RESEARCH INSTRUMENTS 670807 RI Witness Embryology Heated Plate User Manual

Download:
Mirror Download [FCC.gov]
Document ID	3080949
Application ID	kyi9lDPq2dIpBmnYUmQFNQ==
Document Description	User manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	63.14kB (789202 bits)
Date Submitted	2016-07-29 00:00:00
Date Available	2016-07-29 00:00:00
Creation Date	2016-02-18 13:19:23
Producing Software	Adobe PDF Library 10.0.1
Document Lastmod	2016-02-18 13:19:27
Document Title	User manual
Document Creator	Adobe InDesign CS6 (Windows)

User Manual
RI WITNESS™
Embryology Heated Plate
RESEARCH INSTRUMENTS LTD
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com
www.research-instruments.com
Document 6-70-807UM, Issue P1, 18 February 2016
0120
only
Contents
Research Instruments Ltd
CONTENTS
SECTION 1 - PREFACE
SECTION 2 - INTRODUCTION TO RI WITNESS
Indications for Use for RI Witness Embryology Heated Plate
Applicable Part Numbers
Related Documents 
Compatibility
Installation
SECTION 3 - SAFETY WARNINGS
Guidance and Manufacturer’s Declaration (Part 15 of FCC)
— Electromagnetic Emissions
Guidance and Manufacturer’s Declaration (IEC 60601-1-2)
— Electromagnetic Emissions
— Electromagnetic Immunity
— Electromagnetic Immunity
Safety/Information Symbols
Safety and Reliability
Temperature Safety
RFID Reader Environment
Startup / Shutdown Procedure
SECTION 4 - PRODUCT OVERVIEW
Embryology Heated Plate
RI Witness Embryology Heated Plate Specification Table
10
SECTION 5 - RI WITNESS BASIC OPERATION
11
Startup Procedure
11
Shutdown Procedure
11
Connecting to the Software
11
User Interface
11
Achieving the Correct Sample Temperature
12
Changing the Temperature Setpoint Using the Device
13
Changing the Temperature Setpoint using a PC and RI Witness Work Area software
13
Research Instruments Ltd
Contents
CONTENTS
Temperature Calibration 
14
ITO Glass Window Calibration Using Built-In User Interface
14
Full 5-channel Calibration Using PC and RI Witness Work Area Software
15
Tube Reader Antenna Accessory 
16
SECTION 6 - TROUBLESHOOTING
17
Alarms and System Status
18
Audible Alarms
18
Alarm Conditions Codes
19
SECTION 7- CARE AND MAINTENANCE
23
Cleaning23
SECTION 8 - REPAIRS AND RETURNS
24
Reuse Statement
24
RI Repairs System 
24
Product Disposal (European Union)
24
RI Returns System
24
Contact Details
24
Obligation to Inform
24
Feedback24
Section 1
Preface
Research Instruments Ltd
SECTION 1 - PREFACE
Thank you for choosing RI Witness.
This manual provides all necessary information to use RI Witness Embryology Heated Plate 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 for more information.
If the operator is unsure of any of the information contained in this manual they 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 specifications 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 here of may be photocopied
or reproduced in any form without the prior written consent of RI.
This indicates cautionary text which should be followed to avoid injury to users or
damage to samples.
The system should be operated by qualified and trained personnel only.
Section 2
Research Instruments Ltd
Introduction
SECTION 2 - INTRODUCTION TO RI WITNESS
Indications for Use for RI Witness Embryology Heated Plate
To maintain the temperature of human reproductive tissue such as oocytes and embryos through an
assited reproduction (AR) cycle.
0120
only
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
Part Number
Description
6-70-807*
RI Witness Embryology Heated Plate
6-70-809
RI Witness Tube Reader
* 6-70-807 can be supplied in several configurations depending on the required mounting type eg flush
fitted or sit on top.
Related Documents
6-7-121UM
RI Witness Software Manual
Compatibility
RI Witness is used in conjunction with the following:
•
Essential medical devices, eg dishes and tubes, maybe AR or non-AR specific.
•
Non-essential medical devices, eg safety cabinets, incubators, micromanipulators, lasers.
•
Non medical devices (general laboratory equipment), eg work benches, microscopes, PCs.
This device is not intended to be exposed to known sources of electromagnetic Interference (EMI) with
medical devices such as diathermy, and electromagnetic security systems e.g., metal detectors and
electronic article surveillance system.
