HNS 12 Technical Service Manual Rev C

Page 2

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 2

Manufacturer:

Distributor:

STOCKERT GMBH

Bötzinger Straße 72

79111 Freiburg

Germany

B. Braun Melsungen AG

Hospital Care Division

34209 Melsungen

Germany

Phone: +49 (0)761-20716-0

Fax: +49 (0)761-20716-20

E-mail: Info@stockert.de

http://www.stockert.de

Phone: +49 (0)5661-71-0

Fax: +49 (0)5661-71-4845

E-mail: StimuplexHNS12@bbraun.com

http://www.bbraun.com

In the US and Canada distributed by:

B. Braun Medical Inc.

824 Twelfth Avenue

Bethlehem, PA 18018-3524

Phone: 1-800-854-6851

Fax: 1-610-758-9020

E-mail: inquiry@bbraunusa.com

http://www.bbraunusa.com/stimuplex

Caution:

The Stimuplex® HNS 12 may only be used in applications for which this product is intended.

Federal (US) law restricts this device to sale by or on the order of a physician.

Stimuplex® HNS 12 Technical Service Manual

Order number: 6043572 – Rev. C – valid for software version 1.003.x

Meliseptol® and Stimuplex® are registered trademarks of B. Braun Melsungen AG

Page 3

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 3

Contents

3

Contents

Page

1.

1.1

1.2

Technical data................................................................................................................................................5

Battery ..............................................................................................................................................................5

Cleaning and disinfecting the Stimuplex® HNS 12..............................................................................6

2.

2.1

2.2

Maintenance and technical safety checks (with battery installed) ........................................7

Visual inspection of Stimuplex® HNS 12 including accessories ......................................................7

Functional check of Stimuplex® HNS 12 ................................................................................................7

3.

3.1

3.2

3.3

3.4

3.5

Instructions for technical safety checks ............................................................................................9

Visual inspection of Stimuplex® HNS 12 and accessories ................................................................9

Functional check of Stimuplex® HNS 12 ................................................................................................9

Checking the operating controls and monitoring equipment ..........................................................9

Checking the accessories ..........................................................................................................................10

Checking the stimulation signal ..............................................................................................................11

4.

Replacing the electrode cables ............................................................................................................12

5.

Repairs ............................................................................................................................................................12

6.

Test Equipment Logbook Stimuplex® HNS 12 ..............................................................................14

Page 4

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 4

4

The Stimuplex® HNS 12 is a nerve stimulator used for locating peripheral nerves in regional anesthesia and pain therapy.

The Stimuplex® HNS 12 is a class lla medical device according to Council Directive 93/42/EEC.

The device should not be used until it has been subjected to an on-site function test and the persons

responsible for operating the device are instructed now to use the device with the aid of the user

manual.

Page 5

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 5

1. Technical data

5

Type:

Instrument type:

Battery:

Power consumption:

Stimulation current:

Stimulation voltage:

Stimulation frequency:

Stimulus duration:

Stimuplex® HNS 12

BF

9V (alkaline)

6 mA (8 mA max.)

Î = 5 mA (max.) (0–12 kΩ)

Û = 95 V (max.)

1 Hz / 2 Hz ±1% / SENSe (3 Hz)

0.05 ms – 0.10 ms – 0.30 ms – 0.50 ms – 1.00 ms ±1%

SENSe (0.10 ms - 0.10 ms - 0.15 ms to 1.0 ms)

Allowable load impedance:

0 kΩ–12 kΩ

Current measuring accuracy:

± 0.02 mA

Impedance measuring range:

1 kΩ – 90 kΩ for target stimulation current > 0.5 mA

Impedance measuring accuracy:

±10% / ±20% for target stimulation current > 1mA / <= 1mA

Sound pressure level:

51 dB / 54 dB / 63 dB for stimulation / warning / error

Weight:

250g

Operational environmental conditions: 0 – 50° C, max. 90 % relative humidity, no condensation

1.1 Battery

The battery charge status must be checked regularly (MENU info = state of charge indicated in

“percent” and “volt”). Whenever the battery symbol is flashing, the current application can be completed without problems, but the battery should be replaced afterwards.

Please do not replace the battery when the device is switched on. This may damage the LCD

display.

If the voltage is less than 6.00 V, an error message will be displayed and the device will switch off

automatically. Replace battery.

If the Stimuplex® HNS 12 nerve stimulator is not intended to be used for a long period of time, the

battery must be removed to prevent leakage.

