YASUI koplight KS-1 User manual

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:
oDo not throw, bend, or place heavy items on the device.
oReprocess the device if it has been dropped on the floor.
oDo 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.

MD7-EUenAB-2110(8) Page 3/11 2021-10-11 Rev. 8 MD7-EUenAB-2110(8) Page 4/11 2021-10-11 Rev. 8
LED off when the device is not used.
•LED switch button becomes hard when the temperature is between 0 °C to 15 °C. It is recommended that you use
the product in between 15 °C to 40 °C.
Precautions for batteries
•Two (2) × AAA batteries are required to make a light handle work. Provide the batteries separately because they are
not included in the retail packaging:
Battery type Precautions
Nickel-metal hydride (NiMH)
rechargeable
Recommended. Fully charge before each use.
Alkaline/manganese dry cell Battery run time will be shorter. Also, product life may be shortened.
Lithium dry cell
Lithium-ion rechargeable
Do not use to avoid battery leakage and/or overheating.
Note: Battery run time depends on the battery type, capacity, and environment of use.
•In order to avoid battery leakage, corrosion, and/or overheating:
oDo not mix old and new dry cell batteries, rechargeable batteries with different charge levels, batteries of different
capacities, types, and brands.
oObserve correct polarity. Insert the batteries positive terminal first.
oRemove batteries after use.
Assembling and how to use
Assembling
Use the battery inserter and ask for help from a circulating nurse
to assemble a sterile light handle. This is necessary because
the batteries and battery compartment are not sterile:
1. Unfasten tail cap.
2. Attach battery inserter to light handle
(figure 7).
3. Hold light handle and battery inserter,
and ask circulating nurse to insert two
(2) × AAA batteries, positive terminal
first (figure 8).
4. Remove battery inserter.
5. Attach finger hook (optional) to light
handle, and firmly tighten tail cap
(figure 9).
6. Insert the light handle’s head into the
blade handle, and fix by firmly
tightening the screw (figure 10).
Note: Check that the device is correctly
and firmly assembled before each use.
Make sure that the unsterile batteries will
not compromise the sterile field.
(fig. 7) (fig. 8) (fig. 9) (fig. 10)
How to use
Press the LED switch button to turn on the LED light and use the blade to retract the tissues. The LED light transmits
through the blade and illuminates the operative field.
Cleaning and disinfection
Precautions for cleaning and disinfection
•Wear personal protective equipment (PPE) during the procedure.
•Keep the battery compartment dry to prevent malfunction of the light handle (figure 11):
oKeep tail cap firmly tightened during the procedure.
oKeep tail cap firmly tightened when an air blower is used.
oKeep tail cap’s interior side dry also.
oThe tail cap can be removed to clean the interior side of the tail cap and battery
compartment hole. Use a slightly wet cloth to wipe the part. Keep battery
compartment dry after wiping.
•Handle the blade in the following ways to avoid material degradation and injuries during
use:
oDo not apply agents unapproved by the manufacturer, including alkaline or acidic
agents.
oDo not soak in alcoholic disinfectants.
oDo not use ultrasonic cleaning.
•Handle the light handle and accessories in the following ways to avoid damage to the
surface and/or malfunction:
oUse purified water for rinsing and thermal disinfection during the machine (automated) process.
oAlkaline and/or acidic agents may damage the surface. Choose appropriate detergent and/or disinfectant by
referring to detergent and/or disinfectant's instructions for use. Refer to "Specifications" for material information of
koplight.
oDo not use polishing powder and/or metallic scrubbing brushes.
oDo not soak in alcoholic disinfectants and/or saline solution.
oDo not use ultrasonic cleaning.
Initial treatment at point of use
•Press LED switch button to turn off LED light after use.
•Remove excess soil with a disposable wipe immediately after use.
•It is recommended that you perform the rest cleaning procedure immediately after use. If immediate cleaning is not
feasible, take measures to prevent the soil from being dried according to the institute procedures.
•Use suitable closed or covered containers to transport the device to the decontamination area.
