Olympus OME-L200 Manuel utilisateur
INSTRUCTIONS
ORBEYE LED LIGHT SOURCE
OME-L200
Labels and Symbols 1
Important Information — Please Read Before
Use 3
Summary of Equipment Functions 9
Chapter 1 Checking the Package Contents 11
Chapter 2 Nomenclature and Functions 13
Chapter 3 Installation and Connection 19
Chapter 4 Inspection 29
Chapter 5 Operation 39
Chapter 6 Care, Storage, and Disposal 45
Chapter 7 Troubleshooting 47
Appendix 55
Contents
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OME-L200 INSTRUCTION MANUAL
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 3
Intended use .......................................................................................................................... 3
Instruction manual ................................................................................................................. 3
User qualifications ................................................................................................................. 4
Instrument compatibility ......................................................................................................... 4
Spare equipment ................................................................................................................... 4
Prohibition of improper repair and modification ..................................................................... 4
Signal words .......................................................................................................................... 5
Precautions ............................................................................................................................ 5
Summary of Equipment Functions .................................................................................. 9
Chapter 1 Checking the Package Contents ....................................... 11
1.1 Checking the Package Contents ........................................................................... 11
Chapter 2 Nomenclature and Functions ............................................ 13
2.1 Symbols and descriptions ..................................................................................... 13
2.2 Explained parts ....................................................................................................... 14
2.3 Control panel .......................................................................................................... 15
2.4 Side panel ................................................................................................................ 16
2.5 Bottom panel ........................................................................................................... 18
2.6 Surgical microscope connection .......................................................................... 18
Chapter 3 Installation and Connection ............................................... 19
3.1 Precautions for installation and connection ........................................................ 19
3.2 Connection workflow ............................................................................................. 20
3.3 Installing this instrument ....................................................................................... 21
3.4 Connection of cables ............................................................................................. 24
3.5 Connection of cable cover .................................................................................... 27
Chapter 4 Inspection ............................................................................ 29
4.1 Precautions of workflow ........................................................................................ 29
4.2 Inspection workflow ............................................................................................... 30
4.3 Inspection of power ON ......................................................................................... 31
4.4 Inspection of illumination light ............................................................................. 33
4.5 Inspection of spare lamp function ........................................................................ 34
4.6 Inspection of spare lamp brightness control ....................................................... 36
4.7 Power OFF .............................................................................................................. 38
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Contents
OME-L200 INSTRUCTION MANUAL
Chapter 5 Operation ............................................................................. 39
5.1 Precautions for operation ...................................................................................... 39
5.2 Turning the instrument and illumination lamp ON .............................................. 40
5.3 Extinction of illumination lamp ............................................................................. 42
5.4 Power OFF ............................................................................................................... 43
Chapter 6 Care, Storage, and Disposal .............................................. 45
6.1 Care .......................................................................................................................... 45
6.2 Storage .................................................................................................................... 46
6.3 Disposal ................................................................................................................... 46
Chapter 7 Troubleshooting .................................................................. 47
7.1 Troubleshooting ..................................................................................................... 47
7.2 Troubleshooting guide ........................................................................................... 48
7.3 Remedial actions in case of emergency .............................................................. 51
Lighting of spare lamp ......................................................................................................... 51
Control of spare lamp brightness ......................................................................................... 52
Extinction of spare lamp ...................................................................................................... 53
7.4 Returning this instrument for repair ..................................................................... 54
Appendix ................................................................................................. 55
Combination equipment .................................................................................................. 55
System chart ........................................................................................................................ 55
Specifications ................................................................................................................... 57
Environments ....................................................................................................................... 57
Specifications ....................................................................................................................... 58
EMC information .............................................................................................................. 59
License information of Open Source Software ............................................................. 64
Labels and Symbols
1
OME-L200 INSTRUCTION MANUAL
Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are
missing or illegible, contact Olympus.
Side panel
Labels and Symbols
Light guide terminal caution
Caution symbol not to look into the light
guide terminal while the lamp is lit.
Light guide cable port
temperature caution
Caution symbol not to touch the
light guide cable port while it is hot
immediately after extinguishing the
light.
2
Labels and Symbols
OME-L200 INSTRUCTION MANUAL
Bottom panel
Back cover of this instruction manual
Symbol Description Symbol Description
Manufacturer Authorized representative in the
European Community
Serial number
Product plate
Indication of the model name, rated input and
manufacturer name.
CE marking
Crossed-out wheeled
bin’ symbol
Important Information — Please Read Before Use
3
OME-L200 INSTRUCTION MANUAL
Intended use
The light source has been designed to be used with Olympus Surgical Microscope for use in magnified
observation and recording of surgical sites.
Instruction manual
This instruction manual contains essential information on using this instrument safely and effectively.
Before use, thoroughly review this manual and the manuals for ancillary equipment that will be used
during the procedure and use the equipment as instructed.
Keep this and all related instruction manuals in a safe, accessible location. If you have any questions
about any information in this manual, contact Olympus.
