Multistim SENSOR Instruction Booklet Nov 2010

44

1. General information

44 44 44 44 47

2. Product specification/compatibility 2.1 Indication 2.2 Contraindications 2.3 Warnings and precautionary measures 2.4 Constant voltage or constant current

48 48 49 49 49 50

3 Technical description 3.1 Technical data 3.2 Display 3.3 The control keys 3.4 The elements of the display 3.5 Menu structure setup

50 50 51 51 52 52 52 52 53 53 53 53

4. Operation 4.1 Pre-operational check 4.2 Operation of the nerve stimulator 4.3 PAUSE function 4.4 1 Hz/2 Hz mode 4.5 Mode cannula/KAN 4.6 Mode catheter CATH 4.7 Amplitude selection (setting of the nominal stimulation current) 4.8 Display modes for stimulation current 4.9 Indication of current intensity 4.10 Indication of the battery condition 4.11 Adjustment of the stimulation impulse bandwidth

54 54 54 55

5 SETUP-functions 5.1.1 SETUP LEVEL 1: Volume control 5.1.2 SETUP LEVEL 2: Setting of the initial parameters for “Cannula mode” 5.1.3 SETUP LEVEL 3: Setting of the initial parameters for “PEG mode”

55

6 Error messages

55 55

7 The battery 7.1 Battery replacement

56

8 Cleaning and disinfection of the device

56 56 56

9 Maintenance and technical safety checks 9.1 Technical safety checks 9.2 Device roster book in accordance with MPG

56

10 Accessories and spare parts list for MultiStim

56 57

11 Signal gradients, impulse patterns and power diagrams 11.1 Build-up and fall times

57

12 Notes, warnings

58

13 Electromagnetic compatibility (EMC)

English USA

Table of contents

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User Instruction – MultiStim SENSOR

Please read the following information and instructions carefully.

EN ac pe ev ad to pa

The product may only be used by experienced medical staff in accordance with these instructions. PAJUNK® GmbH Medizintechnologie does not give any recommendation for a method of treatment. The treating medical specialist staff is responsible for the course and manner of application and the selection of the patient.

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1. General information Please note: Due to US Medical Device Legislation and specific requirements for devices marketed in the USA the wording of the user instructions for the US may slightly differ from the standard English version.

Nonobservance or contravention of these instructions will cause the guarantee to expire and will lead to endangering the safety of the patient.

English USA

If used in combination with further products, please always observe and comply with the directions for use and the compatibility statements of these products. Please check the product and the packaging for completeness, intactness and the status of sterility before application. Do not use product if you have reason to doubt the completeness, the intactness and the non hazardous status of sterility. MultiStim SENSOR is intended to be used exclusively with PAJUNK® GmbH Medizintechnologie products (e.g. UniPlex cannulae). The accessories may be connected with the device exclusively by way of the enclosed equipment cable. Safe and successful functioning can only be ensured with these products. 2. Product specification/compatibility MultiStim SENSOR is delivered with the following basic equipment: • MultiStim SENSOR muscle- and nerve stimulator • 9 volt block battery • Patient main cable SENSOR • Short-circuit plug • Operating instructions • Storage case for the MultiStim SENSOR and the accessories Please observe by all means: The patient main cable of the MultiStim SENSOR is compatible with that of the MultiStim SENSOR due to its technical design. Please make absolutely sure that the correct cable is respectively used, since the device will otherwise not work as intended! 2.1 Indication The MultiStim SENSOR serves for reliable neuro- and muscle localization, for example in local- and regional anesthesia (diagnostic, intra-operative and therapeutical block). The PAJUNK® MultiStim SENSOR can be used in all cases where the identification of nerves, of nerve fascicles or of nerve roots is required. 2.2 Contraindications The use of a nerve stimulator on patients with known cardiac- or circulatory insufficiencies should be considered carefully. Further contraindications may be caused by anatomical anomalies. 2.3 Warnings and precautionary measures The connecting socket of the stimulation cannula may only be connected to the corresponding mating connector of the patient main cable. If an intermediate cable is used inbetween, please also absolutely ensure correct connection here! The device connector of the connector cable may only be connected to the nerve stimulator, and the clip connection may only be connected to the adhesive electrode on the skin of the patient. These plugs/ connections may under no circumstances be brought into contact with live / current bearing components (e.g. electrical outlets) or with metallic objects. The MultiStim SENSOR may not be used in explosive surroundings to avoid gas explosions of anesthesia gasses or the ignition of combustible liquids. All connected facilities in the environment of the patient must comply with the applicable regulations to avoid injuring the patient. All facilities and accessories must comply with the requirements of 44

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The patient himself may not come into contact with metallic objects which are earthed or which have an electrically conductive connection with other facilities, or which permit capacitive coupling. That is why we recommend the use of a sufficiently insulating/non-conductive, antistatic pad on the operating table. The MultiStim SENSOR may under no circumstances be operated with instruments and accessories other than those which have been authorized, supplied or recommended by the manufacturer. Only PAJUNK® accessories have been technically tested with regard to EMC (electromagnetic compatibility). Accessories of other vendors may lead to seriously harming the equipment- and system properties and may cause lasting impairment to the patient, the user or the equipment. The simultaneous application of surgical RF-devices will evoke the acute risk of burns caused by touching the connections of the MultiStim SENSOR, the connector cable, the cannula tip or the adhesive electrode. It is therefore necessary to disengage all connections to the MultiStim SENSOR and to remove the stimulation cannula from the tissue before surgical RF-devices are used. The stimulation cannula with its connector cable acts as an antenna for RF-energy, which may cause the induction of a very high current density at the tip of the cannula. Nerve fibres in the vicinity may be irreversibly destroyed. The connected stimulator may simultaneously cause the rectification of the RF-energy, which will lead to extremely high direct currents and voltage potentials at the electrodes. The direct current stimulus emitted thereby can be very painful and may trigger intense, irreversible electrophysiological reactions.

