Research Instruments INTEGRA 3 User manual

User Manual
Document 6-54-701UM, Issue 8, MRF 1217, 31st March 2016
RESEARCH INSTRUMENTS LTD
Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK
t: [phone] | f: [phone] |e: [e-mail]
www.research-instruments.com
0120

CONTENTS
 
 
Intended Use 2
Applicable Part Numbers 3
Microscope Compability 3
Installaon 3
 
Guidance & Manufacturer’s Declaraon
- Electromagnec Emissions (IEC 60601-1-2) 5
- Electromagnec Immunity 6
Safety/Informaon Symbols 8
 
System Components 10
Integra 3 System Component Part Numbers 11
Integra 3 System Microscope Adaptor Part Numbers 12
Hardware Overview 13
Rear Panel 14
Packaging and Handling Requirements 14
Integra 3 Specicaon Table 15
 
Petri Dish Posioning 17
Petri Dish Choice 17
Heated Stage Plate 18
Heated Metal Inserts 18
Heated Glass Inserts 18
Fing Micropipees 20
Inserng MPH into Toolholder 21
Inial Pipee Set-up Diagram 21
Inial Pipee Set-up Instrucons 21
Pipee Angle Adjustment 25
Roune Pipee Set-up 25
Shut Down Procedure 26

 
Display 27
User Interface Icons 28
Shortcut Buons 28
Stopwatch 29
Counter 29
Under-stage Lights 29
Height Indicators 30
Height Indicator Calibraon 30
System Informaon 31
 
Heated Stage Plate and Heated Metal Insert (Mode 1) 32
Heated Stage Plate and Heated Glass Insert (Mode 2) 32
Heated Stage Plate and Heated Metal Insert
with Thermosafe™ (Mode 3) 32
Heated Stage Plate Only (Modes 4 and 5) 33
Thermosafe 33
Seng the Temperature 34
Adjusng Specimen (Setpoint) Temperature 34
Temperature Calibraon 35
Calibrang Heated Plates 36
Calibrang Thermosafe Air Heang System 37
 
Status Indicator Light 38
Audible Alarms 38
Event Log 39
 
Safety 40
For ICSI in the USA 40
SAS™ - Screw-Actuated Air Syringe Assembly 41
SAS Specicaon Table 41
SAS Operaon 42
Notes on SAS 42
Equilibraon Procedure 43
SOS™ - Screw-Actuated Oil Syringe Overview 44

SOS Specicaon Table 44
Fing Tubing to a SOS 45
Filling a SOS with Oil 46
Fing a Pipee 49
Using a SOS 49
 
Manipulaon 50
Temperature Controller 51
Alarm Code Tables 52
 
Manipulators 65
Replacing the Micropipee Holder Tip O-ring 66
Thermosafe Air Heang System 67
Air Syringes - Inserng a New O-ring 68
SAS 68
SAS-SE™ 68
Cleaning 69
Liquid Spills 69
Fuses 69
Disposal of Goods 69
 
Reuse Statement 70
RI Repairs System 70
RI Returns System 70
Contact Details 71
Obligaon to Inform 71
Feedback 71

Secon 1
Preface
1
1
Research Instruments Ltd

Thank you for choosing the Integra 3.
This manual provides all necessary informaon to use the Research
Instruments Integra 3 micromanipulaon system. The system should be
operated by trained personnel only. All secons of this manual should be
read and understood fully before any operaon of the system. Please see
the Intended Use for more informaon.
If the operator is unsure of any of the informaon contained in this
manual, they should contact Research Instruments or an appointed
representave before aempng to use this equipment.
In no event does Research Instruments Ltd (RI) assume the liability for any
technical or editorial errors of commission, or omission; nor is Research
Instruments liable for direct, indirect, incidental, or consequenal
damages arising out of the use or inability to use this manual.
RI is constantly updang its products, and therefore reserves the right to
introduce changes in design, equipment and technical features at any me.
The Integra 3 manual belongs with the micromanipulaon system and
should be passed on with the Integra 3 micromanipulaon system if
relocated to another clinic.
The use of ™in this manual indicates a trademark of Research Instruments
Ltd. Any other brand names, referred to in this manual, are trademarks
of their respecve owners.
This indicates cauonary text which should be followed to avoid
injury to users or damage to samples.
The system should be operated by qualied and trained
personnel only.

Introducon to the Integra 3™
2
Research Instruments Ltd
2
Secon 2
* TDU500 has now been replaced by current model TDU3.
Applicable indicaons for use are subject to the regulaons of the country
into which the device is sold. Availability of an Integra 3 Micromanipulator
for clinical use is dependent on the regulatory approval status of the
Integra 3 Micromanipulator in the country the device is intended to be
sold into.


