Operating / User’s Manual MITAKA KOHKI Co., Ltd.
INTRODUCTION Thank you for purchasing the MITAKA Point Setter (holding system for surgical instruments). MITAKA KOHKI Co., Ltd. has been producing many products in the area of astronomical instruments, industrial measuring instruments, and medical instruments since 1966. The pride of true workmanship goes into each component of all our products. We believe that you will fully recognize the high quality of our products with the use of the Point Setter.
SAFETY GUIDELINES (Read carefully before use) IMPORTANT: ◆ The POINT SETTER was designed according to standard IEC 6001-1/EN 60601-1. ◆ Repair, remodeling, maintenance and other technical services must be performed exclusively by an appointed service person of MITAKA KOHKI or those technicians trained by MITAKA KOHKI. MITAKA KOHKI’s guarantee will not cover any mechanical failure or liability caused by an act not in accordance with this instruction.
! CAUTION！ Conditions of installation and operation must correspond to microsurgical requirements and standards: ◆ Careful handling ◆ Clean environment ◆ Avoidance of extreme mechanical stress or impact ◆ Low vibration ◆ Check for proper condition of the unit and its accessories prior to start up ◆ Do not pull on the cable ◆ Do not hold objects which exceed the maximum permissible weight of 2kg (4.
TABLE OF CONTENTS Page Introduction ---------------------------------------------------------------------------------------Safety Guidelines----------------------------------------------------------------------------------Table of Contents --------------------------------------------------------------------------------1. Summary-------------------------------------------------------------------------------------- 2 3 5 6 2.
1. SUMMARY The Point Setter acts as a third arm that can firmly hold an endoscope for a surgeon. Surgeons can operate it quite easily with only one switch required to allow it to be free or to be locked. Surgeons can position their surgical instruments in the desired angle with the use of the Point Setter. The Point Setter has a lock knob and guard panels for its switch to prevent it from coming out of the locked mode, allowing surgeons to use it with confidence.
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Accessories for Endoscope “endoscope holder” PSBU-045 PSSU-040 Endoscope Holder Endoscope Holder (Universalφ10~15mm) (Universalφ5~10mm) PSBU-046 PSFS-070 Endoscope Holder Endoscope Holder (Universalφ10~15mm, Karl Storz Flexible Pediatric 7mm width) PSNS-060 PSWH-050 PSZH-060 PSGH-055 Nitrogen hose with Endoscope Holder Endoscope Holder Endoscope Holder Shrader connector, (for Wolf scope) (for Zamorano scope) (for Gaab scope) 6m length NOTE: There are many kinds of accessories.
3. Handling Instructions A. Sterilization of Endoscope Holder Warning: The Point Setter arm and OR table adapter are never sterilized. Instead they are covered by a sterile drape as referenced in 3. D. (page 15). Sterilize the endoscope holder using the following instructions. Please follow these instructions carefully.
■ Cleaning Instructions for the Endoscope Holder Caution: Wear protective gloves, clothing, and a face mask for cleaning of contaminated endoscope holder. Caution: Hot water (greater than 49 degrees C or 120 degrees F) will alter organic materials (blood and tissue), making them difficult to remove. 1. The endoscope holder should be disassembled. 2. Thoroughly rinse all parts to remove all gross debris. 3. Manual cleaning is recommended.
10. After cleaning, inspect the endoscope holder for cleanliness and damage. 11. Before sterilization, lubricate all moving parts of the endoscope holder with a non-silicone water soluble instrument milk or lubricant (e.g., Codman Preserve per manufacturer’s instructions). Silicon- or oil-based lubricants are not recommended for use because sterilants cannot penetrate the silicone or oil.
b. Flash Sterilization Flash sterilization can be accomplished in either a pre-vacuum or gravity displacement type of sterilization unit. Flash sterilization in a gravity displacement unit proceeds without a drying phase. We have validated flash sterilization using a gravity displacement unit and the following conditions: Temperature: 132.2 to 133.3 degrees C or 270 to 272 degrees F Pressure: 1.85 bar or 27 psi Exposure Time: 10 minutes 3.
C. Before Draping Patient Perform this part before covering the patient with sterile cloth. Set up OR table adapter on the side rail of the operating table. Try to locate the arm at the best position during operating considering the C-arm X-ray or other possible interfering surgical instruments. We recommend that you confirm interference using real equipment and finish this setup before beginning operating. Otherwise, changing the position of the arm during the operation can be very difficult.
