Opera ULTIMATE User manual

User Guide and
Technical Specifications
VISIT OPERABEDS.COM | CALL 0333 222 8584
Enhancing Lives,
Delivering Comfort
OPERA® ULTIMATE
PROFILING MATTRESS

1 | Opera Beds | Opera Ultimate Profiling Mattress User Guide and Technical Specifications | Version 4
1. Explanations of Symbols 2
2. User Instructions 3
3. Maintenance and Inspections 6
4. Safety Instructions 9
5. Technical Specifications 11
6. Guarantee 12
7. Opera Warranty Terms and Conditions 12
Contents

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1. Explanations of Symbols
Read information with this symbol carefully and urgently follow
instructions. This information is safety-relevant.
DANGE R
This symbol indicates general hazards. There is danger to life and health.
Conformity mark in accordance with the European Medical Device
Directives 93/42 EEC amended by 2007/47/EC.
Indoor use only.
This product must be disposed of in a separate refuse collection in the
European Union. Do not dispose of as normal domestic waste.
iRead instructions.
Manufacturer.
Date of Manufacture.
Maximum patient weight.
Conformity mark in accordance with the UK Conformity Assessed.

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2. User Instructions
2.1 Intended Uses
The Opera Ultimate Profiling Mattress is a medical device that is intended to
be used with care beds in residential homes, nursing homes and the domestic
environment as a pressure redistribution mattress. The mattresses are intended
to be used by occupants* weighing up to 280kg/44st 1lb.
The mattress is designed to be used to prevent the development of pressure
ulcers in occupants in the very high risk** category, but it may also be used for
lower risk categories. The mattress can also be used as a mattress to sleep, rest
on and to receive care from.
The mattress can be used in conjunction with profiling care beds, including the
OperaClassic Profiling Beds, the Signature Profiling Beds and the Solo Profiling
Bed collections. Before using the mattress with a care bed, confirm that the
mattress specifications meet the requirements of the care bed.
If the mattress used does not meet the care bed requirements, entrapment and
injury may occur. The mattress may also be used with mattress underlays and fall
prevention systems, always conduct a risk assessment when using the mattress
with other products. Using the mattress with the wrong bed may result in voiding
the warranty terms and conditions.
*The mattress may be used by adults, the elderly and children, subject to a clinicians guidance. The mattress is not
intended to be used by young children or as a cot mattress.
**Indication of use based upon interference pressure readings, this is not a prescriptive criteria. Always defer to a
clinicians judgement, and advice.
2.2 Non Intended Uses
A non-intended use is a use that deviates from the intended purpose and is not
outlined in the Instruction Manual.
Non-intended uses include, but are not limited to the following:
• Loading the mattress beyond the maximum user weight (280kg/44st 1lb).

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• Using the mattress with any devices that will compromise the general safety
and performance requirements of the mattresses.
• Modifying the mattress or mattress cover.
• Using the mattress with a dierent mattress cover or vice versa.
• Using the mattress as an underlay or overlay.
• Using the mattress without it’s cover.
• Using the mattress when the cover or foam is compromised.
Using the mattresses for any of the above uses or a use that is not outlined in this
instruction manual will be regarded as a non-intended use, this may void the
warranty terms and conditions.
2.3 Using the Mattress
The mattress arrives compact rolled, carefully remove the plastic
packaging and unroll. The mattress should be unrolled within 21 days of
receipt. The mattress can be used one hour after unrolling, however it
may take longer before the mattress is fully restored to its original shape.
Before using the mattress for the first time, ensure upon arrival that there
is no damage to the mattress and cover, this includes cuts, tears and
frayed edging. Make sure that once unrolled that the cover seams sit
correctly to the edges of the mattress and that the three zips are fully
closed. Non-compliance may result in fluid ingress through the zips or
openings, this poses a risk of infections.
If the mattress cover is compromised do not use it as this may result
in infection. Take the mattress out of service and inform the person
responsible for the mattress.
Always clean the mattress cover before using it for the first time, and
in between patients. See section 3 on how to maintain and clean the
mattress and cover.
Ensure that the surface of the bed is clear from debris before placing the
mattress onto the bed mattress platform. Not checking this may result in

