Itamar Medical WatchPAT 300 Operation Manual
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Itamar Medical WatchPAT 300 Operation Manual

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WatchPAT™300
Operation Manual
Itamar Medical REF OM2196380
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright © 2002 - 2019 By Itamar Medical Ltd.
WatchPAT™ and PAT
®
are trademarks of Itamar Medical, Ltd.

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Summary of Contents for Itamar Medical WatchPAT 300

  • Page 1 Itamar Medical REF OM2196380 Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright © 2002 - 2019 By Itamar Medical Ltd. WatchPAT™ and PAT ® are trademarks of Itamar Medical, Ltd.
  • Page 2 This manual and the information contained herein are confidential and are the sole property Itamar Medical Ltd. Only Itamar Medical Ltd. or its licensees have the right to use this information. Any unauthorized use, disclosure or reproduction is a direct violation of Itamar Medical’s proprietary rights.
  • Page 3 Record of Editions Edition Date Description Chapter Pages September 2017 Initial Oct 2017 Added labels 1.13 Feb 2018 Change photos Update Note Update standard list Update device label 1.13 Remove note re self-diagnostic test from 2.4.1, 3.7 16, 23 zzzPAT SW Update 'patient test' messages 2.4.3 Remove noting primary/secondary from battery...

  • Page 4: Table Of Contents

    Table of Contents GENERAL INFORMATION ............. 1 Intended Use / Indications for Use ............1 Restrictions for Use ................1 Exclusion Criteria ..................2 Additional Precautions specific to pediatric use ......... 2 Data Generated by the WatchPAT™300 ..........3 Equipment Classification ............... 3 Quality Assurance System: EN ISO 13485 ..........
  • Page 5 Cleaning ....................31 Handling ....................32 Replacing the uPAT Probe Cable ............32 Setting the Time and Date of the WatchPAT™ device ....... 33 Storing the WatchPAT™ device............33 APPLYING THE WATCHPAT™ DEVICE ......34 Preparing for Use of the WatchPAT™ Device ........34 Applying the WatchPAT™...
  • Page 6 APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS ....65 APPENDIX I: SPARE PARTS LIST ...........66 List of Figures Figure 1 – Packed Device ................... 11 Figure 2 – WatchPAT™300 Device with Sensors ..........12 Figure 3 – The Buttons and Display ..............13 Figure 4 –...

  • Page 7: General Information

    Periodic review of the Manual is recommended. 10. Itamar Medical Ltd. makes no representation whatsoever, that the act of reading the Manual renders the reader qualified to operate, test or calibrate the system.

  • Page 8: Exclusion Criteria

    11. The tracings and calculations provided by the WP300 system are intended as tools for the competent diagnostician. They are explicitly not to be regarded as a sole incontrovertible basis for clinical diagnosis. 12. In the event that the system does not operate properly, or if it fails to respond to the controls in the manner described in this Manual, the operator should refer to the Troubleshooting section.

  • Page 9: Data Generated By The Watchpat™300

    3. Special attention on training the pediatric patient and / or his accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT™ device (for further details see section 7 and section 8) 1.5 Data Generated by the WatchPAT™300 The WatchPAT™300 generates a PAT respiratory disturbance index (“PRDI”) , PAT Apnea-Hypopnea Index (“PAHI”), PAT central Apnea-Hypopnea Index (pAHIc),...

  • Page 10: Quality Assurance System: En Iso 13485

    1.7 Quality Assurance System: EN ISO 13485 The Itamar Medical WP300 is compliant to the following standards. STANDARD Medical electrical equipment – Part 1: General requirements IEC 60601-1:2005 + for basic safety and essential performance CORR.1:2006 + CORR.2:2007 + AM1:2012...

  • Page 11: Ce And Tüv Rheinland Compliance

    STANDARD and testing 2009/Technical Corrigendum1 2010 Medical electrical equipment - Part 2-61: Particular ISO 80601-2-61:2011 requirements for basic safety and essential performance of pulse oximeter equipment FDA Quality Systems Regulation (QSR) 21 CFR part 820 Medical devices. Quality management systems. Requirements EN ISO 13485:2016 for regulatory purposes Commission Regulation (EU) on electronic instructions for use...

