Checkpoint 9094 Notice D'utilisation page 3

EN
INDICATIONS FOR USE:
The CHECKPOINT
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
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 seven (7) 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
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 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).
The Checkpoint Stimulator is an adjunctive tool for locating
nerves and testing nerve and muscle excitability. It is not
intended to replace good surgical techniques in locating and
dissecting tissue. The surgeon is ultimately responsible for
identifying exposed motor nerves and tissue.
Rx Only
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)
®
Stimulator is a single-use, sterile device intended to
systemic effects
Model: 9094
(e.g. bradycardia,
3 of 36
DO NOT APPLY
ACROSS CHEST
Interference:
hypotension,
4260-MAN-000-V