrequently encountered.

When the TelePatch is connected begins its startup sequence, it assesses the quality of the ECG

signal. The TelePatch system will signal if there is a problem with the connections or if the

signal voltage is too high or too low for ideal auto-capturing. Messages on the Smartphone's

display will direct any necessary corrections.

Information is also provided in this section to assist with the setup procedure of any

replacement or exchanged TelePatch system component (e.g. Smartphone or Pendant).




USER MANUAL - UTM0000701-04D | 01/06/2017 60

Replaced components of the TelePatch will follow a slightly different setup procedure to the

standard method.

TelePatch System Hookup Testing Information

Quality Hookup Tests Overview

The TelePatch Quality Hookup tests evaluate cable connections, skin preparation, and signal-

voltage conditions. This is a test that is performed automatically by the TelePatch System, with

no indication to, or participation from, the user or patient until specifically directed by specific

commands on the Smartphone.

The Quality Hookup test starts once either:

1. The patient has the electrode patch in place on the chest with the pendant secured in the

electrode patch cradle and the Smartphone is turned on to initiate the patient’s procedure.

OR

2. The patient has the individual electrodes in place with the cable attached to both the

electrodes and the cable cradle, and the Smartphone is turned on to initiate the patient’s

procedure.

The TelePatch System (Pendant and Smartphone) determines whether there is a problem and

the problem will be displayed on the Smartphone.

The option that is used to define how the wireless system handles these conditions is called the

'Setup' option.

The Setup/Normal Setting

All TelePatch systems are shipped in the 'Setup/Normal' mode.

'TEST' SHOULD NEVER BE SELECTED AS A SETTING WITHOUT THE

SUPERVISION AND GUIDANCE OF MEDICOMP PATIENT SUPPORT.

THE PATIENT SHOULD CALL MEDICOMP FOR GUIDANCE IN THE 'TEST'

MODE.

During the Quality Hookup Tests, the Smartphone may display the

following screens before the procedure begins:

Pacemakers




USER MANUAL - UTM0000701-04D | 01/06/2017 61

If the 'Pacemaker' setting is selected, and if a paced beat was detected as typical, the

Smartphone displays a screen to confirm the QRS prior to beginning the procedure.

Lead Position Test

If no QRS is found, the following screen may be

displayed before the procedure begins. If this

screen is displayed, the patient is to follow the

guidance of a Cardiac Monitoring Center technician,

or Patient Support technician.

Skin Prep Results

The results of the skin prep test may be displayed

before the procedure begins.

• Go to PATIENT PREPARATION for additional steps.

• For additional troubleshooting instructions, call Medicomp Patient Support: 800-234-3278

ext. 2370

Error Displays

During procedure hookup, the TelePatch tests for flex circuit or cable breakage, and checks that

its minimal requirements for skin prep and signal voltage are met. These tests could last only a

few minutes or may take longer, depending on what the TelePatch detects. The Smartphone's

“objective” is to make sure that it receives a good signal. This ensures optimal auto-capturing

and good report results.

IMPORTANT POINTS

With very few exceptions, only errors seen with 'Lead Position Test' require that electrodes be

re-located on the patient's chest.

Most of the time, errors seen with “Lead Test Error” and “Testing Skin Prep” require re-

prepping or equipment changes.

Each time you make a change to correct a problem, you will need to tap 'Retry' for the

TelePatch to continue testing.




USER MANUAL - UTM0000701-04D | 01/06/2017 62

USERS WHO ARE WEARING NEUROSTIMULATING PENDANTS CANNOT BE SET UP

WHILE THAT DEVICE IS TURNED ON. THE OPERATION OF THESE PENDANTS INTERFERES WITH

THE TELEPATCH’S ABILITY TO ACQUIRE THE ECG SIGNAL. IF ALLOWED THESE DEVICES SHOULD

BE TURNED OFF WHILE THE PATIENT IS WEARING TELEPATCH.



ext. 2370

Voltage Errors after Several Attempts

For Cable Cradle Procedures

If inadequate signal voltage (can be either low or high) in one channel while the other one is

acceptable, place the electrodes in a ”parallel”, or ”side-by-side” lead arrangement. Identify the channel

that has the acceptable voltage and place the electrodes of the problem channel side-by-side with it. For

example:

Channel A good, Channel B bad - place Black electrode next to White. Configuration will be:

Black and white electrodes on the right upper chest, and red electrode underneath the left

breast.

Channel B good, Channel A bad - place White next to Black. Configuration will be: black and

white electrodes on the right lower chest.


