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e600 User Manual

   

(15PL1010 - Rev.7  28_8_2017)    English version  

e600 
SN  ____________

                                  

 
 
O-Two Medical Technologies Inc. 
45A, Armthorpe Road, Brampton,  
Ontario, Canada, L6T 5M4 
Office: +1 905 792 OTWO (6896)   
N.A. Toll Free: +1 800 387 3405 
Fax: +1 905 799 1339 
Email: [email protected] 
Web: otwo.com 
 
 

 

 

 

Marcel Houben 
Rue Vinave, 32   
4030 LIEGE  Belgique 

Summary of Contents for e Series

Page 1: ...e600 User Manual 15PL1010 Rev 7 28_8_2017 English version e600 Automatic Transport Ventilator User Manual ...

Page 2: ...e600 User Manual 15PL1010 Rev 7 28_8_2017 English version ...

Page 3: ... 5 1 Screen Layout 10 3 5 2 Live Monitoring Parameters 12 3 6 Symbols Notations 13 Chapter 4 Preparation For Use 14 4 1 Set up 14 4 1 1 Connecting electrical power supply 14 4 1 2 Installing replacing the battery 14 4 1 3 Connecting the gas supply 15 4 1 4 Connecting patient circuit 16 4 1 5 Turning Ventilator ON 16 4 2 Pre use check 16 Chapter 5 Operating Instructions 19 5 1 Startup setting the v...

Page 4: ...aning Disinfection 37 8 2 Charging the Battery 37 8 3 Ambient Air entrainment Filter 38 8 4 Servicing 38 Chapter 9 Technical Data 40 9 1 Specifications 40 9 2 Circuit Description 42 9 3 Battery and Power Supply 43 9 4 Battery Operating time 44 9 5 Electromagnetic Compatibility 44 9 6 Oxygen consumption 46 9 7 Oxygen Concentration delivered against different back pressures 46 Chapter 10 Trouble Sho...

Page 5: ...confined space will elevate oxygen levels The ventilation setting will be interrupted during battery replacement while the device is in operational mode and the external power supply is not connected Only use O Two specified hoses patient circuits and external power supplies to avoid affecting the output performance of the ventilator Antistatic or conductive hoses or tubing are not used in the Ven...

Page 6: ... range specified in this manual may result in reduction and or failure in the ventilator s performance In extreme temperature conditions the effect is not noticeable in terms of delivered ventilations but may cause excessive wear in ventilator or components over time Extreme low temperature reduces operation time of the battery Refer to 9 4 battery operating Time Operation of this ventilator outsi...

Page 7: ...tor must only be serviced by the manufacturer or its authorized service centers Device single use patient circuits and battery packs should be safely discarded in accordance with local state and institutional laws and procedures 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 ve...

Page 8: ... emergency and transport ventilator designed for use in the pre hospital intra hospital inter hospital and transport settings It is intended for use with adult child infant patients with a tidal volume from 50 ml upwards who are in respiratory and or cardiac arrest or respiratory distress and who require the ventilatory support ...

Page 9: ... Resume button B Battery operation indicator I Lock button C External power indicator J Waveform selection button D Battery charging indicator K Cancel button E Manual Hold button L Confirmation indicator light F Screen brightness button M Control Selection Knob G Alarm Silence button N ON OFF button M L H I J K G F E D C B A N Figure 1 ...

Page 10: ...y After 4 seconds the ventilator will turn off and all ventilation will stop If the button is pressed and held for less than 4 seconds the ventilator will stay ON Warning At approximately 2 of full battery capacity the ventilator will not start when in the off position or will shut down when operating 3 2 2 Control Selection Knob The Control Selection Knob M in Figure 1 is used to navigate between...

Page 11: ...orms displayed on the screen 3 2 6 Screen brightness Pressing this button will switch between 4 different screens as follows 1 Light background with dark color text and waveform at 100 light intensity 2 Light background with dark color text and waveform at 35 light intensity 3 Dark background with light color text and waveform at 100 light intensity 4 Dark background with light color text and wave...

Page 12: ...n settings but no ventilation will occur unless Pause function is disabled 4 To cancel Pause function press Pause Resume button H again The Resume symbol will flash on the screen with the confirmation symbol and the Confirmation indicator L to guide users to resume ventilation by pressing the Control Selection Knob M 5 When ventilation is resumed the ventilator will recommence ventilation with cur...

