Biegler protherm II User manual

Instructions for use
protherm II
Blood and Infusion Warmer
Edition 2017-11-21 | 220 – 240 V
ENG

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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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Table of contents

1 Warnings and safety instructions .............................................................. 4
2 Description .................................................................................................. 6
2.1 General Description ................................................................................................................... 6
2.2 Scope of delivery ....................................................................................................................... 6
2.3 Consumable material................................................................................................................. 6
3 Initial operation ........................................................................................... 7
3.1 Setting up procedure ................................................................................................................. 7
3.2 Alarms ....................................................................................................................................... 9
3.3 Shutting down the device ........................................................................................................ 10
3.4 Troubleshooting ....................................................................................................................... 11
4 Maintainance ............................................................................................. 11
5 Cleaning and disinfection......................................................................... 12
6 Periodic inspections ................................................................................. 12
7 Manufacturer liability ................................................................................ 14
8 Warranty conditions ................................................................................. 14
9 Return of devices ...................................................................................... 15
10 Disposal ..................................................................................................... 15
11 Electromagnetic compliance.................................................................... 16
12 Manufacturer's declaration ...................................................................... 20
13 Symbols ..................................................................................................... 20
14 Operating and storage conditions ........................................................... 21
15 Technical Data ........................................................................................... 22
16 Manufacturer ............................................................................................. 22

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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. Place the device so that it can easily be disconnected from the
mains.
 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 system must be depressurized before opening the device by switching off
the pressure cuffs or infusion pump and releasing the pressure remaining within
the system. Closing the system forcibly when the warming bags are full and
under pressure may cause the warming bag to burst. The maximum pressure of
the system must not exceed 300 mmHg.
 The device may only be fastened to infusion stands or tripods 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. To prevent the risk of an
electric shock the device shall only be connected to a supply network with
protective earth connection.
 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.
 The device can be influenced by other devices or equipment nearby or it can
influence them. It is subject to special precautions regarding electromagnetic
compatibility (EMC). Portable and mobile RF communication equipment can
affect medical electrical equipment.
 Avoid exerting force to 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 center.
 Persons and services authorized by BIEGLER must carry out repairs and
modifications on the device.

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 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.
 Only sterile BIEGLER consumable materials may be used in conjunction with the
protherm II.
Safety Instructions for consumable materials:
 The consumable materials are intended for single use only.
 Only sterile consumables or material specified by BIEGLER or approved by
BIEGLER for use with this device may be used in conjunction with the
protherm II.
 Only use items with intact individual packaging.
 Consumables are only for one-time use (disposable).
The reuse of disposable products results in possible infection risks for the patient
or user. Product contamination may lead to health problems, diseases or death
of the patient.
 Do not re-sterilize!
The protherm II may not be used if:
 the case 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 somebody an electric shock.
 the fixing clamp is damaged in such a way that safe clamping to the infusion
stand is no longer guaranteed.

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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.
2 DESCRIPTION
2.1 GENERAL DESCRIPTION
The BIEGLER protherm II is a warmer for infusions and transfusions at high flow
rates. The device operates on the basis of the dry heat principle and uses warming
plates heated on both sides.
The medium is heated rapidly, efficiently and gently by using three independently
controlled heat zones.
The design of the casing allows rapid and simple fitting to any suitable infusion
stand. The plate temperature 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 protherm II 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 protherm II and instructions for use
2.3 CONSUMABLE MATERIAL
Large bag Order number: FP1003001
- completely covers heating area; includes two drip chambers with thrombosis
filters, air trap and injection port close to the end of the tube

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3 INITIAL OPERATION
3.1 SETTING UP PROCEDURE
Diag. 1
1 Entry of liquid
2 Mounting for the air trap
3 Air trap
4 Attachment hooks for warmin
g
ba
g
5 Tube holder
6 Clips for closure of device
7 Tube holder
8 Tube holder
Diag. 2
1 Temperature scale
2 Temperature scale
3 Control to increase
temperature
4 Control to decrease
temperature
5 ON / STANDBY switch
6LED ON
7 LED STANDBY