3. Connect hoses Connector from Connector of Nitrogen hose “Point Setter” arm Plug the arm hose into the nitrogen connector of the hospital. 2 Set pressure to 6 ~ 8 kgf/cm or 90 ~ 115 psi or 6.2 to 7.9 bar. (PSNS-060) NOTE: The PSMS comes with a male Schrader connector. Other connectors or adapters can be acquired. a male Shrader connector (PSNS-060) ! CAUTION! Nitrogen gas or compressed air pressure should be 2 6 ~ 8 kgf/cm or 90 ~ 115 psi or 6.2 to 7.9 bar. Excessive pressure is very dangerous.
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 drape. When securing the drape, do not tighten it excessively.
E. Attaching the Endoscope to the Point Setter 1. Installing an endoscope Attach the endoscope to the endoscope holder after sterilization in advance. Use the appropriate endoscope holder for each endoscope. Secure firmly so no movement is present. Install an endoscope holder after sterilization over the drape. Secure firmly so no movement is present. NOTE: When the endoscope holder is installed on the tip of Point Setter, do not tear drape. The endoscope holder goes over the sterile drape.
4. Ready to use Pushing free switch (which is colored gold) allows the arm to move freely. The arm will remain locked at the point by releasing the free switch. ! CAUTION! Safety instructions Operating table Since the Point Setter is attached to the operating table, the strength of the side rails of the operating table affects the stability of the Point Setter. Before using the Point Setter, the side rails of the operating table must be thoroughly checked.
F. OR Table Adapter Brake Knobs – Special Function This knob enables the fitting to rotate. When the knob is in the way, Pull it straight out and rotate. When the knob causes interference. The position of the knob can be adjusted by pulling straight out and rotating the knob.
4. Further Safety Instructions 1. The apparatus must be operated only by an expert. (USA requires a physician approval.) 2. In installing the apparatus pay attention to the following matters: (1) Do not install on a wet place and be sure not to splash water or other liquid. (2) Do not use this apparatus outside the operating room. (3) Great care is necessary in handling the apparatus to avoid a dent or a scrape. (4) Be sure to firmly tighten all clamps and brakes.
5. POINT SETTER inspection & operation test (Recommend Monthly Test) No 1 Measures inspect the outside look 2 inspect the air hoses and connectors 3 inspect the nitrogen gas or air pressure supply 4 Inspect the retention. If Point Setter does not hold 2 kg or more before brakes slip return the unit to factory for repair required result no damage, no dirt or no looseness any parts no damage all connectors are connected accurately ６kgf/cm２～８kgf/cm２ or 6.2 to 7.
Retention > 2 kg or greater of Brake 1 5 Inspect the retention of brake 1 by pushing the torque gauge sideways on the arm switch is inactivated when the knob is at LOCK 6 inspect the lock knob 7 8 9 switch on switch off switch off slowly all brakes get free all brakes get fixed immediately all brakes get fixed POINT SETTER OR table adapter inspection and operation test No 1 Measures inspect the outside look required result no damage, no dirt or no looseness any parts -21-
these parts must be firmly fixed with the clamps 2 inspect the clamps 3 inspect firmness the entire system must be able to be firmly fixed -22-
6. Troubleshooting Failure No function at all Remedy Connect Nitrogen Hose Page 14 2 Holding force too weak Use pressure 6~8 kg/cm or 6.2 to 7.9 bar Or 90-115 psi 14 Turn the safety lock knob on 16 Check weight of the instrument, Maximum load is 2 kg 4 19 14 Check joints of arm Endoscope or device slips 19 13 Check each of the clamps 16 18 Check the operating table 17 If failures cannot be remedied, contact our local representative for service.
7. Labeling ④ ⑤ ① ② ③ ⑤ ① ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ⑤ ① ② ④ ③ ⑤ -24- Make sure that part is securely clamped.
8. Technical Data POINT SETTER Arm Joint number Arm length Catalog No. PSMS2 : : Weight : Maximum load : Model No. : OR Table Adapter Joint number Weight Model No.
Instrument holders Standard holders : Catalog No.
9. Address as of December 26, 2007 Manufacturer of POINT SETTER Mitaka Kohki Co., LTD. 1-18-8 Nozaki, Mitaka, Tokyo 181-0014 Japan Work: 81-422-49-1491 Fax: 81-422-49-1117 Local representatives for service EUROPE, other Countries (including USA): KARL STORZ GMBH & CO. Mittelstrasse 8, D-78532 Tuttlingen, Germany phone: fax: +49 – 7461 – 7080 +49 – 7461 – 76874 USA,: MITAKA USA, Inc.
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: sales@www.mitakakohki.co.jp http://www.mitakakohki.co.
