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WatchPAT

™

ONE System

Operation Manual

STANDARD

IDENTIFICATION

– IP22

Medical devices - Application of usability engineering
to medical devices

IEC 62366:2007 + A1:2014

Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance
- Collateral standard: Usability

IEC 60601-1-6:2010 + A1:2013

Medical devices. Application of risk management to
medical devices

EN ISO 14971:2012

Medical devices. Symbols to be used with medical
device labels, labelling and information to be supplied.
General requirements

ISO 15223-1:2016

Graphical symbols for electrical equipment in medical
practice

PD IEC/TR 60878: 2015

10.

Graphical symbols - Safety colors and safety signs --
Registered safety signs; refer to instruction manual/
booklet

ISO 7010:2019 (M002)

11.

Information supplied by the manufacture with medical
devices

EN 1041:2008 + A1:2013

12.

Biological evaluation of medical devices - Part 1:
Evaluation and testing

ISO 10993-1:2018

13.

Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance
of pulse oximeter equipment

ISO 80601-2-61:2011

14. FDA Quality Systems Regulation (QSR)

21 CFR part 820

15. Medical devices. Quality management systems.

Requirements for regulatory purposes

EN ISO 13485:2016

16.

Federal Communication Commission - R

adio

frequency devices

Federal Code of Regulation (CFR) Title
47, Chapter I, Sub-Chapter A, Part 15

17.

Technical Information Report Risk management of
radio-frequency wireless coexistence for medical
devices and systems.

AAMI TIR69: 2017

18.

American National Standard for Evaluation of
Wireless Coexistence

ANSI IEEE C63.27-2017

19.

Commission Regulation (EU) on electronic
instructions for use of medical devices

EU 207/2012

20.

Medical Device Directive

MDD 93/42 EEC
MDD 2007/47/EC

21.

Directive  on  the  restriction  of  the  use  of  certain
hazardous  substances  in  electrical  and  electronic
equipment

RoHS Directive 2011/65/EU (RoHS
2)

Содержание WatchPAT

Страница 1: ... Medical REF OM2196370 Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Copyright 2019 2020 By Itamar Medical Ltd WatchPAT and PAT are trademarks of Itamar Medical Ltd ...

Страница 2: ...ntained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement available at https www itamar medical com terms and conditions Itamar Medical Ltd 9 Halamish St P O Box 3579 Caesarea Ind Park 3088900 Israel Tel International 972 4 617 7000 US 1 888 7ITAMAR Fax 972 4 627 5598 www itamar medical com Itamar Medical s EU authorized regulatory re...

Страница 3: ... 2020 Current Edition 7 Apr 2020 Note Latest version of the WatchPAT System Operation Manual is available at https www itamar medical com support downloads zzzPAT Software Manual is also available on the zzzPAT installation CD and is installed as part of the software installation Printed copy will be provided within 7 calendar days if requested at no additional cost ...

Страница 4: ...1 10 Symbols Used on the Product Labels 6 1 11 Regulatory Agencies Information 7 2 OVERVIEW 8 2 1 System Description 9 2 2 Finger Probe Description 11 2 3 Chest Sensor Description 12 3 HOME SLEEP TEST 13 3 1 Test Preparation 13 3 2 Sleep Test 16 3 3 Test End 16 3 4 User Interaction with the WatchPAT 17 3 5 Important Notes 33 4 DATA DOWNLOAD AND ANALYSIS 34 5 PRODUCT HANDLING 35 5 1 Battery 35 5 2 ...

Страница 5: ...gure 7 Placing Finger in the Finger Probe 20 Figure 8 Removing TOP Tab while pressing against hard surface 21 Figure 9 Application screen samples A on left explanation and step counting 22 Figure 10 Loading Screen 23 Figure 11 Welcome screen 24 Figure 12 Battery insertion screen 25 Figure 13 Preparation screen 26 Figure 14 PIN Screen 27 Figure 15 Patient Setup Screens chest sensor screen available...

Страница 6: ...HIc 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 WatchPAT should be used only in accordance with physician s instructions For precautions see Section 1 3 2 Only qualified medical personnel may authorize the use of the WatchPAT 3 Qualified medical personnel must instruct the patients and accompanying ind...

Страница 7: ...kers 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 the setting of sustained arrhythmia the WatchPAT s automated algorithm might exclude some periods of time resulting in a reduced valid sleep time A minimum valid sleep time of 90 minutes is required for an automated report genera...

Страница 8: ...ed for snoring level and body position discrete states from the Chest Sensor PRDI and PAHIc are indicated for patients 17 years of age or greater 1 6 Quality Assurance System EN ISO 13485 The WatchPAT is compliant to the following standards STANDARD IDENTIFICATION 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 2005 CORR 1 2006 CORR...

Страница 9: ...12 Biological evaluation of medical devices Part 1 Evaluation and testing ISO 10993 1 2018 13 Medical electrical equipment Part 2 61 Particular requirements for basic safety and essential performance of pulse oximeter equipment ISO 80601 2 61 2011 14 FDA Quality Systems Regulation QSR 21 CFR part 820 15 Medical devices Quality management systems Requirements for regulatory purposes EN ISO 13485 20...

Страница 10: ...tudy results Notes are used to identify an explanation or to provide additional information for purposes of clarification 1 8 Warnings Cautions and Notes The WatchPAT is powered with one off the shelf AAA battery The WatchPAT is portable with continuous operation The WatchPAT uses BF patient applied parts The WatchPAT should only be transported in its original package Environmental conditions duri...

Страница 11: ...ly fire extinguishers approved for use on electrical fires Handle unit with care This unit is sensitive to extreme movements and to falling Do not try to introduce any foreign object into the unit 1 10 Symbols Used on the Product Labels Symbol Explanation Follow instructions for use Date of manufacture Battery Operating Voltage Single use do not re use Temperature limit Use by date Medical device ...

Страница 12: ...ufacturers must Have the device evaluated by an independent lab to ensure it conforms to FCC standards Type BF applied part According to the WEEE Directive 2012 19 EU all waste electrical and electronic equipment EEE should be collected separately and not disposed of with regular household waste Please dispose this product and all of its parts in a responsible and environmentally friendly way The ...

Страница 13: ...ith a chest sensor the Snoring Body Position and the subject s chest movement signals are recorded by the integrated Chest Sensor The recorded data is transmitted to an Application on a mobile phone and is then stored on a Web Server Following the sleep study the recordings are automatically downloaded from the Web Server and analyzed in an offline procedure using the proprietary zzzPAT software T...

Страница 14: ...e zzzPAT 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 a comprehensive detailed report The data of the home sleep test can be viewed on the PC screen and the ...

Страница 15: ...as marked on the product s package A typical Application screen is displayed in Figure 2 Application Screen Figure 2 Application Screen 3 The zzzPAT Analysis tool see Figure 3 is a proprietary PC software utility used by your physician for initializing the study retrieving analyzing and displaying the data More information is provided by the zzzPAT Software User Manual ...

Страница 16: ...tial 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 activ...

Страница 17: ... detector It uses a highly sensitive microphone that responds to snoring and other sounds in the audio range and converts them to a signal that provides a clear reliable indication of the presence of these sounds The Chest Sensor uses a 3 axis accelerometer that provides a signal that reflects the movement of the chest which can be translated both to the patient s sleeping posture supine prone rig...

Страница 18: ...bed time Sleep Test during sleep Test End at wake up The Application screens will guide you throughout the process Before you conduct the home sleep test you should be acquainted with the full description of the test components as described in 3 4 3 1 Test Preparation For optimal data collection the preparation steps need to be followed as described This section describes all possible steps If a s...

Страница 19: ...use this is a precondition for using the Bluetooth communication It is preferred to install the Application in advance so when bed time arrives the Application will be ready to go 3 1 2 Application Setup The wrist device that will be applied on your hand will transmit the recorded data to your mobile phone s Application Place the mobile phone in proximity to the device so the two can easily commun...

