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Watch _PAT - Itamar Medical

1. 6 1 GENERAL INFORMATION eene 1 Intended Use Indications for Use 1 Restrictions for Use lee eeee Leer iieelleee eee n enean anna nana nana 1 EXCIUSION Citi IO nids dan ne datus datur end V eiu deu du eus canne 2 Data Generated by the WatchPAT 200U 2 Equipment Classification 25530 22025202525 2625292029352026252 02 3929 09 20 392625372 2 Quality Assurance System ISO 9001 amp EN ISO 13485 3 CE and CSA Compliance eecee eere eese esee 4 Conventions Used in this Manual 4 Warnings Cautions and Notes Lecce eere eere 5 Safety Precaltiolls iuste sudes de cu Eos sasuEs Ere cosiv ada manne cesser 6 Symbols Used on the Product Labels 7 WatchPAT 200U Device Labels 8 EDAADIOEDSHOT S oci ee errr rrrerrr rrr rer TOF UII TERN EE 8 licis hu 9 System DESCFIDUIONSS ne magna 10 User Interaction with the WatchPAT Device Keys 11 WatchPAT Device Function siint eun EEEkE nenERMESRR ec enr 13 Built In Self Diagnostic Procedures 14 PREPARATION FOR
2. 42 66 555 53 97 57 10 5 92 1024 44 66 58 5643 59 21 6 31 10 78 43 68 585 56 82 60 14 656 11 02 46 68 60 5745 6148 61 12 64 71 67 16 67 96 66 78 65 61 The results are also presented in the next figure The figure presents the mean WatchPAT device with SD error bar WatchPAT 200U System 46 Operation Manual e e Itamar Mean Snore dB e cn on e 35 35 40 45 50 55 60 65 70 75 PSG Snore Values dB Summary statistics mean SD of WatchPAT 200U device by dB meter levels WatchPAT 200U System 47 Operation Manual APPENDIX B TAMPER PROOF TESTING WITH WATCHPAT 200U WatchPAT 200U System Important Notes Preparing a New Study on ZZZPAT Bracelet Connecting the Cable to the WatchPAT device This short guide is designed to instruct a trained operator of the WatchPAT device how to perform a Tamper Proof Testing with the bracelet amp the WatchPAT device For complete WatchPAT training amp instructions please refer to the WatchPAT device user manual and to the zzzPAT user manual While preparing the new study on the ZZZPAT refer to the user manual for detailed instructions check the box Study with Tamper Proof Testing at the bottom of the New Study screen Note Once you enable this option you will HAVE to use a bracelet for the night study The WatchPAT device will NOT function without a bracele
3. Itamar medical WatchPAT 200 Unified Operation Manual Itamar Medical OM2196331 ON Caution Federal U S law restricts this device to sale by or on the order of a physician Not for pediatric use Copyright 2002 2015 By Itamar Medical Ltd WatchPAT and PAT are trademarks of Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of ui 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 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 WatchPATTM200 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 Itamar Medical Ltd 9 Halamish St P O Box 3579 Caesarea Ind Park 3088900 Israel Tel International 972 4 617 7000 US 1 888 7ITAMAR Fax 972 4 627 5598 www itamar medical com This product and or method of use is covered by one or more of the following US patents 6319205 6322515 6461305 6488633 6916289 6939304 7374540 as well as any pending US patent applications and corresponding patents and or a
4. Secure the sensor in place with medical tape Cleaning the sensor Using 70 ethyl alcohol thoroughly clean both sensor and cable SPECIFICATIONS Snoring Sensor Technology Sensitive microphone Body Position Sensor 3 axis Accelerometer Technology Signal Amplitude 0 3 3 V Connector Type 1 mm medical safety connector plug from Plastics Wire Length 3 2 foot 100 cm Physical Size 1 3 inch diameter 32 mm diameter Weight 12 gr Warranty 6 months Temperature Operation 0 to 40 C Storage 20 to 40 C Transport 20 to 60 C Humidity Operating Storage amp 096 93 non Transport condensing Atmospheric pressure Operating amp Storage 10 15 psi Transport 8 15 psi WatchPAT 200U System 44 Operation Manual Snoring and Body Position Accuracy This section gives statistical performance measure for Itamar SBP sensor when used with the WatchPAT device I 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 The Agreement between the device and the video recording was 90 Simple Kappa agreement value was 0 8185 95 confidence level of 0 8059 and 0 8311 II Snoring The snoring level measured by the WatchPAT device with Itamar SBP sensor was compared to a gold standard PSG dB meter placed 1 meter from patient s hea
5. The PAHI and PRDI are estimates of conventional RDI and AHI values and REM DEEP SLEEP LIGHT SLEEP and WAKE stages identification that are produced by polysomnography PSG The WatchPAT 200U also generates optional acoustic decibel detector used for snoring level and body position discrete states from an external integrated snoring and body position SBP sensor 1 5 Equipment Classification The WP200U is a Class Ila medical device under MDD 93 42 EEC 1993 amp Amm 2007 47 EC Annex IX rule 10 WatchPAT 200U System 2 Operation Manual 1 6 Quality Assurance System ISO 9001 amp EN ISO 13485 The Itamar Medical WP200U 1s compliant to the following standards STANDARD l Medical electrical equipment Part 1 General requirements IEC 60601 1 for basic safety and essential performance 2 Medical electrical equipment Part 1 2 General IEC 60601 1 2 requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests 3 Medical Device Software Software Life Cycle Processes IEC 62304 4 Medical electrical equipment Part 1 4 General IEC 60601 1 4 requirements for safety Collateral Standard Programmable electrical medical systems 5 Medical electrical equipment Part 1 11 General IEC 60601 1 11 requirements for basic safety and essential performance Collateral
6. 6 5 Setting the Time and Date of the WatchPAT device 31 6 6 Storing the WatchPAT deVICQ uice ous co dea de i vue a Uva dues 32 7 APPLYING THE WATCHPAT DEVICE 33 7 1 Preparing for Use of the WatchPAT Device 33 7 2 Applying the WatchPAT Device euer 33 7 3 Attaching the uPAT PIODO iiid cione Eon e cus dao aue dates aux aoaaa 34 T 4 Switching On the WatchPAT device 36 7 5 When YOU Wake UD tee einen eines 36 7 6 Important INO LCS Se 0 05 060 200528 37 8 PATIENT TRAINING GUIDELINES 38 8 1 Walk Through the Process of Using the WatchPAT device 38 8 2 Product INTFOCUCTION m 38 8 3 Applying the WatchPAT device eesseus 38 8 4 Switching on the WatchPAT Device 39 8 5 Removing the WatchPAT Device eere eee 39 8 6 mural 39 8 7 Review Safety General and Functional Issues 39 9 TROUBLESHOOTING QUIDE 40 9 1 Operator Error Messages moine oen ene ya ee Dave Cas nissan 40 9 2 Patient Error Messages o rcotrno reo t reuera ene rau eoa rese aiina nn 41 10 SPECIFICA
7. 60601 1 2 2007 Guidance and manufacturer s declaration electromagnetic emissions 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 Emissions test Compliance Electromagnetic environment guidance RF emissions The WP200U uses RF energy only for its internal function Therefore its RF Group 1 emissions are very low and are not likely to cause any interference in nearby CISPR 11 electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Class B The WP200U is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power IEC 61000 3 2 supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 WatchPAT 200U System 60 Operation Manual 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 Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage va
8. Actigraphy Snoring optional Body Position optional PAT and Actigraph 12 bit oximetry 1 noring 12 bit Body Position 5 discrete states LCD display Un ga lt Arms lt 3 in range 70 100 30 150 1 bpm 0 0 5V 10 0 1 10 Hz Micro SD card 64 MB minimum Formatted to FAT 32 Proprietary rechargeable Lithium Ion Battery 500 700 mAh Lithium Ion cell type Proprietary Lithium Ion battery charger 5V DC 5W with USB connector 33V 0 C to 40 C 20 C to 40 C 20 C to 60 C 0 C to 40 C 10 93 non condensing 096 93 non condensing 10 15 psi 8 15 psi 80 x 50 x 20 mm 130 gr excluding uPAT probe weight of 20 gr DA NO Operation Manual 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 amp Body Position Sensor Description The integrated sensor consists internally of two sensors a snore sensor and a body position sensor A Sensor attachment B Sternal notch A Integrated sensor The integrated sensor is powered by the WatchPAT device and does not require a battery It is automatically activated by the WatchPAT when plugged into the Snore amp Body position port The snore sensor is an acoustic decibel detector It uses a very sensitive microphone that responds to snoring and othe
9. Distance in meters m Field strengths from fixed R F transmitters as 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 Ky NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption And reflection from structures objects and people NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the WP200U is used exceeds the applicable RF compliance level above the WP200U should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the WP200U b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m WatchPAT 200U System 62 Operation Manual Recommended Separation Distances The WP200U is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances a
10. IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE B IN NO EVENT SHALL ITAMAR BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE LICENSED SOFTWARE AND OR THE LICENSED PRODUCT AND OR THE THIRD PARTY PRODUCT OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT SERVICES BY ITAMAR EVEN IF ITAMAR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES THE FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE C IN ORDER TO BE ENTITLED TO INDEMNIFICATION HEREUNDER IN CONNECTION WITH AN INFRINGEMENT CLAIM YOU MUST i NOTIFY ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF ii GRANT ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND ii PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR NOTWITHSTANDING THE FOREGOING ITAMAR SHALL HAVE WatchPAT 200U System 55 Operation Manual 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 IN
11. System 9 Operation Manual 2 1 System Description The WP200U system is comprised of the following items e WP200U device that includes Embedded actigraph Embedded pulse oximeter Embedded CPU and electrical circuit card Embedded micro SD card drive Rechargeable Lithium Ion Battery LCD display e uPAT probe includes oximetry O O O 0 10 x9 e uPAT probe connection cable e Wrist Strap e Snore and Body Position sensor optional e Cable for Tamper Proof Bracelet optional e Tamper Proof Bracelet optional e AC adapter e USB cable e Step by Step Reference Guide to be used in conjunction with Section 7 e Quick Reference Cards to be used in conjunction with Section 8 e Carrying case WatchPAT 200U System 10 Operation Manual Figure 1 Packed Device Optional Snore amp 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 For more information refer to the zzzPAT Operation Manual 2 2 User Interaction with the WatchPAT Device Keys The WatchPAT has the following keys see Figure 3 WatchPAT 200U System 11 Operation Manual e Central On Enter key to power on the WatchPAT the only key visible to the patient e Outer ring containing four keys left right up down that
12. TIONS secors renina 42 APPENDIX A WP200U INTEGRATED SNORING BODY POSITIONING SENSOR OPERATING INSTRUCTIONS 43 APPENDIX B TAMPER PROOF TESTING WITH WY Orr A 00 Rn ER 48 APPENDIX C LICENSE AGREEMENT eee eene 52 APPENDIX D REGULATORY REPRESENTATIVE 58 APPENDIX E DESCRIPTION OF THE WATCHPAT 200U UPAT PROBE e 9n 59 APPENDIX F MANUFACTURING DECLARATIONS ACCORDING TO TEC 000012122 oa ins ne on 60 APPENDIX G SPO2 ACCURACY IN THE WATCHPAT 200U 64 WatchPAT 200U System IV Operation Manual APPENDIX H TRAINING RESOURCES 67 APPENDIX T SPARE PARTS LIST ns nds 68 List of Figures Figure 1 Packed DeVICR 1 naines Aaa AE UEM NARA Ea 11 Figure 2 WatchPAT 200U Device with Sensors 11 Figure 3 The Buttons and Display esses 12 Figure 4 Service Ports and Peripherals 13 Figure 5 WatchPAT Wrist Strap ee esses ee eee eee een 13 Figure 6 Charging the WatchPAT Device sees eu 18 Figure 7 Disconnecting the Probe eee eere e eee 20 Figure 8 Probe Disconnected is msn nux amsn eine
13. WatchPAT device is now ready for performance of a sleep study by the patient Figure 9 3 8 WP200U Self diagnostic Test Results and Trouble shooting Should any of the self diagnostic tests fail or report error messages refer to the trouble shooting guide in Section 9 WatchPAT 200U System 21 Operation Manual 3 9 Packing the Carrying Case The following items must be placed inside the carrying case in their respective compartments see Figure Packed Device The WatchPAT device mounted in the Wrist strap with the uPAT probe attached Step by Step Reference Guide to the WatchPAT device Body Position and Snore sensor optional Cable for bracelet optional for patient identification 2 extra uPAT probes and AC adapter optional for multi night Note Demonstrating the use of the WatchPAT device to the patient is important for obtaining reliable recordings and improving patient confidence WatchPAT 200U System 22 Operation Manual 4 OPTIONAL FUNCTIONS 4 1 Using the integrated Snore amp Body Position Sensor The integrated sensor consists internally of two sensors a snore sensor and a body position sensor 18 Integrated sensor Sensor Attachment The integrated sensor is powered by the WatchPATTM device and does not require a battery It is automatically activated by the WatchPAT device when plugged into the Snore amp Body position port The snore sensor is an acoustic decibe
14. com WatchPAT 200U System 57 Operation Manual APPENDIX D REGULATORY REPRESENTATIVE Itamar Medical s authorized regulatory representative 1s 5 Beaumont Gate Shenley Hill Radlett Hertfordshire WD7 7AR England Tel 44 208123 8056 Tel Fax 44 1923859810 WatchPAT 200U System 58 Operation Manual APPENDIX E DESCRIPTION OF THE WAICHPAITM200U 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 This design prevents venous blood pooling engorgement and stasis which inhibits retrograde venous shock wave propagation and allows partial unloading of arterial wall tension that significantly 1mproves the dynamic range of the measured signal The optic component of the probe measures the optical density related changes of the arterial blood volume in the digital arteries associated with each heartbeat Peripheral arterial constrictions when present are shown by attenuation in the PAT signal amplitude a marker of sympathetic activation The uPAT probe also measures the changes in absorbance of the finger at both red and infrared light at peak wavelengths of 660nm and 910nm respectively The maximum optical output power is 65m
15. may be used by the Operator for entering the diagnostic mode and navigating through the diagnostic menu These keys are hidden from the patient LCD d RIGHT ON ENTER LEFT pue 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 e 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 o CHARGER mode while connecting to AC adapter e Info 25 5 line Specific information depending on operational mode e Status last line Message indicating device status depending on operational mode Service Ports and Peripherals The WatchPAT device has 4 ports that are used either for sensor connections or for servicing and charging see Figure 4 e The bracelet port is used for connecting the tamper proof bracelet e The uPAT probe port is used for connecting the uPAT probe WatchPAT 200U System 12 Operation Manual e A port for connecting the optional Snore amp Body Position sensor e The USB port is used for charging or connecting to the PC uPAT probe port Bracelet port Port for optional Snore amp 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 Functi
16. other than Itamar or a person or entity authorized by Itamar to repair Licensed Products WatchPAT 200U System 54 Operation Manual 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 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 WARRANTIES OR CONDITIONS OF OR RELATED TO MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE ACCURACY OR COMPLETENESS OF INFORMATION LACK OF NEGLIGENCE AND CORRESPONDENCE TO DESCRIPTION 5 LIMITATION OF LIABILITY A TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW EXCEPT FOR DAMAGES ARISING UNDER SECTION 4 A ABOVE IN NO EVENT SHALL ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE PRICE YOU PAID FOR THE LICENSED SOFTWARE THE LICENSED PRODUCT OR THE APPLICABLE THIRD PARTY PRODUCT THE FOREGOING LIMITATION SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES
17. provided in Section 2 do not install use or copy the Licensed Software or use the Licensed Product or the Third Party Product The Licensed Software and the Licensed Products are protected by US patent laws trade secret laws copyright laws and international treaty provisions as well as other intellectual property laws and treaties Therefore you must treat the Licensed Software and the Licensed Products like any other copyrighted and protected material or product All title to the Licensed Software and all intellectual property rights in and to the Licensed Software and the Licensed Products shall remain with Itamar 1 DEFINITIONS 1 1 Licensed Product s means the Watch PAT200 Watch PAT200 the Site PAT200 the uPAT Probe and the corresponding components of any Third Party Product with which this License Agreement was received Some Licensed Products are stand alone products and some Licensed Products are incorporated as components within Third Party Products in each case sold or otherwise made available by Itamar and or third parties If you have received this License Agreement with a Third Party Product this License Agreement applies only to the Licensed Product WatchPAT 200U System 52 Operation Manual 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 S
18. the uPAT probe is hanging loose Figure 22Figure 22 Wearing the WatchPAT Device 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 To attach the uPAT probe 1 Insert your index finger or other if so instructed gently into the probe until it reaches the end see Figure 23 2 Make sure that the paper tab marked TOP is above your nail 3 Detach and gradually remove the tab marked TOP slowly and firmly while pressing the tip of probe against a hard surface WatchPAT case table WatchPAT 200U System 34 Operation Manual 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 25 Wearing the WP200U 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 WatchPAT 200U System 35 Operation Manual Note If the Snore amp 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 WatchPA
