Biegler BW 685 Manual

Directions for use
BW 685 / BW 685 S
Blood and Infusion Warmer
TubeFlow
Tube warmer
ENG

BW 685 / BW 685 S / TubeFlow
Edition 06 / 2008
2

BW 685 / BW 685 S / TubeFlow
IMPORTANT
These directions are essential for operating the device. They must therefore
be kept in a suitable place near the device, and should be kept with the
device if it is given 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 operating instructions, 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 is not used before the required service and repair work has
been carried out.
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BW 685 / BW 685 S / TubeFlow
Table of contents
1 WARNINGS AND SAFETY INSTRUCTIONS .............................................. 5
2 DESCRIPTION ............................................................................................. 8
2. GENERAL DESCRIPTION ....................................................................... 8
2.2 SCOPE OF DELIVERY ............................................................................ 8
2.3 CONSUMABLES ...................................................................................... 9
3 INITIAL OPERATION ................................................................................ 10
3. INITIAL OPERATION OF THE DEVICE ................................................. 0
3.2 ALARMS ................................................................................................ 3
3.3 SHUTTING DOWN THE DEVICE .......................................................... 3
3.4 TROUBLESHOOTING ........................................................................... 4
4 MAINTENANCE ......................................................................................... 14
5 CLEANING AND DISINFECTION ............................................................. 15
6 PERIODIC INSPECTIONS ......................................................................... 15
7 MANUFACTURER LIABILITY ................................................................... 20
8 WARRANTY CONDITIONS ....................................................................... 20
9 RETURN OF DEVICES .............................................................................. 21
10 DISPOSAL ............................................................................................... 21
11 ELECTROMAGNETIC COMPLIANCE .................................................... 22
12 MANUFACTURER'S DECLARATION .................................................... 25
13 SYMBOLS ............................................................................................... 26
14 OPERATING AND STORAGE CONDITIONS ......................................... 27
15 TECHNICAL DATA .................................................................................. 28
16 MANUFACTURER ................................................................................... 28
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BW 685 / BW 685 S / TubeFlow
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.
•Unplugging the mains plug is the only safe way to disconnect from the
mains power supply.
•If the high temperature 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.
•The device may only be fastened to infusion stands, tripods or equipment
rails which have sufficient stability and load capacity to support the device.
•The device must only be used in areas in which the electrical installations
are in accordance with the standards and regulations in force.
•The device must not be used in rooms with potential explosion hazard.
•The device must not be immersed in liquids or sterilized with steam or by
thermochemical methods.
•All extraneous influences such as electromagnetic waves or high
temperatures are to be kept to a minimum.
•Strong electromagnetic fields (e.g. from HF therapy or surgical devices)
may cause the system to malfunction. The warmer works perfectly within
the limiting values of the DIN standard EN 6060 - -2. Outside of the
limiting values of the DIN standard EN 6060 - -2, the system may be
impaired.
•Avoid exerting force on the device or its accessories.
•If the device is dropped, damaged due to force, or functions in a way other
than described in the operating instructions, stop using the device
immediately and return it to the service centre.
•Persons and services authorized by BIEGLER must carry out repairs and
modifications on the device.
•Periodic technical safety inspections must be carried out as described in
the "Periodic inspections" section.
•No mechanical or electrical modifications may be made to the components
of the warming system.
•The device may not be set up and operated in direct proximity to devices
which generate high levels of excess heat.
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BW 685 / BW 685 S / TubeFlow
Additional safety instructions for the tube warmer accessory Biegler
TubeFlow from BW 685 S:
•Only operate the TubeFlow with BW 685 S.
•The Biegler TubeFlow may only be clamped to the Biegler blood
warmer BW 685 S with the fixing clamp according to the diagram in the
chapter “Initial operation”.
•Do not bend, cover, warm or cool the Biegler TubeFlow. Do not cover
the TubeFlow with cloths or dressing material. Do not route under blankets,
hot air blankets, etc. Do not expose to direct sunlight or heat radiation.
Route the TubeFlow through the air unencumbered. Do not route into or
through incubators. Overheating of the heated liquid or burns to the patient
cannot be excluded in the event of non-compliance.
•Do not shorten or damage the Biegler TubeFlow.
•Disconnect TubeFlow from BW 685 S only by pulling out the
connecting plug but not by unscrewing it.
The BW 685 / BW 685 S / TubeFlow may not be used if:
•the housing is damaged or one of the front film layers becomes detached.
•the device has been exposed to a hard physical shock (e.g. dropped, hit or
shaken)
•the device has been immersed in water
•the device has triggered a high temperature alarm that was not caused by
external factors.
•the mains power cord or plug is damaged
•the device has given someone an electric shock
•the fixing clamp is damaged in such a way that safe clamping to the
infusion stand is no longer guaranteed.
If there is a malfunction, suitable warning signs should be attached to the
device to ensure that it is not used until the required service and repair work
has been carried out.
Safety Instructions for consumable materials:
•The consumable materials are intended for single use only.
•Only sterile consumables prescribed by BIEGLER may be used in
conjunction with the BW 685 / BW 685 S.
•Only use items with intact individual packaging.
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BW 685 / BW 685 S / TubeFlow
•Only use items packaged with an orange-striped sterility indicator (green
stripe = unsterile; orange stripe = sterile)
7

