Cooper Surgical RI WITNESS User manual

User Manual
RI WITNESS™
0120
Sperm Preparaon Reader
[phone] | customerser[email protected] | coopersurgical.com
Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-70-854UM (2) | DRF 4531| 7 June 2019

CONTENTS
SECTION 1 - PREFACE 1
SECTION 2 - INTRODUCTION TO RI WITNESS 2
Indicaon for Use for RI Witness System 2
Contraindicaon: 2
Applicable Part Numbers 2
Related Documents 2
Compability 2
Installaon 2
SECTION 3 - SAFETY WARNINGS 3
Glossary of Safety/Informaon Symbols 4
Safety and Reliability 5
RFID Reader Environment 5
Guidance and Manufacturer’s Declaraon (Part 15 of FCC)
— Electromagnec Emissions 5
SECTION 4 - PRODUCT OVERVIEW 6
Sperm Preparaon Reader 6
Sperm Preparaon Reader Specicaon Table 6
SECTION 5 - RI WITNESS BASIC OPERATION 7
Electrical Connecons 7
Connecon to the Soware 7
Operaon 8
Cleaning 8
SECTION 6 - TROUBLESHOOTING 9
RFID System 9
SECTION 7 - WARRANTY INFORMATION AND LIMITS ON LIABILITY 10
SECTION 8 - RETURNING PRODUCT TO RI FOR REPAIR 11
Customer Service Contact details 12
US only customers contact details 12
Obligaon to Inform 12
Feedback 12
Research Instruments LtdContents

Secon 1
1
1
Research Instruments Ltd Preface
SECTION 1 - PREFACE
Thank you for choosing RI Witness.
This manual provides all the necessary informaon to use RI Witness Sperm Preparaon Reader and
should be read in conjuncon with any manuals provided with other RI Witness hardware or soware
components that you are using. The system should be operated by trained personnel only. All secons
of this manual should be read and understood fully before any operaon of the system. Please see the
Intended Use secon for more informaon.
If you are unsure of any of the informaon contained in this manual then you should contact Research
Instruments or an appointed representave before aempng to use this equipment.
In no event does Research Instruments Ltd (RI) assume the liability for any technical or editorial errors
of commission, or omission; nor is RI liable for direct, indirect, incidental, or consequenal damages
arising out of the use or inability to use this manual.
The informaon in this manual is current at the me of publicaon. Our commitment to product
improvement requires that we reserve the right to change equipment, procedures and specicaons
at any me. The latest version of the User Manual can be downloaded from soware.research-
instruments.com. The RI Witness manual belongs with the RI Witness system and should be passed on
with the system if relocated to another clinic.
The use of ™ in this manual indicates a trademark of Research Instruments Ltd. Any other brand names,
referred to in this manual, are trademarks of their respecve owners.
© This manual is protected by copyright, all rights reserved, and no part may be photocopied or
reproduced in any form without the prior wrien consent of RI.
This indicates cauonary text which should be followed to avoid injury to users or damage
to samples.
The system should be operated by qualied and trained personnel only.

Secon 2
Introducon
2
Research Instruments Ltd
2
SECTION 2 - INTRODUCTION TO RI WITNESS
Indicaon for Use for RI Witness System
To idenfy and track human samples, using RFID technology, through the assisted reproducon (AR)
cycle, including cryopreservaon.
Contraindicaon:
This device is not intended to be exposed to known sources of electromagnec interference (EMI)
with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID components) and
electromagnec security systems, e.g. metal detectors and electronic arcle surveillance systems.
Applicable indicaons for use are subject to the regulaons of the country into which the device is sold.
Availability of RI Witness for clinical use is dependent on the regulatory approval status of RI Witness
within the country the device is intended to be sold into.
Applicable Part Numbers
Related Documents
6-70-121UM RI Witness WorkArea Soware Manual
6-70-122UM RI Witness Manager Soware Manual
Compability
RI Witness is used in conjuncon with the following:
• Essenal medical devices, e.g. dishes and tubes, maybe AR or non-AR specic.
• Non-essenal medical devices, e.g. safety cabinets, incubators, micromanipulators, lasers.
• Non medical devices (general laboratory equipment), e.g. work benches, microscopes, PCs.
This device has RFID reader capability. If it is the intenon that it be employed in a clinical lab, we
recommend its use alongside other medical devices and that the performance of these medical devices
be monitored for potenal eects of EMI disturbances, and reported when appropriate.
Installaon
Installaons of the RI Witness Sperm Preparaon Reader should be carried out by a RI technician or
other RI authorised personnel. Incorrect installaon could result in overall poor performance.
Part Number Descripon
6-70-854 RI Witness Sperm Preparaon Reader
0120

