Instruction for use

Hypo/Hyperthermia unit
HICO-VARIOTHERM 550
 Instruction for use HICO-VARIOTHERM 550

Hirtz & Co. KG

Bonner Str. 180
50968 Cologne, Germany

Tel.: +49 (0) 2 21 / 37 67 8 – 0

Fax: +49 (0) 2 21 / 37 67 8 – 85

e-mail: info@hico.de
Internet: www.hico.de

Doc. No. 542121; Version 16-03/17 valid from 2017-03

© 2017 Hirtz & Co. KG

HICO-VARIOTHERM 550 2
 Table of Contents

1 General information ..............................................6

1.1 Information regarding these instructions .....................6
1.2 Warnings ..........................................................................7
1.3 Limitation of liability .......................................................7
1.4 Copyright .........................................................................8
1.5 Manufacturer adress .......................................................8

2 Safety .....................................................................9
2.1 Intended use ....................................................................9
2.2 Personnel requirements .................................................10
2.3 General safety information .............................................11
2.4 Danger sources ...............................................................12
2.4.1 Danger of hypothermia or hyperthermia .......................... 12

3 Transport and setup ............................................13

3.1 Scope of delivery and transport inspection ..................13
3.2 Unpacking ........................................................................13
3.3 Waste disposal of packaging material ..........................14

4 Commissioning ...................................................15
4.1 Safety advice ...................................................................15
4.2 Setting up .........................................................................15
4.2.1 Requirements concerning the place of installation .......... 15
4.2.2 Setting up with the unit carrier (optional) ......................... 17
4.2.3 Installation with five-castor stand (optional)..................... 18
4.3 Connecting the HICO-VARIOTHERM 550 ......................19
4.3.1 Filling the system ............................................................ 19
4.3.2 Connecting the water pads.............................................. 20
4.3.3 Electrical connection ....................................................... 21

5 Function and design ...........................................22

5.1 Views of the unit, control and display elements...........22
5.2 Safety installations..........................................................23
5.2.1 Sensors ........................................................................... 23
5.3 Type plate ........................................................................24
5.4 Function ...........................................................................25
5.4.1 Basic principles ............................................................... 25
5.4.2 Indications / Side effects / Contraindications ................... 27

6 Control and operation .........................................31

HICO-VARIOTHERM 550 3
 Table of Contents
6.1 Before switching on ....................................................... 31
6.1.1 Inspection on the unit ...................................................... 31
6.1.2 Water pads ...................................................................... 31
6.2 Operation ........................................................................ 33
6.2.1 Switching on for initial commissioning ............................. 33
6.2.2 Switching on in normal operation .................................... 33
6.2.3 Function test .................................................................... 34
6.2.4 Setting the temperature ................................................... 35
6.2.5 Temperature control operation ........................................ 37
6.2.6 Handling water pads........................................................ 38
6.2.7 Usage of water pads ....................................................... 38
6.2.8 Schematic performance description ................................ 40
6.2.9 Obligations during operation ........................................... 43
6.2.10 Operator language .......................................................... 45
6.3 Alarms ............................................................................. 46
6.3.1 General information ......................................................... 46
6.3.2 Alarm description during operation .................................. 47

7 Cleaning and disinfecting................................... 50

7.1 Safety advice .................................................................. 50
7.2 Unit .................................................................................. 51
7.2.1 Water circulation.............................................................. 51
7.2.1.1. General Information for cleaning the water circuit ....... 51
7.2.1.2. Basic cleaning ............................................................. 51
7.2.1.3. Disinfection ................................................................. 51
7.2.1.4. Flushing und refilling ................................................... 52
7.2.2 Surface ............................................................................ 52
7.2.3 Ventilation openings ........................................................ 52
7.3 Water pads, hose extension .......................................... 54

8 Maintenance and safety related inspection ...... 55

8.1 Maintenance.................................................................... 55
8.1.1 Unit .................................................................................. 56
8.1.2 Water tank ....................................................................... 56
8.1.3 Hose couplings ................................................................ 56
8.2 Safety related inspection ............................................... 57

9 Troubleshooting .................................................. 59
9.1 Safety information .......................................................... 59
9.2 Fault causes and troubleshooting ................................ 60

HICO-VARIOTHERM 550 4
 Table of Contents
10 Waste disposal of old unit ..................................62

11 Technical data and accessories .........................63

11.1 Unit ...................................................................................63
11.2 Accessories...................................................................64
11.3 Symbols ...........................................................................66

12 Guidelines and declaration of manufacturer .....67

13 Brief instruction...................................................71

HICO-VARIOTHERM 550 5
 General information

1 General information
Read the information provided here so that you can quickly
become familiar with the HICO-VARIOTHERM 550 and use its
functions to their full extent.

1.1 Information regarding these instructions

These operating instructions are a component of the HICO-
VARIOTHERM 550 (referred to in the following as unit) and
provide important information for the commissioning, safety,
proper use and maintenance of the unit.
All figures and drawings in these operating instructions are for
general illustration purposes and are not definitive for the details
of their construction.
The operating instructions must always be available, preferably
in the vicinity of the unit. They must be read and applied by all
persons who are responsible for the:
• commissioning,
• operation,
• cleaning,
• maintenance,
• Troubleshooting
of the unit.

HICO-VARIOTHERM 550 6
 General information

1.2 Warnings
The following warning notes are used in these operating
instructions:

•
A warning note of this danger level identifies an imminent
dangerous situation.
Not avoiding this dangerous situation will cause severe injury or
even death.
► Follow the instructions given in this warning note to avoid the
danger of death or severe injury to persons.

•
A warning note of this danger level identifies a possibly
dangerous situation.
Not avoiding this dangerous situation can lead to severe injuries.
► Follow the instructions in this warning note to avoid the risk of
injuries to persons.

A warning note of this danger level identifies a possibly

dangerous situation.
Not avoiding this dangerous situation can lead to minor or
moderate injuries and damage to property.
► Follow the instructions in this warning note to avoid the risk of
injuries to persons or damage to property.

A note highlights additional information to assist in working with

the unit.
Limitation of liability

All technical information, data and notes on installation, operation

and care contained in this manual were up-to-date at the date of
printing and have been entered to the best of our knowledge
under due consideration of our previous experience and
knowledge.
No claims can be enforced on the basis of information,
illustrations and descriptions in these operating instructions.
The manufacturer accepts no responsibility for loss in the event
of:

HICO-VARIOTHERM 550 7
 General information
• failure to comply with the operating instructions
• unintended use
• unprofessional repairs
• technical modifications
• use of non-approved spare parts and accessories
• unauthorised conversions and changes
Translations are made to the best of knowledge. We will not
assume liability for mistakes in translation, even if the translation
was made by us or ordered by us. Only the original German text
is binding.

1.4 Copyright
This documentation is protected by copyright law.
All rights, also the rights for photo-mechanical reproduction,
copying and distribution by means of special methods (e.g. data
processing, data carrier and data networks), even in parts,
remain reserved by Hirtz & Co. KG.
Subject to changes in contents and technical modifications.

1.5 Manufacturer adress

Hirtz & Co. KG
Bonner Str. 180
50968 Cologne
Tel.: 02 21 / 3 76 78-0
Fax: 02 21 / 3 76 78-85
e-mail: hirtz@hico.de

HICO-VARIOTHERM 550 8
 Safety

2 Safety
This chapter contains important safety notes for work with this
unit.
This unit complies with the specified safety regulations. However,
improper use can lead to personal injury or material damage.

2.1 Intended use

This unit is solely intended for the cooling or heating of water
pads 1 used to cool or warm a patient. Any other use exceeding
the use described above is considered as unintended use.
The pads available as an accessory may only be used with HICO
units for use in hypo/hyperthermia treatment.

•
Danger due to improper utilisation!

Dangers may arise from the unit if it is put to unintended use

and/or if it is used for any other purpose.
► Only use the unit for the purpose it is intended for.
► Observe the procedures described in these operating
instructions.
► Use only with original accessories

Claims of any type because of damages resulting from

unintended use are excluded.
The operating company is the sole bearer of the risk.

1 In these operating instructions the term "water pad" describes all Hirtz accessories, such as water mats, water blankets,
water collars, etc. (see also chapter 11.2 Accessories)

HICO-VARIOTHERM 550 9
 Safety

2.2 Personnel requirements

► Work on/with the unit must only be carried out by persons

who are authorised for this work because of their education
and qualification. Apart from this these persons must also be
entrusted with this work by the operator.
► Allow personnel to be trained, instructed, directed or
undergoing general training to only work on or with the unit
under the supervision of an experienced person.
► Persons who are under the influence of drugs, alcohol or
medication that affects their responsiveness may under no
circumstances carry out work on or with the unit.
► Dangers may arise from the unit if it is improperly used by
untrained personnel.
► All generally valid legal and otherwise binding regulations for
the avoidance of accidents and the protection of the
environment, as well as general health and safety
requirements must be observed in addition to the operating
instructions. The operator must instruct his personnel
accordingly.

HICO-VARIOTHERM 550 10
 Safety

2.3 General safety information

Observe the following general safety information for safe

handling of the unit:
► Ensure that the unit (mains cable, housing, couplings etc.)
and water pads are in good condition before commissioning.
► Lay hoses and water pads without creases and kinks.
► Do not touch the hoses and water pads with pointed or sharp
objects. The system cannot work correctly with perforated
pads.
► Fill unit tank with sterile filtered tap water 2, to which a
germicidal agent 3 has been added.
►

► Position unit horizontally and operate; inclination of installation

area ≤ 3 %.
► Height difference between unit and water pad < 1 m.
► Do not cover unit; there are ventilation slots on the bottom
and back; there are ventilation slots and inlet ports for
ventilators on the sides.
► Observe the automatic functional test when switching on.
► Carry out automatic functional test manually at least once a
day during continuous operation.
► Medical Electrical Equipment needs special precautions,
regarding EMC and must be installed and put into operation
according to EMC information, contained in the accompanying
documents.
► Portable and mobile RF communications equipment can
affect Medical Electrical Equipment.