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EN 60 601-1, EN 60 601-1-1, as well as with those of the applicable sub-norms. It is to be taken into account, that in the most unfavorable case, all leakage currents or the auxiliary patient currents may perhaps add up cumulatively and the patient may be endangered by these inadmissibly high values, even if all the rules for the individual facilities have been complied with. It is therefore to be checked in advance, whether the interconnection of the facilities will perhaps cause the permissive limiting values to be exceeded. Improper interconnection of equipment and facilities (system formation) can injure the patient vitally.

To avoid that poor contact of the adhesive electrode will lead to a malpositioning of the stimulation cannula, please ensure that the adhesive electrode, which functions as a neutral electrode here, is in sufficiently sound contact with a low tissue impedance. Fatty tissue, hair, uncleanness, repeatedly used adhesive electrodes and electrodes of inferior quality can influence this tissue impedance adversely and thereby evoke the risk of nerve damage. We therefore recommend, that the contact surface is selected carefully: select only muscular areas with sufficient blood perfusion, and clean, shave and degrease the skin. The position of the adhesive electrode should also not be too far away from the location of the puncture. However, please avoid the thoracal application of the skin-electrode. The MultiStim SENSOR should not be used on patients with implanted electrical devices (e.g. cardiac pacemaker) without previously seeking corresponding medical advice from a specialist. Possibly occurring disturbances of the implanted electrical devices through the stimulating current may constitute a hazard for the patient. The attachment of electrodes in the vicinity of the thorax (rib cage, heart) may increase the risk of ventricular fibrillation (cardiac fibrillation). The stimulator may no longer be used if it displays a direct current- or perhaps a direct voltage-component at the output, please send it in for repair. The patient current should not fall below the following values: 0.15 mA invasive (cannula) Operate the MultiStim SENSOR only with the genuine, CE-labeled PAJUNK® accessories. All accessories must be subjected to a visual inspection at regular intervals. The insulation of the patient lines may not show any damage. Use only high-quality, commercially available (CE-labeled) single-use ECG-adhesive electrodes with pregelled silver/silver chloride contacts. For optimal nerve stimulation, please use only electrodes which are intact and have not dried out. The adhesive electrodes may not be attached in the area of injuries. When discarding the MultiStim SENSOR and the listed accessories, the users must comply with the respective current regulations for the disposal of waste. Special precautions apply for electric medical equipment with regard to EMC (electromagnetic compatibility). Portable and mobile RF-communication facilities may influence the MultiStim SENSOR. This may lead to a malfunction of the device or of the system. 45

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Dynamic electrical- and dynamic magnetic interference fields may interact with the device and the system. These interactions may have an influence on the measurement of the actual stimulus current, and in the extreme case, they may lead to an error in indication and perhaps to a safety-shutdown of the device.

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The MultiStim SENSOR may not be used near equipment emitting strong magnetic fields, e.g. radiotelephones, surgical RF-devices, short wave- or microwave-therapy devices. Any potential introduction of high-frequency currents into the stimulation cannula may lead to a damaging of the nerves.

C EN EN

The device may not be connected with other equipment. If the MultiStim SENSOR is operated nearby to another device, then the devices or the system must be monitored and the correct functioning as intended must be verified in this arrangement as it is being used.

English USA

Under unfavorable conditions, the MultiStim SENSOR may disturb other equipment in its function. We therefore recommend to check all other equipment and facilities for compatibility with the MultiStim SENSOR, and if necessary, to remove these from the patient. The operation of other equipment or systems with the accessories may lead to increased emissions or to reduced interference immunity of these systems. Please observe the enclosed EMC (electromagnetic compatibility) information regarding installation, start-up and operation of the equipment or system (see chapter Electromagnetic Compatibility (EMC)). To avoid damaging the connector cable and the device, please do not hold or carry the device by its connector cables or by its accessories. Do not wind the cable around the device or around other facilities. The winding of the connector cable during normal operation of the stimulator will produce inductive components and may, if very short stimulation pulses are being used, lead to a reduction of stimulation performance or to faulty measurement of the actual stimulation current. Misinterpretations of the reported values can be the consequence. In case of battery leakage, the device should not be operated anymore for safety reasons. The device must be returned to the manufacturer for inspection. Avoid unclean connections. Water and dirt will deteriorate the contact properties of the plug-in connections and lead to unintentional short-circuits or leakage-currents. These may lead to partial- or even total diversion of the stimulation currents, which will cause the stimulation effect to decline, or even to fail completely. In this case, the device cannot display the actually flowing patient current correctly any more. To avoid damaging the MultiStim SENSOR and its accessories, do not use aggressive cleaning agents, further details may be found under item “Cleaning and Disinfection of the Device”. Check all accessories in regular intervals. The insulation of the lines and hardware connections may show no damages. The User Instructions are to be followed for the operation of the MultiStim SENSOR and the corresponding accessories. When sterile accessories are being used, please always provide for sterile environmental conditions. Avoid unintentional bone contact with the stimulation cannula, since the cannula may thereby be substantially damaged which may consequently cause a traumatization of the tissue. Keep the accessories and MultiStim SENSOR away from live / current bearing objects. The electrostatic and electromagnetic fields radiated therefrom may have an influence on the stimulation result, and these themselves may even lead to unwanted stimulation effects in the tissue. The device, the connector cables and the plugs must be kept completely clean and dry before and during the application. Moisture and uncleanness will affect the function of the nerve stimulator and/or the stimulation result. Please note the position of metal implants in the tissue (e.g. plates or electrode cables). They may perhaps conduct the stimulation signals to other locations and can cause detrimental effects there. Implanted electronic equipment may be impaired by the stimulation current, which in turn will lead to a malfunctioning of these implants or may even destroy them. To avoid malfunctions of the MultiStim SENSOR, please check all functions before the intervention and make sure that the accessories are suitable for the application. The accessories used must correspond to safety class type BF. 46

