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DL-00096 Rev. 6

Explanation of Packaging and

Labeling Symbols

Caution, consult accompanying documents

Input 18V DC, 6.7A

Output = 87% - 96% oxygen

Serial number

Catalog number

U.S. federal law restricts this device to sale by

or on the order of a physician

No smoking

No open flame when device is in use or do not incinerate

Do not disassemble

Separate collection for electrical and electronic equipment

Type BF according to electrical safety requirements

Operating atmospheric pressure limitation 0’ to 8,000’

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

Humidity limitation 5% to 93% ± 2% non-condensing

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

Use no oil or grease

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00122

Revision: 3

ECO 10180

Print Colors:
Light Grey- Match GE Plast

ics GY7D412 (Background), approx PMS427C

Yellow- PMS 123C (Symbol)
Black- PMS Process Black (Symbol & Text)

Red- PMS 485C (Symbols)

6.7A

CAUTION:

Consult

accompanying

documents

Keep

Dry

Do not

Disassemble

No Oil

Do Not Remove Filter

When Unit is Operating

WARNING:

or Grease

Smoking

No Open

Flame

Artwork, Product Label, Matchbox

= 87% - 96% Oxygen

DL-00096 Rev. 8

Содержание Oxus

Страница 1: ...Portable Oxygen Concentrator User Manual Reliability Plus by Reliability Plus by ...

Страница 2: ...bout the information in these instructions or about the safe operation of this device contact your distributor ii DL 00183 Rev 4 Manufactured by Oxus Inc 1685 Northfield Drive Rochester Hills Michigan 48309 U S A 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 reproduc...

Страница 3: ... 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 equipmen...

Страница 4: ...prox PMS427C Yellow PMS 123C Symbol Black PMS Process Black Symbol Text 6 7A CAUTION 3 Consult accompanying documents Keep Dry Do not Disassemble No Oil Do Not Remove Filter When Unit is Operating WARNING or Grease No Smoking Artwork Product Label Matchbox 87 96 Oxygen DL 00122 Revision 3 ECO 10180 Print Colors Light Grey Match GE Plastics GY7D412 Background approx PMS427C Yellow PMS 123C Symbol B...

Страница 5: ... Remove Filter When Unit is Operating WARNING or Grease No Smoking pen me Artwork Product Label Matchbox 87 96 Oxygen 00122 ision 3 O 10180 Colors Grey Match GE Plastics GY7D412 Background approx PMS427C w PMS 123C Symbol PMS Process Black Symbol Text PMS 485C Symbols 6 7A CAUTION Consult accompanying documents Keep Dry Do not Disassemble o Oil Do Not Remove Filter When Unit is Operating WARNING G...

Страница 6: ...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 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 use...

Страница 7: ...plemental 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 ...

Страница 8: ...EVICE 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 DISASSEM...

Страница 9: ...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 CO...

Страница 10: ...E 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 ...

Страница 11: ...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 ...

Страница 12: ...ritical 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 ...

Страница 13: ...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...

Страница 14: ...n trator 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 c...

Страница 15: ...ate 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 P...

Страница 16: ...charge Alarm mute key temporarily silences audible alarms or shows the last highest priority alarm Cannula port Green LED indicates device is on Yellow LED indicates caution or attention required Red LED indicates a warning of danger and or a need for urgent action Alarm mute indicator indicates alarm buzzer has been muted Power supply port Patient filter Exhaust ...

Страница 17: ...5 DL 00096 Rev 8 Figure 5 Input filter Battery Compressor filter Air intake Power status battery Power status external Figure 6 Setting Setting ...

Страница 18: ...S 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 your distributor 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 ...

Страница 19: ...gen 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 Figure 8 Note It is recommended that patients use the pull cart to transport the device whenever possible ...

Страница 20: ...8 DL 00096 Rev 8 Intentionally blank ...

Страница 21: ...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 YOUR DISTRIBUTOR OR CLINICIAN TO DETERMINE HOW OFTEN THE CANNULA SHOULD BE REPLACED PRECAUTION ALWAYS F...

Страница 22: ...AN 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 ADJUST...

Страница 23: ...um 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...

Страница 24: ... 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 PRECAUTION NEVER LEAVE THIS DEVICE IN A HOT ENVIRONMENT NEVER LEAVE THIS DEVICE I...

Страница 25: ... 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 your distributor PRECAUTION DO NOT OPERATE THIS DEVICE WITHOUT THE INPUT FILTER IN PLACE IF F...

Страница 26: ...hould be replaced contact your distributor 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 your distributor for replacement filter Replace as shown in Figure 13 Figure 13 ...

Страница 27: ...N 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 your distributor for assistance see Troubleshooting on page 20 DEVICE DI...

Страница 28: ...r 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 movi...

Страница 29: ... The message will be automatically cleared when plugged in to power supply Contact your distributor High Priority Alarms Note These alarms will allow the Portable Oxygen Concentrator to continue operating Alarm Message Check Cannula XX Service Value 51 70 Description No breath detected for 5 minutes Service required Action Check the cannula con nection Be sure to breathe through nose If alarm pers...

Страница 30: ... 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 Contact your distributor Low Priority Alarms Other Messages Message Power removed SW Ver N NNN Self test Shutting off External power Description External power has been disconnected unit is now running on bat...

Страница 31: ... and there is external power connected Non resettable total elapsed time indicator hours 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 A previously set alarm has been automatically cleared Action Charge the battery pack by plugging in to power supply No action is ...

Страница 32: ...tem is connected securely to the power source Ensure the system is powered on Examine the system for damage or expo sure to liquids If problem persists contact your distribu tor See Alarms on page 16 Check connections to ensure 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 outle...

Страница 33: ...hetic 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 spec...

Страница 34: ...ons flicker emissions IEC 61000 3 3 Compliance Group 1 Class B Class A Complies Electromagnetic environment guidance 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 The concentrator is suitable for use in all establishments including domestic establishm...

Страница 35: ...e relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment 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 use...

Страница 36: ... W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as deter mined 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 Compliance level 5 UT 95 dip in UT for 0 5 cycle 40 UT...

Страница 37: ...ated 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 gui...

Страница 38: ...e 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 p...

Страница 39: ...Intentionally blank DL 00183 Rev 4 27 ...

Страница 40: ...Inc All rights reserved DL 00183 Rev 4 Drive Medical Design Manufacturing 99 Seaview Boulevard Port Washington NY 11050 U S A Tel 877 224 0946 www drivemedical com Oxus Inc 1685 Northfield Drive Rochester Hills Michigan 48309 U S A Tel 888 475 1568 E mail info oxusamerica com www oxusamerica com All trademarks are the property of their respective owners 2010 Oxus Inc All rights reserved DL 00183 R...

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