HICO DECUBIMAT 365 operating manual

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Operating manual
Pressure relief system
HICO-DECUBIMAT 365

Hirtz & Co. KG
Bonner Str. 180
50968 Cologne
Tel.: +49 (0) 221 37 67 80
Fax: +49 (0) 221 37 67 885
E-mail: hirtz@hico.de
Internet: www.hico.de
Doc. no. 312802; Version 0-10/10 Valid as of 2010-10
Original German Version 0-08/10 Valid as of 2010-08
© 2010 Hirtz & Co. KG
HICO DECUBIMAT 365 operating manual
HICO-DECUBIMAT 365 2

Table of contents
1 General information .............................................5
1.1 Information on this manual ............................................5
1.2 Warnings..........................................................................6
1.3 Limitation of liability .......................................................8
1.4 Copyright protection.......................................................8
1.5 Manufacturer's address..................................................8
2 Safety.....................................................................9
2.1 Intended use ....................................................................9
2.2 Personnel requirements ...............................................10
2.3 General safety information...........................................11
2.4 Sources of danger.........................................................12
2.4.1 Risk of development of bed sores...............................12
3 Transport and assembly ....................................13
3.1 Scope of delivery and transport inspection................13
3.2 Unpacking the device ...................................................13
3.3 Disposal of packaging material ...................................14
4 Commissioning...................................................15
4.1 Safety information.........................................................15
4.2 Installation .....................................................................15
4.2.1 Requirements pertaining to the installation location....15
4.3 Connection of the HICO-DECUBIMAT 365 ..................16
4.3.1 Preparation of alternating pressure mattress ..............16
4.3.2 Mounting the device....................................................17
4.3.3 Electrical connection ...................................................18
4.3.4 Preparing to use the HICO-DECUBIMAT 365.............19
5 Design and function ...........................................20
5.1 Device views and control and display elements ........20
5.2 Safety devices ...............................................................21
5.2.1 Sensors.......................................................................21
5.3 Type plate ......................................................................21
5.4 Function.........................................................................21
5.4.1 Basic information ........................................................21
5.4.2 Performance features .................................................22
5.4.3 Indications...................................................................23
5.4.4 Contra-indications/side effects....................................23
HICO-DECUBIMAT 365 3

Table of contents
6 Controlling and operating the system..............24
6.1 Before switching the device on ...................................24
6.1.1 System checks............................................................24
6.2 Operation .......................................................................25
6.2.1 Placing the system into operation ...............................25
6.2.2 Optimization of pad pressure ......................................26
6.2.3 Information on handling the alternating pressure
mattress...................................................................................28
6.2.4 Tasks during operation ...............................................28
6.3 Alarms............................................................................28
6.3.1 General information ....................................................28
7 Cleaning and disinfection..................................29
7.1 Safety information.........................................................29
7.2 Device ............................................................................30
7.3 Alternating pressure mattress .....................................31
7.3.1 Mattress ......................................................................31
7.3.2 Cover ..........................................................................32
8 Maintenance and technical function check......33
8.1 Maintenance ..................................................................33
8.1.1 Device.........................................................................34
8.1.2 Hose couplings ...........................................................34
8.1.3 Alternating pressure mattress .....................................34
8.2 Technical function check .............................................35
9 Troubleshooting .................................................37
9.1 Safety information.........................................................37
9.2 Fault causes and troubleshooting...............................38
10 Disposal of old devices......................................39
11 Warranty..............................................................40
12 Technical data and accessories........................41
12.1 Technical data ...............................................................41
12.2 Pictograms.....................................................................42
12.3 Accessories ...................................................................42
13 Guidelines and manufacturer's declaration.....43
14 Quick guide .........................................................46
HICO-DECUBIMAT 365 4

1 General information
1.1 Information on this manual
General information
Read the information in this section in order to quickly become
familiar with the HICO-DECUBIMAT 365 and to use the full
scope of its functions.
This operating manual is an integral part of the scope of
delivery of the HICO-DECUBIMAT 365 (hereinafter "the device"
or, along with the alternating pressure mattress, "the system")
and provides important information on the commissioning,
safety, proper use, and maintenance of the device.
All illustrations and drawings in this operating manual are
intended to serve as general clarification aids and are not
authoritative with regard to details.
This operating manual must be kept in a place where it is
constantly available for use, preferably near to the device. It
must be read and observed by all persons who carry out the
following tasks on the device:
• Commissioning
• Operation
• Cleaning
• Maintenance
• Troubleshooting
HICO-DECUBIMAT 365 5

1.2 Warnings
General information
The following warning indicators are used in this operating
manual:
This level of warning indicates an imminent danger.
If the dangerous situation is not avoided, serious injury or death
will occur.
► Follow the instructions that accompany this warning in order
to prevent serious injury or loss of life.
This level of warning indicates a situation which may be
dangerous.
If the dangerous situation is not avoided, serious injury may
occur.
► Follow the instructions that accompany this warning in order
to prevent injuries.
This level of warning indicates a situation which may be
dangerous.
If the dangerous situation is not avoided, minor or moderate
injury may occur.
► Follow the instructions that accompany this warning in order
to prevent injuries.
HICO-DECUBIMAT 365 6

