Stimuplex Dig RC Technical Service Manual June 2005

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1.

Stimuplex® Dig RC Function Test

Before operating and using the device, the appropriate safety and performance tests must be carried out. 1.1 Function Tests Fit in the battery and turn on the device (current regulator from “0“ to “I“): – the red LED “Batt“ will flash briefly for control – the digital display indicates the initial value “0.2 mA“ – a brief audio signal (beep) sounds Switch over the toggle switch repeatedly: – the audio signal sounds in synchrony with the selected frequency (e.g. 1 Hz = 1 signal/sec. and 2 Hz = 2 signals/sec. respectively) Slowly increase the current regulator and observe the indicators: – the digital display flashes and indicates the present current value – the maximum current adjustment is 5.0 mA – the frequency of the signal changes proportionally to the preselected current value The yellow LED should not light up at any setting of the current regulator during an open circuit. 1.2 Function Tests with shorted Electrode Cable Short the contacts at the ends of the electrode cable (insert the closed alligator clip into the black socket in order to close the circuit by connecting the contacts): – the yellow LED flashes and the digital display stops flashing and indicates the current If the yellow LED does not light when the cable ends are shorted, the cable connection is defective and the cable set should be replaced. (For replacement of the integrated electrode cable see point 4 of the service manual.) The Function Tests should be conducted before each use (Please see also User´s Manual “Short Test Stimuplex® Dig RC“, page 6). In case of functional failure, the unit should be checked by technical staff according to the technical safety test instructions outlined as follows.

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2.

Instructions for technical safety tests

In section 6 of the “Medical Products-Operating Instructions“ technical safety tests must be done. These tests can only be performed by qualified staff (section 6 para. 4 MPBetreibV) according to the following protocols. The following measuring and diagnostic instruments are necessary: – oscilloscope (storage oscilloscope) – voltmeter – resistor (load resistance) 1000 ohms – battery 9 volt 2.1

Check the external condition of the device: – housing is clean and undamaged. If there is any contamination with blood or drugs the housing must be disinfected – labels are legible – dials (current regulator, frequency switch) work – cable set is functional, and visually check the electrode cable for any damage

2.2

Operate through the checking instructions according 1.1 and 1.2

2.3 Check and observe the output signal (pulsed current) All tests must be done to avoid faults and are performed only with a 9 volt battery correctly installed. Blank off the electrode cable to a load resistance of 1000 ohms and connect the oscilloscope in parallel to the load resistance. Adjust a time base of 0.1 msec. and a front-end area (incoming area) of 1 V / div. Set a pulsed current of 5.0 mA with the current regulator on the device and check the output signal with the oscilloscope: – impulse form monophasic rectangular impulse – impulse width 0.1 msec. (± 10 %) – impulse amplitude 5.0 volt (Vp) (± 10 %) – impulse frequency 1 Hz and 2 Hz (± 10 %) Set further current values according to chart 1 and carry out a check with the oscilloscope. The voltage drop of the load resistance corresponds to the preselected current.

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Chart 1 Current mA 5.0 1.0 0.5

Voltage Vp 5.0 1.0 0.5

Tolerance % 앐 10 % 앐 10 % 앐 10 %

2.4 Check the monitoring functions Digital display and yellow LED (current monitoring): Slowly increase the current when the load resistance is switched on and check the digit repetition of the digital display: – the display is 3 digits until 4.99 mA, from 5.0 mA onwards it is 2 digits – the yellow LED is flashing for each current impulse – the prolonged audio signal (beep) is proportional to the selected current Deenergize the load resistance and slowly increase the current again, observe the digital display: – digital display is flashing on the whole area – shortened audio signal – yellow LED should not light up at any setting – a monophasic rectangular impulse of about 40 Vp with inclined negative edge is seen on the oscilloscope Audio signal (frequency and current observation): – sounds with each current impulse – frequency of the audio signal is proportional to the selected current – brief audio signal during an open circuit, long audio signal when the circuit is closed Red LED “Batt“ (Battery voltage check): – is flashing briefly when the device is turned on – is flashing when battery voltage drops below 5.6 V Check the battery voltage: The battery needs to be replaced during the performance of the Technical Safety Test. Verify the battery voltage with the voltmeter after the device has been switched on. 2.5 Check the accessories Remote Control: Connect the Remote Control with the 3-polar plug of the Stimuplex® Dig RC and turn on the device:

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– digital display indicates the initial value of 0.2 mA (± 10 %) – press the “Up“ button of the RC until the final value of 5.0 mA is reached. Duration: 20 sec. – press the “Down“ button of the RC until the initial value of 0.2 mA is reached. Duration: 20 sec. If the time for achieving the initial or final value is exceeded or has fallen below it significantly, the RC is defective and has to be sent back for repair. 3.