2 Depending on the quality of the water (e.g. calcareousness among other things), the lifetime of the unit parts that
come into contact with water is reduced.
3
e.g. 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil
solution). Alternatively, another long-term germinating preservative can also be used, e.g. Micropur or Certisil. For
further information, please contact Hirtz & Co.KG.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of unit parts that come into
contact with water!

HICO-VARIOTHERM 550 11
 Safety
► Check the water flow and water level of the unit regularly
during operation.
► Operate the unit only with an appropriate water level.
► Keep to ambient temperature range (10-30 °C) at
hyperthermia operation, (10-23 °C) at hypothermia operation
and storage temperature range (3-60 °C)
► Apply appropriate measures to position the patient on or under
the water pad (if necessary).
► Do not use water pads as electrical insulation pads in
combination with HF surgery.
► Intermediate layers between the patient and water pad (bed
sheets, surgical cloths, gel pads etc.) adversely affect the heat
transfer.
► Operate the unit only with HICO water pads and original
accessories.
► Do not operate the unit in an oxygen-enriched environment or
in the presence of combustible gases.
► In hyperthermia operation, do not use or combine the unit
together with other heat sources.
► Do not operate the unit in the vicinity of heat sources
(spotlights, direct sunlight, radiators/radiant heaters, etc.).
► Carry out maintenance and safety checks in accordance with
these operating instructions.

2.4 Danger sources

2.4.1 Danger of hypothermia or hyperthermia

There is a risk of the patient may be overheated or

undercooled.
► The body temperature of the patient must be monitored when
using the unit and the water pad on the patient.

HICO-VARIOTHERM 550 12
 Transport and setup

3 Transport and setup

3.1 Scope of delivery and transport inspection
The delivery specification of the HICO-VARIOTHERM 550
consists of:
• HICO-VARIOTHERM 550 unit
• Mains cable
• Hose bracket
• Operating instructions
• Hose extension
• Water pads (optional according to order)

► Check the delivery for completeness and for any visible

damage.
► Immediately report an incomplete delivery or damage caused
by inappropriate packaging or transport to the forwarding
agent, the insurance company and the supplier.

3.2 Unpacking
To unpack the unit:
• Take the unit out of its box and remove the packaging material.
• Place the unit on a level and horizontal base with sufficient
load bearing capacity.

Condensation in the device can lead to failure.

► After unpacking, the unit must be acclimatised for at least two
hours before commissioning when there are temperature
differences of more than 8 °C of the intended ambient
operating temperature.

HICO-VARIOTHERM 550 13
 Transport and setup

3.3 Waste disposal of packaging material

The packaging protects the unit from transport damage. The
packaging materials are selected on the basis of environmentally
friendly and disposal-related factors and are therefore recyclable.
Feeding the packaging back into the material cycle saves raw
materials and decreases generated waste. Dispose of packaging
materials that are no longer required at the collection points for
the »Green Dot« recycling system.

► If possible, keep the original packaging throughout the unit's

lifetime so as to be able to repack the unit properly in case of
repair.

HICO-VARIOTHERM 550 14
 Commissioning

4 Commissioning
This chapter contains important information for commissioning
the unit. Please follow these notes to avoid dangers and
damages.

4.1 Safety advice

Personal and material damage may occur when

commissioning the unit!
Observe the following safety information to prevent hazards:
► The weight of the unit is approx. 17 kg.
► The unit should only be transported, unpacked and installed
by two people.
► Avoid to use the device directly beside or stacked with other
devices.
► If the usage of the device in such case is required. Is it
necessary to observe the device, to guarantee the intended
use.

4.2 Setting up
4.2.1 Requirements concerning the place of installation
For safe and fault-free operation of the unit the set up place,
• must have sufficient load bearing capacity (weight of unit
approx. 17 kg).
• must be level.
• must be horizontal (inclination ≤ 3%).
• must provide 20 cm space to either side of the unit and behind.
• must ensure sufficient ventilation of the device, e.g. in a rack
trolley also upwards.
• must be at the same level as the water pad, i.e. next to the
patient's bed
(max. height difference approx. 0.5 m), for example.
The carrier or the five-castor stand (see chapter 4.2.2 and 4.2.3)
available as accessories meet all of these requirements.

HICO-VARIOTHERM 550 15
 Commissioning

► If the unit is not horizontal, the display in the front of the unit
will indicate the water level incorrectly.
► If the unit is far below the level of the water pad, the water
circulation may be interrupted with heavy patients.
Furthermore, water may flow back into the unit and cause
overflowing of the water tank when the water filling socket is
opened with the unit switched off.

For optimal operation of the unit, the place of installation should

meet
• the following enviromental conditions:
- ambient temperature: 20 °C  3 °C
- relative air humidity: 50 %  20 %
- air pressure: 700 hPa to 1060 hPa

Performance limitations in the attainable pad transition

temperatures under extreme environmental conditions and
selected pad (see chapter 6.2.8 Schematic performance
diagrams), may also lead to restrictions in the intended use.

Condensation in the device can lead to failure.

► If the temperature differences reach more than 8 °C during
installation of the device for the intended operating
environment ambient temperature, allow the unit to
acclimatise for at least two hours before use.

HICO-VARIOTHERM 550 16
 Commissioning

4.2.2 Setting up with the unit carrier (optional)

The stand, which is optionally available as an accessory, makes
the stationary HICO VARIOTHERM 550 mobile.
Install the unit together with the stand as follows:
• Assemble the stand as described in its operating instructions
(K2B0045).
• There are two elongated holes in the base of the stand; place
the HICO-VARIOTHERM 550 on the base of the stand in such
a way that the elongated holes and the thread in the base of
the unit are aligned with one another.
• The base of the stand is screwed to the unit using a knurled
screw.

Personal and material damage may occur when installing

and using the stand with the unit!
► To assemble the stand, observe the safety notes in the
assembly and operating instructions on the stand!
► The stand only serves to carry HICO systems!
► Do not use any aggressive detergents; the stand is not
suitable for use in washing systems!
► The stand should be checked for full functionality of all
components at least once a year:
Are the screw connections still secure?
Cleanse the castors of contaminants so that the brakes work
and the electrical conductivity is not marred.
If a fault is detected, only original spare parts may be used and
only replaced by an expert or customer service.

HICO-VARIOTHERM 550 17
 Commissioning
4.2.3 Installation with five-castor stand (optional)
The five-castor stand available as an accessory makes the
HICO-VARIOTHERM 550, designed as a stationary unit, mobile.
Install the unit together with the stand as follows:
• Assemble the five-castor stand as described in its operating
instructions.
• Place the stand plate (1) on the vertical pipe (2) of the five-
castor stand.
• Fix the plate with the star screw (3).
• There is a safety screw (4) in the stand plate; place the HICO-
VARIOTHERM 550 on the plate in such a way that the screw
and the thread in the base of the unit are aligned with one
another.
• Secure the unit by screwing the safety screw into the base of
the unit.

Personal and material damage may occur when installing

and using the five-castor stand with the unit!
► Five-castor stand assembly: For the safe functioning and
stable condition of the system, it must be ensured that, when
assembling the five-castor stand, the holding rod (2) in the
centre section and all 5 stabilisers with castors are safely
1 2 3 4 mounted in accordance with the instructions and safety
information on the five-castor stand.
► The five-castor stand only serves to carry HICO systems!
► Do not use any aggressive detergents; the five-castor stand
is not suitable for use in washing systems!
The five-castor stand should be checked for full functionality of all
components at least once a year:
► Are the screw connections still secure?
► Cleanse the castors of contaminants so that the brakes work
and the electrical conductivity is not marred.
► This should be checked directly after assembling and at
regular intervals during the operating period (at least with / at
the recommended yearly maintenance interval)
► If a fault is detected, then only original spare parts may be
used and only replaced by an expert or customer service.

HICO-VARIOTHERM 550 18
 Commissioning

4.3 Connecting the HICO-VARIOTHERM 550

Danger caused by water in connection with electricity.

► Only connect the unit to the mains supply after it has been
filled.

4.3.1 Filling the system

• Unscrew the cap from the water filling socket (5), e.g. with a
coin. Take care not to lose the sealing ring of the cap.
• Observe the water level indicator (6) while filling. After filling,
the water level should be slightly below the MAX mark.
• Fill unit tank with sterile filtered tap water 2, to which a
germicidal agent 7 has been added.
•

The usage of a non-proportional share of disinfectants can

reduce the lifetime of those parts of the unit that will come into
contact with water! For initial filling of the unit, please follow the

Danger caused by water in connection with electricity.

Water is electrically conductive.
► If water has been spilled when filling the unit, the unit must
first be thoroughly dried and should only be connected to the
mains supply and switched on after it has completely dried
out.

2 Depending on the quality of the water (e.g. calcareousness among other things), the lifetime of the unit parts that
come into contact with water is reduced.
7
e.g. 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil
solution). Alternatively, another long-term germinating preservative can also be used, e.g. Micropur or Certisil. For
further information, please contact Hirtz & Co.KG.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of unit parts that come into
contact with water!

HICO-VARIOTHERM 550 19
 Commissioning

4.3.2 Connecting the water pads

• The hose bracket (7) provided makes it easier to lay the hoses
7 8
between the pad and the unit. To attach the bracket, loosen
the two knurled screws (8) on the left-hand side of the unit and
then use them to fasten the bracket.

• Push the hose device couplings of a hose extension onto the

coupling pair (9) on the unit.
• Push the hose pad couplings of the hose extension onto the
coupling pair on the water pad.
• The couplings are then correctly connected to each other when
the locking mechanisms on the couplings are engaged in their
corresponding counterparts in such a way that the connection
will no longer come loose by itself.
• You can loosen the coupling again by pushing the metal plate
on the hose coupling and pulling the coupling out.

