CMR versius User manual

CMR Surgical Ltd
1 Evolution Business Park
Milton Road, Cambridge CB24 9NG, UK
Versius Surgical System
Electrosurgery Instrument Cables Reprocessing Instructions (Version 2.0)
REF 70300
Read before use

REF 70300 Versius Electrosurgery Instrument Cables Reprocessing Instructions
© CMR Surgical Ltd 2021
2021-08
Document number U-00350v2.0
This document provides instructions for the reprocessing of the Versius Electrosurgery Instrument Cables.
Rx only
Advena Ltd. Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta

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Table of Contents
Introduction 7
Warning, precaution and information symbols in
this manual 8
Versius Electrosurgery Instrument
Cables description 12
Receiving new electrosurgery instrument cables 13
Transport and storage 13
Repair 13
Disposal 13
Reprocessing Versius Electrosurgery
Instrument Cables 15
Procedures Overview 16
Point-of-use preparation 21
Initial manual cleaning 29
Main cleaning: Full manual cleaning 37
Main cleaning: Automated cleaning and thermal
disinfection 45
Preparation for sterilisation 53
Sterilisation 63
Appendix A
Versius Electrosurgery Instrument Cables 68
Appendix B
Validated equipment and parameters 69
Glossary 72
Index 76

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7
Introduction
Introduction
This manual provides reprocessing instructions for Versius Electrosurgery Instrument
Cables including cleaning, disinfection and sterilisation, and equipment recommended
by CMR Surgical Ltd.
These instructions must be read and fully understood before reprocessing Versius
Electrosurgery Instrument Cables.
These instructions have been validated by CMR Surgical. This does not preclude the
statutory requirements of the sterile services department to undertake process
monitoring, testing and quality control to ensure the eectiveness of the cleaning,
disinfection and sterilisation procedures.
Versius Electrosurgery Instrument Cables are supplied non-sterile, and must be
reprocessed before rst use.
Discolouration of metal surfaces is possible when alkaline enzymatic detergents are
used (pH 8–11). However, this does not impair the functional capability of the Versius
Electrosurgery Instrument Cables.
If there are any questions regarding these instructions or if any Versius Electrosurgery
Instrument Cables show signs of defects or damage, please contact CMR Surgical
customer services. To arrange the return of any aected Versius Electrosurgery
Instrument Cables, please contact CMR Surgical technical support.
CMR Surgical Limited,
1 Evolution Business Park,
Milton Road, Cambridge CB24 9NG, UK
Tel: [phone]
For technical support:
If your system requires technical support
or service, please call our technical support
line:
[phone]
Email: [e-mail]
CMR Surgical Limited,
1 Evolution Business Park,
Milton Road,
Cambridge CB24 9NG, UK
www.cmrsurgical.com

Warning, precaution and information symbols in this manual
This symbol indicates a warning. Warnings in these reprocessing instructions
indicate situations that could result in serious injury to the patient or user.
This symbol indicates a precaution. Precautions in these reprocessing instructions
indicate situations that could result in minor or moderate injury to the patient or
user, or damage to Versius instruments.
This symbol indicates an information point. Information points indicate important
reference information.
Full list of warnings
Versius Electrosurgery Instrument
Cables are supplied non-sterile and
must be reprocessed before rst use.
Transport and store cables in line
with local guidelines. Incorrect
storage could lead to damage to the
cables.
Do not attempt to repair or modify
Versius Electrosurgery Instrument
Cables.
Only use validated cleaning solutions.
Cleaning solutions that have not been
validated (e.g. bleach or hydrogen
peroxide) may result in damage to, or
ineective cleaning of, cables.
Take care when handling
contaminated uids or chemicals, as
skin contact, inhalation or ingestion
may cause harm. Personal Protective
Equipment (PPE) should be worn,
according to local guidelines.
When undertaking point-of-use
preparation and initial manual
cleaning, do not use water or any other
uid, such as enzymatic detergent,
at a temperature higher than 45 °C
(113 °F). This could cause proteins to
stick to the surfaces of the Versius
Electrosurgery Instrument Cables and
may result in ineective cleaning.
Do not use strong acidic (pH < 7)
solutions, cleaners or rinse aids
as these may damage Versius
Electrosurgery Instrument Cables.
Do not use strong alkaline (pH > 11)
solutions, cleaners or rinse aids
as these may damage Versius
Electrosurgery Instrument Cables.
Introduction
8
Introduction

