Professional Documents
Culture Documents
US Version
Inspiration 7i
Ventilator
Revision A of this user manual: Part Number EVM500023 Inspiration 7i Ventilator User Manual, US
Version 05/2011
2011 eVent Medical, Inc. All rights reserved. No part of this User Manual may be reproduced or stored in a
database or retrieval system, or transmitted, in any form or by any means, electronic, photocopying,
recording, or otherwise, without the prior written permission of eVent Medical.
This manual is intended to provide the necessary information required to operate and maintain the
eVent Medical Inspiration 7i Ventilator System. The ventilator should be operated, serviced, and calibrated
by trained professionals. US Federal Law restricts this device to sale by or on the order of a physician.
Intended for use with the Inspiration 7i Ventilator System, this manual is subject to technical modification and
may be revised or replaced by eVent Medical at any time without prior notice. We recommend you have the
most current version of this manual. Nothing in this manual shall limit or restrict in any way eVent Medicals
right to revise or otherwise change or modify, without notice, the equipment (including its software) described
herein. In the absence of an express, written agreement to the contrary, eVent Medical has no obligation to
furnish any such revisions, changes, or modifications to the owner or user of the equipment (including its
software) described herein.
Nothing in this manual shall limit or restrict in any way eVent Medicals right to revise or otherwise change or
modify, without notice, the equipment (including its software) described herein. In the absence of an express,
written agreement to the contrary, eVent Medical has no obligation to furnish any such revisions, changes, or
modifications to the owner or user of the equipment (including its software) described herein.
This manual and its illustrations apply to the Inspiration 7i Ventilator System: PN F730000-7i
Installed software / firmware versions are displayed upon power up on the initial screen. Smart Sigh, Smart
Nebulizer, CLININET, VIRTUAL REPORT and MiniWeb are trademarks of eVent Medical. Inspiration and
eVolution are registered trademarks of eVent Medical.
eVent Medical will provide upon request certain technical, operation, sales and marketing information that
will assist clinicians and trained service professionals.
Installed software / firmware versions are displayed upon power up on the initial screen.
United States
Europe
Fax:
0120
www.event-medical.com
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Table of contents
1
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4.4.1
Auto Control ......................................................................................................................................................... 44
4.4.2
Apnea Backup ....................................................................................................................................................... 45
4.5
SETTING ALARM LIMITS ...................................................................................................................................................... 45
4.5.1
Event Log .............................................................................................................................................................. 47
4.6
SELECTING MONITORED DATA DISPLAYS ................................................................................................................................ 48
4.6.1
Monitoring Data ................................................................................................................................................... 49
4.6.2
Trend Data ............................................................................................................................................................ 50
4.6.3
Loop Study, Available on Inspiration 7i Ventilator Only ....................................................................................... 53
4.7
SPECIAL FUNCTIONS ........................................................................................................................................................... 54
4.7.1
% O2 Increase Key ................................................................................................................................................ 54
4.7.2
Manual Inspiration Key ........................................................................................................................................ 55
4.7.3
Alarm Mute Key .................................................................................................................................................... 55
4.7.4
Smart Nebulizer .................................................................................................................................................... 55
4.7.5
Smart Sigh ............................................................................................................................................................ 56
4.8
USING THE MAIN DISPLAY DURING VENTILATION..................................................................................................................... 57
4.9
MANEUVERS .................................................................................................................................................................... 60
4.9.1
Inspiratory Hold Maneuver................................................................................................................................... 61
4.9.2
Expiratory Hold Maneuver.................................................................................................................................... 61
5
MAINTENANCE ............................................................................................................................................................. 68
6.1
CLEANING AND INSPECTION ................................................................................................................................................. 68
6.2
CALIBRATIONS .................................................................................................................................................................. 70
6.2.1
Proximal Flow Sensor Calibration ......................................................................................................................... 71
6.2.2
System Test ........................................................................................................................................................... 72
6.2.3
Oxygen Sensor Calibration ................................................................................................................................... 73
6.3
PREVENTIVE MAINTENANCE ................................................................................................................................................ 74
6.3.1
Clean or Replace Cooling Fan Filter: ..................................................................................................................... 74
6.3.2
Replace Gas Supply Filters: ................................................................................................................................... 74
6.3.3
Replace Oxygen Sensor:........................................................................................................................................ 75
6.3.4
Replace the Internal Batteries: ............................................................................................................................. 75
6.3.5
Replace Fuses: As Required .................................................................................................................................. 76
6.4
ALARMS TEST PROCEDURE .................................................................................................................................................. 76
6.5
DISPOSAL......................................................................................................................................................................... 77
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9.2.1
9.2.2
10
ABBREVIATIONS ....................................................................................................................................................... 96
11
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Table of Figures
Figure 1: Ventilator Front Panel Controls ..................................................................................................................... 2
Figure 2: Attaching the Ventilator to the Cart............................................................................................................. 23
Figure 3: Ventilator Power Connections .................................................................................................................... 24
Figure 4: Ventilator Oxygen and Air Connections...................................................................................................... 25
Figure 5: Connecting Heliox........................................................................................................................................ 26
Figure 6: Back Panel: Ethernet, RS232, and Nurse Call Connectors ....................................................................... 27
Figure 7: Example Patient Breathing Circuit ............................................................................................................... 28
Figure 8: Infant Nasal Prong Patient Interfaces .......................................................................................................... 29
Figure 9: Nasal Prong Pressure Line Connection ...................................................................................................... 29
Figure 10: EZ-Flow Flow Sensor ................................................................................................................................ 30
Figure 11: Exhalation Valve Cover and Diaphragm.................................................................................................... 30
Figure 12: Nebulizer Connection ................................................................................................................................ 31
Figure 13: POST Screen............................................................................................................................................. 32
Figure 14: Selecting New or Previous Patient ............................................................................................................ 33
Figure 15: Selecting the Config Tab on Standby Screen ........................................................................................... 33
Figure 16: Turning the Ventilator On and Off.............................................................................................................. 36
Figure 17: POST Screen............................................................................................................................................. 37
Figure 18: On/Off/Standby Key Options ..................................................................................................................... 37
Figure 19: Changing a Setting .................................................................................................................................... 38
Figure 20: Linked Setting ............................................................................................................................................ 39
Figure 21: New Patient Startup Screen ...................................................................................................................... 39
Figure 22: New Patient Startup (IBW Automatically Calculated) ................................................................................ 40
Figure 23: New Patient Startup Screen (Only IBW Entered) ...................................................................................... 40
Figure 24: Proposed Settings Screen ......................................................................................................................... 41
Figure 25: Selecting Auto Control ............................................................................................................................... 44
Figure 26: Apnea Backup Settings ............................................................................................................................. 45
Figure 27: Alarm Settings ........................................................................................................................................... 46
Figure 28: Event Log ................................................................................................................................................... 47
Figure 29: Monitoring Tab (Monitoring Data) .............................................................................................................. 48
Figure 30: Monitoring Tab (Trend Data) ..................................................................................................................... 50
Figure 31: Trend Data Cursor ..................................................................................................................................... 51
Figure 32: Entering a User Comment for Trend Data ................................................................................................. 51
Figure 33: Selecting Trend Data Parameters (Vti and Rate Selected) ....................................................................... 52
Figure 34: Viewing Loop Data..................................................................................................................................... 53
Figure 35: Loop Data with Reference Loop Selected ................................................................................................. 54
Figure 36: Smart Nebulizer ......................................................................................................................................... 55
Figure 37: Smart Sigh ................................................................................................................................................. 56
Figure 38: Main Screen Display Elements .................................................................................................................. 57
EVM500023, Inspiration 7i Ventilator User Manual, US Rev A
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This section briefly describes the Inspiration 7i Ventilator System, safety information, and ventilator controls and
indicators.
Reference this manual and the Inspiration 7i Ventilator System Service Manual when performing any
maintenance on the ventilator.
1.1
Intended use
The Inspiration 7i Ventilator System is intended to provide continuous respiratory support in an acute and subacute institutional healthcare environment (for example, hospitals) and may be used with infant, pediatric, and
adult patients requiring invasive and non-invasive ventilatory support. Because the ventilator includes an
integral compressor option and rechargeable internal batteries, it can operate independently of external power
and air supplies, allowing ventilation during intra-hospital patient transport. The ventilator is a class II b medical
device intended for use by qualified, trained personnel under the direction of a physician.
The Inspiration 7i Ventilator System includes these features:
User-selected oxygen concentration
Volume or pressure based breaths delivered in controlled, synchronized intermittent mandatory or
spontaneous modes
Flow or pressure breath triggering
Apnea monitoring and ventilation backup system
Numeric or waveform display of user-defined ventilator data
Respiratory mechanics monitoring
Smart Sigh breaths delivered at user-defined frequency and breath amplitude
User-defined Smart Nebulizer functions
EZ-Flow sensor allows proximal flow monitoring
Prioritized alarm system
Spontaneous Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) modes
Non Invasive Ventilation (NIV) available in all modes
Auto Control
CliniNet Server option allows real-time access to the ventilator for centralized data management
User-configurable graphic user interface (GUI)
Ideal Body Weight (IBW) Calculator
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Only qualified and properly trained personnel should attempt to use, service, or maintain the ventilator:
read this user manual carefully and keep within reach of the device.
Do not use the ventilator in the presence of flammable anesthetics.
Before operating the ventilator, check for proper operation by performing the System Test, Alarms Test,
and Calibration procedures described in this manual.
Touch screen
Mains LED
Alarm mute key
% O2 increase key
Manual Inspiration key
On/Off key
Knob
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1.2
Specifications
1.2.1
Ventilation Modes
CMV
SIMV
PRVCCMV
PRVCSIMV
VS
Spontaneous Ventilation
SPAP
1.2.2
Breath Types
Auto Control
Auto Control
Non-Invasive Ventilation
NIV
VCMV, VSIMV
PCMV, PSIMV, PS
1.2.3
Patient Types
Adult (IBW > 41 kg), Pediatric (IBW > 10 to 40 kg), or Infant (0.3 to
9.6 kg)
1.2.4
Apnea Backup
User selected
1.2.5
Breath Triggering
Pressure triggering
Flow triggering
Adult
Pediatric
Infant
1.2.6
Additional Settings
Respiratory Rate
Adult
1 to 60 b/min
Pediatric
1 to 120 b/min
Infant
1 to 150 b/min
300 to 2000 ml
Pediatric
40 to 500 ml
Infant
5 to 100 ml
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5 to 80 cmH2O or (80
cmH2O PEEP), whichever
is less
Infant
Mandatory
Adult
Pediatric
1.0 to 90 l/min
Infant
1.0 to 60 l/min
Spontaneous
Adult
1 to 180 l/min
Pediatric
1 to 90 l/min
Infant
1 to 60 l/min
ITime (Ti)
0.1 to 10 sec
1 : 9.0 to 4.0 : 1
NIV
On or Off
0.00 to 42.0 s
0 to 70 % of breath cycle
time
21 to 100%
1 (slow), 5 (medium), or 10
(fast)
Flow pattern
Decel. (Decelerating),
De50% (Decelerating 50%),
or Square.