Preparation before cleaning
Prepare device as follows before the main cleaning procedure:
1. Disassemble blade from light handle.
2. Unfasten tail cap.
3. Remove finger hook and batteries.
4. Tighten tail cap.
Recommended procedure for cleaning and disinfection
Step Time Water type Temperature Detergent
Manual pre-
cleaning
1. Soaking 5 minutes Utility water Cold N/A
2. Brush with soft brush
under running water
Until visibly
clean
Utility water Cold N/A
3. Rinse with running
water
Until visibly
clean
Utility water Cold N/A
Continue to machine (automated) cleaning
Machine
(automated)
cleaning
a)
4. Pre-wash 1 minute Utility water Cold N/A
5. Wash 5 minutes Utility water 45 °C Enzymatic
neutral detergent
6. Rinse 1 minute Purified water Cold N/A
Battery inserter
Finger hook
(optional)
Circulating
nurse
Scrub
nurse
2 × AAA
batteries
(fig. 11)

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:
oBatteries are removed
oDevice is cleaned
oDevice is thoroughly dried, including battery
compartment
oTail cap is firmly tightened
•
Store the product under the conditions below:
oClean place at room temperature
oNo direct sunlight
oAvoid ultraviolet light
oAvoid 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

MD7-EUenAB-2110(8) Page 7/11 2021-10-11 Rev. 8 MD7-EUenAB-2110(8) Page 8/11 2021-10-11 Rev. 8
Troubleshooting
Problem Possible cause Solution
LED does not illuminate LED switch button not pressed. Press LED switch button.
Wrong battery polarity. Check battery polarity and set correctly
(refer to “Assembly”).
Batteries have run out. Replace with charged or new batteries.
Tail cap not firmly tightened. Firmly tighten tail cap.
Serial number label in battery compartment
has peeled off and is blocking the battery
terminals.
Remove serial number label.
Water has entered the battery compartment
and caused a circuit malfunction.
Contact the distributor.
Cannot press the LED
switch button
Temperature too low. Warm the tail cap.
Flickering/weak light Tail cap not firmly tightened. Firmly tighten tail cap.
Batteries have run down. Replace with charged or new batteries.
Short battery run time Electrical contact failures. Clean electrical contacts of the light
handle, tail cap, and batteries using a dry
cloth or cotton swab.
Small battery capacity. Replace with larger-capacity batteries
(NiMH rechargeable batteries of ≥900
mAh capacity are recommended).
Product too hot Light handle may be damaged. Stop using the device immediately and
contact the distributor.
Contact your local distributor if the problem still exists after applying the solutions above. Repairs must be conducted by
the authorized persons of the manufacturer.
Appendices
Specifications
•
Product name: koplight blade
Model
code
Tip width
(mm)
Blade length
(mm)
Total length
(mm)
KS-1 10 30 139
KS-2 13 45 139
KS-3 18 45 139
KS-4 18 59 113
KS-5 25 84 113
Material: Polycarbonate
•
Product name: koplight HT blade
Model
code
Tip width
(mm)
Blade
length
(mm)
Total length
(mm)
KS-4H 18 61 122
KS-5H 25 86 122
KS-6H 25 111 122
Material: Polycarbonate
•Product name: koplight light handle
Model code KG-1
Material Body: Anodized aluminum
Lens: Polycarbonate
LED switch button: Fluorine resin
Battery 2 × AAA nickel-metal hydride (NiMH) rechargeable battery
Recommended battery Manufacturer: FDK CORPORATION
Model code: HR-4UTHC
Nominal voltage: 1.2 V
Battery capacity: 900 mAh
Rated input 2.4 V DC
LED Color temperature: 5,000 K
Note: There are slight variances in the color temperature and brightness of the LED.
Dimension Diameter: 15 mm (narrowest point) × Total length: 155 mm
Operating/storage
temperature
0 °C to 40 °C
Note: Recommended operating temperature range is 15 °C to 40 °C. Waterproof
performance degrades in between 0 °C to 15 °C due to hardened O-ring.
Recommended to store at room temperature.
