RESEARCH INSTRUMENTS 670807 RlWITNESS EMBRYOLOGY HEATED PLATE User Manual Users manual

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User ManualRI WITNESS™Embryology Heated Plate+44 (0) 1737 243869 | customerservice@origio.com | origio.comResearch Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UKDocument 6-70-807UM | DRF 3728 | Issue 5 | 1 December 20170120only

CONTENTS  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 7Guidance and Manufacturer’s Declaraon — Electromagnec Immunity 8 Embryology Heated Plate 9RI Witness Embryology Heated Plate Specicaon Table 10 Startup Procedure 11Shutdown Procedure 11Connecng to the Soware 11User Interface 11Operator Posion 12Research Instruments LtdContents

Achieving the Correct Sample Temperature 12Changing the Temperature Setpoint Using the Device 13Changing the Temperature Setpoint Using a PC and RI Witness WorkArea Soware 13Temperature Calibraon 14ITO Glass Window Calibraon Using Built-In User Interface 14Full 5-channel Calibraon Using PC and RI Witness Work Area Soware 15Tube Reader Antenna Accessory 16 Alarms and System Status 18Audible Alarms 18Alarm System Tesng 19Alarm Condions Codes 19 Cleaning 23 Reuse Statement 24RI Repairs System 24Product Disposal (European Union) 24RI Returns System 24Contact Details 24Obligaon to Inform 24Feedback 24CONTENTSContentsResearch Instruments Ltd

Secon 22IntroduconResearch 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. 6-7-121UM RI Witness WorkArea Soware Manual6-7-122UM RI Witness Manager 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. 6-70-807* RI Witness Embryology Heated Plate 6-70-809 RI Witness Tube Reader * 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.0120only

Secon 3Safety Warnings3Research 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 34Safety WarningsResearch 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 3Safety Warnings5Research 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 equipment Do not place metal objects near reader.Do not place electrical equipment near reader. RI Witness hardware may be damaged by incorrect startup and shutdown procedures.“Secon 5 - RI Witness Basic Operaon” on page 11 describes the recommended startup and shutdown procedure for the RI Witness Embryology Heated Plate.

Secon 36Safety WarningsResearch 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 61000-3-2Class AVoltage uctuaons/icker emissionsEN 61000-3-3Complies 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. 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 3Safety WarningsResearch 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/M30A/MPower 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 38Safety WarningsResearch 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 4Product OverviewResearch Instruments Ltd4RI Witness is a system which operates within an assisted reproducon (AR) clinic seng and provides a method of idenfying human samples throughout an AR cycle (from egg and sperm collecon to embryo transfer). The system is intended to minimise the risks associated with tradional/manual double-checking and provides the essenal controls necessary to ensure eggs, sperm and embryos are correctly matched and treated during the AR process.The RI Witness system comprises hardware, rmware and soware components, which can be congured depending on the treatment acvies, number of AR cycles conducted, size and layout of the AR clinic.RFID (radio frequency idencaon) technology provides the means of idenfying the containers (dishes, tubes) in which eggs, sperm and embryos are transferred and stored. The containers are labelled by a clinician with a special RFID tag which has been assigned a unique idener. The unique idener is linked to a paent/couple (specic parentage).As samples are processed as part of an AR cycle, RFID readers (both heated and non-heated) read the tags on the container and their identy and status is conrmed on-screen. If containers containing samples of incompable origin come into contact at any stage of this process, the system acvates an alarm and prompts the clinician to respond.This manual is specically for the Embryology Heated Plate (and associated Tube Reader accessory) in both its ush ed and sit on top conguraon.Other devices in the RI Witness range have their own manuals, as does the soware.Figure 4-1 Sit on Top Heated Reader Figure 4-2 Tube Reader Accessory

Secon 4 Product OverviewResearch Instruments Ltd4Part Temperature Sensor 5 x PT1000 (1 per Channel)Temperature ControlElectrical heang is controlled by a built-in 5-channel PWM temperature controller:• Channel 1-4: Work surface surrounding the ITO glass window is divided into quarters• Channel 5: ITO glass windowTemperature controller accuracy: beer than ±0.2°C when calibrated against a known reference.Displayed resoluon: 0.1°CSetpoint temperature range: 30-45°CDisplays 3 x 7-segment LED display shows the temperature reading from the ITO glass window temperature sensor.Connecvity USB plug type A Power SupplyInput: 85-264VAC (100-240VAC Nominal), 47-63Hz, <3A , Class I Output: 48VDC, Max 4.6A (220W) Operang CondionsTemperature: 15˚C (59˚F) to 40˚C (104˚F). Ambient temperature must be > 5°C below setpoint.Humidity: 15% to 85% RH (Non Condensing)RFID Specicaon Frequency: 13.56Mhz Power: 1WDimensionsWidth: 460mmDepth: 220mm6-70-807 Thickness: 20mm6-70-807-A/-B Thickness: 34mmMass 6-70-807: 3.0kg (plus Power Supply 1.0kg)6-70-807-A/-B: 5.0kg (plus Power Supply 1.0kg)

