ENG

en
Operating instructions

ESH 04
Emergency warmer

Edition 2013-04
ESH 04

IMPORTANT
These operating instructions 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 ....................................................................................... 5
2.1 General description ..................................................................... 5
2.2 Scope of delivery ........................................................................ 5
3 Starting the device........................................................................... 6
3.1 Setting up procedure ................................................................... 6
3.2 Alarms ........................................................................................ 9
4 Maintenance ................................................................................... 10
5 Cleaning and disinfection ............................................................. 10
6 Periodic inspections ...................................................................... 10
7 Manufacturer's liability .................................................................. 11
8 Warranty conditions ...................................................................... 11
9 Return of devices........................................................................... 12
10 Manufacturer's declaration ........................................................... 12
11 Electromagnetic emissions .......................................................... 13
12 Symbols ......................................................................................... 17
13 Operating and storage conditions ................................................ 17
14 Technical Data ............................................................................... 18
15 Manufacturer .................................................................................. 18

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1 WARNINGS AND SAFETY INSTRUCTIONS

 The emergency warmer can only be used or connected in vehicles
where the on-board installations comply with the standards and
regulations in force.
 The emergency warmer must always be used in a hanging position. It
must not be used as a pressure infusion in a horizontal or an incorrect
position. This would be hazardous due to the build up of air bubbles.
 The treating physician must check the condition of the patient at
regular intervals. Failure to do so could seriously harm the patient.
 If the device is attached to infusion stands or tripods, then these must
be sufficiently stable and able to carry the load.
 The device must only be used with electrical installations that comply
with the standards and regulations in force.
 Only use original BIEGLER parts in conjunction with the ESH 04:
mains adaptor 30 W E2EFMW3, PowerPort 12 V
 Unplugging the mains plug is the only safe way to disconnect from the
mains power supply. Only plug the mains adaptor into easily
accessible sockets, to ensure that it can be unplugged from the mains
quickly if required.
 The device must not be used in rooms with potential explosion hazard.
 Persons and services authorized by BIEGLER must carry out repairs
and modifications on the device.
 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 may interfere with other devices set up in the vicinity or
vice versa. It is subject to specific preventive measures in terms of
electromagnetic compatibility (EMC). Portable and mobile RF
communications equipment may interfere with electrical medical
devices.
 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 center.
 Periodic technical safety inspections must be carried out as described
in the "Periodic inspections" section.

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2 DESCRIPTION
2.1 GENERAL DESCRIPTION
The ESH 04 emergency warmer can keep two pre-warmed 500 ml
infusion bottles at a control temperature of 37 °C for up to 90 minutes.
The device is suitable for continuous operation when mains-connected,
and it can also pre-warm infusion bottles in this mode. The ESH 04
emergency warmer has been specifically designed for mobile use.
An insulated compartment with carrying strap offers space for 2 infusion
bottles. An integrated pressure cuff ensures good heat transfer to the
heating foil. The electronics and the battery are located in an aluminum
housing in the upper part of the device. The device is operated via two
buttons (ON + OFF / Standby) on the housing. Unintended operation of
the device is prevented by a safety button, which must be pressed
simultaneously with the function keys.
Its dimensions are 160 x 105 x 300 mm, and it weighs 1.4 kg.

2.2 SCOPE OF DELIVERY

ESH 04 emergency warmer

Mains adaptor 30 W E2EFMW3 Order no. FL1000001
PowerPort 12 V Order no. FL1000002
and instructions for use.

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3 STARTING THE DEVICE

Observe the operating instructions! Users must thoroughly
familiarize themselves with the contents of these instructions
before putting the system in operation. The ESH 04 and
accessories may only be used by qualified specialized staff.

3.1 SETTING UP PROCEDURE

Setting up the system

 Open the zip along the bottom of the emergency warmer.
 Undo the cord.
 If necessary, adjust to the sizes of the bottles.
 Add infusion solutions to the warmer as shown in the diagram. (Care
must be taken that the infusion bottles are inserted "upright" on both
sides of the pressure cuff).

Underside of emergency warmer open Emergency warmer closed

 Tie the cord.

 Use the pressure cuff to inflate to approx. 100 mm Hg, so that the
infusion solutions are optimally placed next to the warming area.

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Charge-LED
ON-LED
Error-LED

OFF / ON Safety-
Standby button

Setting up with mains adaptor

 Connect the emergency warmer using the mains adaptor supplied
(110 - 240 V). When connecting the mains adaptor and the emergency
warmer, the buzzer and alarm LED may be briefly activated. This is a
self-test function. The device starts to charge; this is indicated by the
yellow LED.

 Press the buttons and simultaneously to switch on the device

(Charge LED and green ON LED light up). When switched on at the
mains, the infusion solutions are first heated to 37°C, then the battery
is charged to full capacity and at the same time the infusion solutions
are kept warm at 37 °C.
 If the device is switched off by pressing both the and buttons,
then the heating is also switched off. The charging process continues
until the battery is fully charged (indicated by the yellow charge LED).

Note: The safety button must always be pressed simultaneously along

with the desired function to prevent only one of the buttons being
pressed inadvertently.

