Translated from Japanese to English - www.onlinedoctranslator.

com

* *2017YearTenMonth (Second13Edition) (Revised based on new entry guidelines)

* 2014Year12Month (Second12version)

Medical device notification number 13B1X00277000096issue

mechanical equipment2Medical illuminator General medical equipment General-purpose light sourceJMDNcode32037000

xenon light sourceOME8-SLX

3.specification

[Contraindications/prohibitions]
item specification

* Combined medical device power supply Voltage 100VAlternating current

This product is a surgical microscope (OME-7000,OME-8000,OME-9000) Do voltage fluctuation ±Ten%Within

not use in combination with equipment other than [Injuries to the human body, frequency 50/60Hz
It may lead to damage to the equipment. In addition, functions cannot be secured. frequency variation ±1HzWithin
] Input current (light source
6.5A
stand-alone)

* how to use illumination lighting lamp xenon short arc lamp

Do not install and use this product in the following locations. This product does not (ozoneless)300W
have an explosion-proof structure [There is a risk of explosion or fire. ] lighting method switching regulator
- Places with high oxygen concentration Light intensity adjustment Stepless dimming with optical path blocking diaphragm

- laughing gas (N.2O) in an atmosphere of oxidizing substances such as cooling forced air cooling

- Where combustible anesthetic gas is used emergency lighting lamp Halogen lamp (with mirror)15V
150W
front panel emergency lighting lamp
Presence or absence of emergency lighting lamps
[Shape, structure, principle, etc.] lights up
announcement
display
* * Structure/Construction Unit
medical electricity protection against electric shock
classI
1.composition by equipment form of
This product consists of: of products that protection against electric shock
B.form equipment

(1)xenon light source OME8-SLX classification degree of

(2)emergency lighting lamp DQ0045 Degree of explosion protection Do not use in flammable atmosphere

(3)binder
* May be manufactured and sold individually or in any combination. Four.structure

Block Diagram

2.Name of each part

5.EMC
This product isEMCstandardIEC 60601-1-2:2001conforms to

Actuation/operating principle

The emitted light from the xenon lamp is led to the output connector on the front of the main unit, and

supplies illumination light to the light guide of the connected surgical microscope.

* * [Purpose of use or effect]

Intended use

Used in combination with an operating microscope for illumination of the surgical site.

Please refer to the instruction manual always.

1/2
 Five.Securely fix the hexagon wrench used when replacing the xenon lamp in the storage
* * [How to use] section on the back of the xenon lamp replacement door and store it. If the wrench
1.Connect the power cord to the power connector of this product and the light source device connector of gets into the light source, immediately turn off the power and unplug the power cord
the surgical microscope. for the light source from the light source connector on the stand. Continuing to use the
2.Press the power switch to turn on the illumination lamp. product as is may result in equipment failure or electric shock.
3.Rotate the light adjustment knob to adjust the brightness appropriately for observation.

For details, refer to the "Instruction Manual". * * defect

Other glitches
Precautions for use related to usage, etc.
Equipment damage, malfunction, failure
1.Do not apply excessive force to the connector of each connection part.
An electrical contact may fail and cause malfunction.
* * Adverse event
2.Strong electromagnetic waves (microwave therapy device, short
wave therapy device,MRI, near radios, etc.). Doing so may damage Other adverse events
the product. Electric shock, burns, eye pain from lighting
3.Do not install other equipment next to this product. Due to him not being properly cooled, this

product may stop working or other equipment may malfunction.

Four.Wipe the power switch with dry gauze. Wiping with wet gauze * * [Storage method and validity period, etc.]
may damage the switch or cause an electric shock accident.
Storage method
Five.After wiping the product with gauze soaked in a neutral detergent or
ethanol for disinfection, dry it thoroughly before using it. Using it while it is After use, refer to "Instruction Manual"7Store according to Chapter Care and
wet may cause an electric shock accident. Storage.

service life
[Precautions for use]
The service life of this product is after manufacture and shipment (after delivery).6year

* * Important Basic Note (according to self-certification (our data)).

1.Use the minimum lighting brightness and exposure time for the For the service life, perform pre-use inspections and periodic inspections as

surgical site. There is a risk of tissue burns. indicated in the "attachment" and "instruction manual", and carry out repairs or

- To prevent burns at the surgical site,OME-7000When using the dimmer knob overhauls if necessary according to the inspection results.

on the right side of the center position in combination with , be sure to use
Period of use
physiological saline to prevent the temperature of the surgical site from
rising. When treating a surgical site where physiological saline cannot be The usage period of the main components of this product is as follows.

used, the Senon light source device (OME8-SLX) to the left of the center - Examination lamp: continuous approx.500Time (In the case of intermittent use, it may

position. fluctuate slightly.)

- To prevent burns outside the surgical site,OME-7000When used - Emergency light: approx.50time

in combination with , use the separately sold illumination

range variable unit to block the illumination light from hitting
[Matters related to maintenance and inspection]
the surgical site, or cover the surgical site with wet gauze.
* * User maintenance and inspection items

Before use, check according to the instruction manual. Carry out

repair or overhaul, if necessary, according to the inspection results.

* * [Names of marketing authorization holders and manufacturers]

Manufacturer and distributor:

Olympus Medical Systems Corporation

* 〒192-8507Ishikawacho, Hachioji City, Tokyo Prefecture2951

* Contact information
* TEL 0120-41-7149(Endoscope Customer Service Center)

manufacturer:

Shirakawa Olympus Co., Ltd.

2.Breaker reset operation1only once.1If the power does not turn on after the first reset 〒961-8061Nishishirakawa-gun Nishigo-mura, Fukushima Prefecture3-1

operation, immediately press the lower part of the power switch to turn off the
power and unplug the light source power cord from the light source connector on
the stand. An abnormality or failure of the light source unit may be suspected,
which may result in fire or electric shock.
3.Do not touch the tip of the light guide or the output connector of the light source
immediately after removing the light guide from this product. Because he is so hot,
there is a risk of getting burned.
Four.Do not touch the inside of the xenon lamp replacement door or the halogen lamp replacement door.

Immediately after the power is turned off, the inside of the xenon lamp replacement door and the halogen

lamp replacement door is extremely hot and may cause burns.

Please refer to the instruction manual always.

2/2 ©2002 OLYMPUS MEDICAL SYSTEMS CORP. All rights reserved.

GC9506 14 Printed in Japan 20171006 *0000