MeditechABP and ECG

recordersABPM-04

ambulatory blood pressure recorder

CardioTenscombined ambulatory blood pressure

and ECG event recorder

card(X)plorecombined full disclosure holter ECG,

ambulatory blood pressure andactigraphy recorder

CardioClipECG event recorder

CardioBlueECG event recorder

with wireless communication

CardioMerafull disclosure holter ECG recorder

Important information – precautions for use – read carefully!

This symbol on a Meditech recorder is a warning that you should readthe accompanying documentation (this manual).

Meditech recorders described in this manual, including

ABPM-04 ambulatory blood pressure (ABP) recorderCardioTens combined ABP and ECG event recordercard(X)plore combined holter ECG, ABP and actigraphy recorderCardioClip ECG event recorderCardioBlue ECG event recorder with wireless communicationCardioMera holter ECG recorder

are manufactured by:

Meditech Ltd.

200 Ulloi ut, Budapest, Hungary www.meditech.eufax: +36 1 282 9388 e-mail: meditech@meditech.eu

Please contact us for further product and service information.

Meditech Ltd. maintains a quality assurance system certified according to MSZ EN ISO 9001:2000 and MSZ EN ISO 13485:2003.

Notified Body SGS YarsleyUnit 202b, Worle Parkway fax: +44 1934 522 137Western-super-Mare, BS22 0WA www.sgs.com

! Meditech recorders should not be used if the following cases apply:• patients without an indication for ambulatory ECG and / or

ambulatory blood pressure monitoring• non-cooperative patients• patients in any way unable to operate a recorder as intended• patients requiring urgency / emergency cardiac care• patients with a sensitivity / allergy to adhesive ECG electrodes• unconscious or otherwise incapable patients• patients with serious mobility impairments without supervision• patients with coagulation disturbances• children without supervision• children under the age of 8 years

! Though the blood pressure measurement algorithm used in Meditech ABP recorders has been tested and found to function properly on patients with atrial fibrillation or other common arrhythmias, the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias, Parkinson's disease, or other diseases with tremor.

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! Always consult a physician for interpretation of ECG curves or blood pressure measurements. Note that any blood pressure recording may be affected by body position, the physiological condition of the patient, and other factors.

Meditech recorders described in this manual comply with the requirements of the EU Medical Devices Directive (93/42 EEC).0120 is the identifier of Notified Body (SGS UK)

MDD IIa MDD classification IIa. EMC class B. EMC group 1.

Meditech recorders are internally powered type CF devices.Protection vs. ingress of water: ordinary. Mode of operation: continuous. Meditech ECG/combined recorders are not specifically protected against the discharge of an external cardiac defibrillator.

2006/CT2nnnn

The first four digits of the serial number of a recorder show the year of production. The three characters following the slash serve as device type identifier, or model code. The rest is the actual serial number.

Model codes areBP4 for ABPM-04, CT1 for CardioTens, CT2 for card(X)plore,HC1 for CardioClip, HB1 for CardioBlue, FC1 for CardioMera.

Blood pressure measurements determined with the algorithm of a Meditech ABP recorder on adults are equivalent to those obtained by a trained observer using the cuff/stethoscope auscultation method Korotkoff phase V, within the limits prescribed by the American National Standard for Electronic or Automated Sphygmomanometers. The algorithm also fulfils the requirements of the British Hypertension Society Validation Protocol for Automated Blood Pressure Measuring Devices (algorithm used in all Meditech ABP recorders is identical to that used in the Meditech ABPM-04 device, which received grade B for both systolic and diastolic accuracy; validation study published in Blood Pressure Monitoring 1998; 3(6):363-8 by I Barna & al).

! For information on memory cards, see page 12.For information on electrodes and their application, see page 13.For information on cuffs and their application, see page 15.

! Take care to avoid blocking the air flow in the tube of the cuff. Make sure the cuff and its tubing or the lead wires do not cause strangulation or a circulation problem. Should the patient experience arm numbness or pain remaining after any blood pressure reading is completed, the cuff should be removed to avoid permanent vascular or neural injury.

! No user serviceable parts inside. Meditech recorders contain high complexity electronic and fine mechanical components. If you have any problems, please refer your recorder to qualified service personnel.

File ID: CT2E2211

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Table of Contents

Table of Contents..........................................................................................................5Recommended use of ambulatory blood pressure (ABP) and ECG recorders .............6Care and maintenance...................................................................................................7Safety concerns.............................................................................................................8Working with Meditech recorders.................................................................................9

Rules of monitoring..................................................................................................9Monitoring step by step..........................................................................................10Batteries..................................................................................................................11Using a memory card with CardioMera and card(X)plore.....................................12ECG electrodes and their application.....................................................................13Preparing the patient and the electrodes.................................................................14Real-time ECG monitoring to check electrode placement.....................................14Cuffs and their application – ABP and combined recorders only...........................15

Meditech ABP recorders: ABPM-04, CardioTens and card(X)plore..........................16Accessories.............................................................................................................17Controls and labels.................................................................................................18Using the buttons....................................................................................................19Displays..................................................................................................................20Technical parameters..............................................................................................21

Meditech ECG recorders: CardioClip, CardioBlue and CardioMera.........................22Accessories.............................................................................................................23Controls and labels.................................................................................................24Using the button.....................................................................................................25Multifunctional button on CardioBlue – wireless connection with a computer.....25Acoustic and visual signals....................................................................................26Technical specifications.........................................................................................27

Bluetooth devices: CardioBlue and card(X)plore with Bluetooth..............................28Meditech product warranty information.....................................................................29EMC information........................................................................................................30

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Recommended use of ambulatory blood pressure (ABP) and ECG recorders

Indications for ambulatory ECG monitoringThe following indications are listed for non-pediatric patients in the ACC/AHA Guidelines for Ambulatory Electrocardiography, 1999.1. To assess symptoms possibly related to rhythm disturbances Patients with unexplained syncope, near syncope, or episodic dizziness in whom the

cause is not obvious Patients with unexplained recurrent palpitation2. To assess antiarrhythmic therapy To assess antiarrhythmic drug response in individuals in whom baseline frequency of

arrhythmia has been well characterized as reproducible and of sufficient frequency to permit analysis

To detect proarrhythmic responses to antiarrhythmic therapy in high-risk patients3. To assess pacemaker and ICD function Evaluation of frequent symptoms of palpitation, syncope, or near syncope to assess

device function so as to exclude myopotential inhibition and pacemaker-mediated tachycardia and to assist in the programming of enhanced features such as rate responsivity and automatic mode switching

Evaluation of suspected component failure or malfunction when device interrogation is not definitive in establishing a diagnosis

To assess the response to adjunctive pharmacological therapy in patients receiving ICD therapy

NB: there is no pacemaker spike detector in CardioTens recorders.4. Ischemia monitoring Patients with suspected variant anginaIndications for ambulatory blood pressure monitoringThe following indications are listed in the European Society of Hypertension recommendations for conventional, ambulatory and home blood pressure measurement, 2003.

