STIMPOD NMS 410 & 450 User Manual ver 4.0

Contents

Page

Page

1.

Getting to know the STIMPOD (NMS 410/450)

1

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

Device Description Accessories Device Layout Screen Layout Warning Screens Open Circuit Detection Auto Shutdown Symbols on device battery clip

1 2 3 4 5 6 6 6

2.

Operating Device in Nerve Locating Mode (NMS 410/450)

7

2.1) 2.2) 2.3) 2.4)

Proximity Indicator Adjusting the Current Adjusting the Pulse Width Adjusting the Twitch Frequency

7 8 8 8

3.

Operating Device in Nerve Mapping/Locating Mode (NMS 410/450)

9

3.1) 3.2) 3.3)

Adjusting the Current Adjusting the Pulse Width Adjusting the Twitch Frequency

10 10 10

4.

Operating Device in Neuromuscular Blocking Agent 11 (NMBA) Monitoring Mode (NMS 450)

4.1) 4.2) 4.3) 4.4) 4.5)

Electrode Placement Accelerometer Placement Adjusting the Current Adjusting Stimulation Mode Adjusting the Twitch/ Tetanus Frequency

4.6) Train of Four Mode (TOF) 4.7) Double Burst Mode (DB) 4.8) Post Tetanic Count Mode (PTC) 4.9) Twitch Mode 4.10) Tetanus Mode 4.11) Single Stimulus vs. Repeated Stimulation

11 11 12 12 12

ii

12 13 13 14 14 14

5.

Setting up Device Defaults

15

5.1) 5.2) 5.3) 5.4) 5.5) 5.6) 5.7) 5.8) 5.9)

Languages Current Mode Pulse Width Options Stimulating Frequency Repeat Timer Proximity Indicator Speaker Volume Backlight User Information

15 16 18 18 19 19 20 20 20

6.

Technical Notes

21

6.1) 6.2) 6.3)

Performance Testing Specifications Cleaning and Disinfecting STIMPOD

21 23 23

7.

Products & Accessories

24

1) Getting to know the STIMPOD (NMS 410/450) 1.1)

Device Description

The STIMPOD (NMS 410/450) is 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. The STIMPOD (NMS 450) includes Neuromuscular Blocking Agent Monitoring functionality with real-time feedback achieved by tri-axial accelerometry. CAUTION: This device should only be used by a qualified physician with appropriate knowledge in regional anaesthesia. CAUTION: 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

1.2)

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 Locating Cable: • This cable is used to activate the Nerve Locating mode on the STIMPOD. • The red (anode) connector is designed to clip on to a standard ECG electrode. • The 2mm needle connector will accommodate various makes of needles.

Nerve Mapping/ Nerve Locating Cable: • 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.

NMBA Monitoring Cable (NMS450): • This cable is used to activate the NMBA mode on the STIMPOD. • The red (anode) and black (cathode) connectors are designed to clip onto standard ECG electrodes. • The accelerometer is designed to attach to the contracted appendage (in the case of the ulnar nerve, this will be the thumb).

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. 2

1.3)

Device Layout

Cable Connector • Insert the Nerve Locating Cable, the combined Nerve Mapping / Locating Cable or the NMBA cable to activate the relevant mode.

Display

Multi Functional Clip

Enter / Frequency Button • Press to toggle between Frequencies. • Press to Enter in setup menu.

Menu / Pulse Width Button NMS410/450 (LOC/MAP Mode) • Press to toggle between Pulse Widths. • Press and hold to access Setup Menu. NMS 450 (NMBA Mode) • Press to toggle between Stimulation Modes.

Stimulating LED indicator • Flashing Green: Stimulus delivered. • Flashing Red: Open Circuit.

Pause Button NMS 410/450 (LOC/MAP Mode) • Press to Stop / Start Stimulation. NMS 450 (NMBA 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.

Battery Compartment Cover

On / Off Button • Press to switch unit on / off. 3

1.4)

Screen Layout

Indicators Nerve locating mode

Nerve mapping mode NMBA mode (NMS450)

Non-Linear mode Linear mode

Speaker Volume

Battery Status

Warning

Main Screen

Notifies the user of a discrepancy between current setting and average current of actual stimulus.

• Current Setting Adjust using Wheel. • Diagnostic or Warning Screen

• Average current of actual stimulus

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

Warning Screens

• NMBA Mode (NMS 450) Stimulation Mode TOF, DB, PTC, TET, TWI.

