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Origio BT37 Manual

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BT37 IFU
MA101414-ML
0088
EN

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  • Page 1 BT37 IFU MA101414-ML 0088...

  • Page 4: Table Of Contents

    BT37 IFU Introduction This manual only applies to the following models: BT37; software version 1.0.25 and above. This guide includes important information concerning the safe use of the equipment. It is important that you familiarise yourself with this document before attempting to use the product. Contents Introduction 4 Notices 5...

  • Page 5: Notices

    © 2016 Planer plc Indications for use The Planer BT37 Incubator is intended to be used to provide an environment with controlled temper- ature at or near body temperature, CO₂, O₂ and N₂ gases, and elevated humidity for the development of gametes and embryos during in vitro fertilization (IVF) / assisted reproductive technology (ART) treatments.
  • Page 6 BT37 IFU Use aseptic technique. Sterile, distilled water. Inline gas filter. Visual check. Soapy water. Impermeable to gas. Medical grade premixed gas. High-purity gas regulator. By hand. Use spanner. Do not over-tighten. Wipe clean.
  • Page 7 Clean according to these instructions. Clean and disinfect according to these instructions. Call your distributor. Call service. Competent / trained person. Service engineer. Source of electromagnetic interference such as large transformers or motors etc. Source of heat or cold such as heaters, air conditioning units etc. Weight.
  • Page 8 BT37 IFU Repeat every 30 days. Repeat every 365 days. Repeat an additional 3 times. Wait for time t. Wait until dry. Mains power outlet. Connect mains power. Disconnect mains power. Fully charged battery. Low battery. Check electrical installation, equipment and mains leads. Toxic.

  • Page 9: Symbols On Equipment

    Equipment meeting EN 61010-1 or its equivalent. Audible alarm. Orange indicator. Green indicator. Red indicator. Flashing red indicator. Screened cable. Do not resterilize. Room temperature. Set-point. Set-point change. Symbols on equipment Refer to these instructions. Failure to follow these instructions may result in personal or third-party injury.
  • Page 10 BT37 IFU Premixed gas inlet. Premixed gas outlet. Rx only USA: Caution: Federal law restricts this device to sale by or on the order of a physician or a practitioner trained in its use. Sterilized using irradiation. Do not reuse. Do not use if package is damaged.

  • Page 11: Safety

    Safety  Operating the equipment in a manner not specified within this manual or under conditions outside of the equipment specifications, may result in the protection offered by the equipment being impaired.  CO₂ gas is an asphyxiant.  Use in well ventilated areas.  Consider CO₂...
  • Page 12 BT37 IFU  Contains a sealed lead acid battery. Weight: 4 kg. Composition w/w: Pb 57%, PbO₂ 22%, H₂SO₄ 14% Operating conditions Gases released Normal None Over charging SO₂, SO₃, H₂, CO, H₂SO₄ mist Excessive temperatures  The internal battery is not user-replaceable and may only be replaced by persons trained in the servic- ing of this equipment.

  • Page 13: About The Equipment

    About the equipment The BT37 and accessories are intended for use by embryologists and appropriately qualified biomedi- cal assistants. 1. Chamber lids 2. Humidifier access cover 3. User interface 1. Status indicators 2. Main display 3. Left cursor key 4. Right cursor key 5.
  • Page 14 BT37 IFU 1. Humidifier lid 2. Gas inlet 3. Bottle 4. Tube guide Clear cover 1.7.1 Editing numbers Right arrow increments selected digit.
  • Page 15 Left arrow decrements selected digit. Enter key moves to the right.
  • Page 16 BT37 IFU Keep pressing Enter key to go back. To accept value, select OK and press Enter. To discard value, select Cancel and press Enter.
  • Page 17 To continue editing, select Edit and press Enter. 1.7.2 Main display 1. Chamber base temperatures. 2. Chamber lid temperatures. 3. Humidifier temperature. 4. Gas flow. = bleed flow. = Purging. 5. Chamber base temperatures and gas flow. 6. Set-point for chamber base temperatures. 7.
  • Page 18 BT37 IFU 1.7.3 Menus 1. Display mode. Default display. 2. Change bottle. See Changing the humidifier on page 55 . 3. Configure. See Configuration on page 41 . 4. Test system. Trained personnel only. 5. Set password. See Setting the password on page 40 .
  • Page 19 1.7.4 Status and alarm indicators Standby Normal Unacknowledged alarm Unacknowledged alarm > 5 min Acknowledged alarm Temperatures not ready...
  • Page 20 BT37 IFU 1.7.4.1 Acknowledge alarms 1.7.5 Principle of operation Gas fed from cylinder. Bubbled through humidifier into left and right chambers. Tem- perature of chambers maintained at required temperature.

