Prius Enhance RDX User Manual

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Page 1

Enhance RDX

This manual MUST be given to the user of the product.

BEFORE using this product, this manual MUST be read and saved for future

reference.

Alternating Pressure Mattress System

User Manual

Page 2

Contents

1. Safety ............................................................................................................................................... 4

2. The Purpose of this Manual .................................................................................................... 5

3. Intended Use ................................................................................................................................. 5

4. Indications for Use ..................................................................................................................... 5

5. Intended Users ............................................................................................................................. 5

6. Contraindications for use ........................................................................................................ 5

7. Product Description .................................................................................................................. 5

Master Control Unit Features ................................................................................... 6

Mattress Features .......................................................................................................... 6

8. Technical Data.............................................................................................................................. 7

Master Control Unit ....................................................................................................... 7

Mattress Replacement ................................................................................................. 7

Symbols information essential for proper use .................................................. 8

9. Instructions for Proper Use .................................................................................................... 8

Alarm Function ............................................................................................................... 9

CPR Deflation ................................................................................................................... 9

10. Cleaning .......................................................................................................................................... 9

The Mattress ................................................................................................................. 10

The Master Control Unit ........................................................................................... 10

Replace Air Filter......................................................................................................... 11

Waste Disposal ............................................................................................................. 11

IP21 ................................................................................................................................... 11

11. Storage and Handling ............................................................................................................. 12

Master Control Unit .................................................................................................... 12

Mattress: ......................................................................................................................... 12

12. Maintenance & Troubleshooting ...................................................................................... 12

13. EMC Related Notifications ................................................................................................... 13

14. Expected Service Life ............................................................................................................. 17

15. Limited Warranty .................................................................................................................... 17

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1. Safety

Warning

The safety section contains important information for the safe operation and use of this product. Read this information and any other safety information included with the product.

❖ 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. ❖ Use the product only for its intended use as described in this manual. Do

not use attachments not recommended by the manufacturer.

❖ If pain, irritation, numbness, swelling, or redness occurs discontinue use

and contact a healthcare professional.

❖ This device can be used in home healthcare and professional healthcare

environment.

❖ This device should not be used adjacent to or stacked with other

equipment.

❖ Medical electrical equipment needs special precautions regarding EMC and

needs to be installed according to the EMC information provided.

❖ The product should never be left unattended when plugged in. ❖ Close supervision is necessary when the product is used by, on, near

children or physically challenged individuals.

❖ Never block the air opening of this product or place it on a soft surface,

such as a bed or couch, where the air openings may be blocked. Keep the air openings free of lint, hair, and other similar debris.

❖ Never drop or insert objects into any openings. ❖ DISCONNECT POWER SUPPLY BEFORE OPENING. ❖ Power cable & pump shall be placed at the foot-side of the patient to

prevent any risk of strangulation due to cable.

❖ Please ensure the Enhance RDX Alternating Pressure Mattress System is

used with stable power or in connection with UPS.

❖ To reduce the risk of electrocution:

Always unplug product immediately after use. Do not use while bathing. Do not place or store product where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquids. Do not reach for product that has fallen into water. Unplug immediately.

❖ Do not obstruct the mains plug or position the equipment where the

connection to the mains line can be accidentally disconnected.

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2. The Purpose of this Manual

Caution

❖ The mattress system should always be used in accordance with your

Institution’s 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.

This operation manual is mainly focused on the set up, cleaning and routine maintenance of the Enhance RDX Alternating Pressure Mattress System. We recommend keeping this manual available to answer questions related to the system.

3. Intended Use

The Enhance RDX system is intended for patients who are at risk of developing pressure ulcers according to your sound clinical judgment. The device can also be used for patients who have an existing stage 1, 2, and 3 pressure ulcers, in conjunction with your policy on pressure area management.

4. Indications for Use

Indicated for patients who are at risk of developing pressure ulcers according to your sound clinical judgment.

5. 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.

6. Contraindications for use

Alternating pressure therapy should not be used for patients with unstable fractures, gross edema, burns or an intolerance to motion.

7. Product Description

This product is intended to help reduce the incidence of pressure ulcers while optimizing patient comfort. The Enhance RDX is an alternating mattress replacement system used in the prevention and treatment of pressure ulcers. By using the established principles of alternating therapy the Enhance RDX offers patients a comfortable and relaxing support surface which can prevent skin breakdown and enhance wound healing.

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Master Control Unit Features

⚫ LED indicator for function status. ⚫ Electronic adjustable comfort setting. ⚫ 2-in-1 alternation with 10 minutes cycle time.

Mattress Features

⚫ Modularized design for easy air cell replacement. ⚫ A vapor permeable, oversized, pliable, quilted nylon top cover provides

low shear, friction and moisture protection.

⚫ CPR quick release for rapid deflation. ⚫ Cell in cell design provides additional protection for upper torso

and sacrum in the event there is a loss of power

⚫ Integrated power cable management for organization and safety.

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8. Technical Data

Model Name

Model No.

Size (inch)

10.1” (L) x 4.5” (W) x 8.3” (H)

Weight (lbs)

4.85 lbs (2 kg)

Max Flow Rate

5 L/min

Cycle Time

10 min

Min Operating Pressure

14 +/- 6mmHg

Max Operating Pressure

60 +/- 6mmHg

Rated Voltage

AC 110-120V

Rated Frequency

60 Hz

Fuse Rating

T1AH 250V

Max Current

0.1A

Classification

Class II, Type BF Not AP or AGP type

Ingress of Water Protection

IP21

Mode of Operation

Continuous

Power Cable

15ft, non-shielding, AC powered

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)

15% to 90% non-condensing

Operation Atmospheric Pressure Range

800 hPa to 1060 hPa

Standard

IEC 60601-1, CAN/CSA C22.2 No. 60601-1, IEC 60601-1-2 IEC 60601-1-11

Model Name

Model No

Size (inch)

36” (W) x 80” (L) x 8” (H)

Weight (lbs.)

22 lbs (10 kg)

Cell Number

18 cells

Cells Material

Cover Material

Blue Nylon w/ PU coating finish

Base Material

Black Polyester w/ PVC coating

Weight Capacity

350 lbs (159 kg)

Master Control Unit

Enhance RDX Control Unit FC-PHR0035

Mattress Replacement (applied part)

Enhance RT Mattress FM-PHR0034

Blue Nylon with PU coating

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Symbols information essential for proper use

Type BF Protection Against Electronic Shock

Class II Equipment

Consult instructions for use

Waste Disposal

Caution, Consult accompanying documents

SGS product certification mark

9. Instructions for Proper Use

1. Remove the existing mattress from the bed frame.

2. Replace the standard mattress with mattress system and make sure to orient mattress so that the air tube is placed at the foot of the bed.

3. Secure the straps beneath the mattress to the bed frame.

4. Hang the Master Control Unit on the foot-board of the bed frame.

5. Attach the air tubes connectors to socket on the left panel of the Master Control Unit.

6. Ensure the air hoses are not kinked under the mattress. (Could be verified by simple visual check).

7. Plug in the control unit and turn it on.

8. The pump pressure dial blinks to Max setting and will now inflate the

mattress.

9. Do not press the control button on pump to select alternation or static until

pump pressure dial defaults to solid light and mattress is fully inflated .

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10. Set the required pressure by pressing the “+” to increase pressure or “-“to reduce pressure.

11. Pressure is constantly monitored by the control unit. When pressure is less

than the pump set pressure the “Low Pressure” LED will illuminate and an

alarm will sound.

12. Make sure to turn the power off when the system not in use.

Alarm Function

The Enhance RDX Alternating Pressure System is equipped with a visual and audible alarm in the event of low pressure. During the initial inflation period the system is in low pressure mode and the low pressure LED will illuminate. The audible alarm is set with a delay function to take into consideration the inflation time. The alarm will activate automatically after 45 minutes if the unit does not inflate properly. When the mattress pressure drops from the set pressure during patient repositioning the audible alarm will switch to a 5 minute delay to avoid undesired alarm activation.

CPR Deflation

For emergency mattress deflation turn the CPR valve to the ‘’OPEN’’ position. The

mattress should deflate within 30 seconds. To close the CPR simply turn the valve to the ‘’CLOSE’’ position.

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10 Cleaning

Industrial

Break washes

Cold

10 minutes

Main washes

60°C (140°F)

16 minutes

Extraction

2 minutes

Cold Rinses

Extraction

5 minutes

Domestic

Pre-wash

Cold

Main Wash

60°C (140°F)

10 minutes

Extraction

2 minutes

Cold Rinses

Extraction

5 minutes

CAUTION

SWITCH OFF THE ELECTRICAL SUPPLY TO THE PUMP AND DISCONNECT THE POWER CORD FROM THE MAIN SUPPLY BEFORE CLEANING AND INSPECTION

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).

Tumble Drying or Tunnel Drying is not recommended.

Mattress Cells can be wiped over with a solution of sodium hypochlorite 1000ppm or any other non-phenolic germicidal solution.

The Master Control Unit

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.

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Replace Air Filter

IP Number

First Digit - SOLIDS

Second Digit - LIQUIDS

IP21

Protected from touched by fingers and objects greater than 12.5mm.

Against water : Vertical water drips.

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.

IP21

The IP Code (or International Protection Rating, sometimes also interpreted as Ingress Protection Rating*) consists of the letters IP followed by two digits and an optional letter.

⚫ First Digit: Solids

The first digit indicates the level of protection that the enclosure provides against access to hazardous parts (e.g., electrical conductors, moving parts) and the ingress of solid foreign objects.

⚫ Second Digit: Liquids

Protection of the equipment inside the enclosure against harmful ingress of water.

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11. Storage and Handling

Symptom

Inspection Procedures

Possible Solution

The pump is not functioning or power failure.

1. Check power source connection.

2. Check fuse.

1. Connect to proper power source.

2. Replace fuse.

3. Refer to qualified service technician if problem persist.

Low pressure LED is constantly illuminated or the mattress is not inflating while pump is in operation.

1. Check hoses and hose connections.

2. Check CPR valve.

3. Check air cells for holes or tears other than where designed.

1. Make sure all connections are secure.

2. Make sure CPR valve is in the “CLOSE” position.

3. Replace damaged air cell if necessary.

4. Refer to qualified service technician if problem persist.

Pump is noisy.

1. Make sure pump is resting against a solid surface.

1. Reposition the pump.

2. Refer to qualified service technician if problem persist.

Power failure LED or alarm sound in abnormal when power off.

1. Turn off the power in the standard process then restart the control unit to check if alarm still existing.

2. Check PCB function

1. Refer to qualified service technician if problem persist.

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. ⚫ Set CPR valve to “OPEN” and disconnect the air hose to the pump.

The mattress will now deflate and can be packed for storage.

⚫ 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 (41°F) ~ 60°C (140°F) Relative Humidity: 15% to 90% non-condensing

12. Maintenance & Troubleshooting

No daily maintenance is required. Caregivers should check the patient and control unit setting every two hours. It is intended this equipment should only be serviced by properly qualified, authorized technical personnel. In case of minor trouble please refer to the Troubleshooting table in this section. Contact the provider or Invacare for questions and repair information.

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13. EMC Related Notifications

Rated maximum

output power of

transmitter

Separation distance according to frequency of transmitter

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

0,23

0,1

0,38

0,73

1,2

2,3

3,8

7,3

100

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.

Manufacturer’s declaration-electromagnetic emissions

Emission test

Compliance

Electromagnetic environment-guidance

(for home and professional healthcare environment)

RF emissions CISPR 11

Group 1 RF emissions CISPR

Class B

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations /flicker emissions IEC

61000-3-3

Not applicable

The Enhance RDX is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Enhance RDX should assure that it is used in such an environment.

The Enhance RDX 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 Enhance RDX 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.

Recommended separation distance betweenportable and mobile

RF communications equipment and the Enhance RDX

The Enhance RDX 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 Enhance RDX can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Enhance RDX as recommended below, according to the maximum output power of the communications equipment.

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Manufacturer’s declaration-electromagnetic immunity

The Enhance RDX is intended for use in the electromagnetic environment (for home and

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

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; 30 cycles

Voltage interruptions: 0 % UT; 300 cycle

Power frequency(50, 60 Hz) magnetic field

IEC 61000-4-8

30 A/m 50 Hz or 60 Hz

30 A/m 60 Hz

NOTE UT is the a.c. mains voltage prior to application of the test level.

professional healthcare) specified below. The customer or the user of the Enhance RDX should assure that it is used in such an

environment.

Mains power quality should be that of a typical home healthcare environment. If the user of the Enhance

RDX requires continued

operation during power mains interruptions, it is recommended that the Enhance RDX be powered from an uninterruptible power supply.

The Enhance RDX power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment.

* During DIP interference, the pump will outage these normal. The cells connected with pump still

have air inside which won’t affect the use and function of the system.

* During DIP, the LED of front panel board might anomalous blinking with indicating sound. The

pump will back to normal function after DIP disturbance.

* During DIP, pump will show abnormal but won’t affect essential performance and no need to

worry the basic safety.

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Manufacturer’s declaration-electromagnetic immunity

The Enhance RDX is intended for use in the electromagnetic environment (for home and

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

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.

professional healthcare) specified below. The customer or the user of the Enhance RDX should assure that it is used in such and environment.

Portable and mobile RF communications equipment should be used no closer to any part of the

Enhance RDX 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:

Page 15

Manufacturer’s declaration-electromagnetic immunity

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

equipment

The Enhance RDX is intended for use in the electromagnetic environment (for home and professional

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

450

430 – 470

GMRS 460,

FRS 460

FM c)

±5 kHz deviation

1 kHz sine

0,3

710

704 – 787

LTE Band 13,

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

0,3

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

0,3

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

0,3

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.

healthcare) specified below. The customer or the user of the Enhance RDX should assure that it is used in such an environment.

CAUTION: If abnormal behavior is observed due to EM disturbances, please relocate the device

accordingly.

CAUTION: Please do not use any other cables or accessories not approved by the manufacturer in

this manual to avoid negative influence on electromagnetic compatibility.

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14. Expected Service Life

The Enhance RDX pump has an expected service life of five years. To maintain the condition of the pump, have the pump serviced regularly according to the schedule recommended by Caremed. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Enhance RDX system.

15. Warranty a. Prius Healthcare guarantees this equipment to be free from defects in material and

workmanship for up to 12 months from the date of delivery.

b. All warranty work will be performed at the service address below, shipping charges

prepaid.

c. At Manufacturers discretion we agree to service, repair or replace any equipment or

part found to be defective at no charge.

d. 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 approved procedures and performed by certified technicians.

e. In no event shall Prius Healthcare be liable for any direct, indirect, consequential

damage or loss resulting from the use of equipment.

f. Warranty is non-transferrable.