EZstim II Model ES 400 Operators Manual Rev B

MEANING OF SYMBOLS Your instrument may include symbols on the rear or front panel, the meaning for these symbols are listed below:

Danger - do not use in the presence of flammable anesthetics

Type BF equipment

Attention! Read Instructions

Not user serviceable

EC Representative:

FBI Fred Berninger Importe Bergstrasse 12 82024 Taufkirchen Tel: +49 89 61 453 453 Fax: +49 89 61 453 455 e-mail: [email protected]

Manufactured by:

4235 Greenbriar Drive Stafford, TX, USA 77477-3995 800-231-9841 281-491-6600 http://www.life-tech.com Administrative / Financial Fax: 281-491-6646 Sales / Customer Service Fax: 281-491-7197 Technical and Clinical Support Fax: 281-491-6852

© 2003, 2005 Life-Tech, Inc. All rights reserved. No part of this manual may be reproduced in any manner, in whole or in part, without written permission of Life-Tech, Inc.

TABLE OF CONTENTS SECTION 1 2

3 4 5 6 7 8

DESCRIPTION

PAGE

Precautions ... 1 General Description & Specifications ... 3 Description ... 3 High Output Range ... 3 Low Output Range ... 6 Specifications ... 7 Display, Controls and Inputs ... 9 Assembly ... 16 Operation in High Output Range (Peripheral Nerve Stimulator) ... 17 Operation in Low Output Range (Peripheral Nerve Locator) with or without SoloStimTM Foot Control ... 19 Maintenance ... 23 Limited Warranty ... 25

TABLE OF FIGURES FIGURE

DESCRIPTION

PAGE

2.1 2.2 2.3 2.4 2.5 2.6 3.1 3.2 3.3 3.4 4.1 4.2 5.1 6.1

Twitch Pattern (High Output Range) ... 4 50 Hz ~ Tetanus Pattern ... 4 100 Hz ~ Tetanus Pattern ... 5 Double-Burst Pattern ... 5 Train-of-Four (TO4) Pattern ... 6 Twitch Pattern (Low Output Range) ... 6 Display, Controls and Inputs ... 9 LCD in High Output Range - null mode ... 10 LCD in High Output Range (Peripheral Nerve Stimulator) ... 10 LCD in Low Output Range (Peripheral Nerve Locator) ... 11 Protective Boot (PB) ... 16 Protective Boot and Mounting Bracket (MB-5) ... 16 Connections for use as Peripheral Nerve Stimulator ... 17 Connections for use as a Peripheral Nerve Locator ... 19

7.1

Battery Replacement ... 23

SECTION 1 PRECAUTIONS Before using the instrument, please read these operating instructions carefully. Follow the warnings indicated on the instrument and the safety precautions recommended in this manual. Warnings 1. Federal law (USA) restricts this device to sale by or on the order of a physician. 2. DANGER – EXPLOSION HAZARD: EZstim II is not intended for use in explosive atmospheres. Do not use the instrument in pure oxygen environments or in the presence of flammable anesthetics or other flammable products. General Precautions and Contraindications 1. Follow all instructions for use of the instrument. 2. Do not apply electrodes: · Over the thoracic area · Over the left and/or right temporal regions · In the orbital region · On broken skin 3. After using an alcohol prep to clean the skin, make sure any flammable liquid and/or vapors have evaporated and dispersed before using the instrument. 4. Microshock Hazard: In patients with pacemakers or cardiac abnormalities, the physician in charge must approve the use of the EZstim II. 5. Tetanus Stimulation: While the Twitch, Train-of-Four and Double-Burst stimuli are usually well tolerated in awake patients, Tetanus stimulation can be uncomfortable for fully conscious patients. It is recommended that Tetanus stimulation be used only during anesthesia. 6. Foreign Material: EZstim II is designed to be drip resistant, in its normal orientation. Protect this instrument from immersion, spills, the impact of falling objects, and exposure to excessive smoke, dust, mechanical vibration, or shock. 7. Magnetism: The instrument should be situated away from devices that generate strong magnetic fields. 8. Heat: Situate the unit away from heat sources such as radiators and warming lamps as exposure to high temperatures may affect operation or cause damage. See Section 2, Specifications for temperature recommendations.

1

9.

