This manual has been produced to provide
authorised personnel with information on the
function, routine performance and
maintenance checks applicable to the Prima
SP anaesthetic machine range.
Information contained in this manual is
correct at the date of publication.
The policy of Penlon Limited is one of
continued improvement to its products.
Because of this policy, Penlon Limited
reserves the right to make any changes
which may affect instructions in this manual,
without giving prior notice.
Personnel must make themselves familiar
with the contents of this manual and the
machine’s function before using the
apparatus.
Copyright © Penlon Limited, 2008
All rights reserved.
FOREWORD
(ii)
The Importance of
Patient Monitoring
WARNING
Anaesthetic systems have the capability to
deliver mixtures of gases and vapours to the
patient which could cause injury or death
unless controlled by a qualified anaesthetist.
There can be considerable variation in the
effect of anaesthetic drugs on individual
patients so that the setting and observation
of control levels on the anaesthesia systems
does not in itself ensure total patient safety.
Anaesthesia system monitors and patient
monitors are very desirable aids for the
anaesthetist but are not true clinical
monitors as the condition of the patient is
also dependent on his respiration and the
functioning of his cardio-vascular system.
IT IS ESSENTIAL THAT THESE ELEMENTS
ARE MONITORED FREQUENTLY AND
REGULARLY AND THAT ANY
OBSERVATIONS ARE GIVEN PRECEDENCE
OVER MACHINE CONTROL PARAMETERS
IN JUDGING THE STATE OF A CLINICAL
PROCEDURE.
Before using any monitoring system or
device with the anaesthetic machine, the
user must check that it conforms to the
relevant standard, as listed in the table
below.
Parameter / Device Relevant Standard
Pressure Measuring ISO 8835-2
Pressure Limitation Device EN 60601-2-13:2006 - 51.101.1
Exhaled Volume Monitor EN 60601-2-13:2006 - 51.101.4
Breathing System Integrity Alarm System EN 60601-2-13:2006 - 51.101.5
Continuing Pressure Alarm EN 60601-2-13:2006 - 51.101.6
Oxygen Monitor ISO 7767
Carbon Dioxide Monitor ISO 9918
Breathing Circuit ISO 8835-2
Gas Scavenging ISO 8835-3
Vaporizers ISO 8835-4
Ventilators ISO 8835-5
Agent Monitor ISO 11196
For information on installing and connection of any of these systems or devices, please refer to the relevant manufacturer’s instructions.
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