General information
This level of warning indicates a situation which may result
in damage to property.
If the situation is not avoided, property may be damaged.
► Follow the instructions that accompany this warning in order
to prevent damage to property.
A note provides useful information to facilitate working with the
device.
HICO-DECUBIMAT 365 7

1.3 Limitation of liability
1.4 Copyright protection
General information
All of the technical information, data, and notes in this manual
on the installation, operation, and maintenance of the device
reflect the latest state of technology at the time of going to print
as well as our experience and knowledge to date and are
correct to the best of our knowledge.
No legal claims may be deduced from specifications,
illustrations, and descriptions provided in this manual.
The manufacturer does not accept liability for damages
resulting from the following:
• Failure to observe this manual
• Improper use
1.5 Manufacturer's address
• Improper repairs
• Technical changes
• Use of unauthorized spare parts
• Unauthorized alterations and changes
We strive to provide accurate translations. We do not accept
liability for translation errors, even if the translation was carried
out by or was commissioned by us. The original German text is
authoritative.
This document is protected by copyright.
All rights pertaining to this document and parts thereof -
including photomechanical reproduction, duplication, and
distribution via special processes (such as data processing or
on data carriers or data networks) - are retained by Hirtz & Co.
KG.
We reserve the right to make content changes and technical
changes.
Hirtz & Co. KG
Bonner Str. 180
50968 Cologne
Tel.: 0049 (0) 221 37 67 80
Fax: 0049 (0) 221 37 67 885
E-mail: hirtz@hico.de
HICO-DECUBIMAT 365 8

2 Safety
2.1 Intended use
Safety
This chapter provides important safety information to observe
when working with the device.
This device complies with prescribed safety regulations.
However, improper use can result in injury to persons and/or
damage to property.
This device is exclusively intended for the prevention of
pressure sores in low-risk/moderate-risk cases and for therapy
for cases up to decubitus stage 1 in conjunction with the
associated alternating pressure mattress 1 . Any other or further
use shall be considered to be improper use of the device.
Danger resulting from improper use!
This device can be dangerous if used improperly or for a use
other than its intended use.
► Only use the device for its intended use.
► Observe the procedures outlined in this operating manual.
Claims of all kinds relating to damages due to improper use are
excluded.
The operator bears all risks relating from improper use.
1
For the purposes of this manual, an "alternating pressure mattress" shall be understood to mean a 2chamber
mattress with a honeycomb overlay and a cotton cover.
HICO-DECUBIMAT 365 9

2.2 Personnel requirements
Safety
► Only persons who are entitled to work on/with the device
due to their training and qualifications may do so. In addition,
all persons who work on/with the device must be authorized
to do so by the operator.
► Only permit persons who are being trained, instructed, or
briefed or who are undergoing general training to use the
device if they are supervised at all times by an experienced
person.
► Persons who are under the influence of drugs, alcohol, or
medication that can affect their ability to react must not work
on/with this device.
► This device can be dangerous if it is used improperly by
persons without the requisite training.
► In addition to the instructions in this operating manual,
observe all statutory and other binding regulations pertaining
to accident prevention and environmental protection.
Observe all safety and health requirements. The operator
must instruct his personnel accordingly.
HICO-DECUBIMAT 365 10

2.3 General safety information
Safety
Observe the following general safety information to ensure
safety when working with the device:
► Before starting the device up for the first time, make sure
that the device (mains cable, housing, couplings etc.) and
the alternating pressure mattress are in order.
► Make sure that hoses and covers are laid without twists,
kinks, and folds.
► The hoses must not be blocked or kinked by heavy objects.
► Do not allow pointed, sharp, or hot objects to come into
contact with the alternating pressure mattress or its cells and
hoses. The system cannot work properly with perforated
cells or hoses.
► This device must not be used in an explosive environment (if
flammable gases are present).
► Do not cover the device during use.
► Do not allow liquids to enter the device. If necessary, contact
customer services.
► Unplug the mains cable before opening the device.
► Only use the device with HICO alternating pressure
mattresses and original accessories.
HICO-DECUBIMAT 365 11

2.4 Sources of danger
2.4.1 Risk of development of bed sores
Safety
► The patient should be positioned on the alternating pressure
mattress in a way that prevents him or her from falling out of
bed.
► Implement measures to secure the patient to the alternating
pressure mattress if necessary.
► To avoid cross infections, the alternating pressure mattress
and cover should be cleaned and disinfected before being
used for a new patient.
► Observe the ambient temperature range (10 - 30 ºC) and the
storage temperature range (10 - 40 ºC).
► Do not use the device near heat sources (spotlights, direct
sunlight, radiators, heaters etc.).
► Carry out maintenance tasks and technical function checks
in accordance with this operating manual.
There is a risk of the patient developing bed sores.
► Check the position and condition of the patient for whom the
device and alternating pressure mattress are being used.
HICO-DECUBIMAT 365 12

