Xavant STIMPOD MMS460 User manual

PRODUCT CODE: XT-46006-EN
XM400-31A04-07

i

Manufacturer
Xavant Technology Pty (Ltd)
Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd
Silverton, Pretoria, South Africa, 0184
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
Web: www.xavant.com
Legal Representative in the EU
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Tel: [phone]
Fax: [phone]
Indications for use:
The STIMPOD NMS460 is a Transcutaneous Electrical Nerve Stimulation device
used for symptomatic relief and management of chronic intractable pain and/
or as an adjunctive treatment in the management of post-surgical pain, post
traumatic acute pain problems, as well as an adjunct for pain control due to
rehabilitation.
Contraindications:
• Known neurological disorders.
• Do not use this device on patients who have a cardiac pacemaker, implanted de-
fibrillator, or other implanted metallic or electronic device, because this may cause
electric shock, burns, electrical interference, or death.
• Do not use this device on patients whose pain syndromes are undiagnosed.
Warnings:
• Read the entire User Manual before attempting to use the device.
• Use of cables or accessories other than those supplied with the STIMPOD NMS460
may result in serious injury.
• Maintenance on this device may only be performed by the manufacturer or
persons explicitly authorized by the manufacturer.
• Do not use the STIMPOD NMS460 in close proximity to equipment that produces
strong electromagnetic fields, such as high frequency surgical equipment. The
cable leads could act as antennae and dangerous currents could be induced as
a result.
• The device should not be used adjacent to or stacked with other equipment and
that if adjacent or stacked use is necessary, the device should be observed to verify
normal operation in the configuration in which it will be used.
• The patient should avoid contact with metallic objects that are grounded, produce
an electrical conductive connection with other equipment and/or enable capacitive
coupling.
• The cables should be positioned in such a way that they do not contact either the
patient or other cables.
• Simultaneous connection of a patient to high frequency surgical ME equipment
and the STIMPOD NMS460 may result in burns and possible damage to the
stimulator.
• Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME
equipment may produce instability in the stimulator output.
• Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
• If battery acid has leaked into the device essential circuitry may have been
compromised. In the event of leakage the device must be returned to its
manufacturer for safety checks and possible repairs.
• Do not apply stimulation over the patient’s neck because this could cause severe
muscle spasms resulting in closure of the airway, difficulty in breathing, or adverse
effects on heart rhythm or blood pressure.
• Do not apply stimulation over open wounds or rashes, or over swollen, red,
infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis,
varicose veins).
• Do not apply stimulation over, or in proximity to, cancerous lesions.
• Do not apply stimulation when the patient is in the bath or shower.
• Do not apply stimulation while the patient is sleeping.
• Do not apply the stimulation while the patient is driving, operating machinery,
or during any activity in which electrical stimulation can put the patient at risk of
injury.
• Do not apply stimulation when the leads are open circuited (e.g. when the
electrodes are held in the user’s hands).
• Do not remove electrodes when stimulation is being applied (to avoid unintended,
possibly hazardous, stimulation pathways).
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• Stimulation should not be applied across or through the head, directly on the
eyes, covering the mouth, on the front of the neck, (especially the carotid sinus),
or from electrodes placed on the chest and the upper back or crossing over the
heart.
• Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• Do not apply stimulation over the menstruating or pregnant uterus.
Cautions:
• Remove elements which may adversely affect the connection between the ECG
electrodes and the skin, e.g., dirt, hair, oil.
• Ensure that ECG electrodes are not damaged or dried out.
• ECG electrodes may be used in the higher current ranges (> 10 mA).
• This product must be stored at room temperature.
• This product must be transported in the carry case provided.
• This product and all the accessories have been certified latex free.
• Inspect all parts for any damage or manipulation. Never use any damaged or
manipulated part!
• If an electrically conductive surface of the STIMPOD NMS460 device or its cables
are exposed, such electrically conductive surface may shock a person handling it.
Do not use such a device or accessory, please contact the manufacturer for repair.
• A sterile wipe should be used to disinfect the Nerve Mapping Probe prior to use.
• Keep this device out of reach of children.
• Use this device under the continued supervision of a licensed practitioner.
Precautions:
• Electrical nerve stimulators are not effective for pain of central origin, including
headache caused by central origin.
• Electrical nerve stimulators are not a substitute for pain medications and other
pain management therapies.
• Electrical nerve stimulator devices have no curative value.
• Electrical nerve stimulators are a symptomatic treatment and, as such, suppresses
the sensation of pain that would otherwise serve as a protective mechanism.
• Effectiveness is highly dependent upon patient selection by a practitioner qualified
in the management of pain patients.
• The long-term effects of electrical stimulation are unknown.
• Since the effects of stimulation of the brain are unknown, stimulation should not
be applied across the head, and electrodes should not be placed on opposite sides
of the head.
• The safety of electrical stimulation during pregnancy has not been established.
• Some patients may experience skin irritation or hypersensitivity due to the
electrical stimulation or electrical conductive medium (gel).
• Patients with suspected or diagnosed epilepsy should follow precautions
recommended by their physicians.
• Use caution when patient has a tendency to bleed internally, such as following
an injury or fracture.
• Use caution following recent surgical procedures when stimulation may disrupt
the patient’s healing process.
• Use caution if stimulation is applied over areas of the skin that lack normal
sensation.
Adverse Reactions:
• Patients may experience skin irritation and burns beneath the stimulation
electrodes applied to the skin.
• Patients may experience headache and other painful sensation during or following
the application of electrical stimulation near the eyes and to the head and face.
• Patients should stop using the device and should consult with their physicians if
they experience adverse reactions from the device.
Warranty:
• The STIMPOD NMS460 carries a 12 Month Warranty against defects, provided
that the device was used in accordance with the operating instructions.
• The STIMPOD NMS460 enclosure should not be opened under any circumstances.
Opening the unit will void the warranty.
Note:
• The STIMPOD NMS460 is not intended for home use.
STIMPOD 460 conforms to the following standards:
• IEC 60601-1, IEC 60601-2-10
• IEC 60601-1-2: CISPR 11 Group1 class B; IEC 61000-4-2; IEC 61000-4-3
• ISO 13485, Directive 93-42-EEC, ISO 9001
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Guidance and manufacturers declaration – electromagnetic emissions– for all equipment and systems
The STIMPOD NMS460 is intended for use in electromagnetic environment specified below. The customer or user of the STIMPOD NMS460 should ensure that it is used in such an environ-
ment
Emission Test Compliance Electromagnetic Environment – Guidance
RF Emissions
CISPR 11
Group 2 – Class A The STIMPOD NMS460 must emit electromagnetic energy in order to per-
form its intended function. Nearby electronic equipment may be affected.
The STIMPOD NMS460 is suitable for use in all establishments, other than do-
mestic establishments and may be used in domestic establishments and those
directly connected to the public low voltage power supply network that sup-
plies buildings used for domestic purposes, provided the following warning is
heeded:
WARNING: This equipment/system is intended to be used by healthcare pro-
fessional only. This equipment/system may cause radio interference or disrupt
the operation of nearby equipment. It may be necessary to take mitigation
measures, such as re-orienting or re-locating the STIMPOD NMS460 or shield-
ing the location
Guidance and manufacturers declaration – electromagnetic immunity- for all equipment and systems
The STIMPOD NMS460 is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS460 should ensure that it is used in such an
environment
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 15 kV air
± 6 kV contact
± 15 kV Air
Floors should be wood, concrete or ceramic tile. If the floors are covered with
synthetic material, the relative humidity should be at least 30%
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 50 Hz
30 A/m (Effective)
Power frequency magnetic fields should be at levels characteristic of a typical
location in a typical commercial or hospital environment.
iv

