Page 1
MultiStim SWITCH and
MultiStim SENSOR –
Setting the trend in nerve stimulation
Plexus and Epidural Anaesthesia
Page 2
The essential advantage regarding safety
MultiStim SENSOR and MultiStim SWITCH
With MultiStim SENSOR and MultiStim SWITCH,
®
PAJUNK
stimulators in regional anaesthesia.
has founded a new generation of nerve
Both devices offer a variety of functions for more
safety and efficiency, and are convincing due to
the following advantages:
Aside of a number of identical functions, the two devices are, however, different in the following functions:
The MultiStim SENSOR supports patient friendly,
percutaneous localization and identification of
nerves with the aid of a stimulation handle: the
PEG-electrode (Percutaneous Electronic Guidance)
- a fundamental distinctive feature in relation to
conventional stimulation devices.
Device type: BF
Battery: 9 V
Current intensity: max. 6 mApp / 60 mA
Stimulation voltage: max. 65 V
Stimulation frequency: 1 Hz, 2 Hz
pp
pp
Page 3
- Large, clearly arranged display
- Analogous setting of the intensity of the
stimulation current by means of a notched
turning-knob
- Integrated safety functions
- High-precision, microprocessor-controlled
adjustment of constant current
The MultiStim SWITCH has revolutionized nerve
stimulation through two outstanding innovations:
The new function indicating the patient
resistance permits the instant detection of
intra neural, intravascular and intrathecal cannula
placement, which can be corrected immediately.
A switch-over function enables the anaesthetist to either select the catheter or the cannula
for the stimulation by a simple keystroke. The
maximum current intensity will thereby correspond with the distinct, varying requirements of
peripheral and epidural nerve stimulation.
Device type: BF
Battery: 9 V
Current intensity: max. 6 mApp / 20 mA
Stimulation voltage: max. 95 V
Stimulation frequency: 1 Hz, 2 Hz
pp
pp
Page 4
Easy to view – simple in application
The MultiStim SENSOR
Active output
Pulse indicator
Nominal/actual current intensity
PEG-button
SETUP-button
ON/OFF/Pause
Pulse width
Battery
condition
Pulse frequency
Pulse width
MultiStim SENSOR
While the exact insertion point is determined by means of anatomical landmarks when conventional
stimulation equipment is being used, the MultiStim SENSOR optionally also permits the location of the
puncture site with the aid of the PEG-electrode (Percutaneous Electrode Guidance).
Percutaneous nerve localization with handle
When using the PEG-electrode, the nerve is stimulated through the
skin without requiring a puncture, which will evoke a reflexive
response when the nerve is encountered.
The cannula is introduced at the insertion point identified by means
of this method, and the stimulation current is then switched over to
the cannula by keystroke. The placement of the cannula is performed in the usual manner.
Page 5
PEG- and Cannula button*
Pressing the PEG- or Cannula button will cause the stimulation to be
switched to the handle or to the cannula, as may be required.
The respectively active electrode will thereby be indicated by means of a
corresponding status indicator in the display. The intensity and the
frequency of the stimulation current, as well as the pulse width can be
adjusted separately for both outputs. This button will remain without
function if no PEG-handle has been connected.
* only if the optional PEG-cable and electrode are used
Nominal/actual stimulation current intensity
The intensity of the stimulation current actually flowing through the patient
is measured constantly, and is indicated numerically as well as by bar graph
indicator on the display. The nominal and actual currents are also constantly
compared and indicated visually or acoustically, if the intensity of the
actually flowing current differs from the adjusted current intensity.
SETUP
The device has been provided with a SETUP-function. This function
permits the user himself to determine his individual initial parameters
for the percutaneous and invasive applications.
ON/OFF
PAUSE
The stimulation can be interrupted at any time with the PAUSE - button.
The settings of all stimulation parameters can be changed without emitting
impulses, while the device remains attached to the patient.
Adjustable stimulation pulse width
The stimulation pulse width can be adjusted fast and simple with a button of
its own in a number of steps – with intervals ranging from 0.05 ms, 0.1 ms,
0.2 ms, 0.3 ms, 0.5 ms to 1.0 ms, e.g. for the selective stimulation of sensory
and motor nerve fibres in mixed nerves.
