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GCE Zen-O RS-00500 User Manual
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GCE Zen-O RS-00500 User Manual

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GCE HEALTHCARE
Portable Oxygen Concentrator
Models: RS-00500 & RS-00500C
User Manual

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Summary of Contents for GCE Zen-O RS-00500

  • Page 1 GCE HEALTHCARE Portable Oxygen Concentrator Models: RS-00500 & RS-00500C User Manual...
  • Page 2 English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2...

  • Page 3: Table Of Contents

    English User manual: Zen-O™ Portable Oxygen Concentrator (Models: RS-00500 & RS-00500C) CONTENT 1 . Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1 .
  • Page 4 7 . 7 . Responding to Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 7 .8 .

  • Page 5: Foreword

    1 . FOREWORD Please refer to this manual for detailed instructions on warnings, cautions, specifica- tions, and additional information. Important: Users should read this entire manual before operating the Zen-O™ 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 your distributor.

  • Page 6: Typographical Conventions

    • ISO 7637-2:2011 Road Vehicles - Electrical disturbances from conduction and coupling- Part 2: Electrical transient conduction along supply lines only. • Medical Device Directive 93/42/EEC. This equipment is classified as: • Class II • Class IIa according to the MDD 93/42/EEC •...

  • Page 7: Safety Instructions

    3 . SAFETY INSTRUCTIONS WARNINGS OVERVIEW 3 . 1 . 1 . The device must be used in the carry bag to provide protection from liquid intrusion from rain and/or spills. 2 . There is a risk of fire associated with oxygen equipment and therapy. Do not use near sparks or open flames.
  • Page 8 16 . Use of this device at an altitude above 4,000 m (13,000 feet), or outside the tem- perature range of 5°C (41°F) to 40°C (104°F), or outside the humidity range of 5% to 93% may adversely affect the flowrate and percentage of oxygen and consequently the quality of therapy.

  • Page 9: Cautions Overview

    3 .2 . CAUTIONS OVERVIEW Keep away from heat sources (fireplaces, radiant heaters, etc.) that could cause the operating temperature at or near the device to exceed 40°C (104°F). 2 . The display may be difficult to read under bright lighting conditions (sunlight, interior lights, etc.), move away from direct light for viewing the display.
  • Page 10 17 . Always follow cannula manufacturer’s instructions for proper use. 18 . Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. 19 . Check that this device operates on battery after disconnecting from the power source. 20 .

  • Page 11: Important Information

    3 .3 . IMPORTANT INFORMATION If an extension cord is necessary, use a UL listed 15 amp or higher cord. Do not con- nect any other devices on the same extension cord. Do not use a multisocketed extension cord. 2. Inhale through the nose for the concentrator to work most effectively. Inhaling through the mouth may result in less effective oxygen therapy.

  • Page 12: Product Description

    5 . PRODUCT DESCRIPTION 5 . 1 . SCHEMATIC DESCRIPTION Alarm mute indicator Nasal cannula port Red LED - warning Display screen Green LED - power on Yellow LED - warning Power key Pulse / Flow setting selection keys Battery indicator Alarm mute key Mode key...

  • Page 13: General Instructions Before Use

    6 . GENERAL INSTRUCTIONS BEFORE USE A variety of accessories can enhance the port- ability and use of the Zen-O™ Portable Oxygen Concentrator. In addition to the device, the pack- age contains accessories to get started and a user manual. Contact your home oxygen provider for a complete list of available accessories.

  • Page 14: Battery

    • United Kingdom cord (RS- 00506) • North America cord (RS-00503) • External battery charger - European (RS-00516) • External battery charger - North America (RS-00515) • External battery charger - United Kingdom (RS-00517) • RS-00534 – Humidifier kit Note: Contact your provider or retailer if your specific power supply connection is not listed.

  • Page 15: Nasal Cannula

    IMPORTANT: Ensure power status icon (see Fig. 7) indicates power is connected. If not, check that cord is plugged in completely. (See Chapter 10 - Troubleshooting for more information.) IMPORTANT: While the concentrator is powered from the DC power supply and operating in continuous mode at setting 2, the battery will not charge.

  • Page 16: Pull Cart

    A 15.2m (50ft) cannula must only be used when device is operating at a continuous mode set- ting. CAUTION: 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, including flow rate or oxygen purity.

