CMR versius User manual

CMR Surgical Ltd
1 Evolution Business Park
Milton Road, Cambridge CB24 9NG, UK
Versius Surgical System
Endoscope Reprocessing Instructions (Version 3.0)
REF 70200
Read before use

REF 70200 Versius Endoscope Reprocessing Instructions
© CMR Surgical Ltd 2021
2021-08
Document number U-00347v3.0
This document provides instructions for the reprocessing of the Versius Endoscopes.
Rx only
Advena Ltd. Tower Business Centre, 2nd Flr.,
Tower Street, Swatar, BKR 4013 Malta

4

Table of Contents
Introduction 7
Warning and information symbols in this manual 8
Endoscope description 13
Receiving new endoscopes 15
Dropped or damaged endoscopes 15
Disposal 15
Reprocessing quick reference 17
Reprocessing procedures overview 18
Reprocessing procedures 25
Point-of-use preparation 27
Initial manual cleaning 35
Full manual cleaning 47
Automated cleaning and thermal disinfection 55
Preparation for sterilisation 63
Sterilisation 73
Appendix A
Versius Endoscopes 80
Appendix B
Validated equipment and parameters 81
Glossary 84
Index 88
5

6

7
Introduction
This manual provides reprocessing instructions for Versius Endoscopes, including
cleaning, disinfection and sterilisation, and equipment recommended by CMR Surgical
Ltd. These instructions should be read and fully understood before reprocessing
Versius Endoscopes.
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 Endoscopes are supplied non-sterile, and must be reprocessed before rst use.
Stainless steel baskets with electropolished steel of grade 304 or 316 can be used when
reprocessing Versius Endoscopes. If using a basket, visually inspect the basket for any
wear and tear which may compromise the basket performance and for rust. Make sure
the basket is clean before use and free of any soil particles.
If using a basket for reprocessing Versius Endoscopes, read the instructions provided by
the basket manufacturer before using the basket.
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
Endoscopes.
If there are any questions regarding these instructions or if any Versius Endoscopes
show signs of defects or damage, please contact CMR Surgical customer services. To
arrange the return of any aected endoscope, please contact CMR Surgical technical
support.
Manufactured for CMR Surgical Limited
1 Evolution Business Park, Milton Road, Cambridge CB24 9NG, UK
www.cmrsurgical.com
Email: [e-mail]
Tel: [phone]

8
Introduction
Full list of warnings
Versius Endoscopes are supplied
non-sterile and must be reprocessed
before rst use.
Follow the reprocessing instructions
in this user manual for eective
reprocessing of Versius Endoscopes.
Do not modify Versius Endoscopes.
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.
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, endoscopes.
Always seal the container with the
soaking endoscope inside before
sending it to sterile services. Sealing
the container prevents splashes of
contaminated uid.
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
coagulate proteins to the surfaces
of the Versius Endoscopes and may
result in ineective cleaning.
Handle contaminated endoscopes
according to local guidelines.
Do not use strong acidic (pH<7)
solutions, cleaners or rinse aids
as these may damage Versius
Endoscopes.
Do not use strong alkaline (pH>11)
solutions, cleaners or rinse aids
as these may damage Versius
Endoscopes.
Warning 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 an information point. Information points indicate important
reference information.

9
Introduction
Full list of warnings (continued)
Only trained healthcare professionals
and sterile services technicians
should handle and reprocess
Versius Endoscopes. Inadequate
handling may result in damage to, or
ineective reprocessing of, Versius
Endoscopes.
Do not soak or rinse the endoscope
or light cable adapter in hot water
as this could cause proteins to
aggregate, making it more dicult
for proteins to be removed.
Always ensure that the light cable
adapter is disassembled from the
endoscope (as described in Step 2
of initial manual cleaning) during
initial manual cleaning, full manual
cleaning, automated cleaning and
thermal disinfection, and by Step 4 in
preparation for sterilisation. Return
to the start of initial manual cleaning
if it is discovered at any stage of
reprocessing that the endoscope was
not disassembled.
Always soak the endoscope and light
cable adapter for the recommended
period of time to ensure they are
eectively cleaned.
Always brush the endoscope and
light cable adapter until there is no
visible soil.
Always use at least 5 brushstrokes
to brush the inside of the light cable
adapter. Failure to do so could result
in ineective reprocessing of the
endoscope and light cable adapter.
When brushing the endoscope and
light cable adapter ensure that the
brush used is a soft-bristled nylon
brush. Brushing with a hard, abrasive
brush could scratch the surface of
the endoscope or light cable adapter
which could leave cavities, making
it more dicult to clean, and could
cause pitting, leading to further
damage or rusting.
During full manual cleaning, always
rinse the endoscope and light cable
adapter under running critical water
for the recommended period of time
to ensure contaminants and residue
are removed.
Only use validated parameter
settings. Parameter settings that
have not been validated may
result in damage to, or ineective
cleaning and sterilisation of, Versius
Endoscopes.
Always use ISO15883 compliant
washer/disinfectors.

