Plasmatherm Instructions for Use Ver 1 Issued 2009

Contents 1 1.1 1.2 1.3 1.4 1.5

Introduction Pictograms, signal words and symbols Target group What you must bear in mind at all times Conformities Copyright

2 2.1 2.2 2.3 2.3.1 2.3.2 2.4 2.5 2.6 2.7

Description of the device Components of the Barkey plasmatherm Technology description Symbols Operating panel symbols Symbols used on labels Intended purpose Contraindication Overtemperature protection Safety features

3 3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.4.3

Safety advice Safety advice on the use of the device Safety advice on handling the device Safety advice on environmental influences Electromagnetic properties / safety distances Electromagnetic emission Electromagnetic immunity Recommended safety distance

4 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.2 4.3 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.4.10 4.4.11

Operation Putting into service Siting the device Connecting the power cord, printer and barcode scanner Switching on Switching on if the fill level is too low Filling Opening the heating chamber Loading Selecting and starting a program with the menu system Selecting and starting the "PLASMA" program Changing the remaining time Messages at the start of a program Messages while a program is running Messages after the end of a program Presetting the heating duration of the "PLASMA" program Guideline values for the heating duration when thawing FFP Presetting the heating duration and starting the "BLOOD" program Presetting the heating duration and starting the "HPC" program Presetting the heating duration and starting the "USER" program Heating in continuous operation

4.5 4.6 4.7

Function button assignment Fill level display Barcode scanner

5 5.1 5.2 5.3 5.3.1 5.3.2

Cleaning and care Cleaning Dry paper Changing the water Draining off the water Filling with water

6 6.1 6.2

Maintenance Technical safety inspection (TSI) Replacing the battery

7 7.1 7.2 7.3 7.4 7.5 7.6

Error messages Moisture sensors Overtemperature Paddle blocked Tank is empty Device errors Error numbers

8

Warranty and disclaimer

9

Customer service

10

Factory settings of the programs

11

Specifications 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.

1.1

Pictograms, words and symbols These instructions use the following pictograms, symbols and words to highlight warnings and special advice:

WARNING

CAUTION

NOTE

If disregarded: danger to persons. If disregarded: danger to property, the device or basic device functions. Additional useful advice and information. (the "i" stands for "information".)

You will find the following symbol in instructions about the use and maintenance of the device: Instruction step. Carry out this step as indicated.

►

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

1.2

Target 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.

1.3

What 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.

1.4

Conformities Please read the declaration of conformity in the Appendix to these instructions.

Introduction

1.5

Copyright 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

Covers the heating chamber while 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 cushion

Heat transfer fluid flows through the heating cushions. The cushions heat the materials placed in the device and keep them warm.

5. Cover locking/release button

The locking/release button is used to open and close the heating chamber cover

6. 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).

2 3 1 4

5

6

Figure 1: Barkey plasmatherm

Description of the device

2.2

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 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: Program name BLOOD PLASMA* HPC*** USER CONTINUOUS OPERATION *

User preselectable Heating time Heating time Heating time various parameters can be set as required no

Acting special functions Undulation** no yes yes adjustable or selectable no

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

2.3

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 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

2.3.2

Symbols used on labels Labels showing printed symbols are affixed to the device. These have the following meaning:

IPX 1

This symbol means that the device is protected against vertically dripping 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

2.4

Intended 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.

2.5

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 under „Intended purpose‟. There are no known contraindications when thawing and/or heating blood and blood products.

2.6

Overtemperature 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

2.7

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 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

3.1

Safety advice on the use of the device Before using the device, carefully read and familiarise yourself with these instructions and the user documentation for the opWARNING tional accessories. Only use the device in accordance with the regulations as described previously in this chapter and in accordance with the processes described in this instruction manual. When heating blood and blood products, always ensure that the operating temperature and time limit are not exceeded. Remove and transfuse immediately when signal sounds! The blood products may only be heated 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 heating and that the timed heating is approved by the manufacturer of the medication. If preparations leak, this is due to previously damaged conserve bags (e.g. hairline cracks, damage in transit). The sensors in the Barkey plasmatherm detect leaking moisture and stop the heating process. The undulation function is only activated in the Plasma and HPC programs. Do not use the undulation function for blood conserves due to possible mechanical damage and agglutination 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 personnel.

Safety advice

3.2

Safety advice on handling the device Before using the device, carefully read and familiarise yourself with these instructions and the user documentation for the opWARNING tional accessories. All electrical installations must comply with the relevant applicable regulations and standards in addition to the specifications stated by the manufacturer. Only power supply connections supplied by Barkey GmbH & Co. KG which are designed for the device's rated voltage may be used. The mains plug must be removed from the mains socket to ensure safe isolation of the device from the power supply. The device contains no parts which can be repaired by the user. Do not attempt to repair the device yourself. You should contact the manufacturer or your medical service technician who can request information about repairs from the manufacturer if necessary. Repairs and modifications to the device may only be carried out by Barkey GmbH & Co. KG or authorised personnel. The heating cushions of the device must not be allowed to come into contact with sharp-edged objects. The heating chamber and the heating cushions must be cleaned and disinfected at least once per week! The filter paper must be replaced after each cleaning. An annual safety inspection must be carried out by qualified service technicians or employees of Barkey GmbH & Co. KG. The water must be changed once a year! You should always add two micropur tablets when refilling. CAUTION Do not tilt the device when it is switched on! The battery (lithium battery CR 1225, 3 V) must be replaced every three years by qualified service personnel or employees of Barkey GmbH & Co. KG. Repairs and modifications to the device may only be carried out by qualified service technicians or by employees of Barkey GmbH & Co. KG. The device's rating plate is on the left-hand side of the housing.

