pajunk MultiStim ECO User manual

Nerve stimulation
MultiStimECO

2
English
Instructions for Use
Special notice
Please read the following information and operating instructions carefully.
Rx
only
Caution: Federal law restricts this device to sale by or on the order of a physician.
The device may only be used by qualified medical sta in accordance with
these user instructions.
PAJUNK® does not recommend any particular treatment method. Professional
medical sta are responsible for the way in which the device is used and for
patient selection.
In addition to these instruction for use, the relevant information also applies
according to the corresponding specialist literature and current state of the art
and knowledge.
Failure to comply with the user instructions invalidates the warranty and puts
patient safety at risk.
If used in combination with other products, it is essential that the compatibility
information and user instructions for these other products are taken into account.
A decision regarding the combined use of devices from dierent manufacturers
(where they do not constitute treatment units) is the responsibility of the user.
The device must not be used under any circumstances if there are good reasons
to suspect incompleteness or damage.
Product specification / compatibility / accessories
The MultiStimECO is intended to be used only with PAJUNK® GmbH Medizin-
technologie devices (e.g. UniPlex or SonoPlex cannulas). Safe and successful
functioning can only be guaranteed if these devices are used.
The MultiStimECO is delivered with the following basic equipment:
• MultiStimECO nerve stimulator
• 2 x 1.5V N batteries (LR1, LADY, N size)
• Instructions for use / technical description
• Case to store the MultiStimECO
The MultiStim ECO can be connected to the cannula cable or a disposable
extension cable (either as an extension or to use a stimulation catheter):
The PlugX accessory can also be connected to the MultiStimECO. This allows
using MultiStimECO as a hand-held device. There are separate instructions for
use for PlugX.

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Designation Art. no.
MultiStimECO with case 1151-94-50
Disposable extension cable to connect stimulation
cannulas or catheters; sterile 01151-861Q
PlugX hand-held adapter 1151-94-21
SonoPlex LUER cannulas/sets 001185-xx
001187-xx
SonoPlex Surety®cannulas/sets 001186-xx
001189-xx
All PAJUNK® GmbH Medizintechnologie cannulas/catheter sets used for peri-
pheral regional anaesthesia/nerve blocks using nerve stimulation.
Conformity with the following standards:
EN60601-1; 14971:2000; EN60601-2-10; EN60601-1-2; UL 60601; Directive
93/42/EEC; EN62366:2008; EN60529:2014; ISO 15233-1:2012
Intended use
The MultiStimECO is used to identify and locate peripheral nerves and nerve
cords in local and regional anaesthesia, for example (diagnostic, intraoperative
and therapeutic block).
Indications
Peripheral regional anaesthesia/nerve blocks
Contraindications
There are no device-specific contraindications.
Specific contraindications exist for certain block anaesthesia techniques. Users
should consider them based on the state of the art and an individual risk-benefit
analysis for every patient.
General contraindications for peripheral nerve blocks include:
• Infections at the puncture site
• Clinically manifest coagulation disorders
• Patient refusal
• Neurological deficits

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Complication
Typical complications of peripheral nerve blocks include:
• Toxic reactions (to injection solution)
• Late neurological damage
Specific complications related to certain block anaesthesia techniques may also
occur. Users should consider them based on the state of the art.
Warnings and safety instructions
Connect the connection socket of the stimulation cannula only to the mating
connector of the nerve stimulator. If you use an extension cable, please make
sure that it is correctly connected!
The snap on the back of the device may only be connected to the adhesive elec-
trode. By no means may these plugs/connections get in contact with live parts
(e.g. sockets) or metal objects.
Stimulation must not take place on the head, eyes, mouth or heart.
To avoid a gas explosion of anaesthetic gases or inflammation of flammable
liquids, the MultiStimECO must not be used in explosive atmospheres.
To avoid unintended injury to the patient, all connected equipment in the
patient's environment must comply with the applicable regulations. All equip-
ment and accessories must comply with requirements to EN 60601-1 and
EN60601-1-1 as well as the applicable sub-standards.
Please note that, in the worst case, all leakage currents and/or the patient's aux-
iliary currents might add up so that inadmissibly high values put the patient
at risk, even if all requirements for the individual devices are met. Therefore, it
must be checked in advance whether admissible limit values are exceeded when
equipment is interconnected. Improper interconnection of devices and equip-
ment (formation of systems) can cause life-threatening injuries to the patient.
The patient must not get in contact with metal objects which are earthed or
have an electrically conductive connection with other devices or enable capaci-
tive coupling. We therefore recommend using a suciently insulating, antistatic
cover for the operating table.
Under no circumstances may the MultiStimECO be used with other instru-
ments and accessories than those approved, supplied or recommended by the
manufacturer. Only PAJUNK® accessories have been tested for EMC (electro-
magnetic compatibility). Third-party accessories may lead to serious impair-
ment of the device and system features and cause permanent damage to
patient, user or device.
Do not make any unauthorised changes to the technical equipment of the
device. In case of manipulation, warranty and producer liability expire, and
patient safety is put at risk.

