NMS 410/450X

Quantitative NMT Monitor

Precision Nerve Locator

Product Code: XT-45006-EN

1639 XM400-21A04 v11
Manufacturer Warnings:
• Read the entire User Manual before attempting to use the device.
Xavant Technology PTY (LTD) • Use of cables or accessories other than those supplied with the STIMPOD may result
Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd in serious injury.
Silverton, Pretoria, South Africa, 0184 • Maintenance on this device may only be performed by the manufacturer or persons
Tel: +27 (0) 12 743 5959 explicitly authorized by the manufacturer.
Fax: +27 (0) 86 547 0026 • Do not use the STIMPOD in close proximity to equipment that produces strong
E-mail: [email protected] electromagnetic fields, such as high frequency surgical equipment. The cable leads
Web: www.xavant.com could act as antennae and dangerous currents could be induced as a result.
• Do not apply the STIMPOD to patients with implanted electrical devices, such as
Legal Representative in the EU cardiac pacemakers, without first consulting with an appropriate medical specialist.
• The device should not be used adjacent to or stacked with other equipment and that
Emergo Europe if adjacent or stacked use is necessary, the device should be observed to verify normal
Prinsessegracht 20, 2514 AP The Hague operation in the configuration in which it will be used.
The Netherlands • The patient should avoid contact with metallic objects that are grounded, produce
an electrical conductive connection with other equipment and/or enable capacitive
Caution coupling.
Federal (US) law restricts this device to sale by or on the order of a physician. • 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 may result in burns and possible damage to the stimulator.
Indications for use:
• Operation in close proximity (e.g. 1m) to a shortwave or microwave therapy ME
This product is a nerve stimulation device designed to be used by an anaesthetist during
equipment may produce instability in the stimulator output.
• General Anaesthesia, for the purpose of establishing the efficacy of a Neuromuscular
• Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
Blocking Agent using non-invasive surface electrodes (NMS450X).
• No modification of this equipment is allowed.
• Regional Anaesthesia for the purpose of
• Do not modify this equipment without authorization of the manufacturer.
• Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).
• If this equipment is modified, appropriate inspection and testing must be conducted
• Nerve locating using invasive electrodes/needles (not supplied).
to ensure continued safe use of the equipment.
Contraindications:
• Infection of the puncture site.
Cautions:
• Prior to changing the batteries be sure to switch off the device and remove all the
• Known neurological disorders.
cables.
• Severe coagulation disorders.
• Remove elements which may adversely affect the connection between the
electrodes and the skin, e.g., dirt, hair, oil.
• Prior to placing any applied part (such as Accelerometer, ECG and EMG Electrodes),
inspect the skin area for any pre-existing conditions and avoid if possible.
• Ensure that electrodes are not damaged or dried out.

2
• Large current densities associated with failing electrodes may cause superficial • The Stimpod enclosure should not be opened under any circumstances. Opening
burns. the unit will void the warranty.
• For acceleromyography, the Stimpod is designed to be compatible with standard STIMPOD (NMS 410/450X) conforms to the following standards:
ECG electrodes, however, for high currents the use of a dedicated NMT electrode • IEC 60601-1, IEC 60601-2-10, IEC 60601-2-40
such as the Xavant XT45008 is recommended. • IEC 60601-1-2: CISPR 11 Group1 class A; IEC 61000-4-2; IEC 61000-4-3
• Electrodes that have current densities exceeding 2mA/cm2 may require special • ISO 13485, Directive 93-42-EEC
attention of the operator.
• This product must be stored at 0 – 50°C.
• 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 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.
• The refractory period delay is set at a default value to prevent the user from
repeating stimulation while the nerve synapse is recovering from effects of the
previous stimulation. A refractory period of less than 12 seconds in TOF mode is not
advisable as measurements might not represent the effect of blocking agents on the
neuromuscular junction.

Application Specification:
• The patient population includes patients of all ages, weight and nationality. Patient
health and state is described in contraindications, warnings and cautions.
• The user must be a medical professional with knowledge of anatomy.
• The use environment requirements of the device such as the medical practice and
operating room is described in the guidance and manufacturers declaration.
• The device can be used on any part of the body except for limitation described in
warnings and cautions or identified in section 3 for the NMT mode.

Warranty:
• The Stimpod (device only) carries a 24 month warranty against manufacturing defects,
provided that the device was used in accordance with the operating instructions.
• The cables included in the Stimpod kit carry a 6 month warranty against
manufacturing defects, provided that the cables were used in accordance with the
operating instructions.

3
 Contents

1. Getting to know the STIMPOD (NMS 410/450X) 5 3.6) Adjusting the Current 22
1.1) Device Description 5 3.7) Adjusting Stimulation Mode 22
1.2) Device Layout 6 3.8) Adjusting the Twitch/ Tetanus Frequency 22
1.3) Screen Layout 7 3.9) Train of Four Mode (TOF) 23
1.4) Accessories 8 3.10) Double Burst Mode (DB) 23
1.5) Warning Screens 10 3.11) Post Tetanic Count Mode (PTC) 24
1.6) Open Circuit Detection 12 3.12) Supra Maximal Current Mode (SMC) 24
1.7) Auto Shutdown 12 3.13) Auto Mode 25
1.8) Symbols 12 3.14) Twitch Mode 26
3.15) Tetanus Mode 26
2. Nerve Locating/Mapping Mode (NMS 410/450X) 13
2.1a) Adjusting the Current in LOC mode 14 4. Setting up Device Defaults 27
2.1b) Adjusting the Current in MAP mode 15 4.1) Setup Menu 28
2.2) Adjusting the Pulse Width 16 4.2) User Settings 28
2.3) Proximity Indicator 16 4.3) NMT Settings 29
2.4) Adjusting the Twitch Frequency 16 4.4) Locate Settings 30

3. Neuromuscular Transmission (NMT) 5. Technical Notes 32

Monitoring Mode (NMS 450X) 17 5.1) Performance Testing 32
3.1) Introduction to NMT Monitoring 17 5.2) Specifications 36
3.2) Cables and Sensors for NMT Monitoring 17 5.3) Cleaning and Disinfecting STIMPOD 36
3.3) Stimulation Sites for NMT Monitoring 18 5.4) Guidance and Manufacturers Declaration 37
3.4) AMG Patient Setup 19
3.5) EMG Patient Setup 20 Products & Accessories 40

4
 Getting to Know the STIMPOD
(NMS410/450X)
1
1.1) Device Description
The STIMPOD NMS450X is a quantitative Neuromuscular Transmission (NMT) monitor utilizing either tri-axial accelerometry or electromyography to provide real-time quantitative feedback.