Guidance and manufacturer’s declaration – electromagnetic immunity
The STIMPOD NMS460 is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS460 should assure that it is used in such an
environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3V at 0.15 - 80MHz and 6V at ISM
Frequency.
Home Healthcare: 3V at 0.15 - 80MHz, and
6V at ISM and Radio Amateur Frequency.
3 V/m (10V/m Home Healthcare) at
80 - 2,700MHz, AM Modulation. And
9-28V/m at 385-6000MHz, Pulse Mode and
other Modulation (upon Risk Analysis).
3V at 0.15 - 80MHz and 6V at ISM
Frequency.
Home Healthcare: 3V at 0.15 - 80MHz, and
6V at ISM and Radio Amateur Frequency.
3 V/m (10V/m Home Healthcare) at
80 - 2,700MHz, AM Modulation. And
9-28V/m at 385-6000MHz, Pulse Mode and
other Modulation (upon Risk Analysis).
Portable and mobile RF communications equipment should be used no
closer to any part of the STIMPOD NMS460 , including cables, than the
recommended separation distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d = 1,2 80 MHz to 800 MHz
d = 2,3 800 MHz to 2,5 GHz
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 metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,
a
should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the STIMPOD NMS460 is used exceeds the applicable RF compliance level above, the STIMPOD NMS460 should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the STIMPOD NMS460.
v

