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Section 12

Repairs and Returns

71

Research Instruments Ltd

12

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: [email protected]  

Website: www.research-instruments.com

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

1

, or has malfunctioned; or should the 

Integra 3 be likely to  cause or contribute to  a serious  incident

1

 if the 

malfunction were to recur. Your applicable Competent Authority should 

also be informed. 

1

 as defined in European Medical Device Directive 93/42/EEC as amended, Article 10, paragraph 1, (a), (b).

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 

[email protected]

. Your 

feedback will help us develop the product and supporting materials to 

meet your future needs.
Thank you.

Содержание INTEGRA 3

Страница 1: ...701UM Issue 8 MRF 1217 31st March 2016 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 rese...

Страница 2: ...s 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 Specification Ta...

Страница 3: ...tal Insert with Thermosafe Mode 3 32 Heated Stage Plate Only Modes 4 and 5 33 Thermosafe 33 Setting the Temperature 34 Adjusting Specimen Setpoint Temperature 34 Temperature Calibration 35 Calibrating...

Страница 4: ...SECTION 11 CARE AND MAINTENANCE 65 Manipulators 65 Replacing the Micropipette Holder Tip O ring 66 Thermosafe Air Heating System 67 Air Syringes Inserting a New O ring 68 SAS 68 SAS SE 68 Cleaning 69...

Страница 5: ...ume 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 i...

Страница 6: ...ning specimen temperature during Assisted Reproduction Techniques ART such as Intracytoplasmic Sperm Injection ICSI and Intracytoplasmic Morphologically selected Sperm Injection IMSI Contraindications...

Страница 7: ...ould be treated as a re installation and should therefore be carried out by authorised personnel Please note that installation and servicing is covered separately in the Integra 3 Installation and Ser...

Страница 8: ...al 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 use...

Страница 9: ...and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system i...

Страница 10: ...4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptio...

Страница 11: ...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 electromag...

Страница 12: ...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 us...

Страница 13: ...ture when performing assisted reproduction techniques ART An Integra 3 system consists of a baseplate which fits to a microscope a heated stage two mechanical micromanipulators and two micropipette ho...

Страница 14: ...10 Research Instruments Ltd 4 Figure 4 1 System Components Rear Adaptor Heated Stage Insert Baseplate TDU3 Thermosafe Handrest SOS SAS SE Front Adaptor SAS MPHs Subject to order configuration Syringe...

Страница 15: ...eated 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...

Страница 16: ...on 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 Integra 3 System Microscope Adaptor Part...

Страница 17: ...verview Figure 4 3 On Off Switch Thermosafe Air Filter where fitted Heated Stage Insert Coarse X Y Control Lever Touch screen display Fine X Y Z Control Lever Heated Stage Plate PL3 Toolholder Shortcu...

Страница 18: ...to the equipment the toolholders and where applicable syringes are packed separately and must be fitted before operating the instrument Figure 4 4 Rear Panel Power Supply Adaptor Required Manufacturer...

Страница 19: ...or temperature control Connectivity USB Type B socket for connection to PC running RI Viewer or RI Witness software where used Refer to software manual for further information Connected PC to be compl...

Страница 20: ...hand side The display will light up and the indicated temperature of the heating systems will start to rise The system should not be used until the Status Indicator Light shows a continuously illumina...

Страница 21: ...move the pipette to the left The Fine Control Lever also provides Z movement of up to 5mm by the rotation of the lever Petri Dish Positioning Stage movement is controlled by the X and Y controls as d...

Страница 22: ...e of movement is limited by the diameter of this hole normally 25mm Reposition the dish by hand to view specimens that are outside the area of the hole It may also be necessary to reposition the dish...

Страница 23: ...aser with the microscope focussed on the ITO glass surface as this may damage the ITO coating The Heated Glass Insert is fragile and should be handled with care Do not apply excessive force to the gla...

Страница 24: ...1 1 MPH assembly PURCHASING SIGNATURES THIRD ANGLE PROJECTION 1 AX MPH 1 0mm FOR PAR21 ECN SHEET 1 2 3 5 6 7 4 A B C D E F TOLERANCES UNLESS OTHERWISE STATED X 0 5 X X 0 1 X XX 0 05 RE GEOMETRIC 0 05...

Страница 25: ...narrow section of the MPH into the slot in the toolholder then push inwards Figure 5 8 Lowered Position Adjustment Centring Control Axial Drive Rotate toward front Micropipette Holder MPH Initial Pipe...

