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1. 27 Figure 16 WatchPAT Device with Cable for Bracelet 28 Figure 17 WatchPAT Device with Bracelet 28 Figure 18 Bracelet and WatchPAT Device on a Patient s Hand 28 Figure 19 Cut the Bracelet at the Specified Location 29 Figure 20 Case for a Night Multi Night Study 29 Figure 21 Replacing Oximetry Sensor 33 Figure 22 Probe with Screw I nennen nnt 34 Figure 23 Replacing the PAT Probe 34 Figure 24 Replacing the Battery 35 Figure 25 Finger Designation 38 Figure 26 Putting On the Wrist Strap 38 Figure 27 Wearing the WatchPAT Device 38 Figure 28 Removing Adhesive Cover 39 Figure 29 Positioning Oximetry On Ring Finger 39 Figure 30 Fold Top Flap and Short Flap 39 Figure 31 Wrap The Long
2. 31 6 4 Cleaning the Wrist Strap 32 6 5 TEPAT PODE m i o LOL 32 6 6 The Snore amp Body Position Sensor 32 6 7 alere 32 6 8 Replacing the Oximetry Sensor 32 6 9 Replacing the PAT Probe Cable 33 6 10 Replacing the Battery uuu usa xo Ero 34 6 11 Setting the Time and Date of the WatchPAT Device 35 6 12 Storing the WatchPAT Device 36 7 APPLYING THE WATCHPAT DEVICE 37 7 1 Preparing for Use of the WatchPAT Device 37 7 2 Applying the WatchPAT Device 38 7 3 Applying the Oximetry Sensor 39 7 4 Attaching the Probe uuu 40 7 5 Switching On the WatchPAT Device 42 7 6 When YOU Wake Up uu esca tuna us eonun cota eH 42 7 7 Important 5 42 8 PATIENT TRAINING GUIDELINES 44 8 1 Walk Through the Process of Usi
3. an eonun o oua eo voee 39 Figure 32 Flexiwrap Line Indication 40 Figure 33 Placing Finger PAT Probe eren 41 Figure 34 Removing TOP Tab iiie rini eie oe eua Uo gave saeva oo wawayqa 41 Figure 35 Removing BOTTOM Tab 41 Figure 36 Wearing the WP200 Ready for Sleep 41 List of Tables Table 1 Operator Troubleshooting esse 47 Table 2 Patient Troubleshooting eere eere 48 Table 3 WatchPAT 200 Device Specifications 49 WatchPAT 200 System vii Operation Manual 1 GENERAL INFORMATION This manual is part of the WatchPAT 200 system 1 1 Intended use Indications for Use The WatchPAT 200 WP200 device is a non invasive home care device for use with patients suspected to have sleep related breathing disorders The WP200 is 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 WP200 generates a peripheral arterial tonometry PAT Respiratory Disturbance Index PRDI Apnea Hypopnea index PAHI PA
4. 19 Charging the Battery 19 Preparing the Oximetry Sensor 20 Preparing the Snore and Body Position Sensor 22 Preparing the Wrist Strap 22 Mounting the WatchPAT Device on the Wrist Strap 23 Replacing the PAT Probe 23 Preparing the WatchPAT Device for a New Study 24 Testing the WatchPAT Device 24 WP200 Device Self diagnostic Test Results and Trouble shooting 24 Packing the Carrying Ca ico uuu Exo a aee 25 OPTIONAL FUNC TIONS uu uu u nes nexus Gua u ugs Es uni au 26 Using the Integrated Snore amp Body Position Sensor 26 Tamper Proof Testing with WatchPAT Device 26 Multi night study 29 DATA DOWNLOAD AND ANALYSIS 30 MAINTENANCE suu aus mamans esse 31 WatchPAT 200 System IV Operation Manual 6 1 eee 31 6 2 Cleaning the WatchPAT Device 31 6 3 Cleaning the Oximetry Sensor
5. 1 EXCIUSION Citi IO 02100 utuy c uid edel a end V eiu suwas 2 Data Generated by the WatchPAT 200 Device 2 Equipment Classification T 2 Quality Assurance System ISO 9001 amp ISO 13485 3 CE and CSA Compliancoes 4 Conventions Used in this Manual 4 Warnings Cautions and Notes 5 Safety Precautions 6 Environmental protection 7 Symbols Used On the Product Labels 7 WatchPAT 200 Device Labels 8 gPP WInelgnurieie td 8 OVERVIEW uu uuu eo uasa tas Ei ae a cs ao Dd Mare 9 System Description J J 10 User Interaction with the WatchPAT Device 11 WatchPAT Device Function 13 Built In Self Diagnostic Procedures 14 PREPARATION FOR SLEEP STUDY
6. 7 7 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 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 WatchPAT 200 System 42 Operation Manual 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 any circumstances attempt to fix the problem yourself If you have any questions about using the machine before during or after your at home recording session call the service number WatchPAT 200 System 43 Operation Manual 8 PATIENT TRAINING GUIDELINES 8 1 Walk Through the Process of Using the WatchPAT Device e Product introduction WatchPAT device wrist strap PAT probe oximetry sensor 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 ho
7. 70 UT 80 dip in UT for 25 cycles lt 5 UT lt 5 UT gt 95 dip in UT for 5 s Compliance level 6 kV contact 8 kV air 2 kV for power supply lines Not Applicable 1 kV differential mode 2 kV common mode lt 5 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 WP200 requires continued operation during power mains interruptions it is recommended that WP200 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
8. Itamar medical WatchPAT 200 Operation Manual Itamar Medical OM2196330 Caution Federal U S law restricts this device to sale by or on the order of a physician Not for pediatric use Copyright 2002 2015 By Itamar Medical Ltd WatchPAT and are trademarks of Itamar Medical Ltd This manual and the information contained herein are confidential and are the sole property of 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 WatchPAT 200 device 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 Jtamar 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 application
9. 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 15 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 200 System 36 Operation Manual 7 APPLYING THE WATCHPAT DEVICE Note These instructions are designed to help the patient use the WatchPAT device after seeing a demonstration by trained personnel of how to mount the probes on his her fingers and correctly operate the WatchPAT device The following detailed instructions are summarized in the patient s step by step reference guide They are written as if the reader is the patient using the WatchPAT device 7 1 Preparing for Use of the WatchPAT Device e Before using the WatchPAT device review the following notes e Remove tight clothing rings watches and jewelry from your non dominant hand and wrist and from your neck and chest e The probes may be worn on any two fingers of your non dominant hand We recommend that the oximetry sensor and PAT probe be attached to the ring and index fingers respectively Figure 25 The following instructions relate specifically to these fingers Patients with very large fingers may use their small finger pinky for the PAT Probe e Ensure that fingernails of f
10. generality of the above you may not e distribute reproduce copy assign rent lease or otherwise transfer the rights granted to you under this License Agreement to any third party except explicitly as set forth 1n 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 WatchPAT 200 System 60 Operation Manual not remove or destroy any copyright trademark logo or other proprietary marking or legend placed on or contained in the Licensed Software or a Licensed Product 4 LIMITED WARRANTIES AND DISCLAIMERS a Against Infringement Itamar hereby warrants to you that it has the right to grant you the license to use the Licensed Software and or the Licensed Product and to enter into