Installation
Installations of the RI Witness Embryology Heated plate should be carried out by a RI technician or
other RI authorised personnel. Incorrect installation could result in overall poor performance.
Section 3
Safety Warnings
Research Instruments Ltd
SECTION 3 - SAFETY WARNINGS
This symbol indicates cautionary text which should be followed to avoid injury to users
or damage to samples.
The system should be operated by qualified and trained personnel only.
DO NOT disassemble or modify any part of the RI Witness Embryology Heated plate, or
substitute any component for any other. Doing so may result in damage to samples. This
voids the warranty and/or service contract.
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 To avoid the risk of electric shock, this equipment must only be connected
to a supply mains with protective earth.
WARNING Not to be used in a patient environment.
Section 3
Research Instruments Ltd
Safety Warnings
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 complies with Industry Canada’s licence-exempt RSSs. 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.
Guidance and Manufacturer’s Declaration (IEC 60601-1-2)
— Electromagnetic Emissions
RI Witness is intended for use in the electromagnetic environment specified below. The customer or
the user of RI Witness should ensure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Compliance
Electromagnetic environment guidance
Group 2
RI Witness must emit electromagnetic energy in
order to perform its intended function. Nearby
electronic equipment may be affected.
Class B
Not applicable
Voltage fluctuations/
flicker emissions
RI Witness is suitable for use in all establishments
other than domestic and those directly connected
to the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Not applicable
IEC 61000-3-3
Section 3
Safety Warnings
Research Instruments Ltd
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
— Electromagnetic Immunity
IMMUNITY Test
IEC 60601
Test level
Compliance level
Electro magnetic
environment - guidance
Electrostatic discharge
(ESD)
± 8 kV contact
± 8 kV contact
± 15 kV air
± 15 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
IEC 61000-4-2
Electrical fast transient/
burst
± 2 kV for power supply ± 2 kV for power
lines
supply lines
IEC 61000-4-4
± 1 kV for input/output ± 1 kV for input/
lines
output Lines
Surge
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV differential
Mains power quality
Mode
should be that of a
± 2 kV common mode typical commercial or
hospital environment.
<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 continued
operation during power
mains interruptions, it
is recommended that
RI Witness be powered
from an uninterruptible
power supply or a
battery.
3A/m
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Section 3
Research Instruments Ltd
Safety Warnings
Guidance and Manufacturer’s Declaration
— Electromagnetic Immunity
IMMUNITY Test
IEC 60601
Test level
Compliance Electro magnetic environment level
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of RI Witness, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
d = [3.5/V 1] √p
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
3 Vrms
d = [3.5/V1] √p 80MHz to 800MHz
150 kHz to 80 MHz
d = [3.5/V1 √p 800MHz to 2.5GHz
3 V/m
where p is the maximum output
power rating of the transmitter in
watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m). Field
strengths from fixed RF transmitters,
as determined by an electromagnetic
site survey, a should be less than the
compliance level in each frequency
range. b Interference may occur in the
vicinity of equipment marked with the
following symbol:
80 MHz to 2.5 GHz
3 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters,
an electromagnetic site survey should be considered. If the measured field strength in the location
in which RI Witness is used exceeds the applicable RF compliance level above, RI Witness should be
observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating RI Witness.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V] V/m.
Section 3
Safety Warnings
Research Instruments Ltd
Safety/Information Symbols
Symbol
Meaning
Indicates instruction for disposal of goods.
In accordance with Annex II of the European
Medical Device Directive 93/42/EEC, as amended
by Directive 2007/47/EC under the supervision of
notified body No.0120, SGS, UK Ltd.
In accordance with the European Directive for
R&TTE, Directive 1999/5/EC
Indicates the medical device manufacturer.
Indicates the date of manufacture.
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.
Consult instructions for use.
SN
Only
The four digit number is a unique identifier
assigned to the product.
Caution: US Federal law restricts this device for
sale to or on the order of a licensed healthcare
practitioner.
Research Instruments Ltd
Section 3
Safety Warnings
Safety and Reliability
Please read this manual carefully and follow the instructions to ensure that the system will work safely
and reliably.
Temperature Safety
Safety is the responsibility of the laboratory. Risk assessment and working practices 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 heating systems, it is advisable to perform a periodic check of temperatures using a calibrated
thermocouple thermometer.
