RESEARCH INSTRUMENTS 670807 RI Witness Embryology Heated Plate User Manual

RESEARCH INSTRUMENTS LTD RI Witness Embryology Heated Plate

Contents

User manual

User ManualDocument 6-70-807UM, Issue P1, 18 February 2016RESEARCH INSTRUMENTS LTDBickland Industrial Park, Falmouth, Cornwall TR11 4TA, UKt: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.comwww.research-instruments.comRI WITNESS™0120Embryology Heated Plateonly
CONTENTS  Indicaons for Use for RI Witness Embryology Heated Plate 2Applicable Part Numbers 2Related Documents 2Compability 2Installaon 2 Guidance and Manufacturer’s Declaraon (Part 15 of FCC) — Electromagnec Emissions 4Guidance and Manufacturer’s Declaraon (IEC 60601-1-2) — Electromagnec Emissions 4— Electromagnec Immunity 5— Electromagnec Immunity 6Safety/Informaon Symbols 7Safety and Reliability 8Temperature Safety 8RFID Reader Environment 8Startup / Shutdown Procedure 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 11Achieving the Correct Sample Temperature 12Changing the Temperature Setpoint Using the Device 13Changing the Temperature Setpoint using a PC and RI Witness Work Area soware 13
Temperature 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 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 24CONTENTS
Secon 111PrefaceThank you for choosing RI Witness.This manual provides all necessary informaon to use RI Witness Embryology Heated Plate and should be read in conjuncon with any manuals provided with other RI Witness hardware or soware components that you are using. The system should be operated by trained personnel only. All secons of this manual should be read and understood fully before any operaon of the system. Please see the Intended Use for more informaon.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.In no event does Research Instruments Ltd (RI) assume the liability for any technical or editorial errors of commission, or omission; nor is RI liable for direct, indirect, incidental, or consequenal damages arising out of the use or inability to use this manual.The informaon in this manual is current at the me of publicaon. Our commitment to product improvement requires that we reserve the right to change equipment, procedures and specicaons at any me. The latest version of the User Manual can be downloaded from soware.research-instruments.com. The RI Witness manual belongs with the RI Witness system and should be passed on with the system if relocated to another clinic.The use of ™ in this manual indicates a trademark of Research Instruments Ltd. Any other brand names, referred to in this manual, are trademarks of their respecve owners.© This manual is protected by copyright, all rights reserved, and no part here of may be photocopied or reproduced in any form without the prior wrien consent of RI.             
Secon 22Introducon2To maintain the temperature of human reproducve ssue such as oocytes and embryos through an assited reproducon (AR) cycle.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 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 is not intended to be exposed to known sources of electromagnec Interference (EMI) with medical devices such as diathermy, and electromagnec security systems e.g., metal detectors and electronic arcle surveillance system.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 Warnings33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.
Secon 34Safety Warnings3RI 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.   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 emissionsIEC 61000-3-2 Not applicableVoltage uctuaons/icker emissionsIEC 61000-3-3Not applicable  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 Warnings53   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 61000-4-83A/m 3A/m Power frequency magnec elds should be at levels characterisc of a typical locaon in a typical commercial or hospital environment.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 36Safety Warnings3  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 and mobile RF communicaons equipment should be used no closer to any part of RI Witness, including cables, than the recommended separaon distance calculated from the equaon applicable to the frequency of the transmier. Recommended separaon distanced = [3.5/V 1] √pd = [3.5/V1] √p 80MHz to 800MHzd = [3.5/V1 √p 800MHz to 2.5GHzwhere p is the maximum output power rang of the transmier in was (W) according to the transmier manufacturer and d is the recommended separaon distance in metres (m). Field strengths from xed RF transmiers, as determined by an electromagnec site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and reecon from structures, objects and people. These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and reecon from structures, objects and people.a Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theorecally with accuracy. To assess the electromagnec environment due to xed RF transmiers, an electromagnec site survey should be considered. If the measured eld strength in the locaon in which RI Witness is used exceeds the applicable RF compliance level above, RI Witness should be observed to verify normal operaon. If abnormal performance is observed, addional measures may be necessary, such as re-orienng or relocang RI Witness.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V] V/m.
Secon 3Safety Warnings3 Indicates instrucon for disposal of goods.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/ECIndicates 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 four 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.SNOnly
Secon 38Safety Warnings3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 reposioning the reader and by the proximity of metal objects or electrical equipment that were not present during installaon and tuning. If the device is relocated ensure that the autotuning procedure documented in the RI Witness Soware Manual (6-7-121UM) is followed to ensure opmum level of performance. For cleaning the reader may be lied and returned to the same posion. See “Cleaning” on page 23 for more cleaning details.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 4Product Overview4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 Overview4 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 AntennasEmbryology Heated Plate: 3 Antennas Tube Reader Accessory: 2 Antennas (5 Total)RFID 50Ω Load at 13.56Mhz, 1W MaxDimensionsWidth: 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on115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. 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.To 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 Work Area 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 Work Area soware.Setpoint Adjustment Indicator LightStatus IndicatorLightOset Adjustment 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on5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 5-3 Embryology Heated Plate Heated AreasUnheated AreaUser InterfaceTop LeHeated AreaTop RightHeated AreaBoom LeHeated AreaBoom RightHeated AreaWhen working with mulple samples on the heated plate, it is recommended that only one sample is placed on the window heated area at a me.Temperatures 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.Figure 5-4 Thermometer Probe Posioned in a Petri DishWindow Heated AreaBlue denotes unheated areaRed denotes heated area
