NewLife Elite and NewLife Service Manual Rev B March 2006

NewLife® Elite Service Manual

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AirSep® is a registered trademark of AirSep Corporation. !

NewLife® Elite and NewLife® are registered trademarks of AirSep Corporation.

MN105-1

® AirSep Corporation Rev. B 03/06

NewLife® Elite Service Manual

Table of Contents Section 1.0 Introduction 1.1

Equipment Provider Responsibility

1-1

1.2

Important Notice and Symbol Explanations

1-2

1.3

NewLife® Elite/NewLife® Product Warranty

1-4

1.4

Functional Specifications

1-5

2.1

Description of Operation

2-1

2.2

Operation Check

2-1

2.3

Alarm System

2-2

2.3.1

Battery Test

2-2

2.3.2

Power Failure Alarm Test

2-2

2.4

Oxygen Concentration Test and Specification

2-3

3.1

General Instructions

3-1

3.2

Routine Maintenance by the Patient

3-1

Section 2.0 Operation Check and Oxygen Concentration Test

Section 3.0 Patient Instructions

3.2.1 3.2.2

Cleaning the Air Intake Gross Particle Filter

3-1

Checking the Alarm System Battery

3-2

Section 4.0 Equipment Provider Maintenance 4.1

4.2 AirSep® Corporation

Routine Maintenance

4-1

4.1.1

Air Intake Gross Particle Filter/GPF

4-1

4.1.2

Product Filter Replacement

4-1

4.1.3

Optional Filter Replacement

4-2

4.1.4

Battery Replacement

4-2

4.1.5

Recording Maintenance

4-3

Cleaning and Infection Control

4-3

4.2.1

4-4

Preparing for New Patient Use

i – table of contents

NewLife® Elite Service Manual

Section 5.0 Service 5.1

Components

5-1

5.2

Cabinet Removal

5-1

5.2.1

Removing Side Panel(s)

5-1

5.2.2

Removing Back Panel

5-1

5.2.3

Removing Lower Front Cover

5-1

5.2.4

Removing Control Panel

5-1

5.2.5

Superstructure

5-1

5.2.6

Caster Replacement

5-2

5.3

5.4

5.5

Compressor

5-2

5.3.1

Compressor Replacement

5-3

5.3.2

Capacitor Replacement

5-4

Solenoid Valves

5-4

5.4.1

Feed or Waste Valve Rebuilding

5-4

5.4.2

Feed or Waste Valve Reassembly

5-5

5.4.3

Solenoid Valve Coil Replacement

5-5

Sieve Bed Replacement

5-6

5.5.1

Sieve Bed Removal

5-6

5.5.2

Sieve Bed Installation

5-7

5.6

Cabinet Fan Replacement

5-7

5.7

Circuit Board Replacement

5-8

5.7.1

Circuit Board Removal

5-8

5.7.2

Circuit Board Installation

5-9

5.8

Product Regulator Check and Setting 5.8.1

5.9 5.10

5.11

ii – table of contents

5-10

Setting Product Regulator for Normal Operation

5-10

5.8.2

Product Regulator Lockout

5-10

5.8.3

Back Pressure Correction at 5 lpm

5-11

5.8.4

Product Regulator Cleaning or Rebuilding

5-12

High or Low Pressure Switch Replacement (In Equipped Units)

5-13

Circuit Breaker Replacement

5-14

5.10.1

Circuit Breaker Removal

5-14

5.10.2

Circuit Breaker Installation

5-14

ON/OFF Power Switch Replacement

5-14

5.11.1

5-14

ON/OFF Power Switch Removal

AirSep® Corporation

NewLife® Elite Service Manual

5.11.2

ON/OFF Power Switch Installation

5-15

5.12

Buzzer Replacement

5-15

5.13

Hour Meter Replacement

5-15

5.14

Flowmeter Replacement

5-16

5.14.1

Flowmeter Removal

5-16

5.14.2

Flowmeter Installation

5-16

5.15

Power Cord Replacement

5-16

6.1

Operating Pressure Test

6-1

6.1.1

High Operating Pressure

6-1

6.1.2

Low Operating Pressure

6-2

Section 6.0 Troubleshooting

6.2

General Troubleshooting

6-2

6.3

Troubleshooting Chart

6-4

6.4

Tool Kit and Pressure Test Gauge

6-7

Appendix Exploded Drawings

AirSep® Corporation

Figure 1: Control Panel Assembly

A-1

Figure 2: Main Structure Assembly

A-2

Figure 3: Base and Cabinet Components

A-3

Figure 4: Test Block Assembly

A-4

Figure 5: Valve Block Assembly

A-5

Figure 6: Compressor Assembly

A-6

Figure 7: Adsorption Bed Assembly

A-7

iii – table of contents

NewLife® Elite Service Manual

AirSep® Corporation

NewLife® Elite Service Manual

1.0

Introduction 1.1

Equipment Provider Responsibility All Equipment Providers of the NewLife® Elite/NewLife® Oxygen Concentrator must assume responsibilities for handling, operational check-out, patient instruction, and maintenance. These responsibilities are outlined below and throughout this manual.

WARNING NewLife units must not be used for or with any lifesupporting applications. Geriatric, pediatric, or any other patients unable to communicate discomfort while using this machine may require additional monitoring. Advise patients to immediately notify their Equipment Providers and/or physicians in case of an alarm or any discomfort.

As an Equipment Provider, you must do all of the following: !

!

! ! ! ! ! ! !

!

AirSep® Corporation

Inspect the condition of each NewLife unit immediately upon delivery to your business location. Note any sign of damage, external or internal, on the delivery receipt, and report it directly to both the freight company and AirSep Corporation immediately. Check the operation of each NewLife before delivery to a patient. Always operate the unit for a reasonable length of time and check that the oxygen concentration level is within specifications as referred to in Section 2.4. (Test the battery and power disconnect alarm as described in Section 2.3 of this manual.) Deliver NewLife units only to patients authorized by a physician’s prescription. The NewLife must not be used as a life-supporting device. A backup supply of oxygen must be available. Instruct patients how to use the NewLife in conjunction with the Patient Manual. Instruct patients to notify their physicians and/or Equipment Providers if they experience any signs of discomfort. Instruct each patient how to perform routine maintenance of the air intake gross particle filter and how to check the alarm system battery. (Refer to Section 3.2.) Be available to service each patient at any time. Maintain the NewLife in accordance with Section 4.0. Repair components and replace parts only as outlined in this manual. Use only AirSep parts for replacement in NewLife Oxygen Concentrators. Refer to the NewLife Product Warranty if parts replacement is required within the warranty period.

1-1

NewLife® Elite Service Manual

1.2

Important Notice and Symbol Explanations As you read the manual, pay special attention to the WARNING, CAUTION, and NOTE messages. They identify safety guidelines or other important information as follows:

1-2

WARNING:

Describes a hazard or unsafe practice that can result in severe bodily injury or death.

CAUTION:

Describes a hazard or unsafe practice that can result in minor bodily injury or property damage.

NOTE:

Provides information important enough to emphasize or repeat.

AirSep® Corporation

NewLife® Elite Service Manual

The following harmonized symbols (pictograms), used for nonEnglish language countries, will be located on the exterior of the NewLife unit:

Read the Patient Instruction Manual.

No smoking within five feet of this device, oxygencarrying tubing, or accessories.

No open flames within five feet of this device, oxygencarrying tubing, or accessories.

No oil, grease or petroleum-based products on or near the unit.

Oxygen outlet

Oxygen alarm

Nebulizer option

AirSep® Corporation

1-3

NewLife® Elite Service Manual

1.3

NewLife Product Warranty AirSep Corporation warrants the NewLife Elite/NewLife Oxygen Concentrator to be free from defect in parts and workmanship for one, three, or five years (as specified on the original invoice provided) from the date of delivery to the original purchaser, under normal use and operation. AirSep Corporation’s obligations under this warranty are limited to the repair or replacement of any such item of equipment (or part thereof) shown to be defective or, at AirSep Corporation’s option, to refunding the purchase price of any such defective item of equipment. Each item of equipment for which a warranty claim is asserted shall, at the request of AirSep Corporation, be returned on a prepaid basis with proof of purchase date to the AirSep factory at the expense of the purchaser. The purchaser will be responsible for return freight charges. Replacement parts shall be warranted as stated above for the unexpired portion of the original (one-, three-, or five-) year parts warranty (as specified on the original invoice provided). This warranty does not extend to any item or part subjected to misuse, accident, improper maintenance, or application, or which has been repaired or altered outside of the AirSep Corporation Factory without the express prior written authorization of AirSep Corporation. THE FOREGOING WARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IN FACT OR IN LAW, INCLUDING WITHOUT LIMITATION THE WARRANTY OF MERCHANTABILITY OR THE WARRANTY OF FITNESS FOR PARTICULAR PURPOSE. IT IS EXPRESSLY UNDERSTOOD THAT PURCHASER’S SOLE AND EXCLUSIVE REMEDY FOR DEFECT IN PARTS IS LIMITED TO ENFORCEMENT OF AIRSEP CORPORATION’S OBLIGATION AS SET FORTH ABOVE, AND AIRSEP CORPORATION SHALL NOT BE LIABLE TO PURCHASER OR OTHERS FOR LOSS OF USE OF THE EQUIPMENT OR FOR OTHER SPECIAL, INDIRECT, INCIDENTAL, OR CONSEQUEN-TIAL DAMAGES.

1-4

AirSep® Corporation

NewLife® Elite Service Manual

1.4

Functional Specifications Dimensions:

28.5 in. high, 15.7 in. wide, 14.5 in. deep (72.4 cm high, 40.0 cm wide, 36.8 cm deep)

Weight:

54.0 lb; shipping weight - 59.0 lb (24.5 kg; shipping weight - 29.0 kg)

Electrical Requirements:

120 VAC, 60 Hz, 4 amps, 350 watts 230 VAC, 50 Hz, 4 amps, 350 watts

Capacity:

5 liters per minute at 90% oxygen (Based on 70°F [21°C] at sea level)

Accuracy:

Flowmeter ±5% full scale. (Based on precalibrated analysis.)

Concentration:

1–3 liters per minute at 95% + 0.5/ - 3% 4 liters per minute at 92% + 3.5/ - 3% 5 liters per minute at 90% + 5.5/ - 3%

Response Time:

Allow 5 minutes to attain maximum oxygen concentration.

Positioning:

Operate the unit in an upright position, maintaining at least six inches of open space on all sides for ventilation.

0459

AirSep® Corporation

1-5

NewLife® Elite Service Manual

AirSep® Corporation

NewLife® Elite Service Manual

2.0 Operation Check and Oxygen Concentration Test 2.1

Description of Operation Air enters the NewLife Oxygen Concentrator through an external air intake gross particulate filter. This filtered air enters the compressor via a suction resonator, which quiets the compressor’s suction sound. Pressurized air then exits the compressor and passes through a heat exchanger. The heat exchanger reduces the temperature of the compressed air. Next, a two-way solenoid feed valve directs the air into one of two sieve beds that contain molecular sieve. The unique property of molecular sieve enables it to physically attract (adsorb) nitrogen when air passes through this material, thus producing high concentration oxygen. There are two sieve beds: while one produces high concentration oxygen, the other is purged of the nitrogen it adsorbed (collected) while it made oxygen. Each adsorber produces oxygen for approximately eight seconds and delivers it to the product tank. Oxygen exits the product tank through a pressure regulator, product filter, flow control valve, flowmeter, and finally exits the unit. The flow control valve, which is part of the flowmeter, controls the amount of oxygen delivered to the patient. The NewLife unit delivers up to 95.5% pure oxygen at flow rates from 1–5 lpm. NOTE: NewLife Elite OxiSilent™ option incorporates an additional felt intake filter prior to air entering the compressor.

2.2

Operation Check AirSep tests every NewLife Oxygen Concentrator thoroughly after manufacture. You must perform the following test to ensure that no damage occurred in shipping or handling.

AirSep® Corporation

1

Open and inspect all cartons (that contain units) upon delivery. Unpack the unit and remove it from the carton. Inspect the unit itself for damage. If the exterior of a unit’s carton is damaged, or the unit itself is damaged, note it on the freight bill signed by the driver.

2

Plug in the power cord of the unit, and set the ON/OFF switch to the ON position. Check to see that the following occurs: a.

A continuous alarm loudly sounds for approximately five seconds to indicate that the battery for the alarm is good. See the troubleshooting chart in Section 6.0 of this manual if the unit’s alarm does anything other than sound loudly for five seconds.

b.

The compressor runs. Listen for the sound.

c.

Exhaust air flows out of the bottom of the unit. 2-1

NewLife® Elite Service Manual

d.

3

OPTIONAL: The Oxygen Monitor’s amber light remains on until the oxygen concentration reaches 85% ± 3% (approximately two minutes).

Turn the flowmeter adjustment knob counterclockwise until it stops (wide open). The maximum flow should register 5.5 lpm (the 5.5 lpm line should appear to split the middle of the flowmeter ball) with no connections at the oxygen outlet. If not, refer to Section 5.8.1 to set the product regulator.

4

2.3

Perform an oxygen concentration test, as described in Section 2.4.

Alarm System The NewLife Oxygen Concentrator is equipped with a battery-powered alarm system, which sounds a continuous and loud alarm when a power failure occurs. It sounds an intermittent alarm if the high or low pressure indicators are activated or if the optional oxygen monitor detects lower than therapeutic levels of oxygen concentration. The alarm remains on until you correct the alarm condition or you set the ON/OFF switch to the OFF position. Refer to Section 6.0 for a list of probable alarm causes.

2.3.1 Battery Test Each time the NewLife unit is turned on, a five-second audible alarm sounds to indicate the condition of the battery. NOTE The audio alarm must sound loudly for approximately five seconds each time the unit is turned to ON to indicate the battery is in good condition.

2.3.2 Power Failure Alarm Test To test the power failure alarm, take the following step: Unplug the unit, and set the ON/ OFF switch to the ON position. This should immediately activate the audio alarm. If it does not, refer to the troubleshooting chart in Section 6.0 of this manual.

2-2

AirSep® Corporation

NewLife® Elite Service Manual

2.4

Oxygen Concentration Test and Specification To ensure that the unit’s output of oxygen is within specification, you must perform a test of oxygen concentration. Test the unit upon delivery to a patient and at periodic intervals. Equipment Providers, based on their expertise and documentation, may establish and implement their own protocol to check oxygen concentration. The interval established may be longer or shorter than 90 days, which is AirSep’s default time period for providers who do not choose to establish their own protocol. 1

If an oxygen humidifier bottle is used, remove it from the oxygen outlet.

2

Connect a calibrated oxygen concentration analyzer to the oxygen outlet.

3

Verify that the product flow rate delivered by the unit matches the patient’s prescription and does not exceed the capacity of the unit.

4

Set the unit’s ON/OFF power switch to the ON position. (It takes approximately five minutes for the oxygen concentration to stabilize.) Take oxygen concentration readings every 60 seconds until the analyzer shows that two consecutive readings are the same.

5

Disconnect the oxygen analyzer, and reconnect the humidifier bottle (if used) and any other equipment/ accessories that may be required.

6

Adjust the flowmeter adjustment knob to the prescribed level.

NOTE Do not measure oxygen concentration output after the product stream passes through a humidifier bottle, or erroneous readings will result.

AirSep NewLife Oxygen Concentration Specifications

AirSep® Corporation

Liter Flow

Specification

In Spec

1–3 lpm

95% + 0.5/ - 3%

92% or higher

4 lpm

92% + 3.5/ - 3%

89% or higher

5 lpm

90% + 5.5/ - 3%

87% or higher 2-3

NewLife® Elite Service Manual

AirSep® Corporation

NewLife® Elite Service Manual

3.0 Patient Instructions 3.1

General Instructions It is important that patients thoroughly understand how to operate the AirSep NewLife unit. This enables proper treatment as prescribed by a qualified, licensed physician. You must explain that the purpose of this therapy is to alleviate symptoms. If patients experience any discomfort or the unit alarms, they must notify their Equipment Provider and/or physician immediately. You, as the Equipment Provider, are responsible to see that each patient receives the Patient Manual. Locate the Patient Manual in the pocket on the back of each unit. Explain each step in the operation of the unit to the patient in reference to this manual.

3.2

Routine Maintenance by the Patient To ensure accurate output and efficient operation of the unit, the patient must perform two simple routine maintenance tasks: ! !

Clean the air intake gross particle filter Check the alarm system battery

3.2.1 Cleaning the Air Intake Gross Particle Filter NOTE The patient must clean this filter weekly, as described below. The filter may require daily cleaning if the NewLife unit operates in a harsh environment such as a house heated by wood, kerosene, or oil, or one with excessive cigarette smoke.

AirSep® Corporation

1

Remove the dirty air intake gross particle filter from the back of the NewLife unit, and install the clean filter stored in the pocket on the back of the unit.

2

Wash the dirty filter in warm soapy water, and rinse.

3

Use a soft absorbent towel to remove excess water.

4

Place the clean air intake gross particle filter in the pocket on the back of the unit.

3-1

NewLife® Elite Service Manual

3.2.2 Checking the Alarm System Battery The alarm system battery is tested each time the ON/OFF switch is set to the ON position. A continuous alarm sounds for approximately five seconds to indicate a good battery. If the alarm does anything other than sound loudly for five seconds, instruct the patient to call the Equipment Provider immediately.

3-2

AirSep® Corporation

NewLife® Elite Service Manual

4.0 Provider Maintenance 4.1

Routine Maintenance The NewLife Elite unit has two or three filters and a 9-volt battery that require scheduled maintenance and replacement. To ensure that the unit’s output of oxygen is within specification, you must perform a test of oxygen concentration. Test the unit upon delivery to a patient and at periodic intervals. Equipment Providers, based on their expertise and documentation, may establish and implement their own protocol to check oxygen concentration. The interval established may be longer or shorter than 90 days, which is AirSep’s default time period for providers who do not choose to establish their own protocol. AirSep does not require preventative maintenance on the concentrator. You do not need to perform any maintenance as long as the NewLife unit remains within specifications at the desired flow rate.

4.1.1 Air Intake Gross Particle Filter/GPF The external air intake gross particle filter is located on the back of the unit. You can easily remove it by hand. Instruct the patient to clean this filter weekly. (Refer to Section 3.2.1.) NOTE The filter may require more frequent cleaning if the NewLife unit operates in a harsh environment such as a house heated by wood, kerosene, or oil, or one with excessive cooking or cigarette smoke.

4.1.2 Product Filter Replacement The product filter must be replaced after every 25,000 hours of use. 1

Set the unit’s ON/OFF switch to the OFF position, and unplug the power cord.

2

Remove the side panels to locate the product filter. NOTE Observe the position of the filter before removal.

3

AirSep® Corporation

Cut the tie-wraps, and separate the green tubing from both sides of the filter. 4-1

NewLife® Elite Service Manual

4

Install the new filter with the inlet side in the same position as before. Push the tubing together so that the tubing overlaps the product filter connections, and secure it with the tie-wraps.

5

Record information about the product filter replacement on the History Record Label, which is discussed in Section 4.1.5.

6

Reconnect the back and side panels.

4.1.3 Optional Filter Replacement The optional internal felt filter requires changing every 5,000 hours of use. See below on instructions for changing the filter. 1

Set the unit’s ON/OFF switch to the OFF position, and unplug the power cord.

2

Remove right side panel to locate the felt intake filter.

3

Remove filter in the unit, and replace with a new filter.

4

Remove left side panel and record information about the filter replacement on the History Record Label.

5

Reconnect both side panels.

4.1.4 Battery Replacement Each time the NewLife unit is turned on, the alarm must sound loudly for approximately five seconds to indicate a good battery. An alarm that does anything other than sound loudly for five seconds indicates a weak battery and requires replacement. To replace the battery, take the following steps:

4-2

1

Set the unit’s ON/OFF switch to the OFF position, and unplug the power cord.

2

Remove the left side panel.

3

Lift the battery out of the battery holder.

AirSep® Corporation