Itamar Medical OM2196336 Manuals

Manuals and User Guides for Itamar Medical OM2196336. We have 1 Itamar Medical OM2196336 manual available for free PDF download: Operation Manual

Itamar Medical OM2196336 Operation Manual (77 pages)

Brand: Itamar Medical | Category: Medical Equipment | Size: 2.46 MB

Table of Contents
4
General Information
7
Intended Use / Indications for Use
7
Restrictions for Use
7
Precautions
8
Additional Precautions Specific to Pediatric Use
8
Data Generated by the Watchpat™200U
9
Equipment Classification
9
Quality Assurance System: en ISO 13485
10
CE and 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
User Interaction with the Watchpat™ Device Keys
18
Figure 1 - Packed Device
18
Figure 2 - Watchpat™200U Device with Sensors
18
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
25
Charging the Battery
25
Figure 6 - Charging the Watchpat™ Device
25
Preparing the Snore and Body Position Sensor
26
Preparing the Wrist Strap
26
Mounting the Watchpat™ on the Wrist Strap
27
Replacing the Upat Probe
27
Figure 7 - Disconnecting the Probe
27
Figure 8 - Probe Disconnected
27
Preparing the Watchpat™ Device for a New Study
28
Testing the Watchpat™ Device
28
WP200U Self-Diagnostic Test Results and Trouble-Shooting
28
Figure 9 - Watchpat™ Fully Prepared
28
Packing the Carrying Case
29
Optional Functions
30
Using the Integrated Snore & Body Position Sensor
30
Tamper-Proof Testing with Watchpat™ Device
31
Figure 10 - Watchpat™ Device with Tamper-Proof Bracelet
31
Figure 11 - Bracelet on Patient's Hand
31
Figure 12 - Watchpat™ Device with Cable for Bracelet
32
Figure 13 - Watchpat™ Device with Bracelet
32
Figure 14 - Bracelet and Watchpat™ Device on a Patient's Hand
32
Figure 15 - Cut the Bracelet on a Specified Location
32
Multi-Night Study
33
Figure 16 - Case for 3 Night Multi-Night Study
33
Data Download and Analysis
34
Maintenance
35
Cleaning
36
Handling
37
Replacing the Upat Probe Cable
37
Figure 17 - Upat Probe Cable with Screw
37
Replacing the Battery
38
Figure 18 - Replacing the Upat Probe
38
Setting the Time and Date of the Watchpat™ Device
39
Storing the Watchpat™ Device
39
Figure 19 - Replacing the Battery
39
Applying the Watchpat™ Device
40
Preparing for Use of the Watchpat™ Device
40
Applying the Watchpat™ Device
41
Figure 20 - Finger Designation
41
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
42
Figure 24 - Removing TOP Tab
42
Switching on the Watchpat™ Device
43
Figure 25 - Wearing the Watchpat™- Ready for Sleep
43
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
48
Troubleshooting Guide
49
Operator Error Messages
49
Table 1 - Operator Troubleshooting
49
Patient Error Messages
50
Table 2 - Patient Troubleshooting
50
Specifications
51
Table 3 - Watchpat™200U Specifications
51
Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)
52
Appendix B: Tamper-Proof Testing with Watchpat
58
Appendix C: License Agreement
60
Appendix D: Regulatory Representative
66
Appendix E: Description of the Watchpat™200U Upat Probe
67
Appendix F: Manufacturing Declarations According
68
To Iec 60601-1 & 60601-1-2
68
Appendix G: Spo2 Accuracy in the Watchpat™200U
73
Appendix H: Zzzpat Hardware Requirements
76
Appendix I: Spare Parts List
77

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Itamar Medical OM2196336 Operation Manual (77 pages)

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