RESEARCH INSTRUMENTS 670854 RI Witness Sperm Prep Reader User Manual

RESEARCH INSTRUMENTS LTD RI Witness Sperm Prep Reader

User Manual

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User Manual
RI Witness™
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 6-70-121UM, Issue 13, 26th January 2015, MRF 1636
CONTENTS
SECTION 1 - PREFACE
SECTION 2 - INTRODUCTION TO RI WITNESS™
Intended Use
Medical Device Component
Applicable Part Numbers
2
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
Guidance and Manufacturer’s Declaration
— Electromagnetic Immunity
Safety/Information Symbols
Safety and Reliability
Temperature Safety
Mains Power Supply
10
RFID Reader Environment
10
Startup / Shutdown Procedure
10
SECTION 4 - PRODUCT OVERVIEW
11
Data Capture
12
Imaging12
Traceability13
Cryo13
RI Witness™ Work Area
13
RI Witness™ Manager for Traceability, Data Capture and Imaging
14
RFID Overview
15
The Shared RI Witness™ Database
15
Hardware Overview
16
Work Area Reader Types
16
Multiplexer
17
Control Units
17
CONTENTS
Unheated Control Unit
17
Heated Control Unit
18
Auto Tuning Readers
18
RF Calibration
19
RI Witness™ Work Area Specification Table
20
SECTION 5 - RI WITNESS™ BASIC OPERATION
21
Introduction
21
RI Witness™ RFID tags
22
Tagging Plasticware
22
Dishes and Pots
22
Tubes22
Handling RFID Tags
23
How to Switch On
24
System Information
24
To Open the System Information
25
How to Shut Down a Work Area
25
Logging In
25
Auto Logon
25
Logging Out
26
The WorkArea Interface
27
Performing A Procedure in RI Witness™
28
Beginning a New Cycle in RI Witness™
28
Witness Point Confirmation
30
Double Witness Points
30
Question Witness Points
31
Record Witness Points
32
Unassigned Tags
32
Tag Mismatch
33
Unassigned Tag Removal
33
Record Location of Tags
34
Training Mode
35
Clear Demo Tables (legacy work areas for pre software version 2.3 only)
Admin Assign
35
36
Discards36
Cycle Summary
37
CONTENTS
Daily Lists
37
Windowed Work Area
37
Language and Keyboard Layout
38
Foot Pedal Control
38
To Rename the Work Area
39
To Change the Location of a Work Area
39
To View Work Area Locations or Disable a Work Area
40
Alarm if Tags Left in Work Area
40
SECTION 6 - RI WITNESS™ MANAGER
42
Logging In
42
License Management
42
License Request Form
43
Database Management
45
Initial Screen - Main Menu Buttons
46
Home46
How to Configure the Home Screen
Patients
47
48
Entering New Patient Details into RI Witness™ Manager
48
Editing Existing Patient Details
49
Looking Up Patient Histories
49
Assigning Donor Status 
50
Assigning Partners
50
Cycle Types
51
Starting a New Cycle
51
Assign a Cycle Type
51
Collection and Transfer Dates
52
Cycle Status
52
Revert Status 
52
RI Patient Identity Labels
53
Printing Patient Labels
54
Label Styles
55
Operator Management
55
Operator Details
56
Group Membership
56
Enabled Operators
56
Operator PIN
56
CONTENTS
Clinic Details
56
Mismatch Comments In RI Witness™ Manager
57
The Witness Point Diagram
58
Links59
Reassigned Tags
59
Unassigned Tags
59
Witness Point Inputs
60
Multiple Sources of the Same Tag Type
60
Multiple Tag Types
60
Entry Witness Points
60
Double Witness Points
60
Donor Witness Points
61
Tagged Donations
61
Untagged Donations
62
Witness Point Questions
62
Witness Point Order
63
The Witness Point Log
63
Tag Types
63
Explore the Witness Point Log 
64
Witness Point Log Statistics
64
SECTION 7 - CRYO WITNESSING
65
An Introduction to Cryo Witnessing
65
Printing Barcodes
65
Scanning Barcodes
67
SECTION 8 - RI WITNESS™ MANAGER FOR TRACEABILITY
68
Managing Materials
68
Material Types
68
Material Type Details
69
Notes on GS1 Barcodes
Cycle Types
70
70
Creating a New Batch
70
Deleting a Batch
72
Batch Status
72
Expired Batches
73
View All Batches
74
CONTENTS
Patients - Managing Treatment Cycles
Excluding and Including Batches for a Cycle
74
74
SECTION 9 - DATA CAPTURE
75
An Introduction to Data Capture for Data Collection
75
Collected Data Setup
75
Parameter Configuration
76
Numerical Parameters
76
Text Parameters
76
List Parameters
77
Check Parameters
77
Date, Time and Date Time Parameters
78
Calculation Parameters
78
Built In Parameters
78
Sheet Contents
78
Shared Between Sheets
79
Treatment Cycle Sheets
80
Viewing and Editing Sheets
80
Editing Sheets at the Work Area Touch Screen
80
Viewing and Editing Sheets with RI Witness™ Manager
82
Egg Parameters
82
The Number of Eggs
84
Egg Count Parameter
84
Egg Count Conflict
84
Sheets and Witness Points
86
Cycle Summary Sheets
86
Parameter Attributes
87
Initial Value
87
Editable88
Required88
SECTION 10 - IMAGING
89
How to View Live Images 
89
Multiple Screen Configuration
89
How to Take a Picture 
90
How to Record Video 
91
How to Zoom & Pan the Image 
91
CONTENTS
How to Perform Measurements 
91
How to Select Cameras 
92
Camera Flipping 
92
How to Set the Preset Zoom 
92
How to Configure the Foot Pedal/Keyboard 
92
How to Select Objectives 
92
How to Add Objectives 
93
How to Remove Objectives 
93
How to Check Objective Calibration 
93
Patient Display
93
Use of Saturn™ Laser Systems with RI Witness™ 
94
How to Access Saturn Laser System Information from a Work Area
94
SECTION 11 - TROUBLE SHOOTING
95
SECTION 12 - TEMPERATURE CALIBRATION 
97
Temperature Profile
97
Temperature Profile Checklist
Temperature Calibration
Temperature Calibration Service
Touch Screen Calibration Checklist
SECTION 13- CARE AND MAINTENANCE
97
97
98
99
100
Cleaning100
SECTION 14 - REPAIRS AND RETURNS
101
Reuse Statement
101
RI Repairs System 
101
Product Disposal (European Union)
101
RI Returns System
101
Contact Details
101
Obligation to Inform
101
Feedback102
Section 1
RI Witness™ RFID Tags
Research Instruments Ltd
SECTION 1 - PREFACE
Thank you for choosing RI Witness™.
The RI Witness™ family of products is made up of RI Witness™, Data Capture, Traceability, Imaging and
Cryo.
This manual provides all necessary information to use RI Witness™. 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™
Intended Use
For RI Witness™ heated work areas only.
To identify and track human samples through the assisted reproduction (AR) cycle and where required,
to maintain sample temperature.
Contraindications: There are no contraindications associated with the use of this device.
Medical Device Component
The heated plate (and temperature control) components of this system are classified as a class
II medical device in accordance with Article 9, Annex IX, rule 9 of the Directives 93/42/EEC &
2007/47/ EC, ie it ‘administers or exchanges energy’ to or from the human body. In respect
of the RI Witness™ system, energy is emitted in the form of heat, to or from the AR sample.
There is no direct patient contact.
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
6-70-801
Sit on Top Heated Work Area Assembly
6-70-801/C
Sit on Top Heated Work Area Assembly with Card Reader
6-70-801/T
Sit on Top Heated Work Area Assembly with Test Tube Reader
6-70-801/TC
Sit on Top Heated Work Area Assembly with Card and Test Tube Reader
6-70-802
Flush Fitted Heated Work Area 1 Channel Assembly
6-70-802/C
Flush Fitted Heated Work Area 1 Channel Assembly with Card Reader
6-70-802/T
Flush Fitted Heated Work Area 1 Channel Assembly with Test Tube Reader
6-70-802/TC
Flush Fitted Heated Work Area 1 Channel Assembly with Card and Test Tube Reader
6-70-803
Slim Heated Work Area Assembly
6-70-803/C
Slim Heated Work Area Assembly with Card Reader
6-70-803/T
Slim Heated Work Area Assembly with Test Tube Reader
6-70-803/TC
Slim Heated Work Area Assembly with Card and Test Tube Reader
6-70-804
Flush Fitted Heated Work Area 2 Channel Assembly
6-70-804/C
Flush Fitted Heated Work Area 2 Channel Assembly with Card Reader
6-70-804/T
Flush Fitted Heated Work Area 2 Channel Assembly with Test Tube Reader
6-70-804/TC
Flush Fitted Heated Work Area 2 Channel Assembly with Card and Test Tube Reader
Section 2
Introduction
Research Instruments Ltd
Part Number
Description
6-70-805
ITO Reader
6-70-805/C
ITO Reader with Card Reader
6-70-805/T
ITO Reader with Test Tube Reader
6-70-805/TC
ITO Reader with Card Reader and Test Tube Reader
6-70-806
Sit on Top Heated Work Area 2 Channel Assembly
6-70-806/C
Sit on Top Heated Work Area 2 Channel Assembly with Card Reader
6-70-806/T
Sit on Top Heated Work Area 2 Channel Assembly with Test Tube Reader
6-70-806/TC
Sit on Top Heated Work Area 2 Channel Assembly with Card and Test Tube Reader
6-70-852
Sperm Preparation Work Area Assembly
6-70-852/C
Sperm Preparation Work Area Assembly with Card Reader
6-70-853
Unheated Work Area Assembly
6-70-853/C
Unheated Work Area Assembly with Card Reader
6-70-853/T
Unheated Work Area Assembly with Test Tube Reader
6-70-853/TC
Unheated Work Area Assembly with Card and Test Tube Reader
Compatibility
RI Witness™ is used in conjunction with the following:
•
Essential medical devices - dishes and tubes, maybe AR or not-AR specific.
•
Non essential medical devices - safety cabinets, incubators, micromanipulators, lasers.
•
Non medical devices (general laboratory equipment), eg work benches, microscopes, PCs.
Installation
Installations of RI Witness™ should be carried out by a RI technician or other RI authorised personnel.
Incorrect installation could result in overall poor performance.
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™, 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
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 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 his 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
IEC 61000-3-3
Not applicable
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
Guidance and Manufacturer’s Declaration
— Electromagnetic Immunity
IMMUNITY Test
IEC 60601
Test level
Compliance level
Electro magnetic
environment - guidance
Electrostatic discharge
(ESD)
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 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
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency
± 2 kV for power supply ± 2 kV for power
lines
supply lines
± 1 kV for input/
± 1 kV for input/output
output Lines
lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
± 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.
(50/60 Hz)
magnetic field
IEC 61000-4-8
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 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
Research Instruments Ltd
Safety Warnings
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 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.
Follow instructions for use.
SN
Only
The first four digits are a unique identifier assigned
to the product and the last 2 digits signify the year
of manufacture, eg 5001/13 (this denotes a unique
serial number of 5001 and a year of manufacture
of 2013).
Caution: US Federal law restricts this device for
sale to or on the order of a licensed healthcare
practitioner.
Section 3
Safety Warnings
Research Instruments Ltd
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 on the control unit display if the
currently selected temperature cannot be maintained.
A touch screen warning triangle will also be shown if temperature control has been disabled using the
Turn Off button.
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.
Research Instruments Ltd
Section 3
Safety Warnings
Mains Power Supply
Products from RI require a stable and noise free power supply ( 100V - 240V ). The supply must provide
an earth connection.
The RI Witness™ control unit for heated readers contains a mains power supply.
Do not remove the cover from any RI Witness™ product.
RFID Reader Environment
An RI Witness™ system uses readers to monitor a work area. Readers detect RFID tagged containers
that are placed in the work area.
Each reader is individually tuned to its environment and must not be repositioned after installation. The
performance of RFID tag detection may be compromised by repositioning readers and by the proximity
of metal objects or electrical equipment that were not present during installation.