RFID Reader Environment
An RI Witness system uses Radio Frequency Identification (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 repositioning the reader and by the
proximity of metal objects or electrical equipment that were not present during installation and tuning.
If the device is relocated ensure that the autotuning procedure documented in the RI Witness Software
Manual (6-7-121UM) is followed to ensure optimum level of performance.
For cleaning the reader may be lifted and returned to the same position. See “Cleaning” on page 23
for more cleaning details.
Do not place metal objects near reader.
Do not place electrical equipment near reader.
Do not disconnect reader.
Do follow the startup/shutdown procedures.
Startup / Shutdown Procedure
RI Witness hardware may be damaged by incorrect startup and shutdown procedures.
“Section 5 - RI Witness Basic Operation” on page 11 describes the recommended startup and
shutdown procedure for the RI Witness Embryology Heated Plate.
Section 4
Product Overview
Research Instruments Ltd
SECTION 4 - PRODUCT OVERVIEW
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, firmware and software components, which can be
configured depending on the treatment activities, number of AR cycles conducted, size and layout of
the AR clinic.
RFID (radio frequency identification) 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 identifier. The unique
identifier is linked to a patient/couple (specific 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 confirmed on-screen. If containers containing
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 is specifically for the Embryology Heated Plate (and associated Tube Reader accessory) in
both its flush fitted and sit on top configuration.
Other devices in the RI Witness range have their own manuals, as does the software.
Embryology Heated Plate
Figure 4-1 Sit on Top Heated Reader
Figure 4-2 Tube Reader Accessory
Section 4
Research Instruments Ltd
Product Overview
RI Witness Embryology Heated Plate Specification Table
Part
Description
Temperature Sensor
5 x PT1000 (1 per Channel)
Electrical heating is controlled by a built-in 5-channel PWM temperature
controller:
Temperature Control
•
Channel 1-4: Work surface surrounding the ITO glass window is
divided into quarters
•
Channel 5: ITO glass window
Temperature controller accuracy: better than ±0.2°C when calibrated
against a known reference.
Displayed resolution: 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.
Connectivity
USB plug type A
Input: 85-264VAC (100-240VAC Nominal), 47-63Hz,
Power Supply
<3A , Class I
Output: 48VDC, Max 4.6A (220W)
Operating Conditions
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)
RFID Antennas
Embryology Heated Plate: 3 Antennas
Tube Reader Accessory: 2 Antennas
(5 Total)
RFID
50Ω Load at 13.56Mhz, 1W Max
Width: 460mm
Dimensions
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)
10
Section 5
RI Witness™ Basic Operation
Research Instruments Ltd
SECTION 5 - RI WITNESS BASIC OPERATION
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.
Figure 5-1 Power Supply In-Line Connector
Once the device is plugged in, it will display the current measured temperature on the display. The
status LED will remain off until the temperature has stabilised at the specified setpoint. The time 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 “Alarms and System
Status” on page 18 for more information).
RI suggests that you keep the RI Witness computers and work areas (including the Embryology Heated
Plate) switched on. This means that the heating and monitoring is constant.
Shutdown Procedure
To shutdown the device remove all electrical power by disconnecting the cable from the electrical
outlet.
Connecting to the Software
Plug the device into the tablet or PC (or attached USB hub) using the USB A cable that protrudes from
the device. Once the Windows operating system has recognised the devices within the Embryology
Heated Plate, open the RI Witness Work Area software. To verify that the RI Witness Work Area software
can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or
press the (i) icon). This will bring up the Work Area Status window where the ‘Embryology Reader’ and
‘Temperature Control’ should be listed in the Connected Devices section with a green tick next to them.
For more detailed set up information, refer to the RI Witness software manual (6-70-121UM).
User Interface
The Embryology Heated Plate contains a built in user interface which allows access to basic temperature
setpoint and calibration adjustment. A complete set of calibration options can only be accessed through
the RI Witness Work Area software.
Setpoint
Adjustment
Indicator Light
Up Button
Status
Indicator
Light
Down Button
Offset
Adjustment
Indicator Light
11
Temperature Display
(shows ITO glass
window temperature)
Settings
Button
Figure 5-2 User Interface
Section 5
Research Instruments Ltd
RI Witness™ Basic Operation
Achieving the Correct Sample Temperature
The heated plate is divided into 5 areas for calibration 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.
