taiyo OPELA III User manual

Thank you for purchasing the
Wearable Surgical Lighting System
Fuji Bldg. 5-30-9 Shiba, Minato-ku, Tokyo, 108-0014
Manufacturer:TAIYOCORPORATION
Point of inquiry
IssuedJuly2021OPP02US(02)
TM
is registered in U.S. Patent and Trademark Ofce.
is trademark of Taiyo corporation.
Limited Warranty
9
■Warranty Coverage
•
We will repair or replace the product free of charge if it fails within 1 year from the date of purchase provided it
has been used correctly following the instruction manual and precaution notes of attached labels, etc.
a ) Defect or damage caused by incorrect use and/or inappropriate repair and modications.
b ) Defect or damage caused by dropping after purchase.
c )
Defect or damage caused by re, earthquake, ood, lightning, other natural disasters, pollution or abnormal
voltage from the power source, power supply that is outside the specications (voltage, frequency), etc.
d ) Warranty letter is not provided.
e )
Warranty letter does not indicate date of purchase, name of customer, or name of product, or they have been re-written.
f ) Consumable parts. (battery unit, antibacterial urethane pad, cushion, etc.)
g ) Cause of defect is attributable to anything other than this product.
h ) Any other defect and/or damage caused by usage not specied in this instruction manual.
i) Only the main unit and AC adapter are in scope.
■Disclaimer
• It will not be covered by warranty if the failure or defect falls under any of the following items.
• We assume no responsibility or liability for incidental damages (loss of business prots or interruption
of business) arising from the use of or inability to use the product.
•
This Limited Warranty gives you specic legal rights and you may also have other rights which vary from state to state.
Thank you for purchasing our product. This product has been subjected to extensive inspection to
maintain high quality. However, in case of failure during normal use, we will repair or replace the
product free of charge for 1 year from the date of purchase according to our warranty policy.
LimitedWarrantyLetter
Fuji Bldg. 9F, 5-30-9 Shiba, Minato-ku, Tokyo, 108-0014
Manufacturer:TAIYO CORPORATION
Distributor
Name of
product
Your name
Address
E-mail address
Date of purchase
YY MM DD
Address
( )
TEL
( )
TEL
This warranty is valid only in countries authorized
for sale by the manufacturer.
Be sure for a distributor to fill in the information below.
Wearable Surgical Lighting System OPELA
Ⅲ
Safety Precautions
Part names
使用方法
How to use
Storage
Maintenance
Repair & Inspection
Troubleshooting
Specifications
Warranty
Wearable Surgical Lighting System
Please be sure to read this instruction manual before use.
Please also keep this manual close at hand for future reference.
Instruction Manual
E300019
仕上サイズ A5、中綴じ28ページ、1c/1c

【
Purpose of Use
】To wear on your head and illuminate the field of vision during surgery,
examinations, and treatment.
【Target Users】Physicians, Medical staff
【Place of Use】Indoor
【Models 】
This product is a wearable surgical lighting system focused on the quality of light, while
providing both moveableness (with installed batteries) and a comfortable feel.
Introduction
1
The safety precautions described here are for safe and correct use of the product to prevent
injury to yourself and others, or damage to property.
Safety Precautions
2
-H
(High Illumination Model)Achieves 145,000 Lux in pursuit of high illumination.
Indicates potential death or serious injury
if this description is ignored and improperly handled.
Indicates potential mild or moderate injury
if this description is ignored and improperly handled.
Indicates expected failure, damage, malfunction, or defects
if this description is ignored and improperly handled.
【Basic Performance
】Central Illumination: 6,000 to 145,000 Lux ±10%
(For Mode-H,
Illumination Distance 400 mm(16inch), Illumination
Field Diameter
φ
75 mm(3inch))
【
Continuous Lighting Hours
】・Dimmer Knob MAX (Dimming Level 100%): Approx. 2.5 Hours
・Dimmer Knob # 7 (Dimming Level 70% ): Approx. 3.5 Hours
・Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours
Adjust use in consideration of the surgery time.
If necessary, prepare spare batteries.
The continuous lighting hours are estimates at the time of purchase.
Note that the time of a single use of a battery becomes shorter with each charge.
When the time of a single use is extremely short as compared at the time of purchase,
buy a replacement.
CAUTION
WARNING
NOTICE
■Examples of picture indications
The following symbols indicate actions that you should not perform.
The following symbol indicates an action that you must perform.
■General Precautions
Do not let the product get wet.
It may cause electric shock or failure.
Do not apply strong force or shock, throw the product, or place heavy objects on it.
It may cause battery leakage, heat generation, rupture, ignition, damage to the heat sink of the main unit, or cord breakage.
Do not use the dedicated AC adapter and battery unit with other products.
It may cause electric shock, ignition, or failure.
Do not use products that have loose levers or knobs.
It may cause the product to drop or malfunction. Request for repair at the distributor.
If you drop the product, check that all 3 LED lights illuminate.
If only 2 or fewer LEDs illuminate or if they flicker, discontinue use and contact the distributor.
Do not use damaged or failing products.
It may cause the product to drop, heat generation, or electric shock. Request for repair at the distributor.
CAUTION
Do not disassemble, repair, or modify the product.
It may cause battery leakage, heat generation, rupture, ignition, or damage and failure
of the main unit. If repairs are necessary, contact the distributor.
Do not perform any actions that may damage the cords.
It may cause electric shock or ignition.
• Do not modify the cords. • Do not place heavy objects on the cords.
• Do not forcefully bend, twist, or pull the cords.
• Do not place the cords near heating appliances while charging.
If the cords get damaged, discontinue use and contact the distributor.
WARNING
Indicates an action that you should not perform.
Indicates that the description must be followed.
Indicates that you should not disassemble the product.
■Indications
The safety precautions are classified into and clearly specified as “Warning”, “Caution”, and
“Notice”. Be sure to follow them during use.
Safety Precautions
2
3
IntroductionSafety Precautions

