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WatchPAT 200 Unified
Itamar Medical WatchPAT 200 Unified Manuals
Manuals and User Guides for Itamar Medical WatchPAT 200 Unified. We have
4
Itamar Medical WatchPAT 200 Unified manuals available for free PDF download: Operation Manual
Itamar Medical WatchPAT 200 Unified Operation Manual (82 pages)
For use with patients suspected to have sleep related breathing disorders
Brand:
Itamar Medical
| Category:
Medical Equipment
| Size: 2.88 MB
Table of Contents
Table of Contents
5
1 General Information
9
Intended Use / Indications for Use
9
Restrictions for Use
9
Exclusion Criteria
10
Data Generated by the Watchpat™200 Device
10
Equipment Classification
10
Quality Assurance System: ISO 9001 & ISO 13485
11
CE and CSA Compliance
12
Conventions Used in this Manual
12
Warnings, Cautions and Notes
13
Safety Precautions
14
Environmental Protection
15
Symbols Used on the Product Labels
15
Watchpat™200 Device Labels
16
FDA Information
16
2 Overview
17
System Description
18
Figure 2 - Watchpat™ Device with Sensors
19
Figure 1 - Packed Device
19
Figure 4 - Service Ports and Peripherals
21
Figure 5 - Watchpat™ Wrist with Oximetry Module
21
Figure 6 - Charging the Watchpat™ Device
27
Preparing the Oximetry Sensor
28
Built-In Self-Diagnostic Procedures
22
User Interaction with the Watchpat™ Device Keys
19
Figure 3 - the Buttons and Display
20
Watchpat™ Device Function
21
3 Preparation for Sleep Study
27
Charging the Battery
27
Figure 8 - Preparing the Nonin Oximetry Sensor
29
Figure 7 - Oximetry Sensor
29
Figure 10 - Disconnecting the Probe
31
Figure 11 - Probe Disconnected
31
Figure 12 - a Watchpat™ Device Fully Prepared
32
Preparing the Watchpat™ Device for a New Study
32
Testing the Watchpat™ Device
32
WP200 Device Self-Diagnostic Test Results and Trouble-Shooting
32
Packing the Carrying Case
33
Figure 9 - Wrist Strap
30
Mounting the Watchpat™ Device on the Wrist Strap
31
Replacing the PAT ® Probe
31
Preparing the Snore and Body Position Sensor
30
Preparing the Wrist Strap
30
Figure 13 - the Snoring and Body Position Sensor
34
4 Optional Functions
34
Tamper-Proof Testing with Watchpat™ Device
34
Using the Integrated Snore & Body Position Sensor
34
Figure 15 - Bracelet on Patient's Hand
35
Figure 14 - Watchpat™ Device with Tamper-Proof Bracelet
35
Figure 16 - Watchpat™ Device with Cable for Bracelet
36
Figure 18 - Bracelet and Watchpat™ Device on a Patient's Hand
36
Figure 17 - Watchpat™ Device with Bracelet
36
Multi-Night Study
37
Figure 19 - Cut the Bracelet at the Specified Location
37
Figure 20 - Case for a 3 Night Multi-Night Study
37
5 Data Download and Analysis
38
6 Maintenance
39
Cleaning
39
Cleaning the Oximetry Sensor
39
Cleaning the Watchpat™ Device
39
Cleaning the Wrist Strap
40
Handling
40
Replacing the Oximetry Sensor
40
The PAT Probe
40
The Snore & Body Position Sensor
40
Figure 21 - Replacing Oximetry Sensor
41
Replacing the PAT ® Probe Cable
41
Replacing the Battery
42
Figure 22 - PAT ® Probe with Screw
42
Figure 23 - Replacing the PAT
42
Probe
42
Figure 24 - Replacing the Battery
43
Setting the Time and Date of the Watchpat™ Device
43
Storing the Watchpat™ Device
44
7 Applying the Watchpat™ Device
45
Preparing for Use of the Watchpat™ Device
45
Applying the Watchpat™ Device
46
Figure 27 - Wearing the Watchpat™ Device
46
Figure 26 - Putting on the Wrist Strap
46
Figure 25 - Finger Designation
46
Applying the Oximetry Sensor
47
Figure 29 - Positioning Oximetry on Ring Finger
47
Figure 28 - Removing Adhesive Cover
47
Figure 31 - Wrap the Long Flap
47
Figure 30 - Fold Top Flap and Short Flap
47
Attaching the PAT ® Probe
48
Figure 32 - Flexiwrap Line Indication
48
Figure 35 - Removing BOTTOM Tab
49
Figure 34 - Removing TOP Tab
49
Figure 33 - Placing Finger in PAT
49
Figure 36 - Wearing the WP200 - Ready for Sleep
49
Important Notes
50
Switching on the Watchpat™ Device
50
When You Wake up
50
8 Patient Training - Guidelines
52
Walk through the Process of Using the Watchpat™ Device
52
Product Introduction
52
Applying the Watchpat™ Device
52
Switching on the Watchpat™ Device
53
Removing the Watchpat™ Device
53
Patient Training
54
Review Safety, General and Functional Issues
54
9 Troubleshooting Guide
55
Operator Error Messages
55
Table 1 - Operator Troubleshooting
55
Patient Error Messages
56
Table 2 - Patient Troubleshooting
56
10 Specifications
57
Table 3 - Watchpat™200 Device Specifications
57
Appendix A: Wp200 Integrated Snoring + Body Positioning Sensor Operating Instructions
58
Appendix B: Tamper-Proof Testing with the Wp200
63
Appendix C: License Agreement
