2659da delphi POC covers 9/18/08 12:14 PM Page 1 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.
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: Ge
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.
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.
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.
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.
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.
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.
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.
Contents Classification ........................................................................................ iii Explanation of Packaging and Labeling Symbols ................................. iv Introduction .......................................................................................... vi Manual Version ............................................................................. vi General Information ......................................................................
Device Disposal .................................................................................... 15 Alarm Indicators ................................................................................... 16 Alarms .............................................................................................. 16 Critical High Priority Alarms .......................................................... 16 High Priority Alarms ......................................................................
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.
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.
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.
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.
Battery Input filter Air intake Compressor filter Figure 5. Setting Power status (battery) Setting Power status (external) Figure 6. DL-00096 Rev. 7 DL-00096 rev 7.
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.
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. DL-00096 Rev. 7 DL-00096 rev 7.
Intentionally blank 8 DL-00096 Rev. 7 DL-00096 rev 7.
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.
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.
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.
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.
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.
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. 14 DL-00096 Rev. 7 DL-00096 rev 7.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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12659da delphi POC covers 9/18/08 12:14 PM 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.
