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OM2196335
Itamar Medical OM2196335 Manuals
Manuals and User Guides for Itamar Medical OM2196335. We have
1
Itamar Medical OM2196335 manual available for free PDF download: Operation Manual
Itamar Medical OM2196335 Operation Manual (76 pages)
Brand:
Itamar Medical
| Category:
Medical Equipment
| Size: 3 MB
Table of Contents
Table of Contents
5
General Information
8
Intended Use / Indications for Use
8
Restrictions for Use
8
Precautions
9
Data Generated by the Watchpat™200U
9
Quality Assurance System: en ISO 13485
10
CSA Compliance
11
Conventions Used in this Manual
11
Warnings, Cautions and Notes
12
Safety Precautions
13
Symbols Used on the Product Labels
14
Watchpat™200U Device Labels
15
FDA Information
15
Overview
16
System Description
17
Figure 1 - Packed Device
18
Figure 2 - Watchpat™200U Device with Sensors
18
User Interaction with the Watchpat™ Device Keys
19
Figure 3 - the Buttons and Display
19
Watchpat™ Device Function
20
Figure 4 - Service Ports and Peripherals
20
Figure 5 - Watchpat™ Wrist Strap
20
Built-In Self-Diagnostic Procedures
21
Preparation for Sleep Study
26
Charging the Battery
26
Figure 6 - Charging the Watchpat™ Device
26
Preparing the Snore and Body Position Sensor
27
Preparing the Wrist Strap
27
Mounting the Watchpat™ on the Wrist Strap
28
Replacing the Upat Probe
28
Figure 7 - Disconnecting the Probe
28
Figure 8 - Probe Disconnected
28
Preparing the Watchpat™ Device for a New Study
29
Testing the Watchpat™ Device
29
WP200U Self-Diagnostic Test Results and Trouble-Shooting
29
Figure 9 - Watchpat™ Fully Prepared
29
Packing the Carrying Case
30
Optional Functions
31
Using the Integrated Snore & Body Position Sensor
31
Tamper-Proof Testing with Watchpat™ Device
32
Figure 10 - Watchpat™ Device with Tamper-Proof Bracelet
32
Figure 11 - Bracelet on Patient's Hand
32
Figure 12 - Watchpat™ Device with Cable for Bracelet
33
Figure 13 - Watchpat™ Device with Bracelet
33
Figure 14 - Bracelet and Watchpat™ Device on a Patient's Hand
33
Figure 15 - Cut the Bracelet
33
Multi-Night Study
34
Figure 16 - Case for 3 Night Multi-Night Study
34
Data Download and Analysis
35
Maintenance
36
Cleaning
37
Handling
38
Replacing the Upat Probe Cable
38
Figure 17 - Upat Probe Cable with Screw
38
Replacing the Battery
39
Figure 18 - Replacing the Upat Probe
39
Setting the Time and Date of the Watchpat™ Device
40
Storing the Watchpat™ Device
40
Figure 19 - Replacing the Battery
40
Applying the Watchpat™ Device
41
Preparing for Use of the Watchpat™ Device
41
Figure 20 - Finger Designation
41
Applying the Watchpat™ Device
42
Attaching the Upat Probe
42
Figure 21 - Putting on the Wrist Strap
42
Figure 22 - Wearing the Watchpat™ Device
42
Figure 23 - Placing Finger in Upat Probe
43
Figure 24 - Removing TOP Tab
43
Figure 25 - Wearing the Watchpat™- Ready for Sleep
43
Switching on the Watchpat™ Device
44
When You Wake up
44
Important Notes
45
Patient Training - Guidelines
46
Walk through the Process of Using the Watchpat™ Device
46
Product Introduction
46
Applying the Watchpat™ Device
46
Switching on the Watchpat™ Device
47
Removing the Watchpat™ Device
47
Patient Training
47
Review Safety, General and Functional Issues
47
Troubleshooting Guide
48
Operator Error Messages
48
Table 1 - Operator Troubleshooting
48
Patient Error Messages
49
Table 2 - Patient Troubleshooting
49
Specifications
50
Table 3 - Watchpat™200U Specifications
50
Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)
51
Appendix B: Tamper-Proof Testing with Watchpat
57
Appendix C: License Agreement
59
Appendix D: Regulatory Representative
65
Appendix E: Description of the Watchpat™200U Upat Probe
66
Appendix F: Manufacturing Declarations According
67
To Iec 60601-1 & 60601-1-2
67
Appendix H: Zzzpat Hardware Requirements
75
Appendix I: Spare Parts List
76
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