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Summary of Contents for Itamar Medical WatchPAT 200U
- Page 1 Itamar Medical REF OM2196331 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 Record of Editions Edition Date Description Chapter Pages Resp. (based August 2013 Standards, Preparing for Bonita OM2196330 ed. 9) use, Specifications table and minor wording changes. Update for bracelet and multi-night support. Updated for uPAT probe. July 2014 Insert note Bonita Added WatchPAT™...
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Page 4: 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™200U ..........2 Equipment Classification ............... 2 Quality Assurance System: ISO 9001 & EN ISO 13485 ......3 CE and CSA Compliance ................ - Page 5 Handling ....................29 Replacing the uPAT Probe Cable ............29 Replacing the Battery ................30 Setting the Time and Date of the WatchPAT™ device ....... 31 Storing the WatchPAT™ device............32 APPLYING THE WATCHPAT™ DEVICE ......33 Preparing for Use of the WatchPAT™ Device ........33 Applying the WatchPAT™...
- Page 6 APPENDIX H: TRAINING RESOURCES ..........67 APPENDIX I: SPARE PARTS LIST ...........68 List of Figures Figure 1 – Packed Device ................... 11 Figure 2 – WatchPAT™200U Device with Sensors ........... 11 Figure 3 – The Buttons and Display ..............12 Figure 4 – Service Ports and Peripherals ............13 Figure 5 –...
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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
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 9: Quality Assurance System: Iso 9001 & En Iso 13485
1.6 Quality Assurance System: ISO 9001 & 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 Medical electrical equipment – Part 1-2: General... -
Page 10: 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 Medical electrical equipment - Part 2-61: Particular ISO 80601-2-61 requirements for basic safety and essential performance of pulse oximeter equipment... -
Page 11: 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 12: 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 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 13: Symbols Used On The Product Labels
1.11 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 0473 for Intertek Date of manufacture 2014 3.7V DC Battery Operating Voltage Single use, do not re-use Temperature limit Use-by date... -
Page 14: Watchpat™200U Device Labels
Authorized representative in the European Community 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. -
Page 15: 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 16: 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 17: User Interaction With The Watchpat™ Device Keys
Figure 1 – Packed Device Optional Snore & Body Position 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 18: Figure 3 - The Buttons And Display
Central On/Enter key to power on the WatchPAT™ (the only key visible to the patient) Outer ring containing four keys (left, right, up, down) that may be used by the Operator for entering the diagnostic mode and navigating through the diagnostic menu. -
Page 19: Watchpat™ Device Function
A port for connecting the optional Snore & Body Position sensor The USB port is used for charging or connecting to the PC uPAT probe port Bracelet port Port for optional Snore & Body Position sensor USB port for charging and communication Figure 4 –... -
Page 20: 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™200U System... - Page 21 The following screen will be displayed: 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 22 <-Back More-> TEST FAILED 2:54 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 23 Time elapsed=9:50 Recording… 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...
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Page 24: 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 25: 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 26: 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 27: Preparing The Watchpat™ Device For A New Study
uPAT probe Snore and Body 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 ... -
Page 28: 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 29: 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 The integrated sensor is powered by the WatchPAT™ device and does not require a battery. -
Page 30: Figure 10 - Watchpat™ Device With Tamper-Proof Bracelet
Cable for bracelet Bracelet Figure 10 – 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 31: Figure 12 - Watchpat™ Device With Cable For Bracelet
Figure 12 – WatchPAT™ Device Figure 13 – WatchPAT™ Device with Cable for Bracelet with Bracelet Figure 14 – 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 32: 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 33: 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 34: 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 35: Handling
6.1.3 The uPAT Probe The uPAT probe is designed for a single use only. It may not be cleaned and must be discarded and replaced before each study. 6.1.4 The Snore & Body Position Sensor Using 70% ethyl alcohol, thoroughly clean both sensor and cable. 6.2 Handling Handle with care: ... -
Page 36: Replacing The Battery
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. Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations. -
Page 37: 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 38: Storing The Watchpat™ Device
6.6 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 39: 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 . The following detailed instructions are summarized in the patient’s step-by-step reference guide. -
Page 40: Attaching The Upat Probe
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. Ensure that the WatchPAT™ device is firmly seated in the wrist strap. If not, gently seat the WatchPAT™... -
Page 41: Figure 23 - Placing Finger In Upat Probe
etc.) until the tab is completely removed from the probe (Figure 24). You might feel a slight suction once the tab is removed. The uPAT probe is now attached (Figure 25). Figure 23 – Placing Finger In uPAT Probe Figure 24 – Removing TOP Tab Figure 25 –... -
Page 42: Switching On The Watchpat™ Device
Note If the Snore & Body position sensor is included in the WatchPAT™ device case see Appendix A: WP200U Integrated snoring + Body Positioning Sensor Operating Instructions 7.4 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. -
Page 43: 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 44: Patient Training - Guidelines
8 PATIENT TRAINING – GUIDELINES 8.1 Walk Through the Process of Using the WatchPAT™ device Product introduction – WatchPAT™ device, wrist strap, uPAT probe WatchPAT™ device and wrist strap attachment Probe and sensor attachment Switch on ... -
Page 45: Switching On The Watchpat™ Device
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. If it is loose, gently slide it in until you hear a click. -
Page 46: 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 47: 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 48: Specifications
10 SPECIFICATIONS Table 3 – WatchPAT™200U Specifications Properties Description Itamar’s proprietary probe. Measures PAT and uPAT Probe Oximetry. Recording Time 10 hours (minimum) Channels Measuring 6 signals: PAT, Pulse rate, Oximetry, Actigraphy, Snoring (optional), Body Position (optional) PAT and Actigraph – 12 bit; oximetry – 1% Sample Resolution Snoring –... -
Page 49: Appendix A: Wp200U Integrated Snoring + Body Positioning Sensor Operating Instructions
APPENDIX A: WP200U 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 50 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. When using the SBP it is advised to sleep alone in the room. The sensor is attached on the patient’s chest right under the sternal notch. The sternal notch is the little U shape where the collar bones meet at the top of the breast bone.
- Page 51 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 52 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 53 Summary statistics (mean ± SD) of WatchPAT™200U device by dB-meter levels WatchPAT™200U System Operation Manual...
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Page 54: Appendix B: Tamper-Proof Testing With Watchpat™200U
APPENDIX B: TAMPER-PROOF TESTING WITH WATCHPAT™200U Action Comment Important This short guide is designed to instruct a Make sure the zzzPAT version is: Notes trained operator of the WatchPAT™ 4.2.58 or higher Make sure the WatchPAT™ device device how to perform a Tamper-Proof Testing with the bracelet &... - Page 55 Action Comment Connecting the Connect the red and white connectors Bracelet (other side of the gray cable) to the red and white snaps on the bracelet respectively. Pairing Perform the regular site diagnostic test (“device test” as described in the user WP200U device and the manual).
- Page 56 Action Comment Placing 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 57 Action Comment Explain to The subject may choose to perform the Subject night study during any night during the next week. It’s OK to shower with the bracelet. Instruct subject turn WatchPAT™ device only after it is connected to the bracelet. THE BRACELET IS NOT TO BE REMOVED UNTIL...
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Page 58: 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 59 incorporated as a component within such Third Party Product. 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 60 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 61 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 62 NO 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 GAVE RISE TO THE INFRINGEMENT CLAIM. 6.
- Page 63 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.
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Page 64: 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™200U System Operation Manual... -
Page 65: 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 66: Appendix F: Manufacturing Declarations According
– 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 67 Table 2 - from IEC 60601-1-2:2007 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 68 Table 4 - from IEC 60601-1-2:2007 Guidance and manufacturer's declaration – electromagnetic immunity – WP200U The WP 200U 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 Compliance Immunity test...
- Page 69 Recommended Separation Distances The 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 WP200U, according to the maximum output power of the equipment, as recommended in the table below.
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Page 70: 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 71 WatchPAT™200U System Operation Manual...
- Page 72 2013-08-20 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.
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Page 73: 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 74: 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 Adhesive for Snore and Body Position sensor (a package of 12 units) ...
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