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Installation and Service Manual R I W I T N E S S Embryology Heated Plate
+44 (0) 1737 243869 | customerservice@origio.com | origio.com Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK Document 6-70-807IM | DRF 3728 | Issue 4 | 13 December 2017 0120 only Contents Research Instruments Ltd CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate Contraindications Applicable Part Numbers Related Documents Compatibility Installation SECTION 3 - SAFETY WARNINGS Safety/Information Symbols Safety and Reliability Temperature Safety RFID Reader Environment Startup / Shutdown Procedure Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions Guidance and Manufacturers Declaration Electromagnetic Immunity SECTION 4 - INSTALLATION Installation Checklist SECTION 5 SERVICE CHECKS AND PROCEDURES Component and Connections Damage Checklists Cleanliness 1 2 2 2 2 2 2 2 3 4 5 5 5 5 6 6 7 9 9 12 12 12 Research Instruments Ltd Contents RFID Tag Read Range Checklist Temperature Calibration Checklist SECTION 6 - REPAIRS AND RETURNS Reuse Statement RI Repairs System RI Returns System Product Disposal (European Union) Contact Details Obligation to Inform 13 13 14 14 14 14 14 14 14 Research Instruments Ltd SECTION 1 - PREFACE Thank you for choosing RI Witness. This manual provides all necessary information to use RI Witness Embryology Heated Plate and should be read in conjunction with any manuals provided with other RI Witness hardware or software components that you are using. The system should be operated by trained personnel only. All sections of this manual should be read and understood fully before any operation of the system. Please see the Intended Use for more information. If the operator is unsure of any of the information contained in this manual they should contact Research Instruments or an appointed representative before attempting 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 consequential damages arising out of the use or inability to use this manual. is current at the time of publication. Our commitment to The product improvement requires that we reserve the right to change equipment, procedures and specifications at any time. The latest version of the User Manual can be downloaded from software.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 respective 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 written consent of RI. in this manual information 1 Section 11Preface Research Instruments Ltd SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate To maintain the temperature of human reproductive tissue such as oocytes and embryos through an assisted reproduction (AR) cycle. only 0120 Contraindications This device is not intended to be exposed to known sources of electromagnetic interference (EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID components) and electromagnetic security systems, eg metal detectors and electronic article surveillance systems. Applicable indications for use are subject to the regulations 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. Applicable Part Numbers Part Number 6-70-807*
6-70-809 Description RI Witness Embryology Heated Plate RI Witness Tube Reader
* 6-70-807 can be supplied in several configurations depending on the required mounting type eg flush fitted or sit on top. Related Documents 6-70-121UM RI Witness Software Manual Compatibility RI Witness is used in conjunction with the following:
Essential medical devices, eg dishes and tubes, maybe AR or non-AR specific. Non-essential 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 intention 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 potential effects of EMI disturbances, and reported when appropriate. Installation Installations of the RI Witness Embryology Heated Plate should be carried out by a RI technician or other RI authorised personnel. Incorrect installation could result in overall poor performance. All relevant sections 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 information contained in this manual, they should contact Research Instruments or an appointed representative before attempting to use this equipment. 2 Section 2Introduction to RI Witness2 Research Instruments Ltd SECTION 3 - SAFETY WARNINGS This symbol indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. DO NOT disassemble or modify any part of the RI Witness Embryology Heated plate, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. ONLY use the power cable and power supply adaptor supplied with the system. The cable to the power supply is the disconnect device for this equipment. To remove all electrical power from this product, disconnect the power cable from the electrical outlet. Equipment should be positioned 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. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Not to be used in a patient environment. WARNING Refer to Guidance and Manufacturers Declaration Tables in this section of the User Manual for guidance on the environment suitable for this device. WARNING The temperature of the plate should not be more than 1.5C from the displayed temperature at any time. A temperature of more than 1.5C will cause the temperature inside the dish to change more rapidly and samples are at risk of over-
heating. In this instance samples should be removed from the plate immediately. We recommend the plate temperature be monitored periodically using a calibrated thermocouple thermometer. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING There are no replaceable parts supplied with this device. Should any parts need to be replaced, contact RI or your distributor. WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING Portable RF communications 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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 3 Section 3Safety Warnings3 Safety/Information Symbols Symbol Meaning Research Instruments Ltd Do not dispose of product with normal waste. In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC under the supervision of notified body No.0120, SGS, UK Ltd. In accordance with the European Directive for R&TTE, Directive 1999/5/EC. Indicates the medical device manufacturer. Indicates the date of manufacture. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Consult instructions for use. The five digit number is a unique identifier assigned to the product. Caution: US Federal law restricts this device for sale to or on the order of a licensed healthcare practitioner. Indicates the reference number. SN Only REF 4 Section 3Safety Warnings3 Research Instruments Ltd Safety and Reliability Please read this manual carefully and follow the instructions to ensure that the system will work safely and reliably. Temperature Safety Safety is the responsibility of the laboratory. Risk assessment and working practices 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 heating systems, it is advisable to perform a periodic check of temperatures using a calibrated thermocouple thermometer. RFID Reader Environment An RI Witness system uses Radio Frequency Identification (RFID) readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area. The performance of RFID tag detection 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. Startup / Shutdown Procedure 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 disconnecting the cable from the electrical outlet. 5 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Note: 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 Communications Commision (FCC) Rules. These limits are designed to provide reasonable protection 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 instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential 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 Canadas licence-exempt RSSs. Operation is subject to the following two conditions:
1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions RI Witness is intended for use in the electromagnetic environment specified below. The customer or the user of RI Witness should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions EN 61000-3-2 Voltage fluctuations/
flicker emissions EN 61000-3-3 Group 2 Class B Class A Complies RI Witness must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RI Witness is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 6 Section 3Safety Warnings3 Research Instruments Ltd USA Only Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures. Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test Electrostatic discharge
(ESD) IEC 61000-4-2 IEC 60601 Test level 8 kV contact 15 kV air Compliance level 8 kV contact 15 kV air Electrical fast transient/
burst IEC 61000-4-4 Surge IEC 61000-4-5 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth 2 kV for power supply lines 1 kV for input/
output Lines 1 kV differential Mode 2 kV common mode
<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 5s 30A/M 30A/M Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level. Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of RI Witness requires continued operation during power mains interruptions, it is recommended that RI Witness be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 7 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable RF communications 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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 8 Section 3Safety Warnings3 Research Instruments Ltd SECTION 4 - INSTALLATION Installation Checklist 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 materials ii. Check for sharp edges iii. Check for damage to connectors iv. Check for worn or damaged cables Install software and perform database set up. Refer to 6-70-121IT RI Witness IT Requirements. 2. 3. Position the device in the desired location and adjust the movable aperture as shown below for flush fitted configurations. i. Positioning of Sit On Top Embryology Heated Plate (6-70-807) The sit on top Embryology Heated Plate is intended to fit around a stereo zoom microscope inside of your flow hood or on a workbench. Initially place the heated plate so that the window is centred with the microscope optics. Adjust the position forwards and backwards if required, ie if the front of the device obstructs the air flow at the front of the cabinet then it can be moved back towards the microscope. Move forwards and backwards Window centred with microscope optics Figure 4-1 9 Section 4Installation Checklist4 Legs are also available enabling the Embryology Heated Plate to be supported when placed on top of a stereo zoom microscope light base. Research Instruments Ltd Figure 4-3 ii. Positioning of Flush Embryology Heated Plate (6-70-807-A/B) The Flush Embryology Heated Plate should be mounted in a flow hood tray or other work surface prior to being installed. Mounting guidelines can be provided by RI upon request as each installation 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 optics. Alternatively it can be removed completely if it is not required. Can be flipped over Move forwards and backwards Figure 4-2 10 Section 4Installation Checklist4 Research Instruments Ltd When installing a Flush Embryology Heated Plate the movable aperture will need to be adjusted in order that it is centred with the microscope optics. Refer to Sit On Top section for details of movable aperture adjustment. To slide the movable aperture loosen the 4 screws, slide the aperture into the desired position then re-tighten the screws. Note that to move the aperture into position 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 connections as described in the Start up procedure section in 6-70-807UM RI Witness Embrology Heated Plate User Manual. 5. Connect the USB A plug, that protrudes from the rear left corner of the Embryology Heated Plate, into an available USB socket on the PC or Tablet. Verify the connection to the software as described in Connecting to the Software section 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 tick next to them. 7. Perform temperature calibration of all five heating channels as described in the Temperature Calibration section in 6-70-807UM RI Witness Embrology Heated Plate User Manual. 11 Section 4Installation Checklist4 Research Instruments Ltd SECTION 5 SERVICE CHECKS AND PROCEDURES The following service activities should be performed to service an RI Witness work area. Component and Connections Damage Checklists 1. Check data and power connections for security and damage. 2. Check cable layout. 3. Check for damage to all components. 4. Check that the power supply is positioned in a suitable location, ie where it cannot fall or get damaged. Cleanliness 1. Where fitted, check that Tube Reader connections are clean and free from corrosion. Clean if required
(Refer to Care and Maintenance section 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 optical cleaning wipe, or lint-free cloth moistened with isopropyl alcohol. It may be necessary to polish the glass afterwards with a dry lint-free cloth to remove smears. Take care not to touch the two temperature sensors attached to the surface of the glass. 3. To remove the lower window, first remove (4 screws) the movable aperture (if fitted) from the heated plate. Take a note of the position before removing. Remove one of the window clamp strips (2 screws) and loosen the others, then lift the glass. Adhere a small piece of sticky tape to lift the glass if required. Remove screws to remove aperture Figure 5-1 12 Section 5Service Checklist and Procedures5 Research Instruments Ltd Remove screws Loosen screws Figure 5-2 Temperature Calibration Checklist Verify that the temperature indicated by built in user interface and software matches a reading taken by thermometer for all five heating channels. Refer to the Temperature Calibration section of section in 6-70-807UM RI Witness Embrology Heated Plate User Manual. 13 Section 5Service Checklist and Procedures5 Research Instruments Ltd SECTION 6 - REPAIRS AND RETURNS Reuse Statement Assuming RI Witness is regularly maintained and routinely serviced, it should perform as required for a minimum of 7 years continual use, after which time we recommend you consider its replacement. Should you notice 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 representative promptly. RI Repairs System In the event that you have a problem with a RI instrument, please follow the procedure below to ensure prompt attention. 1. Read the Troubleshooting section in the RI Witness Embryology Heated Plate User Manual 2.
