HILOTHERM ChemoCare User manual

HT 02-c - Operating Instructions
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ChemoCare
Operating Instruction
HILOTHERM GmbH
Wittumweg 38
D-88260 Argenbühl-Eisenharz
Tel. +49 / 75 66 / 9 11 99
0123

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Table of Contents
1. General Description 9. Cuffs
1.1 Purpose 9.1 Variants and Material Properties
1.2 Fields of Application 9.2 Warnings
1.3 Indications and Contraindications 9.3 Field of Application
1.4 Requirements for Operator 9.4 Risk Classification
1.5 Machine Description 9.5 Description of Application
9.6 Storage and Transport
2. Safety Instructions 9.7 Disinfection, Cleaning and Drying
2.1 General Safety Instructions 9.8 Checkup
2.2 Hazard Instructions 9.9 Packaging
2.3 Electromagnetic Compatibility 9.10 Sterilisation
2.4 Ambient Conditions
10. Annex
3. Startup Procedure A Guidelines and
3.1 Function Check Manufacturer’s Declaration
3.2 Positioning the Machine B Declaration of Conformity
3.3 Switching on for the first time and
after changing water
3.4 Filling and Switching on
3.5 Setting Temperature
3.6 Connecting the Cuffs
3.7 Stopping
3.8 Malfunctions
3.9 Menu
4. Cleaning and Disinfection
4.1 General
4.2 Machine Surface
4.3 Cuffs
5. Technical Service and Maintenance
5.1 Replacing the Water Filter and Water Exchange
5.2 Cleaning the Heat Exchanger
5.3 Greasing the Plug Connections
5.4 Technical Service
5.5 Safety Related Inspections
5.6 Liability
5.7 Warranty
6. Storage, Transport, Disposal
6.1 Storage
6.2 Transport
6.3 Disposal
7. Technical Data
7.1 Technical Data
7.2 Icons
7.3 Safety Standard
7.4 Errors and Troubleshooting
8. Accessories and Spare Parts

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Before putting the Hilotherapy system into operation, carefully read the operating
instructions. Pay special attention to the instructions labelled Caution and Warning.
Caution describes a situation leading to possible damage to the device or the attached modules.
Warning describes a situation leading to possible damage to persons.
1. General Description
1.1 Purpose
HILOTHERAPY using the Hilotherm Chemo Care System is a form of physical thermo-therapy
that uses a local constant temperature in the range of 5 ° C to 25 ° C. In this case, several hours
of applications can be carried out without temperature deviations
Used as a prophylactic measure, HILOTHERAPY with Chemo Care significantly reduces the risk
of chemotherapy-induced polyneuropathy (CIPN) - also known as hand-foot syndrome (HFS).
Working principle:
In chemotherapy, parts of the chemotherapeutic agent are delivered via the sweat glands to the
Skin surface, where "free radicals" form in contact with oxygen. These
damage the tissue cells of the skin, especially where they are particularly thick as the cornea
is pronounced and absorbs the substance like a sponge >> on the palm and sole of the foot.
To prevent the chemotherapeutic agent from penetrating the capillaries of the extremities,
Blood circulation and metabolism must be slowed down. This is done by lowering the tissue
temperature.
With the Hilotherapy System Hilotherm Chemo Care consisting of the temperature control units
as well as hand and foot cuffs, the fabric temperature is locally in the range of hands and feet
adjusted to an individual value prescribed by the doctor and kept constantly cool.
The therapy device with the cuffs and connecting hoses forms closed circuit system through
which the cooling medium flows and the set temperature keeps constant
1.2 Fields of Application
Thermotherapy with "Hilotherm Chemo Care" is used prophylactically before and during
chemotherapy to reduce the risk of chemotherapy-induced polyneuropathy
Duration of application
The application of thermotherapy should be half an hour before and during Chemotherapy.
1.3 Indications and Contraindications
Indications for Hilotherapy
Indication for Hilotherapy (localized reduction of tissue temperature) is the chemotherapy-induced
polyneuropathy (CIPN)
A common complication in chemotherapy with certain cytostatic, drugs, such as. Carboplatin,
capecitabine, 5-fu, cyclophosphamide, cytarabine, docetaxel, doxorubicin, oxaliplatin, paclitaxel,
sorafinide and sunitinib, is the hand-foot syndrome.
This refers to side effects on the hands and feet, both shortly after onset chemotherapy or even
during their course or months later may occur.
The symptoms are: numbness on hands and feet with gait insecurity, decrease of tactile
sensation, loss of depth sensitivity, loss of temperature perception, burning pain, disruption of
coordination and hypersensitivity of the skin if contacted.
Contraindications of Hilotherapy
Contraindicated are all forms of cold application in the occurrence of a
Cryoglobulinemia, cold hemagglutination and histamine release.