【
Purpose of Use
】To wear on your head and illuminate the field of vision during surgery,
examinations, and treatment.
【Target Users】Physicians, Medical staff
【Place of Use】Indoor
【Models 】
This product is a wearable surgical lighting system focused on the quality of light, while
providing both moveableness (with installed batteries) and a comfortable feel.
Introduction
1
The safety precautions described here are for safe and correct use of the product to prevent
injury to yourself and others, or damage to property.
Safety Precautions
2
-H
(High Illumination Model)Achieves 145,000 Lux in pursuit of high illumination.
Indicates potential death or serious injury
if this description is ignored and improperly handled.
Indicates potential mild or moderate injury
if this description is ignored and improperly handled.
Indicates expected failure, damage, malfunction, or defects
if this description is ignored and improperly handled.
【Basic Performance
】Central Illumination: 6,000 to 145,000 Lux ±10%
(For Mode-H,
Illumination Distance 400 mm(16inch), Illumination
Field Diameter
φ
75 mm(3inch))
【
Continuous Lighting Hours
】・Dimmer Knob MAX (Dimming Level 100%): Approx. 2.5 Hours
・Dimmer Knob # 7 (Dimming Level 70% ): Approx. 3.5 Hours
・Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours
Adjust use in consideration of the surgery time.
If necessary, prepare spare batteries.
The continuous lighting hours are estimates at the time of purchase.
Note that the time of a single use of a battery becomes shorter with each charge.
When the time of a single use is extremely short as compared at the time of purchase,
buy a replacement.
CAUTION
WARNING
NOTICE
■Examples of picture indications
The following symbols indicate actions that you should not perform.
The following symbol indicates an action that you must perform.
■General Precautions
Do not let the product get wet.
It may cause electric shock or failure.
Do not apply strong force or shock, throw the product, or place heavy objects on it.
It may cause battery leakage, heat generation, rupture, ignition, damage to the heat sink of the main unit, or cord breakage.
Do not use the dedicated AC adapter and battery unit with other products.
It may cause electric shock, ignition, or failure.
Do not use products that have loose levers or knobs.
It may cause the product to drop or malfunction. Request for repair at the distributor.
If you drop the product, check that all 3 LED lights illuminate.
If only 2 or fewer LEDs illuminate or if they flicker, discontinue use and contact the distributor.
Do not use damaged or failing products.
It may cause the product to drop, heat generation, or electric shock. Request for repair at the distributor.
CAUTION
Do not disassemble, repair, or modify the product.
It may cause battery leakage, heat generation, rupture, ignition, or damage and failure
of the main unit. If repairs are necessary, contact the distributor.
Do not perform any actions that may damage the cords.
It may cause electric shock or ignition.
• Do not modify the cords. • Do not place heavy objects on the cords.
• Do not forcefully bend, twist, or pull the cords.
• Do not place the cords near heating appliances while charging.
If the cords get damaged, discontinue use and contact the distributor.
WARNING
Indicates an action that you should not perform.
Indicates that the description must be followed.
Indicates that you should not disassemble the product.
■Indications
The safety precautions are classified into and clearly specified as “Warning”, “Caution”, and
“Notice”. Be sure to follow them during use.
Safety Precautions
2
3
IntroductionSafety Precautions

■Handling the Battery Unit
Do not drop in fire or heat up.
It may cause rupture or ignition.
Do not leave the battery unit under direct sunlight or in sun-heated cars.
It may cause leakage, heat generation, rupture, or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water
and seek medical attention.
It may cause blindness.
Do not cover the battery unit with air-blocking materials (eg. cloth, plastic bag.)
while charging.
It may cause leakage, heat generation, rupture, or ignition.
Do not let conductive foreign objects (such as metals or pencil leads) touch
the OUTPUT jack.
It may short-circuit and cause failure.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
■Precautions for Usage, Charging, and Storage Locations
Do not use, charge, or store in locations other than the specified environment (refer to 8.
Specifications), such as high humidity environments or high temperature environments.
It may cause battery leakage, heat generation, rupture, or ignition. It may also reduce the battery capacity and charging efficiency.
Do not bring the product into MRI environments.
It may get pulled into a powerful magnetic field and cause a serious accident.
Do not use in environments where flammable anesthetics or nitrous oxide is used.
The product is not classified as AP or APG.
Using it may cause flammable gas to ignite and create a fire.
Charge or store in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause battery leakage, heat
generation, rupture, or ignition.
Do not use in locations with much sand or dust.
It may cause failure.
Do not use in locations exposed to pathogens that cannot be disinfected with ethanol.
Using a disinfectant other than ethanol for disinfection may cause discoloration, deformation, or failure.
It may also cause infection due to improper disinfection.
Do not store in locations with corrosive gas or liquid.
It may cause failure or damage.
CAUTION
Do not charge when there is lightning or thunder.
It may cause electric shock, fire, or malfunction.
If there is thunder while charging, do not touch the adapter or battery.
It may cause electric shock.
WARNING
CAUTION
WARNING
NOTICE
NOTICE
4
5
Safety Precautions
Safety Precautions

■Handling the Battery Unit
Do not drop in fire or heat up.
It may cause rupture or ignition.
Do not leave the battery unit under direct sunlight or in sun-heated cars.
It may cause leakage, heat generation, rupture, or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water
and seek medical attention.
It may cause blindness.
Do not cover the battery unit with air-blocking materials (eg. cloth, plastic bag.)
while charging.
It may cause leakage, heat generation, rupture, or ignition.
Do not let conductive foreign objects (such as metals or pencil leads) touch
the OUTPUT jack.
It may short-circuit and cause failure.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
■Precautions for Usage, Charging, and Storage Locations
Do not use, charge, or store in locations other than the specified environment (refer to 8.
Specifications), such as high humidity environments or high temperature environments.
It may cause battery leakage, heat generation, rupture, or ignition. It may also reduce the battery capacity and charging efficiency.
Do not bring the product into MRI environments.
It may get pulled into a powerful magnetic field and cause a serious accident.
Do not use in environments where flammable anesthetics or nitrous oxide is used.
The product is not classified as AP or APG.
Using it may cause flammable gas to ignite and create a fire.
Charge or store in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause battery leakage, heat
generation, rupture, or ignition.
Do not use in locations with much sand or dust.
It may cause failure.
Do not use in locations exposed to pathogens that cannot be disinfected with ethanol.
Using a disinfectant other than ethanol for disinfection may cause discoloration, deformation, or failure.
It may also cause infection due to improper disinfection.
Do not store in locations with corrosive gas or liquid.
It may cause failure or damage.
CAUTION
Do not charge when there is lightning or thunder.
It may cause electric shock, fire, or malfunction.
If there is thunder while charging, do not touch the adapter or battery.
It may cause electric shock.
WARNING
CAUTION
WARNING
NOTICE
NOTICE
4
5
Safety Precautions
Safety Precautions
■Handling the Battery Unit
Do not drop in fire or heat up.
It may cause rupture or ignition.
Do not leave the battery unit under direct sunlight or in sun-heated cars.
It may cause leakage, heat generation, rupture, or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water
and seek medical attention.
It may cause blindness.
Do not cover the battery unit with air-blocking materials (eg. cloth, plastic bag.)
while charging.
It may cause leakage, heat generation, rupture, or ignition.
Do not let conductive foreign objects (such as metals or pencil leads) touch
the OUTPUT jack.
It may short-circuit and cause failure.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
■Precautions for Usage, Charging, and Storage Locations
Do not use, charge, or store in locations other than the specified environment (refer to 8.
Specifications), such as high humidity environments or high temperature environments.
It may cause battery leakage, heat generation, rupture, or ignition. It may also reduce the battery capacity and charging efficiency.
Do not bring the product into MRI environments.
It may get pulled into a powerful magnetic field and cause a serious accident.
Do not use in environments where flammable anesthetics or nitrous oxide is used.
The product is not classified as AP or APG.
Using it may cause flammable gas to ignite and create a fire.
Charge or store in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause battery leakage, heat
generation, rupture, or ignition.
Do not use in locations with much sand or dust.
It may cause failure.
Do not use in locations exposed to pathogens that cannot be disinfected with ethanol.
Using a disinfectant other than ethanol for disinfection may cause discoloration, deformation, or failure.
It may also cause infection due to improper disinfection.
Do not store in locations with corrosive gas or liquid.
It may cause failure or damage.
CAUTION
Do not charge when there is lightning or thunder.
It may cause electric shock, fire, or malfunction.
If there is thunder while charging, do not touch the adapter or battery.
It may cause electric shock.
WARNING
CAUTION
WARNING
NOTICE NOTICE
4 5
Safety Precautions
Safety Precautions