BW 685 / BW 685 S / TubeFlow
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 patented groove design enables multiple extension tubes to be used,
provided that the heating is sufficient for each of the tubes used.
The design of the housing allows rapid and simple fitting to all suitable
infusion stands and equipment rails. The temperature of the heating element
can be set between 37 °C and 4 °C in steps of 0.5 °C, and is clearly
displayed.
The default 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 ensure safe operation.
Optional: The tube warmer accessory Biegler TubeFlow is available as a
warming system for transfusions and infusions between BW 685 S and the
patient. The system can be used in all cases in which the transfusion or
infusion must be heated before reaching the patient.
2.2 SCOPE OF DELIVERY
Blood and infusion warmer BW 685 / BW 685 S and operating instructions
Optional accessory for BW 685 S:
Tube warmer Biegler TubeFlow Order No. 2000
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BW 685 / BW 685 S / TubeFlow
2.3 CONSUMABLES
Various consumables are available according to requirements.
For use with BW 685 or BW 685 S without the tube warmer:
Extension set 350 cm Order no. 35000
Extension set 460 cm Order no. 45000
Extension set with bubble trap 460 cm Order no. 25000
For use with BW 685 S with the tube warmer:
Extension set 530 cm Order no. 6000
Extension set with bubble trap 560 cm Order no. 5000
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BW 685 / BW 685 S / TubeFlow
3 INITIAL OPERATION
Observe the directions for use! Handling of this device requires
knowledge and adherence to these instructions. The BW 685 (S) and
accessories may only be used by qualified specialized staff.
3.1 INITIAL OPERATION OF THE DEVICE
Fix the BIEGLER BW 685 / BW 685 S firmly to the infusion stand using the
clamps at the back (Fig. /8). Only use infusion stands, tripods or equipment
rails that are sufficiently stable.
Connect the power cable to the power supply. Before connecting to the
mains power supply, check that the voltage specified on the device label
matches the mains voltage. The device emits a short beep (control of alarm)
and the standby LED (Fig. /4) lights up.
If a temperature other than 38.5 °C is desired, this can be preset in Standby
mode with the buttons and (Fig. /5 and Fig. /6). If one of the control
buttons is pressed, the current default temperature is shown on the display.
You can use the and buttons to adjust the temperature. The
temperature can only be adjusted in Standby mode.
0
Fig.
Heat exchanger
2 Temperature scale
3 ON / STANDBY button
4 LED STANDBY
5 Button for reducing
the temperature
6 Button for increasing
the temperature
7 Extension tube
8 Fastening clamp
9 Fluid entry point
0 Fluid exit point
Alarm LED
Flow direction

