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Itamar Medical WatchPAT 200 Operation Manual

For use with patients suspected to have sleep related breathing disorders
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WatchPAT™200
Caution: Federal (U.S.) law restricts
this device to sale by, or on the order of, a
physician. Not for pediatric use.
Copyright  2002-2016 By Itamar Medical Ltd.
WatchPAT™ and PAT
Operation Manual
Itamar Medical REF OM2196330
®
are trademarks of Itamar Medical, Ltd.

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Summary of Contents for Itamar Medical WatchPAT 200

  • Page 1 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. Copyright  2002-2016 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 June 2008 Sleep Stages and AHI July 2008 ISO logo, list of standards, Medes Bonita address, pictures Feb 09 Updating: Orit Itamar Medical address -, 11 i, 47 List of standards Labeling 1.10.1 Oct 09 Update for bracelet and multi-night Bonita...
  • Page 4 Feb 2015 Updating Caution and Warning Orit Kelner symbols Adding warning Adding Environmental protection 1.11 section Adding cross reference Updating Manufacturing Declarations App.F 67-70 Adding Nonin Module specifications App.G Adding spare parts list App.I July 2015 Add FDA #K to section 1.14 1.14 Efrat Litman Jan 2016...

  • Page 5: Table Of Contents

    Table of Contents GENERAL INFORMATION ............. 1 Intended use / Indications for Use ............1 Restrictions for Use ................1 Exclusion Criteria ..................2 Data Generated by the WatchPAT™200 Device ........2 Equipment Classification ............... 2 Quality Assurance System: ISO 9001 & ISO 13485 ......3 CE and CSA Compliance ................
  • Page 6 Cleaning ....................31 Cleaning the WatchPAT™ Device............31 Cleaning the Oximetry Sensor ............. 31 Cleaning the Wrist Strap ..............32 ® The PAT Probe ..................32 The Snore & Body Position Sensor ............. 32 Handling ....................32 Replacing the Oximetry Sensor ............32 ®...
  • Page 7 APPENDIX F: MANUFACTURING DECLARATION ACCORDING TO IEC 60601-1-2 ..................67 APPENDIX G: SPO ACCURACY IN THE WP200 ......71 APPENDIX H: TRAINING RESOURCES ...........73 APPENDIX I: SPARE PARTS LIST ...........74 WatchPAT™200 System Operation Manual...
  • Page 8 List of Figures Figure 1 – Packed Device ................... 11 Figure 2 – WatchPAT™ Device with Sensors ........... 11 Figure 3 – The Buttons and Display ..............12 Figure 4 – Service Ports and Peripherals ............13 Figure 5 – WatchPAT™ Wrist with Oximetry Module ........13 Figure 6 –...

  • Page 9: 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 10: Exclusion Criteria

    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. If necessary, contact our service office to report the incident, and to receive further instructions.

  • Page 11: Quality Assurance System: Iso 9001 & Iso 13485

    1.6 Quality Assurance System: ISO 9001 & ISO 13485 The Itamar Medical WatchPAT™200 device is compliant to the following standards. STANDARD Medical electrical equipment – Part 1: General requirements IEC 60601-1 for basic safety and essential performance Medical electrical equipment – Part 1-2: General...

  • Page 12: Ce And Csa Compliance

    Medical Device Directive MDD 93/42 EEC MDD 2007/47/EC FDA Quality Systems Regulation (QSR) 21 CFR part 820 UL standard for safety UL 60601-1 CSA Standard for safety CSA 22.2 No.601.1 Canadian Medical Devices Regulation SOR/98-282 1.7 CE and CSA Compliance The product complies with the CE mark according to MDD (Medical Device Directive) and related standards.

  • Page 13: Warnings, Cautions And Notes

    Notes are used to identify an explanation, or to provide additional information for purposes of clarification. Les notes sont utilisées pour identifier les explications et pour donner des informations supplémentaires dans le but de clarifier. 1.9 Warnings, Cautions and Notes The WatchPAT™200 device is internally powered from a 4.2 V battery.

