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
Contents
1 Introduction
1.1Pictograms, signal words and symbols
1.2Target group
1.3What you must bear in mind at all times
1.4Conformities
1.5Copyright
2 Description of the device
2.1Components of the Barkey plasmatherm
2.2Technology description
2.3Symbols
2.3.1Operating panel symbols
2.3.2Symbols used on labels
2.4Intended purpose
2.5Contraindication
2.6Overtemperature protection
2.7Safety features
3 Safety advice
3.1Safety advice on the use of the device
3.2Safety advice on handling the device
3.3Safety advice on environmental influences
3.4Electromagnetic properties / safety distances
3.4.1Electromagnetic emission
3.4.2Electromagnetic immunity
3.4.3Recommended safety distance
4 Operation
4.1Putting into service
4.1.1Siting the device
4.1.2Connecting the power cord, printer and barcode scanner
4.1.3Switching on
4.1.4Switching on if the fill level is too low
4.1.5Filling
4.2Opening the heating chamber
4.3Loading
4.4Selecting and starting a program with the menu system
4.4.1Selecting and starting the "PLASMA" program
4.4.2Changing the remaining time
4.4.3Messages at the start of a program
4.4.4Messages while a program is running
4.4.5Messages after the end of a program
4.4.6Presetting the heating duration of the "PLASMA" program
4.4.7Guideline values for the heating duration when thawing FFP
4.4.8Presetting the heating duration and starting the "BLOOD" program
4.4.9Presetting the heating duration and starting the "HPC" program
4.4.10Presetting the heating duration and starting the "USER" program
4.4.11Heating in continuous operation
4.5Function button assignment
4.6Fill level display
4.7Barcode scanner
5 Cleaning and care
5.1Cleaning
5.2Dry paper
5.3Changing the water
5.3.1Draining off the water
5.3.2Filling with water
6 Maintenance
6.1Technical safety inspection (TSI)
6.2Replacing the battery
7 Error messages
7.1Moisture sensors
7.2Overtemperature
7.3Paddle blocked
7.4Tank is empty
7.5Device errors
7.6Error numbers
8Warranty and disclaimer
9Customer service 
10Factory settings of the programs
11Specifications 
Declaration of Conformity
ISO Certificate
Barkey plasmatherm device master data sheet
Introduction
1 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.
You have opted for a high-quality product that will give reliable service for many years.
In these instructions you will find all the information you require about the functions, operation and use of the Barkey plasmatherm.
1.1Pictograms, words and symbols
These instructions use the following pictograms, symbols and words to highlight warnings and special advice:
WARNING |
If disregarded: danger to persons. |
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If disregarded: danger to property,
the device or basic device functions.
CAUTION
Additional useful advice and information.
(the "i" stands for "information".)
NOTE
You will find the following symbol in instructions about the use and maintenance of the device:
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Instruction step. |
► |
Carry out this step as indicated. |
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NOTE
The symbols representing the controls and device displays, and the symbols used on device labels, are listed and described in the Chapter Symbols in these instructions.
Introduction
1.2Target group
These instructions are intended for use by:
Medical specialists in hospitals who hold a recognised vocational qualification in human medicine,
CAUTION
Only persons who meet this criterion may use the device.
1.3What you must bear in mind at all times
You must follow the conditions of use and safety advice contained in this instruction manual at all times when using the device. This will ensure that the device is handled properly and that patients and users cannot be put at risk and equipment cannot be damaged.
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. They must be retained throughout the life of the product and handed to any subsequent owner or user. Please ensure that any supplementary instructions which may be issued are kept together with the original instructions.
Carefully read through these instructions before using the device.
Please follow the advice about the intended use of the device in the Chapter Intended purpose and the safety information provided in the Chapter Safety advice. For a better understanding of these chapters you should familiarise yourself with the basic functions of the device as described in the Chapter Description of the device.
You should also comply with the requirements for the training and skills of persons using the device, as indicated in the Chapter Target group.
Medical electrical devices are subject to special safety measures in regard to EMC (electromagnetic compatibility), and you should therefore always ensure that the device is installed and operated in accordance with the EMC advice contained in these instructions.
1.4Conformities
Please read the declaration of conformity in the Appendix to these instructions.
Introduction
1.5Copyright
These instructions for use and all illustrations they contain are protected by copyright. Translation, duplication, reprinting, extraction of images, reproduction using photographic technology and storage and processing in electronic systems, even only excerpts, and any alterations shall require the written authorisation 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 etc. are always stated without reference to the registration or copyright status. Existing industrial property rights and registered trademarks are explicitly acknowledged.
