Invacare Softform Premier Active 2 User manual

Invacare®Softform®
Premier Active 2
This manual must be given to the user of the product.
Before using the product, read this manual and save it for future reference!
EN Mattresses User Manual
DE Matratzen Gebrauchsanweisung
FR Matelas Manuel d’utilisation
ES Colchones Manual del usuario
IT Materassi Manuale d‘uso
PT Colchões Manual de instruções
SV Madrasser Bruksanvisning
NO Madrasser Brukerveiledning
DA Madrasser Brugsanvisning

© Invacare Ltd
Every effort has been made to ensure that the contents of this publication are fully up-to-date
at the time of going to print.As part of its ongoing improvement of products, Invacare Ltd
reserves the right to modify existing models at any time. Invacaredealers will be notied of any
such modications. Any use of this publication, or of parts thereof, as well as any reproduction
of images, must have the written consent of Invacare Ltd.
EN: Complies with Directive 93/42/EEC concerning medical devices.
DE: Konform mit Richtlinie 93/42/EWG für Medizinprodukte.
FR: Conforme à la directive 93/42/ECC relative aux dispositifs médicaux.
IT: Conforme alla direttiva 93/42/ECC relativa ai prodotti medicali.
ES: Cumple con la directiva 93/42/EEC relativa a los productos sanitarios.
PT: Em conformidade com a directiva 93/42/EWG do Conselho relativa aos dispositivos médicos.
SV: Uppfyller direktiv 93/42/EWG om medicintekniska produkter.
NO: Overholder retningslinjerne i 93/42/EWG om medisinsk utstyr.
DA: Overholder direktiv 93/42/EWG om medicinske produkter.
Softform®is a registered trademark of Invacare Ltd.

Contents english
1 General 4
1.1 General information 4
1.2 Symbols 4
1.3 Symbols Guide 4
1.4 Guarantee 4
1.5 Intended use 5
1.6 Product Description 5
1.7 Service Life 5
2 Safety 6
2.1 Safety information 6
3 Setup and installation 7
3.1 Safety information 7
3.2 Installing the system 8
4 Usage 8
4.1 Safety information 8
4.2 CPR Procedure 9
4.3 Pump Software Schematic 10
4.4 Pump Menu Display 11
5 Transport 13
5.1 Safety information 13
5.2 Transport Mode 13
6 Maintenance 13
6.1 Inspection 13
6.2 Cleaning and Care 13
7 After-Use 14
7.1 Storage 14
7.2 Re-Use 15
7.3 Disposal 15
8 Troubleshooting 15
9 Technical Data 16
9.1 General Data 16
9.2 Pump Unit 16

Softform®Premier Active 2 Mattresses General
4
1 General
1.1 General information
Essential nursing care is pivotal in pressure ulcer prevention.
The Softform®Premier Active 2 mattress will positively contribute to
the outcome of a pressure ulcer prevention care plan.
Education, clinical judgement and action based planning based on
vulnerability are fundamental factors in prevention of pressure ulcers.
A range of assessment scales can be used as a formal method of
assessing risk from pressure ulcer development, and should be used in
conjunction with an informal assessment (informed nursing judgement).
Informal assessment is considered to be of greater importance and
clinical value.
Please heed all the notes, particularly the safety information, and act
accordingly.
Should you require more information on the Invacare®Softform®
Premier Active 2 mattress please refer to the Invacare®Softform®
Brochure and contact details on the back page of this User Manual.
1.2 Symbols
Warnings
In this User Manual warnings are indicated by symbols.The warning
symbols are accompanied by a heading that indicates the severity of the
danger.
WARNING
Indicates a hazardous situation that could result in serious
injury or death if it is not avoided.
CAUTION
Indicates a hazardous situation that could result in minor or
slight injury if it is not avoided.
!IMPORTANT
Indicates a hazardous situation that could result in damage to
property if it is not avoided.
Tips and recommendations
iGives useful tips, recommendations and information for efci-
ent, trouble-free use.
1.3 Symbols Guide
Do not pierce
or cut Line dry
Do not dry
clean Declaration of conformity
Do not put
near ame 80°
Recommended
80 °C
247.6 kg User weight
limit of
247.6 kg
Do not iron
Do not bleach Tumble dry low
heat
1.4 Guarantee
We provide a manufacturer’s warranty for the product in accordance
with our General Terms and Conditions of Business. Guarantee claims
can only be made through the relevant specialist dealer.
Standard Invacare®Terms
This is to certify that your Softform® Premier Active 2 Mattress is
warranted by Invacare®Ltd for a period stated in theTable “Technical
Data” of this user guide.
The Warranty of your Invacare®Softform®product is valid from time
of shipping.

