DeVilbiss 1025 Series Instruction Manual

1025 Series Serie de 1025 Série 1025
EN
DeVilbiss® 10-Liter Oxygen Concentrator Instruction Guide
WARNING–Read instruction guide before operating this equipment.
ASSEMBLED IN USA
NO SMOKING
Guía de instrucciones del concentrador de oxígeno de 10-litros de DeVilbiss®
ADVERTENCIA–Lea la guía de instrucciones antes de poner a funcionar este equipo.
ENSAMBLADO EN EE. UU.
NO FUMAR
FR
Guide d’instructions du concentrateur d’oxygène 10-litres DeVilbiss®
AVERTISSEMENT–Lire le mode d’emploi avant d’utiliser ce dispositif.
ASSEMBLÉ AUX ÉTATS-UNIS
NE PAS FUMER
0044
ENGLISH........................................................................................................................................................................................... EN-2
ESPAÑOL .......................................................................................................................................................................................... ES-12
FRANÇAIS ........................................................................................................................................................................................ FR-22
TABLE OF CONTENTS
Symbol Definitions .................................................................................................................... EN - 3
Important Safeguards.................................................................................................................. EN - 3
Introduction.......................................................................................................................... EN - 4
Intended Use .................................................................................................................... EN - 4
Indications For Use ............................................................................................................... EN - 4
Why Your Physician Prescribed Supplemental Oxygen ................................................................................... EN - 4
How Your Concentrator Works ...................................................................................................... EN - 4
Important Parts of Your Concentrator...................................................................................................... EN - 5
Setting Up Your Concentrator ........................................................................................................... EN - 5
Before Operating Your Concentrator ...................................................................................................... EN - 6
Operating Your Concentrator ............................................................................................................ EN - 6
DeVilbiss OSD
Reserve Oxygen System ............................................................................................................... EN - 7
Caring for Your Concentrator ............................................................................................................ EN - 7
Troubleshooting ...................................................................................................................... EN - 7
Overview of Alarms ................................................................................................................... EN - 8
Warranty............................................................................................................................ EN - 9
Return and Disposal................................................................................................................... EN - 9
Provider’s Notes...................................................................................................................... EN - 9
Specifications ........................................................................................................................ EN - 10
Guidance and Manufacturer’s Declaration.................................................................................................. EN - 11
®
Operation.......................................................................................................... EN - 7
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 10-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
10 10
8 8
6 6
4 4
2 2
DeVilbiss 10-Liter Series
EN - 2
A-1025
SYMBOL DEFINITIONS
C US
+35˚C
IP21
It is mandatory to read and understand the operating instructions prior to use.
Electric Shock Hazard. Cabinet to be removed by authorized personnel only.
O
Off
I
On
Catalog Number Danger - No smoking near patient or device.
Serial Number Do NOT use Oil, Grease or Lubricants
Normal Oxygen Do not use near heat or open ames
Reset Low Oxygen Manufacturer
+5˚C
Alternating Current Service Required
Type B applied part
Double Insulated
1010 hPa
840 hPa
Atomospheric Pressure Range 840 to 1010 hPa (Approximate sea level to 5000 ft)
Operating Temperature Range
+5 to +35˚C (+41 to +95˚F)
TUV Rheinland C-US approval mark European Rep CE mark
®
TUV Rheinland Certied approval mark
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
LOT Number
Ingress Protection - Protected against nger access to hazardous parts; protected against
vertically falling water drops. This device contains electrical and/or electronic equipment that must be recycled per EU Directive
EC REP
≤ 10 LPM
10
8 8
6 6
4 4
2 2
European Representative
10
Maximum recommended ow rate: 10 LPM
2012/19/EU- Waste Electrical and Electronic Equipment (WEEE)
IMPORTANT SAFEGUARDS
Read this entire guide before using your DeVilbiss concentrator. Important safeguards are indicated throughout this guide. Pay special attention to all safety information.
READ ALL INSTRUCTIONS BEFORE USING.
WARNING:
A warning indicates the possibility of injury to the user or the operator.
Oxygen causes rapid burning. Do not smoke while your oxygen concentrator is operating, or when you are near a person utilizing oxygen therapy.
