Cooper Surgical RI WITNESS User manual

User Manual
RI WITNESS™
Embryology Heated Plate
[phone] | customerser[email protected] | coopersurgical.com
Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-70-807UM(6) | DRF 4740 | 29 April 2019
0120
Only

CONTENTS
 
 
Indicaons for Use for RI Witness Embryology Heated Plate 2
Contraindicaons 2
Applicable Part Numbers 2
Related Documents 2
Compability 2
Installaon 2
 
Glossary of Safety/Informaon Symbols 4
Safety and Reliability 6
Temperature Safety 6
RFID Reader Environment 6
Guidance and Manufacturer’s Declaraon (Part 15 of FCC) — Electromagnec Emissions 7
Guidance and Manufacturer’s Declaraon (IEC 60601-1-2) — Electromagnec Emissions 7
Guidance and Manufacturer’s Declaraon — Electromagnec Immunity 8
Guidance and Manufacturer’s Declaraon — Electromagnec Immunity 9
 
Embryology Heated Plate 10
RI Witness Embryology Heated Plate Specicaon Table 11
 
Startup Procedure 12
Shutdown Procedure 12
Connecng to the Soware 12
User Interface 12
Operator Posion 13
Achieving the Correct Sample Temperature 13
Research Instruments LtdContents

Changing the Temperature Setpoint Using the Device 14
Changing the Temperature Setpoint Using a PC and RI Witness WorkArea Soware 14
Temperature Calibraon 15
ITO Glass Window Calibraon Using Built-In User Interface 15
Full 5-channel Calibraon Using PC and RI Witness WorkArea Soware 16
Tube Reader Antenna Accessory 17
 
 
Temperature Control: Alarms and System Status 19
Audible Alarms 19
Alarm System Tesng 20
Alarm Condions Codes 20
 
Cleaning 24
Transport 24
Storage 24
 
 
Customer Service Contact details: 27
US only customers contact details: 27
CONTENTS
ContentsResearch Instruments Ltd

Secon 2
2
IntroduconResearch Instruments Ltd
2
Secon 1
1
1
Research Instruments LtdPreface

Thank you for choosing RI Witness.
This manual provides all necessary informaon to use RI Witness Embryology Heated Plate and
should be read in conjuncon with any manuals provided with other RI Witness hardware or soware
components that are being used. 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 for more informaon.
If the operator is unsure of any of the informaon contained in this manual they 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 here of 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.


To maintain the temperature of human reproducve ssue such as oocytes and embryos through an
assisted reproducon (AR) cycle.

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, eg 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 in
the country where the device is sold.


6-7-121UM RI Witness WorkArea Soware Manual
6-7-122UM RI Witness Manager Soware Manual

RI Witness is used in conjuncon with the following:
• Essenal medical devices, eg dishes and tubes, maybe AR or non-AR specic.
• Non-essenal medical devices, eg safety cabinets, incubators, micromanipulators, lasers.
• Non-medical devices (general laboratory equipment), eg 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ons of the RI Witness Embryology Heated plate should be carried out by a RI technician or
other RI authorised personnel. Incorrect installaon could result in overall poor performance.
 
6-70-807* RI Witness Embryology Heated Plate
6-70-809 RI Witness Tube Reader
* 6-70-807 can be supplied in several conguraons depending on the required mounng type, eg ush
ed or sit-on-top.
0120
Only

Secon 3
3
Safety WarningsResearch Instruments Ltd
3

disassemble or modify any part of the RI Witness Embryology Heated plate, or
substute any component for any other. Doing so may result in damage to samples. This
voids the warranty and/or service contract.
 To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protecve earth.
 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.
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.
Refer to Guidance and Manufacturer’s Declaraon Tables in this secon of the
User Manual for guidance on the environment suitable for this device.
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.
The temperature of the plate should not be more than 1.5ºC from the
displayed temperature at any me. A temperature of more than 1.5ºC will cause the
temperature inside the dish to change more rapidly and samples are at risk of over-
heang. In this instance samples should be removed from the plate immediately.
We recommend the plate temperature be monitored periodically using a calibrated
thermocouple thermometer.
There are no replaceable parts supplied with this device. Should any parts
need to be replaced, contact RI or your distributor.
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.
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 Embryology Heated Plate, including cables specied by the manufacturer.
Otherwise, degradaon of the performance of this equipment could result.

