CLAVIS™ User Guide

CLAVIS™ User Guide

Copyright © 2007 Alpine Biomed ApS All rights reserved. The contents of this manual are the property of Alpine Biomed ApS. Any reproduction in whole or in part is strictly prohibited. At the time of printing / transfer to the CD-ROM, this manual correctly described the device and its functions. However, as modifications may have been carried out since the production of this manual, the system package may contain one or more addenda to the manual. This manual including any such addenda must be thoroughly read, before using the device. The following situations void any guarantee(s) and obligations for Alpine Biomed ApS: - The device is not used according to the enclosed manuals and other accompanying documentation. This system is CE marked in conformity with the requirements in the Medical Device Directive 93/42/EEC.

2

CLAVIS™ User Guide

Table of Contents Symbols ... 4 Safety Information ... 5 Safety Requirements ...5 Intended Use... 5 Contraindications... 5

Operating CLAVIS... 7 Control Panel Overview...7 Start – AutoTest...8 EMG Mode ...9 Electrodes... 9 EMG Buttons... 10 Stimulation Mode... 11 Electrodes... 11 Stimulation Buttons ... 12 Cleaning ... 14 Replacing the Battery ... 14 Waste Management ... 15

Accessories ... 16 Technical Data ... 18 Model... 18 Power Supply... 18 Weight ... 18 Dimension (L x W x H)... 18 Operating Conditions ... 18 Storage Conditions... 18 Mode of operation ... 18 Standards ... 18 EMG Performance ... 19 Stimulator Performance... 19

Figures Figure 1. Control Panel Overview ... 7 Figure 2. EMG Electrode Connections ... 9 Figure 3. Electrode Stimulation Connections ... 11 Figure 4. CLAVIS rear side, the battery compartment. ... 15

3

CLAVIS™ User Guide

Symbols Symbol

Explanation See the accompanying documentation and carefully read the following warnings. The device complies with the EC directive 93/42/EEC on medical devices. The device is of type BF, i.e. the applied part is electrically isolated. The device is not user serviceable.

Waste Electrical and Electronic Equipment: Compliance Information.

S/N

Serial number.

REF

Part number. Battery type.

Use by. Caution: In the United state, Federal law restricts this device to sale by or on the order of a physician practitioner.

NOTE: The front panel symbols and buttons can be found in the control panel overview in the section “Operating CLAVIS”.

4 Symbols

CLAVIS™ User Guide

Safety Information Safety Requirements This device is intended to be used by qualified medical personnel, knowledgeable in the field of electrophysiology and with the appropriate education and special training. Before using the instrument, please read these operating instructions carefully. Follow the warnings indicated on the instrument and the safety precautions recommended in this manual. This device has been designed and tested in accordance with the IEC Publication 60601-1 (EN 60601-1) Medical Electrical Equipment. Do not use this device for anything other than what it is intended for by the manufacturer. Alpine Biomed ApS assumes no responsibility when not used as described in this user guide. Medical electrical equipment needs special precautions regarding EMC, and requires installation and servicing according to the information provided in this user guide. The device has been designed for indoor use at temperatures between +10°C and +40°C (+50°F to +104°F). Situate the unit away from heat sources such as radiators and warming lamps as exposure to high temperatures may affect operation or cause damage. Do not use damaged or defective devices. Protect this instrument from immersion, spills, the impact of falling objects, and exposure to excessive smoke, dust, mechanical vibration, or shock. If your device needs servicing, please contact your local Alpine Biomed representative. Caution: In the United state, Federal law restricts this device to sale by or on the order of a physician practitioner.

Intended Use CLAVIS is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Contraindications „ Patient with an implanted electronic device –e.g., a cardiac pace-

maker, or with cardiac abnormalities should not be subjected to electrical stimulation unless specialist medical opinion has first been obtained. Please refer to contraindications for implant systems for further information on pacemakers.

