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Esco MAW-4D User Manual Download Page 100

Multi-zone ART Workstation User Manual Rev. 6.0

100

8.

Observe for standard functionality.

9.

Let the unit warm up and stabilize for 20 min.

10.

Follow the guidelines in the “

29

The Validation guide” section.

11.

Complete user training and finish reading instructions.

12.

After a burn-in phase of 24-hours, the unit is ready for use IF the testing is suc-
cessful.

If there are any deviations from the values included in the test form, they must be dis-
cussed with the user or owner of the Multi-zone ART Workstation.

If there are any suggestions or complaints, these must be recorded in the installation
report form.

34.7 User training

1.

Mains switch on/off.

2.

Explain the essential function of Multi-zone ART Workstation with room facility
for storing the samples.

3.

Explain the temperature control in the Multi-zone ART Workstation (direct heat
transfer with heated lids).

4.

Gas regulation on/off.

5.

Setpoint for temperature, CO

2

and O

2

.

6.

Alarm turn-off procedure (temperature, CO

2

, O

2

or Premix gas) and revert times.

7.

Insertion and removal of heating inserts

8.

Emergency procedures (can be found in the "25 Emergency Procedures" section).

9.

Explain how to clean the device and heating inserts.

10.

External measurement and calibration of temperature.

11.

External measurement and calibration of gas concentration.

12.

How to add and remove a sample.

13.

Data logger functionality, how to establish a connection and re-connection.

Use the User manual section as much as possible to get the User well

acquainted with it.

34.8 After the installation

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. The
date of installation is written in the instrument overview file. The date of installation is
also written in the service schedule.

Suppose  the  Multi-zone  ART  Workstation  user  or  owner  inquiries  about  a  written

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Summary of Contents for MAW-4D

Page 1: ...USER MANUAL Rev 6 0 Date of revised 09 13 2021 Rx only Multi zone ART Workstation ...

Page 2: ...l rights reserved The information in this manual and the accompanying product is copyrighted and all rights are re served by Esco Esco reserves the right to make periodic minor design changes without obligation to notify any per son or entity of such change Sentinel is a registered trademark of Esco Caution Federal law restricts this device to sale by or on a licensed healthcare practitioner s ord...

Page 3: ...maged It must be returned complete meaning all manuals cables accessories etc within 30 days of original purchase in as new and resalable condition The Return Procedure must be followed Return Procedure Every product returned for refund credit must be accompanied by a Return Material Au thorization RMA number obtained from Esco Medical Customer Service All items being returned must be sent prepaid...

Page 4: ...cables and non serialized modules are not covered under this warranty This warranty gives you specific legal rights and you may have other rights which vary from province to province state to state or country to country This warranty is limited to repairing the instrument per Esco Medical s specifications When you return an instrument to Esco Medical for service repair or calibration we rec ommend...

Page 5: ...ired to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality Seal You should break this seal only after you have received factory authorization Do not break the Quality Seal before you have contacted us Following these steps will help ensure that you will retain the original warranty on your instrument without interruption WARNING Unauthorized us...

Page 6: ...nstructions and warnings 16 8 1 Before installation 16 8 2 During installation 16 8 3 Post installation 17 9 Getting started 17 10 Mains connection 18 11 Gas connection and the humidification system 18 11 1 Multi zone ART Workstation without compartments 21 11 2 Multi zone ART Workstation with compartments 22 11 3 Multi zone ART Workstation with compartments and built in gas mixer 24 12 User inter...

Page 7: ... alarms 38 14 Changing the setpoints and heated mode 38 14 1 Temperature setpoint 38 14 2 Gas flow setpoint only for models without a built in gas mixer 39 14 3 CO2 gas concentration setpoint only for models with a built in gas mixer 39 14 4 O2 gas concentration setpoint only for models with a built in gas mixer 39 14 5 Heated Mode 40 15 Surface temperatures and measuring temperature 42 16 Firmwar...

