BIOTRONIK SE and KG CM02-1 Patient Device User Manual CardioMessenger

BIOTRONIK SE & Co. KG Patient Device CardioMessenger

users manual

Preliminary ManualforCardioMessengerFCC ID: QRICM02-1BIOTRONIK GmbH & Co.
1ContentsWhat is Home Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3About This Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4User group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Conventions used in this technical manual . . . 4The CardioMessenger Set and Its Components . . . . . . . . . . . . . . . 5Safety Precautions – What Should I Watch Out For? . . . . . . . . . . . 6Electronic Article Surveillance (EAS) Systems . 8How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . . . . . . 9What must be done before using the Cardio-Messenger? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Where should I put the CardioMessenger? . . .9How do I plug in the CardioMessenger? . . . . . 10The CardioMessenger "traffic light" system .10Turning on the CardioMessenger . . . . . . . . . . 11Turning off the CardioMessenger . . . . . . . . . . 12Charging the CardioMessenger . . . . . . . . . . . . 12How do I know when the batteries are running low? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13How do I know that the CardioMessenger is receiving and transmitting implant data? . . . . 13Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 13Resetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14When Does My Implant Transmit Data? . . . . . . . . . . . . . . . . . . . . . 16How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . 17343 851/A
2Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Technical Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 21Cardio Report . . . . . . . . . . . . . . . . . . . . . . . . . . 21GSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . 21BIOTRONIK Service Center . . . . . . . . . . . . . . . 21SMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21US Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22FCC RF Exposure Requirements . . . . . . . . . . .23Legal Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Electromagnetic compatibility . . . . . . . . . . . . .25Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26General information . . . . . . . . . . . . . . . . . . . . .26Permissible environmental conditions . . . . . .26CardioMessenger remote unit . . . . . . . . . . . . . 26CardioMessenger charging station . . . . . . . . .27Rechargeable battery (integrated) . . . . . . . . . . 27Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3What is Home Monitoring?What is Home Monitoring?Dear Patient.You have received a BIOTRONIK pacemaker or implantable cardioverter-defibrillator (ICD) with a Home Monitoring function. The Home Monitoring fea-ture provides your attending physician with messages recorded by your implant at regular intervals, giving him or her information about your heart’s status.Your implant has a small wireless transmitter. Your patient device, which we will call the Cardio-Messenger, receives the implant messages and transmits them to the BIOTRONIK Service Center. The data are processed there and can be viewed only by your physician via fax and on the Internet (when avail-able) in the form of a comprehensive report called a Cardio report. Your doctor can use these data to decide whether your implant settings need to be updated or if your therapy plan needs to be changed. If necessary, your physician will contact you about making an appointment for a follow-up examination. For Home Monitoring to work, your implant must have the Home Monitoring function, and there must be cel-lular service in your area (GSM network).The power of the transmission in your implant is low so as not to impair your health in any way. Since the transmission range is so short (less than 2 meters, or 6 feet), you need to use the CardioMessenger to send the information to the BIOTRONIK Service Center. Note: If the CardioMessenger is not operational or is located too far from the implant to receive information (more than 6 feet), your implant still functions normally. Only the Home Monitoring function is inactive. Although the data recorded by the implant cannot be transmit-ted, they are saved so that your physician can evaluate them during your regularly scheduled follow-up examination. If you have any questions, please contact your physician.
4About This Technical ManualAbout This Technical ManualUser groupThe CardioMessenger is to be used by patients with a BIOTRONIK pacemaker or an implantable cardio-verter-defibrillator (ICD) with the Home Monitoring function. Conventions used in this technical manualNote: Provides additional information on the features of the CardioMessenger and how to operate it.Caution! If these instructions are not observed, minor injury or equipment damage may occur.WARNING! If these instructions are not observed, death, serious physical injury, or major equipment damage may result.