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Cold urticaria / cold contact urticaria. Also for diseases from the area of functional
Circulatory disorders (eg M. Raynaud), severe arterial disease, pronounced sensory disturbances
and trophic tissue lesions is not a Hilotherapy displayed.
1.4 Requirements for Operator
Operation of the Hilotherapy system is simple and can be carried out by nursing staff or by the
patients themselves. However, the application should be supervised by qualified medical
personnel.
The operators shall familiarise themselves with the operating instructions and the device before
initial operation. The application of the cuff in particular must be carried out with care.
1.5 Machine Description
The Hilotherapy system HT 02-c is a mobile device for localised, professional cold treatment. It
distinguishes itself by its simple handling and ease of operation.
The temperature setting is adjustable from + 5°C to + 25°C
The device is designed for continuous duty.
Basically, the Hilotherapy system consists of the following components:
Cooling and heating unit The cooling and heating units serve to precisely control and
maintain the temperature of the distilled water according to the
chosen values.
Control unit Through the device’s sensors, the control unit acquires the
current data and records them. It also controls the machine’s
processes. The desired temperature values are entered via the
keys (pos. 04).
Display The display (pos. 03) shows the set values and the current
operating condition.
The following describes the use of a cooling unit of the Chemo Care System. The two
cooling units of the HILOTHERM Chemo Care System are identical and therefore identical
to operate.
01 Couplings
02 Filter
03 Display
04 Keypad
05 Filling level indicator and
outlet tube
06 Venting slots
07 Carrying handle
01 1
02 1
05 1
04 1
03 1
06 1
07 1
Picture 1

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2. Safety Instructions
2.1 General Safety Instructions
•Before machine startup, the operator has to check if the device and the application parts are
in a proper state.
•The therapeutical system always consists of a Hilotherapy device, duo hose and cuff(s).
•Use and connect only the original Hilotherapy devices and cuffs.
•In the shut down state, large cuffs (due to the high conductivity of water) can result in
intended changes of body temperature (cooling in the case of heat treatment, warming up in
the case of cold treatment). If the proper procedure cannot proceed due to failures, the cuff
has to be removed.
•If the intended use can not be caused by disturbances, the cuff must be removed.
•During treatment, especially when using several or large cuffs, the patient’s body temperature
should be monitored.
•The Hilotherapy system must not be used within an incubator.
•The cuffs may be damaged by sharp objects.
•The proper flow through the cuff channels may be obstructed by folding or compressing the
cuffs.
•The flow through the tubing may be obstructed by kinks.
•Only fill up the tank with demineralized water.
•When filling up the tank with demineralized water, disconnect the device from the mains.
•Do not cover the venting slots on the sides.
The device may only be operated when positioned on a level and flat surface.
•The device may only be used when all units and displays are working properly.
•In case of failures, switch the device off immediately. Only after the failure condition was
rectified, the machine may be used again. Please inform the manufacturer of any kind of
critical or unclear errors.
•Maintenance interfaces and interfaces used for data transfer may not be used when a patient
is attached to the device.
•Warning! It is not permitted to modify the device.
2.2 Hazard Instructions
•Do not open the housing.
•Prior to maintenance, disconnect the device from power supply.
•Machine maintenance may only be carried out by a qualified service technician.
•The AC voltage source must comply with the data given on the type plate attached to the
back of the machine.
•The Hilotherapy system may only be connected to the mains using a reliable protective earth
conductor. Do not use the system if the functionality of the external protective earth conductor
is in doubt.
•To ensure fire protection, make sure when replacing the fuses that only the same type of
fuses with the same nominal values are used (refer to type plate).
2.3 Electromagnetic Compatibility
In electrical medical appliances, particular attention is to be given to the electromagnetic
compatibility (EMC), that is the device is to be installed and commissioned according to the EMC-
directions contained in this operation instructions (please see instruction and manufacturer’s
declaration in the annex).
Portable and mobile radio communication devices may interfere with the operation of medical
appliances.
Warning: The Hilotherapy system should not be operated next to / on top of other appliances.
However, should this be necessary, the Hilotherapy system must be closely observed to ensure
safe operation.