Page 8: ...r recommended disinfection procedure 57 20 Heat optimization plates 57 21 Humidification 58 22 Temperature validation 58 23 All in one PC 59 23 1 Data Logger Software 60 24 Maintenance 67 25 Emergency Procedures 68 26 User Troubleshooting 69 27 Specifications 70 28 Electromagnetic compatibility 72 29 The Validation guide 75 29 1 Product release criteria 75 29 1 1 Performance 75 29 1 2 Electrical s...

Page 9: ...cumentation form 83 31 12 Recommended additional testing 84 31 12 1 A VOC meter 84 31 12 2 A laser particle counter 84 32 Clinical use 84 32 1 Temperature check 85 32 2 Premixed CO2 and O2 gas concentration check 85 32 3 Premixed CO2 and O2 gas pressure check 86 33 The Maintenance guide 86 33 1 HEPA in line filter for premixed gas 87 33 2 HEPA in line filter for CO2 gas 87 33 3 HEPA in line filter...

Page 10: ...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 95 34 5 Installation procedure at the site 95 34 6 Installation procedure Workstation 98 34 7 User training 100 34 8 After the installation 100 ...

Page 11: ...en in this documentation may result in damage to the unit injury to operating personnel and or poor equipment performance Any internal adjustment modification or maintenance to this equipment must be undertaken by qualified service personnel If the equipment must be relocated make sure it is appropriately fixed on a sup port stand or base and move on a flat surface When necessary move the equip me...

Page 12: ...built into the tab letop The dish is placed under the gas hood where the pH conditions in a buffered media without oil overlay can be maintained Open culture may lead to evaporation and a change in pH if the correct condi tions are not maintained An integral part of the Multi zone ART Workstation is the All in one PC which runs with the Workstation logger software The software functions as a const...

Page 13: ...he following conditions The unit can be in storage for one year If stored longer than one year the unit must be returned to the manufacturer for a new release test The unit can be stored at temperatures between 20 C and 50 C Keep away from direct sunlight Caution consult the accompanying documents for important safety related information such as warnings and precautions that cannot be presented on...

Page 14: ...es Service parts 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 1 carry tray for 1 Multi zone ART Workstation work zone Multi zone ART Work station wi...

Page 15: ...t cannot be presented on the device itself for various reasons 5 Consult instructions for proper use of the device 6 Do not use it if the packing material is damaged 7 Rx Only 8 Keep dry 1 Consult instruction for use 2 Warning on the back of the device indicates that an earth connection is needed and the mains information and an ON OFF push button 3 Lightning bolt indicates the potential risk of e...

Page 16: ...If a forklift is used only lift on the custom built pallet The tabletop itself cannot withstand any lifting in the middle Permanent damage will occur Warranty void if this happens 6 The electronics box under the tabletop is not flush with the rest of the underside Any blows can result in permanent damage Warranty void if this happens 8 2 During installation 1 Never place this unit on top of other ...

Page 17: ...g if the apparatus has been dropped exposed to rain or moisture or does not operate normally The Multi zone ART Workstation con tains high voltage components that may be hazardous 3 Unplug this device during lightning storms or when unused for an extended period of time 4 Protect the power cord from being walked on or pinched particularly at the plug convenience receptacles and the point where it ...

Page 18: ...ection in this manual for the manufacturer s recommended guidelines 10 Mains connection The Multi zone ART Workstation comes with a detachable mains power cord The power cord is prepared for the country in which the unit is intended to be used Do not defeat the safety purpose of the grounding type plug A grounding type plug has two blades and a prong which is provided for your safety If the provid...

Page 19: ...ect the CO2 gas to the CO2 inlet with a suitable silicone tube Ensure the tube is fastened with a clip so that it does not accidentally loosen itself during sudden pressure fluctuation Use the supplied 0 2µ HEPA filter on the gas line before the inlet on the Multi zone ART Workstation Notice the flow direction Figure 11 3 Gas filter The CO2 inlet should be connected to a 5 0 or 6 0 premixed CO2 Th...

Page 20: ...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 to the port below or simply empty bottle without water installed Fill the flask with sterile water One third of the humidification bottle should be filled with sterile water for the Multi zone ART Workstation to work properly and maintain the r...

Page 21: ...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 CO2 concentration can be kept and thus no pH drift will occur Figure 11 8 Gas hood placed over the gas nozzle ...