3 Transport and assembly
3.1 Scope of delivery and transport inspection
3.2 Unpacking the device
Transport and assembly
The scope of delivery of the HICO-DECUBIMAT 365 comprises
the following:
• HICO-DECUBIMAT 365 device
• 2-chamber honeycomb mattress
• Cotton cover (optional)
• Operating manual
► Check the delivery to make sure that it is complete and free
from visible damage.
► Inform the carrier, insurance company, and supplier
immediately if the delivery is incomplete or if damage has
occurred due to inadequate packaging or during transport.
Proceed as follows to unpack the device:
• Remove the device from the box and discard the packaging
material.
• Suspend the device at the foot end of the bed using its bed
mount.
Proceed as follows to unpack the alternating pressure mattress:
• Remove the alternating pressure mattress from the box and
discard the packaging material.
• Lay the alternating pressure mattress on the mattress on the
bed with the hoses pointing towards the foot end of the bed.
The hose connections must be on the top of the overlay
mattress.
HICO-DECUBIMAT 365 13

3.3 Disposal of packaging material
Transport and assembly
The packaging protects the device from transport damage. The
packaging material was selected in consideration of
environmental and technical disposal issues and is thus
recyclable.
Returning the packaging to the material cycle saves on raw
materials and reduces waste. Dispose of packaging material
that is no longer needed at collection points for recyclable
waste.
► If possible, retain the original packaging for the duration of
the warranty period of the device. This will enable you to
pack the device in the proper manner if you make a warranty
claim.
HICO-DECUBIMAT 365 14

4 Commissioning
4.1 Safety information
4.2 Installation
Commissioning
This chapter contains important information on placing the
device into operation for the first time. Observe the information
provided here to avoid danger and prevent damage.
Injury to persons and damage to property can occur when
placing the system into operation!
Observe the following safety information to avoid dangers:
► Make sure that the device is safely mounted on the bed.
► Make sure that the alternating pressure mattress is safely
positioned on the bed and that there are no folds in the
cover (sheets).
► We recommend the use of side railings. The distance
between the top of the railings and the mattress surface
must be at least 21 cm.
4.2.1 Requirements pertaining to the installation location
The installation location must have the following characteristics
to ensure the safe and error-free operation of the
device/system:
• Able to bear the weight of the system
• Be level
• Be horizontal (device inclination of ≤ 5°)
• Be flat (mattress resting surface inclination of max. 10º)
• Provide sufficient downwards space for the device
HICO-DECUBIMAT 365 15

4.3 Connection of the HICO-DECUBIMAT 365
Danger due to electricity!
Commissioning
► Only connect the device up to the mains if the location of the
bed is stable and the mains cable is laid to the plug in a way
that prevents it from being damaged and does not pose a
tripping hazard.
4.3.1 Preparation of alternating pressure mattress
When preparing to place the system into operation, lay the
alternating pressure mattress flat on the bed mattress (with side
railings). The ends of the covers must be folded under
accordingly. The connection hoses should point upwards and
lie at the foot end of the bed. The cover can now be pulled over
the mattress(es). When doing so, pay attention to the position
of the hoses.
HICO-DECUBIMAT 365 16

Commissioning
A cotton sheet should be used on our alternating pressure
mattresses to improve the microclimate and comfort of the
patient. If our alternating pressure mattresses are used
properly, the use of a bed sheet (normal sheet or fitted sheet) to
protect the alternating pressure mattress and an additional draw
sheet to improve the patient's position does not significantly
affect or reduce the function of the alternating pressure
mattress.
Check: If you can fit your flat hand between the patient and the
deaerated cell without touching the patient or hardly touching
the patient, the alternating pressure system is working correctly.
4.3.2 Mounting the device
The device is suspended with the bed mount or positioned at
the foot end of the bed in a way that ensures that the hoses to
the mattress are not blocked or squeezed.
The ends of the alternating pressure mattresses hoses are
pushed onto the two coupling connections of the device far
enough to ensure that they are tight and cannot slip.
Which hose is attached to which coupling connection has no
effect on how the system works.
HICO-DECUBIMAT 365 17

4.3.3 Electrical connection
Danger due to electric current!
Commissioning
Faulty cables and/or plugs can cause life-threatening electric
shocks.
► Check the device cables and plug before connecting them
up to make sure that they are in perfect condition.
To ensure that the device works safely and without errors, note
the following with regard to the electrical connections:
• Before connecting up the device, compare the connection
data (voltage and frequency) on the type plate with the data
for your electrical network. The data must match to prevent
damage to the device.
If in doubt, ask a qualified electrician.
• The socket must be protected with a 16A safety circuit
breaker.
• Connect the device to the mains using the integrated cable.
HICO-DECUBIMAT 365 18

4.3.4 Preparing to use the HICO-DECUBIMAT 365
Commissioning
• Once the hoses of the alternating pressure mattress are
pushed onto the couplings (5) of the device right to the stop
and once the power supply (3) is connected up, switch the
device on using the mains switch (4) on the right-hand side
of the housing.
• The system is filled up in accordance with the set patient
weight (7) (filling phase). Once the filling phase is complete
(takes around 30 minutes), the patient can be placed onto
the mattress.
HICO-DECUBIMAT 365 19

5 Design and function
Design and function
This chapter contains important information on the design and
function of the device.
5.1 Device views and control and display elements
1) Bed mount/device
handle
2) Control panel
3) Mains switch
4) Mains cable
5) Hose couplings
6) Alternating pressure
light
7) Patient weight setting
knob
Rear view (section) of
device with mount
Bed mount/device handle
HICO-DECUBIMAT 365 20