User Interface
Blue denotes
unheated area
Unheated Area
Top Left
Heated Area
Bottom Left
Heated Area
Window
Heated Area
Top Right
Heated Area
Red denotes
heated area
Bottom Right
Heated Area
Figure 5-3 Embryology Heated Plate Heated Areas
When working with multiple samples on the heated plate, it is recommended that only one sample is
placed on the window heated area at a time.
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 conditions, type of Petri dish and the sample preparation. After the system has
been installed in its operating location, the temperature of the heated plate should be adjusted to allow
for this difference.
We recommend using a thermometer calibrated to 37°C fitted 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 preparation and place it on the heated surface
in its normal position. Place the probe of the thermometer in the centre of the dish against the bottom
of the dish and allow the temperature reading to stabilise. Adjust the setpoint temperature until 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.
Figure 5-4 Thermometer Probe Positioned in a Petri Dish
12
Section 5
RI Witness™ Basic Operation
Research Instruments Ltd
Functions of the built-in user interface are shown below.
Changing the Temperature Setpoint Using the Device
The temperature setpoint is applied to all heating channels and is set using the following procedure, or
from within the RI Witness Work Area software. Refer to the RI Witness Software Manual (6-70-121UM)
for further information.
1. Press and hold the Settings button
for 3 seconds.
2. The Setpoint Adjustment Indicator light
will flash. The Temperature Display will now show
the current setpoint (not the current temperature).
3. Adjust the value shown on the Temperature Display using the Up
until the desired setpoint is shown.
and Down
4. Save the temperature by pressing and holding the Settings button
A beep will be heard.
for 3 seconds.
buttons
5. The Setpoint Adjustment Indicator light
will go out and the Temperature Display will now
show the current temperature. Once the temperature has stabilised at the setpoint, the green
Status Indicator Light will illuminate.
Note: To exit the setpoint adjustment mode without saving changes, do not press any buttons for a
short time and the device will return to normal operation (the Setpoint Adjustment Indicator light will
go out).
Changing the Temperature Setpoint using a PC and RI Witness Work Area
software
To change the setpoint using the RI Witness WorkArea software, click on the temperature displayed
at the bottom right hand side of the screen. This will bring up a pop up box with up and down arrows
which can be used to adjust the setpoint temperature. The temperature controller will then begin
controlling using the new settings .
After adjusting the setpoint temperature, check sample temperature inside the Petri dish.
13
Section 5
Research Instruments Ltd
RI Witness™ Basic Operation
Temperature Calibration
Note: It is only possible to calibrate the temperature of the ITO glass window using the built-in user
interface on the Embryology Heated Plate. To perform a full calibration of all 5 heated areas, this must
be done from within the RI Witness Work Area software.
Perform calibration only if the displayed temperature is different to the actual surface temperature of
any of the 5 heated areas. The process of calibration allows the user to manually adjust the temperature
so that the displayed temperatures match the temperature of the surface.
Before temperature calibration can be performed the device must be in the same conditions that it will
be in during normal operation. The temperature calibration is affected by ambient conditions.
Place the probe of a calibrated thermometer in good thermal contact with the surface.
Note: Simply touching the probe on the surface is not adequate. Use a purpose-made surface probe and
use thermal transfer paste. Products sold for computer heatsinks are suitable, and RI can also supply
suitable materials. Wait at least 30 minutes to allow the temperature to stabilise before calibrating.
Heated areas are divided as shown below, with the ‘X’ denoting recommended thermocouple positions
for calibration:
User Interface
Unheated Area
Top Left
Bottom Left
Top Right
Window
Bottom Right
Figure 5-5 Recommended Thermocouple Positions for Temperature Calibration
ITO Glass Window Calibration Using Built-In User Interface
During calibration using the built-in user interface close the RI Witness Work Area software to prevent
interference with the thermometer reading.
1. Position the thermocouple probe on the Window in the location shown above.
2. Press and hold the Settings
and
buttons simultaneously for 3 seconds.
will flash. The Temperature Display will
The Offset Adjustment Adjustment Indicator light
now show the current temperature (which may be a moving value).
and Down
3. Adjust the value shown on the Temperature Display using the Up
buttons until the temperature matches that shown on the external thermometer.