BW 685 / BW 685 S / TubeFlow
Press the button (Fig. /3) to start the heating of the BW 685 / BW 685 S.
The device performs a self-test of safety-relevant functions, the completion of
which is indicated by a short acoustic signal. The BW 685 /
BW 685 S reaches the set target temperature within minute. The actual
temperature (+/- 0.5 °C) is indicated on the display.
Select suitable consumables. See the "Consumables" section.
Prepare infusion or transfusion. Important: The length of the tube between
the BW 685 / BW 685 S and the patient must be at least 40 cm, and the tube
must not be stretched.
Starting from the rear of the heat exchanger, gently pull the extension tube
and coil it forwards in a counter-clockwise direction. It is advisable not to
increase the distance between the BW 685 / BW 685 S and the patient much
beyond 80 cm.
Important: The tube must be completely inserted into the groove (Fig. 2)
The flow direction specified in Figure must be complied with.
Fig. 2
Position of the tube in the groove of the heat exchanger

Fig. 3
Fig. 3. .
Fig. 3.2
BW 685 / BW 685 S / TubeFlow
Optional tube warmer accessory Biegler TubeFlow for BW 685 S
The tube warmer Biegler TubeFlow must be inserted with light pressure as
indicated in diagram 3.2 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 socket on the BW 685 S.
The TubeFlow is also activated when the BW 685 S is switched on; this is
indicated by a green control LED on the TubeFlow.
2
Fig. 3.
Insert the transfusion or infusion line with slight
pressure into the rules of the warming profile.
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 utilized, thereby possibly
harming the medium or patient, since the reference
temperature sensor is located at the distal end.
Fig. 3
Tube warmer
2 Connector
3 Control LED
(Green – Operational / red – Alarm)
4 Fixture
5 Heating profile
6Height adjustment (for tube with or
without bubble trap)
If TubeFlow is not used a special receptacle is
planned for the end of the tube; Fig. 3.2

BW 685 / BW 685 S / TubeFlow
•The control LED appears red for approx. second after switching on, in or-
der to check the alarm functions. An audio signal also sounds during the
test.
•After the test of the alarm function, the control LED switches to green, in-
dicating normal operation.
•In the event of a malfunction, the control LED appears red and an audio
signal sounds.
3.2 ALARMS
The BW 685 / BW 685 S 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 audible low temperature alarm is not
active during the first 60 seconds after switch-on.
In the event of a low temperature alarm, i.e. temperatures < 36.5°C, the 36.5
°C LEDs flash and the device emits an alarm sound every 5 seconds. The
low temperature alarm is automatically cancelled after reaching 36.5℃.
The high temperature alarm is activated when the temperature of the heat
exchanger rises above 42.0℃. In this case, visual (flashing) and audible
(continuous sound) alarm signals are emitted and the heating is switched off.
The device can only be restarted and the alarm disengaged once the device
has been disconnected from the power supply.
Attention: The temperature alarm can also be triggered by external factors,
e.g. exposure to sunlight.
3.3 SHUTTING DOWN THE DEVICE
After being used for treatment, the device is shut down as follows:
Switch the device to Standby mode with the button (Fig. /3).
Depressurize the system by switching off any pressure cuffs or infusion
pumps used. Empty and disconnect the system as far as possible.
Remove the consumables from the heat exchanger (Fig. / ) and from the
optional tube warmer if used, and dispose of them according to the applicable
local regulations
Disconnect the device from the power supply, and clean and disinfect it as
described in the section "Cleaning and disinfection".
3

BW 685 / BW 685 S / TubeFlow
3.4 TROUBLESHOOTING
ERROR (POSSIBLE) CAUSE SOLUTION
LEDs do not light up No power supply Insert the mains plug
No LEDs light up,
even though mains
plug is inserted and
mains voltage
available
Device defective Return device for
servicing
Blue LEDs light up,
device does not heat
Device is in Standby
mode
Press the "ON" button
to start the device
Device sounds alarm
and does not heat
Internal error Return device for
servicing
<36.5° LEDs flash
and device issues
short beeps in 5
second intervals.
Low temperature alarm
has been triggered
The low temperature
alarm is automatically
cancelled after reaching
>36.5 °C.
Alarm LEDs light up,
audio alarm
(continuous tone)
Device was overheated Allow device to cool
down. If the error
occurs again → return
device for servicing
Extension tube
cannot be inserted
into the heating ring
Incorrect diameter of
extension tube
Use extension tube
according to directions
No connection
possibilities for
TubeFlow
Unsuitable device model Suitable device model:
BW 685 S
TubeFlow does not
heat, even though
BW 685 S is
switched on
The TubeFlow is poorly
connected or not
connected at all
Connect the TubeFlow
to the BW 685 S
TubeFlow does not
heat
BW 685 is in Standby
mode
Press the "ON" button
to start the device and
thus switch on the
TubeFlow
4 MAINTENANCE
The BW 685 / BW 685 S was largely designed as a maintenance-free device.
For long-term maintenance of quality and functional safety, we would like to
ask you to observe the following points:
4

