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WatchPAT™300 System

54

Operation Manual

APPENDIX C: LICENSE AGREEMENT

This License

Agreement represents the complete and exclusive understanding between you

and Itamar Medical. The document can be viewed at

https://www.itamar-medical.com/lmages/licensewp.pdf

Should you have any questions concerning this License

Agreement, or if you desire to

contact Itamar Medical for any reason, please write to:

USA:
Itamar Medical Inc.
3290 Cumberland Club Drive, Suite 100
Atlanta, Georgia 30339, USA
Tel: 1 888 748 2627

Worldwide:
Itamar Medical Ltd.
9 Halamish St., P.O.Box 3579
Caesarea Ind. Park, 3088900, Israel
Tel:  +972 4 617 7000

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Summary of Contents for WatchPAT 300

Page 1: ...tamar Medical REF OM2196380 Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright 2002 2019 By Itamar Medical Ltd WatchPAT and PAT are tr...

Page 2: ...e instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement available at www itamar medical com lm...

Page 3: ...3 1 1 6 7 8 10 Appendix D Appendix F Appendix G Appendix H All ii 4 9 16 23 19 20 31 37 41 46 63 61 66 69 4 Sep 2018 Change photos All All 5 Feb 2019 Update sec exclusion criteria Update list of stand...

Page 4: ...2 OVERVIEW 10 2 1 System Description 11 2 2 User Interaction with the WatchPAT Device Keys 13 2 3 WatchPAT Device Function 14 2 4 Built In Self Diagnostic Procedures 15 3 PREPARATION FOR SLEEP STUDY 2...

Page 5: ...41 8 2 Product Introduction 41 8 3 Applying the WatchPAT device 41 8 4 Switching on the WatchPAT Device 42 8 5 Removing the WatchPAT Device 42 8 6 Patient Training 42 8 7 Review Safety General and Fu...

Page 6: ...chPAT Device with Cable for Bracelet 27 Figure 12 WatchPAT Device with Bracelet 27 Figure 13 Bracelet and WatchPAT Device on a Patient s Hand 27 Figure 14 Cut the Bracelet on a Specified Location 28 F...

Page 7: ...Ic is indicated for use in patients 17 years and older All other parameters are indicated for 12 years and older 1 2 Restrictions for Use 1 The WP300 should be used only in accordance with physician s...

Page 8: ...rhythm 3 Sustained non sinus cardiac arrhythmias In cases of patient having accumulative time of regular R R intervals of less than 1 5 hours the WatchPAT 300 system will not have sufficient valid PA...

Page 9: ...age of total sleep time with Cheyne Stokes Respiration pattern CSR and PAT sleep staging identification PSTAGES The WP300 respiratory indices and sleep stages are estimates of conventional values and...

Page 10: ...ctrical systems used in the home healthcare environment IEC 60601 1 11 2015 Degrees of protection provided by enclosures IP Code IP22 IEC 60529 Ed 2 2 COR2 5 Medical devices Application of usability e...

Page 11: ...s substances in electrical and electronic equipment RoHS Directive 2011 65 EU RoHS 2 1 8 CE and T V RHEINLAND Compliance The product complies with MDD 93 42 EEC 1993 Amm 2007 47 EC Medical Device Dire...

Page 12: ...er des r sultats quivoque Notes are used to identify an explanation or to provide additional information for purposes of clarification Les notes sont utilis es pour identifier les explications et pour...

Page 13: ...from the patient BEFORE connecting it to a PC AVERTISSEMENTS Ne pas mouiller l unit loigner le dispositif de toute source d eau ou nourriture En cas d incendie utiliser uniquement des extincteurs hom...

Page 14: ...ns for use Type BF applied part The product is certified by T V RHEINLAND The product is marked with the CE logo 2797 for BSI Date of manufacture Battery Operating Voltage Single use do not re use Tem...

Page 15: ...o sale by or on the order of a licensed healthcare practitioner According to the WEEE Directive 2012 19 EU all waste electrical and electronic equipment EEE should be collected separately and not disp...

Page 16: ...and thus indirectly the level of sympathetic activation Peripheral arterial vasoconstriction which mirrors sympathetic activation is shown as attenuation in the PAT signal amplitude The same probe me...

Page 17: ...o AAA Battery o OLED display Unified PAT and Pulse Oximeter Probe uPAT probe includes oximetry uPAT probe connection cable Wrist Strap Snore and Body Position sensor SBP RESBP optional Cable for Tampe...

Page 18: ...rs An additional item required for the operation of the system is the zzzPAT kit zzzPAT is a proprietary PC software for initializing the study retrieving analyzing and displaying the data For more in...

