DeVilbiss 525 User manual

4.8 (8)
DeVilbiss 525 User manual

525 Series Serie de 525 Série 525

EN DeVilbiss® 5 Liter Oxygen Concentrator Instruction Guide

WARNING– Read instruction guide before operating this equipment.

CAUTION– Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

MADE IN THE USA of U.S. and Imported Parts

DANGER–NO SMOKING

ES Guía de instrucciones del concentrador de oxígeno de 5 litros de DeVilbiss®

Advertencia– Lea la guía de instrucciones antes de poner a funcionar este equipo.

PRECAUCION– La ley federal (EE.UU.) establece que este aparato sólo lo puede vender un médico o por prescripción del mismo.

FABRICADO EN EE. UU. de partes nacionales e importadas

PELIGRO–NO FUMAR

FR Guide d’instructions du concentrateur d’oxygène 5 litres DeVilbiss®

Avertissement– Lire le mode d’emploi avant d’utiliser ce dispositif.

Attention– En vertu de la Loi fédérale américaine, la vente de cet appareil n’est autorisée que par un médecin ou sur ordonnance de ce dernier.

FABRIQUÉ AUX ÉTATS-UNIS avec des pièces des États-Unis et des pièces importées

DANGER–NE PAS FUMER

EN ENGLISH..............................................................................................................................................................

EN-2

ES ESPAÑOL..............................................................................................................................................................

ES-9

FR FRANÇAIS............................................................................................................................................................

FR-17

TABLE OF CONTENTS

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EN - 3

Important Safeguards . . . . . . . . . . . . . . .

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Introduction . . .

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EN - 3

Why Your Physician Prescribed Supplemental Oxygen

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EN - 3

How Your Concentrator Works . . . . . . . . . .

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Important Parts of Your Concentrator . . . . . . . . .

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Setting Up Your Concentrator . . . . . . . . . . . .

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EN - 4

Before Operating Your Concentrator . . . . . . . . . .

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EN - 4

Operating Your Concentrator . . . . . . . . . . . . .

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EN - 5

DeVilbiss OSD® Operation . . . . . . . . . . .

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EN - 5

Reserve Oxygen System . . . . . . . . . . . . . .

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EN - 5

Caring for Your Concentrator . . . . . . . . . . . .

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EN - 5

Provider’s Notes . . . . . . . . . . . . . . . . .

 

   

 

 

 

 

   

 

         

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Troubleshooting . . . . . . . . . . . . . . . . .

 

 

 

 

 

 

     

 

         

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Specifications . . . . . . . . . . . . . . . . .

 

   

 

 

 

     

 

         

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EN - 7

Guidance and Manufacturer’s Declaration . . . . . . .

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EN - 8

CAUTION– Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

INDICATIONS FOR USE– The DeVilbiss Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.

warning

Under certain circumstances, oxygen therapy can be hazardous. Seek medical advice before using an oxygen concentrator. Physician Information

Physician Name:___________________________________________________________________

Telephone: _______________________________________________________________________

Address: ________________________________________________________________________

Prescription Information

Name: _ _________________________________________________________________________

Oxygen liters per minute

at rest:____________________ during activity:____________________ other:______________

Oxygen use per day

Hours:_____________________________________ Minutes:_ ___________________________

Comments:_______________________________________________________________________

DeVilbiss 5-Liter Oxygen Concentrator w/OSD Serial Number:_____________________________

DeVilbiss Equipment Provider Information

Set-Up Person:____________________________________________________________________

This instruction guide was reviewed with me and I have been instructed on the safe use and care of the DeVilbiss Oxygen Concentrator.

Signature:____________________________________________________ Date:_ ________________

Increase

5

 

 

 

 

5

 

 

 

4

 

 

 

 

 

4

 

 

 

 

 

 

 

 

3

 

 

 

 

 

3

 

 

 

2

 

 

 

 

2

 

 

 

 

 

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1

 

 

 

0

 

 

 

 

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LPM O2

DeVilbiss 5-Liter Series

2

A-525D

IEC Symbols

 

It is mandatory to read and understand the

Double Insulated

Danger - No smoking near patient or device.

 

operating instructions prior to use.

 

 

 

 

Attention Consult Instruction Guide

Catalog Number

Use no Oil, Grease or Lubricants

 

Electric Shock Hazard. Cabinet to be

Serial Number

Do not use near heat or open flames

 

removed by authorized personnel only.

 

 

 

O

Off

External Power

Federal (U.S.A.) law restricts this device to sale by

I

On

or on the order of a physician.

