Instructions For Use: Hyperthermia Unit Hico-Aquatherm 660
Instructions For Use: Hyperthermia Unit Hico-Aquatherm 660
Instructions For Use: Hyperthermia Unit Hico-Aquatherm 660
Hyperthermia Unit
HICO-AQUATHERM 660
Instructions for Use HICO AQUATHERM 660
Email: [email protected]
Internet: www.hico.de
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
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”)
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!
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.
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.
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!
4
22) Equipotential bonding bolt
with color marking and
label
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
6
Cf. Scott S.M., Thermal blankets injury in the operating room, Arch. Surg. 34, page 181, 1967
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).
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.
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
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.
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.
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
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
6.2.9.1 Indication-based
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!
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).
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.
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.
10GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden
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!
13GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden
14GermanAssociation for Applied Hygiene (Verband für Angewandte Hygiene), and the list is available from
the mhp-Verlag, Wiesbaden
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.
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
“HEAT OUTPUT 0 W” or
“HEAT-UP PHASE”
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*
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:
Disposal
Manufacturer
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.
HF emissions Class B
according to CISPR 11
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.
Comment: UT is the alternating power supply voltage prior to application of the test level.
d = 1.2√𝑃
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
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.
For temperatures above 38°C, press the arrow key and the
release key at the same time.