Softform®Premier Active 2 MattressesGeneral
5
If a defect or fault is discovered the Invacare®dealer or Local Business
Development Manager from whom the appliance was obtained must be
notied immediately.
The manufacturer will not accept responsibility for damage caused by
misuse or non-observance of the instructions set out in this user guide.
During the period of the warranty any products that have become de-
fective due to faulty workmanship or materials will be renewed without
charge.
The warranty will be forfeited should any unauthorized alteration be
made to the equipment.
Both warranty and re retardancy Certication will become null and
void if non-Invacare®spares are used on any Invacare®Softform®
Mattress products.
The purchaser’s statutory rights under the Consumer Protection Act
are not affected.
Quality and Flame Retardancy
Quality is fundamental to the company’s operation, working within the
disciplines of ISO 9001 and ISO 13485.
The Softform® Premier Active 2 Mattress features the CE mark, in
compliance with the Medical Device Directive.
The foam and covers used to manufacture the Invacare®Softform®ran-
ge of mattresses are independently tested and certied in accordance
with EN 597-1 and EN 597-2 and BS 7177 Crib 5.
The pump unit is tested to EC Directive 89/336/EEC, EN 55022 and
EN 61001-1, 2. Manufactured to comply with EN 60601-1.
For further information please contact Invacare in your country
(addresses see back page of this manual).
1.5 Intended use
This pressure redistribution mattress and pump is intended to be used
in conjunction with an appropriately sized bed frame, as part of an
overall pressure ulcer prevention program of care.
It can be used safely in static mode (deated) for static pressure redis-
tribution, or in dynamic mode (inated) should an alternating pressure
support surface be required.
This product has been designed to deliver effective pressure reduction
to users, when the product is in normal use which is dened by Inva-
care®Ltd as when the support surface is covered with a cotton, cotton
combination or linen bed sheet, and any one of these would be the
only item deployed between the support surface and the user.
1.6 Product Description
The Softform® Premier Active 2 mattress system acts as a static pres-
sure reducing support/mattress for patients at high risk that can, by
facilitating the air pump, introduce effective alternating pressure if the
patients condition requires alternating pressure therapy.
The water-resistant cover provides a vapour-permeable, multi stretch
surface, to promote patient comfort and to maximise the effectiveness
of the foam core.
The complete system comprises of:
A mattress insert comprised of alternate air cells that connect to a
twin air connector hose.
A Micro-processor controlled air pump unit.
A 5 meter power lead.
1.7 Service Life
We estimate a life expectancy of ve years for these products, provided
they are used in strict accordance with the intended use as set out in
this document and all maintenance and service requirements are met.
The estimated life expectancy can be exceeded if the product is care-
fully used and properly maintained, and provided technical and scientic
advances do not result in technical limitations.The life expectancy can
also be considerably reduced by extreme or incorrect usage.
The fact that we estimate a life expectancy for these products does not
constitute an additional warranty.

Softform®Premier Active 2 Mattresses Safety
6
2 Safety
2.1 Safety information
WARNING
▸Do not use this product or any available optional equipment
without first completely reading and understanding these
instructions and any additional instructional material such as
user manuals, service manuals or instruction sheets supplied
with this product or optional equipment. Invacare product
manuals are available at www.invacare.co.uk or your local
dealer. If you are unable to understand the warnings, cau-
tions or instructions, please contact a healthcare professio-
nal, dealer or technical personnel before attempting to use
this equipment – otherwise, injury or damage may occur.
WARNING
Invacare products are specically designed and manufactured
for use in conjunction with Invacare accessories.Accessories
designed by other manufacturers have not been tested by
Invacare and are not recommended for use with Invacare
products.
The introduction of certain third party products between
the mattress surface and the user may reduce or impede the
clinical effectiveness of this product.
’Third party products’ may include, but are not limited to
items including under blankets, plastic sheets and sheepskins,
etc. Heated over blankets must only be used in consultation
with a suitably qualied healthcare professional, as an increase
in temperature can increase the risk of developing pressure
ulcers.
WARNING
Bed sheets must be loosely tted, with creases smoothed out.
Care must always be taken to ensure that the support surface
in contact with the user is kept free from crumbs and other
food debris, and that drip cables, stents, and other foreign
objects do not become entrapped between the user and the
pressure reducing surface of the mattress, as this may result in
the development of pressure ulcers.
WARNING Risk of fire or explosion!
A cigarette can burn a hole in the bed surface and cause
damage to the mattress.Also, patient clothing, bed sheets, etc,
may be combustible and cause a re. Failure to observe this
warning can result in a severe re, property damage and cause
physical injury or death.
There is an explosion risk if used with ammable anesthetics.
There is a possible re hazard when used with oxygen admi-
nistering equipment other than nasal mask or half bed tent
type.
▸Do not smoke while using this device.
▸An oxygen tent may not extend below mattress support
level.
!IMPORTANT
The information contained in this document is subject to
change without notice.
▸Check all parts for shipping damage and test before using.
▸In case of damage, do not use.
▸Contact Invacare/Carrier for further instructions.