(6-70-807UM). If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible. RI Returns System 1. Contact RI to obtain a Returned Materials Authorisation (RMA) number. Note: Goods will not be replaced or refunded without prior agreement and clearly stating 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 additional 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. Product Disposal (European Union) 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. Contact Details ORIGIO a/s, Knardrupvej 2, 2760 Mlv, Denmark Tel: +44 (0) 1737 243869 E-mail: customerservice@origio.com Website: www.origio.com Obligation to Inform In compliance with the European Medical Device Directive 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 patient or user or to a serious deterioration in their state of health. 14 Section 6Repairs and Returns6
1 2 | User manual | Users Manual | 770.71 KiB |
User Manual R I W I T N E S S Embryology Heated Plate RESEARCH INSTRUMENTS LTD Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK t: +44 (0) 1326 372 753 | f: +44 (0) 1326 378 783 |e: sales@research-instruments.com www.research-instruments.com 0120 only Document 6-70-807UM, Issue P1, 18 February 2016 Contents CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate Applicable Part Numbers Related Documents Compatibility Installation SECTION 3 - SAFETY WARNINGS Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions Electromagnetic Immunity Electromagnetic Immunity Safety/Information Symbols Safety and Reliability Temperature Safety RFID Reader Environment Startup / Shutdown Procedure SECTION 4 - PRODUCT OVERVIEW Embryology Heated Plate RI Witness Embryology Heated Plate Specification Table SECTION 5 - RI WITNESS BASIC OPERATION Startup Procedure Shutdown Procedure Connecting to the Software User Interface Achieving the Correct Sample Temperature Changing the Temperature Setpoint Using the Device Changing the Temperature Setpoint using a PC and RI Witness Work Area software Research Instruments Ltd 1 2 2 2 2 2 2 3 4 4 5 6 7 8 8 8 8 9 9 10 11 11 11 11 11 12 13 13 Research Instruments Ltd CONTENTS Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface Full 5-channel Calibration Using PC and RI Witness Work Area Software Tube Reader Antenna Accessory SECTION 6 - TROUBLESHOOTING Alarms and System Status Audible Alarms Alarm Conditions Codes SECTION 7- CARE AND MAINTENANCE Cleaning SECTION 8 - REPAIRS AND RETURNS Reuse Statement RI Repairs System Product Disposal (European Union) RI Returns System Contact Details Obligation to Inform Feedback Contents 14 14 15 16 17 18 18 19 23 23 24 24 24 24 24 24 24 24 Research Instruments Ltd SECTION 1 - PREFACE Thank you for choosing RI Witness. This manual provides all necessary information to use RI Witness Embryology Heated Plate and should be read in conjunction with any manuals provided with other RI Witness hardware or software components that you are using. The system should be operated by trained personnel only. All sections of this manual should be read and understood fully before any operation of the system. Please see the Intended Use for more information. If the operator is unsure of any of the information contained in this manual they should contact Research Instruments or an appointed representative before attempting 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 consequential damages arising out of the use or inability to use this manual. The information in this manual is current at the time of publication. Our commitment to product improvement requires that we reserve the right to change equipment, procedures and specifications at any time. The latest version of the User Manual can be downloaded from software.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 respective 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 written consent of RI. This indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. 1 Section 11Preface Research Instruments Ltd SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate To maintain the temperature of human reproductive tissue such as oocytes and embryos through an assited reproduction (AR) cycle. 0120 only Applicable indications for use are subject to the regulations 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. Applicable Part Numbers Part Number 6-70-807*
6-70-809
* 6-70-807 can be supplied in several configurations depending on the required mounting type eg flush fitted or sit on top. Description RI Witness Embryology Heated Plate RI Witness Tube Reader Related Documents 6-7-121UM RI Witness Software Manual Compatibility RI Witness is used in conjunction with the following:
Essential medical devices, eg dishes and tubes, maybe AR or non-AR specific. Non-essential 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 electromagnetic Interference (EMI) with medical devices such as diathermy, and electromagnetic security systems e.g., metal detectors and electronic article surveillance system. Installation Installations of the RI Witness Embryology Heated plate should be carried out by a RI technician or other RI authorised personnel. Incorrect installation could result in overall poor performance. 2 Section 2Introduction2 SECTION 3 - SAFETY WARNINGS Research Instruments Ltd This symbol indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. DO NOT disassemble or modify any part of the RI Witness Embryology Heated plate, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. ONLY use the power cable and power supply adaptor supplied with the system. The cable to the power supply is the disconnect device for this equipment. To remove all electrical power from this product, disconnect the power cable from the electrical outlet. Equipment should be positioned 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. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Not to be used in a patient environment. 3 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Note: 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 Communications Commision (FCC) Rules. These limits are designed to provide reasonable protection 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 instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential 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 Canadas licence-exempt RSSs. Operation is subject to the following two conditions:
1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions RI Witness is intended for use in the electromagnetic environment specified below. The customer or the user of RI Witness should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/
flicker emissions IEC 61000-3-3 Group 2 Class B Not applicable Not applicable RI Witness must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RI Witness is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 4 Section 3Safety Warnings3 Research Instruments Ltd USA Only Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures. Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test Electrostatic discharge
(ESD) IEC 61000-4-2 IEC 60601 Test level 8 kV contact 15 kV air Compliance level 8 kV contact 15 kV air Electrical fast transient/
burst IEC 61000-4-4 Surge IEC 61000-4-5 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth 2 kV for power supply lines 1 kV for input/
output Lines 1 kV differential Mode 2 kV common mode
<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 5s 3A/m 3A/m Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level. Electro magnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of RI Witness requires continued operation during power mains interruptions, it is recommended that RI Witness be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 5 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test IEC 60601 Test level Compliance level Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m the recommended Electro magnetic environment -
guidance Portable and mobile RF communications equipment should be used no closer to any part of RI Witness, including cables, than separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = [3.5/V 1] p d = [3.5/V1] p 80MHz to 800MHz d = [3.5/V1 p 800MHz to 2.5GHz the maximum output where p power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:
level is Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which RI Witness is used exceeds the applicable RF compliance level above, RI Witness should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating RI Witness. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V] V/m. 6 Section 3Safety Warnings3 Research Instruments Ltd Safety/Information Symbols Symbol Meaning Indicates instruction for disposal of goods. In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC under the supervision of notified body No.0120, SGS, UK Ltd. In accordance with the European Directive for R&TTE, Directive 1999/5/EC Indicates the medical device manufacturer. Indicates the date of manufacture. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Consult instructions for use. SN The four digit number is a unique identifier assigned to the product. Caution: US Federal law restricts this device for sale to or on the order of a licensed healthcare practitioner. Only 7 Section 3Safety Warnings3 Research Instruments Ltd Safety and Reliability Please read this manual carefully and follow the instructions to ensure that the system will work safely and reliably. Temperature Safety Safety is the responsibility of the laboratory. Risk assessment and working practices 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 heating systems, it is advisable to perform a periodic check of temperatures using a calibrated thermocouple thermometer. RFID Reader Environment An RI Witness system uses Radio Frequency Identification (RFID) readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area. The performance of RFID tag detection may be compromised by repositioning the reader and by the proximity of metal objects or electrical equipment that were not present during installation and tuning. If the device is relocated ensure that the autotuning procedure documented in the RI Witness Software Manual (6-7-121UM) is followed to ensure optimum level of performance. For cleaning the reader may be lifted and returned to the same position. See Cleaning on page 23 for more cleaning details. Do not place metal objects near reader. Do not place electrical equipment near reader. Do not disconnect reader. Do follow the startup/shutdown procedures. Startup / Shutdown Procedure RI Witness hardware may be damaged by incorrect startup and shutdown procedures. Section 5 - RI Witness Basic Operation on page 11 describes the recommended startup and shutdown procedure for the RI Witness Embryology Heated Plate. 8 Section 3Safety Warnings3 Research Instruments Ltd SECTION 4 - PRODUCT OVERVIEW RI Witness is a system which operates within an assisted reproduction (AR) clinic setting and provides a method of identifying human samples throughout an AR cycle (from egg and sperm collection to embryo transfer). The system is intended to minimise the risks associated with traditional/manual double-checking and provides the essential controls necessary to ensure eggs, sperm and embryos are correctly matched and treated during the AR process. The RI Witness system comprises hardware, firmware and software components, which can be configured depending on the treatment activities, number of AR cycles conducted, size and layout of the AR clinic. RFID (radio frequency identification) technology provides the means of identifying 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 identifier. The unique identifier is linked to a patient/couple (specific 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 identity and status is confirmed on-screen. If containers containing samples of incompatible origin come into contact at any stage of this process, the system activates an alarm and prompts the clinician to respond. This manual is specifically for the Embryology Heated Plate (and associated Tube Reader accessory) in both its flush fitted and sit on top configuration. Other devices in the RI Witness range have their own manuals, as does the software. Embryology Heated Plate Figure 4-1 Sit on Top Heated Reader Figure 4-2 Tube Reader Accessory 9 Section 4Product Overview4 Research Instruments Ltd RI Witness Embryology Heated Plate Specification Table Part Description Temperature Sensor 5 x PT1000 (1 per Channel) Temperature Control Electrical heating 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 window Temperature controller accuracy: better than 0.2C when calibrated against a known reference. Displayed resolution: 0.1C Setpoint temperature range: 30-45C Displays 3 x 7-segment LED display shows the temperature reading from the ITO glass window temperature sensor. Connectivity USB plug type A Power Supply Input: 85-264VAC (100-240VAC Nominal), 47-63Hz,
<3A , Class I Output: 48VDC, Max 4.6A (220W) Operating Conditions Temperature: 15C (59F) to 40C (104F). Ambient temperature must be > 5C below setpoint. Humidity: 15% to 85% RH (Non Condensing) RFID Antennas RFID Dimensions Mass Embryology Heated Plate: 3 Antennas Tube Reader Accessory: 2 Antennas
(5 Total) 50 Load at 13.56Mhz, 1W Max Width: 460mm Depth: 220mm 6-70-807 Thickness: 20mm 6-70-807-A/-B Thickness: 34mm 6-70-807: 3.0kg (plus Power Supply 1.0kg) 6-70-807-A/-B: 5.0kg (plus Power Supply 1.0kg) 10 Section 4 Product Overview4 Research Instruments Ltd SECTION 5 - RI WITNESS BASIC OPERATION Startup Procedure 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. Figure 5-1 Power Supply In-Line Connector Once the device is plugged in, it will display the current measured temperature on the display. The status LED will remain off until the temperature has stabilised at the specified setpoint. The time 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 information). RI suggests that you keep the RI Witness computers and work areas (including the Embryology Heated Plate) switched on. This means that the heating and monitoring is constant. Shutdown Procedure To shutdown the device remove all electrical power by disconnecting the cable from the electrical outlet. Connecting to the Software Plug the device into the tablet or PC (or attached USB hub) using the USB A cable that protrudes from the device. Once the Windows operating system has recognised the devices within the Embryology Heated Plate, open the RI Witness Work Area software. To verify that the RI Witness Work Area software can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or press the (i) icon). This will bring up the Work Area Status window where the Embryology Reader and Temperature Control should be listed in the Connected Devices section with a green tick next to them. For more detailed set up information, refer to the RI Witness software manual (6-70-121UM). User Interface The Embryology Heated Plate contains a built in user interface which allows access to basic temperature setpoint and calibration adjustment. A complete set of calibration options can only be accessed through the RI Witness Work Area software. Setpoint Adjustment Indicator Light Status Indicator Light Offset Adjustment Indicator Light 11 Up Button Down Button Temperature Display
(shows ITO glass window temperature) Settings Button Figure 5-2 User Interface Section 5RI Witness Basic Operation5 Research Instruments Ltd Achieving the Correct Sample Temperature The heated plate is divided into 5 areas for calibration 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. Unheated Area Window Heated Area Top Left Heated Area Bottom Left Heated Area User Interface Top Right Heated Area Bottom Right Heated Area Blue denotes unheated area Red denotes heated area Figure 5-3 Embryology Heated Plate Heated Areas When working with multiple samples on the heated plate, it is recommended that only one sample is placed on the window heated area at a time. 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 conditions, type of Petri dish and the sample preparation. After the system has been installed in its operating location, the temperature of the heated plate should be adjusted to allow for this difference. We recommend using a thermometer calibrated to 37C fitted 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 preparation and place it on the heated surface in its normal position. Place the probe of the thermometer in the centre of the dish against the bottom of the dish and allow the temperature reading to stabilise. Adjust the setpoint temperature until 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 Positioned in a Petri Dish 12 Section 5RI Witness Basic Operation5 Research Instruments Ltd Functions of the built-in user interface are shown below. Changing the Temperature Setpoint Using the Device The temperature setpoint is applied to all heating channels and is set using the following procedure, or from within the RI Witness Work Area software. Refer to the RI Witness Software Manual (6-70-121UM) for further information. 1. Press and hold the Settings button for 3 seconds. 2. The Setpoint Adjustment Indicator light will flash. 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 until the desired setpoint is shown. and Down buttons 4. Save the temperature by pressing and holding the Settings button A beep will be heard. for 3 seconds. 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. Note: To exit the setpoint adjustment mode without saving changes, do not press any buttons for a short time and the device will return to normal operation (the Setpoint Adjustment Indicator light will go out). Changing the Temperature Setpoint using a PC and RI Witness Work Area software To change the setpoint using the RI Witness WorkArea software, click on the temperature displayed at the bottom 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 settings . After adjusting the setpoint temperature, check sample temperature inside the Petri dish. 13 Section 5RI Witness Basic Operation5 Research Instruments Ltd Temperature Calibration Note: 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 calibration of all 5 heated areas, this must be done from within the RI Witness Work Area software. Perform calibration only if the displayed temperature is different to the actual surface temperature of any of the 5 heated areas. The process of calibration allows the user to manually adjust the temperature so that the displayed temperatures match the temperature of the surface. Before temperature calibration can be performed the device must be in the same conditions that it will be in during normal operation. The temperature calibration is affected by ambient conditions. Place the probe of a calibrated thermometer in good thermal contact with the surface. Note: 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 calibrating. Heated areas are divided as shown below, with the X denoting recommended thermocouple positions for calibration:
Unheated Area Window X Top Left X Bottom Left X User Interface Top Right X Bottom Right X Figure 5-5 Recommended Thermocouple Positions for Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface During calibration using the built-in user interface close the RI Witness Work Area software to prevent interference with the thermometer reading. 1. Position the thermocouple probe on the Window in the location shown above. 2. Press and hold the Settings buttons simultaneously for 3 seconds. and The Offset Adjustment Adjustment Indicator light now show the current temperature (which may be a moving value). will flash. The Temperature Display will 3. Adjust the value shown on the Temperature Display using the Up and Down buttons until the temperature matches that shown on the external thermometer. 4. Save the calibration by pressing and holding the Settings button for 3 seconds. A beep will be heard. 5. The Offset Adjustment Adjustment Indicator light will go out and the Temperature Display will now show the current temperature with applied calibration. Leave the probe in position 14 Section 5RI Witness Basic Operation5 Research Instruments Ltd and once the temperature has stabilised at the setpoint, check that the calibration is accurate. Repeat the calibration process if necessary. The green Status Indicator Light will illuminate once temperatures have stabilised. 6. After adjusting calibration check sample temperatures and adjust the setpoint temperature if required. Note: To exit the window calibration mode without saving changes, do not press any buttons for a short time and the device will return to normal operation. The Offset Adjustment Indicator light will go out. Full 5-channel Calibration Using PC and RI Witness Work Area Software Full calibration of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness Work Area software and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the (i) icon then click Workarea Settings, then Connected Devices, then Temperature Controller, then Check Calibration. The screen will now show the current temperature and calibration offsets of the five different heated areas. Note: RF will be switched off automiatically when on the Temperature Control screen. 3. Each heated area is independent so the order of calibration is not important. Position the thermocouple probe in one of the positions shown above. 4. Allow the reading to stabilise, then compare the temperature shown in the Work Area software with the thermometer reading. 5. A difference within 0.2C is acceptable. If the readings are outside this increase the offset to increase the reading displayed by the software, or decrease the offset to decrease the reading displayed by the software. Allow a small delay for the offset change to register. When changing the offset, the temperature controller will then begin controlling using the new settings, so the surface temperature of that heated area may take a short time to re-stabilise. 6. Repeat this process for all 5 heated areas. 7. Once calibration is complete it is advisable to verify the temperature of each heated area to check that temperature calibration has been carried out effectively. After adjusting calibration, check sample temperatures and adjust the setpoint temperature if required. 15 Section 5RI Witness Basic Operation5 Research Instruments Ltd Tube Reader Antenna Accessory The Tube Reader Antenna is an accessory for the Embryology Heated Plate that allows tags to be read in a vertical orientation. It is specifically 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 attached to the Embryology Heated Plate. The correct mounting orientation position is shown below in Figure 5-6. Tube Reader Antenna Connections Figure 5-6 Tube Reader Connections on the Embryology Heated Plate Refer to Section 7- Care and Maintenance on page 23 for cleaning precautions relating to the Tube Reader Antenna. Tube Reader Antenna Figure 5-7 Tube Reader Correctly Mounted on the Embryology Heated Plate 16 Section 5RI Witness Basic Operation5 Research Instruments Ltd SECTION 6 - TROUBLESHOOTING Problem Possible Cause Solution Tags Reading Intermittently or Only in Certain Areas Tags Not Reading Loose connection Antenna not tuned properly RF Noise/interference Faulty Device Broken tag Poor/no connection or no power. Tag not encrypted WorkArea configuration Antenna not tuned Faulty Device Check security of USB and power cable connections. Navigate to the Workarea Settings screen, then click Connected Devices , then Embryology Reader, then RFID Tuning, then Auto tune. Other devices in the lab can cause RF noise/
interference, contact an RI service representative. Contact an RI Service representative. Check the tag on another device. Check security of USB and power cable connections. Verify that the light on the power supply is illuminated. Navigate to the Workarea Settings screen, then click Connected Devices , then Embryology Reader, then click the down arrow next to Tags. Non encrypted tags are shown as Not Valid. Navigate to the Workarea Settings screen, then click Connected Devices , then Embryology Reader, then RFID Tuning, to check that the number of antennas (channels) is 5 for the Embryology Reader with the Tube Reader Antenna Accessory. Navigate to the Workarea Settings screen, then click Connected Devices , then Embryology Reader, then RFID Tuning, then Auto tune. Contact RI or an RI Service Representative. 17 Section 6Troubleshooting6 Research Instruments Ltd Alarms and System Status The status of the temperature control system is shown by the Status Indicator Light positioned on the user interface of the device. Status Indicator Light Colour Meaning / Priority On Green Yellow constantly on Yellow flashing or Please wait Initial power up/setpoint/mode/calibration changed. The light will be off until temperature of all heating systems is within 1C of setpoint. Ready for use Temperature of all heating systems within 1C of setpoint. Low Priority Alarm Built-in user interface and RI Witness WorkArea software will show current window temperature. Press the buttons to cycle through the Alarm Condition Codes. Refer to tables on the following pages for details of each code. Alarm Condition Codes can be cleared by holding the buttons simultaneously for 3 seconds. A beep will be heard to confirm codes have been cleared. If the alarm sounds, finish the current procedure and promptly investigate the cause of the alarm. Medium Priority Alarm Built-in user interface and RI Witness WorkArea software will show current window temperature. Press the buttons to cycle through the Alarm Condition Codes. Refer to the tables on the following pages for details of each code. Alarm Condition Codes can be cleared by holding the buttons simultaneously for 3 seconds. A beep will be heard to confirm codes have been cleared. and and or When multiple alarms are active, the icon on the RI Witness WorkArea Software on the device and Status Indicator Light for the highest priority alarm will be shown. Note: For a full list of possible faults relating to each alarm condition and applicability of each alarm condition, refer to the tables on the following pages. Audible Alarms Audible alarms are sounded to above. When an alarm sounds, the alarm can be muted by pressing the which also cycles through the Alarm Condition Codes. The alarm audio un-muted each time a new alarm becomes active. When multiple alarms are active, 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. indicate Low and Medium Priority Alarms, as described buttons, or is automatically 18 Section 6Troubleshooting6 Alarm Conditions Codes Alarm Code E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 Fault Condition ITO Window Heating Failure Bottom Right Heating Channel Failure Bottom Left Heating Channel Failure Top Right Heating Channel Failure Top Left Heating Channel Failure Failure Channel ITO Window Sensor Failure
(either main sensor or overheat protection sensor) Bottom Right Sensor Failure Bottom Left Sensor Failure Top Right Sensor Failure Top Left Sensor Failure Priority Fault Description Heating system is not able to heat the specified heating channel. Alarm will be activated 2 minutes after power on if there is less than 1.5C temperature rise between 1 and 2 minutes after power on. If the temperature at 1 minute is already within 2.5C from the setpoint the test is omitted. No signal/out of range signal from temperature sensor. Alarm activates at any time if the sensor circuit fails to read a valid temperature. Low Low/
Medium Low priority alarm is activated if the fault occurs when system is switched on. After this time a medium priority alarm is activated Research Instruments Ltd Solution Restart the device by removing mains power then re-connecting. Alarm Actions Heating controller power is set to 0% for that heating channel until device is restarted. Possible sensor, cable or controller fault. Heating power is set to 0% for that heating channel until a valid temperature is read. If the ITO Window main sensor fails the temperature display will shown
--.-C Note: If the ITO overheat protection sensor is faulty, the display will still show the current temperature. 19 Section 6Troubleshooting6 Priority Fault Description Low /
Medium If fault occurs when the system is switched on Heating channel has exceeded the maximum allowable setpoint temperature. Alarm activated at any time if the temperature sensor exceeds 50C. Medium Heating channel has deviated by more than 1C from the setpoint temperature. Alarm enabled 5 minutes after the temperature reaches 2.5C from the setpoint temperature. Research Instruments Ltd Alarm Code E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 Fault Condition ITO Window Heating Channel Over Temperature Bottom Right Heating Channel Over Temperature Bottom Left Heating Channel Over Temperature Top Right Heating Channel Over Temperature Top Left Heating Channel Over Temperature ITO Window Heating Channel Temperature outside 1C Bottom Right Heating Channel Temperature outside 1C Bottom Left Heating Channel Temperature outside 1C Top Right Heating Channel Temperature outside 1C Top Left Heating Channel Temperature outside 1C Alarm Actions Temperature controller power is set to 0% until temperature falls to below 50C. Note: If the temperature continues to rise past this point, over temperature protection built in to the device will shut down the heating.
