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Section 12

Returning Product to RI for Repair

Research Instruments Ltd

Obligation to Inform

In compliance with the European Medical Device Directive 93/42/EEC as amended, it is your duty to

inform RI and your competent authority 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.

Feedback

Thank you for purchasing an 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 Customer Service. Your feedback will help us develop the product and

supporting materials to meet your future needs.
Thank you.

Customer Service Contact details:
Tel: +45 46 79 02 02
Fax: +45 46 79 03 02
E-mail:

[email protected]

coopersurgical.com

US only customers contact details:
Tel: 800-243-2974
Fax: 800-262-0105

coopersurgical.com

Содержание SATURN 5

Страница 1: ... 5 LASER SYSTEMS only 0120 0120 45 46 79 02 02 customerservice origio com coopersurgical com Research Instruments Ltd Bickland Industrial Park Falmouth Cornwall TR11 4TA UK Document 6 47 500UM 15 DRF 4915 25th June 2019 ...

Страница 2: ...em Component Part Numbers 14 Saturn 5 Active Laser System Mirror Module Part Numbers 14 Saturn 5 Laser System Collimator Module Part Numbers 15 Hardware Overview 15 Laser Specifications 16 Objective Specifications 16 Saturn Active Specifications 16 Electrical Specifications 16 Mains Adaptor for Control Unit and Motor Module 16 Dimensions 16 Operating Conditions 16 Storage Transport Conditions 16 S...

Страница 3: ...e 33 How to Check Laser Target Alignment for Saturn 5 Active Laser System 33 How to Check Laser Target Alignment for Saturn 5 Fixed Laser System 34 How to Check Hole Size Calibration 34 How to Remove a Point from the Hole Size Calibration Graph 35 Laser Target 35 Hole Size Indicator 35 Exclusion Zone 35 How to Adjust Hole Size Pulse Width 36 Preset Pulse Widths 36 How to Fire the Laser Single Puls...

Страница 4: ...or is Research Instruments Ltd liable for direct indirect incidental or consequential damages arising out of the use or inability to use this manual This manual is protected by copyright all rights reserved and no part hereof may be photocopied or reproduced in any form without the prior written consent of Research Instruments Ltd Saturn and RI Viewer are trademarks of Research instruments Ltd All...

Страница 5: ...able Part Numbers Intended Use Indication for Use USA Customers Only For use in assisted reproduction procedures to ablate or thin the zona pellucida of an embryo to facilitate assisted hatching or recovery of cells for pre implantation genetic diagnosis blastomeres The device can also be used on blastocyst stage embryos for biopsy of trophectoderm cells for pre implantation diagnosis procedures a...

Страница 6: ...truments technician or other RI authorised personnel Incorrect installation could result in reduced power output laser misalignment or laser malfunction Relocation of this system should 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 Saturn 5 Laser System Installation Manual 6 47 50...

Страница 7: ...oids the warranty and or service contract DO NOT operate the laser unless it is properly mounted to a microscope 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 Equipmentshouldbepositionedsoastoal...

Страница 8: ... a problem for higher beam energies To eliminate any significant effects from thermal lensing we recommend that the pulse width be kept below 1000μs for clinical Laser Assisted Hatching LAH zona drilling WARNING Only a single opening should be made in the zona pellucida Multiple openings orthosethataretoosmallmaypreventembryohatchingorleadtoabnormaldevelopment WARNING Do not operate the pilot lase...

Страница 9: ...ren born after diode laser assisted hatching European Journal of Obstetrics and Gynaecology 110 176 180 2003 Precautions To minimise the risk of damage to blastomeres administer as few laser pulses as possible at the lowest energy levels possible to achieve the prescribed zona drilling or thinning effect Direct the laser beam toward a section of the zona pellucida where the adjacent perivitelline ...

Страница 10: ...V 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 differential Mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input ...

Страница 11: ...b Interference may occur in the vicinity of equipment marked with the following symbol 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 a Field strengths from fixed transmitters such as base stations for radio cellular cordle...

Страница 12: ...ser 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 Manufacturer Date of Manufacture Reference number Serial Number Refer to Instruction manual Consult instructions for use Direct current DC Class 1 laser product IEC60825 1 2014 Do not dispose of product with nor...

Страница 13: ... to move the position of the laser to the target area on the sample The Fixed model has the laser in a fixed position and the user moves the sample to the target All laser movement Active model only and laser firing is user controlled System Components Note Actual components may differ from those shown The Saturn 5 Laser System comes supplied with the following parts a control unit containing the ...

Страница 14: ...X50 70 right 5 46 151 Mirror module for Olympus IX51 71 81 left 5 46 152 Mirror module for Olympus IX51 71 81 right 5 46 159 Mirror module for IMT2 5 46 135 Mirror module for TMD 5 46 132 Mirror module for Nikon Diaphot 200 300 5 46 130 Mirror module for TE 200 300 5 46 140 Mirror module for TE2000 with Integra Ti 5 46 141 Mirror module for TE2000 without Integra Ti 5 46 142 Mirror module for Niko...