5.2 Safety devices
5.2.1 Sensors
5.3 Type plate
5.4 Function
Design and function
The HICO-DECUBIMAT 365 monitors the following during
operation:
• The counter pressure in accordance with the set patient
weight
The type plate showing the connection and performance data is
on a sticker on the front of the device:
5.4.1 Basic information
The HICO-DECUBIMAT 365 alternating pressure mattress
system for intermittent pressure relief consists of the device, its
suspension mount, and a two-chamber mattress with a
honeycomb overlay and an air flow system. The device
generates compressed air and automatically feeds it into two air
chamber systems in the mattress by means of a distribution
system in a rhythm of around 10 minutes. The all-over microperforation
of the overlay surface enables the flow of air. The
purpose of the system is to prevent and/or treat pressure ulcers
on patients who are at risk of pressure sores by relieving the
pressure on the affected parts of the body (heels, back, and
shoulders). The medical personnel treating the patient decide
whether or not to use the system further.
HICO-DECUBIMAT 365 21

Design and function
The pump pressure to the mattress can be adjusted using a
knob (comfort selector), allowing the mattress to be individually
adjusted in line with the weight of the patient or to distribute the
load on the mattress. The setting can be adjusted for a weight
range of between approx. 40 kg and approx. 120 kg. In
addition, the HICO-DECUBIMAT 365 device enables the
monitoring of the alternating pressure function using an
indicator light that also acts as a control indicator.
5.4.2 Performance features
The system is characterized by the following performance
features:
• A two-chamber honeycomb overlay alternating pressure
mattress with air flow system
• Suitability for use as preventative and treatment aid for
pressure sores of up to stage I
• Automatic pressure control system using sensor technology
• Function monitoring using indicator light
• Patient weight adjustment range of 40 - 120 kg
• Easy to use and clean
• Low noise and vibration
HICO-DECUBIMAT 365 22

5.4.3 Indications
Design and function
The HICO-DECUBIMAT 365 can be used for the following:
• The prevention of pressure sores in low to moderate risk
patients as per NORTON
• The treatment of pressure sores of stage 1 as per SEILER
The HICO-DECUBIMAT 365 is designed for use with patients
weighing up to around 120 kg.
5.4.4 Contra-indications/side effects
Do not use this product on patients with the following
conditions:
• Severe edema
• Acute multiple traumas
• Instable fractures
• A weight of more than 120 kg
The constant alternating pressure reactions of the skin nerves
can trigger an error signal in the brain stem. This error signal
results from constant conflicts between the sensation of
movement and the position of the body. Depending on the
constitution of the patient, this can cause loss of orientation or a
feeling similar to sea sickness. Sea sickness (travel
sickness/motion sickness, "kinetosis" in medical jargon from the
Greek "kinein" (to move)) is associated with pallor, dizziness,
headaches, nausea, and vomiting resulting from unusual
motion.
HICO-DECUBIMAT 365 23

6 Controlling and operating the system
6.1 Before switching the device on
6.1.1 System checks
Controlling and operating the system
This chapter contains important information on operating the
device. Observe the information provided here to avoid danger
and prevent damage.
• Check the device for external damage.
• Make sure the device is connected up properly.
• Check the alternating pressure mattress (surfaces of the
hoses, connections etc.) for external damage. Only use
undamaged alternating pressure mattresses.
• Only connect up original HICO alternating pressure
mattresses that are suitable for use with the HICO-
DECUBIMAT 365.
• Check that the alternating pressure mattress is positioned
correctly on the bed.
The alternating pressure mattress can be connected up and
disconnected with the device switched on or off.
Disconnecting the alternating pressure mattress prevents it
from working. The alternating pressure mattress is deaerated
immediately.
HICO-DECUBIMAT 365 24

6.2 Operation
6.2.1 Placing the system into operation
Controlling and operating the system
Once the system is prepared as per sections 4.3.2 and
4.3.4, connect the device to the mains by plugging it in
and switch it on using the mains switch.
If the mains switch lights up, the device is active.
During the filling phase, the alternating pressure light is
lit, too.
The patient weight is set using the scale on the patient
weight knob.
After around 30 minutes - when the alternating
pressure light goes on and off for the first time - the
alternating pressure mattress is full enough for the
patient to be lain upon it.
The alternating pressure light also acts as a control
indicator, enabling the operator to check that the
system is working properly.
It comes on regularly in line with the alternating
pressure cycle as the mattress cells are filled up.
HICO-DECUBIMAT 365 25

Controlling and operating the system
6.2.2 Optimization of pad pressure
The patient weight scale on the device is designed for patients
lying on their back. Depending on the type of care, the pad
pressure must be checked and adjusted/optimized in
accordance with the information below in order to prevent
pressure sores.
You check that the pad pressure is correct by checking a
deaerated cell in the maximum pad pressure load range (e.g.
under the buttocks) after the patient has been lying down for 10
minutes.
• If you can pass your flat hand between the patient and the
deaerated alternating pressure cell, the pad pressure is OK.
• If the patient's body is touching the underlay in this area, a
higher patient weight setting must be selected.
Setting adjustments should be done in steps of 10 kg. After
changing the setting, you must wait for the duration of an
alternating pressure cycle (up to 10 minutes) before carrying
out the check again. The set weight on the device can be 30 or
40 kg higher than the actual weight of the patient without posing
a danger to the patient or the alternating pressure system.
The anatomy of a patient has a significant influence on the pad
pressure. Thus, in order to avoid pressure sores you may have
to set the weight setting on the device higher than the weight of
the patient if the patient lies in an S-shape or is overweight.
HICO-DECUBIMAT 365 26

