smith&nephew RENASYS GO Instructions De Service page 4

Purpose
This service manual is to provide guidance on regular
service and maintenance checks to be conducted by
trained personnel on RENASYS™ GO devices
(REF 66801244, 66801496).
Note: Service and maintenance checks intended
at a facility level do not require opening the device.
Opening or attempting to open the device housing will
void all warranties and render the user responsible for
all subsequent liabilities associated with the device.
Contact your local Smith & Nephew global customer
assistance or sales representative to resolve device
issues.
Scope
This service manual is only applicable to RENASYS GO
devices (REF 66801244, 66801496) manufactured by Smith
& Nephew.
Responsibilities
It is the responsibility of the facility that owns the device
to perform regular service and maintenance checks of
medical equipment to verify basic device safety and
function prior to any re-use or after prolonged storage
of more than 6 months. The retention of any device
service and maintenance records is the responsibility of
the party performing the procedure. A sample checklist
is provided within this manual to provide guidance
on documenting the recommended service and
maintenance checks; however, this should be managed
at the discretion of each facility.
Training
It is recommended that individuals performing service
and maintenance on the RENASYS GO device be trained
professionals familiar with regular service and maintenance
of medical equipment and use of test equipment required.
Equipment and materials required
The following equipment is recommended to support
service and maintenance of the RENASYS GO device.
Availability and usage is done at the discretion of each
facility.
1.
RENASYS power cord (REF country dependent)
2.
RENASYS power supply (REF country dependent)
3.
RENASYS GO canister (REF 66800914, 66800916,
66800165, 66800695)
4.
RENASYS quick click adaptor
[REF 66801259 included with RENASYS drain kits
(REF 66801251,66801252, 66801253, 66801254,
66801255, 66801256, 66801257, 66801258)]
5.
RENASYS Y-connector (REF 66800971, 66800504)
6.
RENASYS inlet O-ring (REF 66800603)
7.
RENASYS odor filter replacement (REF 66800061)
8.
Plastic O-ring removal tool [Manufactured by Golem
Gear (SKU GG_YellowPick)]
9.
Plastic tweezers (odor filter removal tool)
10.
Suction cup (optional)
11.
Electrical safety analyzer capable of performing
tests according to IEC 62353 (e.g., Rigel® 288
Hand-Held Safety Analyzer, Fluke® ESA615 or
equivalent)
12.
Calibrated pressure gauge with minimum range of
up to 250mmHg vacuum (e.g., Extech® HD750,
406800 or 407910, Digitron® 2000P series,
Dwyer® Series 475 or equivalent)
13.
Protective gloves and eye protection
recommended, consult cleaning agent SDS
14.
Cotton swabs (e.g., Q-tips
15.
Disposable paper towels or cloth
16.
Stopwatch
17.
#1 Pozidriv® screwdriver
18.
Vented hood, or local SOP guidelines for handling
bio hazardous materials
Cleaning materials: The choice of suitable cleaning
material will depend upon facility protocols and local
ordinances in addition to availability of particular brands
in your location.
The following are recommended options:
1.
Alcohol based disinfectant solutions or wipes.
These may be ethanol or isopropyl alcohol (IPA)
based, and are most effective if the alcohol
concentration is 70%.
2.
Chlorine based disinfectants up to a maximum of
1,000 ppm available chlorine. Always rinse and
dry thoroughly after using this type of disinfectant
(e.g., Chlor-Clean®, Actichlor® Plus, Klorsept®,
BioSpot®, Sani-chlor®).
3.
Specifically formulated disinfectants for medical
devices with broad spectrum activity
(e.g., Trionic D).
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