Related Manuals for Barkey plasmatherm
Summary of Contents for Barkey plasmatherm
- 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...
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Page 3: Table Of Contents
Introduction Pictograms, signal words and symbols Target group What you must bear in mind at all times Conformities Copyright Description of the device Components of the Barkey plasmatherm Technology description Symbols 2.3.1 Operating panel symbols 2.3.2 Symbols used on labels... - Page 4 Technical safety inspection (TSI) Replacing the battery Error messages Moisture sensors Overtemperature Paddle blocked Tank is empty Device errors Error numbers Warranty and disclaimer Customer service Factory settings of the programs Specifications Declaration of Conformity ISO Certificate Barkey plasmatherm device master data sheet...
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Page 5: Introduction
Introduction Introduction Congratulations on your decision to use the Barkey plasmatherm for the timed heating of whole blood and blood products thawing and timed heating of fresh frozen plasma (FFP) thawing and timed heating of HPC (stem cells) heating and maintaining the warmth of non-denaturable infusion solutions and other materials in continuous mode. -
Page 6: Target Group
This will ensure that the device is handled properly and that patients and users cannot be put at risk and equipment cannot be dam- aged. Barkey GmbH & Co. KG can accept no liability for damage caused as a result of failure to follow these instructions. WARNING These instructions for use are an integral part of the product. -
Page 7: Copyright
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. -
Page 8: Description Of The Device
Description of the device Description of the device The Barkey plasmatherm is used primarily for thawing and heating fluids contained in bags or bottles and which are intended for medical transfusion or infusion in living organ- isms. Typically these fluids are whole blood, blood products, blood preparations and in- fusion solutions. - Page 9 Description of the device Technical description The Barkey plasmatherm is configured as an electronically regulated dry heating device with an enclosed heating chamber. Bags of fresh frozen plasma (FFP), blood and erythro- cyte concentrates (EC), cryoconserved preparations, cryoconserved stem cells (HPC = haematopoietic progenitor cells) or infusion solutions are placed between soft heating cushions made from a flexible synthetic material.
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Page 10: 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. - Page 11 Description of the device The display elements and controls are identified by symbols as described in the following table: Device On/Off button. Function button 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 which cur- rently appears in the display.
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Page 12: Symbols Used On Labels
Description of the device 2.3.2 Symbols used on labels Labels showing printed symbols are affixed to the device. These have the following meaning: This symbol means that the device is protected against vertically drip- IPX 1 ping water according to IEC 601-1 in its intended operation conditions. This symbol shows the year of manufacture as a four-digit number. -
Page 13: Intended Purpose
If the overtemperature alarm sounds, any preparations that are in the device must be removed and checked before being transferred to the patient. The Barkey plasmatherm must not be used if it has a fault. The device should be examined by Barkey GmbH & Co. KG or authorised personnel. -
Page 14: Safety Features
Description of the device Safety features Safe, gentle thawing and heating conditions for the Blood, Plasma and HPC programs are ensured by a dual overtemperature protection which switches off the device in the event of overtemperature Proven not to destroy important and sensitive biological components of blood and blood products as a result of excessive temperatures or violent mechanical agitation Automatic detection of possible leaks by moisture sensors in the heating chamber The device uses a dry heating process that prevents the contents of damaged con-... -
Page 15: Safety Advice
HPC programs. Do not use the undulation function for blood conserves due to possible mechanical damage and agglutina- tion of erythrocytes. The device must not be used if it has a fault. The device should be examined by Barkey GmbH & Co. KG or authorised per- sonnel. -
Page 16: Safety Advice On Handling The Device
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 be allowed to come into contact with sharp-edged objects. -
Page 17: Safety Advice On Environmental Influences
HF therapy or surgical devices) can lead to malfunctions WARNING in the Barkey plasmatherm. If interference of this type occurs, increase the distance between the Barkey plasmatherm and the device causing the interference, or operate the devices at dif- ferent times. -
Page 18: Electromagnetic Properties / Safety Distances
Gui delines and manufacturers declarati on - Electromagnetic emission The Barkey plas matherm is intended for operation in one of the environ ments listed below. The customer or user of the Barkey p lasmatherm must ensure that it is operated in one of these environments. -
Page 19: Electromagnetic Immunity
Gui delines and manufacturers declarati on - Electromagnetic i mmunity The Barkey plas matherm is intended for operation in one of the electro magnetic environments listed below. The customer or user of the Barkey plas matherm must ensure that it is operated in one of these environments. -
Page 20: Recommended Safety Distance
Gui delines and manufacturers declarati on - Electromagnetic i mmunity The Barkey p lasmatherm is intended for operation in one of the electro magnetic enviro n- ments listed below. The customer or user of the Barkey plas matherm must ensure that it is operated in one of these environments. - Page 21 The Barkey plas matherm is intended for operation in an electro magnetic environ ment in which HF interference is controlled. The customer or user of the Barkey plasmatherm can help avoid electro magnetic interference by observing the minimu m distance between portable an d mobile HF co mmunications devices (transmitters) and the Barkey plas matherm as stated b e- low, depending on the output power of the communicat ion device.
