VWSP-100 Civil Model
VWSP-900 Military Model
User Manual
Ventway Sparrow
Emergency and transport
ventilator
Document Number VWSP-500-03 October 2018
Ventway Sparrow User Manual
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Important
This User Manual is subject to periodic review, update and revision.
Do not use a defective product. Do not repair this product or any of its parts.
If this device does not perform properly, contact an Inovytec representative.
The user of this product has sole responsibility for any malfunction that results
from improper use, faulty maintenance, improper repair, unauthorized
service, damage, or alteration by anyone other than Inovytec Medical
Solutions Ltd.
The safety, reliability, and performance of this device can be assured only
under the following conditions:
• The device has been used according to the accompanying operating
instructions.
• All fittings, extensions, readjustments, changes, or repairs have been
carried out by Inovytec Medical Solutions Ltd.'s authorized representatives.
No part of this publication may be reproduced, stored in a retrieval system or
transmitted in any form by any means, electronic, mechanical, photo
reproductive, recording or otherwise without the express prior written
permission of Inovytec Medical Solutions Ltd.
Inovytec Medical Solutions Ltd. reserves the right to change or improve its
products and accompanying technical literature without specific notice of
changes or improvements.
This product is protected by patents listed on the Inovytec website.
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Contact Information:
Inovytec Medical Solutions Ltd.
3 Hanagar St., POB 7282,
Hod-Hasharon 4501306, Israel
Tel: +972 9 779 41 35
Fax: +972 9 779 41 38
E-mail: Info@Inovytec.com
Web Site: http://www.Inovytec.com
Disclaimer
Information provided by Inovytec Medical Solutions Ltd. is believed to be
accurate and reliable. However, Inovytec assumes no responsibility for the
use of such information, nor for any infringements of patents or other rights
of third parties, that may result from its use.
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this
law, owners of this ventilator must notify Inovytec Medical Solutions Ltd. if
this product is received; lost, stolen, or destroyed; donated or resold; or
otherwise distributed to a different organization. If any such event occurs,
contact Inovytec in writing with the following information:
Originator's organization – Company name, address, contact name, and
contact phone number
Model number, and serial number of the ventilator
Disposition of the ventilator (for example, received, lost, stolen,
destroyed, distributed to another organization), new location and/or
organization (if known and different from originator’s organization) –
company name, address, contact name, and contact phone number
Date when the change took effect
Please address this information to Inovytec Medical Solutions Ltd. at the
address given above.
PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM.
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Contents
1. About This User Manual .......................................................................................................... 9
1.1. TYPES OF WARNINGS, CAUTIONS AND NOTES ....................................................................... 9
1.2. GLOSSARY AND ABBREVIATIONS ................................................................................................... 10
2. Overview of System .............................................................................................................. 11
2.1. DESCRIPTION OF DEVICE ............................................................................................................. 11
3. Conditions for Use ................................................................................................................ 12
3.1. INTENDED USE ......................................................................................................................... 12
3.2. INDICATIONS FOR USE ................................................................................................................ 12
3.3. CONTRAINDICATIONS ................................................................................................................. 13
3.4. LIMITATIONS OF USE ................................................................................................................. 13
4. Safety ................................................................................................................................... 14
4.1. ELECTRICAL SAFETY ................................................................................................................... 14
4.2. EMC COMPLIANCE ................................................................................................................... 14
4.3. SAFETY INSTRUCTIONS ............................................................................................................... 14
5. System Components ............................................................................................................. 18
5.1. UNPACKING THE DEVICE ............................................................................................................. 18
5.2. VENTILATOR – FRONT PANEL ....................................................................................................... 19
5.3. VENTILATOR – REAR PANEL......................................................................................................... 19
5.4. VENTILATOR – USE CONFIGURATION ............................................................................................. 20
5.5. PATIENT CIRCUIT ....................................................................................................................... 21
5.6. PNEUMATIC SECTION – THEORY OF OPERATION ................................................................................ 22
6. Connecting the Ventilator ..................................................................................................... 25
6.1. FRONT PANEL CONNECTIONS ....................................................................................................... 25
6.2. REAR PANEL CONNECTIONS......................................................................................................... 25
7. Power On and Display Startup Screen ................................................................................... 26
7.1. QUICK START ........................................................................................................................... 26
8. Navigating the GUI screens ................................................................................................... 28
8.1. SELECTING SCREEN OPTIONS ....................................................................................................... 28
8.2. EDITING FIELDS ........................................................................................................................ 28
8.3. NAVIGATING BETWEEN SCREENS .................................................................................................. 28
8.4. CONFIRMING OR CANCELLING A MESSAGE ...................................................................................... 29
8.5. SYMBOLS USED IN THE SYSTEM ..................................................................................................... 29
8.6. SYSTEM INDICATORS .................................................................................................................. 30
8.6.1. Battery Status .............................................................................................................. 30
8.6.2. indicators ..................................................................................................................... 31
8.6.3. Alert ............................................................................................................................. 31
9. Getting Started with Ventway Sparrow ................................................................................. 32
9.1. DISCONNECT PATIENT ................................................................................................................ 32
9.2. PATIENT WEIGHT ...................................................................................................................... 33
9.3. VENTILATION MODE .................................................................................................................. 34
9.4. VENTILATION PARAMETERS ......................................................................................................... 35
9.5. NUMERICAL REPRESENTATION OF BREATH PARAMETERS .................................................................... 36
9.6. PRESSURE AND FLOW GRAPHS ...................................................................................................... 37
10. Main Menu ......................................................................................................................... 38
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10.1. MAIN MENU/NEW PATIENT (DISCONNECT PATIENT SCREEN)........................................................... 39
10.2. MAIN MENU/VENT PARAMS .................................................................................................... 39
10.2.1. MAIN MENU/Vent Params/Trigger Sensitivity .......................................................... 40
10.2.2. MAIN MENU/Vent Params/Vent Mode ..................................................................... 40
10.2.3. MAIN MENU/Vent Params/O2 Enrichment ................................................................ 40
10.2.4. MAIN MENU/Vent Params/Patient Weight ............................................................... 40
10.3. MAIN MENU/ALERT SETTINGS ................................................................................................ 41
10.4. MAIN MENU/ADVANCED SETTINGS ............................................................................................ 42
10.4.1. MAIN MENU/Adv Settings/Load Default ................................................................... 42
10.4.2. MAIN MENU/ADV SETTINGS/Brightness ................................................................... 42
10.4.3. MAIN MENU/Adv Settings/Alert volume ................................................................... 43
10.4.4. MAIN MENU/Adv Settings/Language ........................................................................ 43
10.4.5. MAIN MENU/Adv Settings/Tech mode ...................................................................... 43
10.4.5.1. MAIN MENU/ADV SETTINGS/TECH MODE/Set Time ......................................... 44
10.4.5.2. MAIN MENU/ADV SETTINGS/TECH MODE/Calibration ..................................... 44
10.4.5.3. MAIN MENU/ADV SETTINGS/TECH MODE/Work Hours ................................... 45
10.4.5.4. MAIN MENU/ADV SETTINGS/TECH MODE/Self Test ......................................... 46
10.4.5.4.1. MAIN MENU/ADV SETTINGS/TECH MODE/Self Test /Flow and Pressure .. 47
10.4.5.4.2. MAIN MENU/ADV SETTINGS/TECH MODE/Self Test /CVT ........................ 48
10.4.5.4.3. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /VVT ...................... 49
10.4.5.4.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /Blower Test ......... 50
10.4.5.5. MAIN MENU/ADV SETTINGS/TECH MODE/Logbook ......................................... 51
10.4.5.6. MAIN MENU/ADV SETTINGS/TECH MODE/Export Log ...................................... 51
10.4.5.7. MAIN MENU/ADV SETTINGS/TECH MODE/SW Version .................................... 51
10.4.5.8. MAIN MENU/ADV SETTINGS/TECH MODE/SW Update..................................... 52
10.4.5.9. MAIN MENU/ADV SETTINGS/TECH MODE/System Mode ................................. 52
10.4.5.10. MAIN MENU/ADV SETTINGS/TECH MODE/Altitude ........................................ 52
11. Warnings and Alerts ............................................................................................................ 53
11.1. SUMMARY OF ALERT TYPES ....................................................................................................... 53
11.2. SUMMARY OF ALERT LEVELS ...................................................................................................... 54
11.3. WARNING EXAMPLE ................................................................................................................ 55
11.4. ALERT EXAMPLE ..................................................................................................................... 55
12. Default Parameters ............................................................................................................. 56
12.1. START VOLUME VENTILATION .................................................................................................... 56
12.1.1. Oxygen supply ............................................................................................................ 56
12.1.1.1. Connecting the Air Inlet to the Demand Valve .................................................. 57
12.1.2. Recommended devices for monitoring of oxygen ...................................................... 58
12.2. ALERT DEFAULT PARAMETERS: 5 KG TO 70+ KG ........................................................................... 59
12.3. ALERT DEFAULT PARAMETERS: ALL PATIENT WEIGHTS ..................................................................... 59
13. Labels and Symbols ............................................................................................................. 60
13.1. LABELS ................................................................................................................................. 60
13.2. SYMBOLS .............................................................................................................................. 61
14. Cleaning and Disinfecting .................................................................................................... 62
15. Ventilation Methods ........................................................................................................... 63
15.1. SIMV-VC (PS)FLOW CHART..................................................................................................... 63
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15.2. CPAP – SPONTANEOUS BREATHING MODE ................................................................................... 66
