BIOTRONIK SE and KG CM08V-1 Patient Device User Manual 362453 D GA CM II S TLine US indd

BIOTRONIK SE & Co. KG Patient Device 362453 D GA CM II S TLine US indd

Contents

Manual1

CardioMessenger®II-S TLineTransmitter for BIOTRONIK Home Monitoring®Technical Manual362453_D_GA_CM_II-S_TLine_US.ind1 1 17.04.08 16:29:59
©®by BIOTRONIK GmbH & Co. KGAll rights reserved. Specifications subject to modification, revision and improvement.2008-D-05CardioMessenger is a registered trademark of BIOTRONIK GmbH & Co. KGBIOTRONIK mbH & o KWoermannkehre 112359 Berln  ermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804BIOTRONIK, Inc6024 SW Jean rd Bldg B Lake Oswego, OR 97035 Phone (800) 547-0394 (24-hr)Fax (503) 635-9936 salesbotronkcomwwwbotronkcom362453_D_GA_CM_II-S_TLine_US.ind2 2 17.04.08 16:30:00
Call back light (yellow, page 22)Operating light (yellow/green, page 21)Use only original power supply units (page 16)Slot for the brief instructions guide (page 20)Connection for the power supply (page 16)Connections for the landline (page 9 - 14)362453_D_GA_CM_II-S_TLine_innen_1 1 05.05.08 15:00:47
CardioMessenger II-S TLine 1ContentIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . 3How Home Monitoring works. . . . . . . . . . . 3Check the completeness of the delivery . . . 5Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Connection to the landline . . . . . . . . . . . . . 8Connection to the power supply. . . . . . . . 16Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Insert brief instructions guide . . . . . . . . . 20Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Check lights . . . . . . . . . . . . . . . . . . . . . . . 21Call back function . . . . . . . . . . . . . . . . . . . 22Switching Off the System. . . . . . . . . . . . . 23Debugging . . . . . . . . . . . . . . . . . . . . . . . . . . 24Cleaning, maintenance, and disposal . . . . 28Precautionary measures . . . . . . . . . . . . . . 30Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 33Technical data . . . . . . . . . . . . . . . . . . . . . . . 37Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45362453--DCM _II-S_TLine.book Page 1 Tuesday, May 6, 2008 12:56 PM
2CM _II-S_TLine.book Page 2 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Introduction 3IntroductionDear patient: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 implant 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.How Home Monitoring worksYour implant is equipped with a special transmitter (1). Usually at night, the transmitter sends daily information on your heart to the patient device, your CardioMessenger (2).The transmission power from your implant is low and does not impair your health in any way. Its limited transmission range, however, requires the use of the CardioMessenger.The CardioMessenger collects the information received from the implant and automatically transmits it to the CM _II-S_TLine.book Page 3 Tuesday, May 6, 2008 12:56 PM
Introduction4BIOTRONIK Service Center (4) as encoded messages via a landline 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 implant is best configured, or if the therapy needs adjustments. In this way, Home Monitoring serves as a practical diagnostic aid to your physician.CM _II-S_TLine.book Page 4 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Check the completeness of the delivery 5Check the completeness of the deliveryCheck all components for visible damage before using them. Use only components which are undamaged.The delivery includes the following:CardioMessenger II-S TLinePower supply unit with electricity cable and DC plugTelephone cableTechnical manual with brief instructions guideWarning!Use the CardioMessenger only if it is undamaged. Return a damaged CardioMessenger to your physician.CM _II-S_TLine.book Page 5 Tuesday, May 6, 2008 12:56 PM
Check the completeness of the delivery6Warning!Use only the original parts included (for details, see "Technical data", page 37). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and the device's susceptibility to interference.The label on the back side of the CardioMessenger indicates the approved power supply:CM _II-S_TLine.book Page 6 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Setup 7SetupPlace the CardioMessenger on your bedside table. The bedside table is suitable because it usually meets the following conditions:2The CardioMessenger is placed on a solid base and cannot fall.2The distance to the implant is less than 2 meters so that regular data transmission at night is assured.Please take the following into consideration:2Place 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.2Do not place the CardioMessenger next to a television set, microwave oven, or a similar source of electromagnetic interference.2Do not expose the CardioMessenger to temperatures exceeding 40 °C (104 °F). Do not put it on a place with direct sun light and do not place it directly under a halogen spotlight.2Do not expose the CardioMessenger to temperatures lower than 10°C (50°F).2Protect the CardioMessenger against water and high humidity. Do not place it in the bathroom.CM _II-S_TLine.book Page 7 Tuesday, May 6, 2008 12:56 PM