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damaging/puncturing the cover, allowing fluid ingress to contaminate
the foam core, this poses a risk of infection to the user and any care
givers.
Place the mattress down onto the bed, ensuring that the printed side is
facing up. The audit box should be at the foot end of the bed.
Place a clean, light cotton or linen type bed sheet over the mattress.
Do not use heavy duvets or tightly “tucked in” blankets which may
force additional pressure on the toes leading to damage on the
bony prominences of the heels. The usage of additional waterproof
mattress covers, electric blankets, or other similar items, may reduce the
eectiveness of the pressure reducing properties of the mattress. These
may also lead to an additional increase of body temperature which may
result in skin maceration. Please seek clinical advice should you wish to
use any covering other than cotton or linen bed sheets.
Regular turning is recommended for 2-way turning mattresses such as
the Opera Ultimate Profiling Mattress, to prevent foam fatigue. Regular
turning ensures that weight is distributed evenly across both ends of the
mattress, prolonging its service life.
The cover may be removed for cleaning, please see chapter 3 for further
instructions on how to clean the cover. To remove the cover unzip it
and remove from the mattress. When replacing, ensure that the outer
cover is on the outside and not the inside. Non-compliance may result in
compromising the functions of the cover, this includes the antimicrobial,
waterproof, white substrate and chlorine resistance properties. Non-
compliance may result in serious infection and injury.
The label on this mattress has a unique serial number which should be
used in the event of a warranty claim. Never remove the label.

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2.4 Confirm Compliance
When used with a care bed, make sure that the mattress meets the
requirements of the care bed, failure to do this may result in entrapment
hazards and injury.
When using side rails, the side rail height from the top of the mattress
in an uncompressed condition and the top upper edge of the side rail
must be a minimum of 220mm. Failure to comply may result in creating
entrapment and fall hazards which could result in serious injury.
3. Maintenance and Inspections
3.1 Inspections and Audits
It is recommended that audits occur every 6 months to inspect for signs
of damage. In a community setting audits should also be conducted in
between each change of patient. Mattresses should be cleaned as and
when required.
Inspect the inner and outer surfaces of the mattress covers and inspect
the zips and seams for any signs of damage. Failing to check this may
compromise the features of the mattress cover.
If the cover has been stained, soiled or compromised, the inner mattress
must be examined. The white audit substrate on the inside of the cover
helps to identify any strike through from heavy soiling/fluids. If the cover
is compromised the mattress should be withdrawn from use immediately.
If the foam and cover are compromised the mattress and cover should
be withdrawn from use immediately and replaced. Failure to withdraw
the mattress and cover from use poses a significant risk of infection to
the patient and any carers.

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The Mount Vernon Test should be performed during an audit, patient change or
when there are doubts about the foam condition. The test ensures that the foam
continues to deliver support.
Follow the below steps to perform the Mount Vernon Test on the mattress and
cover: • Adjust the bed platform height so that the top of the mattress is level
with the testers hip.
• Standing at the side of the bed, link both hands to form a fist. Keep
the elbows straight and lean forward, push your fists into the mattress
at the points in Figure 1. If the bed base can be felt at any point, the
mattress has ‘bottomed out’, and should be withdrawn from service
immediately. Failing to observe this instruction may pose a significant
risk of pressure damage to the user.
Mattress surface
Figure 1: Mount Vernon Test points
For further information on how to inspect and audit the mattress, please refer to
the following: Mattresses: Prevention of Cross Infection MDA SN 1999 (31), Medical
Device Alert: All types of bed mattresses MDA/2010/002 and the BHTA guidance
on the care, cleaning and inspection of healthcare mattresses (BHTA Protect,
Rinse and Dry). Always follow your local regulations and guidelines.
3.2 Cleaning and Disinfection
Clean the mattress regularly, and as and when required.
For general cleaning and superficial dirt, use a disposable wipe with a solution
of warm water with neutral detergent. Do not use abrasive or phenologic-based
cleaners.
3.1.1 Mount Vernon Test

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To disinfect in situ, use a 0.1% sodium hypochloride solution (1000 ppm chlorine).
Do not use biological or phenolic-based cleaners. Removable, contaminated
covers should be laundered at 65°C for no less than 10 minutes or at 95°C for no
less than 3 minutes.
Thoroughly rinse and dry the cover before re-use or storage. Store in a cool, dry
area.
Do not mangle or iron.
Spin and tumble-dry at no more than 60°C.
3.3 Storage and Care
• Store the mattress flat – do not fold.
• Do not place heavy objects on the mattress surface when not in use.
• Do not allow sharp objects to penetrate the cover or damage its
coating.
• Keepthemattress clean.
• Regularly inspect the interior and exterior of the mattress.
• Donotstore in dampconditions.
• Store out of direct sunlight.
• Store away from sources of ignition and sources of heat, such as,
radiators, open fires, heaters and electric heaters.
When removing packaging, use great care to ensure the cover is not damaged.
To aid storage and handling, store the mattress in a protective covering. When
removing packaging be careful to not damage or catch the mattress cover.
Always clean the mattress before putting back into service and inspect/audit the
mattress and cover.
3.4 Flammability
The Opera Serene meets the requirements of BS7177:2008 for medium hazard.
The mattress meets the requirements of The Furniture & Furnishings (Fire Safety)
Regulations 1988.

