Research Instruments INTEGRA 3 User Manual

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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

0120

www.research-instruments.com

Document 6-54-701UM, Issue 8, MRF 1217, 31st March 2016

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Page 1 User Manual 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 0120 www.research-instruments.com Document 6-54-701UM, Issue 8, MRF 1217, 31st March 2016...
Page 2: Table Of Contents
CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO THE INTEGRA 3 Intended Use Applicable Part Numbers Microscope Compatibility Installation SECTION 3 - SAFETY WARNINGS Guidance & Manufacturer’s Declaration - Electromagnetic Emissions (IEC 60601-1-2) - Electromagnetic Immunity Safety/Information Symbols...
Page 3 SECTION 6 - ELECTRONIC CONTROL SYSTEM Display User Interface Icons Shortcut Buttons Stopwatch Counter Under-stage Lights Height Indicators Height Indicator Calibration System Information SECTION 7 - TEMPERATURE CONTROL Heated Stage Plate and Heated Metal Insert (Mode 1) Heated Stage Plate and Heated Glass Insert (Mode 2) Heated Stage Plate and Heated Metal Insert with Thermosafe™...
Page 4 SOS Specification Table Fitting Tubing to a SOS Filling a SOS with Oil Fitting a Pipette Using a SOS SECTION 10 - TROUBLESHOOTING Manipulation Temperature Controller Alarm Code Tables SECTION 11 - CARE AND MAINTENANCE Manipulators Replacing the Micropipette Holder Tip O-ring Thermosafe Air Heating System Air Syringes - Inserting a New O-ring SAS-SE™...
Page 5: Section 1 - Preface
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 Research Instruments liable for direct, indirect, incidental, or consequential damages arising out of the use or inability to use this manual.
Page 6: Section 2 - Introduction To The Integra 3
* TDU500 has now been replaced by current model TDU3. Applicable indications for use are subject to the regulations 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.
Page 7: Applicable Part Numbers
Leica DMIRB, DMI3000B/4000B/6000B, DMIL, DMi8 Olympus IMT2, IX50/70, IX51/71/81, IX53/73/83 Installation Installation of the Integra 3 system should be carried out by a Research Instruments technician or other RI authorised personnel. Incorrect installation could result in poor pipette set-up and an overall poor performance.
Page 8: Section 3 - Safety Warnings
Research Instruments Ltd SECTION 3 - SAFETY WARNINGS DO NOT disassemble or modify any part of the Integra 3, or substitute any component for any other. Doing so may result in damage to specimens, and this voids the warranty and/or service contract.
Page 9: Guidance & Manufacturer's Declaration
- Electromagnetic Emissions (IEC 60601-1-2) The Integra 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Integra 3 should assure that it is used in such an environment. Emissions test Compliance...
Page 10: Electromagnetic Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Integra 3 is intended for use in the electromagnetic environment specified below. The customer or the user of the Integra 3 should ensure that it is used in such an environment. IMMUNITY...
Page 11 If the measured field strength in the location in which the Integra 3 is used exceeds the applicable RF compliance level above, the Integra 3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Integra 3.
Page 12: Safety/Information Symbols
Section 3 Integra 3™ Safety Warnings Research Instruments Ltd Safety/Information Symbols Symbol Meaning Indicates instruction for disposal of goods. In accordance with Annex II of the European Medical Device Directive 93/42/ EEC, as amended by Directive 2007/47/ 0120 EC under the supervision of notified body No.0120, SGS, UK Ltd.
Page 13: Section 4 - Product Overview
(ART). An Integra 3 system consists of a baseplate which fits to a microscope, a heated stage, two mechanical micromanipulators and two micropipette holders. The system also includes syringes to apply suction and pressure.
Page 14: System Components
Section 4 Integra 3™ Product Overview Research Instruments Ltd System Components Rear Adaptor MPHs Heated Stage Insert, Baseplate, TDU3, Thermosafe Front Adaptor SOS* Power Supply Adaptor SAS-SE* Handrest Syringe Tubing SAS* * Subject to order configuration Figure 4-1...