Connection8ConnectionConnection to the landlineThe CardioMessenger transmits the Home Monitoring data via landline.There are two ways to connect the CardioMessenger to the landline:2Method ACardioMessenger and telephone are operated using the same telephone wall jack.2Method BThe CardioMessenger is operated with a telephone wall jack to which no other device is connected.In both cases, you can use your phone as usual.NoteThe CardioMessenger has been designed for use with an analog landline. Correct operation cannot be ensured if using a digital landline. If you are unsure what kind of landline you are using, please contact your telephone provider. CM _II-S_TLine.book Page 8 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 9Method ATo operate both the CardioMessenger and the telephone using one telephone jackTo operate CardioMessenger and telephone together in one telephone wall jack, proceed as follows:1. On the back side of the CardioMessenger: Remove the sealing plug from phone inlet 1.Phone inlet 1 is labeled with the following symbol: 2. Unplug the telephone cable from the telephone wall jack.CM _II-S_TLine.book Page 9 Tuesday, May 6, 2008 12:56 PM
Connection103. Connect the free end of the telephone cable to phone inlet 1 of the CardioMessenger.The telephone is now connected to the CardioMessenger.4. Remove the sealing plug from phone inlet 2.Phone inlet 2 is labeled with the following symbol: CM _II-S_TLine.book Page 10 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 115. Take the supplied telephone cable and connect one end to phone inlet 2. 6. Connect the other end of the supplied telephone cable to the telephone wall jack.7. Check the telephone connection. Lift and listen to the receiver. The usual dialing tone should be audible.CM _II-S_TLine.book Page 11 Tuesday, May 6, 2008 12:56 PM
Connection12The telephone and CardioMessenger are now connected to the landline.As a next step, connect the CardioMessenger to the power supply (see "Connection to the power supply", page 16).CM _II-S_TLine.book Page 12 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 13Method BOperate the CardioMessenger using an available wall jack.To operate the CardioMessenger in a telephone wall jack to which no other devices are connected, proceed as follows:1. On the back side of the CardioMessenger: Remove the sealing plug from phone inlet 1.Phone inlet 1 is labeled with the following symbol: CM _II-S_TLine.book Page 13 Tuesday, May 6, 2008 12:56 PM
Connection142. Take the supplied telephone cable and connect one end to phone inlet 1. 3. Connect the other end of the supplied telephone cable to the telephone wall jack.CM _II-S_TLine.book Page 14 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 15The CardioMessenger is now connected to the landline.As a next step, connect the CardioMessenger to the power supply (see "Connection to the power supply", page 16).CM _II-S_TLine.book Page 15 Tuesday, May 6, 2008 12:56 PM
Connection16Connection to the power supplyConnect the CardioMessenger to the power supply. The outlet to be used has to be easily accessible. Use the supplied power supply unit with electricity cable and DC plug.Warning!Use only the original parts included (for details, see "Technical data", page 37). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and the device's susceptibility to interference.The label on the back side of the CardioMessenger indicates the approved power supply: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:CM _II-S_TLine.book Page 16 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 172. 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.CM _II-S_TLine.book Page 17 Tuesday, May 6, 2008 12:56 PM
Connection18Self-testThe CardioMessenger automatically conducts a self-test after being connected.At first, both lamps on the front side of the CardioMessenger illuminate 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.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.NoteIt 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. For details on the subject of "Debugging", see page 24.CM _II-S_TLine.book Page 18 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Connection 19If you are operating CardioMessenger and telephone using one telephone wall jack (variant A), the readily connected CardioMessenger looks as follows: If you are operating the CardioMessenger on a free telephone wall jack (variant B), the readily connected CardioMessenger looks as follows: CM _II-S_TLine.book Page 19 Tuesday, May 6, 2008 12:56 PM