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Observe the directions for use! Handling of this device requires
knowledge and adherence to these instructions. The protherm II and
accessories may only be used by qualified specialized staff. The patient
must be monitored throughout the procedure.
Fix the BIEGLER protherm II firmly to the infusion stand using the clamps at the
back. Only use infusion stands or poles that are sufficiently stable.
Connect power cable to power supply. Before connecting to the mains power
supply, check the voltage specified on the device label. The device gives a short
beep and the standby light (Diag.2/7) lights up.
If a different temperature to 38.5 °C is desired, it can be preset in Standby mode
using the controls and (Diag.2/3 and Diag.2/4). 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 protherm II can be started by pressing the control (Diag.2/5).
The protherm II attains the set target temperature within 1 minute. The indicator
display shows the actual temperature (± 0.5 °C) as an illuminated band.
Open the device: release the two clips on the right (Diag.1/6) by pressing the
button on the clip and open the device. The heating zones are visible, the
attachment hooks for the warming bag are on the reverse at the top (Diag.1/4).
Hang the warming bag on the attachment hooks (Diag.1/4) and push the tube
outlets into the tube holders (Diag.1/5, 7, 8). The tube with the two drip chambers
must be placed at the top, the tube to the air trap below (Diag.1/3). The warming
bag hangs without creases in the open device.
Close the protherm II and lock with the clips on the right side (Diag.1/6). Place the
air trap in the mounting provided (Diag.1/2).
Fill the system. Take care that filling proceeds without air bubbles occurring.
When the device is opened, the system must not be under pressure. Closing the
system when it is under pressure can cause the warming bag to burst. The clips
are designed so that they resist opening above a certain operating pressure. The
device must not be forcibly opened.

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3.2 ALARMS
The protherm II can trigger two types of temperature alarm:
Software high temperature alarm Hardware high temperature alarm
Condition The high temperature alarm is
triggered when the temperature of
one of the 6 heating plates rises
above 43.0 °C.
If the temperature rises above 45 °C
due to a software error, at 46 °C ±
3 °C a hardware high temperature
alarm is triggered.
Consequence The heating plates are switched off. The heating plates are switched off.
Resetting The alarm can only be reset by
pulling out the mains plug.
The alarm can only be reset by pulling
out the mains plug. Wait for the
temperature switch to cool down.
Visual signal Yellow alarm LEDs + all green LEDs
constantly on.
Yellow alarm LEDs + all green LEDs
constantly on.
Audio signal Continuous tone 3.6 kHz 71 dBA Continuous tone 3.6 kHz 71 dBA
Priority as per
EN 60601-1-8
Low priority Low priority
Information signals
Low temperature information signal
Condition When the average temperature of the three zones drop below
36.5 °C.
Consequence No consequences in relation to the function of the device.
(information only)
Resetting Automatically when the temperature rises above 36.5 °C.
Visual signal Green LED 36.5 °C flashes at 1 Hz 50 % duty cycle
Audio signal 500 ms long pulse 3.6 kHz every 1 s – 71 dBA

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The low temperature alarm is activated when the average temperature from the
three zones fall 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 one of the six
heating plates exceeds 43.0 °C. In this event visual and audio alarm signals are given
and the heating plates in all the zones are 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 triggered by external
factors, e.g. exposure to sunlight.
To reset the alarm, the mains plug must be pulled out.
All alarms are alarms of “Low priority” according to EN 60601-1-8.
The alarm system does not have to be verified. The alarm limits cannot be
adjusted. The risk management process has found that a shutdown of the alarms
is not meaningful, because it is desirable that the error (e. g. high temperature) is
detected. Resetting of the alarm is only possible through disconnection of the
device from mains. The operator station is in front of the device.
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.2/5).
Depressurize the system by switching off any pressure cuffs or infusion pumps
used. Empty and disconnect the system as far as possible.
Release the two clips on the right (Diag.1/6) and open the device.
Remove the bag from the attachment hooks (Diag.1/4) and dispose of it 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“.

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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
Device sounds alarm and does
not heat
Internal error Return device for servicing
<36.5° LED and device issues
short signals in 1 second
intervals.
Low temperature
information signal has
been triggered
The low temperature information
signal 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
4 MAINTAINANCE
The protherm II is designed as a low-maintenance device. For long-term
maintenance of quality and functional safety, the following points have to be
observed:
 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.