Recommended separation distances between
portable and mobile RF communications equipment and the STIMPOD NMS460
The STIMPOD NMS460 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STIMPOD NMS460 can
help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the STIMPOD NMS460 as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
Not applicable
80 MHz to 800 MHz
d = 1,2
800 MHz to 2,5 GHz
d = 2,3
0,01 -0,12 0,23
0,1 -0,38 0,73
1 - 1,2 2,3
10 -3,8 7,3
100 -12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency
of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Guidance and manufacturers declaration – electromagnetic immunity – for equipment and systems that are non-
life supporting
The STIMPOD NMS460 is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS460 should ensure that it is used in such
an environment
Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Radiated immunity
80MHz - 2.5GHz
80MHz – 1GHz @ 3V/m &
10V/m
1GHz – 2.5GHz @ 10V/m
80MHz – 1GHz @ 3V/m &
10V/m
1GHz – 2.5GHz @ 10V/m
Portable and mobile RF communications equipment can affect MEDICAL
ELECTRICAL EQUIPMENT and should be used no closer to any part of the
equipment, including cables, than the recommended separation distance.
vi

Contents
Page
1. Getting to know the STIMPOD NMS460 1
1.1) Device Description 1
1.2) Accessories 1
1.3) Device Layout 2
1.4) Screen Layout 3
1.5) Adjusting Settings 4
1.6) Open Circuit Detection 4
1.7) Countdown Timer 4
1.8) Shutdown 4
1.9) Symbols on device battery clip 4
2. Setting up Device Defaults 5
2.1) Languages 5
2.2) Stimulation Mode 5
2.3) Pulse Width Options 6
2.4) Stimulating Frequency 6
2.5) Countdown Timer 6
2.6) Speaker Volume 6
2.7) Backlight 7
2.8) User Information 7
3. Technical Notes 8
3.1) Performance Test 8
3.2) Specifications 9
3.3) Cleaning and Disinfecting STIMPOD NMS460 9
4. Products and Accessories 10
vii

1.1) Device Description
The STIMPOD NMS460 is a Low Frequency Neuromodulation Transcutaneous Electrical Nerve Stimulation device, used for symptomatic relief and management of
chronic intractable pain and/or as and adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as and adjunct for pain
control due to rehabilitation.
The STIMPOD NMS460 offers two types of waveforms for the treatment of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines.
The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform. This waveform is
proprietary and is unique to the STIMPOD NMS460. For more information on the benefits of using this modality please visit www.xavant.com.
1.2) Accessories
WARNING: Use of cables or other accessories other than those supplied with the STIMPOD NMS460 may result in serious injury.
NOTE: Standard ECG Electrodes can be used for the anode. Such ECG electrodes need to conform to ANSI/AAMI EC12 on disposable ECG electrodes, ISO 10993 on
biocompatibility and the European Medical Device Directive. ECG electrodes are not included in this package.
Carry Case
1) Getting to know the STIMPOD NMS460
WARNING: If battery acid has leaked into the device essential circuitry may have been compromised. In the event of leakage the device must be returned to its
manufacturer for safety checks and possible repairs.
Batteries:
•This unit uses 4 x AAA penlight batteries.
•Alkaline batteries are recommended.
•When the battery is depleted the unit will prompt the user to replace the battery and switch off.
•Switch device off before replacing battery.
•Remove battery if the device is not to be used for an extended period of time, to prevent
leakage.
Probe Cable:
•The red (anode) connector is designed to clip on to a standard ECG electrode.
•The ergonomically designed Probe is used to stimulate the affected area.
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Display
Multi Functional Clip
Battery Compartment Cover
1.3) Device Layout
Cable Connector
• Insert the Cable
Enter / Frequency Button
•Press to toggle between Stimulating Frequencies.
•Press to Enter in setup menu.
Stimulating LED indicator
•Flashing Green: Stimulus delivered.
•Flashing Red: Open Circuit detected.
Menu / Pulse Width Button
•Press to toggle between Pulse Widths.
•Press and hold to access Setup Menu.
Pause Button
•Press to Start /Stop Stimulation.
The Wheel
•Adjust current in the main operating mode.
•Navigate the Setup Menus.
On / Off Button
•Press to switch unit on / off.
2

