WatchPAT™300 System
5
Operation Manual
STANDARD
#
and testing
2009/Technical
Corrigendum1 2010
14.
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse oximeter equipment
ISO 80601-2-61:2011
15.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
16.
Medical devices. Quality management systems. Requirements
for regulatory purposes
EN ISO 13485:2016
17.
Commission Regulation (EU) on electronic instructions for use
of medical devices
EU 207/2012
18.
Medical Device Directive
MDD 93/42 EEC
MDD 2007/47/EC
19.
Directive on the restriction of the use of certain hazardous
substances in electrical and electronic equipment
RoHS Directive
2011/65/EU (RoHS 2)
1.8
CE and TÜV RHEINLAND Compliance
The product complies with MDD 93/42 EEC: 1993 & Amm.
2007/47/EC (Medical Device Directive) requirements and CE
approved.
The product is marked with the CE logo.
The
product is certified by TÜV RHEINLAND.
1.9
Conventions Used in this Manual
Note
: Throughout this document, the references WatchPAT™, WatchPAT™300,WP and
WP300 device are used to refer to the WatchPAT™300 device.
Note
: Throughout this document, the reference Snore & Body Position sensor is referring
to both SBP sensor and RESBP sensor unless specified otherwise.
Note
: is a WatchPAT™ module that enables identification of central apnea.
functionality can be achieved when using the WatchPAT™ with the RESBP
sensor and compatible software.