Instructions For Use: Hyperthermia Unit Hico-Aquatherm 660

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Instructions for Use

Hyperthermia Unit
HICO-AQUATHERM 660
Instructions for Use HICO AQUATHERM 660

pfm medical hico gmbh


Bonner Str. 180
50968 Cologne, Germany

Tel.: +49 (0) 2 21 / 37 67 8 – 0


Fax: +49 (0) 2 21 / 37 67 8 – 85

Email: [email protected]
Internet: www.hico.de

Material Number GA-592121en-A Valid from Oct. 01, 2020


Based on: GA-592121-A

© 2020 pfm medical hico gmbh

GA-592121en-A HICO-AQUATHERM 660 2


Table of Contents

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


1.1 Information regarding these instructions ..................... 6
1.2 Warnings .......................................................................... 7
1.3 Limitation of liability ....................................................... 8
1.4 Copyright ......................................................................... 8
1.5 Manufacturer’s address .................................................. 8
2 Safety ....................................................................9
2.1 Intended use .................................................................... 9
2.2 Personnel requirements ............................................... 10
2.3 General safety instructions .......................................... 11
2.4 Potential hazards .......................................................... 12
2.4.1 Danger of the hyperthermia ........................................ 12
3 Transport and setup ..........................................13
3.1 Scope of delivery and transport inspection................ 13
3.2 Unpacking ...................................................................... 13
3.3 Disposal of the packaging material ............................. 14
4 Commissioning ..................................................15
4.1 Safety instructions ........................................................ 15
4.2 Setup .............................................................................. 15
4.2.1 Requirements on the installation site / operating
location ....................................................................... 15
4.2.2 Mounting on a wall rail (optional) ................................ 17
4.2.3 Installation with five-castor stand (optional) ................ 18
4.3 Connecting the HICO-AQUATHERM 660 ..................... 19
4.3.1 Filling the system ........................................................ 19
4.3.2 Connecting the water pads ......................................... 20
4.3.3 Electrical connection ................................................... 21
5 Design and function ..........................................22
5.1 Views of the unit, control elements, and display
elements......................................................................... 22
5.2 Safety devices ............................................................... 23
5.2.1 Sensors ....................................................................... 23
5.3 Nameplate ...................................................................... 24
5.4 Function ......................................................................... 25
5.4.1 Basic principles ........................................................... 25
5.4.2 Indications / contraindications / side effects ................ 27
6 Control and operation .......................................30

GA-592121en -A HICO-AQUATHERM 660 3


Table of Contents
6.1 Before switching on ...................................................... 30
6.1.1 Check the unit ............................................................. 30
6.1.2 Water pads.................................................................. 30
6.1.3 Heat output ................................................................. 31
6.2 Operation ....................................................................... 32
6.2.1 Switching on for the first time ...................................... 32
6.2.2 Switching on in normal operation ................................ 32
6.2.3 Functional test............................................................. 33
6.2.4 Setting the temperature .............................................. 34
6.2.5 Temperature control mode .......................................... 36
6.2.6 Handling water pads ................................................... 37
6.2.7 Using water pads ........................................................ 37
6.2.8 Schematic performance charts................................ 39
6.2.9 Responsibilities during operation ................................ 42
6.2.10 Operating language .................................................... 44
6.3 Alarms ............................................................................ 45
6.3.1 General information .................................................... 45
6.3.2 Description of alarms during operation ....................... 45
7 Cleaning and disinfection .................................49
7.1 Safety instructions ........................................................ 49
7.2 Unit ................................................................................. 50
7.2.1 Water circuit ................................................................ 50
7.2.1.1. General Information for cleaning the water circuit ....... 50
7.2.1.2. Basic cleaning ............................................................. 50
7.2.1.3. Disinfection ................................................................. 50
7.2.1.4. Flushing and refilling ................................................... 51
7.2.2 Surfaces ...................................................................... 52
7.2.3 Ventilation slots ........................................................... 52
7.3 Water pads, hose extension ......................................... 53
8 Maintenance and safety check .........................54
8.1 Maintenance .................................................................. 54
8.1.1 Unit ............................................................................. 55
8.1.2 Water tank................................................................... 55
8.1.3 Hose connections ....................................................... 55
8.2 Safety check .................................................................. 56
9 Troubleshooting.................................................58
9.1 Safety instructions ........................................................ 58
9.2 Causes of error and troubleshooting .......................... 59

GA-592121en-A HICO-AQUATHERM 660 4


Table of Contents
10 Disposal of an old unit ......................................61
11 Technical data, unit, and accessories ..............62
11.1 Unit ................................................................................. 62
11.2 Accessories ................................................................... 63
11.3 Symbols ......................................................................... 65
12 Guidelines and manufacturer's declaration .....66
13 Quick Start Guide...............................................70

GA-592121en -A HICO-AQUATHERM 660 5


1 General information
Please read the information in this manual to become
acquainted with the HICO-AQUATHERM 660 as quickly as
possible and to be able to utilise its functions to the full extent.

1.1 Information regarding these instructions


These operating instructions are a component of the HICO-
AQUATHERM 660 (referred to in the following as the “unit”) and
provide important information for the commissioning, safety,
intended use, and maintenance of the unit.
All figures and drawings in these operating instructions are for
general illustration purposes and are not definitive in terms of
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 following:
 Commissioning
 Operation
 Cleaning
 Maintenance
 Troubleshooting

GA-592121en-A HICO-AQUATHERM 660 6


1.2 Warnings
The following types of safety notes are used in these operating
instructions:

A DANGER note identifies an imminent danger situation.


Failure to avoid such a dangerous situation will cause severe
injury or even death.
► Follow the instructions given in this danger note to avoid the
danger of death or severe injury to people.

A WARNING note identifies a potentially dangerous


situation.
Failure to avoid such a dangerous situation can lead to severe
injuries.
► Follow the instructions in this warning note to avoid the risk
of injuries to persons.

A CAUTION note identifies a potentially dangerous


situation or a risk of property damage.
Failure to avoid such a dangerous situation can lead to minor or
moderate injuries and damage to property.
► Follow the instructions in this caution note to avoid the risk of
injury to people and damage to property.

A note highlights additional information to assist you when


working with the unit.

GA-592121en -A HICO-AQUATHERM 660 7


1.3 Limitation of liability
All technical information, data, and notes on installation,
operation, and maintenance contained in this manual were up-
to-date at the time of printing and are provided to the best of our
knowledge based on our previous knowledge and experience.
No claims can be derived on the basis of information,
illustrations, or descriptions provided in these operating
instructions.
The manufacturer accepts no responsibility for loss in the event
of:
 Failure to follow the operating instructions
 Imintended use
 Improper repairs
 Technical modifications
 The use of non-approved spare parts
 Unauthorised conversions and changes
Translations are made to the best of our knowledge. We will not
assume liability for mistakes in translations, even if the
translation was done 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,
duplication, and distribution by means of special methods (e.g.
data processing, data media, and data networks), even in parts,
are reserved by the pfm medical hico gmbh.
Subject to changes in contents and technical modifications.

1.5 Manufacturer’s address


pfm medical hico gmbh
Bonner Str. 180
50968 Cologne

Tel.: +49 (0)2 21 / 3 76 78-0


Fax: +49 (0)2 21 / 3 76 78-85
Email: [email protected]

GA-592121en-A HICO-AQUATHERM 660 8


2 Safety
This chapter contains important safety information for working
with this unit.
This unit complies with the specified safety regulations.
However, imintended use can lead to personal injury or
property damage.

2.1 Intended use


This unit is solely intended for the heating of water pads1 used
to warm a patient.
Any use of the unit for a purpose other than the use described
above is considered imintended use.
The pads available as accessories may only be used with HICO
units for use in the treatment of hypo/hyperthermia.

Danger due to imintended use!


It is dangerous to use the unit improperly and/or use the unit for
any other purpose than the described purpose.
► Only use the unit for its intended purpose.
► Follow the procedures described in these operating
instructions.
► Use only with original accessories.

Claims of any type due to damage resulting from imintended


use are excluded.
The owner is the sole bearer of the risk.

1
In these operating instructions, the term “water pad” describes all Hico accessories such as water mats, water
blankets, water collars, etc. (see also section 12.2 “Accessories”)

GA-592121en -A HICO-AQUATHERM 660 9


2.2 Personnel requirements

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


who are authorised for this work because of their education
and qualifications. In addition, these persons must be
authorised to perform the work by owner.
► Only allow personnel who will be trained, taught, instructed,
or are who undergoing general training to 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.
► Hazards can result when the unit is used improperly by
untrained personnel.
► In addition to the operating instructions, all generally valid
legal and otherwise binding regulations for the prevention of
accidents and protection of the environment as well as
general health and safety requirements must be followed.
The owner must instruct his personnel accordingly.