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Conformity with the following standards: EN 60 601-1; 14971:2000; EN 60601-1-1; EN 60601-2-10; EN 60601-1-4 EN 60601-1-2; 13485:1996; 9001:2000; UL 60601; MPG; Directive 93-42-EWG 2.4 Constant voltage or constant current According to Ohm’s law U⫽R ⫻ I, it is possible to use both, the voltage and the current intensity as the quantity to be measured to determine the intensity (amplitude) of the electrical stimulus. The devices are respectively referred to as voltage-constant or current-constant. The electrical resistance (impedance) in the electrical circuit of a stimulation, which represents the sum of skin-, tissue-, cannula-, electrode cable-resistance etc., will vary within wide ranges. It may vary between <1 k⍀ and infinite. The factors skin humidity, conductivity of the skin and of the tissue and the potential resistance of the adhesive electrode can hardly be influenced. If the voltage (V) is selected as the measure for the intensity of the stimulus impulse, then currents may appear during an application, which – in accordance with Ohm’s law and depending on the resistance – will differ by a manifold. It is therefore better to use a nerve stimulator which permits the exact adjustment of the current intensity (mA) between the two electrodes, the adhesive electrode (anode) and stimulation cannula (cathode). The stimulator with constant current setting must, however, be provided with a very high output impedance – ideally infinite – so that the resistances which may perhaps occur in the external electrical circuit will be negligible, and so that the actually flowing current will be indicated exactly on the display.

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To protect the patient from electrophysiological shock by electrostatic discharge (ESD), it is necessary to wear corresponding clothing and to move about in an appropriately protected environment. An electrostatic discharge (ESD) can cause extremely high current densities to appear at the tip of the cannula, which can damage the surrounding tissue.

Current-constant devices which permit the selection of the current intensity (mA) for the stimulus impulse have gained acceptance within the last few years. For the MultiStim SENSOR, the external load resistance can amount to as much as 12 k⍀. If this load resistance is exceeded, then the actually flowing patient current (the actual stimulation current) can be lower than the adjusted nominal stimulation current. In this case, the nominal stimulation current and the actual stimulation current are indicated separately and visual and acoustic warning indications are emitted. And the relevant impedance is continuously calculated and indicated on the LCD-display in addition.

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The MultiStim SENSOR is a precision instrument for the localization of nerve tracts in the human organism. It was developed to stimulate nerve fibres in the living organism using cannulae for invasive stimulation which normally show a very high contact impedance, to be able to determine the spatial position of these nerve fibres in relation to the tip of the electrode. The stimulation cannulae are designed so that a local anesthetic can be injected in the proximity of the nerve fibre, which will cause a reversible interruption of the conductive system.

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2.5 Accessories The MultiStim SENSOR can be connected with a main patient line for the cannula and PEG-cable: Connection for PEG-handle White connection: Cannula

or

Clamp for adhesive electrode

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Monopolar PEG

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Bipolar PEG

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3.

White connection: Cannula

An additional patient cable is available for stimulation by means of cannula:

Clamp for adhesive electrode

There is an extension cable available for the connection to the cannula (variant autoclavable and variant single use).

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3 Technical description The MultiStim SENSOR generates reproducible square pulses with adjustable frequency and continuously adjustable stimulation current. The scope of adjustment of the impulse current ranges from 0.0 – 6.0 mA if stimulation cannulae are used, and from 0.0 – 60 mA if PEG-handles are used for percutaneous stimulation. The corresponding symbol will be shown synchronously with a short beeping sound in the rhythm of the stimulus for visual and acoustic control. If only the outer circle is visible, then the electrical stimulation circuit is not closed, i.e. there is no stimulation current running through the patient. If the circle is completely full, then the stimulation electrical circuit is closed, i.e. stimulation current is running through the patient. The control sound will become more intensive in this case.

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Due to a high stimulus voltage of max. 95 Vss, this renders an exceptionally large adjustment range for extremely small stimulating electrodes. Please make sure, that only CE-labelled adhesive electrodes are used for stimulation, which have been provided with contact gel in order to keep the transition resistance as low as possible. 3.1 Technical data Type:

MultiStim SENSOR

Type of device

BF

Battery:

9V

Stimulating current:

max. 60 mAss/

Resistance range

0 ⍀ – 60 k⍀

3.

Stimulation voltage:

max. 95 Vss

S

Stimulation frequency:

1 Hz/2 Hz

Stimulation impulse bandwidth:

0,05 ms / 0,10 ms / 0,20 ms/ 0,30 ms/0,50 ms/1,00 ms

Operating conditions:

Transportation- and storage conditions:

Temperature:

10°C to 30°C

Atmospheric humidity:

20% – 65%

Air pressure:

is omitted

Temperature:

10°C to 30°C

Atmospheric humidity:

20% to 65%

Air pressure:

is omitted

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3.2 Display Display, all indications activated (simulated condition)

MultiStim SENSOR has additionally been provided with a permanent analogous indication of the intensity of the stimulation current by means of two bar graphs below the digital display. 3.3 The control keys Function

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Button

Mode: PEG (PEG-electrode) or KAN (cannula indicated by symbol)

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Access to the basic setting

or „On“ / „Off“ / Pause

Selection of the impulse bandwidth

Mode: Impulse-frequency

3.4 The elements of the display Symbol

Meaning Indicates actual current is displayed in mA.

