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Содержание G5 solution

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Страница 2: ...G5 Solution Wearable biosensor Instructions for use 989803199491 ...

Страница 3: ... biosensor and saving patient data 16 Biosensor interface 18 G5 application interface 19 Heart rate transmission configuration 19 Notifications 19 Reviewing data 22 Maintenance 23 Cleaning and disinfection 23 Storage 23 Troubleshooting 24 Specifications 26 Symbols 26 Manufacturer s information 27 Open source software 27 Regulatory and safety specifications 27 EMC and radio regulatory compliance 28...

Страница 4: ...ry to the biosensor to display and store physiological and operational data The software application receives and displays data from the biosensor providing a user interface and exportable file for retrospective review and analysis The application allows configuring the biosensor frequency of data collection and transmission Indications for use The Philips wearable biosensor G5 is indicated for si...

Страница 5: ...compatible device using a USB cable for offline review and analysis Philips wearable biosensor G5 is a wireless single use single location chest worn device that acquires surface electrical waveforms related to cardiac excitations and measures beat to beat intervals The biosensor calculates patient heart rate based upon a combination of patient s single vector ECG and their motion data The biosens...

Страница 6: ...5 Front of biosensor 2 1 2 4 3 5 6 1 2 1 0001AB50012 8 8 7 Back of biosensor ...

Страница 7: ...orts data into a password protected file and displays the following Menu Disconnect biosensor and exit Clear all data and exit Heart rate instantaneous Instantaneous heart rate is measured every beat over the reporting interval which is user configurable between 1 to 30 minutes G5 biosensor battery level Date and time Reporting interval Notifications log ...

Страница 8: ...7 Application dashboard 12 9 10 11 13 14 ...

Страница 9: ...irritated scarred or inflamed areas The biosensor should only be applied to intact skin General warnings and precautions Do not apply to patients with a history of known tape or adhesive allergy The biosensor contains an adhesive which adheres to the skin Warning pacemaker patients Biosensor can detect a patient s pacemaker pulses Biosensor may continue to count the pacemaker rate during occurrenc...

Страница 10: ...sensor to prevent skin irritation Gently swab area under the biosensor with water as you are removing the sensor To frequently collect instantaneous heart rate assess the biosensor connectivity to the G5 application every 8 hours If connectivity is lost the biosensor will store up to 4 hours of data Keep your mobile device charged at all times The biosensor is defibrillation proof Remove the biose...

Страница 11: ...cur try moving biosensor away from the source of the interference You can also move the electronic device or its antenna to another location to solve the problem These guidelines help ensure that the biosensor will not affect the operation of other nearby electronic devices Additionally other electronic devices should not affect the use of the biosensor Security and privacy recommendations Custome...

Страница 12: ...nce Do not share the G5 App password with any unauthorized personnel Use physical security for example locks cameras keycards sensors and so on to restrict unauthorized access of mobile device Use procedural security for example unattended mobile device locking no sharing of access credentials termination checklists risk management that is performing risk assessments and mitigating identified risk...

Страница 13: ...use the biosensor during MRI procedures The biosensor is MRI unsafe Do not use alcohol for cleaning purposes because it dries the skin and may diminish electrical flow Alcohol may also increase likelihood of skin irritation Do not apply the biosensor to patients with skin integrity issues Only apply the biosensor to intact skin Do not apply the biosensor over visible scars Do not apply the biosens...

Страница 14: ...pplied to patients with delicate skin to make removal easier later 3 Prepare biosensor a To open the package pull the two silver layers apart b Carefully remove the biosensor from the package c Examine biosensor for physical damage and liner integrity before setup Note Discard the biosensor and use a new one if the biosensor foam is not intact if the ON button appears damaged or if a liner is miss...

Страница 15: ...o the G5 application 5 Connect G5 biosensor to G5 software application a Open the app on the mobile device by tapping the icon for the G5 software app Note G5 app will be loaded on the customer supplied mobile device by Philips Field Service Note The app will prompt you to enter your password after logging in for the first time b Enter the new password in the New Password and Confirm New Password ...

Страница 16: ...ay take a little time Note If the app could not connect to the selected biosensor verify whether the correct biosensor was selected If not select the correct biosensor f Once the biosensor has successfully connected with the app the app dashboard will be displayed The green light on the biosensor will become steady and will stay on for 20 seconds and then turn off automatically g Visually confirm ...

Страница 17: ...e app dashboard screen Select Disconnect Save and Exit b Using a USB cable plug the mobile device into the computer where patient data will be stored Click Next to proceed c Tap Disconnect and Export Data on app screen This will disconnect the G5 biosensor if one is paired and begin the process of exporting the patient s data Note You must continue with step 2 in order to save the patient s data 2...

Страница 18: ...or additional instructions for viewing patient data 3 Clear data from app and exit Note Be sure to exit the app to delete the patient s files on the mobile device a Tap Clear Data and Exit This will clear out all patient data from the app and exit the application 4 Remove biosensor from patient a Gently peel each side of the biosensor one at a time leaving the center adhered Gently swab with water...

Страница 19: ...Steady green for 20 seconds Setup complete None Biosensor is operating correctly Flashing red Error Remove and replace biosensor No light biosensor broadcasting to app Biosensor is operational None No light biosensor not broadcasting to app Biosensor is not functional Remove and replace biosensor If the light on the biosensor flashes red at any time during use remove the biosensor see Remove biose...