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2.4 Ambient Conditions
The ambient temperatures for safe operation are between + 10 °C and + 26 °C.
If the ambient temperature is higher, the vested cooling capacity can not be provided.
If the device has been subjected to temperatures far beyond the indicated temperature range, let
the device cool off until it has reached room temperature, before starting it again.
Protect the device against excessive heat, dust and direct exposure to the sun.
Warning: The Hilotherapy device is not intended for use in highly explosive environments and
must be kept away from flammable gases and liquids.
3. Startup Procedure
3.1 Function Check
Before taking the Hilotherapy system into operation, make sure the device and the applied parts
(cuffs) are free of damage (see chapter 2, Safety Instructions).
Caution: The device shall only be put into operation when undamaged.
3.2 Positioning the Machine
•The Hilotherapy device shall be placed on a level, flat and hard surface.
•Position the device such that the air ventilation is not impeded.
•Observe a minimum distance to other appliances or furniture of 20 cm on the sides and
10 cm on the top of the device.
•The device must be positioned so that it is easy to disconnect it from the power supply.
•Please ensure that the machine ventilation is not directed towards the patient.
3.3 Switching on for the First Time and after Changing Water
Caution: When operating for the first time or after changing water it is necessary to bleed the air
from the pump system before switching on the Hilotherapy device.
•To bleed insert the de-airing set with plug-in nozzle into one of the couplings on the front.
•Allow air to escape with the syringe.
•Remove de-airing set.
Caution: When starting up for the first time or after changing the water the device should be
switched on only with the cuff connected so that the air can escape from the pump system and
the pump does not run dry.
If the pump runs and water is not pumped into the cuff, bleed the pump again.
3.4 Filling and Switching On
•Fill the water reservoir with demineralized water. The fill level indicator should be between the
"min“ and "max“ markings.
•When starting up for the first time or after changing water bleed pump system, see 3.3.
•Plug in mains plug.
•Switch on device with main switch on rear of unit.
After switching on the device performs a self-test. At the end of this self-test an acoustic
signal sounds and the menu appears on the display, see 3.9.
•Then connect duo hose and cuff.
•Set to desired temperature setting.
•Press button.
•Ensure that water is being pumped through the cuff.
3.5 Setting Temperature
•Change temperature settings with (for higher) and (for lower).
•The set temperature is stored automatically and the Hilotherapy device changes the actual
temperature to the desired values, see temperature value shown in large format in the
display.

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3.6 Connecting of the cuffs and cuff holder
•Assemble the cuff holder to the frame of the trolley
•Assemble the hose isolation to the hose.
•The 2m hose of the cuff is fitted with the grommets on the couplings
plugged into the device, this is done by audible click.
•The cuffs can be fixed by the cuff holder
•Keep the device ventilation free –no hoses in front of device ventilations.
3.7 Stopping
•Press the "Stop" button to stop operation.
•The device can be switched off with the main switch on the rear.
•If the device is not used for longer periods of time, disconnect it from the power supply by
pulling out the mains plug.
3.8 Malfunctions
Malfunctions are indicated by a visual and acoustic alarm.
The cause of the malfunction is shown on the display.
3.9 Menu
Switching on device
Main switch on
Device cooling / heating
Pressure pump off
Device in operation
Device cooling / heating
Pressure pump running
The temperature can be changed in both operating states.
Trouble-Shooting
If a malfunction occurs, the letter "E" appears on the display;
only the current malfunction code is displayed.
The display can be deleted with (X) only after
remedying the malfunction.
Actions for trouble shooting see under Pos 7.4.

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4. Cleaning and Disinfection
4.1 General
Attention! Make sure to disconnect the device from the mains before cleaning!
Do not use sharp objects for cleaning.
4.2 Machine surface
Clean and disinfect the machine’s surface and components with such standard detergents and
surface disinfectants as are approved for clinical use.
Make sure that no fluids enter the device, in particular through the venting slots on the machine
sides.
4.3 Cuffs / Application parts
See chapter 9.7
5. Technical Service, Maintenance, Safety Related Inspections
The Hilotherapy system was developed and manufactured according to the highest quality
standards. If the device is used for the intended use and all maintenance is done, the device will
reach a lifecycle of 10 years or more.
To ensure the long-term safety and operability of the Hilotherapy system, the following
maintenance work should be carried out.
5.1 Replacing the Water Filter and Water Exchange - at least every 6 months
•Remove the grating in the filling hopper using a small screwdriver.
•Remove the filter.
•Pull out the tube of the water level indicator from the casing guide.
•Remove the vent plug.
•Drain the water off completely.
•If necessary, rinse the tank with disinfectant and then rinse it with fresh distilled water.
•Push the outlet tube back into the casing guide.
•Push the vent plug back in.
•Insert the new filter.
•Replace the grating over the filter.
•Fill up above the hopper with distilled water to which a preserving agent, e.g. Ebotec MG, can
be added.
•Bleed off the device (see point 3.3).
5.2 Cleaning the Heat Exchanger - at least every 6 months or if contamination is visible
Dust collecting on the heat exchanger will reduce the cooling performance of the device. The heat
exchanger is located behind the ventilation grille, on the right-hand side of the device.
•Remove the three Phillips screws on the bottom plate below the ventilation grille.
Attention! Do NOT loosen the hexagon socket screws!
•Lift off the ventilation grille and carefully dust off and clean with a soft brush or vacuum
cleaning device.
Attention! The cooling plates on the heat exchanger must not be damaged!
5.3 Greasing the Plug-in Connections - at least every 6 months
The plug-in connections to the tubes must be greased regularly so that they remain easy to plug
in and guarantee that the plug-in nozzles in the couplings engage completely.
•Grease the tips of the plug-in nozzles on the cuff and tube thinly using Vaseline.
•Plug the nozzles in and out of the tube or Hilotherapy device couplings. This transfers the
Vaseline onto the O-rings in the couplings.