11. 33 Placing Finger in PAT Probe Figure 34 Removing TOP Tab Figure 35 Removing BOTTOM Tab Figure 36 Wearing the WP200 Ready for Sleep Note DO NOT remove the PA T probe before the night study 1s terminated Once the probe is removed it cannot be re attached Note If the Snore amp Body position sensor is included in the WatchPATTM device case see Appendix A WatchPAT device Integrated snoring body positioning Sensor operating instructions WatchPAT 200 System 41 Operation Manual 7 5 Switching On the WatchPAT Device You are now ready to switch on the WatchPAT device Just before you lie down to go to sleep firmly press the ON Enter center button Figure 3 until the LCD display lights up After a short delay the LCD will display Good Night Recording PATIENT 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 6 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 The oximetry sensor red light will remain lit Approximately ten hours after the WatchPAT 1s turned on it will switch off This 1s normal
12. 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 5 When charging is complete the LCD will stop blinking and the following screen will be displayed CHARGER Bat 4 2 V Charging complete 6 Disconnect the AC adapter or communication cable The WatchPAT device will switch off in 30 seconds 7 Reseat the WatchPAT device in the wrist strap by gently sliding it back in until a click 1s heard 8 Check that the oximetry module connector is properly connected to the WatchPATTM Should a charging error arise the LCD will blink rapidly and the following screen will be displayed CHARGER Bat 4 2 V Charger fault 3 2 Preparing the Oximetry Sensor Use Nonin 8000JFW Flexi wrap pad and Nonin oximeter as supplied WatchPAT 200 System 20 Operation Manual pL Figure 7 Oximetry Sensor 1 If the sensor was previously used carefully remove the used Flexi wrap pad from the sensor Remove any remaining adhesive from the sensor if necessary clean the sensor using 7040 ethyl alcohol or isopropyl alcohol IPA 2 Place the new Flexi wrap pad with the printed side facing down on a flat surface 3 Partially peel off the paper covering of the pad to expose the adhesive area aroun
13. Compatibility Notes e The WatchPAT 200 requires special precautions with regard to electromagnetic compatibility 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 WP200 e The recommended separation distances in this section must therefore be complied with e The WP200 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 WP200is 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 60601 1 2 2007 Guidance and manufacturer s declaration electromagnetic emissions WP200 The WP200 is intended for use in the electromagnetic environment specified below The customer or the user of the WP200 should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance RF emissions The WP200 uses RF energy on
14. K102567 trade name Watch PAT 200S 3 WP200S 3 and under K081982 trade name Watch PAT 200S 2 WP200S 2 WatchPAT 200 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 1s 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 WatchPAT device is worn on the wrist and is utilizing a plethysmographic based finger mounted probe to measure 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 a
15. LIST 74 WatchPAT 200 System vi Operation Manual List of Figures Figure T Packed DEVIC e aaa 11 Figure 2 WatchPAT Device with Sensors 11 Figure The Buttons and Display 12 Figure 4 Service Ports and Peripherals 13 Figure 5 WatchPAT Wrist with Oximetry Module 13 Figure 6 Charging the WatchPAT device 19 Figure 7 Oximelry SCNSON cei ce eet men cx a oe vue ctas uos avt c ec uu uU E EDU 21 Figure 8 Preparing the Nonin Oximetry 21 Figure 9 Wrist Strap e 22 Figure 10 Disconnecting the Probes 23 Figure 11 Probe Disconnected 23 Figure 12 A WatchPAT Device Fully Prepared 24 Figure 13 The Snoring and Body Position 26 Figure 14 WatchPAT Device with Tamper Proof Bracelet 27 Figure 15 Bracelet on Patient s Hand
16. 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 200 System 51 Operation Manual Snoring and Body Position Accuracy This section gives statistical performance measure for Itamar Medical s SBP sensor when used with the WatchPAT device Body Position The body position measured by the WatchPAT device with Itamar SBP sensor was compared to the gold standard manual scoring of the video recording of 31 patients in 1 minute s epochs total of 7111 epochs during sleep 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 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 head The study included 26 patients and the analysis was done in 30sec epochs The correlation coefficient was calculated using Pearson method assum
17. 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 200 System 30 Operation Manual 6 MAINTENANCE The WatchPAT device has been designed and manufactured to meet all safety requirements applicable to medical equipment To ensure maximum safety of operation the system should be used and maintained in strict compliance with the safety precautions warnings and operating instructions provided in this Manual 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 system have different cleaning requirements e The WatchPAT device e The wrist strap e The oximetry sensor e The Snore amp Body Position sensor 6 2 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
18. WatchPAT 200 System 58 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 provided in Sect
19. been repaired or altered by anyone other than Itamar or a person or entity authorized by Itamar to repair Licensed Products While every reasonable effort has been made to ensure that you will receive Licensed Software that you can use Itamar does not warrant that the functions of the Licensed Software will meet your requirements or that the operation of the Licensed Software will be uninterrupted or error free 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 IS IN TOR
20. device only with the PAT probe attached 6 3 Cleaning the Oximetry Sensor The Nonin pulse oximetry sensor has two parts the single use adhesive band and the optical sensor with cable and plug The sensor cable component is reusable and should be cleaned as described in section 3 23 2 WatchPAT 200 System 31 Operation Manual 6 4 Cleaning the Wrist Strap You may clean the wrist strap with lint free cloth lightly moistened with 70 ethyl alcohol or isopropyl alcohol IPA In order to disinfect the wrist strap by immersing into disinfecting liquid follow the steps Remove WatchPAT device from wrist strap Remove Nonin module from wrist strap Immerse wrist strap in 70 ethyl alcohol or isopropyl alcohol IPA 6 5 The PAT Probe The PAT probe is designed for a single use only It may not be cleaned and must be discarded and replaced before each study 6 6 The Snore amp Body Position Sensor Using 70 ethyl alcohol thoroughly clean both sensor and cable 6 7 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 WP200 to extreme temperature or humidity conditions such as storing in a car or bathroom 6 8 Replacing the Oximetry Sensor Should it become necessary to replace the oximetry sensor proceed as follows l Carefully disconnect the oximetry sensor from the oximetry module on the wrist strap Make sure you remov
21. 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 conditions ou les actions qui peuvent interf rer avec le ramassage de donn es et provoquer des r sultats quivoque WatchPAT 200 System 4 Operation Manual 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 WatchPATTM200 device is internally powered from a 4 2 V battery The WatchPATTM200 device is portable with continuous operation The WatchPAT 200 device uses BF patient applied parts The WatchPAT 200 device uses UL listed power supply USA amp Canada only The power supply is used in a non patient environment only The WatchPATTM200 device should only be transported in its original case There are no serviceable parts inside the WatchPAT 200 device Do not use WatchPAT 200 device for non indicated purpose such as oximetry for ICU patient monitoring or alarm device Environmental conditions during transportation amp storage See Specifications section Environmental conditions during operation See Specifications section Sleep professionals other than patients using the WatchPATTM200 system should read t
22. o LCD display PAT probe oO o PAT9 probe connection cable e Pulse oximeter sensor with single use adhesive pads e Wrist Strap e Snore and Body Position sensor optional e Cable for 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 200 System 10 Operation Manual Figure 1 Packed Device PAT probe Oximetry sensor Optional Snore amp Body Position sensor Figure 2 WatchPAT TV Device with Sensors An additional item required for the operation of the system is the zzzPAT kit zzzPA T 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 device has the following keys see Figure 3 e Central On Enter key to power on the WatchPAT device the only key visible to the patient e 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 These keys are hidden from the patient WatchPAT 200 System 11 Operation Manual UP LCD RIGHT ON ENTER LEFT asa Figure 3 The Buttons and Display LCD Display The display is use
23. properly e Make sure it is not too tight 6 Attaching the PAT 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 Tab s must be fully removed 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 e The oximetry sensor light will glow red during the entire test 8 5 Removing the WatchPAT Device e Demonstrate how to remove the WatchPAT device and place it back in the carrying case e The oximetry sensor light will keep glowing red WatchPAT 200 System 45 Operation Manual 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 done Especially monitor carefully attachment of the oximetry sensor 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 200 System 46 Operation Ma
24. 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 26 4 At this point both probes are hanging loose Figure 27 Figure 26 Putting On the Wrist Strap Figure 27 Wearing the WatchPAT Device WatchPAT 200 System 38 Operation Manual 7 3 Applying the Oximetry Sensor Now you will attach the oximetry sensor to your ring finger as was demonstrated to you and is illustrated in the figures below Please proceed as follows l 2 Figure 28 Removing Adhesive Cover Remove the adhesive strip from the unit see Figure 28 Position the oximetry sensor on your ring finger with the wire on the bottom side of the finger see Figure 29 the finger should reach the centerline marker on the pad Fold the bottom short flaps around your finger see Figure 29 Fold top flap over the finger and fold the short flap around your finger see Figure 30 Complete this procedure by wrapping the long flap around the short wrapped flaps see Figure 31 Ensure that the dotted line of the Flexi wrap pad is properly located as indicated by the arrow see Figure 32 and that
25. 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 1n 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 1s intended to perform Itamar shall a attempt to correct or assist you around errors
26. to application of the test level WatchPAT 200 System 68 Operation Manual Table 4 from IEC 60601 1 2 2007 Guidance and manutfacturer s declaration electromagnetic immunity WP200 The WP 200 is intended for use in the electromagnetic environment specified below The customer or the user of the WP200 should assure that it is used in such an environment IEC 60601 1 2 Compliance Immunity test level Electromagnetic environment guidance Test level Portable and mobile RF communications equipment should be used no closer to any part of the WP200 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 P Conducted RF 3 Vrms IEC 61000 4 6 150 k Hz to 80 MHz d 1 17VP 80 M Hzt o 800 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 is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation 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 NOTE 2 These guidelines apply all situations Electromagnetic propagation is a
27. unit Ne pas introduire un objet tranger a l int rieur de l unit Le syst me WatchPAT 200 doit tre recharg uniquement apr s avoir t retir de la main du patient l est imp ratif de retirer le systeme WatchPAT 200 de la main du patient avant de le relier a l ordinateur pour faire fonctioner les programmes L Oxymetre pur adulte Flex Pulse peut produire des sensibilit s dermatologique aux patients WatchPAT 200 System 6 Operation Manual 1 11 Environmental protection The WatchPAT 200 device including its accessories shall be treated in accordance with the local laws and regulations for proper waste treatment 1 12 Symbols Used On the Product Labels Follow instructions for use Type BF applied part The product is certified by CSA The product complies with the CE mark according to MDD Medical Device Directive and related standards The product is marked with the CE logo Battery Operating Voltage Single use do not re use Medical device Manufacturer Catalogue Number WatchPAT 200 System 7 Operation Manual 1 13 WatchPAT 200 Device Labels SN wal llamar Medical Ltd Located on WatchPAT 200 device 9 Halamish St Caesarea 3088900 Israel ISN AN5O XXX LEDI IDIIN DOD IIE III REF AS22503XX Located on Nonin module 3 7VDC Located on WatchPAT 200 device 1 14 FDA information The WatchPAT200 is cleared by the FDA under
28. xxx2 Nonin module sensor disconnected xx2x PAT probe error used probe xx4x File error no new file xx8x PAT probe error bad probe 4 SBP Snore and Body Position sensor missing warning Note The x stands for 0 F value Hexadecimal code Error codes are additive i e both probe and File errors will produce error code xx6x WatchPAT 200 System 18 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 Disconnect Oximetry module by disconnecting the Oximetry module connector 2 Gently slide the WatchPAT device out of the wrist strap until a click is heard and the USB port is exposed Be careful not to damage the oximetry module connector and cable 3 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 4 The LCD will blink slowly and the following screen will be displayed WatchPAT 200 System 19 Operation Manual CHARGER Vv Charging e The display will show
29. 56 Operation Manual 4 Placing the Make sure you have all 3 parts the Bracelet on the bracelet and two white plastic parts Subject Place the bracelet upside down on a flat surface white side facing up Insert the white plastic part into the two separated holes flat side facing up 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 1s some loose strap left fold it and re insert it into the holes DO NOT CUT LOOSE STRAP Secure the bracelet by placing the second white plastic part on top of the first Make sure it 15 secured tightly CUTTING IT WILL RENDER BRACELET UNUSABLE WatchPAT 200 System 57 Operation Manual Explain to The subJect may choose to perform Subject the 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 the bracelet
30. 7 91 53 32 58 5 94 56 15 59 66 5553 6 37 1147 42 66 555 53 97 57 10 5 92 1024 44 66 58 5643 59 21 61 6 31 10 78 43 68 585 56 82 60 14 62 656 1102 46 68 60 5745 6148 61 12 64 71 5 67 16 67 96 7 66 78 2 67 413 55 68 65 63 50 65 61 K 69 48 The results are also presented in the next figure The figure presents the mean WatchPAT device with SD error bar WatchPAT 200 System 53 Operation Manual e e Itamar Mean Snore dB cn on e 35 35 40 45 50 55 60 65 70 75 PSG Snore Values dB Summary statistics mean SD of WatchPAT 200 device by dB meter levels WatchPAT 200 System 54 Operation Manual APPENDIX B TAMPER PROOF TESTING WITH THE WP200 Important This short guide is designed to Make sure the zzzPAT version 15 Notes instruct a trained operator of the 4 2 58 or higher WatchPAT device on how to Make sure the WatchPATTM testi device embedded soltware version with the bracelet amp the WatchPAT is 2 2176 or higher device For complete WatchPAT training amp instructions please refer to Make sure you enabled the the WatchPATTM device user manual Tamper Proof Testing option and to the zzzPAT user manual from the zzzPAT Setup menu gt General Settings Preparing a While preparing the new study on the New Study on zzzPAT refer to the user manual for ZZZPAT detailed instruct
31. ENT 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 is 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 NO WAIV
32. ER 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 WatchPAT 200 System 63 Operation Manual 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 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 co
33. Operation Manual 3 5 Mounting the WatchPAT Device on the Wrist Strap To mount the WatchPAT device on the wrist strap 1 Gently slide the WatchPAT device into the wrist strap until a click is heard indicating that it is properly seated 2 Connect the oximetry module connector Figure 9 to the oximetry module port on the WatchPAT device Figure 4 3 6 Replacing the PAT Probe Warning The PAT 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 blue tab clip marked by the arrow in Figure 10 and then holding the gray 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 10 Disconnecting the Probe Figure 11 Probe Disconnected Connect a new probe by inserting the gray slider to the probe until the blue tab of the probe clicks into its place Note Take care when inserting the gray slider to insure proper seating in the probe WatchPAT 200 System 23 Operation Manual The WatchPAT device is now ready to perform a sleep study by the patient Figure 12 Snore and Body Position sensor PAT probe Oximetry sensor Figure 12 A WatchPAT Device Fully Prepared 3 7 Prepar
34. T 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 1 NOTIFY ITAMAR IN WRITING PROMPTLY UPON BECOMING AWARE OF AN INFRINGEMENT CLAIM OR THE POSSIBILITY THEREOF ii GRANT WatchPAT 200 System 62 Operation Manual ITAMAR SOLE CONTROL OF THE SETTLEMENT COMPROMISE NEGOTIATION AND DEFENSE OF ANY SUCH ACTION AND iii PROVIDE ITAMAR WITH ALL INFORMATION RELATED TO THE ACTION THAT IS REASONABLY REQUESTED BY ITAMAR NOTWITHSTANDING THE FOREGOING ITAMAR SHALL HAVE 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 INFRINGEM
35. T sleep staging identification PSTAGES and optional snoring level and body position discrete states from an external integrated snoring and body position SBP sensor The WP200 s PSTAGES and SBP provide supplemental information to its PRDI PAHI The WP200 s PSTAGES and SBP are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder prescribing treatment or determining whether additional diagnostic assessment is warranted The WatchPAT 200 device is not indicated for children less than 17 years old 1 2 Restrictions for Use 1 The WP200 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 WP200 3 Qualified medical personnel must instruct the patients how to attach and use the WP200 prior to use 4 In 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 WP200 system in whole or in part may not be modified in any way 7 The WP200 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 WP200 equipment prior to
36. ances between portable and mobile RF communications equipment and the WP200 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 1 17VP d 1 17VP d 2 3 P 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 200 System 70 Operation Manual APPENDIX G SPO2 ACCURACY IN THE WP200 The WatchPAT 200 device uses Nonin module for SPO measurement Nonin module measurement wavelengths and output power parameters e Red 660 nanometers 0 8 mW maximum average e Infrared using NONIN PureLight Sensor 910 nanometers 1 2 mW maximum average This appendix includes information regarding the accuracy of these measurements according to module manufacturer information 1 Overall the ARMS is estimated to be 1 85 across the range of 70 to 100 percent saturation and with 95 co
37. attery gt 500 700 mAh Lithium Ion cell type Proprietary Lithium Ion battery charger 5V DC 5W with USB connector Operating Voltage 3 5 V Storage Device 20 C to 40 C Transport Device C C Sample Resolution C40 C 20 C to 60 Storage amp Transport 0 C to 40 Probe Humidity 1096 9396 non condensing Storage amp Transport 096 93 non condensing Atmospheric Operating amp Storage 10 15 psi m ad ae Dimensions 80 x 50 x 20 mm 170 gr excluding PAT probe weight of 20 gr IN cO WatchPAT 200 System Operation Manual APPENDIX A WP200 INTEGRATED SNORING BODY POSITIONING SENSOR OPERATING INSTRUCTIONS Must be used with zzzPAT v 4 3 and above and WatchPAT 200 Thank you for purchasing an Integrated Snore amp Body Position Sensor Description 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 It is automatically activated by the WatchPAT device 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 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 po
38. attery 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 200 System 34 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 Phillips screw Battery Battery Connector Closed 3 pin Connector Figure 24 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 11 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 200 System 35 Operation Manual 6 12 Storing the WatchPAT
39. ction The WatchPAT device records the following channels e PAT Signal e Oxygen saturation e Actigraphy movement e Acoustic decibel detector for Snoring evaluation optional e Body Position optional WatchPAT 200 System 13 Operation Manual 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 section Tamper Proof Testing with WatchPAT Device 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 Procedures 2 4 1 Opera
40. d 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 1 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 G with the Licensed Product s and i1 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 derogating from the
41. d 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 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 oximetry module port is used for connecting the oximetry module The oximetry module has 2 additional ports one for connecting the oximetry sensor and one for connecting the bracelet see Figure 5 e The PA T probe port is used for connecting the PAT probe 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 WatchPAT 200 System 12 Operation Manual PAT probe port Port for optional Snore amp Body Position sensor Oximetry module port USB port for charging Figure 4 Service Ports and Peripherals and communication Oximetry sensor Bracelet port Wrist strap Oximetry module Oximetry Module connector Figure 5 WatchPAT Wrist with Oximetry Module 23 WatchPAT Device Fun
42. d the two cut out sections 4 Place the sensor on the pad with the back facing the sticky side placing the sensor s protrusions into the corresponding cutout sections as shown in Figure 8 Reapply the paper covering of the pad Flexi wrap pad Oximetry sensor Figure 8 Preparing the Nonin Oximetry Sensor WatchPAT 200 System 21 Operation Manual Warning Nonin sensor Do not use a damaged sensor If the sensor is damaged in any way discontinue use Immedlately and replace the sensor Do not use caustic or abrasive cleaning agents on the sensors Do not autoclave or immerse in liquid of any kind 3 3 Preparing the Snore and Body Position Sensor Attach the small round double sided adhesive sticker to the white snoring sensor by peeling off the cover on one side of the sticker Apply the body positioning adhesive sticker by attaching the sticker s smaller side to the back side of the body position sensor without the Itamar logo For more details see Appendix A WP200 Integrated Snoring Body Positioning Sensor Operating 3 4 Preparing the Wrist Strap The wrist strap requires no special preparation other than ensuring its cleanliness You may clean it if needed Take care not to allow the oximetry module or connector to get wet see Figure 5 See section 6 1 for detailed cleaning instructions Oximetry module connector Oximetry module Figure 9 Wrist Strap WatchPAT 200 System 22
43. e 14 WatchPAT Device with Tamper Proof Bracelet Before the device is given to the patient for home sleep study the technician identifies the patient and secures the bracelet to the patient s wrist by a tamper proof connector that ensures the bracelet will not be removed without cutting the Bracelet F Ba Figure 15 Bracelet on Patient s Hand When preparing the WatchPAT device for a sleep study the technician pairs the Tamper Proof Bracelet and the device and registers the bracelet s unique ID in the WatchPATTM device see Appendix B Tamper proof testing with the WP200 device 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 bracelet s cable 2 connectors to the WatchPAT device The device will not start without connection to the paired Bracelet WatchPAT 200 System 27 Operation Manual Figure 16 WatchPAT Device Figure 17 WatchPAT Device with Cable for Bracelet with Bracelet Figure 18 Bracelet and WatchPAT Device on a Patient s Hand During the recording the device will periodically check the Bracelet connectivity The recording will be stopped if the connection to the Bracelet will be lost for the time exceeding a predefined limit After the recording is completed the patient can cut the Bracelet along the d
44. e the screw prior to disconnecting the sensor 2 Carefully insert the connector of the new oximetry sensor cable to the oximetry sensor port In the oximetry module on the wrist strap see Figure 21 noting proper alignment 3 round protrusions facing up Make sure you secure back the screw WatchPAT 200 System 32 Operation Manual Warning Use only the original screws that belong to the WatchPAT device Using different screws could harm the device Figure 21 Replacing Oximetry Sensor Note Please refer to the Service Manual or the support section of the Itamar Medical web site for preventive maintenance recommendations 6 9 Replacing the PAT Probe Cable To replace the PAT probe cable 1 Carefully disconnect the PAT probe cable from the WatchPAT device Make sure you remove the screw prior to disconnecting the PAT cable WatchPAT 200 System 33 Operation Manual Figure 22 PAT Probe with Screw 2 Connect a new PA T probe cable by gently inserting the connector into the WatchPAT device Make sure you secure back the screw Figure 23 Replacing the 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 10 Replacing the Battery Warning Replace the b
45. ensor The integrated sensor is powered by the WatchPAT 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 decibel detector It uses a very sensitive microphone that responds to snoring and other sounds in the audio range and converts them to a small analog voltage that provides a clear reliable indication of the presence of these sounds The body position sensor uses a 3 axis accelerometer that provides a signal directly proportional to the patient s sleeping posture supine prone right left and sit See Appendix A WP200 Integrated Snoring Body Positioning Sensor Operating 4 2 Tamper Proof Testing with WatchPAT Device The WatchPAT device Tamper Proof bracelet 1s 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 14 WatchPAT 200 System 26 Operation Manual Cable for bracelet Connector for bracelet on Oximetry module Bracelet id ae acm 4 NATS e 7 Figur
46. ffected 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 WP200 is used exceeds the applicable RF compliance level above the WP200 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the WP200 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m WatchPAT 200 System 69 Operation Manual Recommended Separation Distances The WP200 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled The user and or installer of the unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment emitters and the WP200 according to the maximum output power of the equipment as recommended in the table below Table 6 from IEC 60601 1 2 2007 Recommended separation dist
47. fore wait approximately for one minute for the saturation to stabilize when testing Back will move to the previous screen if the Left button is pressed 2 4 4 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 is 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 NIGHTS Time elapsed 9 50 Recording WatchPAT 200 System 17 Operation Manual 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 BiYror xxxx Device S N 2xxxxx 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 bracelet 15 connected the wrong bracelet error message appears e If this 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
48. gnetic 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 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 7 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 13485 Requirements for regulatory purposes Health Canada 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 sup
49. he Operation Manual WatchPAT 200 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 WatchPAT 200 Failure to heed this warning may cause permanent damage to the equipment Do not let the unit get wet Avoid placing food or water on any part of the system In the event of fire use only fire extinguishers approved for use on electrical fires Handle unit with care This unit is sensitive to extreme movements and to falling Do not attempt to connect or disconnect any part of the unit Do not try to introduce any foreign object into the unit The WatchPAT 200 MUST be charged ONLY after being removed from the patient The WatchPAT 200 MUST be removed from the patient BEFORE connecting it to a PC The Adult Flex Pulse Oximetry Sensor may cause skin sensitivity to the patient Discontinue use of the NONIN double backed adhesive tape strips if the patient exhibits allergic reactions to the adhesive material 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
