Opera MAM001-30 User manual

Instructions and Technical
Specifications
VISIT OPERABEDS.COM | CALL 0333 222 8584
Enhancing Lives,
Delivering Comfort
OPERA®F L O A I R
MATTRESS SYSTEM

1 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
Contents
1. Explanation of Symbols 3
2. Safety Precautions 4
3. Warnings 5
4. System Package 6
5. Power Unit Features 7
6. Mattress and Power Unit 9
7. Program Settings 10
8. Patient Transfer and Transport 11
9. Emergency CPR Deflation 11
10. Cleaning Instruction 12
11. Routine Maintenance and Storage 12
12. Troubleshooting 13
13. Return for Service 14
14. Warranty 14
15. Product Specifications 15

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Indications
This air alternating mattress system is designed for patients who endure pressure
ulcer and potential patients who wish to reduce the likelihood of pressure ulcer.
This device is intended to treat and prevent pressure ulcers by facilitating blood
circulation and decreasing pressure of each tissues contact area. Always consult
a physician or healthcare professional before using this mattress system. This
anti-decubitus mattress system is mainly for high risk patient groups.
Thank you for purchasing this anti-decubitus mattress replacement
system. Please read these instructions carefully before setting up and
using the device. Pay special attention to the warnings and other
safety information. Use of genuine components is essential for optimal
performance. If you do not fully understand all the instructions, safety
precautions, and warnings, do not use this device. If you have questions,
please contact Opera on 0333 222 8584.
i
Contradictions
Certain patient conditions are not suitable for using this type of device such as
fracture of unstable vertebrae and illness of unstable vertebrae. Always consult a
physician or health professional before using this device.
The use of this system does not replace the regular repositioning, monitoring
and, nursing of the patient.

3 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
1. Explanation 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.
IP21 Protected against ingress of solid foreign objects ≥12.5mm diameter.
Protected against vertically falling water drops.
Double Insulated (Class II) equipment.
Symbol for Type BF Applied Part Mattress according to IEC/EN 60601-1.
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.

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2. Safety Precautions
2.1 Proper Operation
To ensure proper operation, please inspect and verify that all parts are set up
properly and are anchored securely to the bed system. Verify that the mattress
replacement system does not interfere with the bed frame function. Do not place
anything on top of the power unit. Make sure power cord set is underneath the
bed frame and does not pose a hazard.
2.2 Use of Linens
It is recommended to limit bed linens to a single layer in order to allow moisture
to escape eciently through the coverlet. Breathable incontinent pads are
recommended for use with this mattress system.
2.3 Flammability Hazard
Avoid using this device near open flames, lighters, or cigarettes.
Flammability hazard exists. This device draws air from the surrounding
environment. Thus, cigarette smoking may damage internal components.
2.4 Disinfection Between Patients
This system should be disinfected thoroughly between patients in order to avoid
cross contamination.
2.5 Weight Capacity
Verify that the patient’s weight, accessories, and this mattress replacement
system, do not exceed the bed frame’s manufacturer’s recommended weight
capacity.

5 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
3. Warnings
3.1 Side Rails
Use this mattress with side rails that meet bed rail regulations (BS EN
60601-2-52:2010) to ensure that the gap between the side rail and the
top of the mattress is not large enough to pose risk of head or neck
entrapment. Failure to do so could result in serious patient injury or death.
If applicable, adhere to facility or local guidelines regarding entrapment
regulations.
3.2 Do Not Disassemble
Do not disassemble the power unit if you are not a qualified technician.
Please contact Opera on 0333 222 8584.
3.3 AP/APG Protection
This product is not AP/APG protected.
3.4 Periodic Repositioning
It is recommended that the patient be repositioned periodically while using this
mattress.
3.5 Maintenance
If the equipment needs maintenance, contact Opera on 0333 222 8584 as soon
as possible. For equipment that is no longer functional, make sure to follow
national, state, and/or facility requirements for disposal of the unit.
3.6 Maximum Operating Temperature
The air mattress operates at a maximum temperature of 100 °F (37.7 °C).

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3.7 Sharp Protrusions
Ensure that there are no protruding objects, sharp points, or bed springs
under the mattress as these could puncture the air cells.
3.8 Disposal of Waste
This device must not be disposed of as normal household waste after the
end of its service life. Contact your local waste recycling facility for further
instructions.
4. System Package
4.1 Power Unit Package
Power Unit x 1
Power Cord x 1
Instructions For Use x 1
4.2 Mattress Package
Mattress replacement unit with coverlet x 1.

7 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
5. Power Unit Features
a. Power LED
The green power LED will
light when the main power
rocker switch on the panel is
turned on.
a
b
c
d
b. Pressure
Monitoring LED
Power unit features an
integrated pressure sensor
which monitors the mattress’
internal pressure of the
mattress every six seconds to ensure operation pressure relief and comfort to the
patient.
c. Alert LED
This alert notifies medical sta the mattress has insucient pressure. Audible
alarm will sound for 15 seconds at each cycle and the indicator will stay on until
the problem has been solved.
The lighted LED indicates that the system is operating and the pressure sensor is
monitoring the mattress’ internal pressure.