Страница 15: ...40 5 45 009 Collimator module for Axiovert 100 5 45 011 Collimator module for Axiovert 200 Observer 5 45 450 Collimator module for DMIRB 5 45 470 Collimator module for DMIL 5 45 461 Collimator module for DMI3000B 5 45 460 Collimator module for DMI4000B 6000B 5 45 463 Collimator module for DMi8 Saturn 5 Laser System Collimator Module Part Numbers Hardware Overview Device Label CLASS 1 LASER PRODUCT...

Страница 16: ...hing grounding Range of Movement Approx 370μm 40x 740μm 20x Accuracy 1μm within calibration area 3μm outside see page 33 Saturn Active Specifications Manufacturer Actual Magnification Olympus 40x 20x Nikon CFI60 36x 18x Leica 36x 18x Zeiss 44x 22x Magnification 40x 20x N A 0 49 0 25 Working distance 2 5mm 2 5mm Parfocal distance 45mm adaptor supplied for Nikon CFI60 systems Objective Specification...

Страница 17: ...the Saturn 5 Laser System for use within an ART laboratory Connected to a camera attached to a microscope it provides on screen images of samples under the microscope It can record video and store still images from the microscope in a PC s file system End users should ensure their own PCs are certified compliant to IEC 60950 1 The operator should be positioned to easily access the microscope and a...

Страница 18: ...mera Settings icon on the tool bar 2 Drag the Preset Zoom slider to the required zoom How to Select Cameras 1 Click the General Settings icon on the tool bar The Video Source drop down box will have a list of camera names referring to the cameras connected to the PC 2 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...

Страница 19: ...en in RI Viewer must be the same magnification as the objective in use on the microscope How to Select Objectives 1 Click the Choose Objective Magnification icon on the tool bar 2 Click the required objective magnification How to Add Objectives 1 Click Display Rulers Tool icon on the tool bar 2 Click the Objective Calibration button 3 Click New Objective The magnification will be the same as the c...

Страница 20: ...r the corresponding foot pedal to activate the command 3 Place an object of known dimensions a stage micrometer is supplied with each system for this purpose in the field of view Ensure that the objective selected in RI Viewer matches that being used on the microscope 4 The stage micrometer supplied measures 100µm between the longer lines For best accuracy position each end point of the line at ex...

Страница 21: ...by checking Compress Images If this box is ticked the images are saves as jpg files if not they are are saved as bmp files Images are named by default date and time yyyymmddhhmmss bmp For example a picture taken on the 3rd of January 2012 at 10 35 02 would be named 20120103103502 bmp How to Record Video 1 Click the Take Video icon on the tool bar 2 Whilst video is being captured a recording notifi...

Страница 22: ... is configured from the Settings screen of RI Viewer The RI Viewer Gallery shows all of the images and videos in this folder It allows them to be reviewed and then printed deleted or assigned to a patient Once they have been assigned to a patient they can also have references and comments added These can then be printed alongside the images The Gallery icon in RI Viewer is used to open RI Viewer G...

Страница 23: ...ick The selected images are indicated by the coloured border A single left click will open the image or video in a full screen view See 9 Full Screen View on page page 26 Patient Details The Patient Details screen shows the images that have been assigned to the selected patient along with the patient name reference and comments that have been entered for each image The Delete Print Image Selection...

Страница 24: ...To delete an image or video first select it then press the delete icon A confirmation screen will appear allowing the user to confirm whether the images and videos listed should or should not be deleted 2 Assign Assign is used to assign the selected images and videos to a patient using a unique ID number The image or video will be moved to the patient folder 3 Unselect Unselect will de select all ...

Страница 25: ... click 6 Re Assign If the Patient ID was assigned incorrectly click A pop up box will appear in which the correct patient details relating to the image or video can be input Click OK to save 7 Edit Details Edit Details is used to enter a patient name reference and a comment These are saved with each image and are displayed on the Patient Details screen If a different patient name reference or comm...

Страница 26: ...ew Delete Assign Re Assign Copy and Print can all be actioned from this view To return to the Un Assigned Images and Videos or Patient Details screen click A B 10 Print Preview To preview the image before printing first select the image Then press Print This will open the Print Preview Functions A Print B Print Setting 1 2 8 10 1 2 8 4 5 4 5 ...

Страница 27: ...ient ID of miscellaneous or similar can be created to assign them to Whenever one or more videos are selected either in addition to a number of images or by themselves the print command is unavailable A Print The Print button will print the selected images with the current settings See B Print Settings below B Print Settings Select the printer paper size page range etc required for printing the se...