  • Page 12: Warnings, Cautions And Notes

    Warnings are used to identify conditions or actions, which - if the instructions are ignored - may violate patient safety, or cause damage/malfunction to the system, resulting in non recoverable loss of data. Les avertissements sont utilises pour identifier les conditions ou les actions qui- si elles sont ignorées- peuvent porter atteinte à...

  • Page 13: Safety Precautions

    1.11 Safety Precautions WARNINGS Do not let the unit get wet. Avoid placing food or water on any part of the system. In the event of fire use only fire extinguishers approved for use on electrical fires. Handle unit with care. This unit is sensitive to extreme movements and to falling.

  • Page 14: Symbols Used On The Product Labels

    1.12 Symbols Used on the Product Labels Follow instructions for use Type BF applied part The product is certified by TÜV RHEINLAND The product is marked with the CE logo 2797 for BSI Date of manufacture YYYY-MM-DD Battery Operating Voltage Single use, do not re-use Temperature limit Use-by date...

  • Page 15: Watchpat™300 Device Labels

    Ingress protection IP22 The device is protected against insertion of fingers and vertically dripping water shall have no harmful effect when the device is tilted at an angle up to 15° from its normal position Authorized representative in the European Community Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner According to the WEEE Directive 2012/19/EU, all waste...

  • Page 16: Overview

    OVERVIEW Sleep apnea syndrome is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. Obstructive sleep apnea is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep with the presence of breathing effort, while Central Sleep apnea is characterized by no respiratory effort.

  • Page 17: System Description

    2.1 System Description The WP300 system is comprised of the following items: • WP300 device that includes: o Embedded actigraph o Embedded CPU and electrical circuit card o Embedded flash memory o AAA Battery o OLED display • Unified PAT and Pulse Oximeter Probe (uPAT probe) (includes oximetry) •...

  • Page 18: Figure 2 - Watchpat™300 Device With Sensors

    Optional RESBP sensor uPAT probe Figure 2 – WatchPAT™300 Device with Sensors An additional item required for the operation of the system is the zzzPAT kit. zzzPAT is a proprietary PC software for initializing the study, retrieving, analyzing and displaying the data.

  • Page 19: User Interaction With The Watchpat™ Device Keys

    2.2 User Interaction with the WatchPAT™ Device Keys The WatchPAT™300 has the following keys (see Figure 3): • Central On/Enter key to power on the WatchPAT™ • Horizontal buttons (left and right) that may be used by the Operator for entering the diagnostic mode and navigating through the diagnostic menu.

  • Page 20: Watchpat™ Device Function

    • Internal uPAT probe port is used for connecting the uPAT probe. The port’s compartment can be accessed through a lid in order to replace the cable. • A port for connecting the optional Snore & Body Position sensor. • The USB port is used for connecting to the PC to initialize the device and download the recording.

  • Page 21: Built-In Self-Diagnostic Procedures

    automatic algorithms, detects respiratory and other events that occurred during sleep as well as periods of REM, deep sleep, light sleep and wakefulness. The pulse rate signal is ® derived from the PAT signal and used in the automatic analysis. The software issues comprehensive detailed reports of the study.
  • Page 22 The following screen will be displayed: DIAGNOSTIC 22:40 4.0.0000 20-May-18 ID=123456789 * device xxxxxx set language set battery end testing Select test -> • First line displays title and current time • Second line displays current embedded S/W version and current date •...
  • Page 23 At the completion of the device test, a TEST FAILED indicates a problem that should be taken care of before the device is released for a night study. DEVICE TEST 22:50 ID Error battery=low pat=bad led pat=bad photo file=unloaded <-Back ->More TEST FAILED 1:54...
  • Page 24 2.4.3 Patient Test When the patient (and accompanying individual if needed) turns on the WatchPAT™ device by pushing the On/Enter key (round center button) for about 2 seconds a self- diagnostic test is automatically performed and the following screen is displayed: PATIENT 22:51 Please wait...
  • Page 25 • The error message will be displayed for 1 minute and then the WatchPAT™ device will shut off. • If this is a study with the tamper-proof bracelet and the wrong bracelet is connected the "wrong bracelet" error message appears. •...