Suspected white-coat hypertension Suspected nocturnal hypertension To establish dipper status Resistant hypertension Elderly patient As a guide to antihypertensive drug treatment Type 1 diabetes Hypertension of pregnancy Evaluation of hypotension Autonomic failure

As CardioTens and card(X)plore are combined recorders, they offer special benefits in patients where indications apply for both ambulatory ECG and ABP monitoring.

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Contraindications

Non-cooperative patients, unconscious or otherwise incapable patients Patients requiring urgency / emergency cardiac care Patients with a sensitivity / allergy to adhesive ECG electrodes Patients with coagulation disturbances (for ABP monitoring) Patients with serious mobility or other impairments without supervision Children without supervision; children younger than 8 years (ABP monitoring) Though the blood pressure measurement algorithm used in card(X)plore has been

found to function properly on patients with atrial fibrillation or other common arrhythmias, the oscillometric blood pressure measurement method is generally recommended for use only with special caution in patients with arrhythmias, Parkinson's disease, or other diseases with tremor

Care and maintenance

Protection and cleaningAmbulatory blood pressure and ECG recorders are not specially protected against spills or ingression of water or other liquids. Do not immerse the recorder in water or any cleaning fluid, and protect it from spills and splashes. Do not expose it to heavy rain or steam, and do not wear it in a wet environment including a shower, bath, or swimming pool. In case of minor effects of a wet environment, wipe off dew of water drops with a dry cloth. Keep the recorder in a normal dry room for at least one hour before use if condensation is suspected. In case of ingress of water in the recorder, disconnect electrodes (where applicable), remove batteries from the unit, and refer the unit to authorized service. Never place a recorder unit in a disinfecting or sterilizing machine! A recommended means of cleaning is to wipe the recorder and its accessories with a disinfectant cleaning tissue, e.g., Henkel Ecolab Incides, or a similar product. Alternatively, wipe with a slightly damp cloth then dry it with an antistatic tissue. Do not expose recorders to extreme heat or radiation, including exposure to direct sunlight.The system might not meet its performance specifications if stored or used outside the environmental conditions specified in this manual.Regular checks, warranty, serviceVerification of pressure measurement accuracy is recommended biannually. Check ECG accuracy yearly using a known ECG signal source. Meditech recorders are covered by a two-year warranty under general warranty conditions of Meditech Ltd, see relevant chapter. This warranty does not cover any malfunction or defects arising from improper use, the use of inadequate accessories, accident, theft, or use of the device outside operating environmental specifications or intended measurement range. Removing the closing label from the back side of the device voids this warranty. The patient ECG cable is exchangeable without disassembling the unit. Use a certified biocompatible ECG lead cable of the same specifications, and observe color codes. There are no user serviceable parts inside Meditech recorders; they contain high complexity electronic and fine mechanical components. If you have any problems, refer the recorder to qualified service personnel. Contact Meditech or your distributor for service information.Roll-outMeditech recorders may include an internal NiCd coin cell which may fall under the category of hazardous waste and should be disposed of properly. All other parts of should be handled at roll-out as normal electronic waste.

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Safety concerns

Electric shock hazard protectionMeditech recorders meet relevant shock hazard protection standards. Ambulatory blood pressure (ABP) and combined recorders operate with 4 1.5V AA batteries or 4 1.2V AA rechargeable batteries. Event and holter ECG recorders operate with a single AAA battery. This excludes all electric shock hazards, even in the unlikely case of multiple device errors. Use only standard long-life (alkaline) batteries, or standard NiCd or NiMH rechargeable batteries of the proper size. Do not use lithium batteries. Do not mix different battery types, do not mix new and old batteries.Keep a safety distance of at least 2 meters from any electric devices, metallic objects or other electric conductors during application and removal of ECG electrodes. As long as any patient lead cables (with electrodes) are applied to the patient, not yet applied or disconnected lead cables must not contact potential shock hazard sources or electric conductors, as such contact may, through applied electrodes, serve as a pathway for a potentially life-threatening electric shock.Many personal computers do not meet certain shock hazard protection standards or strict safety regulations applicable to medical devices. Therefore, during the computer-based use of Meditech recorders, keep at least a 2 meter distance between patient and computer. Meditech recorders communicate using a plastic optical cable, whose 4 m standard (and up to 10 m optional) length allows for the required safety distance. The plastic optical cable ensures perfect electric separation and reduces the effects of external electric noise. It does not conduct electricity.BiocompatibilityUse only high quality biocompatible ECG lead cables and disposable electrodes. Use only biocompatible adhesive tape to fix lead cables in pull-relief loops. To avoid infection risks, and for general hygienic reasons, the device, cuff and tubing should never contact the patient's skin directly.Hazardous materialsUsed batteries may qualify as hazardous waste and should be disposed of properly. Meditech recorders do not contain any materials qualified as pharmaceutical substance or tissue of animal origin. They emit no material or energy hazardous to humans.Risk of incorrect diagnosisThe basic intended use of Meditech recorders is to record ECG signals and blood pressure values. Recorded ECG quality depends mainly on electrode contact quality and recording conditions, so valuable recordings are to be expected from properly instructed cooperative patients, using properly applied, high quality electrodes. Patients should be informed about rules of cooperative behaviour, proper handling of the recorder used, and expected results of monitoring in advance. ABP and ECG recorders only provide data to support diagnostic decisions of a qualified physician, they do not automatically provide a diagnosis of any kind. During the evaluation of recorded ECG, possible artefacts due to external disturbances, motion artefacts, and electrical noise should be observed and handled with caution.

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Working with Meditech recorders

The recorder must be programmed from the CardioVisions software installed on the computer. Once the pre-programmed time is reached, the recorder will commence operating automatically and perform blood pressure measurements and/or record ECG signals based on the monitoring plan. To obtain reliable BP readings and high clarity ECG signals, certain rules must be observed.

Rules of monitoring

1. Inform the patient about the goal and expected results of the monitoring. Provide an event diary and rules to observe.

2. Patients should not wear synthetic clothes during ECG monitoring, as this may cause disturbances in ECG recordings due to static electricity and small discharges.

3. Patients can fit the recorder comfortably with the adjustable straps.4. It is advisable to wear a thin shirt under ABP cuffs. This does not influence the

accuracy of blood pressure measurement, but it prevents problems caused by long-time wear of the cuff (sweat, itching, soreness, etc.).

5. The cuff and/or electrodes should be properly placed and connected. Good electrode contact requires skin preparation and electrodes designed for long-term application.

6. Should an electrode become disconnected, it, or a new electrode of the same type should be re-applied to the same position as soon as possible.

7. Patients should avoid excess movement during blood pressure measurements. They should hold their arm loose, slightly away from their chest.