Softform®Premier Active 2 MattressesSetup and installation
7
3 Setup and installation
3.1 Safety information
DANGER Electrical shock hazard!
▸Do not remove pump cover.
▸Refer to qualified service personnel.
▸Before performing any maintenance to the power unit,
disconnect the power lead from the wall outlet.
▸Do not insert items into any openings of the control unit.
Doing so may cause fire or electric shock by shorting the
internal components.
▸The control unit must be kept away from all heat sources
and radiators during operation.
▸Connect the equipment to properly grounded three prong
wall outlet using the 5 meter power lead provided with the
product.
▸Grounding reliability depends upon a properly grounded
receptacle (3-prong).
WARNING Risk of entrapment!
Patient entrapment with the bed side rails may cause injury or
death.
Proper patient assessment and monitoring, and proper main-
tenance and use of equipment is required to reduce the risk
of entrapment.Variations in bed rail dimensions, and mattress
thickness, size and density could increase the risk of entrap-
ment.
▸Mattress must fit bed frame and side rails snugly to prevent
patient entrapment. Follow the bed manufacturer’s instruc-
tions.
▸After any adjustments, repair or service and before use,
make sure all attaching hardware is tightened securely. Rails
with dimensions different from the original equipment sup-
plied or specified by the bed manufacturer may not be inter-
changeable and may result in entrapment or other injury.
WARNING
The Softform® Premier Active 2 is recommended to be ins-
talled on medical bed frames with bed sides or assist rails. It is
preferred that the rails to be in the raised position whenever
the patient is on the bed. Healthcare professionals assigned
to each case should make the nal determination whether
side assist rails are warranted after assessing patient risk of
entrapment.
Controls on the footboard may be obstructed by the power
unit on a few bed frames. It may be necessary to relocate the
power unit.
▸Before placing the patient on the bed, check that air hoses
and power cord are clear of moving bed components.
▸Operate all bed frame motorized functions through their
full range of motion to be certain that there is no pulling,
interference or pinching.

Softform®Premier Active 2 Mattresses Usage
8
3.2 Installing the system
▸Place the pump unit at the end of the
bed (preferably hung by the built in pump
hooks).
▸Detach the Softform® Premier Active 2
twin hose from the end of the mattress.
▸Connect it to the pump.
(An automatic click will signify a secure
connection).
▸Connect the mains power lead to the
pump unit and a suitable power supply.
▸Switch on mains power.
▸Switch on pump switch.
System will pressurise (see chart 4.3,page 10)
shown by a green light and three audible
beeps.
▸Correct pressure shown by a green light
and two audible beeps.
4 Usage
4.1 Safety information
▸Remove all packaging before use.
▸Place the mattress directly on the frame of the bed.
WARNING
It is very important for the patient to reposition themselves,
or to be repositioned, on a regular basis.This must be based
on the clinical judgement of a qualied healthcare professional.
This relieves pressure which helps prevent both tissue com-
pression and potential ulcer formation.
▸Always consult a qualified healthcare professional before
using the Softform® Premier Active 2.
▸Monitor the patient frequently.
CAUTION
▸The printed side of the mattress cover must always be
facing upwards.
▸Make sure that the distance between the surface of the
mattress and the top of the side rail should be at least
220 mm.
!IMPORTANT
Medical equipment including infusion pumps and monitors
should be attached to appropriate bed accessories. In do-
mestic settings common causes of damage include cigarette
burns and the claws of pets that puncture covers, allowing
uid ingress and staining.