We reserve the right to make typographical errors and mistakes, also changes in the interest of technical progress, or which are necessary due to changes in regulations.
Description of the device
2 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 organisms. Typically these fluids are whole blood, blood products, blood preparations and infusion solutions.
2.1 Components of the Barkey plasmatherm
1.Heating chamber cover
2.Filler opening
Covers the heating chamber while heating or thawing is in progress
The filler opening is used to fill the device with heat transfer fluid
3.Paddle
4.Heating cushion
5.Cover locking/release button
6.Operating panel
4
Gently agitates FFP´s during the heating process
Heat transfer fluid flows through the heating cushions. The cushions heat the materials placed in the device and keep them warm.
The locking/release button is used to open and close the heating chamber cover
The Barkey plasmatherm has an operating panel on the front of the device with a multi-line display, 6 buttons and 2 lamps (LEDs).
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Figure 1: Barkey plasmatherm
Description of the device
2.2Technical 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 erythrocyte 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. A heat transfer fluid (distilled or demineralised water) flows through the heating cushions which heat up the materials placed in the device and keep them warm.
All heating is controlled by heating programs. To heat a particular preparation, the user selects the appropriate program on the operating panel using the display and buttons. Different 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:
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User preselectable |
Acting special func- |
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Program name |
tions |
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Undulation** |
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BLOOD |
Heating time |
no |
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PLASMA* |
Heating time |
yes |
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HPC*** |
Heating time |
yes |
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various |
adjustable or select- |
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USER |
parameters can be |
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able |
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set as required |
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CONTINUOUS |
no |
no |
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OPERATION |
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*The setpoint temperature can be increased to +45°C to accelerate the thawing of frozen plasma conserves. The process now operates at a temperature of +45°C and is monitored and timed by the program.
**An undulation function which agitates the heated materials is provided for mixing certain materials such as plasma (FFP, fresh frozen plasma).
***HPC Haematopoietic progenitor cells (stem cells)
CAUTION
With plasma, thorough mixing of the bag's contents is essential as all protein precipitates (cryoproteins) must be dissolved before the plasma can be used.
Description of the device
2.3Symbols
2.3.1Operating panel symbols
Figure 2: Operating panel
The Barkey plasmatherm has an operating panel on the front of the device with a multiline 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.
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 currently appears in the display.
The green light (LED) shows that the device has been switched on.
The yellow light (LED) indicates a device malfunction.
Description of the device
2.3.2Symbols used on labels
Labels showing printed symbols are affixed to the device. These have the following meaning:
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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.
2010
This symbol declares that the device conforms to Medical Device Directive 93/42/EEC of 14 June 1993. The four-digit number indicates the appointed body (TÜV SUED Product Service GmbH) which supervises the manufacturer's quality assurance system.
This symbol indicates the month and year in which the next safety inspection is due.
This symbol advises you that you must read the instruction manual supplied thoroughly.
This hazard symbol advises you that failure to follow the instructions contained in the instruction manual can result in hazards to patients, the device user or the device itself.
This symbol advises you that the device must be disconnected from the mains supply before the device housing can be opened by removing the device screws.
This symbol (on a label inside the device) informs you of the earth connection.
Description of the device
2.4Intended purpose
The Barkey plasmatherm is a thawing and heating device intended for the following applications:
timed heating of whole blood and blood products
thawing and timed heating of frozen plasma conserves
thawing and timed heating of HPC (haematopoietic progenitor cells)
heating and maintaining the warmth of non-denaturable infusion solutions and other materials in continuous operation.
The Barkey plasmatherm can be used whenever it is desirable to prevent the cooling of patients as a result of transfusions, infusion solutions or other materials.
These summarised statements on the intended use of the device are supplemented in this instruction manual by specific descriptions of the various different applications and of the handling of the device. You will find these descriptions in the Chapters Safety advice to Operation of this instruction manual. Please use these chapters to find specific information about usage of the device in individual cases.
2.5Contraindication
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 under „Intended purpose‟.
There are no known contraindications when thawing and/or heating blood and blood products.
2.6Overtemperature protection
Independent overtemperature protection systems monitor the temperature of the device.
In the event of a fault or if an overtemperature limit is reached, the device's heating is switched off, the yellow LED in the display and operating panel lights up and a continuous alarm tone sounds.