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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 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, only ready-made alcohol-based spray
disinfectants (e.g. Meliseptol Foam pure, BRAUN) must be used and the
manufacturer’s instructions must be followed.
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. EN 62353) on the protherm II must be carried out at least every 12
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 device 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.
CHECKING THE WARM-UP PERIOD
This is the time taken by the protherm II 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
The control temperature is checked on the lower third of the rear heating plates,
about 7 cm from the right-hand edge of the device. The sensor of a suitable contact
thermometer (tolerance ± 0.15 °C) is fixed to this place e.g. using adhesive tape.

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The check is performed with the device closed and 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. This check is carried out on each of the three heating areas.
If there is a difference of greater than ± 0.5 °C from the control temperature, there
is a malfunction.
CHECKING THE LOW TEMPERATURE ALARM
Preheat the device to 38.5 °C, then disconnect the mains plug. Hold down the
controls and 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 protherm II 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. There is a malfunction if the low temperature alarm is not triggered.
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 controls and and reconnect the
mains plug. Push the switch. The device now heats up to a target temperature
of 43.5 °C. Observe the temperature indicator carefully. The high temperature
alarm should be triggered at a temperature of 43.0 °C.
For reasons of safety, short beeping sounds are given at intervals of a second in
this operational mode. There is a malfunction if the high temperature alarm is not
triggered.
VISUAL CHECK OF GENERAL CONDITION
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
All relevant electrical safety data should be checked, particularly the earth
conductor resistance and leakage current. If a measured value is outside of the
specified tolerance, there is a malfunction.

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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.

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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 shall 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 DISPOSAL
Dispose of the device and its accessories in accordance with the applicable local
regulations.

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11 ELECTROMAGNETIC COMPLIANCE
Table 201
Guidance and manufacturer´s declaration – electromagnetic emission
The protherm II is intended for use in the electromagnetic environment specified below. The customer or the
user of the protherm II should assure that it is used in such an environment.
Interference emission
measurements
Compliance Electromagnetic environment - guidance
RF emissions acc. to
CISPR 11 Group 1
The protherm II uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions acc. to
CISPR 11 Class B
The protherm II is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public power supply network that also
supplies buildings used for domestic purposes.
Emission of harmonics acc.to
IEC 61000-3-2 Class A
Emission of harmonics acc.to
IEC 61000-3-3 Compliant

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Table 202
Guidelines and manufacturer´s declaration – electromagnetic interference resistance
The protherm II is intended for use in the electro-magnetic environment specified below. The customer or the
user of the protherm II should assure that it is used in such an environment.
Interference
resistance test
IEC 60601 test level Compliance level Electromagnetic environment-
guideline
Electrostatic
discharge
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 %.
Fast transient
/electrical bursts
acc. to 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.
Surges as per
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
of the supply voltage
acc. to 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
protherm II requires continued
operation during power mains
interruptions, it is recommended
that the protherm II 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 AC mains voltage prior to application of the test level.

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Table 204
Guidelines and manufacturer´s declaration – electromagnetic interference resistance
The protherm II is intended for use in the electro-magnetic environment specified below. The customer or the
user of the protherm II should assure that it is used in such an environment.
Interference
resistance test
IEC 60601 test level Compliance level Electromagnetic environment
- guidelines
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
3 V
10 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the protherm II, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation
distance
80Mhz to 800MHz
800MHz to 2,5GHz
where p is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is 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
a
Field 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 protherm II is used exceeds the
applicable RF compliance level above, the protherm II should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the protherm II.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 206
Recommended safety distances between
portable and mobile RF telecommunications devices and the protherm II
The protherm II is intended for use in an electro-magnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the protherm II can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the protherm II as recommended
below, according to the maximum output power of the communications equipment
Protection distance according to transmitter frequency
m
Rated maximum
output power 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 7.0
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.

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12 MANUFACTURER'S DECLARATION
The blood and infusion warmer protherm II as well as BIEGLER consumables
(Heating bags) are medical products as defined by Directive 93/42/EEC.
This is documented through the CE mark.
Notified Body: TÜV SÜD Product Service, Approval Number CE0123
13 SYMBOLS
Certifies compliance with the Directive 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
AC voltage
Serial number
IPX4 Degree of protection against the ingress of splashing water
Application part type B
Manufacturer
2015
Date of manufacture
Protective earthing
"Do not open while pressurised"
see also Section 1 Warnings and safety instructions