Hilger DualStim Instructions for Use Ver 1.1 Sept 2011

Copyright Information This manual copyright © 2006-2011 by WR Medical Electronics Co. All rights reserved. No part of this manual may be reproduced in any form by any means-graphic, electronic, or mechanical, including photocopying, recording, taping, or any information storage and retrieval system-without the written permission or WR Medical Electronics Co. Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1, item number 3900, rev. 09/27/11.

For more information, contact: WR Medical Electronics Co. 1700 Gervais Avenue Maplewood, MN 55109 USA Phone: Toll-free Phone:

651-604-8400 800-635-1312

Fax: Toll-free Fax:

651-604-8499 800-635-9733

E-mail: Web Site:

[email protected] or [email protected] www.wrmed.com

(United States and Canada)

(United States and Canada)

Comments or Questions? We appreciate receiving any suggestions, comments, or questions that would help us to improve this manual. Please forward comments to the address above.

2 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

CONTENTS Warnings and Cautions... 4 Device Information... 5 Sterilization... 5 Batteries... 5 System Classification (IEC601-1/EN60601-1)... 5

Environmental Ratings... 6 Preventive Maintenance and Cleaning... 6 Responsibility of the Supplier... 6 Electromagnetic Compatibility... 6 Safety and Information Symbols... 7 Environmental Protection and Disposal of Equipment... 7 Latex Statement... 7 Technical Specifications... 8 Operation of the Hilger Dual-Stim Nerve Stimulator... 9 Front Panel Description... 9 Bipolar Clinical Probe... 10 Remote Surgical Probe... 10 Monopolar Surgical Disposable Probe... 10 SACS Kit... 10 Electrode Pad Cable... 11 Battery Replacement... 11

References and Suggested Readings... 12

References... 12 Suggested Readings... 12

Service Information... 13

Warranty... 13 Service... 13

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 3

WARNINGS AND CAUTIONS WARNING: Simultaneous contact of the stimulator probe and high frequency surgical equipment, such as an electrocautery device, to a patient may result in burns at the site of the stimulator electrodes and possible damage to the stimulator. Remove probe from the operating site when using electrocautery or electrosurgery devices, and keep electrode pad physically separated and electrically isolated from electrocautery or electrosurgery units. WARNING: Patients with an implanted electronics device, such as a cardiac pacemaker, should not be subject to stimulation unless specialist medical opinion has first been obtained. WARNING: Simultaneous connection of a patient to high frequency surgical equipment and to an electromyography or evoked response equipment may result in burns at the site of the electrical stimulator or biopotential input part electrodes and possible damage to the electrical stimulator or biological amplifiers. WARNING: Avoid accidental contact between connected but unapplied parts and other conductive parts, including those connected to protective earth. WARNING: Avoid trans-thoracic stimulation, for example maintenance of anode and cathode stimulating sites close in proximity. WARNING: Paralyzing Drugs: Be aware of the effects of paralyzing drugs. When injected in close proximity to the nerve, the responsiveness of the nerve and muscle to stimulation may be affected. WARNING: Portable and mobile RF communication devices may affect the Hilger Dual-Stim Nerve Stimulator. This device may also be interfered with by other equipment even if it complies with Cisper limits. In the event that any equipment is adversely affecting this device, remove the interfering equipment from the area. WARNING: Operation in proximity of short wave or microwave therapy equipment may produce instability in the electrical stimulator output. CAUTION: Federal law restricts this device to sale by or on the order of a physician. CAUTION: This device is to be operated only by a physician or trained personnel under the direction of a physician. CAUTION: The Hilger Dual-Stim Nerve Stimulator is not explosion-proof and should not be used in the presence of explosive gases. CAUTION: Do not use the SACS cable with electrically powered drills. Do not allow any active ends of the cable or active tools/probes which are not in use to touch conductive materials such as the operating table, microscope, etc. The ends of the cable and probes are ‘active’ whenever they are connected to the stimulator.

4 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

DEVICE INFORMATION Sterilization: •

The Bipolar Clinical Probe is used only for clinical testing and should not require sterilizing. If desired, it may be gas sterilized. It must not be steam autoclaved.

•

The Remote Probe and SACS cable must be gas sterilized only.

•

SACS clips may be gas sterilized or steam autoclaved.

•

The Surface Electrode Pad Cable is not in the sterile field, and should not require sterilizing. If desired, it may be gas sterilized.

Batteries: •

Replace with four alkaline batteries, size C. See detailed instructions on page 11.

•

Dispose of used batteries according to local regulations.

