EZstim III Model ES500 Operators Manual

Operators Manual

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File Name: EZstim III Model ES500 Operators Manual.pdf

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EZstim* III Peripheral Nerve Stimulator / Nerve Locator – Model ES500 Operator’s Manual

TABLE OF CONTENTS Important Information... 2 Definition Of Symbols ...2 Section 1 – Warnings, Cautions And Indications ... 2 Warnings ...2 Cautions ...2 Patient Considerations ...3 Indications ...3 Intended Users ...3 Use Environment ...3 Section 2 – General Description And Specifications ... 3 A.

Product Description ... 3

Product Specifications ... 3

Product Display, Inputs And Controls ... 4

Section 3 – Instrument Assembly ... 7 A.

Battery Installation/ Replacement ... 7

Interface Cables ...7

Optional Mounting Bracket (MB500) For Pole Mount Use ...7

Section 4 – Instrument Operation In High Output Range ... 8 A.

High Output Patterns ...8

Operation In High Output Range (Peripheral Nerve Stimulator) ... 9

Section 5 – Instrument Operation In Low Output Range ... 9 A.

Low Output Range Patterns ...9

Operation In Low Output Range ... 9

Section 6 – Troubleshooting Guide... 10 Section 7 – Maintenance ... 12 A.

General ... 12

Battery Replacement ... 12

Cleaning ... 12

Sterilization ... 12

Disposal ... 12

Section 8 – Limited Warranty ... 12 Section 9 – EMC Compliance ... 13 1

EZstim* III Peripheral Nerve Stimulator / Nerve Locator – Model ES500

e Operator’s Manual IMPORTANT INFORMATION

Please read these operating instructions prior to using the instrument. Follow all the warnings, precautions and instructions carefully to ensure the safety of patient and/or user.

DEFINITION OF SYMBOLS

Labeling on this instrument includes symbols. See Section 2, General Description and Specifications for the meaning of the symbols on the front panel. The definitions of all the symbols are below: Stand-by Danger - do not use in the presence of flammable anesthetics Type BF equipment

Type BF equipment

Dangerous voltage – refer servicing to qualified personnel Caution

Danger - do not use in the presence of flammable anesthetics Dangerous Voltage

Refer to Instructions Manual/Booklet Not user serviceable

Not user serviceable

WEEE Compliance Protected against solid foreign objects of 12.5 mm diameter and greater. Protected against vertically falling water drops.

Cleaned up version

Intertek’s ETL Listing “C/US” mark Use this device by prescription only 70˚C -40˚C 90% 10% Temperature limitation

Storage Temperature Range Storage Humidity Range Keep Dry Catalog Number

LOT

Lot Number Manufacturer Date of Manufacture Authorized EC Representative EC Directive Compliance

SECTION 1 – WARNINGS, CAUTIONS AND INDICATIONS WARNINGS • DANGER – EXPLOSION HAZARD: Do not use this device in pure oxygen environments or in the presence of flammable or explosive anesthetics. • Federal (USA) law restricts this device to sale by or on the order of a physician. • No modification of this equipment and accessories are 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. • Use of the ES500 adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the ES500 and the other equipment should be observed to verify that they are operating normally. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ES500, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. • Use of accessories and cables other than NSL-5, RBW-5U, or MB500 for the ES500 could result in increased electromagnetic emission or decrease electromagnetic immunity of the device and result in improper operation.

CAUTIONS • DO NOT STERILIZE THE INSTRUMENT. • Do not apply electrodes: • Over the thoracic area • On broken skin • 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. • Prolonged use of tetanic stimulation may result in skin burns. • Use of currents greater than necessary for supramaximal stimulation increases the risk of skin burns. Always increase stimulus current gradually until supramaximal stimulus level is achieved. • Protect this instrument from: • Becoming wet (i.e., immersion or exposure to spilled or dripping fluids, wiping with an excessively wet cloth). • Impact of falling objects. • Exposure to excessive smoke, dust, mechanical vibration or shock. • The instrument should be situated away from devices that generate strong magnetic fields. • 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, General Description and Specifications for temperature recommendations.

• Do not use cables other than those models specified for the ES500. • This unit is tested 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. • Use only alkaline batteries in the ES500. • If the unit is going to be stored for a prolonged period of time, remove the battery. • Do not use the unit if there is evidence of battery leakage.

• 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 neuromuscular junction. • When the RBW-5U 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.

