Xavant STIMPOD NMS 450X User Manual

NMS 410/450X

Quantitative NMT Monitor Precision Nerve Locator

Product Code: XT-45006-EN

XM400-21A04 v10

Manufacturer

Xavant Technology PTY (LTD)

Unit 102, The Tannery Industrial Park, 309 Derdepoort Rd Silverton, Pretoria, South Africa, 0184 Tel: +27 (0) 12 743 5959 Fax: +27 (0) 86 547 0026 E-mail: support@xavant.com Web: www.xavant.com

Legal Representative in the EU

Emergo Europe

Prinsessegracht 20, 2514 AP The Hague The Netherlands

Caution

Federal (US) law restricts this device to sale by or on the order of a physician.

Indications for use:

This product is a nerve stimulation device designed to be used by an anaesthetist during

• General Anaesthesia, for the purpose of establishing the eﬃcacy of a Neuromuscular

Blocking Agent using non-invasive surface electrodes (not supplied) (NMS450X).

• Regional Anaesthesia for the purpose of

• Nerve mapping using the non-invasive Nerve Mapping Probe (supplied).

• Nerve locating using invasive electrodes/needles (not supplied).

Contraindications:

• Infection of the puncture site.

• Known neurological disorders.

• Severe coagulation disorders.

Warnings:

• Read the entire User Manual before attempting to use the device.

• Use of cables or accessories other than those supplied with the STIMPOD 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 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.

• Do not apply the STIMPOD to patients with implanted electrical devices, such as

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

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 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.

• No modiﬁcation of this equipment is allowed.

• Do not modify this equipment without authorization of the manufacturer.

• If this equipment is modiﬁed, appropriate inspection and testing must be conducted

to ensure continued safe use of the equipment.

Cautions:

• Prior to changing the batteries be sure to switch oﬀ the device and remove all the

cables.

• Remove elements which may adversely aﬀect the connection between the

electrodes and the skin, e.g., dirt, hair, oil.

• Ensure that ECG electrodes are not damaged or dried out.

• Large current densities associated with failing ECG electrodes may cause superﬁcial

burns.

• The Stimpod is designed to be compatible with a standard ECG electrode, however,

for high currents the use of a dedicated NMT electrode such as the Xavant XT45008 is recommended.

• Electrodes that have current densities exceeding 2mA/cm2 may require special

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 Specication:

• 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 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 defects,

provided that they were used in accordance with the operating instructions.

• The Stimpod enclosure should not be opened under any circumstances. Opening

the unit will void the warranty.

STIMPOD (NMS 410/450X) conforms to the following

standards:

• IEC 60601-1, IEC 60601-2-10

• IEC 60601-1-2: CISPR 11 Group1 class A; IEC 61000-4-2; IEC 61000-4-3

• ISO 13485, Directive 93-42-EEC

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 CISPR 11

Group 2 – Class A The STIMPOD NMS 410/450X must emit electromagnetic energy in order to perform its

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 reorienting 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) IEC 61000-4-2

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

± 6 kV contact ± 15 kV air

30 A/m 50 Hz

± 6 kV contact ± 15 kV Air

30 A/m (Eﬀective)

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

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 test

Conducted RF IEC 61000-4-6

IEC 60601 test level Compliance level Electromagnetic environment – guidance

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

3V at 0.15 - 80MHz and 6V at ISM Frequency. Home Healthcare: 3V at

0.15-80MHz, and 6V at ISM and Ra dio Amateur Frequency.

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.

Radiated RF IEC 61000-4-3

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).

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.

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.

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

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.

150 kHz to 80 MHz

Not applicable

80 MHz to 800 MHz

d = 1,2

800 MHz to 2,5 GHz

d = 2,3

Guidance and manufacturers declaration – electromagnetic immunity – for equipment and systems that are non- life supporting

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

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.