Page 22: ...also be used With the Carry Tray several dishes can be conveniently being transported between a CO2 incubator and the Multi zone ART Workstation Figure 11 9 Carry Tray 11 2 Multi zone ART Workstation with compartments Figure 11 10 Multi zone ART Workstation with compartments The gas will flow through and circuit in both compartments by the internal FAN The FAN will automatically start when the flo...

Page 23: ...rm s cause The gas flow setpoint can be adjusted in the range from 0 l h to 40 l h with 1 l h increment When the gas flow is active the user can turn on the Purge function by pressing the up key when the status in the menu shows the FLW 1 The gas flow will be switched on for 5 min 40 l h The correct flow is a balance towards maintaining the pH level in the gas usage medium and economy With increas...

Page 24: ...e external source should be 0 4 0 6 bar 5 80 8 70 PSI and must be kept stable If the pressure falls below 0 3 bar 4 40 PSI or rises above 0 7 bar 10 20 PSI it will trigger the gas pressure alarm If an alarm remove the sample to a safe CO2 incubator and investigate the alarm s cause The CO2 gas concentration setpoint can be adjusted from 3 0 to 10 0 with a 0 1 increment The N2 gas concentration set...

Page 25: ...ly indicate the alarm condition by a flashing red circle of light The audio alarm will automatically come back on after 5 min It can be muted again Display panel Shows the information on the current status of the unit The display consists of 7 x high brightness 16 segment LEDs The 1st is red which indicates a user warning The other 6 are blue and used to display normal running conditions Setpoint ...

Page 26: ...nge OR accept Press and hold and keys together for 3 seconds to exit the menu entirely 12 3 Status 12 3 1 Models without a built in gas mixer Soon after system activation the main display will alternate the reading between the following parameters Scroll between the parameters with the key There will be an additional culture mode parameter in the Multi zone ART Workstation and models with compartm...

Page 27: ...t in gas mixer Soon after system activation the main display will alternate the reading between the following parameters Scroll between the parameters with the key If the O2 regulator is deactivated the system will display O2 OFF If the Multi zone ART Workstation has compartments there will be an additional culture mode parameter If the use mode is Open Culture no oil or Paraffin overlay culture t...

Page 28: ...uilt in gas mixer and with a built in gas mixer 12 4 1 Main menu only for models without a built in gas mixer Press the key to enter the menu You can exit the menu by pressing the key Temperature is the first category when you enter the menu Press the key to enter the Temperature sub menu Press the key to scroll to the last category on the menu Press the key to enter the Service sub menu 12 4 2 Ma...

Page 29: ...enu Press the key to scroll further down in the menu Press the key to enter the O2 sub menu Press the key to scroll to the last category on the menu Press the key to enter the Service sub menu 12 5 Sub menus 12 5 1 Temperature sub menu Press the key on the temperature menu to enter the temperature sub menu Calibrate holding down the SP key and using and keys to adjust Move to the next sub menu ite...

Page 30: ...7 2 37 3 and 37 4 When temperature equals the measured temperature let go of the SP key The value is stored and the temperature sensor for the T1 area has been modified Calibration procedure is the same for T1 T12 12 5 2 CO2 sub menu only for models with a built in gas mixer Press the key on the CO2 menu to enter the CO2 sub menu The first item in the CO2 sub menu is CO2 sensor calibration Calibra...

Page 31: ...ll times Example how to calibrate CO2 CO2 gas concertation has to be measured with a suitable and calibrated device The real CO2 concertation has been determined to be 5 4 on the gas sample port Locate CO2 CAL in the CO2 sub menu and press the SP key The display will show Adjust the calibration to the desired level by pressing or keys In this case we want to adjust to 5 4 Press key 4 times The dis...

Page 32: ...e to the next O2 sub menu item with key or one step up with key Toggle O2 regulation on off by holding the SP key and pressing or keys The Default status for the O2 control is OFF Move to the next O2 sub menu item with key or one step up with key N2 flow rate is shown it cannot be adjusted It shows the amount of N2 gas put into the system while regulating The volume is shown in liters hour It usua...

