Great Life Healthcare Universal Therapy System User manual

Universal Therapy System
(UTS)
Handset ： HS-NBE
USER MANUAL
Manufactured for:
Great Life Healthcare, Inc.
www.greatlifehealthcare.com

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Contents
1. Important Safeguards…………………………………………..……………………………………………….
3
2. The Purpose of this Manual.......................................................................................
4
3. Product Description –Intended Use.........................................................................
4
4. General safety...........................................................................................................
4
5. System Control……………………………………………………………………………………………………..
5
6. Installation Guide.....................................................................................................
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7. Maintenance & Troubleshooting..............................................................................
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8. Cleaning & Disinfection Protocol..............................................................................
9
9. Specification..............................................................................................................
10
10. EMC Related Notification..........................................................................................
11. Waste Disposal……………………………………………………………………………………………..………
11-15
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12. Storage and Care.......................................................................................................
13. Symbols Used………………………………………………………………………..................................
14. Expected Service Life…………………………………………………………………………………….........
15. Warranty………………………………………………………………………………………………………........
16. Disclaimer…………………………………………………………………………………………………….........
17. Legal Disclaimer……………………………………………………………………………………………........
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1. IMPORTANT SAFEGUARDS
When using electrical products, especially when children are present, basic safety precautions should
always be followed, including the following:
――This device can be used in home healthcare and professional healthcare environment. ――
DANGER - READ ALL INSTRUCTIONS BEFORE USING THE APPLIANCE
DANGER –To reduce the risk of electrocution:
1. Always unplug this product immediately after use.
2. Do not use while bathing.
3. Do not place or store product where it can fall or be pulled into a tub or sink.
4. Do not place in, or drop into, water or other liquids, unless following specific manufacturers
guidelines.
5. Do not reach for a product that has fallen into water. Unplug immediately.
WARNING –To reduce the risk of burns, electrocution, fire or injury to persons:
1. This product should never be left unattended when plugged into a power outlet.
2. Close supervision is necessary when this product is used by, on, or near children or physically
challenged individuals.
3. Only use this product for its intended purpose, as described in this manual.
4. Never use attachments with this system that have not been recommended or approved by the
manufacturer.
5. Never connect this product to a power supply or operate it if:
A. The system shows any signs of having a damaged cord or plug.
B. It does not appear to work properly or makes any abnormal noise.
C. The products have been dropped, damaged, or dropped into water.
Should any of the above be relevant, return the product to a service center for examination and
repair.
6. Keep the electrical cord away from heated surfaces, open flames, liquids and sharp objects.
7. Never drop or insert any object into any openings.
8. Do not use outdoors, operate where aerosol (spray) products are being used, or where oxygen
is being administered.
9. ALWAYS disconnect from power supply before opening up the mattress.
10. If pain, irritation, numbness, swelling, or redness occurs discontinue use and contact a
healthcare professional.

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2. The Purpose of this Manual
This operation manual is mainly focused on the set-up, cleaning and routine maintenance of the
Universal Therapy System (UTS). We recommend that you keep this manual in a safe location to help
answer any questions that may arise relating to the system.
3. Product Description – Intended Use
The Universal Therapy System (UTS) is an alternating air replacement system designed to prevent and
treat pressure ulcers. The Universal Therapy System (UTS) works on the principle of actively
encouraging tissue blood flow by gently increasing and decreasing pressure within the support surface
over a 10-minute cycle. This results in the reduction of surface pressures helping to prevent tissue
breakdown and encourage healing.
Contraindications: Patient conditions for which the application of pressure therapy on the Universal
Therapy System (UTS) systems. Contraindications include:
*Instable spinal cord injury
*Cervical traction
Intended Care Setting will be in Aged care and Home care.
Intended User Profile:
●At least fifteen years old
●Language understanding:
- Read and understand ‘Westernized Arabic’ numerals when written in Arial font
- Understands hygiene
●Experience Requirement: Have nursing facilities
●Permissible impairments: Except for contraindications
For added durability, and longer working life, the Universal Therapy System (UTS) has been constructed
using high strength components and premium grade materials. The mattress features a heavy-duty
base layer and a water resistant, multi-stretch vapor permeable PU cover to reduce risks of friction and
shear.
4. General Safety
It is important to read the information in this user manual before you use your Universal Therapy
System (UTS).
Please follow the guidelines below for your safety and maintaining of system performance.
●Maximum patient weight is 350 lbs. and minimum user weight is 66 LBS.
●Avoid exposing pump to liquids.
●When cleaning do not use of Phenol based substances.
●This Universal Therapy System (UTS) must be used on top of a bed frame

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5. SYSTEM CONTROL
Item
Description
1
2
3
4
5
6
POWER Switch – Power On (Green LED), Standby (Amber LED)
AUTO Weight Detection function – Enabled by pressing the “Auto” button and will self-adjust the
comfort level according to patient’s weight.
NOTE: The “AUTO” detection mode will be disabled when comfort level is manually adjusted. Press
“AUTO” again to re-activate the automatic weight detection when needed. It will detect around 10
minutes to achieve suggested comfort level based on patient’s weight.
MODE – Cycle through Auto Firm (AF), Alternating (AL) and Static (ST) therapy modes by repeatedly
pressing the “Mode” button – the pump is set to alternating mode by default with “AL” display on
LED window. UTS is programmed to default back to alternating mode after 30 minutes of usage.
Auto Firm (AF)- Fast inflates the mattress to maximum pressure in static mode to perform nursing
procedures. It is programmed to return to alternating mode after 30 minutes of usage by default.
Alternating (AL) - To inflate mattress in alternating mode
Static (ST) - To inflate the mattress to a static surface. The pump will default back to alternating
mode after 30 minutes.
LEVEL – Allows for manual adjustment, by repeatedly pressing “LEVEL” button to accommodate an
individual’s comfort if needed. Default manual setting will be the level detected during “Auto” mode,
or at Level 02 if Auto detection is incomplete. Display of “LEVEL” will automatically go back to
“MODE” when not in operation for 10 seconds.
Alarm Codes Display Window - “PF” stands for Power Failure, displayed in LED window with an
audio alarm to indicate a power outage situation. “LP” stands for Low Pressure, where the system
will alert user with a visual alarm displayed in LED display window, and an audible alarm triggered 5
minutes after visual alarm. (Check)
Lock/Unlock/ Alarm Mute Button - Lock/Unlock button allows user to manually lock (3 seconds)
/unlock (3 seconds) the control panel to safeguard against any undesired/accidental changes to the
settings. Control panel will auto lock when system is not in operation for 5 minutes.
Alarm Mute – Press to mute the audio alarm. The alarm will re-activate after 20 minutes if the
problem is not resolved. (Check)

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Installation Guide: 6.
1. Place the Universal Therapy System (UTS) directly on to bed frame and ensure CPR
valve is at the head end of the bed. Secure and check that the bed straps on the underside
of mattress are fastened to the bed frame correctly (Check moving sections on the bed
frame to make sure that they are not encumbered by the straps and can continue to
operate normally).
2. Hang the handset on the bed rail or mattress platform and plug the power cord into mains
outlet. Ensure that electrical cables are safe, tidy, free of obstruction and are not able to
be caught in the bed frame. The power LED will be at standby mode with amber light
illuminating.
CAUTION: it is important to routinely inspect power cable to ensure it is not
obstructing or causing a tripping hazard. Check and make sure that the power
cable is not under strain or damaged.
3. Ensure that the CPR valve is set to “CLOSE” position (Fig. 1).
4. Turn the power on from handset (Green LED will illuminate).
5. When the Universal Therapy System (UTS) is turned on, the pump will start to inflate the
mattress for around 30 minutes in auto firm mode. During this inflation period, the “AF”
LED will be displayed on LED window to indicate the mattress is not ready to use. When
“AF” switches to “AL” with display on LED window, bed sheet can be added (NOT tucked
under mattress, left to hang freely) and the patient can be placed and positioned on the
mattress surface. The audible alarm is disabled during the inflation period and will resume
its function when “AF” LED goes off.
6. Once the mattress is properly inflated, system will switch to alternating mode. Press “Auto”
button to enable auto detection feature and the system will automatically set to an optimum
pressure according to patient’s weight.
The Universal Therapy System (UTS) also allows the caregiver the flexibility to disable
“Auto” feature and switch to manual adjustment, by repeatedly pressing “LEVEL” button to
accommodate an individual’s comfort need. Default manual setting will be the level
detected during “Auto” mode, or at Level 2 (02 displayed on LED window) if Auto detection
is incomplete.
Please Note: “Auto Firm (AF)” and “STATIC (St)” mode is designed to return to
“Alternating (AL)” mode after 30 minutes of activation.
Fig. 1 Turn the dial to CLOSE
position to inflate air mattress.

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This mattress features a Cardio Pulmonary Resuscitation (CPR) valve at right side
head end of the patient.
In the event of an emergency, turn the CPR valves to the OPEN position for fast deflation
the air mattress. (Fig. 2)
IMPORTANT: Please ensure that all care staff are trained and familiarized with the
mattress and this function.
CAUTION: During power failure/outage, the Universal Therapy System (UTS) will
stop functioning and PF (Power Failure) alarm codes will be displayed on LED
window with audio alarm. The pump will return to its normal operation when power
is resumed.
The design of the system does allow the safe support of a patient even in the case
of a power failure and loss of air from within the mattress. Please do not use any other
cables or accessories not approved by the manufacturer in this manual to avoid negative
influence on electromagnetic compatibility
In the event of product failure, unless the mattress has been ‘set’ to operate as a standard,
non-powered system, return the product to a service center for examination and repair as
soon as possible.
Attention: If the airflow output varies unstably or stops erratically, it might be caused from
EMC disturbance or unstable power socket. Be sure to use the device with a stable power
supply or in connection with Uninterruptible Power Supplies and repress the power ON
button to activate the air mattress system.
Fig. 2 Turn the dial to OPEN
position to release air.

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7. Maintenance & Troubleshooting
No daily maintenance is required. It is intended this equipment should only be serviced by qualified
and authorized technical personnel. It is suggested that professional healthcare and caregivers to check
patients’ conditions and settings every two hours to prevent any emergency or misuse situation.
Fault/Problem
Description
Troubleshooting
Solution
No indication that
the pump is on.
Check Universal Therapy System (UTS) is
connected to the mains power supply.
Check the power is switched on.
Check for loose connection on plug and
main power is switched on.
Secure plug connection and turn
on power from main.
Check if mains socket is faulty.
Try another socket.
Low pressure in
mattress/mattress
is not inflating.
Check Universal Therapy System (UTS) is
connected to the mains power supply.
Ensure the main power is turned on
and Universal Therapy System
(UTS) is plugging into main.
Check Universal Therapy System (UTS)
air connections are fitted securely.
Ensure airflow is coming out from pump.
Ensure connectors are securely
fastened and reconnect pump air
hoses if loose.
Ensure pump is turned on.
Check CPR valve is set to CLOSE position
and is not leaking.
Ensure CPR valve is set to CLOSE
position. Replace a new CPR valve if
an air leak is found.
Check the connector tubes for kinks,
obstructions or damage.
Undo any kinks and obstructions.
Check air intake from filter is not blocked
by linen/dust.
Replace with new filter.
Pump Controls lock
up ‘freeze’.
Turn off and unplug Universal Therapy
System (UTS)
Rest Universal Therapy System
(UTS) for a few seconds and plug
the back in to main and turn on the
pump.
If problem is not resolved, please contact your sales representative for advice.
CAUTION: Please ensure the system is connected to a stable power or in connection with
Uninterruptible Power Supplies.

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8. Cleaning & Disinfection Protocol
It is very important to have a strict cross infection, cleaning and disinfection policy in line with current
Hospital/Nursing Home infection control guidelines. A daily routine check should be carried out & the
following steps should be taken:
1. Remove the bedding.
2. If necessary, inflate the mattress.
3. Ensure that the power unit is off.
4. Unplug the power cord from the wall outlet.
5. Unzip the top cover & check for signs of soiling or damage. Note, if signs of soiling on the underside
of the top cover is present this means the cover is no longer water resistant & should be replaced
immediately.
6. Check all areas of the inner cells & any inner covers or foam sections. Note, any signs of soiling on
foam sections means the foam section must be replaced.
7. Ensure that the underside of the mattress is clear of all sharp objects.
8. Perform one of the following:
- If blood is present, decontaminate the whole mattress product in line with current hospital or
Nursing Home Guidelines.
- If blood is not present, remove any soil from the cover with paper towels.
NOTE: If grossly soiled, the cover should be removed, cleaned and decontaminated.
9. Using a clean sponge or paper towel, wipe down the cover surface and cells with a diluted
detergent solution, recommended cleaner disinfectant or other germicidal detergent solution.
10. Cleaning and disinfection may be carried out on the cover with hand hot water and a neutral
detergent or with a sodium hypochlorite solution (0.1% or 1000 parts per million available
chlorine).
11. Alternatively remove the cover and launder, 95o C (203o F), using normal detergents. It is essential
that articles be thoroughly dried after all cleaning procedures and before storage.
12. Perform the following steps to clean the power unit and hose fittings:
- Open the system and expose the pump which is housed in the corner at the foot end of the
mattress.
- Wipe all controls, chassis and hose fittings with a damp cloth and a mild detergent.
- Using a nylon brush, gently clean all crevices as they can harbor microorganisms.
- Air dry all treated surfaces.
WARNING:
●Switch off the electrical supply to the pump and disconnect the power cable from the mains
before cleaning and inspection.
●Protective clothing should be worn when performing cleaning procedures.
●Do not use Phenol based cleaning solutions.
All equipment should be inspected. Any item that is visibly soiled with the patient’s blood or other body
fluids should be properly cleaned or removed. It is recommended that the system is clean regularly and
after each patient use.
In many cases it will be only be necessary to remove the mattress cover for cleaning. If there is obvious
soiling a complete cleaning or decontamination will be required.

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9. Specification
Model Name:
Universal Therapy System (UTS)
Size in CM (L x W x H):
80” x 36” x 8” cm
Weight of system:
33 lbs.
Cycle Time (min):
10 min
Max User weight
350 lbs.
Minimum User Weight
66 lbs.
Min/Max Pressure:
20 ~ 60 mmHg +/- 6mmHg
Max Flow Rate:
≧6 L/min
Rated Voltage:
AC115Vac / 60Hz
Max Current:
0.2-0.1A
Protection Type:
Class II Type BF
Ingress of Water Protection:
IP22
Mode of Operation:
Continuous
Environment (Temperature)
Operation: 15°C to 35° C (59°F to 95°F)
Storage:5°C to 60°C (41°F to 140°F)
Environment (Humidity)
Operation: 30% to 75% non-condensing
Storage: 30% to 90% non-condensing
Operation Atmospheric Pressure
Range
700 hPa to 1060 hPa
Operation altitude
-1017 feet to 9,843 feet (-310 meters to 3000 meters)
Test Standard:
IEC60601-1, IEC60601-1-2 and IEC60601-1-11
Mattress Material
Top Cover: Two way stretch, PU laminated Nylon
Base Cover: PVC laminated Polyester
Packaging in CM (L x W x H):
67x 27 x 98CM
Accessories
Item
Model
Material
Handset
HS-NBE
ABS

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10. EMC Related Notification
Warning: Medical electrical equipment needs special precautions regarding EMC and needs to be
installed according to the EMC information provided. Careful consideration of this information is
essential when stacking or collocating equipment and when routing cables and accessories.
Warning: RF mobile communications equipment can affect medical electrical equipment.
During test, the wired control box signal display flashed but could return to normal status after the test
was not affected so there is no concern with the basic safety.
Please refer to Risk management Report for the detail.
Manufacturer’s declaration-electromagnetic emissions
The Universal Therapy System (UTS) is intended for use in the electromagnetic
environment (for home and professional healthcare) specified below.
The customer or the user of the Universal Therapy System (UTS) should assure that it is
used in such an environment.
Emission test
Compliance
Electromagnetic environment-
guidance
(for home andprofessional
healthcare environment)
RF emissions CISPR 11
Group 1
The Universal Therapy System (UTS)
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 Universal Therapy System (UTS)
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
Not applicable (120V)
Class A (230V)
Voltage fluctuations
/flicker emissions IEC
61000-3-3
Not applicable (120V)
Compliance (230V)