Page 15: Integra 3 System Component Part Numbers
Research Instruments Ltd Integra 3™ Product Overview The following tables give part numbers of system components and microscope adaptors. All parts are supplied or manufactured by Research Instruments Ltd. Integra 3 System Component Part Numbers Part Number Description 5-54-300 PL3, Left Hand...
Page 16: Integra 3 System Microscope Adaptor Part Numbers
Section 4 Integra 3™ Product Overview Research Instruments Ltd Integra 3 System Microscope Adaptor Part Numbers Note: The front and rear adaptors are specified according to microscope. Part numbers given below include the front adaptor, rear adaptor and fixing screws as required.
Page 17: Hardware Overview
Section 4 Research Instruments Ltd Integra 3™ Product Overview Hardware Overview Micropipette Holder (MPH) Heated Stage PL3 Toolholder Insert Coarse X,Y Control Lever Baseplate Set-up Lever Stage Y Control Heated Stage Plate Shortcut Stage X Control Touch-screen Buttons display Fine X Y Z Control...
Page 18: Rear Panel
Section 4 Integra 3™ Product Overview Research Instruments Ltd Rear Panel Follow Instructions for Use Power On/Off Supply Adaptor Required RX Only Power Mark Rating Serial Number CE Mark USB to PC Connection Quality Check Figure 4-4 Manufacturer’s Details Packaging and Handling Requirements...
Page 19: Integra 3 Specification Table
Section 4 Research Instruments Ltd Integra 3™ Product Overview Integra 3 Specification Table Part Description X, Y and Z movement from one lever Manipulator (X = side to side, Y = front to back, Z = up and down) Fine Control Sub-micron resolution 0.75mm X and Y travel, 5mm Z travel...
Page 20: Section 5 - Basic Operation
Section 5 Integra 3™ Basic Operation Research Instruments Ltd SECTION 5 - BASIC OPERATION Coarse Control Lever Left Coarse Control Lever Right Status Indicator Light Stage Y Control Fine X Y Z Control Stage X Lever Left Control Fine X Y Z Control...
Page 21: Petri Dish Positioning
Section 5 Research Instruments Ltd Integra 3™ Basic Operation The Coarse Control Lever moves the end of the micropipette through a maximum of 4mm in the x-y plane for coarse positioning of the pipette. The Fine Control Lever moves the pipette through a maximum of 0.75mm in the x and y planes, and is used for accurate positioning of tools and specimens for all normal procedures.
Page 22: Heated Stage Plate
Exercise caution when reaching for stage XY control that the Fine Control Lever is not knocked, especially when switching to the Integra 3 after using other stages that have the stage XY control in a different position. Heated Stage Plate The moving stage plate is heated, allowing a dish to be positioned away from the centre of the stage should this be required.
Page 23 Section 5 Research Instruments Ltd Integra 3™ Basic Operation The Heated Glass Insert is fragile and should be handled with care. Do not apply excessive force to the glass surface. Do not place the Petri dish over the frame of the Heated Glass Insert as this area is not heated (page 19).
Page 24: Fitting Micropipettes
Section 5 Integra 3™ Basic Operation Research Instruments Ltd Fitting Micropipettes The Integra 3 is designed to use industry standard 1.0mm diameter glass micropipettes, such as RI’s ICSI Plus range. 1. Partially unscrew the Micropipette Holder (MPH) tip. MPH Tip Figure 5-4 2.
Page 25: Inserting Mph Into Toolholder
Section 5 Research Instruments Ltd Integra 3™ Basic Operation Inserting MPH into Toolholder Raise the Set-up Lever located on the side of the toolholder and rotate the PL3 towards the front if desired. Place the narrow section of the MPH into the slot in the toolholder, then push inwards.
Page 26 Section 5 Integra 3™ Basic Operation Research Instruments Ltd 2. Take an empty and clean Petri dish (set-up dish), and lightly scratch a cross in its centre, on the upper surface. This must be the same type of Petri dish as used clinically.
Page 27 Section 5 Research Instruments Ltd Integra 3™ Basic Operation 9. Turn the Raised Position Adjustment Screw on each side, not the microscope focus, to bring the pipettes into focus. Take care not to apply too much downward pressure to the screw as this may cause the PL3 to drop.