Oxygen makes it easier for a re to start and spread. Do not leave the nasal cannula or mask on bed coverings or chair
cushions if the oxygen concentrator is turned on but not in use. The oxygen will make the materials ammable. Turn the
oxygen concentrator off when not in use to prevent oxygen enrichment.
Keep the oxygen concentrator and cannula at least 2 m (6.5 feet) from hot, sparking objects or naked sources of ame.
SMOKING
Open ames during oxygen therapy are dangerous and are likely to result in re or death. Do not allow open ames within 2 m of the oxygen concentrator or any oxygen carrying accessories.
Equipment not suitable for use in the presence of a ammable anesthetic mixture with air or with oxygen or nitrous oxide.
Smoking during oxygen therapy is dangerous and is likely to result in facial burns or death. Do not allow smoking within the same room where the oxygen concentrator or any oxygen carrying accessories are located.
If you intend to smoke, you must always turn the oxygen concentrator off, remove the cannula and leave the room where either the cannula or mask or the oxygen
concentrator is located. If unable to leave the room, you must wait 10 minutes after you have turned off the oxygen concentrator before smoking.
In order to prevent a re propagating from the patient through the cannula towards the unit, a means of protection should be located as close to the patient as practicable. Please contact your provider for this means of protection.
DeVilbiss 10-liter oxygen concentrators are equipped with a re mitigating outlet tting that prevents propagation of re into the unit.
To avoid electric shock, do not remove the concentrator cabinet. The cabinet should only be removed by a qualied DeVilbiss technician. Do not apply liquid directly to the cabinet or utilize any petroleum-based solvents or cleaning agents.
Improper use of the power cord and plugs can cause a burn, re or other electric shock hazards. Do not use the unit if the power cord is damaged.
The surface temperature of the exhaust vents on the bottom of the unit may exceed 105.8˚F (41 ˚C) under certain conditions.
When device is used under extreme operating conditions, the temperature near the exhaust vents on the bottom of the unit may reach 138.2°F (59°C). Keep body parts a minimum of 30” away from this area.
Use of this device at an altitude above 5000 feet (1524 meters) or above a temperature of 95°F (35°C) or greater than 93% relative humidity may affect the ow rate and
the percentage of oxygen and consequently the quality of the therapy. Refer to specications for details regarding parameters tested.
It is recommended that the homecare provider lock the ow control knob to prevent inadvertent adjustment. A ow setting other than prescribed may affect the patient therapy.
To ensure you receive the therapeutic amount of oxygen delivery according to your medical condition, The Oxygen Concentrator must:
be used only after one or more settings have been individually determined or prescribed for you at your specic activity levels.
be used with the specic combination of parts and accessories that are in line with the specication of the concentrator manufacturer and that were used while your
settings were determined.
If you feel discomfort or are experiencing a medical emergency while undergoing oxygen therapy, seek medical assistance immediately to avoid harm.
Geriatric, pediatric or any other patient unable to communicate discomfort can require additional monitoring and/or a distributed alarm system to convey the information about the discomfort and/or the medical urgency to the responsible caregiver to avoid harm.
For your safety, the oxygen concentrator must be used according to the prescription determined by your physician.
Under certain circumstances, oxygen therapy can be hazardous. Seek medical advice before using an oxygen concentrator.
NO
A-1025
EN - 3
Before attempting any cleaning procedures, turn the unit “Off.”
Do not service or clean this device while in use with a Patient.
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.
Use only water-based lotions or salves that are oxygen-compatible before and during oxygen therapy. Never use petroleum or oil-based lotions or salves to avoid the risk
of re and burns.
Do not lubricate ttings, connections, tubing or other accessories of the oxygen concentrator to avoid the risk of re and burns.
Use only spare parts recommended by the manufacturer to ensure proper function and to avoid the risk of re and burns.
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.
Installation of 515LF-607 low output ow meter package will cause the low ow alarm to not work.
The Device is classied as IP21 which means it is protected against nger access to hazardous parts and protected against vertically falling water drops.
The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be
observed to verify normal operation in the conguration in which it will be used.
This device contains electrical and/or electronic equipment. Follow local governing ordinances and recycling plans regarding disposal of device components.
CAUTION:
A Caution indicates the possibility of damage to the device.
