Itamar Medical WatchPAT 200 User Manual

Name: Itamar Medical WatchPAT 200
Brand: Itamar Medical
Rating: 4 (1 reviews)

82 pages

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WatchPAT™200

Operation Manual

Itamar Medical REF OM2196330

Caution: Federal (U.S.) law restricts

this device to sale by, or on the order of, a

physician. Not for pediatric use.

WatchPAT™ and PAT

are trademarks of Itamar Medical, Ltd.

Default Chapter5
- Table of Contents5
1 General Information9
- Intended Use / Indications for Use9
- Restrictions for Use9
- Exclusion Criteria10
- Data Generated by the Watchpat™200 Device10
- Equipment Classification10
- Quality Assurance System: ISO 9001 & ISO 1348511
- CE and CSA Compliance12
- Conventions Used in this Manual12
- Warnings, Cautions and Notes13
- Safety Precautions14
- Environmental Protection15
- Symbols Used on the Product Labels15
- Watchpat™200 Device Labels16
- FDA Information16
2 Overview17
- System Description18
  - Figure 2 - Watchpat™ Device with Sensors19
  - Built-In Self-Diagnostic Procedures22
- User Interaction with the Watchpat™ Device Keys19
- Figure 3 - the Buttons and Display20
- Watchpat™ Device Function21
3 Preparation for Sleep Study27
- Charging the Battery27
- Preparing the Snore and Body Position Sensor30
- Preparing the Wrist Strap30
Figure 13 - the Snoring and Body Position Sensor34
4 Optional Functions34
- Tamper-Proof Testing with Watchpat™ Device34
- Using the Integrated Snore & Body Position Sensor34
- Figure 15 - Bracelet on Patient's Hand35
- Figure 14 - Watchpat™ Device with Tamper-Proof Bracelet35
- Figure 16 - Watchpat™ Device with Cable for Bracelet36
- Figure 18 - Bracelet and Watchpat™ Device on a Patient's Hand36
- Figure 17 - Watchpat™ Device with Bracelet36
- Multi-Night Study37
Figure 19 - Cut the Bracelet at the Specified Location37
Figure 20 - Case for a 3 Night Multi-Night Study37
5 Data Download and Analysis38
6 Maintenance39
- Cleaning39
- Cleaning the Oximetry Sensor39
- Cleaning the Watchpat™ Device39
- Cleaning the Wrist Strap40
- Handling40
- Replacing the Oximetry Sensor40
- The PAT Probe40
- The Snore & Body Position Sensor40
- Figure 21 - Replacing Oximetry Sensor41
- Replacing the PAT ® Probe Cable41
- Replacing the Battery42
Figure 22 - PAT ® Probe with Screw42
Figure 23 - Replacing the PAT42
Probe42
- Figure 24 - Replacing the Battery43
- Setting the Time and Date of the Watchpat™ Device43
- Storing the Watchpat™ Device44
7 Applying the Watchpat™ Device45
- Preparing for Use of the Watchpat™ Device45
- Applying the Watchpat™ Device46
- Figure 27 - Wearing the Watchpat™ Device46
- Figure 26 - Putting on the Wrist Strap46
- Figure 25 - Finger Designation46
- Applying the Oximetry Sensor47
- Figure 29 - Positioning Oximetry on Ring Finger47
- Figure 28 - Removing Adhesive Cover47
- Figure 31 - Wrap the Long Flap47
- Figure 30 - Fold Top Flap and Short Flap47
- Attaching the PAT ® Probe48
- Figure 32 - Flexiwrap Line Indication48
- Figure 35 - Removing BOTTOM Tab49
- Figure 34 - Removing TOP Tab49
- Figure 33 - Placing Finger in PAT49
- Figure 36 - Wearing the WP200 - Ready for Sleep49
- Important Notes50
- Switching on the Watchpat™ Device50
- When You Wake up50
8 Patient Training - Guidelines52
- Walk through the Process of Using the Watchpat™ Device52
- Product Introduction52
- Applying the Watchpat™ Device52
- Switching on the Watchpat™ Device53
- Removing the Watchpat™ Device53
- Patient Training54
- Review Safety, General and Functional Issues54
9 Troubleshooting Guide55
- Operator Error Messages55
- Table 1 - Operator Troubleshooting55
- Patient Error Messages56
Table 2 - Patient Troubleshooting56
10 Specifications57
Table 3 - Watchpat™200 Device Specifications57
Appendix A: Wp200 Integrated Snoring + Body Positioning Sensor Operating Instructions58
Appendix B: Tamper-Proof Testing with the Wp20063
Appendix C: License Agreement67
Appendix D: Regulatory Representative73
Appendix E: Description of the Watchpat™200 Probe74
Appendix F: Manufacturing Declaration According to75
- Electromagnetic Emissions75
- Recommended Separation Distances78
Appendix G: Spo 2 Accuracy in the Wp20079
Appendix G: Spo Accuracy in the Wp20081
Appendix H: Training Resources81
Appendix I: Spare Parts List82

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Itamar Medical WatchPAT 200 Specifications

General

Connectivity	Bluetooth
Data Storage	Internal memory
Report Generation	Automated report generation
FDA Cleared	Yes
CE Marked	Yes
Device Type	Home Sleep Apnea Test (HSAT)
Measurement Method / Technology	Actigraphy, oximetry
Parameters Measured	Oxygen saturation, pulse rate, body position