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User Manual

US Version
Inspiration 7i
®

Ventilator

Clinician Focused Products


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 Medical’s
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 Medical’s 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

0120
eVent Medical, Inc. Parkmore Business Park West
971 Calle Amanecer, Suite 101 Galway, Ireland
San Clemente, CA 92673
United States

Tel: +1 949 492 8368


Fax: +1 949 492 8382

www.event-medical.com

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Table of contents

1 INTRODUCTION TO THE INSPIRATION 7I VENTILATOR SYSTEM ..................................................................................... 1


1.1 INTENDED USE .................................................................................................................................................................... 1
1.2 SPECIFICATIONS .................................................................................................................................................................. 3
1.2.1 Ventilation Modes .................................................................................................................................................. 3
1.2.2 Breath Types ........................................................................................................................................................... 3
1.2.3 Patient Types .......................................................................................................................................................... 3
1.2.4 Apnea Backup ......................................................................................................................................................... 3
1.2.5 Breath Triggering ................................................................................................................................................... 3
1.2.6 Additional Settings ................................................................................................................................................. 3
1.2.7 Apnea Backup Settings ........................................................................................................................................... 5
1.2.8 Special Screen Settings ........................................................................................................................................... 6
1.2.9 SPAP Mode Settings ............................................................................................................................................... 7
1.2.10 NCPAP+ Mode Settings ........................................................................................................................................... 7
1.2.11 NCPAP Mode Settings............................................................................................................................................. 8
1.2.12 Monitored / Displayed patient values .................................................................................................................... 8
1.2.13 Alarm Limit Settings ............................................................................................................................................. 10
1.2.14 Alarm Priority ....................................................................................................................................................... 11
1.2.15 Power and Gas Supply .......................................................................................................................................... 12
1.2.16 Environmental Data.............................................................................................................................................. 12
1.2.17 Physical Data ........................................................................................................................................................ 13
1.2.18 Technical Data ...................................................................................................................................................... 13
1.3 NOTICES .......................................................................................................................................................................... 14
1.3.1 Copyright Notice ................................................................................................................................................... 14
1.3.2 Trademark Notice ................................................................................................................................................. 14
1.3.3 Notice of Conformity, Compliance and Approvals ................................................................................................ 14
1.3.4 CE Notified Body ................................................................................................................................................... 14
1.3.5 Classification......................................................................................................................................................... 14
1.3.6 Regulatory Notice ................................................................................................................................................. 14
1.4 DEVICE LABELS AND SYMBOLS.............................................................................................................................................. 15
1.5 SAFETY ............................................................................................................................................................................ 17
1.5.1 Responsibilities and guarantees ........................................................................................................................... 17
1.5.2 Basic safety information and warnings ................................................................................................................ 17
1.6 ELECTROMAGNETIC COMPATIBILITY DECLARATION ................................................................................................................... 18
2 VENTILATOR SETUP ...................................................................................................................................................... 23
2.1 ATTACHING THE VENTILATOR TO THE CART............................................................................................................................. 23
2.2 CONNECTING TO POWER .................................................................................................................................................... 24
2.3 CONNECTING TO GAS SUPPLIES ............................................................................................................................................ 25
2.3.1 Heliox .................................................................................................................................................................... 26
2.4 ATTACHING DEVICES TO THE VENTILATOR .............................................................................................................................. 26
2.4.1 Attaching Communication Devices (Ethernet, RS232, and Nurse Call) ................................................................. 27
2.5 ATTACHING THE BREATHING CIRCUIT .................................................................................................................................... 28
2.5.1 Nasal Prongs ......................................................................................................................................................... 29
2.5.2 EZ-Flow Proximal Flow Sensor .............................................................................................................................. 30
2.5.3 Exhalation Valve ................................................................................................................................................... 30
2.5.4 Humidification Devices ......................................................................................................................................... 30
2.5.5 Nebulizer............................................................................................................................................................... 31
3 CONFIGURING THE VENTILATOR .................................................................................................................................. 32
4 VENTILATOR OPERATION ............................................................................................................................................. 36
4.1 TURNING THE VENTILATOR ON AND OFF................................................................................................................................ 36
4.2 USING THE TOUCH SCREEN TO CHANGE VENTILATOR PARAMETERS............................................................................................. 38
4.3 STARTING VENTILATION ...................................................................................................................................................... 39
4.4 SELECTING VENTILATION MODES SAND SETTINGS .................................................................................................................... 42

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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 ALARM HANDLING ....................................................................................................................................................... 62
5.1 ALARM SIGNALS ................................................................................................................................................................ 62
5.1.1 Alarm Mute Key .................................................................................................................................................... 63
5.2 ALARM LOG ..................................................................................................................................................................... 63
5.3 VENTILATOR ALARMS ......................................................................................................................................................... 63
6 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
7 SPARE PARTS ................................................................................................................................................................ 78
8 THEORY OF OPERATION ............................................................................................................................................... 80
8.1.1 V-CMV Mode ........................................................................................................................................................ 80
8.1.2 V-SIMV Mode........................................................................................................................................................ 81
8.1.3 P-CMV Mode ........................................................................................................................................................ 82
8.1.4 P-SIMV Mode ........................................................................................................................................................ 83
8.1.5 VTV Modes (PRVC-CMV, PRVC-SIMV, VS) ............................................................................................................. 83
8.1.6 SPONT Mode......................................................................................................................................................... 84
8.1.7 SPAP Mode ........................................................................................................................................................... 85
8.1.8 NCPAP+ Mode ...................................................................................................................................................... 86
8.1.9 Breath Triggering (All Modes) .............................................................................................................................. 86
8.2 MONITORED PATIENT DATA ................................................................................................................................................ 87
8.3 CLINICAL APPLICATIONS OF REAL-TIME VENTILATOR GRAPHICS .................................................................................................. 88
8.4 GAS MIXING SYSTEM ......................................................................................................................................................... 88
9 VENTILATOR COMMUNICATION PORTS ....................................................................................................................... 90
9.1 NURSE CALL PORT ............................................................................................................................................................. 90
9.2 RS232 SERIAL PORT .......................................................................................................................................................... 90

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Section 1: Introduction to the INSPIRATION 7I Ventilator
9.2.1 Serial Port Protocol ............................................................................................................................................... 91
9.2.2 Serial Port Commands .......................................................................................................................................... 91
10 ABBREVIATIONS ....................................................................................................................................................... 96
11 PNEUMATIC SCHEMATIC ........................................................................................................................................ 100
INDEX ................................................................................................................................................................................. 102

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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

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Section 1: Introduction to the INSPIRATION 7I Ventilator
Figure 39: Main Screen Graphics During Ventilation ................................................................................................. 58
Figure 40: Loop Graphics During Ventilation .............................................................................................................. 59
Figure 41: Maximized Waveform Display ................................................................................................................... 59
Figure 42: Freezing the Main Screen Display............................................................................................................. 60
Figure 43: Selecting Maneuvers ................................................................................................................................. 60
Figure 44: Alarm Display............................................................................................................................................. 62
Figure 45: Viewing the Event Log from the Alarms Tab ............................................................................................. 63
Figure 46: Selecting Calibrations from Patient Startup Screen (Previous Patient Shown) ........................................ 70
Figure 47: Calibrations Screen ................................................................................................................................... 70
Figure 48: Calibrate Proximal Flow Sensor Screen (Calibration Complete) .............................................................. 71
Figure 49: System Test Screen (Block Wye Prompt) ................................................................................................. 72
Figure 50: Oxygen Sensor Calibration Screen (Test Complete) ................................................................................ 73
Figure 51: V–CMV Mode ............................................................................................................................................ 80
Figure 52: V-SIMV Mode ............................................................................................................................................ 81
Figure 53: P-CMV Mode ............................................................................................................................................. 82
Figure 54: P-SIMV Mode ............................................................................................................................................ 83
Figure 55: SPONT Mode ............................................................................................................................................ 84
Figure 56: SPAP Mode ............................................................................................................................................... 85
Figure 57: Breath Triggering ....................................................................................................................................... 86
Figure 58: Flow Data ................................................................................................................................................... 87
Figure 59: Pressure Data ............................................................................................................................................ 87
Figure 60: Back Panel, RJ12 Nurse Call Port............................................................................................................. 90
Figure 61: Back Panel, RS232 Serial Port .................................................................................................................. 90
Figure 62: Inspiration 7i Ventilator System Pneumatic Diagram ............................................................................. 100

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EVM500023, Inspiration 7i Ventilator User Manual, US Rev A P a g e | viii


1 Introduction to the Inspiration 7i Ventilator System

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 sub-
acute 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
 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.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Touch screen

Vent Inop LED Mains LED

% O2 increase key Alarm mute key

Manual Inspiration key On/Off key

Knob

Figure 1: Ventilator Front Panel Controls

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Section 1: Introduction to the INSPIRATION 7I Ventilator

1.2 Specifications
This section provides specifications for the Inspiration 7i Ventilator System.
Pressures are shown on the Inspiration in cmH2O, mbar and Hectopascals (hPa). mbar and hpa are used by some
institutions instead. Since 1 mbar equals 1 hPa, which equals 1.016 cmH2O, the units may be used interchangeably.

Assisted Control Mandatory Ventilation CMV


1.2.1 Ventilation Modes
Synchronized Intermittent Mandatory SIMV
Ventilation
Dual Mode Volume Targeted Ventilation PRVC–CMV
(Pressure Regulated Volume Control) PRVC–SIMV
Volume Targeted Ventilation (Volume VS
Support)
Spontaneous Ventilation SPONT (CPAP + PS)
Spontaneous Positive Airway Pressure SPAP
Nasal Continuous Positive Airway NCPAP+
Pressure with Rate and Base Flow Control
Auto Control Auto Control
Non-Invasive Ventilation NIV
Volume – controlled breaths V–CMV, V–SIMV
1.2.2 Breath Types
Pressure – controlled breaths P–CMV, P–SIMV, PS
Adult (IBW > 41 kg), Pediatric (IBW > 10 to 40 kg), or Infant (0.3 to
1.2.3 Patient Types
9.6 kg)
User selected Breath type, mode and
1.2.4 Apnea Backup
settings
V-CMV; V-SIMV; P-CMV; P-SIMV; PRVC-CMV, PRVC-SIMV; SPAP
Pressure triggering 0.5 to 20.0 cmH2O
1.2.5 Breath Triggering
Flow triggering
Adult 0.2 to 25.0 l/min
Pediatric 0.1 to 15.0 l/min
Infant 0.1 to 10.0 l/min
If flow triggering is disabled, the default Ptrig is 2 cmH2O.
Respiratory Rate
1.2.6 Additional Settings
Adult 1 to 60 b/min
Pediatric 1 to 120 b/min
Infant 1 to 150 b/min
Accuracy: 0 to 100 b/min (± 1 b/min), > 100 b/min + 2% or 2%,
whichever is greater
Tidal Volume and Target Tidal Volume
Adult 300 to 2000 ml
Pediatric 40 to 500 ml
Infant 5 to 100 ml
Minimum Vt setting (5, or 10 ml) is determined by ventilator
configuration by a trained service technician as described in the
Inspiration 7i Ventilator System Service Manual.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Accuracy: 2 to 40 ml: ± 2 ml + 5%; (compliance & BTPS


41 to 2000 ml: ± 10 ml + 5% compensated)
Heliox: ± (10 ml + 10%) Adult Pedi only
PEEP / CPAP 0 to 50 cmH2O or 0 to (80
cmH2O – Pcontrol,
Psupport), whichever is less
Accuracy: ± (2 cmH2O + 4%)
Pcontrol
Adult / Pediatric 5 to 80 cmH2O or (80
cmH2O – PEEP), whichever
is less
Infant 2 to 80 cmH2O (80 cmH2O –
PEEP), whichever is less
Accuracy: ± (2 cmH2O + 4%)
Psupport 0.2 to 80 cmH2O or (80
cmH2O – PEEP), whichever
is less
Accuracy: ± (2 cmH2O + 4%)
Peak Flow (US philosophy configuration) Mandatory
Adult 1.0 to 120 l/min
Pediatric 1.0 to 90 l/min
Infant 1.0 to 60 l/min
Accuracy: 1 to 10 l/min ± (1 l/min + 10%)
11 to 180 l/min: ± (5 l/min + 10%)
Peak Flow Spontaneous
Adult 1 to 180 l/min
Pediatric 1 to 90 l/min
Infant 1 to 60 l/min
I–Time (Ti) 0.1 to 10 sec
(US Philosophy Setting)

I : E Ratio (European philosophy configuration) 1 : 9.0 to 4.0 : 1


Ti, Tp and Te Accuracy: < 10.0 seconds ± 0.01 s
≥ 10.0 seconds ± 0.1 s
Additional Settings NIV On or Off
(continued)
Non-invasive ventilation can be enabled in all modes except NCPAP+
Plateau (insp pause) 0.00 to 42.0 s
(US philosophy configuration)