8. Should blood pressure measurements cause bloodshots, torpidity or pain in the hand, the cuff should be removed from the arm immediately and disconnected from the recorder. Such occurrence should be reported to the physician latest after the monitoring session.

9. Patients may start extra blood pressure measurements with the START button of ABP recorders. They should mark events such as taking medication, waking up or going to sleep with the EVENT button. They may interrupt any single blood pressure measurement if necessary by pressing either button of ABP recorders.

10. Patients should not remove the recorder even at night. By loosening the straps, they can avoid problems when turning in their sleep. The recorder does not disturb most patients at night. Removing a card(X)plore recorder will (even if the electrodes and cuff remain connected) result in the loss of actigraphy data.

11. Should the batteries run down during a monitoring session, they can be simply replaced. Monitoring will continue, and data will not be lost. The memory card should not ever be removed during monitoring from card-capable recorders.

12. Patients should never measure anybody else’s blood pressure with an ABP recorder during an ambulatory blood pressure monitoring session.

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Monitoring step by step

Before you begin, you must have the CardioVisions program properly installed and configured on your computer, and the recorder correctly connected. To program your recorder, you will need a Meditech optical interface cable properly connected to your computer's USB or serial port (or to a USB port using a standard USB-to-serial converter) and the communication port correctly selected in the CardioVisions software. To transfer data to your database after a monitoring session from a CardioMera or card(X)plore recorder, you will also need an SD memory card reader unit, preferably an USB2-type reader, connected to your computer. The memory card necessary for monitoring is by default supplied with the recorder itself. As different computer configurations may require different card reader models, and many computers come originally equipped with one, a memory card reader unit is by default not supplied with a card-based Meditech recorder, but is readily obtainable from local sources.A successful monitoring session consists of the following steps:

1. Inform your patient about monitoring rules well in advance.2. Insert the necessary number of fully charged, proper size batteries into the

battery compartment and check their voltage.3. Insert memory card properly into the card slot (where applicable).4. Start the CardioVisions program, select the preferred recorder type for use.5. Enter new patient data or select patient from the database.6. Apply the cuff and/or electrodes to the patient.7. Connect the recorder to the computer and check electrode placement.8. Create a monitoring plan (possibly containing blood pressure measurement

intervals, ECG monitoring settings and event auto-detection trigger limits).9. Send the monitoring plan from the computer to the recorder unit.

10. Give detailed instructions to the patient who has to wear the recorder.--- Monitoring session (typically 24 hours) ---11. Check if the plan is completed.12. Remove the unit, cuff and electrodes from the returned patient.13. Ask for the patient diary, and ask the patient for any events,

symptoms, observations or complaints.14. Start the CardioVisions program and select the proper recorder type for use.15. If you use a CardioMera or card(X)plore recorder, remove the memory card

from the recorder and insert it into the card reader unit of your computer.16. Transfer collected data from the recorder or card to your database.17. Analyze ECG curves, blood pressure profile, ST trends, etc.18. Create and print the report.

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Batteries

Ambulatory blood pressure (ABP) and combined recorders operate with 4 1.5V AA batteries or 4 1.2V AA rechargeable batteries. Event and holter ECG recorders operate with a single AAA battery. Use only standard long-life (alkaline) batteries, or standard NiCd or NiMH rechargeable batteries of the proper size. Do not use lithium batteries. Do not mix different battery types, do not mix new and old batteries. Never use batteries of low or unknown quality or pre-used batteries, as they may not cover the power needs of the recorder, and they may damage the recorder, for they may contain acidic electrolytes which may leak and corrode electronic components. Should the batteries still run down during a monitoring session, they can be replaced. Monitoring will continue and data will not be lost. The central controller of the recorder watches the state of batteries, and in case of low voltage it turns amplifiers off to prevent false data getting into the memory. If you do not use the recorder, it is advisable to remove batteries since they may run down due to the constant small power consumption of the integrated circuits of the device. Data in the recorder is not lost even if batteries run down or are removed. Used batteries may fall under the category of hazardous waste and should be disposed of properly.

Important! It is strongly recommended to use freshly charged accumulators or new batteries with every patient so that batteries do not run down during monitoring, even in case of very high blood pressure values and/or a long monitoring session. After inserting batteries in ABP recorders, it is advised to check their voltage before programming the recorder. Do not start a new monitoring session with low batteries. The typical voltage for four fully charged rechargeable batteries should be over 5.1 V, and for fresh alkaline batteries, over 6.1 V. It is possible to check battery voltage with the START button.

Important! If a recorder is not used for a long period, the in-built backup cell ensuring the operation of the internal clock may get discharged. In this case keep freshly charged main batteries in the recorder for at least one day; this will recharge the backup cell. It is possible to use the recorder normally in the meantime. If the backup cell is not properly charged, the internal clock may work incorrectly, and the recorder may not start measurements in due time.

Two sets of rechargeable batteries and a charger are by default included in the complete set. Please refer to the relevant product descriptions when charging batteries. A set of properly charged, high capacity batteries will enable an ABP or combined recorder to perform 250-300 blood pressure measurements plus ECG and actigraphy recording where applicable during a 24-48 hour long monitoring session. Take the recorder out of the holder pouch and remove the battery compartment cover on the back-side. Place four properly charged, high capacity AA rechargeables or four new, long-life AA alkaline batteries into the compartment as shown in the polarity drawing. Close the compartment. If you opt to use alkaline batteries, choose high capacity, long-life products to enable reliable operation. Three dots at the bottom of the LCD show low battery voltage.

CardioClip, CardioBlue and CardioMera recorders work with one standard AAA size battery. Insert battery as shown. Use only long-life (alkaline) batteries, NiCd or NiMH rechargeable batteries. Low battery voltage causes the status LED of Meditech ECG recorders to slowly blink in red. Though the recorders can work several days with one battery, it is recommended to insert a new battery or a properly charged rechargeable battery with each new monitoring session.

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Using a memory card with CardioMera and card(X)plore

CardioMera and card(X)plore recorders use SD or MMC flash memory cards to record ECG and other data during the monitoring session. Fully insert

the Meditech-supplied memory card carefully into the recorder, as shown in the picture for card(X)plore, or as shown on the back side of CardioMera recorders. It is highly recommended to use a card exclusively for ECG monitoring; using the same card for other purposes may result in data loss, malfunction, or a failed monitoring session.

NB: All data stored on the card will be erased during programming!

You will need a card reader unit built into or connected to your computer to transfer the recorded data to your database after a monitoring session. It is not possible to transfer such data using the optical interface cable; the only

way is to remove the card from the recorder and insert it in a card reader unit. Use a USB 2.0 reader to transfer data to your PC.