Page 19: ...ections Title Info and Status Title first line Current operational mode and time o PATIENT mode while recording night study o DIAGNOSTIC mode while testing device o PC HOST while connecting to PC Info...

Page 20: ...3 WatchPAT Device Function The WatchPAT records the following channels PAT Signal Oxygen saturation Actigraphy movement Acoustic decibel detector for Snoring evaluation optional Body Position optiona...

Page 21: ...ional 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 Operator Tests The WatchPAT...

Page 22: ...eventh line for exiting the testing mode and turning device off If no test is selected within 3 minutes the WatchPAT device will automatically shut down The right and left buttons will navigate betwee...

Page 23: ...used missing bad connect an unused probe Hardware H W error error code contact customer support SBP RESBP Snore and Body Position sensor warning sensor missing does not affect PASSED status RTC Real T...

Page 24: ...2 51 Please wait Testing If the WatchPAT device passes this self diagnostic test the following screen will be displayed PATIENT 22 51 GOOD NIGHT Time elapsed 9 50 Recording Note During recording the d...

Page 25: ...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 xxx1 battery low xx2x uPAT probe e...

Page 26: ...e or rechargeable NiMH Use a new or fully charged battery for each study Notes Conditions for Battery Use 1 The recording durations depend on the quality of the battery used It is important to always...

Page 27: ...pecial preparation other than ensuring its cleanliness You may clean it if needed See section 6 1 for detailed cleaning instructions 3 4 Mounting the WatchPAT on the Wrist Strap To mount the WatchPAT...

Page 28: ...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 6 Disconnecting the Probe Figure 7 Probe Disconnected Connect a new pr...

Page 29: ...Run the built in self diagnostic facility as described in Section 2 4 above The WatchPAT device is now ready for performance of a sleep study by the patient Figure 8 3 8 WP300 Self diagnostic Test Res...

Page 30: ...th the uPAT probe attached Step by Step Reference Guide to the WatchPAT device Body Position and Snore sensor optional Cable for bracelet optional for patient identification For multi night only extra...

Page 31: ...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...

Page 32: ...ronic 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 Fi...

Page 33: ...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 Figure 11 WatchPAT Device with Cable for...

Page 34: ...selected during New Study function see zzzPAT Software Manual If a 2 or 3 night multi night option is selected the patient must replace the uPAT probe and replace the battery between nights Extra uPA...

Page 35: ...leep clinic for data downloading and analysis by the zzzPAT software To download and analyze the study data 1 Connect the USB port of the WatchPAT device to the computer see Figure 4 The WatchPAT devi...

Page 36: ...cted while replacing a probe The product should be serviced in case any damage to the connector is found d The following items should be visually inspected and replaced if found damaged strap carrying...

Page 37: ...ESBP Sensor X Replace Strap X Replace Carrying Case X Other system parts are not user serviceable parts Any maintenance needs that are not listed here should be performed only by qualified service per...

Page 38: ...designed for a single use only It may not be cleaned and must be discarded and replaced before each study 6 1 4 The Snore Body Position Sensor Using 70 ethyl alcohol thoroughly clean both sensor and c...

Page 39: ...the plastic lid Figure 17 Replacing the uPAT Probe 6 4 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...

Page 40: ...Remove artificial fingernail or dark nail polish from the monitored finger If you are using the SBP RESBP sensor trim chest hair if needed to ensure the sensor attached directly to your skin You may...

Page 41: ...Figure 8 2 Mount the device on the wrist strap according to the orientation depicted on the bracket display and buttons Figure 19 WatchPAT Wrist Strap 3 Ensure that the WatchPAT device is firmly seat...

Page 42: ...ected to the finger probe 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 st...

Page 43: ...move the tab marked TOP slowly and firmly while pressing the tip of probe against a hard surface WatchPAT case table leg etc until the tab is completely removed from the probe Figure 23 You might feel...

Page 44: ...round button Figure 3 until the display lights up After a short delay the screen will display Good Night Recording PATIENT 22 51 GOOD NIGHT Time elapsed 9 50 Recording Note DO NOT remove the uPAT prob...

Page 45: ...off the wrist strap 3 Insert all parts back into the carrying case Note To conserve the battery the display will turn off after a few seconds Pressing the button will restore the display for few seco...

Page 46: ...r disconnect any part of the unit Do not try to introduce any foreign object into the unit Do not try to connect the WatchPAT to an electrical supply or any other device machine or computer If any par...

Page 47: ...he WatchPAT device Use the Demo Kit Demonstrate how to apply the WatchPAT device on your wrist while following the step by step guidelines and referring to the relevant figures Demonstrate the followi...