Plateau (insp pause) 0 to 70 % of breath cycle


(European philosophy configuration) time
Accuracy: ± (0.05 seconds + 1%)
Oxygen (FiO2) 21 to 100%
Accuracy (Delivery): ± (3 %) full scale
On internal compressor: ± (6 %) full scale
Rise time settings 1 (slow), 5 (medium), or 10
(fast)
Flow pattern Decel. (Decelerating),
De50% (Decelerating 50%),
or Square.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Exhalation sensitivity 10 to 80% of peak flow


(Esens %)
Auto Control On or Off
Tapnea (used in Auto Control) 3 to 60 sec

1.2.7 Apnea Backup Settings


Apnea backup modes Adult, Pedi or Infant Apnea backup modes: V-CMV; V-SIMV; P-CMV; P-SIMV; PRVC-CMV;
PRVC-SIMV; SPAP.
Adult Apnea Backup Default settings
Ventilation Mode P–CMV
Trigger type Flow (if flow sensor is On)
Pressure
Resp rate Based on IBW setting
Vt Based on IBW setting
Flow Based on IBW setting
Flow Pattern Decel
Pause 0.0 s
PEEP Based on IBW setting
Oxygen % (FiO2) 10 % above setting
Apnea Backup On or Off
Ti (inspiratory time) Based on IBW setting
Pcontrol Based on IBW setting
Psupport Based on IBW setting
Time (apnea) 20 s
Rise time Based on IBW setting
Trigger Flow 3 l/min (if flow sensor is On)
2 cmH2O
Trigger Pressure
Pediatric Apnea Backup Default settings
Ventilation Mode P–CMV
Apnea Backup Settings
Trigger type Flow (if flow sensor On)
Pediatric (continued)
Pressure
Resp rate Based on IBW setting
Vt Based on IBW setting
Flow Based on IBW setting
Flow Pattern Decel
Pause 0.0 s
PEEP Based on IBW setting
Oxygen % (FiO2) 10 % above setting
Apnea Backup On or Off
Ti (inspiratory time) Based on IBW setting
Pcontrol Based on IBW setting
Psupport Based on IBW setting

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Time (apnea) 20 s
Rise time Based on IBW setting
Trigger Flow 2 l/min (if flow sensor On)
Trigger Pressure 2 cmH2O
Infant Apnea Backup Default settings
Ventilation Mode P–CMV
Trigger type Flow (if flow sensor On)
Pressure
Resp rate Based on IBW setting
Vt Based on IBW setting
Flow Based on IBW setting
Flow Pattern Decel
Pause 0.0 s
PEEP Based on IBW setting
Oxygen % (FiO2) 10 % above setting
Apnea Backup On or Off
Ti (inspiratory time) Based on IBW setting
Pcontrol Based on IBW setting
Psupport Based on IBW setting
Time (apnea) 20 s
Rise time Based on IBW setting
Trigger Flow 1 l/min (if flow sensor On)
Trigger Pressure 2 cmH2O
Smart Nebulizer™ User selected interval and
1.2.8 Special Screen Settings
duration
FiO2 and volume
compensated
Smart Sigh™ User defined: Frequency
and multiples of sighs
Amplitude of sighs (0 to 50
% of volume or pressure
setting)
Special Screen Settings
Main gas supply Air or Heliox
(continued)
Heliox: 0 to 79%
Humidity type None, HME, Warm
Humidified
SPAP Type Cycle + Time
Cycle + Ratio
Time only
Screen setting Lock or Unlock
Brightness settings Numerical setting
Trending time settings (WBM) 1 to 72 hrs
Device ID Numerical setting
(user selectable) 0 to 99

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Phigh 5 to 50 cmH2O or (Plow – 50


1.2.9 SPAP Mode Settings cmH2O)
Plow 0 cmH2O to Phigh setting
Psup High 5 to 80 cmH2O or (80
cmH2O – Phigh), whichever
is less
Psup Low 0.2 to 80 cmH2O or (80
cmH2O – Plow), whichever
is less
SPAP Type Cycle + Time
Cycle + Ratio
Time only
Thigh 0.10 to 59.8 or (60 – Tlow) s,
whichever is less
Tlow 0.20 to 59.9 or (60 – Thigh)
s, whichever is less
Ti, Tp and Te Accuracy: < 10.0 seconds ± 0.01 s
≥ 10.0 seconds ± 0.1 s
Cycles/min
Adult 1 to 60 c/min
Pediatric 1 to 120 c/min
Infant 1 to 150 c/min
Accuracy: 0 to 100 b/min (± 1 b/min),
> 100 b/min + 2% or 2%, whichever is greater
H : L (see time values) 1 : 59.0 to 59.0 : 1
Ti, Tp and Te Accuracy: < 10.0 seconds ± 0.01 s
≥ 10.0 seconds ± 0.1 s
Phigh, Plow accuracy: ± (2 cmH2O + 4%)
Phigh + Psup High will not exceed 80 cmH2O
Plow + Psup Low will not exceed 80 cmH2O
NCPAP+ is only available for Infant patient type
1.2.10 NCPAP+ Mode Settings
Rate 1 to 40 b/min
PEEP/CPAP 2 to 10 cmH2O
Ti 0.25 to 1.50 s
Pcontrol 2 to 30 cmH2O
Flow 2.0 to 12.0 l/min

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NCPAP+ setting relationship: Maximum flow setting to Pcontrol setting


If NCPAP+ setting is: Maximum flow setting is:
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

NCPAP = NCPAP+ with Rate of 0 l/min


1.2.11 NCPAP Mode Settings
PEEP/CPAP 2 to 12 cmH2O
Flow 2 to 28 l/min
NCPAP setting relationship: Maximum flow setting to Pcontrol setting
If NCPAP+ setting is: Maximum flow setting is:
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
1.2.12 Monitored / Displayed patient
values Ppeak 0 to 120 cmH2O
(peak pressure during a breath) Accuracy: ± (2 cmH2O + 4%)
Pmean 0 to 120 cmH2O
(averaged mean pressure) Accuracy: ± (2 cmH2O + 4%)
PEEP 0 to 120 cmH2O
(pressure at end exhalation) Accuracy: ± (2 cmH2O + 4%)
Vti 0 to 5000 ml
(tidal volume delivered) Accuracy: 0 to 40 ml ± (2ml + 5%);
41 to 5000 ml ± (10 ml + 5%)
Vti/kg 0.0 to 50.0 ml/kg
(tidal volume delivered/weight) Normalized to IBW

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Vte 0 to 5000 ml
(exhaled tidal volume) Accuracy: 0 to 40 ml ± (2ml + 5%);
41 to 5000 ml ± (10 ml + 5%)
Displayed as Vte--- if proximal flow
sensor is disabled.
Vte/kg 0.0 to 50.0 ml/kg
(exhaled tidal volume/weight) Normalized to IBW
Ve 0.0 to 50.0 l/min
(exhaled minute volume) Accuracy: ± (0.01 l/min + 5%)
Displayed as Vi if proximal flow
sensor is disabled.
Ve/kg 0.0 to 999 ml/kg
(exhaled minute volume/weight) Normalized to IBW
Ve Spont 0.0 to 50.0 l/min
(spontaneous exhaled minute volume) Accuracy: ± (0.01 l/min + 5%)
Displayed as Vi Spont if proximal
flow sensor is disabled.
Rate 0 to 300 b/min
(measured mandatory and spontaneous Accuracy: 0 to 100 b/min (± 1
breaths per minute) b/min), > 100 b/min + 2%
Rate Sp. 0 to 300 b/min
(measured spontaneous breaths per minute) Accuracy: 0 to 100 b/min (± 1
b/min), > 100 b/min + 2%
Advanced
Ti 0.10 to 99.9 sec
(inspiration time) Accuracy: ± 0.01 sec
Te 0.10 to 99.9 sec
(expiratory time) Accuracy: ± 0.01 sec
PF 0.0 to 300 l/min
(peak inspiratory flow)

PFe 0.0 to 300 l/min


(peak expiratory flow)

I:E 1 : 99.0 to 99 : 1.0


(ratio of inspiratory time to expiratory time)
Monitored Values H:L 1 : 599.0 to 299.0 : 1
(continued)
(Ratio of time at high and low PEEP levels
when SPAP is active)

Ti/Ttot 1.0 to 99.9 %


(calculated I–Time divided by cycle time)

Leak 0 to 100%
(averaged calculated leak (1–Vte/Vti))

O2 15 to 103%
(oxygen concentration) Displayed if O2 sensor is disabled.
HeO2 15 to 103%
(heliox concentration)

Spont% 1h 0 to 100 %
(percentage of spontaneous breaths for the
last 1 hour)

Spont% 8h 0 to 100 %
(percentage of spontaneous breaths for the
last 8 hours)

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Mechanics
Auto PEEP 0 to 100 cmH2O
(Total PEEP minus Set PEEP)

Pplateau 0 to 120 cmH2O


(pressure at end of pause) Accuracy: ± (2 cmH2O + 4%)
RR/Vt (RSBI) 0 to 3000 b/min/l
(rapid shallow breathing index, calculated
breathing rate divided by tidal volume)

Cstat 0 to 300 ml/ cmH2O


(static compliance, lung stiffness)

Cstat/kg 0.00 to 5.00 ml/ cmH2O-kg


(static compliance per weight) Normalized to IBW
Rinsp 0 to 1000 cmH2O/l/se
(ratio of airway occlusion pressure to
maximum negative airway pressure)
Monitored Values With the proximal flow sensor selected ‘Off’ monitored patient data will be
(continued) 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 0.00 to 5.00 %
(ratio of dynamic compliance during last Normalized to IBW
20% of inspiration to total dynamic
compliance)

Real Time Curves


Pressure + Time Pressure over time: measured proximally
or internally in cmH2O
Flow + Time Flow over time: measured proximally or
internally in l/min
Volume + Time Volume over time: measured proximally or
internally in ml
P – V Loop Pressure-volume loop: measured
proximally or internally in cmH2O and ml.
Pressure displayed on x-axis and volume
on the y-axis
F – V Loop Flow-volume loop: measured proximally or
internally in l/min and ml. Flow is displayed
on the y-axis and volume on the x-axis
Monitored Values One or two curves can be selected to display. The ventilator implements an
(continued) auto–scale feature for each curve selection. The CLININET™ applet
provides an auto–scaling feature, manual scaling feature and allows the
curves to be paused.
Delivered FiO2 Oxygen 15 to 103 %
inspiratory oxygen Accuracy: ± 5% of full scale
concentration
HeO2 Oxygen 0 to 79 %
inspiratory heliox
concentration
Pressure Alarms
1.2.13 Alarm Limit Settings
Ppeak High 1 (or 1 > Ppeak Low) to 80 cmH2O
Ppeak Low 0 to 79 (or 1 < Ppeak High) cmH2O
Pmean High 1 (or 1 > Pmean Low) to 80 cmH2O
Pmean Low 0 to 79 (or 1 < Pmean High) cmH2O,
respectively

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Volume Alarms
Vti Limit High Adult: 0 to 2500 ml or Off
Pediatric: 0 to 700 ml or Off
Infant: 0 to 300 ml or Off
Vte High Adult: 5 (or 5 > Vte Low) to 2500 ml or Off
Pediatric: 2 (or 2 > Vte Low) to 700 ml or Off
Infant: 1 (or 1 > Vte Low) to 300 ml or Off
Vti High is displayed if proximal flow sensor is disabled.
Vte Low Adult: 0 to 2495 (or 5 < Vte High) ml or Off
Pediatric: 0 to 700 (or 2 < Vte High) ml or Off
Infant: 0 to 300 (or 1 < Vte High) ml or Off
Vti Low is displayed if proximal flow sensor is disabled.
Ve High 0.10 (or 0.10 > Ve Low) to 50.0 l/min
Vi High is displayed if proximal flow sensor is disabled.
Ve Low 0.0 to 50.0 l/min (or 0.10 < Ve High)
Vi Low is displayed if proximal flow sensor is disabled.
Respiratory Rate Alarms
Resp rate High 2 (or 1 > Resp rate Low) to 200 b/min
Resp rate Low 1 to 199 (or 1 < Resp rate High) b/min
Oxygen Delivery Alarm Automatic Setting
High FiO2 22 to 101 %
Ventilator software automatically sets alarm
limit to 7% above Oxygen % setting.
Alarm Limit Settings Low FiO2 20 to 99 %
(continued) Ventilator software automatically sets alarm
limit to 7% below Oxygen % setting.
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.
High Priority Alarms
1.2.14 Alarm Priority
Battery Flat Disconnection
Internal Pressure Low Air Supply
High Minute Volume Technical Fault
High Oxygen High Pressure
High Tidal Volume Low Minute Volume
Occlusion Low Oxygen
Apnea Low Tidal Volume
Oxygen Supply Low Pressure
Medium Priority Alarms
Check Flow Sensor Tubing Pressure Is Being Limited
P Op High – Volume not delivered High External Voltage
Low Frequency High Leak Rate

