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OM2196390
Itamar Medical OM2196390 User Manual
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WatchPAT™
300
Operation
Manual
Itamar Medical REF
OM2196380
Caution:
Federal
law
restricts
this
device
to
sale
by
or
on
the
order
of
a
licensed
healthca
re
practitioner
Copyright
©
2002
- 2019 B
y
Itamar Medica
l
Ltd.
WatchPAT™
a
nd
PAT
®
are trad
emarks of
Ita
mar Medical
,
Ltd.
2
Table of Contents
Default Chapter
4
Table of Contents
4
1 General Information
7
Intended Use / Indications for Use
7
Restrictions for Use
7
Exclusion Criteria
8
Additional Precautions Specific to Pediatric Use
8
Data Generated by the Watchpat™300
9
Equipment Classification
9
Quality Assurance System: en ISO 13485
10
CE and TÜV RHEINLAND Compliance
11
Conventions Used in this Manual
11
Warnings, Cautions and Notes
12
Safety Precautions
13
Symbols Used on the Product Labels
14
Watchpat™300 Device Labels
15
FDA Information
15
2 Overview
16
Figure 1 - Packed Device
17
System Description
17
Figure 2 - Watchpat™300 Device with Sensors
18
Figure 3 - the Buttons and Display
19
Figure 4 - Service Ports and Peripherals
20
Built-In Self-Diagnostic Procedures
21
Watchpat™ Device Function
20
User Interaction with the Watchpat™ Device Keys
19
3 Preparation for Sleep Study
26
Inserting the Battery
26
Figure 5 - Battery Compartment
27
Mounting the Watchpat™ on the Wrist Strap
27
Preparing the Snore and Body Position Sensor
27
Preparing the Wrist Strap
27
Replacing the Upat Probe
27
Figure 6 - Disconnecting the Probe
28
Figure 7 - Probe Disconnected
28
Packing the Carrying Case
29
Preparing the Watchpat™ Device for a New Study
29
Testing the Watchpat™ Device
29
WP300 Self-Diagnostic Test Results and Trouble-Shooting
29
Figure 8 - Watchpat™ Fully Prepared
29
4 Optional Functions
31
Using the Integrated Snore & Body Position Sensor
31
Figure 9 - Watchpat™ Device with Tamper-Proof Bracelet
32
Figure 10 - Bracelet on Patient's Hand
32
Tamper-Proof Testing with Watchpat™ Device
32
Figure 11 - Watchpat™ Device with Cable for Bracelet
33
Figure 13 - Bracelet and Watchpat™ Device on a Patient's Hand
33
Figure 12 - Watchpat™ Device with Bracelet
33
Multi-Night Study
34
Figure 14 - Cut the Bracelet on a Specified Location
34
Figure 15 - Case for 2 Night Multi-Night Study
34
5 Data Download and Analysis
35
6 Maintenance
36
Cleaning
37
Figure 16 - Upat Probe Cable with Screw
38
Handling
38
Replacing the Upat Probe Cable
38
Setting the Time and Date of the Watchpat™ Device
39
Storing the Watchpat™ Device
39
Figure 17 - Replacing the Upat Probe
39
7 Applying the Watchpat™ Device
40
Preparing for Use of the Watchpat™ Device
40
Applying the Watchpat™ Device
41
Figure 19 - Watchpat™ Wrist Strap
41
Figure 18 - Finger Designation
41
Attaching the Upat Probe
42
Figure 21 - Putting on the Wrist Strap
42
Figure 23 - Removing TOP Tab
44
Figure 24 - Wearing the Watchpat™ - Ready for Sleep
44
When You Wake up
45
Important Notes
46
Figure 20 - Seating Device on Wrist Strap
42
Figure 22 - Placing Finger in Upat Probe
43
Switching on the Watchpat™ Device
44
8 Patient Training - Guidelines
47
Walk through the Process of Using the Watchpat™ Device
47
Product Introduction
47
Applying the Watchpat™ Device
47
Switching on the Watchpat™ Device
48
Removing the Watchpat™ Device
48
Patient Training
48
Review Safety, General and Functional Issues
49
9 Troubleshooting Guide
50
Operator Error Messages
50
Table 1 - Operator Troubleshooting
50
Patient Error Messages
51
Table 2 - Patient Troubleshooting
51
10 Specifications
52
Table 3 - Watchpat™300 Specifications
52
Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)
53
Appendix B: Tamper-Proof Testing with Watchpat
58
Appendix C: License Agreement
60
Appendix D: Regulatory Representative
61
Appendix E: Description of the Watchpat™300 Upat Probe
62
Appendix F: Manufacturing Declarations According
63
To Iec 60601-1 & 60601-1-2
63
Appendix G: Spo2 Accuracy in the Watchpat™300
68
Appendix H: Zzzpat Hardware Requirements
71
Appendix I: Spare Parts List
72
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Itamar Medical OM2196390 Specifications
General
Brand
Itamar Medical
Model
OM2196390
Category
Medical Equipment
Language
English
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