Page 48: ...ear a click 5 Attaching the uPAT Probe Insert finger all of the way into the probe Press tip of probe against a hard surface WatchPAT device case table leg etc while removing tab in order to keep the...

Page 49: ...mself or with the assistance of accompanying individual if needed Verify that the attachment is properly done 8 7 Review Safety General and Functional Issues Avoid exposing the WatchPAT device to extr...

Page 50: ...absent Attach probe Bad Probe is defective Replace probe Hardware status error code WatchPAT device defective Consult Itamar or authorized representative SBP RESBP disconnected even if it is connected...

Page 51: ...ubleshooting Error Possible Reason Action WatchPAT device doesn t switch on ON button not activated Press the ON button firmly for at least 3 seconds uPAT probe not connected Ensure probe is connected...

Page 52: ...terface OLED display Accuracy Pulse rate Amplitude Oximetry 30 150 1 bpm 0 0 5V 10 Arms 3 in range 70 100 PAT Channel Bandwidth 0 1 10 Hz Data Storage Media NOR SPI Flash Capacity 128 MB minimum Power...

Page 53: ...SBP sensor A SBP Sensor attachment B Sternal notch A Integrated RESBP sensor A RESBP Sensor Attachment B Sternal notch The integrated sensor is powered by the WatchPAT device and does not require a b...

Page 54: ...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 RESBP it is advised to sl...

Page 55: ...pochs during sleep The Agreement between the device and the video recording was 90 Simple Kappa agreement value was 0 8185 95 confidence level of 0 8059 and 0 8311 II Snoring The snoring level measure...

Page 56: ...19 44 75 4 65 10 39 40 65 43 44 41 45 09 45 643 45 90 5 07 11 04 40 59 45 45 51 46 30 46 602 46 45 5 17 11 13 40 59 46 46 04 46 86 47 590 47 39 5 31 11 21 40 66 47 46 96 47 82 48 568 48 03 5 17 10 76...

Page 57: ...e figure presents the mean WatchPAT device with SD error bar Summary statistics mean SD of WatchPATdevice by dB meter levels Note The snoring and body position safety and effectiveness was validated o...

Page 58: ...WatchPAT 300 System 52 Operation Manual APPENDIX B Tamper proof testing with WatchPAT...

Page 59: ...WatchPAT 300 System 53 Operation Manual...

Page 60: ...t https www itamar medical com lmages licensewp pdf Should you have any questions concerning this License Agreement or if you desire to contact Itamar Medical for any reason please write to USA Itamar...

Page 61: ...ration Manual APPENDIX D REGULATORY REPRESENTATIVE Itamar Medical s authorized regulatory representative is MEDES Ltd 5 Beaumont Gate Shenley Hill Radlett Hertfordshire WD7 7AR England Tel 44 208123 8...

Page 62: ...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 a...

Page 63: ...s WP300is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below The user and or installer of the unit must ensure that it is used in such an environme...

Page 64: ...act 2 kV 4 kV 8 kV 15 kV air 8 kV contact 2 kV 4 kV 8 kV 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least...

Page 65: ...nded separation Distance in meters m Field strengths from fixed R F transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b In...

Page 66: ...Separation distance according to frequency of transmitter in meters Meters m 150kHz to 80MHz outside ISM Bands d 1 17 P 150kHz to 80MHz inside ISM Bands d 2 P 80MHz to 800MHz d 1 2 P 800MHz to 2 7GHz...

Page 67: ...1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation...

Page 68: ...these measurements following a clinical study of Itamar Medical Pulse Oximetry 1 Overall the Arms is estimated to be 1 9 for the range 70 100 2 The next table shows SpO2 Accuracy Results Comparison t...

Page 69: ...eference CO Oximetry Study ID PR 2017 247 Date 2018 01 23 Clinical Investigator s Clinimark 80 Health Park Drive Suite 20 20 15 10 5 0 5 10 15 20 65 70 75 80 85 90 95 100 WP300 Ref CO Oximeter SpO2 Sa...

Page 70: ...USA Sponsor Itamar Medical Ltd 9 Halamish St POB 3579 Caesarea 3088900 Israel Device s Non Motion Itamar Medical WatchPAT300 Pulse Oximetry Study Date s December 13 15 2017 Note A Functional tester ca...

Page 71: ...e installation o 10GB minimum 60GB recommended disk space on Files folder and at least 1 2GB on boot drive Shared installation o SQL DB drive 1 2GB if using our default MS SQL Express installation and...

Page 72: ...a box of 12 uPAT probes uPAT probe connection cable Wrist Strap Snore and Body Position sensor SBP RESBP Adhesive for Snore and Body Position sensor a package of 12 units Cable for Tamper Proof Bracel...

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