Controlling and operating the system
It can often be useful to increase the patient weight setting.
Doing so increases the pad pressure without impeding the
alternating pressure system and partial pressure relief effect.
This improves the support and mobility of the patient and
minimizes the risk of pressure sores.
The patient weight setting must be increased significantly in
order to prevent pressure sores if the bed surface is on a slant
(an inclination of no more than 10º is recommended). This is
required in order to counteract changes in pressure loads.
Make sure that the distance between the mattress surface and
the top of the bed railings is at least 21 cm.
HICO-DECUBIMAT 365 27

Controlling and operating the system
6.2.3 Information on handling the alternating pressure mattress
6.2.4 Tasks during operation
6.3 Alarms
► When the alternating pressure mattress is disconnected, it
deaerates.
► The alternating pressure mattress is a functional product that
is subject to wear. If you can no longer guarantee that it is
safe to use, you must replace it.
You must always make sure that the patient is positioned
correctly.
Check: If you can fit your flat hand between the patient and the
deaerated cell without touching the patient or hardly touching
the patient, the alternating pressure system is working correctly.
Make sure that the distance between the mattress surface and
the top of the bed railings is at least 21 cm.
6.3.1 General information
The device only issues optical alarms.
Malfunction
If a malfunction occurs, the alternating pressure light remains
on or off permanently (i.e. longer than 10 minutes) or flashes
continuously whilst the mattress is being used in alternating
pressure mode.
HICO-DECUBIMAT 365 28

7 Cleaning and disinfection
7.1 Safety information
Cleaning and disinfection
This chapter contains important information on the cleaning and
disinfection of the device. Observe this information in order to
prevent damage to the device due to incorrect cleaning and to
ensure fault-free operation.
Make sure that you comply with the following safety information
before starting to clean the system:
► Pull out the mains plug before starting to clean and disinfect
the device.
► During the cleaning procedures, protective clothing should
always be worn.
► Do not allow any fluid to enter the device/mattress
chambers.
► Before you use the system again, you must make sure that
all system parts are completely dry.
► Only switch the device back on once it is completely dry.
Sensitive surfaces!
The surfaces of the device and alternating pressure mattress
can be badly damaged by unsuitable cleaning agents or
disinfectants.
► Only use disinfectants based on aldehyde, ammonium
components, or alcohols that do not attack ABS plastic,
PVC, or PU for all surfaces and parts.
► Wherever possible, do not use disinfectants based on
phenol derivatives, since they can shorten the lifetime of
plastics.
HICO-DECUBIMAT 365 29

7.2 Device
Cleaning and disinfection
Wherever possible, use decalcified water. Wipe down the
device with a damp cloth only. Only use warm water (max. 50
ºC) with a mild, commercially available washing up liquid to
clean the device. Wipe off with plain water and rub the device
dry.
The device surface can be disinfected as follows in accordance
with the RKI/DGHM list 2 :
• Wipe/surface disinfection
When using disinfectants, observe the instructions of the
manufacturer. 3
Only switch the device back on once the disinfectant has
completely evaporated.
Check the device for integrity.
2 Robert Koch Institute; German Society for Hygiene and Microbiology
Lists available from the Robert Koch Institute, Berlin/from mhp-Verlag, Wiesbaden
3 List of recommended disinfectants (observe the instructions of the manufacturer)
• For disinfecting the system
- Surface cleaning: Neutral cleaner (concentrate)
- Surface disinfection: Terralin, 0.5% concentration
Sanosil solution, 5% concentration
• For users
- Hand disinfection: Desderman N (concentrate)
HICO-DECUBIMAT 365 30

7.3 Alternating pressure mattress
7.3.1 Mattress
Cleaning and disinfection
To avoid cross-infection, the mattress must be cleaned and
disinfected regularly.
The alternating pressure mattress and hoses are generally
disinfected using one of the following procedures as per the
RKI/DGHM list 2 :
• Surface disinfection, scrub disinfection, disinfection of
excretions
Make sure that only procedures without chlorine or without
organic/inorganic substances with active chlorine as the active
ingredient are used.
In the absence of other possibilities (e.g. if being used in a
domestic setting), the mattress can be wiped down with a cloth
dampened with commercially available detergent/disinfectant 3
(without chlorine-based substances) in accordance with the
manufacturer's instructions.
Check the mattress for integrity.
► The cleaning temperature may not exceed 60 ºC.
► If fluid enters the inside of the chambers or hoses, you must
not place the system into operation.
► The mattress is not autoclavable!
HICO-DECUBIMAT 365 31

