Biegler BW 585 User manual

Instructions for use
BW 585
Blood and Infusion Warmer
0123
EN - Edition 03 / 2007

IMPORTANT:
These instructions are an essential part of the device. They must therefore be
kept in a suitable place near the device and should accompany the device if it is
transferred to other users.
For proper and safe use of this device it is essential that the warnings and safety
instructions, as well as the instructions for use are read and carefully observed
by all users before first using the device.
It is the responsibility of those using the device to fully acquaint themselves with
its proper use and operation.
If a malfunction is suspected, the device is to be taken out of service
immediately and suitable warning signs should be attached to the device to
ensure that it cannot be used before necessary service and repair work has
been carried out.
BIEGLER Instructions for use - BW 585
14 TECHNICAL DATA
Device: Blood and infusion warmer
Type designation: BW 585
Voltage: 230 V / 50-60 Hz or 110 V / 50 Hz
check the voltage specified on the device label
Power consumption: 280 W
Type of protection
against electric shock: I
Degree of protection
against electric shock: B
Degree of protection
against ingress of liquids: IPX4
Safety protection: 230V: primary 2 x 1.6 AT secondary 315 mAT
110V: primary 2 x 3.15 AT secondary 315 mAT
Temperature setting: 37°C - 41°C adjustable in steps of 0.5°C
High temperature cut-out: 42°C / 42.5°C / 45°C±3°C
Max. system pressure: 300 mmHg
Dimensions: WxHxD 140 x 190 x 240 mm
Weight: 2.5 kg
Classification: IIb according to rule 9
Type of operation: continuous operation
15 MANUFACTURER
E. Biegler GmbH
Allhangstrasse 18a
A-3001 Mauerbach
Austria
Tel. [phone]
Fax [phone]
email: [email protected]
www.biegler.com
EN - Edition 03 / 2007 17

Instructions for use - BW 585 BIEGLER
12 SYMBOLS
0123 Certifies compliance with 93/42/EEC
Observe the instructions for use
Do not dispose of this product as unsorted municipal waste
Control for increasing the temperature setting
Control for decreasing the temperature setting
Control for switching On / Standby
13 OPERATING AND STORAGE CONDITIONS
Permissible environmental conditions for transport and storage:
Temperature: 10 – 40°C
Relative humidity: 30 – 75 %
Air pressure: 700 – 1060 hPa
The operating temperature must be in the range of: 10 – 30 °C
Values higher or lower than the ranges specified above may cause damage to
the device or its accessories.
16 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
Table of contents
1 Warnings and safety instructions...................................................................2
2 Description.......................................................................................................4
2.1 General Description.....................................................................................4
2.2 Scope of delivery.........................................................................................4
2.3 Consumable material...................................................................................4
3 Initial operation................................................................................................5
3.1 Setting up procedure...................................................................................5
3.2 Alarms.........................................................................................................6
3.3 Shutting down the device............................................................................7
4 Maintainance....................................................................................................7
5 Cleaning and disinfection...............................................................................7
6 Periodic inspections........................................................................................8
7 Manufacturer liability.....................................................................................10
8 Warranty conditions.......................................................................................10
9 Return of devices...........................................................................................11
10 Manufacturer's declaration.........................................................................11
11 Electromagnetic emission...........................................................................12
12 Symbols........................................................................................................16
13 Operating and storage conditions..............................................................16
14 Technical Data..............................................................................................17
15 Manufacturer................................................................................................17
EN - Edition 03 / 2007 1

Instructions for use - BW 585 BIEGLER
1 WARNINGS AND SAFETY INSTRUCTIONS
•In the event of any suspected malfunction while in operation, the device
should be immediately removed from service and not used for infusions or
transfusions until appropriate investigations have demonstrated that there has
been no impairment.
•If the high temperatur alarm is triggered the supply of liquid to the patient must
be immediately stopped by disconnecting the connection tube to the patient.
The medium being used in the device must no longer be administered to the
patient.
•Non-compliance with the flow direction specified in the instruction manual may
lead to a deviation in the selected control temperature. This could result in
damage to the medium.
•The device may only be fastened to infusion stands or tripods which are
suitable due to their stability and load capacity.
•Only sterile BIEGLER consumable materials may be used in conjunction with
the BW 585.
•The device must only be used in areas in which the electrical installations are
in accordance with the rules and regulations in force.
•Safe disconnection from the mains power supply can only be achieved by
unplugging the mains plug.
•The device must not be used in rooms subject to explosion hazard.
•Repairs and modifications to the device may only be carried out by persons or
service centres authorized by BIEGLER.
•The device must not be immersed in liquids or sterilized with steam or by
thermochemical methods.
•All extraneous influences such as radiation or high temperatures are to be
kept to a minimum.
•Avoid exerting force to the device or its accessories.
•If the device is dropped, damaged by force or if it shows a function deviating
from the instructions for use, do not use the device and return it to the service
centre.
•The periodic technical safety inspections must be carried out according to the
section „periodic inspections“.
2 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
Table 206 – Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM -
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b))
Recommended separation distances between
portable and mobile RF communications equipment and the BW 585
The BW 585 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the BW 585 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the BW 585 as recommended below, according to the maximum output power of the communications
equipment.
11.1.1.1 Separation distance according to frequency of transmitter
m
Rated maximum output of
transmitter
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
0,01 0,12 0,04 0,07
0,1 0,37 0,11 0,22
1 1,17 0,35 0,70
10 3,69 1,11 2,21
100 11,67 3,50 7,00
For transmitters rated at a maximum output power not listed above the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
EN - Edition 03 / 2007 15
Pd 17,1 =
Pd 35,0 = Pd 7,0 =

