WatchPAT™200 System
ii
Operation Manual
Record of Editions
Edition
Date
Description
Chapter
Pages
Resp.
0
March 2008
Preliminary
All
All
1
June 2008
Sleep Stages and AHI
All
All
2
July 2008
ISO logo, list of standards, Medes
address, pictures
All
All
Bonita
3
Feb 09
Updating:
Itamar Medical address
List of standards
Labeling
-, 11
1.6
1.10.1
i, 47
3
7
Orit
4
Oct 09
Update for bracelet and multi-night
support
Bonita
5
July 2011
Standards, Preparing for use,
Specifications table and minor
wording changes.
SpO2 accuracy
App. G
3, 35, 47
Bonita
6
March 2012
New PCB version with new
connectors
Fixed typos and syntax errors.
Changed figures:
1, 2, 6, 12, 13,
15, 17, 18, 19, 21,
23, 24, 25, 28, 35,
37, App. B
3, 5, 8, 10-
13, 16, 17,
19, 22, 24,
26-29, 32-
35, 38, 45,
47, 49
Bonita
7
Feb 2013
Updating standards,
Device compliance, symbols, Labels,
specifications
1.5-1.7
1.11-1.12
10
2-4, 7-8, 48
Orit Kelner
8
May 2013
Updated for Itamar SBP sensor
Updating standards
1.1, 1.2, 1.4, 2.1,
2.2, 3.5, 4.1. 7.1,
App. A
1.6
1, 2, 9, 11,
13, 24, 26,
37, 50-54
3
Bonita
9
July 2013
Updating WATCHPAT™ device label 1.11, 1.12
7-8
Orit Kelner
10
Sep 2013
Updating logo of ISO symbol
Updating PAT
®
probe – Bottom tab
optional
-,
7.4, 8.3
i ,
40, 44
Bonita Dean
11
Feb 2014
Clarification of exclusion criteria
1.3
2
Efrat Litman
12
March 2014
Updating zip code
QR Code
-,
App C
App H
i ,
63
70
Ido Abraham
13
July 2014
Notes – trademarks
latest version of this OM,
Added trademark symbol
Clarifying 2
nd
exclusion criteria
Updating Standards, symbols/labels
Clarification of instruction: Attaching
the probe, applying SBP
Update SBP Cleaning instructions
Temp./humidity parameters update
Medes and Itamar’s addresses
Update QR code table
-,
All
1.3
1.6, 1.11, 1.12
7.4, 8.3 (6), ,
App A
6.1, 6.6
10, App. A
App. C, App. D, -
App. H
i
ii
All
2
3, 7-8
40, 45,
51
31, 32
49,51
65, 66 ,i
71
Ido Abraham
Shelly Ron
Bonita Dean