Indication of the electrical patient-circuit: Electric circuit not closed.

Indication of the electrical patient-circuit: Electrical circuit closed.

The value actually measured corresponds („⫽“) does not correspond („⬆“) to the nominal/set point value (inactive when no pulses are being emitted) (nominal current = actual current)

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Symbol

Meaning Indication of the battery charge level Each of the five segments represents 20 % of the battery capacity. This means: if all five segments are visible, then 100 % of the utilisable battery capacity are available, if no segment is visible, then 0 % capacity is available.

3. Operating modes: PEG, cannula or catheter (only MultiStim SWITCH).

English USA

Indicates, that setup mode is activated. Indication of impulse bandwidth. The numerals and units shown within the symbol render the values selected with the control keys (see description).

4.

3.5 Menu structure setup SETUP level 1

Adjustment/storage of the volume Options to choose from:

SETUP level 2

(decreasing volume, beep sounds)

0

(global mute)

1, 2, 3, 4

(increasing volume, pulse sounds)

Adjustment/storage of “Cannula – current pulse” Options to choose from:

SETUP level 3

A4, A3, A2, A1

set value (control device) storage

Adjustment/storage of “PEG – current pulse” Options to choose from:

set value (control device) storage

4. Operation 4.1 Pre-operational check Please observe: Equipment with divergent behaviour may not be put into operation. In this case, please contact the customer service. Electro-medical devices may only be repaired by the manufacturer or by an institution expressly authorised by the manufacturer. Please go through the following checking procedure before the initial startup: 1. Press the ON button to start the device. At this moment, the device will automatically start a self-test sequence. After successful completion of the self-test sequence, the device will switch to the PAUSE mode. The LCD display will inform you about the current settings. Please replace the battery immediately if there is no indication visible after the device has been switched on. (Observe section Battery.) If the self-test sequence should perhaps have identified a faulty function, then the corresponding error code will be indicated on the LCD. After this occurrence, the device is not operational any more. (Observe section Error Messages.) 2. Check the electrode cable by visual inspection. Damaged cables may not be used. Attach the electrode cable at the top end of the MultiStim device as follows: position the plug of the electrode cable in such manner in the device socket, so that the markings on the device socket and on the connector shell are aligned.

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The plug can be plugged in only in this position; it may not be inserted in any case by using force. Now insert the plug all the way. When the plug has been inserted, it is locked in position and can not be inadvertently disconnected by pulling at the electrode cable. To disconnect the electrode plug, take hold of it at the structured surface near the red dot using your thumb and index finger. The locking mechanism of the plug will be disengaged automatically by pulling away from the device, and the plug can then be removed without problems. The electrode cable cannot be removed otherwise, or the device or the electrode cable may be damaged. The LCD display shows the adjusted nominal stimulation current. The available adjustment range (peak value) may vary (6.0 mA or 60.0 mA), depending on the selected mode.

If the display should permanently show a dissimilar function (»⬆« symbol), there must be a fault in the patient stimulation circuit. 4. Disconnect the electrical connection between the electrode plug and the electrode clamp and remove the red test-plug. A »⬆« symbol may now be seen on the LCD. This indicates, that the selected nominal stimulating current is dissimilar to the actual stimulating current. If the behaviour is different from the one described in 3 and 4, then a faulty cable could be the cause (short-circuit/ interruption). Check the function once more with a second cable. Finally, remove the red shortcircuit plug from the socket of the electrode. 5. Switch the MultiStim off by pressing the ON/OFF/PAUSE button for a longer period of time (min. 2 seconds). (Please observe section Switching ON and OFF) You should turn the device off after use to spare the battery. If you don‘t use the device for a longer period of time, you should remove the battery to avoid leakage. 6. Please observe the Warnings and precautionary measures before you use the device on a patient.

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3. Performance of the short-circuit test: Connect the socket of the stimulating electrode to the stimulating electrode clamp with the aid of the supplied red test-plug (= short circuit). Then increase the nominal stimulating current by turning the knob clockwise to at least 1.0 mA and check the »⫽«-symbol on the display. The display must exhibit an »⫽« a few moments later. Abb. 3

The stimulation mode stored last will remain stored after turning the device off. When the device is switched on again, this setting is reloaded and the stimulation current is set to 0.00 mA, or to a value you have previously selected. The stimulation pulse width is set to the following default-values after the device is switched on: Mode: KAN Cannula 0 – 6 mA PEG Percutaneous 0,0 – 60mA Before every application on a patient, the device settings have to be checked and altered if necessary. 4.2 Operation of the nerve stimulator Switching ON and OFF Pressing the ON/OFF/PAUSE button will switch the MultiStim SENSOR on. After switching on, the device will first perform an automatic self-test. Upon the successful completion of the self-test, the device will immediately change to the PAUSE-mode. For the protection of the battery, the device will automatically switch itself off with a previous acoustic warning after 20 minutes have elapsed since the last pressing of a button. The device is switched off by pressing the ON/OFF/PAUSE button for at least two seconds while the device is turned on. 4.3 PAUSE function While the device is turned on, a short depression of the ON/OFF/PAUSE button or pressing the turning knob will activate the PAUSE mode of the MultiStim SENSOR Stimulation is stopped in this condition. To indicate that the device is in the PAUSE-mode, the »⫽« or »⬆«-symbol will disappear and the value of current intensity, as well as the mA-symbol will begin to flash up. Important: All stimulation parameters can be changed during the PAUSE mode without emitting stimulation impulses to the patient. Renewed short pressing of the ON/OFF/PAUSE button or renewed pressing of the turning knob will end the PAUSE-mode, and the normal stimulation mode is resumed. 51

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4.4 1 Hz/2 Hz mode When the 1 Hz-/2 Hz button is pressed, MultiStim SENSOR will generate a continuous sequence of stimulating impulses with a constant frequency. Upon initial activation, the selected 1 Hz function is displayed on the LCD for 2 seconds instead of the impulse bandwidth indication. Renewed pressing of the 1 Hz- / 2 Hz-button will double the pulse repetition rate to 2 Hz.