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If HF surgical devices are used at the same time, there is an imminent risk of
burns from the MultiStimECO connections, the connecting cable, cannula tip
and adhesive electrode. It is therefore necessary to disconnect all connections
to the MultiStimECO and to remove the stimulation cannula from the tissue
before using HF surgical devices.
The MultiStim ECO must not be used for patients with implanted electrical
devices (such as pacemakers) without prior medical advice from a specialist.
Possible faults of the implanted devices due to stimulation current may consti-
tute a risk for the patient.
Fastening electrodes near the thorax (chest, heart) may increase the risk of car-
diac fibrillation.
Observe positions of metal implants in the tissue (e.g. plates or electrode
cables). They might guide the stimulation signals to other areas and cause
damage there.
To avoid that bad contact of the adhesive electrode leads to an incorrect posi-
tioning of the stimulation cannula, make sure that the adhesive electrode has a
suciently stable contact with a low tissue impedance.
Use the MultiStimECO only with the original (CE-certified) PAJUNK® accessories.
Dynamic electric and magnetic interference fields might cause device/system
interactions. They can aect the measurement of the actual stimulation current
and, in the worst case, lead to a faulty display and a switch-o of the stimulation
for safety reasons (see section "Electromagnetic compatibility").
Check the MultiStim ECO regularly based on the guidelines in these instruc-
tions for use. To avoid malfunction of the MultiStim ECO, check all functions
before use and make sure that the accessories are suitable for the application.
The accessories used must comply with safety class BF.
Before and during use, keep the device, the connecting cables and the plugs
completely clean and dry. Humidity and dirt impair the function of the nerve
stimulator and the stimulation result.
Advance the cannula slowly and in a controlled way. Proceed with the greatest
care and caution when you try to overcome any tissue resistances.
You can interrupt active stimulation any time by pressing the ON/O button of
the device or by manually separating the cannula from the stimulator.
The MultiStim ECO and its listed accessories must be disposed of in compliance
with national provisions. Return the old device to the corresponding registered
EAR (German register for waste electric equipment) collection container or
return it to the manufacturer.

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The MultiStim ECO and its listed accessories must be disposed of in compliance
with national provisions. Return the old device to the corresponding registered
EAR (German register for waste electric equipment) collection container or
return it to the manufacturer.
Technical description
The MultiStimECO generates reproducible rectangular pulses with a frequency
of 1Hz and incrementally adjustable stimulation current. The setting range for
the pulse current is 0.2 to 2.0mA for stimulation cannulas and catheters.
If a current pulse is delivered and the patient circuit closed, the green LED next
to the stimulation button blinks for visual control; for acoustic control, a short
signal tone synchronous to the stimulation rhythm can be heard, i.e. stimula-
tion current flows through the patient.
If the green LED next to the stimulation button is on, either the patient circuit
is not closed or there is a resistance >12kΩ; in these cases, there is no acoustic
signal, i.e. no stimulation current or a stimulation current lower than selected
one flows through the patient. This is additionally indicated by the yellow LED
next to the unequal sign (≠).
Technical data
Type MultiStimECO
Degree of protection against
electric shock EN60601-1
BF
Protection class IEC60529 IP54
Battery 2 x 1.5V LR1 (N size, LADY battery)
Stimulation current Max. 2 mA
Resistance range: 0 Ω - 12 kΩ
Stimulation voltage Max. 24 V
Stimulation frequency 1 Hz
Stimulation pulse width 0.1ms
Operating conditions Temperature: 10 °C to 30 °C
Humidity: 20% – 65%
Pressure range: 700 hPa to 1060 hPa
Transport and storage condi-
tions
Temperature: 10 °C to 30 °C
Humidity: 20% – 65%
Pressure range: 700 hPa to 1060 hPa