Страница 20: ...chPAT device to your non dominant hand Do not close wrist strap too tightly When using the WatchPAT ONE with the chest sensor configuration thread the Chest Sensor through the sleeve of the night shirt and up to the neck opening Peel the white paper from the back of sensor s sticker Attach the Chest Sensor to your chest under the sternal notch to the center of your upper chest bone just below the ...

Страница 21: ...hPAT device or sensors 3 3 Test End In the morning an END RECORDING button will be displayed on the Application screen Press the END RECORDING button and the recording will stop At this stage you should take off the device from your arm finger and chest if exists The last of the recording data still needs to be transmitted from the device so keep the device in proximity of the phone and before you...

Страница 22: ...a battery is inserted When you are ready for the test insert the battery into the battery compartment of the device The compartment is in the bottom part of the device First open the compartment cover as shown in Figure 4 and insert the battery Note that proper positioning of the battery is essential for operation When placing the battery in its place align the polarity marking and of the battery ...

Страница 23: ...tery should not be stored in the WatchPAT battery compartment and only be inserted when the patient is ready for the night test 3 4 2 Wearing the WatchPAT ONE device The WatchPAT components are to be applied on specific location that will provide the required signals The sensors should be applied on the a Wrist b Finger c Chest if a chest sensor is provided 3 4 3 Strapping the Wrist Device The fir...

Страница 24: ... the white paper from the back of sensor s base to expose the sticker Attach the Chest Sensor to your chest under the sternal notch to the center of your upper chest bone just below the front of neck and align the main icon to your body cable pointing down as shown in Figure 6 Chest Sensor placement It is best to trim chest hair if needed to ensure the Chest Sensor attached directly to your skin Y...

Страница 25: ...your finger above your nail 3 Detach and gradually remove the tab marked TOP slowly and firmly while pressing the tip of probe against a hard surface table leg etc until the tab is completely removed from the probe Figure 8 You might feel a slight suction once the tab is removed For small fingers secure the probe to the finger with a medical tape The Finger Probe is now attached Figure 7 Placing F...

Страница 26: ...ion process and other operational activities It is also used to keep the patient informed of the progress of the home sleep test The display is comprised of several fields as depicted in Figure 9 The status of your home sleep test and its progress will be reflected by the Mobile Application see Figure 9 A The center of the screen is used to provide description or guidance It will also be used to w...

Страница 27: ...device passes this self diagnostic test the blinking will have either a green color if connection with Application has happened or red blinking until connection with Application happens A solid red color will indicate that there is a hardware problem NOTE During the data recording the mobile phone turns off the display to conserve battery life Patient can open the Application at any stage as done ...

Страница 28: ...l assure that the phone has the requisites required to run the Application If any limitations are met you will be notified In some cases you will be able to assist to overcome these blocking factors e g storage needs to be freed up or a Bluetooth communication needs to be turned ON In these cases you will be asked to assist with guidance being provided When the installation process requests your p...

Страница 29: ... the same room If the battery is not inserted the Application will display a request to do so see Figure 12 Figure 11 Welcome screen If the Application scanning operation failed to detect an active WatchPAT in its proximity it will indicate that the operation failed Try to detect the failure root cause and start a new scan The most common reasons for a failure to detect the device is a A battery w...

Страница 30: ...T ONE System 25 Operation Manual Figure 12 Battery insertion screen c Preparation Screen The Application will next display the Preparation Screen see Figure 13 This step guides you how to prepare for the study ...

Страница 31: ...ication Number before proceeding see Figure 14 This step is required to confirm your identity to detect a mistakenly someone else using this product Your PIN number is a four digit number that has been agreed with you when the product was provided to you and a hint that might help you remember the PIN is displayed Your phone must have an Internet access at this stage ...

Страница 32: ...WatchPAT ONE System 27 Operation Manual Figure 14 PIN Screen e Patient Setup Screens The Patient Setup screens see Figure 15 are used to guide you when applying the device and its sensors ...

