Cooper Surgical RI Witness 6-70-854 User manual

[phone] | [email protected] | fertility.coopersurgical.com
Research Instruments Ltd
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-70-854UM(5) | DRF 5438 | 9th June 2020
RI Witness™
Sperm Preparation Reader

Section 1
1
1
Research Instruments Ltd Preface
CONTENTS
SECTION 1 - PREFACE 1
SECTION 2 - INTRODUCTION TO RI WITNESS 2
Indication for Use for RI Witness System 2
Contraindication: 2
Applicable Part Numbers 2
Related Documents 2
Compatibility 2
Installation 2
SECTION 3 - SAFETY WARNINGS 3
Glossary of Safety/Information Symbols 4
Safety and Reliability 5
RFID Reader Environment 5
Guidance and Manufacturer’s Declaration (Part 15 of FCC)
— Electromagnetic Emissions 5
SECTION 4 - PRODUCT OVERVIEW 6
Sperm Preparation Reader 6
Sperm Preparation Reader Specication Table 6
Electrical Connections 7
Connection to the Software 7
Operation 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
Serious Incident Event 12
Feedback 12
Research Instruments LtdContents
SECTION 1 - PREFACE
Thank you for choosing RI Witness.
This manual provides all the necessary information to use RI Witness Sperm Preparation Reader
and should be read in conjunction with any manuals provided with other RI Witness hardware or
software components that you are using. The system should be operated by trained personnel
only. All sections of this manual should be read and understood fully before any operation of the
system. Please see the Intended Use section for more information.
If you are unsure of any of the information contained in this manual then you should contact
Research Instruments or an appointed representative before attempting 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 consequential
damages arising out of the use or inability to use this manual.
The information in this manual is current at the time of publication. Our commitment to
product improvement requires that we reserve the right to change equipment, procedures
and specications at any time. The latest version of the User Manual can be downloaded from
software.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 respective owners.
© This manual is protected by copyright, all rights reserved, and no part may be photocopied or
reproduced in any form without the prior written consent of RI.
Patents - please go to this web page to see the patents that protect this
product: www.csipatents.com
A hard copy of this user manual is available on request.
This indicates cautionary 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.
Research Instruments Ltd
Bickland Industrial Park,
Falmouth, Cornwall TR11 4TA, UK

Section 3
3
Safety WarningsResearch Instruments Ltd
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Section 2
Introduction
2
Research Instruments Ltd
2
SECTION 2 - INTRODUCTION TO RI WITNESS
Indication for Use for RI Witness System
To identify and track human samples, using RFID technology, through the assisted reproduction
(AR) cycle, including cryopreservation.
Contraindication:
This device is not intended to be exposed to known sources of electromagnetic interference
(EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID
components) and electromagnetic security systems, e.g. metal detectors and electronic article
surveillance systems.
Applicable indications for use are subject to the regulations 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 Software Manual
6-70-122UM RI Witness Manager Software Manual
Compatibility
RI Witness is used in conjunction with the following:
• Essential medical devices, e.g. dishes and tubes, maybe AR or non-AR specic.
• Non-essential 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 intention 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 potential eects of EMI disturbances, and reported when appropriate.
Installation
Installations of the RI Witness Sperm Preparation Reader should be carried out by a RI technician
or other RI authorised personnel. Incorrect installation could result in overall poor performance.
Part Number Descripon
6-70-854 RI Witness Sperm Preparation Reader
SECTION 3 - SAFETY WARNINGS
DO NOT disassemble or modify any part of the RI Witness Sperm Preparation Reader,
or substitute 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 protective 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 positioned 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 patient environment.
The system should be operated by qualied and trained personnel only.
This symbol indicates cautionary 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 operation. If such use is
necessary, this equipment and the other equipment should be observed to verify
that they are operating 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
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
WARNING Portable RF communications 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 Preparation Reader, including cables specied by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.

Section 3
Safety Warnings
4
Section 3
Research Instruments Ltd
5
Safety WarningsResearch Instruments Ltd
3 3
Glossary of Safety/Information Symbols
Source: ISO 15223-1
BS EN 60601-1
Safety and Reliability
Please read this manual carefully and follow the instructions to ensure that the system will work
safely and reliably.
RFID Reader Environment
An RI Witness system uses Radio Frequency Identication (RFID) readers to monitor a work area.
Readers detect RFID tagged containers that are placed in the work area.
The performance of RFID tag detection may be compromised by the proximity of metal objects
or electrical equipment that were not present during installation.
For cleaning, the reader may be lifted and returned to the same position. 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 domestic environment this product may cause radio
interference in which case the user may be required to take adequate measures.”
Guidance and Manufacturer’s Declaration (Part 15 of FCC)
— Electromagnetic 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 Communications Commision (FCC) Rules. These
limits are designed to provide reasonable protection 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 instruction
manual, may cause harmful interference to radio communications. Operation of this equipment
in a residential 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 contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation,
Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to
the following two conditions:
1. This device may not cause interference.
2. This device must accept any interference, including interference that may cause
undesired operation of the device.
Symbol Meaning Symbol Meaning
In accordance with Radio Equipment
Directive (RED) 2014/53/EU Serial number
Indicates the need for the user to
consult the instructions for use for
important cautionary information
such as warnings and precautions
that cannot, for a variety of reasons,
be presented on the medical device
itself.
Do not dispose of product
with normal waste. Disposal of
according to EU WEEE Directive
This electrical product is
independently certied by MET
to meet USA and Canadian safety
standards.
Direct current (DC)
This product complies with FCC
rules and regulations contained in
US FDA 47 CFR.
This way up
coopersurgical.com
Consult instructions for use -
coopersurgical.com
Hard copies available on request
Stacking limited to 3 units
Manufacturer Keep dry
Date of manufacture
Catalogue or Part number
S
S
N
N
3
0120
CooperSurgical.com
REF
REF
UL 61010-1
CSA C22.2 No. 61010-1
E113973

Section 5
7
RI Witness™ Basic OperationResearch Instruments Ltd
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Section 4
Product Overview
6
Research Instruments Ltd
4
SECTION 4 - PRODUCT OVERVIEW
Sperm Preparation Reader
RI Witness is a system which operates within an assisted reproduction (AR) clinic setting and
provides a method of identifying human samples throughout an AR cycle (from egg and sperm
collection to embryo transfer). The system is intended to minimise the risks associated with
traditional/manual double-checking and provides the essential 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 software components, which can be
congured depending on the treatment activities, number of AR cycles conducted, size and
layout of the AR clinic.
RFID technology provides the means of identifying 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 identier. The unique identier is linked to
a patient/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 identity and status is conrmed on-screen. If containers
holding samples of incompatible origin come into contact at any stage of this process, the
system activates an alarm and prompts the clinician to respond.
This manual refers only to the Sperm Preparation Reader.
Other devices in the RI Witness range have their own manuals, as does the software.
Sperm Preparation Reader Specification 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 connection 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)
Operating Conditions
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
Conditions
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
SECTION 5 - RI WITNESS BASIC OPERATION
Electrical Connections
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
position.
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 vertically 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 Connections
Thumb
Screw
Connection to the Software
Plug the device into the tablet or PC (or powered USB hub) using the USB cable provided
with the device. Once the Windows operating system has recognised the device, open the RI
Witness WorkArea software.
To verify that the RI Witness WorkArea software 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 Preparation Reader should be listed in the
Connected Devices section with a green tick next to it.
For more detailed set-up information, refer to the RI Witness Software Manual (6-70-121UM).
Figure 5-2 WorkArea Status
PowerMini USB
Cable Clamp
Silicone Tubes