Bard Magnum Instrucciones De Uso página 7

Cleaning and
disinfection:
Automated
Maintenance,
Inspection and
Testing:
Packaging:
Sterilization:
Storage:
The above instructions have been validated by the manufacturer of the medical device as suitable methods
for reprocessing of the medical device for reuse. It remains in the operator's responsibility to ensure that the
performed reprocessing with the use of operator's equipment, materials and personnel reached the desired
and necessary result. This requires validation and routine monitoring of the processes. Likewise any variation
INSTRUCTIONS
• Prior to automated cleaning and thermic disinfection:
Do Pre-cleaning (see pre-cleaning above, points 1-3)
• Washer disinfector according to DIN EN ISO 15883-1+-2 with thermal program
(temperature 90-93°C/194-199°F)
• Mildly alkaline cleaner (with manufacturer claim for anodized aluminum)
1) Place the Device with open lid in 22 mm depth penetration setting into the washer
disinfector.
2) After closing the door start the thermal program, the program parameters are
shown in the table below.
3) At the end of the program remove the device.
4) Check if the device is completely dry, if necessary dry with single use, lint free
wipe or towel or dry by an air gun with clean compressed air.
Program step Time
Pre-Rinse
5 min
Dosage
detergent
—
Cleaning 10 min
Rinse 2 min
Disinfection 3 min
Drying
15 min
Check the functionality of the cock and trigger mechanism.
Lubricate the movable parts of the device using silicone-free steam sterilizable lubricant
allowed for use on medical products according to the manufacturer.
Bard recommends the M
use to enhance the performance and longevity of the instrument. Silicone free,
quality medical grade lubricant compatible with steam sterilization should be used
AGNUM ®
to lubricate the M
determine compatibility and for the use of the selected lubricating agent. Ensure
all moving parts of the M
sterilize the instrument after each cleaning and lubrication.
• Pouches consisting of a steam permeable paper side and a non-steam permeable
transparent foil side according to DIN EN ISO 11607
1) Device must be in the 22 mm penetration depth setting and should not be cocked.
2) Pouch the device.
3) Seal the Pouch.
• Sterilizer according to DIN EN 13060 and/or DIN EN 285
• Utilize any of the following fractionated vacuum processes:
- 132°C (270°F), sterilization time of at least 4 minutes
- 134°C (273°F), sterilization time of at least 3 minutes
- 135°C (275°F), sterilization time of at least 3 minutes
1) Place the packaged device in the sterilizer chamber.
2) Start the program.
3) At the end of the program remove the device and let it cool down.
4) Check that the seal of the package is closed and the package is dry.
No special requirements
Water
Cold
manufacturer's
— instructions of
the detergent
Deionized water
Deionized water
Deionized water
—
AGNUM ®
Instrument be cleaned and lubricated after every
Instrument. Refer to the manufacturer's instructions to
AGNUM ®
Instrument are lubricated. End-users may
5
Dosage Temperature
— —
manufacturer's
instructions of
the detergent
— 55°C (131°F)
— —
— 90°C (194°F)
— 90°C (194°F)