Softform®Premier Active 2 MattressesUsage
9
!IMPORTANT
▸To prevent accidental cover damage, do not place hypo-
dermic needles, venflons, scalpels or other similarly sharp
objects onto the mattress. Ensure that all venflons are taped
down correctly with no sharp edges exposed.
▸When using bridging boards or other patient transfer aids,
care should be taken not to damage the mattress cover.
All transfer aids should be checked for any sharp edges or
burrs before use as these can damage the mattress cover.
▸Make sure that the mattresses are not jammed or damaged
by sharp edges when used on beds with an adjustable frame.
▸When using the Softform® Premier Active 2 on a profiling
bed ensure that the knee break is used before the backrest.
4.2 CPR Procedure
The Softform® Premier Active 2 mattress has been fully tested to com-
ply with the current CPR standard of 4 – 5 cm compression depth.This
was achieved at all stages of ination/deation.
A report on these ndings conducted by the Resuscitation Unit at the
University Hospital ofWales, Cardiff is available upon request.
▸Hold down Red CPR button.
▸Pull hose connector rmly away from the pump.
▸Switch off the pump.
Mattress will start to deate.
▸When CPR is complete reactivate the system following chapter 3.2,
page 8.

Softform®Premier Active 2 Mattresses Usage
10
4.3 Pump Software Schematic
Language
Pressure
40 50 60 70 80
System Setup
System OK
60mmHg Alarm event
Rotor Failure
Low Pressure
Switch on pump
English
Norsk
Dansk
Svenska
Português
Italiano
Español
Deutsch
Française

Softform®Premier Active 2 MattressesUsage
11
4.4 Pump Menu Display
Task Action Display
1Power up.
▸Switch pump on.
Three audible beeps.
LCD illuminates.
Green light illuminates.
“System setup” displayed.
After 10 minutes “System OK” displayed.
2Menu option ▸Cannot enter menu. Wait until set up is complete
“System OK”.
3
Disconnection of CPR
or
Disconnection of hose
in mattress.
▸Low Pressure alarm.* “Low Pressure” displayed with audible beeps.
4
Enter menu mode.
(3 second time limit
between each func-
tion).
▸Press arrow Up.
then
▸Press arrow down.
“System OK” with “1” underneath.
“System OK” with “2” underneath.
▸Press OK.
“Pressure” displayed.
Pump display will revert back to “System OK” if no
selection made within 15 sec.

Softform®Premier Active 2 Mattresses Usage
12
Task Action Display
5Pressure adjustment.
▸Press OK button to select
Pressure. Default set at “60mmHg“.
▸Arrow up to selected
pressure.
or
▸Arrow down to selected
pressure.
60 ↑70 ↑80mmHg.
60 ↓50 ↓40mmHg.
▸Press OK button. Pressure displayed under “System OK”.
6Follow sequence 4 to
enter Language mode.
▸Toggle from Pressure using
↑or ↓button.
▸Press OK button.
“Language” displayed.
7Language selection
using sequence 6.
▸Toggle from Language using
↑or ↓button to desired
language.
▸Press OK button.
“English“ default.
Available languages, see chapter 4.3, page 10.
* Low Pressure Alarm will only function after the system has gone through full cycle set up (System OK).

Softform®Premier Active 2 MattressesTransport
13
5 Transport
5.1 Safety information
!IMPORTANT
▸Take care when handling mattresses to ensure no damage
to the cover. It is recommended that two people life/carry
mattresses.
▸Avoid contact with jewellery, nails, abrasive surfaces etc.
▸Do not drag mattresses.
▸Avoid contact with wall, door frames, door catches or locks
etc.
▸Do not transport in roll cages unless completely protected
from the sharp edges of the cage.
5.2 Transport Mode
If it is necessary to move the bed or mattress simply.
▸Turn off power supply.
▸Disconnect pump lead (if necessary the air hose).
▸When system is ready to reactivate following
chapter 3.2, page 8.
Air supply hose should be stored by attaching fastener at foot of the
mattress.
6 Maintenance
6.1 Inspection
Check mattresses (foam, air insert and cover) for strike-through
(this may include uid ingress, stains, rips or damage) after the release
of each patient, after ending of the period of use or on a minimum
monthly basis (depending on which occurs rst) by a suitably qualied
and competent person.
Check mattresses
▸Unzip the cover completely.
▸Check for any staining on the white underside of the cover.
▸Check for any staining on the interior foam.
▸Replace any stained items and dispose of as per local authority
procedure.
6.2 Cleaning and Care
!IMPORTANT
All cleaning agents and disinfectants used must be effective,
compatible with one another and must protect the materials
they are used to clean. For further information on decon-
tamination in Healthcare Environments, please refer to ‘The
National Institute for Clinical Excellence’ guidelines on Infec-
tion Control www.nice.org.uk/CG002 and your local infection
control policy.
Cleaning covers
(Removal of contaminants such as dust and organic matter)
▸Remove all covers for laundering.
▸Launder the covers with the recommended temperature between
60 and 80 °C using a diluted detergent solution
(Instructions on label).
!IMPORTANT
Washing at higher temperatures may cause shrinkage.
Drying covers
▸Hang mattress covers from a line or bar and drip dry in a clean
indoor environment.
or
▸Tumble dry on a low heat setting.
!IMPORTANT
▸Tumble dry setting must not exceed 40 °C.
▸Do not tumble dry for longer than 10 minutes.
▸Dry covers thoroughly before re-fitting to the mattress.