Safety Information 5

CLAVIS™ User Guide

WARNINGS „ The device is not intended for cardiac application. ƒ Do Not apply electrodes: 1. Over the thoracic area 2. Over the left and/or right temporal regions 3. In the orbital region „ The device is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. „ This device must not be used simultaneously with other equipment, or near other equipment, which might give off electrical energy. „ The device is not compatible for use in an MRI magnetic field. „ Do not immerse the device in any liquid. CAUTIONS „ Portable and mobile RF communication equipment can affect medical electrical equipment. „ Always read the instructions accompanying the needles/electrodes used. „ In conditions with bleeding tendency, certain care should be taken when needles are used. „ Conventional precautions should be taken with patients with infectious diseases and broken skin. „ CLAVIS cannot be sterilized. „ After using an alcohol prep to clean the skin, make sure any flammable liquid and/or vapors have evaporated and dispersed before using the instrument.

6 Safety Information

CLAVIS™ User Guide

Operating CLAVIS Control Panel Overview CLAVIS Front Panel

Button/ Symbol

Legend Patient Ground. Reference. EMG input.

1

2

3

1 Speaker 2 Battery power status indicator–yellow light. 3 Power switch (on/off toggle). EMG 1 Activation button. 2 Volume controls.

1

1

2

2

1

3&4

2

Stimulation 1 Activation button. 2 Stimulation Level controls. 3 Current Stimulation Level bar/ Green Lights indicator. 4 Yellow Overload Light indicator. Pulse 1 Pulse Rate button/ Yellow Light indicator. 2 Pulse Width button/ Yellow Light indicator.

Figure 1. Control Panel Overview

Operating CLAVIS 7

CLAVIS™ User Guide

Start – AutoTest Power On /Off Press the Power button to switch on the device. Press the Power button again to switch off the device. When you switch on CLAVIS, it will start an internal auto test, while at the same time it will allow you to verify that the Sound and Indicator Light functions are working properly. NOTE: The device automatically switches off after a period of ten minutes, if left unused.

Correct Functioning 1. Sound: The device emits a series of clicks 2. Indicator Lights: All the indicators ―Current Stimulation Level Bar; Pulse Rate /Width; and Battery Status― will light up for a few seconds. Incorrect Functioning If an internal error is found, the device will go on a “Fail Safe” mode. In the Fail Safe mode, the following failure codes can appear: 1 mA LED: Intensity or Gain too low (first Intensity/Gain combination) 2 mA LED: Intensity or Gain too high (first Intensity/Gain combination) 3 mA LED: Intensity or Gain too low (second Intensity/Gain combination) 4 mA LED: Intensity or Gain too high (second Intensity/Gain combination) 5 mA LED: The reference Voltage is too low (the 3,3V to the PIC® Microcontroller) 6 mA LED: The reference Voltage is too high 7 mA LED: Overload detection failure (detected when not supposed to be present) 8 mA LED: Overload detection failure (Missing detection) 9 mA LED: Critical low battery voltage – exchange battery 10 mA LED: Current Limiter failure If any of the failure codes appear, only the power button will remain operative. Attempt to power off and on the device. If the problems persist, please contact your local Alpine Biomed representative.

8 Operating CLAVIS

CLAVIS™ User Guide

EMG Mode In the EMG mode, the device is used for needle electrode examinations. Throughout the procedure, CLAVIS will emit a series of audible signals varying in intensity and frequency that will help monitoring the localization of the targeted muscle or nerve. Note that the Sound Signal flashes a green light when EMG is activated.

Electrodes CAUTION: Only electrodes recommended by Alpine Biomed must be used. Refer to the Accessories section of this user guide for further information.

Connecting the Electrode Leads to the Device Before starting the procedure, connect the electrode leads to their corresponding color-coded connectors as shown in fig. 2 below.

Figure 2. EMG Electrode Connections

Ref.

