CareFusion Snowden-Pencer Manual Del Usario página 7

Automated Cleaning
A washer/disinfector with demonstrated efficacy
(e.g. FDA approval, validated to ISO 15883,
compliant with HTM 01-01) should be used.
Compatibility and cleaning efficacy was tested with
neutral enzymatic detergents to achieve the required
cleaning before disinfection.
Wash time, disinfection time and dry time are each
shown as a minimum because it is dependent upon
the load size placed into the washer/disinfector.
The thermal disinfection cycle should be performed
to achieve a minimum value A0 = 600 (e.g.
90°C/194°F for 1 minute according to ISO 15883-1)
and is compatible with Fast Clamp.
Enzyme solutions should be used in accordance with
manufacturer's instructions, which include proper
dilution of the enzymatic detergent and contact with
equipment for the amount of time specified on the
label.
1. Prepare a sink with a liquid enzymatic detergent
(Viruzyme at 4ml per litre or equivalent neutral
enzymatic detergent pH 6-8). If other enzymatic
solutions are used, prepare in accordance with
the detergent manufacturer's instructions.
2. Immerse the devices in the detergent and allow
to soak for a minimum of 5 minutes or as per the
detergent manufacturer's instructions. Actuate
all movable parts during the initiation of the soak
time.
3. Use a soft brush for 2-3 minutes to manually
clean the soil from the devices.
4. Remove the devices from the detergent and rinse
in running drinking/potable water.
5. Prepare an ultrasonic bath (compliant with HTM
01-05) with an enzymatic detergent (Viruzyme
at 4ml per litre or equivalent neutral enzymatic
detergent pH 6-8). If other enzymatic solutions
are used, prepare in accordance with the
detergent manufacturer's instructions.
6. Immerse the devices completely in the ultrasonic
bath for a minimum of 10 minutes at 30°C (86°F)
(cycle frequency 37 kHz).
7. Remove the devices from the ultrasonic bath and
rinse in running drinking/potable water.
8. Transfer the devices to a validated automated
washer disinfector for processing. The following
cycle parameters are to be used as a guideline and
indicate the minimum cycle times/temperatures
to achieve the required level of device cleanliness
(longer times may be used if required):
MINIMUM
PHASE RECIRCULATION
TIME
Pre-Wash 2 Minutes
Enzyme
4 Minutes
Wash
Rinse 1 2 Minutes
Deionized
Water 2 Minutes
Rinse 2
Hot
Thermal 1 Minute
Rinse
Drying 9 Minutes
9. On completion of the cycle, remove the cleaned
device parts from the washer and perform a
thorough visual inspection for any remaining
residual contamination. If the devices are
not visually clean, repeat the full process as
described above until they are clean.
Inspection/Maintenance
Proper care and handling is essential for satisfactory
performance of any surgical device. The previous
cautions should be taken to ensure long and
trouble-free service from all your surgical devices.
Inspect devices before each use for broken, cracked,
or tarnished surfaces, movement of hinges, and
chipped or worn parts. If any of these conditions
appear, do not use the device. Return devices to
an authorized repair service center for repair or
replacement.
Immediately proceed to recommended steam
sterilization. Do not store device prior to sterilization.
Packaging
Devices can be loaded into dedicated packaging
systems. Sterilization wrap material must be cleared
for the applicable sterilization modality by your
country's regulatory body. Use in accordance with
packaging manufacturer's sterilization instructions
being sure to protect jaws and cutting edges from
damage.
Sterilization
All devices must be processed in the completely open
position to allow sterilant contact of all surfaces.
All devices with concave surfaces shall be
configured so that water pooling does not occur.
Assure the sterilization parameters utilized are
validated and approved across the instrumentation,
packaging system, and sterilization inserts as
indicated by their individual Instructions for Use.
3
DETERGENT
WATER TYPE AND
TEMPERATURE CONCENTRATION
(IF APPLICABLE)
Cold Drinking/
N/A
Potable Water
• Detergent:
pH-neutral/
enzymatic (pH 6-8)
Hot Water
• Concentration:
55°C (131°F)
Per the detergent
manufacturer's
recommendations
Hot Drinking/
N/A
Potable Water
65°C (149°F) N/A
90°C (194°F) Heated RO Water
90°C (194°F) N/A