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Check Psupport / Pmax High Frequency


High Temperature Check Pcontrol / Pmax
Pmean High Battery Low
Check Flow Sensor Pmean Low
Compressor Check Trigger
Vti Limit Reached

Informational messages
Prox. Line On Right Side Port? Vti Limit Reached
Memory CPU not protected Nebulizer not available
Memory sensor not protected Logbook Cleared
Memory power not protected Flow trigger not available
100% O2 not available Flow calibration not available
AC input 100 to 240 VAC (50/60 Hz)
1.2.15 Power and Gas Supply
Power consumption 120 VA (W)
DC input 24 VDC +/- 10%
Battery Backup on compressor < 120 min
Battery Backup off compressor > 120 min
(with fully charged battery)
Battery Backup when the Inspiration is combined with the Deluxe and / or
Transport plus battery.
Power and Gas Supply Battery Backup On compressor > 240 min
(continued)

Battery Backup off compressor > 600 min (with fully charged battery)
Oxygen inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry, and
oil-free medical grade
Oxygen inlet supply flow 180 l/min (STPD, dry required)
Air inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry, and
oil-free medical grade
Air inlet supply flow 180 l/min (STPD, dry required)
Heliox inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry, and
* Heliox gas source oil-free 80% / 20% Only

Internal compressor 15.8 l/min minute volume at 14.7 psi (1


bar). Compressor operation is enabled
or disabled in configuration screen
Earth leakage current < 300 μA
Enclosure Leakage current 50 μA Maximum

1.2.16 Environmental Data 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 10 to 15.6 psi (700 to 1060 mbar)
pressure
Operating altitude < 9999 ft (3048m) above sea level

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Atmospheric pressure Operating: 52.5 to 120 kPa (maximum


altitude 15,000 ft/4572 m)
Storage (sidestream): 20 to 120 kPa
(maximum altitude 38,600 ft/11,760 m)
Storage (mainstream): 500 to 1200 hPa
(maximum altitude 15,000 ft/4572 m)
* After condensation, store the unit for over 24 hours in an environment with a
relative humidity below 95% non-condensing.
Inspiration 7i Ventilator System
1.2.17 Physical Data
Width x depth x height 16 x 16 x 21 in. (40 x 40 x 53 cm)
(ventilator)
Weight of ventilator 53 lbs (24 kg)
Weight of carts 66 lbs (30 kg) (Deluxe cart)
45 lbs (20.5 kg) (Transport cart)
EZ-Flow proximal flow sensor
Adult/pediatric flow sensor Dead space: 6.9 ml
Sensor length: 3.25 in. (6.35 cm)
Sensor weight: 6.3 grams
Vt range: 100 ml and above
Pediatric/infant flow sensor Dead space: 0.75 ml
Sensor length: 2.0 in. (5.1 cm)
Sensor weight: 4.0 grams
Vt range: 1 – 99 ml
Maximum limited pressure 120 cmH2O via a dedicated pressure
1.2.18 Technical Data
relief valve
Maximum operating pressure 80 cmH2O controlled by high pressure
alarm setting
Measuring and display devices Pressure measurements are made by
solid-state pressure transducers
positioned to monitor internal operating,
inspiratory, and expiratory circuit
pressures
Flow and volume measurement Flow measurements are made by one of
two differential pressure flow sensors,
and are integrated with time to calculate
inspiratory and expiratory volumes. Flow
and volume measurement ranges are
according to monitored data
specifications
Oxygen measurement A galvanic cell is positioned in parallel to
the inspiratory manifold to measure the
delivered oxygen concentrations from 0
to 103%.
Display All data appears on a touch screen
Touch Screen enabled color liquid crystal display (LCD)

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Section 1: Introduction to the INSPIRATION 7I Ventilator
1.3 Notices
1.3.1 Copyright Notice
Copyright © 2010/2011 eVent Medical, Inc.
This work is protected under Title 17 of the U.S. Code and is the sole property of the Company. No part of this
document may be copied or otherwise reproduced, or stored in any electronic information retrieval system,
except as specifically permitted under U.S. Copyright law, without the prior written consent of the Company.
1.3.2 Trademark Notice
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 Notice of Conformity, Compliance and Approvals
The Inspiration Ventilator Systems comply with the requirements of directive
93/42/ EEC concerning Medical Devices and therefore bears the CE mark. 0120

Standards to which conformity is declared


o IEC 601-1 o EN60601-1
o IEC 601-1-2 o EN60601-1-2
o IEC 60601-2-12: 2001 o EN 794-1
o ASTMF1100-90 o EN 46001
o ASTM F1054-87 o ISO 9001
o ISO 5356-1

1.3.4 CE Notified Body


SGS UK
1.3.5 Classification
Classified as protection class I, Type B, internally powered, drip-proof adult / IEC 60601-1:1988
pediatric / infant ventilator for continuous operation. +
A1:1991+A2:1995

1.3.6 Regulatory Notice


US Federal Law restricts the sale of this device except by or on the order of a physician.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

1.4 Device Labels and Symbols


These device labels and symbols appear on the ventilator:

On/Off/Standby key

Alarm Mute key

% O2 Increase key

Manual Inspiration key

Vent Inop indicator

Mains power connected indicator

Indicates there is an active alarm

Indicates that alarms have been silenced

xxx % Backup battery time status

BATT On battery backup

Indicates the settings and screen are locked


Lock / Unlock control is located on Special screen

Nebulizer Nebulizer nipple connector

Flow sensor Flow sensor connector

Device connected to mains

Ethernet Ethernet connection port

RS232 RS232 connection port

Nurse call connection port

Refer to manual for Information, directions and or


warnings intended to prevent potential harm or damage
to the patient, caregiver and device.

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Designates type BF equipment per IEC 601-1

Indicates the degree of protection (drip-proof) by the


IPX1
enclosure.

O2 2-6bar (29-86psi) Oxygen inlet port label

Air 2-6bar (29-86psi) Air inlet port label

DC –Input:
24VDC
DC input connector
90W
3.75A

AC –Input:
100 -240VAC
50/60 Hz
120VA AC input connector
100V: 1.4A
240V: 0.5A
Fuse: 3.15AT

O2 Sensor Oxygen sensor location

SN: Device serial number

To Patient Gas flow to patient from ventilator

From Patient Gas flow from patient to ventilator

Do not obstruct! Do not obstruct port or outlet

Internal battery compartment

Indicates WEEE (Waste Electrical and Electronic Equipment) Registration per EU WEEE
Reg. No. IE 00761, Directive, 2002/96/EC

The internal compressor is not installed

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Section 1: Introduction to the INSPIRATION 7I Ventilator

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.
 Information or directions/warnings intended to prevent potential damage to the patient,
caregiver, or device.
 Explanatory notes and comments relevant to the Inspiration 7i Ventilator System.

1.5.1 Responsibilities and guarantees


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 Basic safety information and warnings
 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 ventilator’s 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

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Section 1: Introduction to the INSPIRATION 7I Ventilator
cooling air, thereby causing the equipment to overheat.
 Adding attachments or other components or sub-assemblies to the ventilator breathing
system may cause the pressure gradient to increase across the ventilator breathing
system, measured with respect to the patient connection.
 To avoid electrical shock while servicing the ventilator, be sure to disconnect the ventilator
from all power sources.
 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 institution’s biomedical engineering department in case of interrupted
ventilator operation, and before relocating any life support equipment.
 Preventive Maintenance, cleaning and sterilization activities must be conducted in
accordance with the procedures and recommended intervals detailed in of this manual to
ensure prolonged operation of the ventilator.
 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 Electromagnetic Compatibility Declaration


Guidance and Manufacturer's Declaration - Electromagnetic Emissions

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 environment.

Emissions Test Compliance Electromagnetic Enforcement - Guidance

The ventilator uses RF energy only for its internal function.


RF Emissions CISPR 11 Group 1 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment

RF Emissions CISPR 11 Class A


The system is suitable for use in all establishments, including
Harmonic emissions
Class A domestic establishments and those directly connected to the
IEC 61000-3-2
public low voltage supply network that supplies buildings used
Voltage fluctuations/flicker for domestic purposes
Complies
emissions IEC 61000-3-3

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Guidance and Manufacturer's Declaration - Immunity

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 environment.

IEC 60601 Test


Immunity Test Compliance Level Electromagnetic Environment - Guidance
Level

Electrostatic Floors should be wood, concrete or ceramic tile. If


+/- 6kV contact +/- 6kV contact
Discharge (ESD) floors are covered with synthetic material, the relative
humidity should be at least 30%.
+/- 8kV air +/- 8kV air
IEC 61000-4-2

Electrical Fast +/- 2kV for power +/- 2kV for power Mains power quality should be that of a typical
Transient/burst supply lines. supply lines. hospital environment

+/- 1 kV for +/- 1 kV for


IEC 61000-4-4 Input/output lines Input/output lines

+/- 1kV +/- 1kV differential Mains power quality should be that of a typical
Surge differential mode mode hospital environment

IEC 61000-4-5 +/- 2 kV common +/- 2 kV common


mode mode

Voltage dips, short <5% Ut <5% Ut Mains power quality should be that of a typical
interruptions and (>95% dip in Ut ) (>95% dip in Ut ) hospital environment. If the user of the ventilator
voltage variations for a 0.5 cycle for a 0.5 cycle requires continued operation during power mains
on power supply interruptions, it is recommended that the ventilator be
input lines. 40% Ut 40% Ut powered from an external battery.
(60% dip in Ut) for (60% dip in Ut) for
IEC 61000-4-11 5 cycles 5 cycles

70% Ut 70% Ut
(30% dip in Ut) for (30% dip in Ut) for
25 cycles 25 cycles

5% Ut 5% Ut
(>95% dip in Ut ) (>95% dip in Ut )
for 5 sec for 5 sec

Power Frequency
(50/60 Hz) magnetic Power frequency magnetic fields should be at levels
field. 3 A/m 3 A/m characteristic of a typical location in a typical hospital
environment.
IEC 61000-4-8

* Note Ut is the a.c. mains voltage prior to application of the test level.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

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 IEC 60601 Compliance


Test Test Level 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 Recommended separation distance:

IEC
3 Vrms 150
61000-4-6
kHz to 80 MHz 3 Vrms
outside ISM
bands (a)

10 Vrms
10 Vrms
150 kHz to
80 kHz in

Radiated RF 10 V/m
10 V/m
IEC 61000-4-
3 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. (c) should be less than
the compliance level in each frequency range (d)

Interference may occur in the vicinity of equipment marked with the following symbol.

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Section 1: Introduction to the INSPIRATION 7I Ventilator

NOTE 1: At 80 MHz and 800 MHz, the higher frequency applies.

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.

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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)

150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 GHz
Rated MHz Outside ISM MHz in ISM MHz
Maximum Bands Bands
Output of
Power of
Transmitter
(watts)

0.01 0.12 0.12 0.12 0.23

0.1 0.38 0.38 0.38 0.74

1 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

An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in
NOTE 3: 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.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagations affected by absorption and
reflection from structures, objects and people.

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2 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 Attaching the Ventilator to the Cart


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

Figure 2: Attaching the Ventilator to the Cart

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Section 2: Ventilator Setup

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.

AC mains power connector

Fuse drawer
Retaining clip

DC (external battery) connector

Figure 3: Ventilator Power Connections


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.

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Section 2: Ventilator Setup

2.3 Connecting to Gas Supplies


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

Oxygen connection nut Air connection nut


Supply pressure 29 to 86 psi Supply pressure 29 to 86 psi
(2 to 6 bar) (2 to 6 bar)

Figure 4: Ventilator Oxygen and Air Connections

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Section 2: Ventilator Setup

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 regulator and heliox DISS kit allows


heliox attachment to air inlet
Heliox
Oxygen connection
connection

Figure 5: Connecting Heliox

2.4 Attaching Devices to the Ventilator


This section describes how to attach other devices to the ventilator, including:
 Communication devices (Ethernet, RS232, nurse call)

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Section 2: Ventilator Setup

2.4.1 Attaching Communication Devices (Ethernet, RS232, and Nurse Call)


Attach communication devices (ethernet, RS232, and nurse call) to the ventilator back panel (Figure 6).

Ethernet connector
Ethernet
activity
LED
RS232 connector
Ethernet
Nurse call connector link
LED

Figure 6: Back Panel: Ethernet, RS232, and Nurse Call Connectors


2.4.1.1 Ethernet Connection (RJ45 connector)
The ethernet connection allows the ventilator’s internal CliniNet Server and its Virtual Report remote viewing
software to connect and transmit data to remote computers. This connection also enables updates to CliniNet
applet software using a standard RJ45 ethernet cable. See the CliniNet Virtual Report User Manual for more
information.
2.4.1.2 RS232 Connection (RJ45 connector)
The RS232 connection allows software downloads from a computer to the ventilator using the software
download cable (eVent Medical part number F910085. Other cables require custom construction. See section 9
for more information.
2.4.1.3 Nurse Call Connection (RJ12 connector)
The nurse call connection allows the ventilator to connect to a remote alarm system. See section 9 for more
information.