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4.5 Mode cannula/KAN MultiStim SENSOR offers the option for stimulation using an invasive stimulation cannula (e.g. PAJUNK® UniPlex NanoLine). The puncture cannula is connected to the Y-cable by means of the connection as provided for such. The adhesive electrode is affixed to the surface of the patient’s skin at an appropriate location (good contact) in order to ensure current conduction. The red electrode clamp (positive pole, anode) is fastened to the adhesive electrode. In stimulation by means of cannula, the current is conducted between the cannula tip (negative pole, cathode) and the red electrode clamp (positive pole, anode). Pressing the »CANNULA/PEG« button permits switching back and forth between the PEG output and the catheter output. If the stimulation by cannula is activated, the symbol »CANNULA« as well as the max. stimulation range »6 mA« will appear. The initial intensity of the stimulation current, the stimulation frequency and the impulse bandwidth are separately adjustable for both of the two outputs (see SETUP-functions). 4.6 Mode catheter CATH The MultiStim SENSOR provides the option to perform stimulation by means of a percutaneous electrode (PEG-handle). The monopolar PEG-handle is connected to the connection port of the patient cable provided for such purpose. The adhesive electrode is affixed to the surface of the patient’s skin at an appropriate location (good contact) in order to ensure current conduction. The red electrode clamp (positive pole, anode) is fastened to the adhesive electrode. In stimulation by means of the handle, the current is conducted between the percutaneous electrode (negative pole, cathode) and the red electrode clamp (positive pole, anode). The adhesive electrode is not applied if the bipolar handle is used. Pressing the »CANNULA/PEG« button permits switching back and forth between the PEG output and the catheter output. If the stimulation by PEG-handle is activated, then the letter string »PEG« as well as the max. stimulation range »60 mA« will appear. The initial intensity of the stimulation current, the stimulation frequency and the impulse bandwidth are separately adjustable for both of the two outputs (see SETUPfunctions). Please observe: If no PEG-cable is detected when switching to the PEG-mode, i.e. the PEG-handle is not connected or is defective, this will cause »no« to appear on the display and an acoustic signal may be heard; the »CANNULA/PEG« button is without function. If the catheter is disconnected in the »PEG« -mode, »no« will appear on the display and acoustic warning-signals will be emitted indicating the absence of the PEG-handle. Now: a) the PEG-handle may be connected again. This will cause the device to return to the original mode or b) the device may be switched to stimulation by cannula by pressing the »CANNULA/PEG« button. 4.7 Amplitude selection (setting of the nominal stimulation current) The intensity of the stimulation current may be adjusted with the aid of the notched turning-knob located in the centre of the device. Turning the knob one increment to the right-hand side (i.e. clockwise) will increase the intensity of the stimulation current by one incremental step. Turning the knob to the left-hand side (i.e. counter-clockwise) will reduce the intensity of the stimulation current by one incremental step. The presently selected intensity of the stimulation current is indicated on the LCD. This specified value will only correspond with the actually emitted stimulation current, if the electrical stimulation circuit is properly closed over the patient. In this case, the selected stimulation current (set point), which is shown on the display, corresponds exactly to the stimulation current actually flowing through the electrical circuit of the patient. This correct function is indicated by the »⫽« symbol. As soon as the selected stimulation current differs from the actually flowing stimulation current, the »⬆« symbol will appear on the display. Please note, that in this case the current actually flowing through the patient might be lower than the desired stimulation current which you have previously selected. An increase of the selected stimulation current might therefore not effect the stimulation current actually flowing through the patient. If this happens, it is absolutely necessary to reduce the 52

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nominal stimulation current, and to discover the cause of the inadequate or missing patient connections. Do not increase the nominal stimulation current under any circumstances before the reason for the faulty current flowing through the patient has been identified clearly and has been remedied.

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Range

Incremental step

Range

Incremental step

> 0,00 mA – 0,50 mA

0,02 mA

> 0 mA – 5 mA

0,2 mA

> 0,50 mA – 1,00 mA

0,05 mA

> 5 mA – 10 mA

0,5 mA

> 1,00 mA – 2,00 mA

0,10 mA

> 10 mA – 20 mA

1,0 mA

> 2,00 mA – 4,00 mA

0,20 mA

> 20 mA – 40 mA

2,0 mA

> 4,00 mA – 6,00 mA

0,50 mA

> 40 mA – 60 mA

5,0 mA

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4.8 Display modes for stimulation current The adjusted value (PRESET value) is indicated on the LCD, as the intensity of the stimulation current is adjusted by turning the knob. If the knob is not turned anymore, the device will automatically switch to indicating the intensity of the stimulation current actually flowing through the patient (ACTUAL value). During the indication of the actually flowing current, a symbol resembling a human being is additionally displayed on the LCD on the left-hand side of the current intensity.