5The CardioMessenger Set and Its ComponentsThe CardioMessenger Set and Its ComponentsThe BIOTRONIK CardioMessenger will not restrict your routine activities. The set comes equipped with the following components:— The CardioMessenger with rechargeable batteries— A charging station with a power supply unit and cableAccessories:— Belt clip1)—Carrying strap2)— Belt carrying case3)The CardioMessenger works like a cell phone and transmits the information received from the implant as a short message (SMS) via a mobile telephone net-work to the BIOTRONIK Service Center. The built-in, rechargeable batteries provide at least 24 hours of wireless operation (away from the charging station). Naturally, the CardioMessenger can also be used when placed in the charging station.1) Catalog number 343 2652) Catalog number 343 2273) Catalog number 343 228
6Safety Precautions – What Should I Watch Out For?Safety Precautions – What Should I Watch Out For?The CardioMessenger and its components are medi-cal devices and therefore comply with strict standards for their development, manufacture, and testing.Please observe the following safety instructions: WARNING! Turn off the CardioMessenger in locations where cell phones are prohibited, such as hospitals or airplanes. Such areas can be identified by the following or simi-lar signs: WARNING! Maintain a minimum distance between the patient device and your implant.Like a cellular phone, the CardioMessenger device can temporarily interfere with your implant if it is too close to it. To avoid interference, maintain a minimum distance of 20 centimeters (7 inches) between the CardioMessenger and implant. Never place the CardioMessenger on your chest directly over the implant. Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket, and not directly on your skin.Caution! Protect the CardioMessenger and charging station from:— Water and high humidity (e.g., in the bathroom)— Temperatures above 40°C (104°F) — Temperatures below 10°C (50°F) for the charging station
7Safety Precautions – What Should I Watch Out For?— Temperatures below -5°C (23°F) for the Cardio-Messenger— Barometric pressure below 700 and above 1060 hPa— Violent shocks or other strong mechanical influ-ences— Strong sources of light (direct sunlight, strong halogen lamps)— Solvents, acids, detergents, and lyes— Handle the antenna with care.Caution! Never use the CardioMessenger if it has been dam-aged; return it to your physician.Before use, make sure that none of the components are visibly damaged.Only use the following original BIOTRONIK devices: — The CardioMessenger— The charging station with the appropriate power supply unit, type FW 7555 M/06Other accessories can increase the interference emit-ted and the device’s susceptibility to interference. Caution! The CardioMessenger may only be opened and repaired by authorized trained personnel, and the rechargeable batteries (type LP 103463) may only be exchanged by professionals.Note: Do not throw away the CardioMessenger with house-hold trash. Dispose of it according to legal guidelines, like you would for other electronic components, such as computers.In particular, rechargeable lithium ion batteries should be disposed of by the manufacturer according to legal guidelines. Caution! The covered data ports are not intended for the user. Do not remove the cover.
8Safety Precautions – What Should I Watch Out For?Electronic Article Surveillance (EAS) SystemsEquipment such as retail theft prevention systems may interact with the implanted device. Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary.
9How Do I Use the CardioMessenger?How Do I Use the Cardio-Messenger?The following section describes how to operate and use the CardioMessenger. What must be done before using the CardioMessenger?Find a suitable place to put the CardioMessenger and charging station. The distance between your implant and the Cardio-Messenger should not be too close in order to prevent interference with implant operation. On the other hand, the distance should not be beyond the implant transmitter’s range. Note: Home Monitoring can only work when the distance between the implant and CardioMessenger is not less than 20 centimeters (7 inches) and not more than 2 meters (6 feet). • Place the device on a solid base so that it cannot fall. • Keep the CardioMessenger from being exposed to moisture; bathrooms, for example, are unsuitable locations for the CardioMessenger.• Do not expose the device to heat; direct sunlight is also not recommended.• Do not place the device next to a television, micro-wave oven, or a similar source of interference.Where should I put the CardioMessenger? A nightstand would be a good place for the Cardio-Messenger since the distance between you and the CardioMessenger would probably not be more than 2 meters (6 feet). In addition, your attending physician will probably select nighttime as the regular trans-mission time.