The battery compartment is located in the base of the nerve stimulator. When installing the battery,

ensure correct polarity and that the battery contacts are not pressed too tightly together to ensure

solid contact.

Only use 9 V alkaline manganese batteries – e.g. VARTA 4922, DURACELL MN 1604.

These will provide you with an optimum operating time. Rechargeable batteries must not be used as

they may cause the device to malfunction.

Page 6

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 6

6

WARNING!

If the battery is leaking, Stimuplex® HNS 12 should no longer be operated for reasons of safety.

It must be returned to the manufacturer for correct cleaning and a safety check.

1.2 Cleaning and disinfecting Stimuplex® HNS 12

Use only soft, damp cloths to clean and disinfect the Stimuplex® HNS 12 and accessories, e.g. the

electrode cable. Water or soap are particularly suitable for this purpose. Ensure that no moisture

penetrates the Stimuplex® HNS 12.

Use only wipe disinfection, no spray disinfection! Avoid condensation!

White spirit or commercially available methanol-free disinfectant in an ethyl alcohol base can be used

for disinfection.

Meliseptol® or white spirit can be used for wipe disinfection.

Caution! The following substances must not be used: trichloroethylene, acetone, butanone, benzene

methyl ethyl ketone, benzene, methanol, cellulose thinner, and 2-propanol or any other organic solvents, acids and sodium hydroxide solution. Disinfectants containing iodine or dyes can discolor the

housing and should not be used.

Page 7

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 7

2. Maintenance and technical safety checks (with battery installed)

We recommend running the following simple checks before starting up operation for the first time

and then regularly (e.g. before daily use):

- Visual inspection of device and accessories

- Functional check of device

2.1 Visual inspection of Stimuplex® HNS 12 including accessories

The following components must be clean and undamaged and not show any contamination:

•

•

•

•

•

•

•

•

•

Housing

Labels

Operating controls (instant set keys)

Keypad

LCD display

Controller dial (digital control knob)

Connecting ports

Electrode cable (e.g. insulation or electrodes not broken)

Test resistor

If included:

• Stimuplex® Pen

• Stimuplex® Remote Control

• Stimuplex® Switch

Never use damaged equipment or accessories!

After visual inspection is successful, carry out the function test.

2.2 Functional check of Stimuplex® HNS 12

Switch on the nerve stimulator. Target stimulation current = 0.00 mA, LED is not flashing, and no

sound is audible. Battery symbol may not be flashing (battery voltage > 7 V). If SENSe is enabled in

the setup/options menu please use Hz quick access button to set frequenzy to 1 Hz or 2 Hz.

• Connect electrode cable to the front of Stimuplex® HNS 12 (to the middle 4-polar plug).

The plug connector configuration prevents wrong polarity connection. – Leave the circuit open.

7

Page 8

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 8

8

• Use the mA function key to set the current range to 5.00 mA – Appears in display.

• Use the ms function key to set the stimulus duration to 0.30 ms – Appears in display.

• Use the Hz function key to set stimulation frequency to 1 Hz – Appears in display.

• Using the control knob, slowly increase the target stimulation current from 0.00 mA to 5.00 mA.

Throughout the entire procedure, warning display must read “Patient current lower than your setting”

and patient current = “0.00 mA”. The LED flashes red in a 1-Hz rhythm and the warning signal is

audible in a 1-Hz rhythm.

• Close the circuit using the 10 kΩ test resistor supplied as an accessory. All warnings (display, LED,

sound) must disappear. The display reads 10 kΩ ± - tolerance. If the warnings do not disappear,

briefly connect the electrode cable to the contacts at the ends of the cable in order to rule out

that test resistor is defective.

• Using the digital control knob, slowly reduce the target stimulation current from 5.00 mA to 0.00

mA. Throughout the entire procedure, the warning display must not read “Patient current lower

than your setting”, and the LED must be flashing green in a 1-Hz rhythm (if applicable yellow for

target stimulation current < threshold current if option is activated).

In the event that the nerve stimulator does not behave as described, its use must be discontinued.

The nerve stimulator and the electrode cable must be technically inspected.

If you have changed any settings please reestablish them and then switch off the nerve stimulator

so that any configured settings (from the medical team) are available when the device is switched

back on.

Page 9

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 9

3. Instructions for technical safety checks

9

These tests may be performed by qualified staff only and in accordance with the following test

instructions (Section 6, para. 4 MPBetreibV). An equipment logbook of the technical safety checks

must be kept (see appendix) and filed for the next safety inspection (Section 6, para. 3 MPBetreibV).