Electrosurgery: This unit is certified to function properly during the use of electrosurgery equipment, only when the following conditions are met: The unit is operating in the High output current range with the NSL-5 lead wire set connected - and The electrosurgery site is at least one (1) foot (30 cm) from the stimulator patient lead electrodes.

10.

Battery Leakage: If the unit is going to be stored for a prolonged period of time, we recommend that you remove the battery to protect the unit from damage caused by battery chemical leakage.

Service 1. Required Service: The unit should be serviced by qualified service personnel when: a. Liquid has ingressed into the instrument. b. It does not appear to operate normally or exhibits a marked change in performance. c. The enclosure is damaged. 2. Servicing: Do not attempt to service the unit beyond that described in the Operating Manual unless directed by Life-Tech Service Personnel. Sterilization 1. The unit is not sterilizable.

2

SECTION 2 GENERAL DESCRIPTION AND SPECIFICATIONS 1.

Description The Model ES400 EZstim II is both a constant current Peripheral Nerve Stimulator (HIGH output current range) and a Peripheral Nerve Locator (LOW output current range). Output current range is determined by the model of patient lead cable connected to the unit. When the RBW-5L (gray & black) patient lead cable is connected, the unit automatically sets to the LOW output current range (0.05 to 5.0 mA). In this range, the unit functions as a nerve locator for use in regional nerve block procedures and can be operated using the optional TM SoloStim foot control. When the NSL-5 (red & black) patient lead cable is connected, the unit automatically sets to the HIGH output current range (0.05 to 80 mA), with no stimulus mode selected (null mode). When the user selects a stimulus mode (1 or 2 Hz Twitch, 50 Hz Tetanus, 100 Hz Tetanus, Double-Burst or Train-of-Four) the unit functions as a nerve stimulator for use in monitoring the effects of skeletal muscle relaxants on the TM Neuromuscular junction. The optional SoloStim foot control is not operational in the High output current range.

NOTE: In this manual, the unit is considered to be in a null mode when no stimulus mode/pattern is selected. The LCD provides a real-time display of user-set functions and battery status, as shown and described in detail in Section 3. The unit has audible chirp/beep feedback in addition to the visible LCD Output Stimulus Pulse Indicator. If for any reason (lead connection, device fault, dying battery, etc.) the output current is less than the displayed mA value for four sequential pulses, a six beep open lead alarm will sound once per second. The Stimulus Amplitude Control dial provides variable current control (0.05 to 5.0 mA in the LOW output range or 0.05 to 80 mA in the HIGH output range). All other controls on the face of the unit are buttons. Depending upon the output range in use, any of the available modes is activated by pressing the button for that mode. The buttons are shown and described in detail in Section 3. The operating modes and associated patterns for the HIGH and LOW output ranges are described below and on the following pages. HIGH OUTPUT RANGE PATTERNS: With the NSL-5 Patient Lead Cable connected, the unit automatically sets to the HIGH output range, with no stimulation pattern active (null mode). While in the null mode, the unit emits no stimulation output current and no audible chirps. When the user selects a mode, the unit stimulates the target nerve with 200 microsecond (0.2 millisecond) wide pulses, in the selected pattern. 3

HIGH OUTPUT RANGE PATTERNS (cont): Twitch: When the twitch mode is selected in the HIGH output range, the default pattern is the 2 Hz Twitch. The user can toggle the pattern frequency between 1 Hz and 2 Hz by pressing the twitch mode button. The unit emits an audible chirp with each stimulus pulse.

Figure 2.1: Twitch Patterns (HIGH Output Range) 50 Hz Tetanus: In this mode, the unit delivers continuous 0.2 millisecond stimulation pulses at a frequency of 50 Hz. The unit delivers tetanic stimulus ONLY while the button is depressed and returns to the prior mode setting (including null mode) when the button is released. The unit emits a continuous tone while the tetanus button is pressed and stimulus is delivered.

Figure 2.2: 50 Hz ~ Tetanus Pattern

4

HIGH OUTPUT RANGE PATTERNS (cont): 100 Hz Tetanus: In this mode, the unit delivers continuous 0.2 millisecond stimulation pulses at a frequency of 100 Hz. The unit delivers tetanic stimulus ONLY while the button is depressed and returns to the prior mode setting (including null mode) when the button is released. The unit emits a continuous tone while the tetanus button is pressed and stimulus is delivered.