Connection20Insert brief instructions guideAttached to the back cover of this technical manual is a removable instructions guide.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.3. Insert the brief instructions guide into the slot on the left side into the housing of the CardioMessenger.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. For details on the subject of "Call back function", see page 22.CM _II-S_TLine.book Page 20 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Operate 21OperateThe 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 implant and transmits it to the BIOTRONIK Service Center. NoteIt indicates a malfunction if the operating light illuminates yellow or does not light up at all. For details on the subject of "Debugging", see page 24.Check lightsCheck once a day whether either of the two lights is illuminated.Usually the operating light illuminates green. The call back light is not illuminated.NoteThe functions of your implant 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".CM _II-S_TLine.book Page 21 Tuesday, May 6, 2008 12:56 PM
Operate22Call back functionWith the aid of the call back light, your physician can ask you to call him. He can turn this light on via the landline. The light will then blink yellow for a maximum time of 3 days.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.Perform call backCall your physician as soon as you realize that the call back light is blinking.NoteThe brief instructions guide with your physician's phone number is located in the housing of the CardioMessenger (see "Insert brief instructions guide", page 20).CM _II-S_TLine.book Page 22 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Operate 23Turn off the call back lightTo turn off the call back light, disconnect the CardioMessenger briefly 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.Both lights will turn off.2. Connect the DC plug to the port again.The CardioMessenger performs the self-test. Afterwards, the operating light will illuminate green and the call back light will no longer be blinking.NoteFor details on the subject of "Connection to the power supply", see page 16.Switching Off the SystemThe CardioMessenger does not have an on/off switch. To turn off the CardioMessenger, disconnect it from the main supply.1. Remove the power plug from the wall outlet.The operating control lamp will turn out. The CardioMessenger is switched off.CM _II-S_TLine.book Page 23 Tuesday, May 6, 2008 12:56 PM
Debugging24DebuggingYou can identify issues with your CardioMessenger by use of the lights on the front side.Light Behavior Operating statusCall back light Off Normal operation; no malfunctionYellow blinking Your attending physician is asking for a call (For details on the subject of "Call back function", see page 22.); no malfunctionYellow blinking Error type B (both lights blink yellow): Repeat the self-test, see next page for further detailsOperating light Off Error type A: Check the power supply, see next pageGreen illumination The CardioMessenger is ready for use;no malfunctionYellow blinking Error type B (both lights blink yellow): Repeat the self-test, see next page for further detailsYellow illumination Error type C (only this light illuminates): Check the landline connection, see next page for further detailsCM _II-S_TLine.book Page 24 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Debugging 25Error type A:Check the power supplyThe operating light is off. CardioMessenger is not ready for use.Check the power supply:2Make sure that the DC plug of the electrical cord is plugged in tightly into the port on the left side of the CardioMessenger.2Make sure that the power supply unit is inserted properly into the wall outlet.2Make 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.Error type BRepeat the self-testBoth lights blink yellow. The CardioMessenger has not concluded the self-test. It is not yet ready for use.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.CM _II-S_TLine.book Page 25 Tuesday, May 6, 2008 12:56 PM
