Mitaka Kohki PSMS2 User manual

Operating / User’s Manual
MITAKAKOHKICo.,Ltd.
POINTSETTER
MODEL: PSMS2
PSMS2-M01 Last update February 14, 2010

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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. MITAKA KOHKI originally created the Point Setter as a holder
arm to retain a brain spatula. Since its original creation, there have been a number of
improvements made to the Point Setter, including its expanded use as a holder for various
other surgical instruments. It is especially valuable for the holding of an endoscope, which
has lately attracted considerable attention in the endoscopy field. Other uses for the Point
Setter include the holding of a retractor, a respirator tube, a CCD camera, and a magnetic
stimulation coil.
Note: In the USA, the Point Setter is FDA 510k approved only for use in holding an
endoscope. MITAKA KOHKI asks its USA customers to contact Mitaka USA at
[phone] regarding other possible FDA approved uses for the Point Setter.
Furthermore, if you have any questions regarding its intended use, please contact us; we are
eager to help our customers in any way that we can.

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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.
◆ All the parts necessary for technical services or repair must be replaced with MITAKA
KOHKI products only.
◆ Please use this instrument carefully in accordance with the instructions contained in
this Operating/User’s Manual.
◆ Special attention should be given to the following warnings:
CAUTION: In the USA, Federal law restricts this device to sale or use by or on
the order of a physician.
DANGER! This indicates possible death or
serious injury in case of misuse.
CAUTION! This indicates possible damage to property or
injuryofpersonsincaseofmisuse.
WARNING! This indicates possible failure to make full use of the Point
Setter.
!
!
!

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! 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 (4.4 lbs)
◆ In case of mechanical failure, contact the manufacturer or the distributor
◆ Never disassemble or overhaul the apparatus
◆ Never modify, alter or disassemble the apparatus in any way
◆ If malfunction or damage of the Point Setter occurs, display an “Out of Order” sign
on the instrument and immediately contact the manufacturer or its agent
◆ Monthly perform Operational Test shown in Section 5 of this document

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TABLEOFCONTENTS
Page
Introduction ---------------------------------------------------------------------------------------- 2
Safety Guidelines----------------------------------------------------------------------------------- 3
Table of Contents --------------------------------------------------------------------------------- 5
1. Summary-------------------------------------------------------------------------------------- 6
2. Parts List---------------------------------------------------------------------------------------- 7
3. Handling Instructions------------------------------------------------------------------------ 9
A. Sterilization ------------------------------------------------------------------- 9
B. General care of Point Setter Surfaces------------------------------------- 12
C. Before Draping Patient --------------------------------------------------- 13
D. Draping the Point Setter ---------------------------------------------------- 15
E. Attaching the Endoscope to the Point Setter ----------------------------- 16
F. OR Table Adapter Brake Knobs ------------------------------------------- 18
4. Further Safety Instructions --------------------------------------------------------------- 19
5. Operational Test ------------------------------------------------------------------------------ 20
6. Troubleshooting ---------------------------------------------------------------------------- 23
7. Labeling -------------------------------------------------------------------------------------- 24
8. Technical Data ------------------------------------------------------------------------------- 25
9. Addresses ------------------------------------------------------------------------------------ 27
Annex: EC DECLRATION OF CONFORMITY
EDITION
PSMS2-M01 December 26, 2007