INVACARE Home Fill II O2 Cylinder Operators Manual Rev E Sept 2005

WARNING

WARNING

DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS, AND INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR A QUALIFIED TECHNICIAN BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE INJURY OR DAMAGE MAY RESULT.

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.

 DANGER Users MUST NOT SMOKE while using this device. Keep all matches, lighted cigarettes or other sources of ignition out of the room in which this product is located. 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.

NOTICE The information contained in this document is subject to change without notice. NOTE: Updated versions of this manual are available on www.invacare.com. HomeFill™II

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TABLE OF CONTENTS

TABLE OF CONTENTS SPECIAL NOTES ... 4 RECEIVING INSPECTION ... 4 INTENDED USE ... 4 SECTION 1-GENERAL GUIDELINES ... 5 SECTION 2-FEATURES ... 8 SECTION 3-TYPICAL PRODUCT PARAMETERS . 9 SECTION 4-INSPECTION AND COMPRESSOR INTERFACE ... 10 Cylinder Prefill Inspection ... 10 Connecting/Disconnecting the Cylinder to/from the Compressor... 13 SECTION 5-OPERATING INSTRUCTIONS ... 18 SECTION 6-MAINTENANCE ... 20 SECTION 7-CYLINDER FILL TIMES ... 21 Troubleshooting ... 21 Replacement Parts - Accessories ... 21 LIMITED WARRANTY ... 22

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HomeFill™II

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.

RECEIVING INSPECTION Remove product from package and inspect for damage. If there is any damage, DO NOT use. Contact your dealer/ Home Care equipment provider.

INTENDED USE To store, regulate, and deliver supplemental oxygen to patients who may have difficulty extracting oxygen from the air they breathe. It is for patients who would normally receive the oxygen via a nasal cannula. The device delivers USP 93% oxygen at a number of different flow/pulse settings. It is intended to be used as an oxygen saving device that may reduce the drying out of the airways.

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Part No 1112648

SECTION 1-GENERAL GUIDELINES

SECTION 1-GENERAL GUIDELINES
WARNING

SECTION 1 - IMPORTANT SAFEGUARDS contains important information for the safe operation and use of this product. 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 health care professional, dealer or technical personnel before attempting to use this equipment - otherwise, injury or damage may occur. “Caution: Federal law restricts this device to sale by or on the order of a physician or any other practitioner licensed by the law of the state in which he/she practices to use or order the use of this device.”

WARNING Only personnel instructed and trained in the use of the HomeFill II O2 Conserving Cylinder should operate this product. Product contains magnetic, ferrous material that may affect the results of an MRI. Be sure all connections are tight and leak free. DO NOT use a liquid leak detector to test for leaks. DO NOT autoclave. DO NOT gas sterilize with ethylene oxide. DO NOT clean with aromatic hydrocarbons. Part No 1112648

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HomeFill™II

SECTION 1-GENERAL GUIDELINES

WARNING DO NOT attempt to repair product. DO NOT immerse product in any kind of liquid. Store product in a clean area when not in use. Only use Invacare Corporation HF2PCL6 carrying bag, HF2PC9 carrying bag, or HF2PCL4 carrying bag. NEVER smoke in an area where oxygen is being administered. ALWAYS confirm prescribed dose before administering to patient and monitor on a frequent basis. DO NOT use if dirt or contaminants are present on or around cylinder, valve, product or connecting devices. NEVER use near any type of flame or flammable/explosive substances, vapors or atmosphere. ALWAYS follow ANSI and CGA standards for Medical Gas Products and Flowmeters (E-7) and Oxygen Handling (G-4). NO OXYGEN is delivered when the pointer is aligned with “Off”. DO NOT block the outlet fitting or kink the cannula when the product is in use, this may damage the unit. The use of this device is limited to the oxygen patient. Cylinders MUST be used only by the oxygen patient and are not to be distributed to any other individual for any purpose. This product is NOT to be used by patients who breathe through their mouths. DO NOT use oils, greases, organic lubricants or any combustible materials on or near this product. Wash and dry hands properly prior to usage. DO NOT use a humidifier with this product. HomeFill™II

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Part No 1112648

SECTION 1-GENERAL GUIDELINES

WARNING DO NOT allow cylinders to tip or fall. Secure gas cylinders so they cannot fall. Ensure cylinder is always in upright position. DO NOT store cylinders near sources of heat or flame. This product is equipped with a relief valve. If you hear a loud hissing or popping sound coming from the product, discontinue use of product, turn the flow selector to the “Off” position, and contact your dealer/Home Care equipment provider. DO NOT use while sleeping without consulting your healthcare provider. This product is designed to operate with a standard single lumen, adult oxygen nasal cannula with a maximum length of seven (7) feet. The cannula is for single patient use only. Cannula MUST be installed on outlet connection prior to use. DO NOT place the unit under clothing while in use. When this product is in use a small amount of oxygen is vented. Wearing the unit under clothing may saturate fabrics with oxygen and cause them to burn rapidly if exposed to sparks or flame. It may take several hours for oxygen levels in fabrics to return to normal.

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HomeFill™II

SECTION 2-FEATURES

SECTION 2-FEATURES
DANGER

This product is not intended as a life-sustaining or life-supporting device.

Outlet Connection

Cannula

Indicator Pointer

Flow Dial

Cylinder Gauge Cylinder Fill Port

FIGURE 2.1 Product Diagram

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Part No 1112648

SECTION 3-TYPICAL PRODUCT PARAMETERS

SECTION 3-TYPICAL PRODUCT PARAMETERS CONSERVER S/N RANGE

1-69,999

75,000 +

INLET PRESSURE RANGE:

300 - 2100 psig

300 - 2100 psig

INTERNAL REGULATED PRESSURE:

50 psig

50 psig

HF2PCL6: Weight

4.3 lbs (1.95 kg)

4.1 lbs (1.86 kg)

HF2PCL6: Overall Length

11.1 in (28 cm)

10.9 in (27.7 cm)

HF2PCL6: Diameter

4.4 in (11.1 cm)

4.4 in (11.1 cm)

HF2PC9: Weight

5.3 lbs (2.4 kg)

5.1 lbs (2.31 kg)

HF2PC9: Overall Length

14.2 in (36 cm)

14 in (35.5 cm)

HF2PC9: Diameter

4.4 in (11.1 cm)

4.4 in (11.1 cm)

HF2PCL4: Weight

N/A

3.6 lbs (1.63 kg)

HF2PCL4:Overall Length

N/A

8.9 in (22.2 cm)

HF2PCL4:Diameter.

N/A

4.4 in (11.1 cm)

DIMENSIONS:

PULSE SETTINGS:

1,2,3,4, & 5

FLOW SETTINGS:

2 LPM Continuous

SAVINGS RATIO:

Up to 4.3:1

Up to 5.7:1

CANNULA REQUIREMENT:

4 ft recommended (MS0204) (7 ft long max) std. adult single lumen oxygen nasal cannula.

OPERATING CONDITIONS TEMPERATURE:

32°F (0°C) to 105°F (40.6°C)

35°F (1.7°C) to 105°F (40.6°C)

ALTITUDE:

0 to 5280 ft (0 to1600 m)

0 to 10,000 ft (0 to 3071 m)

STORAGE CONDITIONS TEMPERATURE:

-40°F (-40°C) to 140°F (60°C)

-40°F (-40°C) to 140°F (60°C)

MAXIMUM HUMIDITY:

Part No 1112648

95%

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HomeFill™II

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE NOTE: Refer to the Homefill ™ II Compressor Owner’s Manual for compressor operating instructions.

Cylinder Prefill Inspection
WARNING All cylinders MUST be inspected before attempting to fill; otherwise, injury or damage may occur. NEVER smoke in an area where oxygen is being administered. NEVER use near any type of flame or flammable/explosive substances, vapors or atmosphere. NOTE: For this procedure, refer to FIGURE 4.1.

The Hydrostatic Testing Date Aluminum cylinders MUST undergo testing every five (5) years.

WARNING

DO NOT fill cylinders that have not been tested in the past five (5) years. Otherwise, serious personal injury may result. Contact your dealer for replacement.

External Examination 1. Examine the outside of the cylinder for the following conditions, and replace the cylinder if they exist: • Dents or dings • Arc Burns HomeFill™II

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Part No 1112648

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE • Oil or Grease • Any other signs of damage that might cause a cylinder to be unacceptable or unsafe for use. 2. Examine the cylinder for evidence of fire or thermal damage. Evidence includes charring or blistering of the paint, or other protective coating or heat sensitive indicator. If fire or thermal damage is found, replace the cylinder. 3. Inspect the cylinder fillport for the following, and replace if found: • Debris, oil or grease • Noticeable signs of damage • Signs of corrosion inside the valve • Signs of excessive heat or fire damage

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HomeFill™II

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE

! DANGER Improper filling or abuse of this cylinder, or failure to follow these safety instructions may cause serious bodily injury or death. High pressure oxidizing gas vigorously accelerates combustion. DO NOT alter or modify cylinder or related components. DO NOT use Oil or Grease. Keep cylinder, cylinder valve, all equipment and connections free of oil and grease to avoid violent ignition resulting in serious bodily injury or death. ! WARNING For medical applications. Use only as directed by a licensed practitioner. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful.

Oxygen Cylinders filled by the Venture HomeFill shall be used for personal use only. "Not to be filled for resale or use by professional users". OXYGEN 2 This cylinder is to be used with the Invacare Venture HomeFill system. This cylinder contains 93 ++ 3% oxygen produced by an oxygen concentrator using the pressure swing adsorption process. DO NOT handle cylinder or use contents until you are professionally trained, including emergency procedures. Use in accordance with Venture HomeFill Operator’s Manual. Open valve slowly. Close valve after each use and when empty. Secure cylinder during storage and use. No smoking in cylinder area. Keep away from heat, flame and spark. Keep out of reach of children. DO NOT drop. Transfilling of this gas is performed by Venture HomeFill Only. Cylinders that have been refinished and/or exposed to elevated temperatures must be hydrostatically tested before filling. Cylinder temperature should not exceed 125°F (52°C). Aluminum cylinders subject to the action of fire or heated to temperatures in excess of 350°F must be withdrawn from service and condemned by trained personnel. DO NOT use caustic paint strippers. Valve and safety relief devices must be removed and replaced by trained and authorized personnel. DO NOT alter or change valve assembly. Invacare Corporation 2101 E. Lake Mary Blvd. Sanford, FL 32773 1-800-832-4707

DO NOT REMOVE THIS PRODUCT LABEL Not for Commercial Resale Part Number 1125090 Rev B - 11/04

FIGURE 4.1 External Examination

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Part No 1112648

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE

Connecting/Disconnecting the Cylinder to/from the Compressor Connecting the Cylinder to the Compressor
WARNING NEVER use tools of any kind to connect/disconnect the cylinder and the compressor. Otherwise, severe injury and/or damage may occur. DO NOT drop oxygen cylinders. Use two (2) hands when handling/transporting oxygen cylinders. Otherwise, injury or damage may occur. DO NOT use a liquid leak detector to test for leaks. NOTE: For this procedure, refer to FIGURE 4.2 and FIGURE 4.3. 1. Examine the cylinder gauge. If the cylinder pressure is less than 1500 psig., proceed to STEP 2 (FIGURE 4.3). NOTE: If the cylinder pressure is greater than 1500 psig., DO NOT attempt to top off this cylinder. It may not fill. 2. Set the regulator flow dial on the cylinder to OFF (FIGURE 4.3). 3. Remove the cylinder and connector fillport covers (if present).

CAUTION

DO NOT connect the outlet (cannula) connection to the HomeFill II unit, otherwise the conserving cylinder will not work properly. 4. Momentarily push DOWN on the outer ring (sleeve) of the connector fillport to reset the connector as shown in FIGURE 4.2. Part No 1112648

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HomeFill™II

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE

NOTE: If the outer ring (sleeve) is in the UP position (GREEN dots not visible), the connector fillport will not be able to accept the cylinder fillport. Pushing DOWN momentarily will reset the connector fillport (GREEN dots visible) to accept the cylinder fillport. PUSH DOWN

Outer Ring (Sleeve) Connector Fillport

GREEN Dots BEFORE COUPLING CYLINDER, PUSH DOWN ON SLEEVE UNTIL GREEN DOTS ARE VISIBLE.

FIGURE 4.2 Resetting Connector Fillport 5. Grasp the cylinder/regulator assembly in the area behind the cylinder gauge (FIGURE 4.3). 6. Position the cylinder in the compressor cradle (FIGURE 4.3). 7. Align the cylinder fillport with the connector fillport (FIGURE 4.3). 8. Pull UP on the outer ring (sleeve) of the connector fillport while pushing DOWN on the cylinder/regulator assembly to couple the cylinder fillport into the connector fillport (FIGURE 4.3). NOTE: The cylinder is properly connected when an audible “click” is heard.

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Part No 1112648

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE Compressor

Cylinder/Regulator Assembly Cylinder Fillport Connector Fillport Outer Ring (Sleeve)

Cylinder Gauge PULL UP

Regulator

Cylinder Cylinder Gauge

Regulator Flow Dial Outlet (Cannula) Connection Cylinder Fillport

Power Switch

Compressor Cradle Connector Fillport

NOTE: Fillport covers not shown for clarity.

Outer Ring (Sleeve)

FIGURE 4.3 Connecting the Cylinder to the Compressor Part No 1112648

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HomeFill™II

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE

Disconnecting the Cylinder from the Compressor
WARNING

NEVER use tools of any kind to connect/disconnect the cylinder and the compressor. Otherwise, severe injury and/or damage may occur. NOTE: For this procedure, refer to FIGURE 4.4. 1. Press the compressor power switch to the Off (O) position. 2. Grasp the cylinder/regulator assembly in the area behind the cylinder gauge. 3. With the other hand, grasp the outer ring (sleeve) of the connector fillport and push DOWN. 4. Lift up on the cylinder/regulator assembly to remove from the connector fillport. Cylinder/Regulator Assembly Cylinder Gauge Compressor

Cylinder Fillport

PUSH DOWN

Outer Ring (Sleeve)

Connector Fillport

FIGURE 4.4 Disconnecting the Cylinder from the Compressor HomeFill™II

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Part No 1112648

SECTION 4-INSPECTION AND COMPRESSOR INTERFACE 5. When the cylinder fillport is disconnected from the connector fillport, release the outer ring (sleeve) of the connector fillport and use two hands to remove the cylinder from the compressor cradle. 6. Place the fillport covers onto the connector and cylinder fillports. NOTE: The fillport covers should be used whenever cylinders are not being filled.

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HomeFill™II

SECTION 5-OPERATING INSTRUCTIONS

SECTION 5-OPERATING INSTRUCTIONS
WARNING NEVER smoke in an area where oxygen is being administered. NEVER use near any type of flame or flammable/explosive substances, vapors or atmosphere. NOTE: For this procedure, refer to FIGURE 5.1. 1. Prior to each use, inspect product for visible damage. DO NOT use if any damage is found. NOTE: If for any reason, any label becomes illegible or lost, contact your dealer/Home Care equipment provider. 2. Be sure regulator is in the “Off” position. Align “Off” with the indicating pointer. 3. Position the cylinder so the oxygen cylinder valve outlet is pointing away from the user and any other person(s).

WARNING

DO NOT direct flow of oxygen at any person, or flammable material when adjusting the flow dial. 4. Attach a standard adult single lumen oxygen nasal cannula, no longer than seven (7) feet to the product’s outlet according to the cannula manufacturer’s instructions. DO NOT use pediatric, low flow nasal cannulas or oxygen masks with this product. NOTE: A unit without cannula attached may pulse if set at position 1-5.

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Part No 1112648

SECTION 5-OPERATING INSTRUCTIONS 5. Place the cannula over your ears and position the prongs in your nose as instructed by your Health Care provider or cannula manufacturer. Refer to FIGURE 5.1. 6. Turn dial until indicating pointer is aligned with the prescribed setting.

FIGURE 5.1 Cannula Placement

WARNING When pointer on contents gauge enters red zone, it is recommended to refill the cylinder on the Invacare HomeFill II Compressor. NO OXYGEN is delivered in between settings. To obtain desired flow, the indicating pointer must align with a specific number on the dial. To avoid injury to patient, ALWAYS confirm prescribed setting before administering to patient and monitor flow on a frequent basis. Only use Invacare Corporation HF2PCL6 carrying bag, the HF2PC9 carrying bag, or the HF2PCL4 carrying bag. 7. Breathe through the nose and feel a pulse of oxygen as you inhale. NOTE: When on a pulse setting, there is flow or a pulse only at the beginning of each breath. If you do not feel the pulse at the beginning of each breath, check the setting. NOTE: Because each patient’s breathing pattern is different and the environment varies, it may be difficult to feel some low setting pulses.

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HomeFill™II

SECTION 6-MAINTENANCE

SECTION 6-MAINTENANCE 1. After each use, clean exterior of the product with a dry, lint free cloth only. 2. Store product in a clean area free from grease, oil, and other sources of contamination.

CAUTION DO NOT use cleaning solutions. DO NOT immerse product in any kind of liquid. All repairs MUST be done by Invacare Corporation.

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Part No 1112648