Page 33: ...to adjust to 5 3 Press key 3 times The display will show 5 0 5 1 5 2 and 5 3 When O2 equals measured O2 let go of the SP key The value is stored and the O2 sensor calibration has been modified Calibration is done by adjusting the O2 level according to a measurement taken from the gas sampling outlet using a precision O2 measurement device only Calibration values should only be changed based on mea...

Page 34: ...remixed gas mode in the Multi zone ART Workstation model with a built in gas mixer it is necessary to use a premixed gas with higher gradation than the setpoint For example if you need to achieve a 5 CO2 gas setpoint premixed gas should have 7 CO2 in its mixture Press to exit back into the menu 13 Alarms The display will show a red A and the affected parameter s status message on a single fault co...

Page 35: ... 1 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 The zone layout and sensor placement are descr...

Page 36: ... 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 13 2 2 O2 alarms The O2 gas level alarm is activated...

Page 37: ... gas pressure If the pressure falls below 0 3 bar 4 40 PSI or rises above 0 7 bar 10 20 PSI it will trigger the alarm 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 m...

Page 38: ...rm conditions The flow will be forced according to the alarms The temperature alarms have 1st priority gas level alarms 2nd and pressure 3rd 14 Changing the setpoints and heated mode 14 1 Temperature setpoint The temperature setpoint can be adjusted in the range from 25 C to 40 0 C The default temperature setpoint is 37 0 C To change the temperature setpoint follow these instructions 1 When the di...

Page 39: ...as flow setpoint and heated mode 14 3 CO2 gas concentration setpoint only for models with a built in gas mixer The CO2 concentration can be adjusted in the range between 3 0 to 10 The default CO2 setpoint is 5 0 To change the CO2 concentration setpoint follow these instructions 1 When the display shows the CO2 gas concentration 2 Hold down the SP key and use and keys to adjust the setpoint one key...

Page 40: ... 3 After changing the temperature let go of the SP key The value is now stored If the display does not show the current O2 reading the key will toggle between the temperature CO2 O2 and heated mode readings 14 5 Heated Mode The table plate has 4 heated modes To change heated mode follow these instructions 1 When the display shows the current heated mode 2 Hold down the SP key and use and keys to a...

Page 41: ...gure 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 as shown in the picture below all other zones are heated up to the temperature setpoint Figure 14 2 Mode 2 Mode 3 Both compartments and the left side of the table plate are ON and controlled ...

Page 42: ...nts 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 in more detail Multi zone ART Workstation is equipped with 12 completely separate PID controllers for temperature measurement Each controller is respons...

Page 43: ...6 CAL T7 CAL T8 CAL T9 CAL T10 CAL T11 CAL and T12 CAL To calibrate the temperature in a particular area please find the corresponding sensor name and adjust it according to a measurement taken using a high precision thermometer 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 ...

Page 44: ...vailable it will be provided to our distributors around the world they will make sure that your incubator runs with the newest available firmware A service technician can do this during the scheduled annual service Please follow these steps to check the firmware which is currently installed on your unit 1 In the menu locate the Service sub menu Serv and press the key to enter The service sub menu ...

Page 45: ...ervice Personnel 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 For more information on the nearest ...

Page 46: ...cation indicates the displayed airflow deviates by 0 02m s 4fpm from actually measured velocities only for products with airflow velocity dis plays Filter replacement when The filters are clogged and the fan s are already adjusted to the maximum setting Filter leaks that cannot be repaired are found during scan testing Fan replacement typically rare if a failure occurs Routine maintenance also inc...

Page 47: ...s are defeated and the window can be moved without the light being switched off How to turn on the Maintenance Mode 1 Press the MENU button Enter ADMIN PIN default ADMIN PIN is 0009 2 If SETTINGS is displayed the ADMIN code has been removed proceed to step 3 a Press SET with 0 flashing b Press SET with 00 last digit flashing c Press SET with 000 last digit flashing d Press SET with 0000 last digit...