For cleaning, readers may be lifted and returned to the same position. See “Cleaning” on page 100 for
more cleaning details.
Do not move readers.
Do not place metal objects near readers.
Do not place electrical equipment near readers.
Do not disconnect readers.
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” describes the recommended startup and shutdown procedure
for the RI Witness™ work area.
10
Section 4
Product Overview
Research Instruments Ltd
SECTION 4 - PRODUCT OVERVIEW
Welcome to the User Manual for the Research Instruments (RI) RI Witness™ System.
RI Witness™, Data Capture, Traceability, Imaging and Cryo are members of the RI Witness™ family
of products. RI Witness™ products share a common database usually referred to as the “Witness”
database.
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.
Computer
Control Unit
RFID Test
Tube Reader
Multiplexer
RI Witne
ss
Touch Screen
RFID Tag
Sit on Top Heated
Work Area Reader
Figure 4-1 RFID tag communicating with various antennas
An antenna is incorporated into a work area reader. A control unit feeds an RF signal to the antenna. An
RFID tag is passive until energised by the signal from the antenna. The energised tag then transmits an
identification code back to the same antenna. See Figure 4-1.
An AR procedure is conducted within the monitored work area. The procedure is defined by a sequence
of Witness Points which are presented on the touchscreen.
11
Section 4
Research Instruments Ltd
Product Overview
Data Capture
Hand written notes are often taken whilst performing laboratory procedures. For example embryo
scores and sperm volumes might be written down on a data sheet and later manually transcribed into
a clinic fertility database.
The features of Data Capture allow data sheets to be designed in RI Witness™ Manager and data entry
to be performed in the laboratory using the work area touch screen. See Figure 4-2.
Data entry may also be performed in RI Witness™ Manager.
Figure 4-2
Lower: Data entry using a RI Witness™ WorkArea touchscreen
Upper: Data sheet design using RI Witness™ Manager
Imaging
With the Imaging feature, you are able to capture images and videos from every microscope in the
laboratory, at every stage of the patient cycle, in real time. All the latest information on a cycle can be
accessed immediately from any networked PC. Images can also be sent to the embryo room to show
the patient prior to embryo transfer.
The Imaging feature is compatible with RI Integra™ and Saturn™ lasers.
Figure 4-3 Example of patient view shown in embryo room
12
Section 4
Product Overview
Research Instruments Ltd
Traceability
Traceability is a software product that links patient treatment cycles with the batches of materials that
are in use.
A barcode reader may be used to scan batches as they are delivered or made ready for use.
The links between treatment cycles and material batches may be explored to generate various reports,
for example a report showing all patients that have been exposed to a particular material batch.
Cryo
The Cryo feature extends the RI Witness™ security system, allowing patient samples to be tracked as
they enter and leave cryo storage, creating a complete record of the patient cycle.
A barcode reader is placed at the work area and used to scan a sample in or out of the cryo storage.
RI Witness™ Work Area
Figure 4-4 An RI Witness™ work area
RFID tagged items are displayed on a touchscreen running RI Witness™ WorkArea software.
A typical RI Witness™ work area includes a PC, touchscreen, one or more tag readers and an RF control
unit. The work area PC runs RI Witness™ WorkArea software to present an operator interface on the
touch screen. See Figure 4-4.
The data presented on the touchscreen is generated from the shared Witness database, all work area
events are logged to the shared Witness database.
13
Research Instruments Ltd
Section 4
Product Overview
RI Witness™ Manager for Traceability, Data Capture and Imaging
RI Witness™ Manager runs on any Windows PC and provides Witness, Data Capture, Cryo, Traceability
and Imaging functionality.
The “patients” RI Witness™ Manager page is used by all operators, the “materials” RI Witness™ Manager
page is unique to Traceability operators and the “witness points” page is unique to Witness operators.
See Figure 4-5.
Figure 4-5 RI Witness™ Manager is used by RI Witness™, Data Capture, Traceability, Imaging and Cryo
14
Section 4
Product Overview
Research Instruments Ltd
The Shared RI Witness™ Database
An example RI Witness™ installation is shown in Figure 4-6. Four work areas with RI Witness™ WorkArea
software, two RI Witness™ Manager PCs and an admin reader PC share a common RI Witness™
database. Traceability, RI Witness™ and Data Capture management functions may be performed at
each RI Witness™ Manager PC.
Work Area
Lab
Manager
Work Area
Lab
Manager
Shared RI Witness™ Database
Work Area
Admin Reader
Work Area
Figure 4-6 The RI Witness™ database is shared by All RI Witness™ WorkArea and RI Witness™ Manager PCs
RFID Overview
Radio-frequency identification (RFID) is the technology used by RI Witness™ to identify tagged
plasticware.
A control unit feeds an RF signal to a matched antenna. An RFID tag is passive until energised by the
signal from the antenna. The energised tag then transmits an identification code back to the same
antenna. See Figure 4-1.
An RFID system works on the principle of inductive coupling, which requires that the antenna be tuned
to match the frequency in use and optimised for the physical environment. Specific cable lengths must
be used for all RF connections.
Each RI Witness™ work area requires a computer, a control unit and at least one antenna. Multiple
antenna work areas require a multiplexer to switch the RF signal between antennas.
Antennas are built into RI Witness™ Readers.
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Research Instruments Ltd
Product Overview
Hardware Overview
Work Area Reader Types
Readers detect RFID (Radio Frequency Identification) tags using tuned antennas. The test tube reader
(2 axis) and the sperm preparation reader (3 axis) use one tuned antenna for each axis. All other readers
use a single tuned antenna.
A flush fitting variant of the heated reader is available, this is integrated into the surface of the safety
cabinet for ease of use. Legs can be fitted to allow further integration with other light bases.
Figure 4-7 ITO reader
Figure 4-10 Sit on top heated reader
Figure 4-12 RFID Test tube reader
Figure 4-8 Card reader
Figure 4-9 Admin reader
Figure 4-11 Sit on top unheated reader
Figure 4-13 Sperm preparation reader
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Product Overview
Research Instruments Ltd
Multiplexer
A multiplexer distributes RF power to multiple antennas.  A multiplexer can feed up to four antennas.
Figure 4-14 An RI multiplexer
Control Units
Control units provide the RF power for readers. They may be used for heated or non-heated work areas
depending on the procedures conducted there.
Unheated Control Unit
The unheated control unit may be used with a multiplexer to drive up to four antennas.
Figure 4-15 Back panel of unheated control unit
Connections:
1. Mains socket
2. USB to PC
3. RF Coaxial OUT to multiplexer or heated reader
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Research Instruments Ltd
Product Overview
Heated Control Unit
The heated control unit contains a temperature controller and may be used with a multiplexer to drive
up to four antennas.
Figure 4-16 Back panel of heated control unit
Connections:
1. RF Coaxial OUT to multiplexer or heated reader
2. USB to PC
3. Heater cable to reader
4. Mains socket
Auto Tuning Readers
Figure 4-17 Sperm preparation reader
Connections:
1. Place the reader in the desired area
2. Remove the cable clamp
3. Connect the power supply
4. Connect the Mini-USB connector
5. Replace the retaining bracket and tighten screw
6. Connect the USB-A connector to the PC, Tablet or USB
Connections are made up of a USB A-B cable and a power supply. The power supply is a 12V power
supply and is external to the device.  The USB is a standard USB 2.0 cable. These are located on the rear
of the device and held in place by a retaining bracket and screw.
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Product Overview
Research Instruments Ltd
RF Calibration
Calibration of the RI Witness™ Sperm Prep Reader is made a lot simpler by having an automatic tuning
system. The procedure for this is as follows.
1. Open RI Witness™ WorkArea. Make sure the RFID reader and Multiplexer are detected.
Figure 4-18
2. Click the Change Settings button on the bottom right of this window.
3. From this you will see the Workarea Settings window. Click on the RFID Reading tab to bring up
the RFID Configuration Window.
Figure 4-19
4. For the Sperm Prep, set the Antenna Configuration to 3. The next thing to do is to click on
Autotune. This will tune the antennas for the area they are situated in. Every time the device is
moved this will need to be done. This will take a few moments but when done the SWR for each
channel should show a value of 1-50. If there are any RI tags in the work area, then they will be
displayed in the grey box.  You are now ready to use the RI Witness™ Sperm Prep Reader.
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Research Instruments Ltd
Product Overview
RI Witness™ Work Area Specification Table
Part
Description
Heating Systems*
Heated metal and glass.
Temperature Sensor*
Digital 14-bit SHT-15 or Analogue PT1000.
Displays*
LCD Display. Accurate to 1 decimal place.
Connectivity
USB Type B socket for connection to PC. Connected PC to be compliant
with IEC 60950-1.
Supply Voltage
100-240VAC, 50-60Hz, Max. 2.6A, Class I.
Operating Temperature*
Temperature: 10°C (50°F) to 42°C (107.6°F).
Humidity: 15% to 85% RH (Non Condensing).
Heater Channels*
2 Channel 1 22VDC at 6A Max. Channel 2 22VDC at 1A max.
RFID
50Ω Load at 13.56Mhz 1.4W Max. I-4 Antennas.
*For heated work areas only
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Section 5
RI Witness™ Basic Operation
Research Instruments Ltd
SECTION 5 - RI WITNESS™ BASIC OPERATION
Introduction
RI Witness™ uses one or more readers to monitor RFID tagged containers in a work area.
The work area interface is presented on a touch screen. See Figure 5-1. The operator touches screen
buttons to log in and select Witness Points.
Figure 5-1 The RI Witness™ WorkArea interface is presented on a touch screen
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Research Instruments Ltd
RI Witness™ Basic Operation
RI Witness™ RFID tags
Tagging Plasticware
Before use in the work area, all plasticware must be RFID tagged and labelled with patient identity.
Rectangular, circular and square tags are available. See Figure 5-2. The sample identity may be assigned
to the RFID tag once the tagged plasticware is placed in a RI Witness™ work area.
Dishes and Pots
RFID tags must be positioned on the base of dishes and pots. The square tag, positioned diagonally, is
recommended for a four well dish.
Do not pre assign. Identity should be assigned as samples are transferred into the
plasticware.
If tagging plasticware in advance of procedures, it is recommended that you test the
tag on a reader prior to transferring patient sample.
Tubes
The rectangular tag is recommended for tubes. Position the long edge of the tag along the length of
the tube and hold in place using tape or a patient identity label. Position tags near the top of tubes to
ensure they are not obscured by thermal blocks or tube warmers.
Square
Tag
Square Tag
Rectangular
Tag
Rectangular Tag
Bridge
Bridge
Peel from here
+ UPM
18 mm
Chip
36 mm
18 mm
18 mm
Peel from here
Circular
Tag
Circular Tag
Dia 43.8mm
+ UPM
Chip
Time-lapseTag
Tag
Time-Lapse
Bridge
Bridge
Chip
375_1
Chip
Peel from here
12 mm
22 mm
Peel from here
Figure 5-2 RI Witness™ tags
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Research Instruments Ltd
Handling RFID Tags
When removing tags, bend the backing strip away from the tag, rather than the tag away from the
backing strip. This will reduce the risk of damaging tags.
1. Start peeling the backing strip away at the “peel from here” point shown in Figure 5-3 to achieve
a peel line as shown.
andbridge
bridge line
chipChip
and
line
peellineline
Peel
Figure 5-3
2. When sticking the tag to the dish, bring the tag into contact with the dish at one point. Then use
your finger or thumb to work the tag onto the dish with a circular movement, moving away from
the initial contact point so as to avoid any kinks in the tag as it sticks to the dish. See Figure 5-4.
Figure 5-4
Storing Tags and Tagged Labware
Unused tags and unused tagged plasticware should not be stored on or near a surface (safety cabinet
or workbench) where a RI Witness™ reader is located.
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RI Witness™ Basic Operation
How to Switch On
RI suggests that you keep the RI Witness™ computers and work areas switched on. This means that the
heating and monitoring is constant.
If you have switched off a heated RI Witness™ work area, please allow 45 minutes for the work area to
return to the required temperature. Please check there is power at the wall socket, the PC and touch
screen (or tablet) and control tower.
