Arjo TheraRest Series User manual

P/N 205559-AH Rev 4 • 12/2019
TheraRest
INSTRUCTIONS FOR USE
Mattress Replacement System
Bedienungsanleitung · Gebruiksaanwijzing · Istruzioni per l’uso · Mode d’emploi ·
Instrucciones de uso
EN · DE · NL · IT · FR · ES

WARNING
To avoid injury, always read this Instructions For
Use and accompanied documents before using
the product.
Mandatory to read the Instructions For Use.
Design Policy and Copyright
® and ™ are trademarks belonging to the Arjo group of companies.
© Arjo 2019.
As our policy is one of continuous improvement, we reserve the right to
modify designs without prior notice. The content of this publication may not
be copied either whole or in part without the consent of Arjo.

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Contents
Introduction........................................................................................................4
Intended use........................................................................................................ 4
Indications... ........................................................................................................4
Contraindications................................................................................................. 4
Risks and Precautions......................................................................................... 4
Safety Information... ............................................................................................5
Serious Incident .................................................................................................. 7
Preparation for Use ...........................................................................................8
Mattress Installation.............................................................................................8
Inspection... .........................................................................................................9
Patient placement and nursing care.............................................................. 10
CPR...................................................................................................................10
Skin Care........................................................................................................... 10
Incontinence / Drainage..................................................................................... 11
General Operation............................................................................................. 11
Care and Cleaning........................................................................................... 12
Preventive Maintenance Schedule.................................................................14
Daily Cleaning... ................................................................................................14
Inspection / System Check-Out......................................................................... 14
Troubleshooting .............................................................................................. 14
7HFKQLFDOVSHFL¿FDWLRQV .................................................................................15
Labels ...............................................................................................................16
Replacement parts ..........................................................................................17

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Introduction
Intended use
The TheraRest™ Mattress Replacement System (MRS) family of products
provide a range of pressure reduction foam mattresses.
Perimeter Plus™ - An advanced technology foam mattress that
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Perimeter Plus™ VE - Foam mattress incorporates visco-elastic foam as a
top comfort layer. By combining the standard features of the Perimeter Plus
mattress with a visco-elastic topper the Perimeter Plus VE mattress is a
premier choice for high-performance, pressure-reducing mattresses.
Indications
TheraRest MRS family of products is indicated for the early intervention and
prevention of pressure ulcers on low-risk patients.
or
For patients seeking improved comfort.
Contraindications
None.
Risks and Precautions
Transfer – Precaution should be taken during patient transfer, including the
locking of caster wheels.
Side Rails and Patient Restraints
WARNING
Use or non-use of restraints, including Side Rails, can be
critical to patient safety. Serious injury or death can result
from the use (potential entrapment) or non-use (potential
patient falls) of Side Rails or other restraints. See related Safety
Information.

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Patient Migration – Specialty surfaces have different shear and support
characteristics than conventional surfaces and may increase the risk of
patient movement, sinking and /or migration into hazardous positions of
entrapment and / or inadvertent bed exit.
Skeletal Traction or Unstable Fracture (if not contraindicated) – With
skeletal traction, unstable pelvic fracture, or any other unstable fracture
(to the extent not contraindicated), maintain physician directed angle of
articulation and guard against risks of patient migration.
Safety Information
Patient Entrance / Exit – Caregiver should always aid patient in exiting the
bed. Make sure a capable patient knows how to get out of bed safely (and, if
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Bed Frame - Always use a standard healthcare bed frame with this
TheraRest mattress, with any safeguards or protocols that may be
appropriate. Bed frame and side rails (if used) must be properly sized
relative to the mattress to help minimize any gaps that might entrap a
patient’s head or body. It is recommended that bed and side rails (if used)
comply with all applicable regulations and protocols.
Brakes – Caster brakes should always be locked once the bed is in
position. Verify that the wheels are locked before any patient transfer to or
from the bed.
Side Rails / Patient Restraints – Whether and how to use side rails or
restraints is a decision that should be based on each patient’s needs and
should be made by the patient and the patient’s family, physician and
caregivers, with facility protocols in mind. Caregivers should assess risks
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falls from the bed) in conjunction with individual patient needs, and should
discuss use or non-use with patient and / or family. Consider not only the
clinical and other needs of the patient but also the risks of fatal or serious
NOTE
Monitor patients frequently to guard against patient entrapment.

