CardioMessenger ®II-S Transmitter for BIOTRONIK Home Monitoring® 362454_D_GA_CM_II-S_US.indd 1 Technical Manual 17.04.
© by BIOTRONIK GmbH & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. 2008-D-05 ® CardioMessenger is a registered trademark of BIOTRONIK GmbH & Co. KG BIOTRONIK GmbH & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 BIOTRONIK, Inc. 6024 SW Jean rd. Bldg. B Lake Oswego, OR 97035 Phone (800) 547-0394 (24-hr) Fax (503) 635-9936 sales@biotronik.com www.biotronik.com 362454_D_GA_CM_II-S_US.indd 2 17.04.
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 9) 362449_D_GA_CM_II-S_innen_EN01.i1 1 29.04.
CardioM essenger_II-S_en.book Page 1 Tuesday,M ay 6,2008 1:11 PM Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 3 Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16 How Home Monitoring works . . . . . . . . . 3 Cleaning, maintenance, and disposal . . . 19 Check the completeness of the delivery . . 5 Precautionary measures . . . . . . . . . . . . . 21 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Guidelines . . . . . . . . . . . . . . . . .
CardioM essenger_II-S_en.
CardioM essenger_II-S_en.book Page 3 Tuesday,M ay 6,2008 1:11 PM 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 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.
CardioM essenger_II-S_en.book Page 4 Tuesday,M ay 6,2008 1:11 PM 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 implant is best configured, or if the therapy needs adjustments. In this way, Home Monitoring serves as a practical diagnostic aid to your physician.
CardioM essenger_II-S_en.book Page 5 Tuesday,M ay 6,2008 1:11 PM 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 Power supply unit with electricity cable and DC plug CardioMessenger II-S Warning! Use the CardioMessenger only if it is undamaged. Return a damaged CardioMessenger to your physician.
CardioM essenger_II-S_en.book Page 6 Tuesday,M ay 6,2008 1:11 PM device's susceptibility to interference.
CardioM essenger_II-S_en.book Page 7 Tuesday,M ay 6,2008 1:11 PM 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 implant is less than 2 meters so that regular data transmission at night is assured. At the same time is the distance to the implant more than 20 centimeters and the CardioMessenger has no influence on your implant.
CardioM essenger_II-S_en.book Page 8 Tuesday,M ay 6,2008 1:11 PM Please take the following also into consideration: 2 Do not expose the CardioMessenger to temperatures lower than 10 °C. 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 Protect the CardioMessenger against water and high humidity.
CardioM essenger_II-S_en.book Page 9 Tuesday,M ay 6,2008 1:11 PM Connection Connect 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 27). Other equipment may impair proper functioning of the CardioMessenger and increase the emitted interference and the device's susceptibility to interference.
CardioM essenger_II-S_en.book Page 10 Tuesday,M ay 6,2008 1:11 PM 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. 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.
CardioM essenger_II-S_en.book Page 11 Tuesday,M ay 6,2008 1:11 PM 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.
CardioM essenger_II-S_en.book Page 12 Tuesday,M ay 6,2008 1:11 PM 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.
CardioM essenger_II-S_en.book Page 13 Tuesday,M ay 6,2008 1:11 PM 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 implant and transmits it to the BIOTRONIK Service Center.
CardioM essenger_II-S_en.book Page 14 Tuesday,M ay 6,2008 1:11 PM 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.
CardioM essenger_II-S_en.book Page 15 Tuesday,M ay 6,2008 1:11 PM 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. Both lights will turn off. 2.
CardioM essenger_II-S_en.book Page 16 Tuesday,M ay 6,2008 1:11 PM 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.
CardioM essenger_II-S_en.book Page 17 Tuesday,M ay 6,2008 1:11 PM 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.
CardioM essenger_II-S_en.book Page 18 Tuesday,M ay 6,2008 1:11 PM 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 Note The connection check can take up to 15 minutes. The operating light illuminates yellow continuously (longer than 15 minutes). The call back light is off. CardioMessenger cannot connect to the BIOTRONIK Service Center.
CardioM essenger_II-S_en.book Page 19 Tuesday,M ay 6,2008 1:11 PM Cleaning, maintenance, and disposal Cleaning Maintenance 2 Keep the CardioMessenger clean and away from dirty or dusty environments. The CardioMessenger is intended for continuous, automatic operation. Once correctly installed, ongoing actions by you are typically not required (e.g. no maintenance is required). 2 Use a soft, lint-free cloth for cleaning.
CardioM essenger_II-S_en.book Page 20 Tuesday,M ay 6,2008 1:11 PM Disposal Do 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.
CardioM essenger_II-S_en.book Page 21 Tuesday,M ay 6,2008 1:11 PM Precautionary measures The CardioMessenger is a medical device and therefore complies with strict requirements for their development, manufacture and testing. Please take the following precautions: Warning! Do not operate the CardioMessenger in sections where cellular phones are not permitted for safety reasons (for example in certain hospital sections).
CardioM essenger_II-S_en.book Page 22 Tuesday,M ay 6,2008 1:11 PM The label on the back side of the CardioMessenger indicates the approved power supply units: Caution! Protect the CardioMessenger from: – Water and high humidity – Temperatures above 40 °C (for example from direct sunlight and strong halogen spotlights) – Temperatures below 10 °C – Solvents, acids, detergents, and lyes Caution! The CardioMessenger may only be opened and repaired by authorized trained personnel.
