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WARRANTY
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC (HMT) warrants to the original
purchaser that reasonable care has been used in the manufacture of the MODEL P8400
HEMOSTATIX THERMAL SCALPEL SYSTEM (HTSS) CONTROLLER and that,
when properly used, it will be free from defects in material or workmanship for a period of
one (1) year after the date of shipment from HMT or any of its authorized distributors.
NOTE
: Hemostatix scalpel handles and blades are warranted to be free from defects
in
materials and workmanship for a period of SIXTY (60) days from the date of shipment
The sole and exclusive remedy with respect to any MODEL P8400 HTSS or any portion
thereof found within its warranty period not to meet these standards is that after return to
and examination by HMT, HMT will without charge at its option either repair or replace
that portion of the MODEL P8400 HTSS found to be defective. This warranty shall not
apply (a) if that portion of the MODEL P8400 HTSS has been repaired or altered by
anyone other than qualified service personnel approved by HMT or altered in any way
which, in HMT’s judgment, affects its usability or reliability; or (b) if the sterile lot or serial
number has been altered, effaced, or removed; (c) if the fault has been caused by abnormal
conditions of operation or misuse including, but not limited to: dropping the controller
unit; opening the controller unit; and/or permitting electrical contact with an active electro
surgical (e.g., Bovie) electrode; operating the unit within 1 m of another electrosurgical
controller unit; or, (d) if in the case of the scalpel blades or handles, the scalpel blades or
handles have been reprocessed and reused.
Except for the replacement of fuses, which can be accessed without opening the controller
unit’s enclosure, any warranty, implied or expressed, is considered void if the tamper-proof
seal on the controller unit’s enclosure is found to be broken. In all such cases, HMT’s
determination will prevail and any repairs or replacements, if requested, will be billed at
HMT’s prevailing normal rates. If so requested, estimates will be submitted before work is
started.
NOTE
: An RMA# issued by HMT must be obtained before any part of the MODEL
P8400 HTSS is returned.
NOTE
: Handles and blades being returned must be cleaned, sterilized, and packaged in
sterile packaging with labeling which verifies the sterility of the handle and/or blade prior
to return to HMT. Any handle and/or blade not properly cleaned, sterilized and packaged
as described in this warranty will be disposed of and no warranty will be in effect.
The foregoing express warranty, as conditioned and limited, is in lieu of and excludes all
other warranties not expressly set forth herein whether expressed or implied by operation of
law or otherwise including, but not limited to, any implied warranties or merchantability or
fitness for particular purpose. HMT shall not be liable for any incidental or consequential
loss, damage, expense or liability direct or indirect with respect to this product. HMT
neither assumes nor authorizes any other person to assume for it any other or additional
liability or responsibility in connection with this product.
SPECIFICATIONS
Model P8400 Hemostatix Thermal Scalpel Controller Unit
NOTE
: The MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYTEM is
suitable for continuous operation.
Patient Leakage Current
(From Patient Connection
to Earth)
≤ 100 microamperes AC – Normal Condition
≤ 500 microamperes AC – Single Fault Condition
≤ 10 microamperes DC – Normal Condition
≤ 50 microamperes DC – Single Fault Condition
Blade Temperature Settings
• VARIABLE, set by USER and displayed
on front panel display as TEMPERATURE
SETTING ranging from 70° C to 300° C in
10° C increments.
Room Operating
Environment
• 1
5
° C to 30° C (Note: Blade temperature is
indexed from room temprature
• 30% - 75% Relative Humidity - Non-
condensing
• 700 to 1060 hPA
Transport & Storage
Environment
• -2
9
° C to +
5
0° C
• 10% -
85
% Relative Humidity
•
570
to 1060 hPA
Moisture Protection
• 7013-8400 Controller Unit -
IPX0
Rating
• 7013-8410 Foot pedal - IPX8
Console Size
• Approximately 7.0 in x 10.9 in
Console Weight
• Approximately 7.25 lbs. (3.3 kg) without power
cord
Power Requirements
• 100-240VAC± 10%
• 50 - 60 Hz ± 1 Hz
Power Input
• 1 A
Power Output
• 60 W dc
Fuses
• T 2A, H 250V (3AB Slo Blo, 2 Amp, glass
body, 6.35 x 31.75 mm) (Quantity 2)
Power Cord
• Approx. 10 ft. Hospital Grade
HEMOSTATIX
THERMAL SCALPEL
SYSTEM is classified as a
Type BF Applied Part, Class
I electrical device and is
certified to the following:
• IEC 60601-1
Ed. 3.1 (2012)
• IEC 60601-1-
2 Ed. 4.0 (2014)