Safety advice

3.3

Safety advice on environmental influences The influence of strong electromagnetic fields (e.g. through the use of 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 different times. The Barkey plasmatherm works perfectly within the limit values set in the EN 60601-1-2 standard. The device can be influenced outside the limit values set by EN 60601-12. 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 materials (e.g. gases, liquids), flammable mixtures of anaesthetic substances with air, flammable mixtures of anaesthetic substances with oxygen or nitrous oxide whose flashpoint is below 50°C. It is imperative that the device is not used in areas in which alcohol disinfectants and anaesthetising substances are being used simultaneously. The device may not be set up or operated in the immediate vicinity of devices with a high heat output. The device must be positioned so as to ensure an unrestricted flow of air around its base.

Safety advice

3.4

Electromagnetic properties / safety distances

3.4.1

Electromagnetic emission 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. Electromagnetic environment Radi ated EMI measurements Compliance guidelines The Barkey plas matherm uses high-frequency energy for interHF outputs in accordance with nal functions only. This means Group 1 CISPR 11 that HF emission is very low, and neighbouring electronic devices are unlikely to be affected. HF outputs in accordance with Class B The Barkey plas matherm is suitCISPR 11 able for use in buildings other than residential and those which Harmonic output in accordance Class A are direct ly connected to a public with IEC 61000-3-2 supply network which is also Emission of voltage fluctuations/ Co mplies used to supply buildings used for flicker according to IEC 61000-3-3 residential purposes.

Safety advice

3.4.2

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. IEC 60601 test Electromagnetic environment Immunity test Compliance level level - Gui deline The floor should be constructed ± 6 kV ± 6 kV Static discharge in wood or concrete or be covcontact discharge contact (ESD) accord ing ered with ceramic tiles. If the discharge to floor is covered with synthetic ± 8 kV air disIEC 61000-4-2 material, the relative hu midity charge ± 8 kV air discharge must be at least 30%. Rapid transient electrical noise/ bursts according to IEC 61000-4-4

Surges according to IEC 61000-4-5

Vo ltage dips, short-time interruptions and fluctuations in supply voltage according to IEC 61000-4-11

± 2 kV for power ± 2 kV for power cords cords ± 1 kV for input and output cords

± 1 kV for input and output cords

± 1kV voltage phase-to-phase

± 1kV voltage phase-to-phase

± 2kV voltage phase-to-earth < 5 % UT (> 95 % d rop of UT ) for 1/2 period

± 2kV voltage phase-to-earth

40 % UT (60 % drop in UT ) for 5 periods 70 % UT (30 % drop in UT ) fo r 25 periods < 5 % UT (> 95 % d rop of UT ) for 5 s

The quality of the supply voltage should comply with a typical business or hospital environment.

The quality of the supply voltage should comply with a typical business or hospital environment.

< 5 % UT (> 95 % d rop of U T ) for 1/2 period The quality of the supply voltage should comply with a typical business or hospital envi40 % UT ronment. If the user of the (60 % drop in UT ) Barkey plas matherm requires for 5 periods continued use even if the power supply is interrupted, we rec70 % UT ommend that the Barkey plas(30 % drop in UT ) matherm is connected to an uninterruptible power supply or for 25 periods battery. < 5 % UT (> 95 % d rop of U T ) for 5 s

Magnetic field at 3 A/ m Magnetic fields at mains fresupply frequency 3 A/ m quency should comply with the (50/60 Hz) actypical values as found in bus icording to IEC ness and hospital environ61000-4-8 ments. NOTE: U T is the mains AC supply before applying the test rule

Safety advice

Gui delines and manufacturers declarati on - Electromagnetic i mmunity The Barkey p lasmatherm is intended for operation in one of the electro magnetic enviro nments listed below. The customer or user of the Barkey plas matherm must ensure that it is operated in one of these environments. IEC 60601 Electromagnetic environment Immunity test Compliance level test level guideline Portable and mobile rad io sets should not be used within a distance fro m the Barkey plas matherm, including cords, that is less than the recommended safety distance as calculated by the relevant equation for the transmit frequency. Recommended safety distance

d

1.17 P

for 150 kHz to 80 MHz Conducted HF interference according to IEC 61000-4-6

3 Ve ff 150 kHz to 80 MHz

3 Ve ff 150 kHz to 80 Mhz

3 V/ m Radiated HF in80 MHz to terference accord- 2.5 GHz ing to IEC 610004-3

3 V/ m 80 MHz to 2.5 GHz

d

1.17 P

for 80 MHz to 800 MHz d

2.33 P

for 800 MHz to 2.5 GHz where P is the nominal power of the transmitter in Watts (W) as stated by the transmitter manufacturer, and d is the recommended safety distance in metres (m). The field strength of stationary transmitters should always be less than the compliance level b at all frequencies in accordance with an onsite investigation a. Interference is possible near devices that display the following symbol.

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 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 itional 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.

Safety advice

3.4.3

Recommended safety distance Recommended safety distances between portable and mobile HF telecommunicati ons 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 elow, depending on the output power of the communicat ion device. Safety distance dependi ng on trans mitter frequency m Nomi nal 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz trans mitter power W d 1,17 P d 1,17 P d 2,33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1,17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 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.