BW 685 / BW 685 S / TubeFlow
•Always keep the device clean (see the "Cleaning and disinfection" section).
•Periodic technical safety inspections must be carried out as described in
the "Periodic inspections" section.
5 CLEANING AND DISINFECTION
Important: Before cleaning or disinfecting, the device must always be
disconnected from the mains power supply by pulling the plug.
The BW 685 / BW 685 S and the optional tube warmer TubeFlow may only
be cleaned using a soft cloth with a water-soluble, non-aggressive cleaning
agent or a special cleaning agent for plastics.
For the purposes of disinfection, only ready-made alcohol-based spray
disinfectants must be used.
Do not disinfect the device with steam (i.e. in autoclaves), hot air or
thermochemical cleaning solutions.
6 PERIODIC INSPECTIONS
The periodic technical safety inspections (according to the local standards in
force - e.g. in Austria, ÖVE/ÖNORM E 875 - ) on the BW 685 / BW 685 S
and the optional tube warmer TubeFlow must be carried out at least every 2
months, by persons authorized to carry out such inspections based on their
training, knowledge and practical experience.
The results of the periodic inspection must be documented, along with the
date, the inspecting agency and the device number.
During the measurements, the heating devices may not be exposed to
sunlight, draughts or other conditions which could affect the measurement.
Important: If a malfunction is discovered during the periodic inspection,
suitable warning signs should be attached to the device to ensure that it is
not used before the required service and repair work has been carried out.
5

BW 685 / BW 685 S / TubeFlow
CHECKING THE WARM-UP PERIOD (BW685/S)
This is the time taken by the BW 685 / BW 685 S to heat up to 38.5 °C from
room temperature. If this time is much more than one minute, there is a
malfunction.
CHECKING THE CONTROL TEMPERATURE (BW685/S)
The control temperature is checked on the groove bed of the heat exchanger.
The sensor of a suitable contact thermometer (tolerance +/- 0. 5 °C) is
attached here, e.g. with a piece of infusion tube. The examination is carried
out at a setting of 38.5 °C. The measured value is read once it has stabilized.
The difference must not exceed +/- 0.5 °C. If there is a difference of greater
than +/- 0.5 °C from the control temperature, there is a malfunction.
CHECKING THE LOW TEMPERATURE ALARM (BW685/S)
Preheat the device to 38.5 °C, then disconnect the mains plug. Hold down
the button and reconnect the mains power plug. After the beep, release
the button. Press the button. The device is now in an operating mode
in which all alarms are active but the heating is switched off. The BW 685 /
BW 685 S now slowly cools down. When the temperature drops below the
36.5 °C threshold, the low temperature alarm should trigger.
For reasons of safety, there is a short beep every second in this operating
mode, and the STANDBY indicator (Fig. /4) flashes. If the low temperature
alarm is not triggered, there is a malfunction.
CHECKING THE HIGH TEMPERATURE ALARM (BW685/S)
Preheat the device to 4 °C and wait for the temperature to stabilize, then
disconnect the mains plug. Hold down the button and reconnect the
mains power plug. After the beep, release the button. Press the button.
The device now slowly heats up to a target temperature of 42.5 °C. Observe
the temperature display carefully. The high temperature alarm should be
triggered at a temperature of 42 °C.
For reasons of safety, there is a short beep every second in this operating
mode, and the STANDBY indicator (Fig. /4) flashes. If the high temperature
alarm is not triggered, there is a malfunction.
6

