User manual | Delphi DL-00183 Oxygen Equipment User Manual

12659da delphi POC covers
9/18/08
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Portable Oxygen Concentrator
User Manual
12659da delphi POC covers
9/18/08
Manufactured by:
Delphi Medical Systems
5725 Delphi Drive
Troy, Michigan 48098-2815 U.S.A.
CUSTOMER SERVICE
Tel: [1] 888.526.1426
0086
12:14 PM
Page 2
European Representative:
MediMark® Europe Sarl
11, rue Emile Zola – BP 2332
38033 Grenoble Cedex 2 France
Tel:
+33 (0) 4 76 86 43 22
Fax: +33 (0) 4 76 17 19 82
E-mail: info@medimark-europe.com
The information in this document is subject to change without notice. This
document contains proprietary information that is protected by copyright. No
part of this document may be reproduced in any manner, in whole or in part
(except for brief excerpts in reviews and scientific papers), without the prior
written consent of Delphi Medical Systems. Before using any Delphi
Medical Systems product, be sure to read carefully and understand all
manuals provided with the product.
For Help
If you have questions about the information in these instructions or about
the safe operation of this device, contact Customer Service at the number
listed above.
ii
DL-00183 Rev. 3
Classification
This equipment is listed with a nationally recognized testing laboratory and
classified with respect to electric shock, fire, and mechanical hazards in
accordance with the following standards:
• EN 60601-1 (1990), Medical Electrical Equipment, Part 1: General
Requirements for Safety +A1(1993) +A2(1995) +A13(1996)
• UL 60601-1 (1st edition, 2006-04-26), Medical Electrical Equipment,
Part 1: General Requirements for Safety
• IEC 60601-1 (2nd edition), Medical Electrical Equipment, Part 1: General
Requirements for Safety, with A1 and A2
• CAN/CSA C22.2 No. 601.1-M90 (R2005), Medical Electrical Equipment,
Part 1: General Requirements for Safety
• IEC 60601-1-4 (2000-2004), Edition 1.1 Consolidated Edition, Medical
Electrical Equipment, Parts 1-4: General Requirements for Safety –
Collateral Standard: Programmable Electrical Medical Systems
This equipment is classified as:
• Class I
• Type BF
• IPX2
• Continuous operation at temperatures of 95°F (35°C) down to 41°F (5°C),
and short-time operation for 25 minutes at temperatures up to 104°F
(40°C) and­ 93% ± 2% relative humidity.
DL-00096 Rev. 7
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WARNING:
No
Smoking
No Open
Flame
No Oil
or Grease
Explanation of Packaging and
Labeling Symbols
No
Smoking
No Open
Flame
No Oil
or Grease
WARNING:
Do Not Remove Filter
When Unit is Operating
Keep
o not
ssemble
No Dry
Open
Flame
No Open
Flame
No
Smoking
No Oil
or Grease
No
Smoking
No Oil
or Grease
CAUTION:
Do Not Remove Filter
When Unit is Operating
Consult
accompanying
documents
Consult
6.7A
Output = 90% ± 3%
oxygen
= 90%
± 3% Oxygen
Serial number
3
CAUTION:
6.7A
6.7A
Do not
Disassemble
Do Not Remove Filter
When Unit is Operating
= 90%
3% Oxygen
Input
18V±DC,
6.7A
= 90% ± 3% Oxygen
No Oil
or Grease
accompanying
documents
Consult
Caution, consult accompanying documents
accompanying
documents
= 90% ± 3% Oxygen
6.7A
CAUTION:
accompanying
documents
CAUTION:
90% ± 3% Oxygen
WARNING:
WARNING:
Do Not Remove Filter
CAUTION: Consult
When Unit is Operating
Consult
Keep
Do not
accompanying
Dry
Disassemble
6.7A
Keep
Dry
Do not
Disassemble
WARNING:
Keep
Dry
Do not
Disassemble
documents
o
king
Do Not Remove Filter
When Unit is Operating
Keep
Dry
Do not
Disassemble
Keep
Dry
WARNING:
Do Not Remove Filter
When Unit is Operating
Catalog number
3
Consult
CAUTION:
U.S. federal law restricts
this
device to sale by
accompanying
or on the order of documents
a physician
Artwork, Product Label, Matchbox
3
Do not
o not
Disassemble
oduct
ssemble
DL-00122
WARNING:
Do Not Remove Filter
Revision:Product
3
Artwork,
Label,
No
No Open
No OilMatchbox
When Unit is Operating
Keep
Do not
ECO
10180 Smoking WARNING:
Flame
or Grease
Dry
Disassemble
WARNING:
Do Not Remove Filter
DL-00122
Do Not Remove Filter
When Unit is Operating
Keep Revision:
Print Colors:3
6.7A
WARNING:
When Unit is Operating
Keep
Dry Matchbox
Do Not Remove
Filter
Label,
Consult
ECO
Light10180
Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C
CAUTION:
Dry
No
No Open
No Oil
When Unit is Operating
Do not
accompanying
YellowPMS
123C
(Symbol)
= 90%
± 3%Disassemble
Oxygen Keep
Smoking
Flame
or Grease
Dry
documents
Print
Colors:
BlackPMS Process Black (Symbol & Text)
CAUTION:
Red-GreyPMS 485C
Light
Match(Symbols)
GE Plast
ics GY7D412 Consult
(Background), approx PMS427C
WARNING:
accompanying Consult
CAUTION:
Yellow- PMS 123C (Symbol)
CAUTION: Consult
Do Not Remove Filter
documents
accompanying
No
No Open
No Oil
When Unit is Operating
Keep accompanying
Do not
Black- PMS Process
Black
(Symbol
&
Text)
Smoking
Flame
or Grease
Dry documents
Disassemble
documents
6.7A
Red- PMS 485C (Symbols)
= 90% ± 3% Oxygen
WARNING:
No smoking
Use 3no oil or grease
No open flame when device is in use or do not incinerate
Do Not Remove Filter
CAUTION: Consult
tch GE
Plast ics No
GY7D412
(Background),
approx
PMS427C
Do not disassemble
No Open
No Oil
When Unit is Operating
Keep
Do not
accompanying
Smoking
Flame
or Grease
Dry
Disassemble
3C (Symbol)
documents
6.7A
Artwork,
Product Label, Matchbox
6.7A
WARNING:
Do Not Remove Filter
cess
Black
(Symbol
&
Text)
= 90%
= 90% ±6.7A
3% Oxygen
No ± 3% Oxygen
No Open
No Oil
When Unit is Operating
Keep
Do not
Smoking
(Symbols)
Flame
Consult
or
Grease
CAUTION:
Dry
Disassemble
WARNING:
Separate
collection
for
electrical
and
electronic
equipment
90% ± 3% Oxygen
accompanying
Do Not DL-00122
Remove Filter
6.7A Product Label, Matchbox
Revision: 3 Artwork,
= 90% ± 3% Oxygen
CAUTION: Consult
Type BF according to electrical safety accompanying
requirements
