Itamar Medical OM2196336 Operation Manual
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Itamar Medical OM2196336 Operation Manual

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WatchPAT™200 Unified
Operation Manual
Itamar Medical REF OM2196336
Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare
practitioner
Copyright © 2015-2020 By Itamar Medical Ltd.
WatchPAT™ and PAT
®
are trademarks of Itamar Medical, Ltd.

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Summary of Contents for Itamar Medical OM2196336

  • Page 1 Operation Manual Itamar Medical REF OM2196336 Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright © 2015-2020 By Itamar Medical Ltd. WatchPAT™ and PAT ® are trademarks of Itamar Medical, Ltd.
  • Page 2 Itamar Medical’s proprietary rights. DISCLAIMER Itamar Medical Ltd. shall not be held responsible in any manner for any bodily injury and/or property damage arising from operation or use of this WatchPAT™200 Unified other than that which adheres strictly to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement in Appendix C.
  • Page 3 Record of Editions Edition Date Description Chapter Pages (based Jan 2018 Updating Copyright OM2196335 Ed.5) Updating screen displays 2.4.3, 7.4 17, 37 Updating typo App.F April 2018 Updated intended use to include AHIc Updating restriction for use Updating exclusion criteria Adding additional precautions Update data generated by the WP200U...

  • Page 4: Table Of Contents

    Table of Contents GENERAL INFORMATION ............. 1 Intended Use / Indications for Use ............1 Restrictions for Use ................1 Precautions ..................... 2 Additional Precautions specific to pediatric use ......... 2 Data Generated by the WatchPAT™200U ..........3 Equipment Classification ............... 3 Quality Assurance System: EN ISO 13485 ..........
  • Page 5 Cleaning ....................30 Handling ....................31 Replacing the uPAT Probe Cable ............31 Replacing the Battery ................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 ....70 APPENDIX I: SPARE PARTS LIST ...........71 List of Figures Figure 1 – Packed Device ................... 12 Figure 2 – WatchPAT™200U 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: Precautions

    11. The tracings and calculations provided by the WP200U 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™200U

    2. The snoring and body position safety and effectiveness was not validated on pediatric patients 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™...

  • Page 10: Quality Assurance System: En Iso 13485

    1.7 Quality Assurance System: EN ISO 13485 The Itamar Medical WP200U is compliant to the following standards. STANDARD Medical electrical equipment – Part 1: General requirements IEC 60601-1 for basic safety and essential performance ANSI/AAMI ES60601 CAN/CSA -C22.2 No.60601-1 Medical electrical equipment – Part 1-2: General...

  • Page 11: Ce And Csa Compliance

    Medical Device Directive MDD 93/42 EEC MDD 2007/47/EC RoHS Directive 2011/65/EU (RoHS2) RoHS - Directive 2011/65/EU 1.8 CE and CSA Compliance The product complies with MDD 93/42 EEC: 1993 & Amm. 2007/47/EC (Medical Device Directive) requirements and CE approved. The product is marked with the CE logo. The product is certified by CSA.

  • Page 12: Warnings, Cautions And Notes

    Cautions are used to identify conditions or actions, which could cause interference with data acquisition and/or impair study results. Les précautions sont utilisées affin d’identifier les conditions ou les actions qui peuvent interférer avec le ramassage de données et provoquer des résultats équivoque. Notes are used to identify an explanation, or to provide additional information for purposes of clarification.

  • Page 13: Safety Precautions

    1.11 Safety Precautions WARNINGS Use only the AC adapter provided (5V DC, 5W maximum capacity power supply). Only authorized personnel may charge the WP200U. Failure to heed this warning may cause permanent damage to the equipment. Do not let the unit get wet. Avoid placing food or water on any part of the system.

  • 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 CSA The product is marked with the CE logo 2797 for BSI Date of manufacture YYYY-MM-DD 3.7V DC Battery Operating Voltage Single use, do not re-use Temperature limit Use-by date...

  • Page 15: Watchpat™200U Device Labels

    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 electrical and electronic equipment (EEE) should be collected separately and not disposed of with regular household waste.

  • Page 16: Overview

    OVERVIEW Obstructive sleep apnea syndrome (OSAS) is considered a major public health problem. The prevalence of the syndrome is estimated at 2% to 5% in the adult population. It is characterized by recurrent events of complete or partial obstruction of the upper airways during sleep, often leading to hypoxemia, and/or arousals associated with sympathetic nervous system activation.

  • Page 17: System Description

    2.1 System Description The WP200U system is comprised of the following items: • WP200U device that includes: o Embedded actigraph o Embedded pulse oximeter o Embedded CPU and electrical circuit card o Embedded micro SD card drive o Rechargeable Lithium Ion Battery o LCD display •...

