Brochure for patients using the Home Monitoring Patient Device
Contents Page What is Home Monitoring? 2 How does the patient device work? 4 Safety precautions –what to look out for 5 How to handle the patient device 8 How do I turn my mobile patient device on? 10 How do I turn my mobile patient device off? 11 When does my implant transmit messages? 14 How do I take care of the device? 15 Frequently asked questions by patients 16 Technical terms and abbreviations 18 Electronic Article Surveillance (EAS) Systems 18 Regulatory Aspects 19 Technical
What is Home Monitoring? Dear Patient, You are the recipient of an implanted pacemaker (PM) or Implantable Cardioverter Defibrillator (ICD). Your implant is a complex electronic device, which benefits your health and improves your quality of life. BIOTRONIK has developed a new feature for your implant called, the Home Monitoring function. The Home Monitoring function permits implant-related monitoring by your doctor.
The Cardio Report is sent to your doctor via FAX at certain predetermined periods decided upon by your doctor. Your doctor can then decide whether your implant settings should be optimized or if the therapy schedule should be changed. If necessary, he or she will contact you about an appointment for a follow-up examination to optimize your pacemaker or ICD.
How does the patient device work? BIOTRONIK has developed a mobile patient device which can always be taken with you to ensure that your personal freedom and mobility are restricted as little as possible. The patient unit consists of the following components: • Mobile Patient device with internal batteries • Charging stand with power supply set The mobile patient device works similarly to a cellular telephone and transmits the messages received from the implant using the Short Message System (SMS).
Safety precautions – What to look out for The patient device and its components were developed, produced and tested according to the latest guidelines and standards. It meets the strict regulations for medical devices. So that your patient device functions without problems, the following safety measures must be carried out: ! Do not use the patient device in areas where a cellular phone is forbidden – hospitals, aircraft aircraft,, etc etc..
! Protect the patient device from external influences such as: – Water immersion – High humidity (e.g.
! Handle the antenna with care. Modifying or sticking other materials on the antenna interfere with the transmission qualities of the patient device. ! In the following cases, return the patient device to your doctor or to the clinic that issued the device: –Your patient device does not function anymore. –You do not need it anymore. ! Do not dispose of the device in household garbage. Because of the rechargeable batteries (Lithium-ion batteries), the device must be disposed of separately.
How do I handle the patient device? Below describes how to begin operating and how to use your patient device. What must be done before starting to use the patient device? Find a safe place for the device. That means: • The device cannot be knocked to the floor or dropped. • It is not too warm or too humid (not in a bathroom). • The device is not in direct sun light. Normally, a bedside table is a suitable place.
How do you connect the device? Check that the operating voltage of your power cord matches the outlet in your home (normally 120 Vac, 60Hz). If both voltages correspond, insert the plug of the power cord into the wall-socket. The power supply cord has a small plug at the opposite end of the cable. Connect this plug to the socket that is located in the back of the charging stand.
How do I turn the mobile patient device on? 1 Push the button on the side of the mobile patient device until a short beep is heard. 2 The light on the top of the patient device will begin to flash orange for approximately 0.5 to 2 minutes. 3 When the light begins flashing green, your patient device is ready for use. If the light alternately flashes two times green and two times orange, your patient device is not able to log onto the local cellular phone system.
How do I turn the mobile patient device off? 1 Push and hold the power button on the side of the patient device until a short “beep” is heard and the light goes out. 2 The unit is off, and no further data can be received or transmitted. How do I recharge the batteries of the mobile patient device? 1 Place the mobile device onto the charging stand. Charging begins immediately. Charging will occur whether the mobile patient device is on or off.
How do I know if the batteries are low or discharged? If the battery charge falls below 10% of the maximum charge, the light on the top of the mobile patient device flashes red. At the same time, 3 short beeps will be heard. When this occurs, recharge the mobile patient device in the charging stand. How can I see if the patient device is transmitting messages? When a message is being transmitted, the light on top of the patient device will flash orange for as long as two minutes.
What do I do if the mobile patient device does not function any more? If the patient device does not function (i.e., the light is out and there is no beep), place the device in the charging stand to recharge it. If the device does not function after recharging, first push the Reset button on the back of the mobile patient device with a pointed object. Then switch the device on, using the power on button on the side – as described on page 9.
When does my implant transmit messages? Your doctor can adjust your implanted device so that it can transmit messages under certain circumstances. There are two possible ways to activate a message transmission: Periodically after a predefined time interval. This yy our doctor inter val is set b interv by your doctor.. 1 The doctor has adjusted your implant so that it transmits periodic messages at a certain time and at periodic intervals (for example: every night at 2:00 am).
How do I take care of the device? In order to use the patient device over a long period of time, it is necessary to treat the device with care. The faultless operation of the device can only be ensured when the following conditions are observed: 1 2 3 Keep the device clean and away from dirty or dusty environments. To clean, use a soft cloth. Moisten the cloth with water when necessary. Avoid direct contact of the device with water. If the patient device does not work, return it to your doctor.
Frequently asked questions by patients ? What happens if I forget to recharge my mobile patient device? The batteries generally supply power for about 15 hours. If the light on the mobile patient device turns red, place the device on the charging stand until the light turns green again (usually up to 5 hours). During the recharging process, the light on the charging stand is orange.
? Can I take my patient device with me everywhere– shopping, walking, sports? Yes. You can always take your mobile patient device with you during your private and working activities, as long as your doctor recommends it and you are not within areas where cellular phones are not permitted. The mobile patient device can be comfortably transported attached to your belt in the supplied soft case. It is also possible to carry it in a normal bag or backpack.
Tec hnical terms and abbre viations echnical abbreviations SMS Short Message Service – This is a digital communication system for mobile phones. Cardio Report Short report containing the current therapy status of the patient on the basis of data transmitted from the implant. Home Monitoring Technical feature of pacemakers and ICDs used to transmit messages over a certain frequency and make them available to your doctor.
Regulator y aspects Regulatory Your implant is equipped with an RF transmitter for wireless communications to the patient device. These messages are transmitted via a radio frequency assigned by the Federal Communications Commission for Medical Implant Communications Service (MICS). The transmitter is authorized by rule under the Medical Implant Communications service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.
For body worn operation, this device has been tested and meets the FCC RF exposure guidelines when used with a Biotronik, Inc. accessory designated for this product, or when used with an accessory that contains no metal and that positions the device a minimum of 0.5 cm from the body.
Tec hnical Data echnical power supply charging stand mobile patient device Model /type 120Vac, 600mA* RUCL 1000 RUCM 200 Volta ge/ oltag power input 120 Vac±10%, 60 Hz 12 V dc, 600 mA 9 V DC, 500 mA Volta ge/ oltag power output 12 Vdc DC/ 600 mA 9 V dc, 500 mA – * UL 2601-1 certified Stoc k and Transpor tation Conditions Stock ransportation temperature +5° C to +55° C humidity 93% relative humidity air pressure 50 mbar to 1250 mbar 21
Addresses BIOTRONIK, Inc. 6024 SW Jean rd. Bldg.
BIOTRONIK, Inc. 6024 SW Jean rd. Bldg.