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4. Safety Instructions
4.1 General Safety Instructions
During the briefing, specific attention must be drawn to any potential
dangers for the first time, the instruction manual must be read
conscientiously and in detail by the user / care personnel.
Any incidents or issues must be reported to Opera at, support@
operabeds.com. Serious incidents should be reported to Opera and the
component authority of the member state.
When the mattress is used with a care bed make sure that the mattress
meets the requirements of the care bed, failure to do this may result in
causing entrapment hazards and injury.
When using the mattress with side rails, the side rail height from the top
of the mattress in an uncompressed condition and the top edge of the
side rail must be a minimum of 220mm, failure to comply may result in
injury caused by entrapment or falls.
If the cover is compromised the mattress should be withdrawn from use
immediately, if the foam and cover are compromised the mattress and
cover should be withdrawn from use immediately and replaced. Failure
to withdraw the mattress and cover from use poses a significant risk of
infection to the patient and any carers.
Do not pierce or compromise the mattress cover, this will compromise the
foam and poses a significant risk of infection to the user and any carers.
Do not use the mattress without the mattress cover, failing to observe
this warning will compromise the infection and control properties of the
mattress, this may result in the development of infections, sores, and
other alignments.
Do not store the mattress near heating devices such as electrical fires,
radiators, or sources of heat, this may result in fire leading to serious
injury, property damage and death.
i

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Avoid contact with sharp objects and abrasive surfaces etc. Do not drag
mattresses, failure to observe this may result in compromising the cover
and foam mattress.
The mattress is not designed for use in a mental health facility, or by
those at risk of vandalising the mattress, using the mattress in this
environment may result in vandalism and the creation of hazardous
situations which may lead to injury, property damage and death.
Do not smoke around or on the mattress, this is a common cause of
fires. Failure to observe this warning may result in severe injury, property
damage and death.
Keep the cover away from young children when not in use, openings can
result in asphyxiation and death.
If the bed base can be felt, the mattress has ‘bottomed out’ and should
be withdrawn from use immediately. Failing to observe this warning may
pose a risk of pressure damage to the user.
When used with a profiling bed, ensure that the mattress is fitted into the
mattress retainers. Failure to do this may result in the mattress moving,
this may result in shear and friction to the users skin which can pose a risk
of pressure ulcer development.
4.2 Service Life and Disposal
The service life of the mattress and cover is dependent upon the manner
of use. The service life may be exceeded if the product is carefully used
and maintained. It may also be significantly reduced by incorrect and/
or significant use. When the service life ends do not dispose as normal
domestic waste, please contact your local waste recycling facility for
further guidance on safe disposal.
To put the mattress back into service conduct an audit on the mattress
and mattress cover as advised in section 3.
It is advised that a cleaning and service record is kept. Always clean the
mattress in between patients and as and when required in accordance
with local guidelines and this instruction manual.

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5. Technical Specifications
5.1 Technical Data
Specifications for the Serene Profiling Mattress
Specifications 3ft 3ft 6’ 4ft
Maximum User
Weight 280kg/44st 1lb
Depth 150mm/6”
Length 1980mm/78”
Width 890mm/35” 1050mm/41.3” 1200mm/47.2”
Weight offoam 12kg 13.5kg 15kg
FoamType Castellated SB40/145 CMHR and SB38/200 CMHR foam
Turn Cycles 2
Warranty 1 year
Mattress Cover
Multistretch cover
with white substrate Yes
Antimicrobial cover
Yes*
*Tested in a group test against Aspergillus niger &
Staphylococcusaureus
Moisture Vapour
Permeable Yes
Cover Material PU coated Nylon
Chlorineresistance 1% (10,000ppm)
Zips 3 sides with fluid ingress prevention overlaps
Seam type HFwelded
Machine washable <95°C
Water resistance Yes
Weight of cover
(Approx.) 1.2kg 1.32kg 1.48kg
Warranty 4 years, reducing in value by 25% per year

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5.2 Classification
Medical Device Class (Under MDR
2017/745 & MDD 93/42 EEC) Class I
CRIB Rating BS7177:2008 - Crib 5 (Ignition source 5)
Treatment/PreventionRiskCategory High/VeryHighRisk
5.3 Storage and Transport
Storage and Transport Conditions
Store the mattress in a dry, dark, clean environment, do not store near heating
appliances such as radiators, open fires or electrical fires. Do not drag the mattress
when transporting.
6. Guarantee
As stated in the Warranty Terms and Conditions, below, Opera provides a
manufacturer’s warranty of 1 year for the mattress and 4 years, reducing by 25%
per year, for the mattress cover from the date of purchase.
7. Opera Warranty Terms and
Conditions
7.1 Warranty Terms
7.1.1 Subject to the terms and conditions set out below, Opera agrees to repair or
replace the product within the United Kingdom at its own cost, and any Opera
accessory supplied with it, purchased by you from Opera. In circumstances
where the product does not perform in accordance with Opera’s specifications
during the warranty period of 4 years, commencing on the date of delivery (or
deemed delivery) of the product.

