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Barkey 212.10043, Instructions For Use Manual

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Description

 of the device 

2.3

 

Symbols 

2.3.1

 

Operating panel symbols  

 

 

Figure 2: Operating panel 

The Barkey plasmatherm has an operating panel on the front of the device with a multi-
line display, 6 buttons and 2 lamps (LEDs). 

The display   

 

displays the menu system for the operation of the device, 

 

displays information about the currently running program and its status, and 

 

outputs warning and error messages.

 

An audible signal draws your attention to the fact that a program has finished, warns of 
operator error or indicates that an error has occurred. A message is additionally shown in 
the display in the event of errors. 

 

 

Summary of Contents for 212.10043

Page 1: ...Instructions for use Barkey plasmatherm Version 1 EN Issued 2009 12 22 for SN 1107500 onwards Manufactured by Barkey GmbH Co KG Gewerbestrasse 8 33818 Leopoldshoehe Germany...

Page 2: ......

Page 3: ...ety distance 4 Operation 4 1 Putting into service 4 1 1 Siting the device 4 1 2 Connecting the power cord printer and barcode scanner 4 1 3 Switching on 4 1 4 Switching on if the fill level is too low...

Page 4: ...er 6 Maintenance 6 1 Technical safety inspection TSI 6 2 Replacing the battery 7 Error messages 7 1 Moisture sensors 7 2 Overtemperature 7 3 Paddle blocked 7 4 Tank is empty 7 5 Device errors 7 6 Erro...

Page 5: ...out the functions op eration and use of the Barkey plasmatherm 1 1 Pictograms words and symbols These instructions use the following pictograms symbols and words to highlight warn ings and special adv...

Page 6: ...user Please ensure that any supplementary instructions which may be issued are kept to gether with the original instructions Carefully read through these instructions before using the device Please fo...

Page 7: ...sation of Barkey GmbH Co KG Any further usage which goes beyond the use of the contents described in connection with the product purchased is not permitted Third party products protected trademarks et...

Page 8: ...hile heating or thawing is in progress 2 Filler opening The filler opening is used to fill the device with heat transfer fluid 3 Paddle Gently agitates FFP s during the heating process 4 Heating cushi...

Page 9: ...ns Dif ferent functions of the device act on the preparation depending on the program selected A number of preferences can also be set The following table provides an overview of these Program name Us...

Page 10: ...2 lamps LEDs The display displays the menu system for the operation of the device displays information about the currently running program and its status and outputs warning and error messages An audi...

Page 11: ...utton or selection button for menu navigation The button s particular function is indicated in the display Confirm button for menu navigation This button is used to acknowledge confirm the function wh...

Page 12: ...es the appointed body T V SUEDProduct Service GmbH which supervises the manufacturer s quality assurance system This symbol indicates the month and year in which the next safety in spection is due Thi...

Page 13: ...of the device in individual cases 2 5 Contraindication The device must not be used to heat or keep warm animals or to thaw heat or keep warm objects or fluids of any kind except those as described und...

Page 14: ...n the heating chamber The device uses a dry heating process that prevents the contents of damaged con serves hairline cracks being contaminated by the heat transfer fluid The heating procedure can be...

Page 15: ...ed and or thawed with the programs specifically intended for them If infusion solutions or medications are heated in the Barkey plasmatherm you must ensure that their efficacy is maintained during hea...

Page 16: ...t repairs from the manufacturer if necessary Repairs and modifications to the device may only be carried out by Barkey GmbH Co KG or authorised per sonnel The heating cushions of the device must not b...

Page 17: ...tside the limit values set by EN 60601 1 2 Portable and mobile HF communication equipment such as mobile phones can affect the device Do not use the device in the immediate vicinity of flammable mater...

Page 18: ...nes HF outputs in accordance with CISPR 11 Group 1 The Barkey plasmathermuses high frequency energy for inter nal functions only This means that HF emission is very low and neighbouring electronic dev...

Page 19: ...i ronment Surges according to IEC 61000 4 5 1kV voltage phase to phase 2kV voltage phase to earth 1kV voltage phase to phase 2kV voltage phase to earth The quality of the supply volt age should comply...

Page 20: ...m The field strength of stationary transmitters should always be less than the compliance level b at all frequencies in accordance with an on site investigationa Interference is possible near devices...