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Page 22: Operation
This procedure is described in the Chapter Cleaning of these instructions. 4.1.1 Siting the device The Barkey plasmatherm is designed for use as a fixed installation inside buildings. It is not intended for mobile use. The Barkey plasmatherm must be set up on a stable, hard and level surface. Unobstructed access to the device from above and in front must be guaranteed. -
Page 23: Connecting The Power Cord, Printer And Barcode Scanner
Optional peripheral devices such as a log printer or a barcode scanner can be connected to the Barkey plasmatherm. If you wish to use such devices, we recommend that you also connect their cables when the power cord of the Barkey plasmatherm is connected to the device. - Page 24 CAUTION Cords may only be connected to the optional accessories, the printer or the barcode scanner when the Barkey plasmatherm has been turned off and the printer has been turned off. ►...
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Page 25: Switching On
"BLOOD" and "PLASMA" and the entry "Menu" which launches the plasmatherm menu system when M e n u the confirm button is pressed. -
Page 26: Switching On If The Fill Level Is Too Low
Switching on if the fill level is too low If the fill level in the Barkey 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. -
Page 27: Filling
The text "OK" at bottom centre now indi- cates that the confirm button is assigned the acknowledge function. Pressing the confirm button ("OK") automatically re- starts the Barkey plasmatherm and dis- plays the main screen with the user menu. Figure 7: Confirmation with "OK" is possible 4.1.5 Filling To fill the device you will need approx. - Page 28 Operation Proceed as following to bleed the heating cushions: ► Pull the left-hand top tube out of the push-fit connector so that the water can rise in the water ducts. ► Wait for around 5 seconds. Now re-connect the tube to the push-fit connector. ►...
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Page 29: Opening The Heating Chamber
Operation Opening the heating chamber ► Press the green button on the front of the device above the operating panel to open the heating chamber, and guide the automatically raised heating chamber cover until it stops. The cover should remain closed when the device is not in use. Press the button to open the heating chamber. -
Page 30: Loading
Operation Loading The Barkey plasmatherm can be loaded with product in two ways: 1. between the heating cushions (effective loading) 2. between dry-paper (filter paper, see also the Chapter Dry paper) and the lower cush- ion (in an emergency only; this option is intended for emergencies and involves a longer warm-up phase because the product on the bottom of the heating chamber is not heated from both sides.) - Page 31 Operation Figure 10: Optional loading positions for conserves...
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Page 32: Selecting And Starting A Program With The Menu System
Operation Selecting and starting a program with the menu system The main screen is displayed automatically when the Barkey plasmatherm is switched on. 2 5 . 1 1 . 09 1 3 : 5 1 :2 6 B L O O D... -
Page 33: Selecting And Starting The "Plasma" Program
Operation 4.4.1 Selecting and starting the "PLASMA" program ► In the main screen, press the confirm button ("Menu") to start the menu system. ► The main menu of the user menu provides 4 options. U se r m en u B a c k P r o g r am H e a t i ng d u ra t i o n... - Page 34 Operation U s er m e nu Pr o g r am B a c k S t a r t P L A S MA S t a r t B L O O D S t a r t H P C ►...
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Page 35: Changing The Remaining Time
With the "PLASMA" program, the nominal temperature of the heat transfer fluid can be preset in the service menu. Details are described in a separate service description which can be requested from Barkey GmbH & Co. KG. Other parameters for the "USER" program can also be preset in the service menu. -
Page 36: Messages At The Start Of A Program
Operation 4.4.3 Messages at the start of a program Blood/whole blood should not be heated if the current operating temperature of the device is over 37 °C, for example if you have previously thawed and heated plasma and you then activate a program for heating blood/whole blood. - Page 37 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 connected to the network, or if the network connection is faulty or the remote terminal is not ready or has a fault, the user is made aware of this by a flashing icon ("...
