STIMPOD NMS460 User Manual

Manufacturer

Warnings:

Xavant Technology PTY (LTD) 169 Garstfontein Road Ashlea Gardens, 0081 Pretoria, South Africa Tel: +27 (0) 12 755 9491 Fax: +27 (0) 12 346 7271 E-mail: [email protected] Web: www.xavant.com

• Read the entire User Manual before attempting to use the device. • Use of cables or accessories other than those supplied with the 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 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.

Legal Representative in the EU Emergo Europe 15 Molenstraat, 2513 BH, The Hague The Netherlands Tel: +31 70 345 8570 Fax: +31 70 346 7299

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.

Indications for use:

The 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.

Warranty:

• The NMS460 carries a 12 Month Warranty against defects, provided that the device was used in accordance with the operating instructions. • The NMS460 enclosure should not be opened under any circumstances. Opening the unit will void the warranty.

Contraindications:

Use of the NMS460 can affect the operation of demand-type cardiac pacemakers. The NMS460 is not recommended for patients with known heart disease without a physician’s evaluation of risk. Do not stimulate over the eyes or carotid sinus nerves. Do not apply the NMS 460 for: • undiagnosed pain syndromes until etiology is established, • electrode placement that causes current to flow transcerebrally (through the head).

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

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Contents Page

1.

Getting to know the STIMPOD NMS460

1

1.1) 1.2) 1.3) 1.4) 1.5) 1.6) 1.7) 1.8) 1.9)

Device Description Accessories Device Layout Screen Layout Adjusting Settings Open Circuit Detection Countdown Timer Shutdown Symbols on device battery clip

1 1 2 3 4 4 4 4 4

2.

Setting up Device Defaults

5

2.1) 2.2) 2.3) 2.4) 2.5) 2.6) 2.7) 2.8)

Languages Stimulation Mode Pulse Width Options Stimulating Frequency Countdown Timer Speaker Volume Backlight User Information

5 5 6 6 6 6 7 7

3.

Technical Notes

7

3.1) 3.2)

Specifications Cleaning and Disinfecting STIMPOD NMS460

7 7

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1)

Getting to know the STIMPOD

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 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: ECG Electrodes are not included in this package. 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.

Carry Case

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.

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. 1

1.3)

Device Layout

Cable Connector • Insert the Cable

Multi Functional Clip Enter / Frequency Button • Press to toggle between Stimulating Frequencies. • Press to Enter in setup menu.

Display

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.

Battery Compartment Cover

On / Off Button • Press to switch unit on / off.

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1.4)

Screen Layout

dicators • Indicators

• Countdown timer

Square Wave q

• Current Setting Adjust using Wheel.

Hybrid RF y

Speaker Volume

• Pulse Width Setting Adjust using Menu / Pulse Width button.

Battery Status

• Stimulating Frequency Setting Adjust using Enter / Hz button.

• Information Screen Actual current delivered

The current displayed in this screen is the actual Average Curre 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.

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.

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!

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1.5)

Adjusting Settings

1.7)

Adjusting the Current

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.

Current Range: 0 – 30 mA adjustable in 1mA increments Circle the Wheel to adjust the current

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.

1.8)

Shutdown

Auto Shutdown

1.6)

STIMPOD NMS460 will automatically switch off after 10 minutes of no user or patient interaction.

Open Circuit Detection

Battery Depleted

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.

When the battery is depleted the unit will prompt the user to replace the battery and switch off.

Closed Circuit Detected: • • • •

1.9)

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.

Symbols on device battery clip Manufacturer Attention! See Instructions for Use

Open Circuit Detected:

Separate collection for electrical and electronic equipment (Applicable to EU community 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.

Manufacturing Date (Year) Serial Number Representative in the EU 47

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)

Hybrid RF Mode The “ “ indicator in the main window tells the user that the device is in Hybrid RF Mode. The radio button next to Hybrid RF Mode will show that it is activated.

Languages

To exit scroll down the menu to EXIT MENU and press enter.

DEFAULT: English

Use the Wheel to navigate to LANGUAGE. Press enter to select.

A conformation screen will show your selection, with an option to ACCEPT.

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.

YES will take you back to the main Setup Menu. NO will take you to the previous screen.

Square uare Wave Mode The e“ “ in indicator in the main window tells the user that the device is in Square uare Wave Mode. The radio button next to Square Wave Mode will show that it is activated.

2.2)

Stimulation Mode

To exit scroll down the menu to EXIT MENU and press enter.

DEFAULT: Hybrid RF Options: Hybrid RF, Square Wave

A conformation screen will show your selection, with an option to ACCEPT.

Use the Wheel to navigate to STIMULATION MODE. Press enter to select.

YES will take you back to the main Setup Menu. NO will take you to the previous screen.

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2.3)

Pulse Width Options

2.5)

DEFAULT: 0.1ms Options: 0.1ms, 0.2ms

Countdown Timer

DEFAULT: 10 minutes Options: Adjustable from 00:01 to 59.59

Use this setup function to activate the preferred pulse widths.

Use the Wheel to navigate to the COUNTDOWN TIMER. Press enter to select.

Use the Wheel to navigate to PULSE WIDTH in the main menu. 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.

Within the PULSE WIDTH Menu, the radio button next to the selected pulse width will show that they have been activated.

2

‘Seconds’ will be highlighted: Use the Wheel to adjust the settings. Press enter to accept the desired setting.

2

A confirmation screen will show your updated values with an option to ACCEPT.

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.

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

2.6)

DEFAULT: 2Hz Options: 1Hz, 2Hz, 5Hz and 10 Hz

Speaker Volume

DEFAULT: Medium Options:

Use the Wheel to navigate to FREQUENCY in the main menu. Press enter to select.

Use the Wheel to navigate to SPEAKER VOLUME. 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.

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 your selection with an option to ACCEPT.

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.

YES will take you back to the main Setup Menu. NO will take you back to the previous screen.

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2.7)

Backlight

2.8)

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.

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. 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.

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.

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.

NOTE: If the selected backlight option is ‘Always On’ the battery life will be drastically shortened.

3)

Technical Notes

3.1)

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 - 7 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

User Information

DEFAULT: No default

3.2)

Cleaning and Disinfecting STIMPOD NMS460

Cleaning: Soap and water, applied with a damp cloth is suitable to clean and disinfect the STIMPOD NMS460. It is imperative that no moisture penetrates the STIMPOD. Disinfecting: Any commercially available methanol - free disinfectant in an ethyl alcohol base can be used for disinfection.

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