• For additional troubleshooting instructions, go to TROUBLESHOOTING OVERVIEW

Lead Position Tests

Lead Test Error

When a Lead Test Error occurs, the Smartphone displays a message

similar to:

THE WHITE ELECTRODE HAS A CONNECTION PROBLEM.

White = White electrode site (A-)




USER MANUAL - UTM0000701-04D | 01/06/2017 63

Red = Red electrode site (A+/B+)

Black = Black electrode site (B-)

Lead errors occur when the lead wire connected to the Cable Cradle detects a very high

resistance that may be caused by one or more of the following conditions:

Very high resistance values

Expiration of Electrodes

Cables disconnected

Very high resistance values

May indicate a problem with the cable. Try changing the cable first, if one is available,

otherwise move on to the next step.

If not done so already, thoroughly wash the electrode site with PLAIN (no lotion or oil) soap and

water. Apply a small amount (about the size of the tip of a cotton swab) of Skin Prep gel to a

paper towel and firmly rub it into the skin at the gel cup site. Wipe off the excess gel. If no Skin

Prep is available, this can also be done with a rough, wet, washcloth. Always apply a new

electrode to the site. In difficult cases, light abrasion with a scrub pad may also be required; this

may occur with users who have very oily skin.

Press down on the center snap of the electrode and Tap 'Retry' on the Smartphone.

If the TelePatch Pendant and Smartphone proceed through to 'Lead Position Test', then after all

tests are completed and the Smartphone is actively 'Monitoring,' change the electrode, this

time making sure that it is in good contact with the skin.

Expiration Date of Electrodes

Check the expiration date on the electrodes. Inspect the electrode(s) in question to verify moist

gel cups. If the gel is dry, you will need to replace the electrode.

Cables (lead wires) not connected

If the electrode cables are disconnected, this error message will also appear.



ext. 2370




USER MANUAL - UTM0000701-04D | 01/06/2017 64

High/Low Voltage Notifications

LOW VOLTAGE IN CHANNEL A

(WHITE [A-]/RED [A+] ELECTRODE PAIR)

Although the TelePatch System automatically adjusts the signal size (voltage) to ensure optimal

analysis, some users may have cardiac anomalies that result in unacceptable signal voltage. The

signal may be too large or too small. The following section describes each error that might

occur. Sometimes, just having the patient lean back in a chair will increase the ECG voltage.

The Smartphone's message for this error is: Low A, Move Red

First, move the red electrode

After repositioning,

Press 'Retry'

If the Smartphone continues to display the error, try an electrode location on the opposite side

of the Red (A+/B+) electrode pictured. Don't try more than a few different locations.


ext. 2370

LOW VOLTAGE IN CHANNEL B

(BLACK [B-], RED [A+] ELECTRODE PAIR

The Smartphone's message for a low voltage in Channel B is: Low B, Move Black

First, move the black electrode

Low Voltage in Channel B, Move Black After repositioning,

Press 'Retry'


of the Black (B-) electrode. Don't try more than a few different locations.


ext. 2370

HIGH VOLTAGE IN CHANNEL A

(RED [A+]/WHITE [A-] ELECTRODE PAIR)

The Smartphone's message for this error is: High A, Move Red

First, move the red electrode

High Voltage in Channel A, Move Red After repositioning,




USER MANUAL - UTM0000701-04D | 01/06/2017 65

Press 'Retry'


of the Red (A+/B+) electrode. Don't try more than a few different locations.


ext. 2370

HIGH VOLTAGE IN CHANNEL B

(BLACK [B-]/RED [A+] ELECTRODE PAIR)

The Smartphone's message for a high voltage in Channel B is: High B, Move Black

First, move the black electrode

High Voltage in Channel B, Move Black After repositioning,

Press 'Retry'


of the Black (B-) electrode pictured. Don't try more than a few different locations.


ext. 2370

SAMPLE SCREEN WARNINGS

Screen Warnings

There are a number of screen warnings that may appear on the

Smartphone screen. Below is a sampling of some of the most common

screen warnings.

Unable to find Pendant

At the very start of a new procedure, if the Smartphone IS turned on and

the Pendant is NOT turned on, the following warning or alert will be

displayed. Turn on the Pendant to proceed. While continuing a procedure,

if the Pendant is NOT turned on when the Smartphone IS turned on, the

following warning or alert will be displayed. Turn on the Pendant to

proceed.




USER MANUAL - UTM0000701-04D | 01/06/2017 66

Pendant is Turned Off

If the Pendant is turned off while in the middle of monitoring, the following warning or alert will

be displayed. Turn on the Pendant to proceed.

Procedure Has Ended

When the procedure ends, an alert will be displayed. Users should return the unit to the

Medicomp address provided in the Patient Guide. Every TelePatch Kit has a postage paid return

envelope. Include all components in the zippered kit and mail from any mailbox.


ext. 2370

Start Procedure Exceptions

Selecting a Pendant

If more than one Pendant is identified after pressing 'Start Procedure,' the patient will be

prompted to 'Select a Pendant to Use.' The instructions below provide detail steps to select a

Pendant before starting a procedure.

Select a Pendant to Use

● User chooses from the list of Pendants on the screen

● Select the Pendant with the unique serial number listed inside the well of the Pendant.

● Tap and highlight the Pendant serial number.

● Tap 'Select'

SAFE BATTERY USE AND DISPOSAL

The TelePatch Cardiac Monitor Pendant operates on a single, 3.7V lithium ion battery.




USER MANUAL - UTM0000701-04D | 01/06/2017 67

Bottom and top views of the TelePatch Pendant Battery

IF PENDANT’S BACKUP BATTERY IS LOW, PATIENT SHOULD CALL MEDICOMP PATIENT SUPPORT: 800-234-3278 ext. 2370.


LOADING BATTERY, OTHERWISE DATA MAY BE LOST. REMINDER: THE POWER BUTTON

IS LOCATED ON THE FACE OF THE PENDANT, BELOW THE SYMPTOM BUTTON.

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. TO ENSURE

SAFE CHARGING AND MAXIMUM PERFORMANCE OVER THE LIFE OF THE PRODUCT

ALWAYS USE THE MEDICOMP PROVIDED CHARGER. DO NOT ATTEMPT TO CHARGE

THE BATTERY ON ANOTHER MANUFACTURER’S CHARGER.

THIS PRODUCT UTILIZES A RECHARGEABLE LITHIUM-ION BATTERY PACK. ALL

BATTERIES WILL SLOWLY DISCHARGE OVER TIME EVEN IF THEY AREN’T USED. TO

ENSURE OPTIMAL PERFORMANCE AND LIFETIME OF THE BATTERY PACK, PLEASE

FULLY CHARGE THE BATTERY AT LEAST ONCE EVERY 6 MONTHS REGARDLESS OF USE. IT IS

FURTHER RECOMMENDED THAT IF THE BATTERY HASN’T BEEN CHARGED MORE RECENTLY

THAN A MONTH AGO THAT IT BE FULLY CHARGED PRIOR TO THE START OF A PATIENT

PROCEDURE.

Safely Loading the Pendant Battery

TelePatch Pendant operates on a rechargeable, lithium ion battery. The battery locks into the

battery well of the back of the TelePatch Pendant.

To safely load the battery into the Pendant:

● Remove the Pendant and one battery from the zippered kit

Insert battery into Pendant.

● Hold Pendant face down in hand or place on a flat surface. There is a well where

battery will be inserted

● Insert battery into well of Pendant: with the Medicomp label facing up, and the two

small tabs into notches in flat wall of the well




USER MANUAL - UTM0000701-04D | 01/06/2017 68

Inserting battery into Pendant battery well

● Slide the latch at back of the battery to left, securing battery in place. Battery is locked

in place when moveable latch is under blue lock icon on label

Battery is unlocked (latch under RED icon) Battery Is locked (latch under BLUE icon)

LOAD ONLY 3.7V LITHIUM ION BATTERIES DELIVERED IN THE TELEPATCH KIT INTO THE

TELEPATCH CARDIAC MONITOR BATTERY COMPARTMENT.

Properly inserted TelePatch Battery

IT IS VERY IMPORTANT TO TURN THE PENDANT OFF BEFORE CHANGING BATTERY,

OTHERWISE DATA MAY BE LOST. THE POWER BUTTON IS LOCATED ON THE FRONT FACE OF THE

PENDANT BELOW THE SYMPTOM BUTTON.




USER MANUAL - UTM0000701-04D | 01/06/2017 69

Battery Maintenance

● Remove the battery from the Pendant during storage or if the Pendant is not to be used

for longer than two (2) weeks.

● Store in a cool, dry place, the best location is in the TelePatch Cardiac Monitor Kit

supplied for your procedure.

Disposal of Rechargeable Lithium Ion Batteries

In accordance with federal laws and regional regulations:

● RETURN all batteries to Medicomp, Inc.

● The rechargeable battery provided with the TelePatch System is NOT to be discarded in

household waste.