(See E27) The temperature controller continues to operate to bring back within the allowable limits. Solution Possible heater or controller fault. This may be caused by placing either hot or cold objects on the device, in particular the ITO Window. In this case either remove the object or wait a short time for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature fluctuations. In this case wait a short while for the temperature controller to respond. 20 Section 6Troubleshooting6 Research Instruments Ltd Priority Fault Description Medium Heating channel has deviated by more than 2.5C from the setpoint temperature. Alarm enabled 5 minutes after the temperature reaches 2.5C from the setpoint temperature. Alarm Actions The temperature controller continues to operate to bring back within the allowable limits. Medium Heating controller did not achieve a temperature within 2.5C of the setpoint in 15 minutes from power on. Temperature controller continues to operate. Solution This may be caused by placing either hot or cold objects on the device, in particular the ITO Window. In this case either remove the object or wait a short time for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature fluctuations. In this case wait a short while for the temperature controller to respond. If the device is operated in an environment where the ambient temperature is colder than the specified operating conditions or if there is a large amount of cold airflow over the device, then this alarm may triggered routinely. If neither of these conditions are present, restart the device. If the fault reoccurs contact an RI Service personnel. Alarm Code E21 E22 E23 E24 E25 E26 E27 E28 E29 E30 Fault Condition ITO Window Heating Channel Temperature outside 2.5C Bottom Right Heating Channel Temperature outside 2.5C Bottom Left Heating Channel Temperature outside 2.5C Top Right Heating Channel Temperature outside 2.5C Top Left Heating Channel Temperature outside 2.5C ITO Window Heating Channel Low Heating Rate Bottom Right Heating Channel Low Heating Rate Bottom Left Heating Channel Low Heating Rate Top Right Heating Channel Low Heating Rate Top Left Heating Channel Low Heating Rate 21 Section 6Troubleshooting6 Research Instruments Ltd Alarm Code E31 Fault Condition Memory Fault Priority Fault Description Low Memory/controller fault. During normal use controller has failed to save data. When power is switched off and then on all values will be returned to factory defaults. E32 Main Over Temperature Protection Medium Main over temperature protection is triggered when the temperature controller is not able to limit heat supplied by the device. Each heating channel is fitted with a standalone monitoring system that shuts down the device in the event of a malfunction. The protection operates at approximately 65C Solution Recalibrate device. If the problem persists after re-
calibration then there may be a fault with the controller. If the problem is resolved by recalibrating then the memory may have been corrupted during saving of values, eg if the device loses power whilst saving values. Contact RI Service or distributor. Alarm Actions System continues to operate until power is removed. When power is returned the screen will show the uncalibrated temperature. Yellow flashing Status Indicator Light illuminates. All heating is switched off. 22 Section 6Troubleshooting6 Research Instruments Ltd SECTION 7- CARE AND MAINTENANCE Cleaning RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a soft cloth and mild detergent. The device may be lifted and returned to its original location. Do not disconnect the cables attached 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 reattaching to ensure cleaning products are not trapped in the interface. Do not use solvents for cleaning. Do not disconnect readers. Do not change the position of readers. 23 Section 7Care and Maintenance7 Research Instruments Ltd SECTION 8 - REPAIRS AND RETURNS Reuse Statement Assuming RI Witness is regularly maintained and routinely serviced, it should perform as required for a minimum of 7 years continual use, after which time we recommend you consider its replacement. Should you notice 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 representative promptly. RI Repairs System In the event that you have a problem with a RI instrument, please follow the procedure below to ensure prompt attention. 1. Read the Troubleshooting section. 2. If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible. Product Disposal (European Union) 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. RI Returns System 1. Contact RI to obtain a Returned Materials Authorisation (RMA) number. Note: Goods will not bereplaced or refunded without prior agreement and clearly stating 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 additional 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. Contact Details Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: +44 (0) 1326 372 753 Fax: +44 (0) 1326 378 783 E-mail: service@research-instruments.com Website: www.research-instruments.com Obligation to Inform In compliance with the European Medical Device Directive 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 patient or user or to a serious deterioration in their state of health. Feedback Thank you for purchasing a RI product. To help RI develop the best tools for ART, we rely on customer feedback. If you have any suggestions for how we can improve our products or the information we provide with them, please send them to feedback@research-instruments.com. Your feedback will help us develop the product and supporting materials to meet your future needs. Thank you. 24 Section 8Repairs and Returns8
1 2 | Users manual | Users Manual | 793.33 KiB |
User Manual R I W I T N E S S Embryology Heated Plate
+44 (0) 1737 243869 | customerservice@origio.com | origio.com Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall TR11 4TA, UK Document 6-70-807UM | DRF 3728 | Issue 5 | 1 December 2017 0120 only Research Instruments Ltd Contents CONTENTS SECTION 1 - PREFACE SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate Contraindications:
Applicable Part Numbers Related Documents Compatibility Installation SECTION 3 - SAFETY WARNINGS Safety/Information Symbols Safety and Reliability Temperature Safety RFID Reader Environment Startup / Shutdown Procedure Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions Guidance and Manufacturers Declaration Electromagnetic Immunity Guidance and Manufacturers Declaration Electromagnetic Immunity SECTION 4 - PRODUCT OVERVIEW Embryology Heated Plate RI Witness Embryology Heated Plate Specification Table SECTION 5 - RI WITNESS BASIC OPERATION Startup Procedure Shutdown Procedure Connecting to the Software User Interface Operator Position 1 2 2 2 2 2 2 2 3 4 5 5 5 5 6 6 7 8 9 9 10 11 11 11 11 11 12 Research Instruments Ltd CONTENTS Achieving the Correct Sample Temperature Changing the Temperature Setpoint Using the Device Changing the Temperature Setpoint Using a PC and RI Witness WorkArea Software Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface Full 5-channel Calibration Using PC and RI Witness Work Area Software Tube Reader Antenna Accessory SECTION 6 - TROUBLESHOOTING Alarms and System Status Audible Alarms Alarm System Testing Alarm Conditions Codes SECTION 7- CARE AND MAINTENANCE Cleaning SECTION 8 - REPAIRS AND RETURNS Reuse Statement RI Repairs System Product Disposal (European Union) RI Returns System Contact Details Obligation to Inform Feedback Contents 12 13 13 14 14 15 16 17 18 18 19 19 23 23 24 24 24 24 24 24 24 24 Research Instruments Ltd SECTION 1 - PREFACE Thank you for choosing RI Witness. This manual provides all necessary information to use RI Witness Embryology Heated Plate and should be read in conjunction with any manuals provided with other RI Witness hardware or software components that you are using. The system should be operated by trained personnel only. All sections of this manual should be read and understood fully before any operation of the system. Please see the Intended Use for more information. If the operator is unsure of any of the information contained in this manual they should contact Research Instruments or an appointed representative before attempting 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 consequential damages arising out of the use or inability to use this manual. The information in this manual is current at the time of publication. Our commitment to product improvement requires that we reserve the right to change equipment, procedures and specifications at any time. The latest version of the User Manual can be downloaded from software.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 respective 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 written consent of RI. This indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. 1 Section 11Preface Research Instruments Ltd SECTION 2 - INTRODUCTION TO RI WITNESS Indications for Use for RI Witness Embryology Heated Plate To maintain the temperature of human reproductive tissue such as oocytes and embryos through an assisted reproduction (AR) cycle. only 0120 Contraindications:
This device is not intended to be exposed to known sources of electromagnetic interference (EMI) with medical devices such as diathermy, CT, MRI, RFID (except other RI Witness RFID components) and electromagnetic security systems, eg metal detectors and electronic article surveillance systems. Applicable indications for use are subject to the regulations 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. Applicable Part Numbers Part Number 6-70-807*
6-70-809
* 6-70-807 can be supplied in several configurations depending on the required mounting type, eg flush fitted or sit on top. Description RI Witness Embryology Heated Plate RI Witness Tube Reader Related Documents 6-7-121UM 6-7-122UM RI Witness WorkArea Software Manual RI Witness Manager Software Manual Compatibility RI Witness is used in conjunction with the following:
Essential medical devices, eg dishes and tubes, maybe AR or non-AR specific. Non-essential 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 intention 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 potential effects of EMI disturbances, and reported when appropriate. Installation Installations of the RI Witness Embryology Heated plate should be carried out by a RI technician or other RI authorised personnel. Incorrect installation could result in overall poor performance. 2 Section 2Introduction2 SECTION 3 - SAFETY WARNINGS Research Instruments Ltd This symbol indicates cautionary text which should be followed to avoid injury to users or damage to samples. The system should be operated by qualified and trained personnel only. DO NOT disassemble or modify any part of the RI Witness Embryology Heated plate, or substitute any component for any other. Doing so may result in damage to samples. This voids the warranty and/or service contract. ONLY use the power cable and power supply adaptor supplied with the system. The cable to the power supply is the disconnect device for this equipment. To remove all electrical power from this product, disconnect the power cable from the electrical outlet. Equipment should be positioned 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. WARNING To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. WARNING Not to be used in a patient environment. WARNING Refer to Guidance and Manufacturers Declaration Tables in this section of the User Manual for guidance on the environment suitable for this device. WARNING The temperature of the plate should not be more than 1.5C from the displayed temperature at any time. A temperature of more than 1.5C will cause the temperature inside the dish to change more rapidly and samples are at risk of over-