19. 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 b As to Licensed Product Itamar warrants that the Licensed Product with which this License Agreement was delivered will be free from defects in design materials and workmanship for a period of one year from the date of delivery of the Licensed Product to you If the Licensed Product contains a defect in design materials or workmanship and such Licensed Product is returned to Itamar within one 1 year of delivery of the Licensed Product to you Itamar will repair or replace the Licensed Product or issue a credit for the purchase price of the Licensed Product with the choice to repair replace or credit being within the sole discretion of Itamar The foregoing repair replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 b c As to Licensed Software Itamar warrants that for a period of ninety 90 days from the date of delivery of the Licensed Software to you the Licensed Software will under normal use be free from defects in materials and workmanship and will perform substantially as it is intended to perform If during such ninety 90 day period the Licensed Software has a defect in materials or workmanship or does not perform substantially as it is intended to perform Itamar shall a attempt to correct or assist you a
20. FRINGEMENT 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 within Third Party Product 7 TRANSFERABILITY You may only transfer or assign the rights and obligations hereunder together with the Licensed Software and or the Licensed Product or Third Party Product as a whole without retaining any rights or subject to Sections 2 and 3 above any obligations arising after the date of such transfer or assignment or retaining any installed or uninstalled copy of the Licensed Software the Licensed Product or the Third Party Product Any attempt by you to rent lease sublicense assign or transfer any of the rights duties or obligations hereunder in any other way 1s forbidden and shall be null and void 8 SEVERABILITY Should any term or provision of this License Agreement be declared void or unenforceable by any court of competent jurisdiction in any country or countries such declaration shall have no effect on the remainder of this License Agreement in such country or countries or on this License Agreement in other countries 9 N
21. O WAIVER The failure of either party to enforce any rights granted to it hereunder or to take action against the other party in the event of any breach hereunder shall not be deemed a waiver by that party as to subsequent enforcement actions in the event of future breaches 10 GOVERNING LAW AND JURISDICTION This License Agreement is governed by the laws of the State of New York excluding its conflict of laws principles The United Nations Convention on Contracts for the International Sale of Goods shall not apply to any of the transactions contemplated by this License Agreement 11 ENTIRE UNDERSTANDING WatchPAT 200U System 56 Operation Manual This License Agreement represents the complete and exclusive understanding between you and Itamar concerning the license by Itamar to you of Licensed Software and Licensed Products and supersedes all prior agreements and representations between the parties with respect to the subject matter hereof unless specifically stated otherwise in a writing signed by Itamar and you This License Agreement may not be amended other than by a written agreement specifically intended for this purpose and signed by 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
22. P Tab aaa aAa 35 Figure 25 Wearing the WP200U Ready for Sleep 35 List of Tables Table 1 Operator Troubleshooting esses 40 Table 2 Patient Troubleshooting eere seres 41 Table 3 WatchPAT 200U Specifications us 42 WatchPAT 200U System V Operation Manual 1 GENERAL INFORMATION This manual is part of the WatchPAT 200 Unified system 1 1 Intended Use Indications for Use The WatchPAT 200U WP200U device is a non invasive home care device for use with patients suspected to have sleep related breathing disorders The WP200U 1s a diagnostic aid for the detection of sleep related breathing disorders sleep staging Rapid Eye Movement REM Sleep Light Sleep Deep Sleep and Wake snoring level and body position The WP200U generates a peripheral arterial tonometry PAT Respiratory Disturbance Index PRDI Apnea Hypopnea index PAHI PAT sleep staging identification PSTAGES and optional snoring level and body position discrete states from an external integrated snoring and body position SBP sensor The WP200U s PSTAGES and SBP provide supplemental information to its PRDI PAHI The WP200U s PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder prescri
23. PAT Operation Manual If a 3 mght multi night option is selected the patient must replace the uPAT probe and charge the device between nights Two extra uPAT probes and a WatchPAT device AC adapter must be added to the WatchPAT device case If a 2 night multi night option is selected the patient must replace the uPAT probe only after the first night without the need to charge the device between nights One extra uPAT probe must be added to the WatchPAT device case In case of multi night study all of the patient studies will be loaded automatically to the ZZZPAT during the upload see zzzPAT Operation Manual Charger 2 extra probes ld Figure 16 Case for 3 Night Multi night Study WatchPAT 200U System 26 Operation Manual 5 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 device will switch off and then switch on in charging mode 2 Activate the zzzPAT software to download and analyze the study data See the zzzPAT Software User Manual for detailed instructions WatchPAT 200U System 27 Operation Manual 6 MAINTENANCE The WatchPAT device has been designed and manufactured to meet all safety requirements applicable to medical equipment To ens
24. SLEEP STUDY 18 Chargind the Ballely cuoc nee dite 18 Preparing the Snore and Body Position Sensor 19 Preparing the Wrist Stap asiasia Eo ra ee nu eu ar Un an eeu e neun 19 Mounting the WatchPAT on the Wrist Strap 20 Replacing the UPAT Probe e eese eee eere rennen nnn 20 Preparing the WatchPAT Device for a New Study 21 Testing the WatchPAT Device ee eee eee 21 WP200U Self diagnostic Test Results and Trouble shooting 21 Packing the Carrying CASO uccee uet uc sue ennemies 22 OPTIONAL FUNCTIONS 1 e eere rna nnn 23 Using the integrated Snore amp Body Position Sensor 23 Tamper Proof Testing with WatchPAT Device 23 Multi night study 225 aisurdieritescidecuc25202102 525 56 03650575220500e0 36 6 0025020825 26 DATA DOWNLOAD AND ANALYSIS 27 MAINTENANCE 2 sien di EE E EYEv eaa Oe caa Gud SoGwa ur Pu Eo er Ives 20 Cleaning soos utat ud ac dad cad aad ad ud uad um uad 28 WatchPAT 200U System lil Operation Manual 6 2 acla oli oro e 29 6 3 Replacing the uPAT Probe Cable 29 6 4 Replacing Ihe Ballery ec eee cie eei ao eee 30
25. Storing the WatchPAT device e The WatchPAT device should be stored in its carrying case at room temperature and low humidity e In order to preserve battery performance when the WatchPAT device is not in use store with the battery fully discharged e Before storing the WatchPAT device allow it to deplete the battery charge until it shuts down automatically WatchPAT 200U System 32 Operation Manual 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 They are written as if the reader is the patient using the WatchPAT device 7 1 Preparing for Use of the WatchPAT Device Before using the WP200U review the following notes Remove tight clothing rings watches and Jewelry from your non dominant hand and wrist and from your neck and chest We recommend that the uPAT probe be attached to the index finger of your non dominant hand Figure 20 The following instructions relate specifically to this finger Patients with very large fingers may use their small finger pinky for the uPAT Probe Ensure that fingernail of finger that will be monitored are well trimmed less than Imm from nail bed with no jagged edges C
26. System 28 Operation Manual 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 amp Body Position Sensor Using 70 ethyl alcohol thoroughly clean both sensor and cable 6 2 Handling Handle with care e Use only the designated case for transportation e Store at room temperature and avoid direct sun light e Do not expose the WatchPAT device to extreme temperature or humidity conditions such as storing in a car or bathroom Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations 6 3 Replacing the uPAT Probe Cable To replace the uPAT probe cable 1 Carefully disconnect the uPAT probe cable from the WatchPATTM device Make sure you remove the screw prior to disconnecting the uPAT cable Figure 17 uPAT Probe Cable with Screw 2 Connect a new uPAT probe cable by gently inserting the connector into the WatchPAT device Make sure you secure back the screw WatchPAT 200U System 29 Operation Manual 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 6 4 Replacing
27. T 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 PALLENT 2251 GOOD NIGHT Time elapsed 9 50 Recording Note To conserve the battery the LCD display will switch off after a few seconds Pressing any button will restore the display for about 30 seconds 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 device is turned on it will switch off This 1s normal WatchPAT 200U System 36 Operation Manual 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 1s not alleviated immediately call the service number e Do not attempt to connect or disconnect any part of the unit e Do not try to introduce any foreign object into the unit e Do not try to connect the unit to an electrical supply or any other unit machine or computer e If any part appears disconnected or does not resemble the illustrations call the service number for assistance e Do not under an
28. W These measurements are used to calculate the oximetry signal in an offline program according to the pulse oximetry principles The uPAT probe is an integral part of the WatchPAT device and is to be used only with the WP200U device WatchPAT 200U System 59 Operation Manual APPENDIX F MANUFACTURING DECLARATIONS ACCORDING TO IEC 60601 1 2 Electromagnetic Compatibility Notes e The WatchPAT 200U WP200U requires special precautions with regard to electromagnetic compatibility e It must be installed and prepared for use as described in section 11 Preparation for Sleep Study Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the WP200U e The recommended separation distances in this section must therefore be complied with e The 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 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 Electromagnetic Emissions e WP200U is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below e The user and or installer of the unit must ensure that it is used in such an environment Table 1 from IEC
29. bing treatment or determining whether additional diagnostic assessment is warranted The WatchPATTM200U device is not indicated for children less than 17 years old 1 2 Restrictions for Use 1 The WP200U should be used only in accordance with physician s instructions For exclusion criteria see Section 1 3 2 Only qualified medical personnel may authorize the use of the WP200U 3 Qualified medical personnel must instruct the patients how to attach and use the WP200U prior to use 4 n the event of equipment malfunction all repairs should be executed by authorized Itamar Medical Ltd personnel or licensed service agents 5 The eligibility of a patient for a PAT study is entirely at the discretion of a physician and 1s generally based upon the patient s medical status 6 The WP200U system in whole or in part may not be modified in any way 7 The WP200U is used as an aid for diagnostic purposes only and should not be used for monitoring 8 Only suitably trained and qualified personnel should be authorized to prepare the WP200U equipment prior to use 9 The WP200U Operation Manual should be carefully studied by the authorized operators and kept where it is easily accessible 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 11 The tracings and calculations provid
30. d CHARGER Bat 3 12 V Charging WatchPAT 200U System 18 Operation Manual e The display will show CHARGER if you are charging with the AC adapter or PC HOST if you are charging with a computer e The current battery voltage is shown e Charge the battery the first time for approximately three hours Thereafter recharging takes approximately 1 1 5 hours 4 When charging is complete the LCD will stop blinking and the following screen will be displayed CHARGER Bat 4 2 V Charging complete 5 Disconnect the AC adapter or communication cable The WatchPAT device will switch off in 30 seconds 6 Reseat the WatchPAT device in the wrist strap by gently sliding it back in until a click 1s heard Should a charging error arise the LCD will blink rapidly and the following screen will be displayed CHARGER Bat 4 7 V Charger fault 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 a man image by peeling off the cover on one side of the sticker For more details see Appendix A WP200U Integrated snoring Body Positioning Sensor Operating 3 3 Preparing the Wrist Strap The wrist strap requires no special preparation other than ensuring its cleanliness You may clean it if needed See section 6 1 for detailed cleaning instructions WatchPAT 200U System 19 Ope
31. d The study included 26 patients and the analysis was done in 30sec epochs The correlation coefficient was calculated using Pearson method assuming a linear relation between the results of the two devices A statistically significant correlation was calculated between the two devices r 0 65 p value 0 0001 The next figure shows a scatter plot of sleep disturbance Index produced by WatchPAT device and dB meter with linear regression line 75 e eo e nm ce Itamar Snore dB e e 45 35 40 45 50 593 60 65 70 75 PSG Snore dB 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 A high correlation was observed between the results of the two devices for the range of 40 70dB where sufficient data points were gathered meaning the resemblance in the results uniformly existed for all the snore levels measured The next table presents the statistics of WatchPAT device measurements per dB meter calculation at that range WatchPAT 200U System 45 Operation Manual PSG Coef Of Lower Upper DB N Mean Std Variation Min Max Median 95 95 Value 96 CI CI 41 76 42 93 4 49 44 44 45 09 46 30 46 86 47 82 48 45 49 08 49 60 50 28 50 59 51 79 52 42 52 60 22 72 29 92 56 15 6 37 11 47
32. e 8 7 Review Safety General and Functional Issues e Avoid exposing the WatchPAT device to extreme conditions high temperature high humidity e Provide a telephone number to call in case of questions or problems WatchPAT 200U System 39 Operation Manual 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 patient Study in zzzPAT uncharged Used Missing B ad Hardware status error code WatchPAT device Consult Itamar or authorized representative defective SBP disconnected even if it WatchPAT device or Consult Itamar or authorized representative is connected SBP sensor defective RTC faulty WatchPAT device Consult Itamar or authorized representative defective Short recording time Patient removed the WP200U Explain proper use to patient or probe from hand prematurely Insufficient battery charge Recharge battery and try again caused early termination of recording Damaged WatchPAT Contact your authorized sales representative device WatchPAT 200U System 40 Operation Manual 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 proble
33. e bracelet WatchPAT 200U System 51 Operation Manual APPENDIX C LICENSE AGREEMENT License To Operator From Itamar IMPORTANT PLEASE READ THIS LICENSE AGREEMENT CAREFULLY BEFORE INSTALLING OR OTHERWISE USING THE LICENSED SOFTWARE AS DEFINED BELOW OR THE PRODUCT WITH WHICH YOU RECEIVED THIS LICENSE AGREEMENT THIS LICENSE AGREEMENT APPLIES TO a ALL LICENSED SOFTWARE b ALL LICENSED PRODUCTS AS DEFINED BELOW AND c ALL THIRD PARTY PRODUCTS INTO WHICH A LICENSED PRODUCT OR LICENSED SOFTWARE IS INCORPORATED SHOULD YOU HAVE ANY QUESTIONS CONCERNING THIS LICENSE AGREEMENT PLEASE CONTACT THE VENDOR FROM WHICH YOU PURCHASED THE LICENSED SOFTWARE LICENSED PRODUCT OR PRODUCT INTO WHICH A LICENSED PRODUCT OR LICENSED SOFTWARE IS INCORPORATED YOU MAY ALSO CONTACT ITAMAR AT THE ADDRESS PROVIDED AT THE END OF THIS 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 1s incorporated Third Party Product you agree to be bound by the terms of this License Agreement with respect to the Licensed Software and Licensed Products If you do not agree to the terms of this License Agreement including without limitation the Restrictions on Use as
34. ed 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 WatchPAT 200U System 1 Operation Manual 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 13 The step by step instructions for the patient should be carefully followed when attaching the unit to the patient 14 The WP200U is not indicated for children less than 17 years old 1 3 Exclusion Criteria The WatchPATTM200U should not be used in the following cases Use of one of the following medications alpha blockers short acting nitrates less than 3 hours before the study 2 Permanent pacemaker atrial pacing or VVI without sinus rhythm 3 Sustained non sinus cardiac arrhythmias n cases of patient having accumulative time of regular R R intervals of less than 1 5 hours the WatchPAT 200U system will not have sufficient valid PAT signal as required to generate a sleep report 1 4 Data Generated by the WatchPAT 200U The WatchPAT 200U generates a PAT respiratory disturbance index PRDI and its derivative the PAT Apnea Hypopnea Index PAHI and PAT sleep staging identification PSTAGES