You may want to check the work area heating and touch screen calibration for accuracy before
commencing work. See “Section 12 - Temperature Calibration” on page 97.
System Information
The system information panel will show:
1. Version numbers for software and firmware
2. Work area location
3. Database version
4. Licensing status including Imaging dongle
5. RFID reader status and multiplexer
6. Temperature control status
7. Saturn™ Laser System status, serial number, firmware details
8. Camera status
9. Integra™ status
Figure 5-5
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Research Instruments Ltd
To Open the System Information
1. Press the Information
icon in the work area or click the Settings
icon from the Imaging
screen.
2. The System Information window shows the current state of the RI Witness™ system.
3.
Indicates there is no problem.
4.
Indicates a problem needs resolving.
5. In system Information, clicking on the closed Padlock
at the bottom of the page will unlock
all the existing configuration settings and also reveal the following settings that are hidden when
the System Information is locked:
• Keyboard / foot pedal controls
• Auto logon
• Language
• Screen configuration
The System Information is locked by default and clicking on the Padlock again will re-lock the settings.
How to Shut Down a Work Area
Do not switch off any RI hardware whilst the WorkArea software is running. To log out, select the user
name, and then select Quit in the user name window. The system will then shut down. See Figure 5-8.
Logging In
It is important to ensure that all RI Witness™ hardware is switched on before the work area software
is activated.
The RI Witness™ software may be activated automatically when the computer is started. If not, double
click the RI Witness™ WorkArea desktop icon.
Figure 5-6 RI Witness™ WorkArea icon
To log in either touch Login, then your username or scan your operator ID tag and enter the appropriate
4 digit PIN if requested.
Note: Operators can change the PIN assigned by the administrator and may assign an ID tag. See Figure
5-9.
Auto Logon
After unlocking the system information, screen navigate to the auto logon section. There you can set up
the username and password (of the machine) for RI Witness™ to auto logon the PC.
1. Click System Information.
2. Unlock settings.
3. Click AutoLogon.
4. Click Yes to the user Account Control message.
5. Enter the details required (contact IT department if unsure).
6. Click Save to Registry.
7. Tick AutoLogon.
Figure 5-7 AutoLogon
8. Click the close window cross.
On installation of the application the application shortcut is placed in the start-up. This causes the work
25 area to automatically start with windows.
Research Instruments Ltd
Section 5
RI Witness™ Basic Operation
Figure 5-8 Logging into RI Witness™
Figure 5-9 RI Witness™ WorkArea logon and PIN entry windows
Logging Out
Log out of the work area when you have finished your procedures by pressing your Username in the
top right corner, then the Red Cross
. An automatic logout may be programmed after a period of
inactivity. This is set using the RI Witness™ Manager Settings page.
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Research Instruments Ltd
The WorkArea Interface
The WorkArea interface screen is divided into 7 regions. See Figure 5-10 .
Emily
Figure 5-10 The WorkArea interface
1. Current patient
This region shows the current patient name, date of birth and ID. When tags from both partners
are present the name shown will be the female patient. The partner’s name will appear in
brackets.
2. Recent history
The recent history region presents the four most recent actions that have been recorded against
the current patient, eg witness points (action/protocol step), operator mismatches, etc. A
timestamp and operator name are also shown.
3. Work area
The work area region displays an icon for each RFID tag detected by the work area. As
tags progress through the witness points of a procedure they are assigned and reassigned
appropriately. A question mark icon will be shown for any tags that have yet to be assigned an
identity by the RI Witness™ system.
4. Status
The status region summarises the work area contents. It is recommended that the number of
tags displayed in the status area is visually confirmed at each stage of a procedure to verify that
each tag has been detected.
Monitor the number of tags in the work area.
5. Temperature
For heated systems this region displays the temperature of the work area. Click the temperature
readout to show a Temperature Control window from where the temperature may be set.
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Section 5
RI Witness™ Basic Operation
6. Witness Points
The witness points region displays options available for the next step as specified by the lab
defined protocol. The top one is the preceding action and the current contents of the work area
determine what next steps are possible. An administrator will also see an Admin Assign option to
assign or reassign dishes outside of the prescribed protocol.
7. Current operator
The current operator region shows who is logged on. A suffix (Admin) is added for operators who
belong to the administrator group. All witness points performed will be attributed to the operator
who is logged in at that time.
Performing A Procedure in RI Witness™
Bring the dish or tube you wish to work on into the work area. If the tag has been identified by RI
Witness™ the patient and the history will be shown on the screen. The options for the next actions will
be shown in yellow on the witness point region.
In the example shown below a “Sperm Wash Tube” and an “Egg Culture Dish” have been placed into
the work area and RI Witness™ has determined that the only appropriate procedure is represented by
the IVF Insemination witness point. See Figure 5-11.
Figure 5-11 The IVF insemination witness point is the only match for the contents of this work area
Beginning a New Cycle in RI Witness™
The first step in the RI Witness™ procedure is when the identity card for the patient is assigned. This
is the most important step in the protocol as if the identity of the patient is correctly assigned at this
point, the security of the cycle is assured.
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Research Instruments Ltd
Starting a New Procedure
1. To start a new procedure, log in then place one or more unassigned, tagged items into the work
area (usually a patient ID card, egg collection dish or sperm pot). A yellow question mark will
show that the tag has been detected and is unassigned. See Figure 5-12. Press the
icon.
2. In the All Patients tab type the  patient name or ID number to locate the correct patient in the
database. See Figure 5-13.
3. Alternatively, the Daily Lists tab shows all Egg Collections and Embryo Transfers scheduled for
the day. Click the patient cycle for either Egg Collection or Embryo Transfer, this will display the
chosen patients details in the work area.
4. Choose which action you intend to register/perform and then click the Confirm
icon again.
5. If a double check by another person has been set at this point, a 2nd Witness window will
appear. This requires a colleague to verify the action by inputting their name and PIN. See
“Double Witness Points” on page 30.
Figure 5-12 Unassigned tag has been detected
Figure 5-13 Choose Patient/All Patients window to assign ID
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Section 5
RI Witness™ Basic Operation
Witness Point Confirmation
At every step in the procedure, a witness point (action) must be registered in the system. Therefore
when an action is performed, select the relevant witness point and confirm by checking the details in
the confirmation window and clicking the Confirm icon
Figure 5-14 Confirming a witness point
Double Witness Points
Critical points, as defined by the administrator, must be witnessed by a second operator. The second
witness must enter their PIN. See Figure 5-15.
Figure 5-15 A double witness point
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Research Instruments Ltd
Question Witness Points
Question Witness Points, as defined by the administrator, require a response from the operator.
Examples of text and numeric questions are shown in Figure 5-16 and Figure 5-17.
The Witness Point question and the operator response is displayed during the final witness point
confirmation window. The question and response also form part of the history logged for this event.
Figure 5-16 Add witness point question
Figure 5-17 Edit witness point question
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Section 5
RI Witness™ Basic Operation
Record Witness Points
Gather all the (tagged) plasticware that are required to perform a procedure and place them in the
work area.
A window representing the work area will display all the tags and show the identity of any tags already
“known” to the system.  
An active patient is selected either manually or automatically; manually by clicking on the Patient
Details section of the work area and choosing a patient from the list, or by the system automatically
selecting the patient identified by the tags in the work area:
• If there is one patient in the work area then this is the current patient.
• If there are 2 patients in the work area who are male/female partners then the female patient is
the current patient.
• If there are 2 or more patients after a donation where the patients are donor / recipient(s) then
the donor is the current patient.
A list of possible witness points is shown, determined by the selected patient and visible tags. Choose
the appropriate witness point.
If the witness point is a tagged donation type, then the recipient will need to be chosen from a list at
this point.
If the witness point requires further information entered by the operator, then this will be asked for.
If the witness point requires a 2nd witness, then another operator will now need to choose their name
and enter their PIN.
A confirmation window summarises all the details relating to the witness point that will be recorded.  
If all the details are correct, then selecting the tick will record the witness point.
If any new tags are added to the work area during the processing of a witness point (or admin assign)
then the witness point will be cancelled. Also, if during the processing of a witness point one of the tags
in the work area drops out of range of the reader(s), then the witness point can be completed and the
tag(s) will be reassigned successfully.
Unassigned Tags
The tags on unused plasticware are unassigned and are shown as a question mark icon in the work area
display. See Figure 5-18. When selecting a witness point unassigned tags are automatically assigned to
the patient currently displayed on the screen. They will be identified as the sample tag defined by the
witness point.
Figure 5-18 The question mark icon represents an unassigned tag
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Research Instruments Ltd
Unassigned Tag Removal
A STOP warning is displayed when an unassigned tag is removed from the work area. See Figure 5-19.
This message informs the operator that an unassigned tag entered and exited the work area without
being registered in the current procedure. If that is correct select Close and continue. If not, replace
the sample/labware in the work area and perform a witness point.
Figure 5-19 Unassigned tag removal
Tag Mismatch
The RI Witness™ system will only allow one patient (with donor) or a couple’s samples to be placed in a
work area at any time. If an unlinked sample is placed in the work area, a continuous alarm will sound and
a mismatch window will appear immediately. The STOP message is displayed.
Figure 5-20 Tag mismatch
1. Remove the samples in order to stop the alarm and select Close to close the window.
2. A mismatch reason window is displayed. The operator must enter an explanation for the mismatch
before work can continue. The explanation will appear in both patients’ cycle histories and will be
visible in the RI Witness™ Manager software.
Note: If the mismatch occurred while no operator was logged in, an explanation for the mismatch is
associated with the operator explaining but not the mismatch itself.
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Section 5
RI Witness™ Basic Operation
Record Location of Tags
At each work area, a location name can be set through the System Information window that uniquely
identifies that work area. In RI Witness™ Manager a list of all the configured locations can be viewed.
When a tag is placed into a work area, the location will be stored with the tag details; then when the
tags associated with a patient are displayed, their last known location will also be displayed. See Figure
5-21.
The name of each work area can be configured initially by any user. An administrator can modify any
location name. A list of locations can be seen in RI Witness™ Manager from where they can be disabled
and enabled. Disabling a location will cause the related work area’s name to be reset to Unknown so it
can then be renamed by a user. Any disabled location can be re-enabled. This will set its name back to
the previous value.
To name a work area:
1. When the work area is started initially you will be required to give the work area location a
name. Any user can initially set the name of a work area. A red cross icon will appear as well as
the System Information icon as a warning triangle.
2. Click the Warning Triangle to open system information.
3. Unlock the settings.
4. Click WorkArea Location.
5. Enter a location description/name.
6. Click the Confirm Icon
When a witness point is completed, the location at which it took place will be recorded.
Note: PCs connected to the RI database must have unique computer names, if connected to a domain
this will be set, otherwise please check.
Figure 5-21 Tags tab
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RI Witness™ Basic Operation
Research Instruments Ltd
Training Mode
For training and testing, any RI Witness™ work area may be set to Training Mode.
1. Log in as an admin operator.
2. Open System Information.
3. Select Screen Configuration / Training Mode.
4. Then tick the Training Mode box.
In Training Mode, the normal work area screen is replaced with an orange background. See Figure 5-22.
On logging out of Training Mode, the training work area events will automatically be deleted.
Figure 5-22 Training mode
Clear Demo Tables (legacy work areas for pre software version 2.3 only)
Training work area events are stored in a demonstration database which may be cleared using RI
Witness™ Manager. An admin operator may click Clear Demo Tables on the General Settings page of
RI Witness™ Manager. Figure 5-23.
Figure 5-23 The RI Witness™ Manager general settings page
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Section 5
RI Witness™ Basic Operation
Admin Assign
Designated operators may use the Admin Assign button, see Figure 5-24, to assign any tag type (sperm
pot, inseminated dish, sperm wash tube, etc) to an unassigned tag at any point.
Note: Admin Assign should only be used under exceptional circumstances and by trained personnel
only.
Note: With Admin Assign you can also change the type of dish already assigned to a patient.