Страница 28: ...n of the zona pellucida where the adjacent perivitelline space is widest or next to an area of fragmentation This will minimise possible damage due to heating of adjacent blastomeres The Exclusion Zone display can help with this To achieve a zona opening of 15µm select a pulse width which will result in a hole size of 9 3µm to 9 5µm A minimum of 4 shots should be applied to breach the inner and ou...

Страница 29: ...niate If creating a hole on day 3 the hole size created should be 15µm as described for Assisted Hatching At day 5 6 of embryo development there should be sufficient compaction of the ICM creating herniation of the TE If the herniated cells are safely away from the ICM TE cells can be aspirated with a biopsy pipette 20 30µm ID If creating a hole on day 5 6 an opening of approximately 15 20µm is ad...

Страница 30: ... the mid plane of the embryo 5 Position the embryo against the surface of the Petri dish using a micromanipulator and holding pipette to minimise embryo movement 6 Choose a suitable location for the laser shot 7 The first attempt to make a hole in the zona pellucida should be made with a short pulse If the hole is too small then use progressively longer pulses until the desired hole size is achiev...

Страница 31: ...sh with the specimen on the microscope stage and hold the specimen on the bottom of the dish with a holding pipette Check you are using the red Saturn 5 Laser System objective To ablate the zona the focal plane must be at the mid section of the embryo Refocus the microscope until the image of the zona is sharp Focus here to ablate Correct Incorrect X Correct focus specimen is sharply focussed Pilo...

Страница 32: ...the field of view Select a short pulse width using the RI Viewer controls The different settings do not vary the power of the laser they control the length of time that the laser is fired If using a Saturn 5 Active Laser System move the target on the screen by clicking the position required with the mouse button Click on the zona pellucida where you want the hole to appear Fire the laser by clicki...

Страница 33: ...er spot is as small as possible The brightness of the pilot laser can be adjusted 6 Click Align Laser 7 The motor will carry out a 7 point alignment at various points on the screen At each motor position click the screen at the exact centre of the pilot laser 8 Click Next to proceed to the next alignment point 9 When the final alignment point is finished click on the screen to drive the motor to t...

Страница 34: ...dicator to work correctly The actual size of hole a laser produces may vary depending on the type of Petri dish and media the characteristics of the embryo and other factors For this reason the Hole Size Indicator may be calibrated To calibrate the Hole Size Indicator you must be using the red laser objective and select the 40X or 20X objective in RI Viewer depending which magnification laser obje...

Страница 35: ... the estimated size of the hole that will be created when the laser is fired Actual hole sizes may vary due to natural differences between specimens The Hole Size Indicator can be turned on or off from the Target Appearance panel on the Laser Settings panel Exclusion Zone The laser generates heat which has the potential to damage critical cells The Exclusion Zone provides a measuring tool to show ...

Страница 36: ... of the size you need The pulse width will be calculated automatically to create the size of hole required How to Fire the Laser Single Pulse Find the sample under the microscope using an objective with wide field of view for example the 4x objective 1 Hold the sample with a holding pipette at the bottom of the dish 2 Switch to the laser objective and focus on the sample 3 Click the Laser Control ...

Страница 37: ...ns How to Enable Biopsy Mode 1 Click the General Settings icon on the tool bar 2 Tick Enable Biopsy Mode This option is available only with Saturn 5 Active Laser System How to Fire the Laser Biopsy Mode 1 Switch to the laser objective 2 Focus on the sample 3 Click the Laser Control Icon on the tool bar 4 Check the sample is just on the bottom of the dish 5 From the Laser Control Panel click Biopsy...

Страница 38: ...mera port not selected Select camera port Laser having no effect Wrong objective used Only use the red Saturn 5 Laser System objective Target misaligned Check alignment Port selector misaligned Check port selector is in correct position Dirt on fibre optic Service required Embryo above dish surface Check the embryo is touching the dish surface Dirt on fibre optic Service required Hole size smaller...

Страница 39: ...lignment must be checked and readjusted after removing the collimator module For further advice on microscope cleaning please contact RI or your microscope supplier Servicing 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 h...

Страница 40: ...modifications or changes to a product will void that product s warranty RI s warranties do not apply to any single or limited use disposable or consumable components or items RI is not responsible for and the owner and operator of the product shall defend indemnify and hold harmless RI from and against all claims damages and other losses resulting from the improper servicing maintenance repair use...

Страница 41: ... CooperSurgical or Origio invoice number All used products must be cleaned and sterilized prior to shipment A signed decontamination declaration may be required All products should be carefully and adequately packed preferably in original packaging Replacement items or additional repairs will be invoiced All packaging should be clearly labeled with the RMA number and statement Urgent Returned Item...

Страница 42: ...ealth Feedback Thank you for purchasing an 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 Customer Service Your feedback will help us develop the product and supporting materials to meet your future needs Thank you Customer Service Contact d...

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