Apex Digital Domus 2 Operation Manual

2
Alternating Pressure Redistribution System
Operation Manual
IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE USING
DANGER - To reduce the risk of electrocution:
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store this product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
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. Evaluate patients for entrapment risk according to protocol and monitor patients appropriately.
2. This system is not for use with patients who have a spinal cord injury.
3. Close supervision is necessary when this product is used on or near children. Electrical
burns or choking accident may result from a child swallowing a small part detached from the
device.
4. Use this product only for its intended use as described in this manual. Do not use other
mattress not recommended by the manufacturer.
5. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it
has been dropped or damaged, or dropped into water. Return the product to your supplier or
Apex Medical Corp. for examination and repair.
6. Keep the cord away from heated surfaces.
7. Never block any air openings of this product or place it on soft surfaces, such as a bed or
couch, where openings may be blocked. Keep the air opening free of lint, hair, and other
similar particles.
8. Never drop or insert any object into any opening or hose.
9. Do not modify this equipment without authorization of the manufacturer.
10. Mattress covers have passed skin sensitization and skin irritation test. However, if you
suspect that you may have had or are having an allergic reaction, please consult a physician
immediately.
11. Do not leave long lengths of tubing around the top of your bed. It could lead to strangulation.
CAUTION –
If there is a possibility of electro-magnetic interference with mobile phones, please increase the
distance (3.3m) between devices or turn off the mobile phone.
NOTE, CAUTION AND WARNING STATEMENTS:
NOTE - Indicate some tips.
CAUTION - Indicate correct operating or maintenance procedures in order to prevent
damage to or destruction of the equipment or other property
WARNING - Calls attention to a potential danger that requires correct procedures or
practices in order to prevent personal injury.
1. INTRODUCTION
This manual should be used for initial set up of the system and for reference purposes.
1.1 General Information
The system is a high quality and affordable mattress system suitable for treatment
and prevention of pressure ulcers.
The system has been tested and successfully approved to the following standards:
EN 60601-1
EN 60601-1-2
EN 55011 Class B
EN 61000-3-2 Class A
EN 61000-3-3
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the EN
60601-1-2:2007. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation. This equipment generates uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on, the
user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
Consult the manufacturer or field service technician for help.
1
1.2 Intended Use
This product is intended:
to help and reduce the incidence of pressure ulcers while optimizing patient comfort.
for long term home care of patients suffering from pressure ulcers.
for pain management as prescribed by a physician.
The product can only be operated by personnel who are qualified to perform general nursing
procedures and have received adequate training in knowledge of prevention and treatment of
pressure ulcers.
NOTE: This equipment is not suitable for use in the presence of flammable anesthetic
mixture with air or with pure oxygen or nitrous oxide.
1.3 Warranty-
The Company warrants the pump at the time of its original purchase and for the subsequence time
of period of one year.
The company warrants the bubble pad at the time of its original purchase and for the subsequence
time of period of six months.
The warranty does not cover the followings:
1. The series number label of pump or pads is turn off or cannot be recognized.
2. Damage to the pump or bubble pad resulting from misconnections with other devices.
3. Damage to the device resulting from accidents.
SYMBOL DEFINITION
Dry clean, Any Solvent
Manufacturer.
Except Trichloroethylene
Authorized representative in the European
Do Not Iron
community.
Tumble Dry, Normal, Low
Attention, should read the instructions.
Heat
Catalogue Number Do Not Tumble Dry
Class II Equipment. Do Not Bleach
"BF" symbol, indicate this product is according
to the degree of protecting against electric Do Not Dry Clean
shock for type BF equipment.
Protected against solid foreign objects of 12.5 Machine wash, regular /
mm and greater. Protection against vertically normal, 60 degrees C
falling water drops (140degrees F)
Refer to instruction manual/ booklet/NOTE on
Temperature Limitation
ME EQUIPMENT "Follow instructions for use
Waste Electrical & Electronic Equipment (WEEE): This product should be handed over to
an applicable collection point for the recycling of electrical and electronic equipment. For
more detailed information about the recycling of this product, please contact your local city
office, household waste disposal service or the retail store where you purchased this
product.
2. PRODUCT DESCRIPTION
2.1 Pump Unit
4
3
Rear
3. Air Hose Port
1 Front
1. Power Switch 4. Hanger
2
5. Power Cord
2. Front Panel 5
2.2 Front panel
1. Pressure Adjust Knob
Pressure adjust knob controls the air pressure output. Please
consult the physician for a suitable setting.
2. Main Power Switch
To turn the pump unit on/off.
3. INSTALLATION
Unpack the box and check the package contents for completeness. If there are any damages,
please immediately contact your supplier or Apex Medical Corp
3.1 Pump & Mattress Installation
1. Place the DOMUS 2 on top of a foam or mattress bed. Secure the
mattress firmly by fixing the straps to the bed frame if available.
NOTE: DOMUS 2 is an overlay system, so there must be a foam or
mattress underneath when using.
2. Hang the pump onto the footboard and adjust hangers so the pump is
secured in an upright position; or place the pump on a flat surface.
3. Connect air hose connectors from air mattress to the pump unit.
NOTE: Check and ensure the air hoses are not kinked or tucked
under mattress.
4. Plug the power cord into electrical outlet.
NOTE: 1. Make sure the pump unit is suitable for the local power
voltage. 2. The plug is also served to disconnect the device. Do not
position the equipment so that it is difficult to disconnect the device.
CAUTION: The pump should only be used with mattress recommended by the manufacturer. Do
not use it for any other purpose.
5. Turn the main power switch found from the right side of the pump to ON position.
Several installation tips are listed below:
After installation, the extra length of the power cord, if any, should be neatly arranged to avoid any
tripping accidents. The EQUIPMENT should be firmly placed at position where users/doctors can
access easily.
2
4.

OPERATION

NOTE: Always read the operating instruction before use.
4.1 General operation
1. Switch on the main power switch on right side of the pump.
2. Adjust the pressure setting based upon patient comfort level by turning the pressure
adjustment knob clockwise to increase firmness.
NOTE: Every time the mattress is set up for use, it is recommended that the pressure first
to be set to the max. The user / career can then adjust air mattress weight levels to the
desired softness after set up has been completed
4.2 Emergency operation
When there is a need to perform emergency CPR on the patient, pull the quick release CPR
tag located at the head-end of the mattress on the right hand side if available. The quick
connector found from the pump unit can also be disconnected to hasten deflation. Be sure to
reconnect the quick connector to the pump unit once restore the power supply.
5. CLEANING
It is important to follow the cleaning procedures before using the equipment on human bodies;
otherwise, patients and/or doctors may have the possibility of getting infection.
CAUTION- Do not immerse or soak pump unit.
Wipe the pump unit with a damp cloth and a mild detergent. If other detergent is used, choose one
that will have no chemical effects on the surface of the plastic case of the pump unit.
Wipe down the mattress with warm water containing a mild detergent. The cover may also be
cleaned by using sodium hypochlorite diluted in water. All parts should be air dried thoroughly
before use.
CAUTION - Do not use phenolic based product for cleaning.
CAUTION - After cleaning, dry the mattress without direct exposure sunlight.
6. STORAGE
1. Lay the bubble pad or mattress on a flat surface and upside down.
2. Roll-up the mattress from the head end towards the foot end.
3. Foot-end strap can then be stretched around the rolled pad/ mattress to prevent
unrolling.
NOTE : Do not fold, crease or stack the mattresses.
7.

MAINTENANCE

1. Check main power cord and do not plug it if there is an abrasion or excessive wear.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes
are stubbed together correctly.
3. Check the airflow from the air hose. The airflow should alternate between each
connector every half-cycle time.
4. Check the air hoses if there is kink or breaks. For replacement, please contact Apex
Medical Corp. or your suppliers.
8. EXPECTED SERVICE LIFE
The products are intended to offer safe and reliable operation when used or installed according to
the instructions provided by Apex Medical. Apex Medical recommends that the system be
inspected and serviced by authorized technicians if there are any signs of wear or concerns with
device function. Otherwise, service and inspection of the devices generally should not be required.
9.

TROUBLESHOOTING

Problem Solution
Power is not ON ‧ ‧ ‧ ‧ Check if the plug is connected to mains.
‧ ‧ ‧ ‧ Pressure setting might be inadequate for the patient, adjust comfort range 1 to 2
Patient is bottoming out
levels higher and wait for a few minutes for best comfort.
1
2
‧ ‧ ‧ ‧ Check if all the snap buttons or straps of mattress are all securely fastened.
Mattress form is loose
‧ ‧ ‧ ‧ Check if the mattress is fixed to the bed frame by straps.
No air produced from some
‧ ‧ ‧ ‧
This is normal since there is alternating mode. Air outlets take turns to produce air
air outlets of the air tube
during their cycle time.
connector
NOTE : If the pressure level is consistently low, check for any leakage (tubes or air hoses). If
necessary, replace any damaged tubes or hoses or contact your local qualified dealer
for repair.
10. TECHNICAL SPECIFICATION
Item Specification
Model Domus 2 (9P-047580)
Power Supply (Note: See rating
AC230V 50Hz, 0.05A
label on the product)
Fuse Rating T1AL, 250V
Dimension (L x W x H) 25 x 12.5 x 8.5 cm / 9.8" x 4.9" x 3.3 "
Cycle Time 9.6 mins.
Weight 1.4 Kg / 3.08 lb
Atmospheric
700 hPa to 1013.25 hPa
Pressure
Operation: 10°C to 40°C (50°F to 104°F)
Temp. Storage: -15°C to 50°C (5°F to 122°F)
Environment
Shipping: -15°C to 70°C (5°F to 158°F)
Operation: 10% to 90% non-condensing
Humidity Storage: 10% to 90% non-condensing
Shipping: 10 % to 90% non-condensing
Classification Class II, Type BF, IP21
Mattress Specification
Model 4" Mattress
190x80x10.2(cm)/
Dimension (L x W x H)
74.8"x31.5" x 4"
Weight 4.3 kg/9.48 lb
Pressure Range (mmHg)
NOTE: Please follow national requirements to dispose the unit properly.
3
Appendix A: EMC Information
Guidance and Manufacturer's Declaration- Electromagnetic Emissions:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Emissions Test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions
Class A
IEC61000-3-2
Voltage fluctuations / Flicker
emissions Complies
IEC61000-3-3
Guidance and Manufacturer's Declaration- Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Immunity Test IEC60601 test level
Electrostatic
±6kV contact
Discharge (ESD)
±8kV air
IEC61000-4-2
Electrical fast
±2kV for power supply line
transient/ burst
±1kV for input/out line
IEC61000-4-4
± 1 kV line(s) to
Surge
line(s)
IEC61000-4-5
± 2 kV line(s) to earth
<5 % U (>95 % dip in
T
Voltage dips, short U )for 0,5 cycle
T
interruptions and 40 % U (60 % dip in U
T T
voltage variations on 5 cycles
power supply input 70 % U (30 % dip in U
T T
lines 25 cycles
IEC61000-4-11 <5 % U (>95 % dip in
T
U )for 5 sec
T
Power frequency
(50/60Hz)
3 A/m
magnetic field
IEC61000-4-8
NOTE: U is the A.C. mains voltage prior to the application of the test level
T
Guidance and Manufacturer's Declaration - Electromagnetic Immunity:
This device is intended for use in the electromagnetic environment specified below. The user of this device should
make sure it is used in such an environment.
Immunity Test IEC60601 test level Compliance
Conducted RF
3 Vrms 150 kHz to 3 Vrms
IEC 61000-4-6
80 MHz outside ISM
a
bands
Radiated RF
IEC 61000-4-3
3 V/m
3 V/m 80 MHz to 2.5
GHz
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz
to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distance for transmitters in these frequency ranges.
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 device is used exceeds the applicable RF
compliance level above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and this
device:
This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and this device as recommended
below, according to the maximum output power of the communications equipment
Separation distance according to frequency of transmitter m
Rated maximum output
power of transmitter
150 kHz to 80 MHz
W =
d 1 2 . P
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
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.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
APEX MEDICAL S.L. APEX MEDICAL CORP.
a
Elcano 9, 6 planta No.9, Min Sheng St., Tu-Cheng,
30- 80
48008 Bilbao. Vizcaya. Spain New Taipei City, 23679, Taiwan
www.apexbrand.com
Print-2012/All rights reserved
Electromagnetic Environment-Guidance
The device 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
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network.
Electromagnetic
Compliance
Environment-Guidance
Floors should be wood, concrete or
±6kV contact ceramic tile. If floors are covered with
±8kV air synthetic material, the relative
humidity should be at least 30 %.
±2kV for power supply Mains power quality should be that of
line atypical commercial or hospital
±1kV for input/out line environment
± 1 kV line(s) to Mains power quality should be that of
line(s) atypical commercial or hospital
environment.
<5 % U (>95 % dip in U ) Mains power quality should be that of
T T
for 0,5 cycle atypical commercial or hospital
)for 40 % U (60 % dip in U ) environment. If the user of this device
T T
for 5 cycles requires continued operation during
)for 70 % U (30 % dip in U ) power mains interruptions, it is
T T
for 25 cycles recommended that the device be
<5 % U (>95 % dip in U ) powered from an uninterruptible power
T T
for 5 sec supply or a battery.
Power frequency magnetic fields
should be at levels characteristic of
3 A/m
atypical location in a typical
commercial or hospital environment.
Electromagnetic Environment-Guidance
Portable and mobile RF communications equipment should
be used no closer to any part of this device, including
cables, than there commended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
=
d 1 2 . P
150kHz to 80MHz
=
d 1 2 . P 150kHz to 80MHz
=
d 2 3 . P
80 MHz to 2.5G MHz
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
b
distance in meters (m).
Field strengths from fixed RF transmitters, as determined by
c
an electromagnetic site survey , should be less than the
d
compliance level in each frequency range .
Interference may occur in the vicinity of equipment marked
with the following symbol:
80 MHz to 800 MHz 800 MHz to 2,5 GHz
=
=
d 2 3 . P
d 1 2 . P
0.12 0.23
0.38 0.73
1.2 2.3
3.8 7.3
12 23
Manufacturing Facility:
Apex Medical (Kunshan) Corp.
No. 1368, Zi Zhu Rd. Kunshan
Kai Fa Hi-Tech Kunshan City,
JiangSu Sheng, China
4 476006-0000 V1.0