► The coupling connections of the hose extension cannot be

"confused" when connecting them to the couplings of the unit
since it makes no difference in what direction the water flows
through the water pad.
► Water pads can also be decoupled when the unit is switched
on. Water dripping out of the coupling is in this case quite
normal and does not indicate a leakage or defect.
In heating operation at 39 °C: Reduce the nominal
temperature before decoupling the water pad.
In cooling operation at 15 °C: Increase the nominal
temperature before decoupling the water pad.
The water in the unit circuit may otherwise briefly go above
the upper or lower limit temperature and the unit may trigger
various alarms.

HICO-VARIOTHERM 550 20
 Commissioning
4.3.3 Electrical connection

Danger caused by electrical current

Defective cables and/or plugs as well as faults in the power
supply can cause life threatening electric shock!
► Check the condition of unit cable and plug before connecting!
► To avoid the risk of electric shock, this unit must only be
connected to the mains with a protective earth conductor!

Please observe the following notes when connecting the unit

electrically to ensure safe and fault free operation:
• Before connecting the unit, compare the electric data (voltage
and frequency) on the type plate with the data of your mains
power supply. This data must match to prevent the unit from
being damaged
Please ask your electrics expert for advice, if in doubt.
• The electric socket must be protected by a 16 A circuit breaker.
• Use the cable supplied with the unit to connect the unit to the
mains supply. The unit socket is located on the rear side of the
unit (see chapter 5.1, Views of the unit, control and display
elements).
• Power supply at the installation site must meet the
requirements for electrical systems in hospitals and medical
environments (see VDE 0100 Part 710:2012-10 "Low-voltage
electrical installations Part 7-710: Requirements for special
installations or locations - Medical locations.").

HICO-VARIOTHERM 550 21
 Function and design

5 Function and design

This chapter contains you important information about the design
and function of the unit.

5.1 Views of the unit, control and display elements

12
10 4) Thread for safety screw
(in base plate)
5 5) Water filler neck with
screw cap
6) Water level indicator
11 9) Hose couplings
10) Unit handles
17 11) Temperature display for
13
18 water pad
6
19 12) Display for status and
14 fault messages
20
13) Fault lamp
21
14) Temperature display for
nominal value
15) Water flow display
15
16) Mains switch
17) Functional test
16
18) Audio paused
19) Nominal value higher
20) Release
9 <35 °C / >38 °C
21) Nominal value lower

Rearview (section) of the

unit with microfuse and
connector plug

HICO-VARIOTHERM 550 22
 Function and design

5.2 Safety installations

5.2.1 Sensors
During operation, the HICO-VARIOTHERM 550 monitors
• the water level in the unit
• whether the water temperature in the circuit corresponds with
the set nominal value
• whether mains voltage is applied
• whether its own functional safe
and emits alarms in case of malfunctions (see chapter 6.3).

The HICO-VARIOTHERM 550 application system has no

monitoring function for measuring of the patient.
► Monitoring core temperature of the patient to be treated must
be carried out regularly independently of the application
system.
► The temperature settings of the transition temperatures on
the pad must be manually entered in the system by the user,
and the individual course of therapy should be corrected or
adjusted accordingly.
► The system should only be used/put into operation by
users who are qualified in its intended use!

HICO-VARIOTHERM 550 23
 Function and design

5.3 Type plate

The type plate with the connection and performance data is
located on the rear side of the unit:

HICO-VARIOTHERM 550 24
 Function and design

5.4 Function
5.4.1 Basic principles
The hypo/hyperthermia unit HICO-VARIOTHERM 550 serves the
purpose of cooling or warming patients by means of water pads.
The unit was developed under due consideration of the latest
safety and application related knowledge about water pad
systems.
The temperature conductance between patient and the water
pad is solely achieved by surface contact. Thanks to its high heat
capacity and heat conductivity, water is an ideal transmission
medium for this type of application.
The sterile filtered tap water is cooled down or heated between
15 °C and 39 °C in a water tank inside the unit by means thermo-
electrical elements and continuously pumped through the water
pad by a centrifugal pump.
Reaching the transition temperature of the pads is
dependent on the environmental conditions and the size of
the pad.
The HICO-VARIOTHERM 550 is characterised by its simple and
safe use, reliability and compact design.
Through its electronic control, the temperature transfer to the
patient can be accurately adjusted whilst at the same time
maintaining high operational safety.
The transition temperature to the patient when warming up
should normally not exceed 40 °C to prevent the risk of burning
in case of long-term applications. This risk occurs not only at too
high temperatures, but also at too low temperatures. At a water
temperature of more than 41 °C, the HICO-VARIOTHERM 550
switches off electronically and electrically to minimise this risk in
case of an equipment fault when warming.

HICO-VARIOTHERM 550 25
 Function and design
Transition temperatures of < 35 °C and > 38 °C must be
consciously set by the user and closely monitored.
In this way, the risk of local temperature accumulation is virtually
ruled out, while ensuring compliance with the requirements
concerning the place of installation and site of application.
Performance limitations in the attainable pad transition
temperatures under extreme environmental conditions and
selected pad (see chapter 6.2.8 Schematic performance
descriptions), may also lead to restrictions in the intended use.
Operating the HICO-VARIOTHERM 550 is simple and intuitive,
incorrect use is almost ruled out.

Danger caused by overestimation and underestimation of

the performance of the system!
Dangers may arise from the unit if it is put to unintended use, and
if desired temperatures under given conditions are not achieved.
The reliable therapeutic use of the system requires the user to
carry out a careful risk assessment and continuous monitoring
and care of the patient.

HICO-VARIOTHERM 550 26
 Function and design
5.4.2 Indications / Side effects / Contraindications
Indications
The HICO VARIOTHERM 550 is of general use in
hypo/hyperthermia treatment for:
• Heat supply in the case of intraoperative or postoperative
hypothermia.
• Heat supply or heat withdrawal to stabilise the patient's
temperature (normothermia).
• Heat withdrawal in case of malignant hyperthermia.
Specifically, the HICO VARIOTHERM 550 can be used in the
support of hypo/hyperthermia treatment in:
• Therapeutic hypothermia in intensive care (mild hypothermia),
• Neuroprotection for patients after cardiac arrest,
• Neuroprotection for cerebral trauma, stroke and in
neurosurgery,
• Myocardial protection after myocardial infarction
• Induced hypothermia in asphyctic newborn infants
• Hypoxic-ischaemic encephalopathy (HIE) in newborn infants

Danger caused by overestimation and underestimation of

the performance of the system!
Dangers may arise from the unit if it is put to unintended use
when:
► Improper observation of physical connections in external unit
accessories and environmental conditions (pad size, ambient
temperature etc.)
► individual and unpredictable patient reactions.
The reliable therapeutic use of the system requires the user to
carry out a careful risk assessment and continuous monitoring
and care of the patient.

HICO-VARIOTHERM 550 27
 Function and design
Side effects
There are no known side effects for the materials used in water
pad systems.
In use, a temperature transfer by means of water pads may be
considered unsatisfactory if:
• less than 20 % of the water pads surface comes into contact
with the patient
• the contact pressure reduces the skin circulation. In this case
there is an additional risk of bedsore.
In warming applications and the related targeted increasing of
the patient's temperature during long-term applications and too
high temperatures, there is always a risk of burning.
In cooling applications and the related targeted lowering of the
patient's temperature (therapeutic hypothermia) there is a also
possibility of burn risk (freezer burn) in the same way as with
warming applications, and side effects may occur such as:
• autonomous reactions (among others shivering),
• electrolyte disturbance,
• higher diuresis (diuresis fluctuations),
• hyperglycaemia (glycaemic fluctuations),
• higher blood loss (due to reduced blood-clotting factors),
• change to the pharmacokinetics,
• increased rate of wound infection (sepsis),
• risk of decubitus
In addition, this can cause reversible dilated pupils; dilated fixed
pupils in an undercooled patient, therefore, must not be a sign of
a serious brain injury.

HICO-VARIOTHERM 550 28
 Function and design
In addition to the described side effects in adults during
therapeutic hypothermia, in newborns the following must still also
be considered:
• (severe) pulmonary hypertension,
• viscosity increase (clotting disorders and manifest thrombosis)
in polycythaemia (polycythaemia > 65 % first after
hemodilution),
• thrombocytopenia,
• arterial hypertension,
• hypovolemia,
• PPHN (Persistent pulmonary hypertension of the newborn),
• bradycardia
• haematuria

In pediatrics, after perinatal hypoxia/ischaemia, moderate

hypothermia of 33 - 34 °C within the first 6 hours for a period of
48 – 72 hours causes a significant improvement in the
neurological outcome between the age of 12 – 18 months.
The inclusion criteria for newborns is ≥ 36 weeks of pregnancy
and in ages < 6 hours with acute encephalopathy and peripartum
asphyxia results.
The exclusion criteria is in ages > 6 hours and newborns "in
extremis".

Contraindications
• advanced malign disease
• persistent state of shock / cardiopulmonary instability
• pregnancy
• coma of different origin
• body temperature below 30 °C during the recording
• time interval when starting resuscitation and cardiac arrest
above 15 minutes
• application distal of arterial cross-clamping

HICO-VARIOTHERM 550 29
 Uncontrolled hypo/hyperthermia associated with increased
patient mortality.
► If the body temperature falls below 32 °C, then life
threatening complications may occur such as cardiac
arrhythmia, metabolic disturbances and cardiac arrest.
► After hypothermia treatment, the patient should be warmed
up again at temperatures of no more than 0.25 °C – 0.5 °C
per hour. Too rapid warming also leads to arrhythmias and
ventricular fibrillation with subsequent risks.
► When used on ischemic limbs there is an increased risk of
tissue damage and shock.

► For low-risk and reliable application of hypo/hyperthermia

treatment, an external continuous monitoring of the body core
temperature (e.g. by taking a measurement in the urinary
bladder) is of the utmost importance.
► The therapeutic moderate mild to moderate hypothermia
requires the user to carry out a careful risk assessment and
continuous monitoring and care of the patient, with regards to
side effects, the prophylaxis of pressure induced lesions and
the efficiency of the system.
► Due to the excellent heat conductivity of water, the patient
may cool down when the unit is switched off or the water pad
is disconnected from the unit. Only leave the water pad in
contact with the patient in normal operation.
► No application distal of arterial cross-clamping!

