MORIA One Use-Plus Specifications

The following are only recommendations. They must be adapted according to the laws
in the country of utilization.
All the products and solutions for cleaning and disinfection must be used according to
the manufacturer’s instructions.
The recommendations for cleaning, disinfection and sterilization are updated and
available on MORIA’s website: http://www.moria-surgical.com
MORIA recommends to:
• avoid touching potentially contaminated areas,
• use gloves when performing cleaning and decontamination tasks.
One Use- Plus & Epi-K™
Operator’s cleaning-disinfection-sterilization-storage instructions
Extract from Epi-K™user manual (#65043) & One Use- Plus user manual (#65040)
Leading Innovations
in Ophthalmology
LASIK
Surgery
Epi-LASIK
Surgery

I) PRE-CLEANING CHECK-LIST
Cleaning Products:
•Moria disposable brush (#19149)
•Soft brush
•Cup
•Lint-free surgical wipes
•Gloves
Solutions:
•Cleaning solution
•Aldehyde-free detergent/disinfectant solution
(e.g.: Alkazyme®, Alkapharm Laboratories)
•Filtered distilled or osmosis-treated water
•Clean,lteredcompressedair(medicalcompressedair)
•Soda solution (1 N)
II) CLEANING-DISINFECTION-STORAGE OF THE HANDPIECE AND ELECTRICAL CABLE
Step 1: Disassembly
1Carefully disassemble keratome parts. Use Moria wrench if head is too tightly screwed on the handpiece.
2Discard the disposable head and aspiration tubing after each procedure in an appropriate container.
Warning:
The reuse of single-use products, or the use of consumables other than those supplied by MORIA, may entail serious
surgical consequences for the patient and damage the microkeratome.
Step 2: Cleaning
3To clean the screw core of the motor and metallic parts, use Moria disposable brush moistened with cleaning solutions.
4Dip the blade oscillation shaft of the motor in a sterile distilled water bath and run the motor back and forth 10 times.
5Remove the motor from the cup, unplug it from the console, and wipe the oscillation shaft of the motor with a lint-free
surgical wipe.
6Cable can be cleaned with a lint-free surgical wipe moistened with cleaning solutions.
7 Air-drytheshaftofthemotorwithclean,lteredcompressedair.
Warning:
• The One Use-Plus & Epi-KTM handpiece must be carefully cleaned after each surgical procedure.
• Do not use abrasives or scrapers to clean any elements of the system ; doing so may result in reduced precision, burrs
and/or irregular tissue resection.
• Do not immerse the motor in the sterile distilled water bath.
• To prevent damaging the connectors and to ensure proper functioning of the motor, never pull on the cables and
never hold the motor by its cable.
Step 3: Disinfection & Drying
8Wipe each part of the motor with a lint-free surgical wipe moistened with disinfecting solutions.
9 Drycarefullywithdisposableinstrumentcleaner(lint-free)thenwithclean,ltered,compressedair.
Warning:
• It is imperative to verify that the devices are perfectly clean and free of any organic or other residues.
• Do not gas sterilize (ETO) the motor.
• Do not autoclave the motor.
• No current sterilization process is compatible with Moria motors.
Step 4: Storage
• Failure to completely dry the inside of the motor can result in oxidation.
• Do not store products that are not completely dry; doing so may create rust and result in irregular corneal resection.
• Do not store with formaldehyde tablets.
• When not in use :
o the One Use-Plus system should be kept in its storage box (#22519514) in a dry atmosphere
o the Epi-KTM system should be kept in its storage box (#22519512) in a dry atmosphere.
1a 1b
2
3a 3b
4a
5
4b
6