Страница 26: ...with spacer 5 LifttheSet upLeverstotheraisedposition Insertholdingandinjection pipettes into the MPHs and clip the MPHs into the toolholders PL3 6 Adjust the angle of each pipette by turning the Pipe...

Страница 27: ...roscope 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 10 If the pipette cannot be brought into focus remove th...

Страница 28: ...the top and bottom of the square cut out 12 Repeat from Step 9 Move to Step 13 when the pipette can be brought into focus with the Raised Position Adjustment Screw 13 Select the low magnification obj...

Страница 29: ...e 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 For example the pipette can be set...

Страница 30: ...njection pipettes into the Micropipette Holders MPH and clip the MPHs into the toolholders PL3 6 Adjust the angle of each pipette if required by turning the Pipette Angle Control 7 Look into the eyepi...

Страница 31: ...hen the main screen is shown See User Interface Icons on page 28 for an explanation of all the icons Temperature displays these show the actual temperature of each heated area Touch the icons to adjus...

Страница 32: ...by their Meaning in Bold typeface eg is referred to as the Height Indicator Sound icon Icon Meaning Icon Meaning Height Indicator Sound Under stage Lights Audio Alarm Increase and Decrease Audio Alarm...

Страница 33: ...con or the 1 button on the left hand side of the Integra 3 The countercanbeusedtocountincrementallyeitherupwardsordownwards between 0 and 99 To count upwards press either the 1 button or press the Inc...

Страница 34: ...ge of movement If the TDU needs to be set away from the centre point in order to bring the pipette into focus then follow the Initial Pipette Set up Instructions on page 21 before proceeding Height In...

Страница 35: ...without saving then any changes to the calibration will not be saved and it will revert to the previous calibration System Information In order to provide additional information in the event of a faul...

Страница 36: ...may become hot to the touch It is recommended that temperatures are checked on a regular basis SECTION 7 TEMPERATURE CONTROL Heated Stage Plate and Heated Metal Insert Mode 1 The Heated Stage Plate an...

Страница 37: ...this system are located underneath the baseplate with the exception of the filter which is located at the rear of the baseplate for ease of access Refer to the Care and Maintenance section for require...

Страница 38: ...Setpoint Temperature The heating systems are factory calibrated such that when the controller is set to 37 C the surface temperature of the heated plate s and air expelled from the Air Heating System...

Страница 39: ...e normally used for manipulation is in position when measuring specimen temperature and adjusting setpoint temperatures Figure 7 1 Temperature Calibration Perform calibration only if the displayed tem...

Страница 40: ...at least 20 minutes to allow the temperature to stabilise before calibrating Recommended positions for temperature measurement during calibration of heated plates are shown below for both metal Figur...

Страница 41: ...Glass Insert it is not recommended that temperatures are measured directly above the objective during calibration This is because the objective cools that part of the plate Either move the objective a...

Страница 42: ...relating to each alarm condition and applicability of each alarm condition refer to the Troubleshooting section of this manual Once activated all alarms are sounded immediately as the alarm condition...

Страница 43: ...h the elapsed time The Event Log displays the last 5 events This is accessible by pressing the Settings icon on the main screen then Event Log or by pressing the Event Log icon which appears on the ma...

Страница 44: ...o the device when in use For ICSI in the USA High pressure can be generated in the system when using small diameter micropipettes viscous fluids or if a micropipette becomes blocked This may cause mic...

Страница 45: ...the hard polythene tubing through the hole in the side of the base 3 Ease the tubing over the spigot ensuring that the tubing is securely fitted 4 The other end of the tubing is fitted to the micropi...

Страница 46: ...use micropipettes to shoot out of the holder Press the E button to release the pressure before loosening the micropipette holder tip to remove a micropipette Figure 9 2 Notes on SAS If the sperm is mo...

Страница 47: ...g pipette Equilibrate with medium 1 Place a drop of PVP medium in the centre of a Petri dish 2 Ensure the rotator is at the lower end of the movement Turn the rotator down clockwise if necessary 3 Pre...

Страница 48: ...nsfer the movement of the control knob to the specimen accurate aspiration and injection can be easily achieved Control Knob Oil Filling Port Locking Knob for Height Angle Adjustment Cylinder Piston F...

Страница 49: ...ult in poor specimen control 1 Slide the nut over the tubing Note The non threaded end should be pushed over first 2 Push the end of the tubing firmly onto the tip of the fitting 3 Tighten the nut ont...

Страница 50: ...air bubbles in the oil Any that are seen can be dislodged by a short sharp movement of the filling syringe and should be allowed to rise to the top of the oil 3 When you are certain there are no air...