It is very important to follow your oxygen prescription. Do not increase or decrease the ow of oxygen – consult your physician.
To prevent product damage, do not attempt to operate the unit without the air lter, or while the lter is still damp.
SAVE THESE INSTRUCTIONS.
INTRODUCTION
This instruction guide will acquaint you with your 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.
Intended Use
The DeVilbiss 10 Liter Oxygen Concentrator intended use is to provide supplemental low ow oxygen therapy for patients suffering from COPD, cardiovascular disease, and
lung disorders. The oxygen concentrator is used in home type environments, homes, nursing homes, patient care facilities, etc.
Indications For Use
The DeVilbiss Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low ow oxygen therapy in the home, nursing homes, patient care
facilities, etc.
NOTE– The device is not intended to be life supporting or life sustaining.
Why Your Physician Prescribed Supplemental Oxygen
Today, many people suffer from heart, lung and other respiratory diseases. Many of these people can benet 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 specic oxygen ow 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.
The oxygen delivery setting has to be determined for each patient individually with the conguration of the equipment to be used, including accessories.
The proper placement and positioning of the prongs of the nasal cannula in the nose is critical to the amount of oxygen delivered to the respiratory system of the patient. Your Delivery settings of the oxygen concentrator should be periodically reassessed for the effectiveness of therapy.
How Your DeVilbiss Oxygen Concentrator Works
Oxygen concentrators are the most reliable, efcient 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 lters the oxygen in
a room, it will not affect the normal amount of oxygen in your room.
EN - 4
A-1025
IMPORTANT PARTS OF YOUR CONCENTRATOR
Please take time to familiarize yourself with your DeVilbiss oxygen concentrator before operating.
1
2
A
3 4
6
5
9 8
7
10
B
15
16
11
14
11
12
Front View (Figure A)
1. Operating instructions
2. Power Switch | = ON O = OFF
3. Flow meter knob
4. Flow meter
5. Circuit breaker – resets the unit after electrical overload shutdown
6. Oxygen outlet – oxygen is dispersed through this port
7. Normal Oxygen (green) light (see page 7)
8. Low Oxygen (yellow) light (see page 7)
9. Red Service Required (red) light – when illuminated contact your
DeVilbiss provider
10. Hour meter
12
13
Back View (Figure B)
11. Handgrip
12. Exhaust
WARNING – When device is used under extreme operating
conditions, the temperature near the exhaust vents on the bottom of
the unit may reach 138.2˚F (59˚C). Keep body parts a minimum of 30”
away from this area.
13. Power cord and/or IEC power connector.
14. Line cord strap
15. Air lter – prevents dirt, dust and lint from entering your unit.
16. Oxygen Outlet Port: Your concentrator is equipped with an auxiliary
oxygen port that can be used to ll oxygen cylinders with an FDA-cleared cylinder lling device that is designed to use oxygen from a concentrator to ll a cylinder. The port is only for use with FDA-cleared lling devices with compatible oxygen input specications. Refer to the cylinder lling device instruction guide for the oxygen input/output specications,
connection and operating instructions.
ACCESSORIES
Transfiller Caddy ........................................................................................................................................................................................................................DeVilbiss 525DD-650
High Flow (6-15 LPM) Bubble Humidifier ....................................................................................................................................................................Salter Labs 7900 or equivalent
Low Flow (up to 6 LPM) Bubble Humidifier ................................................................................................................................................................Salter Labs 7600 or equivalent
High Flow Nasal Cannula ....................................................................................................................................................................................... Salter Labs 1600HF or equivalent
There are many types of humidiers, oxygen tubing and cannulas/masks that can be used with this device. Certain humidiers and accessories may impair the device’s performance. A mask or any nasal cannula can be used with continuous ow 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– The bubble humidier should be supplied with a permanent re stop device. If a bubble humidier needs to be used without a permanent re stop device, a secondary re stop device must be used and placed as close to the humidier as possible. Failing to do so could increase the risk of re.
NOTE– The device should only be used with bubble humidiers that are designed for use with ows up to 10 liters per minute and 20 psi pressure. NOTE– A maximum of 50 feet (15 meters) of crush-proof oxygen tubing, plus 7 feet (2.1 meters) of cannula, plus a bubble humidier 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 re, stops the delivery of
oxygen to the patient. This means of protection should be located as close to the patient as practicable.