Figure 2.3: 100 Hz ~ Tetanus Pattern Double-Burst Stimulus (DBS): In the DBS mode, the unit delivers a stimulation pattern that consists of two groups (bursts) of three 0.2 millisecond pulses. Each of the pulses within a group is separated by 20 milliseconds ± 5%. The delay from the first pulse of the first group to the first pulse of the second group is 750 milliseconds ± 5%. While in the DBS mode, the pattern repeats every ten (10) seconds. Each burst is accompanied by an audible chirp. In addition, while counting down the 10 second interval between auto-repeating patterns, the unit emits a long beep as a reminder that the next stimulus will be delivered in one (1) second.

Figure 2.4: Double-Burst Pattern

5

HIGH OUTPUT RANGE PATTERNS (cont): Train-of-Four (TO4): In the TO4 mode, the unit delivers a group of four 0.2 millisecond pulses, spaced 500 milliseconds ± 5% apart (2 Hz Rate). While in the TO4 mode, the pattern repeats every ten (10) seconds. Each TO4 is accompanied by an audible chirp. In addition, while counting down the 10 second interval between auto-repeating patterns, the unit emits a long beep as a reminder that the next stimulus will be delivered in one (1) second.

Figure 2.5: Train-of-Four Pattern LOW OUTPUT RANGE PATTERNS: With the RBW-5L Patient Lead Cable connected, the unit automatically sets to the LOW output range and is then used to locate the target nerve with constant current 100 microsecond (0.1 millisecond) twitch pulses. The user can toggle the pattern frequency between 1 Hz and 2 Hz (power ON default is 2 Hz) by pressing the twitch mode button. The unit emits an audible chirp with each stimulus pulse.

Figure 2.6: Twitch Patterns (LOW Output Range)

6

2.

Specifications If your unit fails to meet the following specifications, please contact Life-Tech or your local distributor for service. Contact information for EC Representative is located at the front of this manual. Regulatory Standards:

UL2601-1 CSA22.2No.601.1 CE Marked to MDD EC93/42 EN60601-1 EN60601-1-2 EN61000-4-2 EN61000-4-3 EN61000-4-8 EN55011B, Group 1

Ingress Protection:

IP-21 (EZstimTM II) IP-07 (SoloStimTM foot control)

Size (WxDxH):

Pocket size, 3.25" (8.3 cm) wide x 6.0" (15.3 cm) long x 2.25" (5.7cm) high (including knob)

Weight:

9.6 oz (275gm) w/ 9V battery

Battery:

One 9V Alkaline Battery

Storage Environment:

-40o to 70o Celsius (-40o to 158o F)

Operating Environment:

10o to 40o Celsius (50o to 104o F)

10% - 100% RH non-condensing 10% - 100% RH non-condensing

7

Specifications (cont). The specifications listed in the following tables change dynamically to meet the requirements of the Output Current Range in use at the time of operation. When the NSL-5 Patient Lead Cable is connected to the unit, it operates in the HIGH output range as a Peripheral Nerve Stimulator, and the following apply: Operating Parameter

HIGH output range Specification

Output Current

0.05 mA - 80 mA (± 5% from 1.0 - 80 mA into load of 2K Ohms or less)

Pulse Risetime Pulse Width Pulse Frequency

< 75 microseconds 200 microseconds ± 10% Twitch pattern: 1 Hz or 2 Hz ± 5% Tetanus pattern: 50 Hz or 100 Hz ± 5%

When the RBW-5L Patient Lead Cable is connected to the unit it operates in the LOW output range, as a Peripheral Nerve Locator, and the following apply: Operating Parameter

LOW output range Specification

Output Current

0.05 mA - 5.0 mA ( ± 1% from 0.2 to 5.0 mA into load of 11.5K Ohms or less)

Pulse Risetime Pulse Width Pulse Frequency

< 5.0 microseconds 100 microseconds ± 1% Twitch pattern: 1 Hz or 2 Hz ± 1%

8

SECTION 3

EZstim II DISPLAY, CONTROLS AND INPUTS

Figure 3.1: Display, Controls and Inputs

9

1

Display: The LCD displays all of the settings programmed into the unit, as well as the status of various functions, as illustrated and described in detail on the following pages.