Symbol

EMG Electrodes

Color

1

Patient Ground

Green

2

Reference

Red

3

Reference (additional)

Red

4

EMG input (active)

Black

„ Connect the ground electrode to the green patient ground connector ( ) (1). „ Connect the reference electrode to the red reference connector ( ) (2). „ If needed to reduce impedance, connect another reference electrode to the additional red reference connector ( ) (3). „ Connect the EMG needle electrode to the black connector ( ) (4). Operating CLAVIS 9

CLAVIS™ User Guide

Attaching the Electrodes to the Patient Once the electrode leads have been connected to the device, you can attach the ground and reference electrodes to the patient, and when ready, proceed with the EMG needle electrode (active input).

EMG Buttons Activating the EMG Mode –Press the EMG button to activate the EMG mode. –Press the EMG button again to stop the EMG mode. Adjusting Volume –Press the Volume Up button to increase the volume. –Press the Volume Down button to decrease the volume. –For continuous increase or decrease of the volume press and hold down the volume buttons. –Note that the Sound Signal flashes a green light when EMG is activated.

NOTE: The volume can only be adjusted while in EMG mode.

NOTE: The stimulation level can also be adjusted while in EMG mode. Refer to the Stimulation section for a description of the stimulation mode and its buttons.

10 Operating CLAVIS

CLAVIS™ User Guide

Stimulation Mode In stimulation mode, a current pulse train is delivered to the patient. The flashing indicators in the Stimulation Level bar allow you to control the level of current being delivered to the patient.

Electrodes Connecting the Electrode Leads to the Device CAUTION: Only electrodes recommended by Alpine Biomed must be used. Refer to the Accessories section of this user guide for further information.

Before starting the procedure, connect the surface and needle electrode leads to their corresponding color-coded connectors as shown in fig. 3 below.

Figure 3. Electrode Stimulation Connections

Ref. 1

Symbol

Stimulation Electrodes

Color

Internally disconnected during stimulation

Green

2

Anode

Red

3

Anode (additional)

Red

4

Cathode (needle)

Black

„ Connect the reference electrode lead to the red reference connector ( ) (2). „ If needed to reduce impedance, connect another reference electrode lead to the additional red reference connector ( ) (3). „ Connect the needle electrode lead to the black connector ( ) (4).

Operating CLAVIS 11

CLAVIS™ User Guide

Attaching the Electrodes to the Patient Once the electrode leads have been connected to the device, you can attach the surface electrode/s (anode) to the patient, and when ready, proceed with the needle electrode (cathode). WARNING: Avoid trans-thoracic stimulation. Keep the anode and cathode stimulation sites in close proximity. WARNING: Do not use the stimulation mode while attaching the surface electrodes or introducing the needle electrode into the patient.

Stimulation Buttons Activating the Stimulation Mode –Press the STIM button to activate the current stimulation mode. –Press the STIM button again to stop the current stimulation mode. Setting the Pulse Rate and Width –Press the Hz button to switch between 1Hz and 2Hz pulse rate. –The Green light shows the pulse rate selected. –Press the ms button to switch between 0.1ms and 0.2ms pulse width. –The Green light shows the pulse width selected.

Adjusting the Stimulation Level –Press the Increase Stim Level button to increase the stimulation level. It is only possible to increase the STIM Level in steps of 1mA. –Press the Decrease Stim Level button to decrease the stimulation level. For continuous decrease of the STIM Level press and hold down the decrease button.

12 Operating CLAVIS

CLAVIS™ User Guide

Stimulation Level Bar –The Stimulation Level bar ranges from 0mA to 15mA. –The Stimulation Level indicators show the level of current selected. –When Stimulation mode is activated, the indicators are flashing.

Overload Indicator –When the Overload indicator is lit up, it indicates that the device is unable to deliver the selected current. CAUTION: Pay attention to the overload indicator during the stimulation mode. In case of overload, press the STIM button to stop the stimulation. CAUTION: High impedance can be due to a weak connection between the device and the electrodes, or due to degradation of the electrodes.

Operating CLAVIS 13

CLAVIS™ User Guide

Maintenance CLAVIS requires no user maintenance other than cleaning the device after each use and replacing the battery periodically.