ECO 10180
documents
DL-00122
When Unit is Operating
Keep
Dry
documents
CAUTION:
6.7A
Consult
= 90% ± 3% Oxygen
accompanying
documents 3
3
3
A
Oxygen
Revision: 3
pressure limitation 0’ to 8,000’
Print Colors:Operating
ECO atmospheric
10180
Light Grey- Match GE Plast ics6.7A
GY7D412 (Background), approx PMS427C
= 90% ± 3% Oxygen
temperature
limitation -4°F to 140°F
Yellow- PMSStorage
123C
(Symbol)
Print
(-20°C
to Colors:
60°C)
Black- PMS Process
& Text)
LightBlack
Grey-(Symbol
Match GE
Plast ics GY7D412 (Background), approx PMS42
3485C
Humidity
limitation
5%
to
93% ± 2% non-condensing
RedPMS
(Symbols)
YellowPMS
123C (Symbol)
Artwork, Product
Label,
Matchbox
Black- PMS Process Black (Symbol & Text)
DL-00122
Revision: 3 Red- PMS 485C (Symbols)
Artwork, Product Label,
Matchbox
ECO 10180
DL-00122 Label, Matchbox
Artwork, Product
Print3Colors:
Revision:
Artwork,
Label,(Background),
Matchboxapprox PMS427C
Product Label, Matchbox
Light GreyMatch GE Product
Plast ics GY7D412
ECO 10180
DL-00122
Yellow- PMS 123C
3 (Symbol)
DL-00122
Black- PMS Process Black (Symbol & Text)
Colors:
Revision:
3 Print
Revision: 3
oduct
Label,
Matchbox
Artwork,
Product
Label,
Matchbox
3
RedPMSGE
485C
(Symbols)
Light
GreyMatch
Plast
ics GY7D412 (Background), approx PMS427C
ECO
10180
ECO
10180
0
Yellow- PMS 123C (Symbol)
DL-00122
BlackBlack
(Symbol & Text)
Colors:
Revision:
3 PMS ProcessPrint
Red- PMS 485C (Symbols)
Light Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C
ECO 10180
Print Colors:
YellowPMSPMS427C
123C (Symbol)
Match GE Plast ics GY7D412 (Background),
approx
BlackPMS Process (Background),
Black (Symbol & Text) approx PMS427C
GreyGY7D412
PrintMatch
Colors: GE Plast ics
123CLight
(Symbol)
PMS 485C
(Symbols)
Light Grey- Match GE Plast icsRed(Background),
approxLabel,
PMS427CMatchbox
Artwork,
Product
rocess
Black (Symbol
& Text)(Symbol) GY7D412
YellowPMS
123C
YellowPMS Rev.
123C76 (Symbol)
DL-00096
iv
tch
GE
Plast
ics
GY7D412
(Background),
approx
PMS427C
5C (Symbols)
BlackPMS Process
Black (Symbol
(Symbol
& Text)
Black- PMS
Process
Black
& Text)
DL-00122
3C (Symbol) Red- PMS 485C (Symbols)
Revision: 3
3
RedPMS 485C
(Symbols)
cess
Black
(Symbol
& Text)
abel,
Matchbox
DL-00096 rev 7.indd 4
(Symbols)
ECO 10180
6/1/2009 4:48:23 PM
WARNING:
o Open
Flame
No
Smoking
No Oil
or Grease
Do Not Remove Filter
When Unit is Operating
Keep
Dry
Do not
Disassemble
CAUTION:
accompanying
documents
6.7A
= 90% ± 3% Oxygen
Consult
Do not use if packaging is damaged
Handle with care
Date of manufacture
Manufacturer name and address
3
No
Smoking
No Oil
or Grease
Do not
Disassemble
Keep
Dry
KeepWARNING:
dry (This symbol refers to the IPX2
Do Not Remove Filter
When Unit is Operating
classification
of the device)
Artwork, Product Label, Matchbox
DL-00122
Revision: 3
ECO 10180
Keep
Dry
Do not
Disassemble
CAUTION:
Dispose
of used battery properly
accompanying
Consult
documents
WARNING:
Do Not Remove Filter
When Unit is Operating
Do not remove filter while unit is operating
Print Colors:
6.7A
Light Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C
= 90% ± 3% Oxygen
Yellow- PMS 123C (Symbol)
CAUTION: Consult
accompanying
Black- PMS Process Black
(Symbol & Text) Medical equipment with respect to electric shock,
documents
Red- PMS 485C (Symbols)
fire, and mechanical hazards in accordance with UL
60601-1, CAN/CSA C22.2 No. 601.1
6.7A
= 90% ± 3% Oxygen
WARNING! Do not use this device without the
carrying case. Use of this device outside its carrying
case may result in an electric shock hazard.
3
Caution Hot Surface
Artwork, Product Label, Matchbox
DL-00122
Product Label, Matchbox
Revision: 3
ECO 10180
3
80
Print Colors:
Light Grey- Match GE Plast ics GY7D412 (Background), approx PMS427C
Yellow123C(Background),
(Symbol) approx PMS427C
Match GE
Plast icsPMS
GY7D412
123C (Symbol)
Black- PMS Process Black (Symbol & Text)
Process Black
& Text)
Red- (Symbol
PMS 485C
(Symbols)
85C (Symbols)
DL-00096 Rev. 7
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Introduction
MANUAL VERSION
Please refer to this manual for detailed instructions on warnings, precautions,
specifications, and additional information. Printed in U.S.A.
Electronic copies of the current version of the Portable Oxygen
Concentrator User Manual can be found at www.delphimedical.com.
GENERAL INFORMATION
This user manual provides information for users of the Portable Oxygen
Concentrator. For the sake of brevity, the terms “concentrator,” “unit,”
or “device” are sometimes used in this document to refer to the Portable
Oxygen Concentrator.
IMPORTANT:
Users should read this entire manual before operating the Portable
Oxygen Concentrator. Failure to do so could result in personal injury
and/or death. If you have questions about the information in this
user manual or about the safe operation of this system, contact
Customer Service.
TYPOGRAPHICAL CONVENTIONS
These instructions contain warnings, precautions, and notes to help call
attention to the most important safety and operational aspects of the system.
To help identify these items when they occur in the text, they are shown
using the following typographical conventions:
WARNING:
STATEMENTS THAT DESCRIBE SERIOUS ADVERSE REACTIONS
AND POTENTIAL SAFETY HAZARDS.
PRECAUTION:
STATEMENTS THAT CALL ATTENTION TO INFORMATION REGARDING
ANY SPECIAL CARE TO BE EXERCISED BY THE PRACTITIONER AND/
OR PATIENT FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE.
IMPORTANT:
Statements calling attention to additional significant information
about the device or a procedure.
Note: Statements that provide supplemental information.
vi
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INDICATIONS FOR USE
The Portable Oxygen Concentrator is intended to provide supplemental
oxygen in a home, institutional, or travel environment.