Should this occur, switch off the device or disconnect the mains plug and wait for the device to cool down. This may take several minutes. Then switch on the device again, however the fault will return if the cause of the problem has not been rectified.
WARNING
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.
Description of the device
2.7Safety 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 conserves (hairline cracks) being contaminated by the heat transfer fluid
The heating procedure can be monitored. Fluid leakage is easy to detect through the use of transparent heating cushions, the light colours used in the heating chamber and white dry-paper (filter paper) on the heating chamber floor
Plain text displays in the local language
Clearly arranged and labelled displays and controls The device is designed for continuous operation Synthetic enclosure is corrosion free and saves energy
The device is stable, designed not to tip over, and has non-slip feet
Safety advice
3 Safety advice
3.1Safety advice on the use of the device
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Before using the device, carefully read and familiarise yourself |
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WARNING |
with these instructions and the user documentation for the op- |
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tional accessories. |
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Only use the device in accordance with the regulations as de- |
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scribed previously in this chapter and in accordance with the |
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processes described in this instruction manual. |
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When heating blood and blood products, always ensure that the |
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operating temperature and time limit are not exceeded. Re- |
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move and transfuse immediately when signal sounds! |
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The blood products may only be heated and/or thawed with the |
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programs specifically intended for them. |
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If infusion solutions or medications are heated in the Barkey |
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plasmatherm, you must ensure that their efficacy is maintained |
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during heating and that the timed heating is approved by the |
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manufacturer of the medication. |
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If preparations leak, this is due to previously damaged con- |
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serve bags (e.g. hairline cracks, damage in transit). The sensors |
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in the Barkey plasmatherm detect leaking moisture and stop |
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the heating process. |
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The undulation function is only activated in the Plasma and |
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HPC programs. Do not use the undulation function for blood |
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conserves due to possible mechanical damage and agglutina- |
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tion of erythrocytes. |
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The device must not be used if it has a fault. The device should |
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be examined by Barkey GmbH & Co. KG or authorised per- |
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sonnel. |
Safety advice
3.2Safety advice on handling the device
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Before using the device, carefully read and familiarise yourself |
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WARNING |
with these instructions and the user documentation for the op- |
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tional accessories. |
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All electrical installations must comply with the relevant appli- |
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cable regulations and standards in addition to the specifications |
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stated by the manufacturer. |
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Only power supply connections supplied by Barkey GmbH & |
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Co. KG which are designed for the device's rated voltage may |
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be used. |
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The mains plug must be removed from the mains socket to |
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ensure safe isolation of the device from the power supply. |
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The device contains no parts which can be repaired by the user. |
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Do not attempt to repair the device yourself. You should con- |
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tact the manufacturer or your medical service technician who |
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can request information about repairs from the manufacturer if |
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necessary. Repairs and modifications to the device may only |
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be carried out by Barkey GmbH & Co. KG or authorised per- |
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sonnel. |
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The heating cushions of the device must not be allowed to |
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come into contact with sharp-edged objects. |
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The heating chamber and the heating cushions must be cleaned |
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and disinfected at least once per week! The filter paper must be |
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replaced after each cleaning. |
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An annual safety inspection must be carried out by qualified |
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service technicians or employees of Barkey GmbH & Co. KG. |
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The water must be changed once a year! You should always |
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CAUTION |
add two micropur tablets when refilling. |
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Do not tilt the device when it is switched on! |
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The battery (lithium battery CR 1225, 3 V) must be replaced |
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every three years by qualified service personnel or employees |
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of Barkey GmbH & Co. KG. |
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Repairs and modifications to the device may only be carried |
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out by qualified service technicians or by employees of Barkey |
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GmbH & Co. KG. |
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The device's rating plate is on the left-hand side of the housing. |
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Safety advice
3.3Safety advice on environmental influences
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The influence of strong electromagnetic fields (e.g. through the |
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WARNING |
use of HF therapy or surgical devices) can lead to malfunctions |
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in the Barkey plasmatherm. If interference of this type occurs, |
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increase the distance between the Barkey plasmatherm and the |
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device causing the interference, or operate the devices at dif- |
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ferent times. The Barkey plasmatherm works perfectly within |
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the limit values set in the EN 60601-1-2 standard. The device |
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can be influenced outside the limit values set by EN 60601-1- |
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2. |
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Portable and mobile HF communication equipment such as |
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mobile phones can affect the device. |
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Do not use the device in the immediate vicinity of |
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flammable materials (e.g. gases, liquids), |
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flammable mixtures of anaesthetic substances with air, |
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flammable mixtures of anaesthetic substances with oxygen |
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or nitrous oxide |
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whose flashpoint is below 50°C. It is imperative that the device |
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is not used in areas in which alcohol disinfectants and anaes- |
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thetising substances are being used simultaneously. |
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The device may not be set up or operated in the immediate |
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vicinity of devices with a high heat output. |
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The device must be positioned so as to ensure an unrestricted |
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flow of air around its base. |
Safety advice
3.4Electromagnetic properties / safety distances
3.4.1Electromagnetic emission
Guidelines and manufacturers declaration - 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.
