Biegler BW685, BW685S User manual

Instructions for Use
BW 685 / BW 685 S
Blood and Infusion Warmer
Instructions for Use – BW 685 / BW 685 S BIEGLER
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BIEGLER Instructions for Use – BW 685 / BW 685 S
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 following 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.
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Instructions for Use – BW 685 / BW 685 S BIEGLER
Table of contents
1 WARNINGS AND SAFETY INSTRUCTIONS .............................................. 5
2 DESCRIPTION ............................................................................................. 7
2.1 GENERAL DESCRIPTION ....................................................................... 7
2.2 SCOPE OF DELIVERY ............................................................................ 7
2.3 CONSUMABLE MATERIALS ................................................................... 8
3 INITIAL OPERATION .................................................................................. 9
3.1 INITIAL OPERATION OF THE DEVICE ................................................... 9
3.2 ALARMS ................................................................................................ 12
3.3 SHUTTING DOWN THE DEVICE .......................................................... 12
4 MAINTENANCE ......................................................................................... 12
5 CLEANING AND DISINFECTION ............................................................. 13
6 PERIODIC INSPECTIONS ......................................................................... 14
7 MANUFACTURER LIABILITY ................................................................... 16
8 WARRANTY CONDITIONS ....................................................................... 16
9 RETURN OF DEVICES .............................................................................. 17
10 ELECTROMAGNETIC COMPLIANCE .................................................... 18
11 MANUFACTURER'S DECLARATION ..................................................... 21
12 SYMBOLS ............................................................................................... 22
13 OPERATING AND STORAGE CONDITIONS ......................................... 23
14 TECHNICAL DATA .................................................................................. 23
15 MANUFACTURER ................................................................................... 24
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BIEGLER Instructions for Use – BW 685 / BW 685 S

1 WARNINGS AND SAFETY INSTRUCTIONS

should be immediately removed from service and not used for infusions or transfusions until appropriate investigations have demonstrated that there has been no impairment.
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.
rails which are suitable due to their stability and load capacity.
conjunction with the BW 685 / BW 685 S.
are in accordance with the standards and regulations in force.
by unplugging the mains plug.
The device may not be used in rooms subject to explosion hazard.
persons or service centres authorised by BIEGLER.
thermochemical methods.
temperatures are to be kept to a minimum.
fields (e.g. by HF therapy or surgical devices). The warmer works perfectly within the limit values of the Standard EN 60601-1-2. The system can be affected by limit values that do not comply with the Standard EN 60601-1-2.
Avoid exerting force on the device or its accessories.
deviating from the instructions for use, stop using the device immediately and return it to the service centre.
section: “Periodic inspections”)
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Instructions for Use – BW 685 / BW 685 S BIEGLER
warmer BW 685 S with the fixing clamp according to the diagram in the chapter "Initial operation".
the Tubeflow with cloths or dressing material. Do not lead under blankets, warm air blankets, etc. Do not expose to direct sunlight or heat radiation. Lead the Tubeflow through the air unencumbered. Do not lead into or through incubators. Overwarming of the warmed liquid or burns to the patient cannot to be excluded in the case of non-compliance.
Do not shorten or damage the Biegler Tubeflow.
The BW 685 / BW 685 S may not be used if:
the housing is damaged or one of the front film layers becomes detached.
shaken)
the device has been immersed in water
external factors.
the mains power cord or plug is damaged
the device has given somebody an electric shock
infusion stand.
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2 DESCRIPTION

2.1 GENERAL DESCRIPTION

The BIEGLER BW 685 / BW 685 S is a warmer for infusions or transfusions and operates on the basis of a continuous flow warmer, where the heat from the heat exchanger is transferred via the extension tubing to the liquid flowing within it.
The preset temperature after switching on the BW 685 / BW 685 S 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 685 / BW 685 S and instructions for use
Optional accessory for BW 685 S:
Tube warmer Biegler Tubeflow Order no 12000
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Instructions for Use – BW 685 / BW 685 S BIEGLER

2.3 CONSUMABLE MATERIALS

Various consumable materials are available according to requirements.
For use with BW 685 or BW 685 S without tube warmer:
Extension set 3.5 m Order no 35000 Extension set 4.6 m Order no 45000 Extension set with bubble trap 4.6 m Order no 25000
For use with BW 685 S with tube warmer:
Extension set 5.3 m Order no 16000 Extension set with bubble trap 5.3 m Order no 15000
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3 INITIAL OPERATION

Observe the instructions for use! Users must familiarise themselves
in detail with the contents of these instructions for use before putting the system into operation.