NOTE– Your healthcare provider should verify the compatibility of the oxygen concentrator and all of the parts used to connect to the patient before use.
SETTING UP YOUR OXYGEN CONCENTRATOR
1. Position your unit near an electrical outlet in the room where you spend most of your time. NOTEDo not connect to an electrical outlet controlled by a wall switch.
WARNING
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 and cannula at least 2 m (6.5 feet) from hot, sparking objects or naked sources of ame.
2. Position your unit at least 6 inches (16 cm) from walls, draperies or any other objects that might prevent the proper ow of air in and out of your oxygen concentrator. The
oxygen concentrator should be located in a well-ventilated area to avoid pollutants or fumes.
A-1025
EN - 5
BEFORE OPERATING YOUR OXYGEN CONCENTRATOR
Check your oxygen concentrator and accessories for proper operation. Bend the nasal prongs over and squeeze tight to stop the ow of oxygen. Look at the ow meter to see that the indicator ball on the ow meter drops to zero. If the indicator ball does not drop to zero, check all connections for possible leaks. Parts to check for leaks are: tubing connections, humidier bottle and other accessories like rebreaks. Repeat these steps until the ow meter ball drops to zero. Contact your dealer or service supplier immediately if you encounter any
problems.
1. Before operating your unit, always check to be sure the air lter (located on the back of your unit) is clean. Proper cleaning of this lter
is discussed in the Caring For Your Concentrator section on page 7.
2. Attach the appropriate oxygen accessories to the oxygen outlet.
Oxygen Tubing Connection:
a. Thread the supplied oxygen outlet connector onto the oxygen outlet. b. Attach the oxygen tubing directly to the connector (Figure 1).
Oxygen Tubing Connection With Humidication:
If your physician has prescribed an oxygen humidier as part of your therapy, follow these steps (If using a prell, go to step b.):
a. Fill the humidier bottle as per manufacturer’s instructions. b. Thread the wing nut located on the top of the humidier 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 humidier bottle outlet tting (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 120 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 t in a wall outlet only one way. Do not attempt to defeat this safety feature. Your healthcare provider should verify the compatibility of the oxygen concentrator and all of the parts used to connect to the patient before use.
WARNING
Improper use of the power cord and plugs can cause a burn, re or other electric shock hazards. Do not use the unit if the
power cord is damaged.
1
2
3
OPERATING YOUR DEVILBISS OXYGEN CONCENTRATOR
WARNING
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 and cannula at least 2 m (6.5 feet) from hot, sparking objects or naked sources of ame.
The DeVilbiss 10-liter oxygen concentrators are equipped with a re mitigating outlet tting that prevents propagation of re into
the unit.
In order to prevent a re propagating from the patient through the cannula towards the unit, a means of protection should be
located as close to the patient as practicable. Please contact your provider for this means of protection.
1. Press the power switch to the “On” position. When the unit is turned “On,” all three lights (Service Required, Low Oxygen and Normal
Oxygen) on the front panel will illuminate briey and an audible signal will briey alarm conrming that the LEDs and audible signal
are functioning properly. The unit will then operate in “start up” mode with the Low Oxygen light lit until a normal oxygen level is achieved, at which time the Normal Oxygen light will remain lit. The “start up” may take up to 15 minutes.
NOTE– DeVilbiss recommends for optimal service life that the DeVilbiss Oxygen Concentrator be operated for at least 30 minutes after it is powered on. Shorter periods
of operation, operating in extreme temperature/humidity conditions or in the presence of contaminates, and/or handling and storage conditions outside those specied, may affect the long term reliable operation of the product.
WARNING
Oxygen makes it easier for a re to start and spread. Do not leave the nasal cannula or mask on bed coverings or chair cushions if the oxygen concentrator
is turned on but not in use, the oxygen will make the materials ammable. Turn the oxygen concentrator off when not in use to prevent oxygen enrichment.
NOTE– If 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 7 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 7, and contact your
DeVilbiss provider if necessary.
2. Check the ow meter to make sure that the ow meter ball is centered on the line next to the prescribed number of your ow rate.