INTENDED USE
The Portable Oxygen Concentrator is intended to deliver concentrated oxygen
for adult patients with chronic pulmonary diseases such as chronic bronchitis,
emphysema, asthma, or lung cancer, those in the terminal stage of cancer, or
any patient requiring supplemental oxygen. The device is portable, enabling
patients who need an oxygen device to be treated at home according to a
clinician’s prescription or direction. The Portable Oxygen Concentrator is a
prescription-only device, is not intended for use in life-supporting or
life-sustaining situations, and is provided non-sterile. It is designed to be
used indoors or outdoors.
CONTRAINDICATIONS
The Portable Oxygen Concentrator is not intended to be used:
• in life-supporting or life-sustaining situations
• in an operating or surgical environment
• with a non-adult population
• in conjunction with flammable anesthetic or flammable materials
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Warnings and Precautions
WARNINGS OVERVIEW
WARNING:
1. CRITICAL! EXPLOSION HAZARD. DO NOT USE IN THE
PRESENCE OF FLAMMABLE ANESTHETICS!
2. DO NOT USE A PORTABLE OXYGEN CONCENTRATOR OR ANY
ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE.
3. DO NOT ALLOW SMOKING OR OPEN FLAMES NEAR THIS
DEVICE. DO NOT USE THIS DEVICE IN THE PRESENCE OF
POLLUTANTS OR FUMES.
4. DO NOT SUBMERGE THIS DEVICE IN LIQUID. DO NOT EXPOSE
TO WATER OR PRECIPITATION. DO NOT EXPOSE TO DUSTY
CONDITIONS.
5. DO NOT USE LUBRICANTS ON THIS DEVICE OR ANY OF ITS
ACCESSORIES.
6. ALWAYS ENSURE BATTERY IS INSERTED BEFORE USING THIS
DEVICE.
7. IF FEELING ILL OR EXPERIENCING DISCOMFORT WHILE USING
THIS DEVICE, CONTACT CLINICIAN IMMEDIATELY.
8. DO NOT DISASSEMBLE THIS DEVICE OR ANY OF ITS
ACCESSORIES. DO NOT ATTEMPT ANY MAINTENANCE OTHER
THAN TASKS DESCRIBED IN “TROUBLESHOOTING” (PAGE 20).
DISASSEMBLY CAN CREATE AN ELECTRIC SHOCK HAZARD
AND WILL VOID THE WARRANTY. CONTACT CUSTOMER
SERVICE FOR SERVICING BY AUTHORIZED PERSONNEL.
9. RISK OF ELECTRIC SHOCK. DO NOT OPERATE THIS DEVICE
WITHOUT THE CARRYING CASE.
10. THIS DEVICE IS FOR CONTINUOUS OPERATION AT
TEMPERATURES OF 95°F (35°C) DOWN TO 41°F (5°C), AND
SHORT-TIME OPERATION FOR 25 MINUTES AT TEMPERATURES
UP TO 104°F (40°C) AND 93% ± 2% RELATIVE HUMIDITY.
PRECAUTIONS OVERVIEW
PRECAUTION:
1. U.S. FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR
ON THE ORDER OF A PHYSICIAN.
2. IT IS RECOMMENDED AN ALTERNATE SOURCE OF OXYGEN
BE AVAILABLE IN CASE OF POWER OUTAGE OR MECHANICAL
FAILURE. CONSULT PROVIDER OR CLINICIAN FOR AN
APPROPRIATE BACKUP SYSTEM.
3. NON-PRESCRIBED OXYGEN THERAPY CAN BE HAZARDOUS
UNDER CERTAIN CIRCUMSTANCES. USE THIS DEVICE ONLY
WHEN PRESCRIBED BY A CLINICIAN.
viii
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PRECAUTION:
4. IF YOU ARE UNABLE TO HEAR OR SEE ALARMS, DO NOT HAVE
NORMAL TACTILE SENSITIVITY, OR CANNOT COMMUNICATE
DISCOMFORT, CONSULT CLINICIAN BEFORE USING THIS
DEVICE.
5. THIS DEVICE IS NOT DESIGNED FOR USE WITH A HUMIDIFIER
OR NEBULIZER. IF A HUMIDIFIER OR NEBULIZER IS USED WITH
THIS DEVICE, PERFORMANCE MAY BE DIMINISHED AND THE
DEVICE MAY BE DAMAGED.
6. PATIENTS WITH A FAST BREATHING RATE REQUIRING A
HIGHER OXYGEN SETTING MAY REQUIRE MORE OXYGEN
THAN THIS DEVICE CAN PRODUCE. THIS DEVICE MAY NOT
BE APPROPRIATE IN THAT CASE. CONSULT CLINICIAN FOR
ALTERNATIVE TREATMENT.
7. ONLY USE APPROVED ACCESSORIES WITH THIS DEVICE. REFER
TO THE APPROVED ACCESSORIES GUIDE FOR A COMPLETE
LIST OF ACCESSORIES AND CANNULA APPROVED FOR USE
WITH THIS DEVICE. USING UNAPPROVED ACCESSORIES OR
CANNULA MAY IMPAIR THE PERFORMANCE OF THIS DEVICE.
8. REPLACE THE CANNULA ON A REGULAR BASIS. CHECK WITH
CUSTOMER SERVICE OR CLINICIAN TO DETERMINE HOW
OFTEN THE CANNULA SHOULD BE REPLACED.
9. ELECTRICAL CORD AND/OR TUBING LYING ON THE FLOOR
COULD PRESENT A TRIPPING HAZARD.
10.NEVER LEAVE THIS DEVICE IN A HOT ENVIRONMENT. NEVER
LEAVE THIS DEVICE IN A LOW-TEMPERATURE ENVIRONMENT.
EXTREME HIGH OR LOW TEMPERATURES CAN DAMAGE THIS
DEVICE.
11.IF OXYGEN CONCENTRATION DROPS BELOW THE SPECIFIED LEVEL, AN ALARM WILL INDICATE THIS CONDITION. IF ALARM
PERSISTS, STOP USING THIS DEVICE, SWITCH TO AN
ALTERNATE SOURCE OF OXYGEN, AND CONTACT CUSTOMER
SERVICE.
12.DO NOT USE CLEANING AGENTS OTHER THAN THOSE
SPECIFIED IN THIS MANUAL. ALLOW THE CLEANING SOLUTION
TO DRY FROM THE CLEANED SURFACE BEFORE USE.
13.ALWAYS DISCONNECT POWER AND TURN OFF THIS DEVICE
BEFORE CLEANING. SEE “MAINTENANCE AND CLEANING”
(PAGE 12).
14.DO NOT OBSTRUCT AIR INTAKE OR EXHAUST WHEN OPERATING
THIS DEVICE. BLOCKAGE CAN CAUSE BUILDUP OF INTERNAL
HEAT AND SHUT DOWN OR DAMAGE THIS DEVICE.
15.ALWAYS USE IN A WELL-VENTILATED LOCATION.
16.DO NOT OPERATE THIS DEVICE WITHOUT THE INPUT FILTER
IN PLACE. IF FILTER IS REMOVED, PARTICLES MAY BE DRAWN
INTO THE SYSTEM AND MAY DAMAGE THIS DEVICE.
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PRECAUTION:
17.ALWAYS OPERATE DEVICE AT THE SETTING PRESCRIBED BY A
CLINICIAN. DO NOT ALTER THE SETTING UNLESS PRESCRIBED
BY A CLINICIAN.
18.THIS DEVICE IS DESIGNED FOR USE BY ONE PATIENT AT A
TIME.
19.THIS DEVICE MAY NOT REACH SPECIFIED OXYGEN
CONCENTRATION PURITY UNTIL IT HAS BEEN IN USE FOR UP
TO 10 MINUTES.
20. ALWAYS FOLLOW THE MAINTENANCE SCHEDULE AS
SPECIFIED IN “ROUTINE MAINTENANCE” (PAGE 13).
21. IF THIS DEVICE INDICATES AN ABNORMAL CONDITION, SEE
“TROUBLESHOOTING” (PAGE 20).
22. REMOVE BATTERY IF THIS DEVICE IS NOT GOING TO BE USED
FOR MORE THAN SEVEN DAYS. STORE BATTERY IN A COOL,
DRY PLACE.
23. ALWAYS FOLLOW CANNULA MANUFACTURER’S INSTRUCTIONS
FOR PROPER USE.
24. ALWAYS TURN OFF THIS DEVICE WHEN NOT IN USE.
25. DO NOT USE THIS DEVICE WHILE SLEEPING UNLESS UNDER
THE SUPERVISION OF A CLINICIAN.
26. DO NOT PLACE OBJECTS ON TOP OF THIS DEVICE.
27. THIS DEVICE IS RATED IPX2. DO NOT USE IN DUSTY
CONDITIONS.
28. USE CAUTION WHEN TOUCHING THIS DEVICE IN HIGH AMBIENT
TEMPERATURES.
29. CHECK THAT THIS DEVICE OPERATES ON BATTERY AFTER
DISCONNECTING FROM THE POWER SOURCE.
30. ONLY CHARGE BATTERY IN THIS DEVICE OR IN AN APPROVED
CHARGER. (SEE APPROVED ACCESSORIES GUIDE.) IMPORTANT:
1. If an extension cord is necessary, use a UL listed 15 amp or higher
cord. Do not connect any other devices on the same extension cord.
2. Inhale through nose for the concentrator to work most effectively.
Inhaling through mouth may result in less effective oxygen therapy.
3. This device utilizes an oxygen-conserving delivery method, and the
setting on this device may differ from your setting on a continuous
flow oxygen concentrator (if you have been prescribed one). Your
clinician will provide you with specific instructions based on your
specific health condition and other variables.
x
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Contents
Classification ........................................................................................ iii
Explanation of Packaging and Labeling Symbols ................................. iv
Introduction .......................................................................................... vi
Manual Version ............................................................................. vi
General Information ...................................................................... vi
Typographical Conventions ........................................................... vi
Indications for Use ........................................................................vii
Intended Use .................................................................................vii
Contraindications ...........................................................................vii
Warnings and Precautions ...................................................................viii
Warnings Overview ......................................................................viii
Precautions Overview ..................................................................viii
Before You Get Started .........................................................................1
Power Supply .................................................................................... 1
Charging the Battery ...................................................................... 2
Features and Controls ........................................................................... 4
Accessories .................................................................................... 6
Carrying Case .......................................................................... 6
Pull Cart ................................................................................... 7
Operating the Portable Oxygen Concentrator ...................................... 9
Connecting Nasal Cannula ................................................................ 9
Turning On ........................................................................................10
Adjusting Setting ..............................................................................10
Responding to Alarms ......................................................................11
Turning Off .......................................................................................11
Traveling by Air With the Portable Oxygen Concentrator ................11
Maintenance and Cleaning .................................................................. 12
Verifying the Alarm System .............................................................12
Battery Care .....................................................................................12
Environment/Storage ....................................................................... 12
Routine Maintenance .......................................................................13
Cleaning and Changing Filters ......................................................13
Input Filter ..............................................................................13
Patient Filter ...........................................................................14
Compressor Filter ...................................................................14
Exterior Cleaning ..............................................................................15
Accessory Cleaning ..........................................................................15
Device Repair ...................................................................................15
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Device Disposal ....................................................................................15
Alarm Indicators ...................................................................................16
Alarms ..............................................................................................16
Critical High Priority Alarms ..........................................................16
High Priority Alarms ......................................................................17
Medium Priority Alarms ................................................................17
Low Priority Alarms ......................................................................18
Other Messages ...........................................................................18
Troubleshooting ...................................................................................20
Appendix 1: Technical Description ...................................................... 21
Appendix 2: Technical Information ......................................................22
Trademarks ..........................................................................................25
Disclaimer ............................................................................................25
Airline Travel Guidelines ...................................................................... 26
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Before You Get Started
­Always inspect the device and its accessories for any sign of damage before using.
Note: While box or packaging may exhibit some damage, e.g., tears or dents, the device may
still be in a usable condition.
If the device or any accessory shows any sign of damage, contact your
care provider.
Before you get started, check to make sure you have the following:
• Concentrator
• Battery
• Carrying case
• AC/DC power supply
See Approved Accessories Guide for more information.
WARNING:
DO NOT USE A PORTABLE OXYGEN CONCENTRATOR OR ANY
ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE.
POWER SUPPLY
The Portable Oxygen Concentrator can always be used when directly
connected to a power source. However, to enhance its portability, the
Portable Oxygen Concentrator is equipped with a rechargeable lithium-ion
internal battery.
WARNING:
ALWAYS ENSURE BATTERY IS INSERTED BEFORE USING THIS
DEVICE.
Note: Optional power supplies are available for various global use and travel. See Approved
Accessories Guide for complete list.
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Charging the Battery
PRECAUTION:
ONLY CHARGE BATTERY IN THIS DEVICE OR IN AN APPROVED
CHARGER. (SEE APPROVED ACCESSORIES GUIDE.) Prior to using the Portable Oxygen Concentrator for the first time, install the
battery as shown in Figure 1. The battery will latch when fully seated.
Figure 1.
Connect the AC power supply (consult Approved Accessories Guide) by
plugging the round connector into the receptacle on the side of the concentrator. See Figure 2. Plug the other end of the AC power supply into a power
outlet. Always use caution when inserting the power supply to a wall outlet.
Charger requirements are universal to support a wide variety of international
markets, so it can be plugged into an outlet with 100-240V AC, 50-60 Hz.
Allow the battery to charge for a minimum of three hours before use. Once
the battery is completely charged, the device can run on battery for approximately 2-3 hours at a setting of 2.0.
Note: Battery run time may vary based on breathing rate, age of battery, and environmental
conditions. See displayed text on device for battery charge status.
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Figure 2.
Note: Ensure power status icon (see Figure 6, page 5) indicates power is connected. If not, check
that cord is plugged in completely. (See “Troubleshooting” on page 20 for more information.)
To maximize battery life and run time, use while connected to a power
source whenever possible. The internal battery will automatically charge
whenever the concentrator is connected to a power source. The LCD
display will indicate whether the device is operating on battery or external
AC power.
The fully charged battery will retain some level of charge for up to seven
days in this device when not in use.
Note: Battery damage may result if the concentrator’s battery is allowed to discharge completely.
PRECAUTION:
REMOVE BATTERY IF THIS DEVICE IS NOT GOING TO BE USED FOR MORE
THAN SEVEN DAYS. STORE BATTERY IN A COOL, DRY PLACE.
PRECAUTION:
CHECK THAT THIS DEVICE OPERATES ON BATTERY AFTER
DISCONNECTING FROM THE POWER SOURCE.
Note: When not using the battery inside the unit, be sure to store it in the protective sleeve that
was provided with the original package.
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Features and Controls
Power key – turns device on or off
Display screen
Mode key – changes
display information
Alarm mute key – temporarily
silences audible alarms or shows
the last highest priority alarm
Green LED –
indicates
device is on
Red LED – indicates
a warning of danger
and/or a need for
urgent action
Yellow LED –
indicates caution or
attention required
Previous/next
key – changes
setting
Patient filter
Alarm mute indicator – indicates alarm buzzer
has been muted
Cannula port
Figure 3.
Power supply port
Exhaust
Figure 4.
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Battery
Input filter
Air intake
Compressor filter
Figure 5.
Setting
Power status (battery)
Setting
Power status (external)
Figure 6.
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ACCESSORIES
A variety of accessories can enhance the portability and use of the Portable
Oxygen Concentrator. In addition to the device, the package contains
accessories to get started and instructions for use. Refer to the Approved
Accessories Guide for the complete list of available accessories.
Only use a nasal cannula with the following specifications:
• 7’ (2.1 m) long
• High flow
• Three-fluted
• Crush-resistant
• Large internal diameter bore
• Straight non-tapered tips
• Suitable for up to 10 lpm
Note: Recommended model is Salter Labs 1600 HF cannula.
PRECAUTION:
ONLY USE APPROVED ACCESSORIES WITH THIS DEVICE. REFER TO
THE APPROVED ACCESSORIES GUIDE FOR A COMPLETE LIST OF
ACCESSORIES AND CANNULA APPROVED FOR USE WITH THIS DEVICE.
USING UNAPPROVED ACCESSORIES OR CANNULA MAY IMPAIR THE
PERFORMANCE OF THIS DEVICE.
Contact Customer Service for updated information and accessories or if
additional, optional, or replacement accessories are needed.
Carrying Case
To reduce the risk of electric shock, always use the Portable Oxygen
Concentrator with a carrying case (which also further reduces the device noise
during operation). Insert the device in the case such that the display screen is
visible through the clear plastic window and securely fasten all straps. When
properly inserted, it should look like Figure 7. When using the carrying case,
do not carry the concentrator by its handle; use the case’s carrying strap.
WARNING:
RISK OF ELECTRIC SHOCK. DO NOT OPERATE THIS DEVICE WITHOUT
THE CARRYING CASE.
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Figure 7.
Pull Cart
When using the Portable Oxygen Concentrator with a pull cart, attach and
secure the concentrator with the straps as shown in Figure 8. The handle can
be pulled out and adjusted for comfort.
Note: It is recommended that patients use the pull cart to transport the device whenever possible.
Figure 8.
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Intentionally blank
8
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Operating the Portable Oxygen Concentrator
IMPORTANT:
Read “Warnings and Precautions” (page viii) before using this device.
The Portable Oxygen Concentrator is designed for ease of use, with all
functions accessed through just a few keys on the control panel.
The Portable Oxygen Concentrator should be carried in its carrying case,
placed on a cart, or used while laying on a table or upright on the floor. The
patient should be within 7’ of this device during use.
Note: Except during startup and shutdown sequences, the backlight on the display screen will
remain off. Pressing any key will turn the backlight “on” briefly. The backlight will also remain
activated during an un-muted alarm condition.
CONNECTING NASAL CANNULA
PRECAUTION:
REPLACE THE CANNULA ON A REGULAR BASIS. CHECK WITH
CUSTOMER SERVICE OR CLINICIAN TO DETERMINE HOW OFTEN THE
CANNULA SHOULD BE REPLACED.
PRECAUTION:
ALWAYS FOLLOW CANNULA MANUFACTURER’S INSTRUCTIONS FOR
PROPER USE.
Connect the tubing to the cannula port (oxygen discharge) as shown in Figure 9.
Figure 9.
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To connect the cannula to the patient, position the cannula tips in patient’s
nostrils and pass tubing over both ears and under chin. Follow manufacturer’s
instructions.
Slide adapter up tubing to adjust for comfort and fit.
Once the cannula is secured, breathe normally through the nose. The Portable
Oxygen Concentrator will detect a breath and deliver the oxygen during
inhalation.
Note: Improper cannula placement may result in the Portable Oxygen Concentrator being unable
to detect all respiratory efforts of the patient. Ensure cannula is connected securely and it has
been fully inserted.
PRECAUTION:
PATIENTS WITH A FAST BREATHING RATE REQUIRING A HIGHER
OXYGEN SETTING MAY REQUIRE MORE OXYGEN THAN THIS DEVICE
CAN PRODUCE. THIS DEVICE MAY NOT BE APPROPRIATE IN THAT CASE. CONSULT CLINICIAN FOR ALTERNATIVE TREATMENT.
TURNING ON
To turn the Portable Oxygen Concentrator on, press the power key. The
concentrator will chirp and the green, yellow, and red LEDs will flash once,
while the screen displays concentrator software version information and total
elapsed run time information. The green LED will then stay lit.
Note: No adjustments can be made until the startup sequence is completed.
ADJUSTING SETTING
Note: After powering on the Portable Oxygen Concentrator, the startup sequence will take
approximately 35 seconds. Specified oxygen level will be reached within 10 minutes of use.
Increase or decrease the setting using the previous/next key. Pressing the
next (+) key increases the setting 0.5, up to 5.0. Pressing the previous (-) key
decreases setting 0.5, down to 1.0.
The current setting and power source (external power or battery; battery icon
also shows approximate level of charge remaining) are shown on the display
screen as shown in Figures 10 and 11.
Figure 10. Concentrator operating on battery power.
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Figure 11. Concentrator running on external power.
RESPONDING TO ALARMS
PRECAUTION:
IF YOU ARE UNABLE TO HEAR OR SEE ALARMS, DO NOT HAVE
NORMAL TACTILE SENSITIVITY, OR CANNOT COMMUNICATE
DISCOMFORT, CONSULT CLINICIAN BEFORE USING THIS DEVICE.
Pressing the alarm mute key at any time will silence the buzzer. The length of
the mute period depends on the severity of the alarm. (See “Alarm Indicators”
on page 16.) During this mute period, the mute LED will remain illuminated,
indicating the alarm buzzer is muted. Push the mute key again to unmute
alarms. Pressing the mute key when there is no active alarm will mute any
future medium or low priority alarms for eight hours. See “Troubleshooting”
(page 20) for additional information on alarms.