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2.3 General safety instructions

Follow the general safety instructions below 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 the unit’s tank with sterile filtered tap water2 to which a
disinfectant3 has been added.
► Only operate the unit after the tank has been closed by
screwing on the cap.
► Position the unit on a level surface and operate; slope of
installation surface ≤ 3%.
► Height difference between the unit and water pad < 1 m.
► Do not cover unit. There are ventilation openings on the
bottom and back of the unit.
► Monitor the automatic functional test when switching the
unit on.
► Perform an automatic functional test manually at least once
a day during continuous operation.
► Medical electrical equipment is subject to special
precautions regarding EMC and must be installed and put
into operation according to the EMC instructions 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. its hardness, among other things), the lifetime of the parts of the unit
that come into contact with water may be reduced.
3
For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml
Sanosil solution). Alternatively, a different long-term disinfectant and preservative can also be used, e.g.
Micropur or Certisil. If you have any questions, please contact the Customer Service department of pfm medical
hico gmbh.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come
into contact with water!

GA-592121en -A HICO-AQUATHERM 660 11


► During operation, check the water flow and the water level
in the unit at regular intervals.
► Only operate the unit with an appropriate water level.
► Stay within the ambient temperature range (10-30°C) 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 drapes, gel pads, etc.) adversely affect the
heat transfer.
► Only operate the unit 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 mode, 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.).
► Perform maintenance and conduct safety checks according
to these operating instructions.

2.4 Potential hazards


2.4.1 Danger of the hyperthermia

There is a risk of the patient becoming overheated.


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

GA-592121en-A HICO-AQUATHERM 660 12


3 Transport and setup
3.1 Scope of delivery and transport inspection
The scope of delivery of the HICO-AQUATHERM 660 consists
of:
 HICO-AQUATHERM 660 unit
 Mains cable, 3 m
 Hose holder
 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 smooth, level surface with sufficient load
bearing capacity.

Condensation in the unit can lead to failure of the unit.


► After unpacking, the unit must be acclimatised for at least
two hours before commissioning when the actual ambient
temperature differs from the specified ambient temperature
by more than 8°C.

GA-592121en -A HICO-AQUATHERM 660 13


3.3 Disposal of the packaging material
The packaging protects the unit from damage during transport.
The packaging materials are selected on the basis of
environmentally friendly and disposal-related factors and are
therefore recyclable.
Returning the packaging material back into the material cycle
saves raw materials and decreases the amount of waste
produced. Dispose of packaging materials that are no longer
required at the collection points for the “Green Dot” recycling
system or of your local recycling system.

► If possible, please keep the original packaging throughout


the unit’s lifetime so that you can repack the unit properly in
case of repair.

GA-592121en-A HICO-AQUATHERM 660 14


4 Commissioning
This chapter contains important instructions for commissioning
the unit. Please follow these instructions to prevent hazards and
damage.

4.1 Safety instructions

Injuries and property damage can occur when


commissioning the unit!
Follow the safety instructions below to prevent hazardous
situations:
► The weight of the unit is approx. 7 kg.
► The unit should only be transported, unpacked, and
installed by two people.
► Do not use the unit directly next to or stacked on top of other
equipment.
► If it is necessary to operate the unit directly next to or
stacked on top of other equipment in spite of this, then it
necessary to observe the unit to ensure that it is being used
for its intended purpose.

4.2 Setup
4.2.1 Requirements on the installation site / operating location
For safe and trouble-free operation of the unit, the installation
site must fulfil the following requirements:
 It must have sufficient load bearing capacity (weight of unit
approx. 7 kg).
 It must be level.
 It must be horizontal (slope ≤ 3%).
 It must provide 20 cm space on the back of the unit.
 It must ensure adequate ventilation of the unit,
including upward ventilation in an equipment trolley.
 It 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 five-castor stand (see section 4.2.3) available as accessory
meets all of these requirements.

GA-592121en -A HICO-AQUATHERM 660 15


► If the unit is not horizontal, then the display on the front of
the unit will display the water level incorrectly.
► If the unit is far below the level of the water pad, then the
circulation of water may be interrupted when the patient is
heavy. Furthermore, water may flow back into the unit and
cause the water tank to overflow when the water filling neck
is open and the unit is switched off.

For optimal operation of the unit, the installation site should


meet
 the following environmental conditions:
- Ambient temperature: 20°C  3°C
- Relative humidity: 50%  20%
- Air pressure: 700 hPa to 1060 hPa

Performance restrictions in terms of the pad transition


temperatures that can be reached under extreme ambient
conditions and for the selected combination of pads can
also lead to restrictions when used for its intended
purpose.

Condensation in the unit can lead to failure of the unit.


► If the actual ambient temperature differs from the specified
ambient temperature by more than 8°C during installation of
the unit, then allow the unit to acclimatise for at least two
hours before use.

GA-592121en-A HICO-AQUATHERM 660 16


4.2.2 Mounting on a wall rail (optional)
The unit can be mounted on wall rails (5 x 20 mm) typically
found in clinics. For this purpose, fasten the clamp holder (1)
(available as an accessory) on the back panel of the unit using
two screws (3).
 To do this, loosen the clamp holder (1) (available as an
accessory) from the back of the unit, turning it to the required
position, and then tighten it again.
Use the star knob (4) on the clamp holder to fasten the unit to
the rail.

GA-592121en -A HICO-AQUATHERM 660 17


4.2.3 Installation with five-castor stand (optional)
The five-castor stand available as an accessory makes the
HICO-AQUATHERM 660, which was 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.
 Fasten the clamp holder (1) (available as an accessory) to
the five-castor stand in the required position on the bottom of
the unit using the two screws (3).
 Place the HICO-AQUATHERM 660 on the cylinder (2) of the
five-castor stand.
 Fasten the unit in place using the star knob (3).

Injuries and property damage can occur when setting up


the unit!
► Five-castor stand assembly: For the safe operation and firm
stand of the system, it must be ensured when assembling
the five-castor stand that the cylinder (2) in the centre
section and castors are safely mounted on all 5 spokes
(with castors) of the five castor base in accordance with the
assembly instructions and the safety instructions.
► The five-castor base can only be used to mount HICO
systems!
► Do not use any aggressive detergents; the five-castor base
is not suitable for use in washing systems!
All components of the five-castor base should be checked for
full functionality at least once a year:
► Are the screw connections still tight?
► Clean the castors of dirt and grime so that the brakes work
properly and the electrical conductivity is not reduced.
► This should be checked directly after assembly and at
regular intervals during the operating period (during / at the
recommended annual maintenance interval)
► If a defect is detected, use only original spare parts as
replacements and only allow parts to be replaced by a
specialist or customer service.

GA-592121en-A HICO-AQUATHERM 660 18


4.3 Connecting the HICO-AQUATHERM 660

Danger due to 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 neck (5), e.g. with a
coin. Take care not to lose the seal 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 the unit with sterile filtered tap water4 to which a
disinfectant5 has been added.
 After filling, screw the cap hand-tight back onto the water
filling neck until it is properly sealed.

The use of a disproportionately high amount of disinfectant can


reduce the lifetime of parts of the unit that come into contact
with water. When filling the unit for the first time, please follow
the procedure described in section 6.2.1.

Danger due to water in connection with electricity.


Water conducts electricity.
► If water overflows when filling the unit, then 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.

4
Depending on the quality of the water (e.g. its hardness, among other things), the lifetime of the parts of the unit
that come into contact with water may be reduced.
5
For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml
Sanosil solution). Alternatively, a different long-term disinfectant and preservative can also be used, e.g.
Micropur or Certisil. If you have any questions, please contact the Customer Service department of pfm medical
hico gmbh.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come
into contact with water!

GA-592121en -A HICO-AQUATHERM 660 19


4.3.2 Connecting the water pads
 The hose holder (7) provided makes it easier to lay the hoses
between the pad and the unit. To attach the holder, loosen
the two knurled thumb screws (8) on the right-hand side of
the unit and then use them to fasten the holder to the unit.

 Push the hose connectors of a hose extension onto the left


or right hose connections (9) on the unit.
 Push the hose pad connectors of the hose extension onto
the two hose connections on the water pad.
 The connectors are properly connected to each other when
the locking mechanisms on the connectors engage their
corresponding counterparts so that the connection will no
longer come loose by itself.
 You can release the connection again by pushing the metal
plate on the hose connector and then pulling out the
connector.

► The hose extension connections cannot be “confused” when


connecting them to the unit because it makes no difference
which direction the water flows through the water pad.
► Water pads can also be disconnected when the unit is
switched on. It is normal in this case for water to drip out of
the connector and does not indicate leakage or a defect.
In the heating mode at 39°C: Reduce the nominal
temperature before disconnecting the water pad. Otherwise
the water in the unit’s circuit can briefly rise above the upper
temperature limit, and the unit may trigger various alarms.