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Service life 2years
User interface
The current setting is indicated by LEDs.
When the MultiStim ECO is switched on, factory settings are
always activated; these are as follows:
Stimulation current intensity: 0.5 mA (green LED below 0.5mA
is on)
Volume: medium (central green LED above the loudspeaker
symbol is on)
Stimulation: OFF (LED next to stimulation button is o)
Function keys
Button Function
ON / OFF
Volume selection (medium · high · low · medium · high ·
low · etc.)
Selection of the simulation current intensity
(0.2mA · 0.5mA · 0.7mA · 1.0mA · 1.5mA · 2.0mA)
Stimulation ON / OFF (Pause)

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Function symbols
Symbol Meaning
Battery status indicator
Green LED is on: battery okay. Batteries are working, the required
power is available.
Red LED blinks: battery capacity is very low; replace the batteries
as soon as possible.
Red LED is on: batteries are discharged, the stimulator can no
longer be used. Replace the batteries immediately to be able to
use the stimulator again.
Yellow LED o: electric circuit closed, selected current = output
current
Yellow LED is on: electric circuit not closed (e.g. cannula not yet
inserted, adhesive electrode is not correctly positioned, cable is not
correctly connected, too high resistance in the system, etc.)
Warning symbol!
LED o: there is no active warning, you can use the stimulator.
Red LED is on: there is an internal or external fault. You may not or
cannot use the device under any circumstances. Send the Multi-
Stim back to the manufacturer.
Operation
Check and start-up
Please note: Devices showing other reactions must not be put into operation.
Please contact the customer service in such cases. Electromedical devices may
only be opened and/or repaired by the manufacturer or by a body expressly
authorised by the manufacturer.
Please check the following points before each start-up of the device:
1. Press the ON button to switch the device on. The device is switched on
and switches to PAUSE mode. The factory settings are displayed (medium
volume, current intensity: 0.5mA, stimulation: OFF). If the red LED of the
battery status indicator blinks after switching on, you should replace the
batteries. If the red LED of the battery status indicator is permanently lit,
you have to replace the batteries immediately (see section "Batteries"). If
the stimulator detects a malfunction, the red warning LED is on. The device
is no longer ready for use and must be returned to the manufacturer.

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2. Connect the adhesive electrode to the snap at the rear of the
MultiStimECO. Remove the protective film of the adhesive electrode and
attach it together with the stimulator to a suitable location on the patient's
body. For optimum handling of the stimulator, a position near the punc-
ture site is recommended.
3. If you prefer to use a disposable extension cable, plug the yellow con-
nector of the extension cable in the contact jack on the bottom of the
stimulator. Connect the white connector of the extension cable to the
cannula cable or the clamping adapter of the catheter (only for stimulable
catheters). If you do not use an extension cable, plug the connector of the
cannula cable directly in the opening provided for it at the bottom of the
stimulator.
4. After connecting all components and activating the stimulation when the
cannula has not yet been inserted, only green LEDs and the yellow LED
next to the ≠ symbol should be on (open circuit). If this is the case, you can
start using it.
5. As soon as you touch the skin surface with the cannula and/or puncture,
the MultiStimECO starts delivering current pulses. You can perceive this
visually, by the rhythmic blinking of the stimulation LED, as well as acous-
tically.
Operating the nerve stimulator
Switching on/o
To switch the MultiStimECO on, press the ON/OFF button briefly.
To switch the MultiStim ECO o, keep this button pressed for
napprox. 2seconds.
If you do not switch o the stimulator and do not press any
button for 30minutes, the MultiStimECO switches o automati-
cally to save battery power.
Selecting the stimulation current intensity
A stimulation current intensity of 0.5 mA is preset as the start
value. If you want to increase the stimulation current intensity,
press the right selection button (+); to decrease, press the one
on the left (-).
The highest (2.0 mA) and lowest (0.2 mA) stimulation current
intensities are limit values; it is not possible to continuously decre-
ase and/or increase the current intensity. For safety reasons, it is
not possible to go from 0.2mA directly to 2.0mA when pressing
the left selection button (-), for example.

