GCE Zen-O lite RS-00600 User Manual
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GCE Zen-O lite RS-00600 User Manual

Portable oxygen concentrator
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GCE HEALTHCARE
Portable Oxygen Concentrator
Models: RS-00600 & RS-00600C
User Manual

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Summary of Contents for GCE Zen-O lite RS-00600

  • Page 1 GCE HEALTHCARE Portable Oxygen Concentrator Models: RS-00600 & RS-00600C User Manual...
  • Page 3 English ........... . . 2 Deutsch .

  • Page 4: Table Of Contents

    English User manual: Zen-O lite™ Portable Oxygen Concentrator (Models: RS-00600/RS-0600C) CONTENT 1. Foreword ..............4 1.1.
  • Page 5 8. Traveling with the Zen-O lite™ POC by Air ........17 8.1.

  • Page 6: Foreword

    1. FOREWORD Please refer to this manual for detailed instructions on warnings, cautions, specifi ca- tions, and additional information. Important: Users should read this entire manual before operating the Zen-O lite™ Port- able 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 opera- tion of this system, contact your distributor.

  • Page 7: 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 classifi ed as: • Class II • Class IIa according to the MDD 93/42/EEC •...

  • Page 8: 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 fi re associated with oxygen equipment and therapy. Do not use near sparks or open fl...
  • Page 9 14. Do not use a device or any accessory that shows any sign of damage. 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 aff...

  • Page 10: Cautions Overview

    3.2. Cautions Overview Keep away from heat sources (fi replaces, 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 diffi cult to read under bright lighting conditions (sunlight, interior lights, etc.), move away from direct light for viewing the display.
  • Page 11 16. Always follow the cannula manufacturer’s instructions for proper use. 17. Replace the cannula on a regular basis. Check with your home oxygen provider or clinician to determine how often the cannula should be replaced. 18. Check that this device operates on battery after disconnecting from the power source. 19.

  • Page 12: 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 e ectively. Inhaling through the mouth may result in less e ective oxygen therapy.

  • Page 13: Product Description

    5. PRODUCT DESCRIPTION 5.1. Schematic Description Breath detect LED Alarm mute indicator Red LED - warning Display screen Green LED - power ON Yellow LED - warning Pulse setting Power button selection but tons Battery indicator Alarm mute button Air intake Battery Exhaust vent...

  • Page 14: General Instructions Before Use

    6. GENERAL INSTRUCTIONS BEFORE A variety of accessories can enhance the portabil- ity and use of the Zen-O  lite™ 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 15 • Rechargeable battery (RS-00601) • European power cord (RS-00504) • AC power supply – European cord • United Kingdom cord (RS- 00506) (RS-00602) • North America cord (RS-00503) • AC power supply – United Kingdom • External battery charger cord (RS-00603) - European (RS-00516) •...
  • Page 16 IMPORTANT: Battery run time may vary based on breathing rate, age of battery, and environmental conditions. See displayed text on device for battery charge status. IMPORTANT: Ensure power status icon (see Fig. 7) indicates power is connected. If not, check that cord is plugged in completely (see Chapter 10 - Trouble shooting for more information) To maximise battery life and run time, avoid letting the battery deplete and use while connected to a power source whenever possible.

  • Page 17: Nasal Cannula

    6.3. Nasal Cannula Only use a nasal cannula with the following specifi cations: • Length: 1.2m (4ft), 2.1m(7ft) or 7.6m(25ft) • High fl ow • Crush resistant • Large internal diameter bore • Suitable for up to 15 litres per minute (lpm) at a max. pressure of 3.6 psi •...

  • Page 18: Turning On

    IMPORTANT: Improper cannula placement may result in the device being unable to detect all respiratory e orts of the patient. Ensure cannula is connected securely and it has been fully inserted. Cannula 7.2. Turning On port • To turn the device on, press the power button •...

  • 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. 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 Fig.

  • Page 20: Responding To Alarms

    7.7. Responding to Alarms CAUTION: If you are unable to hear or see alarms, do not have normal tactile sensitivity, or cannot communicate discomfort, consult your clinician before using this device. Pressing the alarm mute button at any time will silence the buzzer. The length of the mute period depends on the severity of the alarm (see Chapter 9 - Alarm Indicators).
  • Page 21 Healthcare Provider Consultation 8.1.2. The FAA does not require a passenger to consult with a healthcare provider prior to us- ing a Zen-O lite™ POC on board an aircraft. However, you, together with your healthcare provider, may wish to discuss the following: •...

  • Page 22: Boarding And In-Fl Ight Information

    8.1.4. Documentation You are responsible for the operation of the Zen-O lite™ POC on board the aircraft. For this reason, the FAA recommends that passengers carry with them, at minimum, this User Manual and any other written information provided by your healthcare professional regarding the Zen-O lite™...
  • Page 23 8.2.2. Zen-O lite™ POC as Checked Baggage Your Zen-O lite™ POC may be carried on aircraft as a carry-on or as checked baggage. However, spare lithium batteries are prohibited from being carried in checked baggage on an aircraft. 8.2.3. Considerations Regarding Placement and Stowage of your Zen-O lite™ POC In order for a Zen-O lite™...

  • Page 24: Transportation Security Administration (Tsa) Requirements

    2. During movement on the surface, take-off , and landing, the nasal cannula tubing that is used to dispense oxygen from your properly stowed Zen-O  lite™ POC may not stretch across the row in such a way as to restrict passenger access or become a tripping hazard in an evacuation.