Full list of warnings (continued)
Always seal the container with the
cables inside before sending it to
sterile services. Sealing the container
prevents splashes of contaminated
uid.
During full manual cleaning, always
rinse the cables under running
critical water for at least 1 minute 30
seconds after exposing the cables
to pH 7–11 enzymatic detergent, as
some detergent or contaminants
could remain on the cables.
During full manual cleaning, always
brush the cables under cold running
water using a soft-bristled brush until
there is no visible soil.
During full manual cleaning, ensure
that the cable is fully covered in
pH 7–11 enzymatic detergent when
soaking the cable.
Always use ISO 15883 compliant
washer/disinfectors.
Check that items placed into the
washer/disinfector tray are not
touching or shadowing each other.
This could result in ineective
cleaning/disinfection of the items.
Only use validated parameter
settings. Parameter settings that
have not been validated could result
in damage to, or ineective cleaning
of, Versius Electrosurgery Instrument
Cables.
Always dry the electrosurgery
instrument cables using a lint-free
cloth or with pressurised/medical air
before sterilisation. This is required
if using manual cleaning to clean the
cables and should be done if the
cables are still wet after automated
cleaning and thermal disinfection.
Failure to dry the cables could lead to
the cables not being fully sterilised.
If using a cloth to dry electrosurgery
instrument cables, ensure that the
cloth is lint-free as lint could cause
contamination and/or ineective
sterilisation.
Ensure that electrosurgery
instrument cables have been
thoroughly dried before sterilisation
as any moisture remaining could
result in ineective sterilisation.
9
Introduction

Introduction
Full list of warnings (continued)
Always inspect cables using a
magnifying glass to detect possible
damage or soiling before sterilisation.
Always repeat the entire cleaning
process, including initial manual
cleaning, if any soil is present on the
electrosurgery instrument cables
during the inspection stage.
Do not pack electrosurgery
instrument cables that are cracked
or have faulty insulation as this may
result in burns or other injuries to the
patient or user.
Always pack the cables into
appropriately sized, steam-
permeable sterilisation peel pouches
with one cable only in each peel
pouch for sterilisation. Failure to
do so could result in damage or
ineective sterilisation.
Check that items placed in the
sterilisation tray are not touching or
shadowing each other as this could
result in ineective sterilisation.
Always place packaged cables into a
sterilisation tray before placing the
tray into the steam steriliser to avoid
damage.
The sterilisation process should
conform with ISO 17665-1.
Allow electrosurgery instrument
cables to cool down gradually to
room temperature before handling.
Sudden changes in temperature
could damage electrosurgery
instrument cables.
Full list of precautions
Take care when handling and
transporting Versius Electrosurgery
Instrument Cables to avoid damage.
Do not use an ultrasonic bath when
reprocessing the electrosurgery
instrument cables. Using an
ultrasonic bath will cause damage to
the cables.
Appendix A lists the maximum
number of reprocessing cycles for
Versius Electrosurgery Instrument
Cables. Do not reprocess Versius
Electrosurgery Instrument Cables
beyond their maximum number of
reprocessing cycles as this may result
in damage to the cables.
10
Introduction

Full list of precautions (continued)
Always place the cables into a
washer/disinfector tray before
loading the tray into the washer/
disinfector to avoid damage.
Do not use pressurised or medical
air at greater than 3 bar (43.5 psi) to
avoid damage to the electrosurgery
instrument cables.
Do not coil the cables too tightly
when packing into a peel pouch as
this could result in damage to the
cable. The coil diameter should be at
least 16 mm.
Full list of information points
Follow all applicable national and
local laws and guidelines or hospital
protocols for cleaning/disinfection
and sterilisation.
Always follow the manufacturer’s
recommended concentrations and
application times for the detergent
and disinfectant.
Begin point-of-use preparation within
30 minutes of the surgical procedure
ending.
Do not use abrasive metal brushes
as these may damage the Versius
Electrosurgery Instrument Cables.
Transport and store cables in line
with local guidelines.
Start initial manual cleaning within
4 hours of nishing point-of-use
preparation.
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Introduction