3.1 INITIAL OPERATION OF THE DEVICE

Diag. 1 1 Heat exchanger 2 Temperature scale 3 Control ON / STANDBY 4 LED STANDBY 5 Control for decreasing the
temperature
6 Control for increasing the
temperature 7 Extension tube 8 Fixing clamp 9 Entry of liquid 10 Exit of liquid
Flow direction
Connection of the optional tube warmer Biegler Tubeflow (to the BW 685 S): The tube warmer Biegler Tubeflow must be inserted with light pressure as indicated in diagram 3 into the intended fixture (Diag. 3/4) on the BW 685 S. Remove the dust cap from the BW 685 S and attach the connector of the Tubeflow to the female connector on the BW 685 S.
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Instructions for Use – BW 685 / BW 685 S BIEGLER
Diag. 2 Position of the tube in the groove of the heat exchanger
Important: The tube must be completely inserted into the groove (Diag. 2) The flow direction specified in diagram 1 must be complied with.
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Optional accessory tube warmer Biegler Tubeflow for BW 685 S:
Insert the transfusion or infusion tube into the groove of the tube warmer. Insert the tube over the complete length of the Biegler Tubeflow.
Important: Overwarming can result, if the full length of the tube warmer is not utilised, thereby possibly harming the medium or patient, since the reference temperature sensor is located at the distal end.
Diag. 3 1 Tube warmer 2 Connector 3 Control light
(Green – Operational / red – Alarm)
Fixture
Diag.3
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Instructions for Use – BW 685 / BW 685 S BIEGLER

3.2 ALARMS

The BW 685 / BW 685 S can trigger two types of temperature alarm:

3.3 SHUTTING DOWN THE DEVICE

After being used for treatment, the device is shut down as follows:
Switch the device into Standby mode using control (Diag.1/3).

4 MAINTENANCE

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disinfection").
section "Periodic inspections")

5 CLEANING AND DISINFECTION

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Instructions for Use – BW 685 / BW 685 S BIEGLER

6 PERIODIC INSPECTIONS

CHECKING THE WARM-UP PERIOD
This is the time taken by the BW 685 / BW 685 S to heat up to 38.5°C from room temperature. The device is malfunctioning if it takes much longer than one minute.
CHECKING THE CONTROL TEMPERATURE
CHECKING THE LOW TEMPERATURE ALARM
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CHECKING THE HIGH TEMPERATURE ALARM
VISUAL CHECK OF GENERAL CONDITION
ELECTRICAL SAFETY
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Instructions for Use – BW 685 / BW 685 S 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 basis of the instructions for use and the safety instructions
and service centres expressly authorised by the manufacturer
comply with the applicable national standards, or if power supply during the period of use of the device is not guaranteed
is not complied with.
accordance with the applicable local regulations.

8 WARRANTY CONDITIONS

which the warranty claim is being made.
of the device are complied with.
showing the date of purchase.
customer.
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9 RETURN OF DEVICES

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Instructions for Use – BW 685 / BW 685 S BIEGLER

10 ELECTROMAGNETIC COMPLIANCE

Table 201
Guidelines and manufacturer's declaration – electromagnetic emission
The BW685 is intended for use in the environment specified below. The customer or the user of the BW685 should assure that it is used in such an environment.
Interference emission measurements
RF emissions acc. to CISPR 11
RF emissions acc. to CISPR 11
Emission of harmonics acc. to IEC 61000-3-2
Emission of harmonics acc. to
IEC 61000-3-3
Complian ce
Group 1 The BW685 uses RF energy only for its internal function. Therefore, its RF emissions are
Class B The BW685 is suitable for use in all establishments, including domestic establishments
Class A
Complies
Electromagnetic environment - guidelines
very low and are not likely to cause any interference in nearby electronic equipment.
and those directly connected to the public power supply network that also supplies buildings used for domestic purposes.
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Table 202
Guidelines and manufacturer's declaration – electromagnetic interference resistance
The BW685 is intended for use in the electromagnetic environment specified below. The customer or the user of the BW685 should assure that it is used in such an environment.
Interference resistance test
Electrostatic discharge (ESD) acc. to IEC 61000-4-2
Fast transient /electrical bursts acc. to IEC 61000-4-4
Surge voltages (surges) acc. to IEC 61000-4-5
Voltage dips, short interruptions and voltage variations of the supply voltage acc. to IEC 61000-4-11
Power frequency (50 Hz/60 Hz) magnetic field acc. to IEC 61000-4-8
IEC 60601­test level
± 6 kV contact discharge ± 8 kV air discharge
± 2 kV for power supply lines ± 1 kV for input/output lines
± 1 kV differential mode ± 2 kV common mode
< 5% UT (> 95% dip in UT) for ½ 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 s
3 A/m 3 A/m Power frequency magnetic fields should be at
Compliance level Electromagnetic environment - guideline
± 6 kV contact discharge ± 8 kV air discharge
± 2 kV for power supply lines
± 1 kV normal mode voltage ± 2 kV common mode voltage
< 5% UT (> 95% dip in UT) for ½ 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 s
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
The mains power supply quality should be that of a typical commercial or hospital environment.
The mains power supply quality should be that of a typical commercial or hospital environment.
The mains power supply quality should be that of a typical commercial or hospital environment. If the use of the BW685 requires continued operation during power mains interruptions, it is recommended that the BW685 be powered from an uninterruptible power supply or a battery.
levels characteristic of a typical location in a typical commercial or hospital environment.
Note UT is the AC mains voltage prior to application of the test level.
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Instructions for Use – BW 685 / BW 685 S BIEGLER
1V
P
V
d
∗
  