  • Page 14: Safety Precautions

    1.10 Safety Precautions WARNINGS Use only the AC adapter provided (5V DC, 5W maximum capacity power supply). Only authorized personnel may charge the WatchPAT™200. 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 15: Environmental Protection

    1.11 Environmental protection The WatchPAT™200 device including its accessories shall be treated in accordance with the local laws and regulations for proper waste treatment. 1.12 Symbols Used On the Product Labels Follow instructions for use Type BF applied part The product is certified by CSA The product complies with the CE mark according to MDD (Medical Device Directive) and related standards.

  • Page 16: Watchpat™200 Device Labels

    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. Please dispose this product and all of its parts in a responsible and environmentally friendly way. 1.13 WatchPAT™200 Device Labels Located on WatchPAT™200 device Located on Nonin module...

  • Page 17: 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 18: System Description

    2.1 System Description The WatchPAT™ system is comprised of the following items:  WatchPAT™ system 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 19: User Interaction With The Watchpat™ Device Keys

    Figure 1 – Packed Device ® probe Oximetry sensor Optional Snore & Body Position sensor Figure 2 – WatchPAT™ 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 20: 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 PATIENT mode while recording night study DIAGNOSTIC mode while testing device PC HOST while connecting to PC...

  • Page 21: Watchpat™ Device Function

    ® probe port Port for optional Snore & Body Position sensor Oximetry module port USB port for charging and communication Figure 4 – Service Ports and Peripherals Oximetry sensor Bracelet port Wrist strap Oximetry module Oximetry Module connector Figure 5 – WatchPAT™ Wrist with Oximetry Module 2.3 WatchPAT™...

  • Page 22: 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 second WatchPAT™200 System...
  • Page 23 The following screen will be displayed: DIAGNOSTIC 22:40 2.2140 20-Jul-08 *device test (30001) oxi test end testing Select test ↑↓  First line displays title and current time  Second line displays current embedded S/W version (2.2139) and current date ...
  • Page 24 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=111-11-1111 oxi=mod missing pat=missing <-Back More-> TEST FAILED 2:54 The following are the possible error, warning or information messages: ...
  • Page 25 OXI TEST 22:50 SaO2=98% Attach to finger <-Back Testing… OXI TEST 22:50 SaO2=N/A oxi=mod missing Attach to finger <-Back Testing… The possible oximetry error messages are:  Oximetry error: module or sensor missing - connect oximetry module and sensor.  SaO2= Not Available (N/A) - attach sensor to finger. The blood saturation is continuously updated, therefore wait approximately for one minute for the saturation to stabilize when testing.
  • Page 26 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 27: Preparation For Sleep Study

    PREPARATION FOR SLEEP STUDY 3.1 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: Disconnect the Oximetry module by disconnecting the Oximetry module connector.

  • Page 28: Preparing The Oximetry Sensor

    CHARGER 22:51 Bat=3.12 V Charging…  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 29: Figure 7 - Oximetry Sensor

    Figure 7 – Oximetry Sensor 1. If the sensor was previously used, carefully remove the used Flexi wrap pad from the sensor. Remove any remaining adhesive from the sensor – if necessary clean the sensor using 70% ethyl alcohol or isopropyl alcohol (IPA).

  • Page 30: Preparing The Snore And Body Position Sensor

    Warning - Nonin sensor  Do not use a damaged sensor. If the sensor is damaged in any way, discontinue use immediately and replace the sensor.  Do not use caustic or abrasive cleaning agents on the sensors.  Do not autoclave or immerse in liquid of any kind. 3.3 Preparing the Snore and Body Position Sensor Attach the small round double sided adhesive sticker to the white snoring sensor, by peeling off the cover on one side of the sticker.

  • Page 31: Mounting The Watchpat™ Device On The Wrist Strap

    3.5 Mounting the WatchPAT™ Device on the Wrist Strap To mount the WatchPAT™ device on the wrist strap: 1. Gently slide the WatchPAT™ device into the wrist strap until a click is heard indicating that it is properly seated. 2. Connect the oximetry module connector (Figure 9) to the oximetry module port on the WatchPAT™...

  • Page 32: Preparing The Watchpat™ Device For A New Study

    The WatchPAT™ device is now ready to perform a sleep study by the patient (Figure 12). ® Snore and Body probe Position sensor Oximetry sensor Figure 12 – A WatchPAT™ Device Fully Prepared 3.7 Preparing the WatchPAT™ Device for a New Study Refer to the zzzPAT Software Manual for preparation of the WatchPAT™...