Radiated EMI measurements |
Compliance |
Electromagnetic environment - |
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guidelines |
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The Barkey plas matherm uses |
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high-frequency energy for inter- |
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HF outputs in accordance with |
Group 1 |
nal functions only. This means |
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CISPR 11 |
that HF emission is very low, and |
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neighbouring electronic devices |
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are unlikely to be affected. |
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HF outputs in accordance with |
Class B |
The Barkey plas matherm is suit- |
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CISPR 11 |
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able for use in buildings other |
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Harmonic output in accordance |
Class A |
than residential and those which |
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with IEC 61000-3-2 |
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are direct ly connected to a public |
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Emission of voltage fluctuations/ |
Co mplies |
supply network which is also |
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used to supply buildings used for |
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flicker according to IEC 61000-3-3 |
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residential purposes. |
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Safety advice
3.4.2Electromagnetic immunity
Guidelines and manufacturers declaration - Electromagnetic immunity
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.
Immunity test |
IEC 60601 test |
Compliance level |
Electromagnetic environment |
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level |
- Guideline |
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± 6 kV |
± 6 kV |
The floor should be constructed |
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Static discharge |
in wood or concrete or be cov- |
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contact discharge |
contact |
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(ESD) accord ing |
ered with ceramic tiles. If the |
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discharge |
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to |
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floor is covered with synthetic |
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± 8 kV air dis- |
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IEC 61000-4-2 |
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material, the relative hu midity |
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charge |
± 8 kV air discharge |
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must be at least 30%. |
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Rapid transient |
± 2 kV for power |
± 2 kV for power |
The quality of the supply volt- |
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electrical noise/ |
cords |
cords |
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age should comply with a typi- |
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bursts according |
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cal business or hospital envi- |
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± 1 kV for input |
± 1 kV for input and |
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ronment. |
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IEC 61000-4-4 |
and output cords |
output cords |
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± 1kV voltage |
± 1kV voltage |
The quality of the supply volt- |
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phase-to-phase |
phase-to-phase |
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Surges according |
age should comply with a typi- |
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to IEC 61000-4-5 |
± 2kV voltage |
± 2kV voltage |
cal business or hospital envi- |
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ronment. |
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phase-to-earth |
phase-to-earth |
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< 5 % UT |
< 5 % UT |
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(> 95 % d rop |
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(> 95 % d rop of UT ) |
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of UT ) |
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for 1/2 period |
The quality of the supply volt- |
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for 1/2 period |
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age should comply with a typi- |
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Vo ltage dips, |
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cal business or hospital envi- |
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40 % UT |
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short-time inter- |
40 % UT |
ronment. If the user of the |
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(60 % drop in |
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ruptions and fluc- |
(60 % drop in UT ) |
Barkey plas matherm requires |
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UT ) for 5 peri- |
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tuations in supply |
for 5 periods |
continued use even if the power |
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ods |
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voltage according |
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supply is interrupted, we rec- |
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70 % UT |
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to |
70 % UT |
ommend that the Barkey plas- |
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(30 % drop in |
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IEC 61000-4-11 |
(30 % drop in UT ) |
matherm is connected to an |
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UT ) fo r 25 peri- |
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for 25 periods |
uninterruptible power supply or |
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ods |
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battery. |
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< 5 % UT |
< 5 % UT |
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(> 95 % d rop of |
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(> 95 % d rop of UT ) |
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UT ) |
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for 5 s |
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for 5 s |
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Magnetic field at |
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3 A/ m |
Magnetic fields at mains fre- |
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supply frequency |
3 A/ m |
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quency should comply with the |
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(50/60 Hz) ac - |
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typical values as found in bus i- |
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cording to IEC |
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ness and hospital environ- |
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61000-4-8 |
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ments. |
NOTE: UT is the mains AC supply before applying the test rule
Safety advice
Guidelines and manufacturers declaration - Electromagnetic immunity
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.