Due to continuously new knowledge in the field

hypo/hyperthermia, the information provided here does not claim
to be current or complete.
Hirtz & Co. KG has no responsibility or liability for negligence or
false applications and also cannot specify any medical
recommendations and procedures. The user must independently
weigh up what is used and how this is carried out.

HICO-VARIOTHERM 550 30
 Control and operation

6 Control and operation

This chapter contains important information on handling the unit.
Please follow these notes to avoid dangers and damages.

6.1 Before switching on

6.1.1 Inspection on the unit
Examine the unit for external damage.
Check the water level before and after
• switching on the unit
• connecting the water pad.
The water level must be between both marks on the water level
indicator (6), preferably just below the maximum mark. The filling
difference between both marks is approx. 0.5 litre.

Top up sterile filtered tap water to which a germicidal agent has

been added, if

• the water level is below the minimum mark.

• you want to connect an empty water pad and the water level is
below the maximum mark.

6.1.2 Water pads

• Only connect original HICO hose extensions with HICO water
pads to the HICO-VARIOTHERM 550.
• Check the water pads for external damage before connecting.
Use only undamaged pads.
• Prepare a collecting basin in case a pad should start leaking.
• Use a thin fleece between the water pad and the patient's skin.

HICO-VARIOTHERM 550 31
 Control and operation
Water pads can be coupled and decoupled whether the unit is
switched on or off.

Disconnecting water pads when the unit is switched on:

► In heating operation at 39 °C: Reduce the nominal
temperature before you disconnect the water pad.
► In cooling operation at 15 °C: Increase the nominal
temperature before you disconnect the water pad. The sterile
filtered tap water in the circuit of the unit can otherwise
temporarily exceed the high or low temperature limit and
possibly trigger various alarms.

Intermediate layers between the patient and water pad (sheets,

surgical cloths, gel pads etc.) adversely affect the heat transfer.
► The use of a thin fleece as an intermediate layer is
recommended. Direct skin contact with the pad, which is
made of plastic, can lead to skin damage and increases the
risk of bedsore.
► Pay attention to crease-free installation of the fleece.

HICO-VARIOTHERM 550 32
 Control and operation

6.2 Operation
6.2.1 Switching on for initial commissioning
• Switch on the unit with the push button (16); in switched-off
condition the push button is flush with the front panel.
• If the set nominal value is greater than 38 °C or lower than
35 °C, check whether nominal value is correct before pressing
the release key (20).
• Run the unit for about two minutes to remove any air from the
circuit in the unit.
• Check the water level on the indicator (6); if necessary, switch
off the unit, disconnect it from the mains supply and refill
sterile filtered tap water to which a germicidal agent has been
added.
• Connect a water pad to the unit; the pad and the unit should be
at the same level.
• Reconnect the unit to the mains supply, switch it on and run it
for another two minutes to force all air out of the water pad.
• Check the water level on the indicator (6) again; if necessary,
switch off the unit, disconnect it from the mains supply and
refill sterile filtered tap water to which a germicidal agent has
been added.

6.2.2 Switching on in normal operation

• Switch on the unit using the pressure switch (16); when
switched off, the switch is flush with the front cover.
• If the set nominal value is greater than 38 °C or lower than
35 °C, check whether it is correct and only press the release
button (20) if it is.
• Check the water level on the indicator (6), especially if you
have connected an unfilled water pad.
• After use, switch the unit off using the pressure switch (16)
and disconnect the plug from the mains.

HICO-VARIOTHERM 550 33
 Control and operation
6.2.3 Function test
After switching on the device performs a function test. During this
test observe whether all indicating elements behave as described
below:
• a short audible alarm indicates that the unit is prepared for a
possible power failure alarm

The unit now checks its self-sufficient protection and

• shows the result in the display (12)

• the temperature displays (11) and (14) shows

• the fault lamp (13) lights up
• the audible alarm is on.
This test takes a few seconds.

If the functional tests did not complete successfully, the unit

is no longer fail safe.
Do not operate unit if
► the unit does not issue the short signal tone for the power
failure alarm when switching on.
► the automatic functional test automatically switches the unit
off because it has detected a defect in the independent
protection device.
► one or more displays are defective.
In these cases, have the unit checked by HICO customer
service.

HICO-VARIOTHERM 550 34
 Control and operation
6.2.4 Setting the temperature
• Set the nominal value for the water temperature - i.e. the
temperature on the contact area between water pad and
patient - with the two arrow keys (19) and (21). The
temperature can be set in steps of 0.1 °C between
15 and 39 °C. The temperature display (14) shows the set
nominal value.

• For nominal temperature values above 38 °C, press the up

arrow key (19) and the release key (20) at the same time.

• For nominal temperature values below 35 °C, press the arrow

key (21) and the release key (20) at the same time.

► Temperature below 35 °C, withdraw heat from the patient at a

higher rate.
► Temperatures above 38 °C supply the patient with heat at a
higher rate.
► Places of the body, which are subjected to increased
pressure, may suffer under pressure necrosis and/or burns,
even at temperatures below 40 °C. This applies for long-term
applications and risk patients in particular5.

For the indication and safe operation application, the

chapters 4.2.1; 5.4.2, 6.2.8 and 6.2.9 are to be observed!
External conditions and pad size influence the desired nominal
value; e.g. very high or low nominal values at high or low ambient
temperatures possibly may not be reached and/or when
connecting a large pad or two water pads. In this case, set a
lower or higher nominal value so the unit can safely regulate the
temperature.
Check the water flow on the display (15)!

5 cf. Scott S.M., Thermal blankets injury in the operating room, Arch. Surg. 34, Page 181, 1967

HICO-VARIOTHERM 550 35
 Control and operation
Heat transfer:
The heat transfer (heat supply or heat withdrawal) between
patient and the water pad will only takes place if the temperature
of the water pad is higher or lower than the skin temperature of
the patient at the contact surface.
The measure of heat transfer is proportional
• to the temperature difference of the skin temperature and the
water pad temperature
• to the size of the contact area.
Intermediate layers impair heat transfer (e. g. surgical cloths or
gel pads).

Example of temperature difference:

The heat transfer from the pad to the patient doubles if the temperature
difference between the water pad and the patient is doubled. If the patient's
skin has a temperature of 34 °C at the contact area and the water pad
temperature is raised from 36 °C to 38 °C, then the heat transfer will double
because the temperature difference is doubled from 2 °C to 4 °C.
Due to the thermoregulation of the patient, this is only approximately true.

HICO-VARIOTHERM 550 36
 Control and operation
6.2.5 Temperature control operation

There is a risk of the patient becoming overheated or

undercooled.
► The patient's body temperature must be monitored when
using the unit and water pad on the patient.
If the nominal temperature value is set between 35 °C and 38 °C,
then the unit will start normal operation after switching on and
after the function test, and regulate the water temperature in the
water circuit of the system to the set value.
If the nominal value is higher than 38 °C or lower than 35 °C, the
unit will emit an audible alarm and the message "NOMINAL
VALUE <35/>38 °C!", "RELEASE KEY" appear in the display
(12).
Check whether the nominal value is correct and do not pressing
the release key (20).
The unit starts temperature control operation and the display (12)
shows the reading "HEATING ACTIVE" or "COOLING ACTIVE".

Only leave the water pad in contact with the patient in

normal operation.
Due to the excellent heat conductivity of water, the patient may
cool down when the unit is switched off or the water pad is
disconnected from the unit.

If due to external conditions and pad size a desired nominal

value is not reached within 60 mins after switching on the
system, an alarm message (TEMP.DIFF >1 °C) see chapter
6.3.2 Alarm descriptions during operation…;
In this case, adjust the nominal value to the actual value
displayed.
Check the water flow in the display (15)!

HICO-VARIOTHERM 550 37
 Control and operation
6.2.6 Handling water pads

► Avoid contact with hot, sharp and pointed objects.

► When disconnecting water pads from the switched off unit,
the pad should be lower than the unit. This prevents backflow
and the pads stay sufficiently filled with sterile filtered tap
water for the next use.
► Water pads connected to the unit should never be stored at a
higher level than the unit, e.g. not on top of the unit. The
sterile filtered tap water will in such cases flow from the pad
back into the unit and flow over.
► Water pads should be stored rolled up whenever possible.
Creases and kinks can damage the material.
► Avoid direct sunlight. Heat and UV rays cause material
damage.

6.2.7 Usage of water pads

The water pads can be laid horizontally and be used both as an
underlay and as a cover underneath and over the patient. It is
also possible, if necessary, to use smaller pads and blankets as
a wrap. It is important to ensure a crease and buckle-free routing
of the pad and the hoses so that the water flow is not affected or
caused by the pads not unnecessary pressure points on the
patient. Pay attention to the largest possible surface contact with
the patient, given the particular pad size. The use of a thin fleece
as an intermediate layer is recommended. Direct skin contact
with the pad which is made of plastic can lead to skin damage
and increases the risk of bedsore. Also, pay attention to crease-
free installation of the support pad.

External conditions and pad size influence the desired nominal

value; e.g. very high or low nominal values probably may not be
reached and/or when connecting a large pad. After
commissioning the unit, observe the nominal and actual
temperature differences and in this case set a lower or higher
nominal value after approx. 45-40 min after operation,
corresponding to the actual value on the unit.

HICO-VARIOTHERM 550 38
 Control and operation

► See also chapters 4.2.1 Requirements concerning the place

of installation and 6.1.2 Water pads.
► For a trouble-free and stable operation, the temperature
difference between the nominal and actual value displayed
on the unit should not be greater than 1 °C.
► The thicker the intermediate layers are between patient and
water pad (bed sheets, surgical cloths, gel pads etc.), the
worse the heat transfer.