8
9a 9b
III) CLEANING-DISINFECTION-STERILIZATION-STORAGE OF THE REUSABLE SUCTION RINGS
This protocol has been approved by the French XV/XX National Ophthalmological Hospital (CHNO) (Paris, France), Hygiene/
Sterilisation Department (Dr. Patrice RAT).
Step 5: Double cleaning
10 On leaving the operating theatre, immediately immerse the devices in an aldehyde-free detergent/disinfectant
solution for at least 15 minutes according to manufacturer recommendations.
11 Manual cleaning (or use a machine, provided that it does not recycle the cleaning products, after disassembling the
device where appropriate).
12 Rinse the circuit with water.
13 Immerse the device in an aldehyde-free detergent/disinfectant solution (a different bath from the one above).
14 Manual cleaning (or use a machine, provided that it does not recycle the cleaning products).
15  Rinseusingltereddistilledorosmosis-treatedwater.
16 Wipe the device using a non-woven, lint-free, disposable surgical wipe.
17  Air-drythesuctionringwithclean,lteredcompressedair.
Warning:
• Manual cleaning: mechanical cleaning of the medical device using soft brushes; metal brushes and scouring pads are
prohibited.
• Change the baths after each use.
• Incompatibility:
o Do not use bleach.
o Do not apply this protocol to products made of aluminium alloy.
o Do not apply this protocol to heat-sensitive (motor and turbine).
Step 6: Deactivation of NTAs (Unconventional Transmissible Agents)
• On leaving the operating theatre, immediately immerse the devices in an aldehyde-free detergent/disinfectant
solution for at least 15 minutes according to manufacturer recommendations, and then rinse the devices.
• Cleaning,disinfectantandrinsinguidsmustbestoredinsealedcontainersanddisposedofbyappropriateprocedures
for contaminated biological liquid waste.
• Immerse the device in a soda solution (1 N) for one hour.
• Rinse the device manually three times (using water from the network), and check the pH when performing the last rinse
to prevent any risk of burns (neutral pH). The last rinse must be carried out using microbiologically tested water.
• Wipe the device using a non-woven, lint-free, disposable surgical wipe, and reinstall the device in the normal
disinfection/sterilization circuit.
Warning:
• Inactivation of UTA (unconventional transmissible agents) (only for patients at risk of Creutzfeldt-Jakob disease – CJD
questionnaire / please refer to French Ministry instruction DGS/R13/2011/449-December 2011)
• If the pH is not neutral, perform further rinses until an acceptable pH is reached (close to pH7).
Step 7: Sterilization
Sterilize the sterilization tray using an autoclave (moist heat sterilizer) at a temperature of at least 134°C for 18 minutes.
10
16
11
17
12
7

MORIA SA
15, rue Georges Besse
92160 Antony
FRANCE
Phone: [phone]
Fax: [phone]
www.moria-surgical.com
MORIA Inc
1050 Cross Keys Drive
Doylestown, PA 18902
USA
Phone: [phone]
Fax: + 1 [phone]
www.moria-surgical.com
MORIA JAPAN KK
Inami Bldg. 6F
3-24-2 Hongo Bunkyo-ku
Tokyo 113-0033
JAPAN
Phone: + 81 3 5842 6761
Fax: + 81 3 5842 6762
www.moriajapan.com
Moria Shanghai Ofce
RM4, 10 FL, Kai Li Building
N°432 Huai Hai West Road
200052 Shanghai
CHINA
Phone: [phone]
Fax: [phone]
www.moria-surgical.com.cn
MORIA #65096-B-01.2017
To obtain more information
The One Use-Plus and Epi-KTM systems have been designed for optimal operation, provided
that the recommendations listed in their respective user manual are followed carefully.
In order to maintain the original performance of your microkeratome, MORIA strongly
recommends annual maintenance and servicing of all its reusable products.
As only MORIA and its agents are fully expert in MORIA products, servicing and maintenance
must be carried out by MORIA or its approved agents.
MORIA shall not be held liable for any malfunction or damage to the apparatus, poor results,
orsurgicalcomplicationsduetomaintenancehavingbeencarriedoutbyanunqualied
operator or third party.
Any such unauthorised intervention shall render the guarantee and any maintenance
contract null and void.
Leading Innovations
in Ophthalmology
0459