Page 28 Section 5 Integra 3™ Basic Operation Research Instruments Ltd 11. Refit the PL3 and set the Raised Position Adjustment Screw at the centre of the range of movement using the PL3 Set-up Tool (or measure a height of 14mm). Hold the tool as shown, just to the side of the Raised Position Adjustment Screw.
Page 29: Pipette Angle Adjustment
Section 5 Research Instruments Ltd Integra 3™ Basic Operation Pipette Angle Adjustment Turn the Pipette Angle Control to increase or decrease the angle of the pipette. The tip of the pipette will stay in focus, so the angle can be changed at any time during a procedure.
Page 30: Shut Down Procedure
Section 5 Integra 3™ Basic Operation Research Instruments Ltd 1. Move the Fine (red) and Coarse (blue striped) Levers to a vertical position. Rotate the Fine Control Lever to the centre of the movement as indicated on the display. 2. Take an empty and clean Petri dish (set-up dish), and lightly scratch a cross in its centre, on the upper surface.
Page 31: Section 6 - Electronic Control System
SECTION 6 - ELECTRONIC CONTROL SYSTEM Display When the Integra 3 is switched on, a white screen with the RI logo is shown for a few seconds, then the main screen is shown. See User Interface Icons on page 28 for an explanation of all the icons.
Page 32: User Interface Icons
User Interface Icons The following table explains the meaning of all the user interface icons required to use and adjust the Integra 3 settings and features. The icons are referred to throughout this manual by their ‘Meaning’ in Bold typeface.
Page 33: Stopwatch
Counter The counter can be accessed from the main screen by pressing the Counter icon or the +1 button on the left hand side of the Integra 3. The counter can be used to count incrementally either upwards or downwards between 0 and 99.
Page 34: Height Indicators
These show the vertical position of the toolholders, as set by rotating the Fine Control Levers. If the Fine Control is turned close to the ends of the range of movement, the display will turn red and the Integra 3 will emit three short beeps, repeating every 5 seconds.
Page 35: System Information
Section 6 Research Instruments Ltd Integra 3™ Electronic Control System For each side in turn, rotate the Fine Control Lever fully to the bottom of the range of movement. Touch the Set Minimum Height icon. Rotate the Fine Control to the top of the range of movement and touch the Set Maximum Height icon.
Page 36: Section 7 - Temperature Control
It is recommended that temperatures are checked on a regular basis. When Integra 3 is powered up, the display briefly shows RI and the product logo. After start up the screen shows the actual temperatures of the devices connected. Note: The heating systems are continually monitored for safe operation.
Page 37: Heated Stage Plate Only (Modes 4 And 5)
Integra 3™ Temperature Control Heated Stage Plate Only (Modes 4 and 5) The Integra 3 can be configured to operate only the Heated Stage Plate. This is typically only required when using the Integra 3 with an externally controlled stage insert not manufactured by RI.
Page 38: Setting The Temperature
Section 7 Integra 3™ Temperature Control Research Instruments Ltd Setting the Temperature Do not adjust the temperature with a specimen in place on the heated surface. The setpoint temperature of each heating system can be modified by pressing the icons mentioned on page 32, which are located on the main screen.
Page 39: Temperature Calibration
Section 7 Research Instruments Ltd Integra 3™ Temperature Control Where the Thermosafe Air Heating System is fitted, it is recommended that temperature measurements are made above the centre of the objective and over the heated plate (see Figure 7-1 on page 35).
Page 40: Calibrating Heated Plates
Section 7 Integra 3™ Temperature Control Research Instruments Ltd Temperature calibration can be performed on each of the heating options listed at the start of the Temperature Control section. The calibration screen is accessed by pressing the Settings icon on the main screen, then the Calibrate Sensor icon.
Page 41: Calibrating Thermosafe Air Heating System
RESEA TOLERANCES DRAWING Probe in nozzle HASING MATERIAL DRAWN BY THIRD ANGLE SCALE PRODUCT INTEGRA 3 (UNLESS NUMBER PROJECTION BATCH TRACEABILITY SERIAL OTHERWISE X.XX 0.05 TITLE INTEGRA 3 WITH THERMOSAFE (COMMON) DATE STATED) GEOMETRIC 0.05 DIMENSIONS IN mm FINISH...