  • Page 33: Packing The Carrying Case

    3.10 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 PAT ® probe and oximetry sensor attached.

  • Page 34: 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 Sensor Sensor Attachment Figure 13 - The Snoring and Body Position Sensor The integrated sensor is powered by the WatchPAT™...

  • Page 35: Figure 14 - Watchpat™ Device With Tamper-Proof Bracelet

    Cable for bracelet Connector for bracelet on Oximetry module Bracelet Figure 14 – WatchPAT™ Device with Tamper-Proof Bracelet Before the device is given to the patient for home sleep study, the technician identifies the patient and secures the bracelet to the patient’s wrist by a tamper-proof connector that ensures the bracelet will not be removed without cutting the Bracelet.

  • Page 36: Figure 16 - Watchpat™ Device With Cable For Bracelet

    Figure 16 – WatchPAT™ Device Figure 17 – WatchPAT™ Device with Cable for Bracelet with Bracelet Figure 18 – Bracelet and WatchPAT™ Device on a Patient’s Hand During the recording the device will periodically check the Bracelet connectivity. The recording will be stopped if the connection to the Bracelet will be lost for the time exceeding a predefined limit.

  • Page 37: Multi-Night Study

    Figure 19 – Cut the Bracelet at the 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 Operation Manual).

  • Page 38: 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 39: Maintenance

    Manual. The system contains no user-serviceable parts. It should be maintained and serviced only by qualified service personnel, authorized by Itamar Medical Ltd. Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations.

  • Page 40: Cleaning The Wrist Strap

    6.4 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: Remove WatchPAT™...

  • Page 41: Replacing The Pat ® Probe Cable

    Warning Use only the original screws that belong to the WatchPAT™ device. Using different screws could harm the device. Figure 21 – Replacing Oximetry Sensor Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations. ®...

  • Page 42: Replacing The Battery

    ® Figure 22 – PAT Probe with Screw ® 2. Connect a new PAT probe cable by gently inserting the connector into the WatchPAT™ device. Make sure you secure back the screw. ® Figure 23 – Replacing the PAT Probe Warning Use only the original screw that belongs to the WatchPAT™...

  • Page 43: Setting The Time And Date Of The Watchpat™ Device

    2. Gently open the battery connector by disconnecting the 2 parts (you will need to remove the transparent tape that secures the battery connector closed). 3. Remove the battery. 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).

  • Page 44: Storing The Watchpat™ Device

    6.12 Storing the WatchPAT™ Device  The WatchPAT™ device should be stored in its carrying case at room temperature and low humidity.  In order to preserve battery performance when the WatchPAT™ device is not in use, store with the battery fully discharged. ...

  • Page 45: Applying The Watchpat™ Device

    APPLYING THE WATCHPAT™ DEVICE Note These instructions are designed to help the patient use the WatchPAT™ device after seeing a demonstration by trained personnel of how to mount the probes on his/her fingers and correctly operate the WatchPAT™ device . The following detailed instructions are summarized in the patient’s step-by-step reference guide.

  • Page 46: Applying The Watchpat™ Device

     Ring finger Index finger Small (pinky) finger Figure 25 – 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.

  • Page 47: Applying The Oximetry Sensor

    Applying the Oximetry Sensor Now you will attach the oximetry sensor to your ring finger, as was demonstrated to you and is illustrated in the figures below. Please proceed as follows: 1. Remove the adhesive strip from the unit (see Figure 28). 2.

  • Page 48: Attaching The Pat ® Probe

    Figure 32 – Flexiwrap Line Indication ® 7.4 Attaching the PAT Probe Proper probe placement is critical for good performance. Note The tabs inside the probe should be removed only AFTER the finger is inserted into the probe. ® To attach the PAT probe: 1.

  • Page 49: Figure 33 - Placing Finger In Pat

    ® Figure 33 – Placing Finger in PAT Probe Figure 34 – Removing TOP Tab Figure 35 – Removing BOTTOM Tab Figure 36 – Wearing the WP200 – Ready for Sleep Note ® DO NOT remove the PAT probe before the night study is terminated. Once the probe is removed it cannot be re-attached.