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Starting up for use

 Press the buttons and simultaneously to switch on the device
(green ON LED lights up). When switched on and running on battery
power, the infusion solutions are heated to 37 °C or kept warm for
approx. 90 minutes at 37 +/- 3 °C.
 The yellow LED on the left indicates the status of the battery pack.
A flashing LED indicates that the battery is empty.

Setting up for use

 Depressurize the pressure cuff by "opening" it.
 Hang the emergency warmer in a suitable place or hold it in your hand.
 Connect the infusion fittings.
 Inflate pressure cuff to 300 mmHg.

Important: The emergency warmer must not be used as a

pressure infusion in a horizontal or an incorrect position. If used
incorrectly, it can cause a build-up of air bubbles. This could
seriously harm the patient!

Decommissioning
Switch off the device via the OFF / Standby button and if no charging is
required, unplug the mains adaptor.

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3.2 ALARMS
A basic distinction is made between "Self-test" and "High temperature"
alarms in the emergency warmer.
Alarm – Self-test
The "Self-test" is carried out by the software at periodic intervals.
If malfunctions are found during the “Self-test”, then the device
automatically shuts down. If this error occurs, switch off the device and
then switch it back on. If the error occurs again, the device must be sent
for servicing.
Alarm – High temperature
If the control unit detects an error, then the hardware safety shutdown is
activated. The high temperature is signaled to the user via an illuminated
yellow error LED. The safety shutdown is triggered by the hardware
when the temperature exceeds 55 °C.
The safety shutdown can also be triggered by external factors, e.g.
excessive exposure to sunlight.
Error overview
The ESH 04 triggers Technical Alarms.

Self-test High temperature

Condition Self-test detects a critical error Sensor detects high temperature

Consequence Device shuts down automatically Device shuts down automatically

Resetting Not possible – return device for Automatically after cooling down
servicing

Visual signal Yellow error LED lights up Yellow error LED lights up

Audio signal No audio signal No audio signal

Priority Low Low

The alarm system does not need to be verified. The alarm limits cannot
be adjusted. Risk management has shown that it is not advisable to
deactivate the alarm signals, because detection of the error (e.g. high
temperature) is required. The operator station is in front of the device.
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4 MAINTENANCE
The ESH 04 has been designed to be maintenance free. For long-term
maintenance of quality and functional safety, we would like to ask you to
bear the following points in mind:
 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

The device may only be cleaned using a soft cloth with water-soluble,
non-abrasive cleaning agents or special cleaning agents for plastics.
For the purposes of disinfection, only ready-made alcohol-based spray
disinfectants must be used.
Important: Before cleaning or disinfecting, the device must
always be disconnected from the mains power supply or
external power supply.

6 PERIODIC INSPECTIONS
Periodic technical safety inspections must be performed on the ESH 04
emergency warmer at least every 12 months by persons who are
qualified to carry out such technical safety testing on the basis of their
training, knowledge and practical experience.
 The safety labels on the device and its accessories must be easily
legible.
 The mechanical condition of all components must permit an additional
and safe use (housing, zip, cord, viewing window, seams, cables,
tubes, pressure gauge and hand pump).
 The device must not have any dirt on it that might impair safety.
 If necessary, carry out electrical verification of the mains adaptor.
Results of the periodic inspection along with the date and the testing
station are to be entered on the reverse side of the instructions for use.
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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.

7 MANUFACTURER'S 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 at locations where the electrical installations do not
correspond with the relevant national standards,
 original spare parts are not used or the maintenance interval is not
complied with.
Disposal of the device and its accessories is not carried out in
accordance with the applicable local regulations.

8 WARRANTY CONDITIONS
The manufacturer guarantees that all material and manufacturing defects
that 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 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.

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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 instructions 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.
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 MANUFACTURER'S DECLARATION
The ESH 04 is a medical product as defined by Directive 93/42/EEC.
This is documented through the CE mark.
Notified Body: TÜV Product-Service, Approval Number CE0123

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11 ELECTROMAGNETIC EMISSIONS
Table 1

Guidelines and manufacturer's declaration – electromagnetic emissions

The ESH 04 is intended for use in the environment specified below. The customer or the user of the
ESH 04 should ensure that it is used in such an environment.

Interference Compliance Electromagnetic environment - guidelines

emission
measurements

RF emissions Group 1 The ESH 04uses RF energy only for its internal function.
acc. to CISPR 11 Therefore, its RF emissions are very low and are not likely
to cause any interference to nearby electronic equipment.

RF emissions Class B The ESH 04 is suitable for use in all establishments,

acc. to CISPR 11 including domestic establishments and those directly
connected to the public power supply network that also
supplies buildings used for domestic purposes.

Emission of Class A
harmonics
according to
IEC 61000-3-2

Emission of Compliant
harmonics
according to IEC
61000-3-3

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Table 2

Guidelines and manufacturer's declaration – electromagnetic interference resistance

The ESH 04is intended for use in the electro-magnetic environment specified below. The customer or
the user of the ESH 04 should assure that it is used in such an environment.