● If a battery gets damaged contact Medicomp, Inc.: 877-996-5553

EXPLANATION OF MARKINGS

Equipment markings and caution labels are important for safe and reliable use; they must not

be removed. The following symbols are used in this user manual, patch packaging, lithium ion

battery or the Pendant label. They may also appear on an accessory or accessory packaging.

Icon Description

Pendant,

Lanyard

Operating instructions

Pendant This symbol indicates type BF equipment classified in accordance with IEC Publication IEC 60417-5333 Safety of medical electrical equipment. Type BF equipment: equipment with isolated patient connections, connections not defibrillation-proof.

IP55

Pendant This symbol indicates Ingress protection- Solids: 5 – Ingress of dust is not entirely prevented, but it must not enter in sufficient quantity to interfere with the satisfactory operation of the equipment; complete protection against contact. Liquids: 5 - Water projected by a nozzle (6.3mm) against enclosure from any direction shall have no harmful effects.




USER MANUAL - UTM0000701-04D | 01/06/2017 70

Pendant This symbol informs the user that the respectively labeled component is not to be disposed of in the trash. Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

Pendant.

Lithium Ion

Battery

WEEE LOGO The WEEE logo on this product indicates that this product must not be disposed of with standard waste but rather recycled. Please contact Medicomp, Inc. for more information on proper component disposal. RoHS Compliance This product is in compliance with Directive 2002/95/ EC of the European Parliament and of the Council of 27 January 2003, on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) and its amendments.

Pendant Serial Number

Patch Prescription Required

Patch Caution, consult accompanying documents

Patch Do not reuse. This is a single use item

Patch Batch code of product

Patch Use by date indicated

Patch Catalog Number/Part Number

Lithium Ion

Battery

Item is recyclable. Users should properly dispose of components through




USER MANUAL - UTM0000701-04D | 01/06/2017 71

Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

REACH

Lithium Ion

Battery

EU regulation of chemicals and safe use: Registration, Evaluation, Authorization and Restriction of Chemical substances. Component substances are REACH approved.

Lithium Ion

Battery

Item must not be disposed of to the ‘normal’ household waste, but be separately collected and recycled. Users should properly dispose of components through Medicomp, Inc. Please contact Medicomp, Inc. for information on how to return item for recycling.

Lithium Ion

Battery

Do not incinerate

Lithium Ion

Battery

Product is lead free. Component and Assembly Pb content shall be less than 0.1% by weight of the device (in accordance with IPC/EIA J-STD-006) and shall not be intentionally introduced.

Lead Wire packaging

Lead wires comply with the Performance Standard for electrode lead wires

Shipping packaging

Temperature limitation for shipment of system is -15°C to 60°C (5°F to 140°F).

The TelePatch Pendant should NOT be treated as household waste.

ONLY the Electrode Patch or individual electrodes should be discarded after use.

Return TelePatch, Pendant, and all components in kit provided, to Medicomp,

Inc., using the included postage paid envelope.

EXPECTED LIFE

TelePatch Pendant Unit is expected to provide at least 7 years of normal use.




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Electrode Patch with cradle When the patch no longer sticks well to skin, dispose of in a receptacle out of reach of children and pets.

Lithium Ion Battery Each unit is expected to provide at least 7 years of normal use.

Battery Charger Unit is expected to provide at least 7 years of normal use.

Cable Cradle Unit is expected to provide at least 4 years of normal use.

3-Lead and 5-Lead Cables Cables are expected to provide at least 6 months of normal use.

Electrodes When the patch no longer sticks well to skin, dispose of in a receptacle out of reach of children and pets.

Lanyard When procedure complete dispose of in a receptacle out of reach of children and pets.

PENDANT SPECIFICATIONS

Technical Features

Single button operation Records symptomatic ECG

Memory Characteristics

ECG Channels Memory Card, Micro SD

1 and 2 Channel 4GB

Electrical Characteristics

Frequency Response Input Impedance Differential Range Sampling Rate Resolution

0.05Hz to 100 Hz ≥ 10.0 Mohm +/- 5.0mV A/D 250 samples/second 12 bits

Physical Characteristics

Dimensions Weight

58mm x 38.5mm x 15.5mm 37.5g (Pendant only)

Power Requirements

Battery Type Battery Life

1 Lithium Ion (rechargeable), 1 Coin cell (internal) 7 days, typical usage




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Environmental Durability

Pendant Waterproof Specification IP55

MEDICAL ELECTRICAL EQUIPMENT NEEDS SPECIAL PRECAUTIONS REGARDING EMC

AND NEEDS TO BE INSTALLED AND PUT INTO SERVICE ACCORDING TO THE EMC

INFORMATION PROVIDED IN THIS MANUAL.