PATIENT CONSIDERATIONS

1. Size: 3.5” (8.5 cm) W x 6.5”(16.3 cm) L x 2” (5 cm) H (including knob) NSL-5 cable maximum length: 62” (157 cm) RBW-5U cable maximum length: 62” (157 cm) 2. Weight: 9.6 oz (275gm) with 9V battery 3. Storage Environment: a. -40° to 70° Celsius (-40° to 158° F) b. 10% to 90% RH non-condensing 4. Operating Environment: a. 10° to 40° Celsius (50° to 104° F) b. 10% to 90% RH non-condensing 5. Operating Altitude: ≤ 3,000 meters 6. Expected Service Life: 5 years 7. Battery: One 9V Alkaline Battery Caution: Use only alkaline batteries in the ES500 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:

• Microshock hazard may occur in patients with pacemakers or cardiac abnormalities, the patient’s attending physician must approve the use of the instrument. • Patients with neuromuscular disease, symptoms of myasthenia gravis, Bell’s palsy, muscle weakness, or paralysis may not respond normally to nerve stimulation. The responses may be difficult or impossible to interpret relative to the state of muscle relaxation due to muscle relaxant drugs. • The electrodes should not be applied to an area of the skin where injury, inflammation or other pathology is present or suspected. • Tetanic stimulation can be uncomfortable for fully conscious patients. It is recommended that tetanus stimulation be performed only after anesthesia.

INDICATIONS The EZstim*III is a battery powered Peripheral Nerve Stimulator / Nerve Locator with two (2) indications for use: (1) on the high (0.05 – 80 mA) output current range, the device is used to monitor the effects of skeletal muscle relaxants during general anesthesia. (2) on the low (0.05 – 5.0 mA) output current range, it is used as a Nerve Locator to help locate the tip of a hypodermic needle near the nerve to which local anesthesia is to be delivered in Regional Nerve Block procedures.

INTENDED USERS This device should only be used by a qualified physician or medical professional with appropriate knowledge and skill in general and regional block anesthesia.

2.B. PRODUCT SPECIFICATIONS

Operating Parameter HIGH output range Specification Output Current

0.05 mA – 80 mA (± 5% from 1.0 mA – 80 mA into load of 3.74K Ohms or less)

Pulse Risetime

< 75 microseconds

Pulse Width

200 microseconds ± 10%

Pulse Frequency

Twitch pattern: 1 Hz or 2 Hz ± 5% Tetanus pattern: 50 Hz or 100 Hz ± 5%

USE ENVIRONMENT Hospitals with clinical procedure environment, OR, ICU, PACU, or Pre-Op. Exclusions include use environment indicated above near HF surgical equipment and RF shielded rooms with instruments such as magnetic resonance imaging, where the intensity of the EM disturbances is high.

SECTION 2 – GENERAL DESCRIPTION AND SPECIFICATIONS 2.A. PRODUCT DESCRIPTION The EZstim*III ES500 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-5U 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 (± 3% from 0.1 - 5.0 mA into load of 11.5K Ohms or less)

Pulse Risetime

< 5.0 microseconds 3

Pulse Width

100 microseconds ± 1%

Pulse Frequency

Twitch pattern: 1 Hz or 2 Hz ± 5%

ESSENTIAL PERFORMANCE: • The ES500 in Low Current Mode (LCM) shall deliver LCM ≤ 5.15 mA. • The ES500 in High Current Mode (HCM) shall deliver HCM ≤ 84 mA Caution: Use of the ES500 outside the specified electromagnetic environment may degrade or lose the essential performance due to electromagnetic disturbances. In result, the ES500 may stop operating, restart during procedure, operate outside the current range specified, or go into error mode. NOTE: The unit is considered to be in a null mode when no stimulus mode/pattern is selected in HIGH output range. The LCD provides a real-time display of user-set functions and battery status, as shown and described in detail in Section 2.C. In addition to the visible LCD Output Stimulus Pulse Indicator, the unit provides audible chirp/beep feedback. The Stimulus Amplitude Control dial provides variable current control • 0.05 to 5.0 mA in the LOW output range • 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.

Figure 2.2 – EZstim*III LCD in HIGH output range – null mode

2.C. PRODUCT DISPLAY, INPUTS AND CONTROLS 12

Figure 2.3 – EZstim*III LCD in HIGH output range – stimulus mode selected (Peripheral Nerve Stimulator) 1

2 3 4 5 6 7

Figure 2.1 – Front panel controls

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 in the following sections. 4

Figure 2.4 – EZstim*III LCD in LOW output range (Peripheral Nerve Locator)

Pause Indicator Vertical bars illuminate when in the Pause mode. Current stimulus and 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: • I n 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.

