Ventilator Overview; Indications For Use - Covidien Puritan Bennett 560 User Manual

2 Ventilator Overview

2.1

Indications for Use

The Device name is indicated for the continuous or intermittent mechanical ventilatory support of patients
weighing at least 11 lb (5 kg) who require mechanical ventilation. The ventilator is a restricted medical device
intended for use by qualified, trained personnel under the direction of a doctor. It is essential to read, under-
stand, and follow these instructions before using the Puritan Bennett™ 560 Ventilator.
Target Patients
Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types
of invasive or non-invasive ventilatory support, as prescribed by an attending doctor:
•
Positive Pressure ventilation
•
Assist/Control, SIMV, or CPAP modes of ventilation
•
Breath types including Volume Control, Pressure Control, and Pressure Support
Target Environments
The ventilator is suitable for use in institutional, home, and portable settings. It is not intended for use as an
emergency transport ventilator.
The Puritan Bennett™ 560 Ventilator is suitable for use on commercial aircraft, per FAA requirements. Refer to
chapter A.11, "Standards Compliance and IEC
560 Ventilator may be required by their airline to demonstrate evidence of compliance with the RTCA/DO-
160F standard, as well as other requirements. Contact your airline prior to travel to determine airline specific
requirements and documentation.
Warning
Even though the Puritan Bennett™ 560 Ventilator meets current safety standards, the internal
Lithium-ion battery of the device exceeds the 100Wh threshold and is therefore considered to
be Dangerous Goods (DG) Class 9 – Miscellaneous, when transported in commerce. As such, the
Puritan Bennett™ 560 Ventilator and/or the associated Lithium-ion battery are subject to strict
transport conditions under the Dangerous Goods Regulation for air transport (IATA:
International Air Transport Association), International Maritime Dangerous Goods code for sea
and the European Agreement concerning the International Carriage of Dangerous Goods by
Road (ADR) for Europe. Private individuals who transport the device are excluded from these
regulations although for air transport some requirements apply. For air transport; the Puritan
Bennett™ 560 Ventilator is permitted as checked-in or carry-on baggage. Two spare batteries
per person may be taken on board as carry-on luggage only, with the prior approval of the
airline. This classification and regulatory requirements may vary depending upon the country
and mode of transport. Therefore it is recommended that users verify with the carrier / airline
as to which measures to take before the voyage.
Classification". Patients traveling with the Puritan Bennett™