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MultiStim SWITCH
Brings the future of stimulation right to the point
Active output, for
example „Cannula“
Actually flowing
current
NOMINAL/ACTUAL
current
PAJUNK® MultiStim SWITCH can be used for the
location of peripheral nerves and also for epidural
stimulation. Its application is recommended for all
Pulse indicator
Patient resistance
Pulse width
Battery condition
Current intensity
purposes requiring the identification of nerves, bundle
of nerv fibers and nerve roots. With this device,
Switch-over key „CATH“ /
„Cannula“
SETUP
ON/OFF/PAUSE Pulse width
Pulse frequency
Turning-knob
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PAJUNK® has set new standards in electrical nerve
stimulation, because for the first time ever, it
provides the option for alternative stimulation by
means of cannula or by stimulating catheter.
The MultiStim SWITCH is comparable with the
MultiStim SENSOR with respect to safety and
basic construction, and it has been furthermore
provided with additional functional utilities.
The MultiStim SWITCH is
simultaneously connected
to the cannula and the
catheter by means of a
Y-patient cable.
Connector for
the cannula
Clamp for the adhesive electrode
Connector for the
stimulating catheter
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The revolution in the nerve stimulation
More safety through the indication of pat ient resistance
The MultiStim SWITCH has revolutionized nerve
stimulation. Because MultiStim SWITCH is the
first device, which permits the immediate
identification and correction of a misplaced
cannula, before mechanical or chemical injuries
are caused. Because it has been confirmed on the
basis of medical studies conducted under the
direction of Dr Tsui, that patient resistance will
increase distinctly in cases of intraneural, intravascular and intrathecal punctures.
Muscle (Low impedance)
conductive tip
Nerve (High impedance)
current
Muscle (Low impedance)
conductive tip
Nerve (High impedance)
current
Page 9
Based on this knowledge, PAJUNK® has enhanced
the functional utilities of the MultiStim SWITCH
by adding a continuous indication of the patient
resistance by means of two analogous bar graphs.
The measurement of the resistance connected
therewith is only possible, if the highly precise
®
PAJUNK
stimulation cannula are used.
touch nerve
kΩ
35
30
25
20
15
10
5
0
L brachial
R brachial
L sciatic
penetrated inside nerve sheath
withdraw back out the
nerve sheath
R sciatic
An individual threshold value can be predefined in advance for double safety by means of the
SETUP-button, which will cause an acoustic signal to be emitted if the threshold value is exceeded.
The MultiStim SWITCH therefore provides an essential advantage regarding safety for the patient.
Page 10
Useful options
28
DE8012/M
The MultiStim SWITCH can do more
Stimulation by cannula or catheter
The MultiStim SWITCH provides two alternative options for stimulation: by way of a
cannula or through a stimulating catheter. The corresponding switch-over is actuated
simply by pressing the CATH/Cannula – function key.
If stimulation by cannula is activated, then a cannula symbol will appear on the
display. The maximum stimulation current intensity will be 6 mA.
CATH
Cannula symbol Catheter symbol
If stimulation by catheter is activated, then the word „CATH“ will appear on the
display. In the catheter-mode, the range of stimulation current intensity will be
increased to 20 mA, and will therefore correspond with the specific requirements of
epidural stimulation.
The intensity and the frequency of the stimulation current, as well as the pulse width
can be adjusted and configured separately at any time for both outputs (cannula and
catheter).
Maximum voltage and current intensity
The device emits a stimulation voltage of at most 95 Vpp in order to still obtain a good
stimulation effect on patients with high resistance conditions. The intensity of the
stimulation current for the catheter amounts to 20 mA for safety reasons, and is therefore
also suitable for epidural stimulation.
MultiStim SWITCH
Page 11
mA
0,00
1,00
2,00
3,00
4,00
5,00
6,00
7,00
0102030405060
mA
SETUP-button
Individual programming options differing from the manufacturer’s default
settings can be defined by actuation of the SETUP-button.
- Level 1: Volume of the warning- and monitoring sounds
- Level 2: Stimulation frequency, pulse width and current intensity in
the “Cannula-mode”
- Level 3: Stimulation frequency, pulse width and current intensity in
the “Catheter-mode”
- Level 4: Threshold value, at which the acoustic signal for the patient
resistance will change
- Level 5: Activation of the Choquet/Feugeas table; “Cannula-mode”
Individual definition of a constant pulse width
In the manual mode, stored as manufacturer’s default
setting, the pulse width can be defined by the user. It will
remain constant during the complete application. The
change of the current values is effected manually in fixed,
predefined steps, whereas these steps will be correspondingly large at great distances to the nerve, and will
become smaller as the cannula approaches the nerve.
