O_TWO e600 User manual

e600 User Manual (15PL1010 - Rev.8 Feb 2021)
USER MANUAL
o_two e600
AUTOMATIC TRANSPORT VENTILATOR
01EVE600

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e700 User Manual
TABLE OF CONTENTS
1. Safety 5
2. Intended Use 8
3. Overview 9
3.1. Control and Display Layout 9
3.2. Function Keys 10
3.2.1. ON/OFF 10
3.2.2.Control Selection Knob 10
3.2.3.Lock 11
3.2.4. Alarm Silence 11
3.2.5.Waveform 11
3.2.6.Screen Brightness 12
3.2.7. Cancel 12
3.2.8.Pause/Resume 12
3.2.9.Manual / Inspiratory Hold 13
3.3. External Connectors 14
3.4. Patient Circuit 15
3.5. Display 16
3.5.1. Screen Layout 16
3.5.2.Live Monitoring Parameters 19
3.6. Symbols & Notations 20
4. Preparation For Use 21
4.1. Set up 21
4.1.1. Connecting electrical power supply 21
4.1.2. Installing / replacing the battery 21
4.1.3. Connecting the gas supply 22
4.1.4. Connecting patient circuit 23
4.1.5. Turning Ventilator ON 23
4.2. Pre-use check 23
5. Operate Instructions 27
5.1. Startup & setting the ventilation parameters 27
5.2. Ventilation modes 31
5.2.1. A/C V (Assist Control Ventilation) 32
5.2.2.SIMV (Synchronized Intermittent
Mandatory Ventilation) 34

4e700 User Manual
5.2.3.CPAP (Continuous Positive
Airway Pressure) 36
5.2.4. CPR mode 38
5.3. Turning Ventilator OFF 40
6. Post use 41
6.1. Disconnect device after use 41
6.2. Storage 41
7. Alarms and Indicators 41
7.1. Ventilation Alarms 41
7.2. Battery status indicator 44
7.3. LEDs 45
8. Cleaning, Preventive Maintenance & Servicing 46
8.1. Cleaning & Disinfection 46
8.2. Charging the Battery 46
8.3. Ambient Air entrainment Filter 47
8.4. Preventive Maintenance and Servicing 48
9. Technical Data 49
9.1. Specifications 49
9.2. Circuit Description 51
9.3. Battery and Power Supply 51
9.4. Battery Operating time 52
9.5. Electromagnetic Compatibility 52
9.6. Oxygen consumption 54
9.7. Oxygen Concentration delivered against
dierent back pressures 54
10. Trouble Shooting 55
11. Abbreviations and Acronyms 56
12. Accessories 57
13. Warranty 57

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e700 User Manual
1. Safety
WARNING
• U.S. Federal Law restricts this device to sale by or on the order
of a physician.
• The ventilator shall only be used for the purposes specified
under “Intended Use”.
• The ventilator should only be used by qualified personnel
trained in its use.
• Strict adherence to all instructions contained within this manual
is essential for safe use.
• During use, the patient must be constantly monitored by
qualified personnel.
• Alternate means of ventilation such as a manual resuscitator
must be available in case of power failure or malfunction.
• Keep away from open flames, sparks and grease/oil. To avoid
the risk of fire or explosion this ventilator must not be used
with flammable gases or anaesthetic agents. Operating the unit
in a confined space will elevate ambient oxygen levels.
• The ventilation setting will turn o 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, batteries
and external power supplies to avoid aecting the output
performance of the ventilator. Antistatic or conductive hoses
or tubing are not used in the Ventilator Breathing System.
• Unauthorized modification of this medical device is prohibited.
Do not disassemble or modify any part of the ventilator except
where described in this manual. Any unauthorized disassembly
will void the warranty.
• Do not use this ventilator in toxic environments as entrainment
of ambient air during spontaneous breathing or air mix
mode may permit toxic gases to be delivered to the patient.

6e700 User Manual
• Do not use this ventilator within a Magnetic Resonance Imaging
(MRI, NMR, NMI) suite.
• Do not use this ventilator in hyperbaric (high pressure) chambers.
• Do not use the external electrical power supply outdoors as
moisture may aect its function.
• Do NOT allow the power supply plug to contact the patient.
• The performance of this ventilator may be aected if used
near portable and mobile RF telecommunication devices (cell
phones) within the minimum distance specified in section 9.5
of this user manual.
• The intake and exhaust ports on the patient valve must be left
unobstructed for proper function & safety.
• When using a bacterial filter or HME (Heat Moisture Exchanger)
connect the bacterial filter or HME to the patient connection
between the elbow and the endotracheal tube or face mask,
note that this action will increase the dead space. Bacterial
filters or HME may increase breathing resistances.
• Use pressure regulators maintaining a minimum output flow of
120 L/min at a dynamic pressure of minimum 45 PSI to ensure
the proper functioning of the ventilator.
• Operation of this ventilator outside the environmental condition
range specified in this manual may result in a reduction and or
failure in the ventilator’s performance. In extreme temperature
conditions the eect is not noticeable in terms of delivered
ventilations but may cause excessive wear in the ventilator or its
components over time. Extreme low temperatures reduce the
operating time of the battery (Refer to 9.4 battery operating
Time).
• Operation of this ventilator outside the supply pressures range
detailed in this manual may result in reduction in the ventilator’s
performance, component failure, low pressure alarm or possible
loss of automatic cycling.
• 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.

