Stimuplex® Dig RC

Technical Service Manual

Nerve Stimulator forRegional Anesthesia,Regional Analgesia, Neurology

3

1. Stimuplex® Dig RC Function Test

Before operating and using the device, the appropriate safety andperformance tests must be carried out.

1.1 Function TestsFit 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 valueThe yellow LED should not light up at any setting of the currentregulator during an open circuit.

1.2 Function Tests with shorted Electrode CableShort the contacts at the ends of the electrode cable(insert the closed alligator clip into the black socket in order toclose the circuit by connecting the contacts):

– the yellow LED flashes and the digital display stopsflashing 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 bereplaced. (For replacement of the integrated electrode cable see point 4 ofthe 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 bytechnical staff according to the technical safety test instruc-tions outlined as follows.

4

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 con-

tamination 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 according1.1 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 witha 9 volt battery correctly installed.

Blank off the electrode cable to a load resistance of 1000 ohmsand connect the oscilloscope in parallel to the load resistance.Adjust a time base of 0.1 msec. and a front-end area (incomingarea) of 1 V / div.

Set a pulsed current of 5.0 mA with the current regulator on thedevice 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 acheck with the oscilloscope. The voltage drop of the load resist-ance corresponds to the preselected current.

5

Chart 1

Current Voltage TolerancemA Vp %5.0 5.0 � 10 %1.0 1.0 � 10 %0.5 0.5 � 10 %

2.4 Check the monitoring functionsDigital display and yellow LED (current monitoring):Slowly increase the current when the load resistance is switchedon and check the digit repetition of the digital display:

– the display is 3 digits until 4.99 mA, from 5.0 mAonwards 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 currentagain, 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 theTechnical Safety Test. Verify the battery voltage with the voltmeterafter the device has been switched on.

2.5 Check the accessoriesRemote Control:Connect the Remote Control with the 3-polar plug of theStimuplex® Dig RC and turn on the device:

6

– digital display indicates the initial value of 0.2 mA(± 10 %)

– press the “Up“ button of the RC until the final value of5.0 mA is reached. Duration: 20 sec.

– press the “Down“ button of the RC until the initial valueof 0.2 mA is reached. Duration: 20 sec.

If the time for achieving the initial or final value is exceeded or hasfallen below it significantly, the RC is defective and has to be sentback for repair.

3. A report of the technical safety tests must be made(see appendix) and retained for the next safety regula-tion control (section 6, para. 3 MPBetreibV).

In case of a detected fault the device must be sent back to themanufacturer.

4. Replacement of the electrode cableA defective electrode cable may also be replaced by the hospital’selectronic and biomedical engineering department (EBME). (Codenumber of the substitude electrode cable: 4892917B)

Position the Stimuplex® Dig RC on a soft base and turn the devicewith its bottom panel at the top:

– remove rubber stoppers from the botton panel– unscrew the 4 screws of the bottom panel with a screw-

driver for recessed-head screws– pull off the bottom panel carefully upwards and position

it side by side to the device (take care of the battery-connecting cable!)

– disconnect the electrode cable plug from the plate andtake the electrode cable out of the clamping arrange-ment of the front panel

– press the new electrode cable with its rubber bushinginto the clamping arrangement of the front panel andadjust the cable position

– take care of the coding, do not use excessive force;attach the plug of the electrode cable to the counterplug on the plate

– replace the bottom panel carefully to seal. Take carethat no cables are being squashed (battery cable)

– screw in the four screws of the botton panel

7

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

Repair addresses:

Repair from Germany:Ingenieurbüro Medizin-TechnikE. HauserBüchlweg 33D-82041 Oberhaching b. München

Repair from other EU-countriesvia your B. Braun subsidiary

Repair from non EU-countries:please send to:

B. Braun Melsungen AGLO-WF-DEOB PD-34209 Melsungen

For further request, please contact:B. Braun Melsungen AGPfieffewiesenN. Machal

D-34209 Melsungene-mail: nadja.machal@bbraun.comPhone (0 56 61) 71-47 89Fax (0 56 61) 75-47 87

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: testsTurn 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. � 10 %– impulse amplitude 5.0 volt (Vp) � 10 %– impulse frequency 1 Hz and 2 Hz � 10 %

Set further current values to check:Current mA Voltage Vp Tolerance

5.0 5.0 � 10 %1.0 1.0 � 10 %0.5 0.5 � 10 %

4. Check the monitoring functions Slowly increase the current when the load resistance is switched onand 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)

Check Protocol Stimuplex® Dig RC 8

9

Repair

Electromedical equipment may only be repaired by the manufacturer or by an organization expresslyauthorized 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: � Defect: �

Detailed descriptionof the fault :

Contact Person(Name/Telephone) :

Supply address :

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

W. 03.03.05/6 Nr. 604 3810

Vertrieb für die Schweiz:B. Braun Medical AGPostfach 21CH-6203 Sempach-StationTelefon 041 4 62 62 44

B. Braun Melsungen AGP.O. Box 11 2034201 Melsungen

Tel (0 56 61) 71-0www.bbraun.com

HOSPITAL CARE

0123Vertrieb für Österreich:B. Braun Medical Vertriebsgesellschaft mbHIn den Langäckern 3-5A-2344 Maria Enzersdorf a. Geb. (NÖ)Tel (0 22 36) 8 65 41Fax (0 22 36) 2 5118

Caution:Federal (U.S.A.) law restrictsthis device to sale by or on the orderof physicians.