35. erogating from the generality of the above you may not e distribute reproduce copy assign rent lease or otherwise transfer the rights eranted to you under this License Agreement to any third party except explicitly as set forth in this License Agreement e reverse engineer decompile or disassemble as applicable the Licensed Software or the Licensed Product except as expressly permitted by applicable law or e modify in any manner the Licensed Software and or the Licensed Product unless obtaining the prior written consent of Itamar 3 TRADEMARKS Cardio PAT Sleep PAT and all trademarks and logos which appear on or in connection with the Licensed Software and or the Licensed Products as may be amended from time to time are unless stated otherwise trademarks of Itamar No right license or interest to such trademarks are generated or granted hereunder other than the limited right to use provided herein and you agree that no such right license or interest shall be asserted by you with respect to such trademarks You may not remove or destroy any WatchPAT 200U System 53 Operation Manual 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
36. g 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 Wrap the bracelet around the wrist of the non dominant arm tested arm of the subject Insert the white plastic parts into the holes Make sure it is snug but not too tight If there is some loose strap left fold it and re insert it into the holes DO NOT CUT LOOSE STRAP CUTTING IT WILL RENDER BRACELET UNUSABLE Secure the bracelet by placing the second white plastic part on top of the first Make sure it is secured tightly WatchPAT 200U System 50 Operation Manual di o Wm MT Explain to The subject may choose to perform the Subject night study during any night during the next week Its OK to shower with the bracelet Instruct subject to turn on the WatchPAT device only after it is connected to the bracelet THE BRACELET IS NOT TO BE REMOVED UNTIL THE NIGHT STUDY IS COMPLETED Removing the bracelet before or during the night will cause the device to shut down In the morning instruct to cut the bracelet along the dotted line using small scissors and to put it in the WatchPAT device case along with all the other parts DO NOT THROW BRACELET AWAY Do not try to connect ANY other device to th
37. gression Line Average Reference CO Oximeter SaO2 amp WatchPAT SpO2 WatchPAT 200U System 65 Operation Manual Reference CO Oximetry Range 68 99 Linear Regression Bland Altman y 0 0931x 8 7875 Mean Bias 0 51 pts 726 Upper 95 Limits of Agreement 4 3 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 Clinical Investigator s Clinimark 80 Health Park Drive Suite 20 Louisville Colorado 80027 USA Sponsor Itamar Medical Ltd 9 Halamish St POB 3579 Caesarea 38900 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 WatchPAT 200U System 66 Operation Manual 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 English ZZZPAT User Manual WatchPAT Device Patient Video ZZZPAT Manual Editing of Sleep Scoring WatchPAT 200U System 67 Operation Manual APPENDIX I SPARE PARTS LIST The following ite
38. he Up Down keys 1 navigate between the lines e An asterisk will indicate current selection When moving the 1 keys the asterisk will move to indicate the current selection Press the central Enter key to make the desired selection It is recommended that you perform the Device every time you prepare the WatchPAT for a night study 2 4 2 Device Test At the completion of the device test a TEST PASSED indicates that the device is ready for the night study DEVICE TEST Zo IO a We PP A EP Sbp missing lt Back TEST PASSED 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 22290 aE A PP PS pat missing WatchPAT 200U System Operation Manual lt Back More gt TEST FALLED 2294 The following are the possible error warning or information messages e 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 Battery error low needs charging Probe error used missing bad connect an unused probe Hardware H W error error code contact customer support SBP Snore and Body Position sensor warning sensor missing does not affect PASSED status e RTC Real Time Clock warning faulty indicates problem with internal clock but does not affect PASSED status e Bracelet error miss
39. ing the study file was chosen with the bracelet option but the bracelet is not connected during the device test e Information messages o mult nightzon when a multi night study is required o bracelet on when a study with tamper proof patient identification bracelet is required More indicates that there are more error warning messages and will be displayed if the Right gt button is pressed Back will move to the previous screen if the Left button is pressed 2 4 3 Patient Test When the patient turns on the WatchPAT device by pushing the On Enter key center button for about 2 seconds a self diagnostic test 1s automatically performed and the following screen is displayed PATIENT Please wait Testing If the WatchPAT device passes this self diagnostic test the following screen will be displayed PATIENT GOOD NIGH WatchPAT 200U System 16 Operation Manual 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 Pao d Error xxxx Device S N XXXXX Call Help Desk TEST ABORTED e The error message will be displayed for 1 minute and then the WatchPAT device will shut off e If this is a study with the tamper proof bracelet and the wrong bracele
40. itions ou les actions qui peuvent interf rer avec le ramassage de donn es et provoquer des r sultats quivoque Notes are used to identify an explanation or to provide additional information for purposes of clarification Les notes sont utilis es pour identifier les explications et pour donner des informations suppl mentaires dans le but de clarifier 1 9 Warnings Cautions and Notes The WP200U is internally powered from a 4 2 V battery The WP200U is portable with continuous operation The WP200U uses BF patient applied parts The WP200U uses UL listed power supply USA amp Canada only The power supply is used in a non patient environment only The WP200U should only be transported in its original case There are no serviceable parts inside the WP200U Environmental conditions during transportation amp storage See Specifications section Environmental conditions during operation See Specifications section Sleep professionals other than patients using the WP200U should read the Operation Manual WatchPAT 200U System 5 Operation Manual 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 In the event of fire use only fire extinguishers appro
41. l 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 See Appendix A WP200U Integrated snoring Body Positioning Sensor Operating 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 1s recorded from the right person The bracelet is a single use small plastic band designed to be worn around the wrist of the hand It contains an electronic circuit that signals to the WatchPAT device the integrity of the bracelet and a unique identification During the night the bracelet is connected to the WatchPAT device using a small cable see Figure 10 WatchPAT 200U System 23 Operation Manual 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 Figure 11 Bracelet on Patient s Hand When pre
42. lip and file nail if necessary Remove artificial fingernail or dark nail polish from the monitored finger You may need some assistance putting on the WatchPAT device If needed have someone present to assist you 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 Snore amp Body Position sensor it is advised to sleep alone in the room Index finger Small pinky finger Figure 20 Finger Designation 7 2 Applying the WatchPAT Device To apply the WatchPAT device to your wrist WatchPAT 200U System 33 Operation Manual 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 device in the strap by sliding it into its seating position You will hear a click when the WatchPAT device is properly seated in the strap 3 Place the wrist strap with the WatchPAT device on the non dominant arm and close it snugly but not tightly Ensure that the rounded end is towards the body and the open end towards the fingers You may find it convenient to place the wrist strap with the WatchPAT device face down on the table and then place the back of the wrist over the wrist strap in order to fasten the straps Figure 21 4 At this point
43. m persists the patient may contact Itamar or an authorized representative directly Table 2 Patient Troubleshooting Possible Reason Action WatchPAT device ON button not activated Press the ON button firmly for at least 3 doesn t switch on seconds uPAT probe not connected Ensure probe is connected and try again Probe disconnected Probe may not be connected Check connection of probe to cable and cable to or may be a used probe the WatchPAT device check if probe has been previously used and replace with new probe if necessary WatchPAT device Contact Itamar or authorized representative failure WatchPAT 200U System 41 Operation Manual 10 SPECIFICATIONS Table 3 WatchPAT 200U Specifications Properties uPAT Probe Recording Time Channels Sample Resolution User Interface Oximetry Accuracy PAT Channel Data Storage Power Supply Operating Voltage Pulse rate Amplitude Bandwidth Media Capacity Format type Battery Capacity Cell Type Internal Charger External Power Supply Temperature Humidity Atmospheric pressure Dimensions Operation Storage Device Transport Device Storage amp Transport Probe Operating Storage amp Transport Operating amp Storage Transport LxWxH Weight WatchPAT 200U System Description Itamar s proprietary probe Measures PAT and Oximetry 10 hours minimum Measuring 6 signals PAT Pulse rate Oximetry
44. ms can be ordered and purchased individually e uPAT probe a box of 12 uPAT probes e uPAT probe connection cable e Wrist Strap e Snore and Body Position sensor e Adhesive for Snore and Body Position sensor a package of 12 units e Cable for Tamper Proof Bracelet e Tamper Proof Bracelet a box of 24 bracelets e AC adapter e USB cable e Rechargeable Lithium Ion Battery e Step by Step Reference Guide WP200 Unified Itamar SBP e Quick Reference Cards WP200 Unified e Carrying case WatchPAT 200U System 68 Operation Manual
45. n 20 Figure 9 WatchPAT Fully Prepared 21 Figure 10 WatchPAT Device with Tamper Proof Bracelet 24 Figure 11 Bracelet on Patient s Hand 24 Figure 12 WatchPAT Device with Cable for Bracelet 25 Figure 13 WatchPAT Device with Bracelet 25 Figure 14 Bracelet and WatchPAT Device on a Patient s Hand 25 Figure 15 Cut the Bracelet on a Specified Location 25 Figure 16 Case for 3 Night Multi night Study 26 Figure 17 uPAT Probe Cable with Screw eeesseeus 29 Figure 18 Replacing the uPAT Probe eese 30 Figure 19 Replacing the Battery eese eee 31 Figure 20 Finger Designation ee eee e eee eene eene 33 Figure 21 Putting On The Wrist Strap ee eese eee 34 Figure 22 Wearing the WatchPAT Device e eee 34 Figure 23 Placing Finger In uPAT Probe 35 Figure 24 Hemoving O
46. oftware 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 If you have received this License Agreement with a Licensed Product which incorporates the Licensed Software as a component within such Licensed Product this License Agreement applies to the Licensed Software 2 GRANT OF LICENSE AND RESTRICTIONS ON USE 2 Itamar hereby grants you a non exclusive right to use the Licensed Software solely for its intended use in sleep medicine with the term sleep medicine including Cheyne Stokes respiration as well as research in sleep medicine and Cheyne Stokes respiration 1 with the Licensed Product s and 11 in accordance with the provisions of this License Agreement and the instructions provided in the documentation accompanying the Licensed Software and the Licensed Product You may make one copy of the Licensed Software solely for backup or archival purposes or transfer the Licensed Software to a single hard disk provided you keep the original solely for backup or archival purposes However you may not cause any Licensed Software which is not designed for use on a server to execute or be loaded into the active memory or media of more than one computer at any one time 2 2 Any use of the Licensed Software and or Licensed Product other than as set forth in Section 2 1 above is strictly forbidden Without d
47. on The WatchPAT records the following channels e PAT Signal e Oxygen saturation WatchPAT 200U System 13 Operation Manual e Actigraphy movement e Acoustic decibel detector for Snoring evaluation optional e Body Position optional The overnight sleep study data is stored on an embedded micro SD card in the WatchPAT device After the study is recorded the data is downloaded from the WatchPAT device through the USB cable using the zzzPAT software The zzzPAT software utilizing 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 The whole night data can be viewed on the PC screen and the automatically detected events can be revised manually An optional tamper proof patient identification function is available using a custom bracelet whose presence during the night verifies that the identified patient is indeed the one sleeping with the device see Tamper Proof Testing with WatchPAT Device Tamper Proof Testing with section The patient normally sleeps only one night with the WatchPAT device unless an optional multi night option is selected which enables an up to 3 nights study with the same device see Multi night study section 2 4 Built In Self Diagnostic Proced
48. on during power mains interruptions it is recommended that WP200U be powered from a separate power supply UPS etc Power frequency magnetic fields should be at levels characteristic of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment NOTE UT is the a c mains voltage prior to application of the test level WatchPAT 200U System 61 Operation Manual 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 level Electromagnetic environment guidance Test level Portable and mobile RF communications equipment should be used no closer to any part of the WP200U including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17NP Conducted RF 3 Vrms IEC 61000 4 6 150 k Hz to 80 MHz d 1 17VP 80MHzto800 MHz Radiated RF 3 V m d 2 3VP 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P i s the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d i s the recommended separation
49. or attach it with the man image standing up after peeling off the round adhesive sticker and pressing against the skin e Make sure the sensor is tight against the skin e Secure the snoring sensor in place with medical tape WatchPAT 200U System 38 Operation Manual 3 Wearing the Wrist Strap e Should be comfortable not too tight 4 Attaching the WatchPAT Device e 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 5 Attaching the uPAT Probe e Insert finger all of the way into the probe e Press tip of probe against a hard surface WatchPAT device case table etc while removing tabs in order to keep the finger from moving inside the probe e Remove the Tab by pulling slowly and gradually e The probe is limited to a SINGLE USE Do not remove probe during the night 8 4 Switching on the WatchPAT Device e Demonstrate switching on the WatchPAT device by pressing the round center button e Push button firmly until the LCD display lights up 8 5 Removing the WatchPAT Device e Demonstrate how to remove the WatchPAT device and place it back in the carrying case e The WatchPAT device doesn t switch off once turned on it will record until the battery 1s exhausted 8 6 Patient Training e Following your demonstration have the patient attach the demo device by himself e Verify that the attachment is properly don
50. paring the WatchPAT device for a sleep study the technician pairs the Tamper Proof Bracelet and the device and registers the bracelets unique ID in the WatchPAT device see Appendix B Tamper proof testing with WaTCHPAT 200U The patient can wear the Bracelet for several days continuing normal day to day activity until he is ready to record his sleep study Before starting the recording the patient will need to connect the Bracelet via the bracelets cable 2 connectors to the WatchPAT device The device will not start without connection to the paired Bracelet WatchPAT 200U System 24 Operation Manual 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 After the recording 1s completed the patient can cut the Bracelet along the dotted line and return it with the device for study analysis Figure 15 Cut the Bracelet on a Specified Location WatchPAT 200U System 25 Operation Manual 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 zzz
51. pplications filed in other countries a 9001 20 09 ova AmA AmA ie CC AUTOS Sarg AUTOS C S Nani Intertek Intertek ISO 9001 2008 and EN ISO 13485 2012 See appendix D for contact information of the regulatory authorized representative WatchPAT 200U System Operation Manual Record of Editions Chapter 1 based on August 2013 Standards Preparing for All er o 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 Updating pictures Updating intended use Updating exclusion criteria Updating Standards Updating symbols labels 11 1 7 8 Attaching uPAT probe 35 Medes and Itamar s y 1 58 59 addresses Adding Training Resources appendix me eee epe m 2014 Update Arms limit Oct Nov Updating Caution and Orit Bonita 2014 Warning symbols Adding MDD CE mark and EC rep symbol Updating Manufacturing Declarations Adding cross reference Adding spare parts list EE Declaration Table 2 gt uly 2015 Add FDA K to section SOO Y Orit 1 13 Adding MDD to list of standards Note Latest version of the WatchPAT system Operation Manual is available at http www itamar medical com Support Downloads html WatchPAT 200U System ii Operation Manual Table of Contents 4 4 4 AOONDOUBRWND NR saa eae ei db el et eh eee es WON
