Prius Healthcare USA DynaFlow User manual

1805
DynaFlow
Alternating Low Air Loss
Pressure Relief System
User Manual
Control Unit: FC-PHR0028
Mattress: FM-PHR0008
Manufactured by:
Prius Healthcare USA
4027 Tampa Rd, Suite 3200
Oldsmar, FL 34677
Tel: [phone]
Fax: [phone]
www.priushcusa.com

Content
1. The Purpose of this Manual.................................................................................1
2. Product Description................................................................................................1
Master Control Unit Features
Mattress Features
3. Technical Data ...........................................................................................................3
Master Control Unit
DynaFlow Mattress Replacement
Symbol Definition
4. Instruction for Proper Use...................................................................................4
5. Cleaning ........................................................................................................................8
The Mattress
The Master Control Unit
Replace Air Filter
Waste Disposal
6. Storage and Care....................................................................................................10
7. Maintenance and Troubleshooting...............................................................10
8. EMC Related Notification...................................................................................11
9. Warranty...................................................................................................................16

Warning

Connect the Master Control unit to a proper power source.
Don’t use the system in the presence of any flammable gases.
( such as Anesthetic Agents)

Keep the pump and mattress away from open flame.

Keep sharp objects away from the mattress.
The device is not AP/APG protected.

Do not place a heating device on or close to the mattress system.
Caution

The Alternating System should always be used in accordance with your
Institutions pressure care guidelines.

Re-positioning of the patient is always recommended when using an
alternating pressure air mattress (APAM).

The Control unit can only be repaired by an authorized technician.

Do not drop the control unit.

Do not store the system in direct sunlight or extreme cold conditions

Operation Temp: 15-35°C ( 59-104
℉
) R.H. : 30-75 %

1
1. The Purpose of this Manual
This operation manual is mainly focused on the set up, cleaning and routine
maintenance of the DynaFlow Alternating Anti-Decubitus System. We
recommend you keeping this manual handy to answer most of the question
related to the system.
2. Product Description
The DynaFlow system is a unique and innovative specialized mattress
replacement unit. The system utilizes true low air loss technology with a high
flow rate that provides pressure management for the treatment of pressure
ulcers. The advanced 3 in 1 alternating function also provides active prevention
for pressure relief, especially for those in acute care and long-term care
settings (the cells inflate and deflate in a 3:1 cycle, meaning 2/3 of the body is
always supported at any one time). The system is also come with pulsation
which simulates a massage to assist in maximizing a patient’s comfort.
Intended Users
Healthcare professionals or caregivers who are at least fifteen years in age,
with the ability to read and understand English and Westernized Arabic
Numerals.
This device should not be operated by patient.
The DynaFlow Control Unit Features
User-friendly controls
Large LCD display on each function status.
CPR quick release
Patient Care mode provides quick maximum inflation within seconds to
help transfers and nursing procedures.
Auto Set mode sets mattress pressure based on patient’s height and
weight.
Lock out function avoids tampering with settings.
Mattress Features
Therapeutic micro low air loss helps manage moisture and provides
alternating therapy to prevent and pressure ulcers treatment
Modularized design on each air cell for easy replacement
Highly vapor permeable and oversized pliable quilted nylon top cover
providing low shear, friction and moisture protection
CPR quick release for rapid deflation
Integrated power cable management for tidiness
2” convoluted foam base provides additional safety
Incorporate sensor technology with Auto mode to constantly monitoring
the mattress pressure based on inputting patient’s height and weight

2
Caution
Alternating pressure should not be applied to pain or pain-sensitive
patients. In these cases, we recommend the application of static mode or
other suitable foam overlays or other materials which can be found in
sample supply in the Prius Healthcare USA product range.
Therapy Mode
Selection for
Alternation,
Pulsation and
Static
Maximum
Inflation
Cycle Time
Preset Key
Power Switch
Audio Alarm
On/Off
Auto Set
Panel Lock
Power Failure
Alarm
Sensor Disconnect
Bottom
Out Alarm
Comfort
Setting
LCD Display
Patient’s
BMI Setting