GA-592121en-A HICO-AQUATHERM 660 20


4.3.3 Electrical connection

Hazard due to 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 the unit’s cable and plug before
connecting!
► To avoid the risk of electric shock, this unit must only be
connected to a mains connection with a protective
conductor!
Please follow the instructions below when making the electrical
connections to ensure safe and trouble-free operation of the
unit:
Equipotential bonding conductor
In addition to the protective earth conductor of the mains power
cable, the equipotential bonding conductor (22) a direct
connection between the electrical unit and the equipotential
bonding rail of the electrical system. This reduces the risk of
housing leakage currents becoming too high.
 Connect the equipotential bonding cable to the equipotential
bonding connection and the equipotential bonding rail. Make
sure that a properly functioning and suitable equipotential
bonding conductor and equipotential bonding cable are used
(e.g. according to DIN 42801).
 Before connecting the unit, compare the electrical data
(voltage and frequency) on the nameplate to the electrical
data of your mains power supply. This data must match to
prevent the unit from being damaged. When in doubt, please
ask your electrician for advice.
 The electrical power outlet must be protected by a 16A circuit
breaker.
 Use the cable supplied with the unit to connect the unit to the
mains supply. The power cable socket is located on the rear
of the unit (see section5.1, Views of the unit, control
elements, and display elements).
 The power supply at the installation site must meet the
requirements for electrical systems in hospitals and medical
environments (see VDE 0100-710:2012-10 “Low-voltage
electrical installations Part 7-710: Requirements for special
installations or locations - Medical locations.”).

GA-592121en -A HICO-AQUATHERM 660 21


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

5.1 Views of the unit, control elements, and display elements


12 4) Thread for clamp holder
10 (in base plate and on rear
panel)
5 5) Water filler neck with screw
cap
6) Water level indicator
11 9) Hose connections
10) Handles
17 11) Temperature display for
13
18 water pad
6
19 12) Display for status and
14 error messages
20
13) Error light
21
14) Temperature display for
nominal value
15) Water flow display
15
16) Power switch
17) Functional test
16
18) Mute audio
19) Increase the nominal
temperature value
9 20) Release > 38°C
21) Decrease the nominal
4 temperature value

Rear view of the unit:

5a) Water drain outlet with


5a
screw cap

4
22) Equipotential bonding bolt
with color marking and
label

23) Microfuse and power


cable socket

GA-592121en-A HICO-AQUATHERM 660 22


5.2 Safety devices
5.2.1 Sensors
During operation, the HICO-AQUATHERM 660 monitors
 the water level in the unit
 if the water temperature in the circuit matches the nominal
temperature value set
 if the unit is connected to power
 if the unit is functionally safe
and emits alarms in case of malfunctions (see section 6.3).

The HICO-AQUATHERM 660 application system does not


have a function for monitoring the patient’s measured
values.
► The core temperature of the patient to be treated must be
monitored regularly independent of the application system.
► The temperature settings for the transition temperatures on
the pad must be entered manually 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 to use the system properly!

GA-592121en -A HICO-AQUATHERM 660 23


5.3 Nameplate
The nameplate with the connection and performance data is
located on the rear of the unit:

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5.4 Function
5.4.1 Basic principles
The HICO-AQUATHERM 660 hyperthermia unit serves the
purpose of warming patients using water pads. The latest safety
and application-related knowledge about water pad systems
was applied during the development of the unit.
Heat is transferred between the patient and the water pad
solely through 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 heated to a temperature of 39°C
in a water tank inside the unit by a heating element and is
pumped continuously through the water pad by a centrifugal
pump
The transition temperature to be reached on the pad
depends on the environmental conditions and the size of
the pad.
The HICO-AQUATHERM 660 is characterised by its safe and
easy use, reliability, and compact design.
Using its electronic control, the heat transferred to the patient
can be adjusted accurately while simultaneously maintaining
high operational safety.
The transition temperature on the patient when warming
normally should not exceed 40°C to prevent the risk of burning
when used for a long period of time. This not only a risk when
the transition temperature is too high, but also when it is too
low. To minimise this risk in case of an equipment failure while
warming a patient, the HICO-AQUATHERM 660 switches off
electronically and electrically when a water temperature higher
than 41.5°C is reached.

GA-592121en -A HICO-AQUATHERM 660 25


Transition temperatures > 38°C must be consciously set by the
user and closely monitored.
This virtually rules out the risk of local accumulations of heat,
whereby the requirements for the installation site and the site of
use also must be fulfilled.
Performance restrictions in terms of the pad transition
temperatures that can be reached under extreme ambient
conditions and for the selected combination of pads can also
lead to restrictions when used for its intended purpose.
The HICO-AQUATHERM 660 is easy and intuitive to operate,
and thus helps prevent incorrect use.

Risk due to overestimation or underestimation of the


performance of the system!
Using the unit can also be hazardous when used for its
intended purpose if the desired temperatures cannot be
reached due to the ambient conditions.
The reliable therapeutic use of the system requires the user to
weigh the risks carefully and continuously monitor and care for
the patient.

GA-592121en-A HICO-AQUATHERM 660 26


5.4.2 Indications / contraindications / side effects
Indications
In general, the HICO-AQUATHERM 660 can be used in
hyperthermia treatment for the following purposes:
 To supply heat to the patient in case of intraoperative or
postoperative hypothermia
 To supply or withdraw heat from the patient to stabilise the
patient’s temperature (normothermia)

Risk due to overestimation or underestimation of the


performance of the system!
Using the unit can also be hazardous when used for its
intended purpose in the following cases:
► Improper understanding of physical interactions among
external accessories and due to ambient conditions (pad
size, ambient temperature, etc.)
► Individual and unpredictable patient reactions
The reliable therapeutic use of the system requires the user to
weigh the risks carefully and continuously monitor and care for
the patient.

GA-592121en -A HICO-AQUATHERM 660 27


Side effects
The materials used in water pad systems have no known side
effects.
In applications, the transfer of heat using water pads may be
considered unsatisfactory if the following is true:
 Less than 20% of the surface of the water pad comes into
contact with the patient
 The contact pressure reduces skin circulation. In this case
there is an additional risk of bedsores.
In warming applications and the corresponding specific
increase of the patient’s temperature, there is always a risk of
burning during long-term applications and when the
temperature is too high.
In case of a heat loss and the associated unintentional
reduction of the patient’s temperature (hypothermia), the
following side effects can occur:
 Autonomous reactions (among others, shivering)
 Electrolyte imbalances
 Excess urination (diuresis fluctuations)
 Hyperglycaemia (glycaemic fluctuations)
 Greater blood loss (due to reduced blood-clotting factors)
 Changes in the pharmacokinetics
 Higher wound infection rates (sepsis)
 Risk of decubitus

Contraindications
 Advanced malignant underlying disease
 Persistent state of shock / cardiopulmonary instability
 Pregnancy
 Coma due to other causes
 Body temperature below 30°C upon admission
 Time between cardiac arrest and initiation of resuscitation of
more than 15 minutes
 Distal application of an arterial clamp

GA-592121en-A HICO-AQUATHERM 660 28


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 temperature of the patient
should be increased by no more than 0.25-0.5°C per hour.
Warming too rapidly also leads to arrhythmias and
ventricular fibrillation with the subsequent risks.
► When used on ischaemic limbs, there is an increased risk of
tissue damage and shock.

► For the low-risk and reliable application of


hypo/hyperthermia treatment, it is of utmost importance to
externally and continuously monitor the body core
temperature (e.g. by measuring the temperature in the
urinary bladder).
► Therapeutic hyperthermia requires the user to weigh the
risks carefully and continuously monitor and care for the
patient to detect side effects, prevent pressure-induced
lesions, and ensure 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 during normal operation.
► No distal application of an arterial clamp!

Because new discoveries are constantly being made in the field


of hypo/hyperthermia, the information provided here does not
claim to be current or complete.
The pfm medical hico gmbh is not responsible or liable for
negligent or incorrect use and cannot provide any medical
recommendations or procedures. The user must independently
decide what to use and how to proceed.

GA-592121en -A HICO-AQUATHERM 660 29


6 Control and operation
This chapter contains important instructions and information for
operating the unit. Please follow these instructions to avoid
danger and prevent damage.

6.1 Before switching on


6.1.1 Check the unit
Inspect the unit for external damage.
Check the water level before and after
 switching on the unit and
 connecting a water pad.
The water level must be between both marks on the water level
indicator (6), preferably just below the maximum mark. The
difference in volume between the two marks is approx. 1.0 litre.

Fill with sterile filtered tap water to which a disinfectant has


been added when the following applies:
 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-AQUATHERM 660.
 Check the water pads for external damage before
connecting. Use only undamaged pads.
 Have a collecting basin ready in case a pad should start
leaking.
 Place a thin fleece between the water pad and the patient’s
skin.

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Water pads can be connected and disconnected regardless of
whether the unit is switched on or off.

Disconnecting water pads when the unit is switched on and in


heating mode:
► Reduce the nominal temperature before disconnecting the
water pad. Otherwise the sterile filtered tap water in the
unit’s circuit can briefly rise more than 1°C above the
temperature setting or exceed the upper temperature limit,
and the unit may trigger various alarms.

Intermediate layers between the patient and water pad (bed


sheets, surgical drapes, gel pads, etc.) adversely affect the heat
transfer.
► A thin absorbing cotton linen/sheet should be positioned
between the patient’s skin and the pads. Direct skin contact
with the pad, which is made of plastic, can lead to skin
damage and increases the risk of decubitus.
► Make sure there are no creases in the fleece after
placement.