To precisely posion microtools under a microscope whilst maintaining
specimen temperature during Assisted Reproducon Techniques (ART)
such as Intracytoplasmic Sperm Injecon (ICSI) and Intracytoplasmic
Morphologically-selected Sperm Injecon (IMSI).
Contraindicaons: There are no contraindicaons associated with this
device.

The RI TDU500* Micromanipulator for Assisted Reproducon is
used to accurately posion microtools under a microscope for the
techniques of Assisted Reproducon.
The RI Integra is a conguraon comprising two TDU500*
micromanipulators, two air syringes and temperature control
system within a single housing.
: Federal law restricts this device to sale by or on the order
of a physician or a praconer trained and cered in its use.
Only
0120

Introducon to the Integra 3™

Research Instruments Ltd
2
Secon 2


Zeiss Axiovert 40/100/200, Axio Observer, Axio Vert.A1
Nikon TMD, Diaphot 200/300, TE200/300, TE2000, Ti
Leica DMIRB, DMI3000B/4000B/6000B, DMIL, DMi8
Olympus IMT2, IX50/70, IX51/71/81, IX53/73/83

Installaon of the Integra 3 system should be carried out by a Research
Instruments technician or other RI authorised personnel. Incorrect
installaon could result in poor pipee set-up and an overall poor
performance.
Relocaon of this system should be treated as a re-installaon and
should, therefore, be carried out by authorised personnel.
Please note that installaon and servicing is covered separately in the
Integra 3 Installaon and Service Manual (6-54-701IM). Users within the
USA will not be provided with Integra 3 Installaon and Service Manual.
The only user-serviceable parts are those detailed in the Troubleshoong
and Care and Maintenance Secons.
Ensure that the mains power supply adaptor is prevented from
falling o the bench as this is likely to cause damage to equipment.
 
6-54-110 Integra 3 with Heated Metal Insert
6-54-100 Integra 3with Heated Metal Insert and Thermosafe
6-54-150 Integra 3 Upgrade with Thermosafe
6-54-160 Integra 3 Upgrade without Thermosafe

Integra 3™ Safety Warnings

Research Instruments Ltd
3
Secon 3

disassemble or modify any part of the Integra 3, or
substute any component for any other. Doing so may result
in damage to specimens, and this voids the warranty and/or
service contract.
 operate unless properly mounted to a microscope.
use the power cable and power supply adaptor supplied
with the system.
The cable to the power supply is the Disconnect Device for
this equipment. To remove all electrical power from this
product, disconnect the power cable from the electrical outlet.
Equipment should be posioned so as to allow easy access to
the power cable. The appliance coupler or mains plug is used as
the disconnect and must remain readily operable.
 To avoid the risk of electric shock, this equipment must
only be connected to a mains supply with protecve earth.
 Not to be used in a paent environment.
The microscope itself must be maintained to a high standard.
Problems such as worn focus mechanisms or an insecure video
camera may lead to unreliable focus and image stability, and
could lead to embryo damage.
 Do not modify this equipment without
authorisaon of the manufacturer.

Integra 3™ Safety Warnings
5
Research Instruments Ltd
3
Secon 3


  

RF emissions
CISPR 11 Group 1
The Integra 3 uses RF energy only
for its internal funcon. Therefore,
its RF emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
RF emissions
CISPR 11 Class B The Integra 3 is suitable for use
in all establishments other than
domesc, and may be used in
domesc establishments and those
directly connected to the public low-
voltage power supply network that
supplies buildings used for domesc
purposes, provided the following
warning is heeded.
This equipment/system
is intended for use by healthcare
professionals only. This equipment/
system may cause radio interference
or may disrupt the operaon
of nearby equipment. It may
be necessary to take migaon
measures, such as re-orienng or
relocang the Integra 3 Or shielding
the locaon.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuaons/
icker emissions
IEC 61000-3-3
Complies
The Integra 3 is intended for use in the electromagnec environment
specied below.
The customer or the user of the Integra 3 should assure that it is used in
such an environment.

Integra 3™ Safety Warnings

Research Instruments Ltd
3
Secon 3


The Integra 3 is intended for use in the electromagnec environment
specied below. The customer or the user of the Integra 3 should ensure
that it is used in such an environment.

      
Electrostac
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic le. If oors
are covered with synthec
material, the relave humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for
power supply
lines
± 1 kV for input/
output Lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV
dierenal
mode
± 2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips, short
interrupons
and voltage
variaons on
power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5s
<5 % UT
(>95 % dip in
UT) for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5s
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of the Integra 3 requires
connued operaon during
mains power interrupons,
it is recommended that the
Integra 3 be powered from an
uninterrupble power supply or
a baery.
Power
frequency
(50/60 Hz)
magnec eld
IEC 61000-4-8
3.0 A/m 50/60Hz 3.0 A/m
50/60Hz
Power frequency magnec
elds should be at levels
characterisc of a typical
locaon in a typical commercial
or hospital environment.
UT is the a.c. mains voltage prior to applicaon of the test level.