Secon 5RI Witness™ Basic Operaon11Research Instruments Ltd5Startup ProcedureTo 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. Once the device is plugged in, it will display the current measured temperature on the display. The status LED will remain o unl the temperature has stabilised at the specied setpoint. The me to reach this will vary according to the ambient temperature, but will generally be within 15-30 minutes.Once the temperature has stabilised, the green status light will illuminate (see “Alarms and System Status” on page 18 for more informaon).RI suggests that you keep the RI Witness computers and work areas (including the Embryology Heated Plate) switched on. This means that the heang and monitoring is constant.Shutdown ProcedureTo shutdown the device remove all electrical power by disconnecng the cable from the electrical outlet.Plug the device into the tablet or PC (or aached USB hub) using the USB A cable that protrudes from the device. Once the Windows operang system has recognised the devices within the Embryology Heated Plate, open the RI Witness WorkArea soware. To verify that the RI Witness Work Area soware can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or press the icon). This will bring up the Work Area Status window where the ‘Embryology Reader’ and ‘Temperature Control’ should be listed in the Connected Devices secon with a green ck next to them. For more detailed set up informaon, refer to the RI Witness soware manual (6-70-121UM).The Embryology Heated Plate contains a built in user interface which allows access to basic temperature setpoint and calibraon adjustment. A complete set of calibraon opons can only be accessed through the RI Witness WorkArea soware. Temperature Adjustment Indicator LightStatus IndicatorLightAudio O Indicator LightTemperature Display(shows ITO glass window temperature)Sengs BuonDown BuonUp BuonFigure 5-2 User InterfaceFigure 5-1 Power Supply In-Line Connector

Secon 512RI Witness™ Basic OperaonResearch Instruments Ltd5The heated plate is divided into 5 areas for calibraon purposes. In order to achieve the correct sample temperature place the sample on top of the heated areas shown below. Do not place samples on top of the User Interface.Figure 5-4 Thermometer Probe Posioned in a Petri DishFigure 5-3 Embryology Heated Plate Heated AreasUser InterfaceTop LeHeated AreaTop RightHeated AreaBoom LeHeated AreaBoom RightHeated AreaTemperatures within the Petri dish are adjusted by changing the setpoint temperature as described on the next page. The temperature inside a Petri dish will normally be slightly lower than the heated plate, depending on ambient condions, type of Petri dish and the sample preparaon. Aer the system has been installed in its operang locaon, the temperature of the heated plate should be adjusted to allow for this dierence.We recommend using a thermometer calibrated to 37°C ed with a small thermocouple probe, such as the RI IVF Thermometer to measure the temperature inside the Petri dish. Prepare a Petri dish that mimics your normal Petri dish preparaon and place it on the heated surface in its normal posion. Place the probe of the thermometer in the centre of the dish against the boom of the dish and allow the temperature reading to stabilise. Adjust the setpoint temperature unl the desired temperature in the dish is reached, allowing 20 minutes (or as long as required) in between each setpoint change to allow the Petri dish temperatures to stabilise.Window Heated AreaBlue area not temperature controlledRed denotes heated areaThe operator should be posioned in such a place to easily access the User Interface, work surface of the device and the connected touch screen (if used with the RI Witness WorkArea soware).Place only plasc or glass ware on the window heated area.Ambient temperature must be >5°c from the set point for the temperature control to work eecvely

Secon 5RI Witness™ Basic Operaon13Research Instruments Ltd5The maximum setpoint temperature allowed for this device is 45°C.The temperature setpoint is applied to all heang channels and is set using the following procedure, or from within the RI Witness WorkArea soware. Refer to the RI Witness Soware Manual (6-70-121UM) for further informaon.1. Press and hold the Sengs buon for 3 seconds. 2. The Temperature Adjustment Indicator light will ash. The Temperature Display will now show the current setpoint (not the current temperature). 3. Adjust the value shown on the Temperature Display using the Up and Down buons unl the desired setpoint is shown. 4. Save the temperature by pressing and holding the Sengs buon for 3 seconds. A beep will be heard. 5. The Temperature Adjustment Indicator light will go out and the Temperature Display will now show the current temperature. Once the temperature has stabilised at the setpoint, the green Status Indicator Light will illuminate. To exit the setpoint adjustment mode without saving changes, do not press any buons for 15 seconds and the device will return to normal operaon (the Temperature Adjustment Indicator light will go out).To change the setpoint using the RI Witness WorkArea soware, click on the temperature displayed at the boom right hand side of the screen. This will bring up a pop up box with up and down arrows which can be used to adjust the setpoint temperature. The temperature controller will then begin controlling using the new sengs .Aer adjusng the setpoint temperature, check sample temperature inside the Petri dish.In the event of sensor failure the plate may become hot (up to 65°C).