6.1.3 Heat output


Information: During operation the display on the unit shows the
amount of heat transferred (heat output) by the unit to the
heating pad, which means it shows the heat output in Watt (W)
that was transferred to the environment (air, contact surfaces of
the operating table, etc.) and to the patient.
The percentage of the amount of heat displayed that is actually
transferred to the patient depends on the type and size of the
heating pad and is always less than 100%.
The better the heating pad (e.g. HICO-AQUASOFT) is thermally
insulated from the underlying surface (e.g. the operating table)
and the higher the ratio of the contact area with the patient to the
total area of the heating pad, the higher the percentage of the
total heat output that is transferred to the patient.

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6.2 Operation
6.2.1 Switching on for the first time
 Switch the unit on using the pushbutton (16); when switched
off, the pushbutton is flush with the front panel.
 If the temperature setting is higher than 38°C, then check if
the temperature setting is actually 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 using the pushbutton (16), disconnect the
power cable from the mains supply, and refill it with sterile
filtered tap water to which a disinfectant 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 the air out of the water
pad.
 Check the water level on the indicator (6) again; if necessary,
switch off the unit using the pushbutton (16), disconnect the
power cable from the mains supply, and refill it with sterile
filtered tap water to which a disinfectant has been added.
 Repeat the procedure when connecting a second pad.

6.2.2 Switching on in normal operation


 Switch the unit on using the pushbutton (16); when switched
off, the pushbutton is flush with the front panel.
 If the temperature setting is higher than 38°C, then check if
the temperature setting is actually correct before pressing the
release key (20).
 Check the water level on the indicator (6), especially if you
have connected an empty water pad.
 After use, switch the unit off using the pushbutton (16) and
disconnect the plug from the mains supply.

GA-592121en-A HICO-AQUATHERM 660 32


6.2.3 Functional test
After switching the unit on, it automatically performs a function
test. During this test, monitor the displays to ensure they
behave as described in the following:
 A short audible alarm indicates that the unit is ready in case
of a power failure alarm.
The unit now checks its autonomous safety device and does
the following:
 Shows the result in the display (12)

 The temperature displays (11) and (14) show


 The yellow error light (13) lights up
 The audible alarm is triggered.
This test takes a few seconds.

If the unit does not pass all functional tests successfully,


then the unit is no longer safe to operate.
Do not operate unit in the following cases:
► The unit does not sound the short signal tone for the power
failure alarm when switching on.
► The automatic function test automatically switches the unit
off because it has detected a defect in the independent
safety device.
► One or more displays are defective.
In these cases, have the unit checked by HICO Customer
Service.

GA-592121en -A HICO-AQUATHERM 660 33


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 - using the two arrow keys (19) and (21). The
temperature can be adjusted in increments of 0.1°C between
35°C and 39°C. The temperature display (14) shows the
nominal temperature setting.

 For temperature settings above 38°C, press the up arrow key


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

► At temperatures below 35°C, heat is withdrawn from the


patient at a higher rate.
► At temperatures over 38°C, the patient is provided with heat
at a higher rate.
► Regardless of the temperature, parts of the body that are
subjected to increased pressure may suffer from pressure
necrosis and/or burns. This applies especially to long-term
applications and high-risk patients.6

To ensure reliable indications and safe operation, note the


information in sections 4.2.1, 5.4.2, 6.2.8, and 6.2.9!
External conditions and pad size influence the nominal
temperature setting, e.g. very high or low temperature settings
may not be reached under some circumstances in
environments with high or low ambient temperatures and/or
when connecting one large pad or two smaller water pads. In
this case, set the temperature to a lower or higher value until
the unit can reliably regulate the temperature.
Check the water flow on the display (15)!

6
Cf. Scott S.M., Thermal blankets injury in the operating room, Arch. Surg. 34, page 181, 1967

GA-592121en-A HICO-AQUATHERM 660 34


The unit does not actively regulate the temperature to a
temperature setting that is lower than the current temperature
value. The water pad is cooled passively according to the
ambient temperature or by the body temperature of the patient.
The message “TEMP.DIFF. > 1°C”, “ACTIVE COOLING”, “NOT
POSSIBLE”.

Heat transfer:
Heat is only transferred (supplied) between the patient and the
water pad if the temperature of the water pad is higher than the
skin temperature of the patient on the contact surface.
The rate of heat transfer is directly proportional to the following:
 The difference between the skin temperature and the water
pad temperature
 The size of the contact area
Intermediate layers impair heat transfer (e.g. surgical drapes or
gel pads).

Example of a temperature difference:


The heat transfer from the pad to the patient doubles when the temperature
difference between the water pad and the patient is doubled. If the patient’s
skin has a temperature of 34°C on 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 an approximation.

Example of enlarging the contact area:


To enlarge the contact area, you can connect two water pads of the same
type or of different types to the unit.
With a larger contact area, more heat is transferred, even when the
temperature difference is smaller. The pad temperature - i.e. the nominal
temperature value - can be set to a value that is closer to the patient’s
temperature.

GA-592121en -A HICO-AQUATHERM 660 35


6.2.5 Temperature control mode

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 is set to a value between 35°C and
38°C, then the unit will start normal operation automatically
after it is switched on and after the function test, and will
maintain the water temperature in the water circuit of the
system at the temperature setting.
If the nominal temperature is set to a value higher than 38°C,
then the unit will emit an audible alarm, and the message
“NOMINAL VALUE >38°C!”, “RELEASE KEY” will appear in the
display (12).
Check if the nominal temperature setting is correct, and only
press the release key (20) if it is correct.
The unit starts the temperature control mode and shows
“HEATING ACTIVE” in the display (12) when the temperature
setting is higher than the actual temperature.
The unit does not actively regulate the temperature to a
temperature setting that is lower than the current temperature
value.

Only leave the water pad in contact with the patient during
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 a nominal temperature is not reached within 60 minutes after


switching on the system due to external conditions and the size
of the pad, then an alarm message (TEMP.DIFF >1 °C) will
appear (see section 6.3.2 “Alarm descriptions during
operation”).
In this case, adjust the temperature setting so it matches the
actual value displayed.
Check the water flow on the display (15)!

GA-592121en-A HICO-AQUATHERM 660 36


6.2.6 Handling water pads

► Avoid contact with hot, sharp, and pointed objects.


► When disconnecting a water pad from a unit that is switched
off, 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. never on top of the unit.
Otherwise the sterile filtered tap water will flow from the pad
back into the unit and overflow.
► Water pads should be stored rolled up whenever possible.
Creases and kinks can damage the material.
► Avoid direct sunlight. Heat and UV rays will damage the
material.

6.2.7 Using water pads


The water pads can be placed horizontally and be used both as
an underlay underneath the patient and as a cover over the
patient. It is also possible to use smaller pads and blankets as a
wrap if necessary. It is important to ensure the pad and the
hoses are free of creases and kinks after placement so that the
water flow is not affected and no unnecessary pressure is
applied to the patient. Make sure the contact surface between
the pad and the patient is as large as possible given the
particular pad size. It is recommended to use a thin fleece as an
intermediate layer. Direct skin contact with the pad, which is
made of plastic, can lead to skin damage and increases the risk
of decubitus. Make sure here as well that there are no creases
in the fleece after placement.

External conditions and pad size influence the nominal


temperature setting, e.g. very high or low temperature settings
may not be reached under some circumstances when
connecting one large pad or two smaller water pads. After
starting the unit, monitor the nominal and actual temperature
differences and, after approx. 45-40 min of operation, set the
temperature on the unit to a lower or higher nominal value that
approximately corresponds to the actual value.

GA-592121en -A HICO-AQUATHERM 660 37


► See also section 4.2.1 “Requirements on the installation site
/ operating location” and section 6.1.2 “Water pads”
► For trouble-free and stable operation, the difference
between the nominal temperature setting and actual
temperature displayed on the unit should not be greater
than 1°C.
► The thicker the intermediate layers between patient and
water pad are (bed sheets, surgical drapes, gel pads, etc.),
the poorer the heat transfer.

GA-592121en-A HICO-AQUATHERM 660 38


6.2.8 Schematic performance charts
Explanation:
The data for the performance diagrams was obtained in an
appropriate setting in the laboratory at three different ambient
temperatures and for three different pad combinations.
Desired pad temperatures: 39°C7 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
2 largest pad: LxW: (170 x 50) cm / area: 8,500 cm²

The pad sizes selected are representative of other HICO pad


sizes used in applications.
The following performance charts illustrate limit value analyses
(at extreme conditions) for ambient temperatures, pads, and
settings based on data obtained according to standard
laboratory procedures.

This leads to the following restrictions:


 No restrictions

The values shown the performance charts are approximate


values.

7
In accordance with the requirements of DIN EN 80601-2-35 from August 2010, the temperature of the system is
limited to 39°C.

GA-592121en -A HICO-AQUATHERM 660 39


Performance charts:
The temperature limit values8 to be reached within 10 minutes
to 60 minutes (see diagrams 1-3) after startup and adjustment
of the temperature setting during operation under laboratory
test conditions.

