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Look For These Other Products by PARÉ Surgical, Inc. INNOVATIVE MEDICAL DEVICES Quik-Stitch-Endoscopic Suturing Device Disposable & Reusable The giflx- Disposable Rat tooth Jaw grasping Forceps with Ratcheting handle. Electrosurgical Pencil With LED Light source ® ®

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Page 1: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

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Look For These Other Products by PARÉ Surgical, Inc.INNOVATIVE MEDICAL DEVICES

®

Quik-Stitch-Endoscopic Suturing Device

Disposable & Reusable

®

The giflxDisposable Rat toothJaw grasping Forcepswith Ratchetinghandle.

lectrosurgicalith LED Light

-™

Pencilsource

Page 2: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

MicroGrip by: PARĖ Surgical, Inc.

QUICK START INSTRUCTIONS:

To Open Jaws, Position Hand likes this;

To Close Jaws, Position Hand Like This;

WARRANTY_____________________________________

Upon examination by PAR§ Surgical, PAR§ Surgical warrants that their devices are free

from defects in both material and workmanship. PARE Surgical will not be liable forincidental or consequential damages of any kind. This warranty is in lieu of all otherwarranties whether expressed or implied. Any evidence of attempt to repair theseinstruments will void this warranty. The duration of this warranty is 3 months from the dateof purchase.

SERVICE POLICY________________________________

When problems cannot be resolved using the maintenance and cleaning instructionsprovided by PAR§ Surgical, the Product must be returned to PAR§ Surgical for service or

replacement. Before returning product, obtain a Return Materials Authorization Numberfrom PAR§ Surgical.

Ship all returned product to:

PAR§ Surgical, Inc.

7332 S. Alton Way Suite H, Bldg. 13Centennial, CO 80112-2319USA

IMPORTANT_____________________________________

Due to OSHA regulation 29 CFR part 1910.1030 concerning blood borne pathogens, allused products returned to PAR§ Surgical, for any reason must be decontaminated. (i.e.,

cleaned and sterilized). Proof of decontamination must accompany returned products. Wereserve the right to refuse (or to return collect) products returned in a non-sterile condition.

PAR§ Surgical, Inc.

7332 S. Alton Way SuiCentennial, CO 80112-Ph: 303-689-0187Toll Free: 866-700-727Fax: 303-689-0579www.paresurgical.com___________________

© 2011 by PA

PARÉ Surgic

te H, Bldg. 132319, USA

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______________________________________________________R§ Surgical, Inc. All rights reserved. Quik-Stitch is a trademark of

al, Inc. Printed in USA. 700008 040811A

®

Telephone 49 (0) 7424 958.300

Authorized EuropeanRepresentativeKoscher & Wurtz GmbHEinsteinstrabe 7 ˜SpaichingenD-78549 GERMANY

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Page 3: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

MicroGrip by: PARĖ Surgical, Inc.

5. Squeeze the ratchet handle to close the jaws and secure the tissue.

6. With the tissue secured set the depth of retraction desired and

securely clamping a hemostat on the Cannula tube, outside the

patient, at the point on insertion.

Removal:

1. Release the tissue from the instrument jaws

2. Squeeze the ratchet handle to close the jaws

3. Withdraw the grasper from the surgical site.

Table of Contents:________________________

Quik Start Instructions………Inside Front Cover

Indications……………………………………….….2

Sterilizing……………………………………………3

Instructions for Use…………………….………….7

Warranty and Service……………………………..9

Other Products by: PARE Surgical, Inc……..Back Cover

1

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Page 4: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

MicroGrip by: PARĖ Surgical, Inc.

Indications for the Reposable

MicroGrip Retractor/Grasper:

The MicroGrip instrument is a manual less-invasive surgical device

to be used in laparoscopic procedures to retract, manipulate and/or

grasp soft tissue. The MicroGrip is designed to penetrate soft tissue

to access areas of the human anatomy.