Page 48: ...e 7 The word Maintenance is displayed on the LCD as shown below Figure 18 4 Maintenance mode message is ON 18 2 2 Locating the Speed Controller The user needs to prepare for certification by locating the speed controller to change the motor speed 1 Remove the pre filter and mesh on top of the cabinet 2 The ECMS speed control is located inside 3 For a new cabinet installation turn the speed control...

Page 49: ...net Model Multi zone ART Workstation 4 ft Multi zone ART Workstation 6 ft Left to Right Distance from walls a mm 170 5 170 5 Distance apart x mm 306 307 Front to Back Distance from walls b mm 171 5 171 5 Distance apart y mm 157 157 Average Velocity ______________ m s fpm Maximum Deviation ______________ Acceptance Criteria Average filter face velocity of 0 21 0 02 m s with no single value deviatin...

Page 50: ... 171 5 171 5 Distance apart y mm 157 157 Average Count ___________ for particle size of 0 5 miron and larger samples in 0 028 m3 1 ft3 of air Note The particle count done in the factory is in as built condition If a 0 5 micron counter is used on the field there shall be no more than one particle of 0 5 µm samples in 1 m3 35 3 ft3 of air to reach ISO Class 3 Cleanliness rating ISO Class 3 per ISO 1...

Page 51: ...e and 380 mm above the recessed work surface area Acceptance Maximum corrected noise level of 67 dBA Based on NSF ANSI 49 standard Result Pass Fail Disclaimer 1 This noise test was done in the factory susceptible to reflective reverberant and background noise effects This noise figure may be different than the brochure value that is obtained from the anechoic chamber 2 If the difference between ca...

Page 52: ...erage light reading ____________ lux ft candles Acceptance criteria ____________ Average light reading should be at least 800 lux 74 ft candles Results Pass Fail 18 3 Calibration of Sentinel Gold Control Calibration is only necessary when the air velocity display is inaccurate or faulty alarm setpoints need to be corrected The purpose of calibrating the controller is to let the controller record p...

Page 53: ...to record this sensor ADC point Do not change Motor Duty Cycle or disrupt airflow sensor during this time After the 3 minute countdown has been completed a beep will sound and then the display shows CALIBRATION DONE The screen will go back to the MENU options shown in Step 2 Return the cabinet from Maintenance Mode to Normal Mode If the Calibration Error message is displayed please ensure that air...

Page 54: ...ts 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 It is to prevent over compression on one side of the filter that can cause filter leakage The nut tightening pattern is shown below Figure 18 11 Nut tightening pattern ...

Page 55: ...r replacement scheme 18 6 Replacement of fluorescent lamp and UV lamp 18 6 1 Replacement of Fluorescent Lamp Before changing the fluorescent bulbs ensure that the clean bench is powered down and disconnected from the electrical supply Locate the bulbs Remove the power clips at the ends of the bulbs by gently pulling while holding the bulb steady Remove the bulbs from the mounting clips and replace...

Page 56: ...LPA filtered laminar airflow A flush stainless steel work surface Use of parts that withstand cleaning well 19 2 Manufacturer recommended cleaning procedure Always validate the cleaning procedures locally for more guidance consult your manufacturer or the distributor The routine cleaning procedure is recommended for regular processing and maintenance The combination of standard cleaning procedures...

Page 57: ...sinfectant to disinfect the internal surface and a glass plate on the lid s top Use sterile wipes to apply the disinfectant 4 Wipe all internal surfaces and the top of the lid with three wipes at least Repeat until the wipes are not discolored 5 Change your gloves and after 10 minutes of contact time spray sterile water on the surfaces and wipe them with a sterile wipe 6 Inspect the device if it i...

Page 58: ... Multi zone ART Workstation increase circulating gas humidity which will decrease evaporation risk in media of Petri dishes placed in compartment Usually expected humidification level in the Multi zone ART Workstation compartments would maintain 70 77 One third of the humidification bottle should be filled with sterile water for the Multi zone ART Workstation to work properly and maintain the requ...

Page 59: ...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 Esco Medical can supply an external logging system for the sensors 23 All in one PC The single Multi zone ART Workstation is equipped with one powerful touch enabled AIO PC whereas dual Multi zone ART Workstation 2 AIO ...

