Arjo TheraRest User manual

04�TR�00_INT1_02 • 10/2022
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

EN
WARNING
To avoid injury, always read this Instructions for
use and accompanied documents before using the
product.
Design Policy and Copyright
® and ™ are trademarks belonging to the Arjo group of companies.
© Arjo 2022.
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
End of life disposal ���������������������������������������������������������������������������������������������8
Preparation for Use .......................................................................................... 9
Mattress Installation������������������������������������������������������������������������������������������10
Inspection ���������������������������������������������������������������������������������������������������������10
Patient placement and nursing care............................................................. 11
CPR������������������������������������������������������������������������������������������������������������������ 11
Skin Care���������������������������������������������������������������������������������������������������������� 11
Incontinence / Drainage������������������������������������������������������������������������������������12
General Operation��������������������������������������������������������������������������������������������12
Care and Cleaning..........................................................................................13
Fire Barrier��������������������������������������������������������������������������������������������������������13
Cover Cleaning������������������������������������������������������������������������������������������������� 13
Preventive Maintenance Schedule................................................................15
Daily Cleaning �������������������������������������������������������������������������������������������������� 15
Inspection / System Check-Out������������������������������������������������������������������������15
Troubleshooting ............................................................................................. 15
Technical specications ................................................................................16
Labels ..............................................................................................................17
Replacement parts ......................................................................................... 18

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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 incorporates a
rm side perimeter and a sloped heel section.
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 di󰀨erent 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
necessary, how to release the side rails) in case of re or other emergency.
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 and benets of side rail /
restraint use (including entrapment and patient falls from the bed) in conjunction
with individual patient needs, and should discuss use or non-use with patient
NOTE
Monitor patients frequently to guard against patient entrapment.

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and / or family� Consider not only the clinical and other needs of the patient but
also the risks of fatal or serious 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 entrapment hazards, vulnerable patient prole and guidance to
further 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 Device Safety
for specic local guidance. Consult a caregiver and carefully consider the use
of bolsters, positioning aids or oor pads, especially with 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 necessary, how to release the side
rails) in case of re or other emergency. 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�
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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Avoid Fire Hazards – To minimize risk of re, review and follow FDA’s Safety
Tips for Preventing Hospital Bed Fires�
No Smoking in Bed – Smoking in bed can be dangerous. To avoid the risk of re,
smoking in bed should never be allowed�
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, if
used, raise siderails and recongure bed and accessories as in initial placement.
Fire Barrier Contact - Care should be taken with regards to the re barrier when
the cover is removed. It is recommended that Personal Protective Equipment
(PPE) is used during handling of the mattress with the re barrier exposed to
avoid contact with loose particles� To ensure optimal product performance, avoid
over-handling of the re barrier and handle with care. If the re barrier becomes
damaged or soiled it should be replaced�
Serious Incident
If a serious incident occurs in relation to this medical device, a󰀨ecting 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�
NOTE
For safety information concerning the bed frame refer to the
manufacturers’ User Guide.

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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 the
national or local requirements which may be landll or combustion.

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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�
CAUTION
Do not use sharp instruments to open boxes. Damage to mattress
could result.
NOTE
For the TheraRest MRS 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 a󰀨ect
ination or function, mattress may be used immediately if needed.
Preparation for Use

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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�
Inspection
• Check the product surface for staining and soiling, clean and / or disinfect as
required.
• Check the product surface for tears or cracking, do not use if signicant 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 teal blue 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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It is recommended that all sections of this User Guide be read prior to product
use� Carefully review 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�
• Recongure the bed and accessories as in initial placement.
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.
Patient placement and nursing care

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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 13)�
General Operation
Avoid contact of sharp instruments with TheraRest MRS�

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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
Care should be taken with regards to the re barrier when the cover is removed.
It is recommended that Personal Protective Equipment (PPE) is used during
handling of the mattress with the re barrier exposed to avoid contact with loose
particles� To ensure optimal product performance, avoid over handling of the
re barrier and handle with care. The re barrier should be replaced if soiled or
damaged�
Cover Cleaning
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�
CAUTION
Do not use Phenol-based solutions or abrasive compounds 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 exposed to uids or spills.
CAUTION
The sewn TheraRest MRS cover is cleaned by wipe down methods
only. Do not launder as damage to the base may occur.
Care and Cleaning
Continue with the steps on next page