10
Introduction
Full list of warnings (continued)
Ensure that endoscopes and light
cable adapters are not touching or
shadowing each other when placed
into the washer/disinfector tray.
Failure to do so may result in damage
to, or ineective cleaning and
disinfection of, endoscopes and light
cable adapters.
Always repeat the entire cleaning
process, including initial manual
cleaning, if any residual soil is present
on the Versius Endoscopes and light
cable adapters during the inspection
stage.
When assembling the endoscope
before sterilisation, do not screw the
light cable adapter to the endoscope
too tightly. A looser connection
allows for a sucient ow of the
sterilisation medium and avoids
stress cracks. Tighten the connection
between the light cable adapter and
endoscope before use.
Always carefully inspect the
endoscope during every reprocessing
cycle. Inspect for any signs of damage
or residual soil. Failure to do so may
result in patient harm.
Ensure that endoscopes and light
cable adapters have been thoroughly
dried before sterilisation as any
moisture remaining could result in
ineective sterilisation.
If using a cloth to dry the endoscope
and light cable adapter, ensure
that the cloth is lint-free as lint
could cause contamination and/or
ineective sterilisation.
Always use a magnifying glass to
inspect the endoscope and light
cable adapter for any residual soil or
damage. Residual soil could cause
contamination and/or ineective
sterilisation.
Always use an appropriately sized
steam-permeable sterilisation peel
pouch or interleaved sterilisation
wrap in preparation for sterilisation.
Inappropriately sized sterilisation
peel pouches or sterilisation wrap
may result in damage or tearing of
the peel pouch or wrap and could
cause ineective sterilisation.
Always ensure that the
steam-permeable sterilisation peel
pouch or interleaved sterilisation
wrap does not have tears or damage.
Follow ISO11607-1 and EN868-2
and all applicable local and hospital
guidelines when packing the Versius
Endoscope for sterilisation.
Ensure that items placed in the
sterilisation tray are not touching
or shadowing as this could lead to
ineective sterilisation.

11
Introduction
Full list of warnings (continued)
Only use validated steam-permeable
sterilisation peel pouches or
interleaved sterilisation wrap.
Using sterilisation peel pouches or
sterilisation wrap that have not been
validated may result in damage to,
or ineective sterilisation of, the
endoscope.
Allow Versius Endoscopes to cool
down gradually to room temperature
before handling. Sudden changes
in temperature could result in
ineective sterilisation of Versius
Endoscopes.
The sterilisation process should
conform with ISO17665-1.

12
Introduction
Full list of information points
Begin endoscope point-of-use
soaking within 30 minutes of the
surgical procedure ending.
Start endoscope initial manual
cleaning within 4 hours of nishing
point-of-use preparation.
Do not use an ultrasonic bath when
reprocessing Versius Endoscopes.
Using an ultrasonic bath will damage
Versius Endoscopes.
Always brush the endoscope
and light cable adapter while the
endoscope and light cable adapter
are immersed to avoid splashes with
contaminated detergent or water.
The maximum pressure for
pressurised or medical air should be
5bar (73psi).
Stainless steel baskets can be
used when reprocessing Versius
Endoscopes. If using a basket, read
the instructions provided by the
basket manufacturer.

13
Introduction
Endoscope description
The Versius Endoscopes have shafts with a diameter of 10 mm and a working length of
300 mm. There are two types of endoscope:
●Straight 0º
●Angled 30º
For information and instructions on connecting the Versius Endoscopes to the Versius
Camera Head and on using the Versius Endoscopic Camera, see the Versius Surgical
System User Manual (REF 70000).
The Versius Endoscopes have the following features (labelled in Figures 1, 2 and 3):
●Tip and shaft (Figure 1)
●Glass surfaces (Figure 2)
●Light cable adapter (Figure 3)
●Light cable post (Figure 3)
Shaft
Tip
Figure 1 Versius Endoscope (assembled)

14
Introduction
Glass surfaces
Glass surfaces
Glass surfaces
Figure 2 Glass surfaces on the Versius Endoscope
Light cable adapter Light cable post
Figure 3 Versius Endoscope (disassembled)

15
Introduction
Receiving new endoscopes
Versius Endoscopes are shipped in non-sterile shipper boxes containing individual
boxes. Reprocessing is required before rst use.
Versius Endoscopes are supplied non-sterile and must be reprocessed before
rst use.
See the Instrument and Accessories Manual (REF 70050) for information on before use
inspection and checks.
Dropped or damaged endoscopes
If a Versius Endoscope has been dropped or damaged:
1. Clean and sterilise the dropped or damaged endoscope
2. Carry out the before use inspection and checks described in the Instrument and
Accessories Manual (REF 70050).
If the endoscope passes the inspection and checks, continue using as the endoscope as
normal. In the event that the endoscope does not pass the inspection and checks, do
not use the endoscope and contact CMR Surgical customer services. See page 7 for
contact details.
Disposal
Dispose of Versius Endoscopes following the hospital procedure for processing
biologically contaminated materials.

16

17
Reprocessing
quick reference

18
Reprocessing 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 Versius Endoscopes.
Using an ultrasonic bath will damage Versius Endoscopes.

19
Reprocessing quick reference
Point-of-use preparation
Step 1 Wipe o excess soil
(page 30)
Step 2 Fill container
(page 30)
Step 3 Place endoscope in container
(page 31)
Step 4 Seal container and transport
(page 32)

20
Reprocessing quick reference
Initial manual cleaning
Step 1 Remove endoscope from container
(page 38)
Step 2 Disassemble endoscope
(page 38)
Step 3 Soak endoscope and light cable adapter
(page 39)
Step 4 Rinse endoscope and light cable adapter
(page 41)
Step 5 Immerse endoscope and light cable adapter
(page 42)
Step 6 Brush endoscope and light cable adapter
(page 43)
Step 7 Rinse endoscope and light cable adapter
(page 44)
Proceed to main cleaning with ONE of the following methods:
Full manual cleaning continue to page 47
or
Automated cleaning
and thermal disinfection
continue to page 55