10 How Do I Use the CardioMessenger?While resting at night, your implant data can be sent to the CardioMessenger and then transmitted to the BIOTRONIK Service Center. How do I plug in the CardioMessenger? Make sure that the local supply voltage lies within the permissible operating range of 100-240 Volts at 50-60 Hz. If this is the case, insert the power supply cable plug into the socket. The power supply has a long cable with a small plug at the end. Connect this plug to the charging station.The corresponding port is located on the back of the charging station.After connecting the charging station, the light will be illuminated, and the charging station will then be operational. The CardioMessenger "traffic light" systemYour CardioMessenger has four lights. Three are arranged like a traffic light, and one is separate and monitors the battery. All lights can be lit continuously, flash quickly or slowly, or out. Whether or not the lights flash or are lit continuously, the operation of your implant remains unaffected. LightsThe following section discusses the three modes of the “traffic light” system. Red: When the red light flashes, your attending physi-cian wants you to call. This will rarely occur. You will be informed by your physician if it is necessary to use this feature.
11 How Do I Use the CardioMessenger?Yellow: An illuminated or flashing yellow light indi-cates a temporary stage. This occurs, for example, when the CardioMessenger is looking for a connection to the GSM network.When the yellow light is continuously lit, there is a problem. For further information, see the ”Trouble-shooting” section on page 13.Green: When the green light flashes, it means that the CardioMessenger is operating properly.Battery monitor lightIn the following, the three states of the battery moni-tor light are described as follows:Red: When the light flashes red, the CardioMessenger batteries are nearly empty.Yellow: When the light flashes yellow, there is a prob-lem with charging the CardioMessenger. If the light is continuously yellow, the CardioMessenger is charg-ing.Green: When the light is green, the CardioMessenger is fully charged and can be used up to 24 hours away from the base.Turning on the CardioMessenger Press the on/off button of the CardioMessenger for approximately two seconds. A brief tone will sound, and the yellow light goes on.After approximately ten seconds when the CardioMessenger self-test is over, the yellow and green lights will start to flash. The CardioMessenger is then trying to establish a connection with the mobile telephone network.After five minutes at most, the yellow light will stop flashing, and the green light will start to flash slowly. This means your CardioMessenger is now ready to work.
12 How Do I Use the CardioMessenger?If this does not happen, please refer to the ”Trouble-shooting” section on page 13. Turning off the CardioMessenger Press the CardioMessenger on/off button for approxi-mately two seconds. You will hear a brief tone, and the yellow light will go out.The CardioMessenger is now switched off; no data can be received or transmitted.You can only turn the CardioMessenger back on after approximately five to six seconds.Charging the CardioMessenger When the battery monitoring light flashes red, the CardioMessenger needs to be recharged.Place the CardioMessenger in the charging station. The charging process will start immediately. During the charging process, the battery monitor light of the CardioMessenger will be yellow. If the battery monitor light flashes yellow, there is a problem. Please refer to the ”Troubleshooting” sec-tion on page 13 to find out how to resolve this problem.When the battery monitor light of the Cardio-Messenger is green, charging is complete. Charging usually takes no longer than six hours. Note: When the CardioMessenger is being charged and used at the same time, the battery monitor light can be alternately illuminated green and yellow at the end of the charging process. This does not signify a problem; it simply means that the battery is almost completely charged.
13 How Do I Use the CardioMessenger?How do I know when the batteries are run-ning low?When the CardioMessenger batteries are nearly empty, the battery monitor light will flash red. Place the CardioMessenger in the charging station. Charging will start immediately, which is indicated when the battery monitor light is illuminated yellow. When the batteries are completely charged, the bat-tery monitor light will be green.Note: If you take the CardioMessenger out of the charging station, the battery monitor light will go out to save energy. How do I know that the CardioMessenger is receiving and transmitting implant data? The data are received and transmitted automatically at specific intervals determined by your doctor so that you do not have to monitor data transmission.When the CardioMessenger is receiving data from your implant, the green light will flash faster than nor-mal for two to three seconds. Since this usually occurs at night, you will rarely observe the rapidly flashing green light of the CardioMessenger.After the CardioMessenger receives the implant data, they are sent to the BIOTRONIK Service Center. The green light will flash again slowly until the infor-mation has been transmitted to the BIOTRONIK Ser-vice Center. TroubleshootingProblems with your CardioMessenger are easy to identify, and they are usually easy to deal with.