  • Page 26: Preparation For Sleep Study

    3 PREPARATION FOR SLEEP STUDY Inserting the Battery To insert the battery to the WP300 device: 1. Remove the WP300 device out of the wrist strap by unsnapping the left side of the WP300 strap (the one with higher edge). 2.

  • Page 27: Preparing The Snore And Body Position Sensor

    Figure 5 – Battery Compartment 3.2 Preparing the Snore and Body Position Sensor Attach the small round double sided adhesive sticker to the Snore and Body Position sensor on the back side (front side has an image), by peeling off the cover on one side of the sticker.

  • Page 28: Figure 6 - Disconnecting The Probe

    Remove a used probe by pressing the small tab (clip) marked by the arrow in Figure 6, and then, holding the connector’s slider, gently slide it away from the probe – do not pull the slider off by pulling the cord, as it may damage the wiring. Properly dispose of used probes. Figure 6 –...

  • Page 29: Preparing The Watchpat™ Device For A New Study

    uPAT probe Bracelet connectors Snore and Body Position sensor Figure 8 – WatchPAT™ Fully Prepared 3.6 Preparing the WatchPAT™ Device for a New Study Refer to the zzzPAT Software Manual for preparation of the WP300 for a new study. 3.7 Testing the WatchPAT™ Device Run the built-in self-diagnostic facility as described in Section 2.4 above.
  • Page 30 The following items must be placed inside the carrying case, in their respective compartments (see Figure 1 – Packed Device): • The WatchPAT™ device mounted in the Wrist strap with the uPAT probe attached. • Step-by-Step Reference Guide to the WatchPAT™ device. •...

  • Page 31: Optional Functions

    OPTIONAL FUNCTIONS 4.1 Using the integrated Snore & Body Position Sensor The integrated sensor consists internally of two sensors: a snore sensor and a body position sensor. A - Integrated SBP sensor SBP Sensor Attachment B - Integrated RESBP sensor RESBP Sensor Attachment The integrated sensor is powered by the WatchPAT™...

  • Page 32: Tamper-Proof Testing With Watchpat™ Device

    4.2 Tamper-Proof Testing with WatchPAT™ Device The WatchPAT™ device Tamper-Proof bracelet is an add-on accessory used to authenticate the patient doing a sleep study and assure the study is recorded from the right person. The bracelet is a single use small plastic band designed to be worn around the wrist of the hand.

  • Page 33: Figure 11 - Watchpat™ Device With Cable For Bracelet

    When preparing the WatchPAT™ device for a sleep study, the technician pairs the Tamper- Proof Bracelet and the device and registers the bracelet's unique ID in the WatchPAT™ device (see Appendix B: Tamper-proof testing with WatchPAT™). The patient can wear the Bracelet for several days, continuing normal day-to-day activity until he is ready to record his sleep study.

  • Page 34: Multi-Night Study

    Figure 14 – Cut the Bracelet on a Specified Location 4.3 Multi-night study A patient study may be defined as multi-night study and the patient can sleep up to 3 nights with the same WatchPAT™ device. The multi-night option may be selected during New Study function (see zzzPAT Software Manual).

  • Page 35: Data Download And Analysis

    DATA DOWNLOAD AND ANALYSIS Following the sleep study the WatchPAT™ device is returned to the referring sleep clinic for data downloading and analysis by the zzzPAT software. To download and analyze the study data: 1. Connect the USB port of the WatchPAT™ device to the computer (see Figure 4).

