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Esco MAW-4D User Manual

Multi-zone art workstation
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USER MANUAL
Multi-zone ART Workstation
Rev. 6.0
Date of revised 09.13.2021
Rx only

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  • Page 1 USER MANUAL Multi-zone ART Workstation Rev. 6.0 Date of revised 09.13.2021 Rx only...
  • Page 2 Esco makes no representations or warranties as to the accuracy of the information contained in this manual. In no event shall Esco be held liable for any damages, direct or consequential, arising out of or related to the use of this manual.
  • Page 3 During the war- ranty period, Esco Medical will, at our option, either repair or replace a product that proves to be defective at no charge, provided you return the product (shipping, duty,...
  • Page 4 This warranty extends only to the original purchaser. It does not cover damage from abuse, neglect, ac- cident or misuse, or as the result of service or modification by parties other than Esco Medical.
  • Page 5 In an event where the seal must be broken to gain internal access to the instrument, you must first contact Esco Medical Ltd. You will be required to provide us with the serial number for your instrument, as well as a valid reason for breaking the Quality Seal.

  • Page 6: Table Of Contents

    Table of contents 1 How to use this manual .......................... 11 2 Safety warning ............................11 3 Indication for use............................11 4 About the product ............................ 12 5 Transport, Storage and Disposal ......................13 5.1 Transport ............................13 5.2 Storage and operation environment requirements............13 5.2.1 Storage requirements ......................
  • Page 7 12.4.2 Main menu (only for models with a built-in gas mixer) ........28 12.5 Sub-menus ............................29 12.5.1 Temperature sub-menu ..................... 29 12.5.2 CO sub-menu (only for models with a built-in gas mixer) ........30 12.5.3 O sub-menu (only for models with a built-in gas mixer) ........32 12.5.4 Service sub-menu ........................
  • Page 8 18.2.7 Light Intensity Test (Optional for field testing) ............52 18.3 Calibration of Sentinel™ Gold Control ................... 52 18.4 Replacement of filter ........................53 18.5 Replacement of blower ....................... 55 18.6 Replacement of fluorescent lamp and UV lamp ..............55 18.6.1 Replacement of Fluorescent Lamp .................
  • Page 9 31.1 Gas supply premixed CO ....................77 31.2 Gas supply CO (only for models with a built-in gas mixer) ......... 78 31.2.1 About CO ..........................78 31.3 Gas supply N (only for models with a built-in gas mixer) ..........79 31.3.1 About N ...........................
  • Page 10 33.13 Internal 0.2µ filter for CO gas ....................93 33.14 Internal 0.2µ filter for N gas....................93 33.15 Firmware update ........................93 34 The Installation guide .......................... 94 34.1 Responsibilities ..........................94 34.2 Before installation ......................... 94 34.3 Preparing for installation ......................95 34.4 Bring the following to the installation site ................

  • Page 11: How To Use This Manual

    1 How to use this manual The manual is designed to be read by sections and not ideally from cover to cover. It means that if the manual is read from start to finish, there will be some repetition and overlap.

  • Page 12: About The Product

    (IVF)/assisted reproduction technology (ART) procedures. The workstation also pro- vides humidified gas to maintain gametes and embryos in the working environment. 4 About the product The Multi-zone ART Workstation is a laminar flow workstation intended to work with gametes and/or embryos at or near body temperature during in vitro fertilization (IVF)/assisted reproduction technology (ART) procedures.

  • Page 13: Transport, Storage And Disposal

    not applicable for Multi-zone ART Workstation. 5 Transport, Storage and Disposal 5.1 Transport The devices are packed in a carton box, and it is wrapped to a polyethylene. The box is affixed to a pallet with special straps. A visual inspection should be done if there is any damage. If there was no damage found, the Multi-Zone ART Workstation is prepared to be transported.