In actual applications, the


temperature limit values may differ!!
When used in actual applications, follow the instructions and
note the warnings and information, etc., from the relevant
sections:
4.2.1 Requirements on the installation site / operating
location
5.4.1 Basic principles
5.4.2 Indications / contraindications / side effects
6.2.5 Temperature control mode
6.2.7 Using water pads
6.2.8 Schematic performance charts
6.2.9 Responsibilities 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

15 °C

10 °C

5 °C

°C
2x largest pad Smallest pad

7
The temperatures shown are reference values from the schematic performance charts of the laboratory
analyses. They do not claim to be completely accurate when actually using the system.

GA-592121en-A HICO-AQUATHERM 660 40


Performance chart 1

Ambient temperature 20°C


45 °C

40 °C

35 °C

30 °C

25 °C

Max
20 °C

15 °C

10 °C

5 °C

°C
2x largest pad Smallest pad

Performance chart 2

Ambient temperature 30°C


45 °C

40 °C

35 °C

30 °C

25 °C

Max
20 °C

15 °C

10 °C

5 °C

°C
Largest pad Smallest pad

Performance chart 3

GA-592121en -A HICO-AQUATHERM 660 41


6.2.9 Responsibilities during operation

6.2.9.1 Indication-based

Risk due to overestimation or underestimation of the


performance of the system!
Using the unit can also be hazardous when used for its
intended purpose in the following cases:
► Improper understanding of physical interactions among
external accessories and due to ambient conditions (pad
size, ambient temperature, etc.)
► Individual and unpredictable patient reactions

The reliable therapeutic application of the system requires


the user to carefully weigh the risks between the desired
indication and the performance of the system, as well as to
continuously monitor and care for the patient in terms of
side effects and preventing the formation of pressure
ulcers due to heat or cold.
For the low-risk application of hypo/hyperthermia treatment, it is
of utmost importance to externally and continuously monitor the
body core temperature, e.g. by measuring the temperature in
the urinary bladder, because uncontrolled hypo/hyperthermia is
associated with increased patient mortality. See section 5.4.2
for indications / side effects / contraindications.

The medical information provided here does not claim to be


complete since new discoveries are constantly being made in
the field of hypo/hyperthermia. The pfm medical hico gmbh is
not responsible or liable in any way for negligent or incorrect
use and cannot provide any medical recommendations or
procedures. The user must independently decide what to use
and how to proceed.

GA-592121en-A HICO-AQUATHERM 660 42


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. When the flow of water is optimal, it is
impossible to focus on the individual blades of the impeller.

Performing a function test


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

 The temperature displays show


 The yellow error light (13) lights up
 The display shows FUNCTION TEST.
After passing the test, the display shows the message
“FUNCTION TEST OK”, and the unit automatically resumes
normal operation.

If the function test was not completed successfully, then


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 mode


During long-term operation, check the nominal temperature
setting and actual temperature values shown in the display
regularly; see section 6.2.5 and 6.3.2.

GA-592121en -A HICO-AQUATHERM 660 43


6.2.10 Operating language
The status and error messages in the display (12) can be
displayed in the following languages: German, English, French,
Spanish, Italian, and Polish.
Set the display language as follows:
 Switch the unit on.
 Hold the “Audio paused” (18) key down for about 4 seconds;
the last language setting used appears in the display.
 Keep pressing the “Nominal value higher” (19) arrow key
until the desired language appears in the display.
 About 10 seconds after the last input, the unit will return to its
previous operating status, and the last language displayed is
the active language.

GA-592121en-A HICO-AQUATHERM 660 44


6.3 Alarms
6.3.1 General information
The unit always emits both visual and audible alarms. The
operator is therefore notified immediately in case of a
malfunction, which increases the operational reliability of the
system. The display (12) shows the error that caused the alarm
(except in the case of a power failure alarm).
The alarms are assigned a medium priority9. Ignoring an alarm
can result in the following:
 Minor injuries or discomfort within a period of time that is
usually not long enough for manual corrective action
(immediately).
 Reversible injuries within a period of time that is usually long
enough for manual corrective action (promptly).
 Death or irreversible injury within an undefined period of time
that is greater than the “promptly” time period (delayed).
If the system sounds an alarm for the reasons described in
section 6.3.2, then the alarm can be reset as follows depending
on the expected result.
 Pressing the “Mute audio” key (18) interrupts the audible
alarm for 10 minutes. The error message can be read in the
display (12). The error light (5) continues to flash as long as
the alarm condition is present. The alarm condition must be
eliminated according to the alarm message shown on the
display (12).
 The unit will switch all functions off. The audible alarm cannot
be interrupted. Switch off the unit using the mains switch
(16), take it out of service, and if necessary, have it inspected
by a service technician (Customer Service / Medical
Technology).

Before pressing the “Mute audio” 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!

6.3.2 Description of alarms during operation

6.3.2.1 Display message: WATER LEVEL!?


The unit triggers this alarm when the water level drops below
the MIN mark on the water level indicator (6) during operation.

9 Source: DIN EN 60601-1-8:2008-02 Table 1 – Alarm condition priorities

GA-592121en -A HICO-AQUATHERM 660 45


The display shows “WATER LEVEL!?”, the yellow error light
(13) flashes, and a pulsating signal tone sounds.
 Press the “Mute audio” key (18) to interrupt the audible alarm
for 10 minutes.
 Immediately fill up sterile filtered tap water to which a
disinfectant has been added, until the water level is just
below the MAX mark (6) (see section 4.3.1 Filling the
system).

► When the water level is too low, adequate water circulation


can no longer be guaranteed.
► A water level that is too low can cause damage to
components of the unit and consequently lead to the total
failure of the unit.

6.3.2.2 Display message: TEMP.DIFF > 1°C


If the temperature of the water pad deviates from the
temperature setting by more than 1°C during operation, then
the unit will trigger this alarm. The display shows “TEMP.DIFF.
> 1°C”, the yellow error light (13) flashes, and a pulsating signal
tone sounds.
 Press the “Mute audio” key (18) to interrupt the audible alarm
for 10 minutes.
 Change the temperature setting until the unit is able to
regulate the temperature reliably.

► Connecting or disconnecting a water pad during operation


can create a temperature difference that causes the alarm
to trigger.
► The alarm can be triggered due to unfavourable room
temperatures and/or when large pads or two water pads are
connected because the specified nominal temperature (e.g.
39°C) cannot be reached in this case. Change the
temperature setting until the unit is able to regulate the
temperature reliably.
► After switching on the unit and changing the temperature
setting, this alarm function is suppressed for a defined
period of time.

GA-592121en-A HICO-AQUATHERM 660 46


6.3.2.3 Display message: ALARM TEST DEFECTIVE
CUSTOMER SERVICE
The unit triggers this alarm if it has detected an error during the
automatic or manual function test or has determined that the
autonomous safety device does not respond. The display
shows “ALARM TEST DEFECTIVE” and “CUSTOMER
SERVICE”, the yellow error light (13) flashes, and a pulsating
signal tone sounds.
The audible alarm cannot be interrupted using the “Mute audio”
key (18).
 Switch off the unit using the mains switch (16).
 Switch the unit back on.

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

6.3.2.4 Display message: UNDERTEMPERATURE CHECK UNIT


The unit triggers this alarm when the temperature in the water
tank drops below the lower limit of the measuring range
(approx. 9°C). The display shows “UNDERTEMPERATURE”
and “CHECK UNIT”, the yellow error light (13) flashes, and a
pulsating signal tone sounds. The temperature display shows
.
The audible alarm cannot be interrupted using the “Mute audio”
key (18).
 Switch off the unit using the mains switch (16).
 Take the unit to a warmer environment and wait for about 2
hours.
 Switch the unit back on.

► Only store the unit in the permissible temperature range (3-


60°C), otherwise the unit may become damaged.
► Only operate the unit in the permissible temperature range
(10-30°C), otherwise it will not function reliably and can
become damaged (note the information in section 4.2.1
“Requirements on the installation site / operating location”!)
If the unit still emits an alarm, take it out of service and have it
inspected by a service technician (Customer Service / Medical
Technology).

GA-592121en -A HICO-AQUATHERM 660 47


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 error light lamp (13) flashes, and a pulsating signal
tone sounds.
The audible alarm cannot be interrupted using the “Mute audio”
key (18).
 Switch off the unit using the mains switch (16).
Take the unit out of service and have it inspected by a service
technician (Customer Service / Medical Technology).

6.3.2.6 Power failure alarm


The unit triggers this alarm when the power supply fails during
operation. The yellow error light (13) is lit and a signal tone
sounds. All other displays have no function. The power
accumulator in the unit can maintain the alarm for at least 10
minutes in the event of a power failure.
The audible alarm cannot be interrupted using the “Mute audio”
key (18).
 Switch off the unit using the mains switch (16).

The alarm automatically turns off when the power supply


returns.
The last temperature setting is stored in the unit.
When power is restored, the temperature setting stored must be
checked by the user and confirmed before the unit returns to
normal operation (see section 6.2 “Operation”).