Speaker Volume
Square Wave Hybrid RF
Battery Status
1.4) Screen Layout
•Countdown timer
•Current Setting
Adjust using Wheel.
•Pulse Width Setting
Adjust using Menu / Pulse Width button.
•Warning Screen
•Stimulating Frequency Setting
Adjust using Enter / Hz button.
•Indicators
Insert Cable:
This is the first prompt which the user will encounter as the unit is switched on, and signals that the unit is waiting for the cable to be inserted.
Actual current delivered
The current displayed in this screen is the actual Average Current delivered to the patient. If there is a discrepancy of more than 10% between this
measured current and the current setting a warning sign “ ” will appear. If the actual current delivered is not the same as the current setting it
means that the impedance of the circuit between the device and patient is too high (higher than 13 kOhm). This is most likely caused by a poor
grounding electrode/skin connection.
Pause:
This warning informs the user that the PAUSE button was pressed.
The STIMPOD NMS460 will pause all its activities and wait for the PAUSE button to be pressed again.
Cable not recognised:
This warning informs the user that the inserted cable is not compatible with the STIMPOD NMS460.
Replace Batteries:
This warning informs the user that the batteries are depleted beyond an acceptable level. Continuing to operate the device thus will make it
unreliable. To prevent this the STIMPOD NMS460 flashes this warning for 4 seconds before switching off.
Open Circuit Detected:
This warning informs the user that the two electrodes (i.e. Ecg electrode and treatment probe) do not form the closed circuit. This warning will be
accompanied by a red flashing LED, every time the unit attempts to stimulate.
Error:
The STIMPOD NMS460 has detected a component failure. Please send the device back to the manufacturer for repair!
7
3

50°C
0°C
90%
10%
15
1.5) Adjusting Settings
Adjusting the Current
Current Range: 0 – 30 mA adjustable in 1mA increments
Circle the Wheel to adjust the current
1.7) Countdown Timer
•Start the stimulation by pressing the play/pause button.
•The device will automatically start stimulation at the set
frequency and the countdown timer will start.
•The countdown will start from the time set in the
“Countdown Timer” option in the main menu.
•Pause the timer and the stimulation by pressing the
play/pause button.
•Reset the timer by pressing and holding the play/pause
button for longer than 2 seconds.
•The Countdown Timer defaults at 10 minutes. This setting can
be changed in the Setup Menu.
•The Stimulation will stop when the timer reaches 00:00.
An alarm will sound and the Countdown Timer will reset.
Adjusting the Pulse Width
Options in the Setup Menu: 0.1ms, 0.2ms
Default: 0.1ms
Press Menu/Pulse Width button to toggle between
different Pulse Widths.
Adjusting the Stimulation Frequency
Options in the Setup Menu: 1Hz, 2Hz, 5Hz, 10 Hz
Default: 2Hz
Press Enter/Hz button to toggle between different stimulating frequencies.
1.6) Open Circuit Detection
A few milliseconds prior to the actual stimulation, an impedance measurement
is made to detect whether the connection between the STIMPOD NMS460 and
the patient comprises a closed circuit.
Closed Circuit Detected:
•Stimulation will take place.
•Stimulating sound will be heard
•The LED stimulus indicator will pulse green with every successful stimulus atempt.
•The information screen will show the value of the actual current delivered.
Open Circuit Detected:
•No stimulation will take place.
•No stimulating sound will be heard.
•The LED stimulus indicator will pulse red with every
unsuccessful stimulus attempt.
•A warning screen will appear in the diagnostics screen indicating that an open
circuit was detected.
1.8) Shutdown
Auto Shutdown
STIMPOD NMS460 will automatically switch off after 10 minutes of no user or
patient interaction.
Battery Depleted
When the battery is depleted the unit will prompt the user to replace the
battery and switch off.
1.9) Symbols
Caution
Type BF
Applied Part
Separate collection
for electrical and
electronic equipment
(Applicable to EU
community only)
Manufacturing
Date (Year)
Prescription
use only
Serial Number
Non-sterile
Temperature
limit
50°C
0°C
90%
10%
Humidity
limitation
Manufacturer
Representative
in the EU
Catalogue
Number
Consult instructions
for use
4