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5.4 Technical Service - at least once every 2 years
Visual inspection:
•Are the operating instructions complete?
•Is the type plate complete and legible?
•Are all markings and labelling on the device correct and legible?
•Are all machine components securely attached (no loose parts)?
•Is the machine casing intact?
•Are the plug-in cuff connections intact and easy to use?
•Are all switches and buttons working correctly?
•Does the machine master fuse match the type indicated on the device?
•To change fuses pull out the slot. After changing the fuses push the slot in until it snaps into
place.
•Is the device’s mains plug with integrated master switch free of defects?
•Is the power cord undamaged?
•Are the device and the accessories kept in a clean condition?
•Are the venting slots and the heat exchanger behind them clean?
•Are the accessories kept in a proper condition?
•Exchange water filter and distilled water.
Functional test:
•Function of the cooling unit
•Function of the heating unit (Does it achieve a temp. of + 25°C)
•Function of the pressure pump (Is there sufficient flow to the cuffs?)
•Can you detect any wear? (Unusual noises?)
•Function of the water level sensor (Water level error message upon switching
on the machine with the tank empty?)
In addition, the following inspections can be carried out
•Pressure inspection
•Performance inspections
In case of malfunctions or defects, only put the device into operation again after the problems
have been remedied.
Maintenance measures shall only be carried out by qualified personnel. On request, the
manufacturer shall support the maintenance personnel with training and technical information.
5.5 Safety Related Inspections
During production, a Safety Related Inspection is carried out within the scope of the final
inspection.
In order to maintain operational safety, a further Safety Related Inspection must be carried out if
repair work is carried out on electrical systems.
The operator is responsible for determining the scope of the test and the test interval (see §11
MPBetreibV). However, the STK must be carried out no later than every 2 years at the end of the
month.
5.6 Liability
HILOTHERM GmbH (as manufacturer) only regards itself liable for effects on safety, reliability and
operability of this device, if:
•assembly, upgrading, resetting, modifications or repair work is performed by persons
authorised by the manufacturer.
•the parts and components used for repair work, modifications, upgrades or local applications
are authorized by the manufacturer.
•the wiring being used for the connection of the device complies with the rules and regulations
of the local authorities.
•only accessories authorized by HILOTHERM GmbH are used.
•the device is operated in accordance with the operating instructions.

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5.7 Warranty
The provisions of the German Law are applicable with respect to warranty for defects.
The provisions of the law pertaining to the product liability law are not affected in this respect.
6. Storage, Transport, Disposal
6.1 Storage
The device should be stored dry and horizontal on a level surface, at a temperature of 5 ° C to 40
° C and 10 - 70% RH and air pressure of 700 hPa - 1060 hPa.
Caution: If the device is stored below 0 ° C, the water in the cooling circuit must be completely
drained to prevent damage from freezing.
6.2 Transport
Before transport, the device must be emptied completely.
Do not tilt the device during transport. If the device is tilted during transport, leave the device
standing for 24 hours to regain its full capacity.
Attention: Transport may only take place using a logistics company on palett as transport via a
parcel service often results in the device being damaged.
6.3 Disposal (WEEE Reg. No. DE 25202195)
The device must not be disposed with commercial waste or regular garbage.
In accordance with product responsibility under the terms of § 22 of the German Circular
Economy and Waste Act and the Electrical and Electronic Equipment Act § 2, 2 paragraph 1,
the device must be disposed of in a communal collecting point or returned to the manufacturer.
Please note for disposal that the appliance contains a volume of refrigerant comparable to a
refrigerator (refrigerant R134a).
Warning! The compressor unit contains oil.
7. Technical Data
7.1 Technical Data
Type HT02-c
Article No. 2020 0012
Nominal Voltage 230 VAC 50 HZ
Power input max. 320 VA
Power consumption 2.5 A
Fuse value T 2.5 A 250 V
Protection class I
Degree of protection for
the application part B
Type of protection IP 20
Risk class (93/42 EWG) IIa
Dimensions 430 mm x 275 mm x 268 mm
Weight 10 kg
Cuff connections 2
Water tank capacity min. 1.25 litres, max. 2.25 litres
Temperature range + 5 °C to + 25°C
Control/adjustment tolerance ± 1 ° C
Cold unit
Nominal voltage 230 V 50 HZ
Working pressure 25 bar inherently safe