heating. In this instance samples should be removed from the plate immediately. We recommend the plate temperature be monitored periodically using a calibrated thermocouple thermometer. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING There are no replaceable parts supplied with this device. Should any parts need to be replaced, contact RI or your distributor. WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING Portable RF communications 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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 3 Section 3Safety Warnings3 Research Instruments Ltd Safety/Information Symbols Symbol Meaning Do not dispose of product with normal waste. In accordance with Annex II of the European Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC under the supervision of notified body No.0120, SGS, UK Ltd. In accordance with the European Directive for R&TTE, Directive 1999/5/EC. Indicates the medical device manufacturer. Indicates the date of manufacture. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. Consult instructions for use. The five digit number is a unique identifier assigned to the product. Caution: US Federal law restricts this device for sale to or on the order of a licensed healthcare practitioner. Indicates the reference number. 4 SN Only REF Section 3Safety Warnings3 Research Instruments Ltd Safety and Reliability Please read this manual carefully and follow the instructions to ensure that the system will work safely and reliably. Temperature Safety Safety is the responsibility of the laboratory. Risk assessment and working practices 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 heating systems, it is advisable to perform a periodic check of temperatures using a calibrated thermocouple thermometer. RFID Reader Environment An RI Witness system uses Radio Frequency Identification (RFID) readers to monitor a work area. Readers detect RFID tagged containers that are placed in the work area. The performance of RFID tag detection 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. Startup / Shutdown Procedure RI Witness hardware may be damaged by incorrect startup and shutdown procedures. Section 5 - RI Witness Basic Operation on page 11 describes the recommended startup and shutdown procedure for the RI Witness Embryology Heated Plate. 5 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration (Part 15 of FCC) Electromagnetic Emissions Note: 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 Communications Commision (FCC) Rules. These limits are designed to provide reasonable protection 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 instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential 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 Canadas licence-exempt RSSs. Operation is subject to the following two conditions:
1. This device may not cause interference. 2. This device must accept any interference, including interference that may cause undesired operation of the device. Guidance and Manufacturers Declaration (IEC 60601-1-2) Electromagnetic Emissions RI Witness is intended for use in the electromagnetic environment specified below. The customer or the user of RI Witness should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions EN 61000-3-2 Voltage fluctuations/
flicker emissions EN 61000-3-3 Group 2 Class B Class A Complies RI Witness must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RI Witness is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 6 Section 3Safety Warnings3 Research Instruments Ltd USA Only Compliance with the emissions requirements of CISPR 22 Class A requires the following warning:
This is a class A product. In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures. Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test Electrostatic discharge
(ESD) IEC 61000-4-2 IEC 60601 Test level 8 kV contact 15 kV air Compliance level 8 kV contact 15 kV air Electrical fast transient/
burst IEC 61000-4-4 Surge IEC 61000-4-5 2 kV for power supply lines 1 kV for input/output lines 1 kV line(s) to line(s) 2 kV line(s) to earth 2 kV for power supply lines 1 kV for input/
output Lines 1 kV differential Mode 2 kV common mode
<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 5s 30A/M 30A/M Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency
(50/60 Hz) magnetic field IEC 61000-4-8 Note: UT is the a.c. mains voltage prior to application of the test level. Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of RI Witness requires continued operation during power mains interruptions, it is recommended that RI Witness be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 7 Section 3Safety Warnings3 Research Instruments Ltd Guidance and Manufacturers Declaration Electromagnetic Immunity IMMUNITY Test IEC 60601 Test level Compliance level Electromagnetic environment -
guidance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz 3 Vrms 3 V/m Portable RF communications 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 specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. 8 Section 3Safety Warnings3 Research Instruments Ltd SECTION 4 - PRODUCT OVERVIEW RI Witness is a system which operates within an assisted reproduction (AR) clinic setting and provides a method of identifying human samples throughout an AR cycle (from egg and sperm collection to embryo transfer). The system is intended to minimise the risks associated with traditional/manual double-checking and provides the essential controls necessary to ensure eggs, sperm and embryos are correctly matched and treated during the AR process. The RI Witness system comprises hardware, firmware and software components, which can be configured depending on the treatment activities, number of AR cycles conducted, size and layout of the AR clinic. RFID (radio frequency identification) technology provides the means of identifying 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 identifier. The unique identifier is linked to a patient/couple (specific 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 identity and status is confirmed on-screen. If containers containing samples of incompatible origin come into contact at any stage of this process, the system activates an alarm and prompts the clinician to respond. This manual is specifically for the Embryology Heated Plate (and associated Tube Reader accessory) in both its flush fitted and sit on top configuration. Other devices in the RI Witness range have their own manuals, as does the software. Embryology Heated Plate Figure 4-1 Sit on Top Heated Reader Figure 4-2 Tube Reader Accessory 9 Section 4Product Overview4 Research Instruments Ltd RI Witness Embryology Heated Plate Specification Table Part Description Temperature Sensor 5 x PT1000 (1 per Channel) Temperature Control Electrical heating 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 window Temperature controller accuracy: better than 0.2C when calibrated against a known reference. Displayed resolution: 0.1C Setpoint temperature range: 30-45C Displays 3 x 7-segment LED display shows the temperature reading from the ITO glass window temperature sensor. Connectivity USB plug type A Power Supply Operating Conditions RFID Specification Dimensions Mass Input: 85-264VAC (100-240VAC Nominal), 47-63Hz,
<3A , Class I Output: 48VDC, Max 4.6A (220W) Temperature: 15C (59F) to 40C (104F). Ambient temperature must be > 5C below setpoint. Humidity: 15% to 85% RH (Non Condensing) Frequency: 13.56Mhz Power: 1W Width: 460mm Depth: 220mm 6-70-807 Thickness: 20mm 6-70-807-A/-B Thickness: 34mm 6-70-807: 3.0kg (plus Power Supply 1.0kg) 6-70-807-A/-B: 5.0kg (plus Power Supply 1.0kg) 10 Section 4 Product Overview4 Research Instruments Ltd SECTION 5 - RI WITNESS BASIC OPERATION Startup Procedure 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. Figure 5-1 Power Supply In-Line Connector Once the device is plugged in, it will display the current measured temperature on the display. The status LED will remain off until the temperature has stabilised at the specified setpoint. The time 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 information). RI suggests that you keep the RI Witness computers and work areas (including the Embryology Heated Plate) switched on. This means that the heating and monitoring is constant. Shutdown Procedure To shutdown the device remove all electrical power by disconnecting the cable from the electrical outlet. Connecting to the Software Plug the device into the tablet or PC (or attached USB hub) using the USB A cable that protrudes from the device. Once the Windows operating system has recognised the devices within the Embryology Heated Plate, open the RI Witness WorkArea software. To verify that the RI Witness Work Area software can communicate successfully, navigate to the Work Area Status window (click the yellow triangle or press the (i) icon). This will bring up the Work Area Status window where the Embryology Reader and Temperature Control should be listed in the Connected Devices section with a green tick next to them. For more detailed set up information, refer to the RI Witness software manual (6-70-121UM). User Interface The Embryology Heated Plate contains a built in user interface which allows access to basic temperature setpoint and calibration adjustment. A complete set of calibration options can only be accessed through the RI Witness WorkArea software. Temperature Adjustment Indicator Light Status Indicator Light Audio Off Indicator Light Up Button Down Button 11 Temperature Display