TURNING OFF
PRECAUTION:
ALWAYS TURN OFF THIS DEVICE WHEN NOT IN USE.
To turn the Portable Oxygen Concentrator off, press and hold the power
key. The device will chirp and the screen will display a shutdown message
“Shutting off” for approximately five seconds, then go into low-power mode.
Note: Do not disconnect the AC power supply and remove the battery at the same time while the
unit is running. Always use the power key to turn the device off. Wait until the device has
completely shut down before disconnecting from power and removing the battery.
TRAVELING BY AIR WITH THE PORTABLE OXYGEN CONCENTRATOR
Contact Customer Service for information on airline regulations related to
traveling with the Portable Oxygen Concentrator by air.
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Maintenance and Cleaning
VERIFYING THE ALARM SYSTEM
At startup, the LEDs should light up and buzzer should sound to verify
operation.
BATTERY CARE
Avoid letting battery deplete; operate device when connected to AC power
whenever possible to help keep battery charged. Disconnect battery if the
device will not be used for more than seven days, and store the battery in a
cool, dry place.
Dispose of battery according to local regulations or contact Customer Service.
ENVIRONMENT/STORAGE
The Portable Oxygen Concentrator can operate in the following conditions:
• 41°F to 95°F (5°C to 35°C)
• 5% to 93% ± 2% relative humidity (non-condensing)
• Altitudes between 0’ to 8,000’ above sea level (0 km to 2.4 km)
When not in use, the Portable Oxygen Concentrator should be stored in a
clean, dry environment between -4°F and 140°F (-20°C and 60°C).
Note: The Portable Oxygen Concentrator can be safely stored up to 15,000’ (4,572 m) above sea
level.
WARNING:
THIS DEVICE IS FOR CONTINUOUS OPERATION AT TEMPERATURES
OF 95°F (35°C) DOWN TO 41°F (5°C), AND SHORT-TIME OPERATION
FOR 25 MINUTES AT TEMPERATURES UP TO 104°F (40°C) AND
93% ± 2% RELATIVE HUMIDITY.
PRECAUTION:
NEVER LEAVE THIS DEVICE IN A HOT ENVIRONMENT. NEVER LEAVE
THIS DEVICE IN A LOW-TEMPERATURE ENVIRONMENT. EXTREME HIGH
OR LOW TEMPERATURES CAN DAMAGE THIS DEVICE.
PRECAUTION:
REMOVE BATTERY IF THIS DEVICE IS NOT GOING TO BE USED FOR
MORE THAN SEVEN DAYS. STORE BATTERY IN A COOL, DRY PLACE.
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ROUTINE MAINTENANCE
WARNING:
DO NOT USE LUBRICANTS ON THIS DEVICE OR ANY OF ITS
ACCESSORIES.
PRECAUTION:
REPLACE THE CANNULA ON A REGULAR BASIS. CHECK WITH
CUSTOMER SERVICE OR CLINICIAN TO DETERMINE HOW OFTEN THE
CANNULA SHOULD BE REPLACED.
Device will indicate with an alarm when a filter or device needs to be cleaned
or changed. (Also, see “Troubleshooting” on page 20.)
Cleaning and Changing Filters
Filters in the Portable Oxygen Concentrator should be periodically washed or
replaced as indicated by messages on the display screen.
INPUT FILTER
The input filter is designed to keep particles out of the device and should be
washed frequently, especially if used in a contaminated environment (such as
near construction sites, etc.).
Note: If a replacement input filter is required, contact Customer Service.
PRECAUTION:
DO NOT OPERATE THIS DEVICE WITHOUT THE INPUT FILTER IN PLACE.
IF FILTER IS REMOVED, PARTICLES MAY BE DRAWN INTO THE SYSTEM
AND MAY DAMAGE THIS DEVICE.
PRECAUTION:
ALWAYS DISCONNECT POWER AND TURN OFF THIS DEVICE BEFORE
CLEANING.
Wash the input filter by following these steps:
1. Remove the filter from the device.
2. Rinse under tap water without soap.
3. Air dry.
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PATIENT FILTER
The patient filter is designed to trap airborne particulates. If the device
indicates the patient filter should be replaced, contact Customer Service for
replacement filter. Replace as shown in Figure 12.
Figure 12.
COMPRESSOR FILTER
The compressor filter is designed to trap airborne particulates. If the device
indicates the compressor filter should be replaced, contact Customer Service
for replacement filter. Replace as shown in Figure 13.
Figure 13.
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EXTERIOR CLEANING
WARNING:
DO NOT SUBMERGE THIS DEVICE IN LIQUID. DO NOT EXPOSE TO
WATER OR PRECIPITATION. DO NOT EXPOSE TO DUSTY CONDITIONS.
PRECAUTION:
DO NOT USE CLEANING AGENTS OTHER THAN THOSE SPECIFIED IN
THIS MANUAL. ALLOW THE CLEANING SOLUTION TO DRY FROM THE
CLEANED SURFACE BEFORE USE.
Clean the exterior with a soft cloth slightly dampened with soapy water or a
mixture of 10% household bleach in water.
ACCESSORY CLEANING
Refer to the original cannula manufacturer’s instructions for cleaning the nasal
cannula.
DEVICE REPAIR
Do not attempt to repair the device. Contact Customer Service for assistance
(see “Troubleshooting” on page 20).
DEVICE DISPOSAL
Contact Customer Service regarding disposal of the device.
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Alarm Indicators
If the Portable Oxygen Concentrator detects an alarm condition, it will indicate the alarm visually and audibly within 10 seconds. There are four levels
of alarms: critical high priority, high priority, medium priority, and low priority.
Each is indicated differently by the backlit display; green, yellow, and red
LEDs; and buzzer, as indicated below. In each case, the alarm message and
power status will override the current display.
Note: All alarm conditions and parameters are factory preset; conditions and parameters cannot be
changed or adjusted by the user.
Alarm Status
Audible Tone
Visual Indicator
Mute Time
Critical high
priority
Ten beeps per burst, burst
repeats every 3 seconds
Solid red LED
(and device shuts
off automatically)
20 minutes
High priority
Ten beeps per burst, burst
repeats every 3 seconds
Flashing red LED
20 minutes
Medium priority
Three beeps per burst,
burst repeats every 8
seconds
Flashing yellow LED
8 hours
Low priority
Three beeps per burst,
burst repeats every
10 minutes
Solid yellow LED
24 hours
Note: If two alarm conditions exist at the same time, the highest priority alarm is indicated. If two or
more alarm conditions of equal priority exist at the same time, the most recent one will be displayed.
Note: The most recent alarms indicated by the device are logged for reference by service personnel.
This log is maintained even if the device is powered down or if power is lost for any other reason.