50. ing a linear relation between the results of the two devices A statistically significant correlation was calculated between the two devices 0 65 p value lt 0 0001 The next figure shows a scatter plot of sleep disturbance Index produced by the WatchPAT device and dB meter with linear regression line e ew Itamar Snore dB cn an 35 35 40 45 5 55 60 55 70 5 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 WatchPAT 200 System 52 Operation Manual The next table presents the statistics of WatchPAT device measurements per dB meter calculation at that range PSG Coef Of Lower Upper DB N Mean _ Std Variation Min Max Median 95 95 Value 96 CI CI 40 41 18 41 41 76 42 42 93 3 44 44 44 45 09 5 46 30 46 46 86 7 47 82 45 48 45 49 49 08 50 49 60 51 50 28 52 50 59 53 56 51 79 54 253 51 71 578 1119 40 66 52 51 00 52 42 55 209 5185 5 49 1059 40 66 52 5111 52 60 56 52 72 5
51. ing the WatchPAT Device for a New Study Refer to the zzzPAT Software Manual for preparation of the WatchPAT device for a new study 3 8 Testing the WatchPAT Device Run the built in self diagnostic facility as described 1n Section 2 4 above 3 9 WP200 Device 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 200 System 24 Operation Manual 3 10 Packing the Carrying Case The following items must be placed inside the carrying case in their respective compartments see Figure 1 Packed Device The WatchPAT device mounted in the Wrist strap with the probe oximetry sensor 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 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 200 System 25 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 RATE A Integrated Sensor Sensor Attachment Figure 13 The Snoring and Body Position S
52. ingers that will be monitored are well trimmed less than Imm from nail bed with no jagged edges Clip and file nails if necessary e Remove artificial fingernails or dark nail polish from the monitored fingers e Patient sensitivity to Nonin oximetry sensor may vary due to medical status or skin condition Discontinue use if the patient exhibits allergic reactions to the adhesive material e Do not stretch the Nonin adhesive tape while applying the oximetry sensor This may cause inaccurate readings or skin blisters e You may need some assistance putting on the WatchPAT device If needed have someone present to assist you e 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 1s advised to sleep alone in the room WatchPAT 200 System 37 Operation Manual Ring finger Index finger Small pinky finger Figure 25 Finger Designation 7 2 Applying the WatchPAT Device To apply the WatchPAT device to your wrist 1 Open the carrying case and take out the wrist strap with the WatchPAT device mounted All parts should already be connected as illustrated in Figure 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
53. ion 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 AII 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 WatchPAT 200 the Site PAT200 the PAT 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 incorporated as a component within such Third Party Product WatchPAT 200 System 59 Operation Manual 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 stan
54. ions 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 87 the night study The WatchPAT Study with Tamper Praof Testing device will NOT function without a bracelet connected to it Bracelet Select a Tamper Proof Bracelet for Synchronize WP200 clock with PC clock while Saving to USE WP200 clack 09 06 2009 09 44 the study Connecting the Connect the gray cable with the red Cable to the and white connectors to the WP200 WatchPAT device socket WatchPAT 200 System 55 Operation Manual 4 Connecting the Connect the red and white Bracelet connectors other side of the eray cable to the red and white snaps on the bracelet respectively Pairing the Perform the regular site diagnostic WP200 and the test device test amp oxi test as Bracelet described in the user manual Site Diagnostic Test Make sure the bracelet 15 connected before starting the 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 WatchPAT NO OTHER BRACELET WILL WORK WITH THIS WatchPAT device A unique ID of this bracelet is registered in the WatchPAT System WatchPAT 200 System
55. ly 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 WP200 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 200 System 67 Operation Manual Table 2 from IEC 60601 1 2 2007 Guidance and manutfacturer s declaration electromagnetic immunity WP200 The WP200 is intended for use in the electromagnetic environment specified below The customer or the user of the WP200 should assure that it is used in such an environment 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 variations 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 lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles lt 5 UT
56. m WatchPAT 200 System 64 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 200 System 65 Operation Manual APPENDIX E DESCRIPTION OF THE WATCHPAT 200 PROBE The WatchPAT PA T probe is an opto pneumatic finger mounted probe Its role is to continuously measure the relative state of the vasomotor activity in the distal part of the finger based on a plethysmographic method The PAT probe is designed to cover the distal part of the finger with a uniform pressure field extending to the tip of the finger 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 improves 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 PAT probe is an integral part of the WatchPAT device WatchPAT 200 System 66 Operation Manual APPENDIX F MANUFACTURING DECLARATION ACCORDING TO IEC 60601 1 2 Electromagnetic
57. nfidence ranges from 1 59 to 2 3 2 The next table shows Anws values measured using the Nonin module Range of SpO 95 confidence level 70 80 2 296 3 450 80 90 1 034 1 470 90 100 1 021 1 567 3 The next figure shows the A Bland Altman plot of the Bias SpO2 SaO versus the Mean 2Sa0 2SpO Solid gray lines represent the mean bias Dashed gray lines represent the 95 limits of agreement WatchPAT 200 System 71 Operation Manual Bias 0 Bias 15 Limits of Agreement Linear Regression 10 Spo Sat 10 15 7l Source of data Title Version Date Report ID Clinical Investigator s Sponsor Device s Study Date s WatchPAT 200 System 1 2 3 4 5 T B al 40 100 5 0 2 96 Verification of SpO2 Accuracy Performance of OEM III Pulse Oximeter Module rev 14 in Non Motion Conditions B 2010 01 27 QATR5334 Abbreviated Hypoxia Research Laboratory Department of Anesthesiology M1427 UCSF San Francisco CA 94143 0542 Nonin Medical 13700 Ist Avenue North Plymouth MN 55441 5443 Non Motion OEMIII 8000J July 19 2006 through July 20 2006 72 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 b
58. ng the WatchPAT Device 44 8 2 Product Introduction 44 8 3 Applying the WatchPAT Device 44 8 4 Switching on the WatchPAT Device 45 8 5 Removing the WatchPAT Device 45 8 6 Patent 50e apanapak pasa 46 8 7 Review Safety General and Functional Issues 46 9 TROUBLESHOOTING QUIDE 47 9 1 Operator Error Messages sn nn ma au enue 47 9 2 Patient Error Messages 48 10 SPECIFICATIONS 2 525 suu ESPKE usss Er PRESE 49 APPENDIX A WP200 INTEGRATED SNORING BODY POSITIONING SENSOR OPERATING INSTRUCTIONS 50 APPENDIX B TAMPER PROOF TESTING WITH THE WP200 55 APPENDIX C LICENSE AGREEMENT 59 APPENDIX D REGULATORY REPRESENTATIVE 65 APPENDIX E DESCRIPTION OF THE WATCHPAT 200 PROBE 66 WatchPAT 200 System V Operation Manual APPENDIX F MANUFACTURING DECLARATION ACCORDING TO 2 uu nn sn E 67 APPENDIX G SPO ACCURACY IN THE WP200 71 APPENDIX H TRAINING RESOURCES 73 APPENDIX 1 SPARE PARTS