Figure 5-24 Admin assign
Discards
When a single tag is placed in the work area the Discard button is enabled, see Figure 5-25. Pressing it
will display a confirmation screen with a green tick and red cross. The red cross
will cancel the
will mark the tag as discarded discard and close the confirmation window, whilst the green tick
changing how it is displayed in the work area and preventing any witness points taking place whilst it is
in the work area.
There is also the option from within RI Witness™ Manager to enable Discards to require a Witness.
Once enabled, a witness will be prompted to log in on the screen following the operator selecting the
Discard button, after a successful login the confirmation window will be displayed as usual.
Figure 5-25 Discard
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Research Instruments Ltd
Figure 5-26 Confirm discard
Figure 5-27 Discard in the work area
Cycle Summary
The cycle summary is displayed in the work area at all times; it is a datasheet that has been selected to
be shown from the RI Witness™ Manager.  If a patient is not selected, or there is no cycle summary for
a selected patient, the cycle summary display will say “”.  If the selected patient
contains a cycle summary sheet, this sheet will be displayed in the Cycle Summary area.
Daily Lists
On the patient select window, you can select the daily list which showing list of patients for today. The
date is displayed in the top left of the window. To choose another date and view its related procedures,
click on the left and right arrows at the top of the window. (The left arrow moves the date back one day
and the right arrow advances the date by one day). To select a patient, click on the patient ID number.
Windowed Work Area
For admin stations with admin readers, the WorkArea application can be windowed to allow easy access
to the tag reading functionality.
1. Open the RI Witness™ WorkArea application.
2. Click System Information.
3. Unlock the settings.
4. Click Screen Configuration / Training mode.
5. Tick Windowed WorkArea.
6. Click Save and Quit.
7. If you have multiple screens set up, the work area will now revert to one single work area
screen.
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RI Witness™ Basic Operation
Language and Keyboard Layout
After unlocking the system information screen, navigate to the Language and Keyboard settings. From
there the language on-screen and keyboard style can be changed using a drop-down menu. If the
selected item in either drop down menu is changed, then clicking the red cross will save these changes
and modify the language and keyboard.
1. Click System Information.
2. Unlock the settings.
3. Select your required language from the drop down list.
Figure 5-28 Language selection
4. Select your required keyboard style from the dropdown list.
5. Click the red cross
to save and close the window.
The language used can also be changed from RI Witness™ Manager
1. Click Settings
2. Choose your required language from the drop down list in the Language section
Figure 5-29 RI Witness™ Manager Language Setting
Foot Pedal Control
In the work area the System Information Panel contains a Keyboard / Foot Pedal Shortcuts button
which launches the Keyboard Shortcut Configuration dialog.
Within the keyboard shortcut configuration dialog, each available command is listed followed by an
input box and clear button (with a cross).
To assign a keyboard shortcut to a command, click in the corresponding text / input box and then hold
down the keys you want to assign to this command. The input box will change from “Please Enter
Shortcut Key” to a list of the currently held down keyboard keys separated by +s. Once the keyboard
keys are released those keys are saved to the input box.
Pressing the Clear button will remove the keyboard shortcut for that command.
In order to save these changes you must press the Save and Quit button at the bottom of the dialog.
In the work area, once the shortcuts are set up, simply press the shortcut keys to activate the command.
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Research Instruments Ltd
List of commands:
• Fire / Enter Laser Mode.
◦◦ Enters laser control mode.
◦◦ If already in laser control mode this command fires the laser.
• Preset Laser Down.
• Preset Laser Up.
• Start / Stop Recording.
• Take Picture.
• Zoom In / Zoom Out.
◦◦ Zooms out fully if already zoomed in.
◦◦ If zoomed out zooms into pre-set zoom value at centre.
• Zoom In.
◦◦ Zooms into centre one step.
• Zoom Out.
◦◦ Zooms out from centre one step.
• Freeze Frame.
Please Note: Shortcut keys should be limited to the function keys to avoid conflicts with typing or
barcodes.
To Rename the Work Area
1. Log in as an Admin user.
2. Click System Information.
3. Click WorkArea Location.
Figure 5-30
4. Type the name of the work area using the on screen keyboard.
5. Click the Confirm Icon.
Figure 5-31
To Change the Location of a Work Area
1.
2.
3.
4.
5.
6.
39
Log in as an Admin user.
Click System Information.
Click WorkArea Location.
Click Change Location.
Choose the location required from the list or click Create New Location to set another location name.
Click the Confirm Icon
to accept the change.
Research Instruments Ltd
Section 5
RI Witness™ Basic Operation
To View Work Area Locations or Disable a Work Area
1.
2.
3.
4.
5.
Open RI Witness™ Manager.
Click Settings.
Click WorkArea Locations, you will now see all named work area locations.
Highlight the work area and click Disable.
Disabled accounts can be viewed by ticking Show Disabled Accounts.
Figure 5-32
Alarm if Tags Left in Work Area
To help avoid mismatches being recorded – “Card Left in Reader”.
1. Open RI Witness™ manager.
2. Click Settings.
3. Click General Settings.
4. Under work area settings tick Warn on logout if tags left in WorkArea.
Figure 5-33
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Section 5
RI Witness™ Basic Operation
Research Instruments Ltd
Figure 5-34
41
Section 6
Research Instruments Ltd
RI Witness™ Manager
SECTION 6 - RI WITNESS™ MANAGER
RI Witness™ Manager can be used on PCs or tablets outside of the RI Witness™ work areas, predominately
for administration purposes.
Logging In
1.
2.
3.
4.
Double click the RI Witness™ Manager
desktop icon.
Choose your assigned operator name from the list.
Enter your 4 digit PIN.
Click Login
Figure 6-1 Logging in
License Management
RI Witness™, Traceability, Data Capture, Cryo and Imaging must be licensed.
Licensing information is stored in the shared RI Witness™ database.
On first use of RI Witness™ Manager a license warning window will be shown.
Figure 6-2 License warning
On each subsequent use of RI Witness™ Manager, a license check is made and a similar license warning
window will inform the operator if any licenses are close to expiration.
At any time, the RI License Manager may also be invoked as a separate application by clicking Settings
and then RI License Manager.
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Research Instruments Ltd
Figure 6-3 RI License Manager
License Request Form
If your license is close to expiration, you can quickly renew your license.
1. Click License Manager in the RI Witness™ Manager license warning window. A license request
form will open. See Figure 6-4.
2. Complete the details on the form.
3. If you have a Registration Code issued by RI, enter it at the bottom of the form.
4. Click Send Request after completing all the fields.
5. If internet access is available, a response will be returned by the RI Licensing Server. See Figure
6-5.
43
Figure 6-4 The license request form
Research Instruments Ltd
Section 6
RI Witness™ Manager
6. If internet access is not available, please follow the displayed instructions to save a license
request file. The file should then be emailed to RI at activate@research-instruments.com.
7. Once RI has received your request, a License Data file will be emailed by return.
Figure 6-5 A response from the RI license server
Figure 6-6 The license request email
8. The License Data file should be made available to the RI Witness™ Manager PC where licensing
is performed.
9. Each time RI Witness™ Manager is opened following license request, License Manager window
will be displayed. See Figure 6-7.
10. On receipt of the License Data file, click Import New License File in the license manager
dialogue box. Browse to the emailed license data file and select. The License Manager will now
be updated with the new license details.
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Figure 6-7 The License Manager window
Database Management
RI Witness™ Manager must connect to the shared RI Witness™ database.
1. At RI Witness™ Manager login, a database connections window will be shown if a connection
cannot be made. See Figure 6-8.
Figure 6-8 The RI Witness™ database connection is unavailable
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2. Click the Database Settings page button to show the database connection settings window and
enter the appropriate server name, database name and authentication details. See Figure 6-9.
See the IT Requirements Manual for more details on database management.
Figure 6-9 Database connection settings
Initial Screen - Main Menu Buttons
After login, an initial screen shows a number of main menu buttons. The main menu buttons presented
will depend on operator group membership (administrator, normal) and the mixture of installed
products (RI Witness™, Traceability, Data Capture, Imaging and Cryo).
Home
When first logging into RI Witness™ Manager the Cycles Overview Board is displayed. Clicking the
Home button on the left hand toolbar will return the user to the Home screen. The Refresh button on
the Home screen causes the display to refresh by re-querying the database to find the active treatment
cycles.
1. To see the cycle details of a patient, double click on the row with the patient’s details. A
Treatment Cycle page will open.
Figure 6-10 Home screen
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How to Configure the Home Screen
Each day of a cycle or an event can be given a different colour code to aid easy and quick identification
of the cycle status. This can also assist the ordering of procedures.
To configure the colour coding within the Home screen, follow the steps below. Exact spellings of Cycle
Types and Events used in the Witness Point Diagram must be used.
1. Click Settings.
2. Click Home Screen Configuration.
3. Firstly you will need to set up “States”. These can be days or events and are colour coded.
Tip: You could simply do Day 1,2,3,4,5 to start with.
4. Click + within the States field.
5. Type the name of the State, eg Embryo Freeze, Day 0, Day 1, etc.
6. On clicking the background or foreground (Text Colour) box, a colour picker will appear. Select
the desired colours.
7. Press Save.
8. Next add a cycle type. Click the + button within the Cycle types field. A Cycle Type box will
appear. Type in the cycle type carefully, ensuring there are no spelling mistakes. The cycle type
will need to match what you have already set within the Treatment Cycle Types fields within the
database (See “Cycle Types” on page 70.) An example of a cycle type could be IVF, ICSI / IVF,
FET, ICSI, etc.
Figure 6-11 Home screen
9.
10.
11.
12.
13.
14.
15.
16.
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Click Save.
Select the Cycle Type drop down arrow you would like to colour code.
Click Add Day or Add Event.
Assign a day number, ie 3 for Day 3.
Within the Message field, type the Day description, ie Day 3.
In the State drop down field, chose one of the States that has been set up.
Save.
Repeat for each Cycle Type.
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Patients
Click the Patients button to show the Choose Patient window if no patient has been selected or to view
details of a selected patient.
Figure 6-12 Choose patient screen
1. Type the first few characters of a name or patient ID to browse a selection of matching patients.
2. Highlight the required patient and click OK or double click the required patient to view their
details.
3. Treatment cycles, witness points and tags for the selected patient can also be viewed by
selecting the tabs in this screen.
4. Clinics with Cryo enabled, can print barcodes for the selected patient by clicking Barcode
Printing. Barcodes printed from here will be recognised by the RI Witness™ system as belonging
to the selected patient.
5. Click Label Printing to create adhesive sheets with the selected patient details. These can be
attached to plasticware for this patient’s samples. For further details regarding label printing see
“Printing Patient Labels” on page 54.
Entering New Patient Details into RI Witness™ Manager
1.
2.
3.
4.
Click the Patients button to show the Choose Patient window.
Click on New Patient button.
Enter details into appropriate fields – all fields which have been edited are highlighted in pink.
Save all changes.
Note: From the Patients page there is also an option to add or choose a new patient.
Note: A patient cannot be assigned to a partner until the partner has also been entered into the
RI Witness™ Manager software separately – See “Assigning Partners” on page 50.
Note: Label sheets and barcodes can be printed from this page.
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Figure 6-13 New patient details
Editing Existing Patient Details
Open Patient details as outlined above.
1. Click the Edit button
to change to the editable window.
2. Click the Save button to save changes.
Looking Up Patient Histories
1. From the Patients page, select the Treatment Cycles tab to view all previous cycles undertaken
for a patient or couple.
2. Select the Witness Points tab to view all witness points registered in an open cycle.
3. Select the Tags tab to see all locations that tags assigned to the patient have been seen by RI
Witness™.
Refer to Frequently Asked Questions if necessary.
Figure 6-14 Looking up patient histories
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Assigning Donor Status
In the Patient details window select relevant donor options.
Can Receive Untagged Donations
Can Receive Tagged Donations
Can Donate
Figure 6-15 Assign Donor Status
The availability of the donate checkboxes will depend on the gender of the patient, ie only female
patients can receive donations.
Assigning Partners
1.
2.
3.
4.
Create a new patient entry, or choose existing patient, leaving the partner field blank.
Create a new patient for partner.
