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

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1 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

2 QUICK START INSTRUCTIONS: To Open Jaws, Position Hand likes this; To Close Jaws, Position Hand Like This; WARRANTY Upon examination by PARĖ Surgical, PARĖ Surgical warrants that their devices are free from defects in both material and workmanship. PARE Surgical will not be liable for incidental or consequential damages of any kind. This warranty is in lieu of all other warranties whether expressed or implied. Any evidence of attempt to repair these instruments will void this warranty. The duration of this warranty is 3 months from the date of purchase. SERVICE POLICY When problems cannot be resolved using the maintenance and cleaning instructions provided by PARĖ Surgical, the Product must be returned to PARĖ Surgical for service or replacement. Before returning product, obtain a Return Materials Authorization Number from PARĖ Surgical. Ship all returned product to: PARĖ Surgical, Inc S. Alton Way Suite H, Bldg. 13 Centennial, CO USA IMPORTANT Due to OSHA regulation 29 CFR part concerning blood borne pathogens, all used products returned to PARĖ Surgical, for any reason must be decontaminated. (i.e., cleaned and sterilized). Proof of decontamination must accompany returned products. We reserve the right to refuse (or to return collect) products returned in a non-sterile condition. PARĖ Surgical, Inc S. Alton Way Suite H, Bldg. 13 Centennial, CO , USA Ph: Toll Free: Fax: Authorized European Representative Koscher & Wurtz GmbH Einsteinstrabe 7 Spaichingen D GERMANY Telephone 49 (0) by PARĖ Surgical, Inc. All rights reserved. Quik-Stitch is a trademark of PARÉ Surgical, Inc. Printed in USA A 9

3 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 8

4 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. Instructions for Use: 1. Squeeze the ratchet handle until the jaws are retracted inside Cannula tube. See Figure 6 FIGURE 6 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. 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. 2 7

5 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 Sterilizing: NON-STERILE 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 3 Sterilization Type Gravity Pre-Vacuum Exposure Temp. 132 C 132 C Exposure Time 10 minutes 4 minutes Dry Time 30 minutes not needed *Sterilization Validation Report is maintained in the PARÉ Surgical office. 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. Instructions for Cleaning the MicroGrip: 1. Rinse the entire device in soapy water and rinse off with clear water. 2. Advance the Jaws all the way distally by squeezing together the two larger rings of Handle. The Handle will look like Figure1. 6 3

6 FIGURE 1 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 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 FIGURE 4 4 5