2
3
CONTRAINDICATIONS
The Hemostatix Thermal Scalpel System is contraindicated in the
presence of a FLAMMABLE ANESTHETIC MIXTURE WITH AIR
or OXYGEN or NITROUS OXIDE
.
POTENTIAL ADVERSE EFFECTS
Known potential adverse effects include, but are not limited to,
thermal injury to tissue, including nerves or other delicate tissues, and
inability to effectively provide hemostasis of larger vessels.
SYSTEM WARNINGS
1.
EXPLOSION HAZARD – The Hemostatix Thermal Scalpel
System is contraindicated in the presence of a FLAMMABLE
ANESTHETIC MIXTURE WITH AIR or OXYGEN or
NITROUS OXIDE.
2.
NO MODIFICATION OF THIS EQUIPMENT IS
ALLOWED.
3.
Electrical shock hazard. Do not remove cover. Refer to
manufacturer for service.
4.
Do not attach unapproved components to the HTSS unit to
avoid
electrical shock.
5. Ensure the sound volume is adequately adjusted to that alarms
and alerts are clearly heard
6.
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
7.
Do not place the HTSS controller unit in direct contact with
or
within 1 m of any type of electro-surgical equipment. This
equipment has been tested and found to comply with the limits
for
medical devices to the IEC 60601-1-
2:2014
. These limits
are
designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment
radiates electromagnetic fields and, if not installed and used in
accordance with the instructions, may cause harmful interference.
However, there is no guarantee that interference will not occur
in
a
particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by
turning
the equipment off and on, or is affected by interference
INTRODUCTION
HEMOSTATIX THERMAL SCALPEL BLADES are similar in size,
shape, and sharpness to traditional steel scalpel blades; however,
Hemostatix blades can be heated to a user-selected temperature
appropriate for sealing small vessels as they are cut.
To cut and simultaneously seal blood vessels effectively with minimum
tissue damage, the sharp steel cutting edge of a heated scalpel blade
must be uniformly maintained at the desired temperature within
narrow limits. The Hemostatix Thermal Scalpel System utilizes micro-
circuitry incorporated within the blade itself to maintain the cutting
edge temperature within the necessary tolerance, selectively delivering
additional thermal energy only to those regions of the blade using heat
due to tissue contact. By so doing, the Hemostatix Thermal Scalpel
System automatically compensates for the varying degrees of heat loss
that occur during surgical procedures (depending on the type of tissue
being incised and the rate at which cutting is carried out), maintaining
the cutting edge in the desired temperature range.
In contrast with electrosurgical devices, the Hemostatix Thermal Scalpel
System passes no electrical current through the patient, and there is no
sparking or electrical arcing to the tissue. Electrosurgical devices “cut”
and/or cauterize using electrical currents which pass through the patient
vaporizing tissue at the point of contact and generating heat and tissue
damage down the path of the electrical current. The Hemostatix
Thermal Scalpel System cuts tissue with a sharpened steel edge, like a
conventional cold-steel scalpel blade, and simultaneously seals blood
vessels using heat thermally conducted to the tissue from an elevated-
temperature blade which is electrically insulated from the patient. By
thermally transferring heat from
a uniformly- controlled, essentially constant temperature blade,
the amount of tissue damage associated with hemostatic cutting is
minimized
.
INDICATIONS FOR USE
The Hemostatix Thermal Scalpel System is a surgical instrument
designed to retain the precise, clean cutting characteristics of
the traditional steel scalpel while minimizing blood loss by
simultaneously sealing blood vessels as they are cut, with minimum
damage to surrounding tissue and virtually no muscle stimulation, using
heat thermally conducted to the tissue from an elevated-temperature
blade.
Rx Only – CAUTION: Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
NOTICE TO USERS AND/OR PATIENTS
Any serious incident that has occurred in relation to the device should
be reported to the manufacturer and the competent authority of the
Member State in which the user and/or patient is established
.