7.3.2 Cover
Cleaning and disinfection
The cover is particularly prone to getting dirty and can be
disinfected as per the RKI/DGHM list 2 in accordance with one of
the following procedures:
• Disinfection of laundry, in washing machines at a
temperature of up to 95 ºC
Make sure that only procedures without chlorine or without
organic/inorganic substances with active chlorine as the active
ingredient are used.
We recommend that you wash it in a washer-extractor set up in
accordance with RKI guidelines.
• Water ratio: 1 kg of washing (dry weight) to 5 litres of water
• Main wash at 60 ºC
• Detergent and disinfectant: Eltra by ECOLAB
• Dose per kg of dry weight: 35 g = 60 ml; for a 10 kg load in a
washer-extractor: 600 ml
• 20 minute hold time
If these conditions cannot be met in private usage cases (e.g.
patient care in the home), the cover can be washed in a normal
washing machine at a temperature of up to 95 ºC.
Check the cover for integrity. The lifetime of covers if washed in
a washer-extractor is at least 20 uses.
HICO-DECUBIMAT 365 32

Maintenance and technical function check
8 Maintenance and technical function check
8.1 Maintenance
This chapter contains important information on maintaining the
device. Observe this information in order to prevent damage to
the device due to incorrect maintenance and to ensure faultfree
operation.
We recommend that you enter into a service contract with Hirtz
& Co. KG. By entering into a service contract, you meet the
requirements of the following:
• BetrSichV BGV A3 (Ordinance on Industrial Safety and
Health, Electrical Systems and Equipment)
• Medical Device Directive (93/42/EEC)
• MPBetreibV (Medical Devices Operators Ordinance)
All of the above require a regular technical inspection of
devices.
In addition, having the device maintained by our specialists
ensures the best possible level of operating safety and the
longest possible lifetime for your device.
Do not use cleaning or decontamination procedures that are not
recommended by Hirtz & Co. KG.
Before using a new procedure, check the procedure in
collaboration with Hirtz & Co. KG.
This is the only way to ensure that the procedure will not
damage the device.
HICO-DECUBIMAT 365 33

8.1.1 Device
8.1.2 Hose couplings
Maintenance and technical function check
• Check the integrity of the device's functions every 6 months
at the very least. Commission a service technician (customer
services or medical technology specialist) to remove dirt from
the inside of the device. Do not open the device yourself.
• Make sure that customer services/the medical technology
specialists observe the maintenance intervals and technical
function check frequency.
The tightness of the ends of the hoses drops with age, causing
a reduction in functionality. Check the hoses regularly to make
sure that they fit tightly. If the hose ends become slack, cut off
the section in question. When doing so, make sure that the
hoses are still suitable for use.
8.1.3 Alternating pressure mattress
Check the integrity (leak-tightness) of the mattress as follows on
a regular basis:
Before use:
• Check the hoses and hose connections to make sure that
they are correctly positioned and leak-tight when the system
is not filled.
• Use the device to fill the alternating pressure mattress to the
extent required by the maximum patient weight setting and
check the hoses, hose connections, and mattress cells for
leak-tightness and function over two alternating pressure
cycles.
During use:
• You must always make sure that the patient is positioned
correctly.
Check: If you can fit your flat hand between the patient and
the deaerated cell without touching the patient or hardly
touching the patient, the alternating pressure system is
working correctly.
HICO-DECUBIMAT 365 34

8.2 Technical function check
Maintenance and technical function check
A technical function check must be carried out on the device
regularly (preferably every 12 months) in order to ensure legal
conformity and operating safety as per Medical Device Directive
93/42/EEC (Annex 1, Item 13.6.d) and MPBetreibV (§ 6(1)).
The operator is responsible for making sure that the check is
carried out properly. Due to the stipulations of MPBetreibV (§ 6
(4) 1.+ 3.), this check can only be carried out by Hirtz & Co. KG
or a suitably qualified person. The technical function check
must encompass the following points at the very least:
• Checking the device and system components for external
damage, wear, and aging and checking the legibility of
notices and labels
• Measuring housing and patient leakage current as per the
testing facility and manufacturer's instructions
• Checking all functions in accordance with the operating
manual
• Checking all functions in accordance with the manufacturer's
instructions
• Checking the sensors in accordance with the manufacturer's
instructions
Hirtz & Co. KG can provide authorized persons with the
relevant materials to do this.
HICO-DECUBIMAT 365 35

Maintenance and technical function check
We recommend that you enter into a service contract with Hirtz
& Co. KG in order to ensure compliance with statutory safety
requirements. We will then carry out the annual technical
function test for you.
In the case where maintenance or repair work is to be carried
out on heavily contaminated devices, mattresses, mattress
covers, or accessories that are sent to us and where contact
with such items might result in contamination with specific
germs or bacteria such as MRSA, the system must be
disinfected with a suitable disinfectant and packaged in
accordance with decontamination guidelines and material
compatibility before being dispatched. Otherwise, for safety
reasons we reserve the right not to take receipt of such items or
to carry out additional chemical/thermal treatments on such
items before carrying out a technical inspection or damage
analysis. Any extra costs incurred will be borne by the
customer in such cases.
If you have any questions about service, maintenance, or
technical function checks, please contact us:
Hirtz & Co. KG
Bonner Str. 180
50968 Cologne
Tel.: 0049 (0) 221 37 67 80
Fax: 0049 (0) 221 37 67 885
E-mail: hirtz@hico.de
HICO-DECUBIMAT 365 36