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Page 38: Messages After The End Of A Program
Operation If a "Lack of water" message as described in the Chapter Messages after the end of a pro- gram is acknowledged 4 times at the end of a program without water being topped up, then an active program will be immediately cancelled the next time low water is detected. L a c k o f wa t e r ! F I L L t a n k ►... -
Page 39: Presetting The Heating Duration Of The "Plasma" Program
Operation L a c k o f wa t e r ! F I L L t a n k ► Acknowledge the message with the confirm button ("OK") ► Top up with water as described in Chapter 5.3.2 Figure 21: "Lack of water" message at the end of a programme NOTE This message is also output if the program is cancelled manually or as the result of an er- ror. - Page 40 Operation U s er m e nu User menu B a c k P r o g r am H e a t i ng d u ra t i o n F u n c t io n b ut t o n s The user menu appears.
- Page 41 Operation U se r m en u H e a ti n g du r a t i on B a c k P L A S M A d u r a t. 2 5 :0 0 ► When you have changed the heating B L O O D du r a t .
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Page 42: Guideline Values For The Heating Duration When Thawing Ffp
This displayed temperature is not the same as the tem- perature in the blood products. The heating duration (i.e. the length of time which the Barkey plasmatherm needs to thaw one or four FFP´s simultaneously, for example) will depend on a number of additional factors (such as the initial temperature of the FFP´s, the temperature of the heat transfer... -
Page 43: Presetting The Heating Duration And Starting The "Blood" Program
Operation Conditions Program Filling vol- Loaded with Loaded with Loaded with Loaded with Dimensions ume per FFP 1 FFP 2 FFP´s 3 FFP´s 4 FFP´s PLASMA (approx. 170 x 250ml 110 x 20 mm) no additional packaging Heating duration in minutes to reach 5°C System temperature Number of FFP´s (see Table 1 for layout) 45°C... -
Page 44: 4.4.10 Presetting The Heating Duration And Starting The "User" Program
Operation 4.4.10 Presetting the heating duration and starting the "USER" 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 heated up if the current operating temperature of the device is over 37 °C. -
Page 45: Function Button Assignment
Operation NOTE Time settings and undulation functions are not available in continuous operation. Function button assignment The top two function buttons on the operating panel are assigned programs which you can start as soon as you switch on the device without going through the menu system. In the "Function Buttons"... -
Page 46: Fill Level Display
Operation Fill level display The "Fill level" option is used to check the current fill level in the Barkey plasmatherm. Depending on the level, the message "FILL Tank" (i.e. water is low) or "Tank is FULL" (there is sufficient heat transfer fluid) is displayed. - Page 47 Operation F il l l ev e l T a n k i s FU L L If the tank contains sufficient heat transfer fluid, then "Tank is FULL" is displayed as the status. The display's background light- ing flashes and an intermittent acoustic signal sounds.
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Page 48: Barcode Scanner
Operation Barcode scanner If a barcode scanner is connected to the Barkey plasmatherm DTM and properly config- ured in the service menu, then the user ID and up to 8 sample ID's can be scanned in in the main screen. - Page 49 Operation If you wish to correct or delete the user ID, you must select the "ID" position with the left-hand selection button ("▼"). After a further scan operation the user ID is then over- written with the currently scanned barcode, and the insertion point moves to position "1:". If the right-hand selection button ("...
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Page 50: Cleaning And Care
Cleaning and care Cleaning and care Cleaning The Barkey plasmatherm's smooth surfaces and rounded corners make it simple and easy to clean. The surfaces of the device should be cleaned and wipe-disinfected regularly, if possible after every use, WARNING Before cleaning or wipe-disinfecting the device: Switch off the plasmatherm by operating its On/Off button and disconnect its mains plug from the mains socket. -
Page 51: Dry Paper
► Replace the dry paper after carrying out a full cleaning routine. NOTE Dry paper can be ordered from Barkey GmbH & Co. KG: Article No. 212.10005, pack of 60 sheets... -
Page 52: Changing The Water
When the water is changed every year, there will be no long-term bacterial growth pro- vided micropur tablets and distilled or demineralised water are used. NOTE Micropur tablets 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 ►... - Page 53 Cleaning and care ► Pull the drain tube downwards out of its recess in the base of the device and hold the end of the tube over or in a container ready to catch the heat transfer liquid. Figure 35: Drain tube ►...
