Zephyr Technology BH3-M1 Patient Data Transmitter User Manual User s Manualx
Zephyr Technology Corporation Patient Data Transmitter User s Manualx
User Manual
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| Document ID | 3564244 |
| Application ID | UUH4z7ILHILh3wycatYyQg== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
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| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 222.11kB (2776417 bits) |
| Date Submitted | 2017-09-