System Classification (IEC601-1 / EN 60601-1)

ENVIRONMENTAL RATINGS Type of protection against electric shock

Type BF

Degree of protection against electric shock

Class II

Degree of protection against moisture ingress (IEC529) Ordinary IPX1 Degree of protection in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide Mode of operation

Not protected (unsuitable)

Continuous

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 5

After exposure to transport and storage extremes, allow the system to acclimate before operating. The system should not be subject to transport and storage extremes for an extended period of time.

Operating

Transport and Storage

Temperature:

+ 10° C to + 35° C

- 10° C to + 50° C

Relative humidity

30% to 75%

10% to 95% (non-condensing)

PREVENTATIVE MAINTENANCE AND CLEANING •

Clean the unit when necessary by using a dry cloth. For stubborn stains, a lightly dampened cloth and a mild detergent may be used. Do not immerse.

•

Do not immerse any cables or probes. Cables should be carefully coiled when not in use to prevent tangling or breaking.

•

At the end of service, consult local regulations for disposal of batteries and other system parts.

RESPONSIBILITY OF THE SUPPLIER •

WR Medical Electronics Co. accepts responsibility for the affects of safety, reliability, and performance of the equipment, only if: • Assembly operation, extensions, readjustments, modifications, and re pairs are conducted by persons authorized by WR Medical Electronics Co. • The electrical installation of the room complies with local regulations. • The equipment is used in accordance with the Instructions for Use.

ELECTROMAGNETIC COMPATABILITY • •

The system has been independently tested and found to comply with IEC606011-2 Emissions are limited to CISPR 11 Class A Group 1 (industrial environment). Some care may be needed to minimize disturbance to sensitive receivers. Immunity from external disturbances is assured for operation in normal residential and clean industrial environments. If in doubt, consult WR Medical Electronics Co.

6 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

SAFETY AND INFORMATION SYMBOLS Symbols that appear on the equipment have the following meaning: Attention, consult accompanying documents Type BF Applied Part - F Type patient contact part isolated from other parts of the equipment such that patient leakage currents cannot exceed allowed limits in NORMAL and SINGLE FAULT CONDITION

Power on/off (|/0) Increase current intensity Decrease current intensity Switch between surgical and clincal mode

Latex Statement

No natural rubber latex is used in the manufacturing of this equipment or accessories.

Environmental Protection and Disposal of Equipment

At the end of service, consult local regulations for disposal of batteries and other system parts.

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 7

TECHNICAL SPECIFICATIONS • Current output: 0.0 to 10.0 milliamperes (mA) measured across a 1K + 1% resistive load. Tolerance at 0.0 indicated, with a residual current less than 0.05 mA. Tolerance at 10 mA is +0.4 mA • Pulse width: • Pulse time off: • Pulse frequency: • Hertz:

Clinical mode

Surgical mode

0.0006 seconds +25 microseconds 0.1666 seconds 0.1666 sec +7 milliseconds 6

0.0002 seconds +25 microseconds 0.1998 seconds 0.200 sec at +7 milliseconds 5

• Dial accuracy: linear down to 0.15 mA, residual current of 0.05 at 0.0 indicated. • Batteries: Four 1.5 volt alkaline C Cells • Battery life: 100 hours continuous use between replacement. • Size: 8.5 x 9 x 3 inches (21.6 x 22.8 x 7.6 cm) • Weight: 3.6 lbs (with pole clamp) (1.6 kg)

SYSTEM COMPONENTS

Specific component lists may vary depending on items ordered.

Part number 3900 3901 3905 3119 3903 3904 3188 3194 3146EU 3214

Item description Hilger Dual Stim Main unit Bipolar Clinical Probe, Model Remote Probe, Model HDS Electrode Cream Instructions For Use Adaptor, Hilger DS Monopolar Surgical Probe Surface electrode pad cable SACS Kit Theratrode III Electrode pads

8 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

Single Use or Reuse Reuse Reuse Reuse Single N/A Reuse Single Reuse Reuse Single

Sterile No No Yes N/A N/A No Yes No Yes N/A

Repairable Yes No No No No No No No No No

OPERATION OF THE HILGER DUAL-STIM NERVE STIMULATOR Front Panel Description On/Off Button • •

The On/Off Button turns the instrument on and off; press and hold for at least 2 seconds to turn the unit on or off. An audible, brief beep will occur on power on or power off. Stim automatically powers off after 30 minutes with no user input activity.

Pulse Indicator •

The Pulse indicator will flash each time the current pulse is successfully delivered. It will also flash during power up. The pulse indicator will not flash if the Incomplete Stimulation indicator is on.