3
3. Technical Data
Master Control Unit
Model No. FC-PHR0028
Model Name DynaFlow
Size (inch) LxWxH 12.2“ x 13.2“ x 6.7“
Weight 15.5 Lbs
Cycle Time (min) 3 - 95
Min Operating Pressure 8 +/- 5mmHg
Max Operating Pressure 35 +/- 5mmHg
Max Flow-rate ≧700 l/min
Rated Voltage AC 110-120V
Max Current 3 Amp
Fuse Rating T5AH 250V
Rated Frequency 60 Hz
Classification Class II(W/functional earth), Type BF
Not AP/APG type
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)
Standard
IEC 60601-1,
CAN/CSA C22.2 No. 601.1,
IEC 60601-1-2
Mattress Replacement
Model No FM-PHR0008
Size (inch) LxWxH 80“ x 36“ x 10“
Weight (lbs) 35.5 Lbs
Cells Number 18 cells
Cells Material Nylon coated with PU
Cover Material Nylon woven fabric w/ PU coating finish
Base Material Woven Polyester fabric w/ PVC backing

4
Symbol Definition
Type BF
Protection Against
Electronic Shock
Class II Equipment
Caution, Consult
accompanying
documents
Refer To Instruction
Manual / Booklet
Keep dry Waste Disposal
SGS product
certification mark
Instruction for Proper Use
1. Remove the existing mattress from the bed frame.
2. Replace the standard mattress with mattress replacement system (orient
mattress so that the air tube is at the foot of the bed). Remove the mattress
replacement from the box and place it directly on the bed.
3. Secure straps beneath the mattress to the bed frame.
4. Position the control unit on the foot board of the bed frame.
5. Attach the air tube connector and auto sensor connector to control unit’s
socket.
6. Verify that air hoses are not kinked under the mattress.
7. Attach cover to mattress.
8. Plug in the control unit and turn on the power which is located on the left side
corner on control panel (the STANDBY LED will illuminate).

5
9. Press the STANDBY/OPERATE switch button on the control panel (OPERATE
LED will now be illuminated and the control unit will be in operation)
Auto Set Mode
Ensure the auto sensor connector is connected properly before pressing Auto
SET button. When Auto SET function is activated, control unit is automatically
optimizing patient’s comfort setting base on patient’s BMI input. Press the
PATIENT CARE button for fast inflation. Allow 4-7 min for full inflation.
1. Press the SET button to enter into settings mode to input patient’s BMI.
Settings is divided into three portions. The first settings mode will allow
for selection between Inch/Lbs & Cm/Kgs (Height and Weight will flash
on LCD screen during this mode). Press the SET button a second time to
enter into the next settings mode that allows for selection of height
(Height will flash on the LCD screen during this mode). Press the SET
button again to enter into the last settings mode that allows for selection
of weight (Weight will flash on the LCD screen during this mode). Finally
press the SET button to exit settings mode completely with your selected
settings for height & weight.
2. When the mattress is fully inflated, the caregiver can transfer the patient
onto the mattress. (Note: the mattress can be inflated while a patient is
laying on it)
3. Press PATIENT CARE again to return previous setting.
4. By activating the PATIENT CARE function, all chambers of the mattress
system are inflated with maximum system pressure for 30 minutes. After
30 minutes, the system defaults back to previous setting.
Alternate Mode
1. Press the "MODE" button to select the Alternate and Static Function to
enable the 3-1 alternating functions.

6
Alternation Cycle Illustration
2. Press "CYCLE" button for alternating time setting. Alternating time can be
adjusted from 3 min to 20 min by increments of 1 min and 20 min to 95
minutes by increments of 5 min. The Alternating time will be displayed
on the Time display window on the control panel.
Static Mode
1. Press the "MODE" button to select the Static Mode and adjust the comfort
control by pressing the SOFT/FIRM button to achieve maximum patient
comfort.
2. On this mode the system provides low air loss therapy. Perform a hand
heck by placing a hand under the patient’s buttocks between the cells and
foam. The patient should have at least 4cm of clearance between the
buttocks and the bottom of the mattress. If the STATIC function is
selected the time display will remain blank.
Note: The caregiver can select the “Static Mode” to provide the patient with
only low air loss therapy. To go back to Alternate Mode needs manual switch.
Fowler
When Fowler function is activated (Auto-Set), the mattress will increase the
comfort level setting by 3 levels and provided additional support to the
patient (it is not reccomended for the patient to NOT be placed on Fowler
setting for more than 60 minutes to prevent being on a higher pressure
setting than what is necessary). The Fowler function will engage when
patient head angle is larger than 30 degrees.