To link the 2 patients, select the Choose Partner button to show the Choose Patient window.
Locate partner by typing the first few characters of a name or patient ID in the search window to
browse a selection of matching patients.
5. Click on the patient name and then confirm selection by clicking OK. See Figure 6-16.
Figure 6-16 Assign Partners
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Cycle Types
A cycle relates to a specific course of treatment (IVF, ICSI, IUI, etc).
Only “administrator” operators may create cycle types.
1. Click the Settings main menu button and then click Cycle Types to view all treatment cycle
types. See Figure 6-17.
2. Click New to add each cycle type.
3. Use a right click to Rename a cycle type.
Traceability operators may specify the range of materials that are used in a cycle type. Data Capture
operators may specify the data sheets that are used in a cycle type.
Starting a New Cycle
Figure 6-17 The Treatment Cycle Types Window
1. Click the Patients main menu button and select a patient by entering a name or patient ID.
2. Click the Treatment Cycle Type tab to show the list of treatment cycles for this patient. For a
new patient this list will be empty.
3. On the Treatment Cycle Types tab of the patient screen click Add New Cycle to create a new
cycle. The new cycle is shown with a status of “In Progress” and a cycle type of “Unknown”. See
Figure 6-18.
4. Traceability operators may click the Materials tab to view a list of material batches related to
this cycle.
5. All operators may click the Witness Points tab to view a list of witness points performed during
this cycle.
Assign a Cycle Type
Select a cycle type from the pulldown list.
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Collection and Transfer Dates
If Egg Collection / Embryo Transfer dates are entered on the Details tab of a treatment cycle then these
events will be available from the work area Show Daily Lists touch button.
See “Performing A Procedure in RI Witness™” on page 28 for more details of patient selection using
Daily Lists.
Cycle Status
A newly created cycle will be assigned the status “In Progress”. When the patient treatment has been
completed click End Cycle to change the status to “Completed”.
Revert Status
An administrator operator may click the Revert Status
the status to “In Progress”.
button of a “Completed” cycle to return
Figure 6-18 Starting a new cycle.
1. Click Add New Cycle from the Patients window.
2. Select a Cycle Type from the pulldown on the Treatment Cycle window.
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RI Patient Identity Labels
Laser printable adhesive patient identity labels are available from RI.
The sheet provides a range of label sizes with a selection of normal and reverse printing. See Figure
6-19.
Figure 6-19 RI laser printable label sheet.
Reverse printed labels are viewable through the base of containers.
Label categories such as “Petri Dish” and “Test Tube” are for guidance only. Please select a label
appropriate to your plasticware.
“Test tube” labels may be used to hold a rectangular RFID tag in position along the length of a tube.
The reverse printed “4 well dish” label and the square RFID tag are the recommended choice for a 4
well dish. See Figure 6-20.
RI Labels are an optional component of RI Witness™.
Figure 6-20 Positioning of patient identity labels
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Printing Patient Labels
1. From the patient details window click Label Printing See Figure 6-21.
2. Load a blank label sheet into a laser printer. For repeatability of alignment use a manual feed
path and take care when placing each sheet.
3. Set all “Sheet Alignment” values to zero and click Print Labels.
4. Check the printed sheet. Measure the offsets required to correctly position the printed details
within a label boundary. Pay particular attention to vertical positioning within the smallest label.
See Figure 6-22.
Figure 6-21 The label printing manager
The example shown in Figure 6-22 shows details of an alignment correction within the boundary of the
smallest label.
5. The first print shows incorrect alignment.
6. Vertical alignment is corrected by a negative Y offset.
7. Horizontal alignment is corrected by a positive X offset.
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Figure 6-22 Label text alignment
Label Styles
Use the Label Layout buttons to select an appropriate style.
Style 1 is optimised for popular plasticware, Style 2 maximises the use of available space and Style 3 is
a mixture of Styles 1 and 2.
Note: A rotation alignment correction is rarely required.
Note: Check Print this row only and select a row number to print a single row of the smallest labels
only. This may be useful if reusing a sheet during the alignment process.
Operator Management
Click Operators to display a list of all enabled operators. See Figure 6-23.
Figure 6-23 Operator management
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Operator Details
1. Click Add to specify details for a new operator. See Figure 6-24.
2. Select an operator and click Edit to change operator details.
An operator must have a Username, Full Name and Anonymous ID. The Anonymous ID is used for
printed reports.
Group Membership
Group membership is specified as “normal” or “administrator”.
Some RI Witness™ features are only available to an “administrator” operator. Administrator only
features include the use of admin assign and making changes to the witness point diagram.
Figure 6-24 Operator Details
Enabled Operators
Only enabled operators may log in. Click Disable to remove an operator from the enabled list. Check
“Show Disabled Accounts” to view all operators.
Operator PIN
The operator PIN must be a sequence of 4 numbers.
Clinic Details
Click the Settings main menu button then click General Settings to specify the Name of Clinic that will
appear in all printed reports. SeeFigure 6-25.
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Figure 6-25 The heading of a printed report will show “My Clinic Name” as specified by “Name of Clinic” on the
general settings page.
Mismatch Comments In RI Witness™ Manager
Users can add extra comments to further explain any mismatches in the history
1. Open RI Witness™ Manager.
2. Click the Cycles button.
3. From Treatment Cycles double click the cycle required to view. This can be seen by clicking
patients also.
4. Click the Witness Points tab.
5. Double click the Mismatch witness point.
6. Click the Edit
icon.
7. Enter additional comments.
8. Click Done.
Figure 6-26 Report settings
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The Witness Point Diagram
The witness points that are presented to all work area operators are defined in RI Witness™ Manager
by a witness point diagram.
To view the witness point diagram click the Settings main menu button and then click Witnessing. See
Figure 6-27 and Figure 6-28.
Figure 6-27 The settings screen
Click “Witnessing” to view the witness point diagram
To add a new witness point, click New Witness Point and then click anywhere in the diagram. Enter a
name for the witness point, eg “IVF Insemination”
Use the Witness Point Info panel to specify the attributes of a witness point. Witness point attributes,
eg reassign an “egg culture dish” tag to become an “inseminated dish” tag, are described below.
Tag names such as “inseminated dish” must be defined before they may be referenced by a witness
point. See “Tag Types” on page 63.
Figure 6-28 The witness point diagram.
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Links
The links (arrows) between witness point boxes represent tags (dishes, test tubes, etc) that are the
required inputs and produced outputs of the procedure defined by that witness point.
To create a link, click Add Link and then drag between two witness points.
Reassigned Tags
A witness point may represent the reassignment (transformation) of one tag type into another, eg an
“Egg Culture Dish” becomes an “Inseminated Dish” as the sperm is introduced.
A reassignment is illustrated in Figure 6-29 where the Reassign this dish checkbox is checked to specify
that the selected tag type “Egg Culture Dish” will be reassigned as an “Inseminated Dish” when this
witness point is exercised by the work area operator.
Unassigned Tags
Witness points may require that unassigned (empty, unused) tags be introduced into the work area.
Note: The “IVF Insemination” Witness Point does not require an unassigned tag as the “Unassigned
tags will be assigned to:” pulldown in Figure 6-29 shows “none”.
Where a witness point requires the introduction of an unassigned tag, use the “Unassigned tags will be
assigned to:” pulldown to select the target tag type.
Figure 6-29 Detailed information for the “IVF Insemination” witness point
IVF Insemination
Egg
Culture
Dish
Patient
ID (female)
Inseminated Dish
Figure 6-30 A reassigned tag is represented by a curved line between
the two tag names
An unassigned tag is represented by a straight line between a question mark and the target tag name.
A witness point may specify both a reassignment and the use of an unassigned tag.
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Witness Point Inputs
Incoming links to a witness point specify the tags that must be present before the procedure represented
by the witness point can be performed. If an unassigned tag is specified then that container must also
be present before the procedure can be performed.
Multiple Sources of the Same Tag Type
A witness point with multiple input links of the same tag type eg “dish X”, represents an OR operation,
ie the required container may be sourced from the procedure represented by witness point A OR B.
Dish X Dish X
Figure 6-31 Dish X must be available to
witness point C
Witness point A OR B may be the source
Multiple Tag Types
A witness point with multiple input links of differing tag types represents an AND operation, ie this tag
type AND that tag type are required to perform the procedure represented by this witness point. See
Figure 6-32.
Sperm Wash Tube
Egg Culture Dish
IVF Insemination
Figure 6-32 The “IVF Insemination” witness point
represents a procedure that requires a “Sperm
Wash Tube” AND a “Egg Culture Dish”
Inseminated Dish
Entry Witness Points
Entry (initial, starting) witness points have no incoming links. An entry witness point will always require
an unassigned tag which will become assigned on completion. See Figure 6-33.
Assign Patient ID (female)
? Patient
→ Patient
ID (female)
ID (female)
Assign Egg Wash
Egg Wash Dish
Figure 6-33 “Assign Patient ID (female)” is an
entry witness point as it has no input links
An unassigned tag (here an unassigned ID card )
is required
Double Witness Points
Checking the Double Witness box, see Figure 6-29, changes the completion sequence for a witness
point. A second operator must log in to approve the procedure. Entry witness points are generally
double witness points.
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Donor Witness Points
A mismatch alarm will be generated if tags assigned to patients who are not specified as partners are
introduced to the work area.
The exception to this rule is provided by donor witness points. Checking the Donor box will create a
donor witness point which is given a diagonal colouring. See Figure 6-34.
Assign Egg Wash
Donate Eggs
Egg Wash Dish
Egg Prep
Figure 6-34 A known donor witness point
Tagged Donations
An incoming link to a donor witness point specifies a tagged donation and covers procedures such as
egg/embryo donation/sharing as well as surrogacy.
When the witness point is selected the operator chooses the donation recipient. The recipient identity
is assigned to the tag containing the donated material. The work area now contains tags with a mixture
of donor and recipient identities. This does not trigger a mismatch because the tags have the donor
witness point in common.
Tagged Donations require that the donor and recipient be specified as such via the Can Donate and Can
Receive Tagged Donation check boxes available in the patient details. See Figure 6-35.
Figure 6-35
First Name Wendy
Last Name Rogers
Date of Birth 27 October 1967
Can Receive Untagged Donations
Can Receive Tagged Donations
Can Donate
Partner 36734M Mr John Rodgers
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The Can Donate checkbox specifies
the ability to make a tagged donation.
The Can Receive Tagged Donations
checkbox must be checked for the
recipient.
The donor witness point ensures
that donated tagged material is only
available to patients that   have   the
Can Receive Tagged Donations box
checked in their patient details.
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RI Witness™ Manager
Untagged Donations
Sperm donations are usually untagged.
An donor point will be an entry witness point for a female recipient of donated sperm. The donated
sperm will be transferred to an unassigned tag that is then assigned to the female recipient when the
donor witness point is selected.
The donor witness point ensures that untagged sperm is only available to patients that have the Can
Receive Untagged Donations box checked in their patient details.
Witness Point Questions
A question may be presented to a work area operator. The question and response will be recorded in
the history log.
To set a question for the selected witness point:
1. Click the Add Question button.
2. Choose a question type and enter the question text. See Figure 6-36.
3. The diagram will show an Exclamation           appended
to the witness point name if a question
has been added.
4. Click the Exclamation          to
! edit the question details.
IVF Insemination !
Egg
Culture
Dish
Patient
ID (female)
Inseminated Dish
Figure 6-36 Adding a witness point question that requires a numerical answer
Note the exclamation after the witness point name
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Tag Types
Click Tag Types to specify the name and icon for each RFID tagged item used in the witness point
diagram. See Figure 6-37
Figure 6-37 Tag types
Witness Point Order
From the witness point diagram page click Witness Point Order to specify the order in which points will
be displayed to the work area operator. Click Up or Down to change the order. See Figure 6-38.
Figure 6-38 Setting the witness point order.
The Witness Point Log
Work area events, eg witness point selection and tag mismatches, are logged in the shared database.
The witness point log may be explored in detail or viewed as a summary. A printed report may be
generated from any view of the witness point log.
Click the Witness Points main menu button then click Statistics or Explore to view the witness point
log. See Figure 6-39.