Debugging26If both lights stay permanently illuminated yellow, the CardioMessenger is defective. Return it to your physician.NoteThe connection check can take up to 15 minutes.Error type CCheck the landline connectionThe operating light illuminates yellow continuously (longer than 15 minutes). The call back light is off. CardioMessenger cannot connect to the BIOTRONIK Service Center. 1. Make sure that the one end of the telephone cable is properly inserted into the telephone wall jack.2. Make sure that the other end of the telephone cable is properly inserted into phone inlet 1 on the back of the CardioMessenger.3. Check whether the telephone line is available by lifting and listening to the receiver. You should be able to hear the normal dial tone. 4. Remove the power supply unit from the wall outlet.5. Reconnect it.CM _II-S_TLine.book Page 26 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Debugging 27The 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.NoteThe connection check can take up to 15 minutes.NoteThe CardioMessenger has been designed for use with an analog landline. Correct operation cannot be ensured if using a digital landline. If you are unsure what kind of landline you are using, please contact your telephone provider. If the operating light remains continuously illuminated yellow, contact your physician.CM _II-S_TLine.book Page 27 Tuesday, May 6, 2008 12:56 PM
Cleaning, maintenance, and disposal28Cleaning, maintenance, and disposalCleaning2Keep the CardioMessenger clean and away from dirty or dusty environments.2Use a soft, lint-free cloth for cleaning.Caution!Disconnect the CardioMessenger from the main power supply before attempting to clean it with a moist cloth.2Use a cloth wetted with water for cleaning. However, avoid bringing the CardioMessenger into direct contact with water or solvents.MaintenanceThe CardioMessenger is intended for continuous, automatic operation. Once correctly installed, ongoing actions by you are typically not required (e.g., no maintenance is required).In continuous operation, the longevity of the contained button cell corresponds to the longevity of the CardioMessenger.CM _II-S_TLine.book Page 28 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Cleaning, maintenance, and disposal 29DisposalDo not dispose the CardioMessenger in the usual household trash.CardioMessenger and the power supply unit contain materials that must be correctly disposed of in accordance with environmental protection regulations.If no longer required or if defective, please return the CardioMessenger and all other supplied parts to the physician. Your physician will return all parts to BIOTRONIK.BIOTRONIK ensures the disposal in accordance with the national design of the European guideline 2002/96/EC on electric and electronic used devices (WEE).CM _II-S_TLine.book Page 29 Tuesday, May 6, 2008 12:56 PM
Precautionary measures30Precautionary measuresThe CardioMessenger is a medical device and therefore complies with strict requirements for their development, manufacture and testing.Please take the following precautions:Warning!The device must be located outside the patient's vicinity if the intended user is to be introduced to the device in the hospital.These legal requirements apply for electrical devices in hospitals and do not apply when the CardioMessenger is used at home.Warning!Use the CardioMessenger only if it is undamaged. Return a damaged CardioMessenger to your physician.Warning!Use only the original parts included (for details, see "Technical data", page 37). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and the device's susceptibility to interference.The label on the back side of the CardioMessenger indicates the approved power supply:Caution!Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician (or properly licensed practitioner).CM _II-S_TLine.book Page 30 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Precautionary measures 31Caution!Protect the CardioMessenger from:– Water and high humidity– Temperatures above 40 °C (104 °F) (for example from direct sunlight and strong halogen spotlights)– Temperatures below 10 °C (50 °F)– Solvents, acids, detergents, and lyesCaution!The CardioMessenger may only be opened and repaired by authorized trained personnel.CM _II-S_TLine.book Page 31 Tuesday, May 6, 2008 12:56 PM
Precautionary measures32CM _II-S_TLine.book Page 32 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Guidelines 33GuidelinesUSAFCC RF Exposure RequirementsYour implant is equipped with a radio frequency (RF) transceiver for wireless communications to the CardioMessenger. These messages are transmitted via an RF assigned by the Federal Communications Commission's (FCC) Medical Implant Communications Service (MICS)1). This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.This transceiver shall be used only in accordance with the FCC rules governing the Medical Implant Communications Service.Analog and digital voice communications are prohibited. Although this transceiver has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transceiver will be free from interference.1) Federal Communications Commission for Medical Implant Communications ServiceCM _II-S_TLine.book Page 33 Tuesday, May 6, 2008 12:56 PM