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Page 15: ...11 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version SIMV screen layout CPAP screen layout CPR screen layout ...

Page 16: ...ic will be followed Rate BPM Rate BPM is the rate at which breaths are delivered in one minute It is the monitored breath rate calculated by measuring the time interval Tb in seconds between 2 breaths Rate BPM 60 Tb The number is updated after each breath This number will be displayed for both mandatory and spontaneous breathing phases Vte ml Tidal volume is the volume exhaled from the patient in ...

Page 17: ...Note Offers useful tips to assist in the proper use of the equipment Confirmation Symbol Invalid Setting Symbol Conflict Setting Symbol Keep away from opened flames No smoking around ventilator IPX4 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 ins...

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Page 19: ...cylinder o Secure oxygen cylinders so they do not fall over o Keep away from excessive heat to avoid the risk of explosion o Do not grease or lubricate oxygen fittings cylinder valves and pressure reducers and do not handle with greasy hands to avoid the risk of fire o Only open or close cylinder valves by hand or with the correct cylinder wrench Open the valve slowly and fully Do not use any othe...

Page 20: ... turn on but with no ventilation at this point If the button is pressed and released for less than a second the ventilator will remain OFF Note Do not connect the patient circuit to a patient or the test lung before turning on the ventilator A C V with volume control VCV is the default start up ventilation mode for e600 4 2 Pre use Check The following check must be performed and confirmed by the H...

Page 21: ...ylinder pressure is above 650 PSI 45 bar otherwise replace with new oxygen cylinder Once pressurized turn off the oxygen cylinder and observe the pressure regulator gauge reading If pressure does not drop more than 0 5 PSI every 30 seconds the system is free from leaks To identify and repair the leak 1 Release the remaining gas from the system 2 Tighten all connecters firmly 3 Slowly and fully tur...

Page 22: ...ociated with yellow warning indicator BCI audible alarm associated with red warning indicator must activate in 15 seconds 6 Block patient output completely to activate Pmax alarm should be activated 7 Re connect the test lung BCI visual and audible alarms should be de activated 8 Change Vt and observe changes on the lung live ventilation parameters and the pressure wave form 9 Change Rate and obse...

Page 23: ...tilator is turned on 3 Solid Silhouettes start up figures Shown in Figure 6 will be displayed on the screen representing Infant Child and Adult patient sizes Each size comes with pre set parameters close to the patient s size to guide the user to select for instant start up This eliminates the need for a potentially long set up before starting ventilation Note Start up figures are used during star...

Page 24: ...ion 6 of the screen Figure 4 The user must confirm the selection by pressing the Control Selection Knob M Once confirmed the selected area will be highlighted with solid contrast background Figure 9 Navigate among the available settings by rotating the Control Selection Knob M Press the Control Selection Knob M to choose the desired setting The chosen setting will turn yellow with the flashing con...

Page 25: ...0 500 Mv L calculated values 3 0 3 7 5 0 PEEP cm H2O 5 5 5 P max cm H2O 25 25 30 P min cm H2O 3 3 3 Ti Sec 0 66 1 33 2 0 I E 1 2 1 2 1 2 O2 100 100 100 F trig L min 3 3 3 Figure 7 A C V mode screen w default parameters Child setting Figure 8 Showing frame around Parameter during selection Table 1 A C V mode default settings ...

Page 26: ...de Note When switching between ventilation modes any shared parameter will be carried over and any new parameter will be set to the default 5 2 1 A C V Assist Control Ventilation In AC mode Figure 10 the ventilator can deliver volume ventilation VCV with Tidal Volume and ventilation Rate setting according to patient size see Table 2 below During A C V mode the ventilator will deliver Controlled Ma...

Page 27: ...I E ratio 1 4 3 1 1 2 1 2 1 2 Ti 0 2 9 sec 0 66 1 33 2 0 PEEP OFF 4 20 cm H2O 5 5 5 Trig OFF 1 15 L min 3 3 3 O2 100 or 60 O2 100 100 100 P max 10 80 cm H2O 25 25 30 P min 0 20 cm H2O during I time only 3 3 3 Manual Refer to Manual and I Hold section ready ready ready Ti may be limited below its range depending on set I E ratio and rate Figure 10 A C V waveform Table 2 Default Ventilation Setting ...