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1.2.7
Exhalation sensitivity
(Esens %)
Auto Control
On or Off
3 to 60 sec
Default settings
Ventilation Mode
PCMV
Trigger type
Resp rate
Vt
Flow
Flow Pattern
Decel
Pause
0.0 s
PEEP
Oxygen % (FiO2)
10 % above setting
Apnea Backup
On or Off
Ti (inspiratory time)
Pcontrol
Psupport
Time (apnea)
20 s
Rise time
Trigger Flow
Trigger Pressure
Pediatric
Apnea Backup Settings
Pediatric (continued)
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Apnea Backup
Default settings
Ventilation Mode
PCMV
Trigger type
Resp rate
Vt
Flow
Flow Pattern
Decel
Pause
0.0 s
PEEP
Oxygen % (FiO2)
10 % above setting
Apnea Backup
On or Off
Ti (inspiratory time)
Pcontrol
Psupport
Infant
1.2.8
Time (apnea)
20 s
Rise time
Trigger Flow
Trigger Pressure
Apnea Backup
Default settings
Ventilation Mode
PCMV
Trigger type
Resp rate
Vt
Flow
Flow Pattern
Decel
Pause
0.0 s
PEEP
Oxygen % (FiO2)
10 % above setting
Apnea Backup
On or Off
Ti (inspiratory time)
Pcontrol
Psupport
Time (apnea)
20 s
Rise time
Trigger Flow
Trigger Pressure
Smart Nebulizer
Smart Sigh
Air or Heliox
Heliox: 0 to 79%
Humidity type
SPAP Type
Cycle + Time
Cycle + Ratio
Time only
Screen setting
Lock or Unlock
Brightness settings
Numerical setting
1 to 72 hrs
Device ID
(user selectable)
Numerical setting
0 to 99
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1.2.9
Phigh
5 to 50 cmH2O or (Plow 50
cmH2O)
Plow
Psup High
5 to 80 cmH2O or (80
cmH2O Phigh), whichever
is less
Psup Low
SPAP Type
Cycle + Time
Cycle + Ratio
Time only
Thigh
Tlow
1 to 60 c/min
Pediatric
1 to 120 c/min
Infant
1 to 150 c/min
1 : 59.0 to 59.0 : 1
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1 to 40 b/min
PEEP/CPAP
2 to 10 cmH2O
Ti
0.25 to 1.50 s
Pcontrol
2 to 30 cmH2O
Flow
2 cmH2O
7 l/min
3 cmH2O
8 l/min
4 cmH2O
10 l/min
5 cmH2O
10 l/min
6 cmH2O
10 l/min
7 cmH2O
12 l/min
8 cmH2O
12 l/min
9 cmH2O
12 l/min
10 cmH2O
12 l/min
2 to 12 cmH2O
Flow
2 to 28 l/min
values
2 cmH2O
8 l/min
3 cmH2O
13 l/min
4 cmH2O
15 l/min
5 cmH2O
17 l/min
6 cmH2O
19 l/min
7 cmH2O
21 l/min
8 cmH2O
23 l/min
9 cmH2O
24 l/min
10 cmH2O
25 l/min
11 cmH2O
26 l/min
12 cmH2O
28 l/min
Basic
Ppeak
(peak pressure during a breath)
Pmean
(averaged mean pressure)
PEEP
(pressure at end exhalation)
Vti
(tidal volume delivered)
Vti/kg
(tidal volume delivered/weight)
0 to 120 cmH2O
Accuracy: (2 cmH2O + 4%)
0 to 120 cmH2O
Accuracy: (2 cmH2O + 4%)
0 to 120 cmH2O
Accuracy: (2 cmH2O + 4%)
0 to 5000 ml
Accuracy: 0 to 40 ml (2ml + 5%);
41 to 5000 ml (10 ml + 5%)
0.0 to 50.0 ml/kg
Normalized to IBW
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Vte
(exhaled tidal volume)
Vte/kg
(exhaled tidal volume/weight)
Ve
(exhaled minute volume)
Ve/kg
(exhaled minute volume/weight)
Ve Spont
(spontaneous exhaled minute volume)
0 to 5000 ml
Accuracy: 0 to 40 ml (2ml + 5%);
41 to 5000 ml (10 ml + 5%)
Displayed as Vte--- if proximal flow
sensor is disabled.
0.0 to 50.0 ml/kg
Normalized to IBW
0.0 to 50.0 l/min
Accuracy: (0.01 l/min + 5%)
Displayed as Vi if proximal flow
sensor is disabled.
0.0 to 999 ml/kg
Normalized to IBW
0.0 to 50.0 l/min
Accuracy: (0.01 l/min + 5%)
Displayed as Vi Spont if proximal
flow sensor is disabled.
0 to 300 b/min
Accuracy: 0 to 100 b/min ( 1
b/min), > 100 b/min + 2%
Rate Sp.
0 to 300 b/min
Rate
(inspiration time)
Te
(expiratory time)
PF
PFe
I:E
1 : 99.0 to 99 : 1.0
1 : 599.0 to 299.0 : 1
H:L
(Ratio of time at high and low PEEP levels
when SPAP is active)
Ti/Ttot
1.0 to 99.9 %
Leak
0 to 100%
O2
(oxygen concentration)
15 to 103%
Displayed if O2 sensor is disabled.
HeO2
15 to 103%
(heliox concentration)
0 to 100 %
Spont% 1h
(percentage of spontaneous breaths for the
last 1 hour)
0 to 100 %
Spont% 8h
(percentage of spontaneous breaths for the
last 8 hours)
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Mechanics
Auto PEEP
0 to 100 cmH2O
Pplateau
(pressure at end of pause)
0 to 120 cmH2O
Accuracy: (2 cmH2O + 4%)
RR/Vt (RSBI)
0 to 3000 b/min/l
Cstat
Cstat/kg
(static compliance per weight)
Rinsp
0 to 1000 cmH2O/l/se
With the proximal flow sensor selected Off monitored patient data will be
derived from measurements taken at the internal sensors. In this condition
Vte, and Ve may not be monitored and flow triggering is not available.
C20/C
(ratio of dynamic compliance during last
20% of inspiration to total dynamic
compliance)
0.00 to 5.00 %
Normalized to IBW
Monitored Values
(continued)
Pressure + Time
Flow + Time
Volume + Time
P V Loop
F V Loop
Oxygen 15 to 103 %
Accuracy: 5% of full scale
HeO2
inspiratory heliox
concentration
Oxygen 0 to 79 %
Pressure Alarms
Ppeak High
Ppeak Low
Pmean High
Pmean Low
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Volume Alarms
Vti Limit High
Vte High
Automatic Setting
High FiO2
22 to 101 %
Ventilator software automatically sets alarm
limit to 7% above Oxygen % setting.
Low FiO2
20 to 99 %
Ventilator software automatically sets alarm
limit to 7% below Oxygen % setting.
(continued)
Other Alarms
Apnea (interval)
3 to 60 sec
Apnea (setting)
On or Off
Leak rate
20 to 100 %
AUTO SET automatically sets upper and lower alarm limits based on monitored
data (section 4.5). AUTO SET does not change alarm limits that are Off.
Disconnection
Air Supply
Technical Fault
High Oxygen
High Pressure
Occlusion
Low Oxygen
Apnea
Oxygen Supply
Low Pressure
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Low Frequency
High Frequency
High Temperature
Pmean High
Battery Low
Pmean Low
Compressor
Check Trigger
Informational messages
Logbook Cleared
AC input
Power consumption
120 VA (W)
DC input
Internal compressor
< 300 A
50 A Maximum
(continued)
Ventilator
Operating temperature
10 to 40 C at 10 to 80 % relative
humidity
Storage temperature
-10 to 60 C at 5 to 95 % relative
humidity
Atmospheric operating
pressure
Operating altitude
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Atmospheric pressure
* After condensation, store the unit for over 24 hours in an environment with a
relative humidity below 95% non-condensing.
Weight of ventilator
Weight of carts
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Oxygen measurement
Display
Touch Screen
1.3
Notices
Copyright Notice
1.3.1
Trademark Notice
1.3.2
Inspiration is a registered trademark of eVent Medical. Smart Sigh, Smart Nebulizer, MINIW EB, CLININET and
VIRTUAL REPORT are trademarks of eVent Medical. All other brand names, acronyms and products referenced
in this manual may be trademarked by separate companies.
1.3.3
0120
1.3.4
IEC 601-1
EN60601-1
IEC 601-1-2
EN60601-1-2
EN 794-1
ASTMF1100-90
EN 46001
ASTM F1054-87
ISO 9001
ISO 5356-1
CE Notified Body
SGS UK
1.3.5
Classification
Classified as protection class I, Type B, internally powered, drip-proof adult /
pediatric / infant ventilator for continuous operation.
1.3.6
IEC 60601-1:1988
+
A1:1991+A2:1995
Regulatory Notice
US Federal Law restricts the sale of this device except by or on the order of a physician.
P a g e | 14
1.4
% O2 Increase key
xxx %
BATT
On battery backup
Indicates the settings and screen are locked
Lock / Unlock control is located on Special screen
Nebulizer
Flow sensor
Ethernet
RS232
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IPX1
O2
2-6bar (29-86psi)
Air
2-6bar (29-86psi)
DC Input:
24VDC
90W
3.75A
DC input connector
AC Input:
100 -240VAC
50/60 Hz
120VA
100V: 1.4A
240V: 0.5A
Fuse: 3.15AT
AC input connector
O2 Sensor
SN:
To Patient
From Patient
Do not obstruct!
Indicates WEEE (Waste Electrical and Electronic Equipment) Registration per EU WEEE
Reg. No. IE 00761, Directive, 2002/96/EC
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1.5
Safety
The symbols below are used to draw your attention specifically to the remaining dangers associated with
proper use and to emphasize important technical requirements.
1.5.1
The manufacturer assumes no responsibility and exonerates itself accordingly from liability claims where the
operator or any third party has:
Used the device improperly.
Failed to follow the operating instructions.
Disregarded any warnings, cautions or other technical data.
Modified the device in any way.
Operated the device using accessories that are not listed in the associated product documentation, or do
not meet applicable international standards.
1.5.2
P a g e | 17
The ventilator should only be operated and maintained by personnel with appropriate
technical and clinical training. All patients requiring ventilation must be monitored
appropriately by competent medical personnel.
US Federal Law restricts this device to sale by or on the order of a physician.
Only medical air and medically pure oxygen should be used for ventilation. Do not use
anesthetics and potentially explosive gases. Ensure that the air and oxygen supplies are
completely oil-free.
To avoid any potential fire hazard, keep all matches, lighted cigarettes, and other sources
of ignition away from the device.
Ensure that an alternate source of ventilation is always available when using the
Inspiration 7i Ventilator System.
When the ventilator is connected to an external device via the serial port, the power cord
should be in use to ensure proper grounding.
Check that the remote alarm system (nurse call) is activated before leaving the patient
unattended.
Do not replace any accessories or other parts of the INSPIRATION while a patient is being
ventilated.
Do not use the ventilator unless an internal battery with at least a minimal charge is
installed.
If the ventilator has been stored for an extended period, recharge the battery before use.
Maintenance should always be conducted in compliance with all relevant safety
regulations.
Repairs, assembly, and use must be conducted by trained personnel, and the ventilator
must be checked by trained personnel annually.
A bacteria filter can be placed between the ventilator To Patient outlet and the patient
breathing circuit to prevent cross contamination.
A bacteria filter can be placed between the ventilators exhalation cover and the patient
breathing circuit to prevent possible contaminated patient exhaled gas entering the room.
Do not sterilize the ventilator.
Before each use, check the water traps on the gas inputs for any residual water or
particles.
If any damage to the ventilator is apparent, its life-supporting function can no longer be
guaranteed. Stop using the ventilator immediately and use an alternate form of ventilation.
Do not operate the ventilator in positioned next to a curtain that could block the flow of
EVM500023, Inspiration 7i Ventilator User Manual, US Rev A
The Inspiration 7i Ventilator System complies with the requirements of IEC 60601-1-2 (EMC
Collateral Standard), which include E-field immunity and ESD requirements. However, even
though the device is compliant at the levels of immunity specified in the standard, certain
transmitting devices (cellular phones, walkie-talkies, cordless phones, paging transmitters
etc.) emit radio frequencies that could potentially interrupt ventilator operation if located in
close proximity to the ventilator. Practitioners should be aware that radio frequency
emissions are additive, and that the ventilator must be located a sufficient distance from
transmitting devices to avoid interruption.
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.
Consult with your institutions biomedical engineering department in case of interrupted
ventilator operation, and before relocating any life support equipment.
Use appropriate sampling lines or airway adapters for the patient type. Components that
are too large for the patient can add dead space to the breathing circuit, and components
that are too small for the patient can cause excessive flow resistance.
Verify that gas sample flow is not too high for the patient type.
Measurements can be affected by mobile and RF communications equipment.
Replace the sampling line if the input connector LED flashes red or the ventilator displays
an occlusion message.
Exhaust gases must be returned to the patient breathing circuit or scavenging system.
1.6
Compliance
RF Emissions CISPR 11
Group 1
RF Emissions CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Complies
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Compliance Level
Electrostatic
Discharge (ESD)
Electrical Fast
Transient/burst
IEC 61000-4-4
+/- 1 kV for
Input/output lines
+/- 1 kV for
Input/output lines
Surge
+/- 1kV
differential mode
IEC 61000-4-5
+/- 2 kV common
mode
+/- 2 kV common
mode
<5% Ut
(>95% dip in Ut )
for a 0.5 cycle
<5% Ut
(>95% dip in Ut )
for a 0.5 cycle
40% Ut
(60% dip in Ut) for
5 cycles
40% Ut
(60% dip in Ut) for
5 cycles
70% Ut
(30% dip in Ut) for
25 cycles
70% Ut
(30% dip in Ut) for
25 cycles
5% Ut
(>95% dip in Ut )
for 5 sec
5% Ut
(>95% dip in Ut )
for 5 sec
3 A/m
3 A/m
IEC 61000-4-2
IEC 61000-4-11
Power Frequency
(50/60 Hz) magnetic
field.
IEC 61000-4-8
* Note Ut is the a.c. mains voltage prior to application of the test level.
P a g e | 19
The ventilator is intended for use in the electromagnetic environment specified below. The user of the ventilator
should assure that it is used in such an electromagnetic environment.
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment-Guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the ventilator, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Conducted
RF
IEC
61000-4-6
3 Vrms
10 Vrms
10 Vrms
150 kHz to
80 kHz in
Radiated RF
10 V/m
10 V/m
IEC 61000-43
80 MHz to
2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in meters (m) (b)
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey.
the compliance level in each frequency range (d)
Interference may occur in the vicinity of equipment marked with the following symbol.
P a g e | 20
NOTE 1:
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
(a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range
of 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communication equipment could
cause interference if it is inadvertently brought in to the patient areas. For this reason, an additional factor of 10/3
is used in calculating the recommended separation distances for transmitters in these ranges.
(c ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ventilator is used exceeds the
applicable RF compliance level above, the ventilator should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the ventilator.
(d) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 1V/m.
P a g e | 21
.
Recommended Separation distances Between Portable and Mobile RF Communications Equipment and the
Inspiration 7i Ventilator System
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The use of the ventilator can help to prevent electro-magnetic disturbances by maintaining the minimum distance
between portable and mobile RF communications equipment prior (transmitters) and the ventilator as recommended
below, according to the maximum output of power of the communications equipment.
Separation Distance According to Frequency of Transmitter (meters)
Rated
Maximum
Output of
Power of
Transmitter
(watts)
150 kHz to 80
MHz Outside ISM
Bands
150 kHz to 80
MHz in ISM
Bands
80 MHz to 800
MHz
0.01
0.12
0.12
0.12
0.23
0.1
0.38
0.38
0.38
0.74
1.2
1.2
1.2
2.3
10
3.8
3.8
3.79
7.4
100
12
12
12
12
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2:
The ISM (industrial, scientific and medical) bands between 150 Hz and 80 MHz are 6.765 MHz to 6.795
MHz; 13.553 MHz to 13.567 MHz; 26..957MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
NOTE 3:
NOTE 4:
An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in
the ISM frequency bands between 150 KHz and 80 MHz and in the frequency range 80MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could cause interference if it is
advertently brought into patient areas.
These guidelines may not apply in all situations. Electromagnetic propagations affected by absorption and
reflection from structures, objects and people.
P a g e | 22
Ventilator Setup
This section describes ventilator setup, including attaching the ventilator to the cart, connecting to power,
connecting to gas supplies, attaching other devices to the ventilator, and attaching the patient breathing circuit.
2.1
Follow these steps to attach the ventilator to the cart (Figure 2).
1. Assemble the cart according to its instructions.
2. Set the ventilator onto the cart, aligning the ventilator to the cart.
3. Fasten the ventilator to the cart according to the cart instructions.
Only trained and qualified professionals should assemble, operate, or test the ventilator.
Two people are required to assemble the ventilator on its cart: one to support the
ventilator, and another to attach the ventilator to the cart. Ensure that the flex arm is
positioned toward the front of the ventilator.
Ventilator
Cart
P a g e | 23
2.2
Connecting to Power
The ventilator can run on AC mains or external battery (24 VDC) power (Figure 3). The ventilator runs on
internal battery power if AC and external battery power are not available.
Power cords must be secured using the retaining clip to prevent inadvertent disconnection
of the power cord from the ventilator.
Do not compromise the AC power cord grounding protection by using an ungrounded
extension lead.
Fuses must comply with IEC 60127-2/5, and power cords must comply with IEC 245 Code 53
or IEC 227 Code 53.
Retaining clip
The ventilator is designed to recognize the local mains voltage (100-240 V AC, 50/60 Hz). Use a grounded
three-pole cable for the mains power cord, and install the mains plug into a grounded socket. The ventilator is
designed for use only with the fuses, internal batteries, external battery, and charger specified in section 7.
P a g e | 24
2.3
The ventilator is equipped with oxygen and air supply connections (Figure 4).
The gas supply hoses used for oxygen and air must be approved for at least 147 psi (10
bar) pressure. The permissible gas supply operating pressure range is 29 to 86 psi (2 to 6
bar).
Use medically pure oxygen only.
Oil impairs the individual ventilator components' ability to operate. Air and oxygen
supplies must be completely oil-free. Fault-free operation cannot otherwise be guaranteed.
Warning: pure oxygen combined with oil is highly explosive!
Oxygen connection
Air connection
P a g e | 25
2.3.1
Heliox
The Inspiration 7i Ventilator System can accommodate heliox using an approved heliox adapter or regulator to
connect to the ventilator (Figure 5). Once an adapter or regulator is attached, connect an 80/20 heliox tank.
1. Select the heliox gas type when configuring the ventilator (section 3). The Gas Type button is not displayed
if patient type is Infant. The heliox icon appears on the status bar when heliox is enabled.
2. Allow the ventilator to run with heliox for 5 minutes, then perform the system test and proximal flow sensor
calibration (section 6.2).
Perform a system test and proximal flow sensor calibration to ensure precise delivery
and measurement of tidal volumes before delivering heliox.
Heliox inlet
adapter
iggering
nection
Heliox
connection
2.4
This section describes how to attach other devices to the ventilator, including:
Communication devices (Ethernet, RS232, nurse call)
P a g e | 26
2.4.1
Attach communication devices (ethernet, RS232, and nurse call) to the ventilator back panel (Figure 6).
Ethernet connector
Ethernet
activity
LED
RS232 connector
Ethernet
link
LED
P a g e | 27
2.5
This section describes attaching patient breathing circuits to the ventilator (Figure 7). This section also includes
information on specific components, including nasal prong interfaces, the EZ-Flow proximal flow sensor, the
exhalation valve, humidification devices, and nebulizer,.
To prevent possible cross contamination, always use a bacteria filter that complies with
ASTMF1100-90, F1054-87 and ISO 5356-1 (such as the Puritan Bennett D/Flex or Re/Flex
filters) on the inspiratory limb of the patient circuit.
Do not use antistatic or electrically conductive tubing.
Use the ventilator only with standard breathing circuits (single patient use or reusable) that comply with
international standards ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1 and EN12342.
P a g e | 28
2.5.1
Nasal Prongs
The breathing circuit can include a standard infant circuit with a wye, or a standard infant circuit with infant
nasal prongs replacing the wye (Figure 8). It is important to connect the proximal pressure line correctly when
using nasal prong interfaces. NCPAP+ mode is appropriate for use with nasal prong systems.
hFor nasal prong systems whose pressure port is not centrally located.
Connect pressure line to the port and place pressure port on exhalation
side of the breathing circuit, between nasal prongs and exhalation valve.
Attach one end of the proximal pressure line to right-side silver port on the ventilator front panel (Figure 9).
Attach the other end of the pressure line to the pressure tap on the wye (if using a wye) or the pressure tap at
the exhalation side of the breathing circuit (when no wye is used).
Connect the proximal pressure line from the nasal prongs to the right-side silver port:
connecting to a different port causes the ventilator to alarm.
P a g e | 29
2.5.2
To use the proximal flow sensor option, use the EZ-Flow flow sensor (Figure 10) only.
1. Attach color-coded mutli-line tubing to flow sensor connector on front panel.
2. Attach flow sensor to breathing circuit between the wye and the patient filter, HME, or endotracheal tube
adapter (wider side and blue tubing toward patient connection.
3. To allow continuous purge flow through the flow sensor lines, orient the flow sensor as shown with tubing
pointing up.
To patient connection
To circuit wye
Select the proximal flow sensor On when configuring the ventilator (section 3) and calibrate the flow sensor
(section 6.2.1) before patient use.
2.5.3
Because internal ventilator transducers are not separate from the proximal flow sensor
circuit, it is important to orient the flow sensor with tubing pointing up. This allows the
purge flow to keep the tubing clear and help prevent internal ventilator contamination.
Exhalation Valve
Operate the ventilator only with eVent Medical exhalation valve cover and diaphragm (Figure 11) installed.
2.5.4
Humidification Devices
Any humidification device used with the ventilator must comply with international standards, including
EN8185-1, ISO9360, ASTMF1100-90, F1054-87, and ISO 5356-1.
P a g e | 30
2.5.5
Nebulizer
Use the ventilator only with standard small volume jet nebulizers (single patient use or reusable) and disk filter
that comply with international standards ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1, and
EN12342.
1. Place the nebulizer in the inspiratory limb of the patient circuit based on clinical judgment and manufacturer
recommendations, and use the nebulizer according to manufacturer instructions.
2. Attach nebulizer jet driveline and disk filter attach to the Nebulizer nipple connector on the ventilator front
panel (Figure 12).
Nebulizer connector
The Nebulizer outlet provides a pressure of 14 to 22 psi, which typically generates a nebulizer flow of
6 to 8 l/min. When the nebulizer is active, gas delivery to the patient is compensated to ensure that breath
parameters (volume, flow and FIO2) are not affected.
If flow triggering was active before nebulizer activation, the ventilator uses pressure triggering during
nebulization, and resumes flow triggering when nebulization is complete.
To start nebulization, select Smart Nebulizer On from the ventilator Config tab (section 3).
P a g e | 31
The nebulizer function is not available during Infant ventilation or when delivered flow
drops below 10 l/min.
Only trained users should change ventilator configuration: changing the configuration
can have serious consequences for subsequent ventilation.
Provide an alternate form of oxygen monitoring if turning off the internal oxygen sensor.
If power on self test (POST) detects an error, ventilation is not possible until it is
corrected. Contact a qualified service technician.
Changes to configuration do not take effect until the ventilator is restarted.
P a g e | 32
2. When POST is complete, the screen prompts you to select a new or previous patient (Figure 14).
Select Previous
then ACCEPT
3. Select Previous, then select ACCEPT to go to the Standby screen. Select the Config tab (Figure 15).
Standby
screen
Config tab
Buttons select
user
configuration
screens
P a g e | 33
Description
Humidification Type
Smart Nebulizer
Smart Sigh
Sets breaths to be delivered at a regular interval with higher than normal volume or
pressure. (Smart Sigh button appears if Smart Sigh is enabled by a qualified service
technician as described in the Inspiration 7i Ventilator System Service Manual.)
Sigh: On or Off.
Sigh Factor (additional percentage of set volume or pressure delivered during a sigh
breath) 0 to 50%.
Sigh Every (number of normal breaths delivered between each Smart Sigh delivery):
20 to 200 Breaths.
Sigh Num. (number of consecutive sigh breaths delivered): 1 to 6 times.
Graph Settings
Monitors
Prox.Flow/O2 Sens.
Special
Audio/LCD Level
Audio Level in %.
Screen Clicks: On or Off.
LCD Brightness in %.
Technical
Reserved for use by trained service technicians to test and configure ventilator
hardware characteristics (see the Inspiration 7i Ventilator System Service Manual).
P a g e | 34
P a g e | 35
Ventilator Operation
This section describes how to use the Inspiration 7i Ventilator System, including turning the ventilator on and
off, using the screen, ventilator controls, starting ventilation, selecting settings, setting alarm limits, displaying
monitored data, and using special ventilator functions.
4.1
The Inspiration 7i ventilator must only be operated by clinicians qualified to assess the
patients clinical condition and treatment.
Before connecting the ventilator to a patient, perform the System Test and alarms test
procedures (section 6).
Connect the ventilator to AC power whenever possible (even if the ventilator is turned off)
to allow the internal batteries to recharge.
Availability of some settings depends on applicable regulatory clearances and ventilator
configuration. Check ventilator configuration (section 3) to enable available features, or
contact a qualified service technician.
1. Turn the ventilator on by pressing the On/Off/Standby key (Figure 16) for over one second.
On/Off/Standby key
P a g e | 36
2. The ventilator performs power on self test (POST), a complete check of the ventilator (Figure 17).
3. Once the ventilator is on and you have selected New or Previous patient type, pressing the On/Off/Standby
key again displays a screen (Figure 18) that allows you to select one of these options:
Off: Turn the ventilator off.
Patient Setup: Return to the Patient Startup screen.
Standby: Place the ventilator in Standby mode.
Cancel: Resume normal operation.
P a g e | 37
4.2
Scratching the touch screen can affect its function. Use a finger or a rounded pointer to
touch the surface. The touch screen works if you are wearing gloves. Do not pencils,
ballpoint pens, or fingernails on the touch screen.
Before the installation the ventilator and touch screen are fully calibrated for precise
operation. If required, touch screen calibration must be performed by a qualified service
technician as described in the Inspiration 7i Ventilator System Service Manual.
Use the touch screen and rotary knob to select, change, and activate ventilator parameters. Touch the
parameter to change, turn the knob to adjust the value, then touch the parameter again or push the knob.
Figure 19 shows an example of how to change a setting.
Rotary knob
Touch screen
Setting
value
changed
Setting
change
accepted
To prevent accidental or unaccepted changes, any unaccepted change reverts to its previous value after 10
seconds or if you touch another field before accepting the change.
P a g e | 38
A setting that displays the eVent logo indicates that it is linked to one or more other setting(s). For example
(Figure 20), nebulizer time is linked to whether the nebulizer is on or off. Nebulizer time cannot be selected if
the nebulizer is off.
4.3
Starting Ventilation
1. Once the ventilator passes POST, the screen prompts you to select New or Previous patient (Figure 21).
To use the previously-accepted patient settings, select Previous and press ACCEPT.
P a g e | 39
2. For New patient startup, select New and enter the IBW. The ventilator can automatically calculate the IBW
based on entered values for patient height, gender, and frame (Figure 22) or you can enter the IBW
manually.
If you enter the IBW only, the New Patient startup screen reflects that the other patient parameters are not
entered (Figure 23).
P a g e | 40
8. Press ACCEPT. The display shows proposed mode and settings (Figure 24). Review the settings and
change them if necessary. The ventilator remains in Standby mode until you press ACTIVATE to start
ventilation.
If you enter an IBW of 40 kg or less indicating a infant, or pediatric patient, the screen background is light
blue (male gender) or pink (female gender). If you dont select a gender, the screen background is light
blue. The screen background is dark gray for patients whose IBW is greater than 40 kg (adult), regardless
of gender.
P a g e | 41
4.4
Description
Auto Control
(CMV modes, not
available during
apnea backup)
Auto Control enables the ventilator to automatically transition between CMV and spontaneous
modes in response to the presence or absence of spontaneous breathing without alarms or
clinical intervention.
When Auto Control is on, Time sets the time in seconds without a spontaneous effort to transition
from spontaneous mode back to CMV.
Section 4.4.1 describes Auto Control in more detail.
Apnea backup
Apnea backup provides backup ventilation if the Apnea alarm limit elapses without breath
triggering.
Backup ventilation is delivered according to the selected Apnea Backup modes and settings.
Backup ventilation modes are the same as for normal ventilation except:
The only SPONT mode available for backup ventilation is SPAP (PS and VS are not
available)
OFF is available in any mode type to disable backup ventilation.
Section 4.4.1 describes Apnea backup in more detail.
Cycles
(SPAP mode)
Cycles sets the number of times per minute the ventilator cycles from low PEEP to high PEEP.
Transitions between high and low PEEP levels are synchronized with spontaneous breaths.
Esens
(Spontaneous
breaths)
Exhalation sensitivity sets the percent of peak inspiratory flow at which the ventilator cycles from
inspiration to exhalation. Increasing the Esens setting shortens inspiratory time.
Flow
(Mandatory breaths
in V-CMV and VSIMV)
Peak (maximum) inspiratory flow setting. Available if ventilator is configured for US philosophy
(see the Inspiration 7i Ventilator System Service Manual for more information).
Flow-Pat.
(Volume control
mandatory breaths)
Flow pattern for volume control mandatory breaths. The flow pattern and is unaffected by patient
back pressure or other factors as long as the peak inspiratory flow and pressure limit are not
exceeded. Flow patterns include square, decelerating ramp, and decelerating ramp 50%.
Ftrig
Flow trigger sets the patient inspiratory flow that triggers a breath. Applies to all breaths when
pressure triggering is selected (see Trigger setting).
When flow triggering is selected, the ventilator generates a continuous base flow from the
inspiratory outlet to the expiratory outlet. The base flow is 2 l/min above the flow trigger setting.
NOTE: Adjusting Ftrig changes ventilator sensitivity to patient effort. In case of auto-triggering,
check the ventilator and breathing circuit before increasing the Ftrig setting.
P a g e | 42
Ventilation setting
Description
H:L
(SPAP mode)
H : L sets the ratio of time at high and low PEEP levels when the SPAP Type is Cycle + Ratio.
I:E
(Mandatory breaths)
Ratio of inspiratory time to expiratory time for mandatory breaths. Available if ventilator is
configured for European philosophy (see the Inspiration 7i Ventilator System Service Manual for
more information).
NIV
Selecting NIV (noninvasive ventilation) and Leak Comp. (leak compensation) allows the ventilator
to automatically compensate for circuit leaks of up to 60 l/min, allowing for more effective
ventilation when using a noninvasive patient interface.
The default Trigger setting in NIV is flow. If the proximal flow sensor is disabled pressure
triggering is enabled.
Oxygen
Pcontrol
(Mandatory breaths
in P-CMV and PSIMV)
PEEP
(Not available in
SPAP mode)
Phigh
(SPAP mode)
High PEEP level, the baseline airway pressure during the Thigh phase in SPAP.
Tplateau
(Volume control
mandatory breaths)
Length of plateau or inspiratory pause, expressed in seconds (when ventilator is configured for
US philosophy) or as a percentage of total breath cycle time (European philosophy).
Once the set Vt is delivered, exhalation is blocked for the set plateau time to hold gas in the
patients lungs, increasing Ti. (See the Inspiration 7i Ventilator System Service Manual for more
information how to select US or European philosophy.)
Plow
(SPAP mode)
Low PEEP level, the baseline airway pressure during the Tlow phase in SPAP.
Ptrig
Ptrig sets the pressure trigger (pressure drop below PEEP) that triggers a breath. Applies to all
breaths when pressure triggering is selected (see Trigger setting).
Psup high
(SPAP mode)
The set level of pressure support (above Phigh) during the Thigh phase in SPAP.
Psup low
(SPAP mode)
The set level of pressure support (above Plow) during the Tlow phase in SPAP.
Psupport
(Spontaneous
breaths)
Rate
(Not available in PS,
VS, SPAP)
Sets the time for inspiratory pressure to rise to the set (target) pressure.
Rise time adjusts the initial flow output during a pressure-controlled, pressure-supported, or dualmode volume targeted breath. Faster rise times provide higher initial flow rates and attain target
pressure more quickly.
Vt
(Volume based
modes)
Thigh
(SPAP mode)
Ti
(Pressure based
mandatory breaths)
Sets the inspiratory time for pressure-based mandatory breaths Available if ventilator is
configured for US philosophy (see the Inspiration 7i Ventilator System Service Manual for more
information).
P a g e | 43
Ventilation setting
Description
Tlow
(SPAP mode)
Trigger
4.4.1
Auto Control
Auto Control (Figure 25) enables the ventilator to make automatic transitions between CMV and spontaneous
modes in response to the presence or absence of patient effort. These automatic transitions occur without user
intervention or alarms. Auto Control is designed to detect patient readiness to breathe independently, and can
provide a more synchronous alternative to apnea ventilation for patients whose respiratory drive is variable or
depressed.
If the patient triggers two consecutive breaths when Auto Control is on, the ventilator automatically switches to
a spontaneous mode.
If the patient fails to trigger a breath within the Auto Control time setting, the ventilator automatically switches
back to the original CMV mode. The Auto Control time setting is typically significantly shorter than a typical
Apnea alarm limit.
Turning Auto Control on displays the Esens and Rise Time settings: select the appropriate values for
spontaneous breathing.
When Auto Control is on, the ventilator switches between mandatory and spontaneous modes. The
spontaneous mode is determined by the selected mandatory mode.
If the mandatory mode is:
PRVC-CMV
VS
V-CMV
VS
P-CMV
PS
Turning Auto Control on automatically turns Apnea backup off, and turning Auto Control off automatically turns
Apnea backup on.
P a g e | 44
4.4.2
Apnea Backup
At the new or proposed settings screen, select Apnea backup to view the Apnea Backup Settings screen
(Figure 26), and select the appropriate settings for apnea backup ventilation. Apnea backup ventilation starts if
the Apnea alarm limit elapses without breath triggering. Normal ventilation resumes if the patient triggers two
consecutive breaths.
Turning Auto Control on automatically turns Apnea backup off, and turning Auto Control off automatically turns
Apnea backup on.
4.5
Select the Alarms tab to view alarm limit settings and the event log (Figure 27). For high and low alarm limits,
the value of the lower limit is always less than the higher limit.
Select AUTO SET to set automatic alarm limits based on monitored data. Ensure that the patient is connected
and that monitored values stable before selecting AUTO SET. Review all alarm limits to ensure that they are
appropriate and safe. AUTO SET affects the Ve, Vte, Rate, Ppeak, and Pmean alarms only.
P a g e | 45
Ventilator software automatically sets high and low oxygen % alarm limits to 7% above and
below the O2 setting, and is not adjustable.
Alarm limit
Description
Ve
Vte
Rate
Ppeak
Pmean
Leak
Apnea
Apnea interval (s): time without a breath trigger that starts Apnea
backup ventilation.
Vt lim
P a g e | 46
4.5.1
Event Log
Access the Event Log from the Alarms tab to view the 1,000 most recent events that are applicable to the
currently selected patient (Figure 28). All events include date and time of occurrence.
Selecting a new patient clears the event log. However, the internal ventilator event log intended for use by
service technicians is unaffected by patient selection.
The log allows you to sort the display in order of occurrence, event, or according to user-selected event
markers (section 4.6.2).
P a g e | 47
4.6
The Monitoring tab (Figure 29) allows you to review monitored data and select customized trends, and loops
P a g e | 48
4.6.1
Monitoring Data
Select Monitoring Data (Figure 29) to view up to four monitored data tabs: Basic, Advanced and Mechanics,
Each tab displays real-time monitored data. Dashes next to a parameter indicate that it is not currently
available.
Monitored parameter
Description
Basic tab
Ppeak
Pmean
PEEP
Vti
Vti/kg
Vte
Measured expiratory tidal volume (ml). Available when proximal flow sensor is on.
Vte/kg
Ve
Measured minute volume, the total (spontaneous and mandatory) tidal volume of gas delivered in
the previous minute (l/min).
Ve/kg
Ve Spont
Measured spontaneous minute volume, the total spontaneous tidal volume of gas delivered in the
previous minute (l/min).
Rate
Measured number of spontaneous and mandatory breaths delivered in the previous minute
(b/min).
Rate Spont
Advanced tab
Ti
Te
PF
PFe
I:E
H:L
Ti/Tot
Leak
O2
HeO2
Spont %1h
Ratio of spontaneous respiratory rate to total respiratory rate over the previous hour (%).
Spont %8h
Ratio of spontaneous respiratory rate to total respiratory rate over the previous eight hours (%).
Mechanics tab
Auto PEEP
Pplateau
RSBI
Rapid shallow breathing index, ratio of measured respiratory rate to inspiratory tidal volume
(b/min/l).
C20/C
Ratio of dynamic lung compliance during the last 20% of inspiration (C20) to total dynamic
compliance. A value of < 0.80 can indicate overdistension.
Cstat
Cstat/kg
Rinsp
P a g e | 49
4.6.2
Trend Data
Select Trend Data (Figure 30) to view trended information. Use the Trend Data button on the Config tab
(section 3) to select how many (1, 2, or 3) trended data parameters to display.
Minimize or maximize
display
To minimize or maximize the Trend data display, select the arrow button at the upper left corner.
To adjust the time (horizontal) or value (vertical) axis, touch the axis to view available scales. Changing the
time scale on one display automatically makes the same change to other trended parameters.
4.6.2.1 Event markers, Available on Inspiration 7i Ventilator Only
To enter a specific procedure, select the appropriate event marker: the event marker then appears on the trend
graph.
Touching the graph outside the axis displays a cursor and freezes the waveform (Figure 31). You can touch
and drag the cursor to any point on the time axis, and the numeric values for the cursor position appear on
the graph. You cannot adjust the scale when the cursor is displayed. To remove the cursor display, touch
the Unfreeze icon.
P a g e | 50
Unfreeze icon
Cursor
Numeric value at
cursor position
To enter a comment, select the User Comment event marker: Use the onscreen keyboard to enter the
comment, then select ACCEPT to enter the marker or BACK to cancel (Figure 32).
P a g e | 51
To select a parameter for display, select a displayed parameter, then select the parameter to display in its place
(Figure 33).
Figure 33: Selecting Trend Data Parameters (Vti and Rate Selected)
P a g e | 52
4.6.3
Select Loop Study to view Loop Data (Figure 34), a real-time display of flow-volume (F/V) and pressure-volume
(P/V) loops.
Minimize or
maximize
display
Unfreeze icon
Save Loops
button
Ref. Loop
button
Saved loop
As in Trend Data waveforms, touching the graph outside the axis displays a cursor and freezes the loop. You
can touch and drag the cursor to any point on the time axis, and the numeric values for the cursor position
appear on the graph. You cannot adjust the scale when the cursor is displayed. To remove the cursor
display, touch the Unfreeze icon.
When the loop display is frozen, the Save Loops button appears. Pressing the Save Loops button stores the
current loops display in the left panel. Up to 8 loops displays can be saved at a time. If 8 loop displays are
already stored, saving another automatically deletes the oldest of the saved loops.
P a g e | 53
To display a saved loop for reference, touch the saved loop to display, then selecting Ref. Loop On. The
current loop display appears superimposed over the saved loop (Figure 35).
Touch the Ref. Loop button as needed to toggle between displaying or clearing the selected reference loop.
Current loop
Reference loop
Ref. Loop
button
Reference
loop
Current loop
To delete a saved loop display, touch and hold the saved loop for 2 seconds until a red circled x appears on the
folder icon. Touch the folder again to delete, or touch the time and date information to cancel the delete.
4.7
Special Functions
This section describes special ventilator functions, including the %O2 increase key, Manual inspiration key, and
Smart Nebulizer.
4.7.1
% O2 Increase Key
The % O2 increase key increases oxygen concentration above the set level for 5
minutes.
20% increase for infant patient type
100% FiO2 for pediatric/adult patient type
Pressing the key again during the 5-minute interval returns the oxygen concentration to its original level. When the %O2
increase is active an onscreen indicator displays the actual delivered oxygen concentration.
EVM500023, Inspiration 7i Ventilator User Manual, US Rev A
P a g e | 54
4.7.2
In V-CMV, V-SIMV, P-CMV and P-SIMV, a manual inspiration uses the current settings, except exhalation is
limited to 20% of the set cycle time. The Tcycle of the manual is 4 s (adult and pediatric patient types) or 2 s
(infant patient type) unless the set Rate would result in a shorter Tcycle.
For example, if the set Rate is 10 b/min for an adult patient, Tcycle = 4s for the manual inspiration, the volume
is set Vt, and the target pressure = Pcontrol + PEEP.
In SPONT mode, a manual inspiration is delivered at a target pressure of Pcontrol + PEEP at default settings
for Rate and I:E ratio. Exhalation is limited to 20% of the resulting cycle time.
4.7.3 Alarm Mute Key
Section 5.1.1 describes the Alarm mute key.
4.7.4
Smart Nebulizer
Nebulizer
settings
Select
Smart Nebulizer
P a g e | 55
Smart Sigh
4.7.5
The Smart Sigh feature allows sigh breaths (breaths with higher than normal volume or pressure) to be
delivered at selected intervals. The Smart Sigh feature is available if enabled by a qualified service technician
as described in the Inspiration 7i Ventilator System Service Manual.
Follow these steps to use the Smart Sigh feature (Figure 37):
1. Select the onscreen Config tab, then touch Smart Sigh. (Contact a qualified service technician for
assistance if the Smart Sigh button is not visible.)
2. Select Sigh On, then select these Smart Sigh settings:
Sigh Factor: the additional percentage of set volume or pressure delivered during a Smart Sigh breath.
Sigh Every: the number of normal breaths delivered between each Smart Sigh delivery.
Sigh Num.: the number of consecutive sigh breaths delivered at each Smart Sigh delivery.
Smart Sigh
settings
Select
Smart Sigh
P a g e | 56
4.8
Battery icon
Current mode
Alarms
Monitoring bar
Alarm mute
indicator area
Settings bar
ACTIVATE, LOCK,
UNLOCK buttons
Patient type
Current mode
Patient trigger
Status bar
Displays indicators of specific conditions or events including: alarm silence, O2 sensor off,
calibration required, 100% O2, , heliox, manual inspiration, nebulization, sigh, apnea, and
auto control.
Battery icon
Displayed at the upper right corner of all user screens. Date and time are set during
ventilator configuration (see the Inspiration 7i Ventilator System Service Manual for more
information).
P a g e | 57
Alarms
Monitoring bar
Settings bar
Displays the commonly-adjusted settings that apply to the current or proposed mode,
providing quick access for adjusting them.
ACTIVATE button
LOCK/UNLOCK
button
The LOCK button appears once a mode is activated. Touching LOCK locks the screen
except for the O2 setting.
The UNLOCK button appears once the screen is locked. Touch UNLOCK to unlock the
screen.
This icon indicates that alarm mute is silencing current alarms, and appears above the
ACTIVATE, LOCK, or UNLOCK buttons when Alarm mute (section 5.1.1) is active.
This icon indicates that 2-minute alarm pre-silence is active, and appears above the
ACTIVATE, LOCK, or UNLOCK buttons when Alarm mute (section 5.1.1) is active.
Once ventilation begins, select the Main tab o displays the selected graphics on the main screen (Figure 39: Main
Screen Graphics During Ventilation
Figure
40
Touch axis to toggle through selectable scales.
eVent logo indicates automatically-selected scale.
Monitored
data
parameters
Touch to toggle
between F/V loop,
P/V loop, and Man.
(maneuvers)
Touch to toggle
between Volume,
Flow, and Pressure
Ventilator
settings
Touch to protect
against inadvertent
settings changes
(toggles between
Lock and Unlock)
P a g e | 58
Mandatory breath
(red = inspiration,
blue = exhalation)
Spontaneous breath
(green = inspiration,
light blue = exhalation)
Minimize display
Touching the graph outside the axis displays a cursor and freezes the waveform (Figure 42). You can touch
and drag the cursor to any point on the time axis, and the numeric values for the cursor position appear on
the graph. You cannot adjust the scale when the cursor is displayed. To remove the cursor display, touch
the Unfreeze icon.
P a g e | 59
Unfreeze icon
Cursor
Numeric value at
cursor position
Use the Graph Settings button on the Config tab to change the format of the main screen display (section 3).
4.9
Maneuvers
To access respiratory maneuvers, touch the left panel button to select Man (Figure 42)
Touch to toggle to
Man. (maneuvers)
P a g e | 60
4.9.1
4.9.2
P a g e | 61
Alarm Handling
This section describes audible and visual alarm signals, alarm mute, the alarm log, and alarm handling for the
ventilator.
5.1
Alarm Signals
All audible and visual alarms comply with IEC 60601-1-1-8, EN475 and IEC 60417-5576 recommendations.
Alarms at the 100% volume setting meet IEC 60601-1-1-8 standards and EN475 recommendations.
Alarm priority
Visual
Audible
Comments
HIGH
5 repeating
signals
MEDIUM
3 repeating
signals
INFORMATION
1 signal
Use the Config tab (section 3) to adjust the volume level for audible alarm signals.
The ventilator displays alarms in order of priority from right to left across the screen (
Figure 44), and can display up to three alarms at once. Informational messages appear once per occurrence.
Once an alarm condition is corrected, touch the alarm notification area to clear its display.
Select the Alarms tab to view the alarm and its set limit.
Active
alarms
P a g e | 62
5.1.1
To silence active alarms and any new alarm that occurs during the 2-minute alarm silence: Hold down the Alarm
Mute key on the front panel until the red alarm silence symbol appears. This allows you to pre-silence alarms
under circumstances when new alarms would otherwise occur (for example, during suctioning).
5.2
Alarm Log
Select the Alarms tab then select Event Log to view the most recent 1,000 time-stamped events in order of
occurrence (Figure 45). You can sort the log by event type to view all alarm events together. See section 4.5.1
for more information about the Event Log.
Figure 45: Viewing the Event Log from the Alarms Tab
5.3
Ventilator Alarms
This section describes ventilator alarms and suggests corrective action. Follow corrective action steps in order
to resolve the alarm condition is resolved. If the alarm persists, contact a qualified service technician.
Description
Corrective action
Not applicable.
Contact service.
1.
2.
3.
P a g e | 63
Description
Corrective action
Air supply
High priority alarm. Air supply not available and compressor backup is
not installed or disabled. Ventilation continues with 100% oxygen.
1.
2.
3.
Apnea
High priority alarm. The set apnea time has elapsed without a patient
triggered or mandatory breath, apnea backup disabled. Ventilator
waits for patient trigger or mandatory breath.
Apnea backup
active
High priority alarm. The set apnea time has elapsed without a patient
triggered or mandatory breath. Apnea ventilation begins.
Battery flat
If apnea backup is not enabled in the apnea backup screen, the ventilator does not provide apnea
backup once the apnea interval time has elapsed.
1.
2.
3.
Battery low
3. Replace battery.
Battery not
available
1.
2.
3.
Check
Pcontrol/Pmax
Check
Psupport/Pmax
Compressor
Disconnection
1.
2.
3.
1.
2.
3.
Flow cal. not
available
1.
2.
3.
Description
Corrective action
Gas connected;
Heliox?
Heliox P Low
Use Air
1.
2.
3.
Heliox supply
1.
2.
High external
voltage
High frequency
Medium priority alarm. Possible circuit leak exceeds Leak alarm limit.
Ventilation continues.
1.
2.
3.
High minute
volume
High oxygen
1.
1.
High temperature
Increase O2 not
avail
1.
Int press
low/Disconnect
Logbook cleared
Not applicable.
High pressure
P a g e | 65
2.
3.
2.
2.
Description
Corrective action
Low frequency
Low minute
volume
Low oxygen
High priority alarm. Inspiratory oxygen concentration below ventilatorset alarm limit. Alarm occurs only if oxygen sensor is On in
configuration. Ventilation continues.
1.
Low pressure
Contact service.
Mem power no
protect
Contact service.
Mem sensor no
protect
Contact service.
O2 sensor not
avail
1.
2.
3.
2.
O2 supply
1.
2.
Occlusion
1.
2.
3.
P Op High V not
deliver
1.
2.
P. Line on Right
Side?
P a g e | 66
Description
Corrective action
Pmean high
Pmean low
1.
2.
3.
Pressure is being
limited
1.
2.
Speaker fault
TF xxx
Volume is being
limited
1.
2.
Vti limit reached
P a g e | 67
High priority alarm. Inspiratory tidal volume exceeds Vti alarm limit for
two consecutive breaths. Ventilation continues but cannot deliver
selected Vt.
Maintenance
This section describes maintenance procedures including, cleaning and inspection, calibrations, preventive
maintenance, alarms testing, and disposal.
6.1
Perform all cleaning and sterilization carefully and according to all applicable regulations to ensure that the
ventilator functions safely and effectively.
Dampen a soft cloth with isopropyl alcohol or a nonabrasive glass cleaner and wipe the hard-coat
side of the screen. Do not use vinegar-based solutions. Handle the touch screen with care to
avoid scratches.
Ventilator
exterior
Wipe with an appropriate bactericidal agent before each patient use. Do not use alcohol as a
disinfectant: it does not harm the ventilator but is not proven to be an effective bactericidal or
bacteriostatic agent.
Includes housing, cart, basket, tray, gas supply hoses, power cords, communications adapters
and cables. Do not attempt to clean ventilator interior.
Patient
breathing
circuit and
nebulizer
Humidification
device
Use only patient circuits and nebulizers that comply with relevant international standards
(ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1 and EN12342).
Use only humidification devices that comply with relevant international standards (EN 8185 1, ISO
9360 ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1 and EN12342).
P a g e | 68
Section 6: Maintenance
Mask (silicone
rubber)
Steam autoclave, chemically disinfect, or ETO sterilize reusable accessories between patients Clean and sterilize according to manufacturer recommendations. Deflate air cushion before steam
autoclaving to prevent possibility of explosion
Avoid exposure to grease, oil, silicone-based lubricants, organic solvents (benzene, ether, ketone,
and chlorinated hydrocarbons), acids, concentrated alkaline cleaning products, and phenols and
derivatives.
EZ-Flow
proximal flow
sensor
Reusable EZ-Flow sensor: Follow standard institutional operating procedure to clean then
autoclave using 250 F (121 C) or 275 F (134 C), or cold sterilize between patients.
Replace the flow sensor if damaged or after 50 sterilization cycles.
Remove and discard flow sensor tubing before cleaning the reusable sensor.
Single patient use (SPU) EZ-Flow sensor: replace and discard between patients. The SPU
EZ-Flow sensor and tubing are single use items: do not attempt to reuse or sterilize.
The flow sensor is designed for single-patient use. It is delivered clean and ready for patient
use.
If the sensor must be decontaminated, do not use hard brushes, pointed instruments, or
rough materials. These can damage the flow sensor membrane.
Exhalation
valve cover
Exhalation
diaphragm
P a g e | 69
Exhalation
diaphragm
Exh Cover
Steam autoclave, chemically disinfect, or ETO sterilize the exhalation valve cover between
patients. Follow standard institutional operating procedure to autoclave at 250 F (121 C) or
275 F (134 C).
Inspect the membrane for damage; replace if necessary.
Replace the diaphragm if damaged or after 10 autoclave cycles.
Section 6: Maintenance
6.2
Calibrations
The ventilator provides a Calibrations option at the patient startup screen (Figure 46). Use Calibrations to
calibrate the proximal flow sensor, patient tubing system compliance/leak, or to calibrate the oxygen sensor,
Figure 46: Selecting Calibrations from Patient Startup Screen (Previous Patient Shown)
The Calibrations screen (Figure 47) allows you to select which calibration to perform, and displays the
calibration current calibration status.
Calibration status
P a g e | 70
Section 6: Maintenance
6.2.1
Performing a flow sensor calibration (Figure 48) defines the performance characteristics of the proximal flow
sensor before use. The calibration data is stored in NVRAM and used during normal operation to ensure
accurate proximal measurements.
Perform a flow sensor calibration before each patient use and following flow sensor replacement or sterilization.
Failure to perform proximal flow sensor calibration can lead to inaccuracies in exhaled volume measurements
(Vte) and flow triggering problems (insensitivity or auto-triggering).
The proximal flow sensor calibration requires at least one high-pressure gas
source.
Before performing a flow sensor calibration, select the humidity type in use (Warm Humidifier or Other). The
screen show status messages as it performs the calibration and when the calibration is complete.
If there is an error at any step during the calibration, the calibration stops and the ventilator displays the
appropriate error number and message. Check the flow sensor and circuit verify correct installation and repeat
the calibration. If the problem persists, contact a qualified service technician.
P a g e | 71
Section 6: Maintenance
6.2.2
System Test
Performing a system test (Figure 49) verifies patient tubing system integrity and quantifies compliance and leak
before patient use. The ventilator uses the calculated system compliance on a breath-by-breath basis to
compensate for circuit effects and ensure accurate volume delivery and measurements.
Perform a flow sensor calibration before each patient use and after replacing or modifying patient system
components. Failure to perform the system test can lead to leaks or incorrect compliance factors that can affect
breath delivery and monitoring accuracy.
The screen show status messages as it performs the system test. The ventilator displays a message prompting
you to block the wye: use an appropriate stopper to block the wye and press OK to continue. If all steps are
successful, the calibration is complete.
If there is an error at any step during the calibration, the calibration stops and the ventilator displays the
appropriate number and message. Re-run the test verifying that the circuit is closed and the wye is open and
closed as prompted. If the problem persists, contact a qualified service technician.
P a g e | 72
Section 6: Maintenance
6.2.3
Performing an oxygen sensor calibration (Figure 50) defines internal oxygen sensor performance
characteristics before use by performing a two-point (21% and 100%) calibration. The calibration data is stored
in internal ventilator memory and used during normal operation to ensure accurate FiO2 delivery.
Perform a flow sensor calibration before each patient use and after replacing the oxygen sensor or Sensor
board. Failure to perform the oxygen sensor calibration can lead to inaccurate monitored O2% values.
The oxygen sensor calibration requires high-pressure sources of air and oxygen.
The screen show status messages as it performs the calibration and when the calibration is complete.
If there is an error at any step during the calibration, the calibration stops and the ventilator displays the
appropriate error number and message. Verify that the oxygen sensor is enabled and that all connections are
secure and repeat the calibration. If the problem persists, contact a qualified service technician.
P a g e | 73
Section 6: Maintenance
Preventive Maintenance
6.3
Maintenance procedure
Every year or as
required
As required
6.3.1
6.3.2
P a g e | 74
Section 6: Maintenance
6.3.3
6.3.4
P a g e | 75
Internal
Batteries
Section 6: Maintenance
6.3.5
Mains
outlet
Fuse
drawer
6.4
The alarm test procedures listed below comply with EN 794-1 recommendation. This procedure tests the
following alarms:
High pressure alarm
Low pressure alarm
Disconnection alarm
Low minute volume alarm and low tidal volume
Oxygen supply/Low oxygen alarms
Continuous High pressure alarm
Apnea backup active alarm
Power source transition
Battery low and battery flat
Follow these instructions to test ventilator operation and the below alarms before attaching the ventilator to a
patient.
In addition to the alarms test, perform the System Test calibration (section 6.2.2) to verify breathing circuit
integrity. Correct any test failures and rerun tests before starting ventilation.
1. Select these settings and alarms:
Mode:
VCMV
Ve
Trigger:
Flow
Vte:
Rate:
10 b/min
Rate:
Vt:
500 ml
Ppeak:
PEEP:
5 cmH2O
Apnea:
20 s
Tplateau:
0s
Flow Pat.:
Square
O2:
21 %
Flow:
45 l/min
Ftrig:
2 l/min
2. High pressure alarm test: Allow the ventilator to cycle at the above settings with a test lung
(Puritan-Bennett part number 612 or equivalent) attached. Change the Ppeak high alarm limit to 6 cmH2O.
Verify that the high pressure alarm sounds after two breaths, and that patient pressure is limited to
6 cmH2O. Change the Ppeak High alarm setting back to 40 cmH2O.