- Page 54 Cleaning and care ► Open the drain cock by turning it anticlockwise (90º). Allow the heat transfer liquid to drain off. Figure 37: Opening the drain cock ► Lift the heating cushions slightly and ensure that they drain completely. ► Hold the device firmly and tilt it gently forward until it is completely empty.
- Page 55 Cleaning and care ► Place a suitable funnel in the filler opening and fill the device with the necessary quantity of de-mineralised or distilled water: approx. 9 litres when filling from new approx. 1 litre when topping up after a warn- ing or error message prompting you to top up Figure 38: Filling...
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Page 56: Maintenance
Barkey GmbH & Co. KG. Training for medical technicians in checking and repair- ing the Barkey plasmatherm is available at the factory of Barkey GmbH & Co. KG. Please call us on +49 (5202) 9801-30 for information about current availability and costs. -
Page 57: Replacing The Battery
The device battery (lithium battery CR 1225, 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... -
Page 58: Error Messages
The device's rating plate will be found at the front on its left-hand side. The last 6 errors which have occurred can be retrieved in the service menu. Details are described in a separate service description which can be requested from Barkey GmbH & Co. KG. -
Page 59: Moisture Sensors
If the error message reappears, please contact your medical technical service or the ser- vice department of Barkey GmbH & Co. KG stating the error number and the serial number. -
Page 60: Paddle Blocked
Error messages Paddle blocked If the paddle for the special "Undulation" function is blocked, the following error mes- sage is displayed: ! E r r o r! P a d d l e b l o ck e d ! E r r o r n u m b er : 0 9 8 ►... -
Page 61: Device Errors
Error messages Device errors Device errors can have a variety of reasons. Further diagnosis is possible by reference to the error number (see also the Chapter Error numbers) ! E r r o r! D e v ic e e rr o r ! E r r o r n u m b er : x x x ►... - Page 62 Error messages Error Error description Comments number 10, 11 Display fault There may not be any text visible in the display. The display may not be correct. 20 to 23 Internal device error 30, 31 Checksum of the internal device data is incorrect Checksum of the program memory is incorrect Checksum of the data...
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Page 63: Warranty And Disclaimer
The warranty period for the Barkey plasmatherm is 24 months from purchase. Barkey GmbH & Co. KG gives this warranty in lieu of other warranties on this product granted under contract or statute, including other statutory warranties of marketability or of fitness for a particular purpose, and gives no other commitments. -
Page 64: Customer Service
GmbH & Co. KG will ensure that materials are properly separated, graded and recycled. We advise you to have any necessary repairs carried out by Barkey GmbH & Co. KG or to have your technicians attend special product training courses in testing and servicing. - Page 65 Customer service The customer service department of Barkey GmbH & Co. KG is available for support and assistance as follows Monday to Friday 07.00 - 20.00 Saturday and Sunday 10.00 - 18.00 +49(0)5202- 9801-30. email: info@barkey.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.
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Page 66: 10 Factory Settings Of The Programs
Factory settings of the programs 10 Factory settings of the programs PLASMA program Nominal temperature 45 °C Heating duration 20 min Paddle delay Paddle time 18 min Paddle active 18 min Paddle inactive BLOOD program Nominal temperature 37 °C Heating duration 15 min Paddle delay Paddle time... -
Page 67: 11 Specifications
Specifications 11 Specifications Manufacturer Barkey GmbH & Co. KG Gewerbestrasse 8 33818 Leopoldshoehe Tel.: +49 (5202) 9801-0 Fax: +49 (5202) 9801-99 Type Barkey plasmatherm Order No. 212.10043 230 VAC / 50 - 60 Hz 212.10044 115 VAC / 60 Hz... - Page 68 Specifications Dimensions (w x d x h mm) Cover 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 MDD classification II a...
- Page 69 Barkey plas matherm device master data sheet Device name: __________________________________________ Serial numbers: __________________________________________ Inventory number: __________________________________________ Device location: __________________________________________ Commissioned on: __________________________________________ Identification: 0123 Manufacturer: Barkey GmbH & Co. KG Gewerbestrasse 8 33818 Leopoldshoehe Phone: +49 (5202) 98010 Fax: +49 (5202) 980199 email: info@barkey.de...