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Section 2: Ventilator Setup
2.5 Attaching the Breathing Circuit
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.

Figure 7: Example Patient Breathing Circuit

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Section 2: Ventilator Setup

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.

INCA infant nasal prongs Hudson infant nasal prongs


Argyle infant nasal prongs

Pressure tap on exhalation


side of breathing circuit

oFor nasal prong systems that hFor nasal prong systems whose pressure port is not centrally located.
attach to a patient wye, Connect pressure line to the port and place pressure port on exhalation
connect the proximal pressure side of the breathing circuit, between nasal prongs and exhalation valve.
line to the wye.

Figure 8: Infant Nasal Prong Patient Interfaces


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.

Connect proximal pressure line from


nasal prongs to right-side silver port
of flow sensor connector

Figure 9: Nasal Prong Pressure Line Connection

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Section 2: Ventilator Setup

2.5.2 EZ-Flow Proximal Flow Sensor


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 ventilator front panel


flow sensor connector

To patient connection To circuit wye

Figure 10: EZ-Flow Flow Sensor


Select the proximal flow sensor On when configuring the ventilator (section 3) and calibrate the flow sensor
(section 6.2.1) before patient use.

 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.

2.5.3 Exhalation Valve


Operate the ventilator only with eVent Medical exhalation valve cover and diaphragm (Figure 11) installed.

Exhalation valve diaphragm

Exhalation valve cover

Figure 11: Exhalation Valve Cover and Diaphragm

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.

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Section 2: Ventilator Setup

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

Figure 12: Nebulizer Connection

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).

 The nebulizer function is not available during Infant ventilation or when delivered flow
drops below 10 l/min.

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3 Configuring the Ventilator

The user configuration screens allow you to set ventilator configurations including:
• Humidification type: humidifier, heat-moisture exchanger (HME), or none.
• Smart Nebulizer: on/off and nebulization time.
• Graphics settings: waveforms or loops and number of displays.
• Trend data settings: number of displays.
• Monitored data: number of displays.
• Proximal flow sensor and oxygen sensor: on/off.
• Special: gas type, keyboard, CliniNet trend time.
• Audio/LCD levels: audio level, screen clicks on/off, LCD brightness.

 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.

Follow these steps to configure the ventilator:


1. Turn on the ventilator. The ventilator performs power on self test (POST), a complete check of the
ventilator (Figure 13).

Figure 13: POST Screen

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Section 3: Configuring the Ventilator

2. When POST is complete, the screen prompts you to select a new or previous patient (Figure 14).

Select Previous
then ACCEPT

Figure 14: Selecting New or Previous Patient


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

Figure 15: Selecting the Config Tab on Standby Screen

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Section 3: Configuring the Ventilator

User configuration screen functions:

Configuration parameter Description


Humidification Type Humidifier, HME, or None.
Smart Nebulizer Smart Nebulizer: On or Off.
Nebulization time in minutes.
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 Waveforms or Loops displayed on Main screen.
Number of displays:
Waveforms: 1 – 3 displays.
Loops: 1– 2 displays.
Trend Data Settings Number of Trend Data displays: 1 – 3 displays.
Monitors Number of monitored data displays: 5, 8, or 10 displays (displays appear above the
main screen).
Prox.Flow/O2 Sens. Proximal flow sensor On or Off.
Oxygen sensor On or Off.
NOTE: The proximal flow sensor and oxygen sensor must be calibrated as described
in section 6.2.
Special Gas Type: Air or Heliox
(Gas Type button is not displayed if patient type is Infant).
Keyboard: Standard or Generic Alpha.
CliniNet trend time in hours.
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).

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Section 3: Configuring the Ventilator

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4 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.
 The Inspiration 7i ventilator must only be operated by clinicians qualified to assess the
patient’s 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.

4.1 Turning the Ventilator On and Off


1. Turn the ventilator on by pressing the On/Off/Standby key (Figure 16) for over one second.

On/Off/Standby key

Figure 16: Turning the Ventilator On and Off

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Section 5: Alarm Handling

2. The ventilator performs power on self test (POST), a complete check of the ventilator (Figure 17).

Figure 17: POST Screen


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.

Figure 18: On/Off/Standby Key Options

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Section 5: Alarm Handling

4.2 Using the Touch Screen to Change Ventilator Parameters

 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

Ideal Body Weight Setting Setting


setting selected for value change
change changed accepted

Figure 19: Changing a Setting

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.

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Section 5: Alarm Handling

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.

eVent logo indicates that


Time setting is linked to
Nebulizer On/Off setting

Figure 20: Linked Setting

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.

Figure 21: New Patient Startup Screen

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Section 5: Alarm Handling
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.

Figure 22: New Patient Startup (IBW Automatically Calculated)

If you enter the IBW only, the New Patient startup screen reflects that the other patient parameters are not
entered (Figure 23).

Figure 23: New Patient Startup Screen (Only IBW Entered)

3. Select the Humidification Selection (Humidifier, None, or HME).


4. If displayed, select Gas Type (Air or Heliox).
5. Select Calibration to perform a proximal flow sensor calibration, system test, or oxygen sensor calibration,.
(Section 6 describes how to perform calibration procedures.)
6. Select Flow Sensor On/Off to enable or disable the proximal flow sensor.
7. Select Patient ID to enter the patient, room, and bed identification.

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Section 5: Alarm Handling

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.

Dark gray screen background for


patient with IBW > 40 kg (any gender)

Light blue background for Pink background for


male/unspecified gender female gender patient
patient with IBW < 40 kg with IBW < 40 kg

Figure 24: Proposed Settings Screen


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 don’t 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.

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Section 5: Alarm Handling

4.4 Selecting Ventilation Modes sand Settings


Follow these steps at the Proposed Settings screen:
1. Select the Mode Type: CMV, SIMV, or SPONT
2. Then the Mode Selection:

Infant patient type

3. Once the mode is selected, the applicable settings are displayed.

Ventilation setting Description


Auto Control Auto Control enables the ventilator to automatically transition between CMV and spontaneous
(CMV modes, not modes in response to the presence or absence of spontaneous breathing without alarms or
available during clinical intervention.
apnea backup) 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 Cycles sets the number of times per minute the ventilator cycles from low PEEP to high PEEP.
(SPAP mode) Transitions between high and low PEEP levels are synchronized with spontaneous breaths.

Esens Exhalation sensitivity sets the percent of peak inspiratory flow at which the ventilator cycles from
(Spontaneous inspiration to exhalation. Increasing the Esens setting shortens inspiratory time.
breaths)
Flow Peak (maximum) inspiratory flow setting. Available if ventilator is configured for US philosophy
(Mandatory breaths (see the Inspiration 7i Ventilator System Service Manual for more information).
in V-CMV and V-
SIMV)
Flow-Pat. Flow pattern for volume control mandatory breaths. The flow pattern and is unaffected by patient
(Volume control back pressure or other factors as long as the peak inspiratory flow and pressure limit are not
mandatory breaths) 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.

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Section 5: Alarm Handling

Ventilation setting Description


H:L H : L sets the ratio of time at high and low PEEP levels when the SPAP Type is Cycle + Ratio.
(SPAP mode)
I:E Ratio of inspiratory time to expiratory time for mandatory breaths. Available if ventilator is
(Mandatory breaths) 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 Delivered oxygen concentration.
Pcontrol Pressure above PEEP during the inspiratory phase.
(Mandatory breaths Applies to mandatory breaths in P-CMV and P-SIMV
in P-CMV and P-
SIMV)
PEEP The baseline pressure setting during the expiratory phase.
(Not available in
SPAP mode)
Phigh High PEEP level, the baseline airway pressure during the Thigh phase in SPAP.
(SPAP mode)
Tplateau Length of plateau or inspiratory pause, expressed in seconds (when ventilator is configured for
(Volume control US philosophy) or as a percentage of total breath cycle time (European philosophy).
mandatory breaths) Once the set Vt is delivered, exhalation is blocked for the set plateau time to hold gas in the
patient’s lungs, increasing Ti. (See the Inspiration 7i Ventilator System Service Manual for more
information how to select US or European philosophy.)
Plow Low PEEP level, the baseline airway pressure during the Tlow phase in SPAP.
(SPAP mode)
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 The set level of pressure support (above Phigh) during the Thigh phase in SPAP.
(SPAP mode)
Psup low The set level of pressure support (above Plow) during the Tlow phase in SPAP.
(SPAP mode)
Psupport Pressure above PEEP applied during inspiration to a patient triggered breath.
(Spontaneous
breaths)
Rate Respiratory frequency or number of breaths per minute.
(Not available in PS,
VS, SPAP)
Rise time (Pressure- Sets the time for inspiratory pressure to rise to the set (target) pressure.
based breath types)
Rise time adjusts the initial flow output during a pressure-controlled, pressure-supported, or dual-
mode volume targeted breath. Faster rise times provide higher initial flow rates and attain target
pressure more quickly.
Vt Sets the tidal volume to be delivered during inspiration.
(Volume based Minimum Vt setting (2, 5, or 10 ml) is determined by ventilator configuration by a trained service
modes) technician as described in the Inspiration 7i Ventilator System Service Manual.
Thigh The set duration of the Thigh phase in SPAP.
(SPAP mode)
Ti Sets the inspiratory time for pressure-based mandatory breaths Available if ventilator is
(Pressure based configured for US philosophy (see the Inspiration 7i Ventilator System Service Manual for more
mandatory breaths) information).

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Section 5: Alarm Handling

Ventilation setting Description


Tlow The set duration of the Tlow phase in SPAP.
(SPAP mode)
Trigger Selects flow or pressure triggering.

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.

Adjust Esens and Rise Time for


spontaneous breathing

Turn Auto Control on and set Time

Figure 25: Selecting Auto Control


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: The spontaneous 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.

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Section 5: Alarm Handling

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.

Figure 26: Apnea Backup Settings

Turning Auto Control on automatically turns Apnea backup off, and turning Auto Control off automatically turns
Apnea backup on.

4.5 Setting Alarm Limits


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.

 Ventilator software automatically sets high and low oxygen % alarm limits to 7% above and
below the O2 setting, and is not adjustable.

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Section 5: Alarm Handling

Alarm Settings displays


High alarm limit
current settings for review
and adjustment
Low alarm limit
Event Log displays the
1,000 most recent events

AUTO SET automatically sets upper and


lower alarm limits based on monitored data.

Figure 27: Alarm Settings

Alarm limit Description


Ve High and low exhaled minute volume alarm limit (l/min).
Vte High and low exhaled tidal volume alarm limit (ml).
Rate High and low respiratory rate alarm limit in (b/min).
Ppeak High and low peak pressure during a breath (cmH2O).
Pmean High and low averaged mean pressure during a breath (cmH2O).
Leak Maximum leak rate (%).
Apnea Apnea interval (s): time without a breath trigger that starts Apnea
backup ventilation.
Vt lim High delivered tidal volume limit (ml).

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Section 5: Alarm Handling

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).

Figure 28: Event Log

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Section 5: Alarm Handling

4.6 Selecting Monitored Data Displays


The Monitoring tab (Figure 29) allows you to review monitored data and select customized trends, and loops
 All spirometry measurements are BTPS-corrected.

Figure 29: Monitoring Tab (Monitoring Data)

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Section 5: Alarm Handling

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 Measured peak airway pressure (cmH2O).
Pmean Measured average airway pressure during inspiration (cmH2O).
PEEP Measured positive end expiratory pressure (cmH2O).
Vti Measured inspiratory tidal volume (ml).
Vti/kg Measured inspiratory tidal volume, normalized to patient IBW (ml/kg).
Vte Measured expiratory tidal volume (ml). Available when proximal flow sensor is on.
Vte/kg Measured expiratory tidal volume, normalized to patient IBW (ml/kg).
Ve Measured minute volume, the total (spontaneous and mandatory) tidal volume of gas delivered in
the previous minute (l/min).
Ve/kg Measured total minute volume, normalized to patient IBW (ml/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 Measured number of spontaneous breaths delivered in the previous minute (b/min).
Advanced tab
Ti Measured inspiratory time (s).
Te Measured expiratory time (s).
PF Peak inspiratory flow (l/min).
PFe Peak expiratory flow (l/min).
I:E Ratio of inspiratory time to expiratory time.
H:L Ratio of high PEEP time to low PEEP time (SPAP mode).
Ti/Tot Ratio of inspiratory time to total breath cycle time (%).
Leak Measured leak flow (%).
O2 Fraction of inspired oxygen (%).
HeO2 Fraction of inspired heliox (%).
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 Calculated residual pressure at end exhalation (cmH2O).
Pplateau Plateau pressure (cmH2O).
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 Static compliance, lung stiffness (ml/cmH2O).
Cstat/kg Static compliance, normalized to patient IBW (ml/cmH2O-kg).
Rinsp Inspiratory flow resistance of patient breathing circuit (cmH2O/l/s).