• Stimulating Frequency Setting Adjust using Enter / Hz button.

Explained on Page 5.

Diagnostic Screen NMS 450 (NMBA Mode)

Diagnostic Screen NMS 410 / 450 (LOC / MAP Mode) • Proximity indicator arrow

• Calculated Charge Setting

• Real-time feedback of relative contraction strength measured with the accelerometer

• Countdown timer for repeat mode

• Indication of current setting • 0 mA • Graph indicating shape of actual current stimulus

• Calculated percentage in TOF and DB mode • Twitch Count in PTC and TOF if less than 4 contractions were indentified

• Average charge of actual stimulus 4

1.5)

Warning Screens 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 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 NMS 410/450.

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 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 needle or mapping device) do not form the closed circuit. This warning will be accompanied by a red flashing LED, every time the unit attempts to stimulate.

Fatal Error: The STIMPOD has detected a component failure. Please send the device back to the manufacturer for repair!

55

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 and the patient comprises a closed circuit.

Closed Circuit Detected:

Open Circuit Detected:

• Stimulation will take place. • Stimulating sound will be heard (Single or multiple beeps depending on proximity indicator setting. Sound pitch will follow the current intensity). • The LED stimulus indicator will pulse green with every successful stimulus attempt. • The diagnostic screen will provide active feedback on every pulse delivered.

• 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.

1.7)

Auto Shutdown

STIMPOD will shutdown after 10 minutes of no user or patient interaction.

1.8)

Symbols on device battery clip

Manufacturer

Attention! See Instructions for Use

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

6

Manufacturing Date (Year)

Serial Number

Representative in the EU

2) Operating Device in Nerve Locating Mode (NMS 410/450) Localisation of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting, locating needle (not supplied) through which local anaesthetics can be administered. This procedures involves subcutaneous stimulation of the motor component of the relevant peripheral nerve, to ‘locate’ the nerve. • Select this mode by inserting the Nerve Locating cable. • The STIMPOD will automatically default to the Nerve Locating current range (0.00 - 5.00 mA) and display the ‘ LOC ’ indicator.

2.1)

Proximity Indicator

The proximity indicator is activated when the combination of current and pulse width settings result in a charge which is within the range as selected in the SETUP MENU, section 5.6.

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. 77

2.2)

Adjusting the Current

Current Mode Options:

Sound:

Options in the Setup Menu: Linear Mode, Non-Linear Mode Default: Linear

If sound is enabled: STIMPOD will beep every time that a stimulus was delivered. The pitch of the sound will follow the current intensity level.

Linear Mode:

Non-Linear Mode:

The Linear Mode is called linear because one ‘click’ on the Wheel will correspond with one increment as set in the specific current range. The Linear Mode allows the user to select 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 terms of Current (mA) and Pulse Width (ms). If correctly implemented each adjustment position should afford the user with a relatively linear progression in terms of the distance from needle tip to the nerve.

Default Current range: 0.00 - 5.00mA adjustable in the following default increments: 0.0 - 0.6mA Default 0.1mA 0.6 - 2.0mA Default 0.2mA 2.0 - 5.0mA Default 0.5mA

Default Current and Pulse Width Range: As shown in table 5.1 in section 5.2 circle the Wheel to select the predetermined current and pulse width positions sequentially.

Increments can be adjusted in the Setup Menus (refer to 5.2)

NOTE: Because the 20 definable positions include both current and pulse width settings, pulse width cannot be adjusted independently in this mode. This is indicated on the screen by the fact that pulse width is not highlighted.

Circle the Wheel to adjust current. Warning Notifies the user of a discrepancy between current setting and average current of actual stimulus. Average of actual current delivered.

2.3)

Adjusting the Pulse Width

2.4)

Options in the Setup Menu: 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms Default: 0.1ms, 0.3ms Press Menu/Pulse Width button to toggle between different Pulse Widths.

Adjusting the Twitch Frequency

Options in the Setup Menu: 1Hz, 2Hz, 5Hz Default: 2Hz Press Enter/Hz button to toggle between different stimulating frequencies. 8

3) Operating Device in Nerve Mapping/Locating Mode (NMS 410/450) 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. This mode offers the user the means to do nerve mapping and locating without having to switch or unplug cables. When inserting the Nerve Mapping / Locating Cable, the STIMPOD will default to the Nerve Mapping current range (0-20mA). Current will be directed to the Nerve Mapping probe and 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 mode and behave as described in chapter 2. If contact between the needle and patient is broken, and the nerve mapping probe touches the patient, STIMPOD will switch back to the nerve mapping mode and start 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. • This mode is selected when the Nerve Mapping / Locating cable is inserted. 99

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

• The STIMPOD will automatically default to the Nerve Mapping current range (0-20mA) and display the ‘ MAP ’ indicator.