  • Page 36: Maintenance

    MAINTENANCE The WatchPAT™ device has been designed and manufactured to meet all safety requirements applicable to medical equipment. To ensure maximum safety of operation, the system should be used and maintained in strict compliance with the safety precautions, warnings and operating instructions provided in this Manual. In order to prevent unnecessary failures while patient is using the device, we recommend performing the routine maintenance recommendations as well as the preventive maintenance recommendations as described in this section.

  • Page 37: Cleaning

    Routine maintenance recommendations: Scenario Routine maintenance Back from sleep study Before handing to action patient Cleaning Replace battery Check cable connections Check carrying case Check strap Perform technician test Preventive maintenance recommendations: Scenario Routine maintenance Lesser of: 200 studies, When a defect is action 1 year, error message found or upon error...

  • Page 38: Handling

    6.1.2 Cleaning the Wrist Strap You may clean the wrist strap with lint free cloth lightly moistened with 70% ethyl alcohol or isopropyl alcohol (IPA). In order to disinfect the wrist strap by immersing into disinfecting liquid follow the steps: •...

  • Page 39: Setting The Time And Date Of The Watchpat™ Device

    2. Carefully disconnect the uPAT probe cable from the connector by pulling out the cable. 3. Connect a new uPAT probe cable by gently inserting the connector back into the WatchPAT™ device until a click is heard. Make sure the plastic shoulders of the cable are inserted into the matching cavity on the device before you close the lid.

  • Page 40: Applying The Watchpat™ Device

    7 APPLYING THE WATCHPAT™ DEVICE Note These instructions are designed to help the patient use the WP300 after seeing a demonstration by trained personnel of how to mount the probes on his/her fingers and correctly operate the WatchPAT™ device. Note In the case of pediatric patient, special attention on training the patient and/or his/her accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT™...

  • Page 41: Applying The Watchpat™ Device

     Index finger Small (pinky) finger Figure 18 – Finger Designation 7.2 Applying the WatchPAT™ Device To apply the WatchPAT™ device to your wrist: 1. Open the carrying case and take out the wrist strap with the WatchPAT™ device mounted. All parts should already be connected, as illustrated in Figure 8. 2.

  • Page 42: Attaching The Upat Probe

    Figure 20 – Seating device on wrist strap 4. Place the wrist strap with the WatchPAT™ device on the non-dominant arm and close it snugly but not tightly. Ensure that the end connected to the finger probe towards the fingers. You may find it convenient to place the wrist strap with the WatchPAT™...

  • Page 43: Figure 22 - Placing Finger In Upat Probe

    Note The tab inside the probe should be removed only AFTER the finger is inserted into the probe. To attach the uPAT probe: 1. Insert your index finger (or other if so instructed) gently into the probe until you feel the end (see Figure 22 – ). 2.

  • Page 44: Switching On The Watchpat™ Device

    Figure 23 – Removing TOP Tab Figure 24 – Wearing the WatchPAT™ – Ready for Sleep Note DO NOT remove the uPAT probe before the night study is terminated. Once the probe is removed it cannot be re-attached. Note If the Snore & Body position sensor is included in the WatchPAT™ device case see Appendix A: WatchPAT™...

  • Page 45: When You Wake Up

    Note To conserve the battery the display will turn off after a few seconds. Pressing the button will restore the display for few seconds. 7.5 When You Wake Up When you awake, remove the WatchPAT™ device from your arm as follows: 1.

  • Page 46: Important Notes

    7.6 Important Notes Wearing the WatchPAT™ device should not cause any discomfort or pain. If you experience wrist or arm discomfort, loosen up the wrist strap. If the discomfort is not alleviated immediately, call the service number. • Do not attempt to connect or disconnect any part of the unit. •...

  • Page 47: Patient Training - Guidelines

    8 PATIENT TRAINING – GUIDELINES Instruct the patients (and accompanying individual if needed) how to attach and use the WP300 prior to use. Note In the case of pediatric patient, special attention on training the patient and / or his accompanying individual on use and placement of the device prior to initiating a sleep study with the WatchPAT™...

