Opera SR366 User manual

Instructions and
for Opera®Impulse Auto Hybrid Mattress System
Opera Care, Azure House, Connaught Road, Hull, HU7 3AP
0333 222 8584 | [e-mail] | opera-care.co.uk
IMPULSE AUTO

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Contents
1. Symbols and Indications ........................................................2
2. Safety Precautions...................................................................3
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
16. EMCDeclaration......................................................................13
Care on 0333 222 8584.
Impulse Auto Mattress Instructions and Technical Specification

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1. Explanations of Symbols
Impulse Auto Mattress Instructions and Technical Specification
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
health professional before using this mattress system. This anti- decubitus mattress
system is mainly for high 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.
Conformity mark in accordance with the European
Medical Device Directive_93/42/EEC amended by 2007/47/EC
Symbol for Type BF Applied Part_Mattress according to IEC/EN 60601-1
Read instructions for use
Double Insulated (Class II) equipment
Caution
Manufacturer
Date of Manufacture
WEEE
IP21 Protected against ingress of solid foreign objects ≥12.5mm diameter.
Protected against vertically falling water drops

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
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.
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.
Impulse Auto Mattress Instructions and Technical Specification
Care on 0333 222 8584.

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4. System Package
4.1 Power Unit Package
Power Unit x 1
Power Cord Set x 1
Instructions For Use x 1
4.2 Mattress Package
Mattress replacement unit with coverlet x 1
3.6 Maintenance
If the equipment needs maintenance, contact Opera
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.
3.7 Environmental Operating Conditions
Operating Conditions:
Temperature: 5°C - 40°C
Humidity: 15% - 90%
Atmospheric Pressure: 700hPa - 1060hPa
3.8 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.
3.9 Storage and Transport
Do not fold or bend. Not more than two layers should be stacked on top of each
other. For long- term storage the power unit should be in a box or covered with a dust
protector.
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 Battery Replacement
Incorrect battery replacement may result in risk of explosion. Replace only with
same or equivalent battery type recommended by the manufacturer.
3.10 Disposal of Waste
To protect the environment, dispose of useless device at appropriate collection
sites according to national or local regulations.
Impulse Auto Mattress Instructions and Technical Specification
Care on 0333 222 8584

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1. Power/Mute
Press button to turn on the power unit
and the green LED will light. The LED will
change to orange if abnormal power outage
occurs and audible alarm will sound to
notify medical staff. You may press button
to mute the alarm or it will sound until
power is restored or rechargeable battery
is discharged. The memory re- call function
recalls the previous setting when the pumpi
turned off/on or after a power- outage.
2. Pressure monitoring LED
Power unit features an integrated pressure senor which can monitor the mattress’
internal pressure to achieve optimal internal pressure and to ensure maximum
pressure relief. This LED indicates the system is monitoring the mattress’ internal
3. Alert LED
alarm will sound for 15 seconds at each cycle and the indicator will stay on until the
problem has been solved.
4. Comfort Adjustment
Simply press button to adjust the patient comfort from -2 to 2. Please adjust the
should always perform a hand check by placing their hands underneath patient’s
bottoming out.
5. Power Unit Features
Impulse Auto Mattress Instructions and Technical Specification
1
2
3
4
IMPULSE AUTO

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5
6
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5. Rocker Switch
Power unit’s main power switch.
6. Couplers
Quick release female couplers are used
to secure mattress air hoses to power
unit.
7. Power Receptacle
8. Hanging Hooks
Hanging hooks are designed to hang the
power unit on almost any foot board.
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9. Convenient Handle
The handle provides additional
gripping surface for user to carry
the power unit.
10. Fuse
Fuse Holder
11. Air Filter and Cap
be kept clean to ensure optimal
performance of the power unit.
8
6
Insert power cord set firmly into receptacle.
Impulse Auto Mattress Instructions and Technical Specification

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6. Mattress and Power Unit
Installations
6.1 Remove Existing Mattress
Remove existing mattress from bed frame.
6.2 Secure Mattress Replacement
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 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 right side of the power unit.
for approx. 30 seconds until the power unit is ready before making any program
adjustment.
6.7
patient to lie down on the mattress.
6.8 Ensure patient comfort
the patient for long periods of time.
Impulse Auto Mattress Instructions and Technical Specification

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7. Program Settings
7.1 Adjusting Firmness
Center the patient on the mattress. Adjust the mattress’ internal pressure according
to the patient sensation by using the comfort button on the control panel of the
the mattress’ internal pressure one increment at a time and wait for the system to
stabilize before making another change until a comfortable state is achieved.
7.2 Perform Hand Check
Caregivers should always perform a hand check by placing their hands underneath
is not bottoming out.
8. Patient Transfer and
Transport
8.1 Transfer
processor. To do this increase the comfort setting to +2. 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
depending on the patient’s weight.
2. Unplug the power unit’s power cord set from the wall outlet and the mattress
system also has a safety foam base underneath the air cells to support the
operation, please follow the instructions beginning in Section 6.2.
Impulse Auto Mattress Instructions and Technical Specification

9Impulse Auto Mattress Instructions and Technical Specification
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 6.2.
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.
The recommended wash temperature is 70°C, at 95°C the shrinkage rate is 1%
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
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.
Always replace the coverlet before using the mattress. If the coverlet is not properly
high risk of cross contamination if the mattress is used without a coverlet.
needed, contact Care on 0333 222 8584.Opera

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12. Troubleshooting
Fault Inspection Procedure Remedy
Power unit is not
working. plugged into both the control
unit and the electrical outlet.
Secure power cord set 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 andoperate the unit after
power is restored to the facility or
home.
Power unit does not respond
to possible solutions.
Please contact
for assistance.
Low pressure alert
does not go out in 30
sec. after systems
start.
Possible control failure.
Alert LED is lit during
operation.
Check if there is leakage in air
tubes* or air cells.
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 comfort
setting is correct.
Increase or decrease comfort setting
until appropriate pressure is reached.
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.
Impulse Auto Mattress Instructions and Technical Specification
0333 222 8584
Please contact Opera
for assistance.
Care on
0333 222 8584
Please contact Opera
for assistance.
Care on
0333 222 8584
Opera Care on

11
13. Returns for Service
Service and repair must be performed by an authorised technician
or representative. Please contact Opera
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 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
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 authorised by our company or if in the sole opinion of our
company that the system shows evidence of tampering, abnormal or unreasonable
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
damages or any kind.
Alternating or
Constant mode is not
available.
Possible control failure.
Patient’s wounds
are not responding
to pressure relief
(reddening of skin).
Contact your physician and/or
nursing service immediately.
Impulse Auto Mattress Instructions and Technical Specification
Please contact Opera
for assistance.
Care on
0333 222 8584
Opera Care
Care on 0333 222 8584.
Care on 0333 222 8584
Opera Care.

12
15.
Mattress Dimension
Number of Air Cells 20 Cells
Power Control Unit Dimension 295 x 225 x120 mm
Integrated Foam 50mm (2”)
Material
Mattress Cell – 100 % nylon with TPU
lamination
Coverlet – Quilted nylontaffeta backing
Power Input 220-240Vac, 50Hz, 0.2A
Power Consumption Normal Operation: Max 20W
Power Control Unit Weight 2.5 kgs
Fuse Rating T1A 250V
Power Cord Set
Operating Conditions Temperature: 5°C to 40°C
Humidity:15% to 90%
Atmospheric Pressure:700 to 1060hPA
Transport & Storage Conditions
NiMH Battery 3.6Vdc 600mAh
Maximum Weight Capacity 250kg
Power Unit (Air Pump) Model SR366
Power Unit-Plastic Case_UL 94V-0
Temperature: -25°C to 70°C
Humidity:0% to 90%
IEC / EN Test Standards Safety: IEC/EN 60601-1_v3.1
EMC: IEC/EN 60601- 1-2_v4
System Name IMPULSE Hybrid Mattress System
Impulse Auto Mattress Instructions and Technical Specification
Electrical Classification
AUTO
2000 x 900 x 150 mm (6” depth)
2000 x 1050 x 150 mm (6” depth)
2000 x 1200 x 150 mm (6” depth)
2000 x 1000 x 150mm (6” depth)
Class II
Type BF applied Part_Mattress
This system is not AP/APG Protected.
Continuous operation
IP21
H105VV-F or H05VVH2-F,
2 x Min. 0.75mm, 250VAC
2