(see accompanying table)
Stimulation pulse width
Constant
pulse width
Automatic adjustment of the current intensity
and impulse bandwidth according to the Choquet/
Feugeas table
In the automatic mode, the pulse width depends on the
intensity of the current, and has, on the basis of the
Choquet/Feugeas table, been stored permanently in the
nerve stimulator. The intention of this method is to
achieve a fast, efficient approach to the nerve, on the
basis of a constant charge. The device will correspondingly function with a great pulse width at the beginning,
which will be reduced according to the intensity of the
current in the course of approaching the target nerve.
This option ensures, that the anaesthetist can approach
the nerve in constant steps under continued muscular
response, and can therefore concentrate his full attention
completely on the puncture.
Clicks
Stimulation pulse width
Impulse bandwidth according to Choquet/Feugeas
Clicks
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MultiStim SENSOR and MultiStim SWITCH
All the information at a glance
Nerve stimulator: MultiStim SENSOR
Accessories:
MultiStim SENSOR
1)
MultiStim SENSOR Item no.
incl. equipment case and patient cables for the connection of stimulation cannula 1151-94-30
incl. equipment case, PEG-cable for the connection of stimulation cannula and monopolar handle 1151-94-32
Accessories
1) Patient cable for the connection of stimulation cannula
2) PEG-cable for the connection of stimulation cannula and monopolar handle
3) PEG-electrode - percutaneous, monopolar stimulation handle, autoclavable 1151-94-17
Extension cord for the connection of stimulation cannula, autoclavable*
Disposable extension cord for the connection of stimulation cannula, sterile*
*) Usable for SWITCH and SENSOR
2) 3)
)
01151-861F
)
01151-861Q
1151-94-13
1151-94-14
MultiStim SWITCH
Nerve stimulator: MultiStim SWITCH
MultiStim SWITCH Item no.
incl. equipment case and SWITCH-cables for the
connection of cannula and StimuLong catheter
SWITCH-cabel for the connection of stimulation
cannula and stimulating catheter
1151-94-40
1151-94-07
PAJUNK GmbH
Medizintechnologie
Karl-Hall-Strasse 1
D-78187 Geisingen/Germany
Telefon +49 (0) 77 04 /92 91-0
Telefax +49 (0) 77 04 /92 91-6 00
www.pajunk.com
XS200146A 07/10
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MultiStim SWITCH
Peripheral – Epidural – Spinal
Page 14
Table of contents
25 1. General information
25 2. Product specifi cation/compatibility
25 2.1 Indication
25 2.2 Contraindications
25 2.3 Warnings and precautionary measures
28 2.4 Constant voltage or constant current
28 2.5 Accessories
29 3 Technical description
29 3.1 Technical data
30 3.2 Display
30 3.3 The control keys
30 3.4 The elements of the display
31 3.5 Menu structure setup
English
31 4. Operation
31 4.1 Pre-operational check
32 4.2 Operation of the nerve stimulator
33 4.3 PAUSE function
33 4.4 1 Hz/2 Hz mode
33 4.5 Mode cannula/KAN
33 4.6 Mode catheter CATH
33 4.7 Amplitude selection (setting of the nominal stimulation current)
34 4.8 Display modes for stimulation current
34 4.9 Display of the ACTUAL resistance, patient resistance
34 4.10 Indication of the battery condition
34 4.11 Adjustment of the stimulation impulse bandwidth
35 5 SETUP-functions
35 5.1.1 SETUP LEVEL 1: Volume control
35 5.1.2 SETUP LEVEL 2: Setting of the initial parameters for “Cannula mode”
36 5.1.3 SETUP LEVEL 3: Setting of the initial parameters for “Catheter mode”
36 5.1.4 SETUP LEVEL 4: Resistance indication with warning sound notifi cation
37 5.1.5 SETUP LEVEL 5: Activation of the Choquet table KAN mode
37 5.1.5.1 MultiStim SWITCH Feugeaus/Choquet
38 6 Error messages
38 7 The battery
38 7.1 Battery replacement
39 8 Cleaning and disinfection of the device
39 9 Maintenance and technical safety checks
39 9.1 Technical safety checks
39 9.2 Device roster book in accordance with MPG
39 10 Accessories and spare parts list for MultiStim
39 11 Signal gradients, impulse patterns and power diagrams
40 11.1 Build-up and fall times
40 12 Notes, warnings
41 13 Electromagnetic compatibility (EMC)
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User Instruction – MultiStim SWITCH
1. General information
Please note: Due to US Medical Device Legislation and specifi c requirements for devices marketed in the
USA the wording of the user instructions for the US may slightly differ from the standard English version.
Please read the following information and instructions carefully.
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.
Nonobservance or contravention of these instructions will cause the guarantee to expire and will lead
to endangering the safety of the patient.