Page 42: Section 8 - Alarms And System Status
SECTION 8 - ALARMS AND SYSTEM STATUS The status of the temperature control system is shown by the Status Indicator Light on the left hand side of the Integra 3. Individual temperatures are shown on the touch screen display. Status Indicator Light...
Page 43: Event Log
The Event Log icon will be present on the main screen until the log has been cleared by pressing the Clear Event Log icon or until Integra 3 is powered off.
Page 44: Section 9 - Syringes
Section 9 Syringes Research Instruments Ltd SECTION 9 - SYRINGES Safety High pressure can be generated in the system when using small diameter micropipettes, viscous fluids, or if a micropipette becomes blocked. This may cause micropipettes to shoot out of the holder.
Page 45: Sas - Screw-Actuated Air Syringe Assembly
Section 9 Research Instruments Ltd Syringes SAS - Screw-Actuated Air Syringe Assembly Note: Do not fill the syringe or tubing with oil Spigot Figure 9-1 Hole Hard Polythene Tubing 1. Turn the unit upside down. 2. Insert the end of the hard polythene tubing through the hole in the side of the base.
Page 46: Sas Operation
Section 9 Syringes Research Instruments Ltd SAS Operation Suction/Injection is obtained by turning the rotator on top of the syringe. Injection Suction Equilibration button (E-button) Rotator Figure 9-2 High pressure can be generated in the system when using small diameter micropipettes, viscous fluids, or if a micropipette becomes blocked.
Page 47: Equilibration Procedure
Section 9 Research Instruments Ltd Syringes Equilibration Procedure This procedure balances the pressure in the syringe with the capillary action of the pipette, allowing the most accurate control of the sperm injection. The following is a typical procedure. However, other methods are possible, eg using medium without PVP.
Page 48: Sos - Screw-Actuated Oil Syringe Overview
Section 9 Syringes Research Instruments Ltd SOS - Screw-Actuated Oil Syringe Overview The SOS is a screw actuated syringe for the precise transfer and injection of spermatozoa. By using oil (which has very low compressibility) to transfer the movement of the control knob to the specimen, accurate aspiration and injection can be easily achieved.
Page 49: Fitting Tubing To A Sos
Section 9 Research Instruments Ltd Syringes Fitting Tubing to a SOS Use hard polythene tubing as supplied by RI. Use of soft tubing will result in poor specimen control. 1. Slide the nut over the tubing. Note: The non-threaded end should be pushed over first.
Page 50: Filling A Sos With Oil
Section 9 Syringes Research Instruments Ltd Filling a SOS with Oil RI recommends sterile filtered paraffin oil. Syringes and caps must be screwed ontothe fill port with gentle finger pressure only. Overtightening may damage the fittings. 1. Stand the SOS on its end as shown below. Fill the syringe supplied with oil, unscrew the cap from the fill port and screw the syringe onto the Oil Filling Port.
Page 51 Section 9 Research Instruments Ltd Syringes 4. Turn the SOS to a horizontal position. Add a few drops of oil to the fill port until the oil is level with the top of the port. Figure 9-11 5. Refit the cap ensuring that no air bubbles are trapped underneath.
Page 52 Section 9 Syringes Research Instruments Ltd 7. Stand the SOS on end as shown below. Turn the Control knob to move the plunger below the fill port. Remove the cap from the fill port. Fill the syringe with oil ensuring that there are no air bubbles in the syringe.
Page 53: Fitting A Pipette
Section 9 Research Instruments Ltd Syringes Fitting a Pipette 1. Hold the pipette holder vertically and turn the Control Knob clockwise until a drop of oil emerges from the tip. Slide the pipette into the holder and tighten the tip.
Page 54: Section 10 - Troubleshooting
Section 10 Integra 3™ Troubleshooting Research Instruments Ltd SECTION 10 - TROUBLESHOOTING For any issues not covered below, please contact your distributor or the RI service team directly (see page 71 for RI contact details). Manipulation Problem Possible cause Solution...
Page 55: Temperature Controller
Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Problem Possible Cause Solution Objectives are focused Refocus on the top surface of a Petri dish too high Objectives hit Heated The specimen is too Stage Insert when close to the edge of...