  • Page 22: Installation

    BT37 IFU Installation Uneven load. Install on flat, level and stable surface. Keep away from hot or cold temperature sources such heaters or air-conditioning units. Keep away from sources of electromagnetic interference such as large transformers. Maintain clear space around the equipment.
  • Page 23 Clean and disinfect (see page 63) before use. Connecting the gas Consult media supplier for appropriate gas concentrations. Concentration may need adjustment for local air pressure.
  • Page 24 BT37 IFU Blow through pipes with medical grade gas to clear any foreign bodies.
  • Page 25 Do not over-tighten.
  • Page 26 BT37 IFU...
  • Page 27 Do not over-tighten. Connect up to 10 incubators in series. Check for leaks.
  • Page 28 BT37 IFU Installing the humidifier Use aseptic technique. Do not use if tubing kinked or damaged. Fill with 125 ml sterile, distilled water.
  • Page 29 Remove cap. Refit cap. Ensure tubes aligned correctly. Fit filter.
  • Page 30 BT37 IFU Open humidifier lid. Rotate tube guide to back position. Fit bottle. Press in firmly. Ensure orientation correct.
  • Page 31 Close tube guide. Tubes pass through slot in guide. Route rear tube to right-hand chamber. Route middle tube to left-hand chamber.
  • Page 32 BT37 IFU Rotate front tube and filter 90° anticlockwise. Fit the filter to the gas inlet. Trim tubes if necessary.
  • Page 33 Press tube into grooves. Do not use sharp objects. Ensure there are no kinks Lay clear cover gently over tubes. Cover does not clip in place.
  • Page 34 BT37 IFU Close humidifier lid. Replace bottle and filter every 30 days. Do not refill the bottle. Keep the humidifier lid shut during normal operation.
  • Page 35 External data collection Alarm connection...
  • Page 36 BT37 IFU Connecting to the mains supply...

  • Page 38: Operation

    BT37 IFU Operation Switching on Memory failure: Calibration lost: Check Diagnostics ADC error Call service ... Visually check the tubing every 24 hours, and when samples are added or removed, to ensure there is no build-up of condensation. Do not remove the clear cover during this check. If condensation appears to be forming, refer to the Troubleshooting section.
  • Page 39 In normal run mode, disconnect power, and confirm unit can run from battery for 30 minutes. Reconnect power. Note that the available hold-up time following the test will have been reduced, and it may take up to 24 hours for full capacity to be restored. Check each chamber by using culture medium containing phenol red indicator.
  • Page 40 BT37 IFU Setting the password Set passwords to prevent unauthorised access.
  • Page 41 3.2.1 Resetting the password Configuration Do not attempt to change values unless you understand how to edit numbers; see Editing numbers on page 14. 3.3.1 Changing the control settings...
  • Page 42 BT37 IFU Select Control settings option. After changing any parameters, use the main display to check that the set-points are correct. See Main display on page 17. 3.3.1.1 Changing the temperatures System is factory set for 37.0 °C.
  • Page 43 3.3.1.1.1 Changing the left-hand chamber temperature...
  • Page 44 BT37 IFU 3.3.1.1.2 Changing the right-hand chamber temperature 3.3.1.2 Changing the flow System is factory set for 30 mL/min gas flow. The gas flow does not nor- mally need to be adjusted.
  • Page 45 3.3.1.2.1 Normal gas flow Default flow mode from version 1.0.25 Non-pulsed flow rate. Default 30 mL/min Purge flow rate. Factory set 360 mL/min Purge duration. Default 180 s Bottle change purge duration. Default 540 s...
  • Page 46 BT37 IFU Flow increased for purge duration after lids are shut. No flow during bottle-change. Flow increased for bottle-change purge duration when bottle change complete. 3.3.1.2.2 Pulsed gas flow From version 1.0.25, if bleed off-time = 0, non-pulsed flow is used. Bleed low flow rate.
  • Page 47 Flow increased for purge duration after lids are shut.
  • Page 48 BT37 IFU No flow during bottle-change. Flow increased for bottle-change purge duration when bottle change complete. 3.3.1.2.3 Changing the bleed on-time Recommended 300 s. See Pulsed gas flow on page 46.
  • Page 49 3.3.1.2.4 Changing the bleed off-time Recommended 0 s for normal gas flow (non-pulsed). See Pulsed gas flow on page 46 .
  • Page 50 BT37 IFU 3.3.1.2.5 Changing the purge duration after lids closed Default 180 s. If you open the lids regularly, increase to 300 s. See Normal gas flow on page 45 and Pulsed gas flow on page 46 .
  • Page 51 3.3.1.2.6 Changing the bottle change purge Recommended 540 s. See Normal gas flow on page 45 and Pulsed gas flow on page 46.
  • Page 52 BT37 IFU 3.3.1.2.7 Changing the non-pulsed flow rate Recommended 30 mL/min. See Normal gas flow on page 45 and Pulsed gas flow on page 46 .
  • Page 53 3.3.1.2.8 Returning to the main display Returning to the main display. After changing any parameters, use the main display to check that the set-points are correct. See Main display on page 17 .
  • Page 54 BT37 IFU 3.3.2 Securing the network 3.3.2.1 Setting the network to read-only The network should normally be set to read-only. 3.3.2.2 Allowing network writes The network should normally be set to read-only.
  • Page 55 Changing the humidifier...
  • Page 56 BT37 IFU See Installing the humidifier on page 28 .
  • Page 58 BT37 IFU Switching off Battery backup...
  • Page 60 BT37 IFU...