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7.1.2 This contractual product warranty does not operate to limit rights under the
statutory warranties referred to in clause 7.3.1 below.
7.2 Warranty Conditions
7.2.1 Proof of purchase (invoice) must be provided when requesting service under
warranty.
7.2.2 Opera requires any customer requesting service under the warranty to
comply with directions from Opera sta in relation to troubleshooting any issue
and facilitating any repair or replacement under these Warranty Terms and
Conditions.
7.2.3 The customer is responsible for inspecting all goods received from Opera
upon arrival. In instances where goods have been damaged in transit, the
customer must report this to Opera within 3 working days of receipt of the
product. Failure to report physical damage on arrival within 3 working days of
receipt may result in denial of warranty for physical damage.
7.2.4 Opera reserves the right to replace the product or relevant part with the
same or equivalent product or part, rather than repair it. Where a replacement
is provided, Opera will determine, in its discretion, the closest product within
the current range of products oered by Opera with which to replace the faulty
or damaged product. The replacement product may dier with the replaced
product in size and specifications, at the reasonable election of Opera. Opera
may replace parts with refurbished parts. Replacement of the product or a part
under the warranty does not extend or restart the warranty period.
7.2.5 If Opera is unable to repair or replace the product, the customer will be
provided with credit for Opera products or may be refunded the price of the
product (at Operas election). This credit or refund will be for the amount of the
purchase price of the product, excluding the associated delivery cost.
7.2.6 In the event that a replacement, refund, or store credit is provided as per
section 7.2.5, the faulty item will become the property of Opera.
7.2.7 Opera may seek reimbursement of any costs incurred by you where the
product is found to be in good working order.

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7.2.8 Opera reserves reasonable discretion to determine whether any product
is or is not performing in accordance with Opera specifications, subject to
applicable law.
7.3 General
7.3.1 Legislation may imply warranties, conditions or imposes obligations on
Opera, which cannot be excluded, restricted or modified in relation to consumer
goods.
7.3.2 To the full extent permitted by law, but subject always to clause 7.3.1, the
warranty will not apply in respect of a product:
(a) If the product has not been installed, operated, maintained or used in
accordance with the Opera instructions or specifications provided with the
product;
b) If the factory-applied serial number has been altered or removed from the
product;
(c) To damage, malfunction or failure resulting from alterations, accident, misuse,
abuse, fire, liquid spillage, mis-adjustment of customer controls, use on an
incorrect voltage, power surges and dips, thunderstorm activity, force majeure,
voltage supply problems, tampering or unauthorised repairs by any persons,
use of defective or incompatible accessories, exposure to abnormally corrosive
conditions or entry by any insect, vermin or foreign object in the product.
(d) To damage arising during transportation, installation or while moving the
product or to any transportation costs of the product or any parts thereof to
and from the customer, unless otherwise specified in these warranty terms and
conditions;
(e) To any third-party software or hardware not contained in the product as
originally configured by Opera.
(f) To any failure, to the extent that the failure is not a failure of the product to
perform in accordance with its specifications.
(g) To service of any product whilst it is outside the United Kingdom.

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7.3.3 To the full extent permitted by law, but subject always to clause 7.3.1:
(a) Opera will not be liable for any loss, damage or alterations to third party
products, no matter how occurring; or for any loss or damage arising from loss of
use, loss of profits or revenue, or for any resulting indirect or consequential loss of
damage.
(b) Opera’s aggregate liability in respect of all claims under the warranty shall
not exceed the original purchase price of the product or, at Opera’s option, the
replacement of the product with a like or similar product.
(c) Opera excludes all other warranties, conditions, terms, representations and
undertakings whether express or implied.

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Notes

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Notes

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Notes

19 | Opera Beds | Opera Ultimate Profiling Mattress User Guide and Technical Specifications | Version 4
Azure House, Connaught Road, Kingswood, Hull, HU7 3AP
03332228584 | [e-mail] | operabeds.com
Version 4 | Published in August 2022