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 SWITCH is intended to be used exclusively with PAJUNK® GmbH Medizintechnologie products (e.g. StimuLong catheters, 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 specifi cation/compatibility
MultiStim SWITCH is delivered with the following basic equipment:
• MultiStim SWITCH nerve stimulator
• 9 volt block battery
• Patient main cable SWITCH
• Short-circuit plug
• Operating instructions
• Suitcase for storing SWITCH and accessories
Please observe by all means: The patient main cable of the MultiStim SWITCH 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!
English
2.1 Indication
The MultiStim SWITCH serves for reliable neuro-localization, as for example in local- and regional
anesthesia (diagnostic, intra-operative and therapeutical block). It may be used for locating peripheral
nerves and also for epidural stimulation (Tsui-test). The PAJUNK® MultiStim SWITCH can be used in all
cases where the identifi cation 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 insuffi ciencies should be
considered carefully. Further contraindications may be caused by anatomical anomalies.
2.3 Warnings and precautionary measures
The connecting port of the stimulation cannula or the catheter adapter 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 SWITCH 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 regula-
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tions to avoid injuring the patient. All facilities and accessories must comply with the regulations of
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.
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 suffi ciently insulating/non-conductive, antistatic pad on the operating
table.
The MultiStim SWITCH may under no circumstances be operated with instruments and accessories
other than those which have been authorized, supplied or recommended by the manufacturer. Only
English
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 SWITCH, the connector cable, the cannula tip or the adhesive
electrode. It is therefore necessary to disengage all connections to the MultiStim SWITCH 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 fi bers in the vicinity may be irreversibly destroyed. The connected stimulator may simultaneously cause the rectifi cation 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.
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
suffi ciently sound contact with a low tissue impedance. Fatty tissue, hair, uncleanness, repeatedly used
adhesive electrodes and electrodes of inferior quality can infl uence 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 suffi cient 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 SWITCH 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 fi brillation (cardiac fi brillation).
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 (catheter and cannula)
Operate the MultiStim SWITCH 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 SWITCH 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 com-
patibility). Portable and mobile RF-communication facilities may infl uence the MultiStim SWITCH. This
may lead to a malfunction of the device or of the system.
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Dynamic electrical- and dynamic magnetic interference fi elds may interact with the device and the system.
These interactions may have an infl uence 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.
The MultiStim SWITCH may not be used near equipment emitting strong magnetic fi elds, 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.
The device may not be connected with other equipment. If the MultiStim SWITCH is operated nearby
to another device, then the devices or the system must be monitored and the correct functioning as
intended must be verifi ed in this arrangement as it is being used.
Under unfavorable conditions, the MultiStim SWITCH may disturb other equipment in its function. We
therefore recommend to check all other equipment and facilities for compatibility with the MultiStim
SWITCH, 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 security reasons the device
must be returned to the manufacturer for proper cleaning.
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 fl owing patient current correctly any more.
To avoid damaging the MultiStim SWITCH 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 SWITCH 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 SWITCH away from live / current bearing objects. The electrostatic
and electromagnetic fi elds radiated therefrom may have an infl uence 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 SWITCH, 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.
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.
English
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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; 13485:2003/ AC2007; 9001:2000; UL 60601; MPG; HWG, Directive 93-42-EC
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 infi nite. The factors skin humidity, conductivity of the skin and of the tissue and
the potential resistance of the adhesive electrode can hardly be infl uenced.
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.
English
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 infi nite – so that the resistances which may perhaps occur in the external electrical circuit will be negligible, and so that the actually fl owing current will be indicated exactly on the
display.
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 SWITCH, the external load resistance can amount to as much as 12 k⍀. If this load
resistance is exceeded, then the actually fl owing 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.
The MultiStim SWITCH is a precision instrument for the localization of nerve tracts in the human
organism. It was developed to stimulate nerve fi bers in the living organism using cannulae and special
catheters for invasive stimulation which normally show a very high contact impedance, to be able to
determine the spatial position of these nerve fi bers 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 fi ber,
which will cause a reversible interruption of the conductive system.
2.5 Accessories
The MultiStim SWITCH can (unlike the model SENSOR) be exclusively connected with a patient cable
for cannula and catheter:
Yellow connection: CATHETER
White connection: CANNULA
Clamp for adhesive electrode
In addition patient main cable for cannula stimulation only is available:
White connection: CANNULA
Clamp for adhesive electrode
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There is an extension cable available for each, the connection to the cannula and to the catheter
(variant autoclavable and variant single use).
