AirSep NewLife Intensity 10 Bedienungsanleitung

NewLife®Intensity 10

Oxygen Concentrator

Service Manual

MN134-1 rev C

Expedited Product Warranty Check service is available at 800-482-2473

MN134-1 rev C

iii

Table of Contents

Section 1.0

Introduction

1.1 Equipment Provider Responsibility 1

1.2 Important Notice and Symbol Explanations 2

1.3 Functional Specifications 4

Section 2.0

Operation Check and

Oxygen Concentration Test

2.1 Description of Operation 5

2.2 Operation Check 5

2.3 Alarm System 5

2.3.1 Start Up/Battery Test 6

2.3.2 Power Failure Alarm Test 6

2.4 Oxygen Concentration Test and Specification 6

Section 3.0

Patient Instructions

3.1 Instructions 7

3.2 Routine Maintenance by the Patient 7

3.2.1 Cleaning the Air Intake

Gross Particle Filter 7

3.2.2 Checking the Alarm System Battery 7

Section 4.0

Provider Instructions

4.1 Instructions 8

4.1.1 Air Intake Gross Particle Filter/GPF 8

4.1.2 Felt Filter Replacement 8

4.1.3 Product Filter 8

4.1.4 Battery Replacement 8

4.1.5 Recording Maintenance 9

4.2 Preparing for New Patient Use/Method of 9

Cleaning and Infection Control

MN134-1 rev C

Section 5.0

Main Components 5.1 Components 10

5.2 Cabinet Removal 10

5.2.1 Removing Side Panel(s) 10

5.2.2 Removing Back Panel 10

5.2.3 Removing Lower Front Panel 10

5.2.4 Removing Control Panel 10

5.2.5 Superstructure 10

5.2.6 Caster Replacement 10

5.3 Compressor 11

5.3.1 Compressor Replacement 11

5.3.2 Capacitor Replacement 12

5.4 Solenoid Valves 12

5.4.1 Feed/Waste Valve Replacement 12

5.4.2 Solenoid Valve Coil Replacement 12

5.5 Sieve Beds 13

5.5.1 Sieve Bed Replacement 13

5.6 Cabinet Fan 14

5.6.1 Cabinet Fan Replacement 14

5.7 Circuit Board 14

5.7.1 Circuit Board Replacement 15

5.8 Product Tank Replacement 15

5.9 Product Regulator Check and Setting 16

5.9.1 Setting Product Regulator for Normal Operation 16

5.9.2 Product Regulator Cleaning or 17

Rebuilding

5.10 Circuit Breaker Replacement 17

5.11 I/0 Power Switch Replacement 17

5.12 Buzzer Replacement 18

5.13 Hour Meter Replacement 18

5.14 Flowmeter Replacement 18

5.15 Power Cord Replacement 18

5.16 Oxygen Monitor Circuit Board Replacement 19

MN134-1 rev C

Section 6.0

Troubleshooting

6.1 Operating Pressure Test 20

6.1.1 High Operating Pressure 20

6.1.2 Low Operating Pressure 20

6.2 General Troubleshooting 21

6.3 Troubleshooting Chart 22

6.4 Tool Kit and Pressure Test Gauge 25

MN134-1 rev C

1.0 Introduction

1.1 Equipment Provider Responsibility

All Equipment Providers of the NewLife®Intensity 10 Oxygen Concentrator must assume

responsibilities for handling, operational check-out, patient instruction, and oxygen

concentration checks. These responsibilities are outlined below and throughout this

manual.

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

Inspect the condition of each NewLife Intensity 10 unit immediately upon delivery

to your business location. Note any sign of damage on the delivery receipt, and

report it directly to both the freight company and AirSep Corporation immediately.

Check the operation of each NewLife Intensity 10 before delivery to a patient.

Confirm 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 Intensity 10 units only to patients authorized by a licensed health

care provider or physician’s prescription. The NewLife Intensity 10 must not be

used as a life-supporting device. A backup supply of oxygen must be available.

Instruct patients how to use the NewLife Intensity 10 in conjunction with the Patient

Manual.

Instruct patients to notify their licensed health care provider/physician 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 provide service to each patient at any time.

Maintain the NewLife Intensity 10 in accordance with Section 4.0.

Establish and implement a protocol to check oxygen concentration.

Repair components and replace parts only as outlined in this manual. Use only

AirSep parts for replacement in NewLife Intensity 10 Oxygen Concentrators.

Refer to the NewLife Intensity 10 Product Warranty if parts replacement is required

within the warranty period.

This unit is not a life-support device. Geriatric, pediatric, or any other

patient unable to communicate discomfort while using this oxygen

concentrator may require additional monitoring. Patients with hearing

and/or sight impairments may need assistance with monitoring the

alarms.

This device supplies high-concentration oxygen that promotes rapid

burning. Do not allow smoking or open flames within the same room of

(1) this device, or (2) any oxygen-carrying accessory. Failure to observe

this warning can result in severe fire, property damage, and/or cause

physical injury or death.

Use no oil, grease, or petroleum-based or other flammable products on

or near nasal end of cannula or on the Intensity 10 unit. Oxygen

accelerates the combustion of flammable substances.

MN134-1 rev C

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:

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

death.

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

property damage.

Provides information important enough to emphasize or repeat.

Symbols are frequently used on equipment in preference to words with the intention of

lessening any possibility of misunderstanding caused by language differences. Symbols

can also permit easier comprehension of a concept within a restricted space.

The following table is a list of symbols and definitions that may be used with the NewLife

Intensity 10 Oxygen Concentrator. These symbols are referenced from the appropriate

International Electrotechnical Commission (IEC) standards:

Symbol

Description

Symbol

Description

On (power switched on)

Do not disassemble

Off (power switched off)

Consult instructions for use

Type BF device

Keep in vertical position

Class II device

Fragile –handle with care

Do not smoke

Oxygen concentration warning

LED

Do not expose to open flames

Caution: US federal law restricts

this device for sale or rental by or

on order of a licensed healthcare

provider

Do not grease

Gas outlet, connection to the

circuit

Consult the accompanying

documents

WEEE Directive

Keep unit and accessories dry

MN134-1 rev C

Method for disposing of waste: All waste from the NewLife Intensity 10 (patient circuit,

etc.) must be disposed of using appropriate methods.

Method for disposing of the device: In order to preserve the environment, the

concentrator must only be disposed of using the appropriate methods.

Conformity with EN 60-601 (§ 6.8.2 b):

“The manufacturer, assembler, installer or importer are not considered to be responsible

themselves for the consequences on the safety, reliability and characteristics of a device

unless:

- The assembly, fitting, extensions, adjustments, modifications, or repairs have been

performed by persons authorized by the party in question.

- The electrical installation of the corresponding premises complies with IEC regulations.

- The device is used in accordance with the instructions for use.” If the replacement parts

used for the periodic servicing by an approved technician do not comply with the

manufacturer’s specifications, the latter is absolved from all responsibility in the event of

an accident. Do not open the device while in operation: risk of electrical shock. This

device complies with the requirements of the 93/42/EEC European directive but its

operation may be affected by other devices being used close by, such as diathermy and

high frequency electro-surgical equipment, defibrillators, short wave therapy equipment,

mobile telephones, CB and other portable devices, microwave ovens, induction plates or

even remote control toys, and more generally electromagnetic interferences, which exceed

the levels specified by the EN 60601-1-2 standard.

Classification

Type of protection against electric shock:

Class II Protection from electric shock is achieved by DOUBLE INSULATION.

Protective earthing or reliance upon installation conditions are not required.

Degree of protection against electric shock:

Type BF Equipment providing a particular degree of protection against electric

shock, particularly regarding:

1) allowable leakage current;

2) reliability of protective earth connection (if present).

Not intended for direct cardiac application.

Degree of protection against harmful ingress of water:

Drip-proof equipment –IPX1.

Equipment provided with an enclosure preventing entry of such an amount

of falling liquid as might interfere with the satisfactory and safe operation

of the equipment.

Method of cleaning and infection control allowed:

Please refer to the Maintenance section in the NewLife Intensity 10 Service

Manual.

Degree of safety of application in the presence of flammable anesthetic gases:

Equipment not suitable for such application.

Mode of operation: Continuous duty.

MN134-1 rev C

1.3 Functional Specifications

Oxygen Concentration: 2-9 LPM: 92% +3.5/-3%

10 LPM: 90% +5.5/-3%

(Based on 70°F [21°C] at sea level)

Accuracy: Flowmeter ± 10% or ± 200ml of indicated flow, whichever is

greater.

Response Time: Allow 5 minutes to attain maximum oxygen concentration.

Positioning: Operate the unit in an upright position, maintaining at least

12 inches (30.5cm) of open space on all sides for ventilation.

Dimensions: 27.5 in. high x 16.5 in. wide x 14.5 in. deep

(69.9 cm high x 41.9 cm wide x 36.8 cm deep)

Weight: 58 lb; shipping weight –65 lb

(26.3 kg; shipping weight –29.5 kg)

Electrical: 120 VAC, 60 Hz, 6.0 amps, 590 watts

220-240 VAC, 50 Hz, 3.0 amps, 590 watts

Two-prong polarized plug

Double-insulated cabinet

Alarms: Power Failure

Low Oxygen Concentration (with optional Oxygen Monitor)

Low Pressure

High Pressure

High Temperature

Battery Test

Operating Temperature 41°F to 104°F (5°C to 40°C) for 120 VAC 60 Hz models

Range: 41°F to 95°F (5°C to 35°C) for 220-240 VAC 50 Hz models

Storage Temperature -4°F to 140°F (-20°C to 60°C)

Range:

Humidity: Up to 95% (non-condensing)

MN134-1 rev C

2.0 Operational Check and Oxygen Concentration Test

2.1 Description of Operation

Air is drawn into the NewLife Intensity 10 Oxygen Concentrator through an external air

intake gross particulate filter. Before this air enters the compressor, it passes through the

unit’s 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 concentrated oxygen.

There are two sieve beds: while one produces high concentration oxygen, the other is

purged of the nitrogen it adsorbed (collected) during this pressure swing adsorption (PSA)

cycle. Each adsorber produces oxygen and delivers it to the product tank. Oxygen exits

the product tank through a pressure regulator, flow control valve, and flowmeter. The

NewLife Intensity 10 unit delivers up to 95.5% oxygen at flow rates from 2-10 lpm.

2.2 Operation Check

AirSep tests every NewLife Intensity 10 Oxygen Concentrator thoroughly after

manufacture. You must perform the following test to ensure that no damage occurred in

shipping or handling.

Do not use extension cords with this unit or connect too many plugs

into the same electrical outlet. The use of extension cords could

adversely affect the performance of the device. Too many plugs into

one outlet can result in an overload to the electrical panel, causing the

breaker/fuse to activate or fire if the breaker or fuse fails to operate.

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. Connect unit to power, and set the I/0 power switch to the “I” position. Check to

see that the following occurs:

a. A continuous alarm sounds for approximately five seconds. See the

troubleshooting chart in Section 6.3 of this manual if the unit’s

alarm does anything other than sound for five seconds.

b. The compressor runs and flow is indicated in flowmeter.

c. OPTIONAL: The Oxygen Monitor’s amber light remains on until

the oxygen concentration reaches 85% ±3% (approximately two

minutes). Perform an oxygen concentration test, as described in

Section 2.4.

2.3 Alarm System

The NewLife Intensity 10 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

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