RESEARCH INSTRUMENTS 670807 RlWITNESS EMBRYOLOGY HEATED PLATE User Manual Installation manual

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Installation manual

Installaon and Service ManualRI WITNESS™Embryology Heated Plate+44 (0) 1737 243869 | customerservice@origio.com | origio.comResearch Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UKDocument 6-70-807IM | DRF 3728 | Issue 4 | 13 December 20170120only

Research Instruments LtdContentsCONTENTS  Indicaons for Use for RI Witness Embryology Heated Plate 2Contraindicaons 2Applicable Part Numbers 2Related Documents 2Compability 2Installaon 2 Safety/Informaon Symbols 4Safety and Reliability 5Temperature Safety 5RFID Reader Environment 5Startup / Shutdown Procedure 5Guidance and Manufacturer’s Declaraon (Part 15 of FCC) — Electromagnec Emissions 6Guidance and Manufacturer’s Declaraon (IEC 60601-1-2) — Electromagnec Emissions 6Guidance and Manufacturer’s Declaraon — Electromagnec Immunity 7 Installaon Checklist 9 Component and Connecons Damage Checklists 12Cleanliness 12

RFID Tag Read Range Checklist 13Temperature Calibraon Checklist 13 Reuse Statement 14RI Repairs System 14RI Returns System 14Product Disposal (European Union) 14Contact Details 14Obligaon to Inform 14ContentsResearch Instruments Ltd

Secon 2Introducon to RI Witness™2Research Instruments Ltd2To maintain the temperature of human reproducve ssue such as oocytes and embryos through an assisted reproducon (AR) cycle.This device is not intended to be exposed to known sources of electromagnec interference (EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID components) and electromagnec security systems, eg metal detectors and electronic arcle surveillance systems.Applicable indicaons for use are subject to the regulaons 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.* 6-70-807 can be supplied in several conguraons depending on the required mounng type eg ush ed or sit on top. 6-70-121UM RI Witness Soware ManualRI Witness is used in conjuncon with the following:• Essenal medical devices, eg dishes and tubes, maybe AR or non-AR specic.• Non-essenal medical devices, eg safety cabinets, incubators, micromanipulators, lasers.• Non medical devices (general laboratory equipment), eg work benches, microscopes, PCs.This device has RFID reader capability. If it is the intenon that it be employed in a clinical lab, we recommend its use alongside other medical devices and that the performance of these medical devices be monitored for potenal eects of EMI disturbances, and reported when appropriate.Installaons of the RI Witness Embryology Heated Plate should be carried out by a RI technician or other RI authorised personnel. Incorrect installaon could result in overall poor performance.All relevant secons of this manual should be read and understood fully before any use of RI Witness takes place. 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.0120only 6-70-807* RI Witness Embryology Heated Plate 6-70-809 RI Witness Tube Reader

Secon 33Safety WarningsResearch Instruments Ltd3disassemble or modify any part of the RI Witness Embryology Heated plate, or substute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protecve earth. 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.Not to be used in a paent environment. The system should be operated by qualied and trained personnel only.This symbol indicates cauonary text which should be followed to avoid injury to users or damage to samples. Refer to Guidance and Manufacturer’s Declaraon Tables in this secon of the User Manual for guidance on the environment suitable for this device. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operaon. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operang normally. The temperature of the plate should not be more than 1.5ºC from the displayed temperature at any me. A temperature of more than 1.5ºC will cause the temperature inside the dish to change more rapidly and samples are at risk of over-heang. In this instance samples should be removed from the plate immediately. We recommend the plate temperature be monitored periodically using a calibrated thermocouple thermometer. There are no replaceable parts supplied with this device. Should any parts need to be replaced, contact RI or your distributor. Use of accessories, transducers and cables other than those specied or provided by the manufacturer of this equipment could result in increased electromagnec emissions or decreased electromagnec immunity of this equipment and result in improper operaon. Portable RF communicaons equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Embryology Heated Plate, including cables specied by the manufacturer. Otherwise, degradaon of the performance of this equipment could result.