Page 21: ...nsmitter power W Safety distance depending on transmitter frequency m 150 kHz to 80 MHz P d 17 1 80 MHz to 800 MHz P d 17 1 800 MHz to 2 5 GHz P d 33 2 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1...

Page 22: ...matherm must be set up on a stable hard and level surface Unobstructed access to the device from above and in front must be guaranteed CAUTION The device must be lifted by a minimum of 2 people When c...

Page 23: ...the first time the appropriate signal connection for the peripheral device must be activated before it can be used Details are described in a separate service description which can be requested from...

Page 24: ...ts two captive screws CAUTION Only use the cable supplied to connect the printer Connect the other end to the printer Using a suitable screwdriver secure the plug in position with its two captive scre...

Page 25: ...correctly filled with heat transfer fluid the following information appears in the display for a maximum of 5 seconds the Barkey logo the device name the software version Vx x current version the abb...

Page 26: ...key plasmatherm is too low when it is switched on the menu for filling the tanks is shown first after the initial screen The prompt Fill Tank is addition ally highlighted by flashing NOTE You cannot q...

Page 27: ...icropur tablets in the filler opening CAUTION Always add two micropur tablets to the distilled or de mineralised water For devices supplied new or exchange devices or following maintenance and re pair...

Page 28: ...r waiting for a short time If necessary repeat the start and stop operations a few times until the pump starts pumping fluid Once the heating cushions have been filled open the cover of the heating ch...

Page 29: ...ically so should be guided with one hand to its end stop as shown Figure 8 Cover locking release button To close the heating chamber press the cover down until you hear the button en gaging in the hol...

Page 30: ...es and involves a longer warm up phase because the product on the bottom of the heating chamber is not heated from both sides Lift up the heating cushions by the grip and place the product to be heate...

Page 31: ...Operation Figure 10 Optional loading positions for conserves...

Page 32: ...ction buttons which are pre assigned programs and can be used as selection shortcuts Assigning the shortcut programs is described in the following chapters The left and right hand function buttons can...

Page 33: ...ou will now see the Program submenu the user has a choice of 5 programs PLASMA for thawing FFP s BLOOD for heating blood or EC s HPC for thawing stem cells USER a user configurable program for clinic...

Page 34: ...ce is over 37 C The device will display a warning message in this case When a program is started the display will show the program name the cur rent water temperature and the current remaining time am...

Page 35: ...s not possible 4 4 2 Changing the remaining time While a program is running the user can alter the remaining time usually between 30s and 99min with the left or right hand selection button or If the c...

Page 36: ...you do not wish to start the program Figure 15 Message Water temperature too high 4 4 4 Messages while a program is running If the heating chamber cover is opened while a program is in progress the re...

Page 37: ...nter during the ongoing program When a program has been started the connection to an IT network is also verified if this has been configured in the service menu If the Barkey plasmatherm is not connec...

Page 38: ...al sounds This indicates that the program has finished and pre vents inadvertent further heating Open the heating chamber cover or Acknowledge the end of the program with the confirm button OK Figure...

Page 39: ...xt time low water is detected see the Chap ter Messages while a program is running 4 4 6 Presetting the heating duration of the PLASMA program This chapter describes how to preset the heating duration...

Page 40: ...eating duration menu You will now see this display for setting the heating duration for the PLASMA program Press the confirm button OK The flashing heating duration can now be set individually for the...

Page 41: ...selection button or Figure 25 Changed heating duration for the PLASMA program In the heating duration menu select Back to return to the user menu Figure 26 User menu The heating duration has been succ...

Page 42: ...the heat transfer fluid the fill volume of the FFP s the number of FFP s choice of program etc The guideline values listed in Table 2 guideline heating duration in minutes to reach at least 5 C in ea...

Page 43: ...rting the BLOOD program WARNING Plasma blood and HPC may only be heated for a limited period of time Do not use the device to keep these products warm indefinitely WARNING Blood whole blood may not be...

Page 44: ...ts that are being heated might be impaired or destroyed due to incorrect parameter settings you should always observe the following safety information WARNING The undulation function should not be use...

Page 45: ...right selection button or in the user menu select Function Buttons then press the OK button to confirm your choice Figure 27 User menu A screen is displayed showing both cur rently set shortcut progra...

Page 46: ...the OK button to confirm your choice Figure 29 User menu The filling status will be displayed as shown in the adjacent figure Depending on the level the message FILL Tank i e water is low or Tank is F...