When operating in the LOW output range (as a Peripheral Nerve Locator)... • The RBW-5U interface cable is plugged into the Patient Lead Output Connector (12), and • The range is 0.05 mA to 5.0 mA

... ... ... ... ... Battery Life Remaining 80–100% ... ... ... ... 60–80% ... ... ... 40–60%

If operating in the LOW output range (RBW-5U lead set attached)… The numeric value for the stimulus display extends to: • Two decimal places only when at 0.05 mA • O ne 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 using the Stimulus Control knob (Figure 2.1 - 2). If the unit detects an open/disconnected lead condition or is unable to deliver the displayed current setting for four (4) sequential pulses, it will flash the output level display, and emit an audible indicator of six (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

Long

≥ 1.0 mA

Medium

0.6 mA - 0.9 mA

Short

0.4 mA - 0.5 mA

Micro

≤ 0.3 mA

c Stimulus Range Setting This field of the LCD displays the maximum stimulus current setting that can be achieved by turning the Stimulus Control knob. 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 (12) and • The range is 0.05 mA to 80 mA

Battery Life Indicator

... ... 20–40% ...0–20% The LED segments of the Battery Life Indicator are solidly displayed to the level of current battery life during use, until the battery life drops below 20% (less than eight (8) hours of operation remaining). When the battery life is reduced to a voltage that is indicative of approximately eight (8) hours of operation remaining, the lowest segment and the battery outline will flash at a rate of 1 Hz. When the battery life is reduced to a voltage that is indicative of less than four (4) hours of operation remaining, the lowest segment and the battery outline will flash at a 2 Hz rate. Caution: Operation will cease when battery voltage is insufficient for the unit to function within specifications. When the battery is too low to support proper operation, stimulus will cease and error code Er3 will be displayed along with the flashing outline of the battery symbol. When this occurs, shut off the unit and replace the battery.

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...

Then...

HIGH output (Peripheral Nerve Stimulator) range...

The pulse width setting is 0.2 msec.

LOW output (Peripheral Nerve Locator) range...

The pulse width setting is 0.1 msec.

g Pulse Indicator This field of the LCD 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. Error Codes: When the unit detects either current leakage or a software error, it will cease operation and the LCD will display the appropriate fault code (flashing every 0.5 seconds) until the user turns the unit off. If either Er1 or Er2 is displayed, the device is defective. Discontinue using the ES500. Refer to Section 8.0 - Limited Warranty. If Er3 ( low battery) is displayed, turn the unit off and replace the battery.

Er1: Leakage Current detected

Er2: Software Error detected

Er3: Low Battery detected

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

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 an open lead or paused or null mode condition. 4

Pause button: Press this button to pause and unpause 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. 6

NOTE: There are five (5) 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 deliver a 100 Hz tetanus stimulus current. NOTE: The unit provides up to 30 seconds of tetanic stimulus pulses while one of the Tetanus Mode buttons is actively pressed. It automatically stops delivering current and returns to the prior mode setting if the button is not released within 30 seconds. 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 deliver a 50 Hz tetanus stimulus current. NOTE: The unit provides up to 30 seconds of tetanic stimulus pulses while one of the Tetanus Mode buttons is actively pressed. It automatically stops delivering current and returns to the prior mode setting if the button is not released within 30 seconds. 10 Double-Burst (DBS) 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 auto-repeats every ten (10) seconds until another mode is selected, or the unit is paused or turned OFF. 11 Train-of-Four (TO4) 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 Patient Lead Output Connector: 4-pin connector to attach patient leads for use as follows: If...

Then...

The NSL-5 interface cable is attached...

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

The RBW-5U lead wire set is attached...

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

SECTION 3 – INSTRUMENT ASSEMBLY 3.A. BATTERY INSTALLATION/ REPLACEMENT I nstall the 9V alkaline battery shipped with the unit as shown in Figure 3.1 below. Note: Use only alkaline type batteries in the ES500. Do not use rechargeable batteries.

3.C. OPTIONAL MOUNTING BRACKET (MB500) FOR POLE MOUNT USE 1. A ttach mounting bracket to an IV pole.