7
Alarm On/Off
The Alarm will be triggered when a Sensor Disconnect & Bottoming Out is
detected. Disable the alarm by pressing the button.
Lock Button
1. The Prius DynaFlow is equipped with auto-locking intelligence. All
function keys will be automatically disabled if the control panel is not in
operation for 2 minutes and when this function is engaged an green LED
will illuminate.
2. To unlock the control panel, simply press and hold the “LOCK” button for
5 seconds.
Comfort Level Setting
Note: The pressure level settings on the weight chart are only a guideline. The
proper adjustment of the pressure level must be applied according to
individual patient.
Please be aware that once patients have any uncomfortable feelings or
symptoms, patients must notify healthcare professionals or caregivers to
change product settings suit for patients‘ condition.

8
CPR Deflation
The air hose connectors can be disconnected from the controller to quick
release the air when in an emergency situation where CPR is to be performed.
5. Cleaning
The Mattress
The mattress should be cleaned on the bed weekly using a damp soft cloth and
mild detergent. If top cover or base cover becomes grossly soiled, put on clean
gloves, plastic gown and eye protection before removing top and base covers and
disposing according to standard hospital procedures for contaminated waste and
replace with clean covers.
Covers can be washed and thermally disinfected in a washing machine by
following below procedure: (Never use phenol based cleaning solutions).
Industrial
Break washes
Cold
10 minutes
Main washes
60°C (140°F)
6 minutes
Main washes
70°C (158°F)
10 minutes
Extraction
2 minutes
Cold Rinses
Extraction
5 minutes
Domestic
Pre-wash
Cold
Main Wash
70°C (158°F)
10 minutes
Extraction
2 minutes
Cold Rinses
Extraction
5 minutes
Tumble Drying or Tunnel Drying is not recommended.
Mattress Cells can be wiped over with a solution of sodium hypochlorite1000ppm
or any other non-phenolic germicidal solution.
The Master Control Unit
Caution
SWITCH OFF THE ELECTRICAL SUPPLY TO THE PUMP AND DISCONNECT THE
POWER CORD FROM THE MAIN SUPPLY BEFORE CLEANING AND INSPECTION

9
The pump unit should also be cleaned weekly using a damp soft cloth and mild
detergent.
The pump casing is manufactured from ABS plastic and if the case is soiled the
pump can be wiped down with a sodium hypochlorite solution to dilution of
1000ppm or any EPA- approved hospital grade disinfectant. (Do not use phenol
based cleaning solution).
The air filter should also be cleaned and checked as often as possible at a
minimum of every six months. Air Filter can be removed by pinching center of
the filter and pulling outward from the back of the control unit. Replace Air
Filter
1.Remove air filter and replace with a new one.
2.Use a soft bristle to remove dust and difficult dried-on soil.
NOTE:
1. Do not use phenol based cleaning solutions.
2. Switch off the electrical supply to the pump and disconnect the power cord
from the main supply before cleaning and inspection)
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.
Filter

10
6. Storage and Care
Master Control Unit:
Check the power cord and plug for abrasions or excessive wear.
Plug in the unit and verify air flows from the units hose connection ports.
Place in plastic bag for storage.
Mattress:
Check the air manifold for kinks or breaks. Replace if necessary.
Twist the CPR plug at the head of the mattress and disconnect the air feed
tubes. All the air will now be expelled. Starting at the head end, the
mattress can now be rolled. Use the base mounted straps for
containment.
Place in plastic bag of storage.
It is recommended the following guidelines are used whenever this system is
being stored or transported another location:
Temperature limitations: 5°C ~ 60°C
Relative Humidity: 30% to 90%
7. Maintenance & Troubleshooting
No daily maintenance is required. It is intended this equipment should only be
serviced by properly qualified, authorized technical personnel. In case of minor
trouble please refer as following Troubleshooting.
Symptom
Inspection Procedures
Possible Solution
The pump is not
functioning.
1. Check for correct
power voltage
connected.
2. Check for blown fuse.
1. Connect to correct
main power source.
2. Replace new fuse.
3. Refer to service if
problem persist.
Bottom out LED is
constantly illuminated
or The mattress is not
inflating while pump
is in operation.
1. Check for any loose
connections.
2. Check for CPR valve.
3. Check for air leakage
on air cells.
1. Ensure all connectors
are properly attached.
2. Ensure CPR valve is set
to “CLOSE” position.
3. Replace faulty air cell if
necessary.
4. Refer to service if
problem persist.
Pump is noisy.
1. Ensure pump is resting
against solid surface.
1. Repositioning the
pump.
2. Refer to service if
problem persist.

