Invacare IRC5PO2AW Manuale utente

Dealer: This manual MUST be given to the end

user.

User:

BEFORE using this product, read this

manual and save for future reference.

User Manual

Invacare® Perfecto

2

™

Series

Oxygen Concentrators with SensO

2

HomeFill® Compatible

Model IRC5PO2AW

Model IRC5PO2VAW

English. . . . . . . . . . . . . . . . . .1

French. . . . . . . . . . . . . . . . .33

Italian . . . . . . . . . . . . . . . . .69

German . . . . . . . . . . . . . .104

Polish . . . . . . . . . . . . . . . .141

Czech . . . . . . . . . . . . . . . .177

0434

WARNING

Perfecto

2

™Series 2 Part No 1163145



WARNING

DO NOT use this product or any available optional

equipment without first completely reading and

understanding these instructions and any additional

instructional material such as user manuals, service manuals

or instruction sheets supplied with this product or optional

equipment. If you are unable to understand the warnings,

cautions or instructions, contact a healthcare professional,

dealer or technical personnel before attempting to use this

equipment - otherwise, injury or damage may occur.



ACCESSORIES WARNING

Invacare products are specifically designed and

manufactured for use in conjunction with Invacare

accessories. Accessories designed by other manufacturers

have not been tested by Invacare and are not recommended

for use with Invacare products.

ACCESSORIES

There are many different types of humidifiers, oxygen tubing,

cannulas and masks that can be used with this device. You

should contact your local home care provider for

recommendations on which of these devices will be best for

you. They should also give you advice on the proper usage,

maintenance, and cleaning.

The supply accessories (nasal cannula, mask, tubing,

humidifier, etc.) used to deliver oxygen to the patient need to

include a means to reduce the propagation of fire in the

accessories for the safety of the patient and others. If a

commercially available, fire-activated flow stop device is used

in the accessories setup, it should be placed as close to the

patient as practicable.

Refer to OPTIONAL ACCESSORIES on page 31 for a list of

additional accessories compatible with these models.

TABLE OF CONTENTS

Part No 1163145 3 Perfecto

2

™Series

ACCESSORIES ..................................................2

SPECIAL NOTES ...............................................4

Contraindications................................................................................ 5

LABEL LOCATION ............................................ 6

SECTION 1—GENERAL GUIDELINES .....................7

Operating Information ....................................................................... 8

Radio Frequency Interference.......................................................... 8

SECTION 2—FEATURES ......................................10

SECTION 3—HANDLING ....................................11

Unpacking............................................................................................11

Inspection............................................................................................11

Storage.................................................................................................11

SECTION 4—TECHNICAL DESCRIPTION .............12

Intended Use ......................................................................................12

Technical Description ......................................................................12

SECTION 5—TYPICAL PRODUCT PARAMETERS .13

SECTION 6—OPERATING INSTRUCTIONS ..........17

Introduction........................................................................................17

Select a Location ...............................................................................17

Set Up ..................................................................................................18

Flowrate...............................................................................................22

SensO

2

Oxygen Purity Indicator....................................................23

Initial Startup of the Concentrator ...............................................23

Elapsed Time Meter (Hour Meter) ...............................................24

SECTION 7—MAINTENANCE .............................25

Routine Maintenance........................................................................25

SECTION 8—TROUBLESHOOTING GUIDE ............29

SECTION 9—OPTIONAL ACCESSORIES ...............31

RECYCLING INFORMATION ........................... 32

CUSTOMER SERVICE AND WARRANTY

INFORMATION ............................................ 210

SPECIAL NOTES

Perfecto

2

™Series 4 Part No 1163145

SPECIAL NOTES

Signal words are used in this manual and apply to hazards or

unsafe practices which could result in personal injury or

property damage. Refer to the following table for definitions

of the signal words.

NOTICE

The information contained in this document is subject to

change without notice.

 DANGER

DO NOT SMOKE while using this device. Keep all

matches, lit cigarettes or other sources of ignition out of

the room in which this product is located and away from

where oxygen is being delivered.

NO SMOKING signs should be prominently displayed.

Textiles and other materials that normally would not

burn are easily ignited and burn with great intensity in

oxygen enriched air. Failure to observe this warning can

result in severe fire, property damage and cause physical

injury or death.

SIGNAL WORD MEANING

 DANGER

Danger indicates an imminently hazardous situation

which, if not avoided, will result in death or serious

injury.

 WARNING

Warning indicates a potentially hazardous situation

which, if not avoided, could result in death or

serious injury.

 CAUTION

Caution indicates a potentially hazardous situation

which, if not avoided, may result in property

damage or minor injury or both.

SPECIAL NOTES

Part No 1163145 5 Perfecto

2

™Series

 CAUTION

“Caution: Statutory law can restrict this device to sale by or on

order of a physician, or any other practitioner licensed by the

law of the governmental agency in which he/she practices to

use or order the use of this device.”

Invacare recommends an alternate source of supplemental

oxygen in the event of a power outage, alarm condition or

mechanical failure. Consult your physician or equipment

provider for the type of reserve system required.

This equipment is to be used as an oxygen supplement and is

not considered life supporting or life sustaining.

Contraindications

Invacare is not aware of any contraindications for the Invacare

Perfecto

2

Concentrator Series.

LABEL LOCATION

Perfecto

2

™Series 6 Part No 1163145

LABEL LOCATION

Serial Number Label is

located on the resonator

intake assembly

Specification Label is

located on the back

near the bottom

SECTION 1—GENERAL GUIDELINES

Part No 1163145 7 Perfecto

2

™Series

SECTION 1—GENERAL GUIDELINES

In order to ensure the safe installation, assembly and operation of

the Perfecto

2

concentrator these instructions MUST be followed.

 WARNING

This section contains important information for the safe

operation and use of this product.

 DANGER

Risk of electric shock. DO NOT disassemble. Refer servicing

to qualified service personnel. No user serviceable parts.

TO REDUCE THE RISK OF BURNS, ELECTROCUTION,

FIRE OR INJURY TO PERSONS.

Avoid using while bathing. If continuous usage is required by

the physician’s prescription, the concentrator MUST be

located in another room at least 2.5 m (7 ft) from the bath.

DO NOT come in contact with the concentrator while wet.

DO NOT place or store product where it can drop into water or

other liquid.

DO NOT reach for product that has fallen into water. Unplug

IMMEDIATELY.

If the concentrator has a damaged cord or plug, if it is not

working properly, if it has been dropped or damaged, or

dropped into water, call qualified technician for examination

and repair.

A spontaneous and violent ignition may occur if oil, grease or

greasy substances come in contact with oxygen under pressure.

These substances MUST be kept away from the oxygen

concentrator, tubing and connections, and all other oxygen

equipment. DO NOT use any lubricants unless recommended

by Invacare.

Avoid creation of any spark near medical oxygen equipment.

This includes sparks from static electricity created by any type

of friction.

SECTION 1—GENERAL GUIDELINES

Perfecto

2

™Series 8 Part No 1163145

Operating Information

For optimum performance, Invacare recommends that each

concentrator be on and running for a minimum of 30 minutes

at a time. Shorter periods of operation may reduce maximum

product life.

Keep the oxygen tubing, cord, and unit out from under such

items as blankets, bed coverings, chair cushions, clothing and

away from heated or hot surfaces, including space heaters,

stoves and similar electrical appliances.

DO NOT move or relocate concentrator by pulling on the

power cord.

NEVER drop or insert any object or liquid into any opening.

Invacare recommends that Crush-Proof oxygen tubing be

used with this product and not exceed 15.2 m (50 ft) in length.

There are no user serviceable parts. This does not include

normal maintenance items. See maintenance section for user

maintenance items.

A product should NEVER be left unattended when plugged

in. Make sure the Perfecto

2

is Off when not in use.

Close supervision is necessary when this product is used near

children or physically-challenged individuals.

Additional monitoring or attention may be required for

patients using this device who are unable to hear or see

alarms or communicate discomfort.

DO NOT connect the concentrator in parallel or series with

other oxygen concentrators or oxygen therapy devices.

Radio Frequency Interference

This equipment has been tested and found to comply with

EMC limits specified by IEC/EN 60601-1-2. These limits are

designed to provide a reasonable protection against

electromagnetic interference in a typical medical installation.

SECTION 1—GENERAL GUIDELINES

Part No 1163145 9 Perfecto

2

™Series

Other devices may experience interference from even the low

levels of electromagnetic emissions permitted by the above

standards. To determine if the emissions from the Perfecto

2

is

causing the interference, turn the Perfecto

2

Off. If the

interference with the other device(s) stops, then the Perfecto

2

is causing the interference. In such rare cases, interference

may be reduced or corrected by one of the following

measures:

• Reposition, relocate, or increase the separation

between the equipment.

• Connect the equipment into an outlet on a circuit

different from that to which the other device(s) is

connected.

SECTION 2—FEATURES

Perfecto

2

™Series 10 Part No 1163145

SECTION 2—FEATURES

Oxygen Outlet

Flowmeter

Oxygen Purity Indicator

Lights / Fault and Power

Indicator Lights

Power Switch

Circuit Breaker

Elapsed Time

Meter

Cabinet

Filter

REAR VIEW

*HF Outlet

Fitting

Power

Cord

*NOTE: This outlet fitting

is to be used only for filling

oxygen cylinders with the

HomeFill home oxygen

compressor. The outlet

fitting does not affect

concentrator performance.

Refer to the HomeFill

owner's manual, part

number 1145804, for

connection and operating

instructions. When not in

use, the plug provided with

the concentrator should be

inserted into the outlet

fitting. For more

information about the

HomeFill, contact your

Invacare dealer.

SECTION 3—HANDLING

Part No 1163145 11 Perfecto

2

™Series

SECTION 3—HANDLING

The concentrator should ALWAYS be kept in the upright

position to prevent cabinet damage while being transported.

If the concentrator is to be reshipped by common carrier,

additional cartons are available from Invacare.

Unpacking

NOTE: For this procedure, refer to FIGURE 3.1.

1. Check for any obvious

damage to the carton or

its contents. If damage is

evident, notify the

carrier, or your local

dealer.

2. Remove all loose packing

from the carton.

3. Carefully remove the

concentrator, power cord,

air inlet scoop, assembly

instructions, humidifier,

cannula, labels and user

manual from the carton.

FIGURE 3.1 Unpacking

NOTE: Unless the oxygen concentrator is to be used

IMMEDIATELY, leave concentrator in its packaging for storage

until use of the concentrator is required.

Inspection

1. Inspect/examine exterior of the oxygen concentrator for

nicks, dents, scratches or other damages. Inspect all

components.

Storage

1. Store the repackaged oxygen concentrator in a dry area.

2. DO NOT place objects on top of repackaged concentrator.

SECTION 4—TECHNICAL DESCRIPTION

Perfecto

2

™Series 12 Part No 1163145

SECTION 4—TECHNICAL

DESCRIPTION

Intended Use

Your oxygen concentrator is intended for individual use by

patients with respiratory disorders who require supplemental

oxygen. The device is not intended to sustain or support life.

The concentrator is intended for use within a home or

institutional environment.

Technical Description

The oxygen concentration level of the output gas ranges from

87% to 95.6%. The oxygen is delivered to the patient through

the use of a nasal cannula.

The Invacare Perfecto

2

concentrator uses a molecular sieve

and pressure swing adsorption methodology to produce the

oxygen gas output. Ambient air enters the device, is filtered

and then compressed. This compressed air is then directed

toward one of two nitrogen adsorbing sieve beds.

Concentrated oxygen exits the opposite end of the active sieve

bed and is directed into an oxygen reservoir where it is

delivered to the patient.

The Invacare Perfecto

2

concentrator is capable of operation by

the patient in a home environment or in an institutional

environment. Device operates at a nominal 230 VAC/50 Hertz

supply.

NOTE: Both concentrator models (IRC5PO2AW and

IRC5PO2VAW) have identical operating parameters with the

exception of the product weight and power consumption. Refer to

TYPICAL PRODUCT PARAMETERS on page 13.

Service information will be available upon request to

qualified technical personnel only.

SECTION 5—TYPICAL PRODUCT PARAMETERS

Part No 1163145 13 Perfecto

2

™Series

SECTION 5—TYPICAL PRODUCT

PARAMETERS

NOTE: All parameters apply to both concentrator models

(IRC5PO2AW and IRC5PO2VAW) unless otherwise specified.

Alternating Current

Type BF equipment

Unit running

Unit not running

Attention - Consider Accompanying Documents

DO NOT smoke

Class II, Double Insulated

Protected against dripping water

No Flame

Risk of Electric Shock

This product complies with Directive 93/42/EEC concerning medical

devices.

The launch date of this product is stated in the CE declaration of

conformity.

Electrical

Requirements:

230 VAC ± 10% (253 VAC/207 VAC), 50 Hz

Rated Current

Input:

1.5 A

Sound Level: 40 dBA max

IPX1

SECTION 5—TYPICAL PRODUCT PARAMETERS

Perfecto

2

™Series 14 Part No 1163145

Altitude: Up to 6,000 ft (1828 meters) above sea level without degradation

of concentration levels. Not recommended for use above 6000 ft

(1828 meters).

Atmospheric pressure range: 101.33kPa - 81.22kPa

Oxygen Output

Concentration

Levels:

87% to 95.6% @ 0.5 to 5 L/min

93% ± 3% @ 2 L/min

NOTE: Stated concentration levels achieved after initial warm-up

period (approximately 30 minutes).

Maximum Outlet

Pressure:

34.5 kPa ± 3.45 kPa (5 psi ± 0.5 psi)

Low Flow Alarm: 0.5 to 5 L/min (maximum). For flowrates less than 1 L/min, we

recommend the use of the Invacare Pediatric Flowmeter

Accessory (IRCPF16AW).

Potential

Obstruction Alert

0 L/min to 0.5 L/min

The concentrator detects a condition that may indicate a

potential obstruction of the output oxygen.

Rapid audible beeping alert (this alert is deactivated when

accessories are connected). May be associated with flow setting

of 0.5 L/min or less.

Power

Consumption:

Perfecto

2

AW - 300 W @ 5 L/min, 280 W @ 3 L/min

Perfecto

2

VAW - 320 W @ 5 L/min

Pressure Relief

Mechanism

Operational at:

241 kPa ± 24.1 kPa (35 psi ± 3.5 psi)

Change in

maximum

recommended

flow when back

pressure of 7kPa is

applied:

0.7 L/min

Filters: Cabinet, Outlet HEPA and Compressor Inlet

Safety System: Current overload or line surge shutdown. High temperature

compressor shutdown. High Pressure Alarm w/compressor

shutdown. Low Pressure Alarm w/compressor shutdown.

Battery Free Power Loss Alarm. SensO2 Oxygen System

Possible Obstruction Alert.

Width: 38.1 cm ± 1 cm (15 in ± 3/8 in)

Height: 58.4 cm ± 1 cm (23 in ± 3/8 in)

Depth: 30.5 cm ± 1 cm (12 in ± 3/8 in)

>

SECTION 5—TYPICAL PRODUCT PARAMETERS

Part No 1163145 15 Perfecto

2

™Series

Weight: Perfecto

2

AW - 20.5 kg ± 1 kg (45 lbs ± 2 lbs)

Perfecto

2

VAW - 18.1 kg ± 1 kg (40 lbs ± 2 lbs)

Shipping Weight: Perfecto

2

AW - 22.7 kg ± 1 kg (50 lbs ± 2 lbs)

Perfecto

2

VAW - 20.4 kg ± 1 kg (45 lbs ± 2 lbs)

Operating

Ambient

Conditions:

10°C - 35°C (50°F - 95°F) at 20-60% relative humidity

Exhaust Cooling

Air Temperature:

Less than Ambient +19°C (+ 45°F)

Oxygen Output

Temperature:

Less than Ambient +3°C (+ 8°F)

Cabinet: Impact Resistant flame-retardant plastic cabinet that conforms to

UL 94-V0.

No AP/APG Not suitable for use in the presence of a flammable anaesthetic

mixture.

Standards and

Regulatory Listing:

IEC/EN61000-3-2

IEC/EN61000-3-3,

IEC/EN 60601-1, A1, A2

IEC/EN 60601-1-2

ISO8359

MDD 93/42/EEC, Annex I and IX

CE marked model IRC5PO2AW / IRC5PO2VAW

Electrical: No extension cords.

Placement: No closer than 30.5 cm (12 in) from any wall, furniture,

draperies, or furniture to assure sufficient air flow. Avoid deep

pile carpets and heaters, radiators or hot air registers. Floor

location only.

Tubing: 2 m (7 ft) cannula with a maximum 15 m (50 ft) of Crush-Proof

Tubing (DO NOT pinch).

Time of

Operation:

Up to 24 hours per day.

Recommended

Storage and

Shipping

Temperature:

-29°C to 65°C (-20°F to 150°F) at 15-95% relative humidity.

Environment: Smoke and soot-free. No confined spaces (Example: No closets).

Minimum

Operating Time:

30 Minutes

SECTION 5—TYPICAL PRODUCT PARAMETERS

Perfecto

2

™Series 16 Part No 1163145

O2 INDICATORS

LABEL

SYMBOL

O

2

PURITY INDICATOR LIGHTS

(LED)

SYSTEM OKAY

O

2

over 85%

GREEN Indicator Light

O

2

Between 73% to 85% YELLOW Indicator light

A. YELLOW Solid

B. YELLOW Flashing Sensor

Failure

Call a qualified technician.

SYSTEM FAILURE

O

2

Below 73%

RED Indicator Light

Continuous Audible Alarm

Sieve-GARD Compressor

Shutdown

O

2

SECTION 6—OPERATING INSTRUCTIONS

Part No 1163145 17 Perfecto

2

™Series

SECTION 6—OPERATING

INSTRUCTIONS

Introduction

Your oxygen concentrator is intended for individual use. It is

an electronically operated device that separates oxygen from

room air. It provides high concentration of oxygen directly to

you through a nasal cannula. Clinical studies have

documented that oxygen concentrators are therapeutically

equivalent to other types of oxygen delivery systems.

Your provider will show you how to use your oxygen

concentrator. He/She should be contacted with any questions

or problems regarding your oxygen concentrator. This

owner’s manual will tell you about your concentrator and will

serve as a reference as you use your concentrator.

Select a Location

 WARNING

NEVER block the air openings of the product or place it on a

soft surface, such as a bed or couch, where the air opening

may be blocked. Keep the openings free from lint, hair and the

like.

Move oxygen concentrator at least 30.5 cm (12 in) away from

walls, draperies or furniture.

You may select a room in your house where using your

oxygen concentrator would be most convenient. Your

concentrator can be easily rolled from room to room on its

casters.

SECTION 6—OPERATING INSTRUCTIONS

Perfecto

2

™Series 18 Part No 1163145

Your oxygen concentrator will perform best when operated

under the conditions outlined in the Typical Product

Parameters on page 13. Usage in environments other than

those described may result in the need for increased

equipment maintenance. The air intake of the unit should be

located in a well ventilated area to avoid airborne pollutants

and/or fumes.

Set Up

1. Plug in power cord to an electrical outlet.

2. Connect Humidifier (If So Prescribed).

 WARNING

DO NOT fill humidifier bottle with hot water. Allow boiled

water to cool to room temperature before filling.

DO NOT overfill humidifier.

DO NOT reverse the oxygen input and output connections.

Water from the humidifier bottle will travel through the

cannula back to the patient.

When using tubing connections longer than 2.1 m (7 feet) in

length, position the humidifier as close to the patient as

possible to allow for maximum humidification output.

NOTE: For this procedure, refer to FIGURE 6.1, FIGURE 6.2 on

page 19, FIGURE 6.3 on page 21.

1. Remove cap from bottle.

2. Fill humidifier with boiled tap water or bottled water to

the level indicated by the manufacturer. Boil tap water for

approximately 10 minutes and cool to room temperature

prior to use. Replace the humidifier cap and securely

tighten.

SECTION 6—OPERATING INSTRUCTIONS

Part No 1163145 19 Perfecto

2

™Series

FIGURE 6.1 Filling the Humidifier

3. Insert a flathead screwdriver in the plate groove on the top

edge of the filter access door and gently pry the filter

access door off (FIGURE 6.2).

4. Pull up and remove the humidifier bottle adapter

(FIGURE 6.2).

5. Replace the filter access door and install the air scoop onto

the filter access door by inserting the six tabs on the air scoop

into the six slots on the sides of the filter access door.

FIGURE 6.2 Humidifer Bottle Adapter

6. Attach the humidifier bottle adapter to the humidifier

bottle by turning the wing nut on the humidifier bottle

counterclockwise until it is securely fastened. See Detail

“A” in FIGURE 6.3.

Humidifier

Bottle w/o Cap

Humidifier

Bottle with Cap

Insert Flat

Head

Screwdriver

Here

Filter Access

Door

Humidifier Bottle

Adapter

Cabinet Filter

Air

Scoop

Tabs

Slots

SECTION 6—OPERATING INSTRUCTIONS

Perfecto

2

™Series 20 Part No 1163145

7. Select the location for the humidifier bottle/adapter

assembly:

•When placing the humidifier bottle in the

compartment on the concentrator, attach the

humidifier bottle/adapter tube to the oxygen outlet

connector on the concentrator. See Detail “B” in

FIGURE 6.3.

•To position the humidifier bottle in a patient side

location, place the humidifier bottle/adapter

assembly in the humidifier bottle holder (M1521,

Refer to Optional Accessories on page 31) and place

on a flat surface as close to the patient as possible.

Attach an oxygen tubing connector (MS4301, Refer

to Optional Accessories on page 31) to the end of

the humidifier bottle/adapter tube. Connect one

end of the oxygen supply tubing (MS4107 or

MS4121, Refer to Optional Accessories on page 31)

to the free end of the oxygen tubing connector and

the opposite end to the oxygen outlet connector on

the concentrator.

NOTE: When using tubing connections longer than 2.1 m (7 feet)

in length, position the humidifier as close to the patient as possible

to allow for maximum humidification output.

8. Attach the patients’ nasal cannula supply tube to the

humidifier bottle outlet. See Detail “B” in FIGURE 6.3.

9. After assembly, ensure that oxygen is flowing through the

nasal cannula.

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