■Maintenance Precautions
■Transport and Storage Precautions
Do not wash it by exposing it to or submerging it in water.
It may cause electric shock or failure.
When cleaning, use ethanol for disinfection.
Using detergent or disinfectants other than ethanol for disinfection may cause damage,
discoloration, or failure.
Do not sterilize.
It may cause failure or damage.
Always use the storage bag/hard case when storing or carrying. (Refer to 5-7. Storage)
Leaving the product out or carrying it without putting it in the storage bag/hard case may
cause failure or damage. Also, if the heat sink is bent or warped, you may be unable to wear
the product, or the light source unit may get hot and malfunction.
When the product is moved from a warm place to a cold place (and vice versa),
allow it to settle down for a while before taking out of the package.
Taking it out immediately will cause condensation to occur due to sudden change in temperature,
leading to potential failure.
Do not store with the connection cord still connected to the battery unit.
It may cause failure.
Do not carry by the heat sink.
It may cause failure or damage.
Do not drop the storage bag/hard case.
It may cause failure, damage or injury.
CAUTION
NOTICE
NOTICE
<Image figure>Headsmaybump
Operation table
Others in the vicinityPerson wearing
this product
■Usage Precautions
Avoid direct exposure to the eyes of those in the vicinity.
It may cause damage to the eyes.
Do not look into the light source unit during use.
It may cause damage to the eyes.
Do not cover the light source unit or heat sink with cloth or paper.
The heat will build up and may cause heat generation, ignition, or failure.
Be careful so that your head does not touch others in the vicinity while wearing the product.
It may cause injury, or the product may drop, malfunction, or get damaged.
Do not use the product without wearing it on your head or use while it is secured on a stand.
It may cause an accident such as a fall.
Do not use accessories other than those included with the product.
It may cause battery heat generation, rupture, ignition, electric shock, or failure.
If it has not been used for a long time, check that fluid is not leaking from the battery unit before use.
Touching the fluid may cause burns. Discontinue use, put it in a plastic bag, and contact the distributor.
Place the main unit on the calibration kit instead of directly on a platform or desk.
Otherwise, the illumination position adjustment lever will touch the platform or desk, and may cause it to bend or
cause the protective cap to come off easily. Broken parts can fall into the operating field and cause contamination.
CAUTION
Do not use for ophthalmic procedures.
It may cause damage to the eyes.
Do not use for photosensitive patients or patients who have received photosensitizing agents.
It may cause burns.
Do not use for neonatal transillumination.
It may cause burns.
WARNING
Observe tissue during use of this product.
Heat generated by light energy may cause thermal injury. If thermal injury occurs immediately
discontinue use and take appropriate measures.
Do not use at illumination level higher and at distance closer than necessary.
Heat generated by light energy may cause thermal injury (particularly with prolonged illumination
of a fixed location by multiple light sources, etc.)
6
7
Safety Precautions
Safety Precautions

■Maintenance Precautions
■Transport and Storage Precautions
Do not wash it by exposing it to or submerging it in water.
It may cause electric shock or failure.
When cleaning, use ethanol for disinfection.
Using detergent or disinfectants other than ethanol for disinfection may cause damage,
discoloration, or failure.
Do not sterilize.
It may cause failure or damage.
Always use the storage bag/hard case when storing or carrying. (Refer to 5-7. Storage)
Leaving the product out or carrying it without putting it in the storage bag/hard case may
cause failure or damage. Also, if the heat sink is bent or warped, you may be unable to wear
the product, or the light source unit may get hot and malfunction.
When the product is moved from a warm place to a cold place (and vice versa),
allow it to settle down for a while before taking out of the package.
Taking it out immediately will cause condensation to occur due to sudden change in temperature,
leading to potential failure.
Do not store with the connection cord still connected to the battery unit.
It may cause failure.
Do not carry by the heat sink.
It may cause failure or damage.
Do not drop the storage bag/hard case.
It may cause failure, damage or injury.
CAUTION
NOTICE
NOTICE
<Image figure>Headsmaybump
Operation table
Others in the vicinityPerson wearing
this product
■Usage Precautions
Avoid direct exposure to the eyes of those in the vicinity.
It may cause damage to the eyes.
Do not look into the light source unit during use.
It may cause damage to the eyes.
Do not cover the light source unit or heat sink with cloth or paper.
The heat will build up and may cause heat generation, ignition, or failure.
Be careful so that your head does not touch others in the vicinity while wearing the product.
It may cause injury, or the product may drop, malfunction, or get damaged.
Do not use the product without wearing it on your head or use while it is secured on a stand.
It may cause an accident such as a fall.
Do not use accessories other than those included with the product.
It may cause battery heat generation, rupture, ignition, electric shock, or failure.
If it has not been used for a long time, check that fluid is not leaking from the battery unit before use.
Touching the fluid may cause burns. Discontinue use, put it in a plastic bag, and contact the distributor.
Place the main unit on the calibration kit instead of directly on a platform or desk.
Otherwise, the illumination position adjustment lever will touch the platform or desk, and may cause it to bend or
cause the protective cap to come off easily. Broken parts can fall into the operating field and cause contamination.
CAUTION
Do not use for ophthalmic procedures.
It may cause damage to the eyes.
Do not use for photosensitive patients or patients who have received photosensitizing agents.
It may cause burns.
Do not use for neonatal transillumination.
It may cause burns.
WARNING
Observe tissue during use of this product.
Heat generated by light energy may cause thermal injury. If thermal injury occurs immediately
discontinue use and take appropriate measures.
Do not use at illumination level higher and at distance closer than necessary.
Heat generated by light energy may cause thermal injury (particularly with prolonged illumination
of a fixed location by multiple light sources, etc.)
6
7
Safety Precautions
Safety Precautions
■Maintenance Precautions
■Transport and Storage Precautions
Do not wash it by exposing it to or submerging it in water.
It may cause electric shock or failure.
When cleaning, use ethanol for disinfection.
Using detergent or disinfectants other than ethanol for disinfection may cause damage,
discoloration, or failure.
Do not sterilize.
It may cause failure or damage.
Always use the storage bag/hard case when storing or carrying. (Refer to 5-7. Storage)
Leaving the product out or carrying it without putting it in the storage bag/hard case may
cause failure or damage. Also, if the heat sink is bent or warped, you may be unable to wear
the product, or the light source unit may get hot and malfunction.
When the product is moved from a warm place to a cold place (and vice versa),
allow it to settle down for a while before taking out of the package.
Taking it out immediately will cause condensation to occur due to sudden change in temperature,
leading to potential failure.
Do not store with the connection cord still connected to the battery unit.
It may cause failure.
Do not carry by the heat sink.
It may cause failure or damage.
Do not drop the storage bag/hard case.
It may cause failure, damage or injury.
CAUTION
NOTICE
NOTICE
<Image figure>Headsmaybump
Operation table
Others in the vicinityPerson wearing
this product
■Usage Precautions
Avoid direct exposure to the eyes of those in the vicinity.
It may cause damage to the eyes.
Do not look into the light source unit during use.
It may cause damage to the eyes.
Do not cover the light source unit or heat sink with cloth or paper.
The heat will build up and may cause heat generation, ignition, or failure.
Be careful so that your head does not touch others in the vicinity while wearing the product.
It may cause injury, or the product may drop, malfunction, or get damaged.
Do not use the product without wearing it on your head or use while it is secured on a stand.
It may cause an accident such as a fall.
Do not use accessories other than those included with the product.
It may cause battery heat generation, rupture, ignition, electric shock, or failure.
If it has not been used for a long time, check that fluid is not leaking from the battery unit before use.
Touching the fluid may cause burns. Discontinue use, put it in a plastic bag, and contact the distributor.
Place the main unit on the calibration kit instead of directly on a platform or desk.
Otherwise, the illumination position adjustment lever will touch the platform or desk, and may cause it to bend or
cause the protective cap to come off easily. Broken parts can fall into the operating field and cause contamination.
CAUTION
Do not use for ophthalmic procedures.
It may cause damage to the eyes.
Do not use for photosensitive patients or patients who have received photosensitizing agents.
It may cause burns.
Do not use for neonatal transillumination.
It may cause burns.
WARNING
Observe tissue during use of this product.
Heat generated by light energy may cause thermal injury. If thermal injury occurs immediately
discontinue use and take appropriate measures.
Do not use at illumination level higher and at distance closer than necessary.
Heat generated by light energy may cause thermal injury (particularly with prolonged illumination
of a fixed location by multiple light sources, etc.)
6 7
Safety Precautions
Safety Precautions