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Starting simulation / PAUSE function
After switching on, the MultiStimECO is always in PAUSE mode.
You can recognize this by the fact that the LED next to the sti-
mulation button is o, and you do not hear any acoustic signal.
Press the stimulation button to start stimulation. Press it again to
switch the MultiStimECO back to PAUSE mode.
Important: In PAUSE mode, you can change the stimulation cur-
rent intensity without giving stimulation pulses to the patient.
If the patient circuit is already closed after starting stimulation, the
green stimulation LED blinks in accordance with the frequency in
a 1-Hz rhythm; at the same time, you can hear an acoustic signal
in the same rhythm.
If the patient circuit is still open after starting stimulation, the
green stimulation LED is lit, but there is no acoustic signal, and
the yellow LED next to the unequal sign (≠) is also on. As soon
as the circuit is closed and pulses are delivered to the patient, the
yellow ≠goes out. At the same time, the green stimulation LED
starts blinking and the acoustic signal can be heard.
Setting the volume
When the MultiStimECO is switched on, a medium volume is set
for the acoustic signal.
You can adjust the volume by pressing the volume button
(medium ·high ·low ·medium ·high ·low ·, etc.). The adjusted
volume is indicated by the three green LEDs above. The left LED
means low, the right means high. The LED of the selected volume
is lit in green.
If the yellow LED of the ≠ symbol is lit during operation and the acoustic signal
can no longer be heard, the set amperage is no longer reached. This might be
due to the following causes:
• No stimulation cable is connected or it is defective
• The electrodes are not or not correctly connected.
• The electrical resistance of the patient's tissue is too high.
The active stimulation can also be ended by pressing the ON/OFF button (keep
the button pressed for at least 2seconds).

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Batteries
Please check regularly that the batteries are properly charged. The battery status
indicator helps you with this. If it is green, the battery status is okay. As soon as
it starts blinking red, you should replace the batteries as soon as possible to fur-
ther guarantee reliable stimulation. If the battery status indicator is lit in red, no
more stimulation is possible. You can only continue to use the MultiStimECO if
you replace the batteries immediately.
If you do not use the MultiStimECO for a longer period, remove the batteries
from the device to avoid leakage.
Replacing the batteries
The battery compartment is located at the rear of the MultiStimECO. Open the
compartment by unscrewing the screw of the compartment using a suitable
tool. Replace the batteries.
Always replace both batteries and only use new batteries.
When putting in new batteries, make sure they are positioned correctly.
Only use alkaline manganese batteries (e.g. Varta LR1 / 4001 / LADY / N;
Duracell LR1 / LADY / N; Energizer LR1 / LADY / N).
Each time after replacing the batteries, check the MultiStim ECO before
start-up to make sure that it is still working correctly.
Attention: If the battery is leaking, the MultiStim ECO should no longer be
operated for safety reasons.
Cleaning and disinfecting
Only use soft, humid cloths for cleaning and disinfecting the device. Water,
soapy water and methylated spirit are particularly suitable. Make sure that no
humidity enters the device. Use alcohol or commercially available alcohol-based
disinfectants for disinfection.
Attention: The following products must not be used for cleaning: trichlorethyl-
ene, acetone, butanone, methanol, nitro dilutions.
Maintenance and safety inspections
Check the device for proper function before every use. A defective device must
not be operated. Electromedical devices may only be repaired by the manufac-
turer or by a body expressly authorised by the manufacturer. Add a detailed
error description to your repair order.
Safety inspections
Safety inspections are not required.