Relative humidity 30% to 90%, non-condensing
Atmospheric pressure 70 kPa to 106 kPa
Storage/Transfer
condition
Remove batteries
•Accessories
Product name Model
code
Material
koplight light handle finger hook KY-1 Polycarbonate
koplight light handle O-ring KP-1 Fluorine resin
koplight battery inserter KD-1 Polycarbonate
Retail packaging
Product name Content
koplight blade/koplight HT blade 12 × blades per package.
koplight light handle 1 × light handle, 1 × finger hook, 1 × O-ring, 1 × battery inserter per package.
Note: Batteries are not included.
Safety classifications
Protection against electrical shock Internally powered ME equipment
Degree of protection against electric shock Blade is type BF applied part
Method of sterilization or disinfection Refer to "Cleaning and disinfection" and "Sterilization"
Degree of protection against ingress of water
(IEC 60529)
IPX7
This product is not for use in an oxygen rich environment.
Precautions for interference with other equipment
In order to avoid LED lighting malfunction caused by interference with other equipment:
•Keep away from portable wireless communication devices such as cellular phones by more than 30 cm.
•Do not use close to or stacked on other equipment.
•If electrosurgical instruments can cause malfunctions, try not to use them at the same time.
Note: No malfunction will occur when the device comes into contact with an electric scalpel. Electrosurgical
instruments are generally compatible with the device, but some may cause malfunctions. For further information, refer
to “Electromagnetic Compatibility (EMC).”
Electromagnetic Compatibility (EMC)
This product complies with EMC Standard EN60601-1-2: 2015. This product is intended for use in the electromagnetic
environment specified in the following tables. The following problems may be encountered if the product is used in an
unintended environment:
•LED light does not turn on.
•LED light turns on, but flickering occurs.
•LED light turns on, but there is a significant increase or decrease in illumination that can be visually confirmed.
•LED switch button does not work.

MD7-EUenAB-2110(8) Page 9/11 2021-10-11 Rev. 8 MD7-EUenAB-2110(8) Page 10/11 2021-10-11 Rev. 8
1) Electromagnetic emissions (for all equipment and systems)
Guidance and manufacturer's declaration –electromagnetic emissions
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should
assure that it is used in such an environment.
Emission Test Compliance Electromagnetic environment –guidance
RF emissions
CISPR 11
Group 1 This product uses only RF energy for internal functions. Therefore,
RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
CLASS B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emission
IEC 61000-3-3
Not applicable
2) Electromagnetic immunity (for all equipment and systems)
Guidance and manufacturer's declaration –electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should
assure that it is used in such an environment.
Immunity Test IEC 60601 Test level Compliance Electromagnetic environment –guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV in air
±8 kV contact
±15 kV in air
Floors should be wood, concrete, or ceramic tile. If the
floors are covered with synthetic material, the relative
humidity should be greater than 30%.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
30 A/m 30 A/m The power frequency magnetic field should be the same
level on a typical location in a standard commercial or
hospital environment.
3) Electromagnetic immunity (for non-life support equipment and systems)
Guidance and manufacturer's declaration –electromagnetic immunity
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this product should
assure that it is used in such an environment.
Immunity Test IEC 60601 Test level Compliance Electromagnetic environment –guidance
Conducted
disturbances, induced
by radio-frequency
fields
IEC 61000-4-6
3 Vrms
150 kHz–80 MHz
6 Vrms
150 kHz–80 MHz
ISM and amateur
radio bands in
between
80% amplitude-
modulation (1 kHz)
3 Vrms
150 kHz–80 MHz
6 Vrms
150 kHz–80 MHz
ISM and amateur
radio bands in
between
80% amplitude-
modulation (1 kHz)
Portable and mobile RF communications
equipment should be used no closer to any part of
this product, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.2 √P
(ISM, out of amateur radio band)
d = 2.0 √P
(ISM, amateur radio band)
Recommended separation distance
d = 1.2 √P
80 MHz–800 MHz
d = 2.3 √P
800 MHz–2.7 GHz
Where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a)
,
should be less than the compliance level in each
frequency range
b)
.