14 How Do I Use the CardioMessenger?Note: When the red light in the “traffic light” flashes, it does not indicate a problem. It means you must call your physician. Your physician will inform you if this fea-ture is used.However, when the yellow light in the “traffic light” flashes or is continuously lit, there is a problem. ContinuousflashingFirst turn the CardioMessenger on and off. If you see the green and yellow light flashing for five minutes after turning the CardioMessenger back on, there is no connection to the GSM network. If you place the CardioMessenger in a location with good reception, you will not necessarily need to turn it on or off. Note: It can take up to 15 minutes before a connection is established to a GSM network.If the CardioMessenger is close to your bed and gen-erally cannot establish a connection to the GSM net-work, contact your physician.ContinuousilluminationTurn the CardioMessenger on and off. If the yellow light continues to be illuminated, reset the CardioMessenger by restarting it. Note: Other transmitters can interfere with the receiver that the CardioMessenger uses for implant information. If this should occur, the physician will contact you. Note: A properly functioning CardioMessenger has no influ-ence on the operation of your implant.ResettingIf the yellow CardioMessenger light is flashing or con-tinuously illuminated, you have already turned it on and off, and you have eliminated all possible sources of error, reset it by restarting the CardioMessenger. Press the reset button (located on the back of the CardioMessenger) with a sharp object such as a ball-point pen or the end of a straightened paper clip.
15 How Do I Use the CardioMessenger?Then turn the CardioMessenger on as usual. If only the yellow light is illuminated after five minutes, the CardioMessenger may be defective. Talk with your physician.
16 When Does My Implant Transmit Data?When Does My Implant Transmit Data?There are three times when your implant sends infor-mation. • Your implant is configured by your physician to periodically send messages at a specific time, usually while you are sleeping. • Your physician can also set your implant to auto-matically send a message when certain events occur.• Transmission can be activated by a special magnet (pacemaker patients only). This is done by placing the magnet directly over the implant. Your doctor will explain this to you if, how, and when it is nec-essary.WARNING! Patients with implantable cardioverter-defibrillators should not place a magnet over their chest, as this interferes with the proper functioning of their ICD.WARNING! Pacemakers sometimes use a special magnet to trig-ger a message. If you have a pacemaker, only apply the magnet if your physician explicitly requests it and gives you a suitable magnet.
17 How Do I Take Care of the CardioMessenger?How Do I Take Care of the Cardio-Messenger?Handle the CardioMessenger with care, so that you will be able to use it for a long time and so that BIOTRONIK can guarantee its proper operation:• Keep the device clean and away from dirty or dusty environments.• Use a soft cloth for cleaning. If necessary, the cloth can be moistened with water. Do not immerse the device in water.• Protect the device from direct contact with water. For example, wear the device under your coat when it rains, and use the provided belt carrying case.Give the CardioMessenger back to your doctor when it no longer works.The CardioMessenger does not need to be serviced at regular intervals by a technician. Note: Before each use, inspect the CardioMessenger, charging station, power supply unit and cable, and make sure they are not damaged. If you find damage, consult your physician.If handled properly, the installed batteries should supply the CardioMessenger with 24 hours of power even after 500 charging cycles (which is about two years).If this is not the case, check whether the Cardio-Messenger was completely charged during the next charging cycle. Additional information can be found in the ”Charging the CardioMessenger” section on page 12. If you find that the battery is always running low too soon, contact your physician. The physician will have a new battery installed.Note: When authorized personnel change the battery, they should also check the button cell.
18 AccessoriesAccessoriesYou can wear your CardioMessenger in various ways: • With a clip on your belt (with or without the belt carrying case)• With the clip and the carrying strap. If you wear the CardioMessenger infrequently or do not need the clip to wear it, you can remove the clip. Press the holder and slide it downwards (away from the antenna) and remove the clip.To reattach the clip, slide the holder upwards toward the antenna. Note: When you use the clip with the carrying strap, make sure that the distance between the implant and the CardioMessenger is not less than 20 centimeters (7 inches).
