O-Two e500 User Manual

O-Two e500 User Manual

Automatic transport ventilator
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USER MANUAL
o_two e500
AUTOMATIC TRANSPORT VENTILATOR
01EVE500
e500 User Manual (15PL1011 - Rev.8 Feb. 2021)

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Summary of Contents for O-Two e500

  • Page 1 USER MANUAL o_two e500 AUTOMATIC TRANSPORT VENTILATOR 01EVE500 e500 User Manual (15PL1011 - Rev.8 Feb. 2021)
  • Page 2: Table Of Contents

    4.1.2. Installing / replacing the battery 4.1.3. Connecting the gas supply 4.1.4. Connecting patient circuit 4.1.5. Turning Ventilator ON 4.2. Pre-use check 5. Operate Instructions 5.1. Startup & setting the ventilation parameters 5.2. Ventilation modes 5.2.1. SIMV (Synchronized Intermittent Mandatory Ventilation) e500 User Manual...
  • Page 3 9.2. Circuit Description 9.3. Battery and Power Supply 9.4. Battery Operating time 9.5. Electromagnetic Compatibility 9.6. Oxygen consumption 9.7. Oxygen Concentration delivered against different back pressures 10. Trouble Shooting 11. Abbreviations and Acronyms 12. Accessories 13. Warranty e500 User Manual...
  • Page 4: Safety

    • Only use O-Two specified hoses, patient circuits, batteries and external power supplies to avoid affecting the output performance of the ventilator. Antistatic or conductive hoses or tubing are not used in the Ventilator Breathing System.
  • Page 5 • Operation of this ventilator outside the electrical power range detailed in this manual may result in reduction or failure in the ventilator’s performance. Component failure, inadequate power of internal components may occur. e500 User Manual...
  • Page 6 . • Spare O-Two patient circuits are recommended at all times. • The design of this Ventilator does not incorporate a negative pressure phase during either automatic or manual ventilation.
  • Page 7: Intended Use

    2. Intended Use The e500 is a time-cycled and volume-constant emergency and transport ventilator designed for use in the pre-hospital, intra- hospital, inter-hospital and transport settings. It is intended for use...
  • Page 8: Overview

    Warning indicator Pause/Resume key Battery operation indicator Lock key External power indicator Waveform selection key Battery charging indicator Cancel key Manual/Inspiratory Hold key Confirmation indicator light Screen brightness key Control Selection Knob Alarm Silence key ON/OFF key e500 User Manual...
  • Page 9: Function Keys

    Diagram below illustrates path of cursor when Control Selection Knob is rotated clockwise. Control Selection Knob rotation contour Direction for clockwise knob rotation shown e500 User Manual...
  • Page 10: Lock

    Repetitive use of alarm silence without identification of cause of alarm may pose potential harm to the patient. 3.2.5. Waveform Pressing the Waveform selection key (J) (Figure 01) will switch between the pressure and volume ventilation waveforms. e500 User Manual...
  • Page 11: Screen Brightness

    2. The symbol will flash for 10 seconds and then disappear if the Control Selection Knob (M) (Figure 01) is not selected. Users can also press the Cancel key (K) (Figure 01) to quit this selection before the 10 seconds. e500 User Manual...
  • Page 12: Manual/Inspiratory Hold

    The maximum inspiratory hold time is 6 seconds. After that time, the ventilator will switch to exhalation phase by opening airway pressure to ambient. Note: Manual/ Inspiratory Hold function exists only in SIMV mode. e500 User Manual...
  • Page 13: External Connectors

    3.3. External Connectors DC Input connector Air Intake filter Sensor connector #1 Sensor connector #2 22mm gas output connector Gas supply input Battery door Relieve Flapper Air/O Exhaust Port Figure 02 e500 User Manual...
  • Page 14: Patient Circuit

    Note: To avoid entanglement of the patient circuit tubing and pressure sensing hoses during movement of the patient, the pressure sensing hoses and the 22mm corrugated hose are contained within in a close fitting, non-woven fabric sheath. e500 User Manual...
  • Page 15: Display

    Confirmation request/ Patient effort/ Invalid or Section 7: Conflict setting Figure 04 Note: By changing the ventilation mode, section 6 of the display will change accordingly to reflect the default or set up parameters for each mode. e500 User Manual...
  • Page 16 The followings are screen layouts for each ventilation mode: SIMV screen layout CPAP screen layout e500 User Manual...
  • Page 17 Masked CPR screen layout Masked CPR screen layout e500 User Manual...
  • Page 18: Live Monitoring Parameters

    SIMV, CPR modes as well as spontaneous inspiratory phase of CPAP mode. This number will be updated at the end of each inspiratory phase. Note: Mve, Rate and Paw are not active during CPR mode and displayed with “--“ e500 User Manual...
  • Page 19: Symbols & Notations

    No smoking around ventilator. Ingress protection rating: Splash-proof. Do not immerse. Class II equipment. Protection against electric doesn’t rely on Basic Insulation only, additional safety precautions such as Double or Reinforced insulation are provided. Type BF applied part e500 User Manual...
  • Page 20: Preparation For Use

