Attachment I – Maintenance and general information for the BICOM® device

Important: The BICOM optima Pilot software is an accessory to the BICOM optima device and is only used in combination with it. The therapy information and safety regulations are the same as for the BICOM device.

Caution: The device should not be opened to prevent it being damaged by being handled incorrectly. Please notify our customer services in the event of a fault: phone + 49 89 854 61 01, fax: +49 89 854 61 03.

If you have saved your own programs on your device, keep a written record of the program numbers and therapy parameters so that these are not lost if the device needs to be modified or when it undergoes technical inspection or upgrading. You can set the programs and then print out the parameters.

Operating conditions of the BICOM optima

1. Do not set up and use in humid areas such as bathrooms and laundry rooms, etc. Protect the device from rain and snow.

2. Never place containers holding liquid on the device or right next to it and protect the device from moisture at all times.

3. Wait between about 1 and 2 hours before turning the device on when moving it from a cold into a warm area due to the formation of condensation. The device can be charged during this time however.

4. Do not spill any liquids onto the device; only use a moistened cloth to wipe the device.

5. The therapeutic action of the BICOM optima may be adversely affected if operated in close proximity to a powerful transmitter or power cables. If necessary, use building biology techniques to screen the device.

6. The device should be set up at least 1 m away from heavy metal objects, radiators, powerful lamps, power cables and fluorescent lamps.

7. The air circulation required for cooling should not be obstructed.

8. The power supply must not be covered and should not be screened from the air circulation.

Mechanical influences

1. Never place heavy objects on the BICOM optima.

2. Never insert objects into the device.

3. Do not place magnetic articulated or depth probes on the device.

General basic rules for using the BICOM optima

1. The BICOM optima should not be used by inexpert or untrained staff or those who are unfamiliar with the device.

2. Study the operating instructions and keep them handy to refer to.

3. In the event of a fault, do no open the device but call Regumed’s customer services.

Combining with other devices

1. Do not connect any external devices to the BICOM device other than those specifically provided for by REGUMED.

2. Always use only the accessories specifically provided for by REGUMED (electrodes, cupping electrode set, cables, battery, etc.).

3. Only use the power supply (charger) provided by Regumed to charge and operate the device.

 

Transporting the device and ambient temperature

1. Do not throw or jolt the device when transporting it on account of the battery and electronics.

2. The ambient temperature for transporting and storing the device is between -10°C and +70°C (14°F and 158°F )– while the ambient temperature for operation is between 10°C and + 40°C (50°F and 104°F)

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3. Use the original packaging with the padded lining when shipping the device.

 

Cables and cable connections

1. Use the cable specifically provided for the purpose at all times. In case of doubt, ask our technical service.

2. Caution: The cables with banana plugs may only be used for the intended purpose to connect the electrodes to the BICOM optima and not for any other purpose. They must not be plugged into power supply sockets and/ or similar arrangements.

 

Maintenance, hygiene, cleaning and technical inspections

1. With electrodes and other accessories, observe the cleanliness and hygiene procedures in the guidelines on hospital hygiene and infection in your country which are customary in medical practices.

2. Never test and treat patients with electrodes which have not been cleaned. Dirt and coatings may affect or distort the test and therapy results.

3. Never use petroleum-based cleaning agents to clean the device. A damp (not wet) cloth, if necessary with mild soap suds, is sufficient for this. Keep all solvents away from casing.

4. Do not spray any disinfectant fluids onto the keyboard or into the sockets.

5. Do not use any alcohol or spirit for the front glass. A monitor cleanser is appropriate.

6. When pulling out the cables only grasp them at the plug to avoid damage. This is not always noticed immediately.

7. The BICOM and charger (AC adaptor) must undergo regular safety tests and technical inspections in line with § 6 and 11 of the Medizinprodukte-Betreiberverordnung (MPBetreibV) [regulations governing the setting up, operation, use and maintenance of medical devices]. We recommend testing by REGUMED service every 1 to 2 years, depending on frequency of use.

 

Cable test

1. Use the cable test to test the cables regularly. The cable in the back of the device can remain plugged in and the other end is then fitted into the socket labelled “cable test” on the front.

2. The modulation mat and the chip memory device are automatically checked by the electronics.

 

Battery

1. The battery is a consumable device and therefore not covered by the warranty.

2. If the device is not used for a prolonged period and not charged either, the battery will still discharge slowly as the electric clock draws current from the battery. To save the battery it is recommended that the battery is released and removed (and, if necessary, the power supply also disconnected from the device). The time and date must then be reset when the device is first used again. See also the chapter on accessories. When the battery level shows 25% the battery needs to be charged.

3. If the device is not used for a prolonged period and not charged, it may become totally discharged. Charge the battery for 30 to 60 minutes before using the device. If the battery keeps on discharging itself an internal protective circuit steps in to keep the battery from completely discharging. The device will switch off. After connecting the mains supply the device will need approximately 20 seconds before enough power has been loaded.

4. If after turning on the device the following message appears: “Please turn off your device immediately and charge the battery. In case the charge indicator of the battery does not show any %-numbers please contact REGUMED immediately.” either the battery is completely discharged or there is a technical defect. Charge the battery with the device turned off for approximately 30 minutes and then turn the device on again. If the notice appears again please contact our technical department.

5. The battery needs charging every 30 days if the device is not used.

 

Disposing of harmful substances

1. The battery within the device contains substances which are harmful to the environment. Do not dispose of the battery with the household waste. Regumed will take care of disposal of the battery and also of old devices which are no longer required. In this case please contact Regumed: +49 89-854 6101.

2. The test ampoules we supply do not contain any hazardous or active materials. There is no danger of infection or contamination should they break. The ampoules can be disposed of with the glass household waste.

3. The relevant provisions in the guidelines on hospital hygiene and infection prevention issued in your country should be observed to prevent infection of the user and other people when handling and disposing of bodily substances where there is a risk of infection.

4. Electrodes and cables can be disposed of together with the old device at a civic amenity site.

 

Electrode biocompatibility

The materials used which come into contact with the therapist and/or patient are biocompatible.