  • Page 14: Supplied Service Parts And Accessories

    • 1 HEPA filter for input gas supply (2 x HEPA filters for Multi-zone ART Workstation with gas mixer) • 1 USB stick containing Esco Medical Datalogger software and PDF versions of the manuals • 1 gas hood (Multi-zone ART Workstation without compartments) – 2 gas hoods for Multi-zone ART Workstation 6ft Dual •...

  • Page 15: Safety Symbols And Labels

    7 Safety symbols and labels Several user labels on the surface of the Multi-zone ART Workstation guide the user. User labels are shown below. Table 7.1 Packing box and electrical safety labels Description Image Packing box label: 1. If stored longer than the shelf life, the unit must be returned to the manufacturer for a new release test.

  • Page 16: Important Safety Instructions And Warnings

    Ethernet 8 Important safety instructions and warnings 8.1 Before installation 1. Do not use the product if the package is damaged. Contact Esco Medical or the local representative. 2. Read the User manual thoroughly before use. 3. Always keep these instructions easily accessible near the device.

  • Page 17: Post-Installation

    7. Do not install the device near any heat sources such as radiators, heat registers, stoves or other apparatus that produce heat. 8. Do not use this device near water sources. 9. Always use an external HEPA filter for input CO or premixed gases.

  • Page 18: Mains Connection

    6. Switch on the Multi-zone ART Workstation with the switch under the tabletop (next to the mains cable). 7. Power up the PC by pressing the button in the middle of the inner wall work area. 8. Observe for standard functionality. 9.
  • Page 19 Figure 11.1 Gas inlet under Single tabletop Gas pressure for inlet should be 0.4 – 0.6 bar (5.80 – 8.70 PSI) and it must be kept stable! Always use a high-quality pressure regulator for both gases that can be set with the required precision.
  • Page 20 Figure 11.4 Humidification flask Humidification flask tubes are marked with the number 1 and 2. Same have labeled two outlets. Flask tubes must be connected to outlets according to their number (number “1” tube and connect to the outlet marked with the same number). Figure 11.5 Tubes connected to the flask If no humidification is required or wanted, a U-looped silicone tube must be put from the port marked “Outlet”...

  • Page 21: Multi-Zone Art Workstation Without Compartments

    11.1 Multi-zone ART Workstation without compartments Figure 11.6 Choose gas from the nozzle The gas will flow through the nozzle in the tabletop work area. Figure 11.7 Gas nozzle in tabletop A gas hood must be placed over the outlet. The constant flow will flush the environment so that a correct CO concentration can be kept and thus, no pH drift will occur.

  • Page 22: Multi-Zone Art Workstation With Compartments

    Keep the lids on the dishes when they are placed under the gas hood. The dishes can be placed directly on the warmed surface. A heating optimization plate can also be used. With the Carry Tray, several dishes can be conveniently being transported between a CO incubator and the Multi-zone ART Workstation.
  • Page 23 Figure 11.11 Gas in compartments Gas system overview Required input gas type: premixed CO gas. Check medium types for the correct mixture and validate the mixture with a gas analyzer before use. Required input gas pressure: gas pressure on the external source should be 0.4 – 0.6 bar (5.80 –...

  • Page 24: Multi-Zone Art Workstation With Compartments And Built-In Gas Mixer

    11.3 Multi-zone ART Workstation with compartments and built-in gas mixer Figure 11.12 Multi-zone ART Workstation with compartments and built-in gas mixer The gas will flow through and circuit in both compartments by the internal FAN. CO sensors will provide gas concentration control. Gas system overview Required input gas type: pure CO and N...

  • Page 25: User Interface

    (i.e., 7.0% if 5.0% measured). Be advised that premixed gas consumption will be significantly higher compared to pure gas. Recover to the setpoint will be longer. 12 User interface The main keys and their purpose are presented in table 12.1. Table 12.1 The main keys and their purpose Description Image...

  • Page 26: Activating Heat And Gas Controls

    12.1 Activating heat and gas controls The main controls are activated using the “ON/OFF” switch under the tabletop. 12.2 System menu Press and hold (⇧) and (⇩) keys together for 3 seconds to access the menu. Navigate in menu using: •...