4. Save the calibration by pressing and holding the Settings button
be heard.
for 3 seconds. A beep will
will go out and the Temperature Display
5. The Offset Adjustment Adjustment Indicator light
will now show the current temperature with applied calibration. Leave the probe in position
14
Section 5
RI Witness™ Basic Operation
Research Instruments Ltd
and once the temperature has stabilised at the setpoint, check that the calibration is accurate.
Repeat the calibration process if necessary. The green Status Indicator Light will illuminate once
temperatures have stabilised.
6. After adjusting calibration check sample temperatures and adjust the setpoint temperature if
required.
Note: To exit the window calibration mode without saving changes, do not press any buttons
for a short time and the device will return to normal operation. The Offset Adjustment Indicator
light will go out.
Full 5-channel Calibration Using PC and RI Witness Work Area Software
Full calibration of the 5 heated areas requires that each of the areas is calibrated in turn.
1. Open the RI Witness Work Area software and navigate to the WorkArea Status window.
2. Click on the yellow triangle or the (i) icon then click Workarea Settings, then Connected
Devices, then Temperature Controller, then Check Calibration. The screen will now show the
current temperature and calibration offsets of the five different heated areas.
Note: RF will be switched off automiatically when on the Temperature Control screen.
3. Each heated area is independent so the order of calibration is not important. Position the
thermocouple probe in one of the positions shown above.
4. Allow the reading to stabilise, then compare the temperature shown in the Work Area software
with the thermometer reading.
5. A difference within ± 0.2°C is acceptable. If the readings are outside this increase the offset to
increase the reading displayed by the software, or decrease the offset to decrease the reading
displayed by the software.
Allow a small delay for the offset change to register. When changing the offset, the temperature
controller will then begin controlling using the new settings, so the surface temperature of that heated
area may take a short time to re-stabilise.
6. Repeat this process for all 5 heated areas.
7. Once calibration is complete it is advisable to verify the temperature of each heated area to
check that temperature calibration has been carried out effectively. After adjusting calibration,
check sample temperatures and adjust the setpoint temperature if required.
15
Section 5
Research Instruments Ltd
RI Witness™ Basic Operation
Tube Reader Antenna Accessory
The Tube Reader Antenna is an accessory for the Embryology Heated Plate that allows tags to be read in
a vertical orientation. It is specifically designed to read tags placed on tubes in the RI Tube Holder. The
Tube Reader Antenna is a passive device that only becomes powered when attached to the Embryology
Heated Plate. The correct mounting orientation position is shown below in Figure 5-6.
Tube Reader Antenna
Connections
Figure 5-6 Tube Reader Connections on the Embryology Heated Plate
Refer to “Section 7- Care and Maintenance” on page 23 for cleaning precautions relating to the Tube
Reader Antenna.
Tube Reader
Antenna
Figure 5-7 Tube Reader Correctly Mounted on the Embryology Heated Plate
16
Section 6
Troubleshooting
Research Instruments Ltd
SECTION 6 - TROUBLESHOOTING
Problem
Possible Cause
Loose connection
Antenna not tuned
Tags Reading
Intermittently or Only properly
in Certain Areas
RF Noise/interference
Solution
Check security of USB and power cable
connections.
Navigate to the Workarea Settings screen, then
click Connected Devices , then Embryology
Reader, then RFID Tuning, then Auto tune.
Other devices in the lab can cause RF noise/
interference, contact an RI service representative.
Faulty Device
Contact an RI Service representative.
Broken tag
Check the tag on another device.
Check security of USB and power cable
Poor/no connection or
connections. Verify that the light on the power
no power.
supply is illuminated.
Tag not encrypted
Tags Not Reading
17
Navigate to the Workarea Settings screen, then
click Connected Devices , then Embryology
Reader, then click the down arrow next to Tags.
Non encrypted tags are shown as Not Valid.
Navigate to the Workarea Settings screen, then
click Connected Devices , then Embryology Reader,
WorkArea configuration then RFID Tuning, to check that the number of
antennas (channels) is 5 for the Embryology Reader
with the Tube Reader Antenna Accessory.
Antenna not tuned
Navigate to the Workarea Settings screen, then
click Connected Devices , then Embryology
Reader, then RFID Tuning, then Auto tune.
Faulty Device
Contact RI or an RI Service Representative.