  • Page 17: Operating Zen-O

    • Connect the oxygen adapter hose (max 50 cm) to the angle adapter and fit the other end to the oxygen outlet on the concentrator. Make sure all connections are secure. • Connect the nasal cannula to the humidifier bottle outlet and ensure oxygen is flowing through the cannula.

  • Page 18: Turning On

    7 .2 . TURNING ON • To turn the device on, press the power button • The concentrator will chirp and the green, yellow, and red LEDs will flash once, while the screen displays the device name. Red LED - indicates a warning danger and/or a need for urgent action Yellow LED - indicates caution or attention required Green LED - indicates device is on.

  • Page 19: Eco Mode

    IMPORTANT: If an air leak is suspected, leaks can be detected with a solution of soap and water applied to the cannula-concentrator connection point and looking for bub- bles. IMPORTANT: Flow can be verified by putting the oxygen concentrator in continuous mode and placing the end of the nasal cannula under the surface of a half full cup of water and looking for bubbles.

  • Page 20: Responding To Alarms

    • First, the gauge information for both batteries (or one battery if only one is installed), will be shown • Next, the gauge for just the battery in the first slot , then the number of charge cycles on the battery in the first slot •...

  • Page 21: Traveling With The Zen-O™ Poc By Air

    8 . TRAVELING WITH THE ZEN-O™ POC BY AIR 8 . 1 . PASSENGER PRE-FLIGHT PREPARATION 8 . 1 . 1 . Required Labeling Your Zen-O™ POC is suitable for aircraft use and has met all acceptance criteria of the United States Federal Aviation Administration (FAA).
  • Page 22 IMPORTANT: You may be flying on multiple flights or multiple airlines, which could also involve extended periods of Zen-O™ POC use on the ground between flights. • Zen-O™ owner’s manual information regarding expected duration of battery power. IMPORTANT: You should never rely upon available onboard aircraft electrical power dur- ing a flight.

  • Page 23: Boarding And In-Flight Information

    8 .2 . BOARDING AND IN-FLIGHT INFORMATION 8 .2 . 1 . Carry-on baggage Your Zen-O™ POC is an assistive device. In this case, carriers shall not, in implementing their carry-on baggage policy, count the Zen-O™ POC toward a limit on carry-on items brought into the cabin by a qualified individual with a disability.
  • Page 24 Stowage during Aircraft Movement - During movement on the surface (pushback from the gate and taxi), take-off, and landing, the Zen-O™ POC must be stowed properly and in such a manner that it does not restrict passenger access to any exit or the aisle in the passenger compartment.

  • Page 25: Transportation Security Administration (Tsa) Requirements

    If you have the RS-00500C model (this is stated on the back of your device), this means your device is connected to GCE's Clarity platform. Clarity provides regular updates on your device's performance to your home oxygen provider, enabling them better support you and your device.

  • Page 26: Alarm Indicators

    4. To disable the Airplane Mode: Press and hold both Mute Minus buttons for 4 seconds. IMPORTANT: Activating or de-activating the Airplane mode does not affect the normal operating performance of your device, continue to use your device as normal. 9 .

  • Page 27: Alarms

    IMPORTANT: If the mute button is pressed prior to an alarm condition (for example, to mute the device in a movie theatre), critical high priority and high priority alarms will override the mute function; medium and low priority alarms will be muted for eight hours and twenty four hours respectively from the time the button was pressed.
  • Page 28 Service required. Contact your distributor. *Value: 21-50 9 . 1 .3 . Medium Priority Alarms ALARM DESCRIPTION ACTION MESSAGE No breath detected for 60 seconds Check the cannula connection. Be sure to breathe through nose, If alarm persists, contact your distributor.
  • Page 29 9 . 1 .5 . Other Messages MESSAGE DESCRIPTION ACTION External power has been dis- No action is required. connected; unit is now running on battery. Displayed while unit goes through No action is required. its power-down sequence. Displayed as the battery menu item Verify that the battery pack is cor- when there are no communications rectly installed.

  • Page 30: Troubleshooting

    10 . TROUBLESHOOTING PROBLEM POSSIBLE CAUSE TROUBLESHOOTING System becomes • System may be dis- • Check that the system is connected inoperative connected from the securely to the power source. power source. • Ensure the system is powered on. • System may be •...