HICO-VARIOTHERM 550 39
 Control and operation
6.2.8 Schematic performance description
Explanation:
The performance descriptions have been determined to meet
specific requirements in the laboratory with three different
ambient temperatures and three different pad combinations.
The desired pad temperatures to be reached: 39 °C6 and 15 °C
at Ambient temperature: 10 °C, 20 °C and 30 °C
Water temperature at start of test: 20 °C

Pads used:
1 smallest pad: LxW: (50 x 30) cm / area: 1.500 cm²
1 largest pad: LxW: (170 x 50) cm / area: 8.500 cm²
1 head wrap
1 vest

The selected pad sizes are representative for other pad sizes
used from the HICO range.
The following diagrams for performance descriptions represent,
according to standards established in the laboratory, schematic
limit value observations (extreme conditions) with respect to
ambient temperatures, applied parts and setting possibilities.
This leads to the following restrictions:
• At an ambient temperature of 30 °C only a minimum
temperature of 22 °C is expected for the smallest pad.
• At an ambient temperature of 30 °C only a minimum
temperature of 23 °C is expected for the largest pad.
• At an ambient temperature of 30 °C only a minimum
temperature of 21 °C is expected for the head wrap.
• At an ambient temperature of 30 °C only a minimum
temperature of 23 °C is expected for the vest.
The details of the performance descriptions are approximate
values.

6 In accordance with the requirements of DIN EN 80601-2-35:2009 August 2010, the system is limited to 40 °C
temperature attainment.

HICO-VARIOTHERM 550 40
 Control and operation
Performance chart:
The temperature limit values7 to be reached within 10 minutes to
60 minutes (see diagrams 1-3) after commissioning or the
temperature setting during operation in case of application under
test conditions in the laboratory;

In practical application, the temperature/threshold values

can differ!
Here, the information, warnings and notes etc. are also to be
observed from the relevant chapters:
4.2.1 Requirements concerning the place of installation
5.4.1 Basic principles
5.4.2 Indications / side effects / contraindications
6.2.5 Temperature control operation
6.2.7 Usage of water pads
6.2.8 Schematic performance descriptions
6.2.9 Obligations during operation
6.3.2.2 Alarms; Display message: TEMP.DIFF >1 °C

Ambient temperature 10 °C
45 °C

40 °C

35 °C

30 °C

25 °C
Max
20 °C Min

15 °C

10 °C

5 °C

°C
largest pad smallest pad head wrap vest

Performance chart 1

7 The temperature data are reference values from the schematic performance descriptions of the laboratory investigations.
They do not claim the accuracy in the practical use of the system.

HICO-VARIOTHERM 550 41
 Control and operation

Ambient temperature 20 °C
45 °C

40 °C

35 °C

30 °C

25 °C
Max
20 °C Min

15 °C

10 °C

5 °C

°C
largest pad smallest pad head wrap vest

Performance chart 2

Ambient temperature 30 °C
45 °C

40 °C

35 °C

30 °C

25 °C
Max
20 °C Min

15 °C

10 °C

5 °C

°C
largest pad smallest pad head wrap vest

Performance chart 3

HICO-VARIOTHERM 550 42
 Control and operation
6.2.9 Obligations during operation

6.2.9.1 Indication-based

Danger caused by overestimation and underestimation of

the performance of the system!
Dangers may arise from the unit if it is put to unintended use
when:
► improper observation of physical connections in external unit
accessories and environmental conditions (pad size, ambient
temperature etc.),
► individual and unpredictable patient reactions.
The reliable therapeutic application of the system requires
the user to carry out a careful risk assessment between the
desired indication and performance of the system, as well as
continuous monitoring and care of the patient, with regards
to side effects, the prophylaxis of pressure induced lesions
by heat or cold.
For low-risk application of hypo/hyperthermia, an external
continuous monitoring of the body core temperature (e.g. by
taking a measurement in the urinary bladder) is of the utmost
importance, since uncontrolled hypo/hyperthermia is associated
with increased patient mortality. See chapter 5.4.2 for indications
/ side effects / contraindications.

The medical information provided here, due to continuously new

knowledge in the field hypo/hyperthermia, does not claim to be
complete. Hirtz & Co. KG has no responsibility or liability for
negligence or false applications and also cannot specify any
medical recommendations and procedures. The user must
independently weigh up what is used and how this is carried out.

HICO-VARIOTHERM 550 43
 Control and operation
6.2.9.2 System-related

Check the water flow

During operation, check the water flow in the unit and the pad at
regular intervals. The sight glass of the water flow indicator (15)
features an impeller wheel. With optimal water flow the individual
blades of the impeller are not individually visible.

Carry out function test

During long-term operation check the independent protection
manually at least once every day. For this purpose press the
function test key (17) during operation. The unit now tests the
safety electronics:
• the alarm sounds

• the temperature indicators show

• the yellow fault lamp (13) lights up
• the display shows FUNCTIONAL TEST.
• After successful testing the display shows the message
"FUNCTION TEST OK", the unit will automatically resume
normal operation.

If the function test was not completed successfully, the unit

is no longer safe to operate. In this case
► do not use the unit on a patient.
► have the unit inspected by Customer Service.

Checking the temperature control operation

During long-term operation, check the nominal and actual values
of the temperature display regularly; see chapter 6.2.5 and 6.3.2.

HICO-VARIOTHERM 550 44
 Control and operation
6.2.10 Operator language
The status and error messages in the display (12) can be
displayed in the languages: German, English, French, Spanish,
Italian and Polish.
Set the display language as follows:
• Switch on device on
• Hold the key "Audio paused" (18) depressed for about 4
seconds; the language set last appears in the display.
• Keep pressing the arrow key "Nominal value higher" (19), until
the desired language appears in the display.
• About 10 seconds after the last input the unit will return to its
previous operating status, the language displayed last is
active.

HICO-VARIOTHERM 550 45
 Control and operation

6.3 Alarms
6.3.1 General information
The unit always emits visual and audible alarms. Is
instantaneously informed about any malfunction, which in turn
enhances the operational reliability of the system. The display
(12) shows the fault condition that has caused the alarm (except
power failure alarm).
The alarms are arranged with a medium priority 10. Failure to
comply could result in the following:
• Minor injuries or inconveniences within a period of time which
is not long enough for manual corrective action (direct).
• Reversible injuries within a period of time which is not long
enough for manual corrective action (immediate).
• Death or irreversible injury within an undefined period of time
which is greater than the "immediate" named time period
(delayed).
If for reasons described in chapter 6.3.2 a system alarm
message is given, these can be cancelled as follows depending
on the expected result.
• Pressing the "Audio paused" key (18) interrupts the audible
alarm for 10 minutes. The error message can be read in the
display (12). The flashing fault lamp (5) stays on as long as
the alarm condition is present. The alarm condition is correct
according to the alert message on the display (12).
• The unit will switches off all functions. The audible alarm
cannot be interrupted. Switch off the unit by the mains switch
(16), take it out of and if necessary, have it inspected by a
Service Engineer (Customer Service / Medical Engineering).

Before pressing the "Audio paused" key (18) or the mains switch
(16) to suppress the alarm or take the unit out of service, please
read the error message in the display!

8
Source: DIN EN 60601-1-8:2008-02 Tabelle 1 – Alarmbedingungs-Prioritäten

HICO-VARIOTHERM 550 46
 Control and operation
6.3.2 Alarm description during operation

6.3.2.1 Display message: WATER LEVEL!?

The unit triggers this alarm if the water level drops below the MIN
mark on the water level indicator (6) during operation. The
display shows "WATER LEVEL!?", the yellow fault lamp (13)
flashes and a pulsating signal tone sounds.
• Press the "Audio paused" key (18) to interrupt the audible
alarm for 10 minutes.
• Immediately fill up sterile filtered tap water to which a
germicidal agent has been added, until the water level is just
below the MAX mark (6) (see chapter 4.3.1 “Filling the system
with water”).

► In case of a too low water level a sufficient water circulation

can no longer be assured.
► A too low water level can cause damage to components of
the unit and thus lead to total failure of the unit.

6.3.2.2 Display message: TEMP.DIFF >1 °C

Should the water pad temperature deviate from the set nominal
temperature by more than 1 °C during operation, the unit will
trigger this alarm. The display shows "TEMP.DIFF. >1 °C", the
yellow fault lamp (13) flashes and a pulse signal tone sounds.
• Press the "Audio paused" key (18) to interrupt the audible
alarm for 10 minutes.
• Change the nominal value, until the unit is able to regulate the
temperature reliably.

► Connecting or disconnecting a water pad during operation

can cause an alarm triggering temperature difference.
► The alarm can be triggered in unfavourable room
temperatures, because the specified nominal value (e.g.
15 °C or 39 °C) can in this case not be achieved. Change
the nominal value until the unit is able to regulate the
temperature reliably.
► After switching on the unit and after changing the nominal
temperature this alarm function is suppressed over a
specified period of time.

HICO-VARIOTHERM 550 47
 Control and operation
6.3.2.3 Display message: ALARM TEST DEFECTIVECUSTOMER SERVICE
The unit triggers this alarm if it has detect a fault during the
automatic or manual function test or has found that the
independent protection does not respond. The display shows
"ALARM TEST DEFECTIVE" and "CUSTOMER SERVICE",
the yellow fault lamp (13) flashes and a pulse signal tone sounds.
The audible alarm cannot be interrupted using the "Audio
paused" key (18).
• Switch off the unit at the mains switch (16).
• Switch the unit back on.

If the unit still emits an alarm take it out of service and have it
inspected by a Service engineer (Customer service / Medical
engineering).

6.3.2.4 Display message: UNDERTEMPERATURE CHECK UNIT

The unit triggers this alarm if the water tank temperature falls
below the measuring range (approx. 9 °C). The display shows
"UNDERTEMPERATURE" and "CHECK UNIT". The yellow fault
lamp (13) flashes and a pulsating signal tone sounds. The
temperature display shows .
The audible alarm cannot be interrupted using the "Audio
paused" key (18).
• Switch off the unit with the mains switch (16).
• Take the unit to a warmer environment and wait for about 2
hours.
• Switch the unit back on.