  • Page 50: Switching On The Watchpat™ Device

    7.5 Switching On the WatchPAT™ Device You are now ready to switch on the WatchPAT™ device. Just before you lie down to go to sleep, firmly press the ON/Enter center button (Figure 3) until the LCD display lights up. After a short delay the LCD will display “Good Night! Recording…”...
  • Page 51  Do not try to connect the unit to an electrical supply or any other unit, machine or computer.  If any part appears disconnected or does not resemble the illustrations, call the service number for assistance.  Do not, under any circumstances, attempt to fix the problem yourself. If you have any questions about using the machine, before, during or after your at-home recording session, call the service number.

  • Page 52: Patient Training - Guidelines

    PATIENT TRAINING – GUIDELINES 8.1 Walk Through the Process of Using the WatchPAT™ Device  Product introduction – WatchPAT™ device, wrist strap, PAT ® probe, oximetry sensor  WatchPAT™ device and wrist strap attachment  Probe and sensor attachment  Switch on ...

  • Page 53: Switching On The Watchpat™ Device

     Pull the paper tabs all the way off the body position sensor while attaching it on the skin. 3. Wearing the Wrist Strap  Should be comfortable, not too tight. 4. Attaching the WatchPAT™ Device  Make sure the WatchPAT™ device is properly mounted on the wrist strap.

  • Page 54: Patient Training

     The WatchPAT™ device doesn’t switch off – once turned on it will record until the battery is exhausted. Patient Training  Following your demonstration have the patient attach the demo device by himself.  Verify that the attachment is properly done. Especially monitor carefully attachment of the oximetry sensor.

  • Page 55: Troubleshooting Guide

    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 56: 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 57: Specifications

    10 SPECIFICATIONS Table 3 – WatchPAT™200 Device Specifications Properties Description ® Itamar’s proprietary probe only Probe Recording Time 10 hours (minimum) Oximetry Probe Custom Nonin 8000J Flex Sensor Channels Measuring 4 signals: PAT, Pulse rate, Oximetry, Actigraphy ® and Actigraph – 12 bit; oximetry – 1% Sample Resolution Snoring –...

  • Page 58: Appendix A: Wp200 Integrated Snoring + Body Positioning Sensor Operating Instructions

    APPENDIX A: WP200 INTEGRATED SNORING + BODY POSITIONING SENSOR OPERATING INSTRUCTIONS Must be used with zzzPAT v 4.3 and above, and WatchPAT™200 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 59 Preparing the sensor  Attach the round double sided adhesive sticker to the blue side of the sensor. Applying the sensor Make sure the room you are sleeping in is as quiet as possible during the night, turn off any possible noise sources.
  • Page 60 Snoring and Body Position Accuracy This section gives statistical performance measure for Itamar Medical’s 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 61 The next table presents the statistics of WatchPAT™ device measurements per dB- meter calculation at that range. 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...
  • Page 62 Summary statistics (mean ± SD) of WatchPAT™200 device by dB-meter levels WatchPAT™200 System Operation Manual...

  • Page 63: Appendix B: Tamper-Proof Testing With The Wp200

    APPENDIX B: TAMPER-PROOF TESTING WITH THE WP200 Action Comment Important This short guide is designed to Make sure the zzzPAT version is: Notes instruct a trained operator of the 4.2.58 or higher WatchPAT™ device on how to Make sure the WatchPAT™ perform a Tamper-Proof Testing device embedded software version with the bracelet &...
  • Page 64 Action Comment 4. Connecting the Connect the red and white Bracelet connectors (other side of the gray cable) to the red and white snaps on the bracelet respectively. 5. Pairing the Perform the regular site diagnostic test (“device test” & “oxi test” as WP200 and the Bracelet: described in the user manual).
  • Page 65 Action Comment Placing the Make sure you have all 3 parts: the Bracelet on the bracelet and two white plastic parts. Subject Place the bracelet upside down on a flat surface (white side facing up). Insert the white plastic part into the two separated holes (flat side facing up).
  • Page 66 Action Comment 6. Explain to The subject may choose to perform Subject the night study during any night during the next week. It’s OK to shower with the bracelet. Instruct subject to turn on the WatchPAT™ device only after it is connected to the bracelet.