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Manufacturer’s declaration-electromagnetic immunity
The Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home and
professional healthcare) specified below.
The customer or the user of the Universal Therapy System (UTS) should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment-guidance (for
home and professional
healthcare environment)
Electrostatic
discharge (ESD) IEC
61000-4-2
Contact: ±8 kV
Air±2 kV, ±4 kV, ±8 kV,
±15 kV
Contact: ±8 kV
Air±2 kV, ±4 kV, ±8 kV,
±15 kV
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
+ 2kV for power supply
lines
+ 1kV for input/output
lines
+ 2kV for power supply
lines
Not applicable
Mains power quality should
be that of a typical home
healthcare environment.
Surge IEC 61000-4-
5
+ 0.5kV, +1kV line(s) to
line(s)
+ 0.5kV, +1kV, + 2kV
line(s) to earth
+ 0.5kV, +1kV line(s) to
line(s)
Not applicable
Mains power quality should
be that of a typical home
healthcare environment.
Voltage Dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Voltage dips:
0 % UT; 0,5 cycle
0 % UT; 1 cycle
70 % UT; 25/30 cycles
Voltage interruptions:
0 % UT; 250/300 cycle
Mains power quality should
be that of a typical home
healthcare environment. If
the user of the Universal
Therapy System (UTS)
requires continued operation
during power mains
interruptions, it is
recommended that the
Universal Therapy System
(UTS) be powered from an
uninterruptible power supply
or a battery.
Power frequency
(50, 60 Hz)
magnetic field IEC
61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz and 60 Hz
The Universal Therapy
System (UTS) power
frequency magnetic fields
should be at levels
characteristic of a typical
location in a typical home
healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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Manufacturer’s declaration-electromagnetic immunity
The Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home and
professional healthcare) specified below.
The customer or the user of the Universal Therapy System (UTS) should assure that it is used in such and
environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment-guidance
(for home and professional healthcare
environment)
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms:
0,15 MHz –80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
3 Vrms:
0,15 MHz –80 MHz
6 Vrms:
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
80 % AM at 1 kHz
10 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
Portable and mobile RF communications
equipment should be used no closer to
any part of the Universal Therapy System
(UTS) including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
d = 1,2 √P
d = 1,2 √P 80MHz to 800 MHz
d = 2,3 √P 800MHz to 2,7 GHz
Where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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Recommended separation distance between
portable and mobile RF communications equipment and the Universal Therapy System (UTS)
The Universal Therapy System (UTS) is intended for use in an electromagnetic environment (for
home and professional healthcare) in which radiated RF disturbances are controlled. The
customer or the user of the Universal Therapy System (UTS) can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Universal Therapy System (UTS) 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 =1,2√P
80 MHz to 800 MHz
d =1,2√P
800 MHz to 2,7 GHz
d =2,3√P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,8
3,8
7,3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where p is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Universal Therapy System (UTS) is intended for use in the electromagnetic environment (for home and professional
healthcare) specified below.
The customer or the user of the Universal Therapy System (UTS) should assure that it is used in such an
environment.
Test
frequency
(MHz)
Band a)
(MHz)
Service a)
Modulation b)
Maximum
power
(W)
Distance
(m)
IMMUNITY TEST
LEVEL
(V/m)
Compliance
LEVEL
(V/m)
(for home and
professional
healthcare)
385
380 –390
TETRA 400
Pulse
modulation b)
18 Hz
1,8
0,3
27
27
450
430 –470
GMRS 460,
FRS 460
FM c)
±5 kHz deviation
1 kHz sine
2
0,3
28
28
710
704 –787
LTE Band 13,
17
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
745
780
810
800 –960
GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5
Pulse
modulation b)
18 Hz
2
0,3
28
28
870
930
1 720
1 700 –
1 990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2
0,3
28
28
1 845
1 970
2 450
2 400 –
2 570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2
0,3
28
28
5 240
5 100 –
5 800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2
0,3
9
9
5 500
5 785
NOTE If necessary, to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC
61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50 % duty cycle square wave signal.
c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it
does not represent actual modulation, it would be worst case.
During power outage, pump will stop functioning. It is suggested to be use with a stable power source or an uninterruptable
power supply source. The pump will return to its normal operation when power is resumed.

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11. Waste Disposal
This Product has been supplied from an environmentally aware manufacturer that complies
with the WEEE.
This product may contain substances that could be harmful to the environment if disposed of
in places (landfills) that are not appropriate according the legislation. Please be
environmentally responsible and recycle this product through your recycling facility at its end
of life.
12. Storage and Care
Control unit (Air Pump) & Mattress:
●Check the power cord and plug for abrasions or excessive wear.
●Plug in the unit and verify air flows from the unit’s hose connection ports.
●Ensure the system is clean and free from infection.
●Place in plastic bag for storage.
It is recommended the following guidelines are used whenever this system is being stored or
transported another location:
Temperature limitations: 5oC (41oF) ~ 60oC (140oF)
Relative Humidity 30% ~90%
13. Symbols Used
Type BF
Protection Against
Electronic Shock
Class II Equipment
Operating Instructions
Waste Disposal
Caution, Consult
accompanying
documents
Manufacturer
14. Expected Service Life
The Universal Therapy System (UTS) has an expected service life of 2 years. To maintain the condition
of the pump, have the pump serviced regularly according to the schedule recommended by Comet. Do
NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the
Universal Therapy System (UTS).

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15. Warranty
➢ Comet warrants this equipment to be free from defects in material and workmanship from the
date of delivery.
➢ At manufacturers discretion we agree to service, repair or replace any equipment or part found
to be defective at no charge.
➢ This warranty excludes equipment damaged through shipping, tampering, improper
maintenance, carelessness, accident, negligence, misuse, or which has been altered, repaired or
dismantled other than with the manufacture’s written authorization, following its approved
procedures and by properly qualified technicians.
➢ In no event shall Comet be liable for any direct, indirect or consequential damage or loss
resulting from the use of equipment.
16. Disclaimer
WARNING: The use of side rails and other restraints can result in injury or death - through potential
entrapment and potential patient falls. Please see MHRA Device Bulletin DB 2006(06) for details.
WARNING: Risk of electrical shock, serious injury or death. Only authorized technicians should open
the pump unit for servicing and maintenance procedures. Electrical equipment can be extremely
dangerous if damage or misused.
WARNING: Before any cleaning or disinfection procedure, ensure that the pump system is switched
off and unplugged from the mains power supply.
17. Legal Disclaimer
A. Terms such as ‘Medium Risk’, ‘High Risk’ and ‘Very High Risk’ are a description of a person’s risk
levels, these persons may be at danger of developing a pressure sore at the higher risk status
level. These risk levels are assessed by nurses and as there is a variability between nurse
measurements/observations. Descriptive risk levels should only be used as guideline for the risk
assessment methods being used.
B. Comet uses these factors and terms based on the existing market research and internal research
to show the suitability and effectiveness of the pressure care systems provided. Internal and
external research is and will always be ongoing. These risk factors should not be taken as
prescriptive criteria.
C. Comet support surfaces should be seen as an aid to care and DO NOT replace the need for good
nursing care and intervention. All Comet products must be used as part of an individualized care
plan which include proper nursing practices i.e. turning/re-positioning, and regular patient skin
assessments.
D. Pressure relieving equipment alone will not prevent pressure ulcers. Pressure ulcers are multi
factorial and many external and internal factors cause them to develop. It is up to the
professional judgement of the nurse to assess the risk and develop a care plan which prescribes
suitable pressure reducing/relieving equipment and external care. Some pressure sores are
inevitable due to falls and periods of immobility these sores can develop hours after the injury, in
these instances a pressure ulcer can develop and Comet cannot guarantee the use of the
equipment alone will prevent pressure ulcer formation.
E. The mattress usage guidance within this user guide in relation to clinical guidance, should always
be operated in accordance with best clinical practice outlined by the care giver.

Manufactured for: Great Life Healthcare, Inc.
1108 S Baldwin Ave. Suite 107
Arcadia, CA. 91007
www.greatlifehealtcare.com
By: COMET HEALTHCARE LIMITED
Sertus Chambers, Le Sanalele Complex, Vaea Street ,
Saleufi, Apia, Samoa
AL300471 V1.00