Cleaning The cleaning procedure must be in accordance with your local hygiene authority’s guidelines. 1 Before you start cleaning the device, make sure it is switched off and that the electrode leads are disconnected. 2 Wipe the device with a damp cloth. 3 Remove any excess of water with a dry cloth. 4 In case disinfecting is required, gently wipe the device with a cloth moistened with alcohol. Recommended alcohol solution, max volume 80%. 5 Always wipe the device dry after using the alcohol solution. WARNING: Do not immerse the device in any liquid, or drip water into the connectors, or any other openings in the cover. CAUTION: Do not use solvent silicon based or abrasive cleaning agents to clean the device.

Replacing the Battery Replace the battery when the indicator emits a yellow light. Note that the device will automatically go into “Fail Safe” mode when the battery power is so low that it would affect the performance. CAUTION: Do not use rechargeable batteries. Use only a standard 9V alkaline battery –see the section “Technical Data” in this user guide for further information. CAUTION: Battery Leakage: If the unit is going to be stored for a prolonged period of time, we recommend that the battery is removed to protect the unit from damage caused by battery chemical leakage. NOTE: Always follow the instructions accompanying the batteries.

14 Operating CLAVIS

CLAVIS™ User Guide

Access to the Battery Compartment

Figure 4. CLAVIS rear side, the battery compartment.

1 Turn off the device. 2 Slide open the battery compartment lid on the rear of the device. 3 Remove the old battery by pulling it up from the bottom end. 4 Insert the new battery into the battery compartment making sure that the plus and minus contacts are facing as indicated by the symbols. 5 Slide close the battery compartment lid until it locks in place. CAUTION: Do not use the device if the battery compartment lid is open, or not correctly locked in place.

NOTE: It is recommended that the battery be removed from the device if it is not used for an extended period. Used batteries should be disposed of according to normal hospital/clinic policy or local regulations.

Waste Management Waste Electrical and Electronic Equipment: Compliance Information. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to the local regulations.

Operating CLAVIS 15

CLAVIS™ User Guide

Accessories Alpine Biomed recommends the use of the following accessories with CLAVIS. CAUTION: Use only accessories recommended by Alpine Biomed. Note that the use of accessories other than those recommended by Alpine Biomed may result in increased emissions, or decrease radio interference immunity of the equipment. Part No

Description Needle Electrode (EMG Input, Cathode)

13S042

Bo-ject Disposable Hypodermic Needle, 25 x 0.30 mm (30G), (12 pcs).

13S043

Bo-ject Disposable Hypodermic Needle, 25 x 0.41 mm (27G), (12 pcs).

13S044

Bo-ject Disposable Hypodermic Needle, 37 x 0.41 mm (27G), (12 pcs).

13S045

Bo-ject Disposable Hypodermic Needle, 50 x 0.46 mm (26G), (12 pcs).

13S046

Bo-ject Disposable Hypodermic Needle, 75 x 0.64 mm (23G), (12 pcs).

13S047

Bo-ject Disposable Hypodermic Needle, 37 x 0.46 mm (26G), (12 pcs). Surface Electrodes (Anode, Reference, Patient Ground)

13L045

Pre-gelled Disposable Surface Electrode, 50cm lead w/1.5 mm TPC (12 pcs).

13S021

Pre-gelled Disposable Surface Electrode, 10cm lead w/0.7 TPC (12 pcs).

13S024

Pre-gelled Disposable Surface Electrode, 8cm lead w/0.7 TPC (12 pcs).

13C015

Unshielded Cable w/ 0.7 mm and 1.5 mm touch proof connectors, 80 cm (8 col. Pcs). (Use with surface electrodes 13S021 and 13S024).

13S023

Tab Electrodes with Conductive Adhesive Hydro gel (100 pcs).

13P060

Unshielded Cable with clip Connector, green, 80cm, touch-proof female. (pcs.). (Use with Tab Electrodes 13S023).