  • Page 27: Models With A Built-In Gas Mixer

    If the Multi-zone ART Workstation has compartments, after the display shows “TP 37.0”, the user can see the compartment's temperature by pressing the (⇧) key. Then the display will show: 12.3.2 Models with a built-in gas mixer Soon after system activation, the main display will alternate the reading between the following parameters.

  • Page 28: Main Menu

    If the Multi-zone ART Workstation has compartments, after the display shows “TP 37.0”, the user can see the compartment's temperature by pressing the (⇧) key. Then the display will show: 12.4 Main menu There are two different main menus in the Multi-zone ART Workstation: without a built- in gas mixer and with a built-in gas mixer.

  • Page 29: Sub-Menus

    Temperature is the first category when you enter the menu. Press the (⇨) key to enter the Temperature sub-menu. Press the (⇩) key to scroll further down in the menu. Press the (⇨) key to enter the CO sub-menu. Press the (⇩) key to scroll further down in the menu. Press the (⇨) key to enter the O sub-menu.

  • Page 30: Co Sub-Menu (Only For Models With A Built-In Gas Mixer)

    Example – how to calibrate the temperature: The temperature has to be measured with a suitable and calibrated device. With a quality thermometer, it has been determined that T1 is 37.4 °C. Locate “T1 CAL” in the sub-menu and press and hold the SP key. The display should show: Adjust the temperature by pressing the (⇧) key 4 times while still holding the SP key down.
  • Page 31 Move to the next CO sub-menu item with (⇩) key or one step up with (⇧) key. flow rate is shown (it cannot be adjusted): It shows the amount of CO gas put into the system while regulating. The volume is shown in liters/hour.

  • Page 32: Sub-Menu (Only For Models With A Built-In Gas Mixer)

    Calibration values should only be changed based on measurements taken by a trained user or technician. 12.5.3 O sub-menu (only for models with a built-in gas mixer) Press the (⇨) key on O to enter the O sub-menu. The first item in the O sub-menu is O sensor calibration: Calibrate O...

  • Page 33: Service Sub-Menu

    on the external gas regulator): The value is in bar and it must be 0.4 – 0.6 bar (5.80 – 8.70 PSI) at all times. Example – how to calibrate the O gas concentration has to be measured with a suitable and calibrated device. The real concentration has been determined to be 5.3% on the gas sample port.

  • Page 34: Alarms

    Ver 2.0 is only shown as an example. Consult Esco Medical or the local representative for the number of the latest version. Move to the next service sub-menu item with (⇩) key or one step up with (⇧) key. If the Multi-zone ART Workstation has a built-in gas mixer, there will be a “GAS” function under the service sub-menu.

  • Page 35: Temperature Alarms

    13.1 Temperature alarms All 12 heating zones can trigger a temperature alarm if their temperature varies over ±0.5 °C from the setpoint. Remember that changing the setpoint to more than ±0.5 °C from the current temperature will result in an alarm. The same goes for all calibration adjustments. The number will indicate the zone triggering the alarm following “A”.

  • Page 36: Gas Level Alarms (Only For Models With A Built-In Gas Mixer)

    13.2 Gas level alarms (only for models with a built-in gas mixer) 13.2.1 CO alarms The CO gas level alarm is activated if the concentration of the CO gas deviates more than ± 1% from the setpoint. Remember that changing the setpoint more than ± 1% from the current gas level will result in a gas level alarm.

  • Page 37: Gas Pressure Alarms

    % is too high: The display will lock on the alarm condition and will stop alternating between the standard status messages. If the mute key is pressed, the display will shift to normal status and show the parameters for 5 minutes until the audio alarm comes back on again. The mute alarm key will still show the alarm condition by blinking red while the alarm is muted.