Softform®Premier Active 2 Mattresses After-Use
14
Disinfecting covers
(Reducing the number of microorganisms)
Please contact your hygiene specialist in the event of contamination.
!IMPORTANT
Ensure that any residual detergent has been removed prior to
disinfection.
Light soilage
▸Wipe down the cover with a 0.1% Chlorine Solution (1,000 ppm).
▸Rinse the cover with clean water using a single use nonabrasive cloth.
▸Dry the cover thoroughly.
Heavy soilage
Where the mattress is badly soiled, we recommend cleaning with a
dilute cleaning solution at 80 °C in the washing machine.
!IMPORTANT
1% Chlorine Solution used on a regular basis can diminish the
life of the cover if not rinsed and dried properly.
▸Do not use granules.
▸Clean up all spillages of bodily uids i.e. blood, urine, faeces, sputum,
wound exudater and all other bodily secretions as soon as possible
using a 1% Chlorine Solution (10,000 ppm).
iLarge spillages of blood should be absorbed and removed with
paper towels rst and followed by as above.
▸Rinse the cover with clean water using a single use nonabrasive cloth,
and thoroughly dried.
!IMPORTANT
Polyurethane coated fabrics can absorb liquids for short
periods causing a temporary change to the polyurethane
characteristics.The mattress cover swells temporarily and is
more vulnerable to physical damage for a period after it is
completely surface dried, by which time it will revert to its
previous state.
▸Dry the cover thoroughly.
WARNING
▸Remove contaminated foams from use.
CAUTION
▸Keep clear of open heat sources.
!IMPORTANT
▸Do not use phenols, alcohols, bleaches, or other abrasive
materials.
Change covers
▸Unzip the cover and remove it carefully from the foam core.
!IMPORTANT
▸Ensure that the corners of the foam core are positioned
correctly into the corners of the cover. Ensure that the
profiled side of the foam is facing uppermost when packed
into its cover.
▸Then close the zipper.
7 After-Use
7.1 Storage
!IMPORTANT
▸Store mattresses in a dry environment.
▸Store mattresses within a protective cover.
▸Store items in a flat state on clean, dry, off-flooring free from
sharp edges to avoid any possible damage.
▸Never store other items on top of a mattress.
▸Do not store mattresses next to radiators or other heating
devices.

Softform®Premier Active 2 MattressesTroubleshooting
15
7.2 Re-Use
A cleaning record must be kept as part of the cleaning system.
The product is suitable for repeated use.The number of times it can be
used depends on how often and in which way the product is used.
▸Before reuse, clean the product thoroughly, see chapter 6.2, page 13.
7.3 Disposal
The disposal and recycling of used devices and packaging must comply
with the applicable legal regulation.
8 Troubleshooting
Problem / Alarm Cause Solution
Mattress not inating
(not alternating properly).
Mattress hose disconnected. Connect hose connectors, lock them in place.
Air hose kinked or split. Unkink or replace split hose.
Major leak in air cell. Replace leaking air cell.
Has power and fuse is good, control unit does not come on. Send control unit back to factory for repair.
Not alternating, rotor malfunction. Send control unit back to factory for repair.
No air (pump malfunction). Send control unit back to factory for repair.
No power.
Control unit off. Check power source, turn unit on.
Power cord disconnected. Connect power cord and the power source is on.
No power in the power source. Check the power source has power and turn it on.
Power outage. Wait till the power source has power.
Control unit switched on but no power to unit, fuse blown. Consult engineer, refer to service manual.