Note: If the mute key is pressed prior to an alarm condition (for example, to mute the device in a
movie theater), critical high priority and high priority alarms will override the mute function; medium
and low priority alarms will be muted for eight hours from the time the key was pressed. Press the
mute key off to display the last highest priority alarm. Press the mute key on again to reset the eighthour timer.
ALARMS
When the Portable Oxygen Concentrator sounds an alarm, a corresponding
message will be displayed on the screen. Take appropriate action as directed
in the charts below.
Critical High Priority Alarms
Note: These alarms will disable the Portable Oxygen Concentrator immediately.
Alarm Message
Description
Action
Charge Battery
Battery needs charging.
Recharge the battery
pack by plugging in to
power supply. Ensure all
connections are made
securely.
XX: Service!*
Service required.
Contact Customer
Service.
*Value: 01-20
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High Priority Alarms
Note: These alarms will allow the Portable Oxygen Concentrator to continue operating.
Alarm Message
Description
Action
Check Vents
Device is unable to maintain Be sure air inlet/outlet
oxygen purity.
has not been blocked. If
alarm persists, contact
Customer Service.
Low Battery
Estimated battery life less
than 17 minutes.
Charge the battery pack
by plugging in to power
supply.
Note: The message will be
automatically cleared when
plugged in to power supply.
XX: Service!*
Service required.
Contact Customer
Service.
*Value: 21-50
Medium Priority Alarms
Alarm Message
Description
Action
Check Cannula
No breath detected for 5
minutes.
Check the cannula connection. Be sure to
breathe through nose. If
alarm persists, contact
Customer Service.
Note: The message will be
automatically cleared when
breathing is detected.
XX: Service*
Service required.
Contact Customer
Service.
*Value: 51-70
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Low Priority Alarms
Alarm Message
Description
Action
Replace C-filtr
Compressor filter needs
replacement.
Replace filter. Press and
hold mute key for more
than 4 seconds to reset
the hour counter.
Replace P-filtr
Patient filter needs
replacement.
Replace filter. Press and
hold mute key for more
than 4 seconds to reset
the hour counter.
Wash I-filtr
Input filter needs to be
cleaned.
Wash input filter. Press
and hold mute key for
more than 4 seconds to
reset the hour counter.
Replace batt
Main battery has exceeded
300 recharge cycles.
Contact Customer
Service for replacement.
Note: This alarm will be
automatically cleared once
a new battery is inserted.
Battery will continue to
function after 300 recharge
cycles, but for a shorter time
than a new battery.
Service required.
Contact Customer
Service.
Message
Description
Action
Power removed
External power has been
disconnected; unit is now
running on battery.
No action is required.
SW Ver N.NNN
Display of software version
during startup and calibration. This includes test of
beeper and LEDs.
No action is required.
Self test
Indicates unit is going
No action is required.
through its test at startup.
Displayed for approximately
10 seconds.
Shutting off
Displayed while unit goes
through its power-down
sequence.
No action is required.
External power
External power is
connected.
No action is required.
XX: Service*
*Value: 71-99
Other Messages
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Other Messages, continued
Message
Description
Action
Battery low
Estimated battery life less
than 17 minutes. The unit
will also generate a high
priority alarm as described
above.
Charge the battery pack
by plugging in to power
supply.
Note: The message will be
automatically cleared when
plugged in to power supply.
Fully charged
Displayed as the battery
menu item when the
battery is 100% charged.
No action is required.
Checking power
Displayed as the battery
menu item when the
battery status has recently
changed and the unit
software is analyzing the
change in status.
No action is required.
No battery
Displayed as the battery
menu item when there are
no communications with
the battery.
Verify that the battery pack is correctly installed. Contact
Customer Service if the
battery is fully inserted
and the message
continues to be displayed
longer than 30 seconds.
BattLife NN%
Displayed percentage of
battery charge if at least
10% and there is no
external power connected.
Message is displayed
when mode key is
pressed.
Charging: NN%
NN% displays the current battery charge level.
Displayed when battery
charge is greater than 10%
but less than 100% and
there is external power
connected.
Message is displayed
when mode key is
pressed.
Charging
Battery charge is less than
10% and there is external
power connected.
Message is displayed
when mode key is
pressed.
RT XXXXX
Non-resettable total elapsed
time indicator (hours).
No action required.
Breath rate XX
The patient’s average breath
rate when the device is
delivering the maximum
amount of oxygen and
the bolus is reduced. If no
breaths are detected, the
most recent breath rate is
shown.
Reduce activity level. Be
sure air inlet/outlet has
not been blocked.
Alarm cleared
A previously set alarm has
been automatically cleared.
Note: The message will
automatically clear when
the device returns to normal
operation.
No action required.
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Troubleshooting
Problem
Possible Cause
Troubleshooting
System becomes
inoperative
• System may be
disconnected from the
power source.
• Check that the system
is connected securely
to the power source.
• System may be turned
off.
• Ensure the system is
powered on.
• Critical high priority alarm
has occurred.
• Examine the system
for damage or exposure to liquids.
• If problem persists,
contact Customer
Service.
Any alarm sound or either
(red) or
• See “Alarm Indicators”
on page 16.
• See “Alarms” on
page 16.
• Power is not connected.
• Check connections to
ensure:
(yellow) LED lit
Battery not charging 1. Round receptacles are secure in unit.
2.
Power cord is
connected to AC/DC supply or automotive DC adapter is connected, if applicable.
3. Power cord is
connected to wall outlet, if applicable.
4. Wall outlet has power.
• Battery is not fully inserted. • Ensure battery is fully
seated and latch is
secure.
• Battery is inoperable.
• If problem persists,
contact Customer
Service.
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Appendix 1: Technical Description
Size: 7.4” W x 4.6” D x 11.6” H (188 mm W x 117 mm D x 295 mm H)
Unit weight: Less than 10 lbs (without carrying case or cart)
Power requirements: 100-240V AC (± 10%), 50-60 Hz; battery power 18V DC, 6.7 amps; DC adaptor, 18V DC, 6.7 amps (Note: See Approved Accessories Guide for model and part number of AC
power supply.)
Purity: 90% ± 3% (22°C ± 3°C, 14.29 psia ± 0.04 or 739 mmHg at 40% ± 15% relative humidity)
at all flow rates
Setting: User adjustable 1.0 to 5.0 (with 0.5 increments) (min. 1.0; max. 5.0)
Setting indicator: LCD display
Maximum oxygen discharge pressure: 17 psi at setting of 5.0 Humidity range: 5% to 93% ± 2% non-condensing
Operating altitude: 0’ to 8,000’ relative to sea level (0 km to 2.4 km)
Sound pressure level (measured 1 m from edge of chassis): Less than 50 dB(A) average
Type of protection (electrical): Class I
Degree of protection (electrical): Type BF
Degree of protection (water): IPX2
Degree of safety (flammable anesthetic mixture): Not suitable for use in the presence of a
flammable anesthetic mixture
Operation: Continuous operation at temperatures of 95°F (35°C) down to 41°F (5°C), and short-time
operation for 25 minutes at temperatures up to 104°F (40°C).