3.1)

If sound is enabled: STIMPOD will beep every time that a stimulus was delivered. The pitch of the sound will follow the current intensity level.

Adjusting the Current Average of actual current delivered.

Current Range: 0 - 20mA adjustable in 1mA increments. Circle the Wheel to adjust current.

3.2)

Warning Notifies the user of a discrepancy between current setting and average current of actual stimulus.

Adjusting the Pulse Width

3.3)

Options in the Setup Menu: 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1ms Default: 0.1ms, 0.3ms Press Menu/Pulse Width button to toggle between different pulse widths.

Adjusting the Twitch Frequency

Options in the Setup Menu: 1Hz, 2Hz, 5Hz Default: 2Hz Press Enter/Hz button to toggle between different stimulating frequencies.

When using the Nerve Locating Needle: • Connect the needle to the Nerve Mapping/Locating cable. The moment that the needle penetrates the skin the cable will communicate this to the STIMPOD, switch to nerve locating mode, and switch the stimulation to the needle. The current in locating mode will default to 0.00mA. • The STIMPOD will now function exactly as described in Chapter 2. • If contact between the needle and patient is broken, and the nerve mapping probe touches the patient, STIMPOD will switch back to the nerve mapping mode and start monitoring the needle - patient connection again. Mapping mode will default back to 0mA. • Whenever the nerve mapping probe and the nerve locating needle simultaneously make contact with the patient the needle will have first priority.

10

4) Operating Device in Neuromuscular Blocking Agent Monitoring Mode (NMS 450) Monitoring Neuromuscular Blocking Agents involves stimulating a neural pathway which facilitates the contraction of an appendage. Based on the relative strength of 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. • This mode is selected when the NMBA cable is inserted.

4.1)

Electrode Placement

The electrodes may be placed on any of the following nerves: • Ulnar Nerve • Facial Nerve • Median Nerve • Posterior Tibial Nerve For routine NMBA monitoring purposes, the Ulnar Nerve is preferred because of its accessibility, lack of peripheral muscle involvement and reproducibility .

4.2)

Accelerometer Placement

The tri-axial accelerometer should be attached to the contracting appendage of the patient, to measure the strength of the contraction resulting from the applied electrical stimulus. The accelerometer is only used in the Train-of-Four, Double Burst and Post Tetanic Count Modes, to facilitate monitoring of the efficacy of the Neuromuscular Blocking Agent.

Stimulating the Ulnar Nerve (under normal un-blocked conditions) causes a contraction of the adductor pollicis, which is then monitored either visually or through acceleromyography. Typical electrode placement is done on the volar side of the wrist. The cathode (black electrode clip) is positioned where the proximal bending line crosses the radial side of the flexor carpi ulnaris muscle. The anode (red electrode clip) can be placed 2 - 3cm proximal of the cathode. 11 11

When using the Neuromuscular Blocking Agent Monitoring Mode (NMS 450): 4.3)

Adjusting the Current

Sound: If sound is enabled: STIMPOD will beep every time that a stimulus was delivered. The pitch of the sound will follow the current intensity level.

Linear Mode: In NMBA mode current can only be adjusted in the linear mode. The Linear Mode is called linear because on ‘click’ on the Wheel will correspond with one increment as set in the specific current range.

Average of actual current delivered. Warning Notifies the user of a discrepancy between current setting and average current of actual stimulus.

Default Current range: 0 - 80 mA adjustable in 1mA increments. Circle the Wheel to adjust current.

4.4)

Adjusting Stimulation Mode

4.6)

Options: TOF, DB, PTC, TET, TWI Default: TOF Press Menu/Mode button to toggle between different Stimulation Modes.

4.5)

Train of Four Mode (TOF)

The TOF stimulation comprises four, square waves with a pulse width of 200 microseconds, 500 milliseconds apart. Selecting TOF Mode: • Insert the NMBA cable with the red and black electrode clips as well as the tri-axial accelerometer. • Press the ‘Mode’ button until ‘TOF’ is shown on the display.