67
Appendix D: Regulatory Representative
73
Appendix E: Description of the Watchpat™200 Probe
74
Appendix F: Manufacturing Declaration According to
75
Electromagnetic Emissions
75
Recommended Separation Distances
78
Appendix G: Spo 2 Accuracy in the Wp200
79
Appendix G: Spo Accuracy in the Wp200
81
Appendix H: Training Resources
81
Appendix I: Spare Parts List
82
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Itamar Medical WatchPAT 200 Unified Operation Manual (77 pages)
Brand:
Itamar Medical
| Category:
Medical Equipment
| Size: 2.46 MB
Table of Contents
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
Itamar Medical WatchPAT 200 Unified 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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Itamar Medical WatchPAT 200 Unified Operation Manual (74 pages)
Brand:
Itamar Medical
| Category:
Personal Care Products
| Size: 2.73 MB
Table of Contents
Table of Contents
4
1 General Information
7
Intended Use / Indications for Use
7
Restrictions for Use
7
Exclusion Criteria
8
Data Generated by the Watchpat™200U
8
Equipment Classification
8
Quality Assurance System: ISO 9001 & en ISO 13485
9
CE and CSA Compliance
10
Conventions Used in this Manual
10
Warnings, Cautions and Notes
11
Safety Precautions
12
Symbols Used on the Product Labels
13
Watchpat™200U Device Labels
14
FDA Information
14
2 Overview
15
System Description
16
Figure 2 - Watchpat™200U Device with Sensors
17
Figure 1 - Packed Device
17
Figure 4 - Service Ports and Peripherals
19
Figure 5 - Watchpat™ Wrist Strap
19
Figure 6 - Charging the Watchpat™ Device
24
Preparing the Snore and Body Position Sensor
25
Preparing the Wrist Strap
25
Mounting the Watchpat™ on the Wrist Strap
26
Replacing the Upat Probe
26
Built-In Self-Diagnostic Procedures
20
User Interaction with the Watchpat™ Device Keys
17
Figure 3 - the Buttons and Display
18
Watchpat™ Device Function
19
3 Preparation for Sleep Study
24
Charging the Battery
24
Figure 8 - Probe Disconnected
26
Figure 9 - Watchpat™ Fully Prepared
27
Packing the Carrying Case
28
Figure 7 - Disconnecting the Probe
26
Preparing the Watchpat™ Device for a New Study
27
Testing the Watchpat™ Device
27
WP200U Self-Diagnostic Test Results and Trouble-Shooting
27
4 Optional Functions
29
Tamper-Proof Testing with Watchpat™ Device
29
Using the Integrated Snore & Body Position Sensor
29
Figure 11 - Bracelet on Patient's Hand
30
Figure 10 - Watchpat™ Device with Tamper-Proof Bracelet
30
Figure 13 - Watchpat™ Device with Bracelet
31
Figure 12 - Watchpat™ Device with Cable for Bracelet
31
Figure 15 - Cut the Bracelet on a Specified Location
31
Figure 14 - Bracelet and Watchpat™ Device on a Patient's Hand
31
Multi-Night Study
32
Figure 16 - Case for 3 Night Multi-Night Study
32
5 Data Download and Analysis
33
6 Maintenance
34
Cleaning
34
Figure 17 - Upat Probe Cable with Screw
35
Figure 18 - Replacing the Upat Probe
36
Figure 19 - Replacing the Battery
37
Storing the Watchpat™ Device
38
Setting the Time and Date of the Watchpat™ Device
37
Handling
35
Replacing the Upat Probe Cable
35
Replacing the Battery
36
7 Applying the Watchpat™ Device
39
Figure 20 - Finger Designation
39
Preparing for Use of the Watchpat™ Device
39
Attaching the Upat Probe
40
Figure 22 - Wearing the Watchpat™ Device
40
Figure 21 - Putting on the Wrist Strap
40
Figure 23 - Placing Finger in Upat Probe
41
Figure 25 - Wearing the WP200U - Ready for Sleep
41
Figure 24 - Removing TOP Tab
41
Switching on the Watchpat™ Device
42
When You Wake up
42
Important Notes
43
8 Patient Training - Guidelines
44
Walk through the Process of Using the Watchpat™ Device
44
Product Introduction
44
Applying the Watchpat™ Device
44
Switching on the Watchpat™ Device
45
Removing the Watchpat™ Device
45
Patient Training
45
Review Safety, General and Functional Issues
45
9 Troubleshooting Guide
46
Operator Error Messages
46
Table 1 - Operator Troubleshooting
46
Patient Error Messages
47
Table 2 - Patient Troubleshooting
47
10 Specifications
48
Table 3 - Watchpat™200U Specifications
48
Appendix A: Wp200U Integrated Snoring + Body Positioning Sensor Operating Instructions
49
Appendix B: Tamper-Proof Testing with Watchpat™200U
54
Appendix C: License Agreement
58
Appendix D: Regulatory Representative
64
Appendix E: Description of the Watchpat™200U Upat Probe
65
Appendix F: Manufacturing Declarations According
66
To Iec 60601-1 & 60601-1-2
66
Appendix G: Spo2 Accuracy in the Watchpat™200U
70
Appendix H: Training Resources
73
Appendix I: Spare Parts List
74
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