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Figure 6-39 The witness points screen
Click statistics or explore to view the witness point log
Witness Point Log Statistics
The statistics view summarises the witness point log by presenting significant totals, eg “Tags used” ,
“Patients seen”, etc. The view may be filtered by date. See Figure 6-41.
Figure 6-41 Statistics from the witness point log
Explore the Witness Point Log
The Witness Point Explorer shows events from the witness point log.
The view may be filtered by date, operator, patient and tag type. Shortcut links are provided for common
filters, eg “Monday”, “Admin assigns this week”. See Figure 6-40.
Figure 6-40 Exploring the witness point log
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SECTION 7 - CRYO WITNESSING
An Introduction to Cryo Witnessing
Many embryology labs wish to extend witnessing and reporting to include samples stored in cryo
storage. The Cryo feature is a barcode labelling solution for cryo straws.
Clinics have the option of scanning barcodes that they have already been assigned to samples, and RI
barcodes that have been printed from RI Witness™ Manager and are assigned to a particular patient.
If a clinic only wishes to be able to scan a barcode printed from the RI Witness™ Manager application
1. Open RI Witness™ Manager.
2. Click Settings.
3. Click General settings.
4. Tick the checkbox under the Barcode section Only use RI Barcodes.
Figure 7-1 Only use RI barcodes
Printing Barcodes
1. Open RI Witness™ Manager.
2. From the patient details window click Barcode Printing. See Figure 7-2.
Figure 7-2 RI Witness™ Manager
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Cryo Witnessing
Figure 7-3 Barcode printing window
3. To print barcodes make sure that a correct label printer is plugged into the computer with the
correct label stock loaded into it.
4. Select
• The required number of barcodes
• The starting number
• The freeze date of the barcodes.
5. A preview of the barcodes that will be printed is shown in the Label Preview. The last number
on the second line is the sample number for this patient. This can be edited allowing reprinting
of a particular barcode, for example if the initial printing was misaligned.
6. Click Print Labels.
7. If you are using small style labels you may need to print a blank row to gain access to the printed
labels. To print a blank row of labels, click Print Blank Row.
8. To check the printed labels, measure the Y Offset between the top of the barcode and the top of
the next label and set the print head position on the printer to this value.
Printhead pos. Y
+7.2 mm
Figure 7-4 Aligning the label print stock
1. The first print shows incorrect alignment.
2. Alignment is corrected by setting the 		
printhead Y position
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Scanning Barcodes
In the work area a patient can be chosen by scanning in a sample barcode that has previously been
assigned to this patient.
When completing a witness point that includes a barcoding step, the barcode, either a brand new
barcode or a barcode previously assigned to the current patient, must be scanned prior to the Witness
Point Confirmation screen. See Figure 7-5.
Figure 7-5 Scanning a barcode
If the barcode has not been seen by the system before it will be assigned to the patient after the witness
point is confirmed.
If the barcode has already been scanned and assigned to a different patient, the mismatch alarm is
activated and the differing patient is shown on the mismatch screen. Clicking on the small Red cross
next to the displayed mismatched patient will allow the mismatch screen to be closed and a reason
attached. See Figure 7-6.
Figure 7-6 Barcode mismatch
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Section 8
RI Witness™ Manager for Traceability
SECTION 8 - RI WITNESS™ MANAGER FOR TRACEABILITY
Managing Materials
Material types, eg dishes, pipettes and media must be defined for use within Traceability. A barcode
reader may be used to identify batch lot numbers, expiry dates, etc or these details may be entered
manually. Batches are opened or closed to reflect their availability within the lab.
Click the Materials main menu button to view the materials related features of Traceability. See Figure
8-1.
Figure 8-1 Materials management
Material Types
Material types must be configured before the details of a delivered batch may be recorded.
1. Click the Materials main menu button.
2. Then click Actions to view a list of all material types.
3. Use Add New Type and Add New Group to specify the top level of your materials hierarchy. See
Figure 8-2.
4. Right click a group and select Add Group to extend the hierarchy.
5. Right click a group and select Add Type to add a new material type to that group. See Figure 8-3.
Figure 8-2 Viewing all material types
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Figure 8-3 Right click to add a sub group
Material Type Details
Double click a material type, or right click and select View Material Type to view the material type
details. See Figure 8-4.
Figure 8-4 Material type details
Some materials are marked with a GS1 barcode. A GS1 barcode may contain various combinations of
expiry date, lot number and a unique product identifier known as a GTIN. Here we are only interested
in a product identifier.
1. If you have a barcode, click Scan GTIN and scan the barcode.
2. Manually enter a unique product part number if no GTIN is available.
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Notes on GS1 Barcodes
GS1 is a global barcode standard that may contain a Unique Product Identifier (GTIN ) and may also
contain lot number and expiry date information. Some products have a barcode that does not adhere
to the GS1 standard. Some GS1 barcodes do not contain all the information highlighted above, eg a box
of bottles may have a barcode that contains GTIN, lot and expiry information but an individual bottle
barcode may only have Lot and Expiry information but no GTIN.
Traceability can interpret GS1 barcodes.
A Traceability button must be clicked to interpret a GS1 barcode, eg click Scan It or Scan Batch or
Scan GTIN.
Cycle Types
Treatment cycle types must be configured and linked with material types.
1. Click Settings.
2. Then Treatment Cycle Types.
3. Then the Materials tab to view the materials linked to a cycle type.
4. Tick the materials within the list that are to be associated with the treatment cycle type.
5. Press Save.
As previously described in “Section 6 - RI Witness™ Manager” only administrator operators may create
cycle types. Traceability admin operators may additionally configure the range of materials that are
used when performing a treatment cycle type.
A newly created cycle type will not be associated with any materials. Use the materials check boxes to
specify the range of materials that will be used for the selected cycle type. See Figure 8-5.
Creating a New Batch
A new batch of a GTIN barcoded material may be scanned directly into Traceability.
1. Click the Materials main menu button and then click the Scan It button.
2. You will be prompted to use the barcode scanner to read the barcode. Scan the barcode.
3. As the materials type is already logged in the system, it will recognise the GTIN barcode and add
the necessary details of that batch of materials to the system, eg lot, expiry date, etc within the
Batch Details page.
Materials that are not GTIN barcoded are selected by navigating to the appropriate “material type
details” screen.
1. Click the Materials main menu button then click Actions to show a list of all materials.
2. Double click the material that is being processed to show the Batch Details page for that
material. See Figure 8-7.
3. A list of existing batches of this material is shown. Click Add New Batch to open the batch
details window for a newly created batch and fill in the batch details. See Figure 8-6.
4. Click Scan Batch to create a new batch if a GS1 barcode is available.
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Figure 8-5 Material type details checkboxes specify the range of materials associated with each cycle type
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Figure 8-6 Creating a new batch by scanning a barcode
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Deleting a Batch
RI Witness™ Manager for Traceability
Figure 8-7 Listing all batches of a specific material type
Click “Add Batch” to manually create a batch
Normal batch operations are status changes, eg
• Pending: The batch of materials will shortly be opened and used
• Open: The batch of materials has been opened and is in use within the lab
• Closed: The batch of materials has been closed, has all been used up, has expired, can no longer
be used.
Batches are not routinely deleted.
Admin Operators Only
If a batch is created in error then an admin operator may delete it.
1. Click the Materials main menu button.
2. Click Actions.
3. Double click the material type to be deleted.
4. The list of batches will be shown. Right click the appropriate batch and select Delete.
Batch Status
A newly created batch will be assigned a status of “Pending”. Click Open Batch when the batch is made
available for use. The details displayed for an open batch will include all patient treatment cycles that
are in progress. See Figure 8-8.
When a batch is no longer in use, click Close Batch to change the batch status from “Open” to “Closed”.
Admin Operators Only
If a batch is opened in error, click the Revert Status button
to return the batch status to “Pending”.
If a batch is closed in error, click the Revert Status button
to return the batch status to “Open”.
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Figure 8-8 Patient treatment cycles related to a batch of materials
Expired Batches
When batches are created an expiry date is recorded. If any currently “Open” or “Pending” batches are
expired or within 7 days of expiry then an expiry Report button will be available on the main Materials
screen. See Figure 8-9.
Double click an expired batch to show the batch details screen from which the batch may be closed.
Now remove the batch from use.
The expiry period can be set to your required time period, ie extended to 10 days or shortened to 5
days.
1. Click Settings in the main menu.
2. Click General Settings.
3. Within the Materials section amend the batch expiry warning field.
Figure 8-9 Expired and expiring batches
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RI Witness™ Manager for Traceability
View All Batches
From the main Materials screen click Report to view all batches. A filtered list of all batches is shown,
expired batches are highlighted in red. This list may be filtered by date and by batch status. See Figure
8-10.
Figure 8-10 A filtered view of all batches
Patients - Managing Treatment Cycles
See “Section 5 - RI Witness™ Basic operation” for details of creating and managing a treatment cycle.
When viewing the details of a treatment cycle Traceability operators may click the Materials tab to
show material batches related to this cycle. See Figure 8-11.
Excluding and Including Batches for a Cycle
Batches can be excluded from cycles by right clicking on the batch and choosing Exclude Batch on the
context menu.
Excluded batches can be viewed or hidden by clicking the Hide Excluded Batches button above the
batches list. Excluded batches will be highlighted blue.
An excluded batch can be included again by right clicking on an excluded batch and from the context
menu left clicking Include Excluded Batches. The batch will now be visible in the list of batches for the
cycle.
Figure 8-11 Material batches related to this cycle
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Data Capture
Research Instruments Ltd
SECTION 9 - DATA CAPTURE
An Introduction to Data Capture for Data Collection
Hand written notes are often taken whilst performing laboratory procedures. For example embryo
scores and sperm volumes might be written down on a data sheet and later manually transcribed into
a clinic fertility database.
The features of Data Capture described in this chapter allow data sheets to be designed in RI Witness™
Manager and data entry to be performed in the laboratory using the work area touch screen. Data entry
may also be performed in RI Witness™ Manager.
Collected Data Setup
1. Click Settings.
2. Then click Data Collection to enter the setup screen for data collection. Sheet design is
performed using this screen.
The Collected Data Setup screen, Figure 9-1, is divided into 4 regions. Note that region 4 shows the
properties of an entry selected from regions 1,2 or 3.
Figure 9-1 Collected data setup
1. Sheet Types
Region 1 shows a list of all the sheet types that have been created. Click New to add a new sheet,
set the name of the new sheet using the properties in region 4.
2. Parameters
Parameters are fields that may be placed on a data sheet. For example, a parameter named
“Sperm Volume” that required a numerical value might be added to an “Andrology” data sheet.
Region 2 lists the parameters that have been created and may be added to the contents of a
sheet.
Click the Add button to add a parameter to a sheet contents. The parameter will move from
region 2 to region 3.
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3. Sheet Contents
Region 3 shows the content layout of the selected sheet type. The contents of a sheet are
parameters that have been added to the sheet from region 2. To change the layout order,
highlight the parameter by clicking it. Then use the Up and Down buttons to position it in the
order required.
Once a parameter has been added to a sheet contents, additional attributes may be set. For
example, an default value can be set or a parameter can be marked as required so that an
operator must provide a value.
See “Parameter Attributes” on page 87 for more details.
4. Properties
The properties shown in region 4 reflect the most recently selected entry from regions 1, 2 or 3.
See Figure 9-2.
Figure 9-2 Examples of parameter properties and sheet properties shown in region 4
Parameter Configuration
The contents of a sheet are called parameters.
1. Click New in the parameters region (2) to create a new parameter. The properties region(4) will
show details of the newly created parameter. See Figure 9-3.
2. Enter a name for the new parameter, eg “Sperm Volume”.
3. The first action to perform on a newly created parameter will be to select a parameter type from
the Properties Type drop down menu. Parameter properties depend on the selected parameter
type. For example the text type has properties min and max length whereas a calculation has
two operands and an operation.
Figure 9-3 shows the properties of each parameter type. Figure 9-4 shows the Parameter Type drop
down menu.