  • Page 67: 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 68 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 69 not remove or destroy any copyright, trademark, logo or other proprietary marking or legend placed on or contained in the Licensed Software or a Licensed Product. 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 70 been repaired or altered by anyone other than Itamar or a person or entity authorized by Itamar to repair Licensed Products. While every reasonable effort has been made to ensure that you will receive Licensed Software that you can use, Itamar does not warrant that the functions of the Licensed Software will meet your requirements or that the operation of the Licensed Software will be uninterrupted or error free.
  • Page 71 ITAMAR SOLE CONTROL SETTLEMENT, COMPROMISE, NEGOTIATION AND DEFENSE OF ANY SUCH ACTION, AND (iii) PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR. NOTWITHSTANDING THE FOREGOING, ITAMAR SHALL HAVE INDEMNIFICATION OBLIGATIONS WITH RESPECT TO ANY INFRINGEMENT CLAIM TO THE EXTENT ARISING FROM YOUR USE OF THE LICENSED PRODUCT AND/OR LICENSED SOFTWARE IN CONJUNCTION WITH OTHER HARDWARE OR SOFTWARE WHERE USE WITH SUCH OTHER HARDWARE OR SOFTWARE...
  • Page 72 Itamar and you. Note: Should you have any questions concerning this License Agreement, or if you desire to contact Itamar for any reason, please write to: Itamar Medical Ltd., 9 Halamish St., Caesarea Ind. Park, 3088900, Israel, Facsimile: +972-4-627 5598, or visit Itamar’s web site at www.itamar-medical.com.

  • Page 73: 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™200 System Operation Manual...

  • Page 74: Appendix E: Description Of The Watchpat™200 Probe

    APPENDIX E: DESCRIPTION OF THE WATCHPAT™200 PROBE ® The WatchPAT™ PAT 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 PAT probe is designed to cover the distal part of the finger with a uniform pressure field extending to the tip of the finger.

  • Page 75: Appendix F: Manufacturing Declaration According To

    – before clinical use – 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 76 Table 2 - from IEC 60601-1-2:2007 Guidance and manufacturer's declaration – electromagnetic immunity – WP200 The WP200 is intended for use in the electromagnetic environment specified below; The customer or the user of the WP200 should assure that it is used in such an environment. IEC 60601-1-2 Immunity test Compliance level...
  • Page 77 Table 4 - from IEC 60601-1-2:2007 Guidance and manufacturer's declaration – electromagnetic immunity – WP200 The WP 200 is intended for use in the electromagnetic environment specified below; The customer or the user of the WP200 should assure that it is used in such an environment. IEC 60601-1-2 Compliance Immunity test...

  • Page 78: Recommended Separation Distances

    Recommended Separation Distances The WP200 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 WP200, according to the maximum output power of the equipment, as recommended in the table below.

  • Page 79: Appendix G: Spo 2 Accuracy In The Wp200

    APPENDIX G: SPO ACCURACY IN THE WP200 The WatchPAT™200 device uses Nonin module for SPO measurement. Nonin module measurement wavelengths and output power parameters:  Red: 660 nanometers @ 0.8 mW maximum average  Infrared (using NONIN PureLight® Sensor): 910 nanometers @ 1.2 mW maximum average.
  • Page 80 *Source of data: Title: Verification of SpO2 Accuracy Performance of the OEM III Pulse Oximeter Module (rev 14) in Non-Motion Conditions) Version: Date: 2010-01-27 Report ID: QATR5334 Abbreviated Clinical Investigator(s): Hypoxia Research Laboratory Department of Anesthesiology, M1427 UCSF San Francisco, CA 94143‐0542 Sponsor: Nonin Medical 13700 1st Avenue North...

  • Page 81: Appendix H: Training Resources

    APPENDIX H: TRAINING RESOURCES WatchPAT™ device training materials can be found and downloaded from: www.itamar-medical.com/training These files can also be viewed through any smartphone running QR code reader or optical scanner application, by scanning the code next to each resource. The following resources can be found on this page: Technician Training Presentation Step-by-Step Card –...

  • Page 82: Appendix I: Spare Parts List

    APPENDIX I: SPARE PARTS LIST The following items can be ordered and purchased individually:  PAT probe (a box of 12 PAT probes)  PAT probe connection cable  Wrist Strap  Snore and Body Position sensor  Adhesive set for Snore and Body Position sensor ...

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