15.3. BACKUP VENTILATION MODE .................................................................................................... 69
15.3.1. Backup Ventilation in CPAP ........................................................................................ 69
15.3.2. Backup Ventilation before starting patient ventilation .............................................. 70
15.4. SIMV VC (CPR) .................................................................................................................... 72
15.5. CPAP (CPR) ......................................................................................................................... 73
16. Service and Maintenance .................................................................................................... 74
16.1. DEVICE CALIBRATION AND SOFTWARE UPGRADES .......................................................................... 74
17. Troubleshooting .................................................................................................................. 75
18. Specifications ...................................................................................................................... 76
18.1. DIMENSIONS AND WEIGHT ....................................................................................................... 76
18.2. ENVIRONMENTAL SPECIFICATIONS .............................................................................................. 77
18.3. HARSH ENVIRONMENTAL CONDITIONS ............................................................................. 77
18.3.1. Operation in extreme high / low temperatures ......................................................... 77
18.3.2. Operation in High or Low Altitude ............................................................................. 78
18.3.3. Airborne particulates ................................................................................................. 78
18.4. POWER SUPPLY ...................................................................................................................... 79
18.5. VENTILATION PERFORMANCE ..................................................................................................... 80
18.6. STANDARDS AND SAFETY REQUIREMENTS ..................................................................................... 81
19. Cleaning and Routine Maintenance ..................................................................................... 82
20. Batteries ............................................................................................................................. 83
20.1. BATTERY MAINTENANCE .......................................................................................................... 83
21. Parts and Accessories .......................................................................................................... 84
22. Regulatory .......................................................................................................................... 85
23. Warranty ............................................................................................................................ 86
24. Appendix – Test Alerts ........................................................................................................ 87
24.1. BACKUP VENTILATION .............................................................................................................. 87
24.2. START BACKUP VENTILATION WITH UNKNOWN WEIGHT .................................................................... 88
24.3. CPAP VENTILATION WITH BACKUP VENTILATION ............................................................................ 89
24.4. PATIENT DISCONNECT .............................................................................................................. 90
24.5. HIGH PEEP ........................................................................................................................... 91
24.6. VALVE BLOCKED ...................................................................................................................... 92
24.7. PRESSURE ALERT ..................................................................................................................... 93
24.8. MINUTE VOLUME (MV) ALERT .................................................................................................. 94
24.9. LEAK ALERT ........................................................................................................................... 95
24.10. TIDAL VOLUME ALERT ............................................................................................................ 96
24.11. I:E ALERT ............................................................................................................................ 97
24.12. APNEA ALERT ....................................................................................................................... 98
24.13. POWER ALERT ...................................................................................................................... 99
24.14. LOW BATTERY ALERT ........................................................................................................... 100
24.15. BATTERY TYPE ALERT ............................................................................................................ 101
24.16. VOLTAGE ALERT .................................................................................................................. 102
24.17. TEMPERATURE ALERT ........................................................................................................... 103
24.18. TUBE DISCONNECT ALERT ..................................................................................................... 104
24.19. SERVICE REQUIRED ALERT ..................................................................................................... 105
24.20. FILTER REPLACEMENT REQUIRED ............................................................................................ 106
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24.21. ALTITUDE CHANGE ALERT ..................................................................................................... 107
24.22. SHUTDOWN ALERT .............................................................................................................. 108
24.23. VENTILATION DURING STANDBY (DUE TO PATIENT INSPIRATORY EFFORT) .......................................... 109
25. Appendix – Menu Hierarchy .............................................................................................. 110
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Obtaining Help
If you have a ventilator problem that you cannot solve, and the ventilator was
purchased directly from Inovytec, you may contact Inovytec at
sales@Inovytec.com.
If you have a ventilator problem that you cannot solve, and the ventilator was
purchased from an authorized Inovytec distributor, please contact your
distributor directly to report the problem.
Note: If this ventilator has not been purchased directly
from Inovytec, please ensure that it has been purchased
from an authorized distributor of Inovytec. To obtain a list
of authorized distributors, contact Inovytec at
sales@Inovytec.com.
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1. ABOUT T HIS USER MANUAL
This User Manual provides the information necessary to operate and maintain
the Ventway Sparrow ventilator.
PLEASE READ THIS USER MANUAL BEFORE OPERATING THE SYSTEM. If any
part of this User Manual is not clear, contact Customer Support for assistance.
1.1. TYPES OF WARNINGS, CAUTIONS AND NOTES
Three types of special message appear in this User Manual:
Warning: A warning indicates precautions to avoid the
possibility of personal injury or death.
Caution: A caution indicates a condition that may lead
to damage to equipment, or a lower quality of treatment.
Note: A note provides other important information.
PLEASE RETAIN THIS USER MANUAL FOR FUTURE REFERENCE.
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1.2. GLOSSARY AND ABBREVIATIONS
Apnea Temporary cessation of breathing
BPM Breaths Per Minute
CPAP Continuous Positive Airway Pressure
lpm Liters per minute
Mandatory
Breath
Ventilator initiated breath
MV Minute Volume
NIV Non-Invasive Ventilation
Peak Flow Maximum volumetric flow
PEEP Peak End Expiratory Pressure
PIP Peak Inspiratory Pressure
Pressure
support
Preset pressure delivered to the patient, on top of the
PEEP, during triggered breath
PSV Pressure Support Ventilation
SIMV VC
PS
Synchronized Intermittent Mechanical Ventilation with
Volume Control and Pressure Support
Te Expiratory Time
Ti Inspiratory Time
Tidal
Volume
Normal volume of air displaced between normal
inhalation and exhalation when extra effort is not applied
Triggered
breath
Patient initiated breath
TVe Expired Tidal volume
TV
i
Inspired Tidal volume
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2. OVER VIE W OF SYSTEM
2.1. DESCRIPTION OF DEVICE
The Ventway is an emergency portable ventilator, used for transport, EMS and
military applications.
The situations for which it is intended are characterized by attendance of first
responders with limited triage capabilities, requiring a simple yet highly
effective ventilator, that is self-sufficient and lightweight.
The ventilator is suitable for noninvasive ventilation for a full non-vented
ventilation face mask or invasive ventilation via an endotracheal tube, tracheostomy and laryngeal mask airway (LMA).
Note: The power supply needs to be firmly and permanently
secured in any EMS environment in which the ventilator is
used.
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3. CONDITIONS FOR USE
3.1. INTENDED USE
The Ventway Sparrow lung ventilator is intended for emergency use and
transportation of adult and pediatric patients weighing at least 5 kg (11 lb). It
may be used for invasive or noninvasive ventilation presets. The ventilator is
a restricted medical device intended for use by qualified, trained personnel
under the direction of a physician.
3.2. INDICATIONS FOR USE
The Ventway Sparrow ventilator is intended to provide continuous or
intermittent ventilatory support for the care of individuals who require
mechanical ventilation. Specifically, the ventilator is applicable for adult and
pediatric patients weighing at least 5 kg, who require the following types of
ventilatory support: SIMV - VC (PS), CPAP.
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3.3. CONTRAINDICATIONS
See specific patient instructions regarding performing ventilation or any
use of life support equipment.
Acute Pneumothorax
3.4. LIMITATIONS OF USE
Clinical situations potentially affecting accuracy or performance:
Controlling the flow in the presence of difficult airways, such as severe
lung blockage and asymmetric air entrance to the lung
Low compliance of the airways
Asynchronization between patient and ventilator
Barotrauma
Behavior of the ventilator in case of barotrauma, monitoring and alerting
in these cases.
Note: The use of humidification is not recommended, due to
potential blockage of control and measurement tubes.
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4. SAFETY
4.1. ELECTRICAL SAFETY
The device complies with requirements of IEC/EN 60601-1 for general
requirements for safety of medical electrical equipment:
Class I Equipment BF type applied part
Mode of operation: Continuous measurement
Degree of mobility: Portable
4.2. EMC COMPLIANCE
The unit has Class B compliance.
4.3. SAFETY INSTRUCT IONS
Warnings
Basic safety precautions always should be taken, including all those
listed below.
DO NOT USE BEFORE READING THIS USER MANUAL.
DO NOT use this device for any purpose other than specified in this
manual without written consent and approval from Inovytec Medical
Solutions Ltd.
In case of VENTILATOR failure, the lack of immediate access to
appropriate alternative means of ventilation can result in PATIENT
death.
US Federal Law restricts the sale of this instrument only by, or on the
order of, a physician.
The exhaled volume of the patient can differ from the measured
exhaled volume due to leaks around the mask.
The device shall not be used in a hyperbaric chamber.
The device shall not be used with nitric oxide and explosive or highly
flammable gas mixtures.
The device shall not be used with helium or mixtures with helium.
The device should not be used on unattended patients.
The device accuracy can be affected by the gas added by use of a
nebulizer.
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Cautions
If the device packaging is not intact, do not use the device.
If the device does not turn on, or is not working correctly, discontinue
use. Refer servicing or replacement to qualified service personnel.
Do not disassemble any part of the system components. This system
is not user-serviceable.
Do not use the equipment if it is not working properly or if it has
suffered any damage, for example, by dropping the equipment or
splashing water on it.
If the LCD screen is cracked or damaged, check whether the screen
can be used, and if not, do not use the device.
If the power button is damaged or stuck, disconnect the patient from
the device and remove the battery.
If the rotator switch does not allow changing parameters, the device
cannot be used.
The Patient Circuit is single use only. If it is not removed from a new
container, it may have already been used and should not be used.
The Patient Circuit can be used for the same patient up to five days.
Do not use a Patient Circuit that is not the original Patient Circuit of
the device.
Confirm that the expiration date, found on the Patient Circuit
packaging bag, has not been reached.
The device should be used under medical supervision.
When using external oxygen enrichment, please note the following:
When using demand valve, the oxygen enrichment level will
reach a minimum of 95%.
When using reservoir bag, the oxygen enrichment level may
vary depending on oxygen flow rate.
It is the user’s responsibility to retain information about the patient
(by USB connection). Storage capacity may be sufficient for at least
one year of ventilation.
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Cautions
Repairs should be undertaken only by personnel trained or authorized by Inovytec Medical Solutions Ltd. Do not modify this equipment without authorization from Inovytec Medical Solutions Ltd.
The device may not operate correctly if used or stored outside the
relevant temperature or humidity ranges, as described in the performance specifications.