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d. Lockable Patient Weight Knob
Patient Weight Knob is used to adjust the internal pressure of the mattress
according to patient weight. Simply turn the knob to adjust the pressure setting
if the mattress is too soft or firm to suit each patient’s needs. Caregivers should
always perform a hand check by placing their hands underneath the patient’s
pelvis area to check if there is sucient air support to ensure that the patient is
not bottoming out.
f. Couplers
Quick release female couplers are used
to secure mattress air hoses to the power
unit.
g. Power Receptacle
Insert power cord set firmly into receptacle.
i. Convenient Handle
The handle provides additional
gripping surface for the user to
carry the power unit.
j. Fuse
Fuse Holder
k. Air Filter and Cap
We recommend that the filter
is kept clean to ensure optimal
performance of the power unit.
h
i
e
f
g
h
f
k
j
e. Rocker Switch
Power unit’s main power switch.
h. Hanging Hooks
Hanging hooks are designed to hang the
power unit on almost any footboard.

9 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
6. Mattress and Power Unit Installations
6.1 Remove Existing Mattress
Place mattress replacement on the bed frame with the foot symbol at foot
end. Secure the mattress at each side using anchor straps. Ensure that the
anchor straps do not interfere with any moving parts of the bed frame before
proceeding to the next step.
6.3 Secure Power Unit
Secure the power unit on to the foot board using hanging hooks.
6.4 Connect Hose Couplers
Firmly connect the air hose couplers to the couplers on the power unit.
6.6 Power Up Unit
Plug the power unit into an electrical outlet, and turn on the main power rocker
switch on the control panel.
6.7 Set Patient Weight
Turn the lockable patient weight knob on the power unit’s control panel to
maximum setting to shorten the initial inflation time if needed.
Remove existing mattress from the bed frame.
6.2 Secure Mattress Replacement
6.5 Check CPR Pull Cord
Unzip mattress cover and inspect CPR latch is fully inserted into the socket. It
should arrive fully inserted when first purchased, but it is worthwhile checking,
especially when re-installing the mattress.

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6.8 Wait for Inflation
Wait approximately 30 minutes for the mattress to inflate fully before allowing
the patient to lie down on the mattress.
7. Program Settings
7.1 Adjusting Firmness
Place the patient in the centre of the mattress. Adjust the mattress’ internal
pressure according to the patient weight by using the lockable patient weight
knob on the control panel of the power unit. If the mattress is too soft or too firm,
increase or decrease the mattress’ internal pressure one increment at a time
and wait for the system to stabilise before making another change. Continue this
process until comfort is achieved.
7.2 Perform Hand Check
Caregivers should always perform a hand check by placing their hands
underneath the patient’s pelvis area to check if there is sucient air support to
ensure the patient is not bottoming out.
Tucking the bed sheet in too tightly may reduce the eectiveness of the
system.

11 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
8. Patient Transfer and Transport
8.1 Transfer
It is recommended to have the mattress system fully inflated during the transfer
process. Make sure the bed is secured before proceeding.
8.2 Transport
In the event of a patient transport, two options are available.
1. Detach the mattress’ air hose couplers from the power unit’s
quick release couplers and connect the two air hose couplers
together to retain air in the mattress. The mattress will stay inflated
for approximately 2 hours, depending on the patient’s weight.
2. Unplug the power unit’s power cord from the wall outlet and
the mattress should stay inflated for approximately 40 - 50
minutes. This mattress system also has a safety foam base underneath
the air cells to support the patient for a short period of time in case of
deflation. To resume normal operation, please follow the instructions
beginning in Section 6.2.
9. Emergency CPR Deflation
In the case of emergency, pull hard to remove the mattress’ CPR latch and
detach the quick release coupling from the control unit for emergency
deflation and turn o the power unit by pressing the power/mute button
on the control panel at the same time for emergency deflation. The air
will discharge from the mattress with the patient’s own weight. To resume
normal operation, simply re-insert the CPR latch securely, press the
power/mute button again and reset the patient weight. See instructions
in Section 6.
DANGE R

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10. Cleaning Instruction
The air mattress and power unit must be cleaned thoroughly between patients
to avoid cross contamination. The following is a suggested guideline. Be sure to
follow local infection control policies.
Regular cleaning can be performed at bedside with a disinfectant followed by
drying with a clean dry cloth. Use only mild detergents to clean the coverlet and
the mattress. Any appropriate non-phenolic cleaning agent may be used for
heavy soiling from urine, blood or other bodily fluids. Please ensure that the air
mattress and coverlet are completely dry before letting the patient lie on the
surface again.
Machine wash warm water at maximum 71 °C.
Do not use electric or tumble dryers. Do not iron.
Always unplug the power unit before cleaning. Routine cleaning of power
unit can be done by wiping down with damp cloth using disinfectant or
mild detergent. Never spray liquids directly on the unit itself.
11. Routine Maintenance and Storage
Remove air filter from the rear panel of the power unit by opening up the filter
cap. Inspect the filter for dirt or dust, and clean it with mild soap and water.
Reinsert the dried air filter after cleaning and ensure that the cap is secure. If a
replacement is needed, contact Opera on 0333 222 8584.
Only disinfect and dry systems should be stored. Disconnect the air hoses from
the power unit. Roll up the mattress starting from the head end and working
down toward the foot end. Use the straps to secure it and store in clean plastic or
other storage bag. Store in a cool, dark place.