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Signal path and pulse pattern
Stimulation is performed by means of monophasic, negative rectangular pulses
in all waveforms. Electrical energy is released only for the duration of the stim-
ulation pulse.
Stimulation pulse form: rectangular
Stimulation frequency: 1Hz
Pulse width: 0.1ms
Electromagnetic compatibility (EMC)
The MultiStimECO complies with EN60601-1-2:2007, the standard for electro-
magnetic compatibility (EMC).
Tests for electromagnetic compatibility were carried out by:
LCIE (Laboratoire Central des Industries Electroniques), Aire de la Thur, F-68840
Pulversheim
Guidelinesandmanufacturer'sdeclaration–electromagneticinterference
(acc. to EN60601-1-2:2007; 5.2.2.1 table1)
The MultiStimECO is intended for use in electromagnetic environment as spe-
cified below. Customers or users of the MultiStim ECO must ensure that it is
operated in such an environment.
Interference measure-
ment
Compliance Electromagnetic environment
– guideline
HF emissions according
to CISPR11
Group1 The MultiStim ECO uses
HF energy only for its internal
function. Therefore, its HF emis-
sion is very low, and it is impro-
bable that interferences with
adjacent electronic devices are
generated.

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HF emissions according
to CISPR11
ClassB The MultiStimECO is suitable for
use in facilities other than resi-
dential areas and those directly
connected to the public supply
network, which also supplies
buildings used for residential pur-
poses.
Harmonic current emissi-
ons acc. to IEC61000-3-2
Not applicable
Emission of voltage fluc-
tuations and flicker acc.
to IEC61000-3-3
Not applicable
Guidelines and manufacturer's declaration – electromagnetic immunity
(acc. to EN60601-1-2:2007; 5.2.2.1 table2)
The MultiStimECO is intended for use in electromagnetic environment as spe-
cified below. Customers or users of the MultiStim ECO must ensure that it is
operated in such an environment.
Immunity test IEC60601 test
level
Compliance
level
Electromagnetic environ-
ment – guidelines
Electrostatic
discharge
(ESD) acc. to
IEC61000-4-2
± 6 kV contact
discharge
± 8 kV air
discharge
± 6kV contact
discharge
± 8 kV air
discharge
Floors should be made of
wood or concrete or have
ceramic tiles. If the floors
consist of synthetic material,
relative humidity must be at
least30%.
Electrical fast
transient/burst
according to
IEC61000-4-4
± 2 kV for
power cables
± 1kV for input
and output
cables
Not applicable Not applicable

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Voltages/surges
according to
IEC61000-4-5
± 1 kV exter-
nal conductor
- external con-
ductor voltage
± 2kV external
conductor -
earth voltage
Not applicable Not applicable
Voltage dips,
short inter-
ruptions and
variations of
supply voltage
according to
IEC61000-4-11
< 5% Ur
(>95% dip of Ur) for
½period
40% Ur
(60 % dip of Ur) for
5periods
70% Ur
(30 % dip of Ur) for
25periods
< 5% Ur
(>95% dip of Ur) for
5s
Not applicable Not applicable
Magnetic
fields at supply
frequency
(50/60Hz) acc.
to IEC61000-
4-8
3 A/m Not applicable Not applicable
Uris the AC mains voltage before applying the test levels

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Guidelines and manufacturer's declaration – electromagnetic immunity
(acc. to EN60601-1-2:2007; 5.2.2.1 table4)
The MultiStimECO is intended for use in electromagnetic environment as specified
below. Customers or users of the MultiStimECO must ensure that it is operated in
such an environment.
Immunity
test
IEC60601 test
level
Compliance
level
Electromagnetic environ-
ment – guidelines
Immunity to
conducted
interference
acc. to IEC
61000-4-6
3Veective value
150kHz to 80MHz
within ISM bandsa
Not appli-
cable
Portable and mobile radio
devices should not be used
closer to the MultiStimECO
and its cables than the
recommended safety dis-
tance calculated based on
the equation valid for the
transmitter frequency.
Recommended safety dis-
tance:
d = 3.5/U1√P for 150kHz to
80MHz
d = 12/U1√P for 80MHz to
800MHz
d = 23/U1√P for 800MHz
to 2.5GHz
with P being the maxi-
mum nominal power of
the transmitter in watt(W)
acc. to the information
of the transmitter manu-
facturer and d the recom-
mended safety distance in
metres(m)b.
10Veective value
150kHz to 80MHz
within ISM bandsa
Not appli-
cable