Contents

1. Getting to know the STIMPOD (NMS 410/450X) 8

1.1) Device Description 8

1.2) Accessories 9

1.3) Device Layout 10

1.4) Screen Layout 11

1.5) Warning Screens 12

1.6) Open Circuit Detection 14

1.7) Auto Shutdown 14

1.8) Symbols 14

2. Nerve Locating/Mapping Mode (NMS 410/450X) 15

2.1a) Adjusting the Current in LOC mode 16

2.1b) Adjusting the Current in MAP mode 17

2.2) Adjusting the Pulse Width 18

2.3) Proximity Indicator 18

2.4) Adjusting the Twitch Frequency 18

3. Neuromuscular Transmission (NMT) Monitoring Mode (NMS 450X) 19

3.1) Adjusting the Current 21

3.2) Adjusting Stimulation Mode 21

3.3) Adjusting the Twitch/ Tetanus Frequency 21

3.4) Train of Four Mode (TOF) 22

3.5) Double Burst Mode (DB) 22

3.6) Post Tetanic Count Mode (PTC) 23

3.7) Supra Maximal Current Mode (SMC) 23

3.8) Auto Mode 24

3.9) Twitch Mode 25

3.10) Tetanus Mode 25

4. Setting up Device Defaults 26

4.1) Setup Menu 27

4.2) User Settings 27

4.3) NMT Settings 28

4.4) Locate Settings 29

5. Technical Notes 31

5.1) Performance Testing 31

5.2) Speciﬁcations 34

5.3) Cleaning and Disinfecting STIMPOD 34

Products & Accessories 35

Getting to Know the STIMPOD (NMS 410/450)

1.1) Device Description

The STIMPOD NMS 450X is quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometry.

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.

1.2) Accessories

WARNING: Use of cables or other accessories other than those supplied with the STIMPOD may result in serious injury. NOTE: 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/ Nerve 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.

NMT Monitoring Cable (NMS 450X) (XT-45025):

• 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.

1.3) Device Layout

Cable Connector

Insert the combined Nerve Mapping / Locating Cable or the NMT cable to activate the relevant mode.

Enter / Frequency Button

Press to toggle between Frequencies. Press to Enter in setup menu.

Menu / Pulse Width Button

NMS 410/450X (LOC/MAP Mode)

Press to toggle between Pulse Widths. Press and hold to access Setup Menu.

NMS 450X (NMT Mode)

Press to toggle between Stimulation Modes.

Stimulating LED indicator

Flashing Green: Stimulus delivered. Flashing Red: Open Circuit.

Pause Button

NMS 410/450X (LOC/MAP Mode)

Press to Stop / Start Stimulation.

NMS 450X (NMT Mode)

Press and release to elicit a single stimulation. Press and hold to activate a repeated stimulation.

The Wheel

Adjust current in the main operating mode. Navigate the Setup Menus.

Display

30mA

Aut o

Minima l

NMS 450X

NM T

30.21mA 00:15

Multi Functional Clip

T O F

On / O Button

Press to switch unit on / oﬀ.

Battery Compartment Cover

1.4) Screen Layout

Linear mode

Non-Linear mode

Current Mode

Nerve locating mode Nerve mapping mode

Data Cable

Current Setting

Adjust using wheel

Facial Mode

Pulse Width Setting

Adjust using Menu / Pulse width button

NMT mode (NMS450X)

Speaker Volume Battery Status

Average current of actual stimulus

Warning: Notiﬁes the user of a discrepancy

between current setting and average current of actual stimulus.

Diagnostic or Warning screens

Stimulating Frequency Setting

Adjust using Enter / Hz width button

NMT Mode (NMS450X)

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

Diagnostic Screen NMS 410/450X (LOC / MAP Mode) Diagnostic Screen NMS 450X (NMT Mode)

• Indication of

current setting

• 0 mA

• Proximity indicator arrow

• Calculated Charge Setting

• Average charge of actual stimulus

• Graph indicating shape of actual

current stimulus

• Real-time feedback of relative contraction

strength measured with the accelerometer

• Countdown timer for repeat mode

• Calculated percentage in TOF and DB

mode

• Twitch Count in PTC and TOF if less

than 4 contractions were identiﬁed

+ 25 hidden pages

Xavant STIMPOD NMS 450X User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual