Opera Relieve Overlay User manual

Instructions and
for Opera®Relieve Overlay Mattress System
Opera Care, Azure House, Connaught Road, Hull, HU7 3AP
0333 222 8584 | [email protected] | opera-care.co.uk

1
Contents
1. Symbols and Indications ........................................................2
2. Safety Precautions...................................................................2
3. Warnings.....................................................................................3
4. System Package.......................................................................4
5. Features ......................................................................................5
6. Mattress and Power Unit Installations.................................7
7. Program Settings......................................................................8
8. Patient Transfer and Transport..............................................8
9. ......................................................9
10. Cleaning Instructions...............................................................9
11. Rountine Maintenance and Storage.....................................9
12. Troubleshooting .....................................................................10
13. Returns for Service................................................................11
14. Warranty...................................................................................11
15. .........................................................12
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. In case you have
questions, please contact Opera Care on 0333 222 8584 .
16. EMC Declaration......................................................................13

2
1. Explanations of Symbols
Conformity mark in accordance with the European
Medical Device Directive_93/42/EEC amended by 2007/47/EC
Do not immerse power unit in liquid or spray liquids directly on power unit.
Symbol for Type B Applied part_Mattress according to IEC/EN 60601- 1
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 tissue’s contact area. Always consult a physician or
healthprofessional before using this mattress system. This anti- decubitus mattress
system is mainly for low risk patient group.
Contraindications
Certain patient conditions are not suitable for using this type of device such as
fracture of instable vertebrae and illness of instable 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.
Double Insulated (Class II) equipment
Read instructions for use
Caution
Manufacturer
Date of Manufacture
WEEE

3
3. Warnings
3.1 Siderails
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
contact Opera Care on 0333 222 8584 .
2.2 Use of Linens
It is recommended to limit bed linens to a single layer in order to allow moisture
recommended for use with this mattress system.
2.3 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.
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 bed
frame and does not pose a hazard.

4
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
3.5 Maintenance
If the equipment needs maintenance, contact Opera Care 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 max of 100°F (37.7°C).
3.7 Sharp Protrusions
CAUTION: Ensure that there are no protruding objects, sharp points, or bed springs
under the mattress as these could puncture the air cells.
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.

5Relieve Mattress Instructions and Technical Specication
1. Power Switch
The green power LED will light when the main power rocker switch on the panel is
turned on.
2. 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 rm 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 sufcient air support to ensure that the patient is not bottoming out.
5. Power Unit Features
POWER
WEIGHT
(KG)
30
60
90
120
150
1
2

6
3
4
3. Couplers
Quick release female couplers are used to secure mattress air hoses to power unit.
4. Strain Relief of Power Cord
provided with a molded-on anti-kink bushing held in place by integral slot in bottom
enclosure.
5. Hanging Hooks
Hanging hooks are designed to hang the power unit on almost any foot board.
5
7
6
6. Air Filter
and Cap
We recommends
kept clean to
ensure optimal
performance of
the power unit.
7. Fuse
Fuse Holder
34

7
6. Mattress and Power Unit
Installations
6.1 Secure Mattress Overlay
Place mattress overlay on top of the original mattress with the logo at foot end.
Secure the mattress using the elastic straps at four corners. Please verify all bed
functions are working properly without interference before proceeding to the next
step. Also, check the combined height of the Overlay and Mattress meets bed rail
regulations (BS EN 60601-2-52:2010).
6.2 Secure Power Unit
Secure the power unit onto the foot board using hanging hooks.
6.4 Connect Hose Couplers
Firmly connect the air hose couplers to the couplers on the power unit.
6.5 Check CPR Pull Cord
Unzip mattress cover and inspect CPR latch is fully inserted into socket. It should
when re-installing the mattress.
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
6.8
patient to lie down on the mattress.

8
Relieve Mattress Instructions and Technical Specication
7. Program Settings
7.1 Adjusting Firmness
Place the patient in the center 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 rm, increase or
decrease the mattress’ internal pressure one increment at a time and wait for the
system to stabilize 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 sufcient air support to ensure the patient
is not bottoming out.
IMPORTANT: TUCKING THE BEDSHEET SHEET IN TOO TIGHTLY MAY REDUCE
THE EFFECTIVENESS OF THE SYSTEM.
8. Patient Transfer and
Transport
8.1 Transfer
It is recommended to have the mattress system fully inated during the transfer
processor. 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 inated 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 inated 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 deation. To resume normal
operation, please follow the instructions beginning in Section 6.1.

9
9.
In the case of emergency, pull hard to remove the mattress’ CPR latch and detach
the power unit by pressing the power/ mute button on the control panel at the same
time. The air will discharge from the mattress with patient’s own weight. To resume
normal operation, simply re-insert CPR latch securely, press the power/ mute button
again and reset the patient weight. See instructions beginning in Section 6.1.
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
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.
WARNING! 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
needed, contact Opera Care on 0333 222 8584.
Only disinfected 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.