Strictly follow the warning instructions in this manual.
This instrument is fragile. To prevent damage, please handle with
care, including while packing and unpacking.
Ensure that the system is only used by a trained person familiar with
all system operating procedures. EMS personnel should complete a
training program before operating the Ventway Sparrow.
User is prohibited from changing, adding, removing or disassembling
any system parts. Warranty shall not apply to any defects, failure or
damage caused by improper use and/or improper or inadequate
maintenance and care.
The unit is classified as Class IIb, continuously operated, ordinary
equipment with applied part and with signal input/output parts. The
device is not intended for use in the presence of flammable substances.
To avoid damage to the screen, do not expose the instrument to
direct sunlight for prolonged periods.
The system is approved for IP45 in operation mode with oxygen
enrichment. To prevent damage to the instrument or patient cable,
avoid liquid spillage while cleaning.
It is strongly recommended that all Ventway Sparrow parts be
replaced with parts purchased from Inovytec Medical Solutions Ltd.
or an authorized distributor. Use of other parts may damage the unit
and void the warranty.
The ventilator is suitable for noninvasive ventilation for full nonvented ventilation face mask or invasive ventilation via an
endotracheal tube, tracheostomy and laryngeal mask airway (LMA).
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Cautions
During NIV (Non-Invasive Ventilation) the user should use a
capnograph in order to monitor the CO2 level of the patient.
Covering the ventilator is prohibited.
Ensure that no Latex or natural rubber parts are in patient pathways.
When adding medication to the gas flowing into the patient by using
an MDI or nebulizer, please position between mask/ETT and exhalation valve.
Do not obstruct the gas intake ports.
Discarded used or unused patient circuit is classified as clinical waste.
As such, the user is responsible for complying with all local and
national regulations regarding discarding of clinical waste.
Notes
Dispose of this device and used sensors in accordance with
local regulations.
Use the equipment only for the purpose described in these
instructions for use.
The contents of this manual are subject to change without prior
notice.
The user or any technical personnel who are not formally
authorized by Inovytec Medical Solutions Ltd. should not open
the device under any circumstances. Opening the device could
damage the unit and will void the warranty provided by
Inovytec Medical Solutions Ltd.
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5. SYST EM COMPONENTS
5.1. UNPACKING THE DEVICE
Package contents
1 Ventway Sparrow ventilator
2 User Manual and device documentation
3 Battery pack - Inside ventilator battery
compartment
4 Power supply
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5.2. VENTILATOR – FRONT PANEL
5.3. VENTILATOR – REAR PANEL
Warning: Do not block item (1), the air/oxygen inlet.
Rear Pane:
(1) Air/Lo
w pressure oxygen inlet,
(2) P
ower supply connector,
(3) USB
connector, (4) Power On/Off button, (5) Battery pack lock, (6) Battery pack,
(7) Filter compartment screws
Front Panel:
(1) control knob,
(2) display,
(3) control and sensing tubes port,
(4) patient port
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5.4. VENTILATOR – USE CONFIGURATION
During transport, the ventilator is recommended to be placed in a horizontal
position.
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5.5. PATIENT CIRCUIT
Patient circuits specifications Adult Pediatric
Nominal overall length 180 / 240 cm 180 / 240 cm
Internal volume 690 / 920 CC 318 /424 CC
Inspiratory Resistance to flow 2.7 cmH2O @ 60
lpm
5.4 cmH2O @ 30 lpm
Dead space 17 cc 16.5 cc
Circuit compliance 0.001 L/cmH2O 0.008 L/cmH2O
Corrugated tube diameter 22 mm 15 mm
Delivered tidal volumes Tv > 200 cc 50 ml < Tv < 200 cc
Exhalation valve color Transparent Blue
An authorized HME and anti-bacterial filter must be used at all times, in order
to protect both patient and ventilator from infection.
Assemble the filter between the patient and transducer; if not possible, then
between the ventilator outlet and the patient circuit 22 mm connector.
Warning: All parts of the patient circuit are single-use. Discard
after use. Handle carefully to avoid cross-contamination.
Warning: Do not use antistatic or electrically conductive hoses or
tubing in the ventilator breathing system.
Diagram of patient circuit
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5.6. PNEUMATIC SE CTION – THEORY OF OP ERA TION
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Explanation of Diagram
1
Solenoid valves exhaust – scavenging of gas residue from the solenoids , passed to inlet to prevent oxygen buildup inside the
enclosure.
2
Manifold assembly – encapsulates all electromechanical control elements, membranes, valves and air tubes in one compact
element. This design eliminates the use of air tubes and pneumatic connectors.
3
Inspiratory control valve – controls the main inspiratory valve.
4
Exhalation control valve – controls the patient exhalation valve membrane, located in the patient circuit transducer.
5
Exhalation control tube – transferring pressure from the exhalation control valve to the exhalation valve membrane. It is a
part of the patient circuit.
6
Inspiratory tube – a 15 mm or 22 mm tube, connecting the ventilator and the patient. Used for delivering the gas mixture to
the patient’s airways.
7
PEEP valve – Spring activated membrane (same membrane used for exhalation control). Adjustable by rotating a knob.
8
Anti asphyxia valve – designed to allow the patient to inhale through an emergency intake port separated from the regular
inlet, in case of failure of the ventilator.
9
Blower – A radial blower, referred to sometimes as “turbine”. Intended to generate pressure and flow of gas mixture either
from the ambient air or from a mixture of air and oxygen.
10
Bleeding conduit and valve – orifice used for passing small amounts of flow, compensating for any leaks that may occur in
the patient circuit, and remove any CO2 from the patient circuit.
11
Main inspiratory valve – normally open valve. Main valve designed to allow passage of gas from the blower to the patient.
12
Flow and pressure sensor – a part of the patient circuit. A constant orifice sensor used for acquiring the flow and pressure in
the patient’s airways and passing them to pressure sensors located in the ventilator’s electronic unit.
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Inspiratory (1) vs. Expiratory cycle
During the inspiratory cycle, the exhalation valve membrane is closed, allowing the gas from the ventilator to be
diverted to the patient. Once the inspiration cycle is complete, the membrane opens, allowing the gas from the
patient to be exhaled through the exhalation valve.
The expiratory gas passes through the membrane which is constantly supported by a spring, creating the preset PEEP
value. During expiratory flow, a continuous low flow is delivered into the patient circuit, in order to prevent any rebreathing and to compensate for small leaks that may exist in the various circuit components, facemask or LMA
(Laryngeal Mask Airway).
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6. CONNECT ING THE VENTILATOR
6.1. FRONT PANEL CONNECTIONS
6.2. REAR PANEL CONNECTIONS
1.
Air inlet/Oxygen supply connector – Air inlet and oxygen connector to
demand valve (see Section 12.1.1.1. Connecting the Air Inlet to the Demand
Valve).
2. DC Power connector – Connect power line (AC/DC or DC/DC power supply)
Caution:
Insert t
he three conductor plug into a
properly wired,
three
-
wire,
grounded, hospital grade receptacle. If a three-wire receptacle is not available,
a qualified electrician must install one in accordance with the governing
electrical code. Do not under any circumstances remove the grounding
connector from the power plug. Do not use extension cords or adapters of any
type. The power cord and plug must be intact and undamaged.
3. USB connector – This connector is intended for technicians who
require access to the logbook and device software.
4.
Power On/Off button
5. Battery safety lock
6. Battery pack
7. Filter compartment screws
1 Pressure and flow measurement port
2 Pressure measurement port
3 Expiratory valve port – control tube
4 Ventilator gas output
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7. POWE R ON A ND DISPL AY STARTUP SCR EEN
To start the system, press and hold the Power On button on the back panel
for 3 seconds.
Back panel indicating the Power On button
7.1. QUICK START
In an emergency situation, Quick Start allows you to start the ventilator
immediately, using preset default options.
To perform a Quick Start, press and hold the Power On button for ten
seconds. The following screen will display:
Quick Start initial screen
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After you confirm by selecting the check mark and pressing the control
know, specify the Patient Type:
Patient Type screen
Now the ventilator will operate in Backup mode:
Ventilator running after Quick Start
For information on Backup Mode, see Section 15.3. Backup Ventilation
Mode.
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8. NAVIGAT ING THE GUI SCREENS
8.1. SELECTING SCREEN OPTIONS
To navigate between the screen options,
turn the control knob on the left side of
the device. When the desired option has
been marked by positioning the marker
on its location, press the knob to select
the option.
8.2. EDITING FIELDS
While turning the control knob, fields that can be
modified are highlighted.
To edit a field, press the control knob when positioned on the field. The field will change color.
Rotate the control knob to view different values for the field, and press the
knob to select a value.
8.3. NAVIGATING BETWEEN SCREENS
Press the Back button ( ) to return to the previous screen.
Press the Next Screen button ( ) to return to the previous screen.
Control knob
Patient Weight highlighted
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8.4. CONFIRMING OR CANCELLING A MESSAGE
When a message is displayed by the system that allows a confirm or cancel
response, press Cancel ( ) to reject the action, or press Confirm ( ) to accept
the action.
8.5. SYMBOLS USED IN THE SYSTEM
Back
Next screen
Language
Graphs (Flow / Pressure)
Confirm
Cancel
Manual breath
Main Menu
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8.6. SYSTEM INDICAT ORS
The top left corner of the display shows battery status and system indicators.
8.6.1. BATTERY STATUS
No battery, external power source used
Non-rechargeable battery, no external power source
Non-rechargeable battery, external power source connected
Rechargeable
battery,
external
power
source
connected
(charg
-
ing)
Rechargeable
battery,
external
power
source
connected
(fully
charged)
Rechargeable battery, no external power source connected
Rechargeable battery, not charging
due to battery
tem
perature
protection or faulty battery
Battery charge level is indicated by the following signs :
Battery full
Medium energy level
Low energy level
Battery in critical energy level
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8.6.2. INDICATORS
_T_
Patient trigger detected
_Z_
Pressure sensors are currently being zeroed
Note: While zeroing sensors, the ventilator will
not detect patient triggers.