CardioM essenger_II-S_en.book Page 23 Tuesday,M ay 6,2008 1:11 PM Guidelines USA FCC RF exposure requirements Your 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.
CardioM essenger_II-S_en.book Page 24 Tuesday,M ay 6,2008 1:11 PM The FCC ID number for the CardioMessenger is QRICM08V-1. The FCC ID number for the GSM modem is IHDT56HQ1 for the CardioMessenger II-S/3 and IHDT56FV1 for the CardioMessenger II-S/ 4. The integrated GSM module comply with the Grantees instructions for antenna configuration without having obtained a separate FCC equipment authorization for the module. New antenna configuration for that device will be considered unauthorized equipment.
CardioM essenger_II-S_en.book Page 25 Tuesday,M ay 6,2008 1:11 PM — 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. Adress of responsible party: BIOTRONIK, Inc. 6024 SW Jean rd. Bldg.
CardioM essenger_II-S_en.book Page 26 Tuesday,M ay 6,2008 1:11 PM Electromagnetic compatibility Warranty Note The 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.
CardioM essenger_II-S_en.book Page 27 Tuesday,M ay 6,2008 1:11 PM Technical data General CardioMessenger 2 Operating mode: Continuous operation 2 Type: CardioMessenger II-S Permissible Environmental Conditions 2 Dimensions (WxHxD): approx. 203 x 136.
CardioM essenger_II-S_en.book Page 28 Tuesday,M ay 6,2008 1:11 PM Power supply unit or: 2 Type: PowerBox PA 1010-050 2 Type: FRIWO MMP 15 FW7555O/05 2 Dimensions (WxHxD): approx. 70 x 39 x 25 mm 2 Dimensions (WxHxD): approx. 51.5 x 87.5 x 34 mm 2 DC plug output: Outer diameter 5.5 mm (mass), Inner diameter 2.1 mm (plus) 2 DC plug output: Outer diameter 5.5 mm (mass), Inner diameter 2.
CardioM essenger_II-S_en.book Page 29 Tuesday,M ay 6,2008 1:11 PM or: Technical Manual 2 Type: Nordic Power (SAC) SA110D-05 2 Technical manual with brief instructions guide CardioMessenger II-S 2 Dimensions (WxHxD): approx. 69 x 45 x 35 mm 2 DC plug output: Outer diameter 5.5 mm (mass), Inner diameter 2.1 mm (plus) 2 Input voltage: 100–240 V ~ 50–60 Hz 300 mA 2 Output voltage: 5.1 V DC ± 5 %, 2 A/10.
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CardioM essenger_II-S_en.book Page 31 Tuesday,M ay 6,2008 1:11 PM Appendix Electromagnetic emitted interference according to IEC 60601-1-2 The 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 electromagnetic environment as described below.
CardioM essenger_II-S_en.book Page 32 Tuesday,M ay 6,2008 1:11 PM Electromagnetic emitted interference according to IEC 60601-1-2 The 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 electromagnetic environment as described below.
CardioM essenger_II-S_en.book Page 33 Tuesday,M ay 6,2008 1:11 PM a) 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.
CardioM essenger_II-S_en.book Page 34 Tuesday,M ay 6,2008 1:11 PM Electromagnetic emitted interference according to IEC 60601-1-2 The 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 electromagnetic environment as described below.
CardioM essenger_II-S_en.book Page 35 Tuesday,M ay 6,2008 1:11 PM Checking the interference resistance Test level according to IEC 60601-1-2 Compliance level Guidelines for the electromagnetic environment Voltage drops, brief interruptions and fluctuations in the supply voltage ‹ 5 % UT for 1/2 cycle (› 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.
CardioM essenger_II-S_en.book Page 36 Tuesday,M ay 6,2008 1:11 PM Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission Frequency 150 kHz to 80 MHz 80 MHz up to 800 MHz 800 MHz to 2.5 GHz Equation D = 1.17 P D = 1.17 P D = 2.
CardioM essenger_II-S_en.book Page 37 Tuesday,M ay 6,2008 1:11 PM Index A Ambient conditions . . . . . . . . . . . . . . . . . . 27 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 B Bedside table . . . . . . . . . . . . . . . . . . . . . . . . 7 BIOTRONIK Service Center . . . . . . . . . . 4,13 Blinking . . . . . . . . . . . . . . . . . . . . . . . . 14,16 Brief instructions guide . . . . . . . . . . . . 12,14 Broken CardioMessenger . . . . . . . . . . . . . 21 C Call back function . . .
CardioM essenger_II-S_en.book Page 38 Tuesday,M ay 6,2008 1:11 PM I Illumination . . . . . . . . . . . . . . . . . . . . . . . . . 16 Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,7 L Light 1 . . . . . . . . . . . . . . . . . . . . 10,13,14,16 Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 10,16 M Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 19 Mobile connection . . . . . . . . . . . . . . . . . . . . 4 O Operate . . . . . . . . . . . . . . . . . . . . . . . .
CardioM essenger_II-S_en.book Page 39 Tuesday,M ay 6,2008 1:11 PM U Unsuitable installation location . . . . . . . . . 7 W Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Y Yellow light . . . . . . . . . . . . . . . . . . .