  • Page 25: Placing Your Device In Airplane Mode

    If you have the RS-00600C 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

    9. ALARM INDICATORS If the Zen-O lite™ Portable Oxygen Concentrator detects an alarm condition, it will indi- cate 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 diff...

  • Page 27: Alarms

    button o to display the last highest priority alarm. Press the mute button on again to reset the eight-hour timer. 9.1. Alarms When the concentrator sounds an alarm, a corresponding message will be displayed on the screen. Take appropriate action as directed in the charts below. 9.1.1.
  • Page 28 9.1.3. Medium Priority Alarms Alarm message Description Action No breath detected for 60 Check the cannula connection. seconds Be sure to breathe through nose, If alarm persists, contact your distributor. IMPORTANT: The message will be automatically cleared when breathing is detected. Service required.

  • Page 29: Troubleshooting

    Displayed percentage of battery Message is displayed when bat- charge if at least 10% and there is tery button is pressed. no external power connected. NN% displays the current battery Message is displayed when bat- charge level. tery button is pressed. Displayed when battery charge is greater than 10% but less than 100% and there is external power...

  • Page 30: Maintenance And Cleaning

    Any alarm sound or • See Chapter 9 - See Chapter 9 - Alarm Indicators. either Alarm Indicators. LED lit Battery not charging • Power is not • Check connections to ensure: connected. • Round receptacles are secure in unit. •...

  • Page 31: Service Life

    CAUTION: Do not use cleaning agents other than those specifi ed in this manual. Allow the cleaning solution to dry from the cleaned surface before use. CAUTION: Always disconnect power and turn off this device before cleaning. Clean the exterior with a soft cloth slightly dampened with soapy water or with anti-bac- terial wipes (Isopropyl alcohol 70% solution).
  • Page 32 3. Remove the battery from the device. 4. Press the four release buttons located at the top of the de- vice to remove the top cover of the device as shown in Fig. 5. Use the tool included with the replacement sieve modules Use the tool included with the replacement sieve modules package to rotate the sieve counter clockwise 3 - 4 turns until it can be removed by pulling up towards the top of the...

  • Page 33: 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, this excludes the sieve modules which have only one year warranty. All accessories including batteries are limited to one (1) year warranty.

  • Page 34: Technical Description

    15. TECHNICAL DESCRIPTION Size: 249 mm (W), 97 mm (D), 235 mm (H) 9.8" (W), 3.8" (D), 9.25" (H) Unit weight: 2.5 kg (5.5 lbs) (without carry bag) Power requirements: AC adaptor: 100-240V AC (+/- 10%), 50-60 Hz in, 24V DC, 5.0A out.
  • Page 35 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) Degree of safety Not suitable for use in the presence of a fl ammable anaes- (fl...

  • Page 36: Electromagnetic Compatibility (Emc) Information

    Eco Mode bolus size (ml/breath) versus setting and breath rate Setting Breath per minute 26.4 10.5 19.8 31.5 52.5 15.8 25.2 33.6 13.2 11.3 5.25 15.75 26.25 All values +/- 15% over all operating conditions 15.1. Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special cautions regarding electromagnetic com- patibility (EMC).
  • Page 37 15.1.2. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity Zen-O lite™ is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the concentrator should assure that it is used in such an environ- ment. Immunity test IEC 60601 test Compliance Electromagnetic environment/...
  • Page 38 Power 30 A/m 30 A/m Power frequency magnetic fi elds frequency should be at levels characteristic (50/60 Hz) of a typical commercial or hospital magnetic fi eld environment. IEC 61000-4-8 Immunity test IEC 60601 test Compliance Electromagnetic environment/ level level guidance Conducted RF 3 Vrms 150 kHz...

  • Page 39: Fcc Warning Statement For Model Rs-00600C

    15.1.3. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Zen-O lite™ Portable Oxygen Concentrator The Zen-O lite™ Portable Oxygen Concentrator is intended for use in an electromagnetic environment 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-00600C

    • Changes or modifi cations not expressly approved by the party responsible for compli- ance could void the user's authority to operate the equipment. 15.3. EU RED ARTICLE 10(10) RESTRICTIONS ON USE FOR MODEL RS-00600C: Based on the information available from the European Communication Offi ce (ECO) Fre- quency Information System (EFIS), Zen-O lite™...

  • Page 41: Glossary Explanation Of Packaging And Labelling Symbols

    The SAR limit is 1.6 watts for kilogram in countries that set the limit averaged over 1 gram of tissue and 2.0 watts per kilogram in countries that set the limit averaged over 10 grams of tissue. The highest SAR values measured in accordance with ICNIRP guidelines for this device with an 8mm separation as provided by the carry bag are: Body SAR at 1g: 1.50 W/Kg Body SAR at 10g: 1.81 W/Kg...
  • Page 42 Dispose of used battery No smoking properly Smoking Separate collection for electrical and electronic Class II symbol equipment Complies with applicable EU Directives including Medical Suitable for homecare use Device Directive 40/316...
  • Page 43 GCE Ltd Manufactured for: GCE Ltd 100 Empress Park, Penny Lane, Haydock, Jesus Siqueiros #652, 83170 St Helens WA11 9DB Hermosillo, Mexico 0088 United Kingdom 41/316...

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