Страница 51: ...l is level with the top of the port 5 Refit the cap ensuring that no air bubbles are trapped underneath A small amount of oil may be spilled which should be wiped away with an absorbent paper towel 6...

Страница 52: ...tand 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 t...

Страница 53: ...tteholderverticallyandturntheControlKnobclockwise until a drop of oil emerges from the tip Slide the pipette into the holder and tighten the tip 2 Part fill the pipette with oil by turning the SOS Con...

Страница 54: ...See Figure 10 1 The stiffness of the Coarse Control Lever is too tight or too loose Lever stiffness not adjusted Select the green ended hexagon driver from the tool kit provided Insert the driver int...

Страница 55: ...ture setpoint incorrect Touch the screen on the icon corresponding to the affected heating system Change if necessary then press Save Temperature Controller Problem Possible Cause Solution Objectives...

Страница 56: ...controller power is set to 0 until the Integra 3 is re started Switch off the Integra 3 and verify that the Heated Stage Plate cables and connector are secure and undamaged Possible heater or control...

Страница 57: ...out of range signal from Heated Stage Plate or Thermosafe air temperature sensor Alarm activates at any time if the temperature sensor circuit fails to read a valid temperature Temperature is shown as...

Страница 58: ...point temperature Alarm activates at any time if the temperature sensor exceeds 46 C Heated Stage Plate controller power is set to 0 until temperature falls to below 46 C Temperature is shown as C abo...

Страница 59: ...he setpoint temperature The Heated Stage Plate temperature controller continues to operate This may be caused by placing either hot or cold objects on the stage In this case either remove the object o...

Страница 60: ...ermosafe Air Heating System temperature has deviated by more than 2 5 C from the setpoint temperature Alarm enabled 1 minute after the temperature reaches 2 5 from the setpoint temperature Thermosafe...

Страница 61: ...46 C Temperature is shown as C above 55 C Switch off the Integra 3 and verify that the Heated Stage Insert cables and connector are secure and undamaged Possible heater or controller fault E14 HEATED...

Страница 62: ...he setpoint temperature The Heated Stage Insert temperature controller continues to operate This may be caused by placing either hot or cold objects on the stage In this case either remove the object...

Страница 63: ...e Air Heating System cables and connector are secure and undamaged Possible air flow sensor fan or controller fault E17 AIR FLOW FAILURE Medium The controller is not able to maintain the air flow rate...

Страница 64: ...om dust build up Also check that cables and connector are secure and undamaged Possible heater thermal switch or controller fault E19 HEATED INSERT LOW HEATING RATE Medium Heated Stage Insert was not...

Страница 65: ...sible heater or controller fault Operating the Integra 3 below its ambient temperature specification may produce this alarm E21 THERMOSAFE LOW HEATING RATE Medium Thermosafe Air Heating System was not...

Страница 66: ...d Stage Insert has been disabled Alarm activates at any time Heated Stage Insert controller power is set to 0 until the Integra 3 is re started Switch off the Integra 3 and verify that the Heated Stag...

Страница 67: ...Serial Number System continues to operate until power is removed When power is cycled the screen will show Recalibration Required After power is switched off and then on all heating systems will need...

Страница 68: ...the O ring in the micropipette holder tip see Figure 11 1 on page 66 if worn out Replace the O ring in the SAS air syringe see Figure 11 3 on page 68 Poor control from SAS Syringe Check for Air leaks...

Страница 69: ...essary RI will provide all technical information required to assist in resolving problems The following routine maintenance operations can be carried out by users but can also be carried out by RI aut...

Страница 70: ...ing repeatedly inserted into the MPH Body Tip O ring 1 Unscrew the tip from the body of the MPH 2 Remove the old O ring It may help to use a tool such as a small hexagon wrench to push into the centre...

Страница 71: ...m 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 leve...

Страница 72: ...eaned This should be entrusted to an RI authorised technician only Air Syringes Inserting a New O ring SAS Top O ring in its groove After a lot of use the O ring may need replacing to ensure smooth an...

Страница 73: ...off at the wall switch and the instrument should be completely dry before switching on Never use water to clean the Integra 3 Liquid Spills If liquid is spilt inadvertently immediately turn the elect...

Страница 74: ...ull value during shipping RI Repairs System In the event that you have a problem with an RI instrument please follow the procedure below to ensure prompt attention 1 Read the Troubleshooting section 2...

Страница 75: ...s malfunctioned or should the Integra 3 be likely to cause or contribute to a serious incident1 if the malfunction were to recur Your applicable Competent Authority should also be informed 1 as define...

Страница 76: ......

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