Introduction
Versius Electrosurgery Instrument Cables description
Versius Electrosurgery Instrument Cables connect Versius Instruments to Versius
Bedside Units. Refer to the Versius Instrument and Accessories Manual (REF 70050) for
instructions on using the cables with the Versius Surgical System.
There are two types of Versius Electrosurgery Instrument Cables: monopolar
instrument cables and bipolar instrument cables.
Monopolar instrument cables are blue (see Figure 1) and connect monopolar
instruments, such as the Versius Monopolar Hook, to a bedside unit.
Bipolar instrument cables are grey (see Figure 1) and connect bipolar instruments, such
as the Versius Bipolar Maryland Grasper, to a bedside unit.
Monopolar Bipolar
Figure 1 Monopolar and bipolar instrument cables
Electrosurgery instrument cables have connectors at either end: one connector to
connect the cable to the bedside unit and one connector to connect it to the instrument
(see Figure 2).
Monopolar
instrument
connector Monopolar bedside unit connector Bipolar instrument connector Bipolar bedside unit connector
Figure 2 Monopolar and bipolar instrument cable connectors
12
Introduction

Receiving new electrosurgery instrument cables
Versius Electrosurgery Instrument Cables are supplied non-sterile and must be
reprocessed before rst use.
Transport and storage
Transport and store cables in line with local guidelines. Incorrect storage could lead
to damage to the cables.
Protect cables in storage from direct sunlight. Keep cables in their original packaging
until rst reprocessing the cables.
Repair
Do not attempt to repair or modify Versius Electrosurgery Instrument Cables.
If any Versius Electrosurgery Instrument Cables show signs of defects or damage,
please contact CMR Surgical Customer Services. See page 7 for contact details.
Disposal
Return the Versius Electrosurgery Instrument Cables to CMR Surgical for disposal.
13
Introduction

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15
Reprocessing
Versius
Electrosurgery
Instrument Cables

Procedures Overview
Outline of all procedures
Point-of-use preparation
Initial manual cleaning
Main cleaning: use ONE of the following:
OR
Full manual
cleaning
Automated cleaning
and thermal
disinfection
Sterilisation
Preparation for sterilisation
Do not use an ultrasonic bath when reprocessing the electrosurgery instrument
cables. Using an ultrasonic bath will cause damage to the cables.
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Point-of-use preparation
Step 1 Moisten cable
(page 24)
Step 2 Transport cable
(page 26)
Initial manual cleaning
Step 1 Remove cable from container
(page 32)
Step 2 Brush cable
(page 32)
Step 3 Soak cable
(page 33)
Step 4 Rinse cable under cold running water
(page 34)
Proceed to main cleaning with ONE of the following methods:
Full manual cleaning continue to page 37
or
Automated cleaning
and thermal disinfection
continue to page 45
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Reprocessing Versius Electrosurgery Instrument Cables

Procedures Overview
Main cleaning: Full manual cleaning
Step 1 Immerse cable in detergent (rst time)
(page 40)
Step 2 Brush cable under cold running water (rst time)
(page 41)
Step 3 Immerse cable in detergent (second time)
(page 41)
Step 4 Brush cable under cold running water (second time)
(page 42)
Step 5 Rinse cable under running critical water
(page 42)
Main cleaning: Automated cleaning and thermal disinfection
Step 1 Place cable into washer/disinfector tray
(page 48)
Step 2 Load tray into washer/disinfector
(page 48)
Step 3 Run washer/disinfector
(page 49)
Step 4 Remove cable from washer/disinfector
(page 50)
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Reprocessing Versius Electrosurgery Instrument Cables

Preparation for sterilisation
Step 1 Dry cable
(page 56)
Step 2 Inspect cable
(page 57)
Step 3 Pack cable
(page 59)
Step 4 Place packed cable into sterilisation tray
(page 60)
Sterilisation
Step 1 Load sterilisation tray into steam steriliser
(page 66)
Step 2 Run steriliser
(page 66)
Step 3 Leave cables to cool down
(page 67)
Step 4 Transport and store cables
(page 67)
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Reprocessing Versius Electrosurgery Instrument Cables

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