Secon 3
3
Safety WarningsResearch Instruments Ltd
3
SECTION 3 - SAFETY WARNINGS
DO NOT disassemble or modify any part of the RI Witness Sperm Preparaon Reader, or
substute any component for any other. Doing so may result in damage to samples. This
voids the warranty and/or service contract.
WARNING To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protecve earth.
ONLY use the power cable and power supply adaptor supplied with the system.
The cable to the power supply is the ‘disconnect device’ for this equipment. To remove all
electrical power from this product, disconnect the power cable from the electrical outlet.
Equipment should be posioned so as to allow easy access to the power cable. The appliance
coupler or mains plug is used as the disconnect and must remain readily operable.
WARNING Not to be used in a paent environment.
The system should be operated by qualied and trained personnel only.
This symbol indicates cauonary text which should be followed to avoid injury to users
or damage to samples.
WARNING Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operaon. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operang
normally.
WARNING There are no replaceable parts supplied with this device. Should any parts
need to be replaced, contact RI or your distributor.
WARNING Use of accessories, transducers and cables other than those specied or
provided by the manufacturer of this equipment could result in increased electromagnec
emissions or decreased electromagnec immunity of this equipment and result in
improper operaon.
WARNING Portable RF communicaons equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any
part of the Sperm Preparaon Reader, including cables specied by the manufacturer.
Otherwise, degradaon of the performance of this equipment could result.

Secon 3
Safety Warnings
4
Research Instruments Ltd
3
Glossary of Safety/Informaon Symbols
Source: ISO 15223-1
BS EN 60601-1
Symbol Meaning
In accordance with the Radio Equipment Direcve 2014/53/EU
Indicates the need for the user to consult the instrucons for use for important cauonary
informaon such as warnings and precauons that cannot, for a variety of reasons, be
presented on the device itself
Manufacturer
Date of manufacturer
Reference number
Serial number
Consult Instrucons for use
Direct Currrent
Do not dispose of product with normal waste
Disposal of according to EU WEEE Direcve
This way up
Fragile, handle with care
Stacking limited to 3 units
Keep dry
3
S
N

Secon 3
5
Safety WarningsResearch Instruments Ltd
3
Safety and Reliability
Please read this manual carefully and follow the instrucons to ensure that the system will work safely
and reliably.
RFID Reader Environment
An RI Witness system uses Radio Frequency Idencaon (RFID) readers to monitor a work area.
Readers detect RFID tagged containers that are placed in the work area.
The performance of RFID tag detecon may be compromised by the proximity of metal objects or
electrical equipment that were not present during installaon.
For cleaning, the reader may be lied and returned to the same posion. See “Cleaning” on page 8
for more details.
Do not place metal objects near reader.
Do not place electrical equipment near reader.
USA Only
Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
“This is a class A product. In a domesc environment this product may cause radio interference in
which case the user may be required to take adequate measures.”
Guidance and Manufacturer’s Declaraon (Part 15 of FCC)
— Electromagnec Emissions
Note: This equipment has been tested and found to comply with the limits for a Class A digital device,
pursuant to part 15 of the Federal Communicaons Commision (FCC) Rules. These limits are designed
to provide reasonable protecon against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequency energy and,
if not installed and used in accordance with the instrucon manual, may cause harmful interference
to radio communicaons. Operaon of this equipment in a residenal area is likely to cause harmful
interference in which case the user will be required to correct the interference at their own expense.
Note: This device complies with Industry Canada’s licence-exempt RSSs. Operaon is subject to the
following two condions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause undesired
operaon of the device.