Страница 33: ...sensor screen available only on relevant models Once you are ready to go to sleep and the device is fully applied you will be shown a START RECORDING screen see Figure 16 Start Recording Screen and you should press the button on the Application screen to get the recording started ...

Страница 34: ...ponents see Figure 17 It also displays the time that has passed since you have pushed the START RECORDING key Note that the Application is active the entire night yet the screen will be dimmed by your Mobile phone whenever you stop interacting with it You can reopen the screen whenever you desire just like you would open any of your other Applications that run in the background If you wake up in t...

Страница 35: ...ual Figure 17 The animated Sleep Test Screen When you wake up you should press the END RECORDING button see Figure 18 This will cease any further data acquisition NOTE The LED at the center of the device cover will blink during the night ...

Страница 36: ...r sleep is fully over After you have pressed the END RECORDING button on the Application s screen you may take off the device the Finger Probe and Chest Sensor If the Application needs more time for offloading the data from the device it will display a screen like the ones in Figure 19 asking you to allow some more time for the process to complete A progress indication will be provided Please foll...

Страница 37: ...pletion of the test is indicated with the appearance of the Test Completion screen see Figure 20 The LED of the device will constantly blink in green when all the data from the device has been transferred to the Mobile Phone NOTE Approximately ten hours after the test start the WatchPAT device will stop acquiring data This is normal ...

Страница 38: ...he 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 provided with the product Do not attempt to disconnect any part of the unit Do not try to introduce any foreign object into the unit If any part appears disconnected or does not resemble the illustrati...

Страница 39: ...ed data to a Web Server informing the clinic of its availability and referring to its location for data downloading and analysis by the zzzPAT software To analyze the study data activate the zzzPAT software and download the study data from its location in the Web Server See the zzzPAT Software User Manual for detailed instructions ...

Страница 40: ... may consider placing a new AAA Alkaline battery in the package before shipping to patient 5 2 Handling Handle with care Use only the designated package for transportation Store at room temperature following the conditions on the label and avoid direct sun light Do not expose the WatchPAT device to extreme temperature or humidity conditions such as storing in a car or bathroom 5 3 Storing the Watc...

Страница 41: ...vice has been already in use when in BATTERY screen Return the device to the provider and a new one will be shipped in return Initialization errors occurred please fix them and restart application Insufficient storage space The Application fails to allocate storage on the Mobile phone Free up to 70MB on the Mobile Phone so the Application can operate properly Communication failure please try again...

Страница 42: ...T ONE device is lost or The app cannot communicate with the device Waiting for the communication to resume Mobile phone Bluetooth communication failures or The Application cannot find an active device in its proximity or No battery in device was found Check Bluetooth communication in mobile phone bring the device closer to the Phone Put a fresh Alkaline AAA battery in the device Internet connectio...

Страница 43: ...take the actions specified below If the problem persists you may contact Itamar or an authorized representative directly Device LED s status Possible Reason Action No light Battery depleted or battery is placed backward or hardware error Check the battery If it is good and placed properly there is a hardware error Return device to Itamar Red LED blinks every 10 seconds The Mobile phone ran out of ...

Страница 44: ...itude 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 16MB Power Supply Battery One OTS 1 5V Alkaline AAA battery Operating Voltage 3 3 V Temperature Operation 00 C to 40 0 C Storage 00 C to 40 0 C Transport 200 C to 60 0 C Humidity Operating 10 93 non condensing Storage Transport 0 93 non condensing Atmospheric press...

Страница 45: ...n 1 minute s epochs total of 7111 epochs during sleep The Agreement between the device and the video recording was 90 Simple Kappa agreement value was 0 8185 95 confidence level of 0 8059 and 0 8311 II Snoring The snoring level 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 coe...