Softform®Premier Active 2 Mattresses Technical Data
16
9 Technical Data
9.1 General Data
Product Warranty 1) Firetesting Grade ref &
Colour Nominal density ran-
ge [kg/m3]
Nominal
hardness
range [N]
Maximum
user weight
[kg]
Weight of
product
[kg] 2)
SOFTFORM®
PREMIER ACTIVE 2
Cover: 4 years
Foam: 8 years
EN 597-1, 2
BS 7177: Crib 5
RX 39/120 Pink
RX 39/200 Blue
38 – 40
38 – 40
105 – 135
180 – 200 247.6 14
1) Warranty is against manufacturing defects.
2) Based on the weight of a standard size mattress.This can change if different sizes are ordered.
9.2 Pump Unit
Main Supply 220 / 240V AC, 50 Hz
Rated Input Current 1 A
Supply Fuse 1 A
Noise Level < 32 dB
Classication Class 2 Type BF
Cycle Time 10 min
Size 237 mm x 205 mm x 80 mm
Weight 1.75 kg
Air Flow 4 l/min
Operating Pressure 60 mmHg (8 kPa)
Power 10 W
Warranty on pump 24 months
Warranty on air cell insert 24 months

Inhaltsverzeichnis deutsch
1 Allgemeines 18
1.1 Allgemeine Informationen 18
1.2 Symbole 18
1.3 Symbole im Überblick 18
1.4 Garantie 18
1.5 BestimmungsgemäßeVerwendung 19
1.6 Produktbeschreibung 20
1.7 Produktlebensdauer 20
2 Sicherheit 20
2.1 Sicherheitsinformationen 20
3 Einrichtung and Installation 21
3.1 Sicherheitsinformationen 21
3.2 Einstellen des Systems 22
4 Benutzen 23
4.1 Sicherheitsinformationen 23
4.2 Vorgehen bei Herz-Lungen-Wiederbelebung
(HLW) 23
4.3 Pumpen-Software-Übersicht 24
4.4 Menü-Anzeige Pumpenaggregat 25
5 Transport 27
5.1 Sicherheitsinformationen 27
5.2 Transportmodus 27
6 Wartung 27
6.1 Inspektion 27
6.2 Reinigung und Pege 27
7 Nach dem Gebrauch 29
7.1 Lagerung 29
7.2 Wiederverwendung 29
7.3 Entsorgung 29
8 Störungen beheben 30
9 Technische Daten 31
9.1 Allgemeine Daten 31
9.2 Pumpenaggregat 31

Softform®Premier Active 2 Anti-Dekubitus Matratzen Allgemeines
18
1 Allgemeines
1.1 Allgemeine Informationen
Eine hochwertige Pege ist für die Dekubitusprophylaxe und
-therapie von entscheidender Bedeutung. Zum Erfolg eines entspre-
chenden Pegeplans leisten Softform®Premier Active 2-Matratzen
einen wichtigen Beitrag.
Ausbildung, klinisches Urteilsvermögen und Maßnahmenplanung
entsprechend den Gegebenheiten sind zentrale Erfolgsfaktoren für die
Dekubitusprophylaxe und -therapie.
Als formale Methode zur Beurteilung des Risikos für die Entwicklung
eines Dekubitus kann eine Reihe von Beurteilungsskalen (z. B. Braden-
skala etc.) dienen. Diese müssen gemeinsam mit informeller Beur-
teilung (Beurteilung durch qualiziertes Pegepersonal) Anwendung
nden. Die informelle Beurteilung wird als wichtiger erachtet und stellt
den höheren klinischenWert dar.
Beachten Sie alle Hinweise, besonders die Sicherheitsinformationen,
und handeln Sie danach.
Weitere Informationen zu der Invacare®Softform® Premier Active 2
Matratze nden Sie in der Invacare®Softform®Broschüre, Kontaktad-
ressen auf der Rückseite dieser Gebrauchsanweisung.
1.2 Symbole
Warnungen
Warnungen sind in dieser Gebrauchsanweisung mit Symbolen gekenn-
zeichnet. Die Warnsymbole sind neben einer Überschrift abgebildet, die
auf die Gefährlichkeit hinweist.
WARNUNG
Weist auf eine gefährliche Situation hin, die bei Nichtbeach-
tung zu schwerenVerletzungen oder zum Tod führen kann.
VORSICHT
Weist auf eine gefährliche Situation hin, die bei Nichtbeach-
tung zu leichtenVerletzungen führen kann.
!WICHTIG
Weist auf eine gefährliche Situation hin, die bei Nichtbeach-
tung zu Sachschäden führen kann.
Tipps und Empfehlungen
iNützliche Tipps, Empfehlungen und Informationen für eine
efziente und reibungslose Verwendung.
1.3 Symbole im Überblick
Nicht stechen
oder schneiden Auf Leine trocknen
Nicht chemisch
reinigen Konformi- tätserklärung
Von offenem
Feuer fernhalten 80°
80 °C
empfohlen
247.6 kg Maximales
Benutzergewicht
247 kg
Nicht bügeln
Nicht bleichen Wäsche-
trockner bei
geringer
Temperatur
1.4 Garantie
Wir gewähren für das Produkt eine Herstellergarantie gemäß unseren
Allgemeinen Geschäftsbedingungen. Garantieansprüche können aus-
schließlich über den jeweiligen Fachhändler geltend gemacht werden.