The SD cards supplied by Meditech are ready to use with CardioMera or card(X)plore recorders. Insert the card gently until it locks in place. All data stored on the card when inserted into the recorder may be erased during programming the recorder, even if the write-protect notch is in the locked position. Please note that Meditech assumes no responsibility for the loss or destruction of such data. It is highly recommended to use a card exclusively for CardioMera or card(X)plore monitoring; using the same card for other purposes may result in data loss, malfunction, or a failed monitoring session. Never remove the card, or remove the batteries from a card-based recorder while accessing the card (i.e., during storage, deletion or initialization operations), since data stored in the card may be destroyed. Remove the card from a recorder only if the monitoring session is completed.If you use a card from another source, or need to re-format the card supplied, note that according to Microsoft recommendations a 128 MB SD card should be formatted for a FAT16 file system to work properly with Windows systems. CardioMera and card(X)plore will work with FAT32-formatted cards, but you may experience data access problems with cards formatted so on your computer. The following cards have been tested and are recommended for use: Sandisk SDSDB-128, Kingston SD/128, or Infineon Secure Digital cards.The memory card is a precision electronic device. Place it in the antistatic case provided when carrying and storing it. Failure to do so may result in damage to the card caused by static electricity. Do not apply strong force or impact to the card, nor bend or drop it. Do not put the card in the pocket of your pants, etc. Do not use or store the card in an environment with possibly strong static electricity/electric noise, including immediate proximity of mobile phones. Do not use or store the card in high temperature or humidity, nor subject it to a corrosive environment. Protect the contacts from dirt and particles that may come in contact with, or adhere to, the card. Use only dry, soft cloth to wipe away dirt. Keep the card out of the reach of children to prevent accidental ingestion. If the card is swallowed, seek medical assistance immediately.The lifetime of the card is limited because it uses flash memory. It will not be able to save data after it has been used for a period exceeding its lifetime. In this case, replace the card with a new one.Please note that as a security measure, postal department might subject all articles sent through mail to high level radiation. High level radiation erases all data stored on an SD card and renders the card useless. Please check and verify postal service policies before sending memory cards by mail.

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ECG electrodes and their application

As long as any patient lead cables (with electrodes) are applied to the patient, not yet applied or disconnected lead cables must not contact potential electric shock hazard sources or electric conductors, as such contact may, through still applied electrodes, serve as a pathway for a potentially life-threatening electric shock. Electrodes (and patient lead cables) should in all cases be applied to a patient in a minimum safety distance of 2 m from any electric devices, metallic objects or other electric conductors. Synthetic clothes should be avoided to reduce static discharge related noise. Use of pull-relief loops on lead cables and fixing them with adhesive tape is strongly recommended.CardioClip, CardioBlue and CardioMera recorders may be used with 3 to 7, individually exchangeable ECG lead cables depending on preferred recording parameters. CardioTens uses a 5-lead patient cable to record two bipolar ECG leads (channels), whereas card(X)plore uses a 7-lead cable to record three, where each ECG lead (channel) is defined as a difference between a pair of electrodes, with one neutral electrode used for feedback. Multi-channel recording improves the chance to avoid misdiagnosed recordings, reduces the chance to miss something important due to noise, electrode problems or improper “viewing angle”. See the standard ECG cable color codes and recommended positions in the following table.

ElectrodeColor

EU USA PositionA+ green red left anterior axillary line, intercostal space 5A - red white manubrium sterniB+ white brown left anterior axillary line, intercostal space 5B - yellow black right anterior axillary line, intercostal space 5C+ orange orange left posterior axillary line, intercostal space 5C - blue blue right sternal border, rib 2N black green corpus sterni

Please note that CardioTens uses a non-standard color code: red-white for channel A, yellow-green for channel B, black for neutral.In the recommended layout, described in the table above and shown in the figure, the resulting channels will correspond to the most commonly used ambulatory ECG leads, as follows:

channel A is CM5channel B is CC5channel C is inverse Nehb J (if applied)

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Preparing the patient and the electrodes

1 Clean (and possibly depilate) chestElectrodes should be fixed onto a thoroughly cleaned and, if necessary, depilated skin to ensure a reliable and stable contact. Wearing synthetic clothes will cause static disturbances, adding noise to the ECG. Advise your patient not to wear such clothes during monitoring.2 Attach electrodes to ECG lead cable connectorsAlways do this procedure prior to attaching the electrodes to the patient’s chest. Attaching the ECG cable connectors to the electrodes after placing them on the patient’s chest may cause inconvenience or even pain.3 Remove electrode protection films4 Apply the electrodes to the proper positions (see previous page)5 Create stress-release loops with each cableIt is advised to create a stress-release cable loop on each lead cable, close to the electrode (about 5-10 cm), and fix it to the patient’s skin with non-allergic adhesive tape. This significantly reduces possible technical problems with ECG signals. Loop-protected cables will reduce movement disturbances.6 Combined recorders: connect ECG patient cable to its socket on recorderThe multi-lead ECG patient cable can be connected into the socket on the top of the device by a standard plug. Align plug and socket marks, push and turn gently clockwise. Turn counter-clockwise to disconnect. Observe that pin number matches socket type.

Real-time ECG monitoring to check electrode placement

It is highly recommended to check electrode placement before an ECG recording session to record the best quality ECG signals. The CardioVisions software provides on-line ECG monitoring capability to check electrode placement. Attach electrodes to patient, connect ECG patient cable to the recorder if applicable, and connect recorder to PC to use this function.You can judge the following details with electrode checking:- Is galvanic contact established (do you get ECG curves or not)?- Is the placement of electrodes correct to gain leads as intended?- Are ECG signals clear, with proper polarity and sufficient gain?- Does breathing or other muscle movement not disturb ECG signals?- What are the initial ST levels and heart rate?The on-line ECG monitoring screen will display a moving average ECG cycle in addition to running curves. It will calculate and display heart rate, ST values (depression or elevation from baseline) and a slope value. You can use these values to determine initial heart rate and ST levels and adjust trigger limits accordingly when you create your monitoring plan.

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Cuffs and their application – ABP and combined recorders only

It is advisable to wear a thin shirt or blouse under the cuff. This does not influence the accuracy of blood pressure measurements but it prevents possible problems caused by long-time wear (sweating, itching, etc.). Place the cuff on the upper arm so that the rubber tube points towards the patient’s shoulder and the bladder is placed above the brachial artery, if possible. Contrary to the usual placement with the tube pointing downwards, the advantage is that the patient can wear a loose jacket over the shirt or blouse. Connect the rubber tube of the cuff into the air plug connector, which you can find on the top of the vertically standing ABP recorder. Connect the cuff turning it clockwise with slight pressure.

Note: It is recommended that the cuff be applied as tightly as acceptable for the patient. A loose cuff will cause much longer blood pressure measurement times and possibly aborted measurements. With an overly loose cuff, the recorder must pump to tighten the cuff on the arm and then it must reach the pressure necessary for measurement. This causes considerable inconvenience for the patient and results in less data for evaluation. If the patient removes the cuff for a period during the monitoring session, it should be re-applied with appropriate tightness, with help from another person, if necessary. Should blood pressure measurements cause bloodshots, torpidity or pain in the hand, the cuff should be removed from the arm and disconnected from the recorder. Such occurrence should be reported to the physician latest after the monitoring session.