3 Technical description
The MultiStim SWITCH generates reproducible square pulses with adjustable frequency and continuously adjustable stimulation current. The adjustment range of the impulse current: 0.0 – 6.0 mA if stimulation cannulae are being used, and 0,0 – 20 mA if stimulation catheters are being used.
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.
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-labeled 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 SWITCH
Type of device BF
Battery: 9 V
Stimulating current: max. 20 mAss/
Resistance range
Stimulation voltage: max. 95 Vss
Stimulation frequency: 1 Hz/2 Hz
Stimulation impulse bandwidth: 0,05 ms / 0,10 ms / 0,20 ms/
Operating conditions: Temperature: 10°C – 30°C
Transportation- and storage conditions: Temperature: 10°C – 30°C
0 ⍀ – 60 k⍀
0,30 ms/0,50 ms/1,00 ms
Atmospheric humidity: 20% – 65%
Air pressure: n.a.
Atmospheric humidity: 20% – 65%
Air pressure: n.a.
English
CE
0123
29
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3.2 Display
Display, all indications activated (simulated condition)
MultiStim SWITCH has additionally been provided with a permanent analogous indication of the
patient resistance by means of two bar graphs below the digital.
English
3.3 The control keys
Button Function
Mode: CATH (catheter) or KAN (cannula, represented by symbol)
Access to the basic setting
„On“ / „Off“ / Pause
Selection of the impulse bandwidth
Mode: Impulse-frequency
3.4 The elements of the display
Symbol Meaning
Indicates must-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 („⫽“) or („⬆“) 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 fi ve segments correspond to 20%
of the battery capacity. This means, if all fi ve segments are visible, then 100% of the
utilizable battery capacity are available, if no segment is visible anymore, then there is
0% battery power available.
Operating modes: PEG (ONLY SENSOR!), cannula or catheter.
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).
3.5 Menu structure setup
SETUP level 1 Adjustment/storage of the volume
Options to choose from: A4, A3, A2, A1 (decreasing volume, beep sounds)
0 (global mute)
1, 2, 3, 4 (increasing volume, pulse sounds)
SETUP level 2 Adjustment/storage of “Cannula – current pulse”
Options to choose from: set value (control device) storage
SETUP level 3 Adjustment/storage of “CATH – current pulse”
Options to choose from: set value (control device) storage
SETUP level 4 Adjustment/storage of “Rp – Threshold”
Options to choose from: 0 – 5 (description see table in chapter Setup Level 4)
SETUP level 5 Adjustment/storage of „PW Selection Mode“
Options to choose from: 0, 1 (description see table in chapter Setup Level 5)
English
4. Operation
4.1 Pre-operational check
Please observe: Equipment with divergent behavior 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 authorized 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 identifi ed 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
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cable in such manner in the device socket, so that the red markings on the device socket and on the
connector shell are aligned.
Abb.1 Abb. 2
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 fi nger.
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
English
the adjusted nominal stimulation current. The available adjustment range (peak value) may vary (6.0
mA or 20.0 mA), depending on the selected mode.
3. Performance of the short-circuit test: Connect the socket of the stimu-
lating 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
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 behavior
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 short-circuit 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.
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
CATH catheter 0,0 – 20mA
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 SWITCH on.
After switching on, the device will fi rst 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.
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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 SWITCH. 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 fl ash 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.
4.4 1 Hz/2 Hz mode
When the 1 Hz-/2 Hz button is pressed, MultiStim 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.
4.5 Mode cannula/KAN
MultiStim SWITCH 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 affi xed 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 » « -button permits switching back and forth
between the cannula output and the catheter output.
If the stimulation by cannula is activated, the symbol »KAN« 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
Aside of stimulation using an invasive stimulation cannula, MultiStim SWITCH addition-
ally offers the option for stimulation by means of a catheter (e.g. PAJUNK® StimuLong).
The stimulation catheter or the catheter clamping adapter is also connected to the Y-cable over the
intermediate cable. The adhesive electrode is affi xed 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 catheter, the current is conducted between the catheter tip (negative pole,
cathode) and the red electrode clamp (positive pole).
If the stimulation by catheter is activated, the symbol »CATH« will appear as the status indicator in the
display.
The catheter can now be introduced by way of a previously positioned puncture cannula.
Please observe:
If no catheter connection cable is detected when switching to the CATH mode, i.e. the catheter is
not connected or is defective, this will cause »no« to appear on the display and an acoustic signal
may be heard; the »KANÜLE/CATH« button is without function.