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3� Rinse with a wet towel to remove chemicals�
4� After wipe down, dry the surface with a towel�
5� Ensure the bed linens are retted and not wrinkled under the patient.
6� Clean pump and tubes (if needed) by wiping with a damp cloth�

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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
recommends to contact Arjo. Any unauthorized service, modication, alteration
or misuse may lead to serious injury and / or product damage and will void all
applicable warranties�
Preventive Maintenance Schedule

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Technical specications
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�
THERAREST
MATTRESS
CATALOGUE
NUMBER
DIMENSIONS (mm/in)
Width Length Height
TheraRest MRS
Perimeter Plus™ TRMRLNB35080TEG 880/35 2020/80 180/7
TheraRest MRS
Perimeter Plus™ TRMRLNB35084TEG 880/35 2140/84 180/7
TheraRest MRS
Perimeter Plus™ VE TVMRLNB35080TEG 880/35 2020/80 180/7
TheraRest MRS
Perimeter Plus™ TRMRLNB34078TEG 860/34 1980/78 180/7
FOR SWISS MARKET ONLY
TheraRest MRS
Perimeter Plus™ TRMRLNB35080CHG880/35 2020/80 180/7
TheraRest MRS
Perimeter Plus™ TRMRLNB35084CHG880/35 2140/84 180/7
TheraRest MRS
Perimeter Plus™ VE TVMRLNB35080CHG880/35 2020/80 180/7
TheraRest MRS
Perimeter Plus™ TRMRLNB34078CHG860/34 1980/78 180/7

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SYMBOL EXPLANATION
Do not wash Do not tumble dry
Do not iron Wipeable surface
Maximum Patient Weight PHENOL Do not use Phenol-based
cleaning solutions
Operating instructions -
Consult Instructions for use
Foot end
CE marking indicating
conformity with European
Community harmonised
legislation
Indicates the product is a
Medical Device according to
EU Medical Device Regulation
2017/745
Unique device identier
Labels
UK SYMBOL EXPLANATION
This section is only applicable to United Kingdom (UK) market when UK
marking is applied to the Arjo medical device labelling�
UK marking indicating conformity with UK Medical
Devices Regulations 2002 (SI 2002 No 618, as
amended)
UK Responsible Person & UK Importer:
Arjo (UK) Ltd, ArjoHuntleigh House, Houghton Regis. LU5 5XF
Is the appointed UK Responsible Person as dened in UK Medical Devices
Regulations 2002 (SI 2002 No 618, as amended)�
For Northern Ireland (NI) CE marking will still apply until further amendment
to applicable regulations�

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Replacement parts
Replaceable TheraRest components are listed below� For more information 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 TRFXXXX35080XXX
TRFXXXX35084XXX
TheraRest Perimeter Plus VE foam shell TVFXXXX35080XXX
TheraRest Perimeter Plus foam shell TRFXXXX34078XXX
FIRE BARRIER LINING CATALOGUE NUMBER
Fire barrier lining 633180
THERAREST MATTRESS COVERS CATALOGUE NUMBER
Complete Cover, Reliant Top, Non-Skid Black
Bottom, with handles
TRCRLNB35080TXG
Complete Cover, Reliant Top, Non-Skid Black
Bottom, with handles
TRCRLNB35084TXG
Complete Cover, Reliant Top, Non-Skid Black
Bottom, with handles
TVCRLNB35080TXG
Complete Cover, Reliant Top, Non-Skid Black
Bottom, with handles
TRCRLNB34078TXG

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Intentionally left blank

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WARNUNG
Zur Vermeidung von Verletzungen lesen Sie diese
Bedienungsanleitung und die beigefügten Dokumente,
bevor Sie das Produkt verwenden.
Design-Richtlinie, Urheberrecht
® und ™ sind Marken, die zur Arjo Unternehmensgruppe gehören.
© Arjo 2022.
Wir streben nach kontinuierlicher Verbesserung und behalten uns aus diesem Grund das
Recht vor, Designs ohne vorherige Ankündigung zu ändern. Der Nachdruck dieser Schrift,
auch auszugsweise, ist ohne die Genehmigung von Arjo verboten.