(shows ITO glass window temperature) Settings Button Figure 5-2 User Interface Section 5RI Witness Basic Operation5 Research Instruments Ltd Operator Position The operator should be positioned 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 software). Achieving the Correct Sample Temperature The heated plate is divided into 5 areas for calibration 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. User Interface Blue area not temperature controlled Red denotes heated area Top Left Heated Area Bottom Left Heated Area Window Heated Area Top Right Heated Area Bottom Right Heated Area Figure 5-3 Embryology Heated Plate Heated Areas Ambient temperature must be >5c from the set point for the temperature control to work effectively Place only plastic or glass ware on the window heated area. 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 conditions, type of Petri dish and the sample preparation. After the system has been installed in its operating location, the temperature of the heated plate should be adjusted to allow for this difference. We recommend using a thermometer calibrated to 37C fitted 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 preparation and place it on the heated surface in its normal position. Place the probe of the thermometer in the centre of the dish against the bottom of the dish and allow the temperature reading to stabilise. Adjust the setpoint temperature until 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 Positioned in a Petri Dish 12 Section 5RI Witness Basic Operation5 Research Instruments Ltd Changing the Temperature Setpoint Using the Device The maximum setpoint temperature allowed for this device is 45C. WARNING: In the event of sensor failure the plate may become hot (up to 65C). The temperature setpoint is applied to all heating channels and is set using the following procedure, or from within the RI Witness WorkArea software. Refer to the RI Witness Software Manual (6-70-121UM) for further information. 1. Press and hold the Settings button for 3 seconds. 2. The Temperature Adjustment Indicator light will flash. 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 until the desired setpoint is shown. and Down buttons 4. Save the temperature by pressing and holding the Settings button A beep will be heard. for 3 seconds. 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. Note: To exit the setpoint adjustment mode without saving changes, do not press any buttons for 15 seconds and the device will return to normal operation (the Temperature Adjustment Indicator light will go out). Changing the Temperature Setpoint Using a PC and RI Witness WorkArea Software To change the setpoint using the RI Witness WorkArea software, click on the temperature displayed at the bottom 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 settings . After adjusting the setpoint temperature, check sample temperature inside the Petri dish. 13 Section 5RI Witness Basic Operation5 Research Instruments Ltd Temperature Calibration Note: Using the built-in user interface on the Embryology Heated Plate, it is only possible to calibrate the temperature of the ITO glass window. To perform a full calibration of all 5 heated areas, this must be done from within the RI Witness WorkArea software. Perform calibration only if the displayed temperature is different to the actual surface temperature of any of the 5 heated areas. The process of calibration allows the user to manually adjust the temperature so that the displayed temperatures match the temperature of the surface. Before temperature calibration can be performed the device must be in the same conditions that it will be in during normal operation. The temperature calibration is affected by ambient conditions. Place the probe of a calibrated thermometer in good thermal contact with the surface. Note: 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 calibrating. Heated areas are divided as shown below, with the X denoting recommended thermocouple positions for calibration:
User Interface Top Right X Bottom Right X Top Left X Bottom Left X Window X Figure 5-5 Recommended Thermocouple Positions for Temperature Calibration ITO Glass Window Calibration Using Built-In User Interface During calibration using the built-in user interface close the RI Witness WorkArea software to prevent interference with the thermometer reading. 1. Position the thermocouple probe on the Window in the location shown above. 2. Press and hold the Settings buttons simultaneously for 3 seconds. and The Temperature Adjustment Indicator light will flash. The Temperature Display will now flash between the current temperature (which may be a changing value) and the letters C A L . 3. Adjust the value shown on the Temperature Display using the Up and Down buttons until the temperature matches that shown on the external thermometer. 4. Save the calibration by pressing and holding the Settings button 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 calibration. Leave the probe in position and once the temperature has stabilised at the setpoint, check that the calibration is accurate. Repeat the calibration process if necessary. The green Status Indicator Light will illuminate once temperatures have stabilised. 14 Section 5RI Witness Basic Operation5 Research Instruments Ltd 6. After adjusting calibration check sample temperatures and adjust the setpoint temperature if required. Note: To exit the window calibration mode without saving changes, do not press any buttons for 15 seconds and the device will return to normal operation. The Temperature Adjustment Indicator light will go out and the Temperature Display will stop flashing. Full 5-channel Calibration Using PC and RI Witness WorkArea Software Full calibration of the 5 heated areas requires that each of the areas is calibrated in turn. 1. Open the RI Witness WorkArea software and navigate to the WorkArea Status window. 2. Click on the yellow triangle or the (i) icon then click WorkArea Settings, then Connected Devices, then Temperature Controller, then Check Calibration. The screen will now show the current temperature and calibration offsets of the five different heated areas. Note: RF will be switched off automiatically when on the Temperature Control screen. 3. Each heated area is independent so the order of calibration is not important. Position the thermocouple probe in one of the positions shown above. 4. Allow the reading to stabilise, then compare the temperature shown in the WorkArea software with the thermometer reading. 5. A difference within 0.2C is acceptable. If the readings are outside this increase the offset to increase the reading displayed by the software, or decrease the offset to decrease the reading displayed by the software to match the temperature displayed by the thermometer. Allow a small delay for the offset change to register. When changing the offset, the temperature controller will then begin controlling using the new settings, so the surface temperature of that heated area may take a short time to re-stabilise. 6. Repeat this process for all 5 heated areas. 7. Once calibration is complete it is advisable to verify the temperature of each heated area to check that temperature calibration has been carried out effectively. After adjusting calibration, check sample temperatures and adjust the setpoint temperature if required. 15 Section 5RI Witness Basic Operation5 Research Instruments Ltd Tube Reader Antenna Accessory The Tube Reader Antenna is an accessory for the Embryology Heated Plate that allows tags to be read in a vertical orientation. It is specifically 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 attached to the Embryology Heated Plate. The correct mounting orientation position is shown below in Figure 5-6. Tube Reader Antenna Connections Figure 5-6 Tube Reader Connections on the Embryology Heated Plate Refer to Section 7- Care and Maintenance on page 23 for cleaning precautions relating to the Tube Reader Antenna. Tube Reader Antenna Figure 5-7 Tube Reader Correctly Mounted on the Embryology Heated Plate 16 Section 5RI Witness Basic Operation5 Research Instruments Ltd SECTION 6 - TROUBLESHOOTING RFID SYSTEM Problem Possible Cause Solution Tags Not Reading Metal near reader Loose or no connection RF noise or interference Broken tag Antenna tuning problem Remove any metallic objects from the area, check if the tags come back into Work Area Check security of USB and power cable connections. Verify that the light on the power supply is illuminated Other 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 Area Check whether the tag is readable by a different RI Witness device. If it is not, discard that tag Navigate to the Work Area Settings screen, then click Connected Devices, then Embryology Reader, then RFID Tuning, check that all 5 channels (or 3 if you do not have the tube reader accessory connected) have green ticks next to them. If any have a yellow warning triangle next to them, contact an RI service representative 17 Section 6Troubleshooting6 Research Instruments Ltd Temperature Control: Alarms and System Status The status of the temperature control system is shown by the Status Indicator Light positioned on the user interface of the device. Status Indicator Light Colour Meaning / Priority Off Green (constantly on) Yellow (constantly on) Yellow (flashing) Please wait Initial power up/setpoint/mode/calibration changed. The light will be off until temperature of all heating systems has stabilised. Ready for use Temperature of all heating systems has stabilised. Low Priority Alarm Built-in user interface and RI Witness WorkArea software will show current window temperature. Press the button to cycle through the Alarm Condition Codes. Refer to tables on the following pages for details of each code. If the alarm sounds, finish the current procedure and investigate the cause of the alarm. Medium Priority Alarm Built-in user interface and RI Witness WorkArea software will button to show current window temperature. Press the cycle through the Alarm Condition Codes. Refer to the tables on the following pages for details of each code. If the alarm sounds, finish the current procedure and investigate the cause of the alarm. When multiple alarms are active, the highest priority alarm will be shown or the icon in the RI Witness WorkArea Software, and on the device the Status Indicator Light. Note: For a full list of possible faults relating to each alarm condition and applicability of each alarm condition, refer to the tables on the following pages. Alarm Condition Codes are only displayed whilst the alarm is active and are cleared when the alarm is no longer active. Audible Alarms Audible alarms are sounded to indicate Low and Medium Priority Alarms, as described above. When in alarm condition it is possible to turn the Audio Off by pressing the down button. The Audio Off Indicator Light will illuminate for the duration of the alarm condition. The Audio will return if another alarm is activated or if the Press the Up for full list of Alarm Condition Codes. When multiple alarms are active, the audio for the highest priority alarm will be sounded. The alarm volume is not adjustable. Audible range for alarm system is as follows. button whilst alarms are active to cycle through the error codes. See pages 19 to 22 button is pressed again. Priority Medium Priority Low Priority Range 44.4 - 55.5dB 41.5 - 55.5dB Average 53dB 51.5dB 18 Section 6Troubleshooting6 Research Instruments Ltd Alarm System Testing In order to test functionality of the alarm system hold down the button for 3 seconds when there are no active alarms. This will trigger a medium priority alarm signal, (3 audible pulses and 3 yellow flashes 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. Alarm Conditions Codes Alarm Code E01 E02 E03 E04 E05 E06 E07 E08 E09 E10 Fault Condition ITO Window Heating Failure Bottom Right Heating Channel Failure Bottom Left Heating Channel Failure Top Right Heating Channel Failure Top Left Heating Channel Failure Failure Channel ITO Window Sensor Failure Bottom Right Sensor Failure Bottom Left Sensor Failure Top Right Sensor Failure Top Left Sensor Failure Priority Fault Description Heating system is not able to heat the specified heating channel. Alarm will be activated 2 minutes after power on if there is less than 1.5C temperature rise between 1 and 2 minutes after power on. If the temperature at 1 minute is already within 2.5C from the setpoint the test is omitted. No signal/out of range signal from temperature sensor. Alarm activates at any time if the sensor circuit fails to read a valid temperature. Low Low/