  • Page 38: Multiple Alarms

    “P” stands for pressure. The display will lock on the alarm condition and will stop alternating between the standard status messages. If the mute key is pressed, the display will shift to normal status and show the parameters for 5 minutes until the audio alarm comes back on again. The mute alarm key will still show the alarm condition by blinking red while the alarm is muted.

  • Page 39: Gas Flow Setpoint (Only For Models Without A Built-In Gas Mixer)

    14.2 Gas flow setpoint (only for models without a built-in gas mixer) The gas flow setpoint can be adjusted in the range from 0 l/h to 40 l/h. To change the gas flow setpoint, follow these instructions: 1. When the display shows the current gas flow: 2.

  • Page 40: Heated Mode

    The default O setpoint is 5.0%. To change the O concentration setpoint, follow these instructions: 1. When the display shows the O concentration: 2. Hold down the SP key and use (⇧) and (⇩) keys to adjust the setpoint: one keypress corresponds to a 0.1 change.
  • Page 41 Mode 1: All zones are “ON” and controlled. The zones are heated up to the temperature setpoint. Figure 14.1 Mode 1 Mode 2: Both compartments are “ON” and controlled. The left side and the middle zone are “ON” and controlled. The right side of the area is “OFF”;...

  • Page 42: Surface Temperatures And Measuring Temperature

    The middle zone and right-side area are “OFF”, as shown in the picture below. All other zones are heated up to the temperature setpoint. Figure 14.3 Mode 3 Mode 4: Both compartments are “ON” and controlled. The rest of the table plate is “OFF,” as shown in the picture below. Figure 14.4 Mode 4 15 Surface temperatures and measuring temperature In this section, the Multi-zone ART Workstation temperature controls system is described...
  • Page 43 Esco Medical recommends only a suitable and calibrated device with a precision of at least 0.1 °C. Temperature calibration is done by adjusting the Tx (where x is the sensor number) according to a measurement done on the spot relevant to the dish placement.

  • Page 44: Firmware

    necessary to do iterations before the zone is thoroughly calibrated. Heating modes do not affect the compartments. Be careful when changing the calibration settings – make sure that only the altered value corresponds to where the measurement is done. Give the system time to adjust. There is no crossover heating between the 12 zones when adjusted to temperatures within 0.5 °C.

  • Page 45: The Laminar Flow

    Esco products generally provide years of trouble-free operation; however, they require maintenance and service like all equipment. Maintenance and service should be carried out by trained personnel. Esco offers training courses to equip service providers with the latest skills, information, and tools to maintain and service Esco products successfully.

  • Page 46: Cabinet Field Calibration

    During recertification: − Workstation airflow velocities and flow patterns are verified against the man- ufacturer’s specifications and relevant international standards − Filters are scan-tested to ensure they do not leak − Operator comfort tests may be performed − If airflow velocities are off setpoint, adjustments are made as part of the certi- fication process before final values are recorded •...

  • Page 47: Performing Certification

    Figure 18.1 Steps on how to perform field certification 18.2 Performing Certification 18.2.1 Setting Cabinet in Maintenance Mode To start the certification, ensure the fan and lamps are turned on. The cabinet should then be put to maintenance mode. In Maintenance Mode, all alarms are defeated, and the window can be moved without the light being switched off.

  • Page 48: Locating The Speed Controller

    Figure 18.2 Menu options view in the cabinet 4. Use the “▼“ button until the LCDs SET MODE. Press the SET button, and LCD would show: Figure 18.3 The LCD SET MODE view in the cabinet 5. Use the “▼“ button until the LCDs MAINTENANCE message at the top line of the LCD.

  • Page 49: Nominal Airflow Velocity And Uniformity Test

    testing. 18.2.3 Nominal Airflow Velocity and Uniformity Test The blower should be turned ON for 10 minutes before setting the airflow. Put the Thermo anemometer on a plane that is 150 mm from the filter face, and measure the airflow using the grid below: Figure 18.5 Airflow measuring grid The airflow Grid Plane is 150 mm in front of the filter.