Guidelines34The FCC ID number for the CardioMessenger is QRICM08V-1.The ACTA ID number for the cable modem is AU7MMO1BMT5656SMI for the CardioMessenger II-S/1 and AU7MDO4B2456 for the CardioMessenger II-S/2.Statement according to FCC part 2.1091:The internal/external antennas used for this mobile transmitter must provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in con-junction with any other antenna or transmitter.Statement according to FCC part 15.105:NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful inter-ference in a residential installation. This equip-ment 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 interfer-ence will not occur in a particular installation. If this equipment does cause harmful interfer-ence 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 follow-ing measures:— Reorient or relocate the receiving antenna.— Increase the separation between the equip-ment and receiver.— Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.— Consult the dealer or an experienced radio/TV technician for help.Changes or modifications not expressly approved by this company could void the user's authority to operate the equipment.CM _II-S_TLine.book Page 34 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Guidelines 35Adress of responsible party:BIOTRONIK, Inc.6024 SW Jean rd. Bldg. BLake Oswego, OR 97035Phone (800) 547-0394CanadaThe CardioMessenger is registered at Industry Canada with the following number: IC: 4708A-CM08V1.The cable modem is registered at Industry Canada with the following number: IC: 125A-0015 or 125A-0008.The term "IC:" before the certification/registration number only signifies that the Industry Canada technical specifications were met.This device may not interfere with stations operating in the 400.150-406.000 MHz band in the meteorological aids, meteorological-satellite, and earth exploration-satellite services and must accept any interference received, including interference that may cause undesired operation.CM _II-S_TLine.book Page 35 Tuesday, May 6, 2008 12:56 PM
Guidelines36Electromagnetic compatibilityNoteThe CardioMessenger is protected from disturbances resulting from electromagnetic interference, electrostatic discharges, and other sources – including interference induced by cables. Interfering emissions from the CardioMessenger have been minimized. The CardioMessenger therefore meets the requirements of EN 60601-1-2 in every respect.Warning!Other equipment, including portable and mobile RF radiocommunications equipment may interfere with the CardioMessenger, even if this equipment complies with CISPR emission requirements. However, this possible interference does not affect the implant functionality. WarrantyThe CardioMessenger and all original components by BIOTRONIK are not subject to warranty when used improperly or stored and transported incorrectly. Use only the original packaging when shipping the device.CM _II-S_TLine.book Page 36 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Technical data 37Technical dataGeneral2Operating mode: Continuous operationPermissible Environmental Conditions2Operating temperature: +10°C (50°F) to +40 C (104°F)2Storage and transport temperature:-10°C (14°F) to + 60°C (140°F) 2Relative humidity:30% to 75% (non-condensing)2Atmospheric pressure: 700 hPa to 1060 hPaCardioMessenger2Dimensions (WxHxD):approx. 203 x 136.5 x 80 mm2MICS: Modulation FSK2MICS frequencies: 402–405 MHz, 9 channels, 300 kHz frequency range2MICS transmission power: 25 µW EIRPTelephone cable2Type: VK-1172Length: approx. 2.5 m (8.2 ft)2Outlet: Rj-11CM _II-S_TLine.book Page 37 Tuesday, May 6, 2008 12:56 PM
Technical data38Power supply unit2Type: FRIWO MMP 15 FW7555O/052Dimensions (WxHxD):approx. 51.5 x 87.5 x 34 mm2DC plug output:Outer diameter 5.5 mm (mass),Inner diameter 2.1 mm (plus)2Input voltage:100–240 V ~ 50–60 Hz 400 mA2Output voltage:5VDC ± 5%, 2.4A/12W2Safety class: II or:2Type: Nordic Power (SAC) SA110D-052Dimensions (WxHxD): approx. 69 x 45 x 35 mm2DC plug output:Outer diameter 5.5 mm (mass),Inner diameter 2.1 mm (plus)2Input voltage:100–240 V ~ 50–60 Hz 300 mA2Output voltage:5.1VDC ± 5%, 2A/10.2W2Safety class: II Technical manual2Technical manual with brief instructions guide CardioMessenger II-S TLineCM _II-S_TLine.book Page 38 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Appendix 39AppendixElectromagnetic emitted interference according to IEC 60601-1-2The CardioMessenger is suitable for operation in the indicated electromagnetic environment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electroma-gnetic environment as described below.Measuring the interference Compliance Guidelines for the electromagnetic environmentHigh-frequency interference accor-ding to CISPR 11 Group 1 The CardioMessenger uses RF energy only for its internal function. Therefore, the HF interference is very low and not likely to cause any interference in nearby electronic equip-ment.High-frequency interference accor-ding to CISPR 11 Class B The CardioMessenger is suitable for use in all areas, including living space and those areas that are directly connected to a public power supply system that also supplies buildings inten-ded for residential purposes.Interference of harmonics according to IEC 61000-3-2 Class A according to IEC 61000-3-2Voltage fluctuations/flicker emissi-ons according to IEC 61000-3-3CompliesCM _II-S_TLine.book Page 39 Tuesday, May 6, 2008 12:56 PM