Secon 514RI Witness™ Basic OperaonResearch Instruments Ltd5NotePerform calibraon only if the displayed temperature is dierent to the actual surface temperature of any of the 5 heated areas. The process of calibraon allows the user to manually adjust the temperature so that the displayed temperatures match the temperature of the surface.Before temperature calibraon can be performed the device must be in the same condions that it will be in during normal operaon. The temperature calibraon is aected by ambient condions. Place the probe of a calibrated thermometer in good thermal contact with the surface.  Simply touching the probe on the surface is not adequate. Use a purpose-made surface probe and use thermal transfer paste. Products sold for computer heatsinks are suitable, and RI can also supply suitable materials. Wait at least 30 minutes to allow the temperature to stabilise before calibrang.Heated areas are divided as shown below, with the ‘X’ denong recommended thermocouple posions for calibraon:During calibraon using the built-in user interface close the RI Witness WorkArea soware to prevent interference with the thermometer reading.1. Posion the thermocouple probe on the Window in the locaon shown above.2. Press and hold the Sengs and buons simultaneously for 3 seconds. The Temperature Adjustment Indicator light will ash. The Temperature Display will now ash between the current temperature (which may be a changing value) and the leers CAL. 3. Adjust the value shown on the Temperature Display using the Up and Down buons unl the temperature matches that shown on the external thermometer. 4. Save the calibraon by pressing and holding the Sengs buon for 3 seconds. A beep will be heard.5. The Temperature Adjustment Indicator light will go out and the Temperature Display will now show the current temperature with applied calibraon. Leave the probe in posion and once the temperature has stabilised at the setpoint, check that the calibraon is accurate. Repeat the calibraon process if necessary. The green Status Indicator Light will illuminate once temperatures have stabilised.User InterfaceTop Le Top RightXXX XXBoom LeWindowBoom RightFigure 5-5 Recommended Thermocouple Posions for Temperature Calibraon

Secon 5RI Witness™ Basic Operaon15Research Instruments Ltd56. Aer adjusng calibraon check sample temperatures and adjust the setpoint temperature if required.  To exit the window calibraon mode without saving changes, do not press any buons for 15 seconds and the device will return to normal operaon. The Temperature Adjustment Indicator light will go out and the Temperature Display will stop ashing.Full calibraon of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness WorkArea soware and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the  icon then click , then Connected , then Temperature Controller, then . The screen will now show the current temperature and calibraon osets of the ve dierent heated areas.  RF will be switched o automiacally when on the Temperature Control screen.3. Each heated area is independent so the order of calibraon is not important. Posion the thermocouple probe in one of the posions shown above. 4. Allow the reading to stabilise, then compare the temperature shown in the WorkArea soware with the thermometer reading.5. A dierence within ± 0.2°C is acceptable. If the readings are outside this increase the oset to increase the reading displayed by the soware, or decrease the oset to decrease the reading displayed by the soware to match the temperature displayed by the thermometer.Allow a small delay for the oset change to register. When changing the oset, the temperature controller will then begin controlling using the new sengs, so the surface temperature of that heated area may take a short me to re-stabilise.6. Repeat this process for all 5 heated areas.7. Once calibraon is complete it is advisable to verify the temperature of each heated area to check that temperature calibraon has been carried out eecvely. Aer adjusng calibraon, check sample temperatures and adjust the setpoint temperature if required.