The Stimpod NMS 410 as well as Stimpod NMS 450X is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation
involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated
by establishing the minimum threshold current required, to facilitate a neuromuscular response.

CAUTION: This device should only be used by a qualified physician with appropriate knowledge in anaesthesia.
The sale or purchase of the device is restricted to licensed medical practitioners, as governed by the law of the country/state in which he/she practices, or where the device is
to be used.

5
1.2) Device Layout
1 Cable Connector
Insert the combined Nerve Mapping / Locating
Multi Functional Clip
Cable or the NMT cable to activate the relevant
mode. 1

2 Enter / Frequency Button

Press to toggle between Frequencies.
Press to Enter in setup menu.
30mA
NM T
Display
30.21mA
3 Menu / Pulse Width Button
00:15
NMS 410/450X (LOC/MAP Mode) T
Press to toggle between Pulse Widths. O
F
Press and hold to access Setup Menu.
Auto Minimal
NMS 450X (NMT Mode)
Press to toggle between Stimulation Modes.
2
4 Stimulating LED indicator u

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Flashing Green: Stimulus delivered.
Flashing Red: Open Circuit.
4
5 Pause Button
5
NMS 410/450X (LOC/MAP Mode)
Press to Stop / Start Stimulation. 6
NMS 450X (NMT Mode)
NMS 450X
Press and release to elicit a single stimulation.
Press and hold to activate a repeated stimulation.
7
6 The Wheel
Adjust current in the main operating mode.
Navigate the Setup Menus.

7 On / Off Button Battery Compartment Cover

Press to switch unit on / off.

6
1.3) Screen Layout

Linear mode 1 6 Current Mode

Non-Linear mode Nerve locating mode
Nerve mapping mode
Data Cable 2 NMT mode (NMS450X)
7 Speaker Volume
8 Battery Status
Current Setting 3
Adjust using wheel 9 Average current of actual stimulus
10 Warning: Notifies the user of a discrepancy
between current setting and average
Facial Mode 4 current of actual stimulus.
11 Diagnostic or Warning screens
Pulse Width Setting 5 12 Stimulating Frequency Setting
Adjust using Menu / Pulse width button Adjust using Enter / Hz width button

13 NMT Mode (NMS450X)

Stimulation mode TOF, DB, PTC,
u TET, TWI, SMC and Auto

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Diagnostic Screen NMS 410/450X (LOC / MAP Mode) Diagnostic Screen NMS 450X (NMT Mode)
• Indication of • Real-time quantitative feedback
current setting • Proximity indicator arrow • Countdown timer for repeat mode

• Calculated Charge Setting

• Calculated percentage TOF/DB ratio OR
• Average charge of actual stimulus
NMS 450X TOF/PTC Counts
• 0 mA • Graph indicating shape of actual
A E
current stimulus • Cable Type Identifier: M or M
G G

7
1.4) Accessories
WARNING: Use of cables or other accessories other than those supplied with the STIMPOD may result in serious injury.
NOTE: ECG Electrodes and Nerve Locating needles are not included in this package.
CAUTION: A sterile wipe should be applied to the Nerve Mapping Probe prior to use.

Nerve Mapping/ Nerve Locating Cable (XT-41014):

• This cable is used to activate the Nerve Mapping/Locating mode on the STIMPOD.
• The red (anode) connector is designed to clip on to a standard ECG electrode.
• The ergonomically designed cutaneous Nerve Mapping Probe presents the user with a simple and reliable Nerve
Mapping solution.
• The 2mm needle connector will accommodate various makes of needles.

AMG Accessories (STIMPOD NMS450X)

NMT Monitoring Cable AMG (XT-45025) and 3.5m (XT-45025A):

• This cable is used to activate the NMT mode on the STIMPOD.
• The red (anode) and black (cathode) connectors are designed to clip onto the Xavant NMT electrode (XT-45008) or
onto a standard ECG electrode.
• The accelerometer is designed to attach to the contracted appendage (in the case of the ulnar nerve, this will be
the thumb).

NMT Electrode (XT-45008):

• The colour coded connections indicate the polarity for the NMT cable connections
• The larger surface area of the red (anode) electrode reduces the current density of the anode and
prevents hyperpolarization
• The proprietary gel and gel interface was specifically designed for transmission of large currents.

8
EMG Accessories (STIMPOD NMS450X)

NMT Monitoring Cable EMG 1.8m (XT-45003) and 3.5m (XT-45003A):

• The EMG cable is used to enable EMG based NMT Monitoring on the Stimpod.
• The EMG cable connects directly to the EMG Electrode.

EMG Electrode Large (XT-45009L) and Small (XT-45009S):

• The disposable EMG Electrode is applied directly to the patient for EMG based NMT Monitoring using the EMG
cable.

Smart Data Cables (STIMPOD NMS450X)

Smart Data Cable Philips RS232 (XT-45100C-PHI):

• Interface AMG/EMG data directly to a compatible Philips monitor.

Smart Data Cable NMShow (XT-45100A-NMS):

• Interface AMG/EMG data directly to a PC using the NMShow software.

9
1.5) Warning Screens

Insert Cable Pause

Insert Cable: Pause:

This is the first prompt which the user will encounter as the unit is switched on, and This warning informs the user that the PAUSE button was pressed.
signals that the unit is waiting for the cable to be inserted. The STIMPOD will pause all its activities and wait for the PAUSE button to be pressed again.

Cable Not
Replace Batteries
Recognised

Cable not recognised: Replace Batteries:

This warning informs the user that the inserted cable is not compatible with the NMS This warning informs the user that the batteries are depleted beyond an acceptable
410/450X. level. Continuing to operate the device thus will make it unreliable. To prevent this the
STIMPOD flashes this warning for 4 seconds before switching off.