Page 60: ...r Multi zone ART Workstation models with a built in gas mixer the main display also shows CO2 level CO2 flow CO2 pressure O2 level N2 flow N2 pressure CO2 and O2 setpoints and both active gas mode mix or premix and culture mode under oil culture or open culture Figure 23 3 The Workstation Logger view under normal working conditions with a gas mixer There is also a second display with only shows cu...

Page 61: ... 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 The blue color signifies that the zone is in normal operation mode If there is an alarm the color will shift to red on the relevant zone ...

Page 62: ...ART workstation which cannot be found on any comparable system Some models of Multi zone Workstations contain compartments In this case the zone will have a black border and two temperature values bottom and lid Figure 23 7 Compartment view in the Workstation Logger At the top of the screen 4 navigation buttons are placed in the middle and 3 actions buttons in the right hand corner The MAIN button...

Page 63: ...ph 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 For Multi zone Workstation with compartments the button will contain two values wherein two separate temperature curves will be shown Figure 23 9 Compartment with two temperature values A zoom function is available by touching the screen and swiping the finge...

Page 64: ...w In Multi zone ART Workstation models without a built in gas mixer the user can only see the flow and pressure s historical CO2 data Figure 23 11 The History CO2 data view In Multi zone ART Workstation models with a built in gas mixer the user can see the historical data of CO2 gas concentration setpoint concentration flow and pressure Pressing the O2 button will shift from the CO2 gas data view ...

Page 65: ...torical data of O2 gas concentration setpoint concentration N2 gas 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 view without a gas mixer ...

Page 66: ...n 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 mode view without a gas mixer Figure 23 16 The Report mode view with a gas mixer ...

Page 67: ... on the AIO PC the system will visually alert the user to any alarm conditions and make a rapid shift to the Workstation Logger s full view possible 24 Maintenance The Multi zone ART Workstation is designed to be easy to use but the reliable and safe operation of this equipment is based on the following conditions 1 Correct calibration of temperature and gas level using high precision equipment in...

Page 68: ...emperature alarm goes off Remove all the samples and place them in an alternative or backup device that is not affected by the problem The Multi zone ART Workstation will lose its temperature below a safe level in around 5 minutes Remove the samples from the affected zone They can be relocated to the other zones Each zone is separate so that the other zones will stay safe If multiple temperature a...

Page 69: ...y No wrong CO2 gas pressure to the system Check CO2 gas supply make sure that pressure is kept stable between 0 4 0 6 bar 5 80 8 70 PSI Table 26 3 Data Logger Symptom Cause Action No data is sent to PC System not powered Check mains The system is on standby or switched off Switch the system on The data cable between Incubator and PC not correctly attached Check connection Use only the cable suppli...

Page 70: ...es Smart power in jection electrical heating 9 1 zones Temperature accuracy 0 2 C Temperature uniformity 0 2 C Included advanced features Integrated humidification sys tem HS 1 Surveillance system with data logger AIO PC Heated glass stage Transmitted light source SC 1 with bulb 5 x PT1000 validation ports Dual Integrated humidification system HS 1 Surveillance system with data logger AIO PC 2 x H...

Page 71: ... power in jection electrical heating 7 1 zones Number of MIRI compart ments 2 3 2 Temperature accuracy 0 2 C Temperature uniformity 0 2 C Included advanced features Integrated humidification sys tem HS 1 Surveillance system with data logger AIO PC Heated glass stage Transmitted light source SC 1 with bulb 5 x PT1000 validation ports Dual Integrated humidification system HS 1 Surveillance system wi...

Page 72: ...aration electromagnetic immunity The Multi zone ART Workstationis intended for use in the electromagneticenvironment specified below The customer or the Multi zone ART Workstationuser should ensure that it is used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV conta...

Page 73: ...rom 80MHz to 2 5 GHz Portable and mobile RF communi cations equipment should be used no closer to any part of the Multi zone ART Workstation including cables than the recommended separation distance calculated from the equation applicable to the transmitter s frequency Recommended separation dis tance d 0 35 P d 0 35 P 80MHz to 800 MHz d 0 7 P 800MHz to 2 5 GHz P is the maximum output power rating...

Page 74: ... 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 com...