Integra 3™ Safety Warnings

Research Instruments Ltd
3
Secon 3

      
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
3 V/m
Portable and mobile RF
communicaons equipment
should be used no closer to any
part of the Integra 3, including
cables, than the recommended
separaon distance calculated
from the equaon applicable to
the frequency of the transmier.


Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situaons. Electromagnec propagaon
is aected by absorpon and reecon from structures, objects and people.
Note 3: These guidelines may not apply in all situaons. Electromagnec propagaon
is aected by absorpon and reecon from structures, objects and people.
a Field strengths from xed transmiers, such as base staons for radio (cellular/
cordless), telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess
the electromagnec environment due to xed RF transmiers, an electromagnec site
survey should be considered. If the measured eld strength in the locaon in which
the Integra 3 is used exceeds the applicable RF compliance level above, the Integra 3
should be observed to verify normal operaon. If abnormal performance is observed,
addional measures may be necessary, such as re-orienng or relocang the Integra 3.
b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than
[V 1 ] V/m.
where p is the maximum output
power rang of the transmier
in was (W) according to the
transmier manufacturer
and d is the recommended
separaon distance in metres
(m). Field strengths from xed
RF transmiers, as determined
by an electromagnec site
survey a, should be less than
the compliance level in each
frequency rangeb.
Interference may occur in the
vicinity of equipment marked with
the following symbol:
80MHz to 800MHz
800MHz to 2.5GHz
d = [3.5/V1] √p
d = [3.5/V1] √p
d = [3.5/V1] √p

Integra 3™ Safety Warnings
8
Research Instruments Ltd
3
Secon 3
 
Indicates instrucon for disposal of goods.
In accordance with Annex II of the
European Medical Device Direcve 93/42/
EEC, as amended by Direcve 2007/47/
EC under the supervision of noed body
No.0120, SGS, UK Ltd.
Indicates the medical device
manufacturer.
Indicates the need for the user to consult
the instrucons for use for important
cauonary informaon such as warnings
and precauons that cannot, for a variety
of reasons, be presented on the medical
device itself.
Follow instrucons for use.
The rst four digits are the serial number,
a unique idener assigned to the
product. The last two digits signify the
year of manufacture, eg 5001/13 (this
denotes a unique serial number of 5001
and a year of manufacture of 2013).
Cauon: US Federal law restricts this
device for sale to or on the order of a
licensed healthcare praconer.

Only
S
N
0120

Secon 4
Integra 3™ Product Overview

Research Instruments Ltd
4

Welcome to the user manual for the Research Instruments Integra 3
micromanipulaon workstaon. This manual covers set-up, operaon
and maintenance of the workstaon. Please note that installaon and
servicing is covered separately in the Integra 3 Installaon and Service
Manual (6-54-701IM). Users within the USA will not be provided with
Integra 3 Installaon and Service Manual.
The Integra 3 provides a means of micromanipulang samples placed
under a microscope whilst maintaining sample temperature when
performing assisted reproducon techniques (ART).
An Integra 3 system consists of a baseplate which ts to a microscope, a
heated stage, two mechanical micromanipulators and two micropipee
holders. The system also includes syringes to apply sucon and pressure.
SAS air syringes are supplied as standard, but the SOS oil syringe or SAS-
SE ne control air syringe are available on request. Oponal components
include a double toolholder, an ITO heated glass insert and an air heang
system which is congured according to the customer’s microscope. All
heang systems are electrically powered.
Movement (micromanipulaon) is controlled by mechanical means
only with levers which provide both coarse (XY) and ne (XYZ) control.
Both temperature and movement are controlled manually by the user.

Secon 4
Integra 3™ Product Overview

Research Instruments Ltd
4
Figure 4-1

Rear Adaptor
Heated Stage
Insert,
Baseplate,
TDU3,
Thermosafe
Handrest
SOS*
SAS-SE*
Front Adaptor
SAS*
MPHs
* Subject to order conguraon
Syringe Tubing
PL3
PL3
Power Supply
Adaptor

Secon 4
Integra 3™ Product Overview
11
Research Instruments Ltd
4
 
5-54-300 PL3, Le Hand
5-54-320 PL3, Right Hand
5-54-100 Baseplate Assembly
6-54-400 TDU3 (x2)
6-27-562 MPH (x2)
5-54-283 Heated Stage Insert (Heated Metal Insert, 16mm Diameter)*
5-54-290 Heated Stage Insert (Heated Metal Insert, 25mm Diameter)*
5-54-282 Heated Stage Insert (ITO Heated Glass Insert)*
2-00-893 12V 11A Medical Power Supply Adaptor
5-50-170 Handrest (x2)
6-34-520 SAS Air Syringe*
6-34-530 SAS-SE Air Syringe*
6-34-700 SOS Oil Syringe*
The following tables give part numbers of system components and
microscope adaptors. All parts are supplied or manufactured by Research
Instruments Ltd.