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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

Select parameter name to


display selectable parameters

User comment marker

X-Ray event marker

Touch axis to toggle through selectable scales.


eVent logo indicates automatically-selected scale.

Figure 30: Monitoring Tab (Trend Data)

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.

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Section 5: Alarm Handling

Unfreeze icon

Cursor

Numeric value at
cursor position

Figure 31: Trend Data Cursor

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).

Figure 32: Entering a User Comment for Trend Data

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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)

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Section 5: Alarm Handling

4.6.3 Loop Study, Available on Inspiration 7i Ventilator Only


Select Loop Study to view Loop Data (Figure 34), a real-time display of flow-volume (F/V) and pressure-volume
(P/V) loops.
 Loop data is not available in NCPAP+ mode.

Minimize or
maximize Numeric value at cursor position
display
Cursor

Unfreeze icon

Save Loops
Ref. Loop
button
button

Saved loop

Figure 34: Viewing Loop Data


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.

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Section 5: Alarm Handling
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

Selected reference loop display

To delete a reference loop display, touch and hold for 2 seconds (red x appears):

Touch time /date information cancel delete.

Touch folder again to delete

Figure 35: Loop Data with Reference Loop Selected

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.

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Section 5: Alarm Handling
4.7.2 Manual Inspiration Key
The Manual inspiration key delivers a mandatory breath during the next expiratory phase.
The patient cannot trigger a breath during a manual breath. The Manual inspiration key is
disabled during standard NCPAP mode. The screen displays a Manual indicator when the
manual inspiration is active.
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


Follow these steps to start nebulization (Figure 36):
1. Select the onscreen Config tab, then touch Smart Nebulizer.
2. Select Nebulizer On, then select nebulization Time in minutes. If available, select the nebulization Interval
(time between nebulizations).
An onscreen indicator shows when nebulization is active. During nebulization the nebulizer valve opens
synchronous to inspiration to supply pressure to an external medication nebulizer.

Nebulizer
settings
Select
Smart Nebulizer

Figure 36: Smart Nebulizer

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4.7.5 Smart Sigh


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

Figure 37: Smart Sigh

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4.8 Using the Main Display during Ventilation


Figure 38 shows the main screen display elements.

Status bar Battery icon


Patient trigger indicator
Patient type Time and date
Current mode
Alarms

Monitoring bar

Alarm mute
Settings bar indicator area

ACTIVATE, LOCK,
UNLOCK buttons

Figure 38: Main Screen Display Elements

Patient type Indicates patient type (adult, pediatric, or infant).


Current mode Displayed in the upper left corner of all user screens:
BLUE indicates a normal ventilation mode or Standby.
GREEN indicates the spontaneous mode of Auto Control (section 4.4.1) is active.
RED indicates the current mode in during Apnea backup ventilation.
Patient trigger Appears next to mode, indicates patient-triggered breath:
 Mandatory patient-triggered or manual breath.
 Spontaneous patient-triggered breath.
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 Shows battery and charge status in case of AC power disconnect.
Current date and Displayed at the upper right corner of all user screens. Date and time are set during
time ventilator configuration (see the Inspiration 7i Ventilator System Service Manual for more
information).

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Alarms Up to three active alarm indicators can be displayed simultaneously on user screens:
HIGH PRIORITY ALARMS
MEDIUM PRIORITY ALARMS
INFORMATION MESSAGES
Monitoring bar Displays monitored parameters. The number of monitored parameters displayed is set
using the Config tab (section 3).
Settings bar Displays the commonly-adjusted settings that apply to the current or proposed mode,
providing quick access for adjusting them.
ACTIVATE button This button appears at startup when a proposed mode is selected.
LOCK/UNLOCK The LOCK button appears once a mode is activated. Touching LOCK locks the screen
button 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, Touch to toggle
P/V loop, and Man. between Volume,
(maneuvers) Flow, and Pressure

Ventilator
settings Touch to protect
against inadvertent
settings changes
(toggles between
Lock and Unlock)

Figure 39: Main Screen Graphics During Ventilation

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Section 5: Alarm Handling

If applicable, changes to breath


timing are displayed when
changing ventilator settings

Spontaneous breath
Mandatory breath
(green = inspiration,
(red = inspiration,
blue = exhalation) light blue = exhalation)

Figure 40: Loop Graphics During Ventilation

The color of the waveforms and loops indicate breath type and phase: mandatory (red= inspiration, blue =
exhalation) or spontaneous (green = inspiration, light blue = exhalation).
Select a monitored data parameter to view that all the data parameters in the same category (basic, advanced
and mechanics)Select the parameter button again to return to the graphics display.
To adjust a ventilator setting without changing the mode, touch the setting button (below the graphics) to
highlight, adjust the value, and touch again to activate the new setting.
If the new setting affects breath timing, the left panel displays the I:E ratio, Ti, and Te that would result from the
new setting.
Select the Lock/Unlock button to protect against inadvertent settings changes.
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.
To minimize or maximize the waveform display, select the arrow button at the upper left corner (Figure 41).
Available on Inspiration 7i Ventilator Only

Minimize display

Figure 41: Maximized Waveform 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.

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Section 5: Alarm Handling

Unfreeze icon

Cursor

Numeric value at
cursor position

Figure 42: Freezing the Main Screen Display

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)

Figure 43: Selecting Maneuvers

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Section 5: Alarm Handling
4.9.1 Inspiratory Hold Maneuver
Touch and hold the Insp. Hold button to hold ventilation at the end of the next
inspiration for up to 30 seconds. Normal ventilation resumes when you release the
button or after 30 seconds, whichever occurs first. The ventilator automatically
calculates static compliance (Cstat) during an inspiratory hold. Inspiratory hold is
not available during NCPAP+ mode.

4.9.2 Expiratory Hold Maneuver


Touch and hold the Exp. Hold button to hold ventilation at the end of the next
exhalation for up to 30 seconds. Normal ventilation resumes when you release the
button or after 30 seconds, whichever occurs first. The ventilator automatically
calculates Total PEEP during an expiratory hold. Expiratory hold is not available
during NCPAP+ mode.

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Section 5: Alarm Handling

5 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 Message on red background, 5 repeating Nurse call enabled, alarm cannot be
alarm indicator flashes at 2 Hz. signals cancelled.
MEDIUM Message on yellow background, 3 repeating Nurse call enabled, alarm cannot be
alarm indicator flashes at 0.5 Hz. signals cancelled.
INFORMATION Message on white background, 1 signal Nurse call disabled, message cancelled by
no alarm indicator. pushing knob or by touching alarm section
on screen.
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.

Select Alarms tab to


Active view active alarm
alarms and setting

Figure 44: Alarm Display

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Section 5: Alarm Handling

5.1.1 Alarm Mute Key


The Alarm mute key silences an active alarm for 2 minutes. If a new alarm occurs
or you press Alarm mute again, the silence is canceled. During an alarm silence,
the Alarm indicator lights and the display shows any alarm message(s).

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.

Table 5-1: Ventilator Alarms


Alarm message Description Corrective action
Any message not Not applicable. Contact service.
listed here
100%O2 cal. not Informational message. Oxygen calibration not available, no oxygen 1. Check oxygen supply
avail supply. Oxygen calibration interrupted. connections.
2. Check oxygen supply
pressure.
3. Retry oxygen sensor
calibration.

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Section 5: Alarm Handling

Table 5-1: Ventilator Alarms


Alarm message Description Corrective action
Air supply High priority alarm. Air supply not available and compressor backup is 1. Check air supply
not installed or disabled. Ventilation continues with 100% oxygen. connections.
2. Check air supply pressure.
3. Enable compressor backup.
Apnea High priority alarm. The set apnea time has elapsed without a patient Check patient and ensure that
triggered or mandatory breath, apnea backup disabled. Ventilator settings are appropriate for
waits for patient trigger or mandatory breath. patient condition.
Apnea backup High priority alarm. The set apnea time has elapsed without a patient Check patient and ensure that
active triggered or mandatory breath. Apnea ventilation begins. settings are appropriate for
patient condition.
 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.

Battery flat High priority alarm. Internal battery voltage depleted. Ventilation 1. Connect to AC power and
continues; opens to ambient air if AC power fails. ensure that battery
recharges.
2. Check battery cable
connections.
3. Replace battery.
Battery low Medium priority alarm. Low internal battery voltage. Ventilation 1. Connect to AC power and
continues. ensure that battery
recharges.
2. Check battery cable
connections.
3. Replace battery.
Battery not Information message. The internal battery is not available. Battery 1. Connect to AC power and
available voltage depleted, battery missing, or battery not properly connected. ensure that battery
Ventilation continues. recharges.
2. Check battery cable
connections.
3. Replace battery.
Check Medium priority alarm. Pcontrol setting exceeds Ppeak alarm limit. Adjust Pcontrol and/or
Pcontrol/Pmax (Pcontrol must be < Ppeak limit). Ventilation continues. Ppeak High settings.
Check Medium priority alarm. Psupport + PEEP exceeds Ppeak alarm limit. Adjust Psupport, PEEP, and or
Psupport/Pmax (Psupport + PEEP setting must be < Ppeak limit). Ventilation Ppeak High settings.
continues.
Compressor Medium priority alarm. Compressor failure (if installed). Ventilation Connect to functional air supply
continues with oxygen if possible. and contact service technician.
Disconnection High priority alarm. Possible leak or disconnect in circuit. Ventilation 1. Check circuit connections.
continues. 2. Perform system test.
3. Replace circuit.
FIO2 and delivery Information message. Oxygen calibration not available or was 1. Check oxygen supply
can vary interrupted. connections.
2. Check oxygen supply
pressure.
3. Retry oxygen sensor
calibration.
Flow cal. not Information message. Flow sensor Off in configuration, cannot be Turn flow sensor On and retry
available calibrated. Flow calibration interrupted. flow sensor calibration.
Flow trigger not Information message. Flow trigger not available. Flow sensor 1. Check flow sensor
avail attached incorrectly and requires calibration, or the ventilator is connections.
running on internal compressor (pediatric or adult patient types). 2. Retry flow sensor calibration.
Ventilation continues with pressure triggering.
3. Replace flow sensor.

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Section 5: Alarm Handling

Table 5-1: Ventilator Alarms


Alarm message Description Corrective action
Gas connected; Information message. Appears at startup and during ventilation when Verify that Heliox selection is
Heliox? Heliox gas type is selected. appropriate for patient.
Heliox P Low – High priority alarm. Low heliox supply pressure. Ventilation continues 1. Check heliox supply
Use Air using 100% oxygen. connection.
2. Check heliox supply
pressure.
3. Switch gas type to Air
(Config tab).
Heliox supply High priority alarm. Heliox supply not available. Ventilation continues 1. Check heliox supply
using 100% oxygen. connection.
2. Check heliox supply
pressure.
High external Medium priority alarm. External DC supply voltage is too high. Contact service technician.
voltage Ventilation continues.
High frequency Medium priority alarm. Respiratory rate exceeds Rate alarm limit. Check patient and ensure that
Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limit: +50% of setting. for patient condition.

High leak rate Medium priority alarm. Possible circuit leak exceeds Leak alarm limit. 1. Check circuit connections.
Ventilation continues. 2. Perform system test.
3. Replace circuit.
High minute High priority alarm. Expiratory minute volume exceeds Ve alarm limit. Check patient and ensure that
volume (Alarm occurs only if flow sensor is On in configuration). Ventilation ventilator settings are appropriate
continues. for patient condition.
AUTO SET alarm limits: + 50% of setting in pressure ventilation, 50%
of setting in volume ventilation.
High oxygen High priority alarm. Inspiratory oxygen concentration exceeds 1. Perform oxygen sensor
ventilator-set alarm limit. Alarm occurs only if oxygen sensor is On in calibration.
configuration. Ventilation continues. 2. Replace oxygen sensor.
3. Contact service technician.
High pressure High priority alarm. Pressure exceeds Ppeak alarm limit. Ventilator 1. Check patient and ensure
immediately switches to exhalation for one second without PEEP. that ventilator settings are
Ventilation continues but is pressure-limited. appropriate for patient
AUTO SET alarm limit: +50% of setting. Alarm limit increases to condition.
correspond to % increase during sigh breaths. 2. Check for circuit occlusions.
High temperature Medium priority alarm. Internal ventilator temperature too high. Contact service technician.
Ventilation continues.
High tidal volume High priority alarm. Expiratory volume above Vte alarm limit. Check patient and ensure that
Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limits: + 50% of setting in pressure ventilation, 50% for patient condition.
of setting in volume ventilation. Alarm limit increases to correspond to
% increase during sigh breaths.
Increase O2 not Information message. 100% oxygen not available. Oxygen supply not 1. Check oxygen supply
avail available or oxygen sensor calibration in progress. Ventilation connections.
continues. 2. Check oxygen supply
pressure.
Int press High priority alarm. Ventilator tank pressure too low. Ventilation Ensure that ventilator is securely
low/Disconnect continues, nebulization not available. connected to air and oxygen
supplies.
Inverse ratio set Information message. Settings that determine rate and inspiratory Verify that the setting change and
time result in inverse ratio (inspiratory time exceeds expiratory time). inverse ratio are appropriate for
patient condition.
Logbook cleared Information message. Event log cleared. Not applicable.