19 Frequently Asked QuestionsFrequently Asked QuestionsWhat happens if I forget to recharge my CardioMessenger?If the CardioMessenger is not charged, it cannot receive any data from your implant and transmit them to the BIOTRONIK Service Center. There is no danger to your health, since the implant operates independently from your CardioMessenger. The data recorded by your implant will not get lost either; they will remain available to your physician during your next follow-up appointment.Just recharge the CardioMessenger in the charging station. If this does not work, inform your doctor and follow his instructions. What happens if the CardioMessenger device fails? Does this affect my implant?No, your implant will continue to function as usual. If the CardioMessenger stops working, it cannot receive any information from your implant and send it to the BIOTRONIK Service Center. The messages are still recorded by the implant and can be transmitted and evaluated during a regular fol-low-up examination with your doctor. Try to turn on the CardioMessenger. Additional infor-mation can be found in the ”Troubleshooting” section on page 13. If this does not work, inform your physi-cian.Can I take my CardioMessenger with me everywhere – while I go shopping, walk, or participate in sports?Yes. You can always take your CardioMessenger with you during work or leisure activities, as long as you are not in areas where the use of cellular phones is prohibited.
20 Frequently Asked QuestionsThe CardioMessenger can be comfortably attached to your belt and transported with and without the pro-vided belt carrying case. You can also use a carrying strap. Additional information can be found in the ”Accessories” section on page 18.You can also carry it in a normal bag or a backpack. Please always remember that the distance between the implant and CardioMessenger should not be less than 20 centimeters (7 inches). What should I do when I want to travel?Consult your physician beforehand and inform him or her of your travel plans. You can take the Cardio-Messenger everywhere and plug it in wherever there is suitable supply voltage of 100 - 240 Volts at 50 - 60 Hz. You might need a country-specific adapter. A suitable cellular network is required for the Home Monitoring function. Ask your travel agent about the cellular networks in the country where you’ll be going.While en route to your destination, you must follow the instructions of the carrier, i.e., you will need to turn off the CardioMessenger when on an airplane.
21 Technical Terms and AbbreviationsTechnical Terms and Abbrevia-tionsCardio ReportA report informing a physician of his or her patient's current therapy status; the report is based on the data sent by the implant.GSMGlobal System for Mobile Communications – digital telephone network. Home MonitoringPacemakers and ICDs with the Home Monitoring function are equipped with a transmitter that sends messages over a specific frequency to a mobile patient device. These messages are then transmitted via a cellular network to the BIOTRONIK Service Center and can only be viewed by your physician via fax and the Inter-net (when available) in the form of a Cardio Report. BIOTRONIK Service CenterThis is where the implant data from the patient device are received, processed into graphs and tables, and sent to your physician.SMSShort Message Service – The transmission of text messages on the cellular network.
22 US Regulatory RequirementsUS Regulatory RequirementsYour implant is equipped with a radio frequency (RF) transmitter for wireless communications to the patient device. These messages are transmitted via an RF assigned by the Federal Communications Com-mission's (FCC) Medical Implant Communications Service (MICS).The transmitter is authorized by rule under the Medi-cal Implant Communications service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorologi-cal Satellite, or the Earth Exploration Satellite Ser-vices and must accept interference that may be caused by such aids, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC rules governing the Medical Implant Communications Service.Analog and digital voice communications are prohib-ited. Although this transmitter 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 receiver will be free from interference.The FCC ID number for this device is QRICM02-1.The patient device, as well as the implant itself, must conform with appropriate government standards and regulations.The patient device uses a GSM-Modem that connects to the mobile cellular telephone service at (1900 MHz). BIOTRONIK uses the modem according to the specifi-cations of the manufacturer in compliance with FCC approval requirements.
23 US Regulatory RequirementsFCC RF Exposure RequirementsFor body-worn operation, this phone has been tested and meets the FCC RF exposure guidelines when used with BIOTRONIK accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.This EUT (Equipment Under Test) has been shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled environment/general population exposure limits specified in ANSI/IEEE Std. C95.1-1992 and had been tested in accor-dance with the measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-200X (Draft 6.5, January 2002).