Figure 3.2: EZstim II LCD in HIGH output range - null mode

Figure 3.3: EZstim II LCD in HIGH output range - stimulus mode selected (Peripheral Nerve Stimulator)

10

Figure 3.4: EZstim II LCD in LOW output range (Peripheral Nerve Locator) a

Pause Indicator: Vertical bars illuminate when in the Pause mode. The audible chirp ceases when the unit is paused.

b

Stimulus Setting/Output Display: This field of the LCD displays the stimulus setting/output level of the unit in milliamps (mA). If operating in the HIGH output range (NSL-5 lead set attached)… The unit powers on in the null mode and the display reads - - -. When a mode is selected, then the numeric value for the set stimulus level is displayed: • In integers when the current is between 1 and 80 mA (e.g., 1, 2, 3,… 40,… 53,… 78…) • With two decimal places only when at 0.05 mA. If operating in the LOW output range (RBW-5L lead set attached)… The numeric value for the stimulus display extends to: • Two decimal places only when at 0.05 mA. • One decimal place when the value is greater than 0.05 (e.g., 0.1, 0.2, …0.9, 1.0, 1.1, 1.2, …)

The stimulus output is set either using the Stimulus Control knob (Figure 3.1, 2 ) or the optional foot control (low output range only).

11

Whenever the unit detects an open/disconnected lead condition or is unable to deliver the displayed current setting, it will flash the output level display, and emit an audible alarm of 6 micro chirps every second. The output level display is static when the unit is paused and when stimulus pulses are being delivered. The audible chirp heard with each stimulus pulse (or pattern), changes in duration, depending upon the output range and the delivered stimulus output. Output Range

Chirp Duration

Output Current Level

HIGH

Long

All

LOW

c

Long

1.0 mA

Medium

0.6 mA - 0.9 mA

Short

0.4 mA - 0.5 mA

Micro

0.3 mA

Stimulus Range Setting: This field of the LCD displays the maximum stimulus current setting you can achieve by turning the Stimulus Control knob or pressing the foot control.

When operating in the HIGH output range (as a Peripheral Nerve Stimulator)… • The NSL-5 interface cable is plugged into the Patient Lead Output Connector (13), and • The default range is 0.05 mA to 80 mA (the display reads 80 When operating in the LOW output range (as a Peripheral Nerve Locator)… • The (optional) RBW-5L interface cable is plugged into the Patient lead Output Connector, and • The default range is 0.05 mA to 5.0 mA (the display reads 5.0 - Or If the unit is used with the optional foot control, the current range can be set to a range setting of 1.5 mA (the display

12

d

Battery Life Indicator:

... Battery Life Remaining 80 - 100% ... 60 - 80% ...40 - 60% ...20 - 40% ... 0 - 20% The LED segments of the Battery Life Indicator are solidly illuminated to the level of current battery life during use, until the battery life drops below 20% (less than 8 hours of operation remaining). When the battery life is reduced to a voltage that is indicative of approximately eight hours of operation remaining, the lowest segment (as well as the battery outline itself) will flash at a rate of 1 Hz. When the battery life is reduced to a voltage that is indicative of less than four hours of operation remaining, the lowest segment (as well as the battery outline itself) will flash at a 2 Hz rate. Caution: Operation will cease when battery voltage is insufficient for the unit to function within specifications.

e

Stimulus Repetition Rate: This field of the LCD displays the rate (in Hz) at which the stimulus pulses are delivered when in the Twitch or Tetanus modes. It is blank when the unit is in the null mode, or operating in the DBS or TO4 modes.

f

Pulse Width: This field of the LCD displays the width (duration) of the stimulus pulses. The pulse width default is determined by the stimulus output range at the time of operation. If operating in the… HIGH output (Peripheral Nerve Stimulator) range… LOW output (Peripheral Nerve Locator) range…

g

Then… The pulse width setting is 0.2 msec. The pulse width setting is 0.1 msec.

Pulse Indicator: Displays an LCD waveform representing the operating mode (Twitch, TO4, DBS or Tetanus) that flashes when a stimulus pulse is delivered. Each flash of the pulse indicator is accompanied by an audible chirp. The stimulus pulse indicator will not flash if the unit is in an open lead condition or paused. If the mode is changed when the unit is paused, the static waveform changes to represent the new mode. This field is blank only when the unit is in the null mode. 13

2 Stimulus Control Knob: Rotation of this knob changes the stimulus setting (if paused or open lead) or the stimulus output current.

