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

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Portable Oxygen Concentrator
Model: RS - 00500
User Manual

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Summary of Contents for GCE Zen-O RS-00500

  • Page 1 Portable Oxygen Concentrator Model: RS - 00500 User Manual...
  • Page 3 English ............2 Deutsch .

  • Page 4: Table Of Contents

    English User manual: Zen-O™ Portable Oxygen Concentrator (Model: RS-00500) CONTENT 1. Foreword ................4 1.1.
  • Page 5 8. Traveling with the Zen-O™ POC by Air ........... 18 8.1.

  • Page 6: Foreword

    Foreword Please refer to this manual for detailed instructions on warnings, cautions, speci cations, and ad- ditional 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 7: Typographical Conventions

    This equipment is classi ed as: • Class II • Class IIa according to the MDD 93/42/EEC • Type BF • IP22 with the carry bag 1.3. Typographical Conventions This user manual contains warnings, cautions, and notes to help call attention to the most im- portant safety and operational aspects of the device.

  • Page 8: Safety Instructions

    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 re associated with oxygen equipment and therapy. Do not use near sparks or open ames.

  • Page 9: Cautions Overview

    15. Do not use lubricants on this device or any of its accessories. 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 a ect the owrate and percentage of oxygen and consequently the quality of therapy.
  • Page 10 6. Patients with a fast breathing rate requiring a higher oxygen setting may require more oxygen than this device can produce - see Chapter 15 - Technical Description. This device may not be appropriate in that case. Consult your clinician for alternative treatment. 7.

  • Page 11: Overview Of Important Information

    tenance and Cleaning. 24. Do not obstruct air intake or exhaust vents when operating this device. Blockage can cause buildup of internal heat and shut down or damage this device. 25. Do not place objects on top of this device. 26.

  • Page 12: Product Description

    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 Battery release button Battery...

  • Page 13: General Instructions Before Use

    General Instructions Before Use A variety of accessories can enhance the portability and use of the Zen-O™ Portable Oxygen Concentrator. In addition to the device, the package contains accessories to get started and a user manual. Contact your home oxygen provider for a complete list of available accessories. Always inspect the device and its accessories for any sign of damage before use.

  • Page 14: Battery

    6.2. Battery Zen-O™ Portable Oxygen Concentrator can always be used when directly connected to a power source. However, to enhance its portability, the concentrator is equipped with a rechargeable lithium-ion internal battery. Two batteries can be placed in the concen- trator battery slots or one battery can be placed in either slot.

  • Page 15: Nasal Cannula

    IMPORTANT: While the concentrator is powered from the DC power supply and operating in con- tinuous mode at setting 2, the battery will not charge. IMPORTANT: The DC power supply should be utilised on vehicles with the proper power output rating.

  • Page 16: Pull Cart

    Contact your distributor for updated information and accessories or if additional, optional, or re- placement accessories are needed. 6.4. Pull Cart When using the device with a pull cart, attach and secure the concentrator with the straps as shown in Fig. 4. IMPORTANT: It is recommended that patients use the pull cart to transport the device whenever pos- sible.

  • Page 17: Turning On

    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 t. Once the cannula is secured, breathe normally through the nose.

  • Page 18: Adjusting Setting

    Pulse mode Zen-O™ operating Zen-O™ running on battery power. on external power. Continuous ow mode Fig. 7 7.4. Adjusting Setting IMPORTANT: After powering on Zen-O™, the startup sequence will take approximately 35 sec- onds. Speci ed oxygen level will be reached within 2 minutes of use. •...

  • Page 19: Battery Button

    7.5. Battery Button The battery button allows you to check the status of the battery or batteries. Repeatedly pushing the button will cycle through all the information. • First, the gauge information for both batteries (or one battery if only one is installed), will be shown •...

  • Page 20: Traveling With The Zen-O™ Poc By Air

    Traveling with the Zen-O™ POC by Air 8.1. Passenger Pre- ight 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). This is veri ed by the statement on the back of the POC that states, in red text, “The manufacturer of this POC has determined this device conforms to all applicable FAA acceptance criteria for POC carriage and use on board aircraft”.
  • Page 21 • Zen-O™ owner’s manual information regarding expected duration of battery power. IMPORTANT: You should never rely upon available onboard aircraft electrical power during a ight. • Air carrier requirements to carry a certain amount of batteries are typically available on each airline’s web site.

  • Page 22: Boarding And In- Ight Information

    8.2. Boarding and In- ight 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 quali ed individual with a disability. IMPORTANT: A bag with additional batteries that is required to power the Zen-O™...

  • Page 23: Transportation Security Administration (Tsa) Requirements

    safety rules. For example: 1. Some seats on an aircraft, such as bulkhead seats, may or may not have approved stow- age space to accommodate a Zen-O™ POC during movement on the surface, take-o , and landing. Therefore, the Zen-O™ POC may not be able to be stowed properly during these phases of ight if the Zen-O™...

  • Page 24: Alarm Indicators

    The following general security screening considerations apply to Zen-O™ POCs: 1. The limit of one carry-on and one personal item (e.g., purse, briefcase, or computer case) does not apply to medical supplies, equipment, mobility aids, and/or assistive devices carried by and/or used by a person with a disability. 2.

  • Page 25: 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 from the time the button was pressed.
  • Page 26 9.1.3. Medium Priority Alarms Alarm message Description Action No breath detected for 15 seconds Check the cannula connection. Be sure to breathe through nose, If alarm persists, contact your distributor. IMPORTANT: The message will be automatically cleared when breath- ing is detected. Continuous ow of oxygen is below Check that cannula is not kinked speci cations.
  • Page 27 9.1.5. Other Messages Message Description Action External power has been discon- No action is required. nected; 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 when there are no communications correctly installed.

  • Page 28: Troubleshooting

    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 29: Maintenance And Cleaning

    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 clinician to determine how often the cannula should be replaced. Device will indicate with an alarm when service is required.

  • Page 30: Device Repair And Disposal

    • Dispose of battery according to local regulations or contact your distributor. 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 31: Technical Description

    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 32 Technical Description Degree of safety Not suitable for use in the presence of a ammable anaesthetic ( ammable anaesthetic mixture): mixture Operating Continuous operation at temperatures between 5°C (41°F) and 40°C (104°F). temperature: Storage temperature: Between -20°C (-4°F) and 60°C (140°F). Alarm sound pressure 69 dB(A) level:...

  • Page 33: Electromagnetic Compatibility (Emc) Information

    15.1. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special cautions regarding electromagnetic compat- ibility (EMC). Portable and mobile radio frequency (RF) communications equipment can af- fect devices such as the Zen-O™ Portable Oxygen Concentrator. As such, the device should not be used adjacent to other equipment.
  • Page 34 15.1.2. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Zen-O™ is intended for use in the electromagnetic environment speci ed below. The cus- tomer or the user of the concentrator should ensure that it is used in such an environment. Immunity test IEC 60601 test Compliance Electromagnetic environment/...
  • Page 35 Immunity test IEC 60601 test Compliance Electromagnetic environment/ level level 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 36: Glossary - Explanation Of Packaging And Labelling Symbols

    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 envi- ronment 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 recom- mended below, according to the maximum output power of the communications equipment.
  • Page 37 Complies with applicable EU Directives including Medical Suitable for homecare use Device Directive GCE Ltd Manufactured for: GCE 100 Empress Park, Penny Lane, Haydock, 2676 Paldan Dr, Auburn Hills, St Helens WA11 9DB MI 48326 United Kingdom...

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