Microline Surgical ENTceps Manual De Instrucciones

ENTceps / MicroCeps / CardioForceps – Instructions For Use
For use only with Microline PowerPack™ Dual Control Footswitch (REF 309-004R) and Microline PowerPack™ UPS (Universal
Power Supply) (REF 200-003R) or Microline UPS (Universal Power Supply) (REF 200-004R, 200-006R)
DEVICE DESCRIPTION
The ENTceps / MicroCeps / CardioForceps are a footswitch-activated, hand-held surgical instrument that is powered by a Universal
Power Supply (UPS). They contain a heating element at the distal tip of the instrument. The heating element is activated by means
of the reusable PowerPack Dual Control Footswitch. The power cable extends from the handle of the instrument and terminates at
the Instrument connector for electrical connection to the UPS.
INTENDED USE
The devices are single use and are intended to be used once only for a single patient. The devices are intended for the simultaneous
cutting and cauterization of soft tissue during surgery. The devices may also be used for cutting natural or synthetic, non-metallic,
sutures during surgery.
1. Remove the device from its sterile packaging.
Note: Follow the appropriate Instructions For Use for the PowerPack Dual Control Footswitch and UPS used for the procedure.
2. Insert the connector from the PowerPack Dual Control Footswitch (non-sterile) into the Footswitch connector receptacle of the
UPS unit as per Footswitch Instructions For Use. Ensure the connector plug key properly into the receptacle. Uncoil the power
cord, pass the connector end of the power cord off the sterile field. Insert the connector of the power cord firmly into the
instrument connector receptacle of the UPS. Ensure connector plugs key properly into receptacle. The device is now ready for
use.
3. Pre-check the Microline system for correct set-up and operation. Set-up the UPS and PowerPack Dual Control Footswitch
following the applicable Instructions for Use. Place the device's tips in a small amount of sterile saline. Close the device and
activate the device on high power by use of the PowerPack Dual Control Footswitch. There should immediately be an audible
hissing sound as the saline is heated by the element, and the UPS will emit a high pitch audible signal tone. Repeat with the
PowerPack Dual Control Footswitch operated on variable and the control knob on the UPS turned to the number 8 position. A
lower pitch audible signal tone will be emitted. Repeat pre-check by attempting to activate the device by closing the forceps
without stepping on the foot pedal. If there is a hissing sound as the saline is heated by the element, do not use the Microline
system. Contact your Microline representative for repair or replacement.
Note: The heating element and tone will not operate unless the device is fully closed, the PowerPack Footswitch is connected to
the UPS, and a pedal is depressed.
Note: The footswitch variable power output is adjustable when the device and PowerPack Footswitch are connected to the UPS
and the footswitch is activated with the left footpedal. (See UPS Instructions for Use)
4. To seal/cut tissue, grasp the desired tissue between the tips of the device. Squeeze the handle grips fully together to apply
pressure to the tissue. Depress either pedal of the footswitch. Depressing the left footpedal will activate the heating element at
the tip of the device on variable power. (See Note above) An audible low-frequency tone will accompany the activation of the
heating element. Depressing the right pedal on the footswitch will activate the heating element of the tip of the device on high
power. An audible high-frequency tone will accompany the activation of the heating element. Generally, lower heat ranges
increase the sealing capabilities and increase the time to cut tissue. Higher heating ranges decrease the time to cut and may
decrease seal integrity.
5. After the desired sealing/cutting of the tissue, open the device and then release the pedal of the footswitch. This deactivates the
heating element.
Note: After removing the device, examine tissue for hemostasis. If hemostasis is not present, use appropriate techniques to
achieve hemostasis.
6. If desired, progress to a new region of tissue to be sealed/cut.
Note: It may be desirable to clean the tips of the device during the surgical procedure. A saline-moistened surgical gauze or
sponge may be applied gently along length of the tips of the forceps to remove buildup of coagulated blood and tissue debris.
Avoid twisting or pulling on tips. Applying excess pressure can bend the tips or cause tip misalignment.
7. At the end of the surgical procedure, disconnect and discard the device.
ENTceps (sterile)
1 – Instrument Connector
2 – Tip Cleaning Direction
3 – Heating Element
PRECAUTIONS AND WARNINGS
• The product is sterile unless the package is opened or damaged.
• Do not use if package is opened or damaged. Examine this device prior to use, do not use if damage is found.
• The devices are not designed for reuse or reuse decontamination processes. Reuse of single-use devices creates a potential risk
of patient or user infections, injury, illness or death.
• Do not use if the instrument or the cord is damaged.
• Do not use a scalpel or other sharp metal instrument to clean the device. Doing so may damage the tips and could prevent the
device from functioning properly.
• Refrain from unnecessary activation of the heating element while there is no tissue grasped within the device. This activity may
result in premature degradation of the device. Device is not intended for continuous use. A typical duty cycle of approximately five
(5) seconds on, ten (10) seconds off is recommended.
• Do not immerse the device's handle in liquids.
• Do not touch electrosurgical (Bovie) electrode to the device.
• Use the device only with the Microline PowerPack Dual Control Footswitch and UPS Unit. Use of any other power supply may
damage the device and could prevent it from functioning properly during use.
ENTceps / MicroCeps / CardioForceps
Instructions For Use
Microline Surgical, Inc. 迈克兰器械有限公司.
50 Dunham Road, Suite 1500
Beverly, MA 01915 U.S.A.
Tel: +1(978) 922-9810 | Fax: +1(978) 922-9209
Web: www.microlinesurgical.com
Email: [email protected]
09-39-00450-00-ART, Rev. C 04/2021
1 – Instrument Connector
2 – Tip Cleaning Direction
3 – Heating Element
4 – Finger Location (Squeeze Here)
Dual Control Footswitch
Non Sterile
1 – Variable Power Pedal (left)
2 – High Power Pedal (right)
3 – Power Supply Connector
ENGLISH
MicroCeps (sterile)
Universal Power Supply
Non Sterile
Label graphics may vary
1
CardioForceps (sterile)
1 – Instrument Connector
2 – Tip Cleaning Direction
3 – Heating Element
200-006R