EVM500023, Inspiration 7i Ventilator User Manual, US Rev A
P a g e | 76
Section 6: Maintenance
3. Low pressure, Disconnection, and Low minute volume alarm tests: Change the Ve low alarm limit to
12 l/min and disconnect the test lung from the circuit. Verify that the Disconnection and Low tidal volume
alarms sound after the next breath. Verify that the Low Pressure alarm and Low minute volume alarm
sound after several breaths. Change the Ve low alarm limit back to 2 l/min and reconnect the test lung.
4. Oxygen supply/Low oxygen alarm tests: Change the O2 setting to 100% and disconnect the oxygen supply
line. Verify that the O2 supply alarm sounds immediately, and that the Low Oxygen alarm sounds within a
few breaths. Change the O2 setting back to 21%.
5. Continuous High pressure alarm test: Change the Ppeak high alarm limit to 20 cmH2O and block the
expiratory limb of the circuit. Verify that the High Pressure alarm sounds within two breaths, and that the
alarm is continuous until you unblock the circuit. Unblock the circuit and change the Ppeak high alarm limit
back to 40 cmH2O.
6. Apnea backup active alarm test: Change the Apnea setting to 10 seconds and Rate setting to 5 b/min.
Verify that the Apnea backup active alarm sounds and apnea ventilation begins within 20 seconds (an
onscreen Apnea indicator appears during apnea ventilation). Change Rate back to 10 b/min.
7. Power source transition: Disconnect the mains power cord and verify that an audible tone sounds
immediately. Verify that the ventilator begins battery operation without interrupting ventilation (a battery
icon and estimated capacity are displayed during battery operation). Reconnect the mains power cord and
verify that the AC power indicator is on.
8. Battery low and battery flat alarm: If testing of the internal battery is desired, assure that the battery is fully
charged to greater than 95%. Disconnect the high pressure air source and AC mains and operate the
ventilator on 21% with the internal compressor if available. The ventilator should operate for approximately
2 hours or more depending on settings. If no internal compressor is installed the ventilator batteries take
approximately 4 hours or more (depending on settings) to discharge. Assure that a medium priority low
battery alarm sounds as the ventilator discharges to a low value. The ventilator should continue to run until
a Battery flat alarm occurs. The ventilator should then turn off and continue to sound a high priority alarm
for at least one minute (typically the alarm continues for much longer). The ventilator uses external battery
power first (if available) until depleted, and then switches to internal battery power.
9. High FIO2 alarm: Remove the cover plate for the oxygen sensor and disconnect its electrical connector.
Operate the ventilator with test settings. Verify that the oxygen sensor measurements increase and that the
High Oxygen alarm occurs within a few minutes.
The alarms test procedure is complete.
6.5
Disposal
P a g e | 77
The internal batteries and galvanic oxygen sensor cell contain lead and acid. Dispose of
these materials according to hospital procedures and local governing ordinances.
Risk of electrocution! Some of the devices electronic components carry AC mains
voltage.
Always disconnect the mains plug and remove the internal battery before opening the
ventilator...
Spare Parts
Description
Part number
Pk stands for pack
XX is reserved for the language variant
F910300
F710562
F730744
F710561
F710563
F910089
F710213-PKG
F710214
External battery
F710520
F710521
F910203-PKG
F910204-PKG
F910321
F910322
F910260-PKG
F910214
F910251
F910371
F910039
F930166
Oxygen sensor
F910028
F710616
F710569
Tube Hanger
F710570
Mounting bracket
F710571
F910215
F910355
F910037
F910038
F710528
F710564
F710568
P a g e | 78
P a g e | 79
Theory of Operation
This section describes ventilation modes, monitored values, and gas mixing for the Inspiration 7i
Ventilator SystemVentilation Modes
The Inspiration 7i Ventilator System offers these ventilation modes:
VCMV (volume controlled continuous mandatory ventilation)
VSIMV (volume controlled synchronized intermittent mandatory ventilation)
PRVCCMV (pressure regulated volume control continuous mandatory ventilation)
PRVCSIMV (pressure regulated volume control synchronized intermittent mandatory ventilation)
PCMV (pressure controlled continuous mandatory ventilation)
PSIMV (pressure controlled synchronized intermittent mandatory ventilation)
SPONT (spontaneous ventilation, CPAP + PS) and NIV (noninvasive ventilation, CPAP + PS)
VS (volume support, volume targeted ventilation)
SPAP (spontaneous positive airway pressure ventilation, dual PEEP mode)
NCPAP+ (nasal continuous positive airway pressure with rate and base flow control)
8.1.1
V-CMV Mode
During V-CMV mode (Figure 51), breathing phases are flow or time-controlled. The user sets the tidal volume,
and the ventilator adjusts flow or time to ensure that the set tidal volume is achieved during inspiration.
The patient can trigger a mandatory breath during the exhalation phase trigger window. The breath is pressure
limited if circuit pressure reaches the set high pressure alarm limit.
P a g e | 80
8.1.2
V-SIMV Mode
V-SIMV mode (Figure 52) is a mixture of spontaneous and mandatory ventilation. Mandatory breaths are
volume controlled, and spontaneous breaths are pressure supported. Both mandatory and spontaneous
breaths can be pressure limited during V-SIMV if the current pressure exceeds the set high pressure alarm
limit.
SIMV mode consists of a mandatory expectation phase, followed by a spontaneous phase during which
spontaneous breathing is possible.
1. At the start of SIMV mode the patient can trigger a mandatory breath within the expectation window
(tCMV). If the patient does not trigger a breath during this time, the ventilator delivers a mandatory breath
once the expectation window has elapsed.
2. Spontaneous breathing is possible 200 ms after the start of exhalation, and is possible until the next
expectation window begins. If the patient triggers a breath, the ventilator delivers a pressure-controlled
breath that includes the set level of pressure support and PEEP. The patient can trigger further
spontaneous breaths until the next expectation window begins.
3. Once the SIMV cycle has elapsed, the next expectation window (and a new SIMV cycle) begins and the
patient can trigger a mandatory breath when at least 200 ms of the previous exhalation has elapsed.
During the spontaneous phase, peak inspiratory flow is the criterion for switching from inspiration to exhalation
(breaths are not time-controlled). When inspiratory flow drops to the set exhalation sensitivity (a percentage of
peak flow), exhalation begins.
In SIMV, the rate setting determines the number of mandatory breaths per minute. The I:E and peak flow
settings apply to the mandatory breaths.
SIMV settings include Rate, Vt, PEEP, O2, Flow Pat. I:E (European philosophy) or Flow (US philosophy),
Tplateau, Trigger (Ftrig or Ptrig), Psupport, Esens, and Rise Time.
The ventilator automatically limits the setting range for Rate, I:E, Peak Flow and Plateau to ensure that:
Inspiration time is never less than 10 % of the breath.
Exhalation time is never less than 20 % of the breath.
Maximum peak flow is 180 l/min (3 l/second).
P a g e | 81
8.1.3
P-CMV Mode
In P-CMV mode (Figure 53), the inspiratory and expiratory breathing phases are time-controlled. The user sets
the inspiration pressure (Pcontrol) above the PEEP baseline, and the ventilator maintains Pcontrol during
inspiration. The patient can trigger a mandatory breath within the trigger window.
P-CMV settings include Rate, PEEP, O2, I:E (European philosophy) or Flow (US philosophy), Ti, Pcontrol,
Trigger (Ftrig or Ptrig), and Rise Time.
The ventilator automatically limits the setting range for Rate, I:E, I time and Rise Time to ensure that:
Inspiration time is never less than 10 % of the breath.
Exhalation time is never less than 20 % of the breath.
Pcontrol is greater than or equal to PEEP + 5 cmH20.
P a g e | 82
8.1.4
P-SIMV Mode
P-SIMV mode is a mixture of spontaneous and mandatory ventilation. Mandatory breaths are pressurecontrolled, and spontaneous breaths are pressure supported.
gm
ed
hra
iap
raw
er
P-SIMV settings include Rate, PEEP, O2, I:E (European philosophy) or Flow (US philosophy), Ti, Pcontrol,
Psupport, Trigger (Ftrig or Ptrig), Esens, and Rise Time.
P a g e | 83
8.1.6
SPONT Mode
SPONT is a pressure-based breathing mode that provides ventilation once the patient reaches the inspiratory
trigger threshold (Figure 55). The pressure support setting determines the level of support pressure above
PEEP during an inspiration.
SPONT mode settings include PEEP, O2, Psupport, Trigger (Ftrig or Ptrig), Esens, and Rise time.
P a g e | 84
8.1.7
SPAP Mode
SPAP is a pressure-based breathing mode that allows patients to breathe spontaneously at two user-selected
levels of PEEP. The user sets the levels of high and low PEEP (Phigh and Plow) and level of pressure support
at each PEEP level (Psup high and Psup low).
The user also selects how much time the patient breathes at each PEEP level, depending on the SPAP
settings principle selected in the SPAP settings screen. If the settings principle is:
Cycle + Time: The user selects cycles per minute and the time at high PEEP level (Thigh); or
Cycle + Ratio: The user selects cycles per minute and ratio of high to low PEEP level periods (H:L), or
Time only: The user selects the time settings for both the high and low PEEP levels (Thigh and Tlow).
At each PEEP level, the ventilator delivers a spontaneous breath based on the Psupport, Rise time, and O2
settings when the patient triggers a breath (based on the Ftrig or Ptrig setting). The spontaneous breath ends
based on the Esens setting. Transitions between high and low PEEP levels are synchronized with the patients
spontaneous breath triggers.
Spontaneous Breaths in SPAP Mode
P a g e | 85
8.1.8
NCPAP+ Mode
NCPAP+ mode is intended for infant patient types. Ventilator software automatically sets a default flow rate and
PEEP, which are adjustable for optimum low pressure and disconnect detection to accommodate nasal prongs
are of different internal diameter size. One method of adjustment is to set the highest flow that still results in
alarms when both prongs are opened to air.
Ventilator software determines alarm limit values dynamically during NCPAP+, alleviating the need to adjust
alarm settings. The main display shows a pressure-time graph (no other graphs are available in NCPAP+). O2
is the only monitoring value displayed during NCPAP+.
NCPAP+ settings include: O2, Rate, Ti (US philosophy) or I:E (European philosophy), PEEP, Pcontrol, and
Flow.
8.1.9
During NCPAP+, ensure that a qualified caregiver observes the patient at all times. Due to
the high resistance of infant nasal prongs and large leaks that are typical of infant
ventilation, it is possible for no alarm to occur if the nasal prongs are attached to the
circuit but are out of the patients nose.
Ensure that the proximal pressure line is properly connected to the circuit (central to the
nasal prongs or on the exhalation side) and the ventilator (right-most port of the Flow
sensor connector).
If using the proximal flow sensor, ensure that the flow sensor calibration is performed on
an infant flow sensor.
The ventilator offers pressure flow triggering in NIV and all invasive modes.
Because NCPAP+ is a non-triggering mode, a proximal flow sensor is not required.
Pressure triggering is based on information from an internal pressure sensor. The patient triggers a breath by
decreasing pressure in the breathing circuit (relative to PEEP) by the set Ptrig level.
Flow triggering is based on information from a proximal flow sensor that is attached directly to the patient wye.
Flow triggering requires a constant low flow through the circuit of 2.0 l/min above the set Ftrig level.