Open Circuit
Detected
Press Enter
Open Circuit Detected: To Confirm
This warning informs the user that the contact points of the connected accessory are not
forming a closed circuit. This warning will be accompanied by a red flashing LED, every Current Adjustment in NMT Mode:
time the unit attempts to stimulate. When attempting to adjust the current while in NMT mode the device will show this
message, requesting the user to confirm the adjustment of the current.

Refractory
Delay Active Stimulation In
Progress
Refractory Delay Active:
Once a TOF, DB, or PTC stimulation is performed, the refractory period timer is initiated. Stimulation in Progress:
During the countdown time it will not be possible to perform another stimulation. If Warning shown when the play button is pressed during stimulation.
another stimulation is attempted, this warning screen will appear.

10
 EMI Warning

EMI Warning: Component Error:

Warning shown when a high level of electromagnetic interference is detected. The STIMPOD has detected a component failure. Please send the device back to the
manufacturer for repair!

Incorrect
Electrode Placement

Incorrect/Check electrode placement:

Warning shown when SMC is unable to find a supramaximal current value.

No NMT
Data received

No NMT Data received:

Warning shown when either the AMG or EMG sensor did not respond.

Stimulation aborted

Stimulation aborted:
This warning is shown when:
• SMC: Measured current is more than 10% less or more than the set current.
• NMT: The stimulation was interrupted.

11
1.6) Open Circuit Detection 1.8) Symbols
The Stimpod performs impedance measurements at regular intervals to detect whether
the connection between the STIMPOD and the patient comprises a closed circuit.

Closed Circuit Detected:

• Stimulation will take place.
• Stimulating sound will be heard (Single or multiple beeps depending on proximity Manufacturer Manufacturing Date Caution Separate collection
indicator setting. Sound pitch will follow the current intensity). (Year) for electrical
• The LED stimulus indicator will pulse green with every successful stimulus attempt. and electronic
• The diagnostic screen will provide active feedback on every pulse delivered. equipment
(Applicable to EU
community only)

Open Circuit
Detected

Open Circuit Detected: Serial Number Representative Catalogue Number Prescription

in the EU use only
• 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. 90%
90% 50°C
50°C

10%
10% 0°C0°C
1.7) Auto Shutdown Type BF Non-sterile Humidity limitation Temperature limit
Applied Part
STIMPOD will shut down after 10 minutes of no user or patient interaction.

Consult instructions Medical Device

for use

12
 Nerve Locating/Mapping
Mode (NMS 410/450X)
2
Locating mode (LOC) This mode offers the user the means to do nerve mapping and locating without having
to switch or unplug cables.
Localisation of nerves by electrical stimulation involves connecting the nerve stimulator
to a conducting, locating needle (not supplied) through which local anaesthetics can When inserting the Nerve Mapping / Locating Cable, the STIMPOD will default to the Nerve
be administered. This procedures involves subcutaneous stimulation of the motor Mapping current range (0-5mA). Current will be directed to the Nerve Mapping probe and
component of the relevant peripheral nerve, to ‘locate’ the nerve. the STIMPOD will attempt to stimulate. The moment that the needle penetrates the skin
the cable will sense it and inform the STIMPOD. The stimpod will switch to Nerve locating
• Select this mode by inserting the Nerve Locating / Mapping cable. mode. If contact between the needle and patient is broken, and the nerve mapping probe
• The STIMPOD will automatically default to the Nerve Locating current range (0.00 - touches the patient, STIMPOD will switch back to the nerve mapping mode and start
5.00 mA) and display the ‘ LOC ’ indicator. monitoring the needle - patient connection again. Whenever the nerve mapping probe
and the nerve locating needle simultaneously make contact with the patient the needle
will have first priority.
Mapping Mode (MAP)
• This mode is selected when the Nerve Mapping / Locating cable is inserted.
Percutaneous nerve mapping enables the anaesthesiologist to map out a particular
superficial nerve prior to nerve location with the needle. This is accomplished by
stimulating the motor component of the relevant peripheral nerve percutaneously with
the nerve mapping probe. This technique ensures a higher success rate for directing the
needle to the correct nerve.

13
When using the Nerve Locating / Mapping Cable

3 Warning: Notifies the user of a discrepancy

between current setting and average current
of actual stimulus.
4 If sound is enabled: STIMPOD will beep
every time that a stimulus was delivered. The
pitch of the sound will follow the current
Current Setting 1 intensity level.
Adjust using wheel 5 Average current of actual stimulus

6 Proximity Indicator
Pulse Width Setting 2 7 Stimulating Frequency Setting
Adjust using Menu / Pulse width button Adjust using Enter / Hz width button

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2.1a) Adjusting the Current in LOC mode 1 0.6 - 2.0mA Default 0.2mA
2.0 - 5.0mA Default 0.5mA
Current Mode Options: Linear Mode, Non-Linear Mode
Default: Linear Increments can be adjusted in the Setup Menus

Linear Mode: Circle the Wheel to adjust current.

The Linear Mode is called linear because one ‘click’ on the Wheel will correspond with one Non-Linear Mode:
increment as set in the specific current range. The Linear Mode allows the user to selectNMS 450X
individual incrementing options for the three different current ranges. The Non-Linear Mode facilitates the non-linear nature of the current intensity versus the
distance from the nerve. This mode allows the user to define 20 adjustment positions in
Default Current range: terms of Current (mA) and Pulse Width (ms). If correctly implemented each adjustment
0.00 - 5.00mA adjustable in the following default increments: position should afford the user with a relatively linear progression in terms of the distance
0.0 - 0.6mA Default 0.1mA from needle tip to the nerve.

14
Default Current and Pulse Width Range: NOTE: Because the 20 definable positions include both current and pulse width settings,
As shown in table 1 in section 4.4 circle the Wheel to select the pulse width cannot be adjusted independently in this mode. This is indicated on the
predetermined current and pulse width positions sequentially. screen by the fact that pulse width is not highlighted.

When using the Nerve Mapping Probe (NMS 410/450X):

3 Warning: Notifies the user of a discrepancy

between current setting and average current
of actual stimulus.
4 If sound is enabled: STIMPOD will beep
every time that a stimulus was delivered. The
pitch of the sound will follow the current
Current Setting 1 intensity level.
Adjust using wheel 5 Average current of actual stimulus

6 Proximity Indicator
Pulse Width Setting 2 7 Stimulating Frequency Setting
Adjust using Menu / Pulse width button Adjust using Enter / Hz width button

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2.1b) Adjusting the Current in MAP mode 1 NOTE: The STIMPOD will automatically default to the Nerve Mapping current range
(0-20mA) and display the ‘ MAP ’ indicator.
Current Range: 0 - 20mA adjustable in 1mA increments.
Circle the Wheel to adjust current.