Interference may occur in the vicinity of equipment
marked with the following symbol:
Radiated RF
electromagnetic fields
IEC 61000-4-3
10 V/m
80 MHz–2.7 GHz 10 V/m
Note 1. At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
Note a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio
s,
amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered.
If the measured field strength in the location in which this product is used exceeds the applicable RF compliance level
above, this product should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating this product.
Note b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
4) Recommended separation distances between portable and mobile RF communication devices and this product
This product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of this product can help prevent electromagnetic interferences by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and this product as recommended below, according to the
maximum output power of the communications equipment.
Test
frequency
(MHz)
Bandwidth
a)
(MHz) Services
a)
Modulation
b)
Maximum
power
(W)
Distance
(m)
Immunity test
level (V/m)
385 380–390 TETRA400 Pulse-modulation
b)
18 Hz 1.8 0.3 27
450 430–470 GMRS460
FRS460
FM
±5 kHz Deviation
1 kHz sine
2 0.3 28
710
704–787 LTE Band 13,17 Pulse-modulation
b)
217 Hz 0.2 0.3 9745
780
810
800–960
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE Band 5
Pulse-modulation
b)
18 Hz 2 0.3 28870
930
1720
1700–1990
GSM 1800
CDMA 1900
GSM 1900
DECT
LTE Band 1,3,4,25
UMTS
Pulse-modulation
b)
217 Hz 2 0.3 28
1845
1970
2450 2400–2570
Bluetooth
WLAN 802.11 b/g/n
RFID 2450
LTE Band 7
Pulse-modulation
b)
217 Hz 2 0.3 28
5240
5100–5800 WLAN 802.11 a/n Pulse-modulation
b)
217 Hz 0.2 0.3 95500
5785
Note
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
References
•EN 60601-1:2006+A12:2014: Medical electrical equipment – General requirements for basic safety and essential
performance
•EN 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential
performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
•EN ISO 17664:2017: Processing of health care products – Information to be provided by the medical device
manufacturer for the processing of medical devices
•EN ISO 15883-1:2009+A1:2014: Washer-disinfectors – General requirements, terms and definitions and tests
•EN ISO 17665-1:2006: Sterilization of health care products – Moist heat – Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
•EN ISO 11135:2014+A1:2019: Sterilization of health-care products – Ethylene oxide – Requirements for the
development, validation and routine control of a sterilization process for medical devices
•EN ISO 11607-1:2017: Packaging for terminally sterilized medical devices – Part 1: Requirements for materials,
sterile barrier systems and packaging systems
•EN ISO 11607-2:2017: Packaging for terminally sterilized medical devices – Part 2: Validation requirements for
forming, sealing and assembly processes
•EN 1041:2008+A1:2013: Information supplied by the manufacturer of medical devices

MD7-EUenAB-2110(8) Page 11/11 2021-10-11 Rev. 8 MD7-EUenAB-2110(8) Page 12/11 2021-10-11 Rev. 8
•EN ISO 15223-1:2016: Medical devices – Symbols to be used with medical device labels, labelling and information
to be supplied – Part 1: General requirements
Symbols used
Indicates the item is a
medical device Lot number
Temperature limitation:
0–40 °C
Manufacturer Catalog number
Humidity limitation:
30%–90%
European Authorized
Representative
Non-sterile
Atmospheric pressure
limitation:
70 kPa–106 kPa
Date of manufacture
Sterilized using ethylene
oxide
Type BF applied part
Use by date Do not reuse
RoHS Directive
2011/65/EU
2015/863/EU
Consult instructions for
use
Do not use if package is
damaged or opened
Warnings and
precautions
Sterile barrier system
Note: Not every symbol appears on the product.
Yasui Co., Ltd. MT Promedt Consulting GmbH
2725 Oazakakusa, Kadogawa-cho, Altenhofstrasse 80 66386 St. Ingbert
Higashiusuki-gun, Miyazaki 889-0697 Japan Germany
https://www.yasui-kk.co.jp/en/ https://www.mt-procons.com/