13P062

Unshielded Cable with clip Connector, black, 80cm, touch-proof female. (pcs.). (Use with Tab Electrodes 13S023).

13P064

Unshielded Cable with clip Connector, red, 80cm, touch-proof female. (pcs.). (Use with Tab Electrodes 13S023).

16 Accessories

CLAVIS™ User Guide

Part No

Description Ground Electrodes (Patient Ground)

13S071

Ground Electrode, 10 cm Velcro, 1.5 m lead w/1.5 mm TPC.

13S073

Ground Electrode, 18.5 cm Velcro, 1.5 m lead w/1.5 mm TPC.

13S074

Ground Electrode, 75 cm Velcro, 1.5 m lead w/1.5 mm TPC.

13S077

Ground Electrode, 45 cm Velcro, 1.5 m lead w/1.5 mm TPC.

13L085

Ground Plate Electrode, 1.5 m lead with 1.5 mm touch-proof Connector.

13L086

Ground Plate Electrode, 1.2 m lead with 1.5 mm touch-proof Connector.

Accessories 17

CLAVIS™ User Guide

Technical Data Model „ CLAVIS, model number 15A001.

Power Supply „ Power supply: internally powered equipment: one 9V alkaline battery. IEC-6LR61, ANSI-1604A. „ Power consumption: maximum 2 watts. „ Degree of Protection: BF. ―i.e., the applied part is electrically isolated.

Weight „ 185 g. with battery (6.526 Oz) „ 140 g. without battery (4.938 Oz)

Dimension (L x W x H) „ 140 x 80 x 20 mm

Operating Conditions „ Temperatures: ranging from +10°C to +40°C (ranging from 50°F to 104°F). „ Humidity: ranging from 30% to 75%rh. „ Atmospheric pressure: ranging from 700hPa to 1060hPa.

Storage Conditions „ Temperatures: ranging from -10°C to +50°C (ranging from -40°F to +122°F.). „ Humidity: ranging from 10% to 100%rh. „ Atmospheric pressure: ranging from 700hPa to 1060hPa.

Mode of operation „ Continuous operation.

Standards „ EN 60601-1 (IEC 60 601-1). „ EN 60601-1-2 (IEC 60 601-1-2). „ EN 60601-1-2-40 (IEC 60 601-1-2).

18 Technical Data

CLAVIS™ User Guide

EMG Performance Amplifiers, EMG Mode „ Amplifier gain 1 – approx. 45,000. „ EMG amplifier band width: 600Hz – 5kHz. Patient Connections „ Active input: black 1.5mm TPC*. „ Reference inputs: red 1.5mm TPC*. „ Patient ground: green 1.5mm TPC*. Volume Output „ Speaker band width: 340Hz – 10kHz.

Stimulator Performance STIM Mode „ Output current: 1.0 – 15.0mA. Adjustable in steps of 1mA. „ Electrode impedance: 200 – 7 kΩ. „ Maximum excitation voltage: 100V „ When impedance is higher than 7 kΩ, the device cannot deliver full current stimulus. The Overload indicator will be activated if the selected current level cannot be delivered. STIM Level „ Stim frequency: 1Hz, or 2Hz. „ Pulse width: 0.1ms, or 0.2ms. „ Output waveforms: square forms. Patient Connections „ Active output: black 1.5mm TPC*. „ Reference output: red 1.5mm TPC*.

* TPC: touch proof connectors.

Technical Data 19

For additional information, contact your local Alpine Biomed representative. Alpine Biomed Corp. 17800 Newhope St., Suite B Fountain Valley, CA 92708 USA Tel: +1-714-839-8426 Tel (toll-free USA): +1-800-222-0074 www.alpinebiomed.com Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark Tel: +45 4457 9000 Fax: +45 4457 9010 www.alpinebiomed.com

Manufactured by: Alpine Biomed ApS Tonsbakken 16-18 DK-2740 Skovlunde Denmark Tel: +45 4457 9000 Fax: +45 4457 9010

Printed in Denmark, June 2007 Reg. No. 9031M6113