=
1
5,3
1E
P
E
d
∗
  
=
1
5,3
P
E
d
∗
  
=
1
7
Table 204
Guidelines and manufacturer's declaration – electromagnetic interference resistance to
The BW685 is intended for use in the electromagnetic environment specified below. The customer or the user of the BW685 should assure that it is used in such an environment.
Interference
resistance test
Conducted RF disturbance variables acc. to IEC 61000-4-6
Emitted RF disturbance variables acc. to IEC 61000-4-3
IEC 60601­test level
3 V
eff
150 kHz to 80 MHz
3 V/m 80 kHz to 2.5 GHz
Compliance level
V/m
Electromagnetic environment - guidelines
Portable and mobile RF communications equipment should be used no closer to any part of the BW685, including cables, than the recommended protection distance calculated from the equation applicable to the frequency of the transmitter:
Recommended protection distance:
in V
in
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended protection distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following symbol:
for 80 MHz to 800 MHz
for 800 MHz to 2.5 GHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
a
b
Field strengths from stationary transmitters, such as base stations for radio (cellular /cordless) telephones and
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
absorption and reflection from structures, objects and people.
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 stationary RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BW685 is used exceeds the applicable RF compliance level as specified above, the BW685 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BW685.
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P
V
d
∗
  
=
1
5,3
P
E
d
∗
  
=
1
5,3
P
E
d
∗
  
=
1
7
Table 206
portable and mobile RF communications equipment and the BW685
The BW685 is intended for use in an electromagnetic environment in which radiated RF disturbance variables are controlled. The customer or user of the BW685 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BW685 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter W
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 rated at a maximum output power not listed above, the recommended distance can be determined 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 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.
Recommended protection distances between
Protection distance according to transmitter frequency m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz

11 MANUFACTURER'S DECLARATION

The blood and infusion warmer BW 685 / BW 685 S is a medical product as
defined by Directive 93/42/EEC.
This is documented by attaching the CE mark.
Notified Body: TÜV Product-Service, Approval Number CE0123
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Instructions for Use – BW 685 / BW 685 S BIEGLER

12 SYMBOLS

Certifies compliance with the Directive 93/42/EEC
0123
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
IPX 4
- for optional tube warmer Tubeflow
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Humidity Classes
Degree of protection B
Control for switching On / Standby
Operation Malfunction
I
Do not cover Do not wrap up
Do not expose to direct sunlight Do not cut
BIEGLER Instructions for Use – BW 685 / BW 685 S

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
to the device or its accessories.

14 TECHNICAL DATA

Device: Blood and infusion warmer
Type designation: BW 685 / BW 685 S
Voltage: 230 V / 50Hz
Power consumption: 1.5 A
Protection class: I
Degree of protection: B
Humidity protection: IPX4
Fuses: primary 2 x 1.6 AT secondary 500 mAT
Control temperature: 37°C - 41°C adjustable in 0.5°C steps
Overtemperature shutdown: 42°C / 42.5°C / 45°C±3°C
Max. system pressure: 300 mm Hg
Classification: IIb according to Rule 9
Operational mode: Continuous operation
Dimensions BW 685: WxHxD 228 x 228 x 132 mm
Weight BW 685: 1.9 kg
Dimensions BW 685 S: WxHxD 228 x 278 x 132 mm
Weight BW 685 S: 2.0 kg
Tube warmer Tubeflow
for BW 685 S: Length 1340mm
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Instructions for Use – BW 685 / BW 685 S BIEGLER

15 MANUFACTURER

Biegler GmbH
Allhangstrasse 18a
3001 Mauerbach
Austria
Tel. +43 1 979 21 05
Fax +43 1 979 21 05 16
email: office@biegler.com
www.biegler.com
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Space for notes:
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