Secon 516RI Witness™ Basic OperaonResearch Instruments Ltd5The Tube Reader Antenna is an accessory for the Embryology Heated Plate that allows tags to be read in a vercal orientaon. It is specically designed to read tags placed on tubes in the RI Tube Holder. The Tube Reader Antenna is a passive device that only becomes powered when aached to the Embryology Heated Plate. The correct mounng orientaon posion is shown below in Figure 5-6.Refer to “Secon 7- Care and Maintenance” on page 23 for cleaning precauons relang to the Tube Reader Antenna.Figure 5-6 Tube Reader Connecons on the Embryology Heated PlateFigure 5-7 Tube Reader Correctly Mounted on the Embryology Heated PlateTube Reader AntennaTube Reader Antenna Connecons

Secon 6TroubleshoongResearch Instruments Ltd6  Tags Not ReadingMetal near reader Remove any metallic objects from the area, check if the tags come back into Work AreaLoose or no conneconCheck security of USB and power cable connecons. Verify that the light on the power supply is illuminatedRF noise or interferenceOther electrical devices in the lab can cause RF noise/interference. If a portable electronic device has been brought close to the device, remove it and check if the tags come back into the Work AreaBroken tag Check whether the tag is readable by a dierent RI Witness device. If it is not, discard that tagAntenna tuning problemNavigate to the  screen, then click , then Reader, then , check that all 5 channels (or 3 if you do not have the tube reader accessory connected) have green cks next to them. If any have a yellow warning triangle next to them, contact an RI service representave

Secon 618TroubleshoongResearch Instruments Ltd6The status of the temperature control system is shown by the Status Indicator Light posioned on the user interface of the device. OPlease wait Inial power up/setpoint/mode/calibraon changed.The light will be o unl temperature of all heang systems has stabilised.Green (constantly on)  Temperature of all heang systems has stabilised.Yellow (constantly on) Built-in user interface and RI Witness WorkArea soware will show current window temperature. Press the buon to cycle through the Alarm Condion Codes. Refer to tables on the following pages for details of each code. If the alarm sounds, nish the current procedure and invesgate the cause of the alarm.Yellow (ashing) Built-in user interface and RI Witness WorkArea soware will show current window temperature. Press the buon to cycle through the Alarm Condion Codes. Refer to the tables on the following pages for details of each code. If the alarm sounds, nish the current procedure and invesgate the cause of the alarm.When mulple alarms are acve, the highest priority alarm will be shown or the icon in the RI Witness WorkArea Soware, and on the device the Status Indicator Light.For a full list of possible faults relang to each alarm condion and applicability of each alarm condion, refer to the tables on the following pages. Alarm Condion Codes are only displayed whilst the alarm is acve and are cleared when the alarm is no longer acve.Audible alarms are sounded to indicate Low and Medium Priority Alarms, as described above. When in alarm condion it is possible to turn the Audio O by pressing the down buon. The Audio O Indicator Light will illuminate for the duraon of the alarm condion. The Audio will return if another alarm is acvated or if the buon is pressed again.Press the Up buon whilst alarms are acve to cycle through the error codes. See pages 19 to 22 for full list of Alarm Condion Codes.When mulple alarms are acve, the audio for the highest priority alarm will be sounded. The alarm volume is not adjustable. Audible range for alarm system is as follows.  Medium Priority 44.4 - 55.5dB 53dBLow Priority 41.5 - 55.5dB 51.5dB

Secon 6TroubleshoongResearch Instruments Ltd6Alarm CodeFault   Alarm E01 ITO Window Heang FailureLow Heang system is not able to heat the specied heang channel. Alarm will be acvated 2 minutes aer power on if there is less than 1.5˚C temperature rise between 1 and 2 minutes aer power on. If the temperature at 1 minute is already within ± 2.5˚C from the setpoint the test is omied.Heang controller power is set to 0% for that heang channel unl device is restarted.Restart the device by removing mains power then re-connecng.E02 Boom Right Heang Channel FailureE03 Boom Le Heang Channel FailureE04 Top Right Heang Channel FailureE05 Top Le Heang Channel Failure Failure ChannelE06 ITO Window Sensor FailureLow/ MediumLow priority alarm is acvated if the fault occurs when system is switched on. Aer this me a medium priority alarm is acvated No signal/out of range signal from temperature sensor. Alarm acvates at any me if the sensor circuit fails to read a valid temperature.Heang power is set to 0% for that heang channel unl a valid temperature is read. If any of the ITO Window sensors fail the temperature display will show --.-˚C Possible sensor, cable or controller fault.May also be caused when the device is in over temperature condion.Restart the device by removing the mains power, then reconnect.Contact your distributor or RI Service if fault persists.E07 Boom Right Sensor FailureE08 Boom Le Sensor FailureE09 Top Right Sensor FailureE10 Top Le Sensor FailureIn order to test funconality of the alarm system hold down the buon for 3 seconds when there are no acve alarms. This will trigger a medium priority alarm signal, (3 audible pulses and 3 yellow ashes of the status indicator light). This check should be performed at regular intervals to reduce the chance of missing an alarm due to failed loudspeaker or status indicator light.