Page 56: Alarm Code Tables
Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Alarm Code Tables The following tables on pages 52 to 62 lists Alarm Condition Code numbers, displayed Error Message, Priority, Fault Description, Alarm Actions and a Solution to the fault. Alarm Fault...
Page 57 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Heated Stage Insert is not able to heat. Switch off the Alarm activated Integra 3 and 2 minutes after Heated...
Page 58 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Switch off the Temperature No signal/out of Integra 3 and is shown as range signal from verify that the -.-°C. Heated...
Page 59 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria This may be caused by placing either hot or cold objects on the stage. In this case either remove the...
Page 60 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Thermosafe Switch off the Air Heating Thermosafe air Integra 3 and System heater temperature verify that the controller has exceeded...
Page 61 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Heated Switch off the Heated Stage Stage Insert Integra 3 and Insert temperature controller verify that the has exceeded power is set...
Page 62 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria This may be caused by placing either hot or cold objects on the stage. In this case either remove the...
Page 63 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Thermosafe Air Heating No signal/out of System range signal from controller air flow sensor. power is set FLOW SENSOR Low /...
Page 64 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Switch off the Integra 3 and check for air flow obstructions, A fault has caused Thermosafe verify the the Thermosafe...
Page 65 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting Alarm Fault Alarm Condition Message Priority Description/ Solution Actions Code Alarm Criteria Switch off the Integra 3 and verify that the Heated Stage Heated Stage Plate was not Plate cables able to achieve...
Page 66 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd ITO Heated ITO Heated Glass Glass Insert Insert has come controller The microscope into electrical power is set objective must contact with HEATED to 0% for be lowered so Low / the with the...
Page 67 Section 10 Research Instruments Ltd Integra 3™ Troubleshooting After power is switched off and then on all heating systems will need to be set up and re-calibrated (Refer to the Integra 3 Installation & Memory/Controller Service Manual Fault. 6-54-701IM During normal...
Page 68 Section 10 Integra 3™ Troubleshooting Research Instruments Ltd Problem Possible cause Solution Tip of the micropipette holder has not Tighten the tip if necessary been tightened properly The specimen falls off the holding pipette/ Micropipette tip Replace the micropipette unable to get...
Page 69: Section 11 - Care And Maintenance
Section 11 Integra 3™ Care and Maintenance Research Instruments Ltd SECTION 11 - CARE AND MAINTENANCE Regular servicing by an RI authorised technician will help to ensure that your system performs at its best. We recommend a minimum of one annual inspection and service. However, this may need to be more frequent if systems are heavily used.
Page 70: Replacing The Micropipette Holder Tip O-Ring
Section 11 Integra 3™ Care and Maintenance Research Instruments Ltd Replacing the Micropipette Holder Tip O-ring After a period of use the rubber O-ring inside the Micropipette Holder (MPH) will become worn and will allow air leaks to affect the injection/ aspiration system.
Page 71: Thermosafe Air Heating System
The filter is designed to prevent foreign objects and debris entering the Thermosafe Air Heating System, which could cause a degradation in performance. In all cases the Integra 3 manipulation system is expected to be used in a clean environment. Frequency of filter changes will be determined by the level of cleanliness.
Page 72: Air Syringes - Inserting A New O-Ring
Section 11 Integra 3™ Care and Maintenance Research Instruments Ltd Air Syringes - Inserting a New O-ring After a lot of use the O-ring may need replacing to ensure smooth and accurate operation. Spare O-rings are supplied with the syringe, and can also be ordered from RI.
Page 73: Cleaning
Research Instruments Ltd Cleaning Use a dust cover to protect the Integra 3 when not in use. This will minimise the need for cleaning. We recommend and supply a non-PVC dust cover as plasticisers commonly used in flexible PVC are known to be embryotoxic.
Page 74: Section 12 - Repairs And Returns Procedures
Should you notice impaired performance and/or any issues where safety is compromised, or have any other concerns during the use of this Integra 3, seek the advice of Research Instruments or their authorised representative promptly. RI Repairs System In the event that you have a problem with an RI instrument, please follow the procedure below to ensure prompt attention.
Page 75: Contact Details
Obligation to Inform Please inform RI should you or another user become aware of information that reasonably suggests that the Integra 3 has or may have caused or contributed to a serious incident , or has malfunctioned; or should the...