Softform®Premier Active 2 Anti-Dekubitus MatratzenAllgemeines
19
Allgemeine Bedingungen von Invacare®
Invacare®übernimmt die Garantie für Ihre Softform® PremierActive 2
Matratze für den, in der Tabelle „Technische Daten“ dieser Gebrauchs-
anweisung, genannten Zeitraum.
Die Garantie für Ihr Invacare®Softform®Produkt ist ab dem Zeitpunkt
desVersands gültig.
Wird ein Mangel oder ein Fehler entdeckt, ist der Invacare®-Händler
oder der örtliche Vertriebsbeauftragte, bei dem das Produkt bezogen
wurde, unverzüglich zu informieren.
Der Hersteller übernimmt keineVerantwortung für Schäden infolge
falscherVerwendung oder Nichtbeachtung der in dieser Gebrauchsan-
weisung aufgeführten Anleitungen.
Während des Garantiezeitraums werden alle Produkte, die Mängel
infolge von Herstellungs- oder Materialfehlern aufweisen, kostenlos
ausgetauscht.
Die Garantie verfällt, wenn am Produkt nicht autorisierte Änderungen
vorgenommen werden.
Sowohl die Garantie als auch die Bescheinigung der Schwerentamm-
barkeit verfallen, wenn mit Invacare®Softform® PremierActive 2
Matratzen Ersatzteile von anderen Herstellern als Invacare®verwendet
werden.
Die gesetzlichen Ansprüche des Käufers im Rahmen desVerbraucher-
schutzes sind davon nicht betroffen.
Qualität und Schwerentammbarkeit
Qualität ist für das Unternehmen entscheidend, alle Abläufe sind nach
den Normen ISO 9001 und ISO 13485 ausgerichtet.
Alle Invacare®Softform® PremierActive 2 Matratzen tragen die CE-
Kennzeichnung in Übereinstimmung mit der Richtlinie über Medizin-
produkte.
Der Schaumstoff und die Bezüge, aus dem die Invacare®Softform®
PremierActive 2 Matratzen hergestellt werden, wurde in unabhängigen
Tests gemäß EN 597-1 und EN 597-2 geprüft und zertiziert.
Die Pumpe wurde gemäß EC-Direktive 89/336/EEC, BS EN 55022 und
EN 61001-1, 2 geprüft. Hergestellt gemäß EN 60601-1.
Bitte wenden sie sich für weitere Informationen an die entsprechende
Invacare®-Niederlassung ihres Landes (Kontaktadressen nden sie auf
der Rückseite dieser Gebrauchsanweisung).
1.5 BestimmungsgemäßeVerwendung
Diese Druckverteilungsmatratze und das Pumpenaggregat sind zur
Verwendung mit einem Bettrahmen entsprechender Größe und inVer-
bindung mit einem Gesamtpegeprogramm zur Dekubitusprophylaxe
und -therapie bestimmt.
Sie können die Anti-Dekubitus-Matratze im statischen Betrieb (ohne
aktivemWechseldrucksystem) sicher zur statischen Druckverteilung
oder im dynamischen Betrieb (mit aktivemWechseldrucksytem) ver-
wenden, wenn dies erforderlich ist.
Dieses Produkt wurde im Hinblick auf eine wirksame Druckentlastung
für Patienten bei normalem Gebrauch entwickelt. Invacare®betrachtet
es als einen normalen Gebrauch, wenn die Liegeäche der Matratze mit
einem Bettlaken aus Baumwolle, Baumwollmischgewebe oder Leinen
bezogen ist und zwischen der Liegeäche der Matratze und dem Benut-
zer kein anderer Gegenstand als ein solches Laken liegt.
Die Invacare®Softform®Premier Active 2 Anti-Dekubitus-Matratze ist
mit aktiverWechseldruckeinheit für die Dekubitusprophylaxe und -the-
rapieeinsatz bis einschließlich Grad bzw. Kategorie IV nach EPUAP (Eu-
ropean Pressure Ulcer Advisory Panel) entwickelt.Wird die Invacare®
Softform®Premier Active 2 Anti-Dekubitus-Matratze ohne aktiver
Wechseldruckeinheit betrieben, ist die Matratze bis einschließlich Grad
bzw. Kategorie III nach EPUAP (European Pressure Ulcer Advisory
Panel) einsetzbar. Kontraindikationen sind nicht bekannt. Die Invacare®
Softform® Premier Active 2 Matratze ist für den Einsatz in Pegebetten
vorgesehen. Bitte beachten Sie die entsprechendenVorgaben gemäß
DIN EN 1970 und DIN EN 60601-2-38.