NMS 450X 15
2.2) Adjusting the Pulse Width 2 2.4) Adjusting the Twitch Frequency 7

Options: 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms Options: 1Hz, 2Hz, 5Hz
Default: 0.05ms Default: 2Hz
Press Menu/Pulse Width button to toggle between different Pulse Widths. Press Enter/Hz button to toggle between different stimulating frequencies.

2.3) Proximity Indicator 6

This is only relevant for Locating Mode

The proximity indicator notifies the user that the target charge range has been reached.
This function allows the user to set up an upper and lower limit of charge. When
contraction is elicited at the set charge, this indicator should indicate to the user that the
needle has reached the desired proximity to the nerve. This proximity is indicated both
visually and audibly.

Visual Indication:
• Visually indicated in the diagnostics screen by two arrowheads.
• Arrowhead indicating the lower threshold points upwards.
• Arrowhead indicating the upper threshold points downwards.
• The dotted line representing the selected current will be positioned between the two
arrowheads if the target charge range is entered.

Audible Indication:
• A successful stimulus above the proximity range will make a single beep.
• A successful stimulus within the proximity range will make a double beep.
• A successful stimulus below the proximity range will make a triple beep.

16
 Neuromuscular Transmission
Monitoring (NMT) Mode (NMS 450X)
3
3.1) Introduction to NMT Monitoring 3.2) Cables and Sensors for NMT Monitoring
Monitoring Neuromuscular Blocking Agent involves stimulating a neural pathway The Stimpod NMS450X makes provision for two different sensor technologies for NMT
which facilitates the contraction of an appendage. Based on the relative strength of the Monitoring namely Acceloromyography (AMG) and Electromyography (EMG).
contraction which is the result of a stimulus of specific intensity or waveform, it is possible
to draw conclusions about the efficacy of an injected Neuromuscular Blocking Agent.
NMT Monitoring Cable (AMG)
The Stimulation Modes used in NMT are as follows: Train-of-Four, Double Burst, Post
Tetanic Count, Supra Maximal Current and Auto modes. In this case the NMT Monitoring Cable is fitted with a tri-axial accelerometer that is
attached to the contracting appendage of the patient to measure the strength of the
• These modes can be selected when a NMT Monitoring cable is inserted into the contraction resulting from the applied electrical stimulus.
Stimpod.
NMT Monitoring Cable (EMG)

In this case the NMT Monitoring Cable is fitted with an EMG electrode that is attached to
the contracting appendage of the patient to measure the action potential of the muscle
due to the applied electrical stimulus.

17
3.3) Stimulation Sites for NMT Monitoring
Electrode placement relies on the cathode (black electrode clip) to be as close to the
targeted nerve as possible in order to effectively depolarize the nerve. The anode (red
electrode clip) should be away from the targeted nerve. 1

Anatomical stimulation sites are chosen based on

• Their accessibility during surgery

• The ability to observe the neuromuscular response
• The nerve should be a suitable distance from the responding muscle to
prevent direct muscle stimulation

Stimulation Sites Suitable for AMG

AMG: Anatomically Ideal Stimulation Sites
Targeted Nerve Affected Muscle Contracting Appendage
Ulnar nerve adductor pollicis muscle Thumb
Posterior tibial nerve flexor halluces brevis muscle Big toe
Facial nerve (Zygomatic orbicularis oculi muscle Eye lid
Branch)
Facial nerve (Temporal Branch) corrugator supercili Eye brow
muscle 4
Stimulation Sites Suitable for EMG
EMG: Anatomically Ideal Stimulation Sites
Targeted Nerve Affected Muscle Contracting Appendage
Ulnar nerve adductor pollicis muscle Thumb 5

18
3.4) AMG Patient Setup

1 Check Batteries & Switch Device On 2 Connect NMT Monitoring Cable (AMG) 3 Prepare Skin for Monitoring

Power on device

Patient Setup

4 Attach Electrodes

A
M
G

5 Secure Clips to the electrode

6 Attach Accelerometer to appropriate patient appendage

19
3.5) EMG Patient Setup

1 Check Batteries & Switch Device On 2 Connect NMT Monitoring Cable (EMG) 3 Prepare Skin for Monitoring

Power on device

Patient Setup

4 Attach EMG Electrode

E
M
G

5 Connect EMG Electrode to NMT Monitoring

Cable (EMG)

20
Refractory Period Delay
The three modes: TOF, DB and PTC are subject to refractory period delays, providing a
safety period which prevents the user from repeating stimulation while the nerve synapse
is recovering from the effects of the previous stimulation.
Refractory timer
Immediately after stimulation in one of these modes, the countdown timer is activated and Only displayed after a single
shown on the screen. If repeat mode is activated, only the repeat timer will be displayed stimulation is completed and is
on the screen because the repeat period for the repeat timer will always be larger than the removed after it reaches 00:00.
refractory period timer. If an attempt is made to stimulate while the refractory timer is active
a warning screen will be displayed reminding the user that the refractory period is active.

Default refractory period delays are as follows for the three modes:
TOF: 15 seconds
DB: 1 minute
PTC: 2 minutes

Single Stimulus vs. Repeated Stimulation

• Start the automatic repeat mode by holding the play/pause button down for longer
than 2 seconds. Repeat timer notification
• The device will automatically start a countdown according to the ‘repeat timer’ This icon (clock) displays when
setting as specified in the main menu for each respective mode’s timer. the repeat timer is active.
• The countdown will be indicated next to the clock symbol shown in the diagnostic
screen.
• Disable the automatic repeat mode by pressing and holding the play/pause button
again.
• The Repeat Timer for each mode can be changed in the menu.

