Instructions for Use: GEV019-100
Page 5
1
Introduction
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 cmH
2
O
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.