4.9 Indication of current intensity The actually flowing current in mA is indicated in figures on the display, and also in analogous form at the bottom edge of the display by means of two bar graphs. Indicating range resolution Upper bar graph 20-60 mA Lower bar graph 0-20 mA

Resolution 1 mA Resolution 0,5 mA

4.10 Indication of the battery condition The battery condition is permanently shown on the display by indicating the remaining utilisable battery capacity. Each of the five segments represents 20 % of the battery capacity. This means: if all five segments are visible, then 100 % of the utilisable battery capacity are available, if no segment is visible, then 0 % capacity is available. If there are only 20 % of the battery capacity available, the battery condition indicator will start to flash. Then the battery should be replaced soon, or a substitute battery should be kept at hand for replacement. If no segment is visible anymore, the device will emit acoustic warning signals, as the battery-symbol is flashing. If the battery capacity falls even lower, then the device will shut down automatically for reasons of safety. 4.11 Adjustment of the stimulation impulse bandwidth Pressing this button will activate a program option which allows you to preset the stimulation impulse bandwidth. The current intensity value and the mA-dimension will disappear from the display. Now the stimulation impulse bandwidth indicated in the upper right-hand corner of the display can be adjusted to one of the following values with the aid of the turning-knob: 0,05 ms (⫽ 50 µs) 0,1 ms (⫽ 100 µs) 0,2 ms (⫽ 200 µs) 0,3 ms (⫽ 300 µs) 0,5 ms (⫽ 500 µs) 1,0 ms (⫽ 1000 µs) The adjustment-function is exited and the adjusted value is stored 1 second after the last turning motion, or if the button is pressed once more.

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English USA

Please observe: The stimulation is not interrupted during the adjustment, and the impulse bandwidth is constantly adapted according to the displayed value. It is recommended, to adjust the bandwidth of the stimulation impulses before connecting to the patient, or to conduct the adjustment in the PAUSE-mode. In addition, you should take into account that battery life is shortened considerably when using large impulse bandwidths due to a high emission of energy.

I

C

S

S

5 SETUP-functions 5.1.1 SETUP LEVEL 1: Volume control Pressing the SETUP button once will activate a program option which allows you to control the volume of the monitoring sound as well as of the warning sounds. Your display will show a number appearing on the left-hand side next to the VOL. indication (see table). This number corresponds to a certain predefined volume. This volume may be increased or reduced with the aid of the turning-knob. A value of 4 corresponds to maximum volume. Turning the value to 0 will shut the monitoring sound off. Depressing the SETUP button for a longer period of time (min. 2 seconds) will permanently store the volume-value currently indicated on the display. A monitoring sound is audible during the store-procedure. The device will automatically exit the SETUP-mode and switch to the PAUSE-mode. A short depression of the SETUP button will guide you to the next item of the SETUP-menu without having stored the volume-settings.

5. A th m D va th Th be SE

Volume of the monitoring- and warning sounds

I

S

Display

Monitoring sounds

Warning sounds

P

4

very loud

very loud

S

3

loud

loud

2

medium

medium

1

low

leise

0

off

off

A1

off

low

A2

off

medium

A3

off

loud

A4

off

very loud

S Monitoring- and warning sounds

S

Warning sounds only

5.1.2 SETUP LEVEL 2: Setting of the initial parameters for “Cannula mode” Double-clicking the SETUP button will activate a program option which allows you to individually preset the stimulation parameters for the cannula after the device is switched on. The parameters and the manufacturer’s settings are listed below. Depressing the SETUP button for a longer period of time (min. 2 seconds) will permanently store the values currently indicated on the display. A monitoring sound is audible during the store-procedure, then you are redirected to the PAUSE-mode. A short depression of the SETUP button will guide you to the next item of the SETUP-menu without having changed the existing settings (see 3.8.3). Please observe: The settings for the frequency and the impulse bandwidth must be adjusted in normal operation. i.e. before pressing the SETUP button for the first time. The intensity of the current can still be varied in the SETUP-function with the aid of the turn-knob. ATTENTION: Having selected a too high initial intensity of the stimulation current may lead to painful stimulation of the patient during subsequent introduction of the cannula.

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6 Af de er Af Th ne

Pl E1 E3 E4 E5 E6

7 Th tio te dr M

7. Th m ba 40 an

Cannula-parameter

Adjustment range

Manufacturer’s settings

Stimulation current intensity

0 – 6,00 mA

1,50 mA

Stimulation frequency

1 Hz, 2 Hz

2 Hz

Stimulation impulse bandwidth

50 µs/100 µs/200 µs/300 µs/ 500 µs/1,00 ms

100 µs

e

P

n

e

f

5.1.3 SETUP LEVEL 3: Setting of the initial parameters for “PEG mode” A triple-click of the SETUP button will activate a program option which allows you to individually preset the stimulation parameters for the PEG-handle after the device is switched on. The parameters and the manufacturer’s settings are listed below. Depressing the SETUP button for a longer period of time (min. 2 seconds) will permanently store the values currently indicated on the display. A monitoring sound is audible during the store-procedure, then you are redirected to the PAUSE-mode. The settings for the frequency and the impulse bandwidth must be adjusted in normal operation. i.e. before pressing the SETUP button for the first time. The intensity of the current can still be varied in the SETUP-function with the aid of the turn-knob. Initial parameters for stimulation using the PEG-handle PEG parameter