Adjusting Twitch/Tetanus Frequency

Twitch Mode: Options in the Setup Menu (Stimulating Frequency): 1Hz, 2Hz, 5Hz Default: 2 Hz Press Enter/Hz button to toggle between different stimulation frequencies.

Real-time Accelerometry: • The relative contraction strength caused by each stimulus is indicated graphically in the diagnostic screen as shown in the picture. • In the case that all four contractions could be measured, the percentage of measured contraction strength of the fourth stimulus compared to the first stimulus will be displayed in the diagnostic screen. • If less than four contractions were measurable, the number of contractions that could be identified by the accelerometer will be displayed, e.g., 2/4.

Tetanus Mode: Options: 50Hz, 100Hz Default: 50Hz Press Enter/Hz button to toggle between different stimulating frequencies.

12

4.7)

Double Burst Mode (DB)

4.8)

Post Tetanic Count (PTC)

The DB stimulation comprises a burst of three square waves of 200 microseconds pulse width, 20 milliseconds apart, followed by another burst of three square waves, 750 milliseconds later.

Defaults: Tetanus: 50Hz for 5 seconds Delay: 3 seconds Twitch: 20 twitches at 1Hz

Selecting DB Mode: • Insert the NMBA cable with the red and black electrode clips as well as the tri-axial accelerometer. • Press the ‘Mode’ button until ‘DB’ is shown on the display.

The PTC stimulation comprises a tetanus stimulation followed by a delay and a number of twitches. (Default settings are as shown above) Selecting PTC Mode: • Insert the NMBA cable with the red and black electrode clips as well as the tri-axial accelerometer. • Press the ‘Mode’ button until ‘PTC’ is shown on the display.

Real-time Accelerometry: • The relative contraction strength caused by each stimulus is indicated graphically in the diagnostic screen as shown in the picture. • The percentage of the measured contraction strength of the second contraction compared to the first contraction will be displayed in the diagnostic screen.

Real-time Accelerometry: • Each counted twitch is indicated graphically in the diagnostic screen as shown in the picture above. The number of twitches counted are displayed in the diagnostic screen.

13

4.9)

Twitch (TWI)

4.10) Tetanus (TET)

Defaults: Repeat at 2Hz Adjustable:1Hz, 2Hz and 5Hz

Defaults: 50Hz (adjustable to 100Hz) The Tetanus stimulation comprises series of 200 microseconds square wave pulses repeated at a 50Hz or 100Hz repetition rate or frequency.

The Twitch stimulation comprises a 200 microseconds square wave pulse. If the ‘Play/Pause’ button is pressed the twitch will repeat at the selected frequency.

Selecting TET Mode: • Insert the NMBA cable with the red and black electrode clips as well as the tri-axial accelerometer. • Press the ‘Mode’ button until ‘TET’ is shown on the display.

Selecting TWI Mode: • Insert the NMBA cable with the red and black electrode clips as well as the tri-axial accelerometer. • Press the ‘Mode’ button until ‘TWI’ is shown on the display.

Stimulate/Stop: Start stimulation by holding the ‘Play/Pause’ button down. Stop stimulation by releasing the ‘Play/Pause’ button.

Stimulate/Stop: Start stimulation by pressing the ‘Play/Pause’ button. Stop stimulation by pressing the ‘Play/Pause’ button again. Frequency adjustment: Press the ‘Hz’ button to toggle through the frequencies.

4.11) Single Stimulus vs. Repeated Stimulation • • • • •

Start the automatic repeat mode by holding the play/pause button down for 2 seconds. The device will automatically start a countdown according to the ‘repeat timer’ setting as specified in the main menu. 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 defaults at 2 minutes and can be changed in the Setup Menu.

14

5) Setting up Device Defaults (NMS 410/450) 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.

5.1)

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

Note: The NMS410 does not have the REPEAT TIMER option.

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

15 15

5.2)

Current Mode

The first range will be: 0.00mA - 0.60mA. In this range the user can select one of the following increment options: 0.01mA, 0.02mA, 0.05mA and 0.1mA. The default setting is: 0.05mA. Select the desired increment and proceed to NEXT RANGE.

DEFAULT: Linear Mode Options: Linear Mode, Non-Linear Mode

Linear Mode The second range will be 0.6mA - 2.0mA. In this range the user can select one of the following increment options: 0.05mA. 0.1mA and 0.2mA. The default setting is: 0.1mA. Select the desired increment and proceed to NEXT RANGE.