21
When using the NMT Mode (NMS 450X)
3 Warning: Notifies the user of a discrepancy
between current setting and average current
of actual stimulus.
4 If sound is enabled: STIMPOD will beep
every time that a stimulus was delivered. The
pitch of the sound will follow the current
Current Setting 1 intensity level.
Adjust using wheel 5 Average current of actual stimulus

A E
Stimulation Mode 2 6 Cable Type Indentifier: M or M
G G

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3.6) Adjusting the Current 1 3.8) Adjusting Twitch / Tetanus Frequency
Default Current range: 0 - 80 mA adjustable in 5mA increments.
Circle the Wheel to adjust current. N/A
When the Stimpod starts up in NMT mode, it will revert to the NMT current that was used
previously. In order to adjust the current, circle the adjustment wheel, the current setting
will flash and start to adjust accordingly. At the same time a warning screen will appear
prompting you to press ‘enter’ to confirm. Press ‘enter’ to confirm the current change Twitch Mode: Options (Stimulating Frequency): 1Hz, 2Hz, 5Hz
within 2 seconds. NMS 450X
Default: 2 Hz
Press Enter/Hz button to toggle between different stimulation frequencies.

3.7) Adjusting Stimulation Mode 2 Tetanus Mode: Options: 50Hz, 100Hz

Default: 50Hz
Stimulation mode TOF, DB, PTC, TET, TWI, SMC and Auto Press Enter/Hz button to toggle between different stimulating frequencies.
Default: TOF
Press Menu/Mode button to toggle between different Stimulation Modes.

22
3.9) Train of Four Mode (TOF) 3.10) Double Burst Mode (DB)

u u

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The TOF stimulation comprises four, square waves with a pulse width of 200 microseconds, The DB stimulation comprises a burst of three square waves of 200microseconds pulse
500 milliseconds apart. width, 20 milliseconds apart, followed by another burst of three square waves, 750
milliseconds later.
Selecting TOF Mode:
• Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod. Selecting DB Mode:
• Ensure that TOF is one of the selected Active Modes in the NMT Settings menu (4.3). • Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod.
• Press the ‘Mode’ button until ‘TOF’ is shown
NMS 450Xon the display. • Ensure that DB is one of the selectedNMSActive
450X Modes in the NMT Settings menu (4.3).
• Press the ‘Mode’ button until ‘DB’ is shown on the display.
Real-time Patient Data Displayed:
• The relative contraction strength caused by each stimulus is indicated graphically in Real-time Patient Data Displayed:
the diagnostic screen as shown in the picture. • The relative contraction strength caused by each stimulus is indicated graphically in
• In the case that all four contractions could be measured, the percentage of measured the diagnostic screen as shown in the picture.
contraction strength of the fourth stimulus compared to the first stimulus will be • The percentage of the measured contraction strength of the second contraction
displayed in the diagnostic screen. compared to the first contraction will be displayed in the diagnostic screen.
• If less than four contractions were measurable, the number of contractions that could
be identified will be displayed, i.e. 2/4.

23
3.11) Post Tetanic Count (PTC) 3.12) Supra Maximal Current (SMC)

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The PTC stimulation comprises a tetanus stimulation followed by a delay and a number of SMC mode is used to find the optimal current for the stimulating electrodes placement.
twitches. (Default settings are as shown below) The SMC stimulation comprises of 16 1Hz twitches at increasing current intensities from
5-80mA in 5mA increments. (For Facial mode, this is limited to 8 twitches from 5-40mA).
Defaults: The device will then determine the supra maximal current and change the set current to
Tetanus: 50Hz for 5 seconds that value.
Delay: 3 seconds
Twitch: 20 twitches at 1Hz NMS 450X Important: SMC mode should only be performed
NMS 450X on a non-paralyzed patient.

Selecting PTC Mode: Selecting SMC Mode:

• Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod. • Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod.
• Ensure that PTC is one of the selected Active Modes in the NMT Settings menu (4.3). • Ensure that SMC is one of the selected Active Modes in the NMT setting menu (4.3).
• Press the ‘Mode’ button until ‘PTC’ is shown on the display. • Press the ‘Mode’ button until SMC is shown in the display.

Real-time Patient Data Displayed: Real-time Patient Data Displayed:

• Each counted twitch is indicated graphically in the diagnostic screen as shown in the • The relative contraction strength caused by each stimulus is indicated graphically in
picture. The number of twitches counted are displayed in the diagnostic screen. the diagnostic screen as shown in the picture.

24
3.13) Auto Mode

u u

en

en
men

men
ter

ter
Auto mode is used to conduct Full Case NMT Monitoring. This is achieved through a These zones are:
series of alternating TOF and PTC stimulation sequences to determine the depth-of-block • Recovered: A TOF ratio of larger than 90%
throughout the duration of the procedure. • Minimal: A TOF ratio of between 40% and 90%.
• Shallow: A TOF ratio less than 40%, but all pulses present.
Selecting Auto Mode • Moderate: A TOF count of 1 to 3.
• Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod. • Deep: A PTC Count of 1 or more.
• Ensure that “Auto” is one of the selectedNMS
Active
450X modes in the NMT Settings menu (4.3)
• Profound: A PTC count of 0. NMS 450X
• Press the ‘Mode’ button until ‘Auto’ is shown on the display.

Real-time Patient Data Displayed

• The relative contraction strengths caused by each stimulation is indicated graphically in
the diagnostic screen with the resulting TOF Ratio, TOF Count or PTC Count.
• The Depth of Block is displayed next to the Mode indicator.

Depth-of-Block Zones
The depth-of-block can be classified in terms of six identifiable zones, where each zone
indicates the extent of muscle paralysis the patient is experiencing due to the presence of
a muscle relaxant.

25
3.14) Twitch (TWI) 3.15) Tetanus (TET)

N/A N/A

u u

en

en
men

men
ter

ter
The Twitch stimulation comprises a 200 microseconds square wave pulse. If the ‘Play/ The Tetanus stimulation comprises series of 200 microseconds square wave pulses
Pause’ button is pressed the twitch will repeat at the selected frequency. repeated at a 50Hz or 100Hz repetition rate or frequency.