Figure 3.1: Battery Installation

3.B. INTERFACE CABLES The NSL-5 cable or RBW-5U cable is plugged into the keyed jack on the top of the unit. Caution: Do not use cables other than those models specified for the ES500.

Figure 3.3: Mounting Bracket

2. Slide the ES500 into the mounting bracket.

Figure 3.2: Cable Connection/Disconnection • To connect a cable, align the key on the cable connector with the notch in the input jack and gently press the connectors together. The user will feel a “click” when the cable locks in place. • To disconnect a cable, grasp the black connector and pull it straight away from the unit. Do NOT remove the cable by pulling on the wires.

Figure 3.4: ES500 Docking

SECTION 4 – INSTRUMENT OPERATION IN HIGH OUTPUT RANGE 4.A. HIGH OUTPUT 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 milliseconds) wide pulses, in the selected pattern. 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. 2 Hz Twitch Pattern = 2 twitches per second 500 milliseconds

= 0.2 milliseconds 1 Hz Twitch Pattern = 1 twitch per second 1000 milliseconds

100 Hz Tetanus: Press and hold this button to deliver continuous 0.2 millisecond, 100 Hz stimulation pulses up to a maximum duration of 30 seconds. The unit emits a continuous tone while stimulating. When the tetanus button is released, or if it is pressed continuously for 30 seconds, the unit stops delivering the tetanus stimulus and returns to the prior setting (TO4, Twitch, DBS, or null mode). 100 Hz ~ Twitch Pattern = 10 milliseconds

= 0.2 milliseconds

Figure 4.3: 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. Double-Burst Pattern

= 0.2 milliseconds

= 20 milliseconds

Figure 4.1: Twitch Patterns (HIGH Output Range) 50 Hz Tetanus: Press and hold this button to deliver continuous 0.2 millisecond, 50 Hz stimulation pulses up to a maximum duration of 30 seconds. The unit emits a continuous tone while stimulating. When the tetanus button is released, or if it is pressed continuously for 30 seconds, the unit stops delivering the tetanus stimulus and returns to the prior setting (TO4, Twitch, DBS or null mode). 50 Hz ~ Twitch Pattern = 20 milliseconds

= 0.2 milliseconds

Figure 4.2: 50 Hz ~ Tetanus Pattern

= 0.2 milliseconds 750 milliseconds

Figure 4.4: Double-Burst Pattern

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. Train-of-Four (TO4) Pattern 500 milliseconds

= 0.2 milliseconds

Figure 4.5: Train-of-Four Pattern

4.B. OPERATION IN HIGH OUTPUT RANGE (PERIPHERAL NERVE STIMULATOR)

HIGH Current Nerve Stimulator Lead Wire Set (NSL-5)

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. 2 Hz Twitch Pattern = 2 twitches per second 500 milliseconds

= 0.1 milliseconds 1 Hz Twitch Pattern = 1 twitch per second 1000 milliseconds

Figure 4.6: Connections for use as Peripheral Nerve Stimulator (high output range) 1. If the EZstim*III is on, press the ON/OFF button to turn it off. 2. Set the Stimulus Control knob to the minimal current setting (full counter-clockwise). 3. Attach the NSL-5 Interface Cable to the stimulator input connector. 4. 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. 5. Connect the surface electrodes (Figure 4.6). a. Attach the lead wire snaps to the surface electrodes. b. Peel the protective paper off each electrode and confirm that the conductive gel on the electrode has not dried. c. Apply the electrodes to clean, degreased and shaved skin. 6. Press the ON/OFF button to turn the unit on. The LCD displays null mode functionality. 7. Select the desired output current mode of operation using the buttons on the face of the unit. Refer to Section 2, General Description and Specifications for detailed information on button function. 8. Set the initial desired stimulus output by rotating the Stimulus Control knob clockwise to increase current or counter-clockwise to decrease current. Caution: Always increase stimulus current gradually. Use of currents greater than necessary for supramaximal stimulation increases the risk of skin burns. 9. When the procedure has been completed, press the ON/OFF button to turn the unit off, unclip the cable from the surface electrodes and remove the electrodes from the patient’s skin.

SECTION 5 – INSTRUMENT OPERATION IN LOW OUTPUT RANGE (PERIPHERAL NERVE LOCATOR) 5.A. LOW OUTPUT RANGE PATTERNS With the RBW-5U 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.