Secon 3
Safety Warnings
4
Secon 3
Research Instruments Ltd
5
Safety WarningsResearch Instruments Ltd
3 3

 
Do not dispose of product with normal waste
Disposal of according to EU WEEE Direcve
In accordance with Annex II of the European
Medical Device Direcve 93/42/EEC, as amended
by Direcve 2007/47/EC under the supervision of
noed body No.0120, SGS, UK Ltd.
In accordance with Radio Equipment Direcve
(RED) 2014/53/EU
Indicates the medical device manufacturer
Indicates the date of manufacture
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 medical device itself.
Consult instrucons for use
The ve digit number is a unique idener assigned
to the product
Cauon: US Federal law restricts this device for
sale to or on the order of a licensed healthcare
praconer
Indicates the reference number
Direct current (DC)
S
N
Only
REF
 
This way up
Fragile, handle with care
Stacking limited to 3 units
Keep dry
3
Source: ISO 15223-1
BS EN 60601-1
0120
0120

Secon 3
Safety Warnings
6
Secon 3
Research Instruments Ltd
7
Safety WarningsResearch Instruments Ltd
3 3
RI Witness is intended for use in the electromagnec environment specied below. The customer or
the user of RI Witness should ensure that it is used in such an environment.
Emissions test Compliance 
RF emissions
CISPR 11 Group 1
RI Witness must emit electromagnec energy in
order to perform its intended funcon. Nearby
electronic equipment may be aected.
RF emissions
CISPR 11 Class B
RI Witness is suitable for use in all establishments
other than domesc and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domesc
purposes.
Harmonic emissions
EN 61000-3-2 Class A
Voltage uctuaons/
icker emissions
EN 61000-3-3
Complies
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.

Please read this manual carefully and follow the instrucons to ensure that the system will work safely
and reliably.

Safety is the responsibility of the laboratory. Risk assessment and working pracces should comply with
local regulatory policies.
A warning triangle will be displayed on the work area touch screen and the status LED on the device
user interface will display a yellow status alarm if the currently selected temperature cannot
be maintained.
Gently place your hand on the heated surface to verify that the temperature is appropriate for use.
As with all heang systems, it is advisable to perform a periodic check of temperatures using a calibrated
thermocouple thermometer.

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 proximity of metal objects or electrical
equipment
Do not place metal objects near reader.
Do not place electrical equipment near reader.

RI Witness hardware may be damaged by incorrect startup and shutdown procedures.
“Secon 5 - RI Witness Basic Operaon” on page 12 describes the recommended startup and
shutdown procedure for the RI Witness Embryology Heated Plate.





Secon 3
Safety Warnings

Secon 3
Research Instruments Ltd
9
Safety WarningsResearch Instruments Ltd
3 3
 

Compliance



Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 6 GHz
3 Vrms
3 V/m
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 Embryology Heated
Plate, including cables specied by the
manufacturer. Otherwise, degradaon of
the performance of this equipment could
result.




 

 

Electrostac discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood,
concrete or ceramic le.
If oors are covered
with synthec material,
the relave humidity
should be at least 30%.
Electrical fast transient/
burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
± 1 kV for input/
output Lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV dierenal
Mode
± 2 kV common mode
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips, short
interrupons and voltage
variaons on power
supply input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT ) for
0.5 cycle
40 % UT
(60 % dip in UT) for 5
cycles
70 % UT
(30 % dip in UT) for 25
cycles
<5 % UT
(>95 % dip in UT)
for 5s
<5 % UT
(>95 % dip in UT ) for
0.5 cycle
40 % UT
(60 % dip in UT) for 5
cycles
70 % UT
(30 % dip in UT) for 25
cycles
<5 % UT
(>95 % dip in UT)
for 5s
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of RI Witness
requires connued
operaon during power
mains interrupons, it
is recommended that
RI Witness be powered
from an uninterrupble
power supply or a
baery.
Power frequency
(50/60 Hz)
magnec eld
IEC 61000-4-8
30A/M30A/MPower frequency
magnec elds
should be at levels
characterisc of a
typical locaon in a
typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to applicaon of the test level.

Compliance with the emissions requirements of CISPR 32 Class B requires the following warning:
“This is a class B product. In a domesc environment this product may cause radio interference in
which case the user may be required to take adequate measures.”

Secon 4
Product Overview

Secon 4
Research Instruments Ltd
11
Product OverviewResearch Instruments Ltd
4 4

Part 
Temperature Sensor 5 x PT1000 (1 per Channel)
Temperature Control
Electrical heang is controlled by a built-in 5-channel PWM temperature
controller:
• Channel 1-4: Work surface surrounding the ITO glass window is
divided into quarters
• Channel 5: ITO glass window
Temperature controller accuracy: beer than ±0.2°C when calibrated
against a known reference
Displayed resoluon: 0.1°C
Setpoint temperature range: 30-45°C
Displays 3 x 7-segment LED display shows the temperature reading from the
ITO glass window temperature sensor
Connecvity USB plug type A
For connecon to tablet or PC approved to IEC 60950-1 or IEC 62368
Power Supply
Input: 85-264VAC (100-240VAC Nominal), 47-63Hz,
<3A , Class I
Output: 48VDC, Max 4.6A (220W)
Operang Condions
Temperature: 15˚C (59˚F) to 40˚C (104˚F). Ambient temperature
must be > 5°C below setpoint
Humidity: 15% to 85% RH (Non Condensing)
Pressure Range: 70kPa to 108kPa
Transport/Storage
Condions
Temperature: -40˚C (-40˚F) to 60˚C (140˚F)
Humidity: 5% to 95% RH (Non condensing)
Minimum Pressure: 70kPa
RFID Specicaon Frequency: 13.56Mhz
Power: 1W
Dimensions
Width: 460mm
Depth: 220mm
6-70-807 Thickness: 20mm
6-70-807-A/-B Thickness: 34mm
Mass 6-70-807: 3.0kg (plus Power Supply 1.0kg)
6-70-807-A/-B: 5.0kg (plus Power Supply 1.0kg)

