COOK Medical Nathanson Instrucciones De Uso página 4

Step 5 Continue placement of the ports. When this is
complete, attach the Nathanson Liver Retractor to the
retractor arm and elevate the liver to the desired position.
Periodic release of the retractor pressure may be
necessary throughout the procedure to minimise the
risk of hepatic ischaemia.
Cleaning and sterilizing instructions
• Do not use acidic detergents in automated or manual
cleaning as this will cause corrosion of NLR.
• It is recommended that the NLR is reprocessed as soon
as reasonably practicable, or within at least 30 minutes
following use.
Limitations on reprocessing
Repeated processing has minimal effect on these
instruments. End of life is normally determined by wear
and damage due to use.
Initial treatment at the point of use
1. Keep the NLR moist immediately after use, or as soon
as practical.
2. Remove excess soil from NLR with water and wipe
with non-linting cloth.
Preparation before cleaning
Equipment: soft scrub brushes, detergent (enzymatic
detergent pH 7.0-10.0)
1. Rinse the NLR under ambient running tap water for
3 minutes.
2. Remove excess soil while rinsing using soft brush or
non-linting cloth.
3. Soak the device in prepared enzymatic detergent
solution* for 20 minutes.
4. Use a soft brush to thoroughly clean, especially the
difficult to reach, surfaces for 3 minutes while the
Nathanson Liver Retractor is immersed.
5. Rinse the device under tap water for 3 minutes.
Cleaning (automated)
Equipment: Washer/disinfector, detergent (enzymatic
detergent pH 7.0-10.0)
1. Load products into washer/disinfector.
2. Complete a cleaning cycle using prepared enzymatic
detergent solution 2 .
3. Minimum cycle parameter set points are listed in
Table 1 or alternately use a cleaning cycle validated
for non-complex re-usable medical devices (RMD)s.
4. When unloading, check for complete removal of
visible contaminants. If necessary, repeat cycles or
use manual cleaning.
5. Dry NLR using non-linting cloth and compressed air.
Table 1: Process paremeters – Automated cleaning
Phase Time (Minutes)
Pre-wash 2.2
Wash 4.5
Rinse 15 Seconds
Thermal rinse 1
Drying 7
Cleaning (manual)
Equipment: Sonicator, detergent (enzymatic detergent
pH 7.0-10.0).
1. Sonicate NLR in prepared detergent solution
ultrasonic unit at 45°C (113°F) for 10 minutes with
ultrasonic frequency at 40 kHz.
2. Rinse the NLR using treated water
until no visible contamination remains.
3. Repeat the above cleaning steps if necessary.
4. Dry NLR using non-linting cloth and compressed air.
1 Treated water as defined in AAMI TIR34 Water for
Reprocessing of Medical Devices.
Detergent concentration: Validation was performed
2
using Cidezyme Xtra Multienzyme Detergent.
Detergent concentration used as recommended by
manufacturer: Manual – 8 mL/liter (1 oz per gallon);
Automated: 4 mL/liter (0.5 oz per gallon).
Any equivalent detergent can be used for cleaning.
Detergent concentration to be as per that manufacturer's
recommendation for cleaning processes.
Drying
1. Ensure the Nathanson Liver Retractor is dry before
packaging.
Maintenance
No maintenance required.
Inspection and function testing
Visually inspect for damage and wear.
4
Temperature–
Treated water
Cold water
Set point:
72°C (162°F)
Set point:
91°C (196°F)
Set point:
82.2°C to 93°C
(180°F to 199°F)
Set point: 98.9°C
(210°F) High
2 in
1 for two minutes or