Section 6
Research Instruments Ltd
Troubleshooting
Alarms and System Status
The status of the temperature control system is shown by the Status Indicator Light positioned on the
user interface of the device.
Status Indicator Light Colour
On
Meaning / Priority
Please wait
Initial power up/setpoint/mode/calibration changed.
The light will be off until temperature of all heating systems is
within ±1°C of setpoint.
Green
Ready for use
Temperature of all heating systems within ±1°C of setpoint.
Yellow constantly on
Low Priority Alarm
Built-in user interface and RI Witness WorkArea software will
show current window temperature. Press the
or
buttons to cycle through the Alarm Condition Codes. Refer to
tables on the following pages for details of each code. Alarm
Condition Codes can be cleared by holding the
and
buttons simultaneously for 3 seconds. A beep will be heard to
confirm codes have been cleared. If the alarm sounds, finish the
current procedure and promptly investigate the cause of the
alarm.
Yellow flashing
Medium Priority Alarm
Built-in user interface and RI Witness WorkArea software will
or
show current window temperature. Press the
buttons to cycle through the Alarm Condition Codes. Refer to
the tables on the following pages for details of each code. Alarm
Condition Codes can be cleared by holding the
and
buttons simultaneously for 3 seconds. A beep will be heard to
confirm codes have been cleared.
When multiple alarms are active, the icon on the RI Witness WorkArea Software on the device and
Status Indicator Light for the highest priority alarm will be shown.
Note: For a full list of possible faults relating to each alarm condition and applicability of each alarm
condition, refer to the tables on the following pages.
Audible Alarms
Audible alarms are sounded to indicate Low and Medium Priority Alarms, as described
or
buttons,
above. When an alarm sounds, the alarm can be muted by pressing the
which also cycles through the Alarm Condition Codes. The alarm audio is automatically
un-muted each time a new alarm becomes active.
When multiple alarms are active, the audio for the highest priority alarm will be sounded. The alarm
volume is not adjustable. Low and medium priority alarms are sounded at the same level.
18
Section 6
Troubleshooting
Research Instruments Ltd
Alarm Conditions Codes
Alarm
Code
E01
Fault
Condition
ITO Window
Heating Failure
E02
Bottom Right
Heating Channel
Failure
Bottom Left
Heating Channel
Failure
Top Right
Heating Channel
Failure
Top Left Heating
Channel Failure
Failure Channel
ITO Window
Sensor Failure
(either main
sensor or
overheat
protection
sensor)
Bottom Right
Sensor Failure
Bottom Left
Sensor Failure
Top Right Sensor
Failure
Top Left Sensor
Failure
E03
E04
E05
E06
E07
E08
E09
E10
19
Priority
Low
Low/
Medium
Fault Description
Alarm
Actions
Heating
Heating system is not
able to heat the specified controller
heating channel. Alarm
power is set
to 0% for
will be activated 2
minutes after power
that heating
channel until
on if there is less than
device is
1.5˚C temperature rise
between 1 and 2 minutes restarted.
after power on. If the
temperature at 1 minute
is already within ± 2.5˚C
from the setpoint the
test is omitted.
No signal/out of range
signal from temperature
sensor. Alarm activates
at any time if the sensor
Low priority circuit fails to read a valid
alarm is
temperature.
activated
if the fault
occurs when
system is
switched
on. After
this time
a medium
priority
alarm is
activated
Heating
power is set
to 0% for
that heating
channel
until a valid
temperature
is read.
If the ITO
Window
main sensor
fails the
temperature
display will
shown
--.-˚C
Note: If the
ITO overheat
protection
sensor is
faulty, the
display will
still show
the current
temperature.
Solution
Restart the device
by removing mains
power then
re-connecting.
Possible sensor,
cable or controller
fault.
Section 6
Research Instruments Ltd
Alarm
Code
E11
E12
E13
E14
E15
E16
E17
E18
E19
E20
Fault
Condition
ITO Window
Heating
Channel Over
Temperature
Bottom Right
Heating
Channel Over
Temperature
Bottom Left
Heating
Channel Over
Temperature
Top Right
Heating
Channel Over
Temperature
Top Left Heating
Channel Over
Temperature
ITO Window
Heating Channel
Temperature
outside
± 1°C
Bottom Right
Heating Channel
Temperature
outside
± 1°C
Bottom Left
Heating Channel
Temperature
outside
± 1°C
Top Right
Heating Channel
Temperature
outside
± 1°C
Top Left Heating
Channel
Temperature
outside
± 1°C
Troubleshooting
Priority
Fault Description
Low /
Medium
Heating channel has
exceeded the maximum
allowable setpoint
If fault
temperature. Alarm
occurs when
activated at any time if
the system
the temperature sensor
is switched
exceeds 50˚C.
on
Medium
Heating channel has
deviated by more than
1˚C from the setpoint
temperature. Alarm
enabled 5 minutes after
the temperature reaches
±2.5˚C from the
setpoint temperature.