2.2) Stimulation Mode
DEFAULT: Hybrid RF
Options: Hybrid RF, Square Wave
Use the Wheel to navigate to STIMULATION MODE . Press enter to select.
Hybrid RF Mode
The “ “ indicator in the main window tells the user that the device is in
Hybrid RF Mode.
2) Setting up Device Defaults
Access the Setup Menu by pressing
and holding the Menu/Pulse Width
Button. The setup menu allows the
user to customise all the default
settings.
2.1) Languages
DEFAULT: English
Use the Wheel to navigate to LANGUAGE. Press enter to select.
To select another default language, use the Wheel to
navigate to the preferred language. Press enter to select.
The radio button next to the selected language will show
that it is activated. To exit scroll down the menu to EXIT
MENU and press enter.
A conformation screen will show your selection, with an
option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you to the previous screen.
The radio button next to Hybrid RF Mode will show that
it is activated.
To exit scroll down the menu to EXIT MENU and press
enter.
The radio button next to Square Wave Mode will show
that it is activated.
To exit scroll down the menu to EXIT MENU and press
enter.
A conformation screen will show your selection, with an
option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you to the previous screen.
A conformation screen will show your selection, with an
option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you to the previous screen.
Square Wave Mode
The “ “ indicator in the main window tells the user that the device is in
Square Wave Mode.
Separate collection
for electrical and
electronic equipment
(Applicable to EU
community only)
Temperature
limit
Humidity
limitation
5

17
2.3) Pulse Width Options
DEFAULT: 0.1ms
Options: 0.1ms, 0.2ms
Use this setup function to activate the preferred pulse widths.
Use the Wheel to navigate to PULSE WIDTH in the main menu. Press enter to select.
Within the PULSE WIDTH Menu, the radio button next
to the selected pulse width will show that they have been
activated.
To exit scroll down the menu to EXIT MENU and press
enter. A confirmation screen will show your selection,
with an option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the previous screen.
NOTE: If all pulse widths are deselected the STIMPOD NMS460 will default to 0.1ms and
0.2ms.
2.4) Stimulating Frequency
DEFAULT: 2Hz
Options: 1Hz, 2Hz, 5Hz and 10 Hz
Use the Wheel to navigate to FREQUENCY in the main menu. Press enter to select.
Within the FREQUENCY Menu, the radio button next to
the selected frequency will show that it is has been activated.
Scroll down the menu to EXIT MENU and press enter.
A confirmation screen will show your selection with an
option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the previous screen.
2.5) Countdown Timer
DEFAULT: 10 minutes
Options: Adjustable from 00:01 to 59.59
Use the
Wheel to navigate to the COUNTDOWN TIMER . Press enter to select.
This timer counts down the desired treatment time.
‘Minutes’ will be highlighted: Use the Wheel to adjust
the settings. Press enter to accept the desired setting.
‘Seconds’ will be highlighted: Use the Wheel to adjust
the settings. Press enter to accept the desired setting.
A confirmation screen will show your updated values with
an option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the previous screen.
2.6) Speaker Volume
DEFAULT: Medium
Options:
U se the Wheel to navigate to SPEAKER VOLUME . Press enter to select.
Use the wheel to select the appropriate volume and enter.
Scroll down the menu to EXIT MENU and press enter.
A Confirmation screen will show the new selected volume
with an option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the previous screen.
2
2
6