Alarm sound pressure range: 65 to 85 dB(A)
Alarm system delays: Less than 10 seconds after detection (low oxygen alarms if oxygen is less
than 82% volume fraction at specified environmental conditions)
Oxygen concentrator status indicator: High priority alarm that indicates when oxygen concentration drops below 82%
Maximum Temperature: Under extreme environmental and operating conditions, specific maximum surface temperatures are listed below. Each of these specific surfaces also lists an expected
user contact limit as follows:
The Key panel can reach up to 140°F (60°C). This surface is intended to be touched for less than one
minute at a time. The clear plastic window on the carrying case can reach up to 118.4°F (48°C). This
surface is intended to be touched for less than ten minutes at a time. The remainder of the carrying
case can reach up to 109.4°F (43°C). This surface has no time limitation on user contact.
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Appendix 2: Technical Information
ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION
Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC). Portable and mobile radio frequency (RF)
communications equipment can affect devices such as the Portable Oxygen
Concentrator. As such, the device should not be used adjacent to other
equipment. If this is not practical, then observe the device to make sure it is
operating properly at all times.
Guidance and manufacturer’s declaration: electromagnetic emissions
The Portable Oxygen Concentrator is intended for use in the electromagnetic
environment specified below. The customer or the user of the concentrator should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment/guidance
RF emissions
CISPR 11
Group 1
The Portable Oxygen Concentrator 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 A
The concentrator is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
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Guidance and manufacturer’s declaration: electromagnetic immunity
The Portable Oxygen Concentrator is intended for use in the electromagnetic
environment specified below. The customer or the user of the concentrator should
assure that it is used in such an environment.
Immunity test
IEC 60601 test Compliance
level
level
Electromagnetic
environment/guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6kV contact
± 8kV air
± 15kV contact Floors should be wood,
concrete, or ceramic tile.
± 8kV air
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electric fast
transient/burst
IEC 61000-4-4
± 2kV for
power supply
lines
± 1kV for
input/output
lines
± 2kV for
power supply
lines
± 1kV for
input/output
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1kV
differential mode
± 2kV common
mode
± 1kV
differential mode
± 2kV common
mode
Mains power quality
should be that of a typical
commercial or hospital
environment.
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Immunity test
IEC 60601 test Compliance
level
level
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
< 5% UT
< 5% UT
Mains power quality should
(>95% dip in UT) (>95% dip in UT) be that of a typical
for 0.5 cycle
for 0.5 cycle
commercial or hospital
environment. If the user
40% UT
40% UT
(60% dip in UT) (60% dip in UT) of the Portable Oxygen
Concentrator required
for 5 cycles
for 5 cycles
continued operation during
70% UT
70% UT
power main interruptions,
(30% dip in UT) (30% dip in UT) it is recommended that the
for 25 cycles
for 25 cycles
concentrator be powered
from an uninterruptible
<5% UT
<5% UT
(>95% dip in UT) (>95% dip in UT) power supply or battery.
for 5 sec
for 5 sec
Power frequency magnetic
3 A/m
3 A/m
fields should be at levels
characteristic of a typical
commercial or hospital
environment.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
3 Vrms 150 kHz 3 Vrms
to 80 Mhz
Radiated RF
IEC 61000-4-3
20 V/m 80 Mhz
to 2.5 Ghz
20 V/m
Electromagnetic
environment/guidance
Portable and mobile RF
communications equipment
should be used no closer
to any part of the Portable
Oxygen Concentrator,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the
transmitter.
­ ecommended separation
R
distance:
d = 1.2 √P
d = 1.2 √P 80 MHz to 800
MHz
d = 2.3 √P 800 MHz to 2.5
GHz
Note: At 80 MHz and 800 MHz, the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures,
objects, and people.
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If
the measured field strength in the location in which the Portable Oxygen
Concentrator is used exceeds the applicable RF compliance level above,
the concentrator should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating the concentrator.
a
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed
RF transmitters, as determined by an electromagnetic
site surveya should be less
than the compliance level
in each frequency rangeb.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.
b
24
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Recommended separation distances between portable and mobile RF
communications equipment and the Portable Oxygen Concentrator
The Portable Oxygen Concentrator is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The monitor user can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the monitor as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance (m) according to frequency of transmitter
150 kHz to 80 MHz
d = 1.2 √P
80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 √P
d = 2.3 √P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in meters (m) can be estimated using the equation applicable to
the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by the absorption and reflection from structures, objects, and people.
Trademarks
All trademarks are the property of their respective owners.
Disclaimer
The information in this document has been carefully examined and is believed
to be reliable. Furthermore, Delphi Medical Systems reserves the right to
make changes to any products herein to improve readability, function, or
design. Delphi Medical Systems does not assume any liability arising out of
the application or use of any product or circuit described herein; neither does
it cover any license under its patent rights nor the rights of others.
DL-00096 Rev. 7
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25
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Airline Travel Guidelines
When traveling by air, it is recommended the guidelines listed below
be followed:
1. The patient must be capable of seeing the alarm indicator lights, hearing
the various warning alarms, and taking the appropriate actions should the
unit fail to detect the user’s breathing or a general malfunction occurs. If
the patient is not capable of the above requirement, they must be traveling
with someone who is capable of performing those functions for the user.
2. Person using the Portable Oxygen Concentrator (POC) must not be seated
in an aisle, normal exit row, or emergency exit so as not to restrict access
to the aisle by other passengers. Patients should stow POC while in use,
underneath seat, so that it does not interfere with the movement of other
passengers. If patients are not required to use oxygen during takeoff,
landing, or movement on the surface, they must stow the POC according
to airline regulations (underneath seat or in overhead cabin).
3. Patient is responsible to carry sufficient amount of batteries to last for the
entire trip, including layovers and/or possible flight delays.
4. Batteries, not being used or extra, must be stowed in their protective
cover or/and placed inside the carrying case or placed inside an approved
carry-on baggage, packaged to prevent short circuits and protected from
physical damage.
5. Patient must obtain a signed, licensed clinician statement that medical
oxygen is necessary for the duration of the flight and the maximum
setting allowed onboard an aircraft.
6. The patient must inform the aircraft operator and its crew that the POC
may be used onboard the aircraft.
7. In the event of an alarm, the POC must be turned off or alarms muted.
8. Only oxygen approved lotions or salves may be used by the patient.
9. The patient must operate the POC with battery power only (do not use
the car charger) while onboard the aircraft. The A/C power cord and car
charger options are not approved for onboard aircraft use.
26
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12659da delphi POC covers
9/18/08
12:14 PM
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DL-00183 Rev. 3
27
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Page 4
Delphi Medical Systems
5725 Delphi Drive
Troy, Michigan 48098-2815 U.S.A.
Tel: [1] 888.526.1426
E-mail: medical@delphi.com
www.delphimedical.com
All trademarks are the property of their respective owners.
© 2008 Delphi Corporation. All rights reserved.
DL-00183 Rev. 3
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