Itamar Medical Ltd.
Endo
PAT
TM
x Device
4
Operation Manual
monitoring.
The device is not intended as a screening test in the general patient population.
Itamar Medical Ltd. makes no representation whatsoever, that the act of reading this
Operation Manual renders the reader qualified to operate, test or calibrate the
system.
The tracings and calculations provided by the EndoPAT
TM
x system are intended as
tools for the competent diagnostician. They are explicitly not to be regarded as a
sole incontrovertible basis for clinical diagnosis.
In the event that the system does not operate properly, or if it fails to respond to the
controls in the manner described in this manual, the operator should refer to the
Troubleshooting
section. If necessary, contact our service office to report the
incident and to receive further instructions (customer support can be reached at
+972-4-617 7000 ext. 399, or from the US: (800) 206 6952 ext. 399).
1.6
Quality Assurance System: EN ISO 13485
STANDARD
#
1.
Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance
EN 60601-1:2006
EN 60601-
1:2006/AC:2010
EN 60601-
1:2006/A1:2013
IEC 60601-
1:2005/A1:2012
[the product was
developed according to
IEC 60601-1:2005 +
CORR.1:2006 +
CORR.2:2007 +
AM1:2012 (3
rd
ed+AM1)
ANSI/AAMI ES60601-
1:2005/(R) 2012 and
A1:2012, C1:2009/(R)
2012 and A2:2010/(R)
2012
CAN/CSA -C22.2
No.60601-1 :08
]