52. probe that measures the PAT Peripheral Arterial Tone signal The PAT signal is a measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity and thus indirectly the level of sympathetic activation Peripheral arterial vasoconstriction which mirrors sympathetic activation is shown as attenuation in the PAT signal amplitude The same probe measures RED and IR channels used for the measurement of SpO2 signal The PAT and SpO2 signals are recorded continuously and stored on an embedded micro SD card together with data from a built in actigraph embedded in the WP200U Following the sleep study the recordings are automatically downloaded and analyzed in an offline procedure using the proprietary ZzzPAT software The zzzPAT algorithms use the four WP200U channels PAT Pulse Rate Oxygen saturation and actigraphy for the detection of sleep related breathing disorders and sleep staging Rapid Eye Movement REM Light Sleep Deep Sleep and Wake The zzzPAT uses WP200U s snoring and body position channels SBP to generate snoring level and body position discrete states The use of SBP is optional and according to physician preference The software issues comprehensive reports of the study with statistics and graphic presentation of the results The whole night data can be viewed and the automatically detected events can be revised manually WatchPAT 200U
53. r 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 Indications of use The integrated Snoring amp Body position sensor is an accessory of the WatchPAT home care device for use with patients suspected to have sleep related breathing disorders The integrated sensor monitors the snoring level which aids in the evaluation of the severity of sleep related breathing disorders and the body position which aids in the evaluation of the type of sleep related breathing disorders Preparing the sensor Attach the round double sided adhesive sticker to the blue side of the sensor WatchPAT 200U System 43 Operation Manual 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 1s the little U shape where the collar bones meet at the top of the breast bone To position the sensor attach it with the man image standing up after peeling off the round adhesive sticker and pressing against the skin Make sure the sensor is tight against the skin
54. ration Manual 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 Keep the connector connected to the probe at all times especially during cleaning Replace the probe just before performing the Device test Remove a used probe by pressing the small tab clip marked by the arrow in Figure 7 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 7 Disconnecting the Figure 8 Probe Disconnected Probe Connect a new probe by inserting the blue slider to the probe until the blue tab of the probe clicks into its place Note Take care when inserting the blue slider to insure proper seating in the probe WatchPAT 200U System 20 Operation Manual 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 2 4 above The
55. re 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 Table 6 from IEC 60601 1 2 2007 Recommended separation distances between portable and mobile RF communications equipment and the WP200U Separation distance according to frequency of transmitter in meters Rated maximum output power Meters m of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz Watts W d 2 147NP d 2 147NP d 234P For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 WatchPAT 200U System 63 Operation Manual APPENDIX G SPO2 ACCURACY IN THE WATCHPAT 200U The WatchPAT 200U device uses Itamar Medical Pulse Oximetry system for the measurement of functional oxygen sat
56. riations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 1 2 Test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode b UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles lt 5 UT 70 UT 30 dip in UT for 25 cycles lt 5 UT 5 UT gt 95 dip in UT for5s Compliance level 6 kV contact 8 kV air 2 kV for power supply lines Not Applicable 1 kV differential mode 2 kV common mode b UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles lt 5 UT 70 SAUT 30 dip in UT for 25 cycles b UT lt 5 UT gt 95 dip in UT for5s Electromagnetic environment guidance Mains power quality should be that of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment Mains power quality should be that of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment Mains power quality should be that of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinical environment If the user of the WP200U requires continued operati
57. round errors with efforts which Itamar believes suitable to the problem b replace the Licensed Software with a functionally equivalent software or c issue a credit for the purchase price of the Licensed Software with the choice to correct or assist replace or credit being within the sole discretion of Itamar The foregoing correct or assist replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section 4 c d Limitation of Warranties The warranties contained in Sections 4 b and 4 c above do not cover damage to the Licensed Products or the Licensed Software caused by accident misuse abuse negligence failure to install in accordance with Itamar s installation instructions failure to operate under conditions of normal use and in accordance with the terms of the documentation accompanying the Licensed Product and or the Licensed Software failure to maintain in accordance with applicable documentation accompanying the Licensed Product and or the Licensed Software alteration or any defects not related to materials or workmanship or in the case of Licensed Products design materials or workmanship This warranty does not cover damage which may occur in shipment This watranty does not apply to Licensed Products and or Licensed Software not purchased new This warranty does not apply to any Licensed Product or any individual parts of a Licensed Product which have been repaired or altered by anyone
58. rt 820 20 UL standard for safety UL 60601 1 21 CSA Standard for safety CSA 22 2 No 601 1 22 Canadian Medical Devices Regulation SOR 98 282 23 Medical electrical equipment Part 2 61 Particular ISO 80601 2 61 requirements for basic safety and essential performance of pulse oximeter equipment 1 7 CE and CSA Compliance The product complies with MDD 93 42 EEC 1993 amp 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 207233 1 8 Conventions Used in this Manual Note Throughout this document the references WatchPAT WatchPAT 200U and WP200U device are used to refer to the WatchPATTM200 Unified device 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 ignor es peuvent porter atteinte la s curit des patients ou causer des dommages au syst me et r sulter une perte irr versible des donn es WatchPAT 200U System 4 Operation Manual Cautions are used to identify conditions or actions which could cause interference with data acquisition and or impair study results Les pr cautions sont utilis es affin d identifier les cond
59. standard Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 6 Degrees of protection provided by enclosures IP Code IEC 60529 P22 T Quality management systems requirements ISO 9001 2008 8 Medical devices Quality management systems EN ISO 13485 2012 Requirements for regulatory purposes 9 Medical devices Quality management systems CAN CSA ISO Requirements for regulatory purposes Health Canada 13485 2003 10 Medical devices Application of risk management to ISO 14971 medical devices 11 Medical devices Symbols to be used with medical device ISO 15223 1 labels labelling and information to be supplied General requirements 12 Symbols for use in the labelling of medical devices EN 980 13 Graphical symbols for electrical equipment in medical IEC TR 60878 practice 14 Graphical symbols Safety colours and safety signs ISO 7010 M002 Registered safety signs refer to instruction manual booklet 15 Information supplied by the manufacture with medical EN 1041 devices 16 Biological evaluation of medical devices Part 1 ISO 10993 1 Evaluation and testing 17 Medical devices Application of usability engineering to BS EN 62366 medical devices WatchPAT 200U System 3 Operation Manual 18 Medical Device Directive MDD 93 42 EEC MDD 2007 47 EC 19 FDA Quality Systems Regulation QSR 21 CFR pa
60. t connected to it Select a Tamper Proof Bracelet for the study Connect the gray cable with the red and white connectors to the WatchPAT device socket 48 Make sure the zzzPAT version 1s 4 2 58 or higher Make sure the WatchPAT device embedded software version is 2 2176 or higher Make sure you enabled the Tamper Proof Testing option from the zzzPAT Setup menu gt General Settings M Study with Tamper Proof Testing Synchronize WP200 clock with PC clock while Saving to LISB WP200 clock 09 06 2008 03 44 OSS wees DATE E GCE ASS AN 2 eH 10 OK Operation Manual Connecting the Connect the red and white connectors ae other side of the gray cable to the red and white snaps on the bracelet respectively Pairing the Perform the regular site diagnostic test WP200U device test as described in the user device and the manual Bracelet Make sure the bracelet is connected Site Diagnostic before starting the test Test After tests passed successfully disconnect the bracelet from the WatchPAT device and store them together Note Once the device testing has been done with the bracelet connected the SPECIFIC bracelet must be used with the specific WP200U NO OTHER BRACELET WILL WORK WITH THIS WatchPAT device A unique ID of this bracelet 1s registered in the WatchPAT M device WatchPAT 200U System 49 Operation Manual Placin