NOTE: In this manual, this symbol designates operations that only apply when using the Stimulus Control Knob in the absence of a foot control.

3 On/Off button: Press this button to turn the unit ON and OFF. NOTE: The unit will auto-power off after 20 minutes of either an open lead or paused or null mode condition.

4 Pause button: Press this button to pause and un-pause the stimulus output pulse.

5 Twitch Mode/Stimulus Repetition Rate button: Press this button to set the unit to the Twitch Mode and/or toggle the twitch mode between 2 Hz and 1 Hz.

6 Chirp Volume-Increase button: Press this button to increase the volume of the chirp that accompanies each stimulus output pulse in increments. Press and hold the button for 4 seconds to reach maximum volume.

7 Chirp Volume-Decrease button: Press this button to decrease the volume of the chirp that accompanies each stimulus output pulse in increments. Press and hold the button for 4 seconds to reach minimum volume.

NOTE: There are five levels of chirp volume, the default and four (4) levels up from the default.

8 100 Hz ~ Tetanus Mode button: This button is only enabled when the unit is operating in the HIGH output range. Press and hold the button to operate the unit in the Tetanus Mode, at a stimulus repetition rate of 100 Hz. When the button is released, the unit returns to the previously selected mode, to include null mode.

NOTE: The unit will only provide tetanic stimulus pulses while one of the Tetanus Mode buttons is actively pressed.

9 50 Hz ~ Tetanus Mode button: This button is only enabled when the unit is operating in the HIGH output range. Press and hold the button to operate the unit in the Tetanus Mode, at a stimulus repetition rate of 50 Hz. When the button is released, the unit returns to the previously selected mode, to include null mode.

NOTE: The unit will only provide tetanic stimulus pulses while one of the Tetanus Mode buttons is actively pressed.

14

10 Double-Burst Mode button: This button is only enabled when the unit is operating in the HIGH output range. Press this button to deliver a Double-Burst stimulus. The DBS pattern autorepeats every ten (10) seconds until another mode is selected, or the unit is paused or turned OFF.

11 Train-of-Four Mode button: This button is only enabled when the unit is operating in the HIGH output range. Press the button to deliver a Train-of-Four stimulus. The TO4 pattern auto-repeats every ten (10) seconds until another mode is selected or the unit is paused or turned OFF.

12 Foot Control Input Connector: 5-pin connector to attach the optional foot control input cable.

NOTE: In this manual, this symbol designates operations that only apply when using the foot control.

13 Patient Lead Output Connector: 4-pin connector to attach patient leads for use as follows: If… The provided NSL-5 Interface Cable is attached… The optional RBW-5L Lead Wire Set is attached…

Then… The unit operates only in the HIGH output range, as a Peripheral Nerve Stimulator. The unit operates only in the LOW output range, as a Peripheral Nerve Locator.

15

SECTION 4 ASSEMBLY 1.

To apply the optional Protective Boot, roll the sides of the boot open and slide the unit in, as shown below. Fold the stand out for tabletop placement of the unit.

Figure 4.1: Protective Boot (PB) 2.

To use the optional Mounting Bracket and Protective Boot: a. Remove the stand from the back of the Protective Boot. b. Assemble the two components as shown below. c. Attach to an IV pole.

Figure 4.2: Protective Boot - Mounting Bracket (MB-5) Assembly

16

SECTION 5 OPERATION IN HIGH OUTPUT RANGE (Peripheral Nerve Stimulator)

Figure 5.1: Connections for use as Peripheral Nerve Stimulator (high output range) 1.

If the EZstim II is on, press

2.

Set the Stimulus Control knob to the minimal current setting (full counterclockwise). Attach the NSL-5 Interface Cable to the 4-pin input connector. CAUTION! Take care that you do NOT attempt to force the 4-pin NSL-5 connector into the 5-pin foot control input. This will cause the unit to malfunction and could damage the connector on the lead set. When removing the lead wire set, grasp the black connector and pull it straight away from the unit. Do NOT remove the cable by pulling on the wires. 17

3.

to turn it off.