GA-592121en-A HICO-AQUATHERM 660 48


7 Cleaning and disinfection
This chapter contains important information on cleaning and
disinfecting the unit. Please follow these instructions to avoid
damage to the unit due to improper cleaning and to ensure
trouble-free operation.

7.1 Safety instructions

Follow the safety instructions below before starting to clean the


unit.
► Disconnect the mains plug before you start cleaning and
disinfecting the unit.
► Do not allow any fluids to get inside 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 when
you use the wrong cleaning agents and disinfectants.
► Use only disinfectants based on aldehydes, ammonium
compounds, or alcohols that do not affect ABS plastics,
PVC, or PU on all surfaces and parts.
► If possible, do not use any disinfectants based on phenol
derivatives because these will shorten the lifespan of plastic
materials.

GA-592121en -A HICO-AQUATHERM 660 49


7.2 Unit
7.2.1 Water circuit

7.2.1.1. General Information for cleaning the water circuit


The cleaning process consists of a total of three steps.
Thoroughly clean the unit (basic cleaning) and the accessories
first, then disinfect the unit, and then flush and refill the unit.
The unit should be cleaned and disinfected every 14 days. You
must wear disposable gloves during the entire cleaning process
and avoid contact with the sterile filtered tap water and the
disinfectant.

7.2.1.2. Basic cleaning


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

7.2.1.3. Disinfection
For disinfection purposes, any VAH10-listed disinfectant that is
free of phenolic derivatives can be used. Suitable disinfectants
include Terralin protect, Gigasept FF, Gigasept AF, Mikrozid
AF, or Sanosil S003.

Note the dosage recommended by the corresponding


manufacturer of the disinfectant. If necessary, prepare a
disinfectant solution according to the instructions of the
manufacturer of the disinfectant. Fill the unit with the
disinfectant or the disinfectant solution. Connect the device to
the mains power supply and connect all parts and accessories
to be disinfected to the unit. Switch on the unit and allow it to
run for about two minutes so that the disinfectant can be
distributed throughout the circuit; if necessary, add more
disinfectant or disinfectant solution. Switch off the unit and note
the exposure time specified by the manufacturer of the

10GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden

GA-592121en-A HICO-AQUATHERM 660 50


disinfectant. After the exposure time has expired, disconnect
the unit from the mains power supply and completely empty the
unit and all accessories.

Do not apply any cleaning and decontamination methods other


than the ones recommended by pfm medical hico gmbh.
Before introducing new methods, have them checked together
with pfm medical hico gmbh.
This is the only way to make sure that the unit will not be
damaged by the new method.

7.2.1.4. Flushing and refilling


Fill the unit with sterile filtered tap water11. Connect the unit to
the power supply. Connect any accessories you want to use to
the unit. Switch on the unit and allow the water to circulate for
five minutes. Disconnect the unit from the power supply.
Completely empty the unit and all accessories used.
The cleaning process is now finished. Before putting the unit
back into service, refill the unit using only sterile filtered tap
water to which a disinfectant has been added12.

11
Depending on the quality of the water (e.g. its hardness, among other things), the lifetime of the parts of the unit
that come into contact with water may be reduced.
12
For example 10 ml SANOSIL mixture (from Sanosil, Farchant)  (1000 ml sterile filtered tap water + 10 ml
Sanosil solution). Alternatively, a different long-term disinfectant and preservative can also be used, e.g.
Micropur or Certisil. If you have any questions, please contact the Customer Service department of pfm medical
hico gmbh.
The use of a disproportionately high amount of disinfectant can reduce the lifetime of parts of the unit that come
into contact with water!

GA-592121en -A HICO-AQUATHERM 660 51


7.2.2 Surfaces
If possible, use decalcified water to clean the surfaces of the
unit. Only wipe the unit with a damp cloth. Use only warm water
(max. 50°C) to which a mild commercial dishwashing liquid has
been added. Wipe off again with clean water and wipe the unit
dry with a cloth.
To disinfect the surfaces of the unit, we recommend using a
wipe-down or surface disinfectant from the VAH list13 (e.g.
Mikrozid AF from S&M). When using a disinfectant, follow the
instructions of the manufacturer.
Only switch on the unit after the disinfectant has evaporated
completely.

7.2.3 Ventilation slots


Check the ventilation slots on the back of the unit for dirt and
dust regularly (at least every 6 months). Remove as much dirt
and dust from the surface as possible. Dust deposits in the unit
reduce the performance of the system. Have dirt and dust
inside the unit removed by a service technician (Customer
Service, Medical Technology). Do not open the unit yourself.

Do not apply any cleaning and decontamination methods other


than the ones recommended by pfm medical hico gmbh.
Before introducing new methods, have them checked together
with pfm medical hico gmbh.
This is the only way to make sure that the unit will not be
damaged by the new method.

13GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden

GA-592121en-A HICO-AQUATHERM 660 52


7.3 Water pads, hose extension
If possible, use decalcified water. Wipe off the surfaces with a
damp cloth only. Use only warm water (max. 50°C) to which a
mild commercial dishwashing liquid has been added. Wipe off
again with clean water and wipe the pad until dry.
To disinfect the surfaces of the unit, we recommend using a
wipe-down, surface, or spray disinfectant from the VAH list14
(e.g. Terralin protect from S&M). When using a disinfectant,
follow the instructions of the manufacturer.
Only use the pad again after the disinfectant has evaporated
completely.
Check the pad for damage, deformation, and cracks; replace
the pad if necessary.

Do not apply any cleaning and decontamination methods other


than the ones recommended by pfm medical hico gmbh.
Before introducing new methods, have them checked together
with pfm medical hico gmbh.
This is the only way to make sure that the unit will not be
damaged by the new method.

14GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden

GA-592121en -A HICO-AQUATHERM 660 53


8 Maintenance and safety check
This chapter contains important information on the maintenance
of the unit. Please follow these instructions to avoid damage to
the unit caused by inadequate maintenance and to ensure
trouble-free operation.

8.1 Maintenance
We recommend closing a maintenance contract with the pfm
medical hico gmbh. By closing a maintenance contract, you
fulfil the following requirements:
 Ordinance on Industrial Safety and Health of the German
Employers' Liability Association (BetrSichV BGV A2, VBG 4)
and the new BGV A3
 Medical Device Directive 93/42/EEC,
 German Medical Devices Operator Ordinance (MPBetreibV)
All of these regulations require regular technical inspection of
the units.
Furthermore, maintenance by our experts ensures maximum
operational reliability and the longevity of the unit.

With proper handling and regular maintenance, the unit has a


product lifetime of about 10 years.

When handled properly, the lifespan of the necessary


accessories (water pads and hose extensions) is determined by
the natural aging process and wear through the use of the unit.

GA-592121en-A HICO-AQUATHERM 660 54


8.1.1 Unit
 Check the ventilation slots on the bottom and back of the unit
regularly for dirt and dust.
 Dust deposits in the unit reduce the performance of the
system. Have dirt and dust inside the unit removed by a
service technician (Customer Service, Medical Technology).
Do not open the unit yourself.
 Have the Customer Service or Medical Technology
departments perform the maintenance and safety checks
regularly to ensure the intervals are maintained.

8.1.2 Water tank


Replace the sterile filtered tap water in the water tank at least
every 2 weeks (described in section 7.2.1) as follows:
 Disconnect unit from the mains power supply.
 Place a container (bucket, bowl, etc.) below the front of the
unit or place the unit over a drain (e.g. the drain of a sink).
 Unscrew the cap from the water filling neck (5), e.g. with a
coin.
 Take the water drain hose and place it on one of the front
hose connections (9).
 Tilt the unit forward and drain the water through the water
drain hose until it is completely empty.
 Remove the water drain hose from the front hose connection
and place it aside for now.
 Clean and disinfect the water circuit as described in section
7.2.1.
 Refill the unit with sterile filtered tap water to which a
disinfectant has been added as described in section 4.3.1.
The max. filling capacity of the unit tank is approx. 1.4 litre.

8.1.3 Hose connections


The seal rings (O-rings) on all hose connections are subject to
aging and can become dry and brittle as a result. You should
therefore coat the seal rings with a thin film of silicone paste or
petroleum jelly every 6 months.

GA-592121en -A HICO-AQUATHERM 660 55


8.2 Safety check
In order to maintain legal conformity and operational reliability
according to the Medical Product Directive 93/42/EEC
(Appendix I, section 13.6.d) and the German Medical Devices
Operator Ordinance (MPBetreibV Art. 6(1)), a safety check
must be conducted on the unit every 12 months. The operator
is solely responsible for ensuring these safety checks are
performed. According to the MPBetreibV (section 6(4)(1+3)),
this safety check may only be performed by pfm medical hico
gmbh or a qualified person. The safety check covers the
following points at a minimum:
 Inspection of the device and accessories for external
damage, wear, and aging, and checking the legibility of the
displays and labels
 Measurement of the PE resistance and the earth leakage
current according to the test facility and manufacturer’s data
 Check of all functions according to the operating instructions
 Check of all safety functions according to the manufacturer’s
data
 Check of all sensors according to the manufacturer’s data
(pfm medical hico gmbh provides a service manual for
authorised persons for this purpose).