English
If the catheter is disconnected in the »CATH« -mode, »no« will appear on the display and acoustic
warning-signals will be emitted indicating the absence of the electrode. Now:
a) the stimulation catheter 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 »KANÜLE/CATH« - 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 center 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
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incremental step. The presently selected intensity of the stimulation current is indicated on the LCD.
This specifi ed 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 fl owing
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 fl owing stimulation current , the »⬆«symbol will appear on the display. Please note, that in this case the current actually fl owing 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 fl owing through the patient. If this happens, it is absolutely necessary to reduce the 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 fl owing through the patient has been identifi ed clearly and has been remedied.
4.8 Display modes for stimulation current
English
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 fl owing through the patient (ACTUAL value).
During the indication of the actually fl owing current, a symbol resembling a human being is additionally displayed on the LCD on the left-hand side of the current intensity.
Cannula Catheter
Range Incremental step Range Incremental step
> 0,00 mA – 0,50 mA 0,02 mA > 0 mA – 2 mA 0,1 mA
> 0,50 mA – 1,00 mA 0,05 mA > 2 mA – 5 mA 0,2 mA
> 1,00 mA – 2,00 mA 0,10 mA > 5 mA – 10 mA 0,5 mA
> 2,00 mA – 4,00 mA 0,20 mA > 10 mA – 20 mA 1,0 mA
> 4,00 mA – 6,00 mA 0,50 mA
4.9 Display of the ACTUAL resistance, patient resistance
The current ACTUAL resistance (patient resistance) is shown in analog representation with the aid of
two bar graphs at the bottom edge of the display.
Indicating range resolution
Upper bar graph 20-60 K⍀ Resolution 1k⍀
Lower bar graph 0-20 k⍀ Resolution 0,5k⍀
An acoustic warning (double sound) is additionally emitted when specifi c limits are exceeded
(SETUP Level 4)
4.10 Indication of the battery condition
The battery condition is permanently shown on the display by indicating the remaining utilizable battery capacity. Each of the fi ve segments represents 20% of the battery capacity. This means: if all fi ve
segments are visible, then 100% of the utilizable 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 fl ash. 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 fl ashing. 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:
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Page 25
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.
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.
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 predefi ned 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 SETUPbutton 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.
Volume of the monitoring- and warning sounds
Display Monitoring sounds Warning sounds
4 very loud very loud monitoring- and warn3 loud loud
2 medium medium
1 low leise
0 off off
A1 off low warning sounds only
A2 off medium
A3 off loud
A4 off very loud
ing sounds
English
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).
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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 fi rst 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.
Initial parameters for stimulation using the cannula
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
English
Stimulation impulse bandwidth 50 µs/100 µs/200 µs/300 µs/
500 µs/1,00 ms
5.1.3 SETUP LEVEL 3: Setting of the initial parameters for “Catheter mode”
A triple-click of the SETUP-button will activate a program option which allows you to individually
preset the stimulation parameters for the catheter 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 3.8.4).
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 fi rst time. The intensity of the current can still be varied in the
SETUP-function with the aid of the turn-knob.
100 µs
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.
Initial parameters for stimulation using the catheter
Catheter-parameter Adjustment range Manufacturer’s settings
Stimulation current intensity 0 – 20,00 mA 2,00 mA
Stimulation frequency 1 Hz, 2 Hz 1 Hz
Stimulation impulse band-
width
5.1.4 SETUP LEVEL 4: Resistance indication with warning sound notifi cation
Pressing the SETUP-button briefl y four times will activate a program option which allows you to adjust
the signal sound for the patient resistance.
Here, the threshold value at which the acoustic signal for the patient resistance will change can be
adjusted. Single sound pulses are emitted below this value (one single sound pulse for every patient
stimulation impulse). If the resistance of the patient circuit is higher than the adjusted threshold, this is
signalized acoustically with two short sound pulses for every patient stimulation impulse. The function
is deactivated with the setting value 0. This setting applies for cannula and for CATH.
36
50 µs/100 µs/200 µs/300 µs/500 µs/
1,00 ms
0,5ms
Page 27
Value Threshold
0
1
2
3
4
5
The double sound pulse is not emitted if the nominal current is not reached because, for example, the
resistance in the patient circuit is far too high. This case is signalized with a single sound pulse with a
deeper frequency, indicating the error.
5.1.5 SETUP LEVEL 5: Activation of the Choquet table KAN mode
ATTENTION: This setup level does not have any effect on the catheter mode.
Pressing the SETUP-button briefl y fi ve times will activate a program option which allows you to adjust
the pulse width for the cannula mode. Here, the pulse width selection mode can be selected by means
of the turnable key button. You can either choose manual selection (Selection 0) or automatic selection
of the pulse width according to the Choquet table (Selection 1).