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Immunity
to radiated
interference
acc. to IEC
61000-4-3
3V/m
80MHz to 2.5GHz
3V/m The field strength
of stationary radio
emitters should
be below the
compliance level
at all frequenciesd
according accor-
ding to an on-site
surveyc.
Interference is pos-
sible near devices
with the following
label:
Note1 At 80 MHz and 800 MHz, the higher frequency range
applies.
Note2 These guidelines might not be applicable in all cases. Elec-
tromagnetic propagation is influenced by absorptions and
reflections of buildings, objects and people.
a) ISM frequency bands (for industrial, scientific and medical applications)
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) Compliance levels in ISM bands between 150 kHz and 80MHz and in
the frequency range from 80MHz and 2.5GHz are intended to reduce the
probability that mobile/portable communication devices cause interference
if they are unintentionally brought into the patient's area. For this reason,
an additional factor of 10/3 is used for calculating the recommended safety
distances in these frequency ranges.
c) The field strength of stationary transmitters, such as base stations of radio
telephones and land mobile radios, amateur radio stations, AM and FM radio
and television transmitters, cannot be accurately predetermined in theory. To
determine the electromagnetic environment with regard to stationary trans-
mitters, an investigation of the site of use should be considered. If the measu-
red field strength at the location where the MultiStimECO is used exceeds the
above-mentioned compliance level, the MultiStimECO should be observed
to determine whether it works properly. If unusual performance characte-
ristic are observed, additional measures, such as an altered alignment or a
dierent location for the MultiStimECO, may be necessary.
d) The field strength should be lower than 10V/m across the entire frequency
range from 150kHz to 80MHz.

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Addition: IEC60601-2-10 National Deviation Canada
IEC 60601-2-10 National Deviation Canada cl. 6.8.3 bb)
The maximum output charge per pulse and maximum average current across a
500 ohm resistive load and at the maximum output setting
Maximum Output Charge per pulse:
Q
2.0 mA = I×t
Q
2.0 mA = 2.0 mA×100 µs
Q
2.0 mA = 0.2 µAs
Maximum Average Current across a 500 ohm resistive load and at the maxi-
mum output setting (2.0 mA)
I
average = I ×tw
TStim
I
average = 2.0 mA ×100 µs
1 s
I
average = 0.2 µA
Graphical representation of typical output sign
200 Ω 500 Ω 1000 Ω 2000 Ω OPEN
half setting 1.0mA 200 mV 500 mV 1000 mV 2000 mV 0 mV
full setting 2.0mA 400 mV 1000 mV 2000 mV 4000 mV 0 mV
tw=100µs
TStim=1 s

18
General information
The devices are manufactured in accordance with globally applicable guidelines
for hazardous substances.
BF-type application part
Dispose of all components and materials sorted and in an environmentally
friendly way or have them recycled. If the medical device is no longer used, it
must be disposed of according to the country-specific environmental regula-
tions.
Any serious incident that has occurred while using the device should be
reported to the manufacturer and the corresponding authorities of the country
the user and/or patient are residing in.
PAJUNK® GmbH Medizintechnologie, Karl-Hall-Strasse 1, 78187 Geisingen,
Germany.
Key to symbols used in labelling
Manufacturer Consult instructions for use
Catalogue number
Rx
only
Dispensing with prescription only
(The product may only be used
by qualified medical sta for the
intended purpose.)
Do not use if package is damaged
Keep dry Do not dispose of with domestic
waste
Humidity limitation Advice
Caution Information
Protection against electric shock, type
BF Product is in conformity with the
applicable requirements set out
in Community harmonization
legislation and is monitored by a
notified body
Date of manufacture
Batch code
Non-sterile Consult instructions for use (SO
7010-M002)
Keep away from sunlight Quantity
Temperature limit Translation
Pressure range Medical device
English

19
PAJUNK® GmbH
Medizintechnologie
Karl-Hall-Strasse 1
78187 Geisingen/ Germany
Phone [phone]
Fax [phone]
www.pajunk.comXS190244B_Englisch 2020-01-21
0124