  • Page 50: Particle Count Test

    18.2.4 Particle Count Test Use a particle counter with a sampling rate of 1 ft of air per minute. Put the particle counter sampling cone inside the work zone, following the grid below: Figure 18.6 Particle counter sampling grid The plane is 300 mm on the work surface. Table 18.2 Particle counter sampling grid plane distances in Multi-zone ART Workstation Multi-zone ART Multi-zone ART...

  • Page 51: Noise Level Test (Optional For Field Testing)

    for 5 mins before taking measurement. If there’s a departure with the measurement, follow the procedure in 12.5.1. After calibrating, measure the temperature again. Figure 18.7 Heating zones in Multi-zone ART Workstation Acceptance: Temperature within ± 0.1 of the setpoint Result: Pass / Fail 18.2.6 Noise Level Test (Optional for field testing)

  • Page 52: Light Intensity Test (Optional For Field Testing)

    Once the calibration has been completed, the control will show the air velocity whenever the fan is in operation. All Esco cabinets are factory-tested and calibrated before being shipped. Calibrating the Airflow Nomina Setpoint – 0.21 ± 0.02 m/s (41 fpm):...

  • Page 53: Replacement Of Filter

    • Press the MENU button. If the cabinet is in Maintenance Mode, no PIN will be asked. If the cabinet is in Normal Mode, enter PIN 0009. Press the ▼ button until the display shows “FIELD CALIB”, then press SET. •...
  • Page 54 4. Replace the new filter. Reverse the above steps for the assembly. Figure 18.10 Supply filter removal The nuts used to clamp the filter must be tightened until 50% compressed with an alternating pattern after the new filter is installed. The nuts must be equally tightened to give uniform compression.

  • Page 55: Replacement Of Blower

    18.5 Replacement of blower 1. Pre-filter and mesh must be removed first before proceeding to the blower re- placement instruction. Disconnect electrical connections as necessary to free the blower. 2. Remove the nuts, which clamp the blower. Pull out and lift the blower carefully. 3.

  • Page 56: Replacement Of Uv Lamp

    18.6.2 Replacement of UV Lamp • Disconnect the electrical connections • Take out the old UV lamp by rotating 90o counter-clockwise and pull downward • Install the new UV lamp by pushing it upward and rotate 90° clockwise 19 Cleaning instructions 19.1 Considerations about a sterile device Multi-zone ART Workstation is not a sterile device.

  • Page 57: Manufacturer Recommended Disinfection Procedure

    3. Following cleaning, leave the compartment's lids (in Multi-zone ART Workstation with compartments) open to allow sufficient time to ensure that all alcohol fumes have dissipated. 4. Finally, purified or sterile water is used to wipe the device surfaces. 5. Inspect the device: if visually clean, the device is ready for use. 6.

  • Page 58: Humidification

    Use only the correct type of Carry Tray heat optimization plates for your dishes. Figure 20.1 Carry Tray 21 Humidification If the Multi-zone ART Workstation is used for open culture conditions, humidification and gas hood are recommended. If the Multi-zone ART Workstation is used for culture with a mineral overlay, it is unnecessary to use the humidification system.

  • Page 59: All In One Pc

    Figure 22.1 Pin Esco Medical or your distributor can supply a connector and wire. The zones' temperature conditions can be logged continually externally through the connectors without compromising the unit's performance. Any logging system that uses standard PT-1000 sensors can be used.

