GEKKO GeVentor GEV019-100 User manual

Gekko Medical Pty Ltd
GeVentor Ventilator
GEV019-100
Instructions for Use

Instructions for Use: GEV019-100
Page 2
NOTE:

Instructions for Use: GEV019-100
Page 3
Table of Contents
1Introduction........................................................................................................................................................................ 5
2Labels ................................................................................................................................................................................. 6
3Safety Instructions.............................................................................................................................................................. 8
3.1 Safety Symbols .................................................................................................................................................................... 8
3.2 Warnings and Contraindications......................................................................................................................................... 8
4System Overview.............................................................................................................................................................. 11
4.1 Operating Concept ............................................................................................................................................................ 11
4.2 Device Description............................................................................................................................................................. 13
4.3 Single Use Components..................................................................................................................................................... 15
4.4 Patient Breathing Circuit ................................................................................................................................................... 16
4.5 Power Supply..................................................................................................................................................................... 16
4.6 Gas Connections................................................................................................................................................................ 17
5User Interface................................................................................................................................................................... 19
5.1 Gas Control Knobs ............................................................................................................................................................. 19
5.2 Human Machine Interface (HMI) ...................................................................................................................................... 20
6Operating Instructions...................................................................................................................................................... 27
6.1 Installation ........................................................................................................................................................................ 27
6.2 Pre-Start Checks and Instructions ..................................................................................................................................... 29
6.3 Default Settings................................................................................................................................................................. 29
6.4 Quick Start......................................................................................................................................................................... 30
6.5 Start Up ............................................................................................................................................................................. 30
6.6 Volume Controlled Ventilation (VCV) ................................................................................................................................ 32
6.7 Pressure Controlled Ventilation (PCV)............................................................................................................................... 34
6.8 Respiratory Rate and I:E Ratio Setting .............................................................................................................................. 35
6.9 FiO2Mixture Setting .......................................................................................................................................................... 36
6.10 Gas Flowrate Control (Slope) ............................................................................................................................................ 36
6.11 Suctioning.......................................................................................................................................................................... 37
6.12 Continuous Positive Airway Pressure (CPAP) .................................................................................................................... 38
6.13 PEEP Setting ...................................................................................................................................................................... 38
6.14 Alarms and Faults ............................................................................................................................................................. 39
6.15 Stopping Ventilation.......................................................................................................................................................... 42
6.16 Stand-by / Off-State Mode................................................................................................................................................ 42
6.17 Shutdown .......................................................................................................................................................................... 42
6.18 Unscheduled Stops ............................................................................................................................................................ 43
6.19 Battery Life Indicator......................................................................................................................................................... 44
6.20 Connecting Other Devices ................................................................................................................................................. 45
7Storage and Handling........................................................................................................................................................ 47
7.1 Packaging.......................................................................................................................................................................... 47
7.2 Short Term Storage ........................................................................................................................................................... 47
7.3 Long Term Storage ............................................................................................................................................................ 48
7.4 End of Product Life ............................................................................................................................................................ 48
8Cleaning and Maintenance ............................................................................................................................................... 49
8.1 Cleaning Procedure ........................................................................................................................................................... 49
8.2 Cleaning Agents and Disinfectants.................................................................................................................................... 50
8.3 Maintenance Schedule...................................................................................................................................................... 50
8.4 Maintenance Procedures .................................................................................................................................................. 51
8.5 Calibration......................................................................................................................................................................... 52
9Troubleshooting ............................................................................................................................................................... 53
10 Specifications and Performance........................................................................................................................................ 55

Instructions for Use: GEV019-100
Page 4
10.1 Technical Specifications .................................................................................................................................................... 55
10.2 Electrical Classifications .................................................................................................................................................... 56
10.3 Ventilator Accuracy Testing .............................................................................................................................................. 57
11 Accessories, Spare Parts and Consumables....................................................................................................................... 59
12 Additional Service, Maintenance and Warnings................................................................................................................ 60
13 Warranty and Manufacturer Contacts .............................................................................................................................. 61
14 Glossary of Terms ............................................................................................................................................................. 62
Revision Table:
Revision
Modification / Change / Update
By
Date
0
Initial release for GEV019-60
M Ntombela
24/06/2020
1
Updates per TGA exemption requirements
M Ntombela
10/07/2020
2
Updates per TGA exemption requirements; general improvements; design update for
GEV019-100
M Ntombela
05/08/2020
3
Section 10.4 and Section 10.5 removed
Technical Specifications updated for voltage and frequency range (Section 10)
Update Section 11 update for GEV single use text to include “intended” and Section 4.6
remove re-use note
Remove “including oxygen sensor” on Section 8.5 Calibration
Replace “Intensive Care Unit” with “emergency” on Intended Use section on page 5
Include tidal volume range in Section 6.6 and replace 800 ml with 1,500 ml on “Intended
Patient Population”
Section 4.5 updated 24 VDC to 30 VDC
Section 3.2 Electromagnetic Compatibility updated as per compliant EMC tests
Section 10.1 included update to compliance standard for EMC requirements
Section 4.4 sentence to refer to Section 11 for breathing circuit components
Section 11 details table for breathing circuit components
Section 10.3 updated to add breathing circuit components used for ventilator accuracy
testing
M Ntombela
18/08/2020
4
Section updated, 10.1 Technical Specifications
S Baker
24/08/2020
5
Section 6.17 updated with two HMI pages upon switching off/shutdown with options for
user to go to battery mode or not.
M Ntombela
14/09/2020
6
Labels in Section 2 Updated (first three labels –Front, Patient Circuit and Warning)
M Ntombela
05/10/2020
7
Removed details relating to COVID-19 usage and updated intended use.
S Baird
12/03/2021
8
Added Service and Additional Warnings Section
S Baird
17/05/2021