■Standard Package
Main unit (Model - H)
Cord tie band
Cord clip (Small)
Cord clip (Large)
Antibacterial urethane pad (Front and back hub)
Battery unit
Dedicated AC adapter
Attached belt (M-L or LL)
Storage bag/Hard case (with calibration kit)
Instruction manual (This document)
1
1
2
2
Front hub: 2 sets, back hub: 2
2
1
1
1
1 copy
Description QuantityPart number
A standard package of this product includes the following items.
Please inquire the place of purchase regarding purchases of any additional accessories.
Composition
3
HTH
CBX
CCS
CCL
UPX
BAN
ACX
BLM / BLL
BGX / HCX
OP_P_02US(02)
■Labels Attached to the Product
Mainunit
DedicatedACadapter
Batteryunit
(01)
XXXXXXXXXXXXXXX
XXXXXX
XXXX-XX-XX
(11)
XXXXXX
(21)
XXXXXX
SN
SAMPLE
2
XXXX-XX-XX
XXXXXX-X
(01)XXXXXXXXXXXXXX
(11)XXXXXX(21)XXXXXX-X
SAMPLE
E300019
ANSI/AAMI ES60601-1
CSA-C22.2No.60601-1
Wearable Surgical
Lighting System
OPELAIII Model -H
TAIYO CORPORATION
Symbol Description Symbol Description
Caution
Class II equipment
For indoor use only
Temperature limit
Humidity limitation
Atmospheric pressure
limitation
Direct current
Manufacturer
Alternating current
Refer to instruction
manual/booklet
Caution: Federal law restricts
this product to sale by or on
the order of a physician
Polarity of d.c. power
connector
Serial number
Date of manufacture
■Symbols on Labels
Consult instructions for
use or consult electronic
instructions for use
■Accessories (sold separately)
Cord clip (Small)
Cord clip (Large)
Battery unit
Dedicated AC adapter
Antibacterial urethane pad (Front and back hub)
Attached belt (M-L)
Attached belt (LL)
Storage bag
Hard case
Calibration kit
9
4
1
1
10 set
1
1
1
1
1
Description Order UnitPart number
(Front hub: 10 sets, back hub: 10)
CCS
CCL
BAN
ACX
UPX
BLM
BLL
BGX
HCX
CKX
8
9
Composition
Safety Precautions

■Standard Package
Main unit (Model - H)
Cord tie band
Cord clip (Small)
Cord clip (Large)
Antibacterial urethane pad (Front and back hub)
Battery unit
Dedicated AC adapter
Attached belt (M-L or LL)
Storage bag/Hard case (with calibration kit)
Instruction manual (This document)
1
1
2
2
Front hub: 2 sets, back hub: 2
2
1
1
1
1 copy
Description QuantityPart number
A standard package of this product includes the following items.
Please inquire the place of purchase regarding purchases of any additional accessories.
Composition
3
HTH
CBX
CCS
CCL
UPX
BAN
ACX
BLM / BLL
BGX / HCX
OP_P_02US(02)
■Labels Attached to the Product
Mainunit
DedicatedACadapter
Batteryunit
(01)
XXXXXXXXXXXXXXX
XXXXXX
XXXX-XX-XX
(11)
XXXXXX
(21)
XXXXXX
SN
SAMPLE
2
XXXX-XX-XX
XXXXXX-X
(01)XXXXXXXXXXXXXX
(11)XXXXXX(21)XXXXXX-X
SAMPLE
E300019
ANSI/AAMI ES60601-1
CSA-C22.2No.60601-1
Wearable Surgical
Lighting System
OPELAIII Model -H
TAIYO CORPORATION
Symbol Description Symbol Description
Caution
Class II equipment
For indoor use only
Temperature limit
Humidity limitation
Atmospheric pressure
limitation
Direct current
Manufacturer
Alternating current
Refer to instruction
manual/booklet
Caution: Federal law restricts
this product to sale by or on
the order of a physician
Polarity of d.c. power
connector
Serial number
Date of manufacture
■Symbols on Labels
Consult instructions for
use or consult electronic
instructions for use
■Accessories (sold separately)
Cord clip (Small)
Cord clip (Large)
Battery unit
Dedicated AC adapter
Antibacterial urethane pad (Front and back hub)
Attached belt (M-L)
Attached belt (LL)
Storage bag
Hard case
Calibration kit
9
4
1
1
10 set
1
1
1
1
1
Description Order UnitPart number
(Front hub: 10 sets, back hub: 10)
CCS
CCL
BAN
ACX
UPX
BLM
BLL
BGX
HCX
CKX
8
9
Composition
Safety Precautions
■Standard Package
Main unit (Model - H)
Cord tie band
Cord clip (Small)
Cord clip (Large)
Antibacterial urethane pad (Front and back hub)
Battery unit
Dedicated AC adapter
Attached belt (M-L or LL)
Storage bag/Hard case (with calibration kit)
Instruction manual (This document)
1
1
2
2
Front hub: 2 sets, back hub: 2
2
1
1
1
1 copy
Description QuantityPart number
A standard package of this product includes the following items.
Please inquire the place of purchase regarding purchases of any additional accessories.
Composition
3
HTH
CBX
CCS
CCL
UPX
BAN
ACX
BLM / BLL
BGX / HCX
OP_P_02US(02)
■Labels Attached to the Product
Mainunit
DedicatedACadapter
Batteryunit
(01)
XXXXXXXXXXXXXXX
XXXXXX
XXXX-XX-XX
(11)
XXXXXX
(21)
XXXXXX
SN
SAMPLE
2
XXXX-XX-XX
XXXXXX-X
(01)XXXXXXXXXXXXXX
(11)XXXXXX(21)XXXXXX-X
SAMPLE
E300019
ANSI/AAMI ES60601-1
CSA-C22.2No.60601-1
Wearable Surgical
Lighting System
OPELAIII Model -H
TAIYO CORPORATION
Symbol Description Symbol Description
Caution
Class II equipment
For indoor use only
Temperature limit
Humidity limitation
Atmospheric pressure
limitation
Direct current
Manufacturer
Alternating current
Refer to instruction
manual/booklet
Caution: Federal law restricts
this product to sale by or on
the order of a physician
Polarity of d.c. power
connector
Serial number
Date of manufacture
■Symbols on Labels
Consult instructions for
use or consult electronic
instructions for use
■Accessories (sold separately)
Cord clip (Small)
Cord clip (Large)
Battery unit
Dedicated AC adapter
Antibacterial urethane pad (Front and back hub)
Attached belt (M-L)
Attached belt (LL)
Storage bag
Hard case
Calibration kit
9
4
1
1
10 set
1
1
1
1
1
Description Order UnitPart number
(Front hub: 10 sets, back hub: 10)
CCS
CCL
BAN
ACX
UPX
BLM
BLL
BGX
HCX
CKX
8 9
Composition
Safety Precautions