In the manual mode, the pulse width can be defi ned by the user. In the automatic mode, the pulse
width is dependent on the pulse current and can not be selected and changed directly.
Value Display Setting of the pulse width for KAN
0 „SET“. The KAN pulse width is set manually.
1 „AUT“. The KAN pulse width is determined automatically, depending on the KAN
value
--- k⍀
10 k⍀ If a resistance greater than 10 k⍀ is measured in the patient circuit, then a
15 k⍀ If the measured resistance in the patient circuit is greater than 15 k⍀, then
20 k⍀ If the measured resistance in the patient circuit is greater than 20 k⍀, then
25 k⍀ If the measured resistance in the patient circuit is greater than 25 k⍀, then
30 k⍀ If the measured resistance in the patient circuit is greater than 30 k⍀, then
Effect of the setting
No resistance in patient circuit-threshold value monitoring: single sound
pulses are emitted at all times.
double sound pulse is emitted.
a double sound pulse is emitted.
a double sound pulse is emitted.
a double sound pulse is emitted.
a double sound pulse is emitted.
pulse current.
English
5.1.5.1 MultiStim SWITCH Feugeaus/Choquet
Big distance nervous location
MULTISTIM SWITCH has a particular function allowing big distance nervous location. The rotation of
the cursor habitually used to make vary issued intensity involve not only modifi cations of issued intensity, but also of stimulus duration. For the fi nal positioning of the needle near the nerves, it is important
to keep a stimulus duration at 0,1ms value which is validated by scientifi c data and by the common
practice. On the contrary, during the initial detection of nerves, it is desirable to have a maximum of
range of detection got with big stimulus durations (0,3 or 0,5 or 1ms).
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English
During the initial research of nerve, for a maximum stimulation reach, the cursor is therefore turned
right completely: 1ms and 6mA.
Then, according to the rotation of the cursor towards the left, the stimulus duration automatically
decrease from 1ms to 0,5ms then to 0,3ms and to fi nish to 0,1ms which is the value used in the
classical procedure approach. Issued intensities were calculated to avoid jolts between each stimulus
duration, so that increase or decrease of the amplitude of neuromuscular responses keeps linear and
smooth. So without tiring manipulation and in automatic way, the operator begins a target neuromuscular response from the maximum distance detection allowed by his neurostimulator. Then during
rotation to the left of the cursor (related to the improvement of neuromuscular stimulation) parameters
(intensity and stimulus durations) are decreased up to a stimulus duration of 0,1ms. The operator is
then in the classical positioning procedure.
6 Error messages
After switching the MultiStim SWITCH on, the device will automatically carry out a self-test. If the
device recognizes 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 Program memories faulty
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 fl ashing, 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 SWITCH. 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.
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: trichlorethylene, 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
authorized 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 fi rst operational use of the device
2. Date and time of the familiarization, as well as the names of the persons familiarized with the opera-
tion 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 certifi cate 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 one-time/single use nerve block anesthesia.
• All PAJUNK® stimulation cannulae for continuous nerve block anesthesia.
• Stimulatable PAJUNK® catheters for continuous peripheral nerve blocks.
• Main patient line for connecting stimulation cannulae, stimulation catheters and commercially avail-
able, CE-labeled adhesive stimulation electrodes.
• 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 impulse. 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.
English
Pulse form: square pulse
Frequency: 1 Hz or 2 Hz
Breadth according to selected output
39
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English
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, CATH}.
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).
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 fl owing 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.
40
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The user can use every commercially available CE-labeled self-adhesive electrode for medical purposes.
Do not use the product in case of commun incompatibilities and/or interactions of the material.
The increased attention of the user is required at effective current densities beyond 2 mA/cm2 for all
adhesive electrode surfaces.
A theoretical maximum current density of 32.4 mA/mm2 can be reached if the stimulation cannula is
used!
Only perform wiping disinfection, no spraying disinfection under all circumstances! Avoid condensation!
13 Electromagnetic compatibility (EMC)
MultiStim SWITCH 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 Certifi cation Authority – Reetzstrasse 58 - 76327 Pfi nztal - Germany
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
(according to EN 60601-1-2:2007; 5.2.2.1 Table 1)
MultiStim SWITCH is intended for use in the electromagnetic environment specifi ed below. The
customer or user of the MultiStim SWITCH should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment
RF emission
according to CISPR 11
RF emission
according to CISPR 11
Harmonic emissions
according to IEC 61000-3-2
Voltage fl uctuations/fl icker
emissions according to
IEC 61000-3-3
Group 1 MultiStim SWITCH uses RF
Class B The MultiStim SWITCH is suita-
Not applicable
Not applicable
- guidance
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.
ble for use in all establishments,
including domestic establishments and those directly
connected to the public lowvoltage power supply network
that supplies buildings used for
domestic purposes.