59. nual 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 Possible Reason Not loaded Study not initialized for new Connect device to PC and perform New patient Study in zzzPAT Battery error full Battery defective or uncharged Charge battery or replace Used Probe previously used Replace probe Missing Attach probe Bad Probe is defective Sensor absent SBP disconnected even if it P200 or SBP sensor defective Consult Itamar or authorized representative is connected RTC faulty WatchPAT device defective Consult Itamar or authorized representative Short recording time Patient removed the Explain proper use to patient WatchPAT device or probe from hand prematurely Insufficient battery charge Recharge battery and try again caused early termination of recording Damaged WatchPAT device Contact your authorized sales representative WatchPAT 200 System 47 Operation Manual 9 22 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 Patient Troubleshooting Possible Reason tu
60. onnect an unused probe Oximetry error module missing connect oximetry module 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 missing the study file was chosen with the bracelet option but the bracelet 1s not connected during the device test e Information messages o multi night on 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 Oximetry Test For the oximetry test make sure the sensor is attached to the finger At the end of the test the saturation and or any error message will be displayed WatchPAT 200 System 16 Operation Manual TESI Sa02 98 Attach to finger Spec Testing OXI TEST 22590 SaO2 N A oxi mod missing Attach to finger Back Testing The possible oximetry error messages are e Oximetry error module or sensor missing connect oximetry module and sensor e SaO2 Not Available N A attach sensor to finger The blood saturation is continuously updated there
61. otted line and return it with the device for study analysis WatchPAT 200 System 28 Operation Manual Figure 19 Cut the Bracelet at the Specified Location 4 3 Multi night study A patient study may be defined as multi night study and the patient can sleep up to 3 nights with the same WatchPAT device The multi night option may be selected during New Study function see zzzPA T Operation Manual If a 3 night multi night option is selected the patient must replace the PAT probe and charge the device between nights Two extra PAT 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 PAT probe only after the first night without the need to charge the device between nights One extra PAT 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 ____ y Figure 20 Case for a 3 Night Multi Night Study WatchPAT 200 System 29 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 zzzPA T software To download and analyze the study data 1 Connect the USB port of the WatchPAT device to the computer see Figure 4 The
62. plied 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 200 System 3 Operation Manual 18 Medical Device Directive MDD 93 42 EEC MDD 2007 47 EC 19 FDA Quality Systems Regulation QSR 21 CFR part 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 1 7 CE and CSA Compliance The product complies with the CE mark according to MDD Medical Device Directive and related standards The untt is marked with the CE logo The product is certified by CSA C US 207233 1 8 Conventions Used in this Manual Note Throughout this document the references WatchPAT and WP200 device are used to refer to the WatchPAT 200 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 utilis s pour identifier les conditions ou les actions qui si elles sont ignor es peuvent porter atteinte a la s curit des patients ou causer des dommages au syst me et r sulter une perte irr versible des donn es Cautions are used to
63. rns off while inserted inserted into the WatchPAT device WatchPAT device is on Faulty oximetry sensor Check the oximetry sensor probe for damage and replace if necessary Oximetry sensor Sensor not properly connected Check connection If problem persists disconnected or faulty replace sensor WatchPAT device does ON button not activated Press the ON button firmly for at least 3 not switch on seconds 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 or may be a used probe to the WatchPAT device check if probe has been previously used and replace with new probe if necessary WatchPAT device failure Contact Itamar or authorized representative WatchPAT 200 System 48 Operation Manual 10 SPECIFICATIONS Table WatchPAT 200 Device Specifications Properties PAT Probe Itamar s proprietary probe only Recording Time 0 hours minimum Oximetry Probe Custom Nonin 8000J Flex Sensor Measuring 4 signals PAT Pulse rate Oximetry Actigraphy Channels PAT and Actigraph 12 bit oximetry 1 Snoring 12 bit Body Position 5 discrete states User Interface LCD display Accuracy Pulse rate 30 150 1 bpm Amplitude 0 0 5V 10 Oximetry 70 100 2 digits in units PAT Channel Bandwidth 0 1 10 Hz Data Storage Micro SD card Power Supply Proprietary rechargeable Lithium Ion B
64. rterial vasoconstriction which mirrors sympathetic activation is shown as attenuation in the PAT signal amplitude The PA T signal is recorded continuously and stored on an embedded micro SD card together with data from a built in pulse oximetry sensor mounted on an adjacent finger and an actigraph embedded in the WatchPAT 200 device Following the sleep study the recordings are automatically downloaded and analyzed in an offline procedure using the proprietary zzzPA T software The zzzPAT algorithms use the four WatchPAT channels PA T 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 WatchPAT device 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 200 System 9 Operation Manual 2 1 System Description The WatchPAT system is comprised of the following items e WatchPAT system that includes Embedded actigraph Embedded pulse oximeter Embedded CPU and electrical circuit card Embedded micro SD card drive Rechargeable Lithium Ion Battery
65. s filed in other countries m CC EP ww k 4 C K 207233 er Intertek ISO 9001 2008 and EN ISO 13485 2012 See appendix D for contact information of the regulatory authorized representative WatchPAT 200 System Operation Manual Record of Editions Chapter Pages Resp 0 March 2008 img ARE x June 2008 Sleep Stages and AHI MER uly 2008 ISO logo list of standards Medes w address pictures 09 Updating Orit Itamar Medical address 1 List of standards Labeling i 1 Oct 09 Update for bracelet and multi night Bonita support July 2011 Standards Preparing for use 3 35 47 Bonita Specifications table and minor wording changes SpO2 accuracy App G March 2012 New PCB version with new Changed figures 3 5 8 10 Bonita connectors 1 2 6 12 13 13 16 17 Fixed typos and syntax errors 15 17 18 19 21 19 22 24 23 24 25 28 35 26 29 32 37 App B 35 38 45 47 49 7 Feb 2013 Updating standards 1 5 1 7 2 4 7 8 48 Orit Kelner Device compliance symbols Labels 1 11 1 12 specifications 10 May 2013 Updated for Itamar SBP sensor 1 1 1 2 1 4 2 1 1 2 9 11 Bonita 2 2 3 5 4 1 7 1 13 24 26 Updating standards 5 t 50 54 3 July 2013 Updating WATCHPAT device label x 1 12 Sep 2013 Updatine logo c of ISO symbol Bonita Dean Updating PAT probe Bottom tab A 8 40 44 optional EcB2014 1 Clarification obe
66. sition 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 WatchPAT 200 System 50 Operation Manual Preparing the sensor Attach the round double sided adhesive sticker to the blue side of the sensor Applying the sensor Make sure the room you are sleeping in is as quiet as possible during the night turn off any possible noise sources 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 Secure the sensor in place with medical tape Cleaning the sensor Using 70 ethyl alcohol thoroughly clean both sensor and cable SPECIFICATIONS Snoring