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injury from falling out of bed and from patient entrapment in or around the
side rails, restraints or other accessories. In the US, for a description of
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reduce entrapment risks, refer to FDA’s Hospital Bed System Dimensional
and Assessment Guidance To Reduce Entrapment. Outside the US,
consult the local Competent Authority or Government Agency for Medical
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confused, restless or agitated patients. It is recommended that side rails (if
used) be locked in the full upright position when the patient is unattended.
Make sure a capable patient knows how to get out of bed safely (and, if
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Monitor patients frequently to guard against patient entrapment.
Bed Height – To minimize the risk of falls or injury the bed should always
be in the lowest possible position when the patient is unattended.
Head of Bed Elevation – Keep head of bed as low as possible to help
prevent patient migration.
Skin Care – Monitor skin conditions regularly, especially at bony
prominences and areas where moisture or incontinence may occur or
collect and consider adjunct or alternative therapies for high acuity patients.
Early intervention may be essential to preventing serious skin breakdown.
Avoid Fire Hazards ±7RPLQLPL]HULVNRI¿UHUHYLHZDQGIROORZ)'$¶V
Safety Tips for Preventing Hospital Bed Fires.
No Smoking in Bed – Smoking in bed can be dangerous. To avoid the risk
WARNING
When selecting a standard mattress, ensure the distance
between the top of side rails (if used) and top of mattress
(without compression) is at least 8.66 in (220 mm) to help
prevent inadvertent bed exit or falls. Consider individual patient
size, position (relative to the top of the side rail) and patient
condition in assessing fall risk.

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General Protocols – Follow all applicable safety rules and institution
protocols concerning patient and caregiver safety.
CPR - Level the bed. Lower side rails and initiate CPR per facility protocols.
Consider use of a backboard if indicated. After CPR remove the backboard,
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placement.
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when the cover is removed. It is recommended that Personal Protective
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barrier exposed to avoid contact with loose particles. To ensure optimal
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Serious Incident
If a serious incident occurs in relation to this medical device, affecting
the user, or the patient then the user or patient should report the serious
incident to the medical device manufacturer or the distributor. In the
European Union, the user should also report the serious incident to the
Competent Authority in the member state where they are located.
End of life disposal
Fabric material used on the mattresses or any other textiles, polymers or
plastic materials etc. should be sorted as combustible waste.
Mattresses at the end of life should be disposed of as waste according to
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NOTE
For safety information concerning the bed frame refer to the
manufacturers’ User Guide.

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Preparation for Use
1. Open shipping container.
2. Remove the mattress from the plastic protective cover.
3. Check the mattress surface for tears or cracking; do not use if tears or
cracks are present.
4. If re-installing mattress onto a new frame or for a new patient, check
mattress surface for staining and soiling; clean and / or disinfect as
required (see Care and Cleaning).
5. Level bed and lock brakes
6. Remove the existing mattress from the bed frame, if applicable.
Mattress Installation
1. Position the mattress on the bed frame with the logo facing up and
product information tags at the foot end of the bed.
2. Ensure there are no gaps between the mattress and the bed frame or
the side rails.
CAUTION
Do not use sharp instruments to open boxes. Damage to
mattress could result.
NOTE
For the TheraRest SMS Perimeter Plus VE models; if stored
below room temperature make sure mattress is at room
temperature before proceeding to the next step.
NOTE
The mattress cover may appear wrinkled when unpacked. To
remove wrinkles, allow mattress up to 24 hours to accommodate;
see Troubleshooting for more information. Wrinkles will not
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needed.

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Inspection
• Check the product surface for staining and soiling, clean and / or
disinfect as required.
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tears or cracks are present.
• If the mattress cover was recently replaced, ensure that the foam
is installed correctly in the new cover, with the top of the foam (i.e.,
contoured surface or 6.4 cm (2.5 inches) topper foam) towards the
purple top cover and the sloped foam surface toward the foot end.
CAUTION
Always use a standard healthcare bed frame with safeguards or
protocols that may be appropriate. Frame and side rails must be
properly sized relative to the mattress to help minimize any gaps
that might entrap a patient’s head or body.

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Patient placement and nursing care
It is recommended that all sections of this User Guide be read prior to
product use. Carefullyreview the Contraindications, Safety Information
and Risks and Precautions sections prior to placing a patient on any
TheraRest MRS.
1. Transfer the patient following all applicable safety rules and institution
protocols.
2. Center patient side-to-side and head-to-foot on TheraRest surface.
3. Ensure that all sections of the mattress fully support the patient.
CPR
1. Level the bed.
2. Lower or remove the side rail on the caregiver’s side if necessary.
3. Begin CPR as per facility protocol. Consider use of the backboard if
indicated.
4. After CPR is performed:
• Remove the backboard if used.
• Raise or install the side rail as necessary.
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Skin Care
• Remove excess moisture and keep skin dry and clean.
• Check the patient’s skin regularly, particularly in areas where
incontinence and drainage occur.
• Ensure linens under the patient are not wrinkled.
CAUTION
Mattress handles are for mattress transport only.

