COOK Medical NLRS-1100 Mode D'emploi page 4

Periodic release of the retractor pressure may be
necessary throughout the procedure to minimize 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: non-abrasive brush, 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 a non-abrasive
brush or non-linting cloth.
3. Soak the device in prepared enzymatic detergent
solution (detergent concentration: 8 mL/liter (1 oz per
gallon)) 2
for 20 minutes.
4. Use a non-abrasive 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 (detergent concentration: 4 mL/
liter (0.5 oz per gallon))
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.
2 .
6. Inspect each component visually under a magnifying
lens in a well-lit area for the presence of any
remaining soil. Repeat the Ultrasonic Cleaning steps if
soil is not fully removed.
Table 1: Process parameters – 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
(detergent concentration: 4 mL/liter (0.5 oz per
gallon)) 2 in ultrasonic unit at 45 °C (113 °F) for 10
minutes with ultrasonic frequency at 40 kHz.
2. Rinse the NLR using utility water
3. Dry NLR using non-linting cloth and compressed air.
4. Inspect each component visually under a magnifying
lens in a well-lit area for the presence of any
remaining soil. Repeat the Ultrasonic Cleaning steps if
soil is not fully removed.
1 Utility water as defined in AAMI TIR34 Water for
Reprocessing of Medical Devices.
2
Detergent concentration: Validation was performed
using Cidezyme Xtra Multienzyme Detergent.
Any equivalent detergent can be used for cleaning.
Detergent concentration to be as per that manufacturer's
recommendation for cleaning processes.
Drying
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
1
for two minutes.