► Store the unit only in the permissible temperature range, the

unit may otherwise be damaged (3-60 °C).
► Only operate the unit in the permissible temperature range
(10-30 °C) at hyperthermia and (10-23 °C) at hypothermia,
otherwise it does not function in a fail-safe manner and may
be damaged (Observe chapter 4.2.1 Requirements for
installation and operating site!)
If the unit still emits an alarm take it out of service and have it
inspected by a Service engineer (Customer service / Medical
engineering).

HICO-VARIOTHERM 550 48
 Control and operation
6.3.2.5 Display message: CHECK UNITCUSTOMER SERVICE
The unit triggers this alarm in case of various defects. The
display shows "CHECK UNIT" and "CUSTOMER SERVICE",
the yellow fault lamp (13) flashes and a pulse signal tone sounds.
The audible alarm cannot be interrupted using the "Audio
paused" key (18).
• Switch off the unit with the mains switch (16).
Take the unit out of service and have it inspected by a Service
engineer (Customer service / Medical engineering).

6.3.2.6 Mains failure alarm

The unit triggers this alarm if the power supply fails during
operation. The yellow fault lamp (13) lights up and a permanent
signal sounds. All other displays are without function. The power
accumulator in the unit receives the alarm for at least 10 minutes
without mains supply.
The alarm cannot be interrupted with the "Audio paused" key
(18).
• Switch off the unit with the mains switch (16).

The alarm automatically goes out when the power supply returns.
The temperature set last is stored in the unit.
With restoration of the power supply, the temperature stored
must be controlled by the user and approved before the device
returns to normal operation (see chapter 6.2 Operation).

HICO-VARIOTHERM 550 49
 Cleaning and disinfecting

7 Cleaning and disinfecting

This chapter contains important information about the cleaning
and disinfecting open the unit. Please follow these instructions to
avoid damage caused by incorrect cleaning of the unit and to
assure trouble-free operation.

7.1 Safety advice

Observe the following safety notes before starting to clean the

unit.
► Pull out the mains plug before starting cleaning and
disinfecting the unit.
► Prevent fluids from entering into the unit.
► Let the unit dry completely before switching it on again.

Sensitive surfaces.

The surfaces of the unit and the pads can be destroyed by using
wrong cleaning agents and disinfectants.
► Use only disinfectants based on aldehydes, ammonium
components or alcohols, which will not affect ABS plastics as
well as PVC and PU for all surfaces and parts.
► If possible, do not use any phenol derivative based
disinfectants, because these will shorten the lifetime of plastic
materials.

HICO-VARIOTHERM 550 50
 Cleaning and disinfecting

7.2 Unit
7.2.1 Water circulation

7.2.1.1. General Information for cleaning the water circuit

The cleaning process consists of a total of three steps, all of
which have to be performed in a regular cycle of 14 days. First
the basic cleaning of the unit and the application parts takes
place. This is followed by disinfection, afterwards flushing and
refilling. You have to wear disposable gloves during the entire
cleaning process and avoid contact with the sterile filtered tap
and the cleaning agent.

7.2.1.2. Basic cleaning

Disconnect the unit from the power supply and remove any
accessories that may be connected. Empty the unit and all
accessories (e.g. water pads, extension hoses, etc.) entirely.
Refill the unit with a neutral cleaner (observe manufacturer’s
instructions) and use only sterile filtered tap water for possible
dilution. Connect the parts to be cleaned to the unit and connect
the unit to the power supply. Use the setpoint buttons to set the
temperature to 35 °C. Turn on the unit and leave it on for 30
minutes. Disconnect the unit from the power supply and remove
the connected accessories. Empty the unit and all accessories
entirely.

7.2.1.3. Disinfection
For disinfection, any VAH 11-listed disinfectant which is free of
phenolic derivatives can be used. Suitable are e.g. Terralin
protect, Gigasept FF, Gigasept AF, Mikrozid AF or Sanosil S003.
Observe the dosage recommendation of the respective
manufacturer of the disinfectant. If necessary, prepare a
disinfecting solution according to the instructions of the
manufacturer of the respective disinfectant. Fill the unit with the
disinfectant or the disinfecting solution. Connect the device to the
power supply and connect it to any disinfected application parts.
Turn on the unit and allow it to run for about two minutes so that
the disinfectant can spread throughout the circuit; if necessary,
refill the disinfectant or disinfecting solution. Switch off the unit and
observe the predefined exposure time of the manufacturer of the
disinfectant. Afterwards disconnect the unit from the power supply
and empty the unit and all accessories entirely.

11 Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden

HICO-VARIOTHERM 550 51
 Cleaning and disinfecting

Do not apply any other cleaning and decontamination methods

than the ones recommended by Hirtz & Co. KG.
Before introducing new methods check these together with Hirtz
& Co. KG.
Only this makes sure that the unit will not be damaged by this
method.

7.2.1.4. Flushing und refilling

Fill the unit with sterile filtered tap water 12. Connect the unit to the
power supply. Connect the possible accessories with the unit.
Switch on the unit and allow the circuit to circulate for five
minutes. Disconnect the unit from the power supply. Empty the
unit and possible accessories entirely. This completes the
cleaning process. Before recommissioning the unit, you have to
refill the unit only with sterile filtered tap water to which a
germicidal agent has been added 13.

7.2.2 Surface
If possible, use decalcified water for surface cleaning. Only wipe
the unit with a damp cloth. For cleaning use only warm water
(max. 50 °C) with a mild commercial dish washer liquid. Wipe off
again with clear water and wipe the unit dry with a cloth.
To disinfect the surface of the unit we recommend a wiping or
area disinfection according to VAH-list 14 (e.g. with S&M Mikrozid
AF). When using a disinfectant follow the instructions of the
manufacturer.
Only switch on the unit after the disinfectant has evaporated
completely.

Check ventilation slots on both sides of the unit for contamination

regularly (or at least every 6 months). Remove external

12
Depending on the quality of the water (e.g. calcareousness among other things), the lifetime of the unit parts that
come into contact with water is reduced.
13 e.g. 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml Sanosil
solution). Alternatively, another long-term germinating preservative can also be used, e.g. Micropur or Certisil. For
further information, please contact Hirtz & Co.KG.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of unit parts that come into
contact with water!
14 Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden

HICO-VARIOTHERM 550 52
 Cleaning and disinfecting
contamination as far as possible. Dust deposits in the unit reduce
the performance of the system. Have the contamination on the
inside of the unit removed by a service technician (customer
service, medical engineering). Do not open the unit yourself.

Do not apply any other cleaning or decontamination processes

other than the ones recommended by Hirtz & Co. KG.
Before introducing new methods, check these together with Hirtz
& Co. KG.
Only this makes sure that the unit will not be damaged by this
method.

HICO-VARIOTHERM 550 53
 Cleaning and disinfecting

7.3 Water pads, hose extension

If possible use decalcified water. Only wipe the surfaces with a
damp cloth. For cleaning use only warm water (max. 50 °C) with
a mild commercial dish washer liquid. Wipe off again with clear
water and wipe the surface dry with a cloth.
To disinfect the surface we recommend an area, wiping or
spraying disinfection according to VAH-list 17 (e.g. with S&M
Mikrozid AF). When using a disinfectant follow the instructions of
the manufacturer.
Only use the pad and the hose extension again after the
disinfectant has evaporated completely.
Check the pad and the hose extension for damage, deformation
or cracks; replace damaged accessories.

Do not apply any other cleaning or decontamination processes

other than the ones recommended by Hirtz & Co. KG.
Before introducing new methods, check these together with Hirtz
& Co. KG.
Only this makes sure that the unit will not be damaged by this
method.

17 Verband für Angewandte Hygiene, list available at mhp-Verlag, Wiesbaden

HICO-VARIOTHERM 550 54
 Maintenance and safety related inspection

8 Maintenance and safety related inspection

This chapter contains important information for maintenance of
the unit. Please follow these instructions to avoid damage
caused by inadequate maintenance of the unit and to assure
trouble-free operation.

8.1 Maintenance
We recommend the conclusion of a maintenance contract with
authorised companies. By concluding a maintenance contract
you fulfil the requirements
• of BetrSichV BGV A2 (VBG 4) new BGV A3,
• of medical device directive 93/42/EEC,
• of MPBetreibV,
All of which request regular technical inspection of the units.
Furthermore, maintenance by our experts ensures maximum
operational reliability and longevity of the unit.

With proper and regular maintenance, the unit has a product

lifetime of about 10 years.

When handled properly, the water pads and hose extensions

results in a life span of these necessary accessories from the
natural aging and use wear.

HICO-VARIOTHERM 550 55
 Maintenance and safety related inspection
8.1.1 Unit
• Periodically check the ventilation openings on the side, bottom
and back of the unit regularly for contamination.
• Dust deposits in the unit reduce the performance of the
system. Have the contamination on the inside of the unit
removed by a service technician (customer service, medical
engineering). Do not open the unit yourself.
• Ensure the maintenance and safety check intervals are
maintained by the customer service or medical engineering.

8.1.2 Water tank

Replace the sterile filtered tap water in the water tank at least
every 2 weeks (described in chapter 7.2.1) as follows:
• Disconnect unit from the mains.
• Support container (bucket, baisin etc.) or place the unit onto a
draining device (e.g. rinsing tank).
• Unscrew the cap of the water filler neck (5), e.g. with a coin.
• Take the water drain hose and place it on one of the front
hose couplings (9).
• Tilt the unit forwards and drain the water through the water
drain hose until it is emptied completely.
• Remove the water drain hose from the front hose coupling and
place it aside.
• Clean and disinfect the water circuit as described in chapter
7.2.1
• Refill the unit with sterile filtered tap water to which a
germicidal agent has been added as described in chapter
4.3.1. The max. filling capacity of the unit tank is approx.1 litre.

8.1.3 Hose couplings

The seal rings (O-rings) on all couplings are subject of aging and
become dry and brittle. You should therefore cover the rings with
a thin film of silicone paste or vaseline every 6 months.