CAUTION– It is very important to follow your oxygen prescription. Do not increase or decrease the ow of oxygen – consult your physician. NOTE– Your DeVilbiss provider may have preset the ow meter so that it cannot be adjusted. NOTE– If the ow meter knob is turned clockwise, the ow decreases (and eventually will shut off the oxygen ow). If the knob is
turned counterclockwise, the ow increases.
NOTE– For prescriptions of 10 LPM, be sure the ball is centered on the 10 liter line. The ball should not touch the red line. Setting the
ow higher than 10 may cause the oxygen purity level to drop.
NOTE– The low-ow alarm may activate if the ow meter ball is set below 2 lpm. The unit will continue to run; however, the Service
Required light will come on accompanied by an audible alarm. Adjust the ow meter to your prescribed ow. Do not use a low-output ow meter with this concentrator.
3. Your DeVilbiss concentrator is now ready for use, properly position the cannula or mask (Figure 4) and allow 15 minutes for the oxygen concentrator to reach stated performance.
EN - 6
SMOKING
4
NO
A-1025
DeVilbiss OSD Operation
The OSD (Oxygen Sensing Device) is a device within your concentrator that monitors the oxygen produced by your unit.
The OSD lights on the top panel are dened 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 7 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
DeVilbiss recommends using only original DeVilbiss parts and lters in order to guarantee reliable operation of the product.
WARNING
Do NOT use lubricants, oils or grease.
Before attempting any cleaning procedures, turn the unit “Off.”
Cannula/Mask, Tubing and Humidifier Bottle
Clean and replace the cannula/mask, tubing and humidier bottle according to the manufacturer’s instructions.
Air Filter and Oxygen Outlet Connector
The air lter and connector should be cleaned at least once a week. To clean, follow these steps:
1. Remove the air lter, 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 lter should be completely dry before reinstalling.
CAUTION– To prevent product damage, do not attempt to operate the unit without the air lter or while the lter is still damp.
5
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 qualied 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.
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 qualied DeVilbiss homecare technician.
Minor Troubleshooting Chart
SYMPTOM POSSIBLE CAUSE REMEDY
A. Unit does not operate. All lights are off when the
power switch is “On.” Audible alert is pulsing.
1. Power cord not properly inserted into wall outlet.
2. No power at wall outlet. 2. Check your home circuit breaker and reset if necessary. Use a different
3. Oxygen concentrator circuit breaker activated.
1. Check power cord connection at the wall outlet. On 230 volt units, also check the mains connection on the back of the unit.
wall outlet if the situation occurs again.
3. Press the concentrator circuit breaker reset button located below the power switch. Use a different wall outlet if the situation occurs again.
If the above remedies do not work, contact your DeVilbiss provider.
A-1025
EN - 7
SYMPTOM POSSIBLE CAUSE REMEDY
B. Unit operates. Red Service Required light is
illuminated. Audible alert may be sounding.
1. Air lter is blocked. 1. Check the air lter. If the lter is dirty, wash it following the cleaning
instructions on page 7.
2. Exhaust is blocked. 2. Check the exhaust area and make sure there is nothing restricting the unit exhaust.
3. Blocked or defective cannula, face
mask, or oxygen tubing.
3. Detach cannula or face mask. If proper ow is restored, clean or replace
if necessary. Disconnect the oxygen tubing at the oxygen outlet. If
proper ow is restored, check oxygen tubing for obstructions or kinks.
Replace if necessary.
4. Blocked or defective humidier
bottle.
4. Detach the humidier from the oxygen outlet. If proper ow is obtained, clean or replace humidier.
5. Flow meter set too low. 5. Set ow meter to prescribed ow rate. If the above remedies do not work, contact your DeVilbiss provider.
C. Unit operates. Audible low-frequency vibration
sound is detected.
1. Electronic Assembly Malfunction. 1. Turn your unit “Off.” Switch to your reserve oxygen system and contact
your DeVilbiss provider immediately. D. Yellow Low Oxygen light is on. 1. Unit in “start up” mode. 1. Allow unit up to 15 minutes to complete start up period. E. The yellow Low Oxygen light is on and the
intermittent audible signal is sounding.
1. Flow meter is not properly set. 1. Ensure the ow meter is properly set to the prescribed number. (The
maximum ow meter setting is 6 LPM when an oxygen bottle is being
lled with oxygen from the auxiliary port.)
