INVACARE Perfecto 2 Series Oxygen Concentrators User Manual Model IRC5Pxxx Rev C Sept 2010

WARNING

 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 owner’s 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. NOTE: Updated versions of this manual can be found at www.invacare.com.

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TABLE OF CONTENTS ACCESSORIES ...2 SPECIAL NOTES ...4 LABEL LOCATION ...6 SECTION 1-GENERAL GUIDELINES ...7 Radio Frequency Interference ...8 SECTION 2-FEATURES ...10 SECTION 3-HANDLING ...11 Unpacking...11 Inspection...11 Storage ...11 SECTION 4-TECHNICAL DESCRIPTION ...12 SECTION 5-TYPICAL PRODUCT PARAMETERS .13 SECTION 6-OPERATING INSTRUCTIONS ...17 Introduction...17 Select a Location...17 Set Up...18 Flowrate...21 SensO2 Oxygen Purity Indicator - Model IRC5PO2AW...22 Initial Startup of the Concentrator ...22 Explanation of Indicator Lights - Model IRC5PAW...23 Elapsed Time Meter (Hour Meter)...23 SECTION 7-MAINTENANCE ...24 Routine Maintenance...24 SECTION 8-TROUBLESHOOTING GUIDE ...27 SECTION 9-OPTIONAL ACCESSORIES ...29 RECYCLING INFORMATION ...30 LIMITED WARRANTY ...31 Part No 1160877

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SPECIAL NOTES

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. 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.

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.

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SPECIAL NOTES

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.

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LABEL LOCATION

LABEL LOCATION Perfecto2™ FOR OPERATING INSTRUCTIONS or ALARMS (See Operator’s Manual) DANGER - RISK OF FIRE NO SMOKING - Keep ALL sources of ignition out of the room in which this product is located and away from areas where oxygen is being delivered. Textiles, oil and other combustiles are easily ignited and burn with great intensity in oxygen enriched air. DANGER - ELECTRIC SHOCK DO NOT remove cover. Refer servicing to qualified service personnel. Flowrates below 0.5 L/min will trigger Low Flow Alarm (rapid audible alarm). Set Flowmeter at 2.5 L/min or less when filling HomeFill® cylinders. HomeFill® Compatible

Serial Number Label is located on the resonator intake assembly

Specification Label is located on the back near the bottom

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SECTION 1-GENERAL GUIDELINES

SECTION 1-GENERAL GUIDELINES In order to ensure the safe installation, assembly and operation of the Perfecto2 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. Part No 1160877

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SECTION 1-GENERAL GUIDELINES

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 Perfecto2 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. Perfecto2™Series

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SECTION 1-GENERAL GUIDELINES 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 Perfecto2 is causing the interference, turn the Perfecto2 Off. If the interference with the other device(s) stops, then the Perfecto2 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.

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SECTION 2-FEATURES

SECTION 2-FEATURES Oxygen Outlet Oxygen Purity Indicator Lights / Fault and Power Indicator Lights

Flowmeter

Circuit Breaker

Elapsed Time Meter

Power Switch

REAR VIEW

Cabinet Filter

Power Cord

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*HF Outlet Fitting 10

*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 ownerʹs manual, part number 1116444, 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. Part No 1160877

SECTION 3-HANDLING

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 all the components 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.

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SECTION 4-TECHNICAL DESCRIPTION

SECTION 4-TECHNICAL DESCRIPTION The Invacare Perfecto2 concentrator is used by patients with respiratory disorders who require supplemental oxygen. The device is not intended to sustain or support life. 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 Perfecto2 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 Perfecto2 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. Service information will be available upon request to qualified technical personnel only.

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SECTION 5-TYPICAL PRODUCT PARAMETERS

SECTION 5-TYPICAL PRODUCT PARAMETERS Alternating Current Type BF equipment Unit running Unit not running Attention - Consider Accompanying Documents

DO NOT smoke Class II, Double Insulated

IPX1

Protected against dripping water

Electrical Requirements:

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

Rated Current Input:

1.4 A

Sound Level:

39.5 dBA Average

Altitude:

All Perfecto2 Models: Up to 8,000 ft (2438 meters) above sea level without degradation of concentration levels. From 8,000 ft to 13,129 (4000 meters) below 90% efficiency. All Perfecto2 Models while filling a HomeFill System: Up to 6,000 ft (1828 meters) above sea level without degradation of concentration levels. From 6,000 ft (1828 meters) to 13,129 ft (4000 meters) below 90% efficiency

Oxygen Output Concentration Levels: 87% to 95.6% at 0.5 to 5 L/min 93% ± 3% at 2 L/min NOTE: Stated concentration levels achieved after initial warm-up period (approximately 30 minutes). Part No 1160877

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SECTION 5-TYPICAL PRODUCT PARAMETERS Maximum Outlet Pressure:

34.5 kPa ± 3.45 kPa (5 psi ± 0.5 psi)

Flow Range:

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)

Low Flow Alarm:

0 L/min to 0.5 L/min Rapid Audible Alarm Beeping (No Accessories Connected)

Average Power Consumption:

Perfecto2AW - 300 W @ 5 L/min, 280 W @ > 3 L/min Perfecto2VAW - 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 (SensO2 Model) Low Flow Alarm

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)

Weight:

Perfecto2AW Models - 20.5 kg ± 1 kg (45 lbs ± 2 lbs) Perfecto2VAW Models - 18.1 kg ± 1 kg (40 lbs ± 2 lbs)

Shipping Weight:

Perfecto2AW Models - 22.7 kg ± 1 kg (50 lbs ± 2 lbs) Perfecto2VAW Models - 20.4 kg ± 1 kg (45 lbs ± 2 lbs)

Operating Ambient Temperature:

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

Exhaust Cooling Air Temperature:

Less than Ambient +19°C (+ 35°F)

Oxygen Output Temperature:

Less than Ambient +3°C(+ 6°F)

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SECTION 5-TYPICAL PRODUCT PARAMETERS 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:

IRC5PO2AW/IRC5PAW/IRC5PO2VAW: IEC/EN60601-1, A1, A2 IEC/EN60601-1-2 IEC/EN61000-3-2 IEC/EN61000-3-3, IRC5PO2AW/IRC5PO2VAW Models Only ISO8359 MDD 93/42/EEC, Annex I and IX

CE marked model

IRC5PO2AW & IRC5PO2VAW

Electrical:

No extension cords

Placement:

No closer than 7.5 cm (3 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 No confined spaces (Example: No closets)

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: Minimum Operating Time:

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Smoke and soot-free No confined spaces (Example: No closets) 30 Minutes

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SECTION 5-TYPICAL PRODUCT PARAMETERS IRC5PO2AW & IRC5PO2VAW INDICATORS

LABEL SYMBOL

O2

O2 PURITY

INDICATOR LIGHTS (LED)

SYSTEM OKAY O2 over 85% (± 2%)

GREEN Indicator Light

O2 Between 73% (± 3%) to 85% (±2%)

YELLOW Indicator light A. YELLOW Solid B. YELLOW Flashing Sensor Failure Call a qualified technician.

SYSTEM FAILURE O2 Below 73% (±3%)

RED Indicator Light Continuous Audible Alarm Sieve-GARD Compressor Shutdown

IRC5PAW INDICATORS

LABEL SYMBOL

I/O

Perfecto2™Series

STATUS

INDICATOR LIGHTS (LED)

SYSTEM OKAY

GREEN Indicator Light

SYSTEM FAILURE

RED Indicator light Continuous Audible Alarm Sieve-GARD™Compressor Shutdown Call a qualified technician.

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SECTION 6-OPERATING INSTRUCTIONS

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. Keep unit at least 7.5 cm (3 in) away from walls, draperies, furniture, and the like. 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.

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SECTION 6-OPERATING INSTRUCTIONS 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. DO NOT use in a closet.

Set Up 1. Plug in power cord to an electrical outlet. 2. Connect Humidifier (if so prescribed).

 WARNING 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. NOTE: For this procedure, refer to FIGURE 6.1, FIGURE 6.2 on page 19, FIGURE 6.3 on page 20. 1. Remove cap from bottle. 2. Fill humidifier with distilled water to the level indicated by the manufacturer. Replace the humidifier cap and securely tighten. Humidifier Bottle w/o Cap

Humidifier Bottle with Cap

FIGURE 6.1 Perfecto2™Series

Filling the Humidifier 18

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SECTION 6-OPERATING INSTRUCTIONS 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. Humidifier Bottle Adapter

Insert Flat Head Screwdriver Here

Filter Access Door Cabinet Filter

Air Scoop Slots Tabs

6.

7.

8.

9.

FIGURE 6.2 Humidifer Bottle Adapter 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. Place the humidifier bottle/adapter assembly in the humidifier compartment on the concentrator. See Detail “B” in FIGURE 6.3. Attach oxygen tubing from the humidifier bottle/adapter assembly to oxygen outlet connector on the concentrator. See Detail “B” in FIGURE 6.3. Attach the cannula/patient supply tubing to the humidifier bottle outlet. See Detail “B” in FIGURE 6.3.

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SECTION 6-OPERATING INSTRUCTIONS 10. After assembly, ensure that oxygen is flowing through the cannula. DETAIL “A”

DETAIL “B”

Humidifier Bottle Adapter Humidifier Bottle

Oxygen Tubing

Oxygen Outlet Connector

Humidifier Bottle Outlet Humidifier Bottle

Humidifier Compartment

FIGURE 6.3

Humidifier Compartment

Power Switch NOTE:Forthisprocedure,referto FIGURE 6.4.

On/Off (I/O) Power Switch

1. Press power switch to On position. All the panel lights and the audible alarm will come on for one second, indicating that the unit is functioning properly.

FIGURE 6.4 Power Switch Perfecto2™Series

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