Secon 3Safety Warnings4Research Instruments Ltd3 Do not dispose of product with normal waste.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.In accordance with the European Direcve for R&TTE, Direcve 1999/5/EC.Indicates the medical device manufacturer.Indicates the date of manufacture.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.Consult instrucons for use.The ve digit number is a unique idener assigned to the product. Cauon: US Federal law restricts this device for sale to or on the order of a licensed healthcare praconer.Indicates the reference number.SNOnlyREF

Secon 35Safety WarningsResearch Instruments Ltd3Please read this manual carefully and follow the instrucons to ensure that the system will work safely and reliably.Safety is the responsibility of the laboratory. Risk assessment and working pracces should comply with local regulatory policies.A warning triangle will be displayed on the work area touch screen and the status LED on the device user interface will display a yellow status alarm if the currently selected temperature cannot be maintained.Gently place your hand on the heated surface to verify that the temperature is appropriate for use.As with all heang systems, it is advisable to perform a periodic check of temperatures using a calibrated thermocouple thermometer.An RI Witness system uses Radio Frequency Idencaon (RFID) readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area.The performance of RFID tag detecon may be compromised by proximity of metal objects or electrical equipmentDo not place metal objects near reader.Do not place electrical equipment near reader. To turn the device on, plug the power cable from the device into the power supply in-line connector ensuring it is fully inserted. Then plug the power supply into the wall power outlet.To shutdown the device remove all electrical power by disconnecng the cable from the electrical outlet.

Secon 3Safety Warnings6Research Instruments Ltd3RI Witness is intended for use in the electromagnec environment specied below. The customer or the user of RI Witness should ensure that it is used in such an environment.Emissions test Compliance RF emissionsCISPR 11 Group 2RI Witness must emit electromagnec energy in order to perform its intended funcon. Nearby electronic equipment may be aected.RF emissionsCISPR 11 Class BRI Witness is suitable for use in all establishments other than domesc and those directly connected to the public low-voltage power supply network that supplies buildings used for domesc purposes.Harmonic emissionsEN 61000-3-2 Class AVoltage uctuaons/icker emissionsEN 61000-3-3CompliesNote: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the Federal Communicaons Commision (FCC) Rules. These limits are designed to provide reasonable protecon 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 instrucon manual, may cause harmful interference to radio communicaons. Operaon of this equipment in a residenal area is likely to cause harmful interference in which case the user will be required to correct the interference at their own expense.Note: This device complies with Industry Canada’s licence-exempt RSSs. Operaon is subject to the following two condions:1. This device may not cause interference.2. This device must accept any interference, including interference that may cause undesired operaon of the device.

Secon 37Safety WarningsResearch Instruments Ltd3   Electrostac discharge (ESD)IEC 61000-4-2± 8 kV contact± 15 kV air± 8 kV contact± 15 kV airFloors 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/burstIEC 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 LinesMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 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 modeMains 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 linesIEC 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 5sMains power quality should be that of a typical commercial or hospital environment. If the user of RI Witness requires connued operaon during power mains interrupons, it is recommended that RI Witness be powered from an uninterrupble power supply or a baery.Power frequency(50/60 Hz)magnec eldIEC 61000-4-830A/M 30A/M Power frequency magnec elds should be at levels characterisc of a typical locaon in a typical commercial or hospital environment.Note: UT is the a.c. mains voltage prior to applicaon of the test level.Compliance with the emissions requirements of CISPR 22 Class A requires the following warning: “This is a class A product. In a domesc environment this product may cause radio interference in which case the user may be required to take adequate measures.”

Secon 3Safety Warnings8Research Instruments Ltd3  Compliance  Conducted RF IEC 61000-4-6Radiated RF IEC 61000-4-33 Vrms150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHz3 Vrms3 V/mPortable RF communicaons equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Embryology Heated Plate, including cables specied by the manufacturer. Otherwise, degradaon of the performance of this equipment could result.

Secon 4Installaon ChecklistResearch Instruments Ltd4The following steps must be completed in this order before the system is used: 1. Examine all components for damage that may have occurred during transport, storage or use.i. Check for cracks in materialsii. Check for sharp edgesiii. Check for damage to connectorsiv. Check for worn or damaged cables2. Install soware and perform database set up. Refer to 6-70-121IT RI Witness IT Requirements.3. Posion the device in the desired locaon and adjust the movable aperture as shown below for ush ed conguraons.i. Posioning of Sit On Top Embryology Heated Plate (6-70-807) The sit on top Embryology Heated Plate is intended to t around a stereo zoom microscope inside of your ow hood or on a workbench. Inially place the heated plate so that the window is centred with the microscope opcs. Adjust the posion forwards and backwards if required, ie if the front of the device obstructs the air ow at the front of the cabinet then it can be moved back towards the microscope. Figure 4-1 Window centred with microscope opcsMove forwards and backwards