The bottom left corner of the display shows the active alerts indicator.
8.6.3. ALERT
Caution:
It is
the user’s
responsibility
to
ensure
that the
alert
s are working
properly. See Section 24. Appendix – Test Alerts for instructions on testing
the alerts.
Normal operation
Alert is silenced.
Note: While the alert is silenced (maximum 120
seconds) this indicator is displayed, and the number of active alerts is displayed in parentheses
next to the icon.
Note: The icon serves as an activation button.
Pressing it will open a list of up to five active alerts
ordered by priority.
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9. GETT ING ST ARTED WITH VENTWAY SPARROW
The initial set of screens allow you to start the ventilator and specify settings
such as patient weight, ventilation type, and other basic parameters.
Note: A system alert sound is activated during system startup,
indicating a valid Circuit Verification test.
Note: An emergency quick start can be performed if necessary.
See Section 7.1. Quick Start.
The first screen showing the Ventway Sparrow logo allows the
user to identify whether the display is working properly.
9.1. DISCONNECT PATIENT
Initial screen
Normal procedure after turning on the ventilator is to verify that the patient
is disconnected , then press OK on this initial screen. The system will activate
the blower to verify the correct operation of the device and various components (e.g. patient circuit, sensors and electrical components).
The self test screen will display for about 8 seconds.
Self Test screen
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If the self test fails, the user is advised to check the following:
No oxygen demand valve connected to the ventilator
No oxygen reservoir
Dirty/obstructed inlet filter
Pressure and control tube connected properly (kinks, disconnec-
tion or rupture of the tubes)
No HME or filter are connected to the exhalation valve
Patient is not connected
9.2. PATIENT WEIGHT
Rotate the scroll knob to select the weight of the patient:
Pediatric and adult weight selection screens
Note: If the Main Menu is selected instead of OK, the START
option will be unavailable, since the weight of the patient is
unknown and ventilation parameters are not set. For details on
the Main Menu option, see Section 10. Main Menu.
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9.3. VENTILATION MODE
Select the initial choice of ventilation mode. This can be changed later. See
Section 15. Ventilation Methods for details about each ventilation mode.
Ventilation Mode screen
After ventilation mode is selected, select Invasive or Non-Invasive Mode:
You will be prompted to connect the patient:
Select the preference regarding Invasive or Non-Invasive ventilation
mode.
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Alerts
Menu
Manual
Breath
Graph
9.4. VENTILATION PARAMETERS
The Ventilation Parameters screen displays the relevant patient information ,
updated on a real-time basis:
Ventilation Parameters screen
Select BPM to change the breaths per minute delivered.
Select VTe to change the desired VTe
Select ALERTS to view the current active (silenced) alerts.
Select GRAPH to display the Pressure or Flow graphs – see Section 9.6.
Pressure and flow graphs.
Select MANUAL BREATH to give one breath to the patient using the
current parameters.
Select MENU to display the Menu screen – see Section 10. Main Menu.
Note:
When Non Invasive ventilation mode is applied, only the set
value of VT is displayed in parenthesis. VTE and VTI are displayed as
part of the graphs screens of pressure and flow. In Non Invasive ventilation the ventilator is programmed to compensate for the loss of
volume due to leaks from the facemask or LMA. Actual delivered tidal
volume can only be interpolated, and is not displayed.
Example of Non-Invasive Mode display
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9.5. NUMERICAL REPRESENTATION OF BREATH PARAMETERS
The measured and computed values that are displayed in the system are
calculated using the filtering and smoothing techniques described below.
Patient pressure is displayed to the user by a bar (graphic refreshment
frequency is 10 Hz). The sample rate of the pressure value is 500 Hz. The Peak
Inspiratory Pressure is displayed as a blue background, remaining
throughout the current breath, while the current pressure is displayed in
green.
Altimeter input is averaged per second and linearly interpolated.
Oxygen percentage correction factor for density correction is taken from a
table. Oxygen value is determined by the user.
Flow correction factor is taken from the last performed volume calibration.
Real time flow values are calculated using linear interpolation and corrected
by the oxygen percentage, altitude (atmospheric pressure) and calibration
correction factors.
Inspiratory and expiratory tidal volumes are calculated by integrating the
positive and negative flows over time. The negative (expiratory) tidal volume
and minute volume are displayed to the user. The positive tidal volume is
used to determine timing of the current breath termination and for blower
speed corrections.
Please note that due to possible leaks when using non-invasive ventilation,
VTe and VTi may vary substantially. Nevertheless, in non invasive mode, a
correction to leaks is performed by the ventilator.
BPM is calculated as one minute divided by the latest breath length.
Minute volume is calculated as the latest BPM multiplied by the latest
expiratory tidal volume.
I:E is displayed to the user and is calculated per each breath as the inspiration
time divided by the expiration time.
The latest PEEP is displayed to the user, and is updated per each breath, as
the pressure measured at the end of expiration.
PIP is displayed to the user by a bar graph. It is the highest level of pressure
applied to the lungs during inhalation.
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9.6. PRESSURE AND FLOW GRAPHS
This display shows the graphs of the pressure (in units of cmH2O) over time,
and flow (in units of LPM) vs. time.
Rotation of the knob will switch between flow and pressure graphs.
Flow Graph screen
Pressure Graph screen
During sensor zeroing, diagonal lines are drawn on the graph to indicate no
input from the sensors.
Flow graph screen during sensor zeroing
VT
E
VT
E
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10. MAI N MENU
The Main Menu screen allows the user to view and set various system values.
Menu screen
STOP VENT/START VENT
Stop or start the respiratory function of the device.
NEW PATIENT
View the Disconnect Patient screen and reset all selected parameters. See
Section 10.1. Main Menu/New Patient (Disconnect Patient Screen).
VENT. PARAMS
View patient weight, ventilation mode, and other parameters.
See Section 10.2. Main Menu/Vent Params.
ALERT SETTINGS
Set the thresholds at which the alerts will be displayed. See Section 10.3.
MAIN MENU/Alert settings.
ADV SETTINGS
Set advanced settings, such as technician mode, brightness, language. See
Section 10.4. Main Menu/Advanced Settings.
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10.1. MAIN MENU/NEW PATIENT (DISCONNECT PATIENT SCREEN)
This screen allows the user to restart existing ventilation parameters, e.g.
when ventilating a new patient.
Disconnect Patient screen
10.2. MAIN MENU/VENT PARAMS
These screens allow the user to set the patient weight, ventilation mode, and
other ventilation parameters.
Vent. Param. screen (page 1) Vent. Param. screen (page 2)
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10.2.1. MAIN MENU/VENT PARAMS/TRIGGER SENSITIVITY
Set the trigger sensitivity for the pressure measurements.
Trigger Sensitivity screen
Caution: When closed suction catheterization is performed,
patient trigger sensitivity must be turned to "off".
Caution: During transport ventilation, when the patient is
often moved and subject to abrupt bumps, it is recommended
to decrease pressure triggers sensitivity, in order to avoid auto
triggers (e.g. -5 instead of -2).
.
10.2.2. MAIN MENU/VENT PARAMS/VENT MODE
The ventilation mode was set initially when the device was turned on. See
Section 9.3. Ventilation Mode to change the ventilation mode.
10.2.3. MAIN MENU/VENT PARAMS/O2 ENRICHMENT
10.2.4. MAIN MENU/VENT PARAMS/PATIENT WEIGHT
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The patient weight was set initially when the device was turned on. See
Section 9.2. Patient Weight to change the patient weight.
10.3. MAIN MENU/ALERT SETTINGS
The Alert Settings screens allow the user to set the threshold values for each
type of ventilation parameters alert.
Alert Param. screen (page 1) Alert Param. screen (page 2)
See also Section 11. Warnings and Alerts for more information about warning
and alert messages.
Caution: Boot Fail Alert
The Boot Fail screen appears if the system experiences an error
when starting. Replace ventilator and contact Inovytec support.
Boot Fail screen
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10.4. MAIN MENU/ADVANCED SETTINGS
The Advanced Settings menu screen is shown below.
Advanced Settings menu
These options are explained in the following sections.
10.4.1. MAIN MENU/ADV SETTINGS/LOAD DEFAULT
Set all parameters to their default values by the set weight.
The Load Default screen
10.4.2. MAIN MENU/ADV SETTINGS/BRIGHTNESS
Change the brightness of the display.
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10.4.3. MAIN MENU/ADV SETTINGS/ALERT VOLUME
Change the volume of all sound cues of the system.
10.4.4. MAIN MENU/ADV SETTINGS/LANGUAGE
Change the system display language.
10.4.5. MAIN MENU/ADV SETTINGS/TECH MODE
Tech mode allows the setting of the time, total hours of operation, and
provides a system self-test function.
Tech Mode screens
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10.4.5.1. MAIN MENU/ADV SETTINGS/TECH MODE/SET TIME
Set the system date and time.
The Set Time screen
10.4.5.2. MAIN MENU/ADV SETTINGS/TECH MODE/CALIBRATION
Under Tech mode, the user may perform volume calibration by choosing
the calibration screen.
The Calibration screen requires a device key to be entered:
Calibration screen: Enter key
Then the Patient Type screen displays:
Choose the patient type, before calibrating
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The use of fixed volume 500 cc syringe provides an easy and accurate solution
for volume calibration. The user must move the syringe handle, completing a
cycle in one to two seconds, resulting in an average flow of 15 to 30 lpm. The
calculated tidal volume is displayed for each stroke, and once the tidal volumes (VTI and VTE) are between 490 to 510 cc, the user may finish the calibration process by pressing the scroll knob.