  • Page 18: User Interaction With The Watchpat™ Device Keys

    Figure 1 – Packed Device Optional SBP sensor Optional RESBP sensor uPAT probe Figure 2 – WatchPAT™200U 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: Figure 3 - The Buttons And Display

    RIGHT ON/ENTER DOWN LEFT Figure 3 – The Buttons and Display LCD Display The display is used for reading status and error messages. The display is divided to three sections: Title, Info and Status. • Title (first line): Current operational mode and time o PATIENT mode while recording night study o DIAGNOSTIC mode while testing device o PC HOST while connecting to PC...

  • Page 20: Watchpat™ Device Function

    uPAT probe port Bracelet port Port for optional Snore & Body Position sensor USB port for charging and communication Figure 4 – Service Ports and Peripherals Wrist strap Figure 5 – WatchPAT™ Wrist Strap 2.3 WatchPAT™ Device Function The WatchPAT™ records the following channels: •...

  • Page 21: Built-In Self-Diagnostic Procedures

    LCD display. To run the self-diagnostic procedure: • Press the ENTER button (Center key) for 2 seconds till the Itamar medical logo appears on the LCD screen • Immediately press the UP + DOWN keys (see Figure 3) simultaneously for 1...
  • Page 22 DIAGNOSTIC 22:40 2.2140 20-Jul-08 *device test (30001) end testing Select test ↑↓ • First line displays title and current time • Second line displays current embedded S/W version (2.2139) and current date • Third line displays option for running device test (serial number of device in parenthesis) •...
  • Page 23 The following are the possible error, warning or information messages: • File error: not loaded, missing – the study file was not loaded or somehow the file was deleted • File error: used x/3 x=1..3 – only when multi-night option is selected •...
  • Page 24 Note During recording the LCD display turns off to conserve battery life. Any key pressed during Recording will turn on the LCD for 30 seconds. If the WatchPAT™ device fails this self-diagnostic test, the following screen will be displayed: PATIENT 22:51 Error=xxxx Device S/N=xxxxx...

  • Page 25: Preparation For Sleep Study

    3 PREPARATION FOR SLEEP STUDY Charging the Battery The battery must be charged every time the WatchPAT™ device is prepared for use. The battery may be charged using the AC adapter provided. To charge the WatchPAT™ device: Gently slide the WatchPAT™ device out of the wrist strap until a click is heard and the USB port is exposed.

  • Page 26: Preparing The Snore And Body Position Sensor

    • The display will show “CHARGER” if you are charging with the AC adapter or “PC HOST” if you are charging with a computer. • The current battery voltage is shown. • Charge the battery the first time for approximately three hours. Thereafter recharging takes approximately 1-1.5 hours.

  • Page 27: Mounting The Watchpat™ On The Wrist Strap

    3.4 Mounting the WatchPAT™ on the Wrist Strap To mount the WatchPAT™ device on the wrist strap: Gently slide the WatchPAT™ device into the wrist strap until a click is heard indicating that it is properly seated. 3.5 Replacing the uPAT Probe Warning The uPAT probe connector is very sensitive and therefore should never be left exposed.

  • Page 28: Preparing The Watchpat™ Device For A New Study

    Snore and Body uPAT probe Position sensor Figure 9 – WatchPAT™ Fully Prepared 3.6 Preparing the WatchPAT™ Device for a New Study Refer to the zzzPAT Software Manual for preparation of the WP200U 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 29: Packing The Carrying Case

    3.9 Packing the Carrying Case 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 30: 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 RESBP Sensor Attachment B - Integrated RESBP sensor The integrated sensor is powered by the WatchPAT™...

  • Page 31: 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 32: Figure 12 - Watchpat™ Device With Cable For Bracelet

    to connect the Bracelet, via the bracelet's cable 2 connectors, to the WatchPAT™ device. The device will not start without connection to the paired Bracelet. Figure 12 – WatchPAT™ Device Figure 13 – WatchPAT™ Device with Cable for Bracelet with Bracelet Figure 14 –...

  • Page 33: Multi-Night Study

    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 Operation Manual). If a 3 night multi-night option is selected the patient must replace the uPAT probe and charge the device between nights.

  • Page 34: 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) The WatchPAT™...

  • Page 35: 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 36: Cleaning

    Check strap Perform technician test Preventive maintenance recommendations: Scenario Routine maintenance Lesser of: 200 When a defect is action studies, 1 year, error found or upon error message in device message test Replace battery Replace PAT cable Replace SBP sensor Replace strap Replace charger Replace carrying case...