67. test serial number of device in parenthesis e Fourth line displays option for running oximetry sensor test 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 The Up amp Down keys 1 navigate between the lines e An asterisk will indicate current selection When moving the 7 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 and OXI test every time you prepare the WatchPAT device 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 22290 p pedem Ssbp missing Back TEST PASSED WatchPAT 200 System 15 Operation Manual At the completion of the device test a TEST FAILED indicates a problem that should be taken care of before the device 1s released for a night study DEVICE TEST 22 290 EDS LEE AS oxi mod missing pat missing lt Back More gt TEST FATLED 2354 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 c
68. the two square black protrusions are opposite one another The oximetry sensor is now attached When the WatchPAT device is turned on the sensor will glow red Ring Finger Figure 30 Fold Top Flap and Short Flap Figure 31 Wrap The Long Flap WatchPAT 200 System 39 Operation Manual Figure 29 Positioning Oximetry On Figure 32 Flexiwrap Line Indication 7 4 Attaching the PAT Probe Proper probe placement is critical for good performance Note The tabs inside the probe should be removed only AFTER the finger is inserted into the probe To attach the PAT probe 1 Insert your index finger or other if so instructed gently into the probe until it reaches the end see Figure 33 2 Make sure that the paper tab marked TOP is above your nail and the tab marked BOTTOM is below your finger 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 etc until the tab is completely removed from the probe Figure 34 4 Optional Only if bottom tab is present Detach and pull on the tab marked BOTTOM slowly and firmly towards the back of your hand while still pressing against a hard surface until the tab 1s completely removed Figure 35 You might feel a slight suction once the tabs are removed The PAT probe is now attached Figure 36 WatchPAT 200 System 40 Operation Manual Figure
69. time of regular R R intervals of less than 1 5 hours the WP200 will not have sufficient valid PAT signal as required to generate a sleep report 1 4 Data Generated by the WatchPAT 200 Device The WatchPAT 200 device generates a respiratory disturbance index PRD and its derivative the PAT Apnea Hypopnea Index and PAT sleep staging identification PSTAGES The 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 200 device 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 WatchPAT 200 device is a Class IIa medical device under MDD 93 42 EEC 2007 47 EC Annex IX rule 10 WatchPAT 200 System 2 Operation Manual 1 6 Quality Assurance System ISO 9001 amp ISO 13485 The Itamar Medical WatchPAT 200 device is compliant to the following standards STANDARD I 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 Electroma
70. tor Tests The WatchPAT device 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 it 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 tests e Device Test tests the WatchPAT device for errors before performing a night study make sure all probes are connected before initiating this test e Oximetry Sensor Test verifies oximetry sensor is connected and shows average saturation The Device test 1s the default test Once the device test has passed you should also run the oximetry sensor test Note In all times the current time 1s 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 200 System 14 Operation Manual The following screen wlll be displayed DIAGNOSTIC 22 40 2 2140 20 Jul 08 device test 30001 oxi test 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
71. use 9 The WP200 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 provided by the WP200 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 200 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 WP200 device is not indicated for children less than 17 years old 1 3 Exclusion Criteria The WatchPAT 200 device should not be used in the following cases 1 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 In cases of patient having accumulative
72. w 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 finger nails are closely trimmed 2 Attaching the Snore amp Body Position Sensor optional e The snoring sensor is attached to the base of the patient s neck e To position the sensor place the snoring sensor with the microphone side black opening against the skin using the round double sided adhesive sticker e Make sure the sensor is tight against the skin e Secure the snoring sensor in place with medical tape e Locate the body position sensor on the chest bone WatchPAT 200 System 44 Operation Manual e Pull the paper tabs all the way off the body position sensor while attaching it on the skin 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 Oximetry Sensor Before probe attachment e Demonstrate proper placement of the finger on the Flexi wrap pad note the position of the fold line and that the two black square protrusions are opposite each other e Folding the flaps of the Flexi wrap pad to secure sensor
73. 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 warranty 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 WatchPAT 200 System 61 Operation Manual
74. xclusion Ha P m 12 March 2014 Updating zip code Ido Abraham Ab C 63 QR Code App H 70 13 July 2014 Notes trademarks Ido Abraham latest version of this OM Shelly Ron Added trademark symbol All Bonita Dean Clarifying 2 exclusion criteria 1 3 Updating Standards symbols labels 1 6 1 11 1 12 Clarification of instruction Attaching 7 4 8 3 6 the probe applying SBP App A Update SBP Cleaning instructions 6 1 6 6 Temp humidity parameters update 10 App A Medes and Itamar s addresses App C App D i Update QR code table App H WatchPAT 200 System li Operation Manual Feb 2015 Updating Caution and Warning Orit Kelner symbols Adding warning Adding Environmental protection section Adding cross reference Updating Manufacturing Declarations Adding Nonin Module specifications Adding spare parts list 15 July2015 Add FDA K to section 1 14 Hd ar a Note Latest version of the WatchPAT system Operation Manual is available at http www itamar medical com Support Downloads html WatchPAT 200 System lil Operation Manual Table of Contents ODNOUBRWND NO oc b cb ese ON GENERAL INFORMATION 1 Intended use Indications for Use 1 Restrictions for Use
75. y scanning the code next to each resource The following resources can be found on this page Technician Training Presentation Step by Step Card English 777 User Manual WP200 Patient Video ZZZPAT Manual Editing of Sleep Scoring WatchPAT 200 System 73 Operation Manual APPENDIX SPARE PARTS LIST The following items can be ordered and purchased individually PAT probe a box of 12 PAT probes PAT probe connection cable Wrist Strap Snore and Body Position sensor Adhesive set for Snore and Body Position sensor Pulse oximeter sensor Adhesive set for Pulse oximeter sensor Cable for Tamper Proof Bracelet Tamper Proof Bracelet a box of 24 bracelets AC adapter USB cable Rechargeable Lithium Ion Battery Step by Step Reference Guide WP200 Itamar SBP Quick Reference Cards WP200 Carrying case WatchPAT 200 System 74 Operation Manual

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