61. t is connected the wrong bracelet error message appears e fthis is study with the tamper proof bracelet and the bracelet is not connected the connect bracelet error message appears in order to remind the patient to connect the bracelet The following are the possible error warning messages xxx battery low xx2x uPAT probe error used probe xx4x File error no new file xx8x uPAT probe error bad probe x4xx SBP Snore and Body Position sensor missing warning Note The x stands for 0 F value Hexadecimal code Error codes are additive 1 e both uPAT probe and File errors will produce error code xx6x WatchPAT 200U System 17 Operation Manual 3 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 1 Gently slide the WatchPAT device out of the wrist strap until a click is heard and the USB port 1s exposed 2 Connect the USB port of the WatchPAT device to the AC adapter provided see Figure 6 Warning For charging use only an AC adapter having a5V DC output with SW minimum capacity Using any other AC adapter may cause permanent damage to the WatchPAT and may jeopardize the operator Figure 6 Charging the WatchPAT Device 3 The LCD will blink slowly and the following screen will be displaye
62. tchPAT 200U System 7 Operation Manual Authorized representative in the European Community 1 12 WatchPAT 200U Device Labels aul tamar Medical Ltd iad edical L Located on WatchPAT 200U device 9 Halamish St 2072337 IP22 3 7VDC Located on WatchPATTM200U device 1 13 FDA information The WatchPAT200U is cleared by the FDA under K133859 trade name Watch PAT 200U WP200U WatchPAT 200U System 8 Operation Manual 2 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 The diagnosis and assessment of the sleep apnea patient is based on the Respiratory Disturbance Index RDI the number of Apneas Hypopneas and Respiratory Effort Related Arousals RERA per hour of sleep along with sleep architecture The common consequences of this sleep disruption are daytime sleepiness poor daytime performance and increased vulnerability to accidents Cardiovascular complications such as systemic pulmonary hypertension ischemic heart disease and arrhythmias are the major sequel of OSAS in the adult population The WP200U is worn on the wrist and is utilizing a plethysmographic based finger mounted
63. the Battery Warning Replace the battery only with an authorized battery provided by Itamar Medical Ltd In the event of a battery error message during the self diagnostic tests or after charging it may be necessary to replace the battery To replace the battery 1 Open the battery compartment cover with a Phillips screwdriver WatchPAT 200U System 30 Operation Manual 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 Remove the battery 4 Insert the new battery into the battery compartment 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 Close the battery compartment cover and secure back the screw Battery compartment cover Battery Battery Connector Closed pin Connector Figure 19 Replacing the Battery Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations 6 5 Setting the Time and Date of the WatchPAT device The WatchPAT device Time and Date can be set through the zzzPAT application Refer to the zzzPAT Software Manual for preparation of the WatchPAT device for a new study WatchPAT 200U System 31 Operation Manual 6 6
64. uration of arterial haemoglobin SpO2 This appendix includes information regarding the accuracy of these measurements following a clinical study of Itamar Medical Pulse Oximetry 1 Overall the Arms is estimated to be 3 1 for the range 70 100 2 The next table shows SpO2 Accuracy Results Test Device SpO2 67 100 SpO2 90 100 SpO2 80 90 SpO2 70 8090 Arms Bias Arms Bias Arms Bias Arms Bias WatchPAT M200U Finger Sensor Set Arms 2 1 726 pts Arms 1 4 255 pts Arms 1 9 227 pts Arms 2 7 225 pts 2 H series Bias 0 6 Bias 0 6 Bias 0 9 Bias 1 5 3 The next table shows the Bland Altman plot for Itamar Medical WP200U WatchPAT 200U System 64 Operation Manual Bland Altman Itamar WatchPAT 200 Finger Sensor Set 2 Hi Non Motion Conditions 11 Subjects May 8 10 2013 Itamar Medical Ltd SO1 S02 S03 SOA S05 SO6 S07 SOS s09 10 11 S01 1 SO2 1 S03 1 S04 1 S05 1 S06 1 S07 1 08 1 S09 1 10 1 11 1 S01 2 S02 2 S03 2 S04 2 S05 2 S06 2 S07 2 S08 2 S09 2 S10 2 S11 2 e Upper LOA lower LOA O0O0000000 O Nis P en D 9 04299 Nos gt A by 2 A Bos Ota 65 Vo x o MONS s 800 ESSO a8 EVA SAN 6 L apa 2 6 o9 e o9 O o O 299 _ MAL O N o co n g v x Q O O w N O Qa n j lt x a co w Q tz E w a gt LL LR 000606000080 Re
65. ure 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 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 6 1 Cleaning The various components of the WatchPAT device have different cleaning requirements e The WatchPAT device e The wrist strap e The Snore amp Body Position sensor 6 1 1 Cleaning the WatchPAT Device There is no need to clean the unit during ordinary operation Should it become necessary to clean the WatchPAT device proceed as follows Wipe parts with a clean dry lint free cloth Clean casing with lint free cloth lightly moistened with 70 ethyl alcohol or isopropyl alcohol IPA Warning Clean the WatchPAT device only with the uPAT probe attached 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 Remove WatchPAT device from wrist strap Immerse wrist strap in 70 ethyl alcohol or isopropyl alcohol IPA WatchPAT 200U
66. ures 2 4 1 Operator Tests The WatchPAT 200 unified contains a comprehensive built in self diagnostic procedure This procedure is available to the operator and hidden from the patient The procedure can be accessed if the UP and DOWN keys see Figure 3 are pressed simultaneously after the device is powered ON during the first 30 seconds only after the device is powered ON The procedure performs the following test e Device Test tests the WatchPAT for errors before performing a night study make sure all sensors are connected before initiating this test Note In all times the current time is shown in the upper right hand corner of the LCD display To run the self diagnostic procedure e Press the ENTER button Center key for 2 seconds till the Itamar medical logo appears on the LCD screen e Immediately press the UP DOWN keys see Figure 3 simultaneously for 1 second WatchPAT 200U System 14 Operation Manual The following screen will be displayed DIAGNOSTIC PL 2 2140 20 Jul 08 device test 30001 end testing Select test T e First line displays title and current time e Second line displays current embedded S W version 2 2139 and current date e Third line displays option for running device test serial number of device in parenthesis e Fifth line indicates option for end testing turn device off If no test is selected within 3 minutes the WatchPAT device will automatically shut down e T
67. ved for use on electrical fires Handle unit with care This unit is sensitive to extreme movements and to falling Do not attempt to connect or disconnect any part of the unit Do not try to introduce any foreign object into the unit The WP200U MUST be charged ONLY after being removed from the patient The WP200U MUST be removed from the patient BEFORE connecting it to a PC AVERTISSEMENTS Utiliser seulement un 5V DC 5W alimentation d nergie Seul les techniciens autoris s peuvent charger la montre PAT Ignorer cet avertissement peut causer des dommages irr parables a l quipement Ne pas mouiller l unit L unit est sensible au mouvement extr me est la chute L utiliser avec pr caution Ne pas essayer de brancher ou d brancher une des parties de l unit Ne pas introduire un objet tranger a l int rieur de l unit Le syst me WP200U doit tre recharge uniquement apr s avoir t retir de la main du patient l est imp ratif de retirer le systeme WP200U de la main du patient avant de le relier a l ordinateur pour faire fonctioner les programmes WatchPAT 200U System 6 Operation Manual 1 11 Symbols Used on the Product Labels The product is marked with the CE logo 0473 for Intertek Ingress protection 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 Wa
68. y 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 WatchPAT 200U System 37 Operation Manual 8 PATIENT TRAINING GUIDELINES 8 1 Walk Through the Process of Using the WatchPAT device e Product introduction WatchPAT device wrist strap uPAT probe e WatchPAT device and wrist strap attachment e Probe and sensor attachment e Switch on e Ending the study 8 2 Product Introduction e Open the Demo case and introduce the Quick guide step by step instruction manual e Introduce each component by its name and identify it as in the figures in the manual 8 3 Applying the WatchPAT device Use the Demo Kit e Demonstrate how to apply the WatchPAT device on your wrist while following the step by step guidelines and referring to the relevant figures e Demonstrate the following 1 Hand Preparation e Remove rings watches and jewelry from hand e Remove fingernail polish and artificial nails e Make sure index finger nail is closely trimmed 2 Attaching the Snore amp Body Position Sensor optional e The sensor is attached to the patient s chest right under the sternal notch The sternal notch 1s the little U shape where the collar bones meet at the top of the breast bone e Attach the round double sided adhesive sticker to the blue side of the sensor To position the sens

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