11
8. EMC Related Notifications
Manufacturer’s declaration-electromagnetic emissions
The DYNAFLOW is intended for use in the electromagnetic environment (for
home healthcare) specified below.
The customer or the user of the DYNAFLOW should assure that it is used in such
an environment.
Emission test
Compliance
Electromagnetic environment-guidance
(for home healthcare environment)
RF emissions
CISPR 11
Group 1
The DYNAFLOW 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 DYNAFLOW 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
Compliance

12
Manufacturer’s declaration-electromagnetic immunity
The DYNAFLOW is intended for use in the electromagnetic environment (for home
healthcare) specified below.
The customer or the user of the DYNAFLOW should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment-
guidance
(for home 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 DYNAFLOW
requires continued
operation during power
mains interruptions, it is
recommended that the
DYNAFLOW 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, 60 Hz
The DYNAFLOW 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.

13
Manufacturer’s declaration-electromagnetic immunity
The DYNAFLOW is intended for use in the electromagnetic environment (for home healthcare)
specified below.
The customer or the user of the DYNAFLOW should assure that is used in such and environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment-guidance
(for home 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 e)
10 V/m
80 MHz – 2,7
GHz b)
80 % AM at 1
kHz c)
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 e)
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 DYNAFLOW 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 Pis the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range.b
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.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the DYNAFLOW is used exceeds the applicable RF
compliance level above, the DYNAFLOW should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the DYNAFLOW .
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

14
Recommended separation distance between
portable and mobile RF communications equipment and the
DYNAFLOW
The DYNAFLOW is intended for use in an electromagnetic environment (for home
healthcare) in which radiated RF disturbances are controlled. The customer or the
user of the DYNAFLOW can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the DYNAFLOW 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
N/A
0,12
0,23
0,1
N/A
0,38
0,73
1
N/A
1,2
2,3
10
N/A
3,8
7,3
100
N/A
12
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance din 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.
* During DIP interference, the pump will outage these are normal. The pump outage does not affect
the motor operation.

15
Manufacturer’s declaration-electromagnetic immunity
Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications
equipment
The
DYNAFLOW is intended for use in the electromagnetic environment (for home healthcare)
specified below.
The customer or the user of the
DYNAFLOW 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
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
1720
1700 –
1990
GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3,
4, 25; UMTS
Pulse
modulation b)
217 Hz
2 0,3 28 28
1845
1970
2450 2400 –
2570
Bluetooth,
WLAN,
802.11 b/g/n,
RFID 2450,
LTE Band 7
Pulse
modulation b)
217 Hz
2 0,3 28 28
5240
5100 –
5800
WLAN 802.11
a/n
Pulse
modulation b)
217 Hz
0,2 0,3 9 9
5500
5785
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.

16
9. Warranty
Prius Healthcare USA guarantees that this equipment is free from defects in
material and workmanship. Our obligation under this warranty is limited to
the repair of equipment returned to the service address given below,
transportation charges prepaid, within 12 months after delivery to the
original purchaser for all equipment.
We agree to service and/or adjust any equipment returned for that purpose
and to replace or repair any part, which is proven to be defective at no charge.
This warranty excludes equipment damage through shipping, tampering,
improper maintenance, careless, accident, negligence or misuse, or products
which have been altered, repaired or dismantled other than with the
manufacture’s written authorization and by its approved procedures and by
properly qualified technicians.
In no event shall Prius Healthcare USA be liable for any direct, indirect of
consequential damages or losses resulting from the use of equipment.