  • Page 37: 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 38: Replacing The Battery

    2. Connect a new uPAT probe cable by gently inserting the connector into the WatchPAT™ device. Make sure you secure back the screw. Figure 18 – Replacing the uPAT Probe Warning Use only the original screw that belongs to the WatchPAT™ device. Using different screw could harm the device.

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

    4. Insert the new battery into the battery compartment. 5. Insert the 3 pin connector into the corresponding battery connector (one pin is longer so it may properly be inserted in only one direction). Secure the battery connector closed with a small piece of transparent tape. 6.

  • Page 40: Applying The Watchpat™ Device

    7 APPLYING THE WATCHPAT™ DEVICE Note These instructions are designed to help the patient use the WP200U 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 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 20 – 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 9. 2.

  • Page 42: Attaching The Upat Probe

    Figure 21 – Putting On The Wrist Strap Figure 22 – Wearing the WatchPAT™ Device 7.3 Attaching the uPAT Probe Proper probe placement is critical for good performance. Note The tab inside the probe should be removed only AFTER the finger is inserted into the probe.

  • Page 43: Switching On The Watchpat™ Device

    Figure 25 – 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 44: When You Wake Up

    7.5 When You Wake Up When you awake, remove the WatchPAT™ device from your arm as follows: 1. Remove both probes from your fingers. 2. Take off the wrist strap. 3. Place all parts in the carrying case. Note Pressing the center button does not switch off the WatchPAT™ device. Approximately ten hours after the WatchPAT™...

  • Page 45: 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 46: Patient Training - Guidelines

    8 PATIENT TRAINING – GUIDELINES Instruct the patients (and accompanying individual if needed) how to attach and use the WP200U 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 47: 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 48: Review Safety, General And Functional Issues

    • 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). • Provide a telephone number to call in case of questions or problems. WatchPAT™200U System Operation Manual...

  • Page 49: 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 50: 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 51: Specifications

    10 SPECIFICATIONS Table 3 – WatchPAT™200U Specifications Properties Description Itamar’s proprietary probe. Measures PAT and uPAT Probe 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 Actigraph –...

  • Page 52: Appendix A: Watchpat™ Integrated Snoring + Body Positioning Sensor Operating Instructions (Sbp/Resbp)

    APPENDIX A: WatchPAT™ Integrated snoring + Body Positioning Sensor Operating Instructions (SBP/RESBP) SBP must be used with zzzPAT v 4.3 and above and WatchPAT™200/U RESBP must be used with zzzPAT v 4.6 and above and WatchPAT™200U with embedded 3.3228 and above Thank you for purchasing an Integrated Snore &...
  • Page 53 The snore sensor is an acoustic decibel detector. It uses a very sensitive microphone that responds to snoring and other sounds in the audio range and converts them to a small analog voltage that provides a clear, reliable indication of the presence of these sounds. 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).
  • Page 54 Warranty 6 months Temperature Operation 0 to 40 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 WatchPAT™200U System Operation Manual...
  • Page 55 Snoring and Body Position Accuracy This section gives statistical performance measure for Itamar SBP sensor, when used with the WatchPAT™ device. Body Position The body position measured by the WatchPAT™ device with Itamar SBP sensor was compared to the gold standard, manual scoring of the video recording of 31 patients, in 1 minute’s epochs (total of 7111 epochs) during sleep.
  • Page 56 Coef. Of Lower Upper Mean Variation Median Value 2033 41.10 1.89 4.60 41.01 41.18 1319 41.61 2.67 6.43 41.47 41.76 42.68 3.79 8.88 42.44 42.93 44.12 4.49 10.19 43.80 44.44 44.75 4.65 10.39 44.41 45.09 45.90 5.07 11.04 45.51 46.30 46.45 5.17 11.13...
  • Page 57 Summary statistics (mean ± SD) of WatchPAT™200U device by dB-meter levels Note The snoring and body position safety and effectiveness was validated on adult population only. WatchPAT™200U System Operation Manual...

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

    APPENDIX B: Tamper-proof testing with WatchPAT™ WatchPAT™200U System Operation Manual...
  • Page 59 WatchPAT™200U System Operation Manual...