Alarm
Actions
Temperature
controller
power is set
to 0% until
temperature
falls to below
50˚C.
Solution
Possible heater or
controller fault.
Note: If the
temperature
continues to
rise past this
point, over
temperature
protection
built in to the
device will
shut down
the heating.
(See E27)
The
temperature
controller
continues to
operate to
bring back
within the
allowable
limits.
This may be caused
by placing either
hot or cold objects
on the device, in
particular the ITO
Window. In this
case either remove
the object or
wait a short time
for the setpoint
temperature to be
reached. Sudden
air movements
or temperature
change can also
cause minor
temperature
fluctuations. In
this case wait a
short while for
the temperature
controller to
respond.
20
Section 6
Troubleshooting
Alarm
Code
E21
E22
E23
E24
E25
E26
E27
E28
E29
E30
21
Fault
Priority
Condition
ITO Window
Medium
Heating Channel
Temperature
outside
± 2.5°C
Bottom Right
Heating Channel
Temperature
outside
± 2.5°C
Bottom Left
Heating Channel
Temperature
outside
± 2.5°C
Top Right
Heating Channel
Temperature
outside
± 2.5°C
Top Left Heating
Channel
Temperature
outside
± 2.5°C
ITO Window
Medium
Heating Channel
Low Heating
Rate
Bottom Right
Heating Channel
Low Heating
Rate
Bottom Left
Heating Channel
Low Heating
Rate
Top Right
Heating Channel
Low Heating
Rate
Top Left Heating
Channel
Low Heating
Rate
Research Instruments Ltd
Fault Description
Heating channel has
deviated by more than
2.5˚C from the setpoint
temperature. Alarm
enabled 5 minutes after
the temperature reaches
±2.5˚C from the
setpoint temperature.
Heating controller
did not achieve a
temperature within 2.5˚C
of the setpoint in 15
minutes from power on.
Alarm
Actions
The
temperature
controller
continues to
operate to
bring back
within the
allowable
limits.
Temperature
controller
continues to
operate.
Solution
This may be caused
by placing either
hot or cold objects
on the device, in
particular the ITO
Window. In this
case either remove
the object or
wait a short time
for the setpoint
temperature to be
reached. Sudden
air movements
or temperature
change can also
cause minor
temperature
fluctuations. In
this case wait a
short while for
the temperature
controller to
respond.
If the device is
operated in an
environment
where the ambient
temperature is
colder than the
specified operating
conditions or if
there is a large
amount of cold
airflow over the
device, then
this alarm may
triggered routinely.
If neither of these
conditions are
present, restart the
device. If the fault
reoccurs contact
an RI Service
personnel.
Section 6
Research Instruments Ltd
Alarm
Code
E31
Fault
Condition
Memory Fault
E32
Main Over
Temperature
Protection
Troubleshooting
Priority
Fault Description
Low
Memory/controller
fault. During normal use
controller has failed to
save data. When power
is switched off and
then on all values will
be returned to factory
defaults.
Medium
Main over temperature
protection is triggered
when the temperature
controller is not able to
limit heat supplied by
the device. Each heating
channel is fitted with a
standalone monitoring
system that shuts down
the device in the event
of a malfunction. The
protection operates at
approximately 65°C
Alarm
Actions
System
continues to
operate
until power
is removed.
When power
is returned
the screen
will show the
uncalibrated
temperature.
Yellow
flashing
Status
Indicator
Light
illuminates.
All heating is
switched off.
Solution
Recalibrate device.
If the problem
persists after recalibration then
there may be a
fault with the
controller. If the
problem is resolved
by recalibrating
then the memory
may have been
corrupted during
saving of values, eg
if the device loses
power whilst saving
values.
Contact RI Service
or distributor.