A report of the technical safety tests must be made (see appendix) and retained for the next safety regulation control (section 6, para. 3 MPBetreibV). In case of a detected fault the device must be sent back to the manufacturer. 4. Replacement of the electrode cable A defective electrode cable may also be replaced by the hospital’s electronic and biomedical engineering department (EBME). (Code number of the substitude electrode cable: 4892917B) Position the Stimuplex® Dig RC on a soft base and turn the device with its bottom panel at the top: – remove rubber stoppers from the botton panel – unscrew the 4 screws of the bottom panel with a screwdriver for recessed-head screws – pull off the bottom panel carefully upwards and position it side by side to the device (take care of the batteryconnecting cable!) – disconnect the electrode cable plug from the plate and take the electrode cable out of the clamping arrangement of the front panel – press the new electrode cable with its rubber bushing into the clamping arrangement of the front panel and adjust the cable position – take care of the coding, do not use excessive force; attach the plug of the electrode cable to the counter plug on the plate – replace the bottom panel carefully to seal. Take care that no cables are being squashed (battery cable) – screw in the four screws of the botton panel

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– reinsert the rubber stoppers – carry out an operation check according to point 1.2.

Repair addresses: Repair from Germany: Ingenieurbüro Medizin-Technik E. Hauser Büchlweg 33 D-82041 Oberhaching b. München Repair from other EU-countries via your B. Braun subsidiary Repair from non EU-countries: please send to: B. Braun Melsungen AG LO-WF-DEOB P D-34209 Melsungen For further request, please contact: B. Braun Melsungen AG Pfieffewiesen N. Machal D-34209 Melsungen e-mail: [email protected] Phone (0 56 61) 71-47 89 Fax (0 56 61) 75-47 87

Check Protocol Stimuplex® Dig RC

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Inspections

Status

1. Check the external condition of the device: – housing clean and undamaged – labels legible – current regulator and frequency switch functional 2. Functional Checkups: tests Turn on the device and adjust a current value of 1 mA: – brief audio signal sounds in synchrony with the selected frequency – digital display is flashing Check the frequency switch (toggle switch): – signal sounds in time of a second (1 Hz) or in time of 0.5 seconds (2 Hz) Short the electrode cable: – prolonged audio signal sounds – yellow LED is flashing – digital display indicates the present current (no flashing) 3. Check and observe the output signal (pulsed current): Blank off the electrode cable with a load resistance of 1000 ohms, connect the oscilloscope in parallel. Set a pulsed current of 5.0 mA. Check the output signal with the oscilloscope: – impulse form monophasic rectangular impulse – impulse width 0.1 msec. 앐 10 % – impulse amplitude 5.0 volt (Vp) 앐 10 % – impulse frequency 1 Hz and 2 Hz 앐 10 % Set further current values to check: Current mA Voltage Vp 5.0 5.0 1.0 1.0 0.5 0.5

Tolerance 앐 10 % 앐 10 % 앐 10 %

4. Check the monitoring functions Slowly increase the current when the load resistance is switched on and check the digit repetition of the digital display: – the display is 3 digits until 4.99 mA, from 5.0 mA onwards it is 2 digits – the yellow LED is flashing with each current impulse – the audio signal is proportional to the selected current Deenergize the load resistance and slowly increase the current again: – digital display is flashing on the whole area – abridged audio signal in proportion to the selected current Red LED "Batt": – is flashing briefly when the device is turned on – is flashing when battery voltage drops below 5.6 V (battery empty)

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Inspections

Status

Battery needs to be replaced during Technical Safety Test. 5. Accessory: Remote Control (Option) Connect the RC and turn on the Stimuplex® Dig RC: – digital display indicates initial value of 0.2 mA (± 10 %) Press the "Up" button until the final value of 5.0 mA is reached. Press the "Down" button until the initial value of 0.2 mA is reached. – time duration "Up" and "Down" for each is approximately 20 seconds

Repair

Electromedical equipment may only be repaired by the manufacturer or by an organization expressly authorized by the manufacturer. A detailed description of the fault must be added to the repair order:

Type of device

: Stimuplex® Dig RC Nerve Stimulator

Code number

:

Last battery replacement

:

Check of the Electrode Cable

: OK: 첸

Detailed description of the fault

:

Contact Person (Name/Telephone)

:

Supply address

:

Defect: 첸