Part names
4
Back face
Cord clip
(Large)
Front hub
Size adjustment
knob
AC adapter
cord
Antibacterial
urethane pad
Antibacterial
urethane pad
Back hub
Front face
Main belt
Surface fastener
of the main unit
Assistive belt
DedicatedACadapter
AttachedBelt
Mainunit
Power plug
Power cord
Plug
Label
Light source
unit
Cord tie band
Heat sink
Cord clip
(Small)
Connection cord
How to use
5
Charging Wearing Lighting AfterUseCheck 1Check 2
■Battery Unit: Safety Precautions
Charge in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause leakage, heat generation, or ignition.
Charge in locations according to the Environmental Specifications (Refer to 8. Specifications).
Charging in locations with high temperature and high humidity may cause electric shock, leakage, heat generation, or ignition.
Do not plug and unplug the power plug with wet hands.
It may cause electric shock.
When unplugging the power plug, be sure to hold the power plug, not the power cord.
It may damage the power cord or cause electric shock or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water and
seek medical attention.
It may cause blindness.
Use the dedicated AC adapter when charging.
Using products other than the dedicated AC adapter may cause electric shock, heat generation, leakage, or rupture.
When charging is complete, immediately disconnect the dedicated AC adapter from the battery unit.
Continuing to charge may cause leakage, rupture, ignition, or shorter battery life due to overcharging.
Do not use the main unit while charging.
You may trip on the cord and fall, or the product may drop.
When charging, connect the power plug to an outlet that is easy to reach.
Being unable to unplug the power plug immediately during an emergency may cause an accident.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
Be sure to charge if it is being used for the first time or if it has not been used
for a long time (3 months or longer).
Charging may stop before it is fully charged when it is being charged for the first time in a long time
(3 months or longer). In such cases, repeatedly charge and discharge several times before use.
BatteryUnit
CAUTION
WARNING
NOTICE
Illumination range
adjustment lever
Mirror
Transparent
cover
Illumination
position
adjustment lever
OUTPUT jack
Power lamp
Dimmer knob
Belt clip
Charge lamp
INPUT
jack
Label
Label
Label
10
11
How to use
Part names

Part names
4
Back face
Cord clip
(Large)
Front hub
Size adjustment
knob
AC adapter
cord
Antibacterial
urethane pad
Antibacterial
urethane pad
Back hub
Front face
Main belt
Surface fastener
of the main unit
Assistive belt
DedicatedACadapter
AttachedBelt
Mainunit
Power plug
Power cord
Plug
Label
Light source
unit
Cord tie band
Heat sink
Cord clip
(Small)
Connection cord
How to use
5
Charging Wearing Lighting AfterUseCheck 1Check 2
■Battery Unit: Safety Precautions
Charge in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause leakage, heat generation, or ignition.
Charge in locations according to the Environmental Specifications (Refer to 8. Specifications).
Charging in locations with high temperature and high humidity may cause electric shock, leakage, heat generation, or ignition.
Do not plug and unplug the power plug with wet hands.
It may cause electric shock.
When unplugging the power plug, be sure to hold the power plug, not the power cord.
It may damage the power cord or cause electric shock or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water and
seek medical attention.
It may cause blindness.
Use the dedicated AC adapter when charging.
Using products other than the dedicated AC adapter may cause electric shock, heat generation, leakage, or rupture.
When charging is complete, immediately disconnect the dedicated AC adapter from the battery unit.
Continuing to charge may cause leakage, rupture, ignition, or shorter battery life due to overcharging.
Do not use the main unit while charging.
You may trip on the cord and fall, or the product may drop.
When charging, connect the power plug to an outlet that is easy to reach.
Being unable to unplug the power plug immediately during an emergency may cause an accident.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
Be sure to charge if it is being used for the first time or if it has not been used
for a long time (3 months or longer).
Charging may stop before it is fully charged when it is being charged for the first time in a long time
(3 months or longer). In such cases, repeatedly charge and discharge several times before use.
BatteryUnit
CAUTION
WARNING
NOTICE
Illumination range
adjustment lever
Mirror
Transparent
cover
Illumination
position
adjustment lever
OUTPUT jack
Power lamp
Dimmer knob
Belt clip
Charge lamp
INPUT
jack
Label
Label
Label
10
11
How to use
Part names
Part names
4
Back face
Cord clip
(Large)
Front hub
Size adjustment
knob
AC adapter
cord
Antibacterial
urethane pad
Antibacterial
urethane pad
Back hub
Front face
Main belt
Surface fastener
of the main unit
Assistive belt
DedicatedACadapter
AttachedBelt
Mainunit
Power plug
Power cord
Plug
Label
Light source
unit
Cord tie band
Heat sink
Cord clip
(Small)
Connection cord
How to use
5
Charging Wearing Lighting AfterUseCheck 1Check 2
■Battery Unit: Safety Precautions
Charge in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause leakage, heat generation, or ignition.
Charge in locations according to the Environmental Specifications (Refer to 8. Specifications).
Charging in locations with high temperature and high humidity may cause electric shock, leakage, heat generation, or ignition.
Do not plug and unplug the power plug with wet hands.
It may cause electric shock.
When unplugging the power plug, be sure to hold the power plug, not the power cord.
It may damage the power cord or cause electric shock or ignition.
If fluid in the battery unit gets into your eyes, immediately flush with water and
seek medical attention.
It may cause blindness.
Use the dedicated AC adapter when charging.
Using products other than the dedicated AC adapter may cause electric shock, heat generation, leakage, or rupture.
When charging is complete, immediately disconnect the dedicated AC adapter from the battery unit.
Continuing to charge may cause leakage, rupture, ignition, or shorter battery life due to overcharging.
Do not use the main unit while charging.
You may trip on the cord and fall, or the product may drop.
When charging, connect the power plug to an outlet that is easy to reach.
Being unable to unplug the power plug immediately during an emergency may cause an accident.
If fluid in the battery unit gets on your skin or clothes, immediately flush with water.
It may cause burns.
Be sure to charge if it is being used for the first time or if it has not been used
for a long time (3 months or longer).
Charging may stop before it is fully charged when it is being charged for the first time in a long time
(3 months or longer). In such cases, repeatedly charge and discharge several times before use.
BatteryUnit
CAUTION
WARNING
NOTICE
Illumination range
adjustment lever
Mirror
Transparent
cover
Illumination
position
adjustment lever
OUTPUT jack
Power lamp
Dimmer knob
Belt clip
Charge lamp
INPUT
jack
Label
Label
Label
10 11
How to use
Part names