2. Air lter is blocked. 2. Check the air lter. If the lter is dirty, wash it following the cleaning
instructions on page 7.
3. Exhaust is blocked. 3. Check the exhaust area and make sure there is nothing restricting the unit exhaust.
If the above remedies do not work, contact your DeVilbiss provider.
F Red Service Required light is on and an
intermittent audible signal is sounding.
1. Flow meter is not properly set. 1. Ensure the ow meter is properly set to the prescribed number. (The
maximum ow meter setting is 6 LPM when an oxygen bottle is being lled with oxygen from the auxiliary port.)
2. Air lter is blocked. 2. Check the air lter. If the lter is dirty, wash it following the cleaning
instructions on page 7.
3. Exhaust is blocked. 3. Check the exhaust area and make sure there is nothing restricting the unit exhaust.
If the above remedies do not work, contact your DeVilbiss provider.
4. Electronic Assembly Malfunction. 4. Contact your DeVilbiss provider.
G. If any other problems occur with your oxygen
concentrator.
1. Turn your unit “Off.” Switch to your reserve oxygen system and contact your DeVilbiss provider immediately.
OVERVIEW OF ALARMS
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
Visual Alarm Signal
Meaning
YELLOW
Low O
LED ON
2
YELLOW
Low O
LED ON when O2 is
2
<87%
RED
Service Required LED ON
Audible Alarm Signal
No
Yes
Before O
drops below 82%
2
Yes Turn unit off
Visual Alarm Signal
Cleared by
After startup period, O
2
reaches at least 87%
Action to take
Wait for unit to nish startup
period, up to 15 minutes
Turn unit off See Troubleshooting table
Return unit to provider for
service
EN - 8
A-1025
WARRANTY
DeVilbiss provides warranty for this device. Use only DeVilbiss approved original spare parts for maintenance and repair to retain warranty. Using unapproved or non-original spare parts would void warranty.
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
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). 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 qualied DeVilbiss
provider/service technician.
NOTE– If the following described complete processing of the concentrator by a qualied 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 qualied 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 humidier
bottle.
2. 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., Microbac Forte or Terralin®.
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 lter on the back of the device.
7. Check the oxygen concentration. If the device is within specications, the extended life intake bacteria lter does not need to be replaced between patients. If the concentration is not within specications, the provider should refer to the service manual section on Troubleshooting.
Cleaning
Recommended cleaning interval
Outer Cabinet 7 days 260 Water, use only a damp cloth Air Filter 7 days 104 Mild dish soap and warm water Oxygen Outlet Connector 7 days 104 Mild dish soap and warm water
* number of cleaning cycles determined by recommended cleaning interval and expected service life
Number of cleaning cycles *
Compatible cleaning agents / max washing temperature
Disinfection WARNING
Electric shock hazard. Do not attempt to open or remove cabinet. There are no user-serviceable internal components. NOTE– The disinfection process can only be completed by the manufacturer or by a qualied DeVilbiss provider/service technician.
Recommended disinfection interval
Number of disinfection cycles *
Compatible disinfection agents / max washing temperature
Cabinet parts, inside and out, power cord Between patients 20 Microbac Forte, Terralin®, Aldahol, Cidex
OPA or Peract,1:10 chlorine bleach (5.25%) and water solution
Oxygen Tubing, nasal cannula, Oxygen
Do not clean, replace between patients N/A N/A
outlet connector, humidier bottle
Inside cabinet Between patients N/A Remove dust with a vacuum cleaner
A-1025
EN - 9
SPECIFICATIONS
DEVILBISS 10-LITER SERIES
Catalog Number 1025DS 1025KS
Delivery Rate 2 to 10 LPM 2 to 10 LPM 2 to 10 LPM
Maximum Recommended Flow (@ nominal outlet pressures of zero and
10 LPM 10 LPM 10 LPM
7 kPa)**
Outlet Pressure 20.0 ± 1.0 psi (138 kPa +/- 7 kPa) 20.0 ± 1.0 psi (138 kPa +/- 7 kPa) 20.0 ± 1.0 psi (138 kPa +/- 7 kPa) Electrical Rating 120 V, 60 Hz, 6.1 Amp 230 V~, 50 Hz, 3.2 Amp 240 V~, 50 Hz, 3.2 Amp Operating Voltage Range 102-132 V~, 60 Hz 195-253 V~, 50 Hz 204-264 V~, 50 Hz Oxygen Percentage 2-10 LPM=87%-96% 2-10 LPM=93% +3%/-6% 2-10 LPM=93% +3%/-6% Operating Altitude
(tested at 70˚F {21˚C} only)
0-1500 M (0-5000 ft)
Across the voltage range:
No degradation of performance
Across the voltage range:
No degradation of performance
No degradation of performance
Operating Environment Range*
41˚F (5˚C) to 95˚F (35˚C), humidity
range of 15% to 93% non­condensing
No degradation in performance across
the operating voltage range.