Secon 4Installaon ChecklistResearch Instruments Ltd4Legs are also available enabling the Embryology Heated Plate to be supported when placed on top of a stereo zoom microscope light base.Figure 4-2 Move forwards and backwardsCan be ipped overFigure 4-3 ii. Posioning of Flush Embryology Heated Plate (6-70-807-A/B)The Flush Embryology Heated Plate should be mounted in a ow hood tray or other work surface prior to being installed. Mounng guidelines can be provided by RI upon request as each installaon needs to be considered on an individual basis. A movable aperture is provided on the underneath of the device which is intended to hide surfaces beneath the device from view. The movable aperture can be adjusted forwards and backward in order to centre it with the light source/microscope opcs. Alternavely it can be removed completely if it is not required.

Secon 411Installaon ChecklistResearch Instruments Ltd4When installing a Flush Embryology Heated Plate the movable aperture will need to be adjusted in order that it is centred with the microscope opcs. Refer to Sit On Top secon for details of movable aperture adjustment. To slide the movable aperture loosen the 4 screws, slide the aperture into the desired posion then re-ghten the screws. Note that to move the aperture into posion in front and behind the centre line of the window, it is necessary to turn the movable aperture over. The 4 screws will need to be removed in order to do this. See “Figure 4-2” on page 10.4. Connect the Power connecons as described in the ‘Start up procedure’ secon in 6-70-807UM RI Witness Embrology Heated Plate User Manual.5. Connect the USB A plug, that protrudes from the rear le corner of the Embryology Heated Plate, into an available USB socket on the PC or Tablet. Verify the connecon to the soware as described in ‘Connecng to the Soware’ secon in 6-70-807UM RI Witness Embrology Heated Plate User Manual.6. Go into the RFID Tuning Screen and check that all connected antennas have a green ck next to them.7. Perform temperature calibraon of all ve heang channels as described in the ‘Temperature Calibraon’ secon in 6-70-807UM RI Witness Embrology Heated Plate User Manual.

Secon 5Service Checklist and Procedures12Research Instruments Ltd5The following service acvies should be performed to service an RI Witness work area.1. Check data and power connecons for security and damage. 2. Check cable layout. 3. Check for damage to all components.4. Check that the power supply is posioned in a suitable locaon, ie where it cannot fall or get damaged.Cleanliness1. Where ed, check that Tube Reader connecons are clean and free from corrosion. Clean if required (Refer to ‘Care and Maintenance’ secon in 6-70-807UM RI Witness Embryology Heated Plate User Manual).2. Check cleanliness of both windows’ internal and external surfaces. If required the lower glass can be removed from the underside of the Embryology Heated Plate for cleaning purposes (see below). When cleaning the internal surfaces of the glass use an opcal cleaning wipe, or lint-free cloth moistened with isopropyl alcohol. It may be necessary to polish the glass aerwards with a dry lint-free cloth to remove smears. Take care not to touch the two temperature sensors aached to the surface of the glass.3. To remove the lower window, rst remove (4 screws) the movable aperture (if ed) from the heated plate. Take a note of the posion before removing. Remove one of the window clamp strips (2 screws) and loosen the others, then li the glass. Adhere a small piece of scky tape to li the glass if required.Figure 5-1 Remove screws to remove aperture

Secon 513Service Checklist and ProceduresResearch Instruments Ltd5Verify that the temperature indicated by built in user interface and soware matches a reading taken by thermometer for all ve heang channels. Refer to the ‘Temperature Calibraon’ secon of secon in 6-70-807UM RI Witness Embrology Heated Plate User Manual.Figure 5-2 Loosen screwsRemove screws

Secon 6Repairs and Returns14Research Instruments Ltd6Reuse StatementAssuming RI Witness is regularly maintained and rounely serviced, it should perform as required for a minimum of 7 years connual use, aer which me we recommend you consider its replacement. Should you noce 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 representave promptly. In the event that you have a problem with a RI instrument, please follow the procedure below to ensure prompt aenon.1. Read the ‘Troubleshoong’ secon in the RI Witness Embryology Heated Plate User Manual (6-70-807UM).2. If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible.1. Contact RI to obtain a Returned Materials Authorisaon (RMA) number. Note: Goods will not be replaced or refunded without prior agreement and clearly stang 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 addional 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. 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 this device with ‘normal’ waste. Tel: +44 (0) 1737 243869 E-mail: customerservice@origio.com Website: www.origio.comIn compliance with the European Medical Device Direcve 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 paent or user or to a serious deterioraon in their state of health.