Charging Wearing Lighting AfterUseCheck 1Check 2
1.Turn the dimming knob clockwise to switch it on. If the charge lamp is illuminated
orange, the battery needs to be charged.
2.Turn the dimming knob counter-clockwise to turn it off, and connect the dedicated AC
adapter and battery unit (INPUT jack).
3.The charge lamp will turn orange when you insert the power plug into an outlet, and
then the charging will start.
4.Immediately disconnect the dedicated AC adapter from the outlet and battery unit once
charging is complete.
Charging the Battery Unit
5-1
Charging Wearing Lighting AfterUseCheck 1Check 2
AC adapter cord
Charge lamp
Orange Charging
Orange
Insufciently charged
Off Charged
Charge lamp Status
*When the charge lamp illuminates in orange (insufcient charge) during use, replace the battery unit.
Check 1
5-2
Check that all 3 LED lights illuminate.
Product safety may be affected if only 2 or fewer LEDs illuminate or if they flicker.
Discontinue use and contact the distributor.
<How to check>
Move the Illumination Field Diameter adjustment lever all the way to the right, turn the
dimming knob of the battery unit clockwise to turn it on, and place the palm of your hand
near the light source to check for 3 light sources.
All 3 illuminate
Dimming knob
INPUT jack
Illumination range
adjustment lever (right end)
12
13
How to use
How to use

Charging Wearing Lighting AfterUseCheck 1Check 2
1.Turn the dimming knob clockwise to switch it on. If the charge lamp is illuminated
orange, the battery needs to be charged.
2.Turn the dimming knob counter-clockwise to turn it off, and connect the dedicated AC
adapter and battery unit (INPUT jack).
3.The charge lamp will turn orange when you insert the power plug into an outlet, and
then the charging will start.
4.Immediately disconnect the dedicated AC adapter from the outlet and battery unit once
charging is complete.
Charging the Battery Unit
5-1
Charging Wearing Lighting AfterUseCheck 1Check 2
AC adapter cord
Charge lamp
Orange Charging
Orange
Insufciently charged
Off Charged
Charge lamp Status
*When the charge lamp illuminates in orange (insufcient charge) during use, replace the battery unit.
Check 1
5-2
Check that all 3 LED lights illuminate.
Product safety may be affected if only 2 or fewer LEDs illuminate or if they flicker.
Discontinue use and contact the distributor.
<How to check>
Move the Illumination Field Diameter adjustment lever all the way to the right, turn the
dimming knob of the battery unit clockwise to turn it on, and place the palm of your hand
near the light source to check for 3 light sources.
All 3 illuminate
Dimming knob
INPUT jack
Illumination range
adjustment lever (right end)
12
13
How to use
How to use
Charging Wearing Lighting AfterUseCheck 1Check 2
1.Turn the dimming knob clockwise to switch it on. If the charge lamp is illuminated
orange, the battery needs to be charged.
2.Turn the dimming knob counter-clockwise to turn it off, and connect the dedicated AC
adapter and battery unit (INPUT jack).
3.The charge lamp will turn orange when you insert the power plug into an outlet, and
then the charging will start.
4.Immediately disconnect the dedicated AC adapter from the outlet and battery unit once
charging is complete.
Charging the Battery Unit
5-1
Charging Wearing Lighting AfterUseCheck 1Check 2
AC adapter cord
Charge lamp
Orange Charging
Orange
Insufciently charged
Off Charged
Charge lamp Status
*When the charge lamp illuminates in orange (insufcient charge) during use, replace the battery unit.
Check 1
5-2
Check that all 3 LED lights illuminate.
Product safety may be affected if only 2 or fewer LEDs illuminate or if they flicker.
Discontinue use and contact the distributor.
<How to check>
Move the Illumination Field Diameter adjustment lever all the way to the right, turn the
dimming knob of the battery unit clockwise to turn it on, and place the palm of your hand
near the light source to check for 3 light sources.
All 3 illuminate
Dimming knob
INPUT jack
Illumination range
adjustment lever (right end)
12 13
How to use
How to use

1.Remove the assistive belt and pull the main belt sideways from both directions.
2.
Place the attached belt on your pelvis.
*Wear the attached belt underneath
your surgery gown.
*Wear the attached belt around your
pelvis, not your waist.
3.Wrap the attached belt around your pelvis.
4.Hold the assistive belt at the back. 6.Fasten the assistive belt.
5.Pull the assistive belt. 7.Insert the belt clip of the battery
unit deeply and tightly on the
backside of the main belt.
Fasten the belt.
Charging Wearing Lighting AfterUseCheck 1Check 2
Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Attached belt, battery unit)
5-3
Do not use with other belts.
Do not use with other belts. This may cause the attached belt to loosen and the battery
unit to fall. (Be sure to use the attached belt of this product.)
Wear the attached belt for a couple of hours before use.
Wear it for a couple of hours at first to check that there is no discomfort or itchiness.
You can use it all day once it fits comfortably.
Wrap the attached belt around your pelvis so that it does not loosen.
The battery unit may fall if the attached belt loosens or moves around.
Make sure to put on the attached belt by following the steps in the correct order.
CAUTION
Until the assistive belt
reaches this position
Sliding apart
5 cm (2 inch) below
your pelvic bone
14
15
How to use
How to use

1.Remove the assistive belt and pull the main belt sideways from both directions.
2.
Place the attached belt on your pelvis.
*Wear the attached belt underneath
your surgery gown.
*Wear the attached belt around your
pelvis, not your waist.
3.Wrap the attached belt around your pelvis.
4.Hold the assistive belt at the back. 6.Fasten the assistive belt.
5.Pull the assistive belt. 7.Insert the belt clip of the battery
unit deeply and tightly on the
backside of the main belt.
Fasten the belt.
Charging Wearing Lighting AfterUseCheck 1Check 2 Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Attached belt, battery unit)
5-3
Do not use with other belts.
Do not use with other belts. This may cause the attached belt to loosen and the battery
unit to fall. (Be sure to use the attached belt of this product.)
Wear the attached belt for a couple of hours before use.
Wear it for a couple of hours at first to check that there is no discomfort or itchiness.
You can use it all day once it fits comfortably.
Wrap the attached belt around your pelvis so that it does not loosen.
The battery unit may fall if the attached belt loosens or moves around.
Make sure to put on the attached belt by following the steps in the correct order.
CAUTION
Until the assistive belt
reaches this position
Sliding apart
5 cm (2 inch) below
your pelvic bone
14 15
How to use
How to use
1.Remove the assistive belt and pull the main belt sideways from both directions.
2.
Place the attached belt on your pelvis.
*Wear the attached belt underneath
your surgery gown.
*Wear the attached belt around your
pelvis, not your waist.
3.Wrap the attached belt around your pelvis.
4.Hold the assistive belt at the back. 6.Fasten the assistive belt.
5.Pull the assistive belt. 7.Insert the belt clip of the battery
unit deeply and tightly on the
backside of the main belt.
Fasten the belt.
Charging Wearing Lighting AfterUseCheck 1Check 2
Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Attached belt, battery unit)
5-3
Do not use with other belts.
Do not use with other belts. This may cause the attached belt to loosen and the battery
unit to fall. (Be sure to use the attached belt of this product.)
Wear the attached belt for a couple of hours before use.
Wear it for a couple of hours at first to check that there is no discomfort or itchiness.
You can use it all day once it fits comfortably.
Wrap the attached belt around your pelvis so that it does not loosen.
The battery unit may fall if the attached belt loosens or moves around.
Make sure to put on the attached belt by following the steps in the correct order.
CAUTION
Until the assistive belt
reaches this position
Sliding apart
5 cm (2 inch) below
your pelvic bone
14
15
How to use
How to use