Page 28: ... start of inhalation phase beginning of Ti If no effort was detected during the trigger period the ventilator will initiate mandatory ventilation at the end of trigger window Figure 11 Should the patient demand more flow than set by user he she can withdraw the excess from ambient Table 3 Default Ventilation Setting SIMV Parameter Range Default Infant Child Adult Tidal Volume 50 2000 ml 100 250 50...

Page 29: ...25 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version Figure 11 SIMV waveform ...

Page 30: ...n the ventilator does not trigger patient s spontaneous breathing for a period of time T APNEA set by the user The parameters of back up A C ventilation are defaulted to volume ventilation based on the initial start up patient size selection unless changes are made by the user The trigger changes from pressure trigger P to 3 L min default flow trigger when the ventilator switches to APNEA back up ...

Page 31: ...27 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version Figure 12 CPAP ventilation waveform ...

Page 32: ...ressions and ventilations is 30 2 Figure 13a The CPR mode for intubated patients consists of continuous compressions indicated by an audible prompt and visual animation at a rate of 100 compressions per minute plus automatically delivered breath every 6 seconds Figure 13b The ventilation in CPR mode is flow controlled ventilation The default tidal volume is set according to the initial start up pa...

Page 33: ...29 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version CPR for masked patients On screen chest compressing animation On screen ventilation animation Figure 13 a CPR waveform for masked patient ...

Page 34: ...30 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version CPR for intubated patients On screen intubated CPR animation Figure 13 b CPR waveform for intubated patient ...

Page 35: ...31 e600 User Manual 15PL1010 Rev 7 28_8_2017 English version 5 3 Turning the Ventilator Off Press and hold the ON OFF button for 4 seconds the Ventilator will turn OFF ...

Page 36: ...upply to the ventilator b Disconnect gas supply hose c Disconnect patient circuit from the output connector d Unplug the power cable from mains if no charging is required e Clean and disinfect according to section 8 1 in this manual 6 2 Storage Store ventilator within the following environmental range 40o C to 60o C Rh 15 to 95 ...

Page 37: ...ntinue to flash until the cause of the problem is resolved During alarm silence should a new alarm develop the Alarm Silence function will continue and only the new alarm will be shown flashing on the screen Alarms will be visible in section 4 or section 7 of the display Figure 4 There could be multiple alarm warning symbols visible on the screen indicating multiple failures occurring at the same ...

Page 38: ...ing symbol Red Two bursts with five pulses Low Oxygen 40 PSI Medium Flashing symbol Yellow One burst with three pulses High input pressure 90 PSI High Flashing symbol Red Two bursts with five pulses APNEA High Flashing symbol Red Two bursts with five pulses Empty Battery High Flashing symbol Red Two bursts with five pulses Low Battery Low Flashing symbol N A N A Pause N A Flashing symbol Yellow ev...

Page 39: ...ble 7 2 Battery charging status 1 Full Capacity No Alarm 2 95 of full capacity No Alarm 3 90 of full capacity No Alarm 4 80 of full capacity No Alarm 5 65 of full capacity No Alarm Warning At approximately 2 of full battery capacity the ventilator will not start when it is turned off or will shut down when it is turned on Note Battery capacity levels are detected from measured voltages and the cap...

Page 40: ... depends on the severity of the failure Green color LED Continuous when unit is connected to AC power source during both ON and OFF phases Orange color LED Continuous when unit is charging and off when battery is fully charged during both 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...

Page 41: ...ient circuit Using a wet or damp filter may result in inaccurate parameters and potentially damage the ventilator Warning Risk of Explosion Cleaning agents containing alcohol or grease become flammable when combined with compressed oxygen and can cause explosions 8 2 Charging the battery 1 Connect one end of the external power supply charger to its supply 100 to 240 Volts or on board vehicle socke...

Page 42: ... Always keep the ambient air entrainment port clear of obstructions Always replace the filter after use Warning Avoid particulate and or gaseous pollutants in the ambient air The entrainment of pollutants into the ventilator may cause the ventilator to malfunction or cause danger to the patient 8 4 Preventive Maintenance and Servicing It is recommended that routine preventive maintenance PM and se...

Page 43: ...gh use applications Any malfunction unit should be returned to the manufacturer or an authorized service center since this product is not designed for field disassembly or service Unauthorized repairs will nullify the product warranty Level II service The device shall be returned to the manufacturer or a service center authorized by the manufacturer for bi annual Level II service every 2 years Man...