2.7) Backlight
DEFAULT: 5 Seconds
Options: OFF, 5 seconds, 60 seconds, and Always On
Use the Wheel to navigate to BACKLIGHT in the main menu. Press enter to select.
Within the BACKLIGHT Menu, the radio button next to
the selected setting will show that it has been activated.
Scroll down the menu to EXIT MENU and press enter.
A confirmation screen will show your selection, with an
option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the previous screen.
NOTE: If the selected backlight option is ‘Always On’ the
battery life will be drastically shortened.
2.8) User Information
DEFAULT: No default
The STIMPOD NMS460 offers the user the option to enter user information. Two lines of 20
characters each may be entered. This user information will be displayed for two
seconds when unit is switched on, as per example.
Use the Wheel to navigate to USER INFORMATION in the main menu. Press enter to select.
When both lines have been entered, a confirmation screen
will show your selection, with an option to ACCEPT.
YES will take you back to the main Setup Menu.
NO will take you back to the first USER INFORMATION screen.
A cursor will appear at the first character’s position. Use the
Wheel to navigate to different characters. Press enter
to select the character and move to the next space.
Press enter on the ‘ ‘ character for backspace, on the
‘ ’ character for a space and on the ‘ ‘ character to
enter the line. A warning underneath the textbox will show
the available characters in the line.
7

3) Technical Notes
3.1) Performance Test
Before operating and using the device a performance test must be carried out at
the site of use. The performance test described below is in compliance with the
German § 5 MPBetreibV directive.
• Insert the batteries and switch on the device.
The following screen should appear on the display.
followed by
• Insert the Nerve Mapping Cable.
The following screen should appear on the display.
• The LED should flash RED and no audible feedback should be heard.
• Short-circuit the Nerve Mapping probe and the ECG connector.
The following screen should appear on the display.
• The LED should flash GREEN and if sound is enabled in the menu a beep should
be heard each time a stimulus is delivered.
• Stimulus should occur at the set frequency. (1,2 or 5 Hz).
• Use the adjusting wheel and slowly increase the current to 20mA.
• Monitor that the stimulating waveform, measured and displayed in the diagnostic
window is square. The top part of the square wave should also touch the dotted
line, which represents the current setting.
NOTE:
• If the STIMPOD NMS415 malfunctions in any one of these performance
tests, it should be checked by the relevant technical department.
• Equipment may only be repaired by the manufacturer or by an
organisation expressly authorised by the manufacturer.
• Equipment does not require regular calibration.
Insert Cable
Insert Cable
!
_ _ _
.
!
Insert Cable
Open Circuit
Detected
NMS4X0 VX.00
8

3.2) Specifications
Current Range: 0 - 30mA ± 5%
Pulse Width Options: 0.1ms, 0.2ms
Maximum Stimulation Voltage: 220V
Waveform: Monophasic square wave/ HYBRID RF wave
Stimulating Frequency: 1Hz , 2Hz, 5Hz, 10Hz ± 5%
Load Impedance: 0 kOhm - 5 kOhm
Device Classification: Class IIa, Type BF
Power Supply: 4 x AAA alkaline batteries
Power Consumption: 17mA
Weight: 130g
Dimensions: 145mm x 90mm x 30mm
Operating Temperature: 10 - 40 ° Celsius
Storage and Transport Temperature: 0 - 50 ° Celsius
Operating Humidity: 90% Relative Humidity
3.3) Cleaning and Disinfecting STIMPOD NMS460
Cleaning: Soap and water, applied with a damp cloth is suitable to clean the STIMPOD
NMS460. It is imperative that no moisture penetrates the STIMPOD NMS460.
Disinfecting: Any commercially available methanol - free disinfectant in an ethyl alcohol
base can be used for disinfection.
9

4) Products & Accessories
Product Product Code
NMS 460 PERIPHERAL NERVE STIMULATOR ONLY XT-46000
(No cables or accessories)
NMS 460 PERIPHERAL NERVE STIMULATOR KIT XT-46001
(Including Mapping Probe, Carry Case, IFU)
NERVE MAPPING CABLE XT-46003
CARRY CASE XT-41002
POLE/ WALL MOUNT XT-41007
10

11

Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd
Silverton, Pretoria, South Africa, 0184
Tel: [phone], Fax: [phone]
E-mail: [email protected], Web: www.xavant.com