  • Page 62: Routine Maintenance And Troubleshooting

    BT37 IFU Routine maintenance and troubleshooting <Standby> 37.1 37.1 C <Run> 37.1 37.1 C General cleaning Disconnect mains power. Clean periodically with a damp cloth and sterile water.
  • Page 63 Push the brush or ‘pipe-cleaner’ from the inside of the cham- ber through to the exterior to avoid introducing contamina- tion into the chambers. Wait until dry. Reconnect mains power. Cleaning and disinfecting the chambers 4.2.1 Cleaning These instructions are for the exterior of the device only. Disconnect mains power.
  • Page 64 BT37 IFU Spray surfaces with sterile, distilled water. Wait 2 min. Remove water with clean non-linting cloth (gauze). Use cotton buds or swabs to get into grooves and corners. Repeat 3 more times. Wait until dry. Inspect the equipment to ensure it is visibly clean. Reconnect mains power.
  • Page 65 4.2.2 Disinfecting Clean first (see page 63). Disconnect mains power. Spray surfaces with 70% IPA. Wait 15 min.
  • Page 66 BT37 IFU Remove disinfectant with clean non-linting cloth (gauze). Use cotton buds or swabs to get into grooves and corners. Spray surfaces with sterile, distilled water. Remove water with clean non-linting cloth (gauze). Use cotton buds or swabs to get into grooves and corners. Wait until dry.
  • Page 67 Safety testing Check for leaks.
  • Page 68 In normal run mode, disconnect power, and confirm unit can run from battery for 30 minutes. Reconnect power. Note that the available hold-up time following the test will have been reduced, and it may take up to 24 hours for full capacity to be restored. Calibration and servicing http://www.planer.com/support/service/decontamination-certificate.html...
  • Page 69 Troubleshooting...
  • Page 70 BT37 IFU...
  • Page 72 BT37 IFU Resetting the system Returning for service Clean and disinfect first (see page 63). http://www.planer.com/support/service/decontamination-certificate.html...
  • Page 73 Disposal Do not dispose of with general waste. Clean and disinfect first (see page 63).
  • Page 74 BT37 IFU...

  • Page 76: Specifications

    BT37 IFU Specifications System specifications Dimensions 420 mm wide x 270 mm deep x 210 mm high. Weight 15.5 kg Storage temperature -10 °C to +50 °C Storage humidity 5% to 95% relative humidity non-condensing Storage special instructions Recharge every 4 months by connecting to the mains power supply for 24 hours.
  • Page 77 Control Temperature control range (ambient + 5 °C) to (ambient + 20 °C) 40 °C max. Temperature measurement accuracy ± 0.2 °C Temperature control accuracy ± 0.1 °C measured after any transient effects due to set- point chang- es have subsided. Flow control range 0 ml/minute to 900 ml/minute.
  • Page 78 BT37 IFU Humidifier bottle and filter Item Description Manufacturer Bottle Part number: Sterilized bottle assembly Planer plc CN101568-1 Filter Part number: Syringe filter. 0.2 µm, PALL Corporation HP4642 Supor membrane, 32 mm Gas supply Gas supply Premixed gas. Typically 6% CO₂, 5% O₂, 89% N₂...
  • Page 79 External alarm connections Output Volt free Connector type PHOENIX 3 way horizontal PCB header. # 1181451 Maximum voltage 30 V DC Maximum current Normal operating mode Alarm mode & power disconnected Monitoring Feature Controller 10 Base T Ethernet - RJ45 shielded. Modbus-TCP-IP protocol.
  • Page 80 Manufacturer: Planer plc, 110 Windmill Rd, Sunbury, Middlesex TW16 7HD, UK. Distributor: ORIGIO a/s Knardrupvej 2 DK-2760 Måløv Denmark www.origio.com Tel.: +45 46 79 02 00 Fax: +45 46 79 03 00 Customer Service: E-mail: customer.service@origio.com Tel: +45 46 79 02 02...

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