HICO-VARIOTHERM 550 56
 Maintenance and safety related inspection

8.2 Safety related inspection

In order to maintain legal conformity and operational reliability as
per Medical Product Directive 93/42/EEC (appendix I,
point13.6.d) and MPBetreibV (§ 6(1)) the unit needs to be
subjected to a safety related inspection every 12 months. The
operator is solely responsible for the performance of this safety
related inspection. Based on the MPBetreibV (§ 6 (4) 1.+3.) this
safety related inspection must only be performed by Hirtz & Co.
KG or a qualified person. The safety related inspection covers at
least the following points:
• Inspection of the device and application components for
external damage, wear, aging and legibility of displays and
inscriptions
• Measurement of the PE resistance and the earth leakage
current according to the testing facility and manufacturer's
data
• Inspection of all functions by following the operating
instructions
• Inspection of all safety functions according to manufacturer's
data
• Inspection of all sensors according to manufacturer's data (for
this purpose Hirtz & Co. KG provides a Service Manual for
authorised persons).

HICO-VARIOTHERM 550 57
 Maintenance and safety related inspection

In order to maintain conformity with statutory safety regulations

we recommend to conclude a Safety Related Inspection Contract
with an authorised company to carry out the recommended,
annual safety related inspection.

For heavily soiled units or accessories returned to us for

maintenance or repair, with which there is a suspicion of
contamination by contact with specific pathogens (e.g. MRSA),
the system must pre-disinfected and packaged for transport with
an appropriate disinfectant in accordance with the
decontamination requirements and material compatibility.
Otherwise we reserve the right to reject such units or
components for safety reasons, or, to subject these to additional
treatment (chemo-thermal) before performing a technical revision
or damage analysis. Any additional costs arising from this must
be borne by the customer.

Questions concerning service, maintenance or safety related

inspection should be directly addressed to:

Hirtz & Co. KG

Bonner Str. 180
50968 Cologne

Phone: 02 21 / 3 76 78-0
Fax: 02 21 / 3 76 78-85
e-mail: hirtz@hico.de

HICO-VARIOTHERM 550 58
 Troubleshooting

9 Troubleshooting
This chapter contains important information for fault localisation
and trouble shooting. Please follow these notes to avoid dangers
and damages.

9.1 Safety information

► Repairs on electric devices must only be carried out by

skilled professionals, which may have been trained by the
manufacturer.
► Inappropriate repairs can cause considerable dangers for the
user and damage to the unit.

Opening of the unit by unauthorised persons will lead to the loss

of any warranty claims.
► Repairs to the unit may only be carried out by Hirtz & Co. KG
or by experts trained and/or authorised by Hirtz & Co. KG.

HICO-VARIOTHERM 550 59
 Troubleshooting

9.2 Fault causes and troubleshooting

Fault Possible causes Action
No or insufficient water circulation 1. Hoses or pad kinked 1. Ensure correct laying and
2. Couplings are not engaged positioning

3. Unit is positioned far below 2. Insert couplings firmly into

the water pad each other

4. Intense foam formation 3. Position unit at same height or

above
5. High patient weight
4. Replace water*

6. Pump worn/defective 5. Position unit higher than the

water pad
6. Customer service*

Couplings stiff Sealing ring dry and brittle Grease sealing ring with vaseline,
silicone grease or similar

Coupling connection drips Exterior, visible sealing ring Replace sealing ring*
constantly damaged or missing

Coupling valve of the non- 1. Inner sealing ring damaged 1. Customer service*
connected coupling drips 2. Inner sealing ring 2. Insert and loosen coupling
constantly contaminated several times, if necessary
customer service

Alarm + Display message: 1. Independent protection device Customer service*

"ALARM TEST DEFECTIVE" defective
"->CUSTOMER SERVICE" 2. Pump defective electrically

Alarm + Display message: Coupling or decoupling of the Acknowledge alarm with “Alarm
"TEMP.DIFF. >1 °C" water pad during operation OFF” button

Alarm + Display message every 1. Cooling power insufficient 1. See next line
10 mins.: 2. Cooling elements or pump
"TEMP.DIFF. >1 °C" defective 2. Customer service*
3. Intense foam formation in the
tank 3. Replace water*
4. Bypass interrupted
4. Customer service*

Nominal value is not reached Cooling power insufficient The 3 causes indicated reinforce
during cooling because: each other unfavourably so that at
1. Ambient temperature too high least one cause must be
and/or changed.

2. nominal value too low and/or

3. Water pad too large
(2 water pads)

Alarm + Display message: 1. Water level too low 1. Refill water

“WATER LEVEL!?“ 2. Unit is not horizontal 2. Position unit horizontally
Can be acknowledged for 10
mins. using the "Alarm OFF" 3. Sensor deviation 3. Customer service*
button

HICO-VARIOTHERM 550 60
 Troubleshooting

Fault Possible causes Action

Alarm + Display message: 1. Various defects 1. Customer service*
"CHECK UNIT" 2. Water tank empty 2. Refill water*
"->CUSTOMER SERVICE"
3. Sensor break/closure T1 3. Customer service*
4. Sensor closure T2 4. Customer service*

Alarm + Display message: 1. Unit too cold (< 9 °C) 1. Heat up unit at room
"CHECK UNIT" temperature for a while*
"UNDERTEMPERATURE" 2. Sensor break T2 2. Customer service*
3. Water tank frozen 3. Defrost unit*;
Examine unit for frost damage
(Is water flowing out of the
unit?)  Customer service

Entire device not functioning 1. Mains failure 1. Switch off unit until power
acoustic alarm returns
2. Mains connector no contact 2. Check connector on unit and
in socket for correct fit
3. Customer service*
3. Fuse defective 4. Customer service*
4. Unit defective

* Switch off the unit immediately

HICO-VARIOTHERM 550 61
 Waste disposal of old unit

10Waste disposal of old unit

Old electric and electronic devices very often contain precious
materials. However, they also contain harmful substances, which
were necessary for their function and safety.
If disposed of as residual waste or handled incorrectly these can
cause harm for human health and damage the environment. This
device must not be disposed of with normal industrial or
domestic waste!

► According to the product reliability according to § 22 of the

"Kreislaufwirtschafts- und Abfallgesetzes" (Recycling
Economy and Waste Management Act) and the "Elektro- und
Elektronikgesetzes" (Electrics and Electronics Act) § 2,
section 1, cipher 8, the unit must be handed over to a
corresponding communal collecting point or returned to the
manufacturer.

► In accordance with waste management regulations of the user

the water pad can be disposed of for incineration, together
with domestic waste.

HICO-VARIOTHERM 550 62
 Technical data and accessories

11Technical data and accessories

11.1 Unit
HICO-VARIOTHERM 550
Article No. (REF): 540001 (220 V/230 V) / 540021
(115 V)
Rated voltage: 230 VAC 50/60 Hz / 115 VAC
50/60 Hz / 220 VAC 60 Hz
Power input: 320 W
Current consumption: approx. 1.5 A (220 V/230 V)/ 3 A
(115 V)
Nominal value range: 15-39 °C
Safety shutdown: 41.1-41.5 °C (autonomous safety-
shutdown) This results in a max. surface
temperature on the pad < 41 °C

Correction value: 0.5 °C (Water temp. -temp.-display)

Sensor element: 2 x NTC 5 K
Pump capacity: max. 5.5 l/min., max. 0.21 bar
Warming up time: approx. 5-10 min. (20-37 °C)
Cooling down time: approx. 5-10 min. (20-15 °C)
Fuse rating: 2x T 3,15 A; L 250 V (220 V/230 V)
2x T 5 A; L 250 V (115 V)
Class/type of protection: I, BF (defibrillation protected)
Type of protection IP: IP X1 (drip proof)
Power supply: Must correspond with VDE 0100 Part
710:2012-10 "Electrical safety in medical
environments"
Risk class (93/42/EEC): II b
Ambient temperature: 10-30 °C (hyperthermia operation)
10-23 °C (hypothermia operation)
Relative air humidity: approx. 30-70 %
Transport/storage temperature: 3-60 °C
Air pressure: 700-1060 hPa
Tank volume: approx. 0.5/0.8 l (MIN/MAX)
Permissible height difference: max. 1 m (Unit/Water pad)
Dimensions WxHxD: approx. 200 x 290 x 440 mm
Weight: approx. 17 kg (empty)
Noise emission: approx. 50 dB(A) (1 m)
Alarm level: > 55 dB(A) (3 m)
Test basis: Medical product directive 93/42/EEC,
DIN EN 60601-1, DIN EN 60601-1-2, DIN
EN 80601-2-35
UMDNS code: 12-075
Subject to technical changes

HICO-VARIOTHERM 550 63
 Technical data and accessories

► It is not permitted to make changes to the HICO-

VARIOTHERM 550!

11.2 Accessories
• Hose extension, approx. 3 m (required accessory)
REF:550022
• Thermo hose extension, approx. 2 m
(optional accessory) REF: 660022
• Together with the HICO-VARIOTHERM 550, only original
HICO water pads made of PU may be used (required
accessory);
among others, available sizes and their empty weight:

HICO-Polyurethan- 50 x 170 cm // REF: 550046

water pad 0,91 kg
HICO-Polyurethan- 50 x 92 cm // 0,54 kg REF: 550047
water pad
HICO-Polyurethan- 50 x 30 cm // 0,24 kg REF: 550044
water pad
HICO-Polyurethan- 35 x 170 cm // REF: 550048
water pad 0,67 kg
HICO-Polyurethan- 35 x 92 cm // 0,44 kg REF: 550049
water pad
HICO-Polyurethan- 70 x 60 cm // 0,52 kg REF: 550025
water pad
HICO-Polyurethan- 70 x 120 cm // REF: 550026
water pad 0,90 kg

• Various PU collars for partial temperature output are also

available as accessories

HICO-collar (A) 38 x 26 cm REF: 550081

HICO-collar (D) 27 x 11 cm REF: 550084

• HICO water drain hose (optional accessory; only use for

emptying the unit) REF: 550076

HICO-VARIOTHERM 550 64
 Technical data and accessories

► The performance and application compatibility of PU pads

and PU blankets is to be decided by the user for each
individual case.
Hose and pad material: PU; free of latex, heavy metals
and phthalates.
Ambient temperature in operation: 10 °C to 30 °C
Relative air humidity: approx. 30 % to 70 %
Transport and storage temperature: 3 °C to 60 °C without water
Air pressure: 700 to 1060 hPa
Please take the further required information on the HICO water pads from the respective
brochures and price lists.