Adjustment range

Manufacturer’s settings

Stimulation current intensity

0 – 60,00 mA

20 mA

Stimulation frequency

1 Hz, 2 Hz

1 Hz

Stimulation impulse bandwidth

50 µs/100 µs/200 µs/300 µs/ 500 µs/1,00 ms

0,5ms

English USA

Initial parameters for stimulation using the cannula

6 Error messages After switching the MultiStim SENSOR on, the device will automatically carry out a self-test. If the device recognises a faulty function during the self-test or during normal operation, the corresponding error code will be indicated on the LCD. After that, the device is not operational anymore and may not be used further. The device must by all means be returned to the manufacturer for repair. Please ask your dealer if you need assistance, he will be glad to help you. Please indicate the error code in the repair order. The following error codes are possible: E1 Fault in Program memory E3 Faulty pulse voltage E4 Faulty internal current setting E5 Faulty pulse current (perhaps damaged cable) E6 Battery is empty 7 The battery The proper charge of the battery must be examined regularly. Proceed as described in section Indication of battery condition. A battery capacity of less than 20 % (1 segment visible) will cause the battery condition indicator to start flashing, and the battery should be replaced. If the battery capacity drops to a value which will impair the functionality, the device will switch itself off automatically. If the MultiStim-device is not used for a longer period of time, the battery must be removed to avoid leakage. 7.1 Battery replacement The battery compartment is located on the bottom side of the MultiStim SENSOR. Open the compartment by unscrewing the screw situated on the back side of the device with a suitable tool. Replace the battery. Be sure to check for correct polarity. Exclusively use 9 V alkali-manganese batteries (e.g., VARTA 4022, DURACELL MN 1604). With these batteries you will obtain a prolonged duration of functionality and extremely reliable operation.

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Attention: In case of battery leakage, the device should not be operated anymore for safety reasons. If acid leaks into the inside of the device, essential functional assemblies may be damaged or impaired. The device must be returned to the manufacturer for inspection.

English USA

8 Cleaning and disinfection of the device Only use soft, moistened cloths to clean and disinfect the device and the electrode cables. Water, soapsuds or denaturated alcohol are particularly suitable for this purpose. Take care that no water or moisture enters into the device. Alcohol, or commercially available alcohol based disinfectants containing no methyl alcohol may be used for disinfection. Attention: The following agents may not be employed for cleaning purposes: trichloroethylene, acetone, butanone (methyl ethyl ketone), benzene, methyl alcohol or cellulose thinner (cellosolve, etc.). 9 Maintenance and technical safety checks Check proper condition of the device and the accessories before use. A faulty device may not be operated. Electro-medical devices may only be repaired by the manufacturer or by an institution expressly authorised by the manufacturer. A detailed description of the fault is to be included in the repair order. 9.1 Technical safety checks Technical safety checks are not required. The functioning of the device is to be checked according to the details given in the operating instructions before every application. 9.2 Device roster book in accordance with MPG The operator of class IIa technical medical equipment in accordance with MPG is required to keep a device roster book. The following entries are to be made into the device roster book: 1. Date and time of the functionality test before the first operational use of the device 2. Date and time of the familiarisation, as well as the names of the persons familiarised with the operation of the device 3. Date and time of the performance of the prescribed technical safety checks (if applicable), and of maintenance measures, as well as the name of the person or the company which has carried out the measures 4. Date, time, type and consequences of malfunctions and repeated operating errors of the same type The CE-conformity certificate is component of the device roster book. 10 Accessories and spare parts list for MultiStim The following PAJUNK® products may be used as genuine accessories for the MultiStim devices, and they are available in a wide variety of measurements: • All PAJUNK® stimulation cannulae for nerve block anaesthesia. • All PAJUNK® stimulation cannulae for continuous nerve block anaesthesia. • Monopolar PEG-stimulation handle. • Bipolar PEG-stimulation handle. • Main patient line for connecting stimulation cannulae, PEG-handles and commercially available, CElabelled adhesive stimulation electrodes. • Div. Various extensions and adapter lines. 11 Signal gradients, impulse patterns and power diagrams For all signal gradients, stimulation is effected by means of monophase negative square pulses. Electric energy is emitted only for the duration of the stimulation pulse. Therefore, please note, that the comparison of nominal/effective current (indicated by »⫽« or »⬆«) is exclusively carried out during the period in which the negative stimulation impulse is emitted. This status is saved and displayed during the interpulse period until the next impulse is emitted. Pulse form: square pulse Frequency: 1 Hz or 2 Hz Breadth according to selected output

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1 Th Th Th Th no th

p-

no

-

-

-

English USA

.

11.1 Build-up and fall times The build-up and fall times measured effectively typically amount to 4 µs ± 2 µs. The build-up and fall times hardly depend on the adjusted pulse width (PW) and pulse frequency (PF). They are to a lesser degree dependent on the current amplitude and on the select channel {KAN, PEG}. Their greatest correlation is with the patient resistance (Rp). The upper limiting values apply for the nominal resistance range [1 k⍀ ...12 k⍀]. For greater resistances, the times will increase as indicated in the following illustration. At 50 k⍀, values exceeding 15 µs are possible (particularly for fall time).

e

e

c

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12 Notes, warnings If you have adjusted a stimulation current intensity > 0.06 mA or > 0.2 mA during operation in the CATH mode and 0.00 mA are indicated in the display mode »Indication of the stimulation current intensity actually flowing through the patient«, the following circumstances may be on hand due to the tolerances Full Scale causing this fault: • there is no cable or a faulty stimulation cable connected, • the electrodes are not attached correctly, or they are not attached at all, • the electrical resistance of the patient tissue is too high. The user can use every commercially available CE-labelled self-adhesive electrode for medical purposes. The increased attention of the user is required at effective current densities beyond 2 mA/cm2 for all adhesive electrode surfaces.