9 Troubleshooting
9.1 Safety information
Troubleshooting
This chapter contains important information on locating faults
and troubleshooting. Observe the information provided here to
avoid danger and prevent damage.
► Repairs to electrical appliances may only be made by
professionals who - if necessary - have been trained by the
manufacturer.
► Improper repairs can result in considerable danger to users
and damage to the device.
All guarantee and warranty claims are invalidated if the device
is opened by an unauthorized person.
► The device may only be repaired by Hirtz & Co. KG or by
persons trained and/or authorized by Hirtz & Co. KG.
HICO-DECUBIMAT 365 37

9.2 Fault causes and troubleshooting
Troubleshooting
The following table helps you to identify and eliminate faults. It
does not claim to be complete.
Fault Cause Remedy
Alternating pressure light
permanently off
Alternating pressure light
flashing temporarily
(flash frequency of < 20
seconds)
Alternating pressure light
flashing permanently
(flash frequency of < 20
seconds)
Alternating pressure light
permanently lit
Mains switch light not lit
No pressure build-up due to:
1. Mattress not filled
2. Leaking hose connections
3. Mattress leaks
4. Weak or defective pump
5. Leaking valve disks
6. Defective pressure switch
7. Defective bulb
8. Patient too heavy
Pressure regulation faulty due
to:
1. Patient moving
2. Hoses blocked in mattress
3. Hoses blocked in device
4. Valve disks worn
(undersized)
5. Mattress leaks
Pressure regulation faulty due
to:
1. Hoses blocked on mattress
1. If placing the system into
operation, wait for 30 minutes.
2. Check the hose connections on
the mattress and device and
connect up properly or replace if
necessary.
3. Replace the mattress.
4. Customer services
5. Customer services
6. Customer services
7. Customer services
8. Check the pad pressure as per
section 6.2.3 ("Optimization of
pad pressure") and use a
different alternating pressure
system if necessary.
1. No measures required
2. Check the hoses in the mattress
and remove the kinks or replace
the hoses if necessary.
3. Customer services
4. Customer services
5. Replace the hose/cell/mattress.
1. Check the hoses on the mattress
and remove the kinks or replace
the hoses if necessary.
1. Defective pressure switch 1. Customer services
1. Device not switched on
2. Defective fuse
3. Power failure
1. Switch the device on.
2. Customer services
3. Check the power.
This table merely intends to help you to detect and eliminate faults. It does not claim to be complete.
HICO-DECUBIMAT 365 38

10 Disposal of old devices
Disposal of old devices
Old electrical and electronic devices contain a lot of valuable
material. They also contain harmful substances that were
required during their lifetime to safeguard their function and
safety.
If disposed of as normal rubbish or if handled incorrectly, these
substances can damage people's health or the environment.
This device must not be disposed of as normal commercial or
domestic rubbish!
► As per the product responsibility specifications of § 22 of the
German Waste Management and Recycling Act and § 2,
Para. 1, Art. 8 of the Electrical and Electronic Equipment
Act, this device must be disposed of at an appropriate
communal collection point or returned to the manufacturer.
► The alternating pressure mattress can be disposed of in
domestic rubbish for burning in accordance with user
regulations on waste.
HICO-DECUBIMAT 365 39

11 Warranty
Warranty
The HICO-DECUBIMAT 365 was developed in accordance with
the latest state of technical expertise and is manufactured and
tested at Hirtz & Co. KG to the highest quality standards.
However, should defects be detected by the end user within 24
months of purchase, we will replace the product or repair
defects that are the result of material, design, or production
faults at no charge.
The warranty is invalidated in the following cases:
a) Damage due to improper transport
b) Damage due to exposure to the environment
c) Damage due to improper handling
d) Use of non-authorized accessories
e) Opening of the device by an unauthorized person
HICO-DECUBIMAT 365 40

12 Technical data and accessories
12.1 Technical data
Device Mattress
Technical data and accessories
REF: 310003 REF: 310500
Voltage: 230 V AC 50/60 Hz Number of chambers: 2-chamber system
Current consumption: 35 mA Max. filling pressure: Approx. 230 mbar
Power consumption: Max. 8 W Dimensions (L x W x H): 200 x 90 x 7 (cm)
Current consumption: Max. 0.2 kWh/day Weight: Approx. 2 kg
Safety fuse: T 80 mA Materials: PVC, latex-free,
Air flow: Approx. 5 l/min heavy metals, and
Cycle time: 10 minutes phthalates
Patient weight: 40 - 120 kg, adjustable Ambient temperature: 10 - 30 °C
Classification (IEC 601): SKL II, type BF, IPX 0 Relative air humidity: Approx. 30 - 70%
Risk category (93/42/EEC): I Storage temperature: 10 - 40 °C
Dimensions (W x H x D): Approx. 16 x 30 x 12 cm Air pressure: 1013 hPa (+/-10%)
Noise level: Approx. 23 dB(A) (1m) Cover
Weight: Approx. 2.6 kg REF: 310505
Length of mains cable: 5m Dimensions (L x W x H): 270 x 150 (cm)
Ambient temperature: 10 - 30 °C Weight: Approx. 1 kg
Relative air humidity: Approx. 30 - 70% Ambient temperature: 10 - 30 °C
Transport/storage
temperature:
10 - 40 °C Relative air humidity: Approx. 30 - 70%
Air pressure: 1013 hPa (+/-10%) Storage temperature: 10 - 40 °C
Test basis: MDD 93/42/EEC, Air pressure: 1013 hPa (+/-10%)
Subject to technical changes.
IEC 60601-1 Materials: Cotton
► All named materials for the alternating pressure mattress are
free from latex and heavy metals.
HICO-DECUBIMAT 365 41