English
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Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
(according to EN 60601-1-2:2007; 5.2.2.1 Table 2)
MultiStim SWITCH is intended for use in the electromagnetic environment specifi ed below. The
customer or user of the MultiStim SWITCH should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment – 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 fl oors are covered
with synthetic material,
the relative humidity
should be at least 30 %.
English
Electrical fast transient / burst
according to
IEC 61000-4-4
Surges according to
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 1kV line(s) to line(s)
± 2kV line(s) to earth
< 5% U
r
(>95% dip in Ur)
for 0,5 cycle
Not applicable Not applicable
Not applicable Not applicable
Not applicable Not applicable
on power supply
input lines according to
IEC 61000-4-11
40% U
r
(60% dip in Ur)
for 5 cycles
70% U
r
(30% dip in Ur)
for 25 cycles
< 5% U
r
(>95% dip in Ur)
for 5s
Power frequency
3 A/m 3 A/m Power frequency mag(50/60 Hz) magnetic fi eld according to
IEC 61000-4-8
Ur is the a.c mains voltage prior to application of the test level.
42
netic fi elds should be
at levels characteristic
of a typical location in
a typical cornmercial or
hospital environment.
Page 33
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
(according to EN 60601-1-2:2007; 5.2.2.2 Table 3)
MultiStim SWITCH is intended for use in the electromagnetic environment specifi ed below. The
customer or user of the MultiStim SWITCH should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic envi-
ronment - guidance
Conducted RF
according to
IEC 61000-4-6
3V
rms
150 kHz to 80 MHz
outside the ISM-bands
10Vrms
150 kHz to 80 MHz in
the ISM-bands
a
Not applicable Portable and mobile
a
Not applicable
RF communications
equipment should not
be used no closer to
any part of the MultiStim SWITCH, 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.
Radiated RF
according to
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
10V/m Field strengths from
fi xes 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:
English
Note 1
At 80 MHz and 800 MHz, the higher frequency range applies.
43
Page 34
Note 2
a) The ISM (industrial, scientifi c 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 fi xed transmitters, such as base stations of radio (cellular/cordless) telephones
English
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 fi xed RF
transmitters, an electromagnetic site survey should be considered. If the measured fi eld strength
in the location in which the MultiStim SWITCH is used exceeds the applicable RF compliance level
above, the MultiStim SWITCH should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
MultiStim SWITCH.
d) Over the frequency range of 150 kHz to 80 MHz, fi eld 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-specifi cal compatibility of the individual products. PAJUNK® GmbH Medizintechnologie has no infl uence 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 benefi cial 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 defi ciency, 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.
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and
people
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 modifi cation of the product shall remain reserved.
Products are free of latex.
Made in Germany – manufactured by PAJUNK® GmbH Medizintechnologie
44
Page 35
Storage conditions
30°C
10°C
20
Symbol for:
Keep away from sunlight
Keep away from rain
Consult instructions for use
Do not use if package is damaged
Do not resterilize
Sterilized using ethylene oxide
Do not re-use
Manufactured and monitored acc. to European Legislation for Medical Devices
Manufactured acc. to European Legislation for Medical Devices
PHT
Does not contain Phthalates (acc. to sec. 7.5 of Annex I 93/42/EWG)
PHT
Does contain Phthalates as identifi ed
Does not contain latex
Contains latex
Non-pyrogenic
Pieces
Catalog number, Unique identifi er
Batch-Identifi cation
„Use-by“-date
Date of manufacture
Device Type “BF”
65
English
Catalogue Excerpt/Examples of Products
Product Item No. PU
MultiStim SWITCH in equipment case and SWITCH patients
1151-94-40
cable for the connection of the cannulae and the StimuLong
catheter
Patients cable for Multistim SWITCH 1151-94-07
Cable for connection of stimulating cannulae 1151-94-05
Extension cable, autoclavable 01151-861F
Extension cable, disposable 01151-861Q
45
Page 36
GmbH • Medizintechnologie • Karl-Hall-Straße 1 • D-78187 Geisingen • Germany • Telefon 07704/9291-0 • Telefax 07704/9291-600 · www.pajunk.com
®
XS190174B 2010-03-22
136
0124
PAJUNK
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