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e700 User Manual
CAUTIONS
• When the ventilator is not in use, always turn o the gas supply.
• Never allow oil or grease to come into contact with any part of
the cylinder, regulator, or ventilator.
• After use, always ensure that all components are cleaned in
accordance with the instructions provided in this manual. (See
section 8.1 - Cleaning and Disinfection).
• The use of this device in a carrying case may result in an increase
in oxygen concentration or lower than intended ventilation
volume when used in the 60 % air mix mode. When air mix
mode is being used it is recommended that the ventilator be
placed in its normal operating orientation and the air intake on
the side of the ventilator is not obstructed.
• Never operate the ventilator without an intake filter being fitted,
otherwise particles may contaminate the ventilator and aect
its function.
• This ventilator 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 ventilation.
• Operation of this ventilator below sea level or above 4,000 m
(13,000 feet) may result in reduction or failure in the ventilator’s
performance, low pressure alarm or possible loss of automatic
cycling.
• The ventilator is intended for use in the prehospital, intrahospital,
interhospital and ground transport environments only.
• Connecting the patient circuit to a patient prior to turning on the
ventilator may cause a calibration error.

8e700 User Manual
• The external power supply and battery are component parts of
the medical electrical equipment system.
• The ventilator is considered as a high flow device as its
maximum flow output at pressure of 40.6 PSI is around 100
L/min. It should only be connected to a pipeline system that
allows for the indicated high flow to avoid interfering with the
operation of adjacent equipment.
• Always ensure that all components are assembled correctly
and ready for use.
• When selecting very small tidal volumes during ventilation of
infants, take into consideration the dead space in the patient
circuit.
2. Intended Use
The e600 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
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.

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e700 User Manual
3. Overview
3.1. Control and Display Layout
A
B
C
D
E
F G H I J
K
L
M
N
Figure 01
A H
D K
B I
E L
C J
F M
G N
Warning indicator
Battery operation indicator
External power indicator
Battery charging indicator
Manual/Inspiratory Hold key
Screen brightness key
Alarm Silence key
Pause/Resume key
Lock key
Waveform selection key
Cancel key
Confirmation indicator light
Control Selection Knob
ON/OFF key

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3.2. Function Keys
While all ventilation parameter settings are controlled by the
Control Selection Knob (M) in Figure 1, there are a number of key
membrane buttons which control additional ventilator functions:
3.2.1. ON/OFF
To turn on the ventilator, Press the ON/OFF button (N) in Figure 01
for one second, during that second the associated green LED will
start flashing at a high frequency. After 1 second the ventilator will
turn on but without ventilation until the appropriate patient size
symbol is selected. If the button is pressed and released for less
than a second, the ventilator will remain OFF.
To turn o the ventilator, Press and hold the ON/OFF button for 4
seconds, the green power LED will start flashing at a high frequency.
After 4 seconds the ventilator will turn o 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 o position or will shut down when operating.
3.2.2. Control Selection Knob
The Control Selection Knob (M) (Figure 01) is used to navigate
between parameters, change modes, select primary function change
when rotated, and to confirm function changes when pressed.
Diagram below illustrates path of cursor when Control Selection
Knob is rotated clockwise.
Control Selection Knob
rotation contour
Direction for clockwise
knob rotation shown

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e700 User Manual
3.2.3. Lock
Lock function will disable all buttons and the Control Selection
Knob except for the ON/OFF, Alarm Silence and Day/Night
buttons, which are enabled at all times.
To lock the key membrane or cancel the lock function:
1. Press the Lock key (I) (Figure 01). The Lock symbol will be
displayed on the screen.
2. To cancel the Lock function, press the Lock key (I) again.
3.2.4. Alarm Silence
The Alarm Silence key (G) (Figure 01) will silence the audible alarm
for 120 seconds. It could be also selected without an active alarm to
silence potential alarms. This function is activated or deactivated by
pressing the Alarm Silence key once.
When selected, the Alarm Silence symbol will be displayed on the
left of the screen.
Note: During the Lock function, if any locked key is pressed or the
control knob is pressed or rotated, the Lock symbol on the left of the
screen will flash with these actions.
CAUTION
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.