Meditech ABP and combined recorders recognize and function with three different cuff sizes.Name Bladder

dimensionsSleeve

dimensionsArm circumference

range*Normal adult 12.5 x 22.5 cm 16 x 52 cm 24-32 cmSmall adult (child) 6 x 28.5 cm 9 x 41 cm under 24 cmLarge adult 14.5 x 32 cm 16 x 70 cm 32-42 cm

* When properly applied, the end of the sleeve (the one closer to the tube) should fall in the indicated range.

In ABPM-04, the cuff is the component which, by definition of the relevant standard, is protected against the effects of the discharge of a defibrillator.

Caution!Substitution of a cuff different from that supplied might result in measurement error and/or it might in certain cases cause damage to the main recorder unit.

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Meditech ABP recorders: ABPM-04, CardioTens and card(X)plore

ABPM-04 is a silent, compact and lightweight, programmable ambulatory blood pressure monitor. CardioTens is an innovative combined ambulatory diagnostic tool that highlights the relationship between coronary heart disease and hypertension, and

provides a detailed analysis of various parameters of cardiovascular risk. It records 24-hour blood pressure, ST-segment and heart rate profiles,

and two-channel event ECG strips according to a preset program sequence. CardioTens performs continuous real-time beat-to-beat ECG analysis as well. Automatic event detection with adjustable

preset limits ensures that extra ECG strips and corresponding blood pressure values are recorded during (silent) ischaemic events. card(X)plore is a powerful multifunctional ambulatory cardiovascular diagnostic device. It records 3-channel full disclosure

ECG data and performs full ambulatory blood pressure monitoring simultaneously. As an option, it can record actigraphy data using a

two-axis acceleration sensor. The unit performs continuous real-time beat-to-beat ECG analysis during monitoring. Automatic ECG event detection with adjustable preset limits ensures that corresponding blood pressure values are recorded during (silent) ischaemic events, high or low heart rates, and syncopal episodes. The recorders operate silently and reliably with 4 AA rechargeable batteries. ABPM-04 and CardioTens use in-built solid-state memory; the card(X)plore unit uses a stamp-sized SD (Secure Digital) memory card for no-compression storage to ensure perfect signal quality. The recorders are easily initialized by connecting them to a personal computer using an optical cable link. With the combined ABP/ECG devices, the cable enables on-line, real-time ECG monitoring to achieve the best electrode placement. Patients can start extra blood pressure readings or mark symptomatic events.

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Accessories

setone (1) plastic case or carton packaging (depending on order)one (1) recorder unitone (1) USB or serial interface unit with twin optical cableone (1) pouch for recorder, with shoulder and waist strapsone (1) normal adult size cuffone (1) ECG patient cable - CardioTens and card(X)plore onlyone (1) package of disposable electrodes - CardioTens and card(X)plore onlyone (1) memory card, 128 MB - card(X)plore onlyeight (8) AA rechargeable batteriesone (1) battery chargerone (1) CardioVisions software CDone (1) user guide

recorder packageone (1) carton packagingone (1) recorder unitone (1) pouch for recorder, with shoulder and waist strapsone (1) normal adult size cuffone (1) ECG patient cable - CardioTens and card(X)plore onlyone (1) memory card, 128 MB - card(X)plore only

Accessories may vary from place to place.

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Controls and labels

Front sideCuff connector socketECG cable connector socket(CardioTens and card(X)plore only)

LCDSTART buttonEVENT button

Device name labelMemory card slot(with SD card inserted - card(X)plore only)

Optical interface socket (on bottom)

Back side

Manufacturer's labelInformation label

Battery compartment cover (removed)

Battery compartment

Optical interface socket (on bottom)

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Using the buttons

The START button is plain, without marking, closer to the LCD. Its functions:Manual blood pressure measurementIf it seems necessary, the patient can start an additional, manual blood pressure measurement by pressing the START button shortly. The result with a manual measurement marker will be stored in the memory of the device. Typical causes for this use: dizziness, pain (angina pectoris or headache), palpitation.LCD checkPress and hold the START button to light up all segments of the LCD to check if they all work correctly.Battery voltage checkPress and hold the START button for more than 5 seconds to display battery voltage on the LCD (e.g. 5_24, equal to 5.24 V). The voltage display lasts until you release the button, but not more than 5 seconds. The unit will then return to displaying time. The voltage for fully charged accumulators should be over 5.1 V, and for fresh alkaline batteries over 6.1 V.Cancel a blood pressure measurementThe patient can interrupt a blood pressure measurement by pressing either button at any time while the cuff is pressurized. This will result in immediate fast cuff deflation. Such interruption is limited to the measurement in progress only and has no effect on further operation.

The EVENT button is marked with an indented circle. Its functions:Set a patient event markerThe patient can mark any event without starting a manual blood pressure measurement by pressing the EVENT button briefly. Typical causes for this use: waking up, going to sleep, taking medicine. The patient should be instructed to record the reason for setting an event marker in a diary. Switch between active and passive blood pressure measurement frequency*If this function is enabled during programming, the patient can press and hold the EVENT button for more than 5 seconds to switch the unit to passive blood pressure measurement frequency (or back).

* ABPM-04 onlyCancel a blood pressure measurementThe patient can interrupt a blood pressure measurement by pressing either button at any time while the cuff is pressurized. This will result in immediate fast cuff deflation. Such interruption is limited to the measurement in progress only and has no effect on further operation. This use of the button will not set an event marker.

There is no on-off button. The recorders will execute the monitoring plan as programmed. If the batteries, or - where applicable - the memory card are removed, the recorder will cease to function.

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Displays

LCD check: all segments are displayed

Normal status: time is displayed

Communication with personal computer

Monitoring plan does not work: card(X)plore only

plan not started or memory card missing / removed

Blinking display: card(X)plore only

monitoring plan activation in progress

Monitoring plan is completed card(X)plore only

Lead off, electrode(s) disconnected, all channels card(X)plore only

(observe number and position of segments on the right)

Setting zero pressure levelfor blood pressure measurement

Pumping for blood pressure measurementcurrent pressure in mmHg

Systolic value of just completed measurement [mmHg]

Diastolic value of just completed measurement [mmHg]

Pulse rate value of just completed measurement[beats per minute]

Blood pressure measurement cancelledby pressing a button

Battery voltage display (5.37 V)

Low battery signal (three dots at the bottom)

In addition to these most important displays, a lot of extraordinary situations and errors have their own code displayed on the LCD. These codes are stored together with recorded data and they are listed in the CardioVisions software. This helps service personnel to identify causes of an unexpected behavior, result or error.

