RESEARCH INSTRUMENTS 670807 RlWITNESS EMBRYOLOGY HEATED PLATE User Manual Installation manual

Download:
Mirror Download [FCC.gov]
Document ID	3897025
Application ID	O5DjroG2DfrN/nF9fdX7cg==
Document Description	Installation manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	67.34kB (841791 bits)
Date Submitted	2018-06-21 00:00:00
Date Available	2018-06-22 00:00:00
Creation Date	2017-12-13 10:06:19
Producing Software	Adobe PDF Library 15.0
Document Lastmod	2017-12-13 10:06:22
Document Title	Installation manual
Document Creator	Adobe InDesign CC 13.0 (Windows)

Installation and
Service Manual
RI WITNESS™
Embryology Heated Plate
+44 (0) 1737 243869 | customerservice@origio.com | origio.com
Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
Document 6-70-807IM | DRF 3728 | Issue 4 | 13 December 2017
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
Contraindications 
Applicable Part Numbers
Related Documents 
Compatibility
Installation
SECTION 3 - SAFETY WARNINGS
Safety/Information Symbols
Safety and Reliability
Temperature Safety
RFID Reader Environment
Startup / Shutdown Procedure
Guidance and Manufacturer’s Declaration (Part 15 of FCC) — Electromagnetic Emissions
Guidance and Manufacturer’s Declaration (IEC 60601-1-2) — Electromagnetic Emissions
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
SECTION 4 - INSTALLATION
Installation Checklist
SECTION 5 – SERVICE CHECKS AND PROCEDURES
12
Component and Connections Damage Checklists
12
Cleanliness
12
Research Instruments Ltd
Contents
RFID Tag Read Range Checklist
13
Temperature Calibration Checklist
13
SECTION 6 - REPAIRS AND RETURNS
14
Reuse Statement
14
RI Repairs System 
14
RI Returns System
14
Product Disposal (European Union)
14
Contact Details
14
Obligation to Inform
14
Research Instruments Ltd
Section 1
Preface
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.
Section 2
Introduction to RI Witness™
Research Instruments Ltd
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
assisted reproduction (AR) cycle.
only
0120
Contraindications
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, eg 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
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
6-70-121UM
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 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 effects of EMI disturbances, and reported when appropriate.
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.
All relevant sections of this manual should be read and understood fully before any use of RI Witness takes
place. 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.
Research Instruments Ltd
Section 3
Safety Warnings
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.
WARNING Refer to Guidance and Manufacturer’s Declaration Tables in this section of the
User Manual for guidance on the environment suitable for this device.
WARNING The temperature of the plate should not be more than 1.5ºC from the
displayed temperature at any time. A temperature of more than 1.5ºC will cause the
temperature inside the dish to change more rapidly and samples are at risk of overheating. In this instance samples should be removed from the plate immediately.
We recommend the plate temperature be monitored periodically using a calibrated
thermocouple thermometer.
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 specified 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 Embryology Heated Plate, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Section 3
Safety Warnings
Research Instruments Ltd
Safety/Information Symbols
Symbol
Meaning
Do not dispose of product with normal waste.
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
REF
The five 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.
Indicates the reference number.
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 proximity of metal objects or electrical
equipment
Do not place metal objects near reader.
Do not place electrical equipment near reader.
Startup / Shutdown 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.
To shutdown the device remove all electrical power by disconnecting the cable from the electrical outlet.
Section 3
Safety Warnings
Research Instruments Ltd
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
EN 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
Class A
Voltage fluctuations/
flicker emissions
EN 61000-3-3
Complies
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.
Section 3
Research Instruments Ltd
Safety Warnings
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
Electromagnetic
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 typical
± 2 kV common mode 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.
30A/M
30A/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
Mains power quality
should be that of a typical
commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Section 3
Safety Warnings
Research Instruments Ltd
Guidance and Manufacturer’s Declaration
— Electromagnetic Immunity
IMMUNITY Test
IEC 60601
Test level
Compliance
Electromagnetic environment - guidance
level
Conducted RF IEC
61000-4-6
3 Vrms
3 Vrms
Radiated RF IEC
61000-4-3
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V/m
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 Embryology Heated
Plate, including cables specified by the
manufacturer. Otherwise, degradation of
the performance of this equipment could
result.
Research Instruments Ltd
Section 4
Installation Checklist
SECTION 4 - INSTALLATION
Installation Checklist
The following steps must be completed in this order before the system is used:
1. Examine all components for damage that may have occurred during transport, storage or use.
i. Check for cracks in materials
ii. Check for sharp edges
iii. Check for damage to connectors
iv. Check for worn or damaged cables
2. Install software and perform database set up. Refer to 6-70-121IT RI Witness IT Requirements.
3. Position the device in the desired location and adjust the movable aperture as shown below for flush
fitted configurations.
i.
Positioning of Sit On Top Embryology Heated Plate (6-70-807)
The sit on top Embryology Heated Plate is intended to fit around a stereo zoom microscope
inside of your flow hood or on a workbench.
Initially place the heated plate so that the window is centred with the microscope optics. Adjust
the position forwards and backwards if required, ie if the front of the device obstructs the air
flow at the front of the cabinet then it can be moved back towards the microscope.
Move forwards and
backwards
Window centred with
microscope optics
Figure 4-1
Section 4
Installation Checklist
Research Instruments Ltd
Legs are also available enabling the Embryology Heated Plate to be supported when placed on top
of a stereo zoom microscope light base.
Figure 4-3
ii. Positioning of Flush Embryology Heated Plate (6-70-807-A/B)
The Flush Embryology Heated Plate should be mounted in a flow hood tray or other work surface prior
to being installed. Mounting guidelines can be provided by RI upon request as each installation needs
to be considered on an individual basis.
A movable aperture is provided on the underneath of the device which is intended to hide surfaces
beneath the device from view. The movable aperture can be adjusted forwards and backward in order
to centre it with the light source/microscope optics. Alternatively it can be removed completely if it is
not required.
Can be
flipped
over
Move forwards and
backwards
Figure 4-2
10
Research Instruments Ltd
Section 4
Installation Checklist
When installing a Flush Embryology Heated Plate the movable aperture will need to be adjusted in
order that it is centred with the microscope optics. Refer to Sit On Top section for details of movable
aperture adjustment.
To slide the movable aperture loosen the 4 screws, slide the aperture into the desired position then
re-tighten the screws. Note that to move the aperture into position in front and behind the centre line
of the window, it is necessary to turn the movable aperture over. The 4 screws will need to be removed
in order to do this. See “Figure 4-2” on page 10.
4. Connect the Power connections as described in the ‘Start up procedure’ section in 6-70-807UM RI
Witness Embrology Heated Plate User Manual.
5. Connect the USB A plug, that protrudes from the rear left corner of the Embryology Heated Plate,
into an available USB socket on the PC or Tablet. Verify the connection to the software as described in
‘Connecting to the Software’ section in 6-70-807UM RI Witness Embrology Heated Plate User Manual.
6. Go into the RFID Tuning Screen and check that all connected antennas have a green tick next to them.
7. Perform temperature calibration of all five heating channels as described in the ‘Temperature
Calibration’ section in 6-70-807UM RI Witness Embrology Heated Plate User Manual.
11
Section 5
Service Checklist and Procedures
Research Instruments Ltd
SECTION 5 – SERVICE CHECKS AND PROCEDURES
The following service activities should be performed to service an RI Witness work area.
Component and Connections Damage Checklists
1.
2.
3.
4.
Check data and power connections for security and damage.
Check cable layout.
Check for damage to all components.
Check that the power supply is positioned in a suitable location, ie where it cannot fall or get damaged.
Cleanliness
1. Where fitted, check that Tube Reader connections are clean and free from corrosion. Clean if required
(Refer to ‘Care and Maintenance’ section in 6-70-807UM RI Witness Embryology Heated Plate User
Manual).
2. Check cleanliness of both windows’ internal and external surfaces.
If required the lower glass can be removed from the underside of the Embryology Heated Plate for
cleaning purposes (see below). When cleaning the internal surfaces of the glass use an optical cleaning
wipe, or lint-free cloth moistened with isopropyl alcohol. It may be necessary to polish the glass
afterwards with a dry lint-free cloth to remove smears. Take care not to touch the two temperature
sensors attached to the surface of the glass.
3. To remove the lower window, first remove (4 screws) the movable aperture (if fitted) from the
heated plate. Take a note of the position before removing.
Remove one of the window clamp strips (2 screws) and loosen the others, then lift the glass. Adhere
a small piece of sticky tape to lift the glass if required.
Remove screws to
remove aperture
12
Figure 5-1
Section 5
Research Instruments Ltd
Service Checklist and Procedures
Remove
screws
Loosen
screws
Figure 5-2
Temperature Calibration Checklist
Verify that the temperature indicated by built in user interface and software matches a reading taken by
thermometer for all five heating channels. Refer to the ‘Temperature Calibration’ section of section in
6-70-807UM RI Witness Embrology Heated Plate User Manual.
13
Section 6
Repairs and Returns
Research Instruments Ltd
SECTION 6 - 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 in the RI Witness Embryology Heated Plate User Manual
(6-70-807UM).
2. If you require any further help contact your distributor or RI directly. RI will try to resolve the
problem as quickly as possible.
RI Returns System
1. Contact RI to obtain a Returned Materials Authorisation (RMA) number. Note: Goods will not be
replaced 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.
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 this device with ‘normal’ waste.
Contact Details
ORIGIO a/s, Knardrupvej 2, 2760 Måløv, Denmark
Tel: +44 (0) 1737 243869
E-mail: customerservice@origio.com
Website: www.origio.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.
14