Page 47: ...hen Tank is FULL is displayed as the status The display s background light ing flashes and an intermittent acoustic signal sounds Press the confirm button Back to return to the user menu Figure 31 Fil...

Page 48: ...n for the first sample ID 1 If a user ID is not required you can scan in a dummy code or move to the position of the first sample ID by pressing the left hand selection button You can now scan in the...

Page 49: ...position ID then the user ID is deleted Here again the insertion point then moves to position 1 Correcting or deleting a sample ID is done in the same way The barcodes for the user ID and for the 8 sa...

Page 50: ...ther mochemical cleaning solutions You should use standard commercial preparations based on alcohol without oxygen releasing components with sodium hypochlorite with 1 4 bleach solution or aldehyde c...

Page 51: ...mination within the device itself enabling early recognition If the filter paper becomes moist the two sensors metal contacts on the heating chamber floor are short circuited triggering an audible sig...

Page 52: ...can be ordered from Barkey GmbH Co KG if required Please proceed as follows to replace the water 5 3 1 Draining off the water Switch off the device with the On Off button WARNING Do not pull the devi...

Page 53: ...ice and hold the end of the tube over or in a container ready to catch the heat transfer liquid Figure 35 Drain tube Unscrew the plug from the filler opening at back right on the top of the device by...

Page 54: ...ling with water If you are not filling the device from empty but just topping it up Unscrew the plug from the filler opening as described in the Chapter Draining off the water When filling the device...

Page 55: ...n rise in the water ducts Wait for about 5 seconds Now re connect the tube to the push fit connector First start a program without any material to heat If the pump does not immediately pump heat trans...

Page 56: ...pment 6 1 Technical safety inspection TSI As with all electronic devices the Barkey plasmatherm s temperature setting is dependent on normal ageing and on the tolerances of the electronic components T...

Page 57: ...225 3 V must be replaced every 3 years CAUTION Only qualified service personnel and employees of Barkey GmbH Co KG may replace the battery Please dispose of any batteries properly in accordance with r...

Page 58: ...uiring the device to be switched off proceed as fol lows Note the error message Make a note of the error number and serial number Switch off the device Contact your medical technical service or the se...

Page 59: ...error message Make a note of the error number xxx and serial number SN Switch off the device and allow it to cool down Figure 40 Overtemperature error message An overtemperature condition can occur f...

Page 60: ...error message 7 4 Tank is empty If the tank is empty or if the level in the tank has fallen below a critical level for the heat ing the following error message is displayed Note the error message Swi...

Page 61: ...Make a note of the error number xxx and serial number SN Switch off the device Figure 43 Device error error message 7 6 Error numbers The numbers of the errors which require the device to be switched...

Page 62: ...set time and date 60 The watchdog timer has detected an error 70 to 73 Error with temperature measurement temperature sensors Possible cause sensor open circuit short circuit 80 to 81 Overtemperature...

Page 63: ...structions for use for the use of non original components or for any use installation which does not conform to the instructions for use accompanying such components The use of components and accessor...

Page 64: ...before dispatching the device Return the device for recycling repair only to Barkey GmbH Co KG or its author ised distributor The device must be cleaned and if necessary disinfected before it is disp...

Page 65: ...arkey de WARNING Barkey GmbH Co KG accepts no liability for modifications or repairs to the de vices carried out by the user or by unauthorised third parties without first consult ing the supplier Our...

Page 66: ...addle time 0 min Paddle active 0 min Paddle inactive 0 min HPC program Nominal temperature 37 C Heating duration 5 min Paddle delay 0 5 min Paddle time 4 5 min Paddle active 4 5 min Paddle inactive 0...

Page 67: ...rogram PLASMA 45 C 1600 Watt max Sound pressure level 45 dB A Current consumption 7 A at 230 VAC max 14 A at 115 VAC max Fusing 8 A slow at 230 VAC 15 A slow at 115 VAC Battery type Lithium CR 1225 3...

Page 68: ...er closed 340 x 600 x 320 mm Cover open 340 x 600 x 720 mm Weight empty 18 kg Fill quantity approx 9 litres Refill quantity approx 1 litre device warning Protection rating I MDD classification II a En...

Page 69: ..._______________ Inventory number __________________________________________ Device location __________________________________________ Commissioned on __________________________________________ Identi...

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