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OM2196381
Itamar Medical OM2196381 Manuals
Manuals and User Guides for Itamar Medical OM2196381. We have
1
Itamar Medical OM2196381 manual available for free PDF download: Operation Manual
Itamar Medical OM2196381 Operation Manual (73 pages)
Brand:
Itamar Medical
| Category:
Medical Equipment
| Size: 2.73 MB
Table of Contents
Table of Contents
4
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
Overview
16
System Description
17
Figure 1 - Packed Device
17
Figure 2 - Watchpat™300 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
Built-In Self-Diagnostic Procedures
21
Preparation for Sleep Study
26
Inserting the Battery
26
Preparing the Snore and Body Position Sensor
27
Preparing the Wrist Strap
27
Mounting the Watchpat™ on the Wrist Strap
27
Replacing the Upat Probe
27
Figure 5 - Battery Compartment
27
Figure 6 - Disconnecting the Probe
28
Figure 7 - Probe Disconnected
28
Preparing the Watchpat™ Device for a New Study
29
Testing the Watchpat™ Device
29
WP300 Self-Diagnostic Test Results and Trouble-Shooting
29
Packing the Carrying Case
29
Figure 8 - Watchpat™ Fully Prepared
29
Optional Functions
31
Using the Integrated Snore & Body Position Sensor
31
Tamper-Proof Testing with Watchpat™ Device
32
Figure 9 - Watchpat™ Device with Tamper-Proof Bracelet
32
Figure 10 - Bracelet on Patient's Hand
32
Figure 11 - Watchpat™ Device with Cable for Bracelet
33
Figure 12 - Watchpat™ Device with Bracelet
33
Figure 13 - Bracelet and Watchpat™ Device on a Patient's Hand
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
Data Download and Analysis
35
Maintenance
36
Cleaning
37
Handling
38
Replacing the Upat Probe Cable
38
Figure 16 - Upat Probe Cable with Screw
38
Setting the Time and Date of the Watchpat™ Device
39
Storing the Watchpat™ Device
39
Figure 17 - Replacing the Upat Probe
39
Applying the Watchpat™ Device
40
Preparing for Use of the Watchpat™ Device
40
Applying the Watchpat™ Device
41
Figure 18 - Finger Designation
41
Figure 19 - Watchpat™ Wrist Strap
41
Attaching the Upat Probe
42
Figure 20 - Seating Device on Wrist Strap
42
Figure 21 - Putting on the Wrist Strap
42
Figure 22 - Placing Finger in Upat Probe
43
Switching on the Watchpat™ Device
44
Figure 23 - Removing TOP Tab
44
Figure 24 - Wearing the Watchpat™ - Ready for Sleep
44
When You Wake up
45
Important Notes
46
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
Troubleshooting Guide
50
Operator Error Messages
50
Table 1 - Operator Troubleshooting
50
Patient Error Messages
51
Table 2 - Patient Troubleshooting
51
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: Wp200U Effectiveness in Detecting Central Sleep Apnea Syndrome Using a Threshold of Ahic=10
71
Appendix I: Zzzpat Hardware Requirements
72
Appendix G: Spare Parts List
73
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