 

 

Reset

Normal Oxygen

 

 

Alternating Current

Low Oxygen

 

 

Type B applied part

Service Required

Maximum recommended flow rate: 5LPM

 

 

This device contains electrical and/or electronic equipment that must be recycled per EC

Directive 2002/96/EC - Waste Electrical and Electronic Equipment (WEEE)

Important Safeguards

Read this entire guide before using your DeVilbiss concentrator. Important information is highlighted by these terms throughout this guide:

DANGER

Urgent safety information for hazards that will cause serious injury or death.

WARNING

Important safety information for hazards that might cause serious injury.

CAUTION

Information for preventing damage to the product.

NOTE

Information to which you should pay special attention.

Important safeguards are indicated throughout this guide; pay special attention to all safety information.

DANGER

Read All instructions before Using.

NO SMOKING

Save These Instructions.

 

Introduction

This instruction guide will acquaint you with the DeVilbiss oxygen concentrator. Make sure that you read and understand this guide before operating your unit. Important safeguards are indicated throughout this guide; pay special attention to all safety information. Contact your DeVilbiss equipment provider should you have any questions.

warning

For your safety, the oxygen concentrator must be used according to the prescription determined by your physician.

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

This device contains electrical and/or electronic equipment. Follow local governing ordinances and recycling plans regarding disposal of device components.

Danger

Oxygen causes rapid burning. Do not smoke while your oxygen concentrator is operating, or when you are near a person utilizing oxygen therapy. Do not use within 5 feet (1.6m) of hot, sparking objects or naked sources of flame.

Why Your Physician Prescribed Supplemental Oxygen

Today, many people suffer from heart, lung, and other respiratory diseases. Many of these people can benefit from supplemental oxygen therapy. Your body requires a steady supply of oxygen to function properly. Your physician prescribed supplemental oxygen for you because you are not getting enough oxygen from room air alone. Supplemental oxygen will increase the amount of oxygen that your body receives.

Supplemental oxygen is not addictive. Your physician prescribed a specific oxygen flow to improve symptoms such as headaches, drowsiness, confusion, fatigue, or increased irritability. If these symptoms persist after you begin your supplemental oxygen program, consult your physician.

How Your DeVilbiss Oxygen Concentrator Works

Oxygen concentrators are the most reliable, efficient, and convenient source of supplemental oxygen available today. The oxygen concentrator is electrically operated. The unit separates oxygen from room air which allows high-purity supplemental oxygen to be delivered to you through the oxygen outlet. Although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room.

A-525D

EN - 3

Important Parts of Your Concentrator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Please take time to familiarize yourself with your DeVilbiss oxygen concentrator before operating.

 

 

 

 

 

 

 

 

 

 

 

 

 

Front View (Figure A)

 

9

10

1

2

3

 

 

 

 

 

 

 

 

 

1.

Operating instructions

A

 

B

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.

Green Power light – illuminates when your concentrator is operating.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

 

3.

Power Switch

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

| = ON

 

 

 

 

5

 

 

 

 

 

 

 

 

 

 

O = OFF

 

 

 

 

 

15

 

 

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.

Flow meter knob

 

 

 

 

6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5.

Flow meter

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6.

Circuit breaker – resets the unit after electrical overload shutdown.

 

 

 

 

 

 

11

 

 

 

 

 

 

11

 

 

 

 

 

 

 

 

 

 

7.Oxygen outlet – oxygen is dispersed through this port.

8.

Normal Oxygen (green) light (see page 6).

14

9.

Low Oxygen (yellow) light (see page 6).

 

10.

Red Service Required light – when illuminated contact your DeVilbiss provider.

 

Back View (Figure B)

 

11.

Handgrip

 

12.

Exhaust

12

13.

Power cord and/or IEC power connector.

12

14.

Line cord strap

 

15.

Air filter – prevents dirt, dust, and lint from entering your unit.

13

Accessories

 

Oxygen Outlet Connector - Plastic - 1/pack......................................................................................................................................................................................................

CN100

Bubble Humidifier.........................................................................................................................................................................................................

Salter Labs 7600 or equivalent

There are many types of humidifiers, oxygen tubing and cannulas/masks that can be used with this device. Certain humidifiers and accessories may impair the device’s performance. A mask or any nasal cannula can be used with continuous flow delivery and may be sized according to your prescription as recommended by your homecare provider who should also give you advice on the proper usage, maintenance, and cleaning.