Appendix40Electromagnetic emitted interference according to IEC 60601-1-2The CardioMessenger is suitable for operation in the indicated electromagnetic environment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electroma-gnetic environment as described below.Testing resis-tance to interfe-renceTest level accor-ding toIEC 60601-1-2Conformance level Guidelines for the electromagnetic environmentConducted RF interference accor-ding toIEC 61000-4-63Veff150 kHz to 80 MHz Same as test level The minimum distance of the CardioMessenger from portable and mobile radio devices, including the cables, should correspond to the recommen-ded safe distance that is calculated according to the equation for the suita-ble transmission frequency. Recommended safe distance:D= 1,17Radiated RF inter-ference according to IEC61000-4-33V/m80 MHz to 2.5 GHz Same as test level D= 1,17 for 80 to 800 MHzD= 2,34 for 800 MHz to 2.5 GHz with P as the nominal output of the transmitter in Watts (W) according to the information from the transmitter manufacturer, and d as the recommended safe distance in meters (m).The field strength of stationary transmitting devices should be measured on sitea) and must be lower than the compliance level at all frequenciesb).Interference can be generated when the CardioMessenger is close to devices that have the following warning sign:Note: The higher frequency range applies at 80MHz and at 800MHz.Note: These guidelines may not be applicable in all cases. The spread of electromagnetic waves is influenced by absorption and reflection from buildings, objects, and humans.PPPCM _II-S_TLine.book Page 40 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Appendix 41a) Field strengths from fixed transmitters, such as base stations for radio (cellular(/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measu-red field strength in the location in which the CardioMessenger is used exceeds the applicable RF compliance level above, the Cardio-Messenger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the CardioMessenger.b) Above the frequency range of 150KHz to 80MHz, ensure that field strengths are less than 3V/m.CM _II-S_TLine.book Page 41 Tuesday, May 6, 2008 12:56 PM
Appendix42Electromagnetic emitted interference according to IEC 60601-1-2The CardioMessenger is suitable for operation in the indicated electromagnetic environment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electroma-gnetic environment as described below.Checkingimmunity to noise Test level according to IEC 60601-1-2 Conformance level Guidelines for the electromagnetic environmentDischarge of static elec-tricity (ESD)According to IEC 61000-4-2± 6 kV contact discharge±8 kV air dischargeSame as test level Floors should be made of wood or cement, or have ceramic tiles. When the floor consists of a synthetic material, the rela-tive humidity must be at least 30%.Rapid transient electri-cal disturbances/burstsAccording to IEC 61000-4-4± 2 kV forpower supply lines± 1 kV for input/output linesSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.SurgeAccording to IEC 61000-4-5±1kV normal mode voltage± 2 kV common mode voltageSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.CM _II-S_TLine.book Page 42 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Appendix 43Voltage dips, brief inter-ruptions and fluctuati-ons in the supply voltageAccording to IEC 61000-4-11‹ 5% UT for1/2 cycle(› 95% drop)40% UT for 5 periods(60% drop)70% UT for 25 periods(30% drop)‹ 5% UT for 5 s(› 95% drop)Same as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital. The CardioMessenger is powered by a battery. An interruption in the supply voltage to the power supply unit will not impair the functioning of the CardioMessenger.Magnetic field at the supply frequencies (50/60 Hz)According to IEC 61000-4-83A/m Same as the test level The magnetic field strength should correspond to the typical value in business and hospital environments.Comment: UT is the mains alternating voltage before applying the test levels.Checkingimmunity to noise Test level according to IEC 60601-1-2 Conformance level Guidelines for the electromagnetic environmentCM _II-S_TLine.book Page 43 Tuesday, May 6, 2008 12:56 PM