Страница 20: ...ation The frequency of data collection and transmission is clinician configurable Transmission intermittence period can be adjusted from 1 minute to 30 minutes The biosensor will store data locally up to 4 hours Notifications No connection No Connection notification will be displayed whenever biosensor is not connected with the app No Connection The biosensor is not connected to the app Ensure the...

Страница 21: ...an detect heart rate from 30 220 bpm beats per minute Whenever the heart rate value calculated outside of this range a notification will indicate Out of Range G5 application interface Normal HR Out of Range HR Out of Range The biosensor can detect heart ratefrom 30 220 bpm The calculated heart ratevalue is outside of this range Takea confirmatory independent check of vitals Normal HR Out of Range ...

Страница 22: ...cation in the event the battery level falls below the normal level Biosensor error The biosensor has detected system error that will be displayed under notification log Refer to biosensor troubleshooting section for next steps Normal Biosensor Error The biosensor has detected a system error Refer to the Troubleshooting section of the Instructions for Use 92 Low Low Battery The biosensor battery ha...

Страница 23: ...is on a computer The file must be unlocked using the same password that was used on the G5 biosensor app to review and analyze the data Time stamped heart rate data and notifications are listed in the file Files are named using patient ID and date Use any data analysis software program to sort the data by date as needed ...

Страница 24: ...rated electronics Refer to the instructions for use for the mobile device for cleaning and disinfection procedures Storage Biosensors must be stored in their sealed pouch The pouch cannot be resealed after opening The biosensor should be used immediately after opening the pouch to prevent the hydrogel from drying Biosensors should be stored at Temperature between 15 and 35 C 59 and 95 F Humidity b...

Страница 25: ... properly adhere to the patient s chest If you touched a large area of the adhesive you may need to dispose of the biosensor and apply a new one Before applying a new biosensor to the patient s chest ensure the skin is clean of any oil lotion debris or residue and the area is completely dry Press firmly to adhere the sensor to the patient s skin The patient s heart rate does not seem to be updatin...

Страница 26: ...ng remove and replace the biosensor If there is no red light flashing press down firmly on the biosensor to adhere If the biosensor still does not adhere remove and replace the biosensor The G5 app shows Could not connect to G5 biosensor message Tap Cancel to return to the biosensors in the range screen Enter the patient information and select correct Biosensor ID The biosensor is causing skin irr...

Страница 27: ...d instructions for use Do not use if package is damaged Prescription use only Storage humidity range limits Storage temperature range limits Box of 5 Protected against access to hazardous parts and the ingress of solid foreign objects greater than 12 5mm 0 5 inch and protected against effects of temporary immersion Catalogue number Specifications Storage ambient pressure range limits ...

Страница 28: ...Android SDK Platform to build and run Android apps API25 Google Butterknife Annotation processing 8 8 1 Square Regulatory and safety specifications This Philips product has been tested in a typical configuration as described in this Instructions for Use and are fully compliant with the standards listed below EN IEC 60601 1 2006 EN IEC 60601 1 2006 A1 2013 General requirements for basic safety and ...

Страница 29: ...ISO EC12 2000 2010 Disposable electrodes EMC and radio regulatory compliance This Philips product complies with relevant international and national law and standards on EMC electromagnetic compatibility for this type of product when used as intended Such laws and standards define both the permissible electromagnetic emission levels from product and its required immunity to electromagnetic interfer...

Страница 30: ...suant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not o...

Страница 31: ...ects greater than 12 5mm 0 5 inch and protected against effects of temporary immersion According to the mode of operation Continuous operation ME equipment Type Body worn The device is intended for use in the electromagnetic environment specified below Given the device s electromagnetic emissions and immunity characteristics the customer or user should assure that the device is used within such an...

Страница 32: ...uidance RF Emissions CISPR 11 Group 1 The Philips wearable biosensor G5 Solution uses RF energy only for its internal functions Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The Philips wearable biosensor G5 Solution is suitable for use in all establishments other than domestic establishments and th...

Страница 33: ...ctrostatic discharge ESD IEC 61000 4 2 8kV contact 15kV air 8kV contact 15kV air Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Immunity Test IEC 60601 Test Level Compliance Level Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Electromagnetic Environme...

Страница 34: ...e may occur in the vicinity of equipment marked with the symbol These guidelines 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 ...

Страница 35: ... Heart Rate is calculated Taking into account last 10 beat to beat intervals Excluding the minimum and the maximum intervals Averaging the remaining eight intervals to compute mean_interval and Compute 60 mean_interval in seconds to convert to bpm Heart Rate Sampling Rate 250 samples per second Heart Rate Meter Accuracy and Response to Irregular Rhythm Provides correct heart rates 60 80 90 120 bpm...

Страница 36: ... 1mW Maximum power 8dBm 6 31mW Operating Range 10 meters Line of Sight Environmental Operating Temperature Range 15 35 C Operating Humidity Range 20 85 Operating Atmospheric Pressure Range 10 106 kPa Storage Temperature Range 15 35 C Storage Humidity Range 5 95 Storage Ambient Pressure Range 50 106 kPa Shelf Life 3 Months Software application specifications Mobile device Operating System Android O...

Страница 37: ...www philips com 2018 Koninklijke Philips N V All rights reserved Printed in the United States of America First printing January 2018 Part Number 453564741671 Artwork A 453564741671 2 Rev B ...

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