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Note: This feature is active in ventilation mode screens only.
3.2.7. Cancel
The Cancel key (K) (Figure 01) allows the operator to return to the
previous settings if the last unconfirmed changes in settings are not
required.
3.2.8. Pause/Resume
During activation of the Pause/Resume key (H) (Figure 01), the
ventilator will stop ventilating with all un-locked keys kept active
except for the Manual/Inspiratory Hold key (E).
To activate the Pause function, proceed as follows:
1. Press the Pause/Resume key (H) (Figure 01). The Pause symbol
will flash on the left of the screen along with the confirmation
symbol as well as the Confirmation indicator (L) (Figure 01)
to guide users to activate the pause function by pressing the
Control Selection Knob (M) (Figure 01).
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.
3.2.6. Screen brightness
Pressing the Screen Brightness key (F) (Figure 01) will switch
between 4 dierent brightness levels as follows:
1. Light background with dark color text and waveform at 100%
light intensity.
2. Light background with dark colored text and waveform at 35%
light intensity.
3. Dark background with light colored text and waveform at 100%
light intensity.
4. Dark background with light colored text and waveform at 35%
light intensity.

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e700 User Manual
3. Once activated, a flashing yellow pause symbol will be displayed
on the screen and the ventilator will pause ventilation.
Note:
A. During Pause, there will be an audible alarm associated with
a flashing yellow Warning indicator (A) (Figure 01) every 15
seconds. Users can press the Alarm Silence key to disable the
audible alarm for 2 minutes but the yellow Warning indicator
will continue flashing every 15 seconds.
B. During Pause, users can change and confirm new ventilation
settings but no ventilation will occur until the Pause function
is disabled.
4. To cancel the Pause function, press Pause/Resume key (H)
(Figure 01) again. The “Resume” symbol will flash on
the screen along with the confirmation symbol and the
Confirmation indicator (L) (Figure 01) to guide users to resume
ventilation by pressing the Control Selection Knob (M) (Figure 01).
5. When ventilation is resumed, the ventilator will recommence
ventilation with current settings shown on the screen unless
new set-up selections were made.
3.2.9. Manual/Inspiratory Hold
During the exhalation phase, if the Manual/Inspiratory Hold key (E)
(Figure 01) is pressed, a mandatory breath will be initiated and either
the flow rate or set pressure control parameter will be delivered as
long as the Manual/Inspiratory Hold key remains pressed or until
the I-time setting is achieved.
After I-time if the button still pressed, the ventilator will switch to
inspiratory hold function in which the ventilator will cut the flow
but will keep the exhalation port closed in order to block exhaled
gas from going to ambient resulting in the maintenance of lung
pressure.
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 in all modes except
CPAP and CPR.

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3.3. External Connectors
O
R
P
S
Q
T
DC Input connector
Air Intake filter
Sensor connector #1
Sensor connector #2
22mm gas output connector
Gas supply input
O
P
Q
R
S
T
Figure 02
Battery door
Relieve Flapper
Air/O2Exhaust Port

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e700 User Manual
3.4. Patient circuit
U
WX
Y Z
λ
V
U Y
V Z
Wλ
X
Breathing Control Hose
Sensing hoses
One Way Intake Valve
Exhalation port
Breathing Valve
Flow sensor adapter
Elbow
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.
Figure 03

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2
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.
3.5. Display
3.5.1. Screen Layout
The screen is divided into 7 sections as shown below and each
section is dedicated to display the following parameters:
Figure 04
Section 1: Battery status during charge and discharge.
Section 2: Live ventilation parameters (Vte, Mve, Pawpeak, PawAV,
Rate)
Section 3: Ventilation Modes (A/C V, SIMV, CPAP & CPR)
Section 4: Alarms/ Warnings.
Section 5: Ventilation waveforms.
Section 6: Set up parameters
Section 7: Confirmation request/ Patient eort/ Invalid or
Conflict setting
13
7
4
56

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e700 User Manual
The followings are screen layouts for each ventilation mode:
A/C screen layout
SIMV screen layout

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CPAP screen layout
CPR screen layout

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e700 User Manual
3.5.2. Live Monitoring Parameters
The following Live Monitoring Parameters are displayed at the
section 2 of the screen:
PawAV (cmH2O): Paw AV is the average patient airway pressure
measured during the last 60 seconds. This measurement is
monitored by the ventilator at all times and modes. The number on
the display will be updated every 15 seconds.
Mve (L): Minute volume is the total exhaled volume for the last
60 seconds as calculated using the last 8 breaths. The Mve will
constantly change as the value is recalculated and displayed at the
end of exhalation phase. When unit is first turned on or resumed
after pause or on selecting a new mode, the Mve calculation will
be based on first then second then third and so on until the 8th
exhaled tidal volume when the above logic 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
mandatory, spontaneous or PSV (Pressure Support Ventilation)
breaths. Vte is calculated by the measurement of the entire expired
flow displayed as a volume. Vte display will be updated at the
beginning of the next inspiratory phase (The end of exhalation
phase).
PawPeak (cmH2O): Peak air way pressure is the maximum pressure
measured during the inspiratory phase. The displayed number on
the screen represents the maximum pressure during mandatory
inspiratory phase of A/CV, 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 “--“

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3.6. Symbols and Notations
Consult instructions for use.
Warning! Risk of injury and possible
negative patient outcome.
Warns of material damage and negative
patient outcome.
Oers useful tips to assist in the proper
use of the equipment.
Confirmation Symbol
Invalid Setting Symbol
Conflict Setting Symbol
Keep away from open flames.
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