GA-592121en-A HICO-AQUATHERM 660 56


In order to maintain compliance with statutory safety
regulations, we recommend closing a technical safety
inspection contract with an authorised company to perform the
recommended annual safety check.

For heavily soiled units or accessories returned to us for


maintenance or repair where there is a suspicion of
contamination due to contact with specific pathogens (e.g.
MRSA), the system must be pre-disinfected with an appropriate
disinfectant and packaged for transport in accordance with the
decontamination requirements and material compatibility.
Otherwise we reserve the right to reject such units or
accessories 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
such measures shall be borne by the customer.

Questions regarding service, maintenance, or safety checks


should be addressed directly to:

pfm medical hico gmbh


Bonner Str. 180
50968 Cologne
Tel.: +49 (0)2 21 / 3 76 78-0
Fax: +49 (0)2 21 / 3 76 78-85
Email: [email protected]

GA-592121en -A HICO-AQUATHERM 660 57


9 Troubleshooting
This chapter contains important information on locating errors
and troubleshooting. Please follow these instructions to prevent
hazards and damage.

9.1 Safety instructions

► Repairs on electric devices may only be carried out by


skilled professionals, including personnel trained by the
manufacturer.
► Improper repairs can seriously endanger the user and
cause damage to the unit.

Opening the unit by unauthorised persons will void all rights to


any guarantee and warranty claims.
► Repairs to the unit may only be performed by the pfm
medical hico gmbh or by experts trained and/or authorised
by the pfm medical hico gmbh.

GA-592121en-A HICO-AQUATHERM 660 58


9.2 Causes of error and troubleshooting
Error Possible causes Possible actions

No water circulation or 1. Hoses or pads are 1. Ensure hoses and pads are
insufficient water circulation kinked/folded correctly placed and
positioned
2. Connections are not tight 2. Insert hose connections firmly
into each other
3. Unit is positioned far below 3. Position the unit at the same
the heating pad height as the heating pad or
higher
4. Strong foam formation 4. Change the water*
5. High patient weight 5. Position the unit higher than
the heating pad
6. Pump worn/defective 6. Customer service*

Connectors are hard to connect 1. Sealing ring dry and brittle 1. Grease sealing ring with
petroleum jelly, silicone
grease, or a similar lubricant
Hose connection drips constantly 1. Exterior, visible sealing ring 1. Replace sealing ring*
damaged or missing

Coupling valve of the 1. Inner sealing ring damaged 1. Customer service*


unconnected coupler drips 2. Inner sealing ring dirty or 2. Insert and loosen coupling
constantly contaminated several times, if necessary
contact Customer Service
No heat output value displayed. 1. Temperature difference 1. Heat is only output when the
Display message: (nominal/actual) temperatures are the same

“HEAT OUTPUT 0 W” or
“HEAT-UP PHASE”

Alarm + display message: 1. Independent safety device Customer service*


defective
“ALARM TEST DEFECT”
“->CUSTOMER SERVICE” 2. Pump defective (electrical)

Alarm + display message 1. Connecting or disconnecting 1. Acknowledge alarm with the


the heating pad during “Alarm OFF” key
“TEMP.DIFF. > 1°C”
operation

Alarm + display message every 1. Cartridge heater or pump 1. Customer service*


10 min.: defective
“TEMP.DIFF. > 1°C” 2. Strong foam formation in the 2. Change the water*
tank
3. Bypass interrupted 3. Customer service*
4. Lack of heat output 4. Do not operate unit
continuously (> 1h) without a
heating pad*

GA-592121en -A HICO-AQUATHERM 660 59


Error Possible causes Possible actions

Alarm + display message: 1. Water level too low 1. Refill with water
“WATER LEVEL!?” 2. Unit is not completely 2. Position unit horizontally
Can be acknowledged for 10 min. horizontal
using the “Alarm OFF” key 3. Sensor deviation 3. Customer service*

Alarm + display message: 1. Various defects 1. Customer service*


“CHECK UNIT” 2. Water tank empty 2. Refill with water*
3. Sensor break/short circuit T1 3. Customer service*
“->CUSTOMER SERVICE”
4. Sensor short circuit T2 4. Customer service*
Alarm + display message: 1. Unit too cold (< 9°C) 1. Let the unit warm up at room
temperature for a while*
“CHECK UNIT”
2. Sensor break T2 2. Customer service*
“UNDERTEMPERATURE”
3. Water tank frozen 3. Let the unit defrost*;
Examine unit for frost damage
(is water flowing out of the
unit?)  Customer service
Unit does not function at all and 1. Mains power failure 1. Switch off unit until power
acoustic alarm returns
2. Mains connector does not 2. Check the connector on unit
make contact and in the socket for correct fit
3. Fuse defective 3. Customer service*
4. Unit defective 4. Customer service*

* Switch off the unit immediately

GA-592121en-A HICO-AQUATHERM 660 60


10 Disposal of an old unit
Old electric and electronic devices very often contain precious
metals and valuable materials. However, they also contain
harmful substances that were necessary for their function and
safety.
If disposed of as residual waste or handled incorrectly, these
substances can be harmful to humans and damage the
environment. This device must not be disposed of together with
normal industrial or domestic waste!

► According to the product responsibility requirements


according to Art. 22 of the German Recycling Economy and
Waste Management Act (KrW-/AbfG) and Art. 2(1)(8) of the
German Electrical and Electronic Equipment Act (ElektroG),
the unit must be handed over to a corresponding municipal
collection point or returned to the manufacturer.

► In accordance with waste management regulations applying


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

GA-592121en -A HICO-AQUATHERM 660 61


11 Technical data, unit, and accessories
11.1 Unit
HICO-AQUATHERM 660
Item No. (REF): 590001 (220/230V) / 590020 (115V)
Rated voltage: 230VAC 50Hz / 115VAC 60Hz /
220VAC 60Hz
Power consumption: 530W (230V) / 560W (115V)
Current consumption: Approx. 2.3 A (220V/230V)/ 4.6 A
(115V)
Nominal temperature range: 35-39°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 temperature display)


Sensor element: 2 x NTC 5K
Pump capacity: Max. 19 l/min., max. 0.34 bar
Heating capacity: 500W (at 27°C)
Heat-up time without water pad: Approx. 5-10 min. (20-37°C)
Fuse rating: 2 x T 3.15A L 250V (220V/230V) / 2
x T 5A L 250V (115V)
Class/type of protection: I, BF (defibrillation protection)
IP type of protection: IP X1 (drip proof)
Risk class (93/42/EEC): II b
Power supply Must comply with VDE 0100 Part
710:2002-11 “Electrical safety in medical
environments”.
Ambient temperature: 10-30°C
Relative humidity: Approx. 30-70%
Transport/storage temperature: 3-60°C
Air pressure: 700-1060 hPa
Tank volume: Approx. 0.7/1.4 l (MIN/MAX)
Permissible height difference: Max. 1 m (unit/water pad)
Dimensions WxHxD: Approx. 200 x 290 x 330 mm
Weight: Approx. 7 kg (empty)
Noise emission: Approx. 35 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: 17-648
Subject to technical changes.

GA-592121en-A HICO-AQUATHERM 660 62


► It is not permitted to make changes to the HICO-Aquatherm
660!

11.2 Accessories
 Hose extension, approx. 3 m (required accessory)
REF: 550022
 Thermo-hose extension, approx. 2 m
(optional accessory) REF: 660022
 Equipotential bonding cable 1 m (optional accessory):
REF: 592905
 HICO water drain hose (optional accessory; only used to
empty the unit) REF: 550076
 Only original HICO water pads (required accessory) made of
PU may be used together with the HICO-AQUATHERM 660.
Available sizes and empty weights, among others:

HICO polyurethane 50 x 170 cm // 0.91 REF: 550046


water pad/blanket kg

HICO polyurethane 50 x 92 cm // 0.54 kg REF: 550047


water pad/blanket
HICO polyurethane 50 x 30 cm // 0.24 kg REF: 550044
water pad/blanket
HICO polyurethane 35 x 170 cm // 0.67 REF: 550048
water pad/blanket kg
HICO polyurethane 35 x 92 cm // 0.44 kg REF: 550049
water pad/blanket
HICO polyurethane 70 x 60 cm // 0.52 kg REF: 550025
water pad/blanket
HICO polyurethane 70 x 120 cm // 0.90 REF: 550026
water pad/blanket kg

 Various PU collars for partial output of warmth are also


available as accessories.

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

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

GA-592121en -A HICO-AQUATHERM 660 63


► The suitability of the PU pads and PU blankets for the
intended use must be decided by the user on a case-by-
case basis.

Hose and pad material: PU; free of latex, heavy


metals, and phthalates.
Ambient temperature in operation: 10°C to 30°C
Relative humidity: Approx. 30% to 70%
Transport and storage 3°C to 60°C
temperature:
Air pressure: 700 to 1060 hPa
Please refer to the corresponding brochures and price lists for any further information you
require on the HICO water pads.