Volume Calibration screen
The ventilator compensates for each stroke for tidal volume inaccuracies. The
tidal volume per stroke becomes closer to 500 cc, once it is automatically multiplied by a correction factor. At the beginning of each stroke, the ventilator
generates a sound, indicating to the user to start moving the syringe handle.
10.4.5.3. MAIN MENU/ADV SETTINGS/TECH MODE/WORK HOURS
Work Hours screen
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10.4.5.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST
Self Test screen
The Self Test screen allows four tests:
FLOW AND PRESS – see Section:
10.4.5.4.1 MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /FLOW AND
PRESSURE
CVT (circuit verification test) – see Section:
10.4.5.4.2 MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /CVT
VVT (ventilator verification test) – see Section:
10.4.5.4.3. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /VVT
BLOWER TEST – see Section:
10.4.5.4.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST /BLOWER
TEST
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10.4.5.4.1. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST
/FLOW AND PRESSURE
While the test is in progress, a progress bar displays:
Self test progress bar
When the test is complete, a test result screen displays:
Self test results screen
In this example, the test results indicate that the ventilation circuit is
ready for use, and the ventilator pneumatic and electrical systems are in
order.
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10.4.5.4.2. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST
/CVT
Follow the instructions on the screen for the Circuit Verification Test:
CVT screen
Use a cap to seal off the patient transducer valve:
• Press the navigation knob on the ventilator front panel to begin the
test. A pop-up appears, indicating the test has begun.
• After several seconds, another pop-up will direct the user to remove
the cap blocking the transducer.
• After the ventilator does further testing, the test results will display.
Press the control knob to complete the C.V.T.
CVT Results screen
The following information is displayed:
PRESS. CHECK: Pressure is over 60 [cmH2O]
PRESS. TIME: Time to reach pressure of 40 [cmH2O].
FLOW CHECK: Flow is over 120 [lpm].
FLOW TIME: Acceleration time of blower to 100 [lpm].
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10.4.5.4.3. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST
/VVT
Follow the instructions on the screen for the Ventilator Verification Test:
VVT screen
In the VVT process, the ventilator is checked for:
• System alert – audio
• Patient pressure measurement and pressure performance
• Blower pressure measurement
• Transducer tubes leak
• Motor speed measurement
• Two Solenoid valves
• Solenoid safety release mechanism
• Flow performance and flow zeroing accuracy
• Watchdog safety device
The user specifies two pressure values, while the patient circuit is connected to a manometer. After the user dials in the first pressure value, the
blower increases the pressure and the user dials in the second pressure
value. The values will be used to calibrate the pressure sensor:
VVT pressure calibration screen
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10.4.5.4.4. MAIN MENU/ADV SETTINGS/TECH MODE/SELF TEST
/BLOWER TEST
Follow the instructions on the screen for the Blower Test.
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10.4.5.5. MAIN MENU/ADV SETTINGS/TECH MODE/LOGBOOK
The Logbook screen shows alerts, indications and user interaction with the
ventilator:
Example of an alert
Note: The logbook is displayed in technician mode. Download is
possible only in technician mode.
Note: Press BACK to exit log or SCROLL to continue viewing the log.
10.4.5.6. MAIN MENU/ADV SETTINGS/TECH MODE/EXPORT LOG
10.4.5.7. MAIN MENU/ADV SETTINGS/TECH MODE/SW VERSION
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10.4.5.8. MAIN MENU/ADV SETTINGS/TECH MODE/SW UPDATE
10.4.5.9. MAIN MENU/ADV SETTINGS/TECH MODE/SYSTEM MODE
10.4.5.10. MAIN MENU/ADV SETTINGS/TECH MODE/ALTITUDE
The altitude above sea level is shown on the bottom of the second Tech
Mode submenu.
Example of altitude display: 72 meters
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11. WARNIN GS AND ALERTS
This section provides information about alerts, and examples of typical
system messages.
11.1. SUMMARY OF ALERT TYPES
The following table summarizes the various types of alerts.
Note: If no patient weight was set, the user will not be able to
change any default alert parameters.
Note: Minimal alarm sound level is 80 dB at a distance of one
meter from the ventilator.
Alert type
Value
Range/Display
User
Adjustable
Respiratory rate
High: 12
-
60 bpm
Low: 1-20 bpm
Inspiratory pressure
Limit: 10
-
65 cmH
2
O
Alert: 10-55 cmH2O
Apnea
5-
120 seconds
Leak
0-
100%
Low Tidal Volume Delivered
Off or 15%
-
85%
Volume Limit Reached
70-
1800 mL
Inverse I:E Ratio
ON/OFF
Alert Volume
0 (off) 1
-34
Pressure limit
10-
60 cmH
2
O
Pressure
alert limit
10-
55 cmH
2
O
AC Powe
r Disconnect
Screen icon and an audio cue
Additional
Low Battery
Estimated battery energy
level + Alert
Empty Battery
Screen Icon + Alert
Battery Disconnect
Screen Icon
(swapping)
Check Sensor tubes
Alert
Tube Disconnect
Alert
High PEEP
Alert
Service Notice
Alert
System Boot Failed
Alert
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11.2. SUMMARY OF ALERT LEVELS
Alerts are defined with three levels of importance:
High: Five beeps every two seconds
Medium: Three beeps every five seconds
Low: One beep one time only. Not shown in list of active alerts.
Alert
category
Alert
High level Blower malfunction
Tube disconnect
Patient disconnect
Apnea
System recovered from a
crash
Battery empty
Sensor disconnect
Low respiratory rate
High minute volume
Low minute volume
High inspiratory pressure
Low inspiratory pressure
Leak
Inverse I:E ratio
Battery low
High temperature
Expiratory valve blocked
High PEEP
Low PEEP
Alert
category
Alert
Medium
level
High respiratory rate
Volume limit reached
Low tidal volume
Low pressure
Low level Replace filter
Service needed
Altitude out of range
External power
connected/disconnected
(icon instead of popup
message)
Battery charge
protection active
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11.3. WARNING EXAMPLE
Here is an example of a warning message:
Warning message
11.4. ALERT EXAMPLE
A typical alert appears as follows:
Example of an alert
Note: Press cancel sign (big X) to acknowledge the message
and cancel the alert.
A High PEEP alert is an exception to the normal action taken with an
alert message, since the user may choose to accept the high PEEP value,
if it was intentionally changed. This action saves valuable time adjusting
the PEEP level.
High PEEP alert
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12. DEF AULT PAR AMETERS
12.1. START VOLUME VENTILATION
Patient
Weight
Rate
Tidal
Volume
Max.
Pressure
(Kg)
(bpm)
(ml)
(cm
H2O)
5 35 30 21
10 30 100
23
15 25 150
25
20 20 200
30
30 18 300
33
40 16 400
35
50 14 500
40
60 12 600
40
70+
12
700
40
12.1.1. OXYGEN SUPPLY
When a high-pressure oxygen source that is connected to a demand valve is
not available, the Ventway Sparrow ventilator can accept oxygen from a lowpressure oxygen source such as a reservoir bag connected to a flow meter.
To do this, use an optional low-pressure oxygen enrichment system attached
to the ventilator air inlet port through an optional Ventway adapter.
Adjust the flow of oxygen to reach the desired value of FiO2. Select the "O2
ENRICHMENT" option in the VENT. PARAMS menu. The FiO2 value must be
measured with a calibrated external oxygen analyzer.
If a high-pressure oxygen source is available, an Inovytec-approved demand
valve can be used to connect to the air inlet port, delivering between 30% to
95% FiO2 to the patient. Measure FiO2 with a calibrated external oxygen
analyzer.
The oxygen supply pressure shall be according to manufacturer specifications
(usually 40-60 psi).
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12.1.1.1. CONNECTING THE AIR INLET TO THE DEMAND VALVE
The oxygen demand valve is connected to the device as shown below. The
oxygen demand valve connector is specially threaded to fit securely on top of
the air/oxygen inlet.
Connecting the oxygen demand valve to the air inlet connector
The demand valve/mixer may be adjusted so to mix atmospheric air and
oxygen in ratios between 30% to 95%. The user may change the oxygen
percentage of the gas mixture by rotating a knob at the base of the
demand valve.
The high pressure connection to the demand valve should be performed
using a standard female DISS connector.
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12.1.2. RECOMMENDED DEVICES FOR MONITORING OF OXYGEN
Company Name Product Model
Precision Medical PM5900 Oxygen Monitor
Maxtec MaxO2 ME®
ENVITEC MySign®O
Caution: Use of the low-pressure oxygen system at concentrations
above 60% is NOT recommended, as higher values combined with
varying minute volume due to spontaneous breathing of the patient
may cause inadvertent PEEP.
Caution: Please read the manufacturer's instructions before using
the oxygen monitoring device.
Caution: Oxygen enrichment delay time until reaching 95% oxygen at
the patient port: 45 [S].
Caution: Measurement of oxygen should be performed using an
external oxygen sensor. The location of the sensor should be at the
outlet of the ventilator between the ventilator and the patient circuit.
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12.2. ALERT DEFAULT PARAMETERS: 5 KG TO 70+ KG
Alert
Parameter
Weight
5kg 10kg 15kg 20kg 30kg 40kg 50kg 60kg 70+
kg
Pressure
Alert (cm
H2O)
21 23 25 30 33 35 40 40 40
Pressure
Limit
(cm H2O)
25 28 30 35 40 42 47 50 50
High
Rate
(BPM)
45 40 35 30 30 30 30 25 25
Low
Rate
(BPM)
12 10 10 10 8 6 6 6 6
High
Min.
Vol. (LPM)
2.5 4.2 5.3 5.6 7.6 9 9.8 10.1
12
Low
Min
Vol. (LPM)
1 1 1 2 2 3 3 4 4
12.3. ALERT DEFAULT PARAMETERS: ALL PATIENT WEIGHTS
PEEP > 2.5 cm H2O from set value
Low pressure 5 cm H2O
Leak (%) 100% (off)
Inverse I:E Ratio ON
Low Tidal Volume Alert Range 85% of set volume
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13. LAB ELS AND SYMBOLS
13.1. LABELS
A number of internationally recognized symbols are found on the labels. These
relate to safety requirements and standards and are described below.
