Patient Considerations; Indications; Intended Users; Use Environment - Halyard EZstim III Manuel D'utilisation

• 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.

PATIENT CONSIDERATIONS

• 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.

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 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.
2.B. PRODUCT SPECIFICATIONS
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:
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%
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
Output Current
Pulse Risetime
LOW output range Specification
0.05 mA – 5.0 mA
(± 3% from 0.1 - 5.0 mA into load of
11.5K Ohms or less)
< 5.0 microseconds
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