CardioMessenger II-S Technical Manual Rev G July 2012

Call back light (yellow, page 14) Operating light (yellow/green, page 13)

Slot for the brief instructions guide (page 12) Use only original power supply units (page 9)

Connection for the power supply (page 10)

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Contents Introduction... 3 How Home Monitoring works... 3

Debugging... 16

Check the completeness of the delivery . . 5

Precautionary measures... 21

Setup... 7

Guidelines... 23

Connection... 9 Self-test... 11 Insert brief instructions guide... 12

Technical data... 25 Legend for the Label... 27

Cleaning, maintenance, and disposal . . . 19

Appendix... 29

Operate... 13 Check lights... 13 Call back function... 14 Switch off the system... 15

CardioMessenger II-S

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Introduction Dear patient:

How Home Monitoring works

You have received a pacemaker or implantable cardioverter-defibrillator (ICD) with the additional Home Monitoring function by BIOTRONIK. With Home Monitoring, the state of your heart's health and your device are surveyed on a daily basis while you are at home. Your physician can catch up at regular intervals on how your heart is doing.

Your device is equipped with a special trans- mitter (1). Usually at night, the transmitter sends daily information on your heart to the patient device, your CardioMessenger (2).

CardioMessenger II-S

The transmission power from your implanted device is low and does not impair your  health in any way. Its limited transmission range, however, requires the use of the CardioMessenger.

Introduction

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The CardioMessenger collects the information received from the device and automatically transmits it to the BIOTRONIK Service  Center (4) as encoded messages via a  mobile connection (3). Here, the messages are decoded and made available for viewing by your physician (5) on  a protected web site. Based on the information received, your physician can decide if your device is  best configured, or if the therapy needs adjustments. In this way, Home Monitoring serves as a practical diagnostic aid to your physician.

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Introduction

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Check the completeness of the delivery Check all components for visible damage before using them. Use only components which are undamaged. The delivery includes the following:

Technical manual with brief instructions guide CardioMessenger II-S

Warning!  Use the CardioMessenger only if it is undamaged. Return a damaged CardioMessenger to your physician.

Power supply unit with electricity cable and  DC plug

CardioMessenger II-S

Check the completeness of the delivery

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Warning!  Use only the original parts included (for details, see "Technical data", page 25). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and  the CardioMessenger's susceptibility to interference. The label on the back side of the CardioMessenger indicates the approved power supply units:

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Check the completeness of the delivery

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Setup Place the CardioMessenger on your bedside table. The bedside table is suitable because it usually meets the following conditions: 2 The CardioMessenger is placed on a solid base and cannot fall. 2 The distance to the device is less than 2 meters (6 feet) so that regular data transmission at night is assured. At the same time is the distance to  the device more than 20 centimeters  (7 inches) and the CardioMessenger has no influence on your device.

CardioMessenger II-S

Warning!  The distance between CardioMessenger and device has to be at least 20 centimeters (7 inches). The CardioMessenger contains a mobile module ("Mobile"). In order to prevent any interferences of the device, you have to keep the prescribed minimum distance between device and cellular phone also to the CardioMessenger.

Setup

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Please take the following also into consideration: 2 Place the CardioMessenger in such a  way that the lights can easily be viewed during the day. If the lights disturb you  in your sleep, turn the CardioMessenger away from you. Do not place the  CardioMessenger on the floor, next to, or under your bed. 2 Do not place the CardioMessenger next  to a television set, microwave oven, or a similar source of electromagnetic interference. Note:  If the CardioMessenger is too close to a loudspeaker (or a radio alarm or TV), you may hear interference noises typical for cellular phones.

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Setup

2 Do not expose the CardioMessenger to temperatures exceeding 40°C. Do not put it on a place with direct sun light and do not place it directly under a halogen spotlight. 2 Do not expose the CardioMessenger to temperatures lower than 10°C. 2 Protect the CardioMessenger against water and high humidity. Do not place it in the bathroom.

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Connection Connect the CardioMessenger to the power supply. The outlet to be used has to be easily accessible. Arrange the power cable carefully to reduce the risk of entanglement or strangulation. Use the supplied power supply unit with electricity cable and  DC plug.

The label on the back side of the CardioMessenger indicates the approved power supply units:

Warning!  Use only the original parts included (for details, see "Technical data", page 25). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and  the CardioMessenger's susceptibility to interference.

CardioMessenger II-S

Connection

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1. Connect the DC plug at the end of the electricity cable to the port on the left side of the CardioMessenger. The connector port  is labeled with the following symbol:

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Connection

2. Connect the power supply unit to the outlet. See that the outlet is not controlled by  a light switch. This will prevent you  from turning off the CardioMessenger accidentally.

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Self-test The CardioMessenger automatically conducts a self-test after being connected.  At first, both lamps on the front side of the CardioMessenger light up yellow for a short while.  After about 10 seconds, the call back light will turn off.  Then the CardioMessenger  checks the connection to the BIOTRONIK Service Center. Only the operating light illuminates yellow.

CardioMessenger II-S

The connection check can take up to 15 minutes.  As soon as the connection has been checked successfully, the operating light illuminates green.  The CardioMessenger is now ready for use. The CardioMessenger is intended for continuous operation. It should be connected at all times, especially at night. Note:  It is a sign of malfunction if the operating light remains illuminated yellow for more than 15 minutes or if it does not light up at all. Details on "Debugging" can be found on page 16.

