Mitaka Kohki PSMS2 Manuel d'utilisateur

Operating / User’s Manual MITAKA KOHKI Co., Ltd. POINT SETTER

-10- Cleaning Instructions for the Endoscope Holder Caution: Wear protective gloves, clothing, and a face mask for cleaning of contaminated endo

-11- 10. After cleaning, inspect the endoscope holder for cleanliness and damage. 11. Before sterilization, lubricate all moving parts of the e

-12- b. Flash Sterilization Flash sterilization can be accomplished in either a pre-vacuum or gravity displacement type of sterilization unit. Flash

-13- C. Before Draping Patient Perform this part before covering the patient with sterile cloth. Set up OR table adapter on the side rail o

-14- 3. Connect hoses Nitrogen gas or compressed air pressure should be 6 ~ 8 kgf/cm or 90 ~ 115 psi or 6.2 to 7.9 bar. Exces

-15- D. Draping the Point Setter 1. Cover the Point Setter with the drape. 2. Secure the drape with adhesive tape, which is attached to the

-16- E. Attaching the Endoscope to the Point Setter 1. Installing an endoscope Install an endoscope holder after steriliz

-17- Safety instructions Operating table Since the Point Setter is attached to the operating table, the strength of

-18- F. OR Table Adapter Brake Knobs – Special Function This knob enables the fitting to rotate. W

-19- 4. Further Safety Instructions 1. The apparatus must be operated only by an expert. (USA requires a physician approval.) 2. In installi

-2- INTRODUCTION Thank you for purchasing the MITAKA Point Setter (holding system for surgical instruments). MITAKA KOHKI Co., Ltd. has been produc

-20- 5. POINT SETTER inspection & operation test (Recommend Monthly Test) No Measures required result 1 inspect the outside look no damage,

-21- 5 Inspect the retention of brake 1 by pushing the torque gauge sideways on the arm Retention > 2 kg or greater of Brake 1 6 inspect the lock

-22- 2 inspect the clamps these parts must be firmly fixed with the clamps 3 inspect firmness the entire system must be able to be firmly fixed

-23- 6. Troubleshooting Failure Remedy Page No function at all Connect Nitrogen Hose 14 Use pressure 6~8 kg/cm or 6.2 to 7.9 bar Or 90-115 psi 1

-24- 7. Labeling ① ② ③ ④ ⑤ ① ① ② ③ ④ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ Make sure that part is securely clamped.

-25- 8. Technical Data POINT SETTER Catalog No. PSMS2 Arm Joint number : 6

-26- Instrument holders Catalog No. Standard holders : Universal holder, small (φ5～10mm)

-27- 9. Address as of December 26, 2007 Manufacturer of POINT SETTER Mitaka Kohki Co., LTD. 1-18-8 Nozaki, Mitaka, Tokyo 181-0

-28- MITAKA KOHKI CO., LTD. 1-18-8 Nozaki, Mitaka, Tokyo 181-0014 Japan Work: 81-422-49-1491 Fax: 81-422-49-1117 e-mail: [email protected]

-3- SAFETY GUIDELINES (Read carefully before use) IMPORTANT: ◆ The POINT SETTER was designed according to standard IEC 6001-1/EN 60601-1. ◆

-4- ! CAUTION！ Conditions of installation and operation must correspond to microsurgical requirements and standards: ◆ Careful handling ◆

-5- TABLE OF CONTENTS Page Introduction -----------------------------------------------------

-6- 1. SUMMARY The Point Setter acts as a third arm that can firmly hold an endoscope for a surgeon. Surgeons can operate it quite easi

-7- 2. Part List ①Endoscope holder ②Free switch ③Safety lock knob ④Arm ⑤OR table adapter ⑥Manual ball joint ① ② ③ ④ ⑤ ②

-8- Accessories for Endoscope “endoscope holder” PSBU-046 Endoscope Holder (Universalφ10~15mm, Pediatric 7mm width) PSFS-070 Endoscope Holder Karl

-9- 3. Handling Instructions A. Sterilization of Endoscope Holder Warning: The Point Setter arm and OR table adapter are never steri