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Technical parameters

Power supply:4 AA rechargeable NiCd or NiMH batteries or 4 AA alkaline batteries

Display:liquid-crystal

Data storage:internal solid state memoryin ABPM-04 and CardioTens;128 MByte MMC or SD cardin card(X)plore

Data transmission:programming and electrode checkon USB or serial optical cable, 115200Baudreading collected data with memory card and compatible reader in card(X)plore

PC interface:special optoelectronic interfacewith RS232 or USB connector

Operating environment:+10 to +45 °C of temperature10 to 95 % humidity, non condensing83 to 103 kPa atmospheric pressure

Storage conditions:-20 to +50 °C of temperature10 to 95 % humidity, non condensing

Size:82 x 124 x 33.5 mm

Weight:app. 330 g (batteries included)

Blood pressure measurement method:oscillometric

Blood pressure maximum storage:over 400 programmed measurements+ manual measurements & events

Pressure measurement range:0-300 mmHg

Static accuracy:± 3 mmHg or ± 2% of measured value(stability: 2 years)

Blood pressure measurement range:30-260 mmHg, pulse 40-200 beat/min

Blood pressure measurement accuracy:the same BP measuring algorithm has been BHS- validated in the ABPM-04 device

Pressure sensor:

piezo-resistiveInflation:

automatically controlled pumpSafety:

maximum inflation 300 mmHg;independent safety release valve

Deflation and rapid air release:automatic pressure release valve

ECG electrodes:standard holter electrodes

ECG leads:2 ECG channels in CardioTens;3 ECG channels in card(X)plore

ECG lead off detection:in card(X)plore only,separately for each channel

Pacemaker spike detection:in card(X)plore only,2-level hardware detector

ECG sampling rate:200 Hz in CardioTens;600 Hz in card(X)plore (300 Hz storage)

ECG frequency range and A/D resolution:0,05 to 100 Hz (-3dB); 4 uV, 12 bit

ECG input dynamic range and impedance:16 mVpv ; 100 MOhm

ECG DC offset tolerance:± 300 mV

ECG storage:24 to 96 hours full disclosure on 3 channels (depends on memory card and selected storage quality) in card(X)plore;4 hours total length of ECG strips on2 channels plus 24-hour ST and RR datain CardioTens

ECG filters:baseline antidrift filteradaptive powerline hum filteradaptive muscle noise filter

Actigraphy (card(X)plore only):24 to 51 hours total on 2 channels

Actigraphy sensor (card(X)plore only):2-axis polysilicon accelerometer

Actigraphy measurement range, sampling and sensitiviy (card(X)plore only):

± 2 g; 10 Hz; better than 0.01 g

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Meditech ECG recorders: CardioClip, CardioBlue and CardioMera

CardioMera is a miniature and versatile holter ECG recorder. Initialized with the CardioVisions software and properly

applied to the patient, CardioMera records ECG curves on its SD memory card continuously. Whenever the patient presses its button, the device will also record an event marker. CardioMera will operate reliably for 48 hours with its single AAA size battery. However, the background of possible cardiac symptoms is often

difficult or impossible to clarify with even a holter recording. CardioClip, a looping ECG event recorder, or

CardioBlue, its wireless version, help to solve this problem by extending cardiac event recording to several days.

These looping recorders constantly keep ECG data from the last several minutes in their loop memory, and whenever the patient presses their button, they will store ECG strips both preceding and following the event (pre-post recording). With CardioMera, CardioClip and CardioBlue, lead/channel layout and ECG quality is programmable before the monitoring session. You can achieve optimal use of main storage memory by selecting economy to diagnostic ECG quality, one to five independent channels, and, with event recorders, flexible pre- and post-event recorded strip length. In pre-post recording mode, CardioClip and CardioBlue will operate reliably for over a week with their single AAA size battery. Should an even longer observation period be necessary, these recorders can be switched to post-event recording mode. In this mode, they are expected to run for several months. CardioClip and CardioBlue will store ECG data in its built-in solid state memory. After a recording session, data collected by CardioMera can be transferred to a personal computer by inserting the memory card in a card reader unit, ECG strips collected by CardioClip can be transferred via an optical interface cable, and CardioBlue data can be transferred using Bluetooth wireless connection either directly or through a compatible mobile phone.

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Accessories

setone (1) carton packagingone (1) recorder unitone (1) USB or serial interface unit with twin optical cable – except CardioBlueone (1) Bluetooth wireless USB adaptor – CardioBlue onlyeight (7) ECG lead cables, color-codedone (1) package of disposable electrodesone (1) memory card, 128 MB – CardioMera onlyone (1) AAA alkaline batteryone (1) CardioVisions software CDone (1) user guide

recorder packageone (1) carton packagingone (1) recorder uniteight (7) ECG lead cables, color-codedone (1) memory card, 128 MB – CardioMera onlyone (1) AAA alkaline battery

Accessories may vary from place to place. Electrodes and lead cables are also available from third parties. Use only certified biocompatible accessories; use electrodes designed for long-term (ambulatory) monitoring use.

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Controls and labels

Front sidestatus LEDcommunication LED

clip

pushbutton

lead cable plugs

Back sidebattery compartment (on the side)optical socket (except CardioBlue)serial number & model coderequired labelingSD card in socket(CardioMera only)

lead layout guide

lead cable plugs

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Using the button

The only button of Meditech ECG recorders is plain, visually marked and it can be found just in the middle of the properly connected clip. Its function is to start a recording (in case of event recorders), or set an event marker if ECG recording is already in progress (in CardioMera). The patient can do this by shorty pressing the button during the recording session.There is no on-off button. The recorders will execute the monitoring plan as programmed. If the battery, or - where applicable - the memory card is removed, the recorder will cease to function.

Multifunctional button on CardioBlue

If you press and hold the button of CardioBlue, the LEDs will show different signals depending on how long the button is held. If you press the button, then release it within 3 seconds, the device will start an ECG recording as described above. If you hold the button pressed longer, the device will sound a triple beep at the 3rd second, and the (Bluetooth) communication LED will start blinking fast in green. This fast blinking will last for an additional total length of 5 seconds, and if you release the button during this period, CardioBlue will switch to Bluetooth discoverable mode. If you keep holding the button pressed longer, the device will sound another triple beep at exactly 8 seconds, and the (Bluetooth) communication LED will start blinking slowly in green. This slow blinking will last for an additional total length of 5 seconds, and if you release the button during this period, CardioBlue will switch to Bluetooth active search mode, trying to establish wireless connection with a Bluetooth modem whose properties it finds in its programming information. If you keep holding the button pressed for a total sum length of 13 (3+5+5) seconds or more, and then you release it, the device will do nothing, just return to its standard operation.

In summary:

Seconds elapsed from depressing button until release:

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14

start recording … become Bluetooth … start connection … nothingdiscoverable with Bluetooth modem

Wireless connection with a computer

You can connect CardioBlue to your personal computer by switching it to Bluetooth discoverable mode, then initializing Bluetooth connection from the PC software. In Bluetooth discoverable mode, the Bluetooth LED on CardioBlue will show constant green. If connection is not initialized from the computer for one minute, CardioBlue will return from its Bluetooth discoverable mode to its standard operation. If wireless connection is successfully set up from the computer, CardioBlue will sound one long beep.

