6
7
19
.
The Handle and Footswitch connector
ports on the front of the
Hemostatix controller are not to be
utilized for any other purpose
than to connect to specified
compatible components designed by
Hemostatix.
20
.
DO NOT allow saline, or any other fluid, to enter the handle
during use. Saline is highly conductive and will interfere with
the
circuitry inside the handle causing the handle not to work
properly.
21
.
Rx Only – CAUTION: Federal (U.S.A.) law restricts this device
to sale by or on the order of a physician.
22
.
USE WITH PLASTIC ADHESIVE DRAPES – When the skin
incisions are to be made through a plastic adhesive skin drape,
use
the scalpel handle and blade in the OFF position (handle
switched
OFF).
23
.
USE WITH ELECTROSURGICAL UNITS – DO NOT touch
the Hemostatix Thermal Scalpel blade to any electrosurgical
(e.g., Bovie) tip as significant damage to the Hemostatix Thermal
Scalpel controller unit will result. Keep at least 1 cm between
the
blade and the electro surgical tip. The Hemostatix Thermal
Scalpel CANNOT BE USED to conduct electro-surgical current
through clamps.
24
.
AVOIDING INADVERTENT PATIENT BURNS – DO
NOT
rest the Hemostatix Thermal Scalpel handle and/ or
blade on
surgical drapes or on the patient during use. When
energized, the
blade is sufficiently hot such that patient
burns can result from
inadvertent patient contact. When the Hemostatix Thermal
Scalpel handle is not being used, it is HIGHLY
RECOMMENDED that the handle ON/OFF switch be
positioned OFF. Care should be taken to avoid unintended
activation of COAG mode by inadvertently depressing the
COAG
button
or foot pedal.
25
.
GROUNDING – Reliability can only be achieved when the
equipment is connected to a properly equivalent receptacle
marked “Hospital Grade”.
26
.
STERILIZATION – The Model P8400 Hemostatix Thermal
Scalpel Handle is provided STERILE provided the primary sterile
packaging is unopened and undamaged.
27
.
Remove and discard of used disposables following local
regulations for proper disposal of contaminated material.
28
.
Electrical shock hazard. Do not remove cover. Refer to
manufacturer for service.
29
.
If the user has any questions regarding compatibility of accessories
or cables they should contact Hemostatix Medical Technologies,
LLC.
18
. In the unlikely event that the handle is unable to be turned off
normally due to a mechanical failure or due to debris in the
handle, the controller should be turned off and the disposable
replaced
COMPONENT PRECAUTIONS
1. Model P8400 Hemostatix Thermal Scalpel System Blades are
provided sterile and ARE NOT intended for reuse.
2. Blades are surgically sharp and used blades may be extremely
hot to the touch. Always use a sponge, clamp or hemostat to
grasp the used blade. Always follow proper sharps precautions
when handling a blade and biohazard disposal techniques when
discarding a used blade.
3. DO NOT BEND THE BLADE – Care should be taken not to
bend the blade while cleaning, insertion, or reinsertion as the
heater leads may become broken and the blade stop working.
4. The HTSS blade’s non-stick coating cleans most effectively when
hot. Best results are obtained using dry 4x4 gauze when the blade
is hot.
5. Accurate calibration can only be achieved if the blade is at
room temperature when it is inserted into the handle. If the
blade becomes accidentally dislodged from the handle, turn the
handle OFF, dip the blade in sterile water to cool it to room