Immunity test |
IEC 60601 |
Compliance level |
Electromagnetic environment - |
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test level |
guideline |
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Portable and mobile rad io sets should |
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not be used within a distance fro m the |
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Barkey plas matherm, including cords, |
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that is less than the recommended |
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safety distance as calculated by the |
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relevant equation for the transmit |
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frequency. |
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Recommended safety distance |
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d |
1.17 P |
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for150 kHz to80 MHz |
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Conducted HF |
3 Ve ff |
3 Ve ff |
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d |
1.17 P |
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interference ac- |
150 kHz to |
150 kHz to 80 |
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cording to IEC |
80 MHz |
Mhz |
for 80 MHz to800 MHz |
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61000-4-6 |
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3 V/ m |
3 V/ m |
d |
2.33 P |
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Radiated HF in- |
80 MHz to |
80 MHz to 2.5 |
for 800 MHz to 2.5GHz |
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terference accord- |
2.5 GHz |
GHz |
where P is the nominal power of the |
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ing to IEC 61000- |
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transmitter in Watts (W) as stated by |
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4-3 |
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the transmitter manufacturer, and d is |
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the recommended safety distance in |
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metres (m). |
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The field strength of stationary |
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transmitters should always be less |
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than the compliance level b at all |
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frequencies in accordance with an on- |
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site investigationa. |
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Interference is possible near devices |
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that display the following symbol. |
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NOTE 1 At 80 M Hz and 800 MHz the higher frequency range applies.
NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic variables is affected by absorption and reflection of buildings, objects and people.
a |
The field strength of static transmitters, such as base stations of radio telephones and |
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mobile land radios, amateur radios, AM and FM radio and telev ision transmissions cannot be accurately theoretically determined in advance. You should consider carrying out a site survey to determine the electro magnetic environ ment with regard to static transmitters. If the measured field strength at the location where the Barkey plasmatherm is being used exceeds the above compliance levels, the Barkey p lasmatherm should be monitored to ensure that the device is functioning as intended. If unusual performance characteristics are observed, add i- tional measures such as changing the align ment or location of the Barkey p lasmatherm may be necessary.
b |
The field strength should be less than 3 V/ m in the frequency range 150 kHz to 80 M Hz. |
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Safety advice
3.4.3Recommended safety distance
Recommended safety distances between portable and mobile
HF telecommunications devices and the Barkey plas matherm
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.
Nominal |
Safety distance depending on trans mitter frequency m |
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trans mitter |
150 kHz to 80 MHz |
80 MHz to 800 MHz |
800 MHz to 2.5 GHz |
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power W |
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d 1,17 P |
d 1,17 P |
d 2,33 P |
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0.01 |
0.12 |
0.12 |
0.23 |
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0.1 |
0.37 |
0.37 |
0.74 |
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1 |
1.17 |
1,17 |
2.33 |
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10 |
3.69 |
3.69 |
7.38 |
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100 |
11.67 |
11.67 |
23.33 |
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For transmitters whose maximu m no minal output is not given in the above table, the recommended safety distance d in metres (m) can be determined using the equation belonging to the appropriate column, where P is the maximu m no minal output of the transmitter in Watts (W) as stated by the transmitter manufacturer.
NOTE 1 The higher frequency level applies at 80 M Hz and 800 MHz.
NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic variables is affected by absorption and reflection of buildings, objects and people.
Operation
4 Ope ration
4.1Putting into service
If you are putting a new or repaired device into service, you should first select a suitable location for it
connect the necessary cords
and fill the device with heat transfer fluid.
CAUTION
You must disinfect the heating cushions and heating chamber before using the device. This procedure is described in the Chapter Cleaning of these instructions.
4.1.1Siting 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.
CAUTION
The device must be lifted by a minimum of 2 people. When carrying, grip the device by the bottom edge only. Recesses are provided in the base for safe carrying.
CAUTION
The device is ventilated from below. It should therefore not be placed on a soft surface into which its feet could sink. There must be a minimum distance of 50 mm on 3 sides of the Barkey plasmatherm between it and walls, cabinets or other devices.
CAUTION
When selecting the location for the device, it is imperative that you maintain the
distances stated in the Chapter 
of this instruction manual from other devices with electromagnetic emission.
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