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Acoustic and visual signals

CardioMera, CardioClip and CardioBlue all have an in-built buzzer and two red-green dual-color LEDs to display information on their status, or warn about possible problems. Most beep and blink functions can be disabled during programming, but important signals will overrule the program presets.

Startup sequenceSELF-TEST When a battery is inserted, the recorder performs a self-test. The LEDs

will light up in the following sequence: status green then red, communication green then red.

SUCCESS The recorder will beep once, light up both LEDs in green for 2 seconds, then emit 4 short beeps. This means it is ready to work as programmed.

FAILURE The recorder will light up both LEDs in red for 2 seconds, sound a long beep, and then restart the self-test.

The status LEDREADY Slow green blinks - if not disabled, the status LED will blink shortly

once every 2 seconds in green to show that the recorder is ready to store ECG as programmed.

FORMATTING CARDIOMERA ONLY - Continuous red - the status LED will light up in red when the SD card is being formatted during programming to show that during this procedure the card must not be removed.

RECORDING Continuous green in event recorders - if not disabled , the status LED will light up during the time of ECG recording. Slow green double blinks in CardioMera – continuous green in a full-disclosure recorder would mean too much power consumption.

ELECTRODE Fast red blinks - the status LED will blink shortly once every half second in red to show electrode disconnection, accompanied by repeated beeps if enabled. This function is always active during the monitoring session in pre-post recording mode and during real-time monitoring. It also works during ECG storaging if an event recorder is programmed to post-event mode.

BATTERY LOW Slow red blinks - the status LED will blink shortly once every 2 seconds in red to show that the battery should be changed.

The communication LEDThe communication LED will light up in green during all communication between the recorder and a personal computer.

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Technical specifications

Power supply 1 AAA alkaline or rechargeable battery

Power consumption < 150 mA (when recording ECG)

Operation with 1 battery 4 days (Holter)1 week (looping mode in event recorders)3 months (post-event mode, event recorders only)

ECG channels up to 3 independent bipolar or 5 unipolar channels

Lead layouts 1, 2 or 3 bipolar leads2, 3 or 5 unipolar leads

A/D resolution 12 bit

Sampling frequency 1200 Hz or 600 Hz

Storage frequency 600 Hz, 300 Hz or 150 Hz

Storage capacity: event recorders quality and channel dependent

storage 150 Hz 300 Hz 600 Hz

1 channel 136 min 68 min 34 min2/3 channel 68 min 34 min 17 min5 channel 34 min 17 min 8 min

Storage capacity: CardioMera quality and channel dependent

24-h file size 150 Hz 300 Hz 600 Hz

1 channel 26 MB 52 MB 105 MB2/3 channel 52 MB 105 MB 210 MB*5 channel 105 MB 210 MB* 421 MB**

* 256 MB SD card required

** 512 MB SD card required

Frequency range storage @ 600 / 300 Hz 0.05-100 Hz (-3 dB)@ 150 Hz 0.05-50 Hz (-3 dB)

Dynamic range, sensitivity 16 mV p-v, 4 µV

DC offset tolerance +/- 300 mV

Input impedance 100 MOhm

Accuracy < 5 %

Pacemaker detection integrated hardware detector

Operator controls 1 pushbutton

Display 2 dual-color LEDs

Storage conditions -20 ~ 60 °C, 10 ~ 95 % humidity (non-condensing)70 ~ 106 kPa atmospheric pressure

Operating conditions 10 ~ 45 °C, 10 ~ 95 % humidity (non-condensing)70 ~ 106 kPa atmospheric pressure

Dimensions 66 x 59 x 17 mm

Weight ~ 54 g (incl. battery)

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Bluetooth devices: CardioBlue and card(X)plore with Bluetooth

CardioBlue is a device with wireless communication, and card(X)plore is optionally available with wireless communication as well, both using Bluetooth technology. Most up-to-date computers today come with in-built Blueetoth capability, or are easily extendible using a small USB Bluetooth dongle. Bluetooth functionality works seamlessly in Windows XP Service Pack 2 or newer releases, but it usually can be added to older Windows versions as well. Windows XP Help, as well as the documentation of Bluetooth dongles, contain detailed information how wireless devices can be used, and this is described in detail in CardioVisions Help as well. However, if you use CardioBlue, you may need the following information during the first startup procedure after the installation of CardioVisions.

If you wish to use a CardioBlue or a card(X)plore with Bluetooth under Windows XP SP 2, follow the steps below. With other Windows versions, please refer to the documentation of the Bluetooth device used in your computer.

1. If you wish to use a wireless, Bluetooth-capable Meditech device, open the Options window of CardioVisions and select the Communication category. Select the type of the device, then click on the Bluetooth settings button. In the appearing dialog, click on the Connect setup button to go to the next step.

2. In the appearing window you can see Meditech devices which have already been added to your computer. Place fresh batteries into the new (CardioBlue or card(X)plore with Bluetooth) device and make it discoverable.

[In case of CardioBlue, press the button of CardioBlue for more than 3 seconds but less than 8 seconds and then release it. The Bluetooth LED of the CardioBlue emits green light, indicating the device is discoverable.

In case of card(X)plore press both buttons of card(X)plore for more than 3 seconds but less than 8 seconds and then release it. The LCD of card(X)plore displays the PC-- marking.]

Both devices remain discoverable for a minute then switch back to stand by mode. If the device switches back to stand by mode, make it discoverable again.

After you have made the device discoverable, click on the Add button.

3. If there is a moving torch, the PC searches for Bluetooth devices. If the device switches back to stand by mode, make it discoverable again then click on the Add button.

4. After the search the found devices are listed. The name of the device in case of CardioBlue is HB1_xxxx, and in case of card(X)plore it is CT2_xxxx. Where xxxx is the last four digits of the serial number which could be also found on the back of the device. By selecting the appropriate device the OK button will be active, please click on it.

5. As authentication key (PIN), please enter the last four digits of the serial number. After entering the key, click on the Finish button.

6. Wait until the system installs the new device.

By clicking on the Test button you can check the communication. Make the device discoverable before the test as described above.

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Meditech product warranty information

(a) RECORDER WARRANTY. The main recorder unit will be free from defects in materials and workmanship under normal use and service for a period of two (2) years from the date of receipt. This warranty covers the recorder unit only. This warranty does not cover any accessories that might come with the recorder unit.

(b) ACCESSORIES WARRANTY. The non-disposable accessories delivered with the recorder unit will be free from defects in materials and workmanship under normal use and service for a period of one (1) year from the date of receipt. This warranty does not cover disposable accessories, packaging materials, accumulators and batteries, cuffs, or any of their components.