  • Page 31: Maintenance And Cleaning

    11 . MAINTENANCE AND CLEANING 11 . 1 . ROUTINE MAINTENANCE WARNING: Do not use lubricants on this device or any of its accessories. CAUTION: Replace the cannula on a regular basis. Check with your distributor or clini- cian to determine how often the cannula should be replaced. Device will indicate with an alarm when service is required.

  • Page 32: Device Repair And Disposal

    • Dispose of battery according to local regulations or contact your distributor. 13 . WARRANTY The device warranty is limited to three (3) years from date of sale to GCE´s customer or 15,000 hours of total use. All accessories including the batteries are limited to one (1) year warranty.

  • Page 33: Technical Description

    15 . TECHNICAL DESCRIPTION Size: 212 mm (W), 168 mm (D), 313 mm (H) 8.3" (W), 6.6" (D), 12.3" (H) Unit weight: 4.66 kg (10.25 lbs) (without carry bag and cart) Power requirements: AC adaptor: 100-240V AC (+/- 10%), 50-60 Hz in, 24V DC, 6.25A out.
  • Page 34 Degree of protection IP22 in carry bag (protection against small objects and tilted (water): dripping water) IP20 out of carry bag (protection against small objects and no protection against water entering the concentrator) Technical Description Degree of safety Not suitable for use in the presence of a flammable anaesthetic (flammable anaesthetic mixture): mixture...
  • Page 35 Pulse mode bolus size (ml/breath) versus setting and breath rate SETTING BREATH PER MINUTE All values +/- 15% over all operating conditions Eco Mode bolus size (ml/breath) versus setting and breath rate SETTING BREATH PER MINUTE 10.5 19.8 31.5 52.5 59.4 15.8 25.2...

  • Page 36: Electromagnetic Compatibility (Emc) Information

    15 . 1 . ELECTROMAGNETIC COMPATIBILITY (EMC) INFORMATION Medical electrical equipment requires special cautions regarding electromagnetic com- patibility (EMC). Portable and mobile radio frequency (RF) communications equipment can affect devices such as the Zen-O™ Portable Oxygen Concentrator. As such, the de- vice should not be used adjacent to other equipment.
  • Page 37 15 . 1 .2 . Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Zen-O™ is intended for use in the electromagnetic environment specified below. The customer or the user of the concentrator should ensure that it is used in such an environ- ment.
  • Page 38 IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC TEST LEVEL LEVEL ENVIRONMENT/GUIDANCE Conducted RF 3 Vrms 150 kHz 3 Vrms Portable and mobile RF communi- IEC 61000-4-6 to 80 Mhz cations equipment should be used no closer to any part of the device, Radiated RF 3 V/m 80 Mhz 3 V/m...

  • Page 39: Fcc Warning Statement For Model Rs-00500C

    15 . 1 .3 . Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Zen-O™ Portable Oxygen Concentrator The Zen-O™ Portable Oxygen Concentrator is intended for use in an electromagnetic en- vironment in which radiated RF disturbances are controlled. The concentrator user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the concentrator as recommended below, according to the maximum output power of the communica-...

  • Page 40: Eu Red Article 10(10) Restrictions On Use For Model Rs-00500C

    15 .3 . EU RED ARTICLE 10(10) RESTRICTIONS ON USE FOR MODEL RS-00500C: Based on the information available from the European Communication Office (ECO) Fre- quency Information System (EFIS), Zen-O™ (model RS-00500C) complies with stipulated radio frequency radiation limits. The table below demonstrates compliance to Article 10 (10) of the European Union Radio Equipment Directive (RED) and confirms that there are no restrictions with regards to its use by patients in member states of the European Union;...

  • Page 41: Glossary - Explanation Of Packaging And Labelling Symbols

    16 . GLOSSARY - EXPLANATION OF PACKAGING AND LABELLING SYMBOLS Operating atmospheric pres- See Instructions Before Use sure limitation 0´ to 13,000´ (0 Kpa to 50.2 Kpa) Storage temperature limit- Type BF according to electri- ation -20°C to 60°C (-4°F to cal safety requirements 140°F) Humidity limitation 5% to 93%...
  • Page 42 E-mail: support@baro2.com Phone: 0345 100 0084 Bar O2 Limited T/A the OxygenStore, Unit 5A Mount Industrial Estate, Mount Road, Stone, Staffordshire, ST15 8LL Company Registered in UK No 04192727 VAT Registration No 770 4717 24 EORI GB770471724000 Dun and Bradstreet D-U-N-s No 232439047...

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