VWSP-100 Civil Model
VWSP-900 Military Model
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13.2. SYMBOLS
The following table explains the meaning of each symbol on the label.
Symbol Meaning
Consult instructions for use
Manufacturer
European approval mark
Authorized representative in the European Community
Serial Number
Catalogue number
Batch code
Direct current
Do not dispose of, contact for recycling
FCC Symbol
Caution: law prohibits dispensing without prescription
Caution, consult accompanying documents
Type BF Applied Part
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14. CLE ANING AND DISINFECTING
Caution: The system is approved for IP45 in operation mode with
oxygen enrichment. To avoid damage to the instrument or patient
cable, be careful of liquid spillage while cleaning.
Caution: Do not expose the instrument, patient cable or sensors to
sprays, or any other type of solvents.
Caution: Be sure to turn the power off and disconnect the AC power
cord from the power source before performing cleaning
procedures.
This instrument requires routine cleaning, which includes removal of any
soil or dirt from the external surfaces. A soft cloth dampened lightly with
water may be used.
Spray the entire surface of the device with 70% alcohol.
Leave the alcohol on the device for an exposure time of 2-3 minutes.
Wipe the surface of the device with Pharma-Wipes 70% alcohol.
Inspect the device for residual debris. Should any debris remain, repeat the
entire cleaning procedure until all debris is removed.
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15. VENTILATION ME THO DS
15.1. SIMV-VC (PS)FLOW CHART
In SIMV-VC, the patient is supplied with the set tidal volume VT during the
mandatory breaths. The mandatory breaths are synchronized with the
patient’s own breathing attempts. Mandatory breaths are prevented from
being applied during spontaneous expiration, by providing that a patienttriggered mandatory breath can only be triggered within a trigger window.
If the expiration phase (and with it the spontaneous breathing time) is
shortened on account of synchronization, the next expiration phase will be
extended. This adaptation prevents a change in the number of mandatory
breaths. If no independent breathing attempt is detected during the trigger
window, the machine-triggered mandatory breaths are applied. Thus, the
minute volume MV remains constant over time. If the breathing attempts
of the patient are insufficient to trigger the mandatory breath, the
machine-triggered mandatory breaths are applied. The patient can breathe
spontaneously at PEEP level during the expiration phase. During spontaneous breathing at PEEP level, the patient can be pressure-supported
using PS.
Please note:
1. The number of breaths is set by the patient weight (more weight = less
breaths/minute). BPM=mandatory breaths.
2. It is volume controlled (although pressure is constantly being mon-
itored).
3. Either the machine or patient can trigger the breath.
4. Trigger definition: If the patient reaches -2 cm H2O in less than 300
msec. then a trigger breath is initiated.
5. Trigger activation window: 300 msec after termination of breath until
initiation of new breath
If no independent breathing attempt is detected during the trigger
window, the machine-triggered mandatory breath is applied.
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6. If no spontaneous breathing attempt is detected during the inspiratory
trigger window, the machine-triggered mandatory breath is applied.
The mandatory tidal volume (VT) results from the pressure difference
between PEEP and Pinsp, the lung mechanics and the breathing effort of
the patient. Pinsp is the inspiratory pressure (pressure in the lung
throughout the inspiratory cycle). If the lung mechanics changes (pressure,
water in the lungs etc.) the ventilation will not change the volume, and the
only change may be the PIP (within the safety/alert pressure values).
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Note: Through the entire ventilation
cycle, we need to test that:
The patient is still connected (no de-
crease in PEEP pressure)
Expiratory flow is undisturbed (pressure
has decreased – nothing is blocking the
ex. valve)
Value of Ti/Te is OK (within the norm)
.
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15.2. CPAP – SPONTANEOUS BREATHING MODE
During the spontaneous ventilation modes, the patient carries out the
majority of the breathing effort. The pressure support ventilation level PS
can be adjusted. The default PSV level is 18 cm H2O.
As long as the patient’s airways are below the PEEP + PSV level, the ventilator will perform ventilation support. This setting directly affects the flow
and thus the supplied tidal volume (VTI).
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CPAP Backup ventilation
Note: BPM is based on patient
weight and other parameters.
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15.3. BACKUP VENTILATION MODE
Note: Backup will not occur when the user inserts weight, selects
a ventilation mode and does not press OK. In this situation, a trigger is received from the patient and the respiration is performed
according to the ventilation mode.
Backup mode is an alternative ventilation method taking place when the
ventilator patient circuit is connected to the patient in these situations:
1. Patient is ventilated in CPAP mode from more than 10 seconds for
pediatric (5KG) and up to more than 25 seconds for an adult (70+
KG).
2. Patient is connected to the ventilator, and for some reason, the user
did not start ventilation after connecting the patient. The backup
starts after three breaths.
3. Patient is connected to the ventilator, and user has paused ventilation. In this case when trigger is sensed by the ventilator, the ventilation will automatically resume.
The result of using this backup mode is that the patient will be ventilated in
case of losing the ability to initiate spontaneous breaths in CPAP mode, or
if an emergency or user error has occurred in the preliminary stages of
ventilation setup, or when pausing the ventilator for some reason without
resuming ventilation.
15.3.1. BACKUP VENTILATION IN CPAP
If during CPAP ventilation, the patient stops initiating spontaneous breaths
from more than 10 seconds for pediatric (5KG) and up to more than 25
seconds for an adult (70+ KG) --> Apnea alert appears.
Then backup ventilation is initiated:
-Screen displays an alert: "Backup Ventilation Started" and "OK" button for
user approval appears. Ventilation will start even if user has not pressed
OK. Alert will appear on screen while audio prompt is activated.
BPM = patient weight based
Volume, Pressure, MV and all other alerts which are patient weight
based remain unchanged.
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Ventilation method is changed to SIMV - VC - PS with the last patient
weight parameters dialed in.
BPM value is patient weight based.
Resuming to CPAP ventilation will be possible either by patient trigger
(will alert on screen: "CPAP ventilation resumed" - "OK"), or user
switching back to CPAP or SIMV - VC - PS manually, through the
"MENU" option on the main screen.
All alerts and user inputs will be logged in logbook.
An alert is issued "Backup ventilation active"--"OK".
15.3.2. BACKUP VENTILATION BEFORE STARTING PATIENT VENTILATION
If patient is connected to the ventilator, the following conditions may also
initiate backup ventilation:
a) Ventilation has not started yet, but ventilator is turned on (either
patient weight, ventilation method or start command was not chosen
by the user).
b) Patient trigger sensed.
If conditions a) and b) above were met, then backup ventilation starts.
"Backup ventilation mode" alert is activated - "OK" displays.
o If the user approves, the Patient Type window appears,
and then the backup starts.
o If the user does not approve, the action is canceled and
the ventilation does not start.
The "Backup ventilation mode" icon appears on top of the screen
after last alert was either accepted or discarded.
If Patient weight was entered, the device ventilates according to the given
weight parameters.
If Patient weight was not entered:
1. Initial pressure support value is set to PS=10 cm H2O.
2.
Tidal volume is calculated during ventilation.
3. 3 breaths are given to the patient at identical parameters (PS=10
cmH2O) at 10 BPM rate.
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4. After 3 breaths, the patient weight is evaluated by using TV
average of the last 3 breaths:
TV[cc] Patient weight [kg]
50-70 5
71-140 10
141-210 15
211-280 20
281-420 30
421-560 40
561-700 50
701-840 60
Over 841 70+
5. Evaluating patient weight will establish the other ventilation parameters as per a more complete table given in the URS/SRS,
including maximum TV, BPM etc.
If Patient weight and ventilation mode were entered, ventilation will
start in selected mode and will issue an alert “Ventilation started –
“OK”.
If patient trigger is sensed, then spontaneous breath is initiated with
the same ventilation parameters.
• An alert appears "Backup ventilation active -- OK".
• User may change the ventilation parameters by entering MENU and
selecting new ventilation parameters.
If the ventilator did not complete the initial verification, an alert will
be activated 15 seconds after starting backup ventilation: "Initial ventilator verification needed --OK". This alert will appear only once.
3. Backup Ventilation in Pause mode
In case the user chose to pause the ventilation for any reason, and
patient trigger (pressure -2.5 cm H
2
O or -5 lpm or greater) was sensed,
then ventilation is resumed with the exact same parameters as set by
the user. The alert is issued: "Ventilation is resumed -- OK".
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15.4. SIMV VC (CPR)
In SIMV-VC (CPR), as in the normal SIMV-VC (PS), the patient is supplied
with the set tidal volume VT during the mandatory breaths.
The only difference in this setup, is that patient triggering is switched to
OFF. This is very useful during cardiopulmonary resuscitation combining
chest compressions.
Chest compression is known to activate undesirable patient triggers
causing the ventilator to continue delivering spontaneous breaths at a high
rate (uncontrolled auto triggering).
By turning off the triggers, the ventilator will not alert due to high minute
volume, breath rate or inadequate I:E ratio.
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15.5. CPAP (CPR)
This setup delivers constant pressure into the patient airways as in the
regular CPAP ventilation method, but without any pressure support during
triggers (no response to spontaneous breaths).
Constant pressure values can be set between 5 to 10 cm H2O, without
activation of triggers. PEEP is set by the external PEEP control knob on the
patient transducer.
This setup saves the time of entering the ventilation parameters menu,
trigger sensitivity, and decreasing the trigger sensitivity.
CPR mode may be used when prolonged cardiopulmonary resuscitation
(CPR) is performed. The following parameters are displayed in CPR mode :
BPM – Number of compressions sensed by the
patient pressure sensor. The number may vary
due to the strength, frequency of compressions, and leaks from the patient airways.