(c) CUFF WARRANTY. The cuff(s) - if delivered with a recorder unit - will be free from defects in materials and workmanship under normal use and service for a period of six (6) months from the date of receipt. This warranty covers the cuff(s) delivered with a recorder unit exclusively.

(d) SOFTWARE WARRANTY. The CardioVisions software under normal use will perform substantially in accordance with the accompanying written/electronic documents for a period of ninety (90) days from the date of receipt.

This warranty is valid at the representative address of Meditech Ltd. unless otherwise displayed upon a commercial invoice or any other valid business document duly signed by the supplier and the recipient of the Meditech product. If such business document displaying a certain site for warranty validity cannot be presented, this warranty is valid at Meditech HQ office in Budapest, Hungary. This warranty does not cover any malfunction or defects of the recorder unit or any of its accessories arising from improper use, the use of inadequate accessories, accident, theft, or use of the recorder unit outside its operating environmental specifications and intended measurement range. Removing the closing label from the back side of the recorder unit, or opening the unit any other way voids this warranty.

EXCLUSION OF BIOHAZARD. Meditech will not accept for repair potentially infectious products or accessories, especially pouches and cuffs, that might have been in direct contact with the patient, and could not be, or (potentially) were not, properly disinfected, even within the warranty period. If a problem occurs within the warranty period, such accessories will be replaced without any physical inspection, reserving the rights to hold an inspection when found necessary.

NO OTHER WARRANTIES. Meditech disclaims all other warranties, either expressed or implied, including, but not limited to, implied warranties of merchantability and fitness for a particular purpose, with regard to the recorder unit, any accessory or other accompanying hardware, and the CardioVisions software.

NO LIABILITY FOR CONSEQUENTIAL DAMAGES. In no event shall Meditech be liable for any special, incidental, indirect, or consequential damages whatsoever (including, without limitation, damages for loss of business profits, business interruption, loss of business information, loss of data, or any other pecuniary loss) arising out of the use of or inability to use the recorder unit, its accessories and/or the CardioVisions software, even if Meditech has been advised of the possibility of such damages.

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EMC information

Medical electrical equipment should be used with precautions according to EMC, and must be installed according to the EMC notices disclosed in this manual as mobile RF transceivers could adversely affect it.

Directive and declaration of manufacturer – Electromagnetic EmissionMeditech recorders described in this manual are suitable for use in the specified electromagnetic environment. The purchaser or user should assure that they are used in an electromagnetic environment as described below

Emission test Compliance Electromagnetic EnvironmentRadiated and conducted RF emission

CISPR 11

Group 1 Except for their intended wireless communication functions in the range of the Bluetooth radio spectrum (where applicable), Meditech recorders use RF energy only for their internal functions. Therefore, the emission is very low and not likely to cause any interference in nearby electronic equipment.

Radiated and conducted RF emission

CISPR 11

Class B Meditech recorders are suitable for use in domestic establishments and in establishments directly connected to the low voltage power supply network which supplies buildings used for domestic purposes.

Harmonic emission

IEC61000-3-2

Not applicable ---

Voltage fluctuations / Flickers

IEC61000-3-3

Not applicable Meditech recorders are suitable for use in establishments directly connected to a public low voltage mains network.

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Directive and declaration of manufacturer – Electromagnetic immunityMeditech recorders are suitable for use in the specified electromagnetic environment. The purchaser or user should assure that they are used in an electromagnetic environment as described below.

Immunity test IEC601-1-2 test level

Compliance level

Electromagnetic environment

Electrostatic discharge (ESD)

IEC 61000-4-2

±6KV contact

±8KV air

±6KV contact

±8KV air

Floors are wood, concrete or ceramic tile, or floors are covered with synthetic material and the relative humidity is at least 30 percent.

Electrical fast transient/ burst

IEC 61000-4-4

±2KV for power supply lines

±1KV for input/output lines

Not applicable

---

Surge

IEC 61000-4-5

±1KV differential mode

±2KV common mode

Not applicable

---

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5% UT (>95% dip) for 0.5 cycle;

40% UT (60% dip) for 5 cycles;

70% UT (30% dip) for 25 cycles;

<5% UT (>95% dip) for 5 sec.

Not applicable

---

Power frequency (50/60Hz) magnetic field

IEC 61000-4-8

3A/m 3A/m Power frequency magnetic fields are at levels characteristic of a typical location in a typical commercial and/or hospital environment.

Note: UT is the nominal voltage of mains.

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Directive and declaration of manufacturer – Electromagnetic immunityMeditech recorders are suitable for use in the specified electromagnetic environment. The purchaser or user should assure that they are used in an electromagnetic environment as described below.

Immunity test IEC601-1-2 test level

Compliance level

Electromagnetic environment

Conducted RF

IEC 6100-4-6

3Veff

150KHz - 80MHz

Not applicable

Portable and mobile RF communications equipment are used no closer to any part of Meditech recorders, including cables, than the Recommended Separation Distance calculated the formula written below.

Recommended Separation distance:

Radiated RF

IEC 61000-4-3

3V/m

80MHz – 2,5GHz

3V/m d=[3,5/3V/m]√P;(80MHz – 800MHz)

d=[7/3V/m]√P;(800MHz – 2,5GHz)

where:

P is the highest radiated power disclosed by the manufacturer of transmitter [W];

d is the recommended separation distance [m].

1. note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is applicable.

2. note: These are guidelines. Actual conditions may vary.

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Recommended separation distanceMeditech recorders are intended to be used in electromagnetic environment with controlled RF disturbances. The purchaser or user may help to reduce electromagnetic disturbances by defining the separation distance between the transportable or mobile RF telecommunication equipment (transmitters) and Meditech recorders, depending on the highest output power of the telecommunication equipment.

Separation distance in function of the frequency of the transmitter [m]

The highest output power of the transmitter

[W]

150KHz – 80MHzd=[3,5/V1]√P

80MHz – 800MHz

d=[3,5/E1]√P

800MHz – 2,5GHzd=[7/E1]√P

0,01 Not applicable 0,12 0,230,1 Not applicable 0,38 0,731 Not applicable 1,2 2,310 Not applicable 3,8 7,3100 Not applicable 12 23

If this table does not contain the highest output power of the transmitter, the d separation distance [m] can be calculated by the formula, depending on the frequency of the transmitter, where P is the rated highest output power of the transmitter [W].

1. note: in case of frequency 80MHz or 800 MHz, the formula for the higher range is applicable.

2. note: These are guidelines. Actual conditions may vary.

Meditech CardioBlue (model code HB1) recorders, as well as Meditech card(X)plore (model code CT2) recorders equipped with Bluetooth option contain a separately manufactured Bluetooth transceiver, which meets the requirements of standards listed below:– EN 60950:2000;– EN 300 328 Ver. 1.4.1.;– EN 301 489-1 Ver. 1.4.1.;– EN 301 489-17 Ver. 1.2.1.;

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