24 Legal ConsiderationsLegal ConsiderationsYour implant transmits diagnostic data to the Cardio-Messenger via an RF assigned by the European Con-ference of Postal and Telecommunications Adminis-tration for the operation of Ultra Low Power Active Medical Implants (CEPT/ERC REC 70-03). BIOTRONIK is legally obligated to inform you that the radio service does not have exclusive use of the assigned frequencies and that the transmission of implant data is not permitted to interfere with other radio services.The frequency and technical parameters of the built-in transmitter have been carefully selected to ensure that interference with other services as well as with the data transmission of the implant is unlikely.Furthermore, BIOTRONIK is obligated to inform you that the regulatory agency can withdraw the fre-quency allocation and prohibit the radio service between the implant and CardioMessenger. Since this service is currently being established throughout Europe and North America, withdrawal of the fre-quency allocation is not expected in the foreseeable future.The CardioMessenger, like the implant itself, has been evaluated by an independent testing authority for its compliance with statutory regulations. Therefore, the device carries the following approval mark:
25 Legal ConsiderationsIn addition, the CardioMessenger contains a GSM modem (Motorola g18e) that establishes the connec-tion to the cellular network at the frequencies of 900/1800 MHz and 1900 MHz. BIOTRONIK uses the modem in accordance with the manufacturer’s specifications and in compliance with regulatory requirements.The GSM modem has been evaluated and approved by an independent authority for its compliance with the statutory regulations. As an indication of this, it car-ries the following approval mark(IMEI Number: 350030-95-xxxxxx-x):Electromagnetic compatibilityNote: The CardioMessenger is protected from disturbances resulting from electromagnetic interference, electro-static discharges, and other sources – including inter-ference induced by cables. Interfering emissions from the CardioMessenger have been minimized. The CardioMessenger therefore meets the requirements of EN 60601-1-2 60601 in every respect.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.
26 Technical DataTechnical DataGeneral informationClass of protection IIDegree ofprotectionIP 30Operating mode Continuous operationPermissible environmental conditionsDuring operation:Temperature: + 10°C to + 40°C (50°F to 104°F) while charging- 5°C to + 40°C (23°F to 104°F) while dischargingRel. humidity: 30% to 70% (non-condensing)Atmosphericpressure:700 hPa to 1060 hPaShipping and storage:Storage temp.: - 20°C to + 25°C (- 4°F to 77°F) for 2 years with battery- 20°C to + 70°C (- 4°F to 158°F) without batteryShipping temp.: - 20°C to + 50°C (- 4°F to 122°F) for 2 weeks with bat-teryRel. humidity: 30% to 70% (non-condensing)Atmosphericpressure:700 hPa to 1060 hPaCardioMessenger remote unitDimensions(WxHxD)60 x 132 x 38 mm Weight Approx. 200 g (with battery)Charging voltage 5.2 V DC / 0.8 AMax. charge time 6hoursSerial ports Infrared and 15-pin connectorReceiving frequency 403.65 MHz
27 Technical DataBandwidth 300 kHzTransmissionfrequencies900/1800 MHz (not for US), 1900 MHzTransmissionpowerMax. 1 Watt (1900 MHz); Max. 2 Watt (900/1800 MHz)CardioMessenger charging stationDimensions(WxHxD)90 x 82 x 105 mmWeight Approx. 110 gInput voltage 6 V DC / 1 AOutput voltage 5.2 V DC / 1 ARechargeable battery (integrated)Model Lithium ion (LP 103463 AR)Dimensions(WxHxD)Approx. 34 x 63 x 10.2 mmWeight Approx. 45 gOperating voltage 3.7 V (nominal)Charge voltage 4,2 V DCMax. chargingcurrent1.5 C (2700 mA)Capacity 1800 mAh (typical)Power supplyModel FW 7555M/06Dimensions 51.5 x 87.5 x 34 mmPower cable length 2 metersConnector typeto the deviceAccording to EN 60320/C7Connector typeto the power outletAccording to EN 50075 p.1Input voltage 100 - 240 V AC at 50 - 60 Hz, 400 mAOutput voltage 6 V DC / 2.1 A
28 AppendixAppendixElectromagnetic emitted interference according to IEC 601-1-2The CardioMessenger is suitable for operation in the indicated electromagnetic environ-ment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electromagnetic environment as described below.Measuring the emitted interference Conformance Guidelines for the electromagnetic environmentRadiofrequency emitted interference according to CISPR 11Group 1 The CardioMessenger must trans-mit electromagnetic energy to ful-fill the function for which it was in-tended. Nearby electronic devices can be affected.Radiofrequency emitted interference according to CISPR 11Class B The CardioMessenger is suitable for use in all areas, including living space and those areas that are di-rectly connected to a public power supply system that also supplies buildings intended for residential purposes.Emitted interference of harmonics according to IEC 61000-3-2Class D according to IEC 61000-3-2Emitted interference of voltage fluctuations/flicker according to IEC 61000-3-3Conformance