BW 685 / BW 685 S / TubeFlow
VISUAL CHECK OF GENERAL CONDITION
(BW685/S)
The device should be checked for mechanical damage (general condition)
and for the completeness of the stickers, particularly the device label on the
reverse. If there is mechanical damage to the device which could cause risk
of injury or impair its functionality, this constitutes a malfunction.
ELECTRICAL SAFETY (BW685/S)
All relevant electrical safety data should be checked, particularly the earth
conductor resistance (should be < 0.3 Ohm) and leakage current (should be
< 0.75 mA). If a measured value is outside of the specified tolerance, there is
a malfunction.
VISUAL CHECK OF GENERAL CONDITION
(TubeFlow)
The TubeFlow to be examined must first be subject to a visual check.
The device should be checked for mechanical damage (general condition)
and for the completeness of the device label.
Furthermore, the device must not display any contamination or corrosion
which could impair safety, particularly in the area of the plug connector.
If there is mechanical damage to the device which could cause risk of injury
or impair its functionality, this constitutes a malfunction.
7

BW 685 / BW 685 S / TubeFlow
CHECKING THE CONTROL TEMPERATURE (TubeFlow)
The temperature check must be performed at an ambient temperature of 22
°C ± °C. During the measurement, the heating device must not be exposed
to sunlight, draughts or other conditions which could affect the measurement.
The TubeFlow heating device must be attached in its intended position
according to these operating instructions.
The head of the TubeFlow is inserted into the fixing clamp.
The end of the TubeFlow is inserted into the groove on the fixing clamp.
A suitable digital thermometer, as well as a temperature sensor with a
diameter of 5 mm, is required for the temperature measurement.
Insert the temperature sensor into the heating profile at
the end of the TubeFlow, centrally with respect to the
position of the bulge (see Fig. 4).
At least 20 cm of the sensor line must be inserted into
the heating profile.
Switch the BW 685 S on and check whether the alarm
function is checked.
Wait for 45 minutes. After this time, the TubeFlow has
reached its preset temperature of 39 °C and is evenly
heated throughout.
Now connect the temperature sensor to the digital
thermometer. The measured temperature value is now
entered into the inspection protocol. The measured
temperature must be 39.0 °C ± .5 ℃.
OVERTEMPERATURE CONTROL (TubeFlow)
8
Temperature sensor Fig. 4

BW 685 / BW 685 S / TubeFlow
An independent temperature sensor is installed in the TubeFlow warmer. The
electronic system continuously monitors the sensor. The heating is
permanently switched off if a certain predefined temperature is exceeded.
In order to examine this overtemperature activation, a calibrated circulation
thermostat which can be set to temperatures between 39 °C and 45 °C is
required.
Switch the circulation thermostat on. Set a temperature of 40 °C on the
circulation thermostat.
Insert the end of the heating profile of the TubeFlow into the water bath of the
circulation thermostat, further than the additional insulation.
Start up the TubeFlow. Wait until a temperature of 40 °C has been reached in
the circulation thermostat.
Increase the temperature on the circulation thermostat in steps of 0.5 °C, and
wait until the set temperature has been reached in the circulation thermostat.
The overtemperature function should be triggered at 42 °C +/- .5 °C. As
soon as the trigger temperature has been reached, an audio signal sounds
and the LED on the control unit lights up red.
The temperature set on the circulation thermostat when the overtemperature
alarm was triggered corresponds to the trigger temperature of the
overtemperature protection of the TubeFlow.
If the temperature value is outside of the tolerance range, the TubeFlow must
be returned to the manufacturer for recalibration.
9

BW 685 / BW 685 S / TubeFlow
7 MANUFACTURER LIABILITY
The manufacturer and the supplier of the device reject any liability if:
•the device is not used in accordance with the directions for use.
•the user is not sufficiently informed about the functioning of the device
corresponding with the directions for use and the safety instructions
•repairs are not performed exclusively by the manufacturer or by persons
and service centers expressly authorized by the manufacturer
•the device is used in places in which the electrical installations do not
comply with the applicable national standards, or if the power supply during
the period of use of the device is not guaranteed
•original spare parts are not used or the maintenance interval is not adhered
to.
8 WARRANTY CONDITIONS
The manufacturer guarantees that all flaws of material and workmanship
which arise within 24 months from the 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 regarding 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 operating instructions, the device has been damaged by force or
operating error, or has been used in any way contrary to the operating and
safety instructions. The warranty will also be void if original Biegler materials
were not used as replacement parts, or measures for repair were undertaken
by persons not authorized by the manufacturer or supplier.
20