Hico Medical Systems HICO-VARIOTHERM 550 User manual

Instruction for use
Hypo/Hyperthermia unit
HICO-VARIOTHERM 550

Instruction for use HICO-VARIOTHERM 550
HICO-VARIOTHERM 550 2
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: [e-mail]
Internet: www.hico.de
Doc. No. 542121; Version 16-03/17 valid from 2017-03
© 2017 Hirtz & Co. KG

Table of Contents
HICO-VARIOTHERM 550 3
1General 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
2Safety.....................................................................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
3Transport and setup............................................13
3.1 Scope of delivery and transport inspection..................13
3.2 Unpacking........................................................................13
3.3 Waste disposal of packaging material ..........................14
4Commissioning ...................................................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
5Function 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
6Control and operation.........................................31

Table of Contents
HICO-VARIOTHERM 550 4
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
6.2.10Operator language ..........................................................45
6.3 Alarms............................................................................. 46
6.3.1 General information.........................................................46
6.3.2 Alarm description during operation..................................47
7Cleaning 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
8Maintenance 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
9Troubleshooting..................................................59
9.1 Safety information.......................................................... 59
9.2 Fault causes and troubleshooting................................ 60

Table of Contents
HICO-VARIOTHERM 550 5
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

General information
HICO-VARIOTHERM 550 6
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.
1.1Information 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.

General information
HICO-VARIOTHERM 550 7
1.2Warnings
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:

General information
HICO-VARIOTHERM 550 8
•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.
1.4Copyright
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.
1.5Manufacturer 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: [e-mail]

Safety
HICO-VARIOTHERM 550 9
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.
2.1Intended use
This unit is solely intended for the cooling or heating of water
pads1used 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.
1In 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)

Safety
HICO-VARIOTHERM 550 10
2.2Personnel 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.

Safety
HICO-VARIOTHERM 550 11
2.3General 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 water2, to which a
germicidal agent3has 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.
2Depending 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.
3e.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!

Safety
HICO-VARIOTHERM 550 12
►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.
2.4Danger sources
2.4.1Danger 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.

Transport and setup
HICO-VARIOTHERM 550 13
3 Transport and setup
3.1Scope 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.
3.2Unpacking
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.

Transport and setup
HICO-VARIOTHERM 550 14
3.3Waste 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.

Commissioning
HICO-VARIOTHERM 550 15
4 Commissioning
This chapter contains important information for commissioning
the unit. Please follow these notes to avoid dangers and
damages.
4.1Safety 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.
4.2Setting up
4.2.1Requirements 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.

Commissioning
HICO-VARIOTHERM 550 16
►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.

Commissioning
HICO-VARIOTHERM 550 17
4.2.2Setting 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.

Commissioning
HICO-VARIOTHERM 550 18
4.2.3Installation 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
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.
1 2 3 4

Commissioning
HICO-VARIOTHERM 550 19
4.3Connecting 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.
4.3.1Filling 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 water2, to which a
germicidal agent7has 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.
2Depending 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.
7e.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!

Commissioning
HICO-VARIOTHERM 550 20
4.3.2 Connecting the water pads
•The hose bracket (7) provided makes it easier to lay the hoses
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.
7 8