Rate – Audio prompt frequency ranging from
80 to 120 may be activated in order to indicate
rhythm of compressions to the caregiver.
PEEP – Adjust by rotating the rotator knob of the exhalation valve.
Pressure bar graph – Pulmonary pressure is displayed on the bar graph.
Manual breath – The activation of manual breath will result in a single
pressure support breath, of default value (PEEP + 18 cmH2O). The caregiver
may change the PSV value by entering the Ventilation Parameters menu.
Caution: If an unexpected shutoff event occurs, the ventilator will
alert for the unexpected shutoff when it is next activated. If the
incident occurred during patient ventilation, and the event took
place no more than two minutes before, the ventilator will
continue with the last ventilation parameters automatically.
Display in CPR mode
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16. SER VICE AND MAINTENANCE
Note: The user or any technical personnel who are not formally
authorized by Inovytec Medical Solutions Ltd. must not open the
Ventway Sparrow device under any circumstances. Opening the
Ventway Sparrow device may damage the unit and will void the
warranty provided by Inovytec Medical Solutions Ltd.
The system requires maintenance on a routine basis of 15,000 operation hours
or three years (whichever is first). Service should only be provided
by an authorized Inovytec Medical Solutions Ltd. representative.
16.1. DEVICE CALIBRATION AND SOFTWARE UPGRADES
Calibration and upgrade of the software are performed by the factory, or
in technician mode using a password provided by Inovytec.
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17. TRO UBLESHOOTING
The following table lists some typical conditions that may occur when using
the system.
Condition Possible Cause Recommended Action
Battery disconnected
Not inserted
properly
Firmly insert battery in its
place
DC connector connected
and no sign of charging
Power supply not
connected to
power source or
DC connector
Check connection to ventilator and power source
Patient circuit
verification failed
Accessories or
patient connected,
control tube
connector
disconnected
Check patient circuit connections
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18. SPE CIF ICATIONS
18.1. DIMENSIONS AND WEIGHT
Width 165 mm
Length 167 mm
Height 60 mm
Weight Civilian version: 1 kg with batteries
Military version: 1.3 kg with batteries
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18.2. ENVIRONMENTAL SPECIFICATIONS
Operating
Temperature
-18 °C to 50 °C (0 °F to 122
°F)
Storage
Temperature
-20 °C to 70 °C (-4 °F to
158
°F)
Relative
Humidity
10% to 90%
Water
and
Dust
Resistance
IP45 (with
oxygen
enrichment
)
IP20 (when using power supply)
Note:
First digit
(“4
” In
IP45
, or “2” in
IP20)
relates to object size protection (<1 mm).
Second digit (“5” in IP45 or “0” in IP20) indicates protection from water jets from any
direction.
Atmospheric
Pressure
700
hPa
to
1060
hPa
Altitude
-
370
to
4500
meters
(-
1,200 to 14,764 feet)
Total
External
Sound
Level
54 dBa
at
0.6 meter
distance
Max acoustic energy level
55 [dBa]
18.3. HARSH ENVIRONMENTAL CONDITIONS
The Ventway Sparrow is designed to operate in extreme environments,
such as ground and transport. The Ventilator continuously monitors the
ambient pressure, temperature and other parameters, and compensates
for these changes.
Although the unit may activate a low priority alert that indicates exceeding regular operation conditions, please remember that these alerts
are advisory, and the unit will continue to operate normally.
18.3.1. OPERATION IN EXTREME HIGH / LOW TEMPERATURES
During high temperature operation, the ventilator may prompt an alert
regarding its high temperature charge limit. The battery protection
circuit will stop charging below 0°C and over 50°C, as measured inside
the battery pack.
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Normal ventilator operation may create heat in the battery compartment. When operating in a hot environment you should remove the ventilator padded case, increasing heat dissipation into the environment.
During low temperature operation, it is recommended to use the ventilator padded case. This will insulate the unit from the outside temperature and retain the internal heat created by the blower motor and other
electrical heat-generating components.
18.3.2. OPERATION IN HIGH OR LOW ALTITUDE
The Ventway Sparrow is designed to operate at an altitude of -370 to
4,500 meters (-1,200 to 15,000 feet). An internal altimeter measures the
ambient pressure, allowing the ventilator to compensate the flow
calculations for the changes in density and pressure.
If the operation altitude is outside of the specified values, a low priority
alert will be activated. In this case the user should monitor the Peak
Inspiratory Pressure (PIP) and adjust the tidal volume so the same PIP is
achieved. It is also advised to monitor the breathing sounds and chest
excursion to assure the unit maintains adequate ventilation.
18.3.3. AIRBORNE PARTICULATES
The inlet filter of the Ventway Sparrow provides protection of gas flow
paths through the inlet and emergency intake ports. However, in areas
where fine dust is present, it is recommended to use a disposable bacterial/viral filter.
This may prolong the lifetime of the internal filter. Visually inspect the
filter for dust and dirt buildup for extended operation in dusty
environments.
If the filter becomes dirty, it must be replaced. Circuit Verification Test
(CVT) must be performed without the filter attached to the ventilator,
since it may cause a pressure drop that will result in not passing the test.
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18.4. POWER SUPPLY
External
AC-DC
Adapter
Input
100
to 264 VAC, 50-60 Hz, max
1.6 A
Output 16-24 VDC , 120 W
Internal
Battery
8 x CR123
cells
for 12VDC
configuration
(2 x 4S1P
)
4 x 18650
Li-
Ion for 14.8VDC
rechargeable
configuration (4S1P)
Recharge
Time
6 hours
Operating
Time
(internal
battery)
4 hours
Note: T
he time required for the ventilator to warm from the minimum
storage temperature between
uses until it is ready for intended use is 20
minutes in STP conditions.
Note: T
he time required for the ventilator to cool from the maximum storage
temperature between uses until it is ready for intended use is 30 minutes.
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18.5. VENTILATION PERFORMANCE
Note:
Measurement accuracy of calibration e
quipment may
affect the respiratory parameters display by the following
parameters:
Volume calculation : +/-2% or 20 [cc]
Inspiratory and expiratory times : +/- 0.02 [s]
Pressure :
+/-
0.75% or +/
- 0.1 [mbar]
Note:
If temperature exceeds the range of
-18°
C to 50
°
C, a
temperature alert may be activated. This may result in breath
parameters inaccuracies that exceed the tolerances specified
below.
Note:
If humidity exceed
s 95% and condensation occurs, it
may lead to water droplet buildup in the sensing
tubes
.
Note:
If t
he ventilator is exposed to altitudes outside of the
defined values, the ventilator may be unable to accurately
compensate for volume and pressure deviations.
Respiratory
Rate
1 – 12 ±1, 12 – 60 ± 2
bpm
Tidal
Volume
50-1800
mL
Acc
uracy
of
Respiratory Volume
Measurement
±15%
+ 4 ml
Inspiratory
Pressure
Limit
5 to 65 cm H2O
Inspiratory
Time
0.3
to 3
±10%
sec
Peak
Flow
(PIF)
130 (-
5% to +10%)
% L/min
Spontaneous to 180 ±10% L/min
Oxygen
Mix
(FiO
2
) 21%
to
95%
±5%
O2
PEEP
3 to 13 cm H2O ±1, (external
ly adjusted)
Trigger
Sensitivity
-2 to 10 cm
H2O Pressure,
Off
PS 5 to 45 cm
H2O
Controlled
Pressure
5 to 65 cm
H2O
FiO
2
low
pressure
enrichment
21%
to
100%
(low
and
high
pressure
oxygen
source)
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18.6. STANDARDS AND SAFETY REQUIREMENTS
The Ventway Sparrow meets the requirements of the following international standards:
IEC 60601-1 Medical electrical equipment — Part 1: General
requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment — Part 1-2: General
requirements for basic safety and essential performance — Collateral Standard: Electromagnetic
disturbances — Requirements and tests
IEC 60601-1-12 Medical electrical equipment - Part 1-12: General
requirements for basic safety and essential performance - Collateral Standard: Requirements for
medical electrical equipment and medical electrical systems intended for use in the emergency
medical services environment
ISO 80601-2-12 Medical electrical equipment -- Part 2-12:
Particular requirements for basic safety and
essential performance of critical care ventilators
ISO 10651-3 Lung ventilators for medical use -- Part 3: Par-
ticular requirements for emergency and transport
ventilators
EN 794-3 Lung ventilators. Particular requirements for
emergency and transport ventilators
RTCA DO-160G Environmental Conditions and Test Procedures
for Airborne Equipment
Rotary wing – Helicopters
EN 1789 Medical vehicles and their equipment. Road
ambulances
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19. CLE ANING AND R OUT INE MAINTEN ANC E
Part Procedure Comments
Ventilator 1. Spray entire
surface with 70%
Alcohol
2. Do not wipe
device for 1 min.
3. Wipe device
with pharma wipes
70% alcohol
Do not allow liquid to
penetrate into the ventilator.
Inspect for residual debris.
Air Inlet Filter Replace every 300
hours (or 1 month)
of operation, or as
necessary.
Do not attempt to clean
or reuse the air inlet
filter.
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20. BATTERIES
The Sparrow can be configured with two battery options: an internal, rechargeable, battery pack, and a rechargeable battery pack. The battery
should be charged or replaced when not in use. For long storage periods,
the battery should not be inserted into the battery compartment of the
ventilator.
20.1. BATTERY MAINTENANCE
Rechargeable batteries
The internal battery pack is charged from the external device connector,
using the supplied 18-24 volt regulated power supply.
Caution:
If
the batteries
do
not
charge,
replace
the char
ger or the
batteries.
Caution:
Battery failure may occur if maintenance is not performed on
time and according to instructions.
Note:
If
charging
at
temperatures
over
35°C (
95°F)
, charging
time
may
be
extended, and battery thermal protection may be a
ctivated preventing
the battery charge.
Shelf life: 4 years. First time charging: 6 hours.
