MD7-EUenAB-2110(8)
Page 5/11
2021-10-11 Rev. 8
MD7-EUenAB-2110(8)
Page 6/11
2021-10-11 Rev. 8
7. Rinse
3 minutes
Purified water
Cold
N/A
8. Thermal disinfection
b)
2.5 minutes
Purified water
93 °C
N/A
9. Dry
Until
thoroughly dry
N/A
Minimum
100 °C
N/A
a) Washer-disinfector should be compliant with EN ISO 15883 series.
b) Disinfection process may be required depending on the guidelines of your country. This product is compatible with
thermal disinfection at temperatures between 80 °C to 93 °C.
Inspection and maintenance
Inspection
Inspect the items below before each use. Do not use the device if any problems are found.
•
No damage or deformation
•
No dirt, foreign object, and/or peel-offs on surface
•
No cracks or major scratches on blade
•
No cracks on lens
•
Light handle’s head (LED side) does not rotate
•
Tail cap can be firmly tightened
•
LED switch button is not broken and LED works
Maintenance
•
Wipe the metal wear debris off when it is found around the tail cap’s screw thread. It is
recommended that you apply lubricant:
1. Remove tail cap.
2. Apply suitable amount of medical lubricant to a cloth.
3. Hold light handle and point the battery compartment hole downward.
4. Wipe screw thread with the cloth, paying attention that the lubricant does not enter the
battery compartment.
Note: Do not directly apply lubricant to the light handle.
•
Damaged O-ring should be replaced to keep the light handle waterproof:
1. Unfasten tail cap.
2. Remove damaged O-ring.
3. Set new O-ring in the right position (figure 12), paying attention not to scratch it.
4. Check that new O-ring is not distorted.
5. Attach finger hook (optional), and firmly tighten the tail cap.
(fig. 12)
Packaging
•
The device should be packaged in sterile packaging before sterilization. The
packaging material and procedure should be in accordance with EN ISO
11607-1 and EN ISO 11607-2.
•
Prepare light handle as follows before packaging. Noncompliance can lead to
battery explosion during sterilization and/or incomplete sterilization:
1. Check that there are no batteries in the battery compartment.
2. Firmly tighten the tail cap.
3. Loosen the tail cap by one (1) rotation (about 360°, figure 13).
Note: Do not completely separate the tail cap during sterilization unless you
use ethylene oxide gas sterilization. Doing so can cause malfunction.
Sterilization
Precautions for sterilization
•
There will be malfunctions and/or material degradation when the device is sterilized by any methods other than the
recommended methods.
•
Do not change the sterilization method during the product lifetime.
Recommended sterilization
•
Applicable sterilization methods
Product
Steam
Hydrogen peroxide
Ethylene oxide gas
Light handle
Not applicable
Applicable
Applicable
Blade, finger hook, and
battery inserter
Applicable
Applicable
Applicable
•
Steam sterilization parameters
Item
Recommended condition
Precautions
Cycle type
Pre-vacuum
•
Steam sterilization must not be applied to the light
handle.
•
Temperature must not exceed 121 °C.
Temperature
121 °C
Exposure time
30 minutes
•
Hydrogen peroxide sterilization parameters
Item
Recommended condition
Precautions
Temperature
47 °C to 55 °C
•
Repeated hydrogen peroxide sterilization may cause
early material degradation.
Exposure time
47 minutes
Note: The manufacturer used a sterilizer equivalent to STERRAD®100NX® in the validation.
•
Ethylene oxide gas sterilization parameters
Item
Recommended condition
Precautions
Temperature
50 °C to 60 °C
Relative humidity
≥
40%
Gas concentration
300 to 1100 mg/L
Exposure time
≥
4 hours
Aeration time
≥
8 hours
Storage
•
Check for the points below before storage:
o
Batteries are removed
o
Device is cleaned
o
Device is thoroughly dried, including battery
compartment
o
Tail cap is firmly tightened
•
Store the product under the conditions below:
o
Clean place at room temperature
o
No direct sunlight
o
Avoid ultraviolet light
o
Avoid high humidity
Disposal
Dispose of the product according to the institute procedures and any applicable laws, regulations, and rules of your
country.
Limitation of liability/Incident reporting
Yasui Co., Ltd. does not assume any liability when the product is misused and/or mishandled. Read these Instructions
for Use carefully before use and keep in an easily accessible place for later reference. Only professionally trained
healthcare personnel are allowed to use this product.
If a serious incident occurs in relation to this product, it should be reported to the manufacturer and/or distributor. In the
European Union, it should also be reported to the competent authority of the member state in which the user and/or
patient is located.
O-ring
With O-ring
O-ring
groove
Without O-ring
(fig. 13 – loosen 360°)
Tail cap LED switch button