 Five-castor base, see section 4.2.3 (optional accessory)

GA-592121en-A HICO-AQUATHERM 660 64


11.3 Symbols
Unit fuses

The level of protection against electrical shock in the pads


corresponds to type BF protection (defibrillation protection).

Exercise caution! (e.g. do not operate the unit in the


presence of combustible gases)

Observe / follow the instruction manual

Disposal

Manufacturer

Also involved in the conformity assessment procedures:


DEKRA Certification GmbH,
Handwerkstraße 15
70565 Stuttgart

GA-592121en -A HICO-AQUATHERM 660 65


12 Guidelines and manufacturer's declaration
Guidelines and manufacturer's declaration – electromagnetic emissions
Tables for medical electrical equipment, general Information:
Table 1
Guidelines and manufacturer's declaration – electromagnetic interference

The HICO-Aquatherm 660 is designed for operation in the electromagnetic environments listed in the
tables and text of these operating instructions. The customer or user of the unit or system should ensure
that the unit is used in an appropriate environment.

Electrical interference Agreement Electromagnetic environment - guidelines


measurements

HF emissions Group 1 The HICO-Aquatherm 660 uses RF energy


according to CISPR 11 exclusively for its internal functions. Therefore,
its RF emission level is very low, and it is
unlikely that it will interfere with nearby
electronic devices.

HF emissions Class B
according to CISPR 11

Emission of harmonics (EN 60601-1-


according to IEC 61000-3-2 2:2015 Table 2)
Class A

Emission of Agrees The HICO-Aquatherm 660 is designed for use


voltage fluctuations/flicker in facilities other than residential areas and in
according to IEC 61000-3-3 facilities that are directly connected to a public
power supply that also supplies residential
buildings.

GA-592121en-A HICO-AQUATHERM 660 66


Table 2

Guidelines and manufacturer’s declaration – Electromagnetic immunity


The HICO-Aquatherm 660 is designed for operation in an electromagnetic environment like the one listed below. The
customer or user of the HICO-Aquatherm 660 should ensure that the device is used in such an environment.

Immunity IEC 60601 Compliance level Electromagnetic


tests test level environment - guidance

Electrostatic discharge ±8 kV contact discharge ±8 kV contact discharge Floors should be wood, concrete, or
(ESD) according to ceramic tile. If the floor is covered
±15 kV air discharge ±15 kV air discharge
IEC 61000-4-2 with a synthetic material, then the
relative humidity must be at least
30%.

Electrical fast ±2 kV for mains cables ±2 kV for mains cables The quality of the power supply
transient (EFT) / ±1 kV for input and Not applicable voltage should correspond to that of
bursts output lines a typical commercial or hospital
environment.
according to
IEC 61000-4-4

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

Voltage dips, short <5% UT Voltage dips: The quality of the power supply
interruptions, voltage should correspond to that of
(>95% dip in UT) 0% UT for 0.5 cycle (1
and voltage variations a typical commercial or hospital
for ½ cycle phase) environment. If the user of the
according to
40% UT 0% UT for 1 cycle HICO-Aquatherm 660 requires
IEC 61000-4-11 continued operation during
(60% dip in UT)
70% UT for 25/30 cycles interruptions of the power supply,
for 5 cycles
(50/60 Hz) then we recommend supplying the
70% UT HICO-Aquatherm 660 with power
(60% dip in UT) from an uninterruptible power supply
for 25 cycles Voltage interruption: or a battery.

<5% UT 0% UT for 250/300 cycles


(>95% dip in UT) (50/60 Hz)
for 5 sec

Power frequency 30 A/m 30 A/m Power frequency magnetic fields


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

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

GA-592121en -A HICO-AQUATHERM 660 67


Table 4

Guidelines and manufacturer’s declaration – Electromagnetic immunity


The HICO-Aquatherm 660 is designed for operation in an electromagnetic environment like the one listed below. The
customer or user of the HICO-Aquatherm 660 should ensure that the device is used in such an environment.

Immunity tests IEC 60601 test Compliance level Electromagnetic


level environment - guidance

Conducted RF 3 Vrms 3 Vrms Portable and mobile radio


equipment should be used no
interference 150 kHz to 80 MHz 150 kHz to 80 MHz closer to the HICO-Aquatherm
according to IEC 660 and its power cables than
6 Vrms 6 Vrms
61000-4-6 the recommended separation
ISM and amateur ISM and amateur bands distance calculated from the
bands equation applicable to the
frequency of the transmitter.
Recommended separation
distance:

d = 1.2√𝑃

Radiated (EN 60601-1- (EN 60601-1-2:2015 Table 4)


RF interference 2:2015 Table 4) 3 V/m d = 1.2√𝑃 80 MHz to 800 MHz
according to IEC 3 V/m 80 MHz to 2.7 GHz
61000-4-3
80 MHz to 2.7 GHz (Proximity fields for wireless
(Proximity fields for communication equipment EN d = 2.3√𝑃 800 MHz to 2.5 GHz
wireless 60601-1-2:2015 Table 9) Where P is the output power
communication 380 - 390 MHz rating of the transmitter in watts
equipment EN (W) according to the transmitter
27 V/m; PM 50%; 18 Hz manufacturer and d is the
60601-1-2:2015 430 - 470 MHz recommended separation
Table 9) distance in meters (m).
28 V/m; (FM ±5 kHz, 1 kHz
380 - 390 MHz The field strength from a
sine) PM; 18 Hz
stationary radio transmitter, as
27 V/m; PM 50%; 704 - 787 MHz determined by an
18 Hz electromagnetic site surveya,
9 V/m; PM 50%; 217 Hz should be less than the
430 - 470 MHz compliance levelb in all frequency
800 - 960 MHz
28 V/m; (FM ±5 ranges.
28 V/m; PM 50%; 18 Hz
kHz, 1 kHz sine) Interference may occur in the
PM; 18 Hz 1700 - 1990 MHz vicinity of equipment marked with
28 V/m; PM 50%; 217 Hz the following symbol.
704 - 787 MHz
9 V/m; PM 50%; 2400 - 2570 MHz
217 Hz 28 V/m; PM 50%; 217 Hz
800 - 960 MHz 5100 - 5800 MHz
28 V/m; PM 50%; 9 V/m; PM 50%; 217 Hz
18 Hz
1700 - 1990 MHz
28 V/m; PM 50%;
217 Hz
2400 - 2570 MHz
28 V/m; PM 50%;
217 Hz
5100 - 5800 MHz
9 V/m; PM 50%;
217 Hz

GA-592121en-A HICO-AQUATHERM 660 68


NOTE 1: At 80 MHz and 800 MHz, the higher 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, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the HICO-Aquatherm 660 is used exceeds the
compliance level listed above, then the HICO-Aquatherm 660 should be monitored to verify normal operation. If
abnormal performance is observed, additional measures might be necessary, such as re-orienting or relocating the
HICO-Aquatherm 660 or the use of a shielded location with higher RF shielding effectiveness and filter attenuation.
b The field strength should be less than 3 V/m over the frequency range of 150 kHz to 80 MHz.

Table 6
Recommended separation distance between portable and mobile
RF communications equipment and the HICO-Aquatherm 660

The HICO-Aquatherm 660 is designed for operation in an electromagnetic environment in which RF interference is
controlled. The customer or the user of the HICO-Aquatherm 660 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
HICO-Aquatherm 660 depending on the power output of the communications equipment as indicated below.

Output power of the transmitter Separation distance depending on the transmitter frequency
W m

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2√𝑃 d = 1.2√𝑃 d = 2.3√𝑃

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
using the equation shown in the corresponding column, where P is the maximum output power rating of the
transmitter in watts (W) according to the manufacturer of the transmitter.
NOTE 1: At 80 MHz and 800 MHz, the higher 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.

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13 Quick Start Guide
 Connect the unit to the mains supply.
 Connect the water pad to the unit.
 Check the water level on the unit.
 Switch on the unit using the mains switch and watch the
automatic function test.
 If the nominal temperature setting is > 38°C when switching
on the unit, then an alarm will be emitted. Acknowledge and
start by pressing the release key.
 Set the temperature with the arrow keys.

 For temperatures above 38°C, press the arrow key and the
release key at the same time.

 Depending on the application, place the water pad under or


on top of 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 alarms of medium priority (“WATER LEVEL!?” and


“TEMP.DIFF > 1°C”) can be interrupted for 10 minutes using
the “Mute audio” key.
 All other acoustic alarms of medium priority cannot be
interrupted. Switch off the unit using the mains switch (16).

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When certain errors occur, the unit will switch off all functions.
Take the unit out of service and submit it to a service technician
for inspection and to restore its operational reliability.

There is a risk of the patient becoming 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 in the following cases:


► The display has failed.
► Individual segments of the temperature display have failed
(temperature can no longer be read properly).
► The yellow error light (13) is continuously lit or does not light
up at all (functional test).
► The alarm signal tone continues to sound or does not sound
at all (functional test).
► The unit does not respond when you press a key.
► The unit does not respond as described in section 6.2.3
“Functional test” when switching on the unit or during a
function test.

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Notes

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