Integra LifeSciences Jarit Instrucciones De Uso

Integra Jarit Take-Apart Endoscopic Instruments
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Instructions for Use
DEVICE DESCRIPTION
Integra Jarit Take-Apart Endoscopic Instruments are reusable,
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non-sterile, fully-assembled, monopolar electrosurgical instruments
comprised of three individual parts – handle, shaft and stainless steel
insert.
INDICATIONS FOR USE
Integra Jarit Take-Apart Endoscopic Instruments are intended for use in
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laparoscopic gynecologic surgery and other operative procedures under
endoscopic observations. For use when a rigid endoscopic instrument
for grasping, dissecting and/or other manipulation of soft tissue is
determined to be appropriate by the surgeon. For those instruments with
electrosurgical capability, current can be used for coagulation and/or
cutting as determined necessary and appropriate by the surgeon.
CONTRAINDICATION
Instruments should not be used for anything other than their intended
use.
WARNINGS
Discard instrument after suspected Creutzfeldt-Jakob Disease (CJD)
exposure.
DO NOT flash sterilize Integra Jarit Take-Apart Endoscopic
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Instruments. The instruments have not been validated for flash
sterilization.
Do not use instrument or cable if insulation is not fully intact.
Danger of injury from burns and/or explosion from flammable gases!
Application of the HF device according to its intended use can
involve spark formation.
Activating the electrosurgical unit simultaneously with the aspiration
/ irrigation feature may increase capacitive coupling through the
shaft area and alter the path of the electrical energy away from the
target.
Patients should be monitored closely for possible gas embolism.
Localized burns to the patient or physician may result from electrical
current carried through conductive objects (such as trocar cannuals).
Electrical current may be generated in conductive objects by
direct contact with the active electrode, or by the active accessory
(electrode or cable) being in close proximity to the conductive object.
PRECAUTIONS
Check screws on instruments after ultrasonic cleaning. Vibration from
ultrasonic cleaning may cause them to loosen or fall out.
For electrosurgical instruments, use the least amount of power
appropriate for the application. For electrosurgical cables,
disconnect from the generator or instrument by grasping the
connector only. Do not pull the cable by the cord.
Take-Apart Endoscopic instruments are supplied non-sterile and
must be cleaned, lubricated and sterilized prior to use according to
hospital protocol and procedures outlined in this document. Failure
to follow these procedures will invalidate instrument's warranty and
can cause instrument to fail.
Inappropriate use of instruments will lead to damage that is usually
not repairable.
During a surgical procedure, when locking mechanism of handle is
engaged and insert is grasping patient tissue, do not rotate or twist
instrument as this may cause damage to the working tip.
Activation of an electrosurgical device when not in contact with
target tissue or in a position to deliver energy to target tissue may
cause capacitive coupling.
SAFE HANDLING AND PREPARATION
Read the Instructions for Use and keep them in a safe place.
Use the product only in accordance with its intended use, see
INDICATIONS FOR USE.
Clean the product either manually or mechanically prior to the initial
sterilization.
Store products in a dry, clean and safe place.
Prior to each use, inspect the product for: loose, bent, broken, cracked,
worn, or fractured components.
Do not use the product if it is damaged or defective.
Replace any damaged components immediately with original spare
parts.
To avoid damage to the working tip:
Introduce the product carefully through the working channel
(e.g., trocar).
Do NOT manually twist or turn the instrument once the locking
mechanism has been engaged.
Follow the safety instructions of the HF manual very carefully.
Only use electrocautery instruments up to their peak voltage rating
for the applicable HF surgical mode. Integra
Endoscopic Instruments have a peak voltage rating of 3,000 V
tested frequency of 450 kHz.
Adjust the HF power output to the intended operation. Take into
account the clinical experience or reference values.
Select the lowest possible HF power output.
Keep the product's contact surfaces clean during the operation.
The accessory voltage rating of the product is 3,000 V
The accessory voltage rating must exceed or be equal to the
maximum peak output voltage at which the product is operated
in combination with an appropriate HF device at an appropriate
operating mode/setting (see IEC 60601-2-2).
Integra Jarit
® ®
surgical generator that operates at the below parameters.
The listed values are maximum guiding values. Please read the
operating manual specific for the HF surgical generator to be
used prior to operating the instruments to ensure the HF-surgical
generator parameters are appropriate for the intended procedure.
Waveform
Cutting 1 (pure)
Cutting 2 (blend)
Cutting 3 (super blend)
Endo-mode
Contact coagulation
Forced Prep
To avoid HF burns:
The product's working tip must be in the user's field of vision
whenever HF power is activated.
Prior to activating the HF device, make certain the working end of
the product is not touching any electrically conductive accessories.
Prior to each use, visually check the product for: damage to or
surface changes on, the insulation.
Never put down the product on or next to the patient.
When using accessories for endoscopy or laparoscopy applications,
deactivate the automatic switch-on mode of the HF generator.
Follow the instructions for use of the HF generator.
DIRECTIONS FOR DISASSEMBLY AND RE-ASSEMBLY
A. DISASSEMBLY
Step 1: For handles with ratchets: Push gold-plated lever down to
detach/disassemble ratchet connection. For handles without ratchets:
Go directly to Step 2.
Jarit Take-Apart
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and
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Take-Apart Endoscopic are to be used with an HF
HF Power Voltage Peak to Peak
max. 400 W at 300 Ω max. 2300 V
max. 300 W at 300 Ω max. 2500 V
max. 200 W at 300 Ω max. 2700 V
max. 100 W at 200 Ω max. 2800 V
max. 250 W at 200 Ω max. 3200 V
max. 120 W at 200 Ω max. 3900 V
.
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