22
Section 7
Care and Maintenance
Research Instruments Ltd
SECTION 7- CARE AND MAINTENANCE
Cleaning
RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a soft cloth and
mild detergent. The device may be lifted and returned to its original location. Do not disconnect the
cables attached to the device.
If the Tube Reader Antenna is removed for cleaning be mindful to allow the contact surfaces on both the
Heated Plate and the Tube Reader Antenna to fully dry before reattaching to ensure cleaning products
are not trapped in the interface.
Do not use solvents for cleaning.
Do not disconnect readers.
Do not change the position of readers.
23
Research Instruments Ltd
Section 8
Repairs and Returns
SECTION 8 - REPAIRS AND RETURNS
Reuse Statement
Assuming RI Witness is regularly maintained and routinely serviced, it should perform as required for
a minimum of 7 years continual use, after which time we recommend you consider its replacement.
Should you notice impaired performance and/or any issues where safety is compromised, or have any
other concerns during the use of RI Witness, seek the advice of RI or their authorised representative
promptly.
RI Repairs System
In the event that you have a problem with a RI instrument, please follow the procedure below to ensure
prompt attention.
1. Read the ‘Troubleshooting’ section.
2. If you require any further help contact your distributor or RI directly. RI will try to resolve the
problem as quickly as possible.
Product Disposal (European Union)
If the product is no longer serviceable it must be sent back to RI to be destroyed in an
environmentally safe way. Do not dispose of RI Witness products with ‘normal’ waste.
RI Returns System
1. Contact RI to obtain a Returned Materials Authorisation (RMA) number.
Note: Goods will not bereplaced or refunded without prior agreement and clearly stating the
RMA number.
2. Pack the item carefully in its original packaging. RI will not accept responsibility for damage due
to incorrect packaging. Replacement items or additional repairs will be invoiced.
3. Clearly label the package with the RMA number, mark the package “Urgent - Returned Items For
Repair”, and ship to the address on the next page. Goods should be insured for their full value
during shipping.
Contact Details
Research Instruments Ltd, Bickland Industrial Park,
Falmouth, Cornwall, TR11 4TA, UK
Tel: +44 (0) 1326 372 753 Fax: +44 (0) 1326 378 783
E-mail: service@research-instruments.com
Website: www.research-instruments.com
Obligation to Inform
In compliance with the European Medical Device Directive 93/42/EEC as amended, it is your duty to
inform RI if you believe this device has, or may have, caused or contributed to the death of a patient or
user or to a serious deterioration in their state of health.
Feedback
Thank you for purchasing a RI product. To help RI develop the best tools for ART, we rely on customer
feedback. If you have any suggestions for how we can improve our products or the information we
provide with them, please send them to feedback@research-instruments.com. Your feedback will help
us develop the product and supporting materials to meet your future needs.
Thank you.
24


---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.7
Linearized                      : Yes
XMP Toolkit                     : Adobe XMP Core 5.3-c011 66.145661, 2012/02/06-14:56:27
Create Date                     : 2016:02:18 13:19:23Z
Metadata Date                   : 2016:02:18 13:19:27Z
Modify Date                     : 2016:02:18 13:19:27Z
Creator Tool                    : Adobe InDesign CS6 (Windows)
Instance ID                     : uuid:38a4eb8d-1072-4863-a23a-1cdb19b3604e
Original Document ID            : xmp.did:222ABD753592E311BF37A4FDECD85711
Document ID                     : xmp.id:6531DD2542D6E51195B5A1CF6E87E68F
Rendition Class                 : proof:pdf
Derived From Instance ID        : xmp.iid:6431DD2542D6E51195B5A1CF6E87E68F
Derived From Document ID        : xmp.did:21D9A14486D4E511A090AE7FCE5E85E0
Derived From Original Document ID: xmp.did:222ABD753592E311BF37A4FDECD85711
Derived From Rendition Class    : default
History Action                  : converted
History Parameters              : from application/x-indesign to application/pdf
History Software Agent          : Adobe InDesign CS6 (Windows)
History Changed                 : /
History When                    : 2016:02:18 13:19:23Z
Format                          : application/pdf
Producer                        : Adobe PDF Library 10.0.1
Trapped                         : False
Page Count                      : 28
Creator                         : Adobe InDesign CS6 (Windows)

EXIF Metadata provided by EXIF.tools