• Five-castor stand, see chapter 4.2.3 (optional accessory)

• Unit carrier (moveable); total height approx. 1 m; see chapter
4.2.2 (optional accessory).

For the unit carrier, observe the associated instructions for

use.
Excerpt of the safety information on the unit carrier:
► Assembly, handling and use require careful attention to these
safety instructions.
► The unit must be screwed to the insert panels with the 2
knurled screws included!
► To move forward, the brake rollers must be released! Driving
over obstacles, soft flooring and ramps must be carried out
very carefully.
► Stationary unit carriers are to be secured using the catch-
rollers.
► The electrically conductive rollers serve only to dissipate the
static charge.
► Hirtz & Co. KG is only responsible for the safety and function
of the unit carrier if the installation and operating instructions
are followed in every respect, and only used specifically for
this equipment and accessories provided by Hirtz & Co. KG.

HICO-VARIOTHERM 550 65
 Technical data and accessories

11.3 Symbols

Unit fuses

The degree of electric protection against shock in the application

part the pads corresponds with type BF (defibrillation protected).

Extreme caution! (e.g. do not operate the unit in the presence of

combustible gases)

Full instruction manual / operating instructions

Observe / follow instruction manual

Waste disposal

Year of manufacture

Manufacturer

Also involved in the conformity assessment procedures:

DEKRA Certification GmbH,
Handwerkstraße 15
70565 Stuttgart

HICO-VARIOTHERM 550 66
 Guidelines and declaration of manufacturer

12Guidelines and declaration of manufacturer

Guidelines and declaration of manufacturer – electromagnetic emissions
Tables for medical electrical equipment general Information:
Table 1
Guidance and manufacturer declaration – Electromagnetic emission

The HICO-Variotherm 550 is designed for operation in the electromagnetic environment

listed below. The customer or user of the HICO-Variotherm 550 should ensure that the
device be used in such an environment.
Emission test Agreement Electromagnetic environment - guidance

RF emissions according to Group 1 The HICO-Variotherm 550 uses RF energy

exclusively for its internal function.
CISPR 11 Therefore, its RF emission is very small. It is
unlikely that nearby electronic devices
will be disturbed.

RF emissions according to Class B The HICO-Variotherm 550 is designed for use in all
premises, including such
CISPR 11 residential areas that are directly connected to a
public power supply that also
Harmonics according to Class A supplies residential buildings.
IEC 61000-3-2

Voltage fluctuations/ correspond

flicker according to IEC 61000-3-3

HICO-VARIOTHERM 550 67
 Guidelines and declaration of manufacturer
Table 2

Guidance and manufacturer declaration – Electromagnetic immunity

The HICO-Variotherm 550 is designed for operation in the electromagnetic environment listed below.
The customer or user of the HICO-Variotherm 550 should ensure that the device is used in such an environment.
Emission tests IEC 60601 test level Compliance level Electromagnetic
environment - guidance

Electrostatic discharge ±6 kV contact discharge ±6 kV contact discharge Floors should be wood,

(ESD) according to IEC concrete or ceramic tile. If the
61000-4-2 ±8 kV air discharge ±8 kV air discharge floor is covered with synthetic
material, the relative humidity
should be at least 30 %.

Fast transient electrical ±2 kV for mains cables ±2 kV for mains cables The quality of the power
interferences variables supply should correspond to
/ bursts ±1 kV for input and ±1 kV for input and
that of a typical commercial or
according to IEC hospital environment.
output cables
61000-4-4 output cables

Surge voltage/Surges ±1 kV differential mode ±1kV differential mode The quality of the power
according to supply should correspond to
IEC 61000-4-5 voltage voltage that of a typical commercial or
±2 kV common mode ±2 kV common mode
hospital environment.

voltage voltage

Voltage dips, short <5 % UT <5 % UT The quality of the power

interruptions and (>95 % dip in UT) (>95 % dip in UT) supply should correspond to
variations of the power for ½ cycles for ½ cycles that of a typical commercial or
supply hospital environment. If the
40 % UT 40 % UT user of the HICO-Variotherm
according to IEC (60 % dip in UT) (60 % dip in UT) 550 demands a continued
61000-4-11 for 5 cycles for 5 cycles operation during interruptions
70 % UT 70 % UT of the power supply, we
recommend to supply the
(60 % dip in UT) (60 % dip in UT)
HICO-Variotherm 550 from an
for 25 cycles for 25 cycles uninterruptible power supply or
<5 % UT <5 % UT a battery.
(>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s

Power frequency 3 A/m 3 A/m Magnetic fields at the mains

(50/60 Hz) Magnetic frequency should correspond
field according to to that of a typical commercial
IEC 61000-4-8 and hospital environment

Note: UT is the alternating power supply voltage prior to application of the test level

HICO-VARIOTHERM 550 68
 Guidelines and declaration of manufacturer
Table 4
Guidance and manufacturer declaration – Electromagnetic immunity

The HICO-Variotherm 550 is designed for operation in the electromagnetic environment listed below.
The customer or user of the HICO-Variotherm 550 should ensure that the device is used in such an environment.

Emission tests IEC 60601 test level Compliance level Electromagnetic environment -
guidance

Portable and mobile radio equipment

should be used no closer to the
HICO-Variotherm 550 and its power
cables, than the recommended safety
distance calculated from the equation
applicable to the frequency transmitter.

Recommendet safety distance:

d = 1,2√𝑃𝑃
Conducted RF interference 3 V actualvalue 3V
according to IEC 61000-4- 150 kHz to 80 MHz
6
d = 1,2√𝑃𝑃 80 MHz to 800 MHz
Radiated RF interference 3 V/m
3 V/m
according to IEC 61000-4- 80 MHz to 2,5 GHz
3 d = 2,3√𝑃𝑃 800 MHz to 2,5 GHz

Where P is the output power rating

of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
safety distance in
meters (m). The field strength from a
stationary radio transmitter, according to
an onsite survey a is less than the
compliance level b for all frequency
ranges.

In the environment of equipment marked

with the following symbol, interferences
are possible.

NOTE 1: At 80 MHz and 800 MHz, the higher the frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by
the absorption and reflection from structures, objects and people.

a Field strength from fixed transmitters such as base stations for radio (cellular/wireless) telephones and land mobile
radios, amateur radio, AM/FM radio stations and TV stations cannot be predicted theoretically with accuracy. To
determine the electromagnetic environment of a stationary transmitter, a site survey should be considered. If the
measured field strength in the location in which the HICO-Variotherm 550 is used exceeds the conformity level
listed above then the HICO-Variotherm 550 should be monitored to verify normal operation. If abnormal
performance is observed, additional measures might be necessary, such as readjusting the HICO-Variotherm 550
or changing to another location.
b The field strength is less than 3 V/m over the frequency range of 150 kHz to 80 MHz.

HICO-VARIOTHERM 550 69
 Guidelines and declaration of manufacturer
Table 6

Recommended safety distance between portable and mobile RF telecommunication devices and
the HICO-Variotherm 550
The HICO-Variotherm 550 is designed for operation in an electromagnetic environment, in which the RF
disturbances are controlled. The customer or the user of the HICO-Variotherm 550 can help to
prevent electromagnetic disturbances by keeping a minimum distance between portable and mobile RF
Telecommunication devices (transmitter) and the HICO-Variotherm 550 depending on the power output of the
communication device, as indicated below.

Output power of Safety distance, depend on the transmitted frequency

the transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

d = 1,2√𝑃𝑃 d = 1,2√𝑃𝑃 d = 2,3√𝑃𝑃

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23
For transmitters whose maximum output power rating is not listed in the table above, the distance
can be determined by calculating the equation on each column, 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 the frequency range applies.
NOTE 2: These guidelines may not apply in all situations. The propagation of electromagnetic waves is affected by
the absorption and reflection from structures, objects and people.

HICO-VARIOTHERM 550 70
 Brief instruction

13Brief instruction
• Connect the unit to the mains supply
• Couple the water pad to the unit.
• Check the water level on the unit.
• Switch on the unit by the mains switch and watch the
automatic function test.
• If the nominal temperature value is >38 °C or <35 °C when
switching on the unit, an alarm will be emitted. Acknowledge
and start by pressing the release key once.
• Set the temperature with the arrow keys.

• For temperatures higher than 38 °C, press the arrow key and
release key together.

• For temperatures below 35 °C, press arrow key and release

key together.
• Depending on the application, place the water pad under or
over the patient.
• Monitor the body temperature of the patient.
• Monitor the water level and water flow on the unit.
• In case of continuous operation perform a manual function test
once every day by pressing the "Function test" key.

• Acoustic warnings of medium priority (“WATER LEVEL!?” and

“TEMP.DIFF >1 °C”) can be interrupted using the "Audio
paused" key.

• All other acoustic alarms of medium priority cannot be

interrupted. Switch off the unit at the mains (16).

HICO-VARIOTHERM 550 71
 Brief instruction

With certain faults, the unit will switch off all functions. Take the
unit out of service and submit it to a Service Engineer for
inspection and to re-establish the operational reliability.

There is a risk of the patient may be overheated or

undercooled.
► Monitor the patient's body temperature when using the unit
and the water pad on the patient.

Do not start the unit if

► the display has failed,

► individual segments of the temperature display have failed
(temperature can no longer be read safely),
► the yellow fault lamp (13) lights permanently or not at all
(functional test),
► the signal tone continues to sound or does not sound at all
(functional test),
► the unit does not respond to key operation,
► the unit does not respond as described in chapter 6.2.3
"Functional test" when switching on or when running a
function test.

HICO-VARIOTHERM 550 72
 Brief instruction
Notes

HICO-VARIOTHERM 550 73