Defaults: Repeat at 2Hz Defaults: 50Hz (adjustable to 100Hz)

Adjustable:1Hz, 2Hz and 5Hz
Selecting TET Mode:
Selecting TWI Mode: NMS 450X • Ensure that an NMT Monitoring CableNMS(AMG/EMG)
450X is inserted in the Stimpod.
• Ensure that an NMT Monitoring Cable (AMG/EMG) is inserted in the Stimpod. • Ensure that ‘TET’ is selected in the ‘Active Modes’ menu option under ‘NMT Settings’
• Ensure that ‘TWI’ is selected in the ‘Active Modes’ menu option under ‘NMT Settings’ (4.3)
(4.3) • Press the ‘Mode’ button until ‘TET’ is shown on the display.
• Press the ‘Mode’ button until ‘TWI’ is shown on the display. • Press the ‘Hz’ button to toggle through the frequency options.
• Press the ‘Hz’ button to toggle through the frequency options.
Real-time Patient Data Displayed:
Real-time Patient Data Displayed The stimulation is initiated by pressing and holding the Play/Pause button, and stopped
Stimulation is initiated and stopped by pressing the ‘Play/Pause’ button. No patient by releasing the Play/Pause button. No patient response data is measured in TET mode.
response data is measured in TWI mode.

26
 Setting up Device Defaults
4
The setup menu allows the user to customize device parameters. Access the Setup Menu
by pressing and holding the menu button. To exit the menu, the menu button may be
pressed again. A block at the top of each menu indicates which menu is currently active.

The menu is controlled using the menu button, the enter button and the wheel. Two
blocks at the bottom of the screen indicates what action will occur when a button is
pressed, the block bottom left corresponds to the menu button and the block bottom
right with the enter button.

In general, the menu button will cause the menu to go back to the previous state or
cancel the current action, while the enter button will act on the current menu item (select
/ accept / toggle). Clockwise rotation on the wheel will generally mean next (menu item /
option) or increase (selected value), while counter clockwise will generally mean previous
(menu item / option) or decrease (selected value).

27
4.1) Setup Menu Language options: English (default), French, Italian, Dutch, Spanish, Portuguese, German,
Swedish, Danish, Greek, Czech and Polish.
The setup menu contains 3 sub menus, the contents of each will be covered in detail
in the next sections. Use the wheel to select an item and the enter key to enter the Volume options: Off, Low, Medium (default) and High. During operation, an icon on the
corresponding menu. Menu button to exit. main device screen will indicate the currently selected volume.
1) User Settings – Settings regarding the user’s preferences, such as language, buzzer
volume, backlight settings and user info. Backlight options: Off, 5s (on for 5 seconds after last activity), 60s (on for 60 seconds after
2) NMT Settings – Settings regarding NMT modes such as TOF or PTC. These settings last activity) and Always On.
include refractory and repeat timers, active modes and whether the device is
currently being used with a facial electrode or not. Note: The battery life will be drastically shortened if Always On is selected.
3) Locate Settings – Settings regarding Locate mode, including proximity indicator
levels and current mode settings (linear / non-linear). User Info: The User Info menu item will open another menu page which allows the user
to enter two lines of personal information of 20 characters each. This menu is controlled
using two modes: Edit mode and Scroll mode. To change from Edit mode to Scroll mode,
press the menu button and from Scroll mode to Edit mode, press the enter button. In Scroll
mode the menu button will close the User Info menu and return to the User Settings menu.

4.2) User Settings

The language, buzzer volume and backlight can be set by scrolling to the appropriate
menu item using the wheel, selecting it using the enter button, then changing the
In edit mode the wheel will change the character at the current position. When the
selected option using the wheel and accepting the new value using the enter button.
desired character is selected, pressing the enter button will move the cursor to the next
position. This will happen unless the character is backspace ( ) or enter ( ).
When the current character is the last of the line, the cursor will continue to the line not
currently being edited. Backspace will clear the current position and move the cursor to
the previous position. The enter character will move the cursor to the start of the line not
currently being edited.

28
 Timers: The timer items are changed in a two-step process, changing the number of
minutes first and then the number of seconds. Use the wheel to navigate to the item
which should be changed, then press the enter key to start editing.

In scroll mode, the wheel can freely change the cursor position. Any character can be
step 1
selected and then changed in edit mode by pressing the enter button.

4.3) NMT Settings

This menu contains the repeat and refractory timers for TOF, DB and PTC, the AUTO
timers for the different levels of block, the active NMT modes and whether facial mode is
activated. The active modes and timers are grouped in expandable menu items. To view
the contents of an expandable menu item, press the enter button while an expandable
item is selected. The contents can then be hidden by pressing the enter button again. step 2

In step 1, the wheel will change the number of minutes. The enter button will accept the
value and continue to step 2, while the menu button will revert to the previous timer value
and cancel editing. In step 2, the wheel will change the number of seconds. The enter
button will accept the timer value and conclude editing. The menu button will return the
process to step 1.
step 1
Active modes: This can be used to limit the amount of NMT modes which are available
during operation to limit the amount of button presses necessary to get to the required
mode. Pressing the enter button will toggle the item between active and inactive. The
available modes include TOF, DB, PTC, TWI, TET, SMC and Auto.

step 2

29
Facial Mode: This item is toggled (On or Off ) by pressing the enter key. When on, the Current mode - Linear: The linear mode is called linear because one ‘click’ on the wheel will
resultant current determined by SMC will be limited to a 40mA maximum. correspond with one increment as set in the specific current range. In the linear mode,
Pulse Width is not affected when turning the wheel. Pulse Width is selected when the
Menu/Pulse Width button is pressed. The Linear Mode essentially allows the user to select
4.4) Locate Settings different increment options for each of the three different current ranges.

Settings which are relevant to the locating mode is managed through this menu.
It contains the proximity indicator expandable menu item, current mode item and
depending on the selected current mode either linear current mode range settings or an
item to navigate to the non-linear settings.

The increment for each range can be set by scrolling to the range to be changed, initiating
edit using the enter button and then selecting a different option using the wheel. Each
range has preset options which can be selected.

Current Mode – Non-linear: The Non-Linear Mode facilitates the non-linear nature of the
Proximity Indicator: The upper and lower limits of the proximity indicator as described current intensity versus the distance from the nerve. The required current intensity is
in 2.1 can be set by expanding the proximity indicator menu item, selecting the limit to proportional to the square of the distance from the electrode to the nerve fibre.
be changed using the wheel, then pressing enter to start editing and then changing the
value using the wheel. When the desired value is reached, the enter button will accept the This mode allows the user to define 20 adjustment positions in terms of current (mA) and
change. Alternatively, to discard the change press Cancel (menu button). pulse width (ms). If correctly implemented each adjustment position should afford the
user a relatively linear progression in terms of the distance from needle tip to the nerve.