  • Page 48: Switching On The Watchpat™ Device

    • If needed, trim chest hair to ensure the sensor attached directly to your skin. • To position the sensor attach it with the image standing up (cable pointing down) after peeling off the round adhesive sticker and pressing against the skin. •...

  • Page 49: Review Safety, General And Functional Issues

    • Following your demonstration have the patient attach the demo device by himself or with the assistance of accompanying individual if needed. • Verify that the attachment is properly done. 8.7 Review Safety, General and Functional Issues • Avoid exposing the WatchPAT™ device to extreme conditions (high temperature, high humidity) •...

  • Page 50: Troubleshooting Guide

    9 TROUBLESHOOTING GUIDE 9.1 Operator Error Messages If an error message is displayed while performing the self-diagnostic tests, take the actions specified below. If the problem persists contact Itamar or an authorized representative. Table 1 – Operator Troubleshooting Error Possible Reason Action File error Not loaded...

  • Page 51: Patient Error Messages

    9.2 Patient Error Messages If an error message is displayed when the patient powers on the WatchPAT™ device, the patient should take the actions specified below. If the problem persists the patient may contact Itamar or an authorized representative directly. Table 2 –...

  • Page 52: Specifications

    10 SPECIFICATIONS Table 3 – WatchPAT™300 Specifications Properties Description Itamar’s proprietary probe. Measures PAT uPAT Probe and Oximetry. Recording Time Approx. 10 hours Channels Measuring 4-7 signals: PAT, Pulse rate, Oximetry, Actigraphy, Snoring (optional), Body Position (optional), Chest Movement (optional) PAT and Actigraphy –...

  • Page 53: Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)

    APPENDIX A: WatchPAT™ Integrated snoring + Body Positioning Sensor Operating Instructions (SBP/RESBP) RESBP/SBP must be used with zzzPAT v 5.0 and above. Thank you for purchasing an Integrated Snore & Body Position Sensor. Description The integrated sensor consists internally of two sensors: a snore sensor and a body position sensor.
  • Page 54 The body position sensor uses a 3-axis accelerometer that provides a signal directly proportional to the patient's sleeping posture (supine, prone, right, left and sit). For RESBP only: The chest movement signal uses the same 3-axis accelerometer to provide raw chest movement signal data for measuring subject’s breathing during the night. Indications of use The integrated Snoring &...
  • Page 55 Storage -20 to 40 Transport -20 to 60 0% – 93% (non- Humidity Operating, Storage & Transport condensing) 10 – 15 psi Atmospheric pressure Operating, & Storage 8 – 15 psi Transport Snoring and Body Position Accuracy This section gives statistical performance measure for Itamar SBP sensor, when used with the WatchPAT™...
  • Page 56 An estimation of the error in each snoring level was calculated by looking at the WatchPAT™ device measurement cut by the results of dB-meter in intervals of 1 dB in the range of above 40dB (below 40 dB was considered not clinically significant being background noise).
  • Page 57 2.37 3.53 64.52 69.48 The results are also presented in the next figure. The figure presents the mean WatchPAT™ device with SD error bar. Summary statistics (mean ± SD) of WatchPATdevice by dB-meter levels Note The snoring and body position safety and effectiveness was validated on adult population only.

  • Page 58: Appendix B: Tamper-Proof Testing With Watchpat

    APPENDIX B: Tamper-proof testing with WatchPAT™ WatchPAT™300 System Operation Manual...
  • Page 59 WatchPAT™300 System Operation Manual...

  • Page 60: Appendix C: License Agreement

    APPENDIX C: LICENSE AGREEMENT This License Agreement represents the complete and exclusive understanding between you and Itamar Medical. The document can be viewed at https://www.itamar-medical.com/lmages/licensewp.pdf Should you have any questions concerning this License Agreement, or if you desire to contact Itamar Medical for any reason, please write to: USA: Itamar Medical Inc.