---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : Yes
Language                        : en-GB
Tagged PDF                      : Yes
XMP Toolkit                     : Adobe XMP Core 5.6-c143 79.161210, 2017/08/11-10:28:36
Create Date                     : 2017:12:13 10:06:19Z
Metadata Date                   : 2017:12:13 10:06:22Z
Modify Date                     : 2017:12:13 10:06:22Z
Creator Tool                    : Adobe InDesign CC 13.0 (Windows)
Instance ID                     : uuid:b7947cac-f607-42a7-957b-c70aaaf0646b
Original Document ID            : xmp.did:5D15E1B0F992E311BBB297A26A6C4A7B
Document ID                     : xmp.id:45150fbe-53b6-4a49-b187-328c9297fc26
Rendition Class                 : proof:pdf
Derived From Instance ID        : xmp.iid:270703c1-246a-d14d-a655-411f52b06d55
Derived From Document ID        : xmp.did:49121931-444f-0d44-84be-d06caf5a320e
Derived From Original Document ID: xmp.did:5D15E1B0F992E311BBB297A26A6C4A7B
Derived From Rendition Class    : default
History Action                  : converted
History Parameters              : from application/x-indesign to application/pdf
History Software Agent          : Adobe InDesign CC 13.0 (Windows)
History Changed                 : /
History When                    : 2017:12:13 10:06:19Z
Format                          : application/pdf
Producer                        : Adobe PDF Library 15.0
Trapped                         : False
Page Count                      : 20
Creator                         : Adobe InDesign CC 13.0 (Windows)

EXIF Metadata provided by EXIF.tools