The following measuring and testing equipment is required:

Oscilloscope (storage oscillograph) for checking the output signal

Settings:

- Time base = 20 µs/div (500 ms/div) for stimulation frequency measurement

- Resolution = 500 mV, 1 V, 2 V, 10 V/div (full screen)

- Mode = High resolution is recommended for maximum accuracy (HiRes) or

sample

- Trigger = falling slope, e.g. 30 %

Ohmmeter for checking test resistance

Test resistor 10 kΩ +/- 1%

9 V battery alkaline, battery voltage > 7 V (a fresh battery is recommended).

3.1 Visual inspection of Stimuplex® HNS 12 and accessories

See Section 2.1. – Enter results in equipment logbook.

3.2 Functional check of Stimuplex® HNS 12

See Section 2.2. – Enter results in equipment logbook.

3.3 Checking the operating controls and monitoring equipment

• Check instant set keys (keypad)

mA key: Press the mA key repeatedly. In the display, the value is highlighted by a border for approx.

3 seconds. Only a value highlighted by a border can be changed by repeatedly pressing the key.

Adjustable current range settings are 1.00 mA or 5.00 mA.

ms key (SENSe disabled only for 1 Hz and 2 Hz): Press the ms key repeatedly. In the display, the

value is highlighted by a border for approx. 3 seconds (see above). Adjustable settings are 0.10 ms,

0.30 ms, 1.00 ms stimulus duration (0.05 ms and 0.50 ms, if applicable).

Hz key: Press Hz key repeatedly. In the display, the value is highlighted by a border for approx.

3 seconds (see above).

Adjustable stimulation frequency settings are 1 Hz, 2 Hz or SENSe (if enabled).

Page 10

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 10

10

MENU and ON/OFF keys:

When the stimulation screen is displayed, press I
arrow key ➝ Main Menu is displayed.

Use  to select “Setup” menu.

Press
key. “Setup” menu is displayed.

Press  key. Main menu reappears in the display.

Press ON/OFF key briefly. The stimulation screen reappears.

• Check digital control knob

In the stimulation screen turn control knob clockwise; this increases the target stimulation current;

turn knob counter clockwise to reduce target stimulation current.

• LCD display: Readability check. If necessary, increase contrast by selecting Contrast menu.

Using the digital control knob, set target stimulation current = 5.00 mA.

• Check LED display with open circuit – LED lights up red.

• Check LED display with closed circuit – LED lights up green.

• Check Sound with open and closed circuit. If necessary, increase volume by selecting Volume

menu.

Enter results in equipment logbook.

3.4 Checking the accessories

• Measure 10 kΩ ± 1 % test resistance with the ohmmeter. Enter results in equipment logbook.

• Check electrode cable as described in Section 2.2. Enter results in equipment logbook.

If available:

• Connect Stimuplex® Remote Control to front of Stimuplex® HNS 12 (3-polar plug on left). The

plug connector configuration prevents any wrong polarity connection.

• Use the remote control buttons to increase target stimulation current and reset to 0.00. Enter

results in equipment logbook.

• Connect the Stimuplex® Switch to front of Stimuplex® HNS 12 (4-polar plug) and check the

device as described in the Stimuplex® Switch Instructions for use on page 4.

Page 11

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 11

11

• Connect Stimuplex® Pen to electrode cable. Increase target stimulation current. The warning

“Patient current lower than your setting” appears in the display. Then close the circuit with the

test resistor. The warnings (display, LED, sound) must disappear. Enter results in equipment logbook.

3.5 Checking stimulation signal

To prevent disturbances, perform all tests only when the 9-volt battery is installed.

Connect the electrode cable using the 10 kΩ +/- 1% test resistor – connect the oscillograph with

GND clip on the red clamp parallel to test resistor (see page 15 for tolerances).

Set stimulus duration = 0.10 ms – target stimulation current = 1.00 mA.

• Pulse form rectangular, negative.

• Measure stimulus duration – Enter results in equipment logbook.

Set stimulus duration = 0.10 ms – target stimulation current = 0.30 mA.

• Measure actual stimulation current – Enter results in equipment logbook.

Set stimulation frequency = 2 Hz – target stimulation current = 1.00 mA.

• Measure stimulation frequency – Enter results in equipment logbook.

Set stimulus duration = 0.10 ms – target stimulation current = 0.50 mA.

• Measure actual stimulation current – Enter results in equipment logbook.

Set stimulus duration = 0.10 ms – target stimulation current = 1.00 mA.

• Measure actual stimulation current – Enter results in equipment logbook.