Page 44: ...Inspiratory hold Maximum Inspiratory hold time 6 sec I E Ratio 1 4 3 1 20 PEEP cm H2O 0 4 20 10 or 2 cm H2O CPAP cm H2O 4 20 10 or 2 cm H2O O2 60 or 100 15 Pmax cm H2O 10 80 10 or 2 cm H2O Pmin cm H2O 0 20 10 or 2 cm H2O Ti sec 0 2 9 20 Trigger sensitivity L min 1 15 or 2 cm H2O below baseline in CPAP mode only APNEA back up time sec 10 60 0 5s Battery Operating time at room temperature hrs 18 hrs...

Page 45: ...ith mask Dead space of patient valve with elbow Approx 35 ml Compliance disposable hose system 16 6 ml kPa Resistance of Patient Hose system Inhalation and Exhalation Less than 6 cmH2O at 60 l min Less than 6 cmH2O at 30 l min Environment condition Ventilator Operating 18o C to 50o C Rh 15 to 95 Storage 40o C to 60o C Rh 15 to 95 Battery Pack Charge 0o C to 40o C Discharge 20o C to 60o C Storage 2...

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Page 47: ... behaviour of the ventilator will not be affected while the battery is charging AC DC Power Supply Model PMP90 13 2 01CV0105 Input Voltage 100 240 VAC Input Current 1 06 0 45 A Input Frequency 47 63 Hz Output Voltage 19 VDC Output Current 4 74 A Maximum DC Output Plug 2 5 x 5 5 x 11 mm DC Output Cable Length 6 AC Power Cord Length 6 Weight 642 g EMC performance Meet requirements of IEC60601 1 2 Sa...

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Page 49: ...Power frequency 50 60 Hz magnetic field IEC61000 4 8 3 A m 30 A m Conducted RF IEC61000 4 6 3Vrms 50kHz to 80 MHz outside ISM bands 3 Vrms 10Vrms 150kHz to 80 MHz in ISM bands 10 Vrms Radiated RF IEC61000 4 3 10 V m 80 MHz to 2 5 GHz 30 V m O Two e600 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The user can help prevent electromagnetic in...

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Page 51: ... patient ventilation circuit check tube position adjust Pmax alarm value Apnea spontaneous breathing failed or disconnection faulty sensor Switch to Assist Control ventilation ensure connections tight Replace patient circuit No Oxygen 20 PSI Change Oxygen cylinder Low Oxygen 40 21 PSI Change Oxygen cylinder Leakage measured expiratory volume is 40 lower than set Check leakage in breathing system I...

Page 52: ...per minute I E Ratio of inspiration time to expiration time LED Light Emitting Diode Mve Exhaled Minute Volume Mv Minute volume O2 Percentage of Oxygen inspired Paw AV Average airway pressure Paw peak Peak airway pressure PEEP Positive End Expiratory Pressure Pmax Maximum airway pressure Pmin Minimum airway pressure SIMV Synchronized Intermittent Mandatory Ventilation T APNEA Apnea Alarm time Te E...

Page 53: ...ower supply Cord Canada and the US 01CV0106 5 Battery Pack 01CV9100 6 e Ventilator External Power Supply 01CV0105 7 SMART MOUNT Mounting Bracket for Road ambulance 01EV7035 8 FIXED MOUNT Mounting Bracket for mobile setting 01EV7036 9 1L Test lung 01TA8152 10 Bacterial and Viral Filter case of 40 Bacterial and Viral Filter unit Dead space and Resistance 30 Lpm of Viral and Bacterial filter 26 ml 0 ...

Page 54: ...rs deemed to be out of specification must be returned to O Two Medical Technologies Inc or one of its approved Service Centers for service and or repair We recommend that a service contract be obtained with O Two Medical Technologies Inc or one of its approved Service Centers and that all repairs also be carried out by them Only authentic O Two Medical Technologies Inc spare parts may be used for ...

Page 55: ...e600 User Manual 15PL1010 Rev 7 28_8_2017 English version ...

Page 56: ... SN ____________ O Two Medical Technologies Inc 45A Armthorpe Road Brampton Ontario Canada L6T 5M4 Office 1 905 792 OTWO 6896 N A Toll Free 1 800 387 3405 Fax 1 905 799 1339 Email resuscitation otwo com Web otwo com Marcel Houben Rue Vinave 32 4030 LIEGE Belgique ...

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