  • Page 60: Data Logger Software

    23.1 Data Logger Software Under normal working conditions, on the PC display, the user should see numeric values. Figure 23.2 The Workstation Logger view under normal working conditions (without a gas mixer) For Multi-zone ART Workstation models with a built-in gas mixer, the main display also shows CO level, CO flow, CO...
  • Page 61 Figure 23.4 The Workstation Logger 2 display view under normal working conditions (with a gas mixer) If the signal is lost, dotted lines will appear instead of numeric values. Figure 23.5 The Workstation Logger main view when the signal is lost Once the signal is established, numeric values will be shown.
  • Page 62 Figure 23.6 The Workstation Logger main view when there is a low-temperature alarm in the T2 area In this way, the user will always have a clear visual indication of the regular operation and an easy way to identify and respond to a malfunction. This is a unique safety feature of the Multi-zone ART workstation, which cannot be found on any comparable system.
  • Page 63 parameters. It is useful for documentation of the stability of the system and to identify errant behavior. Figure 23.8 The “History” temperature data view Several extra buttons appear in the graph view. By pressing the button with the number for the zone, the user can see temperatures and toggle “ON/OFF” graphs for each zone in the view.
  • Page 64 Pressing the “Reset” button will jump back to full view. Figure 23.10 The zoom-in graph view If there are data accumulated, it is possible to shift between a “Week”, “Day” and “Hour” view. Pressing the CO button will shift from the temperature data view to the CO gas data view.
  • Page 65 Figure 23.12 The “History” O data view The user can see historical data of O gas concentration setpoint, concentration, N flow and pressure. The “Alarm” button will bring up the graphical alarm view. Alarm conditions for the pa- rameters are shown as red on the timeline, thus making easy identification possible. Figure 23.13 The graphical “Alarm”...
  • Page 66 Figure 23.14 The graphical “Alarm” view (with a gas mixer) The “Report” button will bring up the report mode. All the Multi-zone ART workstation's running parameters can easily be documented and printed as a report or exported in PDF, Excel or Word for convenient ISO quality management compliance. Figure 23.15 The “Report”...

  • Page 67: Maintenance

    The 3 action buttons are located on the right-hand side: • The “Reconnect” button allows the system to reconnect with the sensors (in case of data loss due to USB connection issues). • The “Minimize” button toggles the full-screen format off for the Workstation Log- ger.

  • Page 68: Emergency Procedures

    Warranty is considered to be void if service and maintenance are not followed. Warranty is considered void if service and maintenance procedures are done not by trained and authorized personnel. 25 Emergency Procedures Total loss of power to or on the unit: •...

  • Page 69: User Troubleshooting

    Please refer to the software correctly installed installation guide Table 26.4 Display Symptom Cause Action Contact your Esco Medical Missing segment(s) in display Failure in the PCB Distributor to replace the PCB Table 26.5 Keyboard Symptom Cause Action The absent or erratic function...

  • Page 70: Specifications

    27 Specifications Table 27.1 Multi-zone ART Workstation general specifications MAW-6D MAW-6D MAW-6D Technical specifications MAW-4D MONO DUAL Work area dimensions 1260 x 500 x 710 1870 x 490 x 780 1870 x 500 x 710 mm (WxDxH) External dimensions with-...
  • Page 71 Table 27.2 Multi-zone ART Workstation with MIRI compartments general specifications ® MAW-4D MAW-6D MAW-6D MAW-6D Technical specifications MONO-MC DUAL-MC MP-MC Work area dimensions 1260 x 500 x 710 1870 x 490 x 780 1870 x 500 x 710 mm (WxDxH)

  • Page 72: Electromagnetic Compatibility

    28 Electromagnetic compatibility Table 28.1 Electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Multi-zone ART Workstation is intended for use in the electromagnetic environment specified below. The customer or the Multi-zone ART Workstation user should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 73 Guidance and manufacturer’s declaration – electromagnetic immunity The Multi-zone ART Workstation is intended for use in the electromagnetic environment specified below. The customer or the Multi-zone ART Workstation user should ensure that it is used in such an environment. IEC 60601 Compliance Electromagnetic environment- Immunity test...
  • Page 74 Table 28.3 Recommended separation distances Recommended separation distances between portable and mobile RF communication equipment and the Multi-zone ART Workstation The Multi-zone ART Workstation is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the Multi-zone ART Workstation user, can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF com- munications equipment (transmitters) and the Multi-zone ART Workstation as recommended below ac- cording to the maximum output power of the communications equipment.