= 0.1 milliseconds

Figure 5.1: Twitch Patterns (LOW Output Range)

5. B. OPERATION IN LOW OUTPUT RANGE

LOW Current Nerve Locator/ Regional Block Lead Wire Set (RBW-5U)

Figure 5.2: Connections for use as Peripheral Nerve Locator button to turn 1. I f the EZstim*III is on, press the ON/OFF it off. 2. Set the Stimulus Control knob to the minimal current setting (full counter-clockwise). 3. Attach the RBW-5U Lead Wire Set to the stimulator input connector. 4. Attach the lead wire snap to the surface electrode. NOTE: The surface electrode is connected to the red, positive (+) polarity output connector for nerve location. a. Peel the protective paper off the surface electrode and confirm that the conductive gel on the electrode has not dried. b. Apply electrode to clean, degreased and shaved skin that is not in the distribution area of the nerve being blocked. 5. Press the ON/OFF button to turn the unit ON. An open lead condition is indicated by the flashing Stimulus Setting/Output display and the audible 6-chirp indicator because the needle and the surface electrode are not yet connected to the patient. 6. Set the initial desired stimulus output by rotating the Stimulus Control knob clockwise to increase current or counter-clockwise to decrease current. 9

7. Connect the Regional Block Needle (Figure 5.2) to the regional block lead wire set (RBW-5U). a. QuikBloc*, ProBloc*II, ProLong*, EchoBright* and EchoLong* regional block needles connect directly into the black touch-proof connector. b. Other brands of needles that utilize a 2.0 mm pin connect directly to the white touch-proof connector. Caution: Do not use the ES500 with needles plugged into both the black and white touch-proof connectors at the same time. 8. Perform the procedure following instructions for the regional block needle and in accordance with preferred clinical techniques. 9. During the procedure: Press...

To...

Then...

Toggle the unit between the (default) 2 Hz twitch pattern and a 1 Hz twitch.

The twitch repetition rate is 1 or 2 Hz.

Pause the unit.

Delivery of stimulus current for the selected mode is suspended until the Pause button is pressed again.

10. When the procedure has been completed, press the ON/OFF button to turn the unit OFF, and remove the surface electrode. 11. Disconnect the reusable regional block lead wire set from the stimulating wire of the needle, using a slight twist of the connectors.

SECTION 6 – TROUBLESHOOTING GUIDE THE BELOW ARE ALL RECOVERABLE ISSUES. PLEASE PROCEED TO THE NEXT SECTION FOR NON-RECOVERABLE ISSUES IF NONE OF THESE TIPS RESOLVE THE PROBLEMS.

Problem

Probable Cause

ES500 will not turn on.

Battery is not installed. Battery is installed in wrong orientation. Battery is dead.

ES500 indicates open lead.

RBW-5U leadset is not plugged into connector. Replace leadset. Replace lead. Return electrode is defective. Return electrode is not attached. Return electrode is not properly attached to patient. Needle is not inserted into patient. Battery is too low to source selected current - replace battery. High resistance is detected, clean skin and replace electrode.

ES500 battery level lowest segment is flashing.

Battery is low - replace battery.

ES500 does not deliver stimulus.

Unit is paused. Press pause to unpause unit.

Train of Four button does not select Train of Four.

Normal behavior if RBW-5U leadset is attached. Attach NSL-5 leadset. NSL-5 leadset is defective, replace leadset.

DBL Burst button does not select DBS.

Normal behavior if RBW-5U leadset is attached. Attach NSL-5 leadset. NSL-5 leadset is defective, replace leadset.

ES500 will only allow current setting up to 5 mA.

Normal behavior if RBW-5U leadset is attached. Attach a NSL-5 leadset to stimulate muscles at > 5 mA.

ES500 displays only --- (null mode).

This is normal null mode behavior. Press pause to preset current. Press any waveform button to start stimulation.

Current knob does not adjust current while displaying --- .

This is normal null mode behavior. Press pause to preset current. Press any waveform button to start stimulation.

50Hz or 100Hz Tetanus does not continue to stimulate after button is released.

This is normal behavior.

50Hz or 100Hz Tetanus stimulus shuts off after 30 seconds of holding button down.

This is normal behavior.

ES500 shuts off after 20 minutes in pause, or null mode, or open lead mode.

This is normal behavior.

Error Code Er3 displayed.

Dead battery. Power unit off and install a fresh battery before further use of the device.

THE BELOW ARE ALL NON-RECOVERABLE ISSUES - STOP USING THE UNIT. Problem

Probable Cause

Device will not turn on.