Incomplete Stimulation Indicator •

• •

The Hilger Dual-Stim automatically compensates for changes or variations in tissue or contact resistance in order to maintain the current constant level. However, if the resistance is greater than that which the instrument can accommodate, or if there is a faulty connection or break in the cable, the current reading as shown on the display will not be valid, and the Incomplete Stimulation indicator will flash. When the light goes off, the current as set on the display is passing through the tissues, and the Pulse indicator will be flashing. If the Incomplete Stimulation indicator stays on, try the following: Check the Low Battery indicator. If the light is on, the batteries may need to be replaced. Repeat the skin preparation more carefully to lower the resistance. If the indicator light is not illuminated at low current settings, but comes on as the current is increased, the instrument is not able to accommodate the resistance at the higher settings.

Low Battery indicator •

This instrument is powered by four alkaline batteries, size “C”, which have a useful life of approximately 100 hours. If the Low Battery indicator is illuminated, the battery voltage is too low for the stimulator to work correctly and the batteries should be replaced immediately. When the Low battery indicator first illuminates, there is less than one hour of battery life remaining. We recommend using industrial grade Alkaline C Cell batteries for replacement. See Battery Replacement procedure on page 11.

Current Intensity Display •

The backlit digital display indicates current intensity and gives the current reading in milliamperes (mA). The current intensity can be adjusted from 0.0 to 10.0 mA using the Current Control buttons located to the right of the digital display, or by using the buttons on the remote probe (in a surgical setting).

Current Intensity Increase/Decrease Buttons •

To increase or decrease current intensity, press the designated arrow to the right of the display. Press and release the desired button to change the intensity setting by 0.1 mA. Press and hold the desired button to rapidly change current intensity.

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 9

Mode Indicator

The Hilger Dual-Stim has two modes of operation. Clinical Mode

Surgical Mode

Pulse width (on time) 0.006 seconds

Pulse width (on time) 0.002 seconds

Pulse off time 0.166 seconds

Pulse off time 0.1998 seconds

Frequency 6 Hz

Frequency 5 Hz

•

Pressing the Clinical/Surgical mode selection button will toggle between these modes, and the active mode will be indicated by the designated LED light.

Bipolar Clinical Probe •

•

• •

The small stainless steel ball on the Bipolar Clinical Probe is the active electrode, and is applied to the area of the nerve trunk or branches to deliver the stimulating current. The larger ball is the return, or “indifferent” electrode, which must also be in contact with the skin to complete the current path through the tissues. Be aware that placing the large ball directly over one of the nerve branches may cause secondary stimulation of one of the other branches. The small button at the center of the probe body is used to turn the current on and off. Pressing the button will apply current only while the button is depressed. When placing the probe on the skin or removing it from the skin, the current switch must be off (not pressed in). Making or breaking contact with the skin while the current is on can cause patient discomfort. The arms of the probe can be extended to a distance of about 3 inches for testing, and can be closed for storage. To ensure good skin conductivity, remove cosmetics and skin creams from the areas where the electrodes will be applied. Massage electrode cream into the skin, and allow it to penetrate for a few minutes. Apply a small amount of electrode cream to the ball tips of the electrode. Note: if an excessive amount of electrode cream is on the skin, some current may travel through the cream instead of passing through the tissues.

Remote Surgical Probe • • • • • •

The Remote Probe has a 0.55mm flexible tip which is flush-tipped, insulated, and can be bent to any angle. This probe is reusable and can be sterilized by methods listed in the Sterilization Guidelines. The Remote Probe has two buttons on the hand piece for controlling current output. The front button increases current output, and the back button decreases current output. Do not simultaneously press both buttons. Connect the Remote Probe at the connector labeled Probe on the bottom of the unit. An Electrode Pad Cable and pad must always be used when using the Remote Probe. Affix the electrode pad to the patients shoulder contralateral to the site of surgery. Excessive current of repeated stimulation applied to a nerve can cause nerve fatigue.

10 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

Monopolar Disposable Probe • •

•

The Monopolar Disposable Probe has a 0.55mm flexible tip which is flush-tipped, insulated, and can be bent to any angle. This probe is for single use. Dispose of this probe after use. Connect the Monopolar Disposable Probe into the Adaptor Cable, and connect the adaptor Cable into the connector jack labeled Probe on the bottom of the unit. An Electrode Pad Cable and pad must always be used when using the Monopolar Disposable Probe. Affix the electrode pad to the patients shoulder contralateral to the site of surgery. Excessive current of repeated stimulation applied to a nerve can cause nerve fatigue.