Appendix44Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission fre-quency 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzEquation D= 1,17 D= 1,17 D= 2,34Rated power of transmitter (W) Safe distance (m) Safe distance (m) Safe distance (m)0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.7 3.7 7.4100 11.7 11.7 23.4For transmitters whose maximum nominal output is not indicated in the above table, the distance can be calculated using the equation in the column, where P is the maximum nominal output of the transmitter in Watts (W) according to the transmitter’s manufacturer.Note: The higher frequency range applies at 80MHz and at 800MHz.Note: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is affected by absorption and reflection by structures, objects and people.P P PCM _II-S_TLine.book Page 44 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Index 45IndexAAmbient conditions . . . . . . . . . . . . . . . . . . 37Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 39BBedside table . . . . . . . . . . . . . . . . . . . . . . . . 7BIOTRONIK Service Center . . . . . . . . . . 4, 21Blinking . . . . . . . . . . . . . . . . . . . . . . . . 22, 24Brief instructions guide . . . . . . . . . . . . 20, 22Broken CardioMessenger . . . . . . . . . . . . . 30CCall back function . . . . . . . . . . . . . . . . . . . 22Call back light . . . . . . . . . . . . . . . . . . . 18, 22Call your physician . . . . . . . . . . . . . . . . . . 22Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Check the landline connection . . . 11, 18, 26Check the telephone connection . . . . . . . 11Checking the power supply . . . . . . . . . . . . 25Clean it . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Connection to the landline . . . . . . . . . . 8, 19Connection to the power supply . . . . 16, 19DDamaged CardioMessenger . . . . . . . . . 5, 30DC plug . . . . . . . . . . . . . . . . . . . . . . . 5, 23, 38Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 24Defective CardioMessenger . . . . . . . . . . . 30Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Distance to the implant . . . . . . . . . . . . . . . 7EElectricity cable . . . . . . . . . . . . . . . . 5, 16, 23Electromagnetic Compatibility . . . . . . . . 36Electromagnetic emitted interference . . 39GGreen light . . . . . . . . . . . . . . . . . . . 18, 21, 24Guidelines Canada . . . . . . . . . . . . . . . . . . 35Guidelines USA . . . . . . . . . . . . . . . . . . . . . 33CM _II-S_TLine.book Page 45 Tuesday, May 6, 2008 12:56 PM
Index46HHome Monitoring . . . . . . . . . . . . . . . . . . . . .3Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . .30IIllumination . . . . . . . . . . . . . . . . . . . . . . . . .24Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 7LLandline connection . . . . . . . . . . . . . . . . . . .4Light 1 . . . . . . . . . . . . . . . . . . . .18, 21, 22, 24Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . .18, 24MMaintenance . . . . . . . . . . . . . . . . . . . . . . . .28OOperate . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Operating light . . . . . . . . . . . . . . . .18, 21, 24Original parts . . . . . . . . . . . . . . . . . . . . .5, 37Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17PPackage Contents . . . . . . . . . . . . . . . . . . . . 5Perform call back . . . . . . . . . . . . . . . . . . . 22Phone inlet 1 . . . . . . . . . . . . . . . . . . . . . 9, 13Phone inlet 2 . . . . . . . . . . . . . . . . . . . . . . . 10Physician call back light . . . . . . . . . . . . . . 24Physician's phone number . . . . . . . . . 20, 22Port for power connection . . . . . . . . . . . . 16Power connection port . . . . . . . . . . . . . . . 16Power supply unit . . . . . . . . . . . . . . 5, 16, 38Precautionary measures . . . . . . . . . . . . . . 30RReady-for-service status . . . . . . . . . . . . . 21Recommended separation distances . . . 44Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31SSafety instructions . . . . . . . . . . . . . . . . . . . 30Sealing plug . . . . . . . . . . . . . . . . . . . 9, 10, 13Self-test . . . . . . . . . . . . . . . . . . . . . . . . 18, 25Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Suitable installation location . . . . . . . . . . . 7CM _II-S_TLine.book Page 46 Tuesday, May 6, 2008 12:56 PM
CardioMessenger II-S TLine Index 47Switch off the system . . . . . . . . . . . . . . . . 23Switching on the system . . . . . . . . . . . 21, 23TTechnical data . . . . . . . . . . . . . . . . . . . . . . 37Telephone cable . . . . . . . . . . 5, 10, 11, 14, 37Telephone wall jack . . . . . . . . 8, 9, 11, 13, 14Transmitter of the implant . . . . . . . . . . . 3, 7Turn off the call back light . . . . . . . . . . . . 23UUnsuitable installation location . . . . . . . . . 7WWarranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 36YYellow light . . . . . . . . . . . . . . . . . . . 18, 22, 24CM _II-S_TLine.book Page 47 Tuesday, May 6, 2008 12:56 PM

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