1.
Replacing the antibacterial urethane pad
Replace the antibacterial urethane pad with a
new one if sweat or stains bother you.
2.Turn the size adjustment knob
counter-clockwise to make the size
bigger.
3.
Set the connection cord along the cord clip,
and hold the main unit with both hands.
4.Place your forehead against the
front hub.
5.Lift your head with the front hub
kept attached to your forehead.
6.Turn the size adjustment knob to
lock the main unit into position.
7.Tie the connection cord of the main
unit with a tie band, and connect the
main unit to the battery unit (OUTPUT
jack) with the connection cord.
8.Put on your surgery gown. Flip your
gown when controlling the battery
unit.
Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Main unit)
5-4
OUTPUT jack
Connection
cord
Charging Wearing Lighting AfterUseCheck 1Check 2
Check 2
5-5
Nearly horizontal Tilted
Put the product on yourself in front of a
mirror before washing your hands.
It may fall off if others put the product on for you
as it tends to become loose or tilt. Be sure to
put it on yourself in front of a mirror before
washing your hands, to ensure it is worn in the
correct position.
Check that it is worn in the correct position with no loose points.
Wear the product in the correct position as shown below so that it does not move. A loose t
may result in the device falling.
If the device cannot be worn in the correct position, discontinue use and contact the location
of purchase, as it may have a distortion or defect.
*Tie your hair below the main unit.
Wear it deeply, up to slightly above your eyebrows.
Cord tie band
If the heat sink touches your head, calibrate the height of the heat sink with the calibration kit.
(Refer to 5-8. Maintenance
【Calibrating the heat sink height】)
Example of
front hub:Leave a gap
and attach
Do not adjust the position of the heat sink with your hands.
It may damage the heat sink. Make sure to use the calibration kit.
NOTICE
CAUTION
Correct Incorrect
Cord clip
(Large)
Cord clip
(Small)
16
17
How to use
How to use

1.
Replacing the antibacterial urethane pad
Replace the antibacterial urethane pad with a
new one if sweat or stains bother you.
2.Turn the size adjustment knob
counter-clockwise to make the size
bigger.
3.
Set the connection cord along the cord clip,
and hold the main unit with both hands.
4.Place your forehead against the
front hub.
5.Lift your head with the front hub
kept attached to your forehead.
6.Turn the size adjustment knob to
lock the main unit into position.
7.Tie the connection cord of the main
unit with a tie band, and connect the
main unit to the battery unit (OUTPUT
jack) with the connection cord.
8.Put on your surgery gown. Flip your
gown when controlling the battery
unit.
Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Main unit)
5-4
OUTPUT jack
Connection
cord
Charging Wearing Lighting AfterUseCheck 1Check 2
Check 2
5-5
Nearly horizontal Tilted
Put the product on yourself in front of a
mirror before washing your hands.
It may fall off if others put the product on for you
as it tends to become loose or tilt. Be sure to
put it on yourself in front of a mirror before
washing your hands, to ensure it is worn in the
correct position.
Check that it is worn in the correct position with no loose points.
Wear the product in the correct position as shown below so that it does not move. A loose t
may result in the device falling.
If the device cannot be worn in the correct position, discontinue use and contact the location
of purchase, as it may have a distortion or defect.
*Tie your hair below the main unit.
Wear it deeply, up to slightly above your eyebrows.
Cord tie band
If the heat sink touches your head, calibrate the height of the heat sink with the calibration kit.
(Refer to 5-8. Maintenance
【Calibrating the heat sink height】)
Example of
front hub:Leave a gap
and attach
Do not adjust the position of the heat sink with your hands.
It may damage the heat sink. Make sure to use the calibration kit.
NOTICE
CAUTION
Correct Incorrect
Cord clip
(Large)
Cord clip
(Small)
16 17
How to use
How to use
1.
Replacing the antibacterial urethane pad
Replace the antibacterial urethane pad with a
new one if sweat or stains bother you.
2.Turn the size adjustment knob
counter-clockwise to make the size
bigger.
3.
Set the connection cord along the cord clip,
and hold the main unit with both hands.
4.Place your forehead against the
front hub.
5.Lift your head with the front hub
kept attached to your forehead.
6.Turn the size adjustment knob to
lock the main unit into position.
7.Tie the connection cord of the main
unit with a tie band, and connect the
main unit to the battery unit (OUTPUT
jack) with the connection cord.
8.Put on your surgery gown. Flip your
gown when controlling the battery
unit.
Charging Wearing Lighting AfterUseCheck 1Check 2
Wearing (Main unit)
5-4
OUTPUT jack
Connection
cord
Charging Wearing Lighting AfterUseCheck 1Check 2
Check 2
5-5
Nearly horizontal Tilted
Put the product on yourself in front of a
mirror before washing your hands.
It may fall off if others put the product on for you
as it tends to become loose or tilt. Be sure to
put it on yourself in front of a mirror before
washing your hands, to ensure it is worn in the
correct position.
Check that it is worn in the correct position with no loose points.
Wear the product in the correct position as shown below so that it does not move. A loose t
may result in the device falling.
If the device cannot be worn in the correct position, discontinue use and contact the location
of purchase, as it may have a distortion or defect.
*Tie your hair below the main unit.
Wear it deeply, up to slightly above your eyebrows.
Cord tie band
If the heat sink touches your head, calibrate the height of the heat sink with the calibration kit.
(Refer to 5-8. Maintenance
【Calibrating the heat sink height】)
Example of
front hub:Leave a gap
and attach
Do not adjust the position of the heat sink with your hands.
It may damage the heat sink. Make sure to use the calibration kit.
NOTICE
CAUTION
Correct Incorrect
Cord clip
(Large)
Cord clip
(Small)
16
17
How to use
How to use