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Incontinence / Drainage
• Use moisture-impermeable underpads for incontinent patients.
• Wipe surface clean and replace the bed linens as required (see “Care
and Cleaning” on page 12).
General Operation
Avoid contact of sharp instruments with TheraRest MRS.

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Care and Cleaning
The following process is recommended, but should be adapted to comply
with local institution protocols. If you are uncertain, you should seek advice
from your local Infection Control Specialist. TheraRest MRS should be
routinely decontaminated between patients and at regular intervals while in
use.
Fire Barrier
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removed. It is recommended that Personal Protective Equipment (PPE) is
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contact with loose particles. To ensure optimal product performance, avoid
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be replaced if soiled or damaged.
Cover Cleaning Options
Sewn TheraRest MRS (Top cover cannot be removed from base)
1. Remove or push the bed linens to the center of the mattress.
2. Wipe and rinse any soiling from the mattress surface and base. Use
1000 ppm chlorine or 70% alcohol.
3. Rinse with a wet towel to remove chemicals.
CAUTION
Do not use Phenol-based solutions or abrasive componds or
pads on the cover during decontamination process as these will
damage the surface coating. Do not boil or autoclave the cover.
Covers should be wiped down immediately after it has been
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CAUTION
The sewn TheraRest MRS cover is cleaned by wipe down
methods only. Do not launder as damage to the base may occur.

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4. After wipe down, dry the surface with a towel.
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6. Clean pump and tubes (if needed) by wiping with a damp cloth.
RF Welded TheraRest MRS (Detachable top cover)
1. Push the bed linens to the center of the mattress to wipe down, remove
to launder the top cover or wipedown as described below.
2. Wipe and rinse any soiling from the mattress surface and base. Use
1000 ppm chlorine or 70% alcohol.
3. Rinse with a wet towel to remove chemicals.
4. After wipe down, dry the surface with towel.
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Laundering Detachable Top Cover
1. Unzip the top cover from the base for laundering. Do not launder base
as damage may occur.
2. Recommended wash temperature for top cover is 60° C (140° F) for 15
minutes.
3. Maximum wash temperature is 95° C (203° F) for 15 minutes.
4. Tumble dry at 60° C (140° F) or air dry.
5. Maximum drying temperature 80° C (176° F).
CAUTION
RF Welded TheraRest MRS has a detachable top cover that
can be laundered. However the base is cleaned by wipe down
methods only. Do not launder the base as damage may occur.

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Preventive Maintenance Schedule
Preventive maintenance for TheraRest consists of regular cleaning (see
Care and Cleaning) and an overall system check-out to be performed at the
intervals described below.
All components must be cleaned, disinfected and inspected after each
patient’s use and before use by a new patient. Always use standard
precautions, treating all used equipment as contaminated. Institutions
should follow local protocols for cleaning and disinfection.
Daily Cleaning
The cover should be wiped daily with a mild soap and water solution. After
wipe down, dry the surface with a towel.
Inspection / System Check-Out
Check each of the following before placing TheraRest MRS with a new
patient:
1. Check the mattress surface for tears or cracking; do not use if tears or
cracks are present.
2. Ensure the mattress is free of stains and is not overly faded.
Troubleshooting
Do not attempt troubleshooting outside this guide or where the solution
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alteration or misuse may lead to serious injury and / or product damage and
will void all applicable warranties.

15
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WEIGHT
Maximum recomended patient
weight* 158,8 kg (350lb)
TheraRest Perimeter Plus 15 kg (33lb)
based on 35 in x 80 in x 7 in MRS
TheraRest Perimeter Plus VE 15.9 kg (35lb)
based on 35 in x 80 in x 7 in MRS
* Patient weight capacity may vary depending on frame use. Please consult frame
manufacturer.
DIMENSIONS
Minimum lenght 190,5 cm (75 in)
Maximum lenght 213 cm (84 in)
Minimum width 81.5 cm (32 in)
Maximum widht 96 cm (38 in)
Height 17.78 cm (7 in)
Dimensions varie depending on model.
Additional sizes are available Width 1.3 cm (0.5 in) increments, Length 2.5 cm (1 in)
increments.