12.2 Pictograms
12.3 Accessories
Technical data and accessories
The mattress component used is classified as type BF in
accordance with the degree of protection from electric shock.
The device is classified into protection class II for protection
from electric shock.
Warning! Always read and observe the operating instructions.
Observe the operating instructions.
Only original HICO alternating pressure mattresses may be
used with the HICO-DECUBIMAT 365 device.
HICO-DECUBIMAT 365 42

Guidelines and manufacturer's declaration
13 Guidelines and manufacturer's declaration
Guidelines and manufacturer's declaration - electromagnetic transmissions
Table of general specifications for electrical medical devices: Reduced version
Table 201
Row
1 Guidelines and manufacturer's declaration - electromagnetic transmissions
2 The [device or system] is intended for operation in environments like those specified in the tables and
texts of this operating manual. The customer or user of the [device or system] should ensure that it is
used in this kind of environment.
3 Emitted interference measurements Compliance
4 HF emissions
As per CISPR 11
6 HF emissions
As per CISPR 11
7 Emissions of
harmonic oscillations as per IEC 61000-3-2
8 Emissions of
voltage fluctuations/flicker
As per IEC 61000-3-3
Group 1
Class B
Class A
Not applicable
9 [See 6.8.3.201 a) 3) and Fig. 201.]
HICO-DECUBIMAT 365 43

Table 202
Interference resistance
tests
Electrostatic discharge
(ESD) as per IEC 61000-
4-2
Fast transient
disturbance
variables/bursts
As per IEC 61000-4-4
Surge voltages as per
IEC 61000-4-5
Voltage drops, short
interruptions, and
fluctuations in supply
voltage as per IEC
61000-4-11
Magnetic field for supply
frequency (50/60 Hz) as
per
IEC 61000-4-8
Guidelines and manufacturer's declaration
IEC 60601 test level Compliance level
±6 kV contact discharge
±8 kV air discharge
±2 kV for mains cables
±1 kV for input and
output lines
±1 kV normal mode voltage
±2 kV common mode voltage
95% dip in UT)
for ½ period
40% U
(60% dip in UT)
for 5 periods
70% UT
(60% dip in UT)
for 25 periods
95% dip in UT)
for 5 seconds
3 A/m 3 A/m
±6 kV contact discharge
±8 kV air discharge
±2 kV for mains cables
±1 kV for input and
output lines
±1kV normal mode voltage
±2kV common mode voltage
95% dip in UT)
for ½ period
40% U
(60% dip in UT)
for 5 periods
70% UT
(60% dip in UT)
for 25 periods
95% dip in UT)
for 5 seconds
HICO-DECUBIMAT 365 44

Table 204: NON-life-sustaining systems
Guidelines and manufacturer's declaration
Interference resistance tests IEC 60601 test level Compliance level
Conducted HF interferences as
per
IEC 61000-4-6
Radiated HF interferences as per
IEC 61000-4-3
Radiated HF interferences as per
EN 60601-2-35
3 Veff
150 kHz to 80 MHz
3 Veff
80 MHz to 2.5 GHz
HICO-DECUBIMAT 365 45
3 V
3 V/m
10 V/m 10 V/m
Table 206: Safety clearances from wireless telecommunication devices
Rated power of
transmitter
W
Safety clearance in relation to transmission frequency
(m)
150 kHz to 80 MHz
d=P*exp0.5*3.5/V1
80 MHz to 800 MHz
d=P*exp0.5*3.5/E1
0.01 0.12 m 0.12 m 0.24 m
0.1 0.37 m 0.37 m 0.74 m
1 1.17 m 1.17 m 2.34 m
10 3.69 m 3.69 m 7.38 m
100 11.67 m 11.67 m 23.34 m
800 MHz to 2.5 GHz
d=P*exp0.5*7/E1

14 Quick guide
Quick guide
• Suspend the device to the foot end of the hospital bed using
the bed mount (1).
• Place the alternating pressure mattress onto the bed
mattress with the hoses at the foot end of the bed and tuck
the ends of the covers into the bed mattress.
• Place the cotton cover over the alternating pressure
mattress.
• Place the connection hoses of the alternating pressure
mattress onto the two hose connection pieces (5) of the
device.
• Connect up the device to the mains, use the mains switch (3)
to switch it on, and adjust the patient weight setting using the
knob (7).
• After around 30 minutes, when the alternating pressure light
(6) goes out and comes back on for the first time, you can
place the patient onto the alternating pressure mattress.
• The alternating pressure light (7) lights up and goes off in
accordance with the alternating pressure cycle. If the light
stays on or off (for more than 10 minutes) once the system
has been placed into operation, there is a malfunction.
HICO-DECUBIMAT 365 46

Notes
Quick guide
HICO-DECUBIMAT 365 47