  • Page 75: The Validation Guide

    29 The Validation guide 29.1 Product release criteria The Esco Medical Multi-zone ART Workstation undergoes a strict quality and performance testing before being released for sale. 29.1.1 Performance Each component used in the Multi-zone ART Workstation is tested during the manufacturing process to ensure a defect-free unit.

  • Page 76: Communication & Data Logging

    In the following, we describe these tests and the equipment necessary to perform them. A test documentation form is also provided. A copy must be provided to Esco Medical for internal device tracking and device history record. 30.1 Mandatory equipment All equipment must be of high quality and calibrated.

  • Page 77: Recommended Additional Equipment

    a resolution minimum of 0.1 °C • A Pressure tester with a range of 0.0 – 1.0 bar. • A Multimeter. Additional equipment only needed for Multi-zone ART Workstation with a built-in gas mixer: • A CO analyzer with a range of 0.0 – 10.0%. •...

  • Page 78: Gas Supply Co (Only For Models With A Built-In Gas Mixer)

    Connect the gas bottle and adjust the pressure. Fill up the humidification bottle with sterile water and connect the tubes. Put the gas hood on the tabletop over the gas outlet. Measure the CO concentration with a gas analyzer inside the gas hood. PASS: CO concentration measured must correspond to the Premixed gas.

  • Page 79: Gas Supply N (Only For Models With A Built-In Gas Mixer)

    atmospheric pressure. A high concentration of carbon dioxide (10.0% or more) can asphyxiate quickly without warning with no possibility of self–rescue regardless of the oxygen concentration. The User should make sure the CO used is safe and moisture-free. Below is a list of some standard component concentrations.

  • Page 80: About N

    PASS: N concentration measured must be between 95.0%– 100%. The use of N gas with moisture will damage the flow sensors. Moisture level must be verified on the gas manufacturer's certificate: only 0.0 ppm v/v Max is permissible. 31.3.1 About N Nitrogen makes up a significant portion of the earth's atmosphere with 78.08% by volume.

  • Page 81: Co Gas Pressure Check (Only For Models With A Built-In Gas Mixer)

    PASS: The value must be 0.4 – 0.6 bar. Please refer to the User manual sections for more information. 31.5 CO gas pressure check (only for models with a built-in gas mixer) The Multi-zone ART Workstation requires a pressure of 0.4 – 0.6 bar (5.80 – 8.70 PSI) on the input gas line.

  • Page 82: Temperature Check: Heating System Zones

    The device must be set up as closely as the condition under which it will be running in clinical use. Make sure that the Esco Medical data logger software is running. Check that parameter are logged and give a meaningful reading. Let the device run without interfering for at least 6 hours.

  • Page 83: Cleaning

    31.11 Test documentation form The "Installation report" form must be completed with the tests-passed status filled by installation personnel and submitted to Esco Medical before the device is taken into clinical use. Multi-zone ART Workstation User Manual Rev. 6.0...

  • Page 84: Recommended Additional Testing

    32 Clinical use Congratulations! Your device is now ready for clinical use with the validation tests completed and the test report submitted to Esco Medical. It should provide many years of stable service. It is necessary to monitor the performance of the device continually.

  • Page 85: Temperature Check

    32.1 Temperature check The temperature check is performed using a high-precision thermometer. Place the thermometer on each zone and verify the temperature. Calibrate if necessary. Please refer to the "12.5.1 Temperature sub-menu" section for more information on how to perform the temperature calibration. PASS: •...

  • Page 86: Premixed, Co And O Gas Pressure Check

    PASS: The value must be 0.4 – 0.6 bar. Please refer to the user manual for more information. 33 The Maintenance guide The Multi-zone ART Workstation from Esco Medical contains high precision quality components. These components are chosen to ensure the high durability and performance of the equipment.