Softform®Premier Active 2 Anti-Dekubitus Matratzen Sicherheit
20
1.6 Produktbeschreibung
Das Softform®Premier Active 2-Anti-Dekubitus-Matratze dient als
statische Druckverteilungsunterlage/-matratze für Hochrisiko-Patienten,
die durch Inbetriebnahme des Pumpenaggregats über ein effektives
Wechseldrucksystem verfügt, sollte der Zustand des Patienten eine
Wechseldruck-Therapie erfordern.
Der wasserabweisende Bezug bietet eine wasserdampfdurchlässige
Stretchoberäche zur Erhöhung des Patientenkomforts und für eine
optimale Wirksamkeit des Schaumstoffkerns.
Das vollständige System besteht aus:
Einem zwei-schichtigen Schaumstoffmatratzenkern,
einem Wechseldruckzellensystem (zwischen den zweischichtigen
Schaumstoffmatratzenkern gelagert),
Anschlussschläuchen,
einem Pumpenaggregat mit einem Mikroprozessor,
einem Inkontinenz-PU-Vollbezug (atmungsaktiv, wasserundurchlässig,
bielastisch)
und ein 5 m-langes Stromkabel.
1.7 Produktlebensdauer
Die Nutzungsdauer dieser Produkte beträgt schätzungsweise fünf
Jahre, vorausgesetzt, sie werden streng in Übereinstimmung mit dem
in diesem Handbuch beschriebenen Einsatzzweck verwendet und alle
Wartungs- und Serviceanforderungen werden erfüllt. Bei sorgfältigem
Umgang und ordnungsgemäßer Pege sowie unter der Voraussetzung,
dass technische und wissenschaftliche Fortschritte nicht zu technischen
Einschränkungen führen, kann das Produkt länger genutzt werden.
Durch hohe Beanspruchung oder falschen Umgang oder falscheWie-
deraufbereitung kann sich die Nutzungsdauer auch reduzieren.
Die Tatsache, dass wir für diese Produkte eine erwartete Lebensdauer
angeben, begründet keine zusätzliche Garantie.
2 Sicherheit
2.1 Sicherheitsinformationen
WARNUNG
▸Verwenden Sie dieses Produkt oder möglicherweise
vorhandenes Zubehör erst nachdem Sie diese Anweisun-
gen und mögliches zusätzliches Anweisungsmaterial, wie
zu dem Produkt oder dem möglichen Zubehör gehörende
Gebrauchsanweisung, Servicehandbücher oder Merkblätter,
vollständig gelesen und verstanden haben. Invacare-Bedie-
nungsanleitungen erhalten Sie unter www.invacare.de oder
bei Ihrem Händler vor Ort. Falls die Warnungen, Sicher-
heitshinweise und Anweisungen unverständlich sind, wenden
Sie sich bitte an den zuständigen Händler, bevor Sie die
Ausrüstung verwenden.Andernfalls kann es zuVerletzungen
und Sachschäden kommen.
WARNUNG
Die Konstruktion und die Herstellung der Invacare®-Produkte
sind so speziell, dass ausschließlich Invacare®-Zubehör ver-
wendet werden darf. Zubehörteile von anderen Herstellern
sind nicht von Invacare®getestet worden und werden für die
Verwendung mit Invacare®-Produkten nicht empfohlen.
Der Gebrauch von bestimmten Drittanbieterprodukten
zwischen der Matratzenoberäche und dem Patienten kann
die klinische Wirksamkeit dieses Produkts reduzieren oder
verhindern.
Der Begriff „Drittanbieterprodukte“ kann Matratzenauagen,
Kunststofffolien, Schaffell usw. beinhalten, ist jedoch nicht
darauf beschränkt. Beheizbare Bettlaken dürfen nur in Abspra-
che mit einer medizinisch ausreichend qualizierten Person
verwendet werden, da ein Temperaturanstieg das Risiko von
Dekubitus erhöhen kann.