    4. Preparation for Use 4.1. Setup 4.1.1. Connecting the electrical power supply The e500 is designed to operate using one of the following power options: • Internal rechargeable battery pack • AC/DC external power supply. CAUTION • A fully charged battery must always be installed for safety...
  • Page 21: Connecting The Gas Supply

    3. Turn cylinder valve slowly and fully. WARNING Extra care must be taken when handling oxygen: • The e500 must only be used with medical oxygen. • Only use approved medical oxygen compressed gas cylinders. • Always begin use with a full oxygen cylinder.
  • Page 22: Connecting Patient Circuit

    4.1.4. Connecting the Patient Circuit Attach the O-Two patient circuit (Figure 03) to the 22mm gas output connector (S) (Figure 02). 2. Connect the sensing hoses (V) (Figure 03) of the patient circuit to their corresponding connectors (Q) & (R) (Figure 02).
  • Page 23 Visually inspect the ventilator for mechanical damage 2. Ensure that battery is fully charged. 3. Ensure the e500 is connected to a gas supply (Cylinder or piping system) capable of delivering flow of 120 L/min and maintaining a minimum pressure of 45 PSI (3 Bar) and a maximum 87 PSI (6 Bar) output pressure.
  • Page 24 1. To confirm correction of the leak. Note: If a leak is still present and no external leak was detected using the above processes, the unit must be returned to the manufacturer or its authorised service center for service or repair. e500 User Manual...
  • Page 25 13. Turn off the oxygen cylinder and check for low pressure and no pressure audible and visual alarms. 14. Turn off the Ventilator by pressing ON/OFF key for 4 seconds. e500 User Manual...
  • Page 26: Operate Instructions

    (Figure 06) will be displayed on the screen. This eliminates the need for a potentially long set up before starting ventilation. Note: Start-up selection dial is used during start up only and are not active during ventilation. e500 User Manual...
  • Page 27 O-Two e500 v1.9.15 Figure 06 - Start-up Selection Dial Healthcare providers navigate among these 12 combination set- tings by rotating the Control Selection Knob (M). The parameter setting will be highlighted if it is selected. Once the desired set- ting is selected, the user must confirm the selection by pressing the Control Selection Knob (M) to start ventilation.
  • Page 28 TABLE 1 SIMV mode default settings SIMV SETTINGS Default Rate (BPM) Selected or 10 Vt (ml) Selected or 500 PEEP (cm H P max (cm H P min (cm H 100% F trig. (L/min) e500 User Manual...
  • Page 29 Figure 07 - SIMV mode screen w/ default parameters (Child setting) Figure 08 - Showing frame around parameter during selection Figure 09 - Showing selected parameter with solid contrasting background e500 User Manual...
  • Page 30: Ventilation Modes

    5.2. Ventilation Modes The e500 ventilator is equipped with a number of ventilation modes to enable the healthcare provider to tailor the ventila- tor settings to the patient’s specific respiratory requirements. Ventilation could be delivered invasively (ET tube) or non-inva- sively (mask).
  • Page 31: Simv (Synchronized Intermittent Mandatory Ventilation)

    100% P max. 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 80 P min. 0, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20 Manual Refer to Manual and I-Hold section ready e500 User Manual...
  • Page 32 Figure 10 - SIMV waveform e500 User Manual...
  • Page 33: Cpap (Continuous Positive Airway Pressure)

    Carry over from (100% or 60%) previous mode T APNEA (sec) 10, 15, 20, 25, 30, 40, 45, 50, 55, 60 100/20,150/20, 200/20, 250/20, 300/10, Vt/f (A) Carry over from 350/10,400/10, 450/10, 500/10, 600/10, (ml/BPM) previous mode 650/10 e500 User Manual...
  • Page 34 Figure 11 - SIMV waveform with pressure support e500 User Manual...
  • Page 35: Cpr Mode

    10, 15, 20, 25, 30, 35, 40, 45, 50, Carry over from P max. 55, 60, 80 previous mode Carry over from P min. 0, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 20 previous mode 100% 100% e500 User Manual...
  • Page 36 CPR FOR MASKED PATIENTS On screen chest compressing animation On screen ventilation animation Figure 12.a - CPR waveform for masked patient e500 User Manual...
  • Page 37: Turning Ventilator Off

    CPR FOR MASKED PATIENTS On screen intubated CPR animation Figure 12.b - CPR waveform for intubated patient 5.3. Turning the Ventilator Off Press and hold the ON/OFF key for 4 seconds, the Ventilator will turn OFF. e500 User Manual...
  • Page 38: Post Use

    During “alarm silence”, should a new alarm develop, the Alarm Silence function will continue and only the new visual alarm will be shown flashing on the screen. Alarms will be visible in section 4 or section 7 of the display (Figure 04). e500 User Manual...
  • Page 39 In this case the visible and audible alarms will be based on highest priority alarm. All ventilation alarms of e500 are listed in the following Table-5. TABLE 5 - Ventilation Alarms and Symbols Visual Alarm...
  • Page 40 Setting conflict is when the ventilator detects a conflict in the setting like reaching the Pmax level. In this case users can make adjustments from and beyond the conflict point while the symbol will be displayed during the adjustment. e500 User Manual...
  • Page 41: Battery Status Indicator