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 containing
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 is specically for the Embryology Heated Plate (and associated Tube Reader accessory) in
both its ush-ed and sit-on-top conguraons.
Other devices in the RI Witness range have their own manuals, as does the soware.

Figure 4-1 Sit on Top Heated Reader Figure 4-2 Tube Reader Accessory

Secon 5
RI Witness™ Basic Operaon
12
Secon 5
Research Instruments Ltd
13
RI Witness™ Basic OperaonResearch Instruments Ltd
5 5

The heated plate is divided into 5 areas for calibraon purposes. In order to achieve the correct sample
temperature, place the sample on top of the heated areas shown below. Do not place samples on top
of the User Interface.
Figure 5-4 Thermometer Probe Posioned in a Petri Dish
Figure 5-3 Embryology Heated Plate Heated Areas
User Interface
Top Le
Heated Area
Top Right
Heated Area
Boom Le
Heated Area
Boom Right
Heated Area
Temperatures within the Petri dish are adjusted by changing the setpoint temperature as described on
the next page. The temperature inside a Petri dish will normally be slightly lower than the heated plate,
depending on ambient condions, type of Petri dish and the sample preparaon. Aer the system has
been installed in its operang locaon, the temperature of the heated plate should be adjusted to allow
for this dierence.
We recommend using a thermometer calibrated to 37°C ed with a small thermocouple probe, such
as the RI IVF Thermometer to measure the temperature inside the Petri dish.
Prepare a Petri dish that mimics your normal Petri dish preparaon and place it on the heated surface
in its normal posion. Place the probe of the thermometer in the centre of the dish against the boom
of the dish and allow the temperature reading to stabilise. Adjust the setpoint temperature unl the
desired temperature in the dish is reached, allowing 20 minutes (or as long as required) in between
each setpoint change to allow the Petri dish temperatures to stabilise.
Window
Heated Area
Blue area not
temperature
controlled
Red denotes
heated area

The operator should be posioned in such a place to easily access the User Interface, work surface of the
device and the connected touch screen (if used with the RI Witness WorkArea soware).

Startup Procedure
To turn the device on, plug the power cable from the device into the power supply in-line connector
ensuring it is fully inserted. Then plug the power supply into the wall power outlet.
Once the device is plugged in, it will display the current measured temperature on the display. The
status LED will remain o unl the temperature has stabilised at the specied setpoint. The me to
reach this will vary according to the ambient temperature, but will generally be within 15-30 minutes.
Once the temperature has stabilised, the green status light will illuminate (see “Temperature Control:
Alarms and System Status” on page 19 for more informaon).
RI suggests that you keep the RI Witness computers and work areas (including the Embryology Heated
Plate) switched on. This means that the heang and monitoring is constant.
Shutdown Procedure
To shutdown the device remove all electrical power by disconnecng the cable from the electrical
outlet.

Plug the device into the tablet or PC (or aached USB hub) using the USB A cable that protrudes from
the device. Once the Windows operang system has recognised the devices within the Embryology
Heated Plate, open the RI Witness WorkArea soware. To verify that the RI Witness Work Area soware
can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or
press the icon). This will bring up the Work Area Status window where the ‘Embryology Reader’ and
‘Temperature Control’ should be listed in the Connected Devices secon with a green ck next to them.
For more detailed set-up informaon, refer to the RI Witness soware manual (6-70-121UM).

The Embryology Heated Plate contains a built-in user interface which allows access to basic temperature
setpoint and calibraon adjustment. A complete set of calibraon opons can only be accessed through
the RI Witness WorkArea soware.
Temperature
Adjustment
Indicator Light
Status
Indicator
Light
Audio O
Indicator Light
Temperature Display
(shows ITO glass
window temperature)
Sengs
Buon
Down Buon
Up Buon
Figure 5-2 User Interface
Figure 5-1 Power Supply In-Line Connector
Place only plasc or glass ware on the window heated area.
Ambient temperature must be >5°C from the setpoint for the temperature control
to work eecvely