HNS 12 Technical Service Manual Rev C

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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: [email protected] http://www.stockert.de

Phone: +49 (0)5661-71-0 Fax: +49 (0)5661-71-4845 E-mail: [email protected] 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: [email protected] 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

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Contents

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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

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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.

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1. Technical data

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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.

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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.

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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.

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• 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.

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3. Instructions for technical safety checks

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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).

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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.

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• 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.

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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 from all EU countries to: Stockert GmbH Bötzinger Straße 72 79111 Freiburg Germany

Please send repairs from all other countries to: B. Braun Melsungen AG LO-WF-DE08P Attn.: Mr. Grützmacher 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: [email protected] Telephon (0 56 61) 71-16 75 Telefax (0 56 61) 75-16 75

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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!

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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

Functional check

Passed

Failed

Passed

Failed

Operational and monitoring elements check Operational and monitoring elements Keys Control knob LC Display LED display green (yellow, if applicable), red Sound, warning signal

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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 Tolerance 0.10 ms, 1.00 mA Square, negative 0.10 ms, 1.00 mA 0.098 ms – 0.102 ms 2 Hz, 1.00 mA 1.98 Hz – 2.02 Hz 0.10 ms, 0.30 mA, 10 kΩ +/- 1% 0.26 mA – 0.34 mA 0.10 ms, 0.50 mA, 10 kΩ +/- 1% 0.46 mA – 0.54 mA 0.10 ms, 1.00 mA, 10 kΩ +/- 1% 0.96 mA – 1.04 mA 0.10 ms, 5.00 mA, 10 kΩ +/- 1% 4.96 mA – 5.04 mA 0.10 ms, 5.00 mA, 10 kΩ +/- 1% 9 kΩ – 11 kΩ

Remarks:

Technical inspector:

Date:

Signature:

Passed

Failed

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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

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