Страница 46: ...lculation at that range PSG DB Value N Mean Std Coef Of Variation Min Max Median Lower 95 CI Upper 95 CI 40 2033 41 10 1 89 4 60 40 54 40 41 01 41 18 41 1319 41 61 2 67 6 43 40 54 41 41 47 41 76 42 908 42 68 3 79 8 88 40 62 41 42 44 42 93 43 746 44 12 4 49 10 19 40 58 42 43 80 44 44 44 719 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...

Страница 47: ...9 58 13 61 12 64 15 62 53 3 93 6 28 56 68 64 60 36 64 71 65 22 64 41 6 21 9 64 49 70 67 61 66 67 16 66 48 66 90 3 66 5 48 59 70 68 5 65 83 67 96 67 42 65 76 3 28 4 99 60 71 67 64 74 66 78 68 27 64 56 2 67 4 13 55 68 65 63 50 65 61 69 6 67 2 37 3 53 64 70 67 64 52 69 48 The results are also presented in the next figure The figure presents the mean WatchPAT device with SD error bar Summary statistic...

Страница 48: ...at https www itamar medical com terms and conditions 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 7...

Страница 49: ...WatchPAT ONE System 44 Operation Manual APPENDIX B Left Blank Intentionally ...

Страница 50: ...ion of the performance of this equipment could result Electromagnetic Compatibility Electromagnetic Emissions WatchPAT is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below The user must ensure that it is used in such an environment No unexpected behavior was detected during immunity testing and performance was met Table 1 from IEC 60601 1 2 201...

Страница 51: ...els characteristic of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment NOTE UT is the a c mains voltage prior to application of the test level Table 4 from IEC 60601 1 2 2014 Guidance and manufacturer s declaration electromagnetic immunity WatchPAT The WatchPAT is intended for use in the electromagnetic e...

Страница 52: ...lines may not apply in all situations Electromagnetic propagation is affected by absorption And reflection from structures objects and people 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 electromagnet...

Страница 53: ...ns equipment and the WatchPAT Rated maximum output power of transmitter Watts W 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 d 2 3 P 0 01 0 12 0 2 0 12 0 23 0 1 0 37 0 63 0 37 0 73 1 1 17 2 0 1 17 2 3 10 3 7 6 32 3 7 7 3 100 11 7 20 11 7 23 For ...

Страница 54: ...0 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 b 217 Hz 2 0 3 28 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 9 5500 5785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna...

Страница 55: ...r the range 70 100 2 The next table shows SpO2 Accuracy Results Comparison to Reference CO Oximetry WatchPAT 70 100 90 100 80 90 67 80 ARMS Spec 3 for range of 70 100 pts 1350 415 460 475 Pass Bias 0 4 0 4 0 6 0 9 ARMS 1 88 1 10 1 62 2 54 Note The range of 70 to 100 includes reference data down to 67 3 The next plot shows the Bland Altman plot for Itamar Medical WatchPAT 20 15 10 5 0 5 10 15 20 65...

Страница 56: ...tigator s Clinimark 80 Health Park Drive Suite 20 Louisville Colorado 80027 USA Sponsor Itamar Medical Ltd 9 Halamish St POB 3579 Caesarea 3088900 Israel Device s Non Motion Itamar Medical WatchPAT Pulse Oximetry Study Date s December 13 15 2017 NOTE The clinical study was conducted with the WP300 with the same Pulse Oximetry System for the measurement of functional oxygen saturation of arterial h...

Страница 57: ...e found to have AHIC 10 by the PSG on a standard 30 seconds epoch by epoch comparison1 A total of 10 509 aggregated epochs were derived from these patients and the following results were obtained Sensitivity 51 3 Specificity 93 7 Positive Predictive Value PPV 78 4 Negative Predictive Value NPV 81 3 Overall Agreement 80 7 Source of Data Study Title Diagnosis of Sleep related Respiratory Disorders i...

Страница 58: ...e user is encouraged to eliminate the interference by one or more of the following measures Re orient or re locate the receiving antenna Increase the distance between the device and the receiver Connect the device to an outlet on a circuit different from the one that supplies power to the receiver Consult the dealer or an experienced radio TV technician WARNING Changes or modifications to this uni...

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