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Refrigerant R 134a
Filling quantity 100 g
Pressure Pump
Nominal voltage 15 V
Operating pressure 0.5 bar +0,1
Heating unit
Nominal voltage 230 V
Power input 220 VA
Ambient Conditions
Storage temperature min. + 0 °C, max. + 40 °C
Storage humidity 10 - 70% RH non-condensing
Ambient temperature during
operation + 10 °C to + 25 °C
Humidity during Operation 0 - 80% rel. humidity, non-condensing
7.2 Icons
On device and packaging, you will find the following icons:
Warning sign, the device causes temperature changes
filling device
outlet device
Read operating instructions before starting the device
Manufacturing date
(YYYY)
Device type B
(Protection against electric shock)
CE Conformity labelling according to EU Directive 93/42/EEC on
medical devices with admission authority labelling
0123
2
No recycling / single use device
Do not dispose of in general industrial or
household refuse containers
AQUA DEST.

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7.3 Safety Standards
Classification
Pursuant to the classification criteria stated in the addendum IX EG-RL 93/42 EEC, the
Hilotherapy system is a Class IIa Standard 9 device (active medical product for therapeutical
purposes).
In terms of the GMDN classification, the device is assigned to No. P 42463, and the cuffs to
No. P 44604.
The Hilotherapy system is neither assigned to Annexes 1 and 2 nor to Annex 3 of the
MPBetreibV.(Medical Devices Operator Ordinance).
Standards and Guidelines
EC-Directive 93/42/EEC of the council on medical products as of June 14, 1993,
Medical Devices Act as of August 2, 1994
DIN EN 60 601-1
DIN EN 60 601-1-2
DIN EN ISO 10993-1
HILOTHERM GmbH retains the right to change specifications without further notice.
7.4 Malfunctions and Troubleshooting
Error
Possible Cause
Measures
Device does not work,
no display readings
1. No mains supply
2. Fuse defect
3. Repeated fuse defect
4. Mains plug not connected
5. Device is defect
1. Switch off device
2. Replace fuse
3. Technical Service
4. Check plug-in connection of the
mains
5. Technical Service
No cooling
1. Heat exchanger is blocked
with dust
2. Device is defect
1. Clean heat exchanger carefully with
vacuum cleaner or a soft brush
2. Technical Service
No or insufficient
water circulation
1. Pump has not been vented
2. Tubing or cuff kinks
3. Plug-in coupling is not locked
in place
4. Pump is defect
1. Vent the pump, see 3.3
2. Correct positioning
3. Press plug-in couplings together
until they lock in position
4. Technical Service
Display reading
“E21”
1. Insufficient water in tank
2. Water level indicator arrest
1. Replenish with distilled water
2. Remove water and fill up again
Display reading
“E11”
Pump defect
1. Technical Service
Display reading –
temperature failure
“E01”
Temperature difference between
the two temperature sensors
detected.
1. Recalibration
2. If 1 not successful call
technical Service
Display reading –
temperature failure
“E02”
Temperature sensors not
connected / cable break
1. Recalibration
2. If 1 not successful Repair
Display reading –
temperature failure
“E03”
Temperature too low < 3°C
1. Recalibration
2. If 1 not successful Check ambient
conditions, allow device to warm up
Display reading –
temperature failure
“E04”
Temperature too high > 42°C
1. Recalibration
2. If 1 not successful Check ambient
conditions, allow device to cool
down
Display reading –
temperature failure
“E05”
Increased temperature difference
between the two temperature
sensors detected.
1. Recalibration
2. If 1 not successful Repair

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Display reading –
temperature failure
“E99”
Control system defect
1. Technical Service
Plug-in connection of the
tubing difficult to insert
1. O-ring not lubricated
2. Plug-in connection damaged
1. Lubricate plug-in nozzle with
Vaseline
2. Technical Service
In any case of temperature failure E0x a recalibration
of the temperature system is useful
This recalibration is done by pressing all 3 buttons
(up, down and enter) during switching on the device.
Switch of the device and start it again
Attention! Opening up of the device
results in the loss of warranty and liability claims!
8. Accessories and spare parts
Any accessories and spare parts are available at HILOTHERM GmbH or your authorised dealer.
Accessories
Only use original HILOTHERM parts and accessories.
Attention! You must not use any other devices or accessories in combination with the
Hilotherapy device.
Standard accessories list for one device
Qty
Article number
Description
1
40000332
Power cord (C, F, 230V 50 Hz)
2
40000259
Duo hose
1
40000379
De-airing set
Spare Parts
Only the use of original spare and replacement parts guarantees the safety and reliability of our
device. Parts may only be exchanged by qualified personnel.
The Hilotherapy system is constantly being developed and improved.
It is important for you to provide us with the following details so that you will always receive the
adequate spare part, even if there have been technical changes.
Name Typ HT 02-c Serial No. ………………..
Year of manufacture ………………..
9. Cuffs
9.1 Variants and Material Properties
Cuffs for thermo-therapeutic applications in anatomically adapted forms:
•Hand cuff
•Foot cuff slipper
Material properties:
Cuff material: Thermoplastic Polyurethane (TPU) - latex-free
Tubing: Thermoplastic Polyurethane (TPU)
Plug-in nozzle: Nickel-plated brass / POM

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9.2 Warnings
•The cuffs shall only be used when attached to the Hilotherapy device.
•Cuffs must not be brought into contact with chemicals containing benzol and phenol.
•Check the integrity of the cuff before applying the cuff (no blistering, no leakage). Only intact
cuffs should be used. When abnormalities occur during the treatment, e.g. Blistering or
leakage, the application should be stopped immediately. In case of defects of the hose and
the capillary system of the cuffs these are to be discarded.
•When handling the sleeves, make sure that they are not damaged by sharp objects.
•Care should be taken not to obstruct the flow of the channels in the cuffs by folding the cuffs
or pressing them.
•When connecting / disconnecting the duo hose to / from the cuffs, a small amount of water
may leak from the device. Make sure that this water does not come into contact with wound
dressings and bandages!
•A resterilisation of used cuffs (e.g. with the Ethylenoxide procedure) is not possible.
•Eye cuffs must not exert pressure on the eye!
9.3 Fields of Application on the Patient / Specific Function
The cuffs are only intended for external application.
The cuffs are placed on respective skin areas either on top of dressings or directly on intact skin.
In repeated therapeutical applications we recommend a patient-related allocation of a certain cuff.
Single-use cuffs are for single use only and must not be reprocessed!
These EM cuffs may turn yellow when used over an extended period of time or cyan color of the
cuff material come. This discoloration is material-related and does not represent any hygienic
hazard to the user.
9.4 Risk classification of medical products in accordance with RKI guidelines
Risk assessment and evaluation shall be in accordance with Federal Health Gazette No. 44
(2001): 1115-1126: Hygiene Requirements in processing medical products. It is the owner’s
responsibility that recycling measures are carried out by qualified persons using a suitable and
validated procedure.
The individual recycling steps shall be matched to
•the medical product
•the recycling type
•the application on the patient.
The cuffs are only intended for contact with intact skin. Make sure to place wound dressings on
pathologically altered skin areas (e.g. abrasions, infective wounds …) prior to cold treatment.
With regard to the type of application of the cuffs and the related risk, these are classified as
uncritical medical product.
External application of the cuffs on intact skin (e.g. within the scope of physiotherapeutic and
rheumatologic treatments) or on top of a wound dressing (e.g. post-operatively within the scope of
plastic surgery, vascular surgery, ENT …).
9.5 Description of Application
For the individual application on certain body areas, choose a suitable cuff form and connect the
cuff to the Hilotherapy device in accordance with the instructions given in the manual (see point
3.6). When connecting or disconnecting the tube plug-in nozzles to the Hilotherapy device,
several drops of water may leak from the device. Make sure that these drops do not come into
contact with wound dressings and bandages!
When full, place the cuff gently and without exerting any pressure (especially significant for eye
cuff use!) on the body parts to be treated. It may be necessary to hold the cuffs in place using
strips or bandage.
The duration of the treatment must comply with the orders of the attending physician.
9.6 Storage and Transport

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The cuffs are delivered under low-germ conditions, sealed in a transport and dust-protection bag
and packed into an outer shipping carton. Make sure to store the cuffs in a dust-free and dry
environment at consistent room temperature without UV radiation.
9.7 Disinfection, Cleaning and Drying
Cuffs, devices and accessories are manufactured in a clean and hygienically safe condition and
are delivered accordingly. However, the condition of the products mentioned in the delivery state
cannot be stated as "sterile".
9.7.1 Cuffs
Cuffs labeled as single patient use cannot be reprocessed and are only intended for use during
treatment on one patient.
Depending on the doctor's instructions, disinfection may be necessary before applying the cuffs to
wound dressings or to the area of the body to be treated.
Reprocessing / period of use
Cuffs that are not marked as single-use products can be cleaned, reprocessed and disinfected.
This also applies to multiple cuffs that are provided with PU foam insulation on the outer surfaces.
If the preparation is carried out properly and depending on the frequency of use, multiple cuffs can
be used over a period of about one year.
Due to the frequent use of the multiple cuffs and the reprocessing process, the cuffs are subject to
wear due to the application.
Wear-related errors and defects on the cuffs are not subject to any warranty claims
Cleaning and disinfection process
The manual cleaning and disinfection of the cuffs should be carried out on the patient after
treatment with usual and approved cleaning and surface disinfectants in the hospital area.
Relevant information such as the list of approved disinfectants and recommendations for
disinfection procedures can be found on the website of the Robert Koch Institute (www.rki.de)
Wiping disinfection is recommended for the smooth surfaces of the sleeves, and a wipe or spray
disinfection for surfaces with a fabric-like surface (blue insulation). Disinfection must be carried
out by qualified personnel.
The cuffs and the insulation are made of polyurethane, this material is well compatible with a
variety of disinfectants. With regard to compatibility, concentration and exposure time of the
disinfectant, the respective manufacturer's instructions must be observed.
When properly carried out, at least 10 conditioning cycles can be performed on multiple collars.
A hygiene and disinfection plan with corresponding process descriptions and work instructions as
part of quality management must be prepared by the operator in order to be able to document a
comprehensible and validated treatment process.
Example of a machine cleaning and disinfection of non-critical medical devices
The cleaning, disinfection, rinsing and drying is carried out in a washer-disinfector with a validated
chemical or chemical-thermal process at max. 55 ° C possible. The sleeve is to be fixed within the
device chamber in suitable holders in such a way that the surface of the film can be easily washed
around by the cleaning and disinfection media. The procedure should be followed by automatic
drying in the device. The use of the mechanical process must be carried out by qualified
personnel in accordance with the specifications of the quality management (eg process
description, work and process instructions) of the operator.
9.7.2 Basic device
The surface of the equipment consists mainly of ABS plastic and can be ideally treated by wiping
disinfection if necessary after selecting a suitable method and disinfectant.
Disinfection of the cooling circuit is not necessary if the maintenance requirements and regular
water changes are observed

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9.8 Checkup
After successfully cleaning and disinfecting the cuffs, carry out a visual inspection and checkup on
the cuffs. If the cuff foil, tubing and / or plug-in nozzles are damaged, the cuff needs to be
discharged.
In case of residual dirt, repeat cleaning and disinfection procedure in accordance with the hygiene
guidelines (see point 9.7).
Prior to applying the cuff to the patient, the cuff must be attached to the Hilotherapy device and
filled up to check for leaks.
9.9 Sterilization
The cuffs cannot be sterilized.
10. Annex Guidelines and Manufacturer’s Declaration
A1
Table 1 (IEC 60601-1-2)
1
Guidelines and Manufacturer’s Declaration on Electromagnetic Emissions
2
The HT 02-c is designed for use in ambient conditions as described below.
The customer or operator of the HT 02-c has to make sure the system is being used in
such an environment.
3
Interference emission
measurement
compliance
Guideline for
electromagnetic environment
4
HF-emissions compliant with
CISPR 11
Group 1
The Hilotherapy system uses
only HF-energy for its internal
functions. Thus, its HF-emissions
are very low and it is improbable
that it will interfere with the
operation of neighbouring
devices.
5
HF-emissions compliant with
CISPR 11
Class B
The Hilotherapy system is
designed for the use in all
facilities as well as living
quarters, including those facilities
connected to a power supply that
also serves residential buildings.
6
Emission of harmonic waves
compliant with IEC 61000-3-2
Class A
7
Emission of voltage surges/flickers
complying with IEC 61000-3-3
EN 61000-3-3