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Table 5-1: Ventilator Alarms


Alarm message Description Corrective action
Low frequency Medium priority alarm. Respiratory rate below Rate alarm limit. Check patient and ensure that
Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limit: +50% of setting. for patient condition.

Low minute High priority alarm. Expiratory minute volume below Ve alarm limit. Check patient and ensure that
volume Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limits: + 50% of setting in pressure ventilation, 50% for patient condition.
of setting in volume ventilation.
Low oxygen High priority alarm. Inspiratory oxygen concentration below ventilator- 1. Perform oxygen sensor
set alarm limit. Alarm occurs only if oxygen sensor is On in calibration.
configuration. Ventilation continues. 2. Replace oxygen sensor.
3. Contact service technician.
Low pressure High priority alarm. Pressure cannot be attained in the breathing 1. Check circuit connections.
circuit, possible leak or disconnect. Ventilation continues.
2. Perform system test.
AUTO SET alarm limit: +50% of setting.
3. Replace circuit.
Low tidal volume High priority alarm. Expiratory volume below Vte alarm limit. Check patient and ensure that
Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limits: + 50% of setting in pressure ventilation, 50% for patient condition.
of setting in volume ventilation.
Mem CPU not Information message. Internal ventilator electronics (CPU board) not Contact service.
protected configured for write protect.
Mem power no Information message. Internal ventilator electronics (power board) not Contact service.
protect configured for write protect.
Mem sensor no Information message. Internal ventilator electronics (sensor board) Contact service.
protect not configured for write protect.
Nebulizer not avail Information message. Nebulizer disabled or Infant patient type Enable nebulizer or change
selected. Ventilation continues without nebulization. patient type if appropriate.
O2 sensor not Information message. Oxygen sensor is depleted or disconnected. 1. Check to make sure the O2
avail sensor cable is connected
and undamaged.
2. Replace O2 sensor
O2 supply High priority alarm. Oxygen supply not available. Ventilation continues 1. Check oxygen supply
with air. connections.
2. Check oxygen supply
pressure.
Occlusion High priority alarm. Patient circuit occluded, ventilator opens to 1. Check patient and ensure
ambient air. that ventilator settings are
appropriate for patient
condition.
2. Check for circuit occlusions.
3. Provide alternate ventilation
and contact service
technician.
P Op High – V not Medium priority alarm. Volume limited by Ppeak alarm limit (Ppeak 1. Check patient and ensure
deliver High – 5 cmH2O). Volume-limited ventilation continues. that ventilator settings are
appropriate for patient
condition.
2. Check for circuit occlusions.
P. Line on Right High priority alarm. Single proximal airway line connected to incorrect Reconnect the proximal airway
Side? ventilator port. line to the right side (silver) port
on the flow sensor pressure ports

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Section 5: Alarm Handling

Table 5-1: Ventilator Alarms


Alarm message Description Corrective action
Pmean high Medium priority alarm. Mean circuit pressure exceeds Pmean alarm Check patient and ensure that
limit. Ventilation continues. ventilator settings are appropriate
AUTO SET alarm limit: +10 cmH2O of setting. for patient condition.

Pmean low Medium priority alarm. Mean circuit pressure below Pmean alarm 1. Check circuit connections.
limit. Possible leak or disconnect. Ventilation continues. 2. Perform system test.
AUTO SET alarm limit: -10 cmH2O of setting. 3. Replace circuit.
Pressure is being Medium priority alarm. Inspiratory pressure limited by Ppeak alarm 1. Check patient and ensure
limited limit. Pressure-limited ventilation continues. that ventilator settings are
appropriate for patient
condition.
2. Check for circuit occlusions.
Speaker fault High priority alarm. Main alarm speaker failure. Continuous alarm Provide alternate ventilation and
sounds, ventilation continues. contact service technician.
TF xxx High priority alarm. Technical fault (xxx is the specific code). Provide alternate ventilation and
Ventilator opens to ambient air. contact service technician.
Volume is being High priority alarm: Pressure exceeds Ppeak alarm limit. Ventilator 1. Check patient and ensure
limited immediately switches to exhalation for one second without PEEP. that ventilator settings are
Ventilation continues but cannot deliver selected Vt. appropriate for patient
condition.
2. Check for circuit occlusions.
Vti limit reached High priority alarm. Inspiratory tidal volume exceeds Vti alarm limit for Check patient and ensure that
two consecutive breaths. Ventilation continues but cannot deliver ventilator settings are appropriate
selected Vt. for patient condition.

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6 Maintenance

This section describes maintenance procedures including, cleaning and inspection, calibrations, preventive
maintenance, alarms testing, and disposal.

6.1 Cleaning and Inspection


Perform all cleaning and sterilization carefully and according to all applicable regulations to ensure that the
ventilator functions safely and effectively.

 Only trained personnel should perform Maintenance procedures.


 To prevent transmission of disease, use protective equipment when handling
contaminated filters, HMEs or other patient accessories.
 To prevent damage to ESD-sensitive components, always follow ESD guidelines when
servicing and handling components inside the ventilator.
 Follow manufacturer guidelines and maintenance instructions explicitly, using only
specified parts. Clean, disinfect and or sterilize ventilator components and accessories as
instructed in this section.
 Do not reuse single-patient use bacteria filters, Flow Sensors, and other accessories. They
must be discarded after single use.
 Do not attempt to sterilize the interior of the ventilator. Do not attempt to sterilize the whole
ventilator with ETO gas.
 Exposure to sterilizing agents may reduce the useful life of certain parts. Using more than
one sterilization technique on a single part may damage a part.
 Because cleaning, sterilization, sanitation, and disinfection practices vary widely among
health care institutions. It is not possible for eVent Medical to specify or require specific
practices that will meet all needs, or to be responsible for the effectiveness of cleaning,
sterilization, and other practices carried out in the patient care setting. This manual only
gives general guidelines for cleaning, disinfecting, and sterilizing. It is the user’s
responsibility to ensure the validity and effectiveness of the actual methods used.
 For additional guidance please refer to the National Standards and Recommended
Practices for Sterilization (AAMI STBK0809-S) Association for the Advancement of Medical
Instrumentation / 02-Feb-2009.

Clean and inspect the ventilator as follows:

Touch screen 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 Wipe with an appropriate bactericidal agent before each patient use. Do not use alcohol as a
exterior 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 Clean and sterilize reusable patient circuit components according to manufacturer
breathing recommendations. Replace and dispose of single patient use items between patients according to
circuit and manufacturer instructions.
nebulizer
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).
Humidification Clean and sterilize reusable active humidifiers according to manufacturer recommendations.
device Replace and dispose of single use passive humidification devices according to manufacturer
recommendations.
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).

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Section 6: Maintenance

Mask (silicone Steam autoclave, chemically disinfect, or ETO sterilize reusable accessories between patients -
rubber) 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 Reusable EZ-Flow sensor: Follow standard institutional operating procedure to clean then
proximal flow autoclave using 250 °F (121 °C) or 275 °F (134 °C), or cold sterilize between patients.
sensor  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 Steam autoclave, chemically disinfect, or ETO sterilize the Exhalation
valve cover exhalation diaphragm between patients. Follow standard diaphragm
institutional operating procedure to autoclave at 250 °F
(121 °C) or 275 °F (134 °C).
 Replace if damaged or after 100 autoclave cycles.
 Solutions such as Medizyme, Pyroneg, Control 3,
Solution 2, and CIDEX® have been tested according
to the manufacturers’ guidelines. Other brand names
with similar active ingredients may also be suitable.
 Do not autoclave if medications containing chlorinated Exh Cover
or aromatic hydrocarbons are used.
Exhalation Steam autoclave, chemically disinfect, or ETO sterilize the exhalation valve cover between
diaphragm 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.

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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)

Select Calibrations from


patient startup screen

The Calibrations screen (Figure 47) allows you to select which calibration to perform, and displays the
calibration current calibration status.

Buttons select which


calibration to run

Calibration status

Figure 47: Calibrations Screen

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Section 6: Maintenance
6.2.1 Proximal Flow Sensor Calibration
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.

Figure 48: Calibrate Proximal Flow Sensor Screen (Calibration Complete)


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.

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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.

Figure 49: System Test Screen (Block Wye Prompt)


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 system test requires at least one high-pressure gas source.

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.

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Section 6: Maintenance

6.2.3 Oxygen Sensor Calibration


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.

Figure 50: Oxygen Sensor Calibration Screen (Test Complete)


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.

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Section 6: Maintenance

6.3 Preventive Maintenance

 Only trained personnel should perform preventive maintenance according to these


instructions.

Perform these ventilator preventive maintenance procedures at the following intervals:

Interval Maintenance procedure


Every 250 hours or as Clean or replace the cooling fan filter (Section 6.3.1).
required
Every year or as Replace the cooling fan filter (section 6.3.1).
required
Replace the gas supply filters (section 6.3.2).
Replace the oxygen sensor (section 6.3.3).
A qualified service technician must run a performance verification as described in
the Inspiration 7i Ventilator System Service Manual.
Every two years or as Replace the internal batteries (section 6.3.4).
required
Calibrate internal batteries following replacement as described in the
Inspiration 7i Ventilator System Service Manual.
As required Replace fuses (section 6.3.5).

6.3.1 Clean or Replace Cooling Fan Filter:


 Every 250 Hours and Every Year or as required
 Check the fan filter regularly for blockages and contamination and clean as required.

1. Use a small flat-blade screwdriver to loosen the


filter cover screw, then pull cover from back panel.
2. Replace the fan filter or wash under running
water. Do not reinstall the cleaned filter until
completely dry.
3. Push the filter cover back into the back panel and
retighten screw.

6.3.2 Replace Gas Supply Filters:


 Every Year or as required
 Check the gas supply filters regularly for blockages and contamination and clean or replace as
required.

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Section 6: Maintenance

The gas supply filters on the back panel protect the


ventilator from water and particulate contamination.
1. Turn the filter housing counterclockwise to
remove. Clean the housing with a solution of
water and mild detergent.
2. Replace the filter element. Do not attempt to clean
the filter element.
3. Reinstall the filter housing.

6.3.3 Replace Oxygen Sensor:


 Every Year or as required
 Use recommended replacement oxgen sensors only. Always calibrate the oxygen sensor after
replacement.

1. Use a 2.5-mm Allen wrench to loosen the four


screws that secure the back panel cover.
2. Carefully disconnect the oxygen sensor cable.
3. Twist the oxygen sensor counterclockwise and
remove.
4. Twist a new sensor clockwise into place.
5. Connect the cable to the new sensor.
6. Replace the cover and retighten the screws.

6.3.4 Replace the Internal Batteries:


 Every Two Years or as required
 Always replace both batteries at the same time.
 Use recomended replacement batteries only.
 Always perform the System Test and Alarms Test after replacing the batteries.
 Calibrate internal batteries following replacement as described in the Inspiration 7i Ventilator System
Service Manual.
1. Remove power cord, gas supply hoses, and gas
supply filter housings.
2. Remove air and oxygen inlet water traps.
3. Remove the screws that attach small oxygen
sensor cell access door (if applicable) and/or the
rear battery compartment panel.
4. Slide the internal battery pack from the device and
disconnect the battery wires. Note the orientation
of the battery harness. A wiring diagram is on the
inside of the battery compartment panel.
Internal
5. Set the battery pack aside. Replace every two Batteries
years or as needed.

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Section 6: Maintenance
6.3.5 Replace Fuses: As Required
1. Unplug the mains cord.
2. Push down the clip between the two fuses and pull
out the fuse drawer. Mains
outlet
3. Replace the fuses with 3.15A, T type, H (breaking
capacity) 250V.
Fuse
4. Reinstall the fuse drawer. drawer

6.4 Alarms Test Procedure


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

 See section 1.3 for product compliance and approval Notices.

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: V–CMV Ve 50 l/min high, 2 l/min low


Trigger: Flow Vte: 1000 ml high, 200 ml low
Rate: 10 b/min Rate: 100 b/min high, 1 b/min low
Vt: 500 ml Ppeak: 40 cmH2O high, 3 cmH2O low
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.