Page 75: ...ilt in gas mixer Pass II Internal sensor CO2 concentration variation from setpoint within 0 2 absolute Pass III Internal sensor N2 concentration variation from setpoint within 0 2 absolute Pass IV Gas flow CO2 less than 2 l h Pass V Gas flow N2 less than 8 l h 29 1 2 Electrical safety An electric safety test is also carried out using a high performance medical safety tester with each unit to ensur...

Page 76: ...ity item 30 Validation on site Even though at Esco Medical we strive to do the most comprehensive tests before the device is shipped to the customer there is no way to be sure that everything is still OK at the location when the device is set up Therefore in keeping with established good medical device practice we have set up a validation test regimen that must be completed before the device can b...

Page 77: ...ll minimize the likelihood of problems on site 31 Testing 31 1 Gas supply premixed CO2 O2 Multi zone ART Workstation without a built in gas mixer can only use premixed CO2 O2 gas Multi zone ART Workstation with a built in gas mixer can use either premixed CO2 O2 or pure CO2 and O2 gas A humidified gassing system is provided to avoid evaporation and maintain a safe pH level in open culture bicarbon...

Page 78: ...out a lid and a suitably large opening Set the pressure flow so that the bottle is flushed continually with gas without increasing pressure in the bottle i e the amount of gas exiting the bottle should be equal to the gas volume entering the bottle Pressure build up will affect the measured CO2 concentration as CO2 concentration is pressure dependent Sample from the bottle near the bottom with the...

Page 79: ... methane 50 ppm v v max of which 20 ppm v v Acetaldehyde 0 2 ppm v v max Benzene 0 02 ppm v v max Carbon Monoxide 10 ppm v v max Methanol 10 ppm v v max Hydrogen Cyanide 0 5 ppm v v max Total Sulphur as S 0 1 ppm v v max 31 3 Gas supply N2 only for models with a built in gas mixer For the regulation to maintain the correct O2 concentration levels in the Multi zone ART Workstation MIRI compartments...

Page 80: ...e standard component concentrations Please note that the values given are NOT the proper amounts only an example Research Grade 99 9995 Contaminant Argon Ar 5 0 ppm Carbon Dioxide CO2 1 0 ppm Carbon Monoxide CO 1 0 ppm Hydrogen H2 0 5 ppm Methane 0 5 ppm Oxygen O2 0 5 ppm Water H20 0 5 ppm 31 4 Premixed gas pressure check The Multi zone ART Workstation with and or without a built in gas mixer requ...

Page 81: ...r to the User manual sections for more information 31 6 N2 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 Therefore the gas pressure must be held stable at all times For safety this unit has a built in digital gas pressure sensor that monitors the incoming gas pressure and alerts the...

Page 82: ...ll temperatures measured on the bottom of the compartments where the dishes are located must not deviate more than 0 2 C from the setpoint If calibration is needed please refer to the 12 5 1 Temperature sub menu section for more information on how to perform the temperature calibration An iterative process may be needed if differences in the temperature levels are found and compensated through the...

Page 83: ...sical signs of dirt or dust The unit should look generally tidy Clean the unit externally with a lint free cloth moistened with a 70 alcohol solu tion Switch off the device and remove the mains lead Wipe the inside of the Multi zone ART Workstation the surface of the work area and the compartments with a lint free cloth moistened with a 70 alcohol solu tion Wipe the lids in the same way Let the li...

Page 84: ...the fan switched on a sample should be taken inside the work area with the sample opening pointing towards the side of the work area either left or right Pass 0 3 micron 100 ppm Ensure that the sample lines do not contain any particles 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 shoul...

Page 85: ...g system running For Multi zone ART Workstation with MIRI compartments the sample is taken from one of the sample ports located in the back of the unit It is essential to have a high precision gas analyzer for CO2 and O2 available to do the test Please follow these simple rules while testing gas concentration in MIRI compartments Check the CO2 O2 gas setpoint Check the actual CO2 O2 gas concentrat...

Page 86: ...nents are chosen to ensure the high durability and performance of the equipment However continual validation of the performance is necessary User validation should be done as a minimum according to instructions given in the 29 The Validation guide section If problems are encountered contact Esco Medical or your local representative However to sustain the high performance level and avoid system err...