13 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
12. Troubleshooting
Fault Inspection Procedure Remedy
Power unit is not
working
Check if power cord is firmly
plugged into both the control
unit and the electrical outlet.
Secure power cord into control
unitand/or electricaloutlet.
Check if the power switch is in
the on position. Turn power switch to on position.
Check if the power surge has
shut down the power unit.
A power surge may overload the
circuitry temporarily.Turn the
unit o, and check the fuse for
damage. Turn theunit onagain
withnormal procedure.
Make sure there is no power
failure.
Turn on and operate the unit
after power is restored to the
facilityor home.
Power unit does not respond
to possible solutions. Please contact Opera on 0333 222 8584 for assistance.
Power unit
is working,
but mattress
replacement is not
inflating
and/or
Bottoming outis
occurring
and/or
Patient leaves a
deep indentation
at the contact area
which does not
return back to its
originalshape.
CheckCPRPull Cord. Unzip mattress cover and inspect CPR latch is fully
inserted into socket.
Check if mattress’ air hose
couplers are properly
connectedtopowerunit’s
quickrelease couplers.
Secureair hose couplers firmly
into place.
Verify that patient weight
setting is correct.
Increaseor decrease weight
setting until appropriate
pressure is reached.
Inspect air filter for dust and
dirt. Clean or replace air filter.
Lift mattress coverlet up
to check if air cells are
connectedcorrectly.
Make sure all air cells are
properly linked to air supply.
Lift mattress coverlet up to
check if air tubes are kinked or
obstructed.
Check andadjust airtubes
positions.
Check if air cells are cut or
cracked Please contact Opera on 0333 222 8584 for assistance.
Patient’s wounds
arenot responding
to pressure relief
(reddening ofskin).
Contact your physician and/or
nursing service immediately.

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13. Return for Service
Service and repair must be performed by Opera authorised technicians or
representatives. Please contact Opera on 0333 222 8584.
14. Warranty
We warrant the product to be free from defects from the date of purchase.
Please inspect all accessories when you purchase our product. If there is any
damage or missing accessories when you receive the product, please ask for a
replacement from Opera on 0333 222 8584 within three days of purchase.
The warranty period for the products are according to the regulations in your
country, the minimum period is 2 years from date of purchase for the power unit
and 2 years for the mattress and the coverlet. The warranty coverage of any
product is contingent up on its purchase from Opera.
Warranty coverage will not be extended to any product on which the production
lot number has been removed or defaced on which repair has been attempted
by any person or agency not authorized by our company or if in the sole opinion
of our company that the system shows evidence of tampering, abnormal or
unreasonable abuse, negligence, accident or operation without regard for
the restrictions specified in the instructions which accompany the system. This
warranty does not cover normal maintenance such as cleaning, adjustment,
lubrication, and updating of equipment or parts. If the damage is a result from
improper operation, a reasonable service fee and part cost will be charged.
The warranty stated above is the only warranty made and is in lieu of all
other warranties whether expressed or implied, including any warranty of
merchantability or fitness for a particular reason, we will not be liable for
consequential or incidental damages of any kind.

15 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
15. Product Specifications
System Name Flo Air Mattress System
Power Unit (Air Pump) Model SR365
Mattress Dimension 2000 x 900 x 180mm (7” depth)
2000 x 1050 x 180mm (7” depth)
Number of Air Cells 20 Cells
Power Control Unit
Dimension 295 x 225 x 120mm
Material
Power Unit - Plastic Case rated UL 94V-0
Mattress Cell - 100% nylon with TPU lamination
Coverlet - Quilted Nylontaeta Backing
Power Input 220 - 240Vac, 50Hz, 0.2A
Power Consumption Normal Operation: Max 10W
Power Control Unit Weight 2.5 kg
Fuse Rating T1A 250V
Electrical Classification Class II Type BF applied part mattress.
IP Code IP21
Operation Mode This system is not AP/APG Protected.
Continuous operation.
Power Cord Set
H05VV-F or H05VVH2-F,
2 x Min. 075mm
250Vac
Operating Conditions
Temperature: 5°C - 40°C
Humidity: 15% - 90%
Atmospheric Pressure: 700 - 1060hPA
Transportation & Storage
Conditions
Temperature: -25°C - 70°C
Humidity: 0% - 90%
IEC/EN Test Standards Safety: IEC/EN 60601-1_v3.0
EMC: IEC/EN 60601-1-2_v3
Maximum Weight Capacity 150 kg

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Notes

17 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
Notes

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Notes

19 | Opera Beds | Opera Flo Air Mattress System Instructions and Technical Specifications | Version 2
Azure House, Connaught Road, Kingswood, Hull, HU7 3AP
03332228584 | [e-mail] | operabeds.com
Version 2 | Published in August 2022