Drive Medical Harmony True Low Air Loss Tri-Therapy Mattress Replacement System Le manuel du propriétaire

Harmony

True Low Air Loss Tri-Therapy Maress Replacement System

Système de Remplacement de Matelas d’air Réelle à Basse

Pression Trois Thérapies

Baja Perdida de Aire Real con Sistema de Reemplazo de

Colchon de Tres Terapias

Instruction Manual • Guide d’utilisation • Manual de Instrucciones

Model Nos.: 14200, 14200-42 and 14200-48

PLEASE READ ALL INSTRUCTIONS BEFORE USE.

LISEZ TOUTES LES INSTRUCTIONS AVANT D’UTILISER VOTRE APPAREIL.

LEA POR FAVOR TODAS LAS INSTRUCCIONES

ANTES DE USAR SU EQUIPO.

Rev6.3.20

Contents

IMPORTANT SAFEGUARDS .......................................................................... 1

GROUNDING INSTRUCTIONS .................................................................... 2

1. Introduction ................................................................................................. 4

2. Product Description .................................................................................. 6

3. Installation ................................................................................................. 10

4. Operation ....................................................................................................12

5. Cleaning .......................................................................................................13

6. Storage ........................................................................................................14

7. Maintenance ...............................................................................................15

8. TROUBLESHOOTING .............................................................................16

9. EXPECTED SERVICE LIFE ....................................................................16

10. Technical Description ............................................................................... 17

Appendix A: EMC Information ....................................................................18

1

IMPORTANT SAFEGUARDS

READ ALL INSTRUCTIONS BEFORE OPERATING THIS DEVICE.

NOTE, CAUTION AND WARNING STATEMENTS DEFINED:

NOTE - Indicates helpful tips for using the system.

CAUTION - Indicates correct operating or maintenance procedures in order to prevent

damage to or destruction of the equipment or other property.

WARNING - Calls aention to a potential danger that requires correct procedures or

practices in order to prevent personal injury.

DANGER - Indicates death or serious injury will result if proper precautions are

not taken.

DANGER - To reduce the risk of electrocution:

1. Always unplug this product immediately aer using.

2. Do not use while bathing.

3. Do not place or store 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 facility protocol and monitor

patients appropriately.

2. Use this product according to the manual and medical professionals’ instructions.

3. Close supervision is necessary when this product is used on or near children.

Electrical burns or choking accidents 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.

5. Never operate this product if it has a damaged cord or plug, if it is not working prop-

erly, if it has been dropped or damaged, or dropped into water. Return the product

to a service center for examination and repair.

6. Keep the cord away from heated surfaces.

7. Never block the air openings of this product or place it on a so surface, where their

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.

2

10. Maress covers have passed skin sensitization and skin irritation tests. 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.

12. Connect this product to a properly grounded outlet only. See Grounding Instruc-

tions.

CAUTION –

1. If there is a possibility of electro-magnetic interference with mobile phones, please

increase the distance (11 .) between devices or turn oﬀ the mobile phone.

SAVE THESE INSTRUCTIONS

GROUNDING INSTRUCTIONS

DANGER - Improper use of the grounding plug can result in a risk of electric shock.

If repair or replacement of the cord or plug is necessary, do not connect the grounding

wire to either ﬂat blade terminal. The wire with insulation having an outer surface that is

green with or without yellow stripes is the grounding wire.

NOTE - If the repair or replacement of the cord is necessary, please contact a qualiﬁed

electrician or serviceman. To reduce the risk of electric shock, do not modify the cord or

plug in any way.

Check with a qualiﬁed electrician or serviceman if the grounding instructions are not

completely understood, or if in doubt as to whether the product is properly grounded.

3

SYMBOLS

IP20

Protected against solid foreign objects of 12,5 mm and greater; No Protection against

vertically falling water drops, Keep Dry! ( Only for 120V System)

Protected against solid foreign objects of 12,5 mm and greater; Protection against vertically

falling water drops ( Only for 230V System)

Temperature limitation/temperature range

Consult operating instructions for use.

"BF" symbol, indicate this product is according to the degree of protecting against electric

shock for type BF equipment

Grounding terminal

A ention, read the accompanying information carefully.

Do Not Bleach

Do Not Iron

Tumble Dry, Normal, Low Heat

Dry clean, Any Solvent Except Trichloroethylene

Machine wash, regular / normal, 95 degrees C (203 degrees F)

Disposal of 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 oﬃ ce, household waste disposal service or the

retail store where you purchased this product.

4

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 Tri-Therapy maress replacement system including alternating pressure,

pulsation and true low air loss. These therapies are intended for the prevention and

treatment of all stages of pressure injuries.

The system has been tested and successfully approved with the following standards:

EN 60601-1

EN 60601-1-2

EN 55011 Class B

IEC61000-3-2

IEC 61000-3-3

FOR US AND CANADA ONLY

The product was tested with medical equipment and meets AAMI STD. ES60601-1 &

CSASTD. C22.2 NO. 60601-1. preventing electric shock, ﬁre and risk of physical injury.

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. Howev-

er, 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 inter-

ference by one or more of the following measures:

• Reorient or relocate the receiving device.

• Increase the separation distances between the equipments.

• Connect the equipment into an outlet on a circuit diﬀerent from that to which the

other device is connected.

• Consult the manufacturer or ﬁeld service technician for help.

5

1.2 Intended Use

This product is intended:

• to help reduce the incidence of pressure injuries while optimizing patient comfort

• for use primarily in acute or long term health care facilities

• for pain management

NOTE: Equipment not suitable for use in the presence of a ﬂammable anes-

thetic mixture with air or with oxygen or nitrous oxide.

NOTE: L’équipement ne peut être utilisé s’il y a risque de mélange d’un anesthé-

sique inﬂammable avec l’air ou l’oxygène ou oxyde nitreux.

6

2. Product Description

2.1 Pump and Maress System

1. Quick Connector for CPR

2. Control Unit

3. Maress

4. Maress Foam Pocket

5. Cable Management Loops

5

3

7

2.2 Control Unit

2.2 Control Panel

Front

1. Quick Connector for CPR

2. Front Panel

Rear

1. Power Switch

2. Power Socket

3. Fuses

4. Integrated Handle

5. Mounting Bracket

6. Pump Bumper

7. Air Filter

System Failure

Soutien Technique

Low Pressure

Static

Statique

Alternate

Alterné

Pulsation

Seat Inflation

Gonflage Du Siège

Pression Faible

Fermeté

Automatique

AutoFirm

Power Failure

Perte D’alimentation

Système De Remplacement De Matelas D’air Réelle À Basse Pression Trois Thérapies

2

1

5

6

7

4

3

8

1. Comfort Weight Seings Buons

The “Comfort Seing” controls the air pressure output based on the patient’s weight.

When patient’s weight seing is increased ( ), the output pressure will increase

When the patient’s weight seing is decreased ( ), the output of air pressure will

decrease. When a patient’s condition has signiﬁcantly changed, reassess the comfort

weight seing level. When a patient’s condition has signiﬁcantly changed, reassess ap-

propriateness of product and comfort seing level.

NOTE: Maximum weight: 14200= 440 lbs

14200-42= 700 lbs

14200-48= 990 lbs

2. Therapy Modes Buon

A. Static

Redistribute body mass over a greater surface area at a constant air pressure based on

your Comfort Weight seing.

B. Alternating Pressure

1-in-2 alternating cell cycle achieves periodic pressure relief. There are four selectable

cycle times available: 5, 10, 15, 20 minutes. Caregivers can select one of the four cycle

times based upon patient comfort and desired outcome.

C. Pulsation

Encourage lymph and blood ﬂow for increased oxygenation. The entire maress pulsates

between a decreased and increased pressure level in all cells every 15 seconds.

D. Seat Inﬂate

The Seat Inﬂation features additional support to the patient during head raised position

(Fowler), ingress, and egress for the prevention of booming out.

NOTE: When head of bed is elevated 30 degrees or higher, it is recommended

the caregiver engage Seat Inﬂate to prevent possible booming out.

NOTE: Every time the maress is initialized (inﬂated), it will automatically go

to “Auto Firm” mode to hasten inﬂation. Once the system is ready to use, the

system will automatically begin in static mode or revert to the previously set

therapy mode.

3. On/oﬀ

Press to turn the unit On or Oﬀ. Press Oﬀ to turn Oﬀ/Standby the unit.

NOTE: The power switch on the side of pump must be turned on.

9

4. Panel Lock

Should the panel remain untouched for 5 minutes, the panel lock feature will Lock the

panel and a green LED light will display. This feature helps prevent accidental or unin-

tentional seing changes. To unlock, press Panel Lock buon for 3 seconds.

5. Cycle Time

During alternating pressure therapy mode there are four selectable cycle times: 5, 10,

15, 20 minutes. By pressing the Cycle Time buon, User can select one of the four cycle

times based upon patient comfort and desired outcome.

6. Alarm Mute

Press alarm mute buon to temporary suspend the alarms for low pressure, power fail-

ure or system failure. Should the problem continue, the alarms will resound within three

minutes to notify the caregiver until resolved.

A. Low Pressure Indicator

Should the Quick connector become disconnected, the lower pressure LED indica-

tor will light up and the low pressure alarm will activate. This alarm may sound within

20 seconds. Once the low pressure problem is resolved the Control Unit will resume

operation in the previously set mode. NOTE: The low pressure indicator will not be

detected if air cells of maress are purposely disconnected.

B. Power Failure Alarm

Should there be a power failure outage, the Power Failure LED indicator will light up

and the Power Failure alarm will activate immediately. Press the alarm mute buon

to deactivate.

C. System Failure

Should there be a System Failure issue, the System Failure LED indicator will light

up. This may be caused by a motor related issue. Please consult the manufacturer or

ﬁeld service technician for help.

7. AutoFirm/ Nursing Key

The system will go into AutoFirm mode automatically when the power switch is turned

on. This insures the Control Unit reaches its maximum operating pressure. Once the

maximum pressure level is reached, the Control Unit will automatically switch to the

previously selected comfort level in STATIC mode, or the user can press the THERAPY

modes buon to select another therapy. User can also use this function as full maress

inﬂation during patient ingress/egress or normal nursing procedure for beer support.

10

3. Installation

Unpack the box to inspect for any damage, which may have occurred during shipment. If

there are any damages, please contact your provider immediately.

3.1 Control Unit & Ma ress Installation

1. Place the ma ress on top of the bed frame.

Please note for the foot end. There are

securing straps on the base of the ma ress.

Secure the ma ress ﬁ rmly by ﬁ xing the

straps to the bed frame, ensure that moving

sections of the bed are still free to move.

WARNING: The Harmony ma ress is a

ma ress replacement system and must not

be installed on top of an existing ma ress.

2. Hang the control unit onto bed rail (foot-

end), and adjust hangers to best upright

position of the Control Unit.

NOTE: Do not place the Control Unit on

the ﬂ oor.

3. Connect the Quick Connector from air

ma ress to the Control Unit. Make sure the

connector is in the right position as per the

diagram on the le . When a “click” sound is

felt or heard, the connection is completed

and secured.

NOTE: The Control Unit is only operable

when the Quick Connector is connected to

the system.

NOTE: Check and ensure the air hoses are

not kinked or tucked under ma ress.

1

Push

2

11

4. Plug the power cord into electrical outlet.

NOTE:

Make sure the Control 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 diﬃ cult to disconnect the device.

CAUTION: The Control Unit can only

be applied to the ma ress recommended

by the manufacturer. Do not use it for any

other purpose.

5. Then turn the main power switch to ON

position.

6. A er installation, the extra length of

the power cord, if any, should be neatly

arranged through the cable management

loops on the le side of the ma ress to

avoid a tripping hazard.

NOTE: Do not connect any cable to the

reserved signal port next to the quick

connector. The cap should always

remain on.

Grounding:

See Grounding Instructions on Page 2.

ON

12

4. Operation

NOTE: Always read the operating instructions before use.

4.1 GENERAL OPERATION

1. Switch on the main power switch found

on the le side of the Control Unit while

facing the User. Press ( ) on the control

panel to turn on the power.

2. The system will automatically go into “Auto

Firm” mode for a few minutes of inﬂ ation.

3. When the initial inﬂ ation (Auto Firm pro-

cess) is completed, the system will auto-

matically enter into Static mode

4. Using the Comfort Weight Se ing bu ons,

adjust according to the weight and height

of the patient, adjust the pressure se ing

to the most suitable level without bo om-

ing out.

5. Using the Therapy Mode bu on choose the

desired therapeutic mode.

NOTE: Seat inﬂ ate mode should be used for

ingress and egress at all times to prevent bot-

toming out.

When CPR needs to be performed, click on

the release bu on on Quick Connector and

quickly detach the connector from the system

to release air.

4.2 CPR

System Failure

Soutien Technique

Low Pressure

Static

Statique

Alternate

Alterné

Pulsation

Seat Inflation

Gonflage Du Siège

Pression Faible

Fermeté

Automatique

AutoFirm

Power Failure

Perte D’alimentation

Système De Remplacement De Matelas D’air Réelle À Basse Pression Trois Thérapies

13

5. Cleaning

It is important to follow the cleaning procedures before using the system.

Wipe down the Control Unit with a damp cloth pre-soaked with a mild detergent. Avoid

contact with dust and proximity to dusty areas. Make sure that any cleaning agents you

use will not harm or corrode the plastic casing on the Control Unit . If your doctor or

medical facilities have other special cleaning instruction, please follow the professional

instruction.

CAUTION: Do not immerse or soak Control Unit .

WARNING: Do not remove the housing of the Control Unit to avoid electrical

shock. All disassembly or repair should be done by professional technicians

CAUTION: The Control Unit does not need oil lubrication, please do not disas-

semble the system.

Cover Material:

• Silver

+

Ion

• Polyﬁber/ Polyurethane Stretch

Wipe down the maress unit with a damp cloth pre-soaked with warm water containing

a mild detergent. Approved intermediate level disinfectants may be used according to

the cover material. Please refer to the chart below for recommended disinfectants.

The maress top cover can be completely removed for laundry with water temperature

up to 95°C; however, it is recommended that the user still check with local policy to

determine the time/temperature ratio required to achieve thermal disinfec¬tion. Aer

cleaning, please avoid dust and proximity to dusty areas. All parts should be air dried

thoroughly before use.

Polyurethane Stretch Top Cover Vinyl Boom Cover

Recommended Quaternary Phenolics

Acceptable Chlorine Bleach (1:10) Quaternary, Chlorine

Bleach (1:10)

Not Recommended Phenolics Quat/Isopropyl

CAUTION: Aer cleaning, dry the maress without direct exposure of sunlight.

14

6. Storage

1. To quickly deﬂate the maress for storage, click on the release buon on the Quick

Connector

2. Roll from the foot end towards the head end with CPR valve open, and make sure

the tubing is not kinked.

3. Foot-end strap can then be stretched around the rolled maress to prevent unroll-

ing. Fasten the buckle strap to secure the packed maress.

4. The power cord can be wrapped around the Control Unit bumper on the back pack

the Control Unit with protective package.

5. Place the whole system into the carrying bag.

NOTE: Do not kink, crease or stack the maresses and do not store the system

in direct sunlight, high temperature or moist area.

15

7. Maintenance

7.1 General

1. Check main power cord and and plug for abrasions or excessive wear.

2. Check ma ress cover for signs of wear or damage. Ensure ma ress cover is securely

on and tubes are connected together correctly.

3. Check the air hoses for any kinks or breaks. For replacement, please contact your

local provider.

7.2 Fuse replacement

External Fuse replacement:

1. Disconnect the plug from the main power source

when a blown fuse is suspected.

2. Use a proper tool to open the fuse holder.

3. Insert a new fuse of the correct rating in, and

replace the fuse holder back to correct position.

The fuse should be rated as 5A / 250V (for 120V

system) and T3.15A /250V (for 230V system) type.

7.3 Air Filter Replacement

1. Replace the air ﬁ lter located at the side of the

Control Unit.

2. The ﬁ lter is reusable and can be washed gently

with a mild detergent and water. Air dry the ﬁ lter

before use.

3. Check and replace air ﬁ lter regularly if environ-

ment is dirty

7.4 Rechargeable Ba ery

1. The rechargeable ba ery is designed to support power failure alarm. To check if the

rechargeable ba ery has been drained out, unplug the power cord and see if the

Power Failure indicator will light up along with buzzer and last for a few minutes.

2. If the Power Failure Alarm is unable to work or the ba ery might need to be re-

placed (approximate life expectancy 6 months or 300 cycles), please contact your

dealer or notify the technician for replacement.

1. Replace the air ﬁ lter located at the side of the

2. The ﬁ lter is reusable and can be washed gently

3. Check and replace air ﬁ lter regularly if environ-

16

8. Troubleshooting

Problem Solution

Power is not ON

Check if the plug is connected to control unit

Check for a blown fuse.

Low Pressure Alarm is on

Check if the Quick Connector is tightly secured.

Check if all tubing connections along maress are secured.

Check if the air hoses are kinked or broken

Power Failure Alarm is on

Check if the power is suddenly shut down.

Check if the power cord is connected properly.

Patient is booming out

Pressure seing might be inadequate for the patient, adjust comfort

range 1 to 2 levels higher and wait for a few minutes for best comfort.

Maress form is loose

Check if all the snap buons or straps of maress are all securely

fastened.

Check if the maress is ﬁxed to the bed frame by straps.

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.

9. EXPECTED SERVICE LIFE

This product is intended to oﬀer safe and reliable therapy when installed and operated

according to the instructions provided by Drive Medical. Drive Medical recommends

that the system be inspected and serviced by authorized technicians if there are any

signs of wear or concerns with device functionality and indications on products. Other-

wise, service and inspection of the devices generally should not be required.

17

10. Technical Description

SPECIFICATIONS:

Pump

Power Supply (Note: See rating

label on the product)

AC 110-120V 60Hz, 4.5A (for 120V system)

Fuse Rating T5AL 250V(for 120V system)

Dimension (L x W x H) 34 x 16.3 x 23.5 (cm) or 13.4” x 6.4” x 9.3” (in)

Weight 5 kg or 11.02 lb

Classiﬁcation

Class I, Type BF,

IP21 (for 230V System ), IP20 (for 120V System)

Applied Part: Air Maress

Not suitable for use in the presence of a ﬂammable

anesthetic mixture (No AP or APG protection)

Environmental Information

Environment

Temperature

Operation: 10° C to 33° C (50° F to 91° F)

Storage: -15° C to 50° C (5° F to 122° F)

Shipping: -15° C to 70° C (5° F to 158° F)

Humidity

Operation: 10% to 90% non-condensing

Storage: 10% to 90% non-condensing

Shipping:10 % to 90% non-condensing

Operating

Altitude

2000 m (Maximum)

Maress

Model

8” Maress

2” foam pocket is provided

Size of Maress 36” maress 42” maress 48” maress

Dimension (L x W x H)

78.7” x 35.4” x 8”

200 x 90 x 20.3 cm

78.7” x 42” x 8”

200 x 107 x 20.3 cm

78.7” x 48” x 8”

200 x 122 x 20.3 cm

Weight 16.5 lb / 7.5 kg 18.8 lb /8.5 kg 21.0 lb / 9.5 kg

Maximum Weight

Capacity

Static mode 440 lb / 200 kg 700 lb / 320 kg 990 lb / 450 kg

Therapy mode 400 lb / 180 kg 650 lb / 300 kg 920 lb / 420 kg

NOTE: 1. Consult Drive Medical for further technical documents.

2. The speciﬁcation is also suitable for other areas operating with same

power supply.

3. Maress dimension and weight is measured without foam cushion

4. The manufacturer reserves the right to modify the speciﬁcation

without notice.

18

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

Group1

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

Immunity Test Levels

Compliance

Levels

Electromagnetic

Environment-Guidance

Professional

Healthcare

Facility

Environment

Home

Healthcare

Environment

Electrostatic

Discharge (ESD)

IEC61000-4-2

±8kV contact

±15kV air

±8kV contact

±15kV air

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

IEC61000-4-4

±2kV for power supply line

±1kV for input/output line

±2kV for power

supply line

±1kV for input/

output line

Mains power quality should be that of

atypical commercial or hospital environ-

ment

Surge

IEC61000-4-5

± 1 kV line(s) to

line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to

line(s)

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth

Mains power quality should be that of

atypical commercial or hospital environ-

ment.

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Drive Medical Harmony True Low Air Loss Tri-Therapy Mattress Replacement System Le manuel du propriétaire

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