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SYMBOL EXPLANATION
Wash at 60°C, 95°C Max
for 15 minutes
60°C
Max 80°C
Tumble Dry at 60°C, 80°C
Max
Do not iron Wipeable surface
Maximum Patient Weight PHENOL Do not use Phenol-based
cleaning solutions
Consult Instructions For
Use Foot end
CE marking indicating
conformity with European
Community harmonised
legislation
Labels

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Replacement parts
Replaceable TheraRest components are listed below. For more informa-
tion such as pricing or additional spare parts that are not on this list, please
contact your local Arjo representative.
TheraRest mattress components
FOAM SHELLS CATALOGUE NUMBER
TheraRest Perimeter Plus foam shell KTP-FC (specify size)
TheraRest Perimeter Plus VE foam shell KTV-FC (specify size)
FIRE BARRIER LINING CATALOGUE NUMBER
7KHUD5HVW9(¿UHEDUULHUOLQLQJ FBL-MILLIKEN
THERAREST MATTRESS COVERS CATALOGUE NUMBER
Complete Cover, BarrierFlex Top,
Non-Skid Black Bottom, with handles
TRCBFNB(WWWLL)PXS
Complete Cover, BarrierFlex Top,
Non-Skid Black Bottom, no handles
TRCBFNH(WWWLL)PXS
Complete Cover, SoFlux Top,
Non-Skid Black Bottom, with handles
TRCSONB(WWWLL)NXS
Complete Cover, SoFlux Top,
Non-Skid Black Bottom, no handles
TRCSONH(WWWLL)NXS
Complete Cover, SoFlux Top,
Vinyl Grey Bottom, with handles
TRCSOVG(WWWLL)NXS
Complete Cover, SoFlux Top,
Vinyl Grey Bottom, no handles
TRCSOVH(WWWLL)NXS
Complete Cover, Premium RF Welded
Top, Non-Skid PU Bottom, with handles
TRCPRPU(WWWLL)NXS
Table continues on the next page

18
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THERAREST MATTRESS COVERS CATALOGUE NUMBER
Complete Cover, Premium RF Welded
Top, Non-Skid PU Bottom, No handles
TRCPRPN(WWWLL)NXS
Top Cover, Premium RF Welded Top TRCPRXX(WWWLL)NXS
Base Cover, Non-Skid PU, with handles TRCXXPU(WWWLL)NXS
Base Cover, Non-Skid PU Bottom, no
handles
TRCXXPN(WWWLL)NXS

WARNUNG
Zur Vermeidung von Verletzungen lesen Sie
diese Bedienungsanleitung und die beigefügten
Dokumente, bevor Sie das Produkt verwenden.
Bedienungsanleitung unbedingt lesen!
Design-Richtlinie und Urheberrecht
® und ™ sind Marken der Arjo Unternehmensgruppe.
© Arjo 2019.
Da kontinuierliche Verbesserung unser Firmengrundsatz ist, behalten wir uns das
Recht vor, Designs ohne vorherige Ankündigung zu verändern. Der Nachdruck
dieser Schrift, auch auszugsweise, ist ohne die Genehmigung von Arjo verboten.

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Inhalt
Einführung .......................................................................................................21
Verwendungszweck...........................................................................................21
Indikationen... ....................................................................................................21
Kontraindikationen............................................................................................. 21
Risiken und Vorsichtsmaßnahmen....................................................................21
Sicherheitshinweise........................................................................................... 22
Schwerwiegender Vorfall ..................................................................................24
Vorbereitung für den Einsatz.......................................................................... 25
Anbringung des Matratzensystems... ................................................................25
Inspektion... .......................................................................................................26
/DJHUXQJXQG3ÀHJHGHV3DWLHQWHQ ..............................................................27
CPR (kardiopulmonale Reanimation)................................................................ 27
+DXWSÀHJH ......................................................................................................27
Inkontinenz/Drainage.........................................................................................28
Allgemeine Bedienung.......................................................................................28
3ÀHJHXQG5HLQLJXQJ......................................................................................29
Zeitplan für die vorbeugende Wartung.......................................................... 31
Tägliche Reinigung............................................................................................ 31
Inspektion/Systemprüfung................................................................................. 31
Fehlerbehebung...............................................................................................31
Technische Daten............................................................................................32
Gefahrgutklasse ..............................................................................................33
Ersatzteile.........................................................................................................34