30
 Current Pulse Width Charge These values can be viewed or changed in the Non-linear Settings menu. The charge value
Position for each or the twenty positions are displayed graphically, and the current and pulse width
(mA) (ms) (µC)
value of each position can be viewed by scrolling to that position using the wheel.
1 0.3 0.1 0.03
2 0.43 0.1 0.043
3 0.58 0.1 0.058
4 0.76 0.1 0.076
5 0.97 0.1 0.097
6 1.2 0.1 0.12
7 1.4 0.1 0.14
To change the charge at a specific position, a 2 step process can be followed. Select the
8 1.7 0.1 0.17 position which should be changed using the wheel and press the enter button to start
step 1. The current is changed using the wheel in this step and the menu button will
9 2 0.1 0.2
cancel the change. When satisfied with the current, the enter button can be used to
10 2.3 0.1 0.23 continue to step 2: changing the pulse width. The pulse width for the selected position
can be changed using the wheel. The menu button will return to step 1 and the enter
11 2.7 0.1 0.27
button will accept the change and conclude editing.
12 3 0.1 0.3
13 3.4 0.1 0.34
14 3.8 0.1 0.38
15 4.3 0.1 0.43
16 4.8 0.1 0.48
step 1
17 1.8 0.3 0.54
18 2.1 0.3 0.63
19 2.4 0.3 0.72
20 2.7 0.3 0.81
Table 1 Default non-linear settings

step 2

31
 45 Technical Notes
5.1) 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 Cable
Insert Cable

• Insert the batteries and switch on the device.

The following screen should appear on the display.

5.1.1) Nerve Locating Mode

• Insert the Nerve Mapping/Nerve Locating Cable.

The following screen should appear on the display.
NMS4X0 VX.00
User Information
0.00
followed by Open
OpenCircuit
Circuit
! Detected
Detected

32
• The LED should flash RED and no audible feedback should be heard. 5.1.2) Combined Nerve Mapping/Nerve Locating Mode
• Short-circuit the needle connector and the ECG connector.
The following screen should appear on the display. • Insert the Nerve Mapping/Nerve Locating Cable.
The following screen should appear on the display.

Open Circuit
! Detected

• The LED should flash GREEN and if sound is enabled in the menu a beep should be
heard each time a stimulus is delivered. • The LED should flash RED and no audible feedback should be heard.
• Stimulus should occur at the set frequency. (1,2 or 5 Hz). • Short-circuit the Nerve Mapping probe and the ECG connector.
• Use the adjusting wheel and slowly increase the current to 5.00mA. The following screen should appear on the display.
• 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 as shown below.

• 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 as shown below.

In order to test the Nerve Locating connection and device functionality follow the
instructions in 5.1.1.

33
5.1.3) NMT Monitoring Mode (AMG)
(NMS450X only)

• Insert the NMT Monitoring Cable (AMG).

The following screen should appear on the display.
A
M
G

Offener Stromkreis
Open Circuit
! • Separate the red and black electrode connectors to cause an open circuit between
erkannt
Detected
them.

• Ensure that the device is in ‘TOF’ mode.

• Short-circuit the red and black electrode connectors.
Offener Stromkreis
Open Circuit
! erkannt
Detected

A • Press the ‘play/pause’ button.

M
G The following screen should appear on the display.
• No audible feedback should be heard.

• Use the adjusting wheel and increase the current to 80mA.

• Press the ‘play/pause’ button while shaking the accelerometer.

The NMS450X should respond as follows:

• The LED should flash GREEN in accordance with the four stimulations.
• Each stimulation should be accompanied by an audible ‘beep’.
• In ‘Diagnostic window’ four bars of different heights should indicate that the
accelerometer detected movement.
• Monitor the actual current delivered to ensure that the warning sign does not appear.

34
5.1.4) NMT Monitoring Mode (EMG)
(NMS450X only)

• Insert the NMT Monitoring Cable (EMG).

The following screen should appear on the display.
E
M
G

Offener Stromkreis
Open Circuit
! • Separate the red and black electrodes to create an open circuit.
erkannt
Detected

• Ensure that the device is in ‘TOF’ mode.

• Short-circuit the red and black electrode connectors. Offener Stromkreis
Open Circuit
! erkannt
Detected

• Press the ‘play/pause’ button.

E • The red LED will flash once.
M
G • No audible feedback should be heard.

• If the STIMPOD malfunctions in any one of these performance tests, it should

be checked by the relevant technical department in accordance with the test
• Use the adjusting wheel and increase the current to 80mA. instructions in the Technical Service Manual.
• Equipment may only be repaired by the manufacturer or by an organisation expressly
The NMS450X should respond as follows: authorised by the manufacturer.
• Equipment does not require regular calibration.
• The LED should flash green and if sound is enabled in the menu a beep should be
heard each time a stimulus is delivered.
• In ‘Diagnostic window’ no bars should be displayed.
• Monitor the actual current delivered to ensure that the ‘Current Warning’ sign does
not appear.

35
5.2) Specifications

Operating Modes: Nerve Locating Mode Nerve Mapping Mode NMT Mode
NMS 410/450X NMS 410/450X NMS 450X
Current Range 0.00 - 5.00 mA ± 5% 0 - 20mA ± 5% 0 - 80mA ± 5%
Pulse Width Options 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms ± 5% 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms ± 5% 0.2ms ± 5%
Maximum Stimulation Voltage 100V 400V 400V
Stimulus Monophasic square wave Monophasic square wave Monophasic square wave
Stimulating Frequency 1Hz , 2Hz, 5Hz ± 5% 1Hz , 2Hz, 5Hz ± 5% 1Hz, 2Hz, 5Hz, 50Hz, 100Hz ± 5%
Load Impedance 0 kOhm - 20 kOhm 0 kOhm - 20 kOhm 0 kOhm - 5 kOhm