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A2
Table 2 (IEC 60601-1-2)
Guidelines and Manufacturer’s Declaration on Electromagnetic Noise Immunity
The HT 02-c is designed for use in ambient conditions as described below. The customer or
operator of the HT 02-c has to make sure the system is being used in such an environment.
Noise immunity
checks
IEC 60601 –Test
level
Corresponding
level
Guidelines for
Electromagnetic
Environment
Discharge of static
electricity (ESD) in
compliance with
IEC 61000-4-2
± 6 kV contact
discharge
± 8kV air discharge
± 6 kV Contact
discharge
± 8 kV air discharge
The flooring should be wood,
concrete or ceramic tiles. If
the flooring consists of
synthetic material, relative
humidity should at least be
30%.
Rapid transient
electrical
interferences/bursts
in compliance with
IEC 61000-4-4
± 2 kV for mains
connection
± 1 kV for input and
output connections
± 2 kV
for mains
connection
not applicable
The quality of the supply
voltage should meet the
standards for typical
commercial or clinical
environments.
Surges in
compliance with
IEC 61000-4-5
± 1 kV line to line
± 2 kV line to earth
± 1 kV line to line
± 2 kV line to earth
The quality of the supply
voltage should meet the
standards for typical
commercial or clinical
environments
Voltage drops,
short
disconnections and
surges of the
supply voltage in
accordance with
IEC 61000-4-11
< 5% UT
(>95% drop of UT)
for half a cycle
40% UT
(60% drop of UT)
for 5 cycles
70% UT
(30% drop of UT)
for 25 cycles
5% UT
(95% drop of UT)
for 5s
0% UT
40% UT
70% UT
5000 mS
The quality of the supply
voltage should meet the
standards for typical
commercial or clinical
environments.
Should the operator of the
Hilotherapy system require
continued operation in the
event of power blackout, we
recommend supplying the
Hilotherapy system via an
interruption-free power
supply or battery.
Magnetic field with
power frequency at
50/60 Hz in
accordance with
IEC 61000-4-8
3 A/m
3 A/m
Magnetic fields induced by
power frequency should
correspond with the values
that are typical for
commercial or clinical
environments.
Footnote: UTdescribes the mains AC voltage prior to applying the test levels.

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A3
Table 4 (IEC 60601-1-2)
Guidelines and Manufacturer’s Declaration – Electromagnetic Noise Immunity
The HT 02-c is designed for use in ambient conditions as described below. The customer or
operator of the HT 02-c has to make sure the device is being used in such an environment.
Noise immunity
checks
Noise immunity
Test level
Corresponding
level
Guidelines for Electromagnetic
Environment
Conducted HF-
disturbance
compliant with
IEC 61000-4-6
Radiated HF-
disturbances
compliant with
IEC 61000-4-3
3 V eff
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
U1 = 3 V
E1 = 3 V/m
The distance from the Hilotherapy
system including its supply lines to any
portable and mobile kind of radio
equipment should not be less than the
recommended protection distance that
is calculated from the equation for the
transmitted frequency.
Recommended protective distance:
d=[
1
5,3
V
]
P
d=[
1
5,3
E
]
P
for 80 MHz to 800 MHz
d=[
1
7
E
]
P
for 80 MHz to 800 MHz
with P as the nominal performance of
the transmitter in Watt (W) due to the
data given by the manufacturer of the
transmitter and d being the
recommended protective distance in
metres (m).
Due to a field surveya, the field
strength of stationary radio transmitters
in all frequencies should be less than
the corresponding levelb.
In the vicinity of devices being marked
with the following icon, interferences
may occur.
Footnote 1: For 80 MHz and 800 MHz, the higher frequency range applies.
Footnote 2: These guidelines may not be applicable in all cases. The expansion of electromagnetic
fields is also affected by absorptions and reflexions of buildings, objects and persons.
a) In theory, it is not possible to predict the exact field strength of stationary transmitters such as
wireless phone base stations, mobile transmitting stations, amateur radio stations, AM and FM
broadcasting and television stations. Therefore, a survey of the location should be considered to
evaluate the electromagnetic ambient environment with regard to stationary transmitters. If the
measured field strength of the location using the Hilotherapy system exceeds the corresponding
levels stated above, the device should be closely observed to establish whether it is working as
intended. In case the device is observed to have unusual capability features, additional steps may
be necessary, e.g. realigning or relocating the Hilotherapy system.
b) Within the frequency range of 150 kHz to 80 MHZ the field strength should be less than [V1] V/m.

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A4
Table 6 (IEC 60601-1-2)
Recommended Protection Distances between portable and mobile HF
telecommunications devices and the HT 02-c
The HT 02-c is intended for use in electromagnetic environments with controlled HF
disturbances. The customer or user of the HT 02-c can positively influence the situation by
observing a minimum distance between the HT 02-c and portable and mobile HF
telecommunication devices (transmitters) –depending on the output power of the communication
device (as shown below).
Power rating of
the transmitter
W
Protective distance, depending on the transmitting frequency
M
150 kHz to 80 MHz
d=[
1
5,3
V
]
P
80 MHz to 800 MHz
d=[
1
5,3
E
]
P
800 MHz to 2,5 GHz
d=[
1
7
E
]
P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.70
3.70
7.37
100
11.70
11.70
23.33
For those transmitters whose power rating is not indicated in the table above, the recommended
protective distance d in metres (m) may be calculated using the corresponding equation in the
particular column, with P being the maximum power rating of the transmitter in Watt (W)
(according to transmitter manufacturer’s data).
Footnote 1: For 80 MHz and 800 MHz, the higher frequency range applies.
Footnote 2: These guidelines may not be applicable in all cases. The expansion of
electromagnetic fields is also affected by absorptions and reflexions of buildings, objects and
persons.

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Chemo Care
-c