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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
To dispose of the ventilator and its components and accessories:
 Deliver the device, free of charge and duty paid, to the manufacturer for disposal, or
 Surrender the device to a licensed private or public collection company, or
 Properly recycle or dispose of the parts.
All disposals must comply with applicable local regulations. Consult the responsible authorities for guidance
and requirements. Recycling and disposal procedure must not:
 Pose risk to human health.
 Damage the environment.
 Cause a noise or odor nuisance.
 Damage the surroundings or landscape.

 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 device’s electronic components carry AC mains
voltage.
 Always disconnect the mains plug and remove the internal battery before opening the
ventilator...

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7 Spare Parts

Description Part number

SPU stands for single patient use Pk stands for pack


PKG stands for package XX is reserved for the language variant

Air/oxygen inlet filter kit (2 Pk) F910300


Cart, Inspiration Ventilator, Deluxe F710562
Cart, Inspiration Ventilator, Transport F730744
Cylinder mounts, cart, dual US E – cylinder F710561
Cylinder mounts, cart, dual European cylinder F710563
Ethernet interface option F910089
Exhalation diaphragm (10 Pk) F710213-PKG
Exhalation valve cover F710214
External battery F710520
External battery charger F710521
EZ-Flow sensor, Adult/Pediatric, SPU (10 Pk) F910203-PKG
EZ-Flow sensor, Infant/Pediatric, SPU (10 Pk) F910204-PKG
EZ-Flow sensor, reusable, cold sterilizable, Adult/Pediatric (1 Pk) F910321
EZ-Flow sensor, reusable, cold sterilizable, Infant/Pediatric (1 Pk) F910322
Tubing, EZ-Flow sensor, SPU (10 Pk) F910260-PKG
(for use with reusable flow sensors)
Filters, cooling fan (5 Pk) F910214
Internal battery (includes two batteries) F910251
Manual, Technical, Inspiration F910371
Manual, User, Inspiration F910039
CliniNet & Virtual Report Viewing System User Manual F930166
Oxygen sensor F910028
Flex Arm Assembly (includes) F710616
 Flex Arm (circuit support arm) F710569
 Tube Hanger F710570
 Mounting bracket F710571

Test lung kit F910215


Infant test lung F910355
Hose, DISS, Air F910037
Hose, DISS, Oxygen F910038
Heliox Adaptor, Air–Heliox 21 F710528
Heliox Kit, DISS, UK F710564
Heliox kit, DISS, Flotec F710568

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8 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:
V–CMV (volume controlled continuous mandatory ventilation)
V–SIMV (volume controlled synchronized intermittent mandatory ventilation)
PRVC–CMV (pressure regulated volume control continuous mandatory ventilation)
PRVC–SIMV (pressure regulated volume control synchronized intermittent mandatory ventilation)
P–CMV (pressure controlled continuous mandatory ventilation)
P–SIMV (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.

Figure 51: V–CMV Mode

V-CMV settings include Rate, Vt, PEEP, O2, Flow Pat., I:E (European philosophy) or Flow (US philosophy),
Tplateau, Trigger (Ftrig or Ptrig).
The ventilator automatically limits the setting range for Rate, I:E, Peak Flow and Plateau to ensure that:
Inspiration time is never less than 100 ms or 10 % of the breath.
Exhalation time is never less than 200 ms or 20 % of the breath.

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Section 8: Theory of Operation
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.

Figure 52: V-SIMV Mode

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).

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Section 8: Theory of Operation

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.

Figure 53: P-CMV Mode

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.

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Section 8: Theory of Operation

8.1.4 P-SIMV Mode


P-SIMV mode is a mixture of spontaneous and mandatory ventilation. Mandatory breaths are pressure-
controlled, and spontaneous breaths are pressure supported.
gm

ed

hra
iap raw
er

Figure 54: P-SIMV Mode

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.

8.1.5 VTV Modes (PRVC-CMV, PRVC-SIMV, VS)


Volume targeted ventilation (VTV) provides pressure based breaths (with decelerating flow pattern and square
pressure pattern) that target Vt by adjusting delivered pressure on a breath-to-breath basis. VTV modes deliver
pressure-controlled or pressure-supported breaths whose pressure varies as needed to achieve the selected
target tidal volume.
Delivered pressure levels do not vary by more than 3 cmH2O from breath to breath or 1.5 cmH2O when the Vt
setting is below 5 ml. The ventilator starts by delivering a standard volume ventilation test breath with a
decelerating flow curve and short plateau. If the plateau pressure is stable, the ventilator calculates compliance
and establishes a pressure target for the first PRVC breath. The ventilator then delivers a pressure control style
breath with the Ti or I:E ratio set at that starting pressure.
PRVC-CMV is an assist control mode in which all breaths are mandatory. The ventilator delivers breaths in
response to patient trigger efforts, or according to the set respiratory rate. The ventilator delivers pressure
controlled breaths with pressure levels that vary as needed to achieve the target tidal volume.
PRVC-SIMV mode is similar to PRVC-CMV except that all breaths in excess of the set respiratory rate are
spontaneous breaths. The spontaneous breaths in PRVC-SIMV can be pressure supported.
VS is a spontaneous breath mode in which all breaths are spontaneous. The ventilator delivers breaths in
response to patient effort, and patient effort determines the respiratory rate and inspiratory time. The ventilator
delivers pressure-supported breaths with pressure levels that vary as needed to achieve the set target Vt. The
starting test breath is pressure-support breath at 10 cmH2O (6 cmH2O when Vt setting is below 5 ml) and
subsequent pressure support breaths are then delivered with increasing or decreasing pressure targets to
restore the preset target tidal volume. Pressures will not vary by more than 3 cmH2O per breath or 1.5 cmH2O
when Vt setting is below 5 ml. Volume Support is delivered in a spontaneous mode only and so is not available
in SIMV.
VTV settings include Vt, Rate, PEEP, O2, I:E (European philosophy) or Flow (US philosophy), Ti, Pcontrol,
Esens, Psupport, Trigger (Ftrig or Ptrig), Esens, and Rise Time.
The ventilator automatically limits the setting ranges to ensure that:
Inspiration time is never less than 100 ms.
Exhalation time is never less than 200 ms.

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Section 8: Theory of Operation
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.

Figure 55: SPONT Mode

SPONT mode settings include PEEP, O2, Psupport, Trigger (Ftrig or Ptrig), Esens, and Rise time.

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Section 8: Theory of Operation

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 patient’s
spontaneous breath triggers.

Spontaneous Breaths in SPAP Mode

Figure 56: SPAP Mode

SPAP mode affects these monitored values:


 Vte (exhaled tidal volume): reflects only spontaneous exhaled volumes at either PEEP level when SPAP is
active.
 Ve (exhaled minute volume): includes total minute volume, including spontaneous exhaled volumes at both
PEEP levels and during the low to high PEEP level transition.
 H:L (ratio of time at high to low PEEP levels): is available for display on the Monitoring screen.
Pressure limitation occurs during SPAP if the current pressure exceeds the set high pressure alarm limit.
SPAP settings include Cycles, H:L, Phigh, Plow, Thigh, Tlow, Psup high, Psup low, Esens, O2, Rise Time, and
Trigger (Ftrig or Ptrig).
The ventilator automatically limits the setting ranges to ensure that:
Insufflation time is never less than 100 ms.
Exhalation time is never less than 200 ms.

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Section 8: Theory of Operation

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.

 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 patient’s 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.

8.1.9 Breath Triggering (All Modes)


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
Flow
triggering
triggering

Figure 57: Breath Triggering

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Section 8: Theory of Operation

8.2 Monitored Patient Data


Figure 58 and Figure 59 illustrate flow and pressure data monitoring.
If enabled in the ventilator configuration, the proximal flow sensor is measures flow data. In case of alarm or
incorrect calibration or if the proximal flow sensor is not installed, the ventilator uses the internal flow sensor to
measure patient flow data.

Figure 58: Flow Data

Patient Monitoring: Pressure Data

Figure 59: Pressure Data

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Section 8: Theory of Operation

8.3 Clinical Applications of Real-Time Ventilator Graphics


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 patient’s 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 Gas Mixing System


The ventilator’s 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

Oxygen and air supplies normal Gas mixture accuracy ± 1% FIO2 full scale. None.
Oxygen supply normal, compressor on Ventilator switches to compressor operation Air supply alarm.
(air supply failure) when air supply fails. Gas mixture accuracy ± 5%
FIO2 full scale.
Compressor operation is only available if
compressor backup is installed and enabled.
Flow sensor calibration and nebulizer function are
not available.
Oxygen supply normal, air supply and Ventilator supplies 100% oxygen. Air supply alarm.
compressor failure Compressor operation is only available if
compressor backup is installed and enabled.
Oxygen supply failure, air supply normal Ventilator supplies 100% air. O2 supply alarm.
Oxygen supply failure, compressor on Ventilator supplies 100% air from the O2 supply alarm.
(air supply failure) compressor.
Compressor operation is only available if
compressor backup is installed and enabled.
Oxygen supply failure, air supply and No gas delivery. Air supply, O2 supply alarms.
compressor not installed
Oxygen supply failure, air supply and No gas delivery. Air supply, O2 supply alarms.
compressor failure

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9 Ventilator Communication Ports

This section describes the ventilator nurse call and RS232 serial communication ports.

9.1 Nurse Call Port


The nurse call port allows the ventilator to connect to a remote alarm system. Figure 60 summarizes nurse call
port configuration.

Pin Function

1 Not in use

2 NC (Normal Closed)

3 NO (Normal Open)

4 Not in use

5 Common
6 1
Not in use
6

Figure 60: Back Panel, RJ12 Nurse Call Port

9.2 RS232 Serial Port


The nurse call port allows the ventilator to communicate all settings and measurements. Figure 61 summarizes
serial port configuration.

Pin Function

1 DCD (Data carrier detect)

2 RTS (Ready to send)

3 CTS (Clear to send)

4 DTR (Data terminal ready)


8 1
5 GND (Ground)

6 DSR (Data set ready)

7 RXD (Receive data)

8 TXD (Transmit data)

Figure 61: Back Panel, RS232 Serial Port

The ventilator’s serial port is pre-configured with these nonadjustable settings:


Baud rate: 9600
Data bits: 8
Stop bits: 1
Parity: Off
Flow control: Off

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Section 9: Ventilator Communication Ports

9.2.1 Serial Port Protocol


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 Serial Port Commands


The serial port uses these commands to communicate:
RSET <Carriage return>
When the ventilator receives the RSET command, it clears all data from its receive buffer. The ventilator does
not respond to the host system.
SNDA <Carriage return>
When the ventilator receives the SNDA command, it responds to the host system with code MISCA, followed
by ventilator settings and monitored data.
The MISCA response follows this format:

MISCA 706 97 <STX> Field 1 Field 2 <ETX> <CR>


Response to Number of Number of Start of data Data fields, left-justified and End of Terminating
SNDA bytes data fields transmission padded with spaces transmission carriage return
command between between character character
<STX> <STX> (02 hex)
and and
<ETX> <ETX>

 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.