  • Page 61: Appendix D: Regulatory Representative

    APPENDIX D: REGULATORY REPRESENTATIVE Itamar Medical’s authorized regulatory representative is: MEDES Ltd. 5 Beaumont Gate, Shenley Hill, Radlett, Hertfordshire WD7 7AR. England Tel: +44 208123 8056 Tel / Fax: +44 1923859810 WatchPAT™300 System Operation Manual...

  • Page 62: Appendix E: Description Of The Watchpat™300 Upat Probe

    APPENDIX E: DESCRIPTION OF THE WATCHPAT™300 UPAT PROBE The WatchPAT uPAT probe is an opto-pneumatic finger-mounted probe. Its role is to continuously measure the relative state of the vasomotor activity in the distal part of the finger based on a plethysmographic method. The uPAT probe is designed to cover the distal part of the finger with a uniform pressure field extending to the tip of the finger.

  • Page 63: Appendix F: Manufacturing Declarations According

    – to check the equipment for correct operation under the conditions of use. • The use of accessories other than those specified or sold by Itamar Medical as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the unit.
  • Page 64 The WP300 is intended for use in the electromagnetic environment specified below; The customer or the user of the WP300 should assure that it is used in such an environment. IEC 60601-1-2 Immunity test Compliance level Electromagnetic environment - guidance Test level 8 kV contact 8 kV contact...
  • Page 65 Table 4 - from IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – WP300 The WP300 is intended for use in the electromagnetic environment specified below; The customer or the user of the WP300 should assure that it is used in such an environment. IEC 60601-1-2 Compliance Immunity test...
  • Page 66 Recommended Separation Distances The WP300 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled. The user and/or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment (emitters) and the WP300, according to the maximum output power of the equipment, as recommended in the table below.
  • Page 67 IEC 60601-1-2: 2014 4th Edition Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test Maximum Immunity Test Compliance Band Service Modulation Distance Frequency Power Level Level (MHz) (MHz) (V/m) (V/m) Pulse 380-390 TETRA 400 modulation 18Hz GMRS 460 430-470 ±...

  • Page 68: Appendix G: Spo2 Accuracy In The Watchpat™300

    APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™300 The WatchPAT™300 device uses Itamar Medical Pulse Oximetry system for the measurement of functional oxygen saturation of arterial haemoglobin (SpO2). This appendix includes information regarding the accuracy of these measurements following a clinical study of Itamar Medical Pulse Oximetry.
  • Page 69 Bland-Altman Plot: WP300 Non-motion, 11 Subjects, December 13-15, 2017 Upper LOA Lower LOA Reference CO-Oximeter & WP300 (SaO2+ SpO2 )/2 Mean Regression Line Reference: Bland-Altman Range 70-100% Linear Regression (Bland Altman) y = 3.7344 + -0.03937 x Mean Bias 0.41 # pts 1350 Upper 95% Limits of Agreement...
  • Page 70 Louisville, Colorado 80027, USA Sponsor: Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel Device(s): Non-Motion: Itamar Medical WatchPAT300 Pulse Oximetry Study Date(s): December 13-15, 2017 Note A Functional tester cannot be used to assess the accuracy of the internal pulse oximeter.

  • Page 71: Appendix H: Zzzpat Hardware Requirements

    APPENDIX H: ZZZPAT HARDWARE REQUIREMENTS Hardware configuration: Computer Pentium 4 3GHz or higher 1 available USB port XGA screen resolution (minimum 1024 x 768 pixels) RAM 1GB or higher Disk space requirements: • Standalone installation o 10GB minimum / 60GB recommended disk space on Files folder and at least 1.2GB on boot drive •...

  • Page 72: Appendix I: Spare Parts List

    APPENDIX I: SPARE PARTS LIST The following items can be ordered and purchased individually: • uPAT probe (a box of 12 uPAT probes) • uPAT probe connection cable • Wrist Strap • Snore and Body Position sensor (SBP/RESBP) • Adhesive for Snore and Body Position sensor (a package of 12 units) •...

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