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.
EN - Edition 03 / 2007 3