    Red color warning LED. TABLE 6.2 - Battery charging status Full Capacity No Alarm 95% of full capacity No Alarm 90% of full capacity No Alarm 80% of full capacity No Alarm 65% of full capacity No Alarm e500 User Manual...
  • Page 42: Leds

    ON and OFF phases. During OFF phase this light will start flashing when battery capacity drops to around 90 %. Green color LED - Continuous when unit is operated using internal battery. e500 User Manual...
  • Page 43: Cleaning, Preventive Maintenance & Servicing

    Make sure no liquids enter the ventilator connections or the ventilator. WARNING Do not immerse the e500 Ventilator or patient circuit or supply hoses in disinfectant or other liquids, serious electric shock hazard and damage to the ventilator may occur. If the Ventilator is accidently submerged in any liquid it must be returned to the manufacturer for factory service.
  • Page 44: Ambient Air Entrainment Filter

    5 hours on a single charge. 8.3. Ambient Air Entrainment Filter The e500 entrains ambient air through the internal Venturi system for ventilation when the O concentration is set at 60%. This provides not only decreased oxygen concentration but also increases the ventilator operating time on an oxygen cylinder.
  • Page 45: Servicing

    The device shall be returned to the manufacturer or a service center authorized by the manufacturer for Level II service every 2 years. Manufacturer full service The device shall be returned to O-Two Medical Technologies for Manufacturer Full Service every 6 years. WARNING...
  • Page 46: Technical Data

    ALTITUDE COMPENSATION up to 4000 m (13000 feet) BATTERY HOT SWAP No BUILT-IN BATTERY CHARGER Yes AC/DC POWER SUPPLY 100-240 VAC/ 19 VDC, 4.74 A PATIENT CIRCUIT O-Two Electronic Ventilator Circuit MOUNTING BRACKET Smart Mount multi-configuration frame DISPLAY 4.3" Color TFT Mve, Vte, Paw(AV), PAW(Peak), Rate (bpm),...
  • Page 47 * Volume measurements corrected to BTPS (Body Temperature 37 C, barometric Pressure 101.3Kpa under Saturated 100% humidity) conditions. **Transient Operation: The e500 is capable to keep its specifications when operated in normal use for a period not less than 20 minutes under - 20 C and +50 C.
  • Page 48: Circuit Description

    Ambient Filter Ventilator When a gas source (medical oxygen) is supplied to the e500 ventilator via the gas input connection, the gas will flow into the Flow control valve which is used to control both the flow and rate of ventilation.
  • Page 49: Battery Operating Time

    O-Two e500 has been tested and complies with IEC 60601-1-2:2007 requirements. Electromagnetic Emissions O-Two e500 is intended for use in the electromagnetic environment specified below. The user of O-Two e500 should assure that it is not used in environments outside those specified: e500 User Manual...
  • Page 50 30 V/m IEC61000-4-3 80 MHz to 2.5 GHz O-Two e500 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications...
  • Page 51: Oxygen Consumption

    9.6. Oxygen Consumption For a “D” size cylinder (capacity of 425 liters), pressurized to 2015 PSI and with the e500 set to the Adult default setting (Vt= 500ml, Rate= 10BPM, 100% Oxygen) the pneumatic operating time is 85 minutes without PEEP (0.2 min/L) and is 39 minutes with maximum PEEP (0.089 min/L).
  • Page 52: Trouble Shooting

    Battery No proper charging/Faulty Charge Battery as per instructions/ discharges battery Replace battery quickly Change Battery/connect power e500 cannot be Battery empty/no power supply supply/ send to O-Two for repair or switched on connected/defective service e500 User Manual...
  • Page 53: Abbreviations And Acronyms

    Positive End Expiratory Pressure P max Maximum airway pressure P min Minimum airway pressure SIMV Synchronized Intermittent Mandatory Ventilation T APNEA Apnea Alarm time Expiratory time Thin Film Transistor Inspiration time Trig. Triggering flow rate Exhaled Tidal volume Tidal volume e500 User Manual...
  • Page 54: Accessories

    Using unspecified parts/accessories 2. An attempt to service by unqualified persons/entities 3. Negligence 4. Normal wear and tear (filters, batteries, patient circuits) Note: O-Two Warrants the battery for a period of one year from the date of purchase. e500 User Manual...
  • Page 55 O-Two Medical Technologies Inc. or if the apparatus is used in a manner not conforming to its intended use.
  • Page 56 Your Representative is: O-TWO MEDICAL TECHNOLOGIES INC. For your nearest Authorized O-Two Distributor In North America call Toll Free 1-800-387-3405 MedNet EC-REP GmbH SERIAL N Borkstrasse, 10 48163 Münster, Germany www.otwo.com 45A Armthorpe Road, Brampton, ON, Canada, L6T 5M4 Telephone: +1 905 792-OTWO (6896) N.A. Toll Free: +1 800 387 3405...

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01eve500

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