*Subject to order conguraon

Secon 4
Integra 3™ Product Overview
12
Research Instruments Ltd
4
 
5-54-120 Olympus IX51/71, IX53/73/83
5-54-140 Olympus IX50/70
5-54-134 Olympus IMT2
5-54-122 Nikon TE200/300, TE2000, Ti, Diaphot 200/300
5-54-136 Nikon TMD
5-54-142 Leica DMIL
5-54-124 Leica DMIRB/DMI3000B/4000B/6000B/DMi8
5-54-128 Zeiss Axiovert 100/200, Axio Observer, Axio Vert.A1
5-54-144 Zeiss Axiovert 40

 The front and rear adaptors are specied according to microscope.
Part numbers given below include the front adaptor, rear adaptor and
xing screws as required.
Please consult RI for tments to microscopes not listed above.

Secon 4
Integra 3™ Product Overview

Research Instruments Ltd
4
Figure 4-2

Figure 4-3
On/O
Switch
Thermosafe
Air Filter
(where ed)
Heated Stage
Insert
Coarse X,Y
Control Lever
Touch-screen
display
Fine X Y Z Control
Lever
Heated Stage
Plate
PL3 Toolholder
Shortcut
Buons
Stage Y Control
Stage X Control
Set-up Lever
Micropipee
Holder (MPH)
Baseplate

Secon 4
Integra 3™ Product Overview

Research Instruments Ltd
4

To prevent transit damage to the equipment, the toolholders and, where
applicable, syringes are packed separately and must be ed before
operang the instrument.
Figure 4-4

Power
Supply
Adaptor
Required
Manufacturer’s Details
Power
Rang
Serial
Number
USB to
PC Connecon
On/O
CE Mark
Quality Check
Follow
Instrucons
for Use
RX Only
Mark

Secon 4
Integra 3™ Product Overview
15
Research Instruments Ltd
4
 
Manipulator
Fine Control
X, Y and Z movement from one lever
(X = side to side, Y = front to back, Z = up and down)
Sub-micron resoluon
0.75mm X and Y travel, 5mm Z travel
Manipulator
Coarse Control
X and Y movement
10 micron resoluon
4mm X and Y travel
PL3 Toolholders Pipee locaon
Pipee angle adjustment 16 to 43 degrees
Heang Systems
(conguraon dependent)
Heated Metal Insert: 16mm
25mm
ITO Heated Glass Insert
Thermosafe Air Heang System
Temperature Controller
Accuracy: beer than ±0.1°C when calibrated against
known reference.
Displayed resoluon: 0.1°C
Setpoint Temperature Range: 30-45°C
Displays 3.5” LCD touch screen display for temperature control
Connecvity
USB Type B socket for connecon to PC running RI Viewer
or RI Witness soware (where used). Refer to soware
manual for further informaon.
Connected PC to be compliant with IEC 60950-1
XY Stage Aluminium Heated Stage Plate
40mm travel in X and Y (25 and 33mm per turn)
Syringes Choice of SAS (air), SAS-SE (air) and SOS (oil)
Dimensions Footprint (not including microscope)
Width 56cm, depth 38cm
Weight
Maximum weight of microscope mounted components
(excluding front and rear adaptors): 10.4kg
Actual weight is conguraon dependent
Mains Power Adaptor Input: 100-240VAC, 50-60Hz, Max. 1.8A, Class I
Output: 12VDC, Min. 11A (132W)
Operang Range Temperature: 15°C (59°F) to 40°C (104°F)
Humidity: 15% to 85% RH (non condensing)
Micropipee
Compability
Compable with Research Instruments micropipees
(or other industry standard 1mm OD micropipees of
equivalent specicaon).

Power
Supply
Adaptor
Required
Power
Rang
Serial
Number

Secon 5
Integra 3™ Basic Operaon

Research Instruments Ltd
5

Fine X Y Z Control
Lever Right
Fine X Y Z Control
Lever Le
Stage Y
Control
Stage X
Control
Coarse Control Lever Le Coarse Control
Lever Right
Figure 5-1
Status Indicator
Light
Switch on the power at the rear right hand side. The display will light up
and the indicated temperature of the heang systems will start to rise.
The system should not be used unl the Status Indicator Light shows a
connuously illuminated green light. This indicates that the temperature
has seled. Refer to the ‘Alarms and System Status’ secon for a full
denion of each Status Indicator Light colour.
The operator should be posioned in such a place to easily access the
microscope and also view the image on the PC monitor (where used).
Y
Z
X