1.Turn the dimming knob clockwise to turn it on and adjust the brightness.
2.Adjust the light source position and range according to the operative eld you want
to illuminate.
3. Turn the dimming knob counter-clockwise after use to turn it off, then remove the
connection cord of the main unit from the battery unit.
The optimal illumination position depends on the operation.
Adjust the light source position according to the operative eld you want to illuminate.
Charging Wearing Lighting AfterUseCheck 1Check 2
Charging Wearing Lighting AfterUseCheck 1Check 2
How to Adjust Lighting
5-6
Illumination range adjustment lever
<Movetotheleft>
Increases
illumination range
<Movetotheright>
Decreases
illumination range
Illuminationrangeadjustment
Dimming knob
Power lamp
Green: ON
Off : OFF
Dark Bright
Illumination position
adjustment lever
<Slideup>
Light source position
moves to the back
Back side Front side
Illuminationpositionadjustment
【Case of illuminating
in vertical direction】
Major abdominal surgeries
(heart, lung, kidney, liver, etc.)
【Case of illuminating
in the horizontal direction】
Surgeries in which the operative field is
near the level of the eye of the operator
(anus, vaginal opening, etc.)
The illumination position will no longer be aligned if your posture or
operative field changes during surgery. Change the angle of your head
according to the operative field or re-adjust the illumination position.
*
Adjust use in consideration of the required surgery time.
If necessary, prepare spare batteries.
・
Dimmer Knob MAX (Dimming Level 100%)
:
Approx. 2.5 Hours
・
Dimmer Knob # 7 (Dimming Level 70%): Approx. 3.5 Hours
・
Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours
【Continuous Lighting Hours】
1 2 3 4 5 6 7 8
MAX
<Slidedown>
Light source position
moves to the front
18
19
How to use
How to use

1.Turn the dimming knob clockwise to turn it on and adjust the brightness.
2.Adjust the light source position and range according to the operative eld you want
to illuminate.
3. Turn the dimming knob counter-clockwise after use to turn it off, then remove the
connection cord of the main unit from the battery unit.
The optimal illumination position depends on the operation.
Adjust the light source position according to the operative eld you want to illuminate.
Charging Wearing Lighting AfterUseCheck 1Check 2 Charging Wearing Lighting AfterUseCheck 1Check 2
How to Adjust Lighting
5-6
Illumination range adjustment lever
<Movetotheleft>
Increases
illumination range
<Movetotheright>
Decreases
illumination range
Illuminationrangeadjustment
Dimming knob
Power lamp
Green: ON
Off : OFF
Dark Bright
Illumination position
adjustment lever
<Slideup>
Light source position
moves to the back
Back side Front side
Illuminationpositionadjustment
【Case of illuminating
in vertical direction】
Major abdominal surgeries
(heart, lung, kidney, liver, etc.)
【Case of illuminating
in the horizontal direction】
Surgeries in which the operative field is
near the level of the eye of the operator
(anus, vaginal opening, etc.)
The illumination position will no longer be aligned if your posture or
operative field changes during surgery. Change the angle of your head
according to the operative field or re-adjust the illumination position.
*
Adjust use in consideration of the required surgery time.
If necessary, prepare spare batteries.
・
Dimmer Knob MAX (Dimming Level 100%)
:
Approx. 2.5 Hours
・
Dimmer Knob # 7 (Dimming Level 70%): Approx. 3.5 Hours
・
Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours
【Continuous Lighting Hours】
1 2 3 4 5 6 7 8
MAX
<Slidedown>
Light source position
moves to the front
18 19
How to use
How to use
1.Turn the dimming knob clockwise to turn it on and adjust the brightness.
2.Adjust the light source position and range according to the operative eld you want
to illuminate.
3. Turn the dimming knob counter-clockwise after use to turn it off, then remove the
connection cord of the main unit from the battery unit.
The optimal illumination position depends on the operation.
Adjust the light source position according to the operative eld you want to illuminate.
Charging Wearing Lighting AfterUseCheck 1Check 2
Charging Wearing Lighting AfterUseCheck 1Check 2
How to Adjust Lighting
5-6
Illumination range adjustment lever
<Movetotheleft>
Increases
illumination range
<Movetotheright>
Decreases
illumination range
Illuminationrangeadjustment
Dimming knob
Power lamp
Green: ON
Off : OFF
Dark Bright
Illumination position
adjustment lever
<Slideup>
Light source position
moves to the back
Back side Front side
Illuminationpositionadjustment
【Case of illuminating
in vertical direction】
Major abdominal surgeries
(heart, lung, kidney, liver, etc.)
【Case of illuminating
in the horizontal direction】
Surgeries in which the operative field is
near the level of the eye of the operator
(anus, vaginal opening, etc.)
The illumination position will no longer be aligned if your posture or
operative field changes during surgery. Change the angle of your head
according to the operative field or re-adjust the illumination position.
*
Adjust use in consideration of the required surgery time.
If necessary, prepare spare batteries.
・
Dimmer Knob MAX (Dimming Level 100%)
:
Approx. 2.5 Hours
・
Dimmer Knob # 7 (Dimming Level 70%): Approx. 3.5 Hours
・
Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours
【Continuous Lighting Hours】
1 2 3 4 5 6 7 8
MAX
<Slidedown>
Light source position
moves to the front
18
19
How to use
How to use

1.
Check that the calibration kit is firmly
pushed to the bottom of the storage bag.
3.
Place the battery unit in the front
pocket of the storage bag, and firmly
close the lid of the pocket.
2.
Place
the main unit on the calibration kit,
and firmly close the lid of the storage bag.
*Match the orientation of the main unit with that in
the illustration affixed to the calibration kit.
*Match the orientation of the main unit with that in the illustration affixed to the calibration kit.
*Do not place the dedicated AC adapter on the main unit.
*Do not place the battery unit on the main
unit. The heat sink may get damaged and
cause malfunction.
*Wrap the battery unit with buffer material.
*Store the dedicated AC adapter in the side
pocket of the storage bag.
Storage
5-7
Charging Wearing Lighting AfterUseCheck 1Check 2
Store in locations according to the Environmental Specifications (refer to 8. Specifications).
Storing in locations with high temperature and high humidity may cause electric shock, leakage,
heat generation, or ignition.
Storing in locations with high temperature and high humidity may cause electric shock, battery
leakage, heat generation, or ignition. It may also reduce the battery capacity and charging efficiency.
Store in locations away from direct sunlight.
The temperature will increase due to direct sunlight, and may cause leakage,
heat generation, or ignition.
Always use the storage bag/hard case when storing or carrying.
Leaving the product out or carrying it without putting it in the storage bag/hard case
may cause failure or damage. Also, if the heat sink is bent or warped, you may be
unable to wear the product, or the light source unit may get hot and malfunction.
Do not store with the connection cord still connected to the battery unit.
It may cause failure.
Do not store in locations with corrosive gas or liquid.
It may cause battery leakage, heat generation, rupture, ignition, or failure.
Check that the light source unit has cooled down to normal
temperature before placing it into the storage bag/hard case.
Putting the light source unit in the bag while it is warm, it may cause a malfunction.
Do not drop the storage bag/hard case.
It may cause failure, damage or injury.
Do not wet the storage bag/hard case.
It may cause failure, damage or injury.
CAUTION
NOTICE
【Hard case】
【Storage bag】
1.
Push the square buttons and pull the
latches, then open the lid of the hard case.
2.Check that the calibration kit is rmly
pushed to the bottom of the hard case.
3.
Place the main unit on the calibration
kit and other
components to the
correct location and orientation as
shown in the picture.
4.Close the lid and push the latches
rmly.
Hard case
Latches
Battery unit
Dedicated AC adapter
Attached beltMain unit on the
calibration kit
20
21
Storage
Storage
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