G (

M c

I

E d a I

A theoretical maximum current density of 32.4 mA/mm2 can be reached if the stimulation cannula is used!

English USA

Only perform wiping disinfection, no spraying disinfection under all circumstances! Avoid condensation! Do not use the product in case of commun incompatibilities and/or interactions of the material. 13 Electromagnetic compatibility (EMC) MultiStim SENSOR complies with the standard for electromagnetic compatibility (EMC) EN 60601-12:2007. The tests for electromagnetic compatibility were performed by: Nemko GmbH & Co. KG – Testingand Certification Authority – Reetzstrasse 58 - 76327 Pfinztal - Germany Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (according to EN 60601-1-2:2007; 5.2.2.1 Table 1)

E s a I

S I

V i v o i i I

MultiStim SENSOR is intended for use in the electromagnetic environment specified below. The customer or user of the MultiStim SENSOR should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emission according to CISPR 11

Group 1

MultiStim SENSOR uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emission according to CISPR 11

Class B

Harmonic emissions according to IEC 61000-3-2

Not applicable

Voltage fluctuations/flicker emissions according to IEC 61000-3-3

Not applicable

The MultiStim SENSOR is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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P ( n i I

U

n!

MultiStim SENSOR is intended for use in the electromagnetic environment specified below. The customer or user of the MultiStim SENSOR should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) according to IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient / burst according to IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

Not applicable

Not applicable

Surges according to IEC 61000-4-5

± 1kV line(s) to line(s) ± 2kV line(s) to earth

Not applicable

Not applicable

Voltage dips, short interruptions and voltage variations on power supply input lines according to IEC 61000-4-11

< 5% Ur (>95% dip in Ur) for 0,5 cycle

Not applicable

Not applicable

3 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical cornmercial or hospital environment.

40% Ur (60% dip in Ur) for 5 cycles 70% Ur (30% dip in Ur) for 25 cycles

t

< 5% Ur (>95% dip in Ur) for 5s

-

c

English USA

s.

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (according to EN 60601-1-2:2007; 5.2.2.1 Table 2)

Power frequency (50/60 Hz) magnetic field according to IEC 61000-4-8

3 A/m

Ur is the a.c mains voltage prior to application of the test level.

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N

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions (according to EN 60601-1-2:2007; 5.2.2.2 Table 3) MultiStim SENSOR is intended for use in the electromagnetic environment specified below. The customer or user of the MultiStim SENSOR should assure that it is used in such an environment. IEC 60601 test level

Compliance level

Electromagnetic environment - guidance

Conducted RF according to IEC 61000-4-6

3Vrms 150 kHz to 80 MHz outside the ISM-bandsa

Not applicable

10Vrms 150 kHz to 80 MHz in the ISM-bandsa

Not applicable

Portable and mobile RF communications equipment should not be used no closer to any part of the MultiStim SENSOR, including cables, than the recommended separation distance calculated from the equation applicable to frequency of the transmitter. Recommended separation distance: d = 3,5/U1√P for 150kHz to 80MHz d = 12/U1√P for 80MHz to 800MHz d = 23/U1√P for 800MHz to 2,5GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m)b.

English USA

Immunity test

Radiated RF according to IEC 61000-4-3

Note 1

10 V/m 80 MHz to 2.5 GHz

10V/m

Field strengths from fixes RF transmitters, as determined by an electromagnetic site survey,c should be less than the compliance level in each frequency range.d Interference may occur in the vicinity of equipment marked with the following symbol:

At 80 MHz and 800 MHz, the higher frequency range applies.

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a

b

c

d

Li PA ca TH RE to cu as se us M an ne M PA re sh co

G In Al Pr M

St

y

-

-

r

a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz and 40.66 MHz to 40.70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in the calculating the recommended separation distance for transmitters in these frequency ranges. c) Field strengths from fixed transmitters, such as base stations of radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MultiStim SENSOR is used exceeds the applicable RF compliance level above, the MultiStim SENSOR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MultiStim SENSOR. d) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Limitation of Warranty/Disclaimer PAJUNK® GmbH Medizintechnologie guarantees to manufacture its products with greatest possible care. THIS IS THE ONLY VALID GUARANTEE, AND IT SHALL REPLACE ALL OTHER WARRANTIES GIVEN AND REPRESENTATIONS MADE. It shall be observed, that due to the biological differences of the persons to be treated, no product is always absolutely effective under all environmental conditions and circumstances. Components of the sets manufactured by PAJUNK® GmbH Medizintechnologie, as well as their individual components are compatible with each other. Before the use of individual products/ sets of PAJUNK® GmbH Medizintechnologie in connection with products from other companies, the user must ensure the application-specifical compatibility of the individual products. PAJUNK® GmbH Medizintechnologie has no influence on the application of the product, on the diagnosis of the patient and on the handling of the product outside of the company. PAJUNK® GmbH Medizintechnologie can neither guarantee a beneficial nor a complication-free application of the product. PAJUNK® GmbH Medizintechnologie therefore assumes no liability for damages and costs. PAJUNK® GmbH Medizintechnologie will replace products showing a deficiency, which is to be represented by PAJUNK® GmbH Medizintechnologie. Employees of PAJUNK® GmbH Medizintechnologie shall not be authorised to amend the aforementioned conditions, to extend liability, or to accept or consent to additional product-related obligations.

English USA

d

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people

Note 2

General Notes In accordance with U.S. law, this product may only be sold by a physician or upon his prescription. All rights to change or modification of the product shall remain reserved. Products are free of latex. Made in Germany – manufactured by PAJUNK® GmbH Medizintechnologie Storage conditions 65

30°C 10°C

20

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