Because reliable and precise measurements are essential for flow triggering, the proximal
flow sensor must always be calibrated prior to initial use.
For safety reasons a redundant backup pressure trigger of 2 cmH20 is always active. Flow triggering is disabled
if the flow sensor is incorrectly calibrated, or a flow sensor alarm is active.
Pressure
triggering
Flow
triggering
P a g e | 86
8.2
P a g e | 87
8.3
Real-time loops and curves can illustrate how settings may affect the patient:
The pressure-volume loop can show changing compliance or resistance values, and can be used to assess the
suitability of PEEP and Vt settings.
The flow-volume loop can show changes in inspiratory or expiratory peak flow, and can be used to assess the
effectiveness of bronchodilator therapy during pressure breaths or spontaneous breathing.
The pressure-time waveform can help assess pressure settings or triggering thresholds.
The flow-time waveform can be used to assess peak spontaneous flows during spontaneous breathing before
and after bronchodilator therapy.
The flow-time curve can also be used to detect intrinsic PEEP (also known as occult or auto PEEP), when
expiratory flows do not reach baseline before the next breath. The ventilator displays measured circuit
PEEP above the PEEP setting, identifying intrinsic PEEP.
To determine if there is additional pressure in the lungs, select Exp. Hold during active exhalation (section
4.9.1). This allows gas in the patients lungs to equilibrate with the circuit pressure, and the ventilator
displays the equilibrated total PEEP at the next update: total measured PEEP - set PEEP = intrinsic PEEP.
8.4
The ventilators internal gas mixing system provides the set oxygen concentration in the gas delivered to the
patient, and ensures that the internal tank pressure is correct. Table 8-1 summarizes gas mixing system
operation.
When ventilating infant and pediatric patients, the internal operating pressure is reduced to
enable more precise gas delivery.
If gas supplies fail, the gas mixing system tries to maintain tank pressure if possible so that ventilation can
continue at the defined settings. The optional internal compressor automatically starts if the wall air supply
pressure drops below 29 psi (2 bar).
Table 8-1: Gas Mixing System Operation
System status
Ventilator response
Notification
None.
O2 supply alarm.
O2 supply alarm.
No gas delivery.
No gas delivery.
P a g e | 88
This section describes the ventilator nurse call and RS232 serial communication ports.
9.1
The nurse call port allows the ventilator to connect to a remote alarm system. Figure 60 summarizes nurse call
port configuration.
Pin
Function
Not in use
NC (Normal Closed)
NO (Normal Open)
Not in use
Common
Not in use
9.2
The nurse call port allows the ventilator to communicate all settings and measurements. Figure 61 summarizes
serial port configuration.
Pin
Function
GND (Ground)
P a g e | 90
9.2.1
The Inspiration serial communication protocol is specifically designed for the ventilator and allows complete
monitoring of all settings and measurements. For specific information about this protocol please refer to RS232
eVent Inspiration Protocol V1.1.
9.2.2
MISCA
Response to
SNDA
command
706
97
Number of
bytes
between
<STX>
and
<ETX>
Number of
data fields
between
<STX>
and
<ETX>
<STX>
Start of data
transmission
character
(02 hex)
Field 1
Field 2
<ETX>
<CR>
End of
Terminating
transmission carriage return
character
The MISCA command response is designed to be compatible with the MISCA command
response from Puritan-Bennett Ventilators, including the 7200, 700 Series, and 800 Series.
In the fields where the command response differs from Puritan-Bennett ventilators, the
field description describes the difference.
Field number
P a g e | 91
Field content
MISCA (5 characters)
10
11
12
Field number
Field content
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
P a g e | 92
Field number
P a g e | 93
Field content
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
Field number
Field content
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
100
101
102
<ETX>
103
<CR>
P a g e | 94
P a g e | 95
10 Abbreviations
Abbreviation
Definition
Ampere
AC
Alternating current
ATPD
Auto control
A setting that allows automatic transition between mandatory and spontaneous mode settings
b/min
BTPS
c/min
CB
Clinical bulletin
cmH2O
Cstat
Static compliance
Cstat/kg
DC
Direct current
Decel
Decel 50%
Esens
Exhalation sensitivity
F/V
Flow-volume loop
FIO2
FRC
Ftrig
GUI
H:L
Ratio of time at high to low PEEP levels (SPAP mode setting and monitored value)
HME
Heat-moisture exchanger
Hz
Hertz (1 Hz = 1 cycle/sec )
I:E
ID
Internal diameter
Liter
l/min
LCD
Leak
Calculated leak
ml
Milliliter (1 ml = 10
ms
Millisecond
NCPAP+
Nasal continuous positive airway pressure plus with rate and base flow
NIV
Noninvasive ventilation
O2
Oxygen
P-CMV
P/V
Pressure-volume loop
Pcontrol
PEEP
P a g e | 96
bar)
l)
Abbreviation
Definition
PF
Peak flow
PFe
Phigh
Plow
Pmean
Ppeak
Pplateau
Prox
Proximal
PRVC
PRVC-CMV
PRVC-SIMV
Pressure regulated volume control synchronized intermittent mandatory ventilation, a VTV mode
PS
Pressure support
psi
P-SIMV
Psup high
Psup low
Psupport
Pressure support
Ptrig
Rate
Rate Sp
Rate/Vt
Calculated respiratory rate divided by tidal volume (rapid shallow breathing index)
Rinsp
Inspiratory resistance
RS232
Serial interface
RSBI
second
SPAP
SPONT
Spontaneous Ventilation
Square
STPD
Tapnea
Te
Expiratory time
TF
Technical fault
Thigh
Ti
Ti
Ti/Ttot
TIB
Tlow
TS
Touch screen
UI
User interface
P a g e | 97
Abbreviation
Definition
Volt
V-CMV
V-SIMV
VA
Volt-ampere (watt)
VAC
VDC
Ve
Ve Spont
Ve/Kg
VS
Vte
Vte/Kg
Vti
VTV
Watt
WBM
Microampere
P a g e | 98
P a g e | 99
11 Pneumatic Schematic
P a g e | 100
P a g e | 101
Index
%
% O2 Increase key ............................... 54
Ethernet connection........................... 26
Exhalation valve ................................. 30
EZ-Flow sensor ..................................... 1
A
Abbreviations .................................... 96
Alarm handling ................................... 62
Alarm limit settings ............................ 10
Alarm priority ..................................... 11
Alarm signals ...................................... 62
Alarms test ..................................... 1, 76
Apnea backup ....................................... 3
Attaching other devices to the
ventilator ....................................... 26
Auto PEEP ..................................... 10, 88
B
Backup pressure trigger ..................... 86
Base flow ............................................ 86
Basic warnings .................................... 17
Battery
replacement .................................. 75
Battery life .......................................... 12
Bias flow ............................................. 86
Breath triggering ............................ 3, 86
Breathing circuit
configuration ................................. 28
NCPAP+ patient interface .............. 29
G
Gas mixing system .............................. 88
Gas mixing system operation ............ 88
Gas supply
filter replacement .......................... 74
Graphics ............................................. 10
flow-time curve ............................. 88
F-V loop ......................................... 88
pressure-time curve ...................... 88
P-V loop ......................................... 88
H
Heliox ....................................... 6, 12, 78
Heliox connection............................... 26
Humidification devices ....................... 30
C
C20/C .................................................. 10
Calibrations ........................................ 70
oxygen sensor ................................ 73
proximal flow sensor ..................... 71
Cart, attaching to ventilator ............... 23
Cleaning and inspection ..................... 68
Clinical application of real-time curves
and loops ....................................... 88
CLININET ............................................... 27
CO2 monitor connection ..................... 26
Communication ports ......................... 90
Compliance, tubing ............................ 72
Configuration screens ........................ 32
Configuring the ventilator .................. 32
Connecting gas supplies ..................... 25
Connecting to power .......................... 24
Contact information .............................. i
Cstat ................................................... 10
Cstat/kg .............................................. 10
D
Device Labels and Symbols................. 15
Disposal .............................................. 77
L
Labels ................................................. 15
Leak, patient tubing ........................... 72
M
Maintenance ...................................... 68
Man Insp breath settings ................... 55
Manual inspiration key ....................... 55
MISCA response ................................. 91
Mode description
VTV ................................................ 83
Modes .................................................. 3
Modes, theory of operation ............... 80
Monitored data .................................... 8
Monitored values
description..................................... 87
E
Electromagnetic compatibility
declaration .................................... 18
Environmental data ............................ 12
P a g e | 102
O
On/Off/Standby key ........................... 36
Ordering parts .................................... 78
Oxygen sensor
calibration ..................................... 73
P
Part numbers ...................................... 78
Parts list .............................................. 78
Patient types ........................................ 3
PCMV Mode ..................................... 82
P-CMV mode description ................... 82
Physical data....................................... 13
Pneumatic schematic....................... 100
Power and gas supply ......................... 12
Power connections ............................. 24
Pressure triggering ............................. 86
Pressure units ....................................... 3
Pressure-time waveform .................... 88
Preventive maintenance .................... 74
Product specifications
additional settings ........................... 3
Alarm priority ................................ 11
alarms ............................................ 10
apnea settings ................................. 5
apnea ventilation............................. 3
Auto alarm ..................................... 10
breath triggering ............................. 3
breath Types .................................... 3
cart dimensions ............................. 13
Cart weights................................... 13
environmental data ....................... 12
high priority alarms ....................... 11
internal compressor ...................... 12
medium priority alarms ................. 11
monitored and displayed data ........8
operating temperature .................. 12
physical data .................................. 13
power and gas supply .................... 12
Special screen functions .......... 6, 7, 8
storage temperature ..................... 12
technical data ................................ 13
ventilation modes ............................ 3
ventilator dimensions .................... 13
ventilator weight ........................... 13
Proximal flow sensor .......................... 30
calibration ..................................... 71
PSIMV Mode..................................... 83
P-SIMV mode description ................... 83
P-V loop .............................................. 88
RSBI .................................................... 10
RSET command................................... 91
R
Rapid shallow breathing index ........... 10
Real timecCurves ................................ 10
Respiratory mechanics
Auto PEEP ...................................... 10
C20/C ............................................. 10
Cstat .............................................. 10
Cstat/kg ......................................... 10
Rinsp .............................................. 10
Rinsp ................................................... 10
RR/Vt .................................................. 10
RS232 connection ............................... 26
RS232 interface pin assignments ....... 27
RS232 serial port
commands ..................................... 91
protocol ......................................... 91
RS232 serial port pinout ..................... 90
P a g e | 103
Safety ................................................. 17
Safety information ............................. 17
Smart Nebulizer.................................... 6
Smart Sigh ............................................ 6
SNDA command ................................. 91
SPAP mode ................................. 7, 8, 85
SPAP mode description ...................... 85
Spare parts ......................................... 78
Special screen ....................................... 6
Specifications ....................................... 3
SPONT mode ...................................... 84
SPONT mode description ................... 84
Spont% 1h ............................................ 9
Spont% 8h ............................................ 9
Supply gas connections ...................... 25
Symbols ........................................ 15, 17
System test ......................................... 72
V
VCMV Mode ..................................... 80
V-CMV mode description ................... 80
Ventilator operation ........................... 36
Ventilator setup ................................. 23
VIRTUAL REPORT ..................................... 27
V-SIMV mode description .................. 81
VTV modes description ...................... 83
W
Waveforms ......................................... 10