Numerical Parameters
The properties of a numerical parameter include a minimum value, a maximum value and an output
format. The format specifies the number of decimal places to be used when displaying numbers.
Format None means that the value entered by an operator will not be formatted. Figure 9-5 shows the
Format pull down.
Text Parameters
The properties of a text parameter include a minimum length and a maximum length. Leave these
properties blank if length restrictions are not required when the operator enters a value for this
parameter.
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Figure 9-3 Parameter properties depend on the selected parameter type
Select from: Number, Text, Check, List, Date, Time, Date Time, Built In and Calculation
Figure 9-4 Selecting a
parameter type
Figure 9-5 Selecting a
numerical format
Figure 9-6 The properties of a list
parameter
List Parameters
List parameters allow the operator to choose a value from a pre-defined list. The properties of a list
parameter are shown in Figure 9-6.
Click the Edit Lists button to show the Manage Lists window. The example shown in Figure 9-7 highlights
the “Polar Body Position” list that contains the 3 values “PB6”, “PB12” and “No Injection”. The “Polar
Body Position” list is assigned to the “Inj” list parameter. See Figure 9-6.
Check Parameters
Check parameters take Yes/No values.
Sheets presented by RI Witness™ Manager will show checkboxes. A work area touch screen will offer
a selection of Yes or No.
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Date, Time and Date Time Parameters
Date and time values are viewed and edited using RI Witness™ Manager. An operator may type a value,
eg 12:30 or 14/08/2010 15:35. A date picker window is also available. Figure 9-8.
Calculation Parameters
Calculations perform an operation on two operands, eg add two numbers or join two pieces of text.
The operands of a calculation may be parameters of any type including calculation types. A example
calculation is shown in Figure 9-9.
Built In Parameters
Built in parameters will display values derived from the associated treatment cycle, eg the egg collection
date. Figure 9-10 shows the available built in values.
Figure 9-7 The manage lists window
Figure 9-8 Setting a date time value
Figure 9-9 Adding two numbers using a calculation parameter
Figure 9-10 Selecting a built in value
Sheet Contents
Click the parameters Add button to move parameters to a sheet contents (region 3). In the example
shown in Figure 9-11, four list parameters have been added to the contents of the Embryo Development
sheet.
Figure 9-12 shows another example of sheet contents where two list parameter and four number  
parameters form the contents of the Sperm Pre Prep sheet.
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Figure 9-11 Adding parameters to the Embryo Development sheet
Figure 9-12 Adding parameters to the Sperm Pre Prep sheet
Shared Between Sheets
A parameter may be part of the contents of many sheets. The same parameter may be editable on
sheet A and sheet B and but not editable on sheet C. A parameter that appears on many sheets has
a single shared value. In the above example a value change on sheet A would automatically appear
changed on sheets B and C.
The contents of a summary sheet might take parameters from many other sheets. See “Cycle Summary
Sheets” on page 86 for more details. See “Parameter Attributes” on page 87 for more details of
the editable/ non editable parameter attribute.
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Data Capture
Treatment Cycle Sheets
Treatment cycle types, eg IVF, ICSI or IUI, will have different data collection requirements. For example,
a sheet designed for IUI would not be used during an ICSI treatment.
1. Click Settings then Treatment Cycle Types to associate sheet types with a treatment cycle type.
2. The Data Collection tab lists all available sheets. Check the boxes of those that are associated
with the selected cycle type. See Figure 9-13.
3. Click Save.
When a list of sheets is presented to an operator, they will be ordered as specified here. Use the Up and
Down buttons to change that order.
Viewing and Editing Sheets
During a treatment cycle an operator may view and edit the values on a sheet. Each treatment cycle
will start with blank copies of the sheet types that have been associated with the treatment type being
performed.
Figure 9-13 Use the checkboxes to associate sheets with the selected treatment cycle type
Editing Sheets at the Work Area Touch Screen
Sheets may be viewed and edited on a laboratory work area touch screen.
If sheets have been associated with the treatment cycle type being performed, then a Data Sheet
button will be shown on the touch screen. See Figure 9-14.
Touch the Data Sheet button to see a list of available sheets. Touch a Sheet Name button to view or edit
the sheet values. See Figure 9-15 and Figure 9-16.
Use the touch screen Up and Down arrow buttons to highlight the sheet value to be edited. Notice that
the type of the value required is indicated to the left of the value entry box, eg 123 for numerical input,
ABC for text input and indicating use of the arrow keys for list and Yes/No input.
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Figure 9-14 Touch the “Data Sheets” button to view or edit all sheets associated with this treatment
Figure 9-15 Touch buttons for each available sheet are shown in the work area
Figure 9-16 Use the touch keyboard to edit sheet values
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Data Capture
Viewing and Editing Sheets with RI Witness™ Manager
Data values will most likely be entered at the work area touch screen but sheets may also be viewed
and edited using RI Witness™ Manager.
1. Select a patient.
2. Click the Treatment Cycles tab and then double click a cycle to show the Treatment Cycle
screen.
3. Click the Sheets tab to view or edit any sheet associated with this treatment shown in Figure
9-17.
Egg Parameters
The properties of a parameter include a Relates To setting that defaults to Cycle, ie a treatment cycle
does not have multiple values for this parameter. See Figure 9-18.
However many parameter values will relate to an individual egg. Change the Relates To setting from
“Cycle” to “Egg” for such parameters. Egg related parameters are displayed to the operator as a table
containing one row for each egg. See Figure 9-19 and Figure 9-20.
On the work area touch screen, touch a row of the egg table to edit the values for that egg. See Figure
9-21. Note: The circular arrow buttons at the top of the screen may be used to select another egg
without returning to the table view.
Figure 9-17 Editing sheet values with RI Witness™ Manager
Figure 9-18 The relates to setting defaults to cycle
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Figure 9-19 A RI Witness™ Manager view showing a table of egg related parameters.
Figure 9-20 A RI Witness™ work area touch screen view showing a table of egg related parameters
Figure 9-21 Entering values for egg number 1 at the work area touch screen
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Data Capture
The Number of Eggs
1. Click Settings.
2. Then Treatment Cycle Types to view a list of treatment types.
The Data Collection tab is used to associate sheet types with a treatment type as described earlier in this
chapter. The Data Collection tab also offers an Egg Count Parameter setting. The drop down menu for
the Egg Count Parameter is a list of all parameters. Select one parameter that will contain a numerical
value. The selected parameter will control the number of rows in any table of egg related parameters.
Egg Count Parameter
The parameter selected to represent the egg count can be any parameter with a numerical value that
relates to a cycle. In Figure 9-22 the parameter called “Total Number of Eggs” has been selected from
a list of all parameters.
As an example, “Total Number of Eggs” might be a calculation parameter whose operands are other
parameters. See Figure 9-22.
Figure 9-22 The number of eggs involved in a treatment is set using the egg count parameter
Figure 9-23 This calculation parameter has been selected as the egg count parameter in the example
shown in Figure 9-22
Egg Count Conflict
Changes to the value of the parameter set as the Egg Count Parameter will change the number of rows
in any table of egg related parameters.
If the number of eggs is increased, then the number of rows in all egg tables will automatically increase.
If the number of eggs is decreased, then the number of rows in all egg tables will not automatically
decrease. A decrease in the number of eggs will be indicated in RI Witness™ Manager as an Egg /
Embryo Count Conflict. See Figure 9-24.
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A conflict resolution window is shown when the Egg/Embryo Count Conflict button is clicked. See
Figure 9-25. The conflict resolution window allows the operator to manually select the egg records that
will be deleted to achieve the required decrease in egg count. The conflict will be resolved when the
number of egg records equals the value indicated by the Egg Count Parameter.
If it is decided that a decrease must be “undone”, then click the Cancel button to exit the conflict
resolution window and increase the value of the Egg Count Parameter to match the number of egg
records.
Figure 9-24 The Egg/Embryo Count Conflict button is shown if the value of the parameter selected as the egg
count parameter is decreased
Figure 9-25 The Egg/Embryo Count Conflict window
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Data Capture
Sheets and Witness Points
The work area touch screen Data Sheets button offers access to all the data sheets that have been
associated with a treatment type.
A more selective approach to data collection is possible by linking a sheet type to a witness point. See
Figure 9-26.
When a touch screen Witness Point button is touched, the linked sheet will be automatically presented
so that the operator may enter data related to the procedure being performed. See Figure 9-27.
Figure 9-26 The selected witness point “IVF Insemination” is linked to the data collection sheet
“ 4 Insemination/ICSI”, see above at bottom right
Figure 9-27 A witness point will trigger the presentation of a linked data collection sheet
Cycle Summary Sheets
Any sheet type may be selected as the cycle summary sheet.
1. Click Settings in the main menu bar.
2. Then click Treatment Cycle Types.
3. Use the Cycle Summary drop down menu to select the sheet type that will become the
summary sheet for this treatment type. See Figure 9-28.
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A typical summary sheet would show parameter values from many other sheets. See “Shared Between
Sheets” on page 79 for more details.
Quick access to a read only view of the cycle summary sheet is visible in the work area via the touch
screen Cycle Summary Button. See Figure 9-29.
Figure 9-28 Select one sheet to become the cycle summary sheet
Figure 9-29 Touch the cycle summary button to see the cycle summary sheet
Touch again to return to the original display
Parameter Attributes
Parameters that have been added to a sheet contents may be given sheet specific attributes. Click
Settings then Data Collection. See Figure 9-30.
Initial Value
Click in the Initial Value column and enter a value.
Initial values are linked with the Overwrite and Create checkboxes.
An initial value setting will be ignored unless a combination of Overwrite and or Create is also checked.
See Figure 9-31.
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Figure 9-30 Setting parameter attributes.
Initial Value, Editable, Overwrite, Create and Required
Editable
The value of editable parameters may be changed. If this checkbox is not checked then the parameter
will be shown “greyed out” and may not be changed on this sheet.
Required
Description
Required
Editable
Overwrite
Create
An operator must enter a value for a required parameter. The sheet cannot be saved until a value is
entered. Required parameters are highlighted with an asterisk on the work area touch screen and in
red when viewed in RI Witness™ Manager.
What does this combination mean ?
The value may not be edited
n/a
Editing allowed but may be left blank.
A value must be entered but it may not be left blank.
If a value already exists it will be overwritten with the initial value. The user cannot change the value.
n/a
If a value already exists it will be overwritten with the initial value. The user may change the value.
If a value already exists it will be overwritten with the initial value. The user may change the value but it may not be
left blank
If no value exists then show the initial value.
The user may not change this value.
n/a
If no value exists then show the initial value.
The user may change this value.
If no value exists then show the initial value.
The user may change this value but it may not be left blank.
The initial value will be shown, overwriting any existing value.
The user may not change this value.
n/a
The initial value will be shown, overwriting any existing value.
The user may change this value.
The initial value will be shown, overwriting any existing value.
The user may change this value but it may not be left blank.
Figure 9-31 Combining parameter attributes
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Section 10
Imaging
Research Instruments Ltd
SECTION 10 - IMAGING
How to View Live Images
A camera will need to be connected to the PC running RI Witness™ and the drivers installed correctly
to view live images within RI Witness™. The Imaging security dongle must also be fitted to a USB port
and a valid Imaging license issued.
RI Witness™ software will automatically recognise both analogue and compatible digital camera devices
connected to the PC. If there is only one camera device detected, it will show the live image for that
device. If multiple camera devices are connected, it will use the camera that was last selected from the
video source drop down box.
If there are multiple cameras attached to the PC, the device you want the live image to be viewed from
may be selected.
To do this, select the Camera from the dropdown list on the Settings panel.
Multiple Screen Configuration
Multiple Imaging screens can be configured for use with Imaging.
1. Open System Information.
2. Unlock settings.
3. Touch Screen Configuration / Training Mode.
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Figure 10-1 Combining parameter attributes
4. Set your desired configuration
If the work area is windowed, then multiple displays will not be shown. Windowed work area
is recommended for Admin PCs with readers connected. To enable simply tick the Windowed
WorkArea box.
5. The current operator and patient will be displayed on the secondary Imaging screen.
Figure 10-2 Imaging screen showing operator and patient
Both operators and patients may be changed by clicking the appropriate area on the Imaging screen.
