Barkey Plasmatherm User manual

Instructions for use

Barkey plasmatherm

Version1 EN

Issued 2009-12-22

for SN 1107500 onwards

Manufactured by:

Barkey GmbH & Co. KG

Gewerbestrasse 8

33818 Leopoldshoehe

Germany

Contents

1Introduction

1.1 Pictograms, signal words and symbols

1.2 Target group

1.3 What you must bear in mind at all times

1.4 Conformities

1.5 Copyright

2Description of the device

2.1 Components of the Barkey plasmatherm

2.2 Technology description

2.3 Symbols

2.3.1 Operating panel symbols

2.3.2 Symbols used on labels

2.4 Intended purpose

2.5 Contraindication

2.6 Overtemperature protection

2.7 Safety features

3Safety advice

3.1 Safety advice on the use of the device

3.2 Safety advice on handling the device

3.3 Safety advice on environmental influences

3.4 Electromagnetic properties / safety distances

3.4.1 Electromagnetic emission

3.4.2 Electromagnetic immunity

3.4.3 Recommended safety distance

4Operation

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

4.1.5 Filling

4.2 Opening the heating chamber

4.3 Loading

4.4 Selecting and starting a program with the menu system

4.4.1 Selecting and starting the "PLASMA" program

4.4.2 Changing the remaining time

4.4.3 Messages at the start of a program

4.4.4 Messages while a program is running

4.4.5 Messages after the end of a program

4.4.6 Presetting the heating duration of the "PLASMA" program

4.4.7 Guideline values for the heating duration when thawing FFP

4.4.8 Presetting the heating duration and starting the "BLOOD" program

4.4.9 Presetting the heating duration and starting the "HPC" program

4.4.10 Presetting the heating duration and starting the "USER"program

4.4.11 Heating in continuous operation

4.5 Function button assignment

4.6 Fill level display

4.7 Barcode scanner

5Cleaning and care

5.1 Cleaning

5.2 Dry paper

5.3 Changing the water

5.3.1 Draining off the water

5.3.2 Filling with water

6Maintenance

6.1 Technical safety inspection (TSI)

6.2 Replacing the battery

7Error messages

7.1 Moisture sensors

7.2 Overtemperature

7.3 Paddle blocked

7.4 Tank is empty

7.5 Device errors

7.6 Error numbers

8Warranty and disclaimer

9Customerservice

10 Factorysettings of the programs

11 Specifications

Declaration of Conformity

ISO Certificate

Barkey plasmatherm device master data sheet

Introduction

1Introduction

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 willgive reliable service for many years.

In these instructions you will find allthe information you require about the functions, op-

eration and use of the Barkey plasmatherm.

1.1 Pictograms, words andsymbols

These instructions use the following pictograms, symbols and words to highlight warn-

ings and special advice:

WARNING

If disregarded: danger to persons.

CAUTION

If disregarded: danger to property,

the device or basic device functions.

NOTE

Additional useful advice and information.

(the "i" stands for "information".)

You willfind 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 instruc-

tions.

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 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. 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 to-

gether 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 In-

tended purpose and the safety information provided in the Chapter Safetyadvice.

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 de-

vice.

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 bycopyright.

Translation, duplication, reprinting, extraction of images, reproduction using photo-

graphic technology and storage and processing in electronic systems, even only excerpts,

and any alterations shallrequire 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 trade-

marks are explicitly acknowledged.

We reserve the right to make typographical errors and mistakes, also changes in the inter-

est of technical progress, or which are necessary due to changes in regulations.

Description of the device

2Description 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.

2.1 Components of the Barkeyplasmatherm

Heating chamber

cover

Covers the heating chamber while heating or

thawing is in progress

Filleropening

The filler opening is used to fillthe device with

heat transfer fluid

Paddle

Gently agitates FFP´s during the heating process

Heating cushion

Heat transfer fluid flows through the heating

cushions. The cushions heat the materials placed

in the device and keep themwarm.

Cover locking/release

button

The locking/release button is used to open and

close the heating chamber cover

Operating panel

The Barkey plasmatherm has an operating panel

on the front of the device with a multi-line dis-

play, 6 buttons and 2 lamps (LEDs).

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 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. A heat transfer fluid (distilled or de-

mineralised water) flows through the heating cushions which heat up the materials placed

in the device and keep themwarm.

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. 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

User preselectable

Actingspecial func-

tions

Undulation**

BLOOD

Heating time

PLASMA*

Heating time

yes

HPC***

Heating time

yes

USER

various

parameters can be

set as required

adjustable or select-

able

CONTINUOUS

OPERATION

* The setpoint temperature can be increased to +45°C to accelerate the thawing of fro-

zen 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 pre-

cipitates (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 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 anerror has occurred. A message is additionally shown in

the display in the event of errors.

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