The ` ` indicator in the main window tells the user that the device is in Linear Mode. The linear mode is called linear because one ‘click’ on the wheel will 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 three different increment options for three different current ranges.

The third range will be: 2.0mA - 5.0mA. In this range the user can select one of the following increment options: 0.1mA, 0.2mA and 0.5mA. The default setting is: 0.2mA. Select the desired increment and proceed to EXIT MENU.

Use the Wheel to navigate to CURRENT MODE. Press enter to select. Use the Wheel to navigate to Current Mode. Press enter to select. The radio button next to Linear Mode will show that it is 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 Linear Mode settings.

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

Non - Linear Mode

YES will take you to the next screen. NO will take you to the Current Mode Menu.

The ` ` indicator in the main menu window tells the user that the device is in Non-Linear Mode. The Non-Linear Mode facilitates the non-linear nature of the current intensity versus the distance from the nerve. The required current intensity is proportional to the square of the distance from the electrode to the nerve fibre. This mode allows the user to define 20 adjustment positions in terms of Current (mA) and 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. The defaults are indicated in table 5.1. A graph of table 5.1 is shown in figure 5.1.

The next screen will enquire whether the user would like to change the settings. YES will take you to the next screen. NO will take you back to the main Setup Menu.

16

Position

Current (mA)

Pulse Width (ms)

Charge (μC)

It should be noted that the charge of the default values shows a typical quadratic curve. At a pulse width of 0.1ms the current follows the charge.

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

8

1.7

0.1

0.17

9

2

0.1

0.2

10

2.3

0.1

0.23

11

2.7

0.1

0.27

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

NOTE: In this mode the Pulse Width is preset and linked to a specific position. When operating the device in this mode the Pulse Width button is deactivated. All positions are accessed sequentially by manipulating the wheel.

16

4.8

0.1

0.48

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

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

1

2

3

4

5

6

Charge

7

8

9

10

11 12

Current

13 14 15

16

17 18 19 20

Pulse Width

Figure 5.1 Once a limit of 5mA is reached the pulse width is increased to 0.3ms. After 0.3ms the slope of the charge on the graph is increased. NOTE: Each position in this adjustment mode can be defined individually. The user is advised to experiment and adjust the values in order to meet clinical expectations.

To adjust the default position values, use the Wheel to navigate to Non-Linear Mode. Press enter to select. The radio button next to Non-Linear will show that it has been activated.

Table 5.1

17 17

5.3)

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

Pulse Width Options

DEFAULT: 0.1ms, 0.3ms Options: 0.05ms, 0.1ms, 0.3ms, 0.5ms, 1.0ms

YES will take you to the next screen. NO will take you back to the Current Mode Menu.

Use this setup function to activate the preferred pulse widths.

The next screen will enquire whether the user would like to change the settings.

To change the default pulse widths, use the Wheel to navigate to PULSE WIDTH in the main menu. Press enter to select. The radio button next to the selected pulse width will show that they have been activated.

YES will take you to a screen showing all the positions and their values. NO will take you back to the main Setup Menu. All positions will be shown with their respective current and pulse width settings. Scroll down to the position that needs to be adjusted and press enter.

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.

When entering the screen the current setting will be highlighted. Adjust to the required value and press enter. Next the pulse width setting will be highlighted. Adjust to the required value and press enter. The STIMPOD will calculate and display the charge as adjustments are made.

NOTE: If all pulse widths are deselected the STIMPOD will default to 0.1ms and 0.3ms.

5.4)

Stimulating Frequency

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

NOTE: A warning will indicate if the net charge resulting from the user’s settings is either lower than the previous position or higher than the following position.

To change the default frequency, use the Wheel to navigate to FREQUENCY in the main menu. Press enter to select. The radio button next to the selected frequency will show that it is has been selected. Scroll down the menu to EXIT MENU and press enter.

Once a new current and pulse width setting has been entered for the relevant position, the device will again show all the positions and their values. The user can now adjust any other position values following the same steps. To exit, scroll down the menu and EXIT MENU and press enter.

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

A confirmation screen will draw a graph reflecting the net charge for every position, with an option to ACCEPT. YES will take you back to the main Setup Menu. NO will take you back to the screen showing all the positions with their respective current and pulse width settings.

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

18