Secon 6TroubleshoongResearch Instruments Ltd6Alarm CodeFault   Alarm E11 ITO Window Heang Channel Over TemperatureLow / MediumIf fault occurs when the system is switched onHeang channel has exceeded the maximum allowable setpoint temperature. Alarm acvated at any me if the temperature sensor exceeds 50˚C.Temperature controller power is set to 0% unl temperature falls to below 50˚C.  If the temperature connues to rise past this point, over temperature protecon built in to the device will shut down the heang.Possible heater or controller fault.E12 Boom Right Heang Channel Over TemperatureE13 Boom Le Heang Channel Over TemperatureE14 Top Right Heang Channel Over TemperatureE15 Top Le Heang Channel Over TemperatureE16 ITO Window Heang Channel Temperature outside ± 1°CMedium Heang channel has deviated by more than 1˚C from the setpoint temperature. Alarm enabled 10 minutes aer the temperature reaches ±2.5˚C from the setpoint temperature.The temperature controller connues to operate to bring back within the allowable limits.This may be caused by placing either hot or cold objects on the device, in parcular the ITO Window. In this case either remove the object or wait a short me for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature uctuaons. In this case wait a short while for the temperature controller to respond. E17 Boom Right Heang Channel Temperature outside ± 1°CE18 Boom Le Heang Channel Temperature outside ± 1°CE19 Top Right Heang Channel Temperature outside ± 1°CE20 Top Le Heang Channel Temperature outside ± 1°C

Secon 6Troubleshoong21Research Instruments Ltd6Alarm CodeFault   Alarm E21 ITO Window Heang Channel Temperature outside ± 2.5°CMedium Heang channel has deviated by more than 2.5˚C from the setpoint temperature. Alarm enabled once it has reached ±2.5˚C from the setpoint temperature and is more than 1 minute aer power on.The temperature controller connues to operate to bring back within the allowable limits.This may be caused by placing either hot or cold objects on the device, in parcular the ITO Window. In this case either remove the object or wait a short me for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature uctuaons. In this case wait a short while for the temperature controller to respond. May also be caused when the device is in over temperature condion.Restart the device by removing the mains power, then reconnect.Contact your distributor or RI Service if fault persists.E22 Boom Right Heang Channel Temperature outside ± 2.5°CE23 Boom Le Heang Channel Temperature outside ± 2.5°CE24 Top Right Heang Channel Temperature outside ± 2.5°CE25 Top Le Heang Channel Temperature outside ± 2.5°C

Secon 622TroubleshoongResearch Instruments Ltd6Alarm CodeFault   Alarm E26 ITO Window Heang Channel Low Heang RateMedium Heang controller did not achieve a temperature within 2.5˚C of the setpoint in 15 minutes from power on.Temperature controller connues to operate.If the device is operated in an environment where the ambient temperature is colder than the specied operang condions or if there is a large amount of cold airow over the device, then this alarm may triggered rounely. If neither of these condions are present, restart the device. If the fault reoccurs contact an RI Service personnel.E27 Boom Right Heang Channel Low Heang RateE28 Boom Le Heang Channel Low Heang RateE29 Top Right Heang Channel Low Heang RateE30 Top Le Heang Channel Low Heang RateE31 Memory Fault Low Memory/controller fault. System failed to read or write data correctly. If it happens during run me the system will carry on with current data. If it happens during start up the system will load the default values and needs reconguraon of setpoint calibraon.System connues to operate unl power is removed. When power is returned the system will operate with the default calibraon and setpoint values.Set the setpoint temperature then re-calibrate. If the problem persists then there may be a fault with the controller. If the problem is resolved then the memory may have been corrupted during saving of values, eg if the device loses power whilst saving values.

Secon 7Care and Maintenance23Research Instruments Ltd7RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a so cloth and mild detergent. Do not disconnect the cables aached to the device. If the Tube Reader Antenna is removed for cleaning be mindful to allow the contact surfaces on both the Heated Plate and the Tube Reader Antenna to fully dry before reaaching to ensure cleaning products are not trapped in the interface.Do not use solvents for cleaning.Do not disconnect readers.

Secon 824Repairs and ReturnsResearch Instruments Ltd8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.2. If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible.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.1. Contact RI to obtain a Returned Materials Authorisaon (RMA) number.  Goods will not bereplaced 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. 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: service@research-instruments.com Website: www.research-instruments.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. 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 suggesons for how we can improve our products or the informaon we provide with them, please send them to feedback@research-instruments.com. Your feedback will help us develop the product and supporng materials to meet your future needs.Thank you.