No degradation in performance across
the operating voltage range.
No degradation in performance across
Power Consumption 120 vac, 60HZ: 639 watts average 230 vac, 50Hz: 664 watts average 240 vac, 50Hz: 670 watts average Weight 42 lbs. (19 Kilograms) 42 lbs. (19 Kilograms) 42 lbs. (19 Kilograms) Safe Working Load 53 lbs. (24 Kilograms) 53 lbs. (24 Kilograms) 53 lbs. (24 Kilograms)
Sound Pressure Level at 3 and 10LPM
<59 dBA <57 dBA <57 dBA
Sound Power Level at 3 and 10 LPM <69 dBA <67 dBA <67 dBA
Dimensions
24.5”H x 13.5”W x 12”D (62.2 x 34.2 x 30.4 cm)
24.5”H x 13.5”W x 12”D (62.2 x 34.2 x 30.4 cm)
Maximum Limited Pressure 35 PSIG (241 kPa) 35 PSIG (241 kPa) 35 PSIG (241 kPa) Operating System Time Cycle / Pressure Swing Time Cycle / Pressure Swing Time Cycle / Pressure Swing
The visible “low oxygen” indicator
will activate at the following level
(The audible alarm will alert at
approximately 85%. At less than 60%, the
red “service required” light will activate.)
Storage Conditions -13˚F (-25˚C) to 158˚F (70˚C), humidity
range of 15% to 93% non-condensing,
including condensation
Class II Equipment Double Insulated;
86% ± 3%
Equipment Class and Type
Type B Applied Part
Ordinary Equipment, IP21
(The audible alarm will alert at
approximately 85%. At less than 60%, the
red “service required” light will activate.)
-13˚F (-25˚C) to 158˚F (70˚C), humidity
range of 15% to 93% non-condensing,
Class II Equipment Double Insulated;
86% ± 3%
(The audible alarm will alert at
approximately 85%. At less than 60%, the
red “service required” light will activate.)
-13˚F (-25˚C) to 158˚F (70˚C), humidity
range of 15% to 93% non-condensing,
including condensation
Class II Equipment Double Insulated;
Type B Applied Part
IP21 TUV
Approval Body and Safety Standard
IEC 60601-1 3rd Edition
TUV
In Process
IEC 60601-1 3rd Edition
IEC 60601-1
IEC 60601-1-11
ISO 80601-2-69
CE mark No Yes Yes EMC Compliance To EN60601-1-2 EN60601-1-2 EN60601-1-2
*NOTE– The OSD performance at 41˚F (5˚C) to 95˚F (35˚C), 95% R.H. through voltage range on the 1025 veried at 670m.
**The maximum recommended ow is 6 LPM when an oxygen bottle is being lled with oxygen from the auxiliary oxygen port. Specications subject to change without notice.
Oxygen Concentration vs Flow Rate
1025UK
Across the voltage range:
the operating voltage range.
24.5”H x 13.5”W x 12”D (62.2 x 34.2 x 30.4 cm)
86% ± 3%
including condensation
Type B Applied Part
IP21 TUV
IEC 60601-1 3rd Edition
IEC 60601-1
IEC 60601-1-11
ISO 80601-2-69
Flow L/m
%O
2
10 87% - 92%
9 87% - 93% 8 87% - 95% 7 87% - 96% 6 87% - 96% 5 87% - 96% 4 87% - 95% 3 87% - 95% 2 87% - 94%
EN - 10
A-1025
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