Instructions for use - BW 585 BIEGLER
Table 204 – Guidance and manufacturer´s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING (see 6.8.3.201 b))
Guidance and manufacturer´s declaration – electromagnetic immunity
The BW 585 is intended for use in the electromagnetic environment specified below. The customer
or the user of the BW 585 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance
level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 V
150 kHz to 80 Mhz
3 V/m
80 MHz to 2,5 GHz
Portable and mobile RF communications equipment
should be used no closer to any part of the BW 585,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
11.1.1 Recommended separation distance
80 MHz to 800 Mhz
800 MHz to 2,5 GHz
where pis the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation
distance in metres (m).b
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and reflection from structures, objects
and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the BW 585 is used exceeds the applicable RF compliance level above, the BW 585 should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BW 585.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
14 EN - Edition 03 / 2007
Pd 17,1 =
Pd 35,0 =
Pd 7,0 =
BIEGLER Instructions for use - BW 585
The BW 585 must not be used in the following circumstances:
•If the case is damaged or one of the front film layers becomes detached
•If the device has been exposed to a hard physical shock (e.g. dropped, hit or
shaken)
•If the device has been immersed in water
•If the device has triggered a high temperatur alarm that was not caused by
external factors
•If the mains power cord or plug is damaged
•If the device has given somebody an electric shock
•If the fixing clamps are damaged and no longer assure safe clamping to the
infusion stand
Should a malfunction be evident, suitable warning signs should be attached to
the device to ensure that it cannot be used before necessary service and repair
work has been carried out.
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Instructions for use - BW 585 BIEGLER
2 DESCRIPTION
2.1 GENERAL DESCRIPTION
The BIEGLER BW 585 is a warmer for infusions or transfusions and operates on
the basis of continuous flow heating, where the heat from the heat exchanger is
transferred via the extension tubing to the liquid flowing within it.
The patented groove design enables several extension tubes to be used,
provided that there is sufficient heating provided for each of the tubes placed in
position.
The design of the casing allows rapid and simple fitting to any suitable infusion
stand. The temperature of the heating element can be set between 37°C and
41°C in steps of 0.5°C and is displayed as an illuminated band.
The preset temperature after switching on the BW 585 is 38.5°C.
The alarm and self-test functions for high and low temperature that are
incorporated into the device assure safe operation.
2.2 SCOPE OF DELIVERY
Blood and infusion warmer BW 585 and instructions for use.
2.3 CONSUMABLE MATERIAL
Various consumable materials are available according to requirements.
Order numbers:
Extension set 3.5 m FP1002001 Order no. 35000
Extension set 4.6 m FP1760110 Order no. 45000
Extension set with bubble trap 4.6 m FP4600001 Order no. 25000
4 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
Table 202 – Guidance and manufacturer's declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6))
Guidance and manufacturer´s declaration – electromagnetic immunity
The BW 585 is intended for use in the electromagnetic environment specified below. The customer
or the user of the BW 585 should assure that it is used in such an environment.
Immunity test IEC 60601
test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity
should be at least 30 %.
Electrical fast
transient / burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 2 kV for power
supply lines
not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
± 1 kV differential
mode
± 2 kV common mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(>95 % dip in UT)
for 5 sec
< 5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT
(>95 % dip in UT)
for 5 sec
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the BW 585 requires continued
operation during power mains
interruptions, it is recommended
that the BW 585 be powered
from an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the a. c. mains voltage prior to application of the test level.
EN - Edition 03 / 2007 13