USE THE TELEPATCH SYSTEM ONLY WITH THE LEADS, ELECTRODES, AND ACCESSORIES

RECOMMENDED BY MEDICOMP. USE OF OTHER ACCESSORIES MAY ADVERSELY AFFECT

THE PERFORMANCE OF THE DEVICE OR MAY RESULT IN STRONGER ELECTROMAGNETIC

EMISSIONS OR REDUCE THE ELECTROMAGNETIC IMMUNITY OF TELEPATCH CARDIAC MONITOR

PM750.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The PM750 is intended for use in the electromagnetic environment specified below.

Emissions Test

Compliance Electromagnetic Environment - Guidance

RF emissions CISPR 11 Group 1 The PM750 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11 Class B The PM750 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Harmonic emissions IEC 61000-3-2

Not Applicable

Voltage Fluctuations/ flicker emissions IEC 61000-3-3

Not Applicable

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PM750 is intended for use in the electromagnetic environment specified below. The customer or user of the PM750 should assure that it is used in such an environment.




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Immunity Standards per 60601-1-2 :2014, (Home Healthcare Environmental) and ETSI EN301 489-1 V1.9.2 (2011-09)

Immunity Test IEC 60601 Test Level/Limits

Compliance Limits Compliance Level

Electrostatic discharge (ESD) IEC 61000-4-2

2kV,4kV,6kV 8kV (+/-) Contact 2kV,4kV,8kV, 15kV (+/-) AIR



Electrical fast transient/burst IEC 61000-4-4

±2.0kV AC/DC Mains ±1kV Signal and Control Lines



Voltage Dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

70% of Vnom, 25 cycles at 0deg 0% of Vnom, 0.5cycles at 0deg, 45deg, 90deg, 180deg, 225deg, 270deg, 315deg 0% of Vnom, 1.0 cycles at 0deg 0% of Vnom cycles at 0deg



Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m (Both 50Hz, 60Hz) 30 A/m (Both 50Hz, 60Hz) 30 A/m (Both 50Hz, 60Hz)

NOTE: EUT PM750 Pendant shuts down between +/-8 and 15kV Air Discharge. It is recommended that you restart the device (wait 30 seconds after power down) upon occurrence of this event.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The PM750 is intended for use in the electromagnetic environment specified below. The customer or user of the PM750 should assure that it is used in such an environment.

Immunity Standards per 60601-1-2 :2014, (Home Healthcare Environmental) and ETSI EN301 489-1 V1.9.2 (2011-09)

Immunity Test IEC 60601 Compliance Limits Compliance Level




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Test Level/Limits

Conducted RF IEC 61000-4-6

3Vrms 150kHz to 80MHz, 80% AM 1kHz



Radio Frequency Electromagnetic Field Amplitude 61000-4-3

10 V/m, 80 MHz to 2.7 GHz, 80% AM 1kHz



Radiated RF IEC 61000-4-3

385MHz: 27V/m @ 18Hz pulse modulation 450MHz: 28V/m @ FM modulation 710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation 810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation 1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation 2450MHz: 28V/m @ 217Hz Pulse modulation 5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation

385MHz: 27V/m @ 18Hz pulse modulation, 450MHz: 28V/m @ FM modulation 710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation 810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation 1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation 2450MHz: 28V/m @ 217Hz Pulse modulation 5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation

385MHz: 27V/m @ 18Hz pulse modulation, 450MHz: 28V/m @ FM modulation 710MHz, 745MH, 780MHz: 9V/m @ 217 Hz pulse modulation 810MHz, 870MHz, 930MHz: 28V/m @ 18Hz Pulse modulation 1720MHz, 1845MHz, 1970MHz: 28V/m @ 217 Hz Pulse Modulation 2450MHz: 28V/m @ 217Hz Pulse modulation 5240MHz, 5500MHz, 5785MHz: 9V/m @ 217 Hz Pulse modulation

Recommended separation distances between portable and mobile RF communications equipment and the

PM750

The PM750 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of PM750 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PM750 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output Separation distance according to frequency of transmitter




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of transmitter (W) 150 kHz to 80 MHz d = 1.167√P

80 MHz to 800 MHz d = 1.167√P

800 MHz to 2,5 GHz d = 2.333√P

0.01 .12 .12 .23

0.1 .37 .37 74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: 1 - At 80 MHZ and 800 MHZ, the separation distance for the higher frequency range applies. NOTE: 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

cardiac monitor pm750 · pdf filethe standard telepatch cardiac monitor pm750 kit comes with...

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