Connection

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Insert brief instructions guide Attached to the back cover of this technical manual is a removable instructions guide.

3. Insert the brief instructions guide into the slot on the left side into the housing of the CardioMessenger.

This guide helps to inform you quickly about the function and colors of the lights. Additionally, you can list your physician's phone number at the back cover of this guide. 1. Remove the guide from this technical manual. 2. Write your physician's or the clinic's name and phone number on the back cover of this guide.

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Connection

Now the brief instructions guide with your physician's phone number are ready at hand. Use it if the call back function of the CardioMessenger was activated by your physician. Details on "Call back function" can be found on page 14.

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Operate The CardioMessenger does not have an on/off switch. After connecting it, it is ready for use as soon as the operating light illuminates green. It is intended for continuous operation and should remain connected at all times, especially at night. The CardioMessenger automatically receives the information from your device and transmits it to the BIOTRONIK Service Center. Note:  It indicates a malfunction if the operating light illuminates yellow or does not light up at all. Details on "Debugging" can be found on page 16.

CardioMessenger II-S

Check lights Check once a day whether either of the two lights is illuminated.  Usually the operating light illuminates green. The call back light is not illuminated.  Note:  The functions of your device are  not affected at any time by the CardioMessenger, irrespective of the illumination or blinking of the lights. See the next page for details on the subject "Call back function".

Operate

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Call back function

Perform call back

With the aid of the call back light, your physician can ask you to call him. Via mobile network, he can turn the light on. The light  will then blink yellow for a maximum time  of 3 days.

Call your physician as soon as you realize that the call back light is blinking.

 The call back light blinks if your physician expects your call. Your physician will let you know whether he or she intends to use this function in general.

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Operate

Note:  The brief instructions guide with your physician's phone number is located in  the housing of the CardioMessenger (see "Insert brief instructions guide", page 12).

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Turn off the call back light

Switch off the system

To turn off the call back light, disconnect the CardioMessenger briefly from the main supply.

The CardioMessenger does not have an on/ off switch. To turn off the CardioMessenger, disconnect it from the main supply.

1. Pull the DC plug at the end of the electricity cable out of the port on the left side of the CardioMessenger.

1. Remove the power plug from the wall outlet.

Both lights will turn off.

The operating control lamp will turn out.  The CardioMessenger is switched off.

2. Connect the DC plug to the port again. The CardioMessenger performs the selftest. Afterwards, the operating light will illuminate green and the call back light will no longer be blinking. Note:  Details on "Connection" can be found on page 9.

CardioMessenger II-S

Operate

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Debugging You can identify issues with your CardioMessenger by use of the lights on the front side. Light

Behavior

Operating status

Call back light

Off

Normal operation; no malfunction

Yellow blinking

Your attending physician is asking for a call (Details on "Call back function" can be found on page 14); no malfunction

Yellow blinking

Error type B (both lights blink yellow):  Repeat the self-test, see next page for further details

Off

Error type A: Check the power supply, see next page

Green illumination

The CardioMessenger is now ready for use; no malfunction

Yellow blinking

Error type B (both lights blink yellow):  Repeat the self-test, see next page for further details

Yellow illumination

Error type C (only this light illuminates):  Check the mobile connection, see page 18

Operating light

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Debugging

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Error type A Check the power supply

Error type B Repeat the self-test

The operating light is off. CardioMessenger is not ready for use.

Both lights blink yellow. The CardioMessenger has not concluded the self-test. It is not yet ready for use.

Check the power supply: 2 Make sure that the DC plug of the electrical cord is plugged in tightly  into the port on the left side of the CardioMessenger. 2 Make sure that the power supply unit is inserted properly into the wall outlet. 2 Make sure that the outlet has current, for example by temporarily connecting the bedside lamp to the outlet and by turning the lamp on. If you do not find any errors, contact your physician.

CardioMessenger II-S

1. Remove the power supply unit from the wall outlet. 2. Reconnect it. The CardioMessenger restarts and performs the self-test. Both lights will illuminate yellow. The call back light will turn off once the self-test is complete. The operating light will remain illuminated yellow. Next, the CardioMessenger checks the connection to the BIOTRONIK Service Center. The operating light switches to green once the connection test is sucessful. The CardioMessenger is now ready for use.

Debugging

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If both lights stay permanently illuminated yellow, the CardioMessenger is defective. Return it to your physician. Note:  The connection check can take up to 15 minutes. Error type C Check the mobile connection The operating light illuminates yellow continuously (longer than 15 minutes).  The call back light is off. CardioMessenger cannot connect to the BIOTRONIK Service Center. 1. Remove the power supply unit from the wall outlet. 2. Put the CardioMessenger on a place with better mobile reception. Make sure that the distance to the device is still less than two meters (6 feet).

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Debugging

3. Reconnect the CardioMessenger. The CardioMessenger restarts and performs the self-test. It checks the connection to the BIOTRONIK Service Center. The operating light switches to green once the connection test is sucessful. The CardioMessenger is now ready for use. Note:  The connection check can take up to 15 minutes. If near your bed is a place where the CardioMessenger cannot get a connection  to the BIOTRONIK Service Center in general, talk to your physician.