Secon 5RI Witness™ Basic Operaon135Funcons of the built-in user interface are shown below.The temperature setpoint is applied to all heang channels and is set using the following procedure, or from within the RI Witness Work Area 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 Setpoint 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 Setpoint 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 a short me and the device will return to normal operaon (the Setpoint 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.
Secon 514RI Witness™ Basic Operaon5 It is only possible to calibrate the temperature of the ITO glass window using the built-in user interface on the Embryology Heated Plate. To perform a full calibraon of all 5 heated areas, this must be done from within the RI Witness Work Area soware.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 Work Area 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 Oset Adjustment Adjustment Indicator light will ash. The Temperature Display will now show the current temperature (which may be a moving value). 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 Oset Adjustment 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 Unheated AreaUser 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on155and 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.6. 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 a short me and the device will return to normal operaon. The Oset Adjustment Indicator light will go out.Full calibraon of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness Work Area soware and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the  icon then click , then , then  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 Work Area 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.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on5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6  Tags Reading Intermiently or Only in Certain AreasLoose connecon Check security of USB and power cable connecons.Antenna not tuned properlyNavigate to the  screen, then click  , then , then , then .RF Noise/interference Other devices in the lab can cause RF noise/interference, contact an RI service representave.Faulty Device Contact an RI Service representave.Tags Not ReadingBroken tag Check the tag on another device.Poor/no connecon or no power.Check security of USB and power cable connecons. Verify that the light on the power supply is illuminated.Tag not encryptedNavigate to the  screen, then click  , then  then click the down arrow next to Tags. Non encrypted tags are shown as .WorkArea conguraonNavigate to the   screen, then click  , then , then  , to check that the number of antennas (channels) is 5 for the Embryology Reader with the Tube Reader Antenna Accessory.Antenna not tuned Navigate to the  screen, then click  , then , then , then .Faulty Device Contact RI or an RI Service Representave.
Secon 618Troubleshoong6The status of the temperature control system is shown by the Status Indicator Light posioned on the user interface of the device. On Inial power up/setpoint/mode/calibraon changed.The light will be o unl temperature of all heang systems is within ±1°C of setpoint.Green  Temperature of all heang systems within ±1°C of setpoint.Yellow constantly on Built-in user interface and RI Witness WorkArea soware will show current window temperature. Press the or buons to cycle through the Alarm Condion Codes. Refer to tables on the following pages for details of each code. Alarm Condion Codes can be cleared by holding the and buons simultaneously for 3 seconds. A beep will be heard to conrm codes have been cleared. If the alarm sounds, nish the current procedure and promptly 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 or buons to cycle through the Alarm Condion Codes. Refer to the tables on the following pages for details of each code. Alarm Condion Codes can be cleared by holding the and buons simultaneously for 3 seconds. A beep will be heard to conrm codes have been cleared.When mulple alarms are acve, the icon on the RI Witness WorkArea Soware on the device and Status Indicator Light for the highest priority alarm will be shown.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.Audible alarms are sounded to indicate Low and Medium Priority Alarms, as described above. When an alarm sounds, the alarm can be muted by pressing the or buons, which also cycles through the Alarm Condion Codes. The alarm audio is automacally un-muted each me a new alarm becomes acve.When mulple alarms are acve, the audio for the highest priority alarm will be sounded. The alarm volume is not adjustable. Low and medium priority alarms are sounded at the same level.
Secon 6Troubleshoong6    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 Failure (either main sensor or overheat protecon sensor)Low/ 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 the ITO Window main sensor fails the temperature display will shown --.-˚C  If the ITO overheat protecon sensor is faulty, the display will sll show the current temperature. Possible sensor, cable or controller fault.E07 Boom Right Sensor FailureE08 Boom Le Sensor FailureE09 Top Right Sensor FailureE10 Top Le Sensor Failure
Secon 6Troubleshoong6    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. (See E27)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 5 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ng216    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 5 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. 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°CE26 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 Rate
Secon 622Troubleshoong6    E31 Memory Fault Low Memory/controller fault. During normal use controller has failed to save data. When power is switched o and then on all values will be returned to factory defaults.System connues to operate unl power is removed. When power is returned the screen will show the uncalibrated temperature.Recalibrate device. If the problem persists aer re-calibraon then there may be a fault with the controller. If the problem is resolved by recalibrang then the memory may have been corrupted during saving of values, eg if the device loses power whilst saving values.E32 Main Over Temperature ProteconMedium Main over temperature protecon is triggered when the temperature controller is not able to limit heat supplied by the device. Each heang channel is ed with a standalone monitoring system that shuts down the device in the event of a malfuncon. The protecon operates at approximately 65°CYellow ashing Status Indicator Light illuminates. All heang is switched o. Contact RI Service or distributor.
Secon 7Care and Maintenance237RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a so cloth and mild detergent. The device may be lied and returned to its original locaon. 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.Do not change the posion of readers.
Secon 824Repairs and Returns8Assuming 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 RI Witness products 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.   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.

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