Secon 4
Product Overview
6
Research Instruments Ltd
4
SECTION 4 - PRODUCT OVERVIEW
Sperm Preparaon Reader
RI Witness is a system which operates within an assisted reproducon (AR) clinic seng and provides
a method of idenfying human samples throughout an AR cycle (from egg and sperm collecon to
embryo transfer). The system is intended to minimise the risks associated with tradional/manual
double-checking and provides the essenal controls necessary to ensure eggs, sperm and embryos are
correctly matched and treated during the AR process.
The RI Witness system comprises hardware, rmware and soware components, which can be
congured depending on the treatment acvies, number of AR cycles conducted, size and layout of
the AR clinic.
RFID technology provides the means of idenfying the containers (dishes, tubes) in which eggs, sperm
and embryos are transferred and stored. The containers are labelled by a clinician with a special RFID
tag which has been assigned a unique idener. The unique idener is linked to a paent/couple
(specic parentage).
As samples are processed as part of an AR cycle, RFID readers (both heated and non-heated) read the
tags on the container and their identy and status is conrmed on-screen. If containers holding samples
of incompable origin come into contact at any stage of this process, the system acvates an alarm and
prompts the clinician to respond.
This manual refers only to the Sperm Preparaon Reader.
Other devices in the RI Witness range have their own manuals, as does the soware.
Sperm Preparaon Reader Specicaon Table
Part Descripon
RFID Reader Frequency: 13.56 MHz
Power Output: 1W
No. of Antennas: 3
Read Range: Anywhere within the footprint of the product
Power Supply Input: 100-240VAC, 50-60Hz, <3A , Class I, 0.8-0.4A
Output: 12VDC 2.5A Max (30W)
USB USB 2.0 Socket Type Mini B
For connecon to tablet or PC approved to IEC 60950-1 or IEC 62368
Material(s)
Corian (Curved Baseplate),
Powder Coated Stainless Steel (Side Antennas)
ABS (Lower Cover)
Aluminium (Rear and lower covers)
Operang Condions
Temperature: 10˚C (50˚F) to 42˚C (108˚F)
Humidity: 15% to 85% RH (Non condensing)
Pressure: Pressure Range: 70kPa. to 108kPa.
Storage/Transport
Condions
Temperature: -40˚C (40˚F) to 60˚C (140˚F)
Humidity: 15% to 85% RH (Non - condensing)
Pressure: Pressure Range: 70kPa. to 108kPa.
Dimensions
Width: 276 mm
Length: 234 mm
Height: 148.5 mm
Mass 2.9kg + Power supply 0.3kg

Secon 5
7
RI Witness™ Basic OperaonResearch Instruments Ltd
5
SECTION 5 - RI WITNESS BASIC OPERATION
Electrical Connecons
1. In order to secure the USB and power cable into the device there are two silicone tubes
provided that need to be placed around each cable before the cables are clamped in posion.
2. Remove the thumb screw from the cable clamp at the rear of the device.
3. Plug both cables into their connectors with the cables running vercally down.
4. Ret the cable clamp and thumb screw such that the silicone tube is clamped in the slots in the
cable clamp.
Figure 5-1 Hardware Connecons
Thumb Screw
Connecon to the Soware
Plug the device into the tablet or PC (or powered USB hub) using the USB cable provided with the
device. Once the Windows operang system has recognised the device, open the RI Witness WorkArea
soware.
To verify that the RI Witness WorkArea soware can communicate successfully, navigate to the
WorkArea Status window, by clicking the yellow triangle or pressing the icon. This will bring up the
WorkArea Status window in which the Sperm Preparaon Reader should be listed in the Connected
Devices secon with a green ck next to it.
For more detailed set-up informaon, refer to the RI Witness Soware Manual (6-70-121UM).
Figure 5-2 WorkArea Status
PowerMini USB
Cable Clamp
Silicone Tubes

Secon 5
RI Witness™ Basic Operaon
8
Research Instruments Ltd
5
Operaon
The Sperm Preparaon Reader detects tagged containers that are brought into the work area. When a
sample is to be transferred between containers, bring both containers into the work area. The Sperm
Preparaon Reader will detect the tags and the RI Witness system will record the step.
Cleaning
The Sperm Preparaon Reader may be cleaned with a so cloth and mild detergent. The device may be
lied and returned to its original locaon. Do not disconnect the cables aached to the device.

Secon 6
9
TroubleshoongResearch Instruments Ltd
6
SECTION 6 - TROUBLESHOOTING
RFID System
Problem Possible Cause Soluon
Tags Not Reading
Metal near reader Remove any metallic objects from the area, check
if the tags reappear in the Work Area
Loose or no connecon
Check security of USB and power cable
connecons. Verify that the light on the power
supply is illuminated
RF noise or interference
Other electrical devices in the lab can cause RF
noise/interference. If a portable electronic device
has been brought close to the device, remove it
and check if the tags reappear in the Work Area
Broken tag Check whether the tag is readable by a dierent
RI Witness device. If it is not, discard that tag
Antenna tuning
problem
Navigate to the Work Area Sengs screen,
then click Connected Devices, then Sperm
Prep Reader, then RFID Tuning, check that all 3
channels have green cks next to them. If any
have a yellow warning triangle next to them,
contact an RI service representave