Images are captured for the patient’s cycle currently active in the work area. Images captured for the
active cycle will be displayed in the RI Witness™ Manager sorted by date and time.
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Imaging
Figure 10-3 Images captured shown in the RI Witness™ Manager screen
Ensure that there is a location set to store captured images. This is set in RI Witness™ Manager.
1. Click Settings in the Main Menu tool bar.
2. Click General Settings.
3. Set the desired file path within the Image Storage Location field.
10
Figure 10-4 Image storage location
How to Take a Picture
This is available on both the work area screen and secondary Imaging screen.
1. Log in using your operator name and PIN.
2. Ensure there is a patient with an active / open cycle in the work area.
3. Press the Camera icon
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How to Record Video
This is available on both the work area screen and secondary Imaging screen.
1. Login using your operator name and PIN.
2. Ensure there is a patient with an active / open cycle in the work area.
3. Click the Film icon
4. Each video recording can last for a maximum of one hour. This eliminates the problem of
accidentally leaving the software recording and possibly rendering the computer unusable.
5. When freeze frame is set as keyboard shortcut, the live image recording can be paused. A
second press of the shortcut key will restart the live image recording.
6. Press or click Pause to stop recording.
How to Zoom & Pan the Image
Available on the Imaging screen
There are three ways to zoom into an area on the screen.
1. Place the mouse at a point on the screen. Click and hold the right mouse button, then release.
This will zoom to the preset zoom level into the spot where the mouse is placed. To zoom out,
click and hold the right mouse button.
2. Place the mouse at a point on the screen and use the scroll wheel on the mouse (if available).
This will give the user control over how much digital zoom is given.
3. Using the tool bar at the bottom of the screen, click the + icon to zoom in incrementally. To
zoom out by the same amount, click on the - icon on the tool bar. The magnifying glass icon will
zoom in and out by the preset zoom.
Whilst using digital zoom, a thumbnail image of the screen will appear in the top left of the screen. At
the top of this panel is the amount of magnification you are using. When zoomed out fully, this panel
will not appear on the screen.
Zooming in and zooming out can also be achieved using the foot pedal.
How to Perform Measurements
Available on the Imaging screen
1. Click Measure icon
on the tool bar.
2. Click on the screen to select a start point for the measurement.
3. Click on the screen a second time to select an end point for the measurement.
10
The ends of the line can be dragged to change the measurement.
Lines can be removed by clicking the cross in the context window.
During laser operation, lines are shown but cannot be dragged/created and no measurements will be
displayed.
Lines and measurements are shown on an image when images are taken in Line Mode.
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Imaging
How to Select Cameras
Available on both the work area screen and secondary Imaging screen.
1. Open System Information.
2. Unlock settings.
3. Press
4. Click on the drop down box to allow the selection of cameras. Clicking on the required camera
in the list will change the live image to that of the selected camera.
Camera Flipping
Available on both the work area screen and secondary Imaging screen.
1. Open System Information.
2. Unlock settings.
3. Press
4. Tick Flip Video Horizontal (for camera devices that support these options).
5. Tick Flip Video Vertical (for camera devices that support these options).
How to Set the Preset Zoom
Available on the Imaging screen.
1. Click the Image Settings icon
from the Imaging screen.
2. Drag the Preset Zoom slider to the required zoom.
How to Configure the Foot Pedal/Keyboard
Available on both the work area screen and secondary Imaging screen.
1. Open System Information.
2. Unlock settings.
3. Press .
4. Click the corresponding edit button to assign a shortcut.
5. Hold down the key or press the foot pedal to assign.
6. Click or press the green tick
to save the shortcut.
10
Once the shortcuts are set up, press the shortcut keys or the corresponding foot pedal to activate the
command.
How to Select Objectives
Available on the Imaging screen.
1. Click the Magnification
on the tool bar.
2. Click the required objective magnification.
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How to Add Objectives
Available on the Imaging screen.
1. Click
on the tool bar.
2. Click the Objective Calibration button.
3. Click New Objective. The magnification will be the same as the current magnification.
4. Click the required objective to edit objective magnification and fine adjustment values.
How to Remove Objectives
Available on the Imaging screen.
1. Click
on the tool bar.
2. Click the Objective Calibration button.
3. Click X next to an objective.
How to Check Objective Calibration
Available on the Imaging screen
1. Click
on the tool bar.
2. Click the Objective Calibration button to open the Objective Calibration panel.
3. Place an object of known dimensions (a stage micrometer is supplied with each system for this
purpose) in the field of view.
4. Ensure that the objective selected in Imaging matches that being used on the microscope.
5. The stage micrometer supplied measures 100μm between the longer lines. For best accuracy,
position each end point of the line at exactly the same relative position on the scale, for
example at the right hand edge of each vertical line.
6. Drag the rulers to the point where the stage micrometer is going to be measured from and use
the fine adjustment up and down until the ruler scale matches the stage micrometer.
Patient Display
1. To configure a screen as a patient display simply select the Patient Display Configuration for the
desired screen. The screen will display the RI logo until the display is turned on.
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On
Off
Figure 10-5
2. To turn the patient display on/off so that it shows the video from the camera, click the On or
Off button either on the work area or on the patient display panel on the Imaging display.  The
Imaging display shows a preview of what the patient display will show. See Figure 10-5.
3. To take a snapshot of the video to use on the patient display, press the Pause button on the
work area or patient display panel.
4. To re-enable live streaming of the video, press Play.
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Imaging
Figure 10-6 Information shown on patient display
Note: When a current patient is activated via the work area, the patient name and ID will appear on the
Patient Display. It will only be visible if the patient display is turned on. See Figure 10-6.
5. Closing the main window will also close the patient display.
Use of Saturn™ Laser Systems with RI Witness™
RI Witness™ can be run alongside and in conjunction with Saturn™ Laser Systems. Please refer to the
Saturn™ Laser System user manual for full instructions.
How to Access Saturn Laser System Information from a Work Area
To access settings and information from the work area
1. Open System Information.
2. Unlock settings.
3. Detailed information about the Saturn™ Laser System will be displayed.
4. Press Setting icon
to enable Biopsy or Multi-Pulse Modes.
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Figure 10-7 Saturn™ Laser System information
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Troubleshooting
Research Instruments Ltd
SECTION 11 - TROUBLE SHOOTING
Problem
Tags Reading
Intermittently or Only
in Certain Areas
Possible Cause
Solution
RF noise
Many devices in the lab can cause RF noise.
Contact RI or a RI representative.
Antenna not tuned
Metal objects may change antenna tuning.
Position the antenna where it will be used. If
the antenna that is not tuned is an auto tuning
antenna follow the instructions shown in “RF
Calibration” on page 19, otherwise contact RI
or a RI representative to retune the antenna.
Antenna not tuned
Metal objects may change antenna tuning.
Position the antenna where it will be used. If
the antenna that is not tuned is an auto tuning
antenna follow the instructions shown in “RF
Calibration” on page 19, otherwise contact RI
or a RI representative to retune the antenna.
Loose connection
Check for any cables unplugged or not tightened
fully.
Control unit / antenna /
Contact RI or a RI representative.
multiplexer faulty
Broken tag
Check the tag on a different antenna.
Tag not encrypted
Use the System Information. Non encrypted tags
are shown in red.
RF noise
Tags Not Reading
11
Many devices in the lab can cause RF noise. Contact
RI or a RI representative.
Use the System Information to check that the
number of antennas matches the number in
WorkArea configuration
the work area. Also check that the temperature
controller is specified correctly.
Antenna not tuned
Metal objects may change antenna tuning. Position
the antenna where it will be used. If the antenna
that is not tuned is an auto tuning antenna follow
the instructions shown in “RF Calibration” on page
19, otherwise contact RI or a RI representative
to retune the antenna.
Loose connection
Check for any cables unplugged or not tightened
fully. Contact RI or a RI representative.
Control unit / antenna /
Contact RI or a RI representative.
multiplexer faulty
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Problem
Multiplexer / Control
Unit / Temp Controller
Missing
Troubleshooting
Possible Cause
Solution
Use the System Information to check that the
number of antennas matches the number in
RI Witness™ WorkArea the work area. Also check that the temperature
configuration
controller is specified correctly.
Loose connection
Check for any cables unplugged or not tightened
fully.
Control unit / antenna / Contact RI or a RI representative
multiplexer faulty
Database Missing
Use the System Information to check that database
RI Witness™ WorkArea
connection is specified correctly. Contact your IT
configuration
department for assitstance.
Loose connection
Check for any unplugged or loose network cables.
Replace with a known good cable.
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Temperature Calibration
Research Instruments Ltd
SECTION 12 - TEMPERATURE CALIBRATION
Temperature Profile
Before checking the temperature profile, it is important to establish if the reader is a one or two channel
reader. This can be done by turning off the control box and restarting. At the beginning of the start-up
procedure the control box screen will show a tick or a cross next to the channel number (see heated
control box display warnings). If the reader is a single channel it will display a tick next to channel one
and a cross next to channel two, while a 2 channel will display a tick next to both.
The temperature gradient over the heated plate should not exceed 1.5°C. In a single channel reader
the temperature difference between the centre of the glass window and the highest temperature
measured away from the window should not exceed 3.0°C. For a dual channel reader the temperature
difference between the centre of the glass window and the highest temperature measured away from
the window should not exceed 1.5°C.
Temperature Profile Checklist
1. Follow this guide to position small amounts of thermal paste at each point to be measured.
Figure 12-1 Temperature profile template
2. Complete the form ‘RI Witness™ Heated Antenna Service Record’ for each heated reader. The latest
forms are available by contacting RI.
3. Use a thermometer probe secured with masking tape to measure the temperature at each of
the 14 points. Allow 3-5 minutes for the probe reading to stabilise at each measurement point.
Temperature Calibration
12
The objective of temperature calibration is to ensure that the temperature indicated by the RI Witness™
software is within 0.2°C of the temperature measured on a heated reader surface.
Ensure that the work area setup is as it will be used, eg microscope light on, fan on, etc.
We recommend using a thermometer calibrated at 37°C fitted with a small thermocouple probe, such
as the RI IVF Thermometer.
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Temperature Calibration
Temperature Calibration Service
1. Switch the control unit ON.
2. Make sure the control unit RF power is switched off to avoid interference with a thermometer
reading.
3. Place a small amount of thermal compound 5cm to the right of the reader window. Position a
thermometer probe in the compound and secure the probe with masking tape.
4. Wait until the thermometer temperature stabilises. This can take up to 45 minutes.
5. Compare the temperature shown in the work area software with the thermometer reading.
A difference within +/-0.2°C is acceptable.
6. If the readings are outside the above requirement then click temperature to open the temperature
offset settings and make adjustments. Increase the offset to increase the displayed reading,
decrease the offset to decrease it.
7. Allow a small delay for the offset change to register.
Figure 12-2
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Touch Screen Calibration Checklist
The touch screen cursor should accurately track the position of an operator finger. If accuracy problems
are experienced then use a mouse to activate the calibration utility and perform the following checklist.
1. Double click the touchkit desktop icon, then click 4 Points Calibration on the Tools tab.
2. The touch screen shows a blinking X in the lower left corner. Touch and hold the blinking X until it
stops blinking and moves to the next  corner position. Repeat the touch and hold for each corner
of the screen. On completion a “calibration finished” message is displayed.
3. Touch the screen in a few random locations. Repeat the calibration if the cursor is not correctly
positioned.
Figure 12-3 Touchkit : USB controller screen shot
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Research Instruments Ltd
Section 13
Care and Maintenance
SECTION 13- CARE AND MAINTENANCE
Cleaning
RI Witness™ readers may be cleaned with a soft cloth and mild detergent. A reader may be lifted and
returned to its original location. Do not disconnect the cables attached to any reader.
Do not use solvents for cleaning.
Do not disconnect readers.
Do not change the position of readers.
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Section 14
Repairs and Returns
Research Instruments Ltd
SECTION 14 - 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 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.
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.
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Research Instruments Ltd
Section 14
Repairs and Returns
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.
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