Instructions for use - BW 585 BIEGLER
11 ELECTROMAGNETIC EMISSION
Table 201 – Guidance and manufacturer´s declaration – electromagnetic emission –
for all EQUIPMENT AND SYSTEMS (see 6.8.3.201 a) 3))
The BW 585 is intended for use in the electromagnetic environment specified below. The customer or the user
of the BW 585 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
The BW 585 uses RF energy only for its internal
function. Therefor, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
The BW 585 is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
12 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
3 INITIAL OPERATION
Users must familiarise themselves in detail with the contents of these
instructions for use before putting the system into operation.
3.1 SETTING UP PROCEDURE
Fix the BIEGLER BW 585 firmly to the infusion stand using the clamps at the
back (Diag.1/9). Only use infusion stands or poles that are sufficiently stable.
Connect power cable to power supply. Before connecting to mains power
supply, check the voltage specified on the device label. The device gives a short
beep and the standby light (Diag.1/5) lights up.
If a different temperature to 38.5°C is desired, it can be preset in Standby mode
using the controls and (Diag.1/6 and Diag.1/7). If an adjustment control is
pressed, the visual display indicates the existing preset temperature. By
repeated operation of the control or the temperature can be reset. The
indicator automatically goes out after approximately 7 seconds. Resetting of
temperature can only be performed in Standby mode.
Heating of the BW 585 can be started by pressing the control (Diag.1/3).
The BW 585 attains the set target temperature within 1 minute. The indicator
display shows the actual temperature (+/- 0.5°C) as an illuminated band.
EN - Edition 03 / 2007 5
Diag. 1
1 Heat exchanger
2 Temperature scale
3 ON / STANDBY switch
4LEDindicatorON
5 LED indicator STANDBY
6 Control to decrease
temperature
7 Control to increase
temperature
8 Extension tube
9Clamps
10 Entry of liquid
11 Exit of liquid
Flow direction

Instructions for use - BW 585 BIEGLER
Select suitable consumable material. See section „consumable material“.
Prepare infusion or transfusion. Attention: The length of the tube between the
BW 585 and the patient must be at least 40 cm and the tube must not be
streched.
Beginning at the back of the heat exchanger the extension tube is gently pulled
and coiled in an anti-clockwise direction towards the front. It is advisable that the
gap between the BW 585 and patient does not exceed much more than 80 cm.
Important: The tube must be completely inserted into the groove (Diag. 2).
The flow direction specified in diagram 1 must be complied with.
3.2 ALARMS
The BW 585 can trigger two types of temperature alarm:
The low temperature alarm is activated when the temperature of the heat
exchanger drops below 36.5°C. The audio low temperature alarm is deactivated
during the first 60 seconds after switching on.
The high temperature alarm is activated when the temperature of the heat
exchanger exceeds 42.0°C. In this event visual and audio alarm signals are
given and the heating is switched off. To reset the device or switch off the alarm,
the device must first be disconnected from the power supply.
Attention: The temperature alarm can also be set off externally e.g. by exposure
to sunlight.
3.3 SHUTTING DOWN THE DEVICE
After being used for treatment, the device is shut down as follows:
6 EN - Edition 03 / 2007
Diag. 2
Position of the tube in the
groove of the heat exchanger
BIEGLER Instructions for use - BW 585
If the manufacturer is required to meet a warranty claim in accordance with
these terms, the customer shall bear the costs and risks of transport of the
device from and to the place of use.
The manufacturer and/or supplier under no circumstances assume liability for
slight negligence. The compensation for lost earnings and profits is likewise
excluded.
9 RETURN OF DEVICES
Devices must be carefully cleaned and disinfected before being placed in the
original packaging for returning.
If the original packaging is no longer available, the product has to be suitably
packaged for the method of dispatch.
10 MANUFACTURER`S DECLARATION
The blood and infusion warmer BW 585 is a medical product as defined by
Directive 93/42/EEC.
This is documented with the CE mark.
Notified Body: TÜV Product-Service, Approval Number CE0123
EN - Edition 03 / 2007 11