Terms used in this manual
Important Information — Please Read Before Use
ORBEYE Surgical microscope (OME-V200)
The surgical microscope designated by Olympus to be used in combination with this
instrument.
Automatic brightness control
Function that automatically adjusts illumination light to keep the image brightness
constant even when the observation conditions such as the working distance and
magnification change.
Hospital grade wall mains outlet
The hospital grade wall mains outlet is a wall AC mains power outlet socket having the
exclusive terminal for grounding.
Light guide cable
The cable formed by bundling several optical fibers. Used to transmit the light emitted
from this instrument to the illumination lens of the surgical microscope.
Spare lamp
This is light source used temporarily in the case of failure of this instrument.
4
Important Information — Please Read Before Use
OME-L200 INSTRUCTION MANUAL
User qualifications
The operator of this instrument must be a physician or medical personnel under the supervision of a
physician and must have received sufficient training in clinical procedures of microsurgery using
surgical microscopes. This manual, therefore, does not explain or discuss the details of microsurgery
using surgical microscopes.
For details of microsurgery using surgical microscopes, the physician and operator are requested to
judge from their viewpoints as specialists.
Instrument compatibility
This instrument should be used in combination with the ancillary equipment shown in “System chart”
on page 55. Using incompatible equipment can result in patient or operator injury and/or equipment
damage as well as malfunction.
This instrument complies with EMC standard for medical electrical equipment edition 4
(IEC 60601-1-2: 2014).
Spare equipment
To avoid interruption of procedure due to an unexpected event such as equipment failure in the middle
of operation, be sure to hold ready the spare equipment.
Prohibition of improper repair and modification
Never allow a person other than Olympus-qualified personnel to disassemble or modify the instrument,
as this may result in injury of the patient or operator as well as damage to the equipment. Olympus will
not assume any liability for human accidents or equipment damage occurred due to repair by a person
other than Olympus-qualified personnel.
Important Information — Please Read Before Use
5
OME-L200 INSTRUCTION MANUAL
Signal words
The following signal words are used throughout this manual:
Precautions
Follow the warnings and cautions given below when handling this instrument. This information is to be
supplemented by the warnings and cautions given in each chapter.
WARNING
• Strictly observe the following precautions. Failure to do so may place the patient
and medical personnel in danger of an electric shock.
Do not souse or spill a liquid such as water over this instrument. Should a liquid
penetrate this instrument, immediately stop using it and contact Olympus.
Do not prepare, inspect, or use this instrument with wet hands.
• Never install and operate this instrument in locations where:
The concentration of oxygen is high;
Oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere;
Flammable gases are present in the atmosphere;
Flammable liquids are near.
Otherwise, explosion or a fire may result because this instrument is not
explosion-proof.
• Do not use the equipment for ophthalmic surgery or during procedures in which the
illumination may make direct contact with the patient’s eye. The strong illumination
can injure the retina.
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor
or moderate injury. It may also be used to alert against unsafe practices or potential
equipment damage.
Indicates additional helpful information.
WARNING
CAUTION
NOTE
6
Important Information — Please Read Before Use
OME-L200 INSTRUCTION MANUAL
WARNING
• Do not use for purposes other than those described in “Intended use” on page 3,
as this may result in injury of the patient or operator as well as damage to the
equipment.
• This instrument should be used under the conditions specified in “Environments”
on page 57. Otherwise, imperilment of safety or failure of equipment may result as
well as malfunction.
• This product may interfere with other medical electric equipment used in
combination with it. Before use, refer to the “Appendix” to confirm the compatibility
of this instrument with all equipment to be used.
CAUTION
• Observe the following warnings on the illumination light emitted from the
illumination lens of the surgical microscope. It may produce organic changes of
living body, including protein degeneration, tissue drying and burns, if it is used
erroneously.
Always be careful not to cause drying or burns of the observed region.
The brightness observed on the monitor may sometimes differ from the actual
brightness of the light emitted from the surgical microscope.
Usually, the auto brightness control function maintains the illumination light at
optimum brightness. However, when the spare lamp is used, adjust the
brightness always at an optimum level by controlling the spare lamp brightness
control knob.
Always use the equipment for the minimum required period.
The illumination light has a potential of exerting unfavorable effects to the living
tissues. Be sure to limit the time of irradiation on the observed region at
minimum.
Reserve a sufficient working distance.
If the illumination is incident with the observed region and surrounding tissues
for an extended period while the working distance of the surgical microscope is
set shorter than required, increased irradiation on the living tissues may exert
unfavorable effects on them. To prevent this, be careful not to use a shorter
working distance than necessary.
Cool the tissues that tend to dry early or be affected by heat.
If the observed region has a drying tendency or concerns related to affection by
heat, take a measure to cool the living tissues in addition to the
countermeasures against the warnings above. The method of cooling includes
frequent pouring of saline and coverage with sterilized wet gauze. A similar
cooling measure is also required when the illumination is incident to the living
tissues outside the observed region.
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