Domus 0P-077540 3D Alternating Pressure Redistribution System User Manual

User Manual
Care for a healthy life
MODEL NO.: 9P-077540
PLEASE READ THE MANUAL BEFORE USE

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 tong 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 13.3ml 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.

SYMBOLS

| Authorized representative in the European community.
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| Catalog, reorder or reference number
| Manufacturer
| Complies with standards protecting against electric shock for type BF equipment.
| Attention, you should read the accompanying information carefully!
| Attention – Observe proper Disposal of Electrical S Electronic Equipment (WEEE):
This product should be handed over to an appropriate 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.
| Consult operating instructions for use
| Protected against solid foreign objects of 12,5 mm and greater; Protection against vertically falling water drops
| Class II
| Temperature limitation/temperature range
| Dry clean, Any Solvent Except Trichloroethylene
| Do Not Iron
| Tumble Dry, Normal, Low Heat
| Do Not Tumble Dry
| Do Not Bleach
| Do Not Dry Clean
| Machine wash, regular / normal, 95 degrees C 1203 degrees F)
| Machine wash, regular / normal, 60 degrees C 1140 degrees F)

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:
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 61000-3-2
Class A IEC/EN 61000-3-3
CISPR 11 Group 1, Class B
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2. 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.
1.2 Intended
Use This product is intended to help and reduce the incidence of pressure ulcers while optimizing patient comfort. It also provides following purposes:
■ 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 the knowledge of prevention and treatment of pressure ulcer.  NOTE: Equipment is not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.

Product Description

Unpack the box to check for any damage which may have occurred during shipment. If there is any damage, please contact the point of purchase immediately.
2.1 Pump and Mattress System

1. CPR
2. Pump Unit
3. Mattress System
4. Quick Connector

2.2 Pump Unit Front

1. Quick Connector Slot
2. Display Panel

Rear

1. Power Switch
2. Power Cord
3. Bed Frame Hangers
4. Air Filter

2.3 Front Panel

1. Pressure Adjust Levels
   Pressure adjust levels controls the air pressure output. When press , the output pressure will increase. Vice versa tor decreasing air pressure. Higher- pressure output will support the heavier weight patient. In order to find the correct pressure setting: First inflate the mattress to max pressure level, have the patient lie on top of the mattress, then decrease the pressure gradually until the patient feet most comfortable without bottoming out. Have the caregiver insert palm facing up and place between patient’s buttock’s area and static cell. Should the palm able to touch patient’s buttock, increase the pressure until the skin is least 1/2″ inch away from the palm. Always leave at least 1″ inch space between patient’s buttock area to the static cell under to prevent bottoming out.

2. Therapy Mode
   A. Alternate icig Continuously and sequentially inflates and deflates air cells to achieve periodic pressure relief every 10 minutes and avoid prolonged pressure on any single point beneath the patient.
   B. Continuous Low Pressure (CLPI
   Constantly non-alternating mode. The system will redistribute body mass over a greater surface area at a constant low pressure. All of the air cells are equally inflated at lower pressure when compared to the respective comfort level in alternating mode.

3. Alarm Mute
   Press alarm mute button to temporary suspend the low-pressure alarm (LED light and buzzerl. Should the situation not resolved within 3 minutes, the alarm shall resume to notify the patient.
   A. PFA !Power Failure Alarm
   During power failure situation, the Power Failure LED light will be lit on with acoustic buzzer. By pressing the mute button to disable both buzzer and LED.
   B. Low Pressure Indicator
   When low pressure LED lights up, the pressure inside of air mattress is below normal. Please refer to the troubleshooting section.
   C. Tech. Support
   This feature will light during mechanical failure situation. User should notify the authorized technician for repair.

4. Panel Lock
   If the control panel remains untouched for 5 minutes, a green LED will light and the control panel will lock all settings. This will prevent the settings from being accidentally changed during normal operation. To unlock, simply press the Panel lock button for three seconds.

Installation

Unpack the box and check the package content and if there is any item missing.
Package Content List
■ Mattress unit x 1 (may not be included if only pump unit is purchased)
■ Pump unit x 1
■ User manual x 1
Inspect equipment for damage which may have occurred during shipment. If there is damage, please contact your dealer immediately.
3.1 Pump S Mattress Installation

1. Place the mattress or pad on top of the bed frame. Please note for the foot end. If it is an overlay system ‘mattress height less than 81 please make sure there is a foam or a current mattress underneath.
   WARNING: The overlay mattress must be applied on the underlying mattress.

2. Hang the pump onto bed rail (foot-end), and adjust hangers to best upright position of the pump, or place the pump on a flat surface.

3. Connect air hose connectors from air mattress to the pump unit. When a “click” sound is felt or heard, the connection is completed and secured.
   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. Do not position the equipment so that it is difficult to operate the disconnecting device
   2. The plug is also used to disconnect the device.
   CAUTION: The pump can only be applied to the mattress recommended by the manufacturer. Do not use it for any other purpose. (Applied part: air mattress(

5. Then turn the main power switch to ON position.
   NOTE:You can unplug the unit to power-off the device.
   CAUTION:The pump supplied with the mattress can only be used for mattresses recommended by the manufacturer. Do not use it for any other purpose. ‘applied part: air mattress( NOTE:IFor models WITHOUT the low-air- loss function( During power outages, you can cover the Quick Connector with the transport cap to maintain air pressure inside the air cells.
   NOTE: After installation, make sure any excess cord or tubing is removed from possible foot traffic to avoid accidental tripping. All EQUIPMENT should be positioned to always allow unhindered patient access by physicians and caregivers.
   The EQUIPMENT should be firmly placed at position where users/doctors can access easily.

Operation

4.1 General operation

1. Switch on the main power switch found on the side of the pump.
2. Once the pump begins delivering air into the mattress it will take approximately 30 minutes to fully inflate the mattress.
3. Every time when mattress is first setup for use, It will be forced to execute Maxfirm for the quickest inflation. The low-pressure indicator (yellow LED) will light up when the mattress is not fully inflated at initial inflation. If the appropriate pressure is reached, the low-pressure indicator (yellow LED) will go off.
4. When the initial inflation (Maxfirm process) is completed, the system will enter the “alternating mode”
5. According to the weight and height of the patient, adjust the pressure setting to the most comfortable level without bottoming out, then the pressure in mattress will slowly increase to the intended value after the air mattress is ready to use.
   NOTE: Every time when mattress is first setup for use, It will be forced to execute Maxfirm for the quickest inflation. User can then adjust air mattress to the desired softness afterwards.

4.2 Emergency CPR Operations

CPR must be performed on a firm surface. Therefore, if an emergency CPR situation occurs with the patient on the mattress, the mattress must be quickly deflated. This is done by quickly pulling on the CPR tag located at the head of the mattress on the patient’s right-side. The quick connector found from the pump unit can also be disconnected to hasten deflation.
4.3 Pressure Set Up
Users can adjust pressure of air mattress to a desired softness by adjusting the comfort keys. Please consult your physician for a suitable setting.
Patient can lie on the mattress after the pump is running in the alternating mode; this indicates the pressure is reached to the desired softness.
NOTE: Check to see if the suitable pressure is selected by sliding one hand between the deflated air cells and the patient to ensure patient is not bottoming out. Users should be able to feel the minimum contact. If the pump unit is equipped without alarm buzzer, the Low Pressure indicator will light up until the low-pressure fault condition is resolved.
4.4 Low Pressure Function
When an abnormal low pressure is occurred, the Low Pressure indicator (yellow LEO) will light up. Check that connections are correctly made and that they are correctly installed as per installation instructions.
NOTE: If the pressure level is consistently low, check for any leakage (tubes or connecting hoses). If necessary, replace any damaged tubes or hoses. Or contact local qualified dealer for repair.
If the pump unit is equipped with alarm buzzer, the alarm will buzz and the Low Pressure indicator light up when air pressure is below normal. To mute the alarm, simply press the 45 button on the panel. However, the low pressure indicator remains until the low-pressure fault condition is solved.
4.5 Mode Selection
Press the 1 button to choose desired therapy mode.
4.6 Alarm Mute
When low-pressure situation occurred, both the LED light and buzzer will sound off to warn the user. By pressing the button, it will temporary mute the buzzer so the caregiver may check for possible air leaks. Should the situation not resolved within 3 minutes; the alarm will resume to beep.

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. Wipe the pump unit with a damp cloth and a mild detergent, and keep it away from dust. If other detergent is used, choose one that will have no chemical effects on the surface of the plastic case of the pump unit.
CAUTION- Do not immerse or soak 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. The carrying bag (if available) should be turned inside-out and completely wiped-down using disinfectant solutions. Allow it to air-dry thoroughly and then turn it back and wipe down the outside of the bag with disinfectant solutions.

Cover Material: Nylon/PU|
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Cover Material: Silver+ Nylon/PU
Cover Material: Stretch|

CAUTION- Do not use phenolic based product for cleaning.
CAUTION- Dry the mattress without direct exposure to sunlight after cleaning.

Storage

1. To store the mattress, lay the mattress out flat and upsides down.
2. Roll from the head end towards the foot end with CPR valve open.
3. Foot-end strap can then be stretched around the rolled mattress to prevent unrolling.
   NOTE: Do not fold, crease or stack the mattresses.Avoid direct sunshine.

Maintenance

7.1 General

1. Check main power cord and plug if there is abrasions or excessive wear.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed together correctly.
3. Check airflow from the quick connector. The airflow should alternate between each connector every half -cycle time if its in alternating mode. LI. Check the air hoses if there is kink or breaks. For replacement, please contact our local dealers.

7.2 Air Filter Replacement

1. Open the air filter cap located at the back of pump.
2. The filter is reusable and can be washed gently with a mild detergent and water. Dry the filter before use.
3. Check and replace air filter regularly if environment is dirty.

Expected Service Life:

The products are intended to offer safe and reliable operation when use 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 and indication on products. Otherwise, service and inspection of the devices generally should not be required.

Trouble Shooting

1. Power is not ON
   • Check if the plug is connected to mains.

2. Low pressure indicator is ON
   • Check if the connection between quick connector to pump unit is tightly secured.
   • Check if all tubing connections along mattress are secured.
   • Check if the CPR valve is sealed.
   • Check if there are any air leakage on air cells.

3. Patient is bottoming out
   • Pressure setting might be inadequate for the patient, adjust comfort range 1 to 2 levels higher and wait for a few minutes for best comfort.

4. Mattress form is loose
   • Check if all the snap buttons or straps of mattress are all securely fastened.
   • Check if the mattress is fixed to the bed frame by straps.

5. No air produced from some air outlets of the air tube connector
   • This is normal since there is alternating mode. Air outlets take turns to produce air during their cycle time.
   If the above information does not solve your problems, please contact your local agent directly. They might require a technician to take care the problem.

Technical Specification

-15° C to 50° C (5°F to 122° Fl Shipping: -15° C to 70° C 15° F to 158° F)
Humidity| Operation: 10% to 90% non-condensing Storage: 10% to 90% non- condensing Shipping:10 % to 90% non-condensing
Atmospheric
Pressure| Operation: 700 hPa to 1013.25 hPa Storage: 50 – 106 kPa
Shipping: 50 – 106 kPa
Classification| Class It, Type BF, IP21 Applied Part: Air Mattress
Not suitable for use in the presence of a flammable anesthetic mixture Illo AP or APG rotection)
Mattress| Specification|
Model| 5′ Overlay| 5″ . Y Replacemen:| 8″ Replacement
Dimension (L xW x HI| 200 x 90 x 13 cm
78.7″ x 35.4″ x 5″| 200 x 90 x 20 cm
78.7′ x 35.4″ x 8″
200 x 85 x 13 cm 78.7″ x 33.4″ x 5″| 200 x 85 x 20 cm 78.7′ x 33.4″ x 8″
200 x 80 x 13 cm 78.7″ x 31.5″ x 5″| 200 x 80 x 20 cm 78.7″ x 31.5″ x 8′
Weight| 5.6 kg / 12.5 lb| 6.9 kg / 15.2 lb
Max. Support Weight| 200 Kg / 440 lb| 250 Kg / 550 lb
Pressure Range| 6 comfort level settings

1. Consult the distributor or EU representative for further technical documents.
2. These specifications are also applicable for other regions operating with the same power supply.
3. Mattress dimensions and weight is measured without foam base.
4. The manufacturer reserves the right to modify the specifications without prior notice.

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 mr’.(, sure it is used in such an environment.
Warning:

1. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used.
2. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
3. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Pump, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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.

|
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Basic EMC standard| Immunity Test Levels Professional HOME healthcare HEALTHCARE
facility environment ENVIRONMENT ±8kV contact +15kV air| Compliance Levels
±8kV contact +15kV air| Electromagnetic Environment-Guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Electrostatic Discharge (ESD) IEC61000-4-2
Electrical fast transient/ burst IEC61000-4-4| ±2kV for power supply line
±1kV for input/output line| ±2kV for power supply line ±1kV for input/outpu t line| Mains power quality should be that of atypical commercial or hospital environment
Surge IE661000-4-5| ± 1 kV linelsIto line(s)
± 2 kV linels) to earth| ± 1 kV linels) to linels)| ± 1 kV linels) to
line(s)| Mains power quality should be that of atypical commercial or hospital environment.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11| Voltage Dips: it 100% reduction for 0.5 period, .. 111100% reduction for 1 period, iiil 30% reduction for 25/30 period, Voltage Interruptions:
100% reduction for 250/300 period| 230V| Mains power quality should be that of a typical commercial or hospital environment. If the user of this device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) magnetic field IEC61000-4-8| 30 A/m| 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.
Conducted RF IEC 61000-4-6| 3 Vrms 0,15 MHz – 80 MHz 6 Vrms in ISM bands between 0,15 MHz and 80 MHz 80 °A 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| 6Vrms| 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 =a 150kHz to 80MHz
d =0.6a 80MHz to 800MHz d =1.2J 800 MHz to 2.7GHz
Radiated RF EM Fields
IEC61000-4-3| 3 V/m 80 MHz to 2.7 GHz
80 % AM at 1 kHz 385-6000 MHz,| 10 V/m 80 MHz to 2,7 GHz
80 % AM at 1 kHz 385-6000 MHz,| 1OV/m
| 9-28V/m, 80% AM(1kHz) pulse mode and other modulation| 9-28V/m, 80% AM(lkHz) pulse I mode and other modulation| | Where P is the maximum output mode and other mode and other power rating of the transmitter in modulation modulation watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (ri).’ Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey ,8 should be less than the compliance level in each frequency ranged. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: UT is the a.c. mains voltage prior to the application of the test level
NOTE 2 : At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 3: 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 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.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 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

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  ransmitter 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  ffected by absorption and reflection fram structures, objects, and people.

Apex Medical S.L.
Elcano 9, 6° planta
48008 Bilbao. Vizcaya. Spain
Apex Medical Corp.
No. 9, Min Sheng St., Tu-Cheng,
New Taipei City, 23679, Taiwan
www.apexmedicalcorp.com
Print-2019/All rights reserved
776015-0000 V1.0

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