SACS Kit (Silverstein Adaptor for Continuous Stimulation) •

•

The SACS kit can be used for stimulating the tips of non-electrified surgical devices and pneumatic drills. There are three clip sizes available for attaching onto the un-insulated portion of the instrument or drill. For complete instructions of using the SACS kit, please see the SACS Kit IFU. The SACS coil plugs into the Adaptor Cable, and the Adaptor Cable plugs in to the connector jack on the bottom of the unit labeled Probe. An Electrode pad Cable must always be used when using the SACS Kit.

Electrode Pad Cable •

The Electrode Pad Cable plugs into the connector labeled Pad on the bottom of the unit. An electrode pad is attached to the snap end, and is placed on the patients shoulder opposite surgical site. An Electrode Pad Cable is not required when using the Bipolar Clinical Probe.

Electrodes • •

Current densities for any electrode exceeding 2 mA r.m.s./cm² may require the special attention of the operator. WR Medical recommends the use of electrodes capable of allowing a maximum output value of 15 mA.

Battery Replacement •

If battery replacement is necessary, as indicated by the Low Battery indicator, replace the batteries immediately. This instrument uses four alkaline size “C” batteries. We recommend the use of industrial grade Alkaline C Cell batteries. 1. 2. 3. 4. 5. 6.

Perform battery replacement with unit resting on a flat work surface, not while attached to pole. Remove the two small end plates at the top and bottom of the front cover. Using a small Phillips head screwdriver, carefully remove the front cover to expose the battery compartment. Pull the green/red twisted cable by the white connector to remove it from the front cover. Remove the old batteries from the holder. Insert the new batteries, being sure that the positive and negative contacts of the terminals are properly placed. Replace the cover and the end plates.

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 11

References and Suggested Readings References 1.

Hilger, Jerome A. “Facial Nerve Stimulator,” trans., American Academy Opthalmology and Otolaryngology 64:74–76, Jan.–Feb., 1964.

2.

Campbell, E.D.R.; Hickey, R.P.; Nixon, K.H.; and Richardson, A.T. “Value of Nerve Excitability Measurements in Prognosis of Facial Palsy,” British Medical Journal 2:7–10, July 7, 1962.

Suggested Readings Adour, Kedar K. “Global MST: Predicting Prognosis for Bell’s Palsy and Ramsay Hunt Syndrome Patients.” Report from instructional course given at the American Academy of Otolaryngology, Head and Neck Surgery, San Diego, CA, Sept., 1994. Campbell, E.D.R. “A Simple Prognostic Test in Facial Palsy,” Journal of Laryngology 77:462–66, June, 1963. Gates, George A. “Nerve Excitability Testing: Technical Pitfalls and Threshold Norms Using Absolute Values.” Laryngoscope 103:379–85, Apr., 1993. Lewis, Brent I.; Adour, Kedar K.; Kahn, Jonathan M.; Lewis, Alison J. “Hilger Facial Nerve Stimulator: A 25-Year Update.” Laryngoscope 101:71–74, Jan., 1991. May, M. “Maximum Stimulation Test (MST).” In The Facial Nerve. Thieme Medical Publishers, New York: 1986. Manos-Pujol, Manuel; Adour, Kedar K. “Who’s Afraid of the Facial Nerve.” Excerpted from Otology (Chapter 21), S.E. Lucente, ed. St. Louis: Mosby, 1995. Ruboyianes, John M.; Adour, Kedar K.; Santos, David W.; Von Doersten, Peter G. “The Maximal Stimulation and Facial Nerve Conduction Latency Tests: Predicting the Outcome of Bell’s Palsy.” Laryngoscope 104:1–6, Jan., 1994.

12 • Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1

Service Information Warranty

The Hilger Dual-Stim Nerve Stimulator is warranted to be free of defects in material and workmanship for a period of two years from purchase date. Probes and cables are warranted for 90 days from purchase date. Warranty is void if the unit has been damaged by electrocautery. All warranty service must be provided at WR Medical Electronics Co.

Service

Service and technical questions are welcome. Because of the specialized circuitry of this instrument and the need for special test instruments, we recommend that it be returned to the manufacturer for necessary servicing, except for routine battery replacement. To send in a unit for service, please ship by insured method, and signify that it is USA made if sending from outside the USA.

Send to: WR Medical Electronics Co. Technical Service Department 1700 Gervais Avenue Maplewood, MN 55109 USA Phone: Toll-free phone:

651-604-8400 800-635-1312

Fax: E-Mail:

651-604-8499 [email protected]

(USA only)

Hilger™ Dual-Stim Nerve Stimulator Instructions for Use, version 1.1 • 13