10
12. Troubleshooting
Fault Inspection Procedure Remedy
Power unit is not
working. plugged into both the control
unit and the electrical outlet.
Secure power cord into control unit
and/or electrical outlet.
Check if the power switch is
in the ON position.
Turn power switch to ON position.
Check if power surge has
shut down the power unit.
A power surge may overload the
circuitry temporarily. Turn the unit
off, and check the fuse for damage.
Turn the unit on again with normal
procedure.
Make sure there is no power
failure.
Turn on and operate the unit after
power is restored to the facility or
home.
Power unit does not respond
to possible solutions.
Please contact Opera Care on 0333
222 8584 for assistance.
Power unit
is working,
but mattress
replacement is not
and/or
Bottoming out is
occurring
and/or
Patient leaves a deep
indentation at the
contact area which
does not return back
to its original shape.
Check CPR Pull Cord Unzip mattress cover and inspect
CPR latch is fully inserted into
socket.
Check if mattress’ air hose
couplers are properly
connected to power unit’s
quick release couplers.
place.
Verify that patient weight
setting is correct.
Increase or decrease weight
setting until appropriate pressure is
reached.
dirt.
Lift mattress coverlet up
to check if air cells are
connected correctly.
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 and adjust air tubes’
positions.
Check if air cells are cut or
cracked.
Please contact Opera Care on 0333
Patient’s wounds
are not responding
to pressure relief
(reddening of skin).
Contact your physician and/or
nursing service immediately.
222 8584 for assistance.

11
13. Returns for Service
Service and repair must be performed by Opera Care authorised technician or
representative. Please contact Opera Care 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 Care 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 year from date of purchase for the power unit and 2 year for
the mattress and the coverlet. The warranty coverage of any product is contingent
up on its purchase from Opera Care.
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
Disposal of Waste
To protect the environment, dispose of useless device at appropriate collection
sites according to national or local regulation.
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 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 or any kind.

12
15.
Mattress Dimension 2000x900x130mm (5” depth)
Number of Air Cells 16 Cells
Power Control Unit Dimension 260x220x90mm
Material
Mattress Cell – 100 % nylon with TPU
lamination
Coverlet – Quilted nylontaffeta backing
Power Input 220-240Vac, 50Hz, 0.05A
Power Consumption Normal Operation: Max 6W
Power Control Unit Weight 2.5 kgs
Fuse Rating T1A 250V
Class II Type B, double insulated
IPX0, do not immerse power unit in any
liquid or spray any liquids directly on the
power unit.
This system is not AP/APG Protected.
Continuous operation
Power Cord
Operating & Transportation & Storage
Conditions
Temperature:5°C~40°C
Humidity:15%~60%
Atmospheric Pressure:700~1060hPA
IEC/EN Test Standards Safety: IEC/EN 60601- 1_v3.0
EMC: IEC/EN 60601- 1- 2_v3
Maximum Weight Capacity 150kg
Power Unit (Air Pump) Model SR303
Power Unit_Plastic Case rated UL 94V-0
System Name RELIEVE Overlay Mattress System
H05VV-F or H05VVH2-F,
2 x Min. 0.75mm2
Product Specifications

13
16. EMC Declaration
Declaration of Conformity
For EN 60601-1-2 (3rd Ed.)
Company Name : Alpine HC Limited
Company Address : Azure House, Connaught Road, Kingswood, HULL, HU7 3AP, UK
Trade Name : OPERA
Report Number : ETC 18-01-RBO-022-01
Power Supply : 220-240Vac, 50Hz, 20W
Recommended separation distances between
portable and mobile RF communications equipment and the ME equipment
The Air Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Air Pump can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Air Pump as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=








1
5,3
V
P
80 MHz to 800 MHz
d=








1
5,3
E
P
800 MHz to 2.5 GHz
d=








1
7
E
P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.7 3.7 7.37
100 11.67 11.67 23.33

14
Declaration – electromagnetic emissions and immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
The Air Pump declaration – electromagnetic immunity
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3V Portable and mobile RF communications equipment should be
used no closer to any part of the EQUIPMENT or SYSTEM
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Interference may occur in the vicinity of equipment marked
with the following symbol.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz
3V/m
Declaration – electromagnetic immunity
The Air Pump system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Air Pump system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines ±2 kV for power supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
＜5 % UT
(＞95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜5 % UT
(＞95 % dip in UT) for 5 sec
＜5 % UT
(＞95 % dip in UT) for 0.5 cycle
40 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜5 % UT
(＞95 % dip in UT) for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended that
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Declaration – electromagnetic emissions
The Air Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Air Pump
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
CE emissions
CISPR11 Group 1
The Air Pump uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in nearby electronic equipment.
RE emissions
CISPR11 Class B The Air Pump is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
Flicker emissions
IEC 61000-3-3
Complies

Opera Care, Azure House, Connaught Road, Hull, HU7 3AP
0333 222 8584 | [email protected] | opera-care.co.uk
U-2S2301-30831-G V1.1