Note– A maximum of 50 feet (15 meters) of crush-proof oxygen tubing plus 7 feet (2.1 meters) of cannula plus a bubble humidifier is allowed between the concentrator and the patient.

Note– The oxygen supply accessory (patient tubing) shall be equipped with a means that in case of fire stops the delivery of oxygen to the patient. This means of protection should be located as close to the patient as practicable.

SETTING UP YOUR OXYGEN CONCENTRATOR

1.Position your unit near an electrical outlet in the room where you spend most of your time.

danger

Keep the oxygen concentrator at least 5 feet (1.6 m) from hot, sparking objects or naked sources of flame.

NOTE– Do not connect to an electrical outlet controlled by a wall switch. No other appliances should be plugged into the wall outlet.

2.Position your unit at least 6 inches (16 cm) from walls, draperies, or any other objects that might prevent the proper flow of air in and out of your oxygen concentrator. The oxygen concentrator should be located so as to avoid pollutants or fumes.

Before Operating Your Oxygen Concentrator

1.Before operating your unit, always check to be sure the air filter (located on the back of your unit) is clean. Proper cleaning of this filter is discussed in the Caring For Your Concentrator section on page 5.

2.Attach the appropriate oxygen accessories to the oxygen outlet.

Oxygen Tubing Connection:

a.Thread the oxygen outlet connector onto the oxygen outlet.

b.Attach the oxygen tubing directly to the connector (Figure 1).

Oxygen Tubing Connection With Humidification:

If your physician has prescribed an oxygen humidifier as part of your therapy, follow these steps (If using a prefill, go to step b.):

a.Fill the humidifier bottle with distilled water. Do not overfill.

b.Thread the wing nut located on the top of the humidifier bottle to the oxygen outlet so that it is suspended (Figure 2). Make sure it is securely tightened.

c.Attach the oxygen tubing directly to the humidifier bottle outlet fitting (Figure 3).

3.Your physician has prescribed either a nasal cannula or face mask. In most cases, they are already attached to the oxygen tubing. If not, follow the manufacturer’s instructions for attachment.

4.Remove the power cord completely from the line cord strap. Make sure the power switch is in the “Off” position, and insert the plug

into the wall outlet. The unit is double insulated to guard against electric shock.

NOTE– (only 115 volt units) The plug on the DeVilbiss oxygen concentrator has one blade wider than the other. To reduce the risk of electric shock, this plug is intended to fit in a wall outlet only one way. Do not attempt to defeat this safety feature.

warning

Improper use of the power cord and plugs can cause a burn, fire, or other electric shock hazards. Do not use the unit if the power cord is damaged.

1

2

3

EN - 4

A-525D

Operating Your DeVilbiss Oxygen Concentrator

danger

Oxygen causes rapid burning. Do not smoke while your oxygen concentrator is operating, or when you are near a person utilizing oxygen therapy. Keep the oxygen concentrator at least 5 feet (1.6 m) from hot, sparking objects or naked sources of flame.

1.Press the power switch to the “On” position. When the unit is turned “On,” all four lights (Power, Service Required, Low Oxygen,

and Normal Oxygen) on the front panel will illuminate briefly and audible signal will briefly alarm. After a few seconds, only the

Power and Normal Oxygen lights will remain lit.

danger

Do not lay the cannula down while the concentrator is delivering oxygen. High concentrations of oxygen can cause rapid burning.

DANGER

NO SMOKING

NOTE– If the Service Required light illuminates and the audible signal alarms but the unit is not operating, there is no power to the unit. Refer to the Minor Troubleshooting chart on page 6 and contact your DeVilbiss provider if necessary.

NOTE– If an audible low-frequency vibration sound is detected, the unit is not operating properly. Refer to the Minor Troubleshooting chart on page 6, and contact your DeVilbiss provider if necessary.

2. Check the flow meter to make sure that the flow meter ball is centered on the line next to the prescribed number of your flow rate.

CAUTION– It is very important to follow your oxygen prescription. Do not increase or decrease the flow of oxygen – consult your physician. NOTE– Your DeVilbiss provider may have preset the flow meter so that it can not be adjusted.

NOTE– If the flow meter knob is turned clockwise, the flow decreases (and eventually will shut off the oxygen flow). If the knob is turned 4 counterclockwise, the flow increases.

NOTE– For prescriptions of 5 LPM, be sure the ball is centered on the 5 liter line; the ball should not touch the red line. Setting the flow higher than 5 may cause the oxygen purity level to drop.

NOTE– The low-flow alarm will activate if the flow meter ball is set below .3 lpm. The unit will continue to run; however, the Service Required light will come on accompanied by an audible alarm. Adjust the flow meter to your prescribed flow.

3.Your DeVilbiss concentrator is now ready for use, properly position the cannula or mask (Figure 4). Allow 20 minutes for oxygen concentrator to reach stated performance.

DeVilbiss OSD Operation

The OSD (Oxygen Sensing Device) is a device within your concentrator that monitors the oxygen produced by your unit. When the unit is turned “On,” all four lights (Power, Service Required, Low Oxygen, and Normal Oxygen) on the front panel will illuminate briefly. After a few seconds, only the Power and Normal Oxygen lights will remain lit.

The OSD lights on the front panel are defined as follows:

Green Normal Oxygen light–acceptable oxygen level.

Yellow Low Oxygen light– below an acceptable oxygen level.

If the oxygen purity falls below the acceptable level, the green Normal Oxygen light will shut off and the yellow Low Oxygen light will illuminate. Switch to your reserve oxygen system. Refer to the Minor Troubleshooting section in this guide on page 6 and contact your DeVilbiss provider.

As an added safety feature should the oxygen purity continue to drop, an intermittent audible signal will sound. Contact your DeVilbiss provider immediately. Do not attempt any other maintenance.

Reserve Oxygen System

As a precaution, your DeVilbiss provider may supply you with a reserve oxygen system. If your unit loses electrical power or fails to operate correctly, the Patient Alert System will sound to signal you to switch to your reserve oxygen system (if provided) and contact your DeVilbiss provider.

Caring For Your DeVilbiss Oxygen Concentrator

 

Note– Use no lubricants, oils or grease.

 

warning

 

Before attempting any cleaning procedures, turn the unit “Off.”

 

Cannula/Mask, Tubing, and Humidifier Bottle

 

Clean and replace the cannula/mask, tubing, and humidifier bottle according to the manufacturer’s instructions.

5

 

Air Filter and Oxygen Outlet Connector

 

The air filter and connector should be cleaned at least once a week. To clean, follow these steps:

 

1.Remove the air filter, located on the back of the unit. Remove the oxygen outlet connector (if used).

2.Wash in a solution of warm water and dishwashing detergent (Figure 5).

3.Rinse thoroughly with warm tap water and towel dry. The filter should be completely dry before reinstalling.

CAUTION– To prevent product damage, do not attempt to operate the unit without the air filter or while the filter is still damp.

Exterior Cabinet

As needed, clean the concentrator exterior cabinet by using a damp cloth or sponge with a mild household cleaner and wipe it dry.

warning

To avoid electric shock, do not remove the concentrator cabinet. The cabinet should only be removed by a qualified DeVilbiss technician. Do not apply liquid directly to the cabinet or utilize any petroleum-based solvents or cleaning agents.

Use of harsh chemicals (including alcohol) is not recommended. If bactericidal cleaning is required, a non-alcohol based product should be used to avoid inadvertent damage.

A-525D

EN - 5

Provider’s Notes - Cleaning and Disinfection When There is a Patient Change

When medical devices have already been used with a patient, contamination with human pathogenic germs should be assumed (unless there is evidence to the contrary), and the next patient, user or third party should be protected by appropriate handling and preparation.

Therefore, when there is a patient change, people must be protected during the transport and handling of the device, and the device must be fully processed, i.e., cleaned and disinfected, by suitably trained personnel before reuse to protect the next patient. The complete processing may only be done by the manufacturer or by a qualified DeVilbiss provider/service technician.

Note–If the following described complete processing of the concentrator by a qualified DeVilbiss provider/technician is not possible, the device must not be used by another patient!

DeVilbiss Healthcare recommends that at least the following procedures be carried out by the manufacturer or a qualified third party between uses by different patients.

Note–If preventive maintenance is due at this time, these procedures should be carried out in addition to the servicing procedures.

1.Dispose of all accessory components that are not suitable for reuse, i.e., particularly the oxygen tubing, the nasal cannula/mask, oxygen outlet connector and humidifier bottle.

2.Caution–the concentrator must be disconnected from the power supply for this step: Open the concentrator and remove all dust deposits inside the cabinet with an appropriate vacuum cleaner.

3.Clean and disinfect all parts of the cabinet inside and outside and the power cord with a suitable disinfecting agent, e.g., Aldahol, Cidex OPA or Peract.

4.Check the cord, the plug on the back of the device, the power switch, the fuse holder and the indicator light for possible damage.

5.Replace all damaged or worn components.

6.Replace the cabinet air filter on the back of the device.

7.Check the oxygen concentration. If the device is within specifications, the extended life intake bacteria filter does not need to be replaced between patients. If the concentration is not within specifications, the provider should refer to the service manual section on Troubleshooting.

Troubleshooting

The following troubleshooting chart will help you analyze and correct minor oxygen concentrator malfunctions. If the suggested procedures do not help, switch to your reserve oxygen system and call your DeVilbiss homecare provider. Do not attempt any other maintenance.

warning

To avoid electric shock hazard, do not remove the cabinet. The cabinet should only be removed by a qualified DeVilbiss homecare technician.

Minor Troubleshooting Chart

Symptom

 

Possible cause

 

remedy

A. Unit does not operate. Power light is off when the

1.

Power cord not properly inserted

1.

Check power cord connection at the wall outlet. On 230 volt units, also

power switch is “On.” Audible alert is pulsing and

 

into wall outlet.

 

check the mains connection on the back of the unit.

Service Required light is flashing.

 

 

 

 

2.

No power at wall outlet.

2.

Check your home circuit breaker and reset if necessary. Use a different

 

 

 

 

wall outlet if the situation occurs again.

 

3.

Oxygen concentrator circuit

3.

Press the concentrator circuit breaker reset button located below the

 

 

breaker activated.

 

power switch. Use a different wall outlet if the situation occurs again.

 

 

 

If the above remedies do not work, contact your DeVilbiss provider.

B. Unit operates, the Power light is on when the

1. Air filter is blocked.

1.

Check the air filter. If the filter is dirty, wash it following the cleaning

power switch is “On.” Red Service Required light

 

 

 

instructions on page 5.

is illuminated. Audible alert may be sounding.

 

 

 

 

2.

Exhaust is blocked.

2.

Check the exhaust area; make sure there is nothing restricting the unit

 

 

 

 

exhaust.

 

3.

Blocked or defective cannula, face

3.

Detach cannula or face mask. If proper flow is restored, clean or replace

 

 

mask, or oxygen tubing.

 

if necessary. Disconnect the oxygen tubing at the oxygen outlet. If

 

 

 

 

proper flow is restored, check oxygen tubing for obstructions or kinks.

 

 

 

 

Replace if necessary.

 

4.

Blocked or defective humidifier

4.

Detach the humidifier from the oxygen outlet. If proper flow is obtained,

 

 

bottle.

 

clean or replace humidifier.

 

5.

Flow meter set too low.

5.

Set flow meter to prescribed flow rate.

 

 

 

If the above remedies do not work, contact your DeVilbiss provider.

C. Unit operates, the power light is on when power

 

 

1.

Turn your unit “Off.” Switch to your reserve oxygen system, and contact

switch is “on,” audible low-frequency vibration

 

 

 

your DeVilbiss provider immediately.

sound is detected.

 

 

 

 

D Both the green Normal Oxygen and the yellow

1.

OSD malfunction.

1.

Contact your DeVilbiss provider.

Low Oxygen lights are either on or off.

 

 

 

 

E. Yellow Low Oxygen light is on or the yellow Low

1.

Flow meter is not properly set.

1.

Ensure the flow meter is properly set to the prescribed number.

Oxygen light is on and the intermittent audible

 

 

 

 

2.

Air filter is blocked.

2.

Check the air filter. If the filter is dirty, wash it following the cleaning

signal is sounding.

 

 

 

instructions on page 5.

 

 

 

 

 

3.

Exhaust is blocked.

3.

Check the exhaust area; make sure there is nothing restricting the unit

 

 

 

 

exhaust.

 

 

 

If the above remedies do not work, contact your DeVilbiss provider.

EN - 6

A-525D

Symptom

 

Possible cause

 

remedy

F Red Service Required light is on and an

1.

Flow meter is not properly set.

1.

Ensure the flow meter is properly set to the prescribed number.

intermittent audible signal is sounding.

 

 

 

 

2.

Air filter is blocked.

2.

Check the air filter. If the filter is dirty, wash it following the cleaning

 

 

 

 

instructions on page 5.

 

3.

Exhaust is blocked.

3.

Check the exhaust area; make sure there is nothing restricting the unit

 

 

 

 

exhaust.

 

 

 

If the above remedies do not work, contact your DeVilbiss provider.

G. If any other problems occur with your oxygen

 

 

1.

Turn your unit “Off.” Switch to your reserve oxygen system, and contact

concentrator.

 

 

 

your DeVilbiss provider immediately.

Specifications

DeVilbiss 5-Liter Series

Catalog Number

525DS

 

 

Delivery Rate (Lower delivery rates available for low flow applications)

1 to 5 LPM

 

 

Maximum Recommended Flow(@ nominal outlet pressures of zero and 7 kPa)

5 LPM

Outlet Pressure

8.5 psig (58.6 kPa)

Electrical Rating

115 V, 60

Hz, 3.3 Amp

Operating Voltage Range

97-127

V~, 60 Hz

Oxygen Percentage

1-5 LPM=93%±3%

Operating Altitude

 

 

(tested at 21°C only) 0-1500 M (0-4921 ft)

1500-4000 M (4921-13123 ft)

Operating Environment Range*

Across the voltage range: No degradation of performance

Tested at nominal voltage only: No degradation of performance

5°C to 40°C, humidity range of 10% to 95%

No degradation in performance across the operating voltage range.

Power Consumption

 

310 Watts Average

275 Watts @ 2.5 LPM & below

 

Weight

36 lbs. (16.3 Kilograms)

Sound Level (ISO 8359:1996 from front)

 

48 dbA

Dimensions

24.5”H x 13.5”W x 12”D

(62.2 x 34.2 x 30.4 cm)

 

Pressure Relief Valve

40 psig±5psig (276 kPa±34.5 kPa)

Operating System

Time Cycle / Pressure Swing

The visible “low oxygen” indicator will activate at the following level

84% ± 2%

(The audible alarm will alert at approximately 75%. At less than 60%, the red “service

 

required” light will activate.)

Storage Conditions

-40°C to 70°C, humidity range of 10% to 100%, including condensation

 

Class II Equipment Double Insulated;

Equipment Class and Type

 

Type B Applied Part

 

 

 

Ordinary Equipment, IPX0

Approval Body and Safety Standard

 

CSA

CAN/CSA-C22.2 No. 601.1-M90

 

EMC Compliance To

 

EN60601-1-2

*Note: The OSD performance at 5°C to 40°C, 95% R.H. through voltage range on the 525DS verified at 670m.

Specifications subject to change without notice.

A-525D

EN - 7

DeVilbiss guiDance anD manufacturer’s Declaration

WARNING

Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic Compatibility [EMC] information provided in the accompanying documents.

Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.

The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

NOTEThe EMC tables and other guidelines provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment – Guidance

 

 

 

RF Emissions CISPR 11

Group 1

This device uses RF energy only for its internal function. Therefore, its RF emissions are very low and

are not likely to cause any interference in nearby electronic equipment.

 

 

RF Emissions CISPR 11

Class B

 

Harmonic emissions IEC 61000-3-2

Class B

This device is suitable for use in all establishments including domestic and those directly connected to

 

 

the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations / flicker

Complies

emissions

 

 

 

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an environment.

 

IEC 60601 Test

Compliance

 

Immunity Test

Level

Level

Electromagnetic Environment - Guidance

 

 

 

 

Electrostatic discharge (ESD)

±6kV contact

Complies

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic

IEC 61000-4-2

±8kV air

material, the relative humidity should be at least 30%

 

Radiated RF IEC 61000-4-3

3 V/m 80MHz to 2.5GHz

Complies

Field strengths outside the shielded location from fixed RF transmitters, as

determined by an electromagnetic site survey, should be less than 3 V/m.

 

 

 

Interference may occur in the vicinity of equipment marked with the following

Conducted RF IEC 61000-4-6

3 Vrms 150kHz to 80MHz

Complies

symbol:

 

 

 

 

 

Electrical fast transient

±2kV power line

Complies

 

IEC 61000-4-4

±1kV I/O lines

 

 

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1kV differential

Complies

 

±2kV common

 

 

 

 

Power frequency magnetic field

3 A/m

Complies

Power frequency magnetic fields should be at levels characteristic of a typical

IEC 61000-4-8

location in a typical commercial or hospital environment.

 

 

Voltage dips, short interrupts and

>95% dip 0.5 cycle

 

Mains power quality should be that of a typical commercial or hospital environment.

60% dip 5 cycles

 

 

If the user of this device requires continued operation during power mains

voltage variations on power supply

Complies

70% dip 25 cycles

interruptions, it is recommended that the device be powered from an uninterruptible

input lines IEC 61000-4-11

 

95% dip 5 secs.

 

power supply or battery.

 

 

 

 

 

 

 

 

 

EN - 8

A-525D

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