MISCA response format:

MISCA Response Format

Field number Field content

1 MISCA (5 characters)

2 706 (3 characters; the number of bytes between <STX> and <ETX>)


3 97 ( 2 characters; the number of fields between (<STX> and <ETX>)

4 <STX> (start of transmission)

5 Ventilator time (HH:MM_) (6 characters)


6 Not used (13 characters)

7 Not used (6 characters)

8 Not used (12 characters)


9 Mode setting (6 characters)

10 Respiratory rate setting (6 characters)

11 Tidal volume setting (6 characters)


12 Peak flow setting (6 characters)

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Section 9: Ventilator Communication Port

MISCA Response Format

Field number Field content

13 O2% setting (6 characters)

14 Not used (6 characters)

15 PEEP/ CPAP setting (6 characters)

16 Plateau time (6 characters)

17 Not used (6 characters)

18 Not used (6 characters)

19 Not used (6 characters)

20 Not used (6 characters)

21 Apnea interval (6 characters)

22 Apnea tidal volume setting (6 characters)

23 Apnea respiratory rate setting (6 characters)

24 Apnea peak flow setting (6 characters)

25 Apnea O2% setting (6 characters)


26 Pressure support setting (6 characters)

27 Inspiratory flow pattern (6 characters)

28 Not used (6 characters)


29 Nebulizer setting (On or Off) (6 characters)

30 100% O2 setting (On or Off) (6 characters)

31 Not used (6 characters)


32 Not used (6 characters)

33 Not used (6 characters)

34 Total respiratory rate (6 characters)


35 Exhaled tidal volume (6 characters)

36 Exhaled minute volume (6 characters)

37 Spontaneous minute volume (6 characters)


38 Peak airway pressure (6 characters)

39 Mean airway pressure (6 characters)

40 End inspiratory pressure (6 characters)


41 Not used (6 characters)

42 High pressure limit (6 characters)


43 Low inspiratory pressure (6 characters)

44 Not used (6 characters)

45 Low tidal exhaled tidal volume (6 characters)

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Section 9: Ventilator Communication Ports

MISCA Response Format

Field number Field content

46 Low exhaled minute volume (6 characters)

47 High respiratory rate (6 characters)

48 High pressure alarm status (6 characters)

49 Low inspiratory pressure alarm status (6 characters)

50 Not used (6 characters)

51 Low tidal volume alarm status (6 characters)

52 Low minute volume alarm status (6 characters)

53 High respiratory rate alarm status (6 characters)

54 Low O2 supply alarm status (6 characters)

55 Not used (6 characters)

56 Low internal battery alarm (6 characters)

57 Apnea alarm status ( 6 characters)

58 Not used (6 characters)


59 Not used (6 characters)

60 Not used (6 characters)

61 Not used (6 characters)


62 Not used (6 characters)

63 Static compliance (6 characters)

64 Static resistance (6 characters)


65 Dynamic compliance (6 characters)

66 Dynamic resistance (6 characters)

67 Not used (6 characters)


68 Not used (6 characters)

69 Not used (6 characters)

70 Not used (6 characters)


71 Flow sensitivity setting (6 characters)

72 Not used (6 characters)

73 Not used (6 characters)


74 Not used (6 characters)

75 Not used (6 characters)


76 Not used (6 characters)

77 Not used (6 characters)

78 Not used (6 characters)

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Section 9: Ventilator Communication Port

MISCA Response Format

Field number Field content

79 Not used (6 characters)

80 Not used (6 characters)

81 Not used (6 characters)

82 Not used (6 characters)

83 Not used (6 characters)

84 Not used (6 characters)

85 PC inspiratory pressure setting (6 characters)

86 Inspiratory time setting (6 characters)

87 Not used (6 characters)

88 PC apnea pressure setting (6 characters)

89 PC apnea rate setting (6 characters)

90 PC apnea inspiratory time setting (6 characters)

91 PC apnea O2% setting (6 characters)


92 Not used (6 characters)

93 Alarm silence state (6 characters)

94 Apnea alarm status ( 6 characters)


95 Disconnect alarm status (6 characters)

96 Not used (6 characters)

97 Not used (6 characters)


98 Not used (6 characters)

100 Not used (6 characters)

101 Monitored I:E ratio (6 characters)


102 <ETX>

103 <CR>

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Section 9: Ventilator Communication Ports

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10 Abbreviations

Abbreviation Definition
A Ampere
AC Alternating current
ATPD Actual temperature and pressure, dry
Auto control A setting that allows automatic transition between mandatory and spontaneous mode settings
b/min Breaths per minute
BTPS Body temperature and pressure, saturated
c/min Cycles per minute (SPAP mode setting)
CB Clinical bulletin
–3
cmH2O Centimeter of water pressure (1 cmH2O = 10 bar)
Cstat Static compliance
Cstat/kg Static compliance normalized to IBW
DC Direct current
Decel Decelerating flow pattern (ramp)
Decel 50% Decelerating 50% flow pattern (ramp)
Esens Exhalation sensitivity
F/V Flow-volume loop
FIO2 Fraction of inspired oxygen (oxygen concentration)
FRC Functional residual capacity
Ftrig Flow trigger level
GUI Graphical user interface
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 Ratio of inspiratory to expiratory times
ID Internal diameter
l Liter
l/min Liters per minute
LCD Liquid crystal display
Leak Calculated leak
–3
ml Milliliter (1 ml = 10 l)
ms Millisecond
NCPAP+ Nasal continuous positive airway pressure plus with rate and base flow
NIV Noninvasive ventilation
O2 Oxygen
P-CMV Pressure control continuous mandatory ventilation
P/V Pressure-volume loop
Pcontrol Control pressure, inspiratory pressure during a pressure based breath
PEEP Positive end expiratory pressure

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Section 10: Abbreviations

Abbreviation Definition
PF Peak flow
PFe Peak expiratory flow
Phigh High PEEP level (SPAP mode setting)
Plow Low PEEP level (SPAP mode setting)
Pmean Mean inspiratory pressure
Ppeak Peak inspiratory pressure
Pplateau Plateau (inspiratory hold) pressure
Prox Proximal
PRVC Pressure regulated volume control
PRVC-CMV Pressure Regulated Volume Control Continuous Mandatory Ventilation (a VTV mode)
PRVC-SIMV Pressure regulated volume control synchronized intermittent mandatory ventilation, a VTV mode
PS Pressure support
psi Pressure per square inch (1 bar = 14.50 psi)
P-SIMV Pressure control synchronized intermittent mandatory ventilation
Psup high Level of pressure support in addition to high PEEP (SPAP mode setting)
Psup low Level of pressure support in addition to low PEEP (SPAP mode setting)
Psupport Pressure support
Ptrig Pressure trigger level
Rate Measured total (mandatory and spontaneous) breaths per minute
Rate Sp Rate of spontaneous breathes per minute
Rate/Vt Calculated respiratory rate divided by tidal volume (rapid shallow breathing index)
Rinsp Inspiratory resistance
RS232 Serial interface
RSBI Rapid shallow breathing index (a monitored value)
S second
SPAP Spontaneous Positive Airway Pressure
SPONT Spontaneous Ventilation
Square Square wave flow pattern
STPD Standard temperature and pressure, dry
Tapnea Apnea alarm limit
Te Expiratory time
TF Technical fault
Thigh Time at high PEEP level (SPAP mode setting)
Ti Set inspiratory time
Ti Monitored inspiration time
Ti/Ttot Calculated inspiratory time divided by total cycle time
TIB Technical Information Bulletin
Tlow Time at low PEEP level (SPAP mode setting)
TS Touch screen
UI User interface

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Section 10: Abbreviations

Abbreviation Definition
V Volt
V-CMV Volume Control Continuous Mandatory Ventilation
V-SIMV Volume Control Synchronized Intermittent Mandatory Ventilation
VA Volt-ampere (watt)
VAC Volt, alternating current
VDC Volt, direct current
Ve Exhaled minute volume
Ve Spont Spontaneous minute volume
Ve/Kg Minute volume normalized to IBW
VS Volume Support (a VTV mode)
Vte Exhaled tidal volume
Vte/Kg Exhaled tidal volume normalized to IBW
Vti Inspired tidal volume
VTV Volume targeted ventilation
W Watt
WBM Web based monitoring
μA Microampere

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Section 10: Abbreviations

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11 Pneumatic Schematic

Figure 62: Inspiration 7i Ventilator System Pneumatic Diagram

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Section 11: Pneumatic Diagram

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.

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Index
Ethernet connection........................... 26 NCPAP+ patient interface ................... 29
% Exhalation valve ................................. 30 Nebulizer ............................................ 31
EZ-Flow sensor ..................................... 1 Gas delivery compensation when
% O2 Increase key ............................... 54 active ........................................ 31
Output pressure ............................ 31
A F when unavailable .......................... 31
Fan filter replacement and cleaning ...74 Notices
Abbreviations .................................... 96 Flow triggering ................................... 86
Alarm handling ................................... 62 copyright, trademark, regulatory ..14
when disabled ............................... 86 Nurse call
Alarm limit settings ............................ 10
Flow-time waveform .......................... 88 interface pin assignments ............. 27
Alarm priority ..................................... 11
Fuse replacement ............................... 76 warning.......................................... 17
Alarm signals ...................................... 62
F-V loop .............................................. 88 Nurse call connection ......................... 26
Alarms test ..................................... 1, 76
Apnea backup ....................................... 3 Nurse call port pinout ........................ 90
Attaching other devices to the G
ventilator ....................................... 26 Gas mixing system .............................. 88 O
Auto PEEP ..................................... 10, 88 Gas mixing system operation ............ 88 On/Off/Standby key ........................... 36
Gas supply Ordering parts .................................... 78
B filter replacement .......................... 74 Oxygen sensor
Graphics ............................................. 10 calibration ..................................... 73
Backup pressure trigger ..................... 86 flow-time curve ............................. 88
Base flow ............................................ 86
F-V loop ......................................... 88
Basic warnings .................................... 17
pressure-time curve ...................... 88 P
Battery
P-V loop ......................................... 88 Part numbers ...................................... 78
replacement .................................. 75
Parts list .............................................. 78
Battery life .......................................... 12
Patient types ........................................ 3
Bias flow ............................................. 86 H P–CMV Mode ..................................... 82
Breath triggering ............................ 3, 86 Heliox ....................................... 6, 12, 78 P-CMV mode description ................... 82
Breathing circuit Heliox connection............................... 26 Physical data....................................... 13
configuration ................................. 28 Humidification devices ....................... 30 Pneumatic schematic....................... 100
NCPAP+ patient interface .............. 29
Power and gas supply ......................... 12
I Power connections ............................. 24
C Inspiration 7i Ventilator System part
Pressure triggering ............................. 86
C20/C .................................................. 10 Pressure units ....................................... 3
numbers ........................................... i
Calibrations ........................................ 70 Pressure-time waveform .................... 88
Intended use ........................................ 1
oxygen sensor ................................ 73 Preventive maintenance .................... 74
Internal compressor ........................... 12
proximal flow sensor ..................... 71 Product specifications
intrinsic PEEP ...................................... 88
Cart, attaching to ventilator ............... 23 additional settings ........................... 3
Introduction ......................................... 1
Cleaning and inspection ..................... 68 Alarm priority ................................ 11
Clinical application of real-time curves alarms ............................................ 10
and loops ....................................... 88 L apnea settings ................................. 5
CLININET ............................................... 27 Labels ................................................. 15 apnea ventilation............................. 3
CO2 monitor connection ..................... 26 Leak, patient tubing ........................... 72 Auto alarm ..................................... 10
Communication ports ......................... 90 breath triggering ............................. 3
Compliance, tubing ............................ 72 breath Types .................................... 3
Configuration screens ........................ 32
M cart dimensions ............................. 13
Configuring the ventilator .................. 32 Maintenance ...................................... 68 Cart weights................................... 13
Connecting gas supplies ..................... 25 Man Insp breath settings ................... 55 environmental data ....................... 12
Connecting to power .......................... 24 Manual inspiration key ....................... 55 high priority alarms ....................... 11
Contact information .............................. i MISCA response ................................. 91 internal compressor ...................... 12
Cstat ................................................... 10 Mode description medium priority alarms ................. 11
Cstat/kg .............................................. 10 VTV ................................................ 83 monitored and displayed data ........8
Modes .................................................. 3 operating temperature .................. 12
Modes, theory of operation ............... 80 physical data .................................. 13
D Monitored data .................................... 8 power and gas supply .................... 12
Device Labels and Symbols................. 15 Monitored values Special screen functions .......... 6, 7, 8
Disposal .............................................. 77 description..................................... 87 storage temperature ..................... 12
technical data ................................ 13
ventilation modes ............................ 3
E N ventilator dimensions .................... 13
Electromagnetic compatibility Nasal CPAP mode description (NCPAP+) ventilator weight ........................... 13
declaration .................................... 18 ....................................................... 86 Proximal flow sensor .......................... 30
Environmental data ............................ 12 Nasal prongs ....................................... 29 calibration ..................................... 71

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P–SIMV Mode..................................... 83 RSBI .................................................... 10 System Test .......................................... 1
P-SIMV mode description ................... 83 RSET command................................... 91
P-V loop .............................................. 88
T
S Table of contents............................ iii, vi
R Safety ................................................. 17 Technical data .................................... 13
Rapid shallow breathing index ........... 10 Safety information ............................. 17 Theory of operation ........................... 80
Real timecCurves ................................ 10 Smart Nebulizer.................................... 6
Respiratory mechanics Smart Sigh ............................................ 6
Auto PEEP ...................................... 10 SNDA command ................................. 91
V
C20/C ............................................. 10 SPAP mode ................................. 7, 8, 85 V–CMV Mode ..................................... 80
Cstat .............................................. 10 SPAP mode description ...................... 85 V-CMV mode description ................... 80
Cstat/kg ......................................... 10 Spare parts ......................................... 78 Ventilator operation ........................... 36
Rinsp .............................................. 10 Special screen ....................................... 6 Ventilator setup ................................. 23
Rinsp ................................................... 10 Specifications ....................................... 3 VIRTUAL REPORT ..................................... 27
RR/Vt .................................................. 10 SPONT mode ...................................... 84 V-SIMV mode description .................. 81
RS232 connection ............................... 26 SPONT mode description ................... 84 VTV modes description ...................... 83
RS232 interface pin assignments ....... 27 Spont% 1h ............................................ 9
RS232 serial port Spont% 8h ............................................ 9 W
commands ..................................... 91 Supply gas connections ...................... 25
Waveforms ......................................... 10
protocol ......................................... 91 Symbols ........................................ 15, 17
RS232 serial port pinout ..................... 90 System test ......................................... 72

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