Secon 7
10
Research Instruments Ltd
7
Warranty Informaon & Limits on Liability
SECTION 7 - WARRANTY INFORMATION AND LIMITS ON LIABILITY
Research Instruments Limited (RI) warrants that this item will be free from defects in materials and
workmanship for one year from the date of installaon. If RI determines that the product fails to
conform to that warranty during the one-year period, RI will repair or replace the product, at RI’s
discreon, free of charge.
To return the product to RI, a customer must comply with RI’s Returned Goods Policy described in
this manual and the warranty requires the customer to return the product to RI in accordance with
the RI Returns Instrucon. RI will return products (that it repaired or replaced under warranty) to the
same customer who returned those products, at RI’s expense F.O.B. the customer’s facility. Under all
other circumstances, RI will return products to the same customer who returned those products at the
customer’s expense.
RI’s warranes do not cover damage caused by misuse, improper care, improper use of chemicals or
cleaning methods, loss, the, use of non-authorized parts servicing by non-authorized personnel or
negligent or intenonal conduct on the part of the owner or user of the product, nor do they cover
normal wear and tear or general maintenance. Any modicaons or changes to a product will void that
product’s warranty. RI’s warranes do not apply to any single- or limited-use, disposable or consumable
components or items.
RI is not responsible for, and the owner and operator of the product shall defend, indemnify and
hold harmless RI from and against, all claims, damages, and other losses resulng from the improper
servicing, maintenance, repair use or operaon of the product or the owner or operator’s negligence
or willful misconduct, and use of inadequate packing and packaging when returning product for repair.
The above warranes are in lieu of, and RI hereby disclaims, all other warranes, express or implied,
wrien or oral, with respect to RI’s products, including the warranes of merchantability and tness for
a parcular purpose. No terms, condions, understandings or agreements that purport to modify the
above warranes or that make any addional warranes for any RO product shall have any legal eect
unless made in wring and signed by an authorized RI corporate ocer.
RI shall not under any circumstances be liable for lost prots, damages from loss of use or lost data, or
indirect, special, incidental or consequenal damages under its warranes or otherwise for any claim
related to RI’s products, even if RI has been advised, knew or should have known of the possibility
of such damages. RI’s liability with respect to a product covered by a warranty or otherwise shall be
limited in all circumstances to the purchase price of that product.

Secon 8
11
Returning Product to RI for RepairResearch Instruments Ltd
8
SECTION 8 - RETURNING PRODUCT TO RI FOR REPAIR
Please refer to the ‘Troubleshoong’ secon in this manual before returning product to RI. If you
connue to have a problem with your device, please follow these instrucons:
Goods will be accepted for return for the following reasons:
• If shipment was made without the customer’s authorizaon or order
• If incorrect items were shipped
• If defecve items were shipped
• If defecve goods are covered by the standard warranty
To return product, you must contact Customer Service for a Returned Merchandise Authorizaon (RMA)
number. Items will not be accepted without an RMA number. Please have the following informaon:
• Reason you wish to return the goods
• Quanty, descripon, part number, serial number of the goods
• Date of receipt of order
• Customer’s purchase order and the CooperSurgical or Origio invoice number
All used products must be cleaned and sterilized prior to shipment. A signed decontaminaon
declaraon may be required.
All products should be carefully and adequately packed, preferably in original packaging. Replacement
items or addional repairs will be invoiced.
All packaging should be clearly labeled with the RMA number and statement “Urgent – Returned Items
for Repair”.
Return Address:
Research Instruments Ltd,
Bickland Industrial Park,
Falmouth, Cornwall, TR11 4TA, UK
Shipments must be sent prepaid by the customer and insured for their full value during shipping. Freight
collect shipments will not be accepted, and goods will be returned to sender.
If Customer intends to return equipment ordered in error, the following restocking charges and terms
will apply:
• 25 percent within 60 days from date of shipment
• Goods must be returned unused, in the original carton, and in marketable condion
• Refurbishing and replacement charges will be added to the restocking charges for damaged
or missing items
• No return aer 60 days
• No refund on sterile, single-use disposable products

Secon 8
Returning Product to RI for Repair
12
Research Instruments Ltd
8
Customer Service Contact details
Tel: [phone]
Fax: [phone]
E-mail: cus[email protected]
coopersurgical.com
US only customers contact details
Tel: [phone]
Fax: [phone]
coopersurgical.com
Obligaon to Inform
Any serious incident that has occurred in relaon to this device should be reported to customerservice@
origio.com and the competent authority of the Member State in which the user and/or paent is
established.
Please provide customer service with full details of the incident including any applicable serial or LOT
numbers. In some instances, it may be necessary to return the device to the manufacturer to assist in
their invesgaon of the incident.
Feedback
Thank you for purchasing a CooperSurgical RI product. To help us develop the best tools for ART, we
rely on customer feedback. If you have any suggesons for how we can improve our products or the
informaon we provide with them, please send them to cust[email protected]. Your feedback
will help us develop the product and supporng materials to meet your future needs.
Thank you