MD7-EUenAB-2110(8)
Page 1/11
2021-10-11 Rev. 8
MD7-EUenAB-2110(8)
Page 2/11
2021-10-11 Rev. 8
koplight
™
Cordless Lighted Retractor
Instructions for Use
Contents
Intended use ............................................................................................................................... 1
Contraindications ........................................................................................................................ 1
Name of parts ............................................................................................................................. 2
Warnings and precautions .......................................................................................................... 2
Warnings
Precautions
Precautions for batteries
Assembling and how to use ........................................................................................................ 3
Assembling
How to use
Cleaning and disinfection ............................................................................................................ 4
Precautions for cleaning and disinfection
Initial treatment at point of use
Preparation before cleaning
Recommended procedure for cleaning and disinfection
Inspection and maintenance ....................................................................................................... 5
Inspection
Maintenance
Packaging ................................................................................................................................... 5
Sterilization ................................................................................................................................. 5
Precautions for sterilization
Recommended sterilization
Storage ....................................................................................................................................... 6
Disposal ...................................................................................................................................... 6
Limitation of liability/Incident reporting ........................................................................................ 6
Troubleshooting .......................................................................................................................... 7
Appendices ................................................................................................................................. 7
Specifications
Retail packaging
Safety classifications
Precautions for interference with other equipment
Electromagnetic Compatibility (EMC)
References
Symbols used
Read these instructions carefully before use.
Intended use
Intended uses of this product are to provide 1) access to the operative field by retracting the incisions and/or wounds
with the blade, and 2) auxiliary illumination to the operative field with LED lighting. This product is a combination of two
medical devices for convenience in clinical use.
Contraindications
There are no known contraindications.
Name of parts
“Blade”
“Light handle”
and accessories
(disassembly)
Lens (LED)
LED switch button
Head
Battery
compartment
“O-ring”
“Battery inserter”
Blade handle
(fig.1)
(fig. 2)
• Product name:
• Product name:
Tail cap
koplight blade
koplight HT blade
“Finger hook”
(fig. 3)
(fig. 4)
(fig. 5)
(fig. 6)
• Product name: koplight light handle
• Accessories:
koplight light handle finger hook –
“Finger hook”
koplight light handle O-ring –
“O-ring”
koplight battery inserter –
“Battery inserter”
Warnings and precautions
Warnings
•
This product is not sterile. Cleaning and sterilization must be performed before each use.
•
Do not use the device more than the maximum number of uses. Doing so can cause injuries:
Product
Maximum number of uses Details
Blade
Two (2) times
Material degrades after the third time. Maintain a usage record.
Light handle and
accessories
Not defined
Stop use when there is a malfunction and/or damage. Refer to
“Inspection and maintenance.”
•
Do not reuse the device if it is used in a patient with Creutzfeldt-Jakob disease or related diseases.
•
Remove the batteries before sterilization to avoid battery explosion.
•
Do not point the LED light directly at eyes.
•
Do not use the device in combination with blades, light handles, or accessories from other manufacturers.
•
Do not modify or disassemble the device, unless specified in these Instructions for Use.
Precautions
•
Handle the device with care to avoid malfunction of the light handle and injuries during use:
o
Do not throw, bend, or place heavy items on the device.
o
Reprocess the device if it has been dropped on the floor.
o
Do not use the blade if there is any deformation, cracks, or major scratches.
•
The blade is made of durable material and unlikely to break under normal circumstances. However, in the rare event
of blade breakage, carefully collect the pieces fallen into the patient’s body.
•
Do not use the light handle in an oxygen rich environment. Doing so can cause fire.
•
Avoid direct contact of the light handle with the patient because there is risk of electric shock. It is recommended that
you spread an insulation sheet over the patient’s body.
•
Device temperature may reach 55 °C when the LED light is continuously used. It is recommended that you turn the
Note:
•
O-ring does not have to be removed from the light
handle unless damaged.
•
Light handle’s head should not be disassembled.
