APEX Domus 1 Alternating Bubble System User Manual

: June 12, 2024
: Apex

Table of Contents

IMPORTANT SAFEGUARDS
- READ ALL INSTRUCTIONS BEFORE USING
INTRODUCTION
- General Information
Intended Use
SYMBOL DEFINITION
PRODUCT DESCRIPTION
INSTALLATION
CLEANING
STORAGE
MAINTENANCE
TECHINICAL SPECIFICATION
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

APEX Domus 1 Alternating Bubble System User Manual

IMPORTANT SAFEGUARDS

READ ALL INSTRUCTIONS BEFORE USING

DANGER – To recuce the risk of electrocution

Always unplug this product immediately after using.
Do not use while bathing.
Do not place or store this product where it can fall or be pulled into a tub or sink.
Do not place in or drop into water or other liquid.
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:
Evaluate patients for entrapment risk according to protocol and monitor patients appropriately.
This system is not for use with patients who have a spinal cord injury.
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.
Use this product only for its intended use as described in this manual. Do not use other mattress not recommended by the manufacturer.
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.
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.
Never drop or insert any object into any opening or hose. 9. Do not modify this equipment without authorization of the manufacturer.
Do not directly contact mattress without top cover. Apex medical corp. provides optional covers that 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.
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.

INTRODUCTION

This manual should be used for initial set up of the system and for reference purposes.

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 61000-3-2 Class A
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 devicels) arw connected
Consult the manufacture or field service technician for help

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.
1.2 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:

The series number label of pump or pads is turn off or cannot be recognized.
Damage to the pump or bubble pad resulting from misconnections with other devices.
Damage to the device resulting from accidents.

Manufacturer.

Authorized representative in the European community.
Attention should read the Instruction

Attention, should read the instructions.
Class II Equipment.

“BF” symbol, indicate this product is according to the degree of protecting against electric shock for type BF equipment.

Protected against solid foreign objects of 12.5 mm and greater.
Protection against vertically falling water drops (Model:OP-047580, 9P-0475001

Refer to instruction manual/ booklet/NOTE on ME EOUIPMENT “Follow instructions for use

Temperature Limitation

Waste Electrical S Electronic Equipment IWEEE): 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.

SYMBOL DEFINITION

PRODUCT DESCRIPTION

**Pump Unit

**

FRONT

Power Switch
Front Panel

Rear

Air hose port
Hanger
Power Cord

Front

Pressure Adjust Knob Pressure adjust knob controls the air pressure output. Please consult the physician for a suitable setting.
Main Power Switch To turn the pump unit on/off.

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.

Pump S Mattress Installation

Place the bubble pad or mattress on top of the bed frame. Secure the mattress firmly by fixing the straps to the bed frame if available.
NOTE: Please cover the mattress with a cotton sheet if using bubble oad to enhance comfort **NOTE:** Please cover the mattress with a top cover to avoid direct skin contact with mattress. Consumer may contact Apex Medical Corp for optional mattress covers which have passed skin sensitization and skin irritation test.
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.
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. Li. Plug the power cord into electrical outlet

NOTE:

Make sure the pump unit is suitable for the local power voltage.
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.

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.

OPERATION
NOTE: Always read the operating instruction before use. 4.1 General operation

Switch on the main power switch on right side of the pump.
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
Emergency operation
When there is a need to perform emergency CPR on the patient, pull and disconnect the tube from the pump unit.. Be sure to reconnect the quick connector to the pump unit once restore the power supply.

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.

STORAGE

Lay the bubble pad or mattress on a flat surface and upside down.
Roll-up the mattress from the head end towards the foot end.
Foot-end strap can then be stretched around the rolled pad/ mattress to prevent unrolling.

NOTE: Do not fold, crease or stack the mattresses.

MAINTENANCE

Check main power cord and do not plug it if there is an abrasion or excessive wear.
Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed together correctly.
Check the airflow from the air hose. The airflow should alternate between each connector every half-cycle time.
Check the air hoses if there is kink or breaks. For replacement, please contact Apex Medical Corp. or your suppliers.

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.

Problem	Solution
Power is not ON	Check if the plug is connected to mains.
Patient is bottoming out	Pressure setting might be inadequate for the

patient, adjust comfort range1 to 2 levels higher and wait for a few minutes for best comfort.
| 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
air outlets of the air tubeconnector| produce air during theft cycle time.

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.

TECHINICAL SPECIFICATION

Item	Specification
Model	Domusl
(9P-047580)	Domusl
(9P-047500)	Domus 1

NOTE: Please follow national requirements to dispose the unit properly. 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	Electromagnetic Environment-Guidance
RF emissions CISPR 11	Group 1	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
RF emissions CISPR 11| Class B| The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network
Harmonic emissions IEC61000-3-2| Class A
Voltage fluctuations / Flicker emissions IEC61000-3-3| Complies
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.

Basic EMC standard| ImmunityTest LevelsProfessional healthcare     HOME HEALTHCAREf.3,-      ,h; q.t..; f,,,,,.?n.                      Fie,nomv7ijr| Compliance li                         ,Levets| Electromagnetic Environment- Guidance
---|---|---|---
Eiectrostatc Dischatga                               [ESN
€1:610uu-gr-2| .&&V contact otsky air| kElorVconta ‘ alSkY air| $’iCiu.: r:J;        oi:C.J, cocrete or·   :.-ild tile. If hoofs are covered with- etic                     matenal,       the relativeccity Should he at least 30 %._
EleetlfCal                  fasttransient/ burst€(61000-44| 12101f or power suppty line
1110/for mputiouOulline| t2kV for pc,’.- supply line 1110/ ‘ input/out.; line| . s powerquMity should be that of.   :al    commercial        or    hospital
•• -: –meat
Sur ge Ecu000-21-6| e 1 kV line’s/ totineisl I 21n/ line(sIto ear h| * I Id/line’s) totinels1| to 1 IN rIN totinelsI| E‘ power quality snow oe mat or . :al commercial or hospital . ,…–tmenL
Voltage dips, shortinterruptions         andvoltage variations on power supply input linesEC61000-4-11| Voltage Dips:i1100% remotion for 0.5 period, iii 100l& reduction for 1 period,Oil 3(I16 reduction for 25 30 period, Voltage Interruptions:100% reduction for 250/300 period| 120/230V| .   ‘ s power quality snow be that at. %.; cal commercial or hospital . ‘: i meat If the user of This device . –es continued operation during :.ci mains interruptions, it is . –mended that the device be .,-. Ted from an uninterruptible .. c • snooty or a battery.
Power trecpency 160/60Hz)magnetic field EC61000-4-8| 33 Arm| KIA/rn| 3CA : IT.| ..y        frequency      magnetic       betas. d be at levers characteristic of a : . al. location in a typical – 7 axial or hospital enWronment.
Concocted RF
EC 61000-4.6| 3vrms0,16 MHz-80 MHz6 ens., ISM bands between 0,15 MHz and 80 MHz80 %AM at 1 kHz| StarsCLIS MHz-60 MHz6 YrrnS in   ISM        andamateur radio bands between0, %AM at 1 kHz 15 MHz and 80 MHz 80| 6Vnns| ·: ulis anti                             morale                       RI-
:um munications equipment should be used no closer to any part of the device, including caters, than there commended         separation distancecalculated from the equation applicable to the frequency of the transmitter.Recommended separation distance d -415_,Sekliz to 90141t I •0.6/0 80letz to e0et4Hz d • 1.21a SW lilt to 276HzWhere Pis the maximum output power
rating of the transmitter in walls MI
according            to     the    transmittermarnfacturee and d Is the recommended separaton distance in meters Imlbstrengths           from feted antransmitters,      as determined by anelectromagnetic          site survey    .a
should be less than the compbance level in eachfrequency ranged. rterference may occur in Vie vicinityof   equipment   marked         with the
following symbol:000
II
Radiated RF EM FieldsEC61000-4-3| 3 Y/m 80 MHz to 27 6Hz80 %AM at I kHz38S-6000                   MHz,9-28V/ra,           80%AMOkitzl pulse made and othermodulation| 10 yin 80 lot to2,7 GHz8u %AM at I kHz3asicop MHz9-28V/m,    Boleand                                  pulse modeand othermodulation| 18/11″
NOTE EIJI is Met                         mains voltage prior to the application of the test levelNOTE 2At 80 MHz aid 800 MHz, Die higher frequency rarge applies.fiOTE 3: These guidelines may not apply in all     tuations. Electromagnetic propagation s affected by absorption and reflectionfrom structures, oblectsand people
aPieta strengths trom fixed transmitters, such as base stations tor raoo Iceitaar/cortiess) telephones and tendmobile radios, amateur radio, Ail and FM radio broadcast and TY broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to f iced RE transmitters, an electromagnetic site surrey should beconsidered. If the measured field strength in the location in which the device is used exceeds the applicatle RE compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorentingar relocating the device.Mover the frequency ranee 150 kHz to 60114 field strengths should be less than10 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.

Rated maximum outputpowerof transmitter 1111| Separation distance150 kHz to 80 MHz d =4A5| according to frequency of80 MHz to 800 MHz d =0.6#)| transmitter m800 MHz to 2,7 GHz d =1.211 5
---|---|---|---
0.01| 0.1| 0.06| 0.12
0.1| 0.31| 0.19| 0.38
1| 1| 0.6| 1.2
10| 3.1| 1.9| 3.8
100| 10| 6| 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 (WI 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.