  • Page 87: Hepa In-Line Filter For Premixed Gas

    Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 88: Hepa In-Line Filter For N Gas

    Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 89: Co Sensor (Only For Models With A Built-In Gas Mixer)

    This sensor's lifetime is more than 6 years, but for safety reasons, Esco Medical recommends the sensor to be replaced once every 4-years. Please follow these safety precautions when changing the sensor: •...

  • Page 90: Gas Box (Only For Models Without A Built-In Gas Mixer)

    Please follow these safety precautions when changing the internal gas pump: • Always use an original gas pump (contact Esco Medical or your local distributor for more details or ordering). • Change the gas box within 2 years from the date of installation.

  • Page 91: Gas Lines

    (applicable in the Multi-zone ART Workstation with a built-in gas mixer). This sensor's lifetime is more than 3 years, but Esco Medical recommends the sensor to be replaced once every 2 years for safety reasons.

  • Page 92: Pressure Regulators

    Please follow these safety precautions when changing the filter: • Always use the original filter (contact Esco Medical or your local distributor for more details or ordering). • Change the filter once every year.

  • Page 93: Internal 0.2Μ Filter For Co Gas

    Please refer to the service manual for replacement instructions. 33.15 Firmware update If Esco Medical has released a newer version of the firmware, this should be installed on the Multi-zone ART Workstation during the yearly scheduled service. Please refer to the service manual for instructions on how to update the firmware.

  • Page 94: The Installation Guide

    All individuals who will perform installation, repair and/or maintenance of the instrument must be trained by Esco Medical or a qualified training center. Experienced service technicians or embryologists conduct training to ensure that the installation personnel clearly understand the instrument's functions, performance, testing, and maintenance.

  • Page 95: Preparing For Installation

    8. N gas outlet with 0.6 – 1.0 atm above ambient if the clinic uses reduced oxygen levels. 9. Tubes that fit 4 mm hose nipple and HEPA filter. 10. Access to a PC with USB for the data logging. 34.3 Preparing for installation Bring the "Installation report"...
  • Page 96 2. Position the pre-assembled support stand below the cabinet. Do not lower the cabinet onto the support stand yet. Figure 34.2 Multi-zone ART Workstation, cabinet and support stand 3. Remove the 4 bolts as shown below. Figure 34.3 4 bolts in the Multi-zone ART Workstation cabinet 4.
  • Page 97 Figure 34.4 4 long bolts in the Multi-zone ART Workstation cabinet 6. Unscrew the 4 bolts as shown below and remove the 4 pcs of angle brackets. Figure 34.5 4 pcs of angle brackets removal 7. Pull out the metal pallet. The installation is now completed. Multi-zone ART Workstation User Manual Rev.

  • Page 98: Installation Procedure: Workstation

    Figure 34.6 Metal pallet in the Multi-zone ART Workstation 34.6 Installation procedure: Workstation 1. Follow the guidelines in the safety instructions and warnings section ("2 Safety warning" section). 2. Insert the computer into the frame from the backside. Connect the cables to suit- able positions.
  • Page 99 Figure 34.8 Main power connection in the Multi-zone ART Workstation 5. Use the gas hose, connect it to the Multi-zone ART Workstation and secure the gas lines. Figure 34.9 Gas line connection under the tabletop 6. Set gas pressure on the external gas regulator at 0.4 – 0.6 bar (5.80 – 8.70 PSI). 7.

  • Page 100: User Training

    When the installation trip is finished, a copy of the original "Installation report" form must be sent to Esco Medical Ltd. It will be saved with the device records. According to the ISO procedure and Medical Device Directive, a paper copy of the completed and signed installation test form is stored in the unique device's device history record.
  • Page 101 "Installation report". The completed and signed "Installation report" form must be sent to the clinic. Any deviations/complaints/suggestions from the Installation visit are reported in the CAPA system. If a critical error has occurred, information about this will be reported directly to QC or QA. If the Multi-zone ART Workstation fails any of the "Installation report"...

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