Contraindications:

Blind Insertion in laparoscopic surgical procedures

Warnings and Precautions;

Read and understand all warnings, contraindications, and

instructions in this document prior to use

1. The MicroGrip is shipped non-Sterile and needs to be sterilized

before using in a surgical procedure. For instructions on how to

sterilize the MicroGrip see section “Sterilizing”.

2. The MicroGrip Retractor/Grasper should be used only by

physicians possessing adequate training and familiarity with

laparoscopic techniques and instruments.

3. When used in laparoscopy the MicroGrip Retractor/Grasper

should only be inserted under direct laparoscopic visualization.

4. MicroGrip Retractor/Graspers should be handled carefully to

avoid inadvertent damage to the instrument tip.

Instructions for Use:

1. Squeeze the ratchet handle until the jaws are retracted inside

Cannula tube. See Figure 6

FIGURE 6

2. Using a #11 blade, create a small incision at the point of

desired insertion.

3. Using direct visualization, introduce the tip of the jaws

through the skin and advance them slowly into the surgical

site.

4. After the tip of the jaws can be seen in the surgical space,

using your thumb and index finger, slowly release the ratchet

to advance the opening of the jaws until they are fully

opened.

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Page 5: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

MicroGrip by: PARĖ Surgical, Inc.

5. Wash the Jaws, rod, Cannula Tube and handle with soapy

water and rinse in clear water. Set aside to dry.

Note: The Cannula tube can become flared during surgical

use. It is recommended that the Cannule tube be replaced

between each procedures

7. To reassemble, squeeze the two Jaws together, using your thumb

and index figure, and push them into the proximal end of the

Cannula tube until the threads on the Cannula Tube mate with the

threads of the Handle. See Figure 5

FIGURE 5

8. As in step 5, hold the Cannula Tube in one hand and the handle

in the other hand. Rotate the handle clockwise while pushing the

Cannula Tube into the direction of the Handle until the Jaws

protrude about 3mm beyond the Cannula Tube.

9. The MicroGrip is ready to be Steamed Sterilized per instruction

For Sterilizing.

Sterilizing:

MicroGrip Graspers are provided Non-Sterile and need to be

sterilized before use.

Sterilization using steam is the only technique that has been

validated to ensure the sterility or functional integrity of the

device.

The following steam sterilization parameters have been validated*

to insure sterilization of the MicroGrip:

Sterilize the Device in the Closed Position Fully Assembled

Gravity Flash Pre-Vacuum Flash

Number of Pulses 3Sterilization Type Gravity Pre-VacuumExposure Temp. 132°C 132°CExposure Time 10 minutes 4 minutesDry Time 30 minutes not needed

*Sterilization Validation Report is maintained in the PARÉSurgical office.

Instructions for Cleaning the MicroGrip:

1. Rinse the entire device in soapy water and rinse off with clearwater.

2. Advance the Jaws all the way distally by squeezing together thetwo larger rings of Handle. The Handle will look likeFigure1.

NON-STERILE

3

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Page 6: Look For These Other Products by PARÉ Surgical, Inc ...paresurgical.com/new_product/microgrip.pdf · *Sterilization Validation Report is maintained in the PARÉ Surgical office

MicroGrip by: PARĖ Surgical, Inc.

FIGURE 1

3. Rinse the Jaws and the distal end of the Cannula tube in soapy

and then clear water.

4. Pull the Jaws inside the cannula tube by placing your thumb

inside the ring at the proximal end of the Handle and place your

index and middle finger around the distal ring and squeeze the two

parts closer together until all but the very tip of the Jaws are inside

the Cannula tube. The handle should look like figure 2.

FIGURE 2

5. Hold the Cannula tube with one hand and hold the Handle in the

other hand, rotate the Handle in a counter-clock wise direction until

all of the threads of the Cannula Tube are exposed and the Jaws can

be pulled through the tube. Remove the Cannula tube completely

from the handle. See Figures 3 and 4

FIGURE 3

FIGURE 4

5

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