Instructions for Use: GEV019-100
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1Introduction
Name of Device: GeVentor
Model: GEV019-100
Manufacturer: Gekko Medical Pty Ltd
323 Learmonth Road
Ballarat
VIC
Australia
3350
IFU Document Overview: This Instructions for Use (IFU) document contains important information for the installation,
operation and maintenance of GeVentor GEV019-100 intended for use in clinical intensive care
settings. Please read and understand its contents before installation and operation.
Product Misuse: Gekko Medical Pty Ltd manufactures products to required standards and genuine parts have been
designed and tested to ensure continued product quality and performance in use. The failure to
properly select, install, or use authorised Gekko parts and accessories may adversely affect the
performance and safety features of this product. Furthermore, any modification of Gekko’s
products, removal of original components, or use of the product other than for its intended
purpose or not in accordance with this IFU document may impair the safety and performance of
these products in use. These actions or failures are regarded as product misuse which are not
covered under Gekko’s warranty.
Intended Use: The GeVentor is intended to provide continuous or intermittent ventilatory support to individuals
who require mechanical ventilation. The GeVentor is intended to be used by qualified, trained
personnel under the direction of a physician. Specifically, the GeVentor is applicable for treating
adult patients.
Intended Patient Population: The intended adult patient population who require pressure-based or volume-based continuous
respiratory support with tidal volumes with accurate control of these pressures from 5 - 50 cmH2O
and tidal volumes 200 –1,500 ml.
Environment of Use: The device is intended for use in hospitals and hospital-type facilities, which provide respiratory
care for patients requiring respiratory support. The device may be used for intra-hospital transport
within a hospital or hospital-type facility. The device is intended for transport between hospitals
or hospital-type facilities. The device is not to be used in the presence of
flammable anaesthetics. The device is intended for sale by or on the order of a physician only. The
device is intended for operation by trained and qualified personnel.

Instructions for Use: GEV019-100
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2Labels
Front:
The front labels of the GeVentor areas per the label given below.
Patient circuit:
On the side of the GeVentor, where the patient breathing circuit is connected, the label below is available.

Instructions for Use: GEV019-100
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Warning:
On the rear of the GeVentor, the label below is available.

Instructions for Use: GEV019-100
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3Safety Instructions
It is a requirement of owners and users of the GeVentor to develop safe work procedures for the operation of their equipment.
Owners should carry out appropriate risk assessments to establish safe work practices for activities associated with the GeVentor
under the owner’s control.
3.1 Safety Symbols
Four levels of reader alert may be utilised within this manual and appear in full-width boxes. Non-observation of reader alerts can
cause hazards.
DANGER
Indicates a hazardous situation, which if not
avoided, will result in death or serious injury.
WARNING
Indicates a hazardous situation, for example,
information about dangerous voltages or actions
that could result in bodily harm or injury
CAUTION
Failure to heed CAUTION alerts can result in
moderate or minor injury, damage to the device or
associated equipment
NOTE
Provided to assist and guide personnel with helpful
additional information.
3.2 Warnings and Contraindications
Device Use:
The use of the GeVentor requires comprehensive understanding of the GeVentor as per this IFU document. The GeVentor must
be used for its intended use only and in the environment as stated in Section 1. Failure to adhere to the instructions statements
constitutes inconsistent use of the GeVentor as per its intended use.
Maintenance:
The GeVentor must be inspected and maintained regularly as detailed in Section 8 (Maintenance and Cleaning) of this IFU
document. It is recommended that servicing be performed by qualified service personnel. Gekko Medical Pty Ltd recommends a
service contract is agreed upon, and that all parts used are genuine parts supplied by the manufacturer.

Instructions for Use: GEV019-100
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Connection to Electrical Supply Power:
DANGER
Risk of electrical shock. Device to be connected to
earthed mains power outlet only. Before operating
the GeVentor, adhere to instructions provided in
Section 6 of this document.
DANGER
Risk of electrical shock. Device to be connected to
earthed mains power outlet only. Before operating
the GeVentor, adhere to instructions provided in
Section 6 of this document.
Explosion Hazard:
DANGER
Risk of explosion. Do not allow oxygen supply
components to come into contact with elements
(such as fuels, heat, oils) that may result in
combustible or explosive gas mixtures.
Device Connection:
CAUTION
This device should only be connected to a pipeline
installation designed using a diversity factor that
allows for the indicated high flow at a specified
number of terminal outlets, to avoid exceeding the
flow. This will minimise the risk that the GeVentor
interferes with the operation of adjacent equipment.
Ensure that manual back-up ventilation is available.
Electromagnetic Compatibility:
CAUTION
This device has been tested for EMC and is compliant
with the requirements of IEC 60601-1-2: 2014
Keep away from possible sources of electromagnetic
emissions.

Instructions for Use: GEV019-100
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Interactions with Other Devices:
CAUTION
Other devices that may be connected to the GeVentor
must comply with approved design, installation and
operation requirements for use with the GeVentor. If
in doubt, contact the manufacturer. Refer to Section
6.20 for more detail.
Alterations to Breathing System:
WARNING
Alterations to the breathing system may affect
ventilator accuracy and patients must be
monitored closely. This includes the use of
humidifiers.
Patient Precautions and Safety:
Always check unit operation with a bag/test lung before connecting to the patient to ensure correct settings have been made and
the unit is delivering as prescribed.
CAUTION
When connected to the patient and operating,
healthcare professionals must ensure that no water
or fluids are allowed to ingress into the device.
Remove all potential hazards in close proximity to the
patient and GeVentor. Ensure that the patient is
suitably monitored to provide appropriate GeVentor
performance and the condition of the patient.
Refer to the relevant section of this document for more detail on the required subject to better understand the safety aspects of
the GeVentor.