Checkpoint 9394 Notice D'utilisation page 2

EN
INDICATIONS FOR USE:
The CHECKPOINT
device intended to provide electrical stimulation of exposed motor nerves
or muscle tissue to locate and identify nerves and to test nerve and
muscle excitability.
CONTRAINDICATION:

Do NOT use this Stimulator when paralyzing anesthetic agents are
in effect, as an absent or inconsistent response to stimulation may
result in inaccurate assessment of nerve and muscle function.
WARNINGS:

Do NOT apply stimulation across the
patient's chest because the introduction of
electrical current into the chest may cause
rhythm disturbances to the patient's heart.

Do NOT leave Stimulator unattended in
the surgical field.

Do NOT use Stimulator in the presence of
flammable anesthetics.

Do NOT use this Stimulator in patients with implanted electronic
devices. Stimulus current near such devices may cause them to
malfunction.

Do NOT use in cerebrospinal fluid, brain, meninges, or spinal
cord.

Do NOT use the Stimulator while delivering electrocautery.
Electrocautery may interfere with or damage the Checkpoint Head
& Neck Stimulator or cause injury.

Use of a tourniquet may reduce nerve and muscle excitability
distal to the tourniquet. If a decrease in nerve or muscle response
to stimulation is observed, it may be necessary to take down the
tourniquet and allow time for re-perfusion before testing with
Checkpoint.

Do NOT attempt to reuse with another patient. Serious patient
cross-infection or pyrogenic reaction could occur.
PRECAUTIONS:

Single use only. Once turned ON, the Stimulator will not turn OFF
and will remain operational for approximately four (4) hours.

Use the Stimulator at 0.5mA initially and increase the amplitude as
needed.

Do NOT bend the probe or apply excessive pressure where the
probe enters the nose cone. Do NOT use the Checkpoint Head &
Neck Stimulator as a dissecting tool or for any other purpose not
specified in these Instructions for Use.

The needle return electrode may cause stimulation. Place the
needle return electrode in an area away from excitable tissue and
away from the stimulation area to avoid confusion.

Do NOT submerge or saturate the Checkpoint Head & Neck
Stimulator with fluid.

The Stimulator may interfere with patient monitoring equipment in
the operating room while stimulating.

Portable and mobile Radio Frequency (RF) communications
equipment can interfere with the Stimulator. Do not use such
equipment while delivering stimulation.

The Stimulator is not likely to cause any interference in nearby
electronic equipment through Electromagnetic Interference (EMI)
(complies with CISPR 11, Type A). For additional information on
Electromagnetic
http://www.checkpointsurgical.com/510k/

.

Be aware that using the device in the vicinity of certain nerves can
have
laryngospasm).
Rx Only
Head & Neck Surgical Nerve Stimulator/Locator
INSTRUCTIONS FOR USE
Patented (AU, CN, DE, ES, FR, UK, HK, IT, US) -
www.checkpointsurgical.com/patents
Ⓓ (AU, CA, CN, HK, IT, JP, DE, ES, FR, UK, US)
®
Head & Neck Stimulator is a single-use, sterile
systemic effects
Model: 9394
(e.g. bradycardia,
2 of 36
DO NOT APPLY
ACROSS CHEST
Interference:
hypotension,
L0023-MAN-001-G