Permissible battery pack charging temperature range: 0°C to 50°C (32°F to
122°F)
Permissible temperature range for long-term storage: 10°C to 35°C (50°F
to 95°F)
Charge Interval: 6 months in standard temperature and pressure
Shelf life: 4 years or 1000 cycles at 25°C (77°F). A cycle is defined as one
charge and one discharge.
Max discharge current 10[A]
Storage temperature for shipping state (about 40% capacity of fully
charged state):
1 month
-30°C to 60°C (-22°F
to
140°F)
3 month
-20°C to 45°C (-4°F to 113°F)
1 year
-20°C to 20°C (-4°F to 68°F)
Non-Rechargeable batteries
Shelf life: 5 years. Long term storage: -20°C to 35°C (-4°F to 95°F)
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21. PARTS AND ACCE SSO RIES
This Section outlines information for ordering and shipment of replacement parts for the Ventway Sparrow.
All equipment and accessories are available directly from Inovytec Medical
Solutions Ltd. or from an authorized distributor. For a list of Inovytec
Medical Solutions Ltd. distributors please visit our web site at
sales@Inovytec.com.
When ordering parts, specify the serial number of the unit and the part
number of the item(s) ordered. A schedule of part numbers may be found
in the Equipment and Accessory Inventory list below.
Forward orders to:
Inovytec Medical Solutions Ltd.
3 Hanagar St., POB 7282,
Hod-Hasharon 4501306, Israel
Tel: +972 9 7794135
E-mail: Info@Inovytec.com
Web Site: http://www.Inovytec.com
Caution: It is strongly recommended that all Ventway Sparrow
parts be replaced with parts purchased from Inovytec Medical
Solutions Ltd. or an authorized distributor. Use of other parts may
damage the unit and could void the unit warranty.
Note: Dispose of this device and of used sensors in accordance with
local regulations.
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22. REGULATORY
Manufacturer:
Inovytec Medical Solutions Ltd.
3 Hanagar St., POB 7282,
Hod-Hasharon 4501306, Israel
Tel: +972 9 7794135
E-mail: Info@Inovytec.com
Web Site: http://www.Inovytec.com
Européen Agent Information:
OBELIS S.A.
Bd Général Wahis, 53
B-1030 Brussels
Belgium
Telephone +3227325954
Fax: +3227326003
E-mail: mail@obelis.net
Website www.obelis.net
0086
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23. WARRANTY
Service Support
Repairs of the System under warranty must be made by authorized repair
centers. If the device needs repair, contact Inovytec Medical Solutions Ltd.
service department or your local distributor.
If shipping the device is required, pack the device and its accessories
carefully to prevent shipping damage.
Duration
Inovytec Medical Solutions Ltd. will repair or replace, at its sole discretion,
the product or any defective part, provided it is returned to Inovytec
Medical Solutions Ltd. service within 30 days.
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24. APP ENDIX – TES T ALERTS
The following instructions explain how to test all the alerts that can be
activated by the system, to ensure that they are working properly.
24.1. BACKUP VENTILATION
Step Procedure Action Expected Results
1
Start a new patient
via the menu.
Set the lung
simulator simulated
weight to 50 kg.
Message requesting to disconnect the patient.
2
Generate inhalation
trigger.
The software switches to the running ventilation screen
with unknown weight, in SIMV ventilation mode.
The software indicates that it is in backup ventilation.
3
Inspect the
parameters on the
screen.
The blower starts, with PS = DefaultPS, and presents the
ventilation parameters.
4
Wait for two
breathes.
The following ventilation parameters are automatically set
according to the simulated patient weight:
Alert Pressure, Minute Volume M.V., BPM, Tidal volume Vt,
Ti, Te, PS, trigger sensitivity.
5
Wait for a few
minutes.
Ventilation continues with parameters suitable for a patient
weighing approx. 50 kg.
The software keeps indicating that it is in backup ventilation
mode.
The software instructs the user to perform patient circuit
test (via the menu).
6
Stop ventilation. Ventilation stops.
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24.2. START BACKUP VENTILATION WITH UNKNOWN WEIGHT
Step Procedure Action Expected Results
1
Start a new patient
via the menu.
Set the lung
simulator simulated
weight to 70 kg.
Message requesting to disconnect the patient.
2
Generate inhalation
trigger.
The software switches to the running ventilation screen
with unknown weight, in SIMV ventilation mode.
The software indicates that it is in backup ventilation.
3
Inspect the
parameters on the
screen.
The blower starts, with PS = DefaultPS, and presents the
ventilation parameters.
4
Wait for two
breathes.
The following ventilation parameters are automatically set
according to the simulated patient weight:
Alert Pressure, Minute Volume M.V., BPM, Tidal volume Vt,
Ti, Te, PS, trigger sensitivity.
5
Wait for a few
minutes.
Ventilation continues with parameters suitable for a patient
weighing approx. 70 kg.
The software keeps indicating that it is in backup ventilation
mode.
The software instructs the user to perform patient circuit
test (via the menu).
6
Stop ventilation. Ventilation stops.
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24.3. CPAP VENTILATION WITH BACKUP VENTILATION
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg.
Select 60 kg and then
CPAP ventilation
mode.
Mode is set. The blower starts.
The software switches to running ventilation, in CPAP mode.
CPAP - Apnea
3
Wait for the apnea
timer to run out.
The software switches to SIMV mode, backup mode is indicated.
4
Wait for the next
exhalation phase and
for pressure to reach
PEEP value.
Wait until Te time
has passed.
The software switches to inhalation phase:
Inspiratory control valve opens and exhalation valve closes.
5
Allow for a few
breaths cycles.
The software switches between phases, using SIMV ventilation
mode.
6
Wait for the next
exhalation phase and
for pressure to reach
PEEP value.
After more than
MinRestDuration
after PEEP reached,
generate inhalation
trigger.
Trigger is detected & inhalation phase starts (Inspiratory control
valve opens and exhalation valve closes).
The software switches back to CPAP normal mode.
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24.4. PATIENT DISCONNECT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then CPAP
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in CPAP mode.
3
Decrease PEEP to
PEEP -2.
The software alerts: “Patient disconnection”.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
5
Select to view active
alerts via the menu.
Patient Disconnection alert is shown.
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24.5. HIGH PEEP
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Increase PEEP above
the limit.
The software indicates to the user that PEEP is above the
PEEP limit.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
5
Select to view active
alerts via the menu.
Alert is shown.
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24.6. VALVE BLOCKED
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Slowly decrease the
expiratory flow.
The software alerts: “valve blocked”.
4
Increase flow back to
normal.
The alert disappears.
5
Silence the alert. Alert indication on the screen, but alert is silenced.
6
Select to view active
alerts via the menu.
Alert is shown.
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24.7. PRESSURE ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Slowly decrease the
inspiration pressure
under the min
inspiration alert
settings.
The software alerts: “Low Pressure”.
4
Increase pressure
back to normal.
The alert disappears.
5
Slowly increase the
inspiration pressure
above the max
inspiration alert
settings.
The software alerts: “High Pressure”.
Caution: The interval from the moment that the
airway pressure equals the high-pressure alarm
limit, to the moment that the pressure starts to
decline, must not exceed 80 ms.
6
Silence the alert. Alert indication on the screen, but alert is silenced.
7
Select to view active
alerts via the menu.
Alert is shown.
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24.8. MINUTE VOLUME (MV) ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Slowly decrease MV
under the min MV
alert settings.
The software alerts: “MV Alert”.
4
Increase pressure
back to normal.
The alert disappears.
5
Slowly increase MV
above the max MV
alert settings.
The software alerts: “MV Alert”.
6
Silence the alert. Alert indication on the screen, but alert is silenced.
7
Select to view active
alerts via the menu.
Alert is shown.
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Page 95 of 110
24.9. LEAK ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Slowly increase a leak
in the ventilation.
After a short pause, the software alerts: “Leak Alert”.
4
Close the leak. The alert disappears.
Ventway Sparrow User Manual
Page 96 of 110
24.10. TIDAL VOLUME ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Slowly decrease the
Tidal volume (TV) to
70%.
When TV is below 80%, the software alerts: “Low Tidal
Volume Alert”.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
5
Increase TV above
80%.
The alert disappears.
6
Change settings to
disable TV.
TV is disabled.
7
Slowly decrease the
Tidal volume (TV) to
50%.
Alarm is not set.
Ventway Sparrow User Manual
Page 97 of 110
24.11. I:E ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Change the I:E ratio
to be below 1.
The software alerts: “I:E Alert”.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
5
Change the settings
to disable I:E Alert.
I:E alert is off.
6
Change the I:E ratio
to be below 1.
The software doesn’t issue an alert.
Ventway Sparrow User Manual
Page 98 of 110
24.12. APNEA ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then CPAP
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in CPAP mode.
3
Wait without
generating inhalation
triggers.
After the set time for Apnea alert, the software alerts:
“Apnea Alert” and switches to backup ventilation mode.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
5
Select to view active
alerts via the menu.
Alert is shown.
Ventway Sparrow User Manual
Page 99 of 110
24.13. POWER ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Disconnect the
ventilator from the
power.
The software indicate Power is disconnected.
4
Inspect the battery
level.
Battery level is indicated to the user.
5
Reconnect the
ventilator to power.
The software indicates Power is connected.
Ventway Sparrow User Manual
Page 100 of 110
24.14. LOW BATTERY ALERT
Step Procedure Action Expected Results
1
Start up the Sparrow
ventilator.
Complete the patient
circuit test.
The software switches to the ventilation phase, weight
selection screen.
2
Set the simulator to
the patient weight of
60 kg. Select 60 kg
and then SIMV
ventilation mode.
Mode is set. The blower starts.
The software switches to running ventilation, in SIMV mode.
3
Wait until the battery
level reaches
CriticallyLowBattery
level.
The software indicate CriticallyLowBattery level.
4
Silence the alert. Alert indication on the screen, but alert is silenced.
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