Medium Low priority alarm is activated if the fault occurs when system is switched on. After this time a medium priority alarm is activated Solution Restart the device by removing mains power then re-connecting. Alarm Actions Heating controller power is set to 0% for that heating channel until device is restarted. Heating power is set to 0% for that heating channel until 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 condition. Restart the device by removing the mains power, then reconnect. Contact your distributor or RI Service if fault persists. 19 Section 6Troubleshooting6 Priority Fault Description Low /
Medium If fault occurs when the system is switched on Heating channel has exceeded the maximum allowable setpoint temperature. Alarm activated at any time if the temperature sensor exceeds 50C. Medium Heating channel has deviated by more than 1C from the setpoint temperature. Alarm enabled 10 minutes after the temperature reaches 2.5C from the setpoint temperature. Research Instruments Ltd Alarm Code E11 E12 E13 E14 E15 E16 E17 E18 E19 E20 Fault Condition ITO Window Heating Channel Over Temperature Bottom Right Heating Channel Over Temperature Bottom Left Heating Channel Over Temperature Top Right Heating Channel Over Temperature Top Left Heating Channel Over Temperature ITO Window Heating Channel Temperature outside 1C Bottom Right Heating Channel Temperature outside 1C Bottom Left Heating Channel Temperature outside 1C Top Right Heating Channel Temperature outside 1C Top Left Heating Channel Temperature outside 1C Alarm Actions Temperature controller power is set to 0% until temperature falls to below 50C. Note: If the temperature continues to rise past this point, over temperature protection built in to the device will shut down the heating. The temperature controller continues to operate to bring back within the allowable limits. Solution Possible heater or controller fault. This may be caused by placing either hot or cold objects on the device, in particular the ITO Window. In this case either remove the object or wait a short time for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature fluctuations. In this case wait a short while for the temperature controller to respond. 20 Section 6Troubleshooting6 Research Instruments Ltd Priority Fault Description Medium Heating channel has deviated by more than 2.5C from the setpoint temperature. Alarm enabled once it has reached 2.5C from the setpoint temperature and is more than 1 minute after power on. Alarm Actions The temperature controller continues to operate to bring back within the allowable limits. Solution This may be caused by placing either hot or cold objects on the device, in particular the ITO Window. In this case either remove the object or wait a short time for the setpoint temperature to be reached. Sudden air movements or temperature change can also cause minor temperature fluctuations. In this case wait a short while for the temperature controller to respond. May also be caused when the device is in over temperature condition. Restart the device by removing the mains power, then reconnect. Contact your distributor or RI Service if fault persists. Alarm Code E21 E22 E23 E24 E25 Fault Condition ITO Window Heating Channel Temperature outside 2.5C Bottom Right Heating Channel Temperature outside 2.5C Bottom Left Heating Channel Temperature outside 2.5C Top Right Heating Channel Temperature outside 2.5C Top Left Heating Channel Temperature outside 2.5C 21 Section 6Troubleshooting6 Priority Fault Description Medium Heating controller did not achieve a temperature within 2.5C of the setpoint in 15 minutes from power on. Alarm Actions Temperature controller continues to operate. Research Instruments Ltd Alarm Code E26 E27 E28 E29 E30 Fault Condition ITO Window Heating Channel Low Heating Rate Bottom Right Heating Channel Low Heating Rate Bottom Left Heating Channel Low Heating Rate Top Right Heating Channel Low Heating Rate Top Left Heating Channel Low Heating Rate E31 Memory Fault Low Memory/controller fault. System failed to read or write data correctly. If it happens during run time the system will carry on with current data. If it happens during start up the system will load the default values and needs reconfiguration of setpoint calibration. System continues to operate until power is removed. When power is returned the system will operate with the default calibration and setpoint values. Solution If the device is operated in an environment where the ambient temperature is colder than the specified operating conditions or if there is a large amount of cold airflow over the device, then this alarm may triggered routinely. If neither of these conditions are present, restart the device. If the fault reoccurs contact an RI Service personnel. 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. 22 Section 6Troubleshooting6 Research Instruments Ltd SECTION 7- CARE AND MAINTENANCE Cleaning RI Witness Embryology Heated Plate and Tube Reader Antenna may be cleaned with a soft cloth and mild detergent. Do not disconnect the cables attached 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 reattaching to ensure cleaning products are not trapped in the interface. Do not use solvents for cleaning. Do not disconnect readers. 23 Section 7Care and Maintenance7 Research Instruments Ltd SECTION 8 - REPAIRS AND RETURNS Reuse Statement Assuming RI Witness is regularly maintained and routinely serviced, it should perform as required for a minimum of 7 years continual use, after which time we recommend you consider its replacement. Should you notice 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 representative promptly. RI Repairs System In the event that you have a problem with a RI instrument, please follow the procedure below to ensure prompt attention. 1. Read the Troubleshooting section. 2. If you require any further help contact your distributor or RI directly. RI will try to resolve the problem as quickly as possible. Product Disposal (European Union) 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. RI Returns System 1. Contact RI to obtain a Returned Materials Authorisation (RMA) number. Note: Goods will not bereplaced or refunded without prior agreement and clearly stating 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 additional 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. Contact Details Research Instruments Ltd, Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: +44 (0) 1326 372 753 Fax: +44 (0) 1326 378 783 E-mail: service@research-instruments.com Website: www.research-instruments.com Obligation to Inform In compliance with the European Medical Device Directive 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 patient or user or to a serious deterioration in their state of health. Feedback Thank you for purchasing a RI product. To help RI develop the best tools for ART, we rely on customer feedback. If you have any suggestions for how we can improve our products or the information we provide with them, please send them to feedback@research-instruments.com. Your feedback will help us develop the product and supporting materials to meet your future needs. Thank you. 24 Section 8Repairs and Returns8
frequency | equipment class | purpose | ||
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1 | 2018-06-22 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Class II permissive change or modification of presently authorized equipment |
2 | 2016-07-29 | 13.56 ~ 13.56 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
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1 2 | Effective |
2018-06-22
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1 2 |
2016-07-29
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1 2 | Applicant's complete, legal business name |
RESEARCH INSTRUMENTS LTD
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1 2 | FCC Registration Number (FRN) |
0023761844
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1 2 | Physical Address |
BICKLAND INDUSTRIAL PARK
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1 2 |
FALMOUTH, N/A TR11 4TA
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1 2 |
United Kingdom
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
h******@acbcert.com
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1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
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app s | FCC ID | |||||
1 2 | Grantee Code |
2ACOO
|
||||
1 2 | Equipment Product Code |
670807
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||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
W******** T******
|
||||
1 2 | Title |
Mr
|
||||
1 2 | Telephone Number |
+(44)********
|
||||
1 2 | Fax Number |
+(44)********
|
||||
1 2 |
w******@research-instruments.com
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|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
RESEARCH INSTRUMENTS LTD
|
||||
1 2 | Name |
W******** T********
|
||||
1 2 | Physical Address |
BICKLAND INDUSTRIAL PARK
|
||||
1 2 |
FALMOUTH, TR114TA
|
|||||
1 2 |
FALMOUTH, TR11 4TA
|
|||||
1 2 |
United Kingdom
|
|||||
1 2 | Telephone Number |
+44 1******** Extension:
|
||||
1 2 |
+(44)******** Extension:
|
|||||
1 2 |
W******@RESEARCH-INSTRUMENTS.COM
|
|||||
1 2 |
w******@research-instruments.com
|
|||||
app s | Non Technical Contact | |||||
1 2 | Firm Name |
RESEARCH INSTRUMENTS LTD
|
||||
1 2 | Name |
W**** H****
|
||||
1 2 | Physical Address |
BICKLAND INDUSTRIAL PARK
|
||||
1 2 |
FALMOUTH, TR114TA
|
|||||
1 2 |
FALMOUTH, TR11 4TA
|
|||||
1 2 |
United Kingdom
|
|||||
1 2 | Telephone Number |
+44 1******** Extension:
|
||||
1 2 |
+(44)******** Extension:
|
|||||
1 2 |
W******@RESEARCH-INSTRUMENTS.COM
|
|||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | RlWITNESS EMBRYOLOGY HEATED PLATE | ||||
1 2 | RI Witness Embryology Heated Plate | |||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 | Original Equipment | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
Eurofins Hursley Ltd
|
||||
1 2 | Name |
A******** C****
|
||||
1 2 | Telephone Number |
00-44********
|
||||
1 2 | Fax Number |
00-44********
|
||||
1 2 |
a******@eurofins.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 13.56000000 | 13.56000000 | |||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 13.56000000 | 13.56000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC