This device contains an alarm system which monitors the state of the device and alerts of abnormal operation, loss of essential performance or failures . Alarm conditions are

shown on the LED display. The alarm system functions are tested at power up by lighting all visual alarm indicators and sounding the audible alarm (beep).

All alarms are Low Priority Technical Alarms .

Alarm Condition

LED Indicator

Start-up Period

Low Oxygen

Concentration

Malfunction

RETURN AND DISPOSAL

This device may not be disposed of with household waste . After use of the device, please return the device to the provider for disposal . This device contains electrical and/or

electronic components that must be recycled per EU Directive 2012/19/EU-Waste Electrical and Electronic Equipment (WEEE). Non-infectious used accessories (e.g. nasal

cannula) can be disposed of as residential waste. The disposal of infectious accessories (e.g. nasal cannula from an infected user) must be made via an approved waste

disposal company . Names and addresses can be obtained from the local municipality .

PROVIDER'S NOTES - Cleaning and Disinfection When There is a Patient Change

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 the following described complete processing of the concentrator by an appropriately trained individual is not possible, the device should not be used by another

patient.

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

1 .

Use disinfectants safely . Always read the label and product information before use .

2 .

Always wear personal protective equipment when performing this procedure . Use suitable gloves and safety glasses . Cover exposed skin on arms to prevent accidental

contact with bleach solution that has been applied to the concentrator .

3 .

Dispose of all accessories that are not suitable for reuse . This includes but may not be limited to the oxygen tubing, tubing connectors, nasal cannula and/or mask,

oxygen outlet connector, and humidifier bottle.

Clean the exterior of the concentrator with a clean lint-free cloth. Heavy soil should be removed with a clean lint-free cloth dampened with water. A soft bristled brush

dampened with water can be used to remove stubborn soil . Dry the concentrator using a clean lint-free cloth if water was used to remove soil .

Use 5.25% chlorine bleach (Clorox Regular Liquid Bleach or equivalent). Mix one (1) part bleach with four (4) parts water in an appropriate clean container. This ratio

produces a one (1) part bleach to five (5) total parts solution (1:5). The total volume (amount) of solution required is determined by the number of concentrators in need

NOTE – An alternate suitable disinfecting agent (e.g. Mikrobac® forte or Terralin® Protect) may also be used. Follow disinfectant manufacturer's

of disinfection .

instructions.

6 .

Apply the bleach solution in an even manner to the cabinet and power cord using a clean lint-free cloth . The cloth should be dampened only and not dripping of solution .

Do not use a spray bottle to apply the solution . Do not saturate the device with the solution . Take care that no solution enters the vent areas on the concentrator base or

the Auxiliary O2 fitting area on the back of the unit. Avoid over-saturating the cabinet seams so that no solution residue builds up in these areas. Avoid the caster wells

located on the bottom of the unit .

7 .

Exposure time of the disinfectant solution should be 10 minutes minimum to 15 minutes maximum .

8 .

After the recommended exposure time, all surfaces of the concentrator should be wiped with a clean lint-free cloth dampened with drinking quality water no warmer than

room temperature. Dry the unit with a dry, clean lint-free cloth. This is to remove residue that may stain or leave a film on the unit, especially after repeated disinfections.

9 .

Check the cord, the plug on the back of the device, the power switch, the fuse holder, and the indicator lights for possible damage . Replace all damaged or worn

components .

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

11. Check the oxygen concentration. If the device is within specification, the extended life intake bacteria filter does not need to be replaced between patients. If the oxygen

concentration is not within specification, the provider should refer to the service manual section on Troubleshooting.

12 . OPTIONAL INSIDE CLEANING: 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 . Close the concentrator .

NOTE – There is no portion of the gas pathways through the concentrator that could be contaminated with body fluids under normal conditions.

The device patient connection may unintentionally become contaminated with expired gases for a single fault condition i .e ., a hose internal to the device becomes

disconnected. This condition will cause no flow out of the device and/or an alarm condition. Should this occur, refer to the service manual for additional instructions.

Disinfection

NOTE – The disinfection process can only be completed by the manufacturer or by an appropriately trained individual.

Cabinet, power cord

Oxygen tubing, tubing connectors, nasal cannula/mask,

oxygen outlet connector, humidifier bottle, cabinet air filter

Optional - Inside cabinet

EN - 10

Visual Alarm Signal

Audible Alarm Signal

Meaning

YELLOW

Low O