Page 87: ... gas removes any particles found in the incoming gas Failure to use the HEPA filter may cause damage to the high precision flow sensor which calculates the amount of gas entering the system and disturbing the gas flow system 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 Chan...

Page 88: ... of gas entering the system and disturbing the gas flow system 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 Failure to change the filter on time will result in low no cleaning of incoming N2 gas Warranty void if wrong non original filter is...

Page 89: ...n Failure to change the oxygen sensor on time will result in low no regulation of O2 concentration Warranty void if wrong non original sensor is used Please refer to the service manual for replacement instructions 33 5 CO2 sensor only for models with a built in gas mixer The CO2 regulation uses the CO2 sensor to keep the gas concentration at the chambers desired level This sensor s lifetime is mor...

Page 90: ...s pump is used to transport the mixed gas through the chambers In time the performance of this pump can be affected causing a longer recovery time Therefore this pump must be replaced once every 2 years to maintain the fast recovery time after lid openings Please follow these safety precautions when changing the internal gas pump Always use an original gas pump contact Esco Medical or your local d...

Page 91: ...ng Please follow these safety precautions when changing gas lines Always use original gas lines contact Esco Medical or your local distributor for more details or ordering Change the gas lines within 3 years from the date of installation Failure to change the gas lines may cause slow recovery times or breakdowns Warranty void if wrong non original gas lines are used Please refer to the service man...

Page 92: ...ssure regulators contact Esco Medical or your local dis tributor for more details or ordering Change the regulators within 4 years from the date of installation Failure to change the regulators may cause breakdowns Warranty void if wrong non original regulators are used Please refer to the service manual for replacement instructions 33 12 Internal 0 2µ filter for premixed gas The round shape in li...

Page 93: ... 14 Internal 0 2µ filter for N2 gas The round shape in line 0 2µ HEPA filter for N2 gas removes any particles found in the incoming gas Failure to use the HEPA filter may cause damage to the high precision flow sensor which calculates the amount of gas entering the system and disturbing the gas flow system Please follow these safety precautions when changing the filter Always use the original filt...

Page 94: ...eeks before the installation due the user owner at the clinic is contacted via e mail to plan the exact time to perform the installation When a convenient time has been determined travel and accommodation arrangements can be made The released Multi zone ART Workstation must be sent 1 3 weeks before installation depending on the clinic location Check with shippers about local customs regulations an...

Page 95: ...fore every installation trip to ensure it contains the necessary tools Always bring the latest versions of firmware and data logging software Bring these files on a labeled memory stick to the service site 34 4 Bring the following to the installation site Installation report form Service manual for the Multi zone ART Workstation Updated service tool kit Memory stick with the latest released firmwa...

Page 96: ... 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 Lower the cabinet slowly and carefully onto the support stand Ensure the support stand is aligned correctly with the cabinet 5 Secure the support stand to the cabinet using the 4 long bolts ...

Page 97: ...7 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 ...

Page 98: ...he 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 Figure 34 7 Cable connection in the back of the Multi zone ART Workstation 3 Connect the power cable to the UPS 4 Connect the main power cable to the Multi zone ART Workstation ...

Page 99: ...ct 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 Switch on the Multi zone ART Workstation by pressing the button on the back Figure 34 10 Power button on the back of the Multi zone ART Workstation ...

Page 100: ...off procedure temperature CO2 O2 or Premix gas and revert times 7 Insertion and removal of heating inserts 8 Emergency procedures can be found in the 25 Emergency Procedures section 9 Explain how to clean the device and heating inserts 10 External measurement and calibration of temperature 11 External measurement and calibration of gas concentration 12 How to add and remove a sample 13 Data logger...

Page 101: ...mation about this will be reported directly to QC or QA If the Multi zone ART Workstation fails any of the Installation report form acceptance criteria or it in any way suffer from a severe error and incubation parameters are compromised the Multi zone ART Workstation must be taken out of service until it is repaired exchanged or anew test approves the Multi zone ART Workstation The User and owner...

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