Instructions for use - BW 585 BIEGLER
7 MANUFACTURER LIABILITY
The manufacturer and the supplier of the device reject all liability if:
•the device is not used in accordance with the instructions for use
•the operating personnel are inadequately qualified or are not sufficiently
informed about the functioning of the device on the basis of the instructions
for use and the safety instructions
•repairs are not performed exclusively by the manufacturer or by persons and
service centres expressly authorised by manufacturer
•the device is used in places in which the electrical installations do not comply
with the applicable national standards, or if power supply during the period of
use of the device is not guaranteed
•original spare parts material are not used or the maintenance interval is not
complied with.
Disposal of the device and its accessories is carried out in accordance with the
applicable local regulations.
8 WARRANTY CONDITIONS
The manufacturer guarantees that all flaws of material and workmanship which
arise within 24 months from date of purchase will be repaired free of charge.
Claims are only accepted under the following terms:
•The manufacturer and/or supplier is informed immediately of the fault for
which the warranty claim is being made.
•The instructions of the manufacturer and/or supplier on storage or return of
the device are complied with.
•Presentation of a legible copy of the invoice for the device concerned,
showing the date of purchase.
•An exact description of the defects or malfunctions identified by the customer.
The manufacturer's warranty will be void if it is found that the maintenance,
disinfection and inspection instructions have not been followed according to the
instructions for use, the device was damaged by force or operating error, or was
used in any way contrary to the instructions for use and safety instructions. The
warranty will also be void if not original Biegler materials were used as
replacement parts, or measures for repair were undertaken by persons not
authorised by the manufacturer or supplier.
10 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
Switch the device into Standby mode using control (Diag.1/3).
Release pressure from the system by switching off any pressure cuffs or
infusion pumps used. Empty and disconnect the system as far as possible.
Remove the consumable material from the heat exchanger (Diag.1/1) and
dispose of it according to the relevant regulations.
Disconnect the device from the power supply and clean and sterilize as in
section „cleaning and disinfection“ of these instructions.
4 MAINTAINANCE
The BW 585 is designed as a low-maintenance device. To preserve the quality
and functional safety, please comply with the following points:
•Always keep the device and its accessories clean (see section: cleaning and
disinfection).
•The periodic technical safety inspections must be carried out (see section:
periodic inspections)
5 CLEANING AND DISINFECTION
The device may only be cleaned using a soft cloth with water-soluble, non-
aggressive cleaning agent or a special cleaning agent for plastics.
For the purposes of disinfection, ready-made alcohol-based spray disinfectants
can be used.
Important: Before cleaning or disinfection, the device must always be
disconnected from the mains power supply.
EN - Edition 03 / 2007 7

Instructions for use - BW 585 BIEGLER
6 PERIODIC INSPECTIONS
Periodic technical safety inspections must be performed on the BW 585 at least
every 12 months by persons who on the basis of their training, knowledge and
practical experience are qualified to carry out such technical safety testing.
The results of the periodic inspection are to be entered, together with the date
and the inspecting agency, on the reverse side of the instructions for use.
Important: If a malfunction is identified in the periodic inspection, affix a suitable
warning notice on the device to ensure that it can no longer be used until the
necessary repairs have been carried out.
CHECKING THE WARM-UP PERIOD
This is the time taken by the BW 585 to heat up to 41.0°C from room
temperature. The device is malfunctioning if it takes much longer than one
minute.
CHECKING THE CONTROL TEMPERATURE
The control temperature is checked on the groove bed of the heat exchanger.
The sensor of a suitable contact thermometer (tolerance +/- 0.15°C) is fixed to
this place e.g. using a piece of infusion tubing. The check is performed at a
temperature setting of 38.5°C. The measured value is read after it has
stabilized. The difference must not exceed +/- 0.5°C. There is a malfunction if a
difference from control temperature of greater than +/- 0.5°C is obtained.
CHECKING THE LOW TEMPERATURE ALARM
Preheat the device to 38.5°C, then disconnect the mains plug. Hold down the
control and reconnect the mains plug. Push the switch. The device is now
in an operational state where all the alarms are active, but the heating is
switched off. The BW 585 now slowly cools down. When the temperature drops
below the 36.5°C threshold, the low temperature alarm should be active.
For reasons of safety, short beeping sounds are given at intervals of a second in
this operational mode and the LED ON and STANDBY indicators flash
alternately (Diag.1/4 and Diag.1/5). There is a malfunction if the low temperature
alarm is not triggered.
8 EN - Edition 03 / 2007
BIEGLER Instructions for use - BW 585
CHECKING THE HIGH TEMPERATURE ALARM
Preheat the device to 41°C and wait for the temperature to stabilize, then
disconnect the mains plug. Hold down the control and reconnect the mains
power plug. Push the switch. The device now heats up to a target
temperature of 42.5°C. Observe the temperature indicator carefully. The high
temperature alarm should be triggered at a temperature of 42°C.
For reasons of safety, short beeping sounds are given at intervals of a second in
this operational mode and the LED ON and STANDBY indicators flash
alternately (Diag.1/4 and Diag.1/5). There is a malfunction if the high
temperature alarm is not triggered.
VISUAL CHECK OF GENERAL CONDITION AND STICKERS
The device should be checked for mechanical damage (general condition) and
for the completeness of sticker information, particularly the plate on the reverse.
There is a malfunction if mechanical damage to the device is evident which
could be harmful or impair the functional operation of the device.
ELECTRICAL SAFETY
All relevant electrical safety data should be checked, particularly the earth
conductor resistance (< 0.3 Ohm) and leakage current (< 0.75 mA). There is a
malfunction if there is a value outside the tolerances.
EN - Edition 03 / 2007 9