  • Page 60: Appendix C: License Agreement

    This License Agreement is a legal agreement between you (as an individual, company, organization or other entity) and Itamar Medical Ltd. (“Itamar”). By installing, copying, or otherwise using the Licensed Software, and/or by using the Licensed Product or third party product into which a Licensed Product or Licensed Software is incorporated (“Third Party...
  • Page 61 1.2. “Licensed Software” means the zzzPAT software, the associated media and accompanying materials provided to you with such zzzPAT software. Some Licensed Software is a stand-alone product and some Licensed Software is incorporated as a component within a Licensed Product, in each case sold or otherwise made available, by Itamar and/or third parties.
  • Page 62 4. LIMITED WARRANTIES AND DISCLAIMERS a. Against Infringement. Itamar hereby warrants to you that it has the right to grant you the license to use the Licensed Software and/or the Licensed Product and to enter into this License Agreement and that neither the Licensed Software nor the Licensed Product(s) infringes the intellectual property rights of any third party.
  • Page 63 uninterrupted or error free. Itamar is not responsible for problems caused by changes in the operating characteristics of the hardware or operating system software you are using, nor for any problems in the interaction of the Licensed Software with non-Itamar software. ITAMAR HEREBY DISCLAIMS, WITH RESPECT TO THE LICENSED PRODUCTS AND THE LICENSED SOFTWARE, ALL OTHER WARRANTIES AND CONDITIONS, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY...
  • Page 64 SOFTWARE WHERE USE WITH SUCH OTHER HARDWARE OR SOFTWARE GAVE RISE TO THE INFRINGEMENT CLAIM. 6. TERMINATION Without prejudice to any other rights or remedies, Itamar may terminate this License Agreement immediately if you fail to comply with any of its terms and conditions. In the event of such termination, you must, within ten (10) business days of receiving notice of termination from Itamar, cease all use of the Licensed Software and destroy all copies thereof, and cease all use of the Licensed Product (including Licensed Product incorporated...
  • Page 65 Note: Should you have any questions concerning this License Agreement, or if you desire to contact Itamar for any reason, please write to: USA: Itamar Medical Inc. 3290 Cumberland Club Drive, Suite 100 Atlanta, Georgia 30339, USA Tel: 1 888 748 2627 Worldwide: Itamar Medical Ltd.

  • Page 66: Appendix D: Regulatory Representative

    APPENDIX D: REGULATORY REPRESENTATIVE Itamar Medical’s authorized regulatory representative is: Arazy Group GmbH The Squaire 12, Am Flughafen, 60549 Frankfurt am Main, Germany WatchPAT™200U System Operation Manual...

  • Page 67: Appendix E: Description Of The Watchpat™200U Upat Probe

    APPENDIX E: DESCRIPTION OF THE WATCHPAT™200U 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 68: Appendix F: Manufacturing Declarations According

    The recommended separation distances in this paragraph must therefore be complied with. • The Itamar Medical’s WP200U must not be used near or on top of another device. If this cannot be avoided, it is necessary – before clinical use – to check the equipment for correct operation under the conditions of use.
  • Page 69 Table 2 - based on IEC 60601-1-2:2014 Guidance and manufacturer's declaration – electromagnetic immunity – WP200U The WP200U is intended for use in the electromagnetic environment specified below; The customer or the user of the WP200U should assure that it is used in such an environment. IEC 60601-1-2 Immunity test Compliance level...
  • Page 70 determined by an electromagnetic site survey , should be less than the compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations .Electromagnetic propagation is affected by absorption And reflection from structures objects and people.
  • Page 71 Recommended Separation Distances The Itamar Medical’s WP200U 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 Itamar Medical’s WP200U, according to the maximum output power of the...
  • Page 72 Table 9 - based on IEC 60601-1-2:2014 Proximity Fields from RF Wireless Communication Equipment Test Band Service Modulation Maximum Distance Immunity Minimum frequency power (W) TEST separation (MHz) (MHz) LEVEL distance (V/m) 360-390 TETRA 400 Pulse modulation 18 Hz 430-470 GMRS 460, FRS 460 ±5 kHz...

  • Page 73: Appendix G: Spo2 Accuracy In The Watchpat™200U

    APPENDIX G: SPO2 ACCURACY IN THE WATCHPAT™200U The WatchPAT™200U 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 74 Reference: CO-Oximetry Range 68-99% Linear Regression (Bland Altman) y = -0.0931x + 8.7875 Mean Bias 0.51 # pts Upper 95% Limits of Agreement Lower 95% Limits of Agreement -3.3 *Source of data: Title: Itamar SpO2 Accuracy Validation vs Reference CO- Oximetry, PR2013-062 Date: 2013-08-20...
  • Page 75 Clinical Investigator(s): Clinimark 80 Health Park Drive, Suite 20 Louisville, Colorado 80027, USA Sponsor: Itamar Medical, Ltd. 9 Halamish St POB 3579, Caesarea 3088900 Israel Device(s): Non-Motion: Itamar Medical WatchPAT 200 Pulse Oximetry Study Date(s): May 8-10, 2013 Note A Functional tester cannot be used to assess the accuracy of the internal pulse oximeter.

  • Page 76: 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) Colors set to 16 bits or higher 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 77: 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) • Snore and Body Position sensor (RESBP) •...

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