Interference IEC 60601-
test Compliance Electromagnetic environment -

resistance test level level guideline

Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or

discharge ± 8 kV ± 8 kV ceramic tile. If floors are covered with
IEC 61000-4-2 air air synthetic material, the relative
humidity should be at least 30 %.

Fast transient ± 2 kV for power ± 2 kV for power The mains power supply quality
/electrical bursts supply lines supply lines should be that of a typical commercial
acc. to IEC 
2 kV± 1 kV for or hospital environment.
61000-4-4 input/output lines

Surges as per ± 1 kV ± 1 kV The mains power supply quality

IEC 61000-4-5 differential mode differential mode should be that of a typical commercial
± 2 kV ± 2 kV or hospital environment.
common mode common mode

Voltage dips, < 5 % UT < 5 % UT The mains power supply quality

short interruptions (> 95 % fall in (> 95 % fall in UT) should be that of a typical commercial
and voltage U T) for ½ period or hospital environment.
variations of the for ½ period If the user of the ESH 04 requires
supply voltage 40 % UT continued operation even in the case
acc. to IEC 40 % UT (60 % fall in UT) of power supply interruptions it is
61000-4-11 (60 % fall in UT) for 5 periods recommended to connect the ESH 04
for 5 periods to an uninterruptible power source or
70 % UT a battery.
70 % UT (30 % fall in UT)
(30 % fall in UT) for 25 periods
for 25 periods
< 5 % UT
< 5 % UT (> 95 % fall in UT)
(> 95 % fall in for 5 s
U T)
for 5 s

Power frequency 3 A/m 3 A/m Magnetic fields at this power

(50 Hz/60 Hz) frequency should be at levels
magnetic field characteristic of a typical location in a
IEC 61000-4-8 typical commercial or hospital
environment.

NOTE UT is the AC mains voltage prior to application of the test level.

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Table 4

Guidelines and manufacturer's declaration – electromagnetic interference resistance

The ESH 04 is intended for use in the electro-magnetic environment specified below. The customer or
the user of the ESH 04 should ensure that it is used in such an environment.

Interference IEC 60601- Compliance Electromagnetic environment - guidelines

resistance test 
test level level

Portable and mobile RF communications

equipment should be used no closer to any part of
the ESH 04, including cables, than the
recommended protection distance calculated from
the equation applicable to the frequency of the
transmitter:
Recommended protection distance:

Conducted RF 3 Veff 3 V 1 in V
disturbance 150 kHz to
variables acc. to 80 MHz
IEC 61000-4-6

Radiated RF 3 V/m 3  E1 in
disturbance 80 MHz to V/m
variables 2.5 GHz
according to IEC for 80 MHz to 800 MHz
61000-4-3

for 800 MHz to 2.5 GHz

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 meters (m).
Field strengths from fixed RF transmitters, as
a
determined by an electromagnetic site survey
should be less than the compliance level in each
b
frequency range.
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 propagation is affected by absorption and reflection from structures, objects and people.

a
Field strengths from stationary 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 resulting from stationary RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ESH 04 is used exceeds the
applicable RF compliance level above, the ESH 04 should be observed to verify normal operation. If abnormal performance characteristics are observed,
additional measures may be necessary, such as reorienting or relocating the ESH 04.

b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

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Table 6

Recommended safety distances between

portable and mobile RF telecommunications devices and the ESH 04

The ESH 04 is intended for use in an electromagnetic environment in which radiated RF disturbance
variables are controlled. The customer or user of the ESH 04 can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the ESH 04 as recommended below, according to the maximum output
power of the communications equipment.

Protection distance according to transmitter frequency m

Rated
maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
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.

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12 SYMBOLS
Certifies compliance with the Directive 93/42/EEC
0123
Observe the directions for use

Do not dispose of this product as unsorted municipal waste

SN Serial number
Safety button (This button must always be pressed
simultaneously along with the desired function to prevent only
one of the buttons being pressed inadvertently)
OFF / STBY button

ON button (thermal control)

Degree of protection Type B IPX4 Splash-proof

AC voltage DC voltage

Date of manufacture Manufacturer

Permissible relative
Permissible temperature for
humidity for transport
transport and storage
and storage
Protection class II device (mains adaptor)

13 OPERATING AND STORAGE CONDITIONS

The ambient operating temperature should be in the range of

-25 to 35 °C.
Permissible environmental conditions for transport and storage:
Temperature: -10 – 40°C
Relative air humidity: 30 – 75 %
Air pressure: 700 – 1060 hPa
Important: Values higher or lower than the ranges specified
above may cause damage to the device or its accessories.
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14 TECHNICAL DATA
Device: Emergency warmer
Type designation: ESH 04
Voltage: 12V DC
Power consumption : max. 20 W
Type: power and battery operation
Humidity protection: splash proof IPX4
Degree of protection: B
Dimensions: 160 x 105 x 300 mm
Weight: 1.3 kg
Classification: IIb according to rule 9
Operating mode: Continuous operation
Application part: IV set (not included)
Mains adaptor
Type designation: 30 W E2EFMW3
Input: 100 – 240 V AC | 50-60 Hz | 620 mA
Output: 12 V DC | 2.5 A max.

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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