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16. EMC Declaration
Impulse Auto Mattress Instructions and Technical Specification
Declaration of Conformity
For EN 60601-1-2 (4th Ed.)
Company Name: Opera Care
Company Address: Azure House, Connaught Road, HULL, HU7 3AP, UK
Trade Name: OPERA
Model No.:
SR365 (Opera Flo), SR366 (Opera Flo Auto),
SR366 (Opera ECLIPSE Auto), SR366 (Opera IMPULSE Auto),
SR366 (Opera Flo Digital)
Report Number: ETC 19-12-RBO-038
Power Supply: AC 220 - 240V , 50/60Hz , 0.2A
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
2.01.01.010.0
7.04.04.01.0
3.22.12.11
4.77.37.301
3.327.117.11001
Declaration – electroma
g
netic 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
RF emissions
CISPR 11 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.
RF emissions
CISPR 11 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

14Impulse Auto Mattress Instructions and Technical Specification
Declaration – electromagnetic emissions and immunity –
for EQUIPMENT and SYSTEMS that are use in the professional healthcare facility
environment or in the home healthcare environment
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 ; 6 Vrms
150 kHz to 80 MHz
3 Vrms ; 6 Vrms
150 kHz to 80 MHz
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 ; 10V/m
80 MHz – 2.7 GHz
80%
3 V/m ; 10V/m
80 MHz – 2.7 GHz
80%
Proximity fields
from RF wireless
Communications
equipment
IEC 61000-4-3
27 V/m 385 MHz 27 V/m 385 MHz
28 V/m 450 MHz 28 V/m 450 MHz
9 V/m 710 MHz 9 V/m 710 MHz
745 MHz 745 MHz
780 MHz 780 MHz
28 V/m 810 MHz 28 V/m 810 MHz
870 MHz 870 MHz
930 MHz 930 MHz
28 V/m 1720 MHz 28 V/m 1720 MHz
1845 MHz 1845 MHz
1970 MHz 1970 MHz
28 V/m 2450 MHz 28 V/m 2450 MHz
9 V/m 5240 MHz 9 V/m 5240 MHz
5500 MHz 5500 MHz
5785 MHz 5785 MHz
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
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 kV
air
±8 kV contact
±2 kV , ±4 kV , ±8 kV , ±15 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
±0.5 kV
±1 kV differential mode
±2 kV common mode
±0.5 kV
±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
0 %
UT ; 0 , 5 cycle
At 0
o
, 45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
and 315
o
0 % UT ; 1 cycle
and
70 %
UT ; 25/30 cycle
Single phase: at 0
o
0 % UT ; 0 , 5 cycle
At 0
o
, 45
o
, 90
o
, 135
o
, 180
o
,
225
o
, 270
o
and 315
o
0 % UT ; 1 cycle
and
70 %
UT ; 25/30 cycle
Single phase: at 0
o
Mains power quality should be that of a
typical commercialor 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
30 A/m 30 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.

U-2S2205-30631-G V1.2
Opera Care, Azure House, Connaught Road, Hull, HU7 3AP
0333 222 8584 | [email protected] | opera-care.co.uk