Stimulus duration = 0.10 ms – current range = 5.00 mA. Using the control knob, set target stimulation current = 5.00 mA.

• Measure actual stimulation current – Enter results in equipment logbook.

• Check impedance display with 10 kΩ test resistor. Enter results in equipment logbook.

If faults are detected, return the device – including accessories – to the manufacturer

or distributor for repair.

Page 12

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 12

12

4. Replacing the electrode cable

A faulty electrode cable can be easily replaced on-site with a new one. The polarized connector prevents any wrong connection of electrode cable.

– B. BRAUN Code number for replacement electrode cable: 4892070

5. Repairs

Electrical and electronic equipment may only be repaired by the manufacturer or by an organization

expressly authorized by the manufacturer.

Unauthorized persons opening or attempting to repair Stimuplex® HNS 12 can create a dangerous

situation and will cause all warranty claims to be null and void.

Any order for repairs must be accompanied by a detailed description of the fault (see next page).

Please send repairs

Please send repairs from

from all EU countries to: all other countries to:

Stockert GmbH

B. Braun Melsungen AG

Bötzinger Straße 72

LO-WF-DE08P

79111 Freiburg

Attn.: Mr. Grützmacher

Germany

34209 Melsungen

Germany

For further request,

please contact:

B. Braun Melsungen AG

HC-SY-DE08 P Attn.: Mr. Krapf

Pfieffewiesen

34212 Melsungen

Germany

e-mail: Heiko.Krapf@bbraun.com

Telephon (0 56 61) 71-16 75

Telefax (0 56 61) 75-16 75

Page 13

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 13

13

ERROR REPORT

Product:
STIMUPLEX® HNS 12

Connection Cable

Serial-No. ____________

Others: _______________________

Customer

(Clinic)

(Stamp)

Contact person: ___________________________________________

Phone no.: _________________________

Fax-no.: _________________________

Date when error appeared: _______________________

Exact description of the error:

In which situation did the error appear:

Device settings:

Accessories in use:

________________________________________

________________________________________

________________________________________

________________________________________

________________________________________

Patient hazards?
No

Cat.-No.

_____________

_____________

_____________

_____________

_____________

LOT-No.

______________

______________

______________

______________

______________

Yes Description: _______________________________________

Error report recorded by: __________________________________ on: ____________________

Please return the error report together with the defect device!

Page 14

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 14

14

6. Test Equipment Logbook Stimuplex® HNS

Serial No.

________________

Test equipment for the test:

Measuring device

Ohmmeter

Oszilloscope

Type

Calibrated

Next calibration

Visual inspection

Operating elements

Housing

Labels

Keypad (instant set keys)

LC Display

Control knob

Plugs

Electrode cable

Test resistor

Stimuplex® Remote Control if available

Passed

Failed

Stimuplex® Pen if available

Passed

Failed

Passed

Failed

Functional check

Operational and monitoring elements check

Operational and monitoring elements

Keys

Control knob

LC Display

LED display green (yellow, if applicable), red

Sound, warning signal

Page 15

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

Seite 15

15

Accessories functional check

Accessories

Test resistor 10 kΩ +/- 1 %

Electrode cable

Stimuplex® Remote Control, if available

Stimuplex® Pen, if available

Passed

Failed

Stimulation signal check

Test

Pulseform

Stimulation duration

Stimulation frequency

Stimulation current

Stimulation current

Stimulation current

Stimulation current

Impedance

Stimuplex® HNS 12 Setting

0.10 ms, 1.00 mA

0.10 ms, 1.00 mA

2 Hz, 1.00 mA

0.10 ms, 0.30 mA, 10 kΩ +/- 1%

0.10 ms, 0.50 mA, 10 kΩ +/- 1%

0.10 ms, 1.00 mA, 10 kΩ +/- 1%

0.10 ms, 5.00 mA, 10 kΩ +/- 1%

0.10 ms, 5.00 mA, 10 kΩ +/- 1%

Tolerance

Square, negative

0.098 ms – 0.102 ms

1.98 Hz – 2.02 Hz

0.26 mA – 0.34 mA

0.46 mA – 0.54 mA

0.96 mA – 1.04 mA

4.96 mA – 5.04 mA

9 kΩ – 11 kΩ

Remarks:

Technical inspector:

Date:

Signature:

Passed

Failed

Page 16

6043572_Stimuplex_HNS12_TSM_16s_GB

13.05.2009

11:23 Uhr

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Tel +49 (0) 56 61-71-0

Date of last revision April 2009

W. 01,2.01.08/6

6043572

0509

www.bbraun.com

Seite 16