Technical Specifications NMS 410/450X 5.3) Cleaning and Disinfecting STIMPOD NMS 410/450
Device Classification Class IIa, Type BF
Cleaning: Soap and water, applied with a damp cloth is suitable to clean and
Power Supply 4 x AAA alkaline batteries
disinfect the STIMPOD. It is imperative that no moisture penetrates the STIMPOD.
Power Consumption 17mA Disinfecting: Any commercially available methanol - free disinfectant in an ethyl
Waveform Constant Current, Monophasic Square alcohol base can be used for disinfection.
Wave
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
Transport and Storage Humidity 90% Relative Humidity
Operating Atmospheric Pressure 50 – 106kPa
Transport and Storage Atmospheric Pressure 50 – 106kPa

36
5.2) Guidance and Manufacturers Declaration

Guidance and manufacturers declaration – electromagnetic emissions– for all equipment and systems
The STIMPOD NMS 410/450X is intended for use in electromagnetic environment specified below. The customer or user of the STIMPOD NMS 410/450X should assure that it is used
in such an environment

Emission Test Compliance Electromagnetic Environment – Guidance

RF Emissions Group 2 – Class A The STIMPOD NMS 410/450X must emit electromagnetic energy in order to perform its
CISPR 11 intended function. Nearby electronic equipment may be affected.

The STIMPOD NMS 410/450X is suitable for use in all establishments, other than
domestic establishments and may be used in domestic establishments and those
directly connected to the public low voltage power supply network that supplies
buildings used for domestic purposes, provided the following warning is heeded:

WARNING: This equipment/system is intended to be used by healthcare professional

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 NMS 410/450X or shielding the location

Guidance and manufacturers declaration – electromagnetic immunity- for all equipment and systems
The STIMPOD NMS 410/450X is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS 410/450X should assure that it
is used in such an environment

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. If the floors are covered with synthetic
IEC 61000-4-2 ± 15 kV air ± 15 kV Air material, the relative humidity should be at least 30%

Power frequency (50/60 Hz) 30 A/m 50 Hz Power frequency magnetic fields should be at levels characteristic of a typical location
magnetic field 30 A/m (Effective) in a typical commercial or hospital environment.
IEC 61000-4-8

37
 Guidance and manufacturer’s declaration – electromagnetic immunity
The STIMPOD NMS410/NMS450X is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS 410/450X should assure that
it is used in such an environment.
Immunity IEC 60601 test level Compliance level Electromagnetic environment – guidance
test
Portable and mobile RF communications equipment should be used no closer to any
part of the STIMPOD NMS 410/450X, including cables, than the recommended separation
distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF 3V at 0.15 - 80MHz and 6V at ISM 3V at 0.15 - 80MHz and 6V at ISM
IEC 61000-4-6 Frequency. Home Healthcare: 3V at Frequency. Home Healthcare: 3V at
0.15-80MHz, and 6V at ISM and Ra- 0.15-80MHz, and 6V at ISM and Ra-
dio Amateur Frequency. dio Amateur Frequency.

3 V/m (10V/m Home Healthcare) at 3 V/m (10V/m Home Healthcare) at d = 1,2 80 MHz to 800 MHz
Radiated RF 80-2,700MHz, AM Modulation. And 80-2,700MHz, AM Modulation. And
IEC 61000-4-3 9-28V/m at 385-6000MHz, Pulse 9-28V/m at 385-6000MHz, Pulse d = 2,3 800 MHz to 2,5 GHz
Mode and other Modulation (upon Mode and other Modulation (upon
Risk Analysis). Risk Analysis). 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.
a
Field 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 NMS 410/450X is used exceeds the applicable RF compliance level above, the STIMPOD NMS 410/450X 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 NMS 410/450X.

38
 Recommended separation distances between portable and mobile RF communications equipment and
the STIMPOD NMS410/450X
The STIMPOD NMS 410/450X is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the STIMPOD NMS
410/450X can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
STIMPOD NMS 410/450X as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power m
W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Not applicable d = 1,2 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 NMS 410/450X is intended for use in the electromagnetic environment specified below. The customer or the user of the STIMPOD NMS 410/450X should assure that it
is used in such an environment

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Radiated immunity 80MHz – 1GHz @ 3V/m & 10V/m 80MHz – 1GHz @ 3V/m & 10V/m Portable and mobile RF communications equipment can affect MEDICAL
80MHz - 2.5GHz 1GHz – 2.5GHz @ 10V/m 1GHz – 2.5GHz @ 10V/m ELECTRICAL EQUIPMENT and should be used no closer to any part of the
equipment, including cables, than the recommended separation distance.

39
 Products & Accessories
STIMPOD NMS410 KIT: PRECISION NERVE LOCATOR Product Code XT-41011
(Including Nerve Locating/Mapping Cable, Carry Case, IFU)
STIMPOD NMS450 KIT: QUANTITATIVE NMT MONITOR AMG (1.8M) Product Code XT-45021
(Including Nerve Locating/Mapping cable, NMT Monitoring Cable AMG (1.8m), Carry Case, IFU)
STIMPOD NMS450 KIT: QUANTITATIVE NMT MONITOR EMG (1.8M) Product Code XT-45021B
(Including NMT Monitoring Cable EMG (1.8m), Carry Case, IFU)
NERVE LOCATING/MAPPING CABLE Product Code: XT-41014
NMT MONITORING CABLE AMG (1.8m) Product Code: XT-45025
NMT MONITORING CABLE AMG (3.5m) Product Code: XT-45025A
NMT MONITORING CABLE EMG (1.8m) Product Code: XT-45003
NMT MONITORING CABLE EMG (3.5m) Product Code: XT-45003A

NMBA ELECTRODE (Pack of 10) Product Code: XT-45008

EMG ELECTRODE LARGE (Pack of 1) Product Code: XT-45009L
EMG ELECTRODE SMALL (Pack of 1) Product Code: XT-45009S

ACCELEROMETER STRAP (Pack of 5) Product Code: XT-45007

POLYPROPYLENE CARRY CASE Product Code: XT-41002
INSTRUCTIONS FOR USE Product Code: XT-45006-EN

(Refer to www.xavant.com for additional languages)

40
41
 Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd
Silverton, Pretoria, South Africa, 0184
Tel: +27 (0) 12 743 5959, E-mail: [email protected]
(01)6009880396221(10)xxxxxxxxxx Web: www.xavant.com

42