29 AppendixSusceptibility to electromagnetic interference according to IEC601-1-2Note: These guidelines may not be applicable in all instances. The spread of electromagnetic waves is influenced by absorption and reflection from build-ings, objects, and humans.Note: Interference can be generated when the CardioMes-senger is close to devices that have the following warning sign:The CardioMessenger is suitable for operation in the indicated electromagnetic environ-ment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electromagnetic environment as described below.Testing susceptibility to interference Test level ac-cording to IEC 60601-1-2Conformance level Guidelines for the electro-magnetic environmentConducted RF interfer-ence according to IEC 61000-4-63 Veff150 kHz to 80 MHzSame as the test level The minimum distance of the CardioMessenger from portable and mobile radio devices, including the ca-bles, should correspond to the recommended safe dis-tance that is calculated ac-cording to the equation for the suitable transmission frequency. Recommended safe distance:Radiated RF interfer-ence according to IEC 61000-4-33 V/m80 MHz to 2.5 GHzSame as the test level for 80 to 800 MHzfor 800 MHz to 2.5 GHz with P as the nomi-nal output of the transmitter in Watts (W) according to the information from the trans-mitter manufacturer, and d as the recommended safe distance in meters (m).D12P,=D12P,=D23P,=
30 AppendixSusceptibility to electromagnetic interferenceaccording to IEC 601-1-2Note: The user can experience environmental conditions in a home different from those cited in the guidelines concerning the electromagnetic environment without endangering himself or herself.The CardioMessenger is suitable for operation in the indicated electromagnetic environ-ment. The customer and/or operator of the CardioMessenger should make sure that it is used in an electromagnetic environment as described below.Checkingsusceptibility to interferenceT es t l ev el ac co r di ng to IEC 60601-1-2 Conform-ance level Guidelines for the electro-magnetic environmentDischarge of staticelectricity (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 ce-ramic tiles. When the floor consists of a synthetic ma-terial, the relative humidity must be at least 30%.Rapid transient electri-cal disturbances/burstsaccording to IEC 61000-4-4± 2 kV for power cables Same as the test levelThe quality of the supply voltage should correspond to that in a typical business and/or hospital.Power surgesaccording to IEC 61000-4-5± 1 kV normal mode voltage± 2 kV common mode voltageSame as the test levelThe quality of the supply voltage should correspond to that in a typical business and/or hospital.Voltage dips, brief inter-ruptions and fluctua-tions in the supply volt-age according to IEC 61000-4-11‹ 5% UT for 1/2 period (› 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 levelThe quality of the supply voltage should correspond to that in a typical business and/or hospital. The Cardio-Messenger 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 61000-4-83 A/m Same as the test levelThe magnetic field strength should correspond to the typical value in business and hospital environments.NOTE: UT is the AC supply voltage before applying the test level
31 AppendixSusceptibility to electromagnetic interference for devices that are not life-sustaining.These guidelines may not be applicable in all instances. The spread of electromagnetic waves is influenced by absorption and reflection from struc-tures, objects, and humans.Transmission frequency 150 kHz to 80 MHz 150 kHz to 800 MHz 800 MHz to 2.5 GHzEquationNominal output of the transmitter (W) Safe distance (m) Safe distance (m) Safe distance (m)0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters whose maximum nominal output is not indicated in the above table, the dis-tance can be calculated using the equation in the column, where P is the maximum nominal out-put of the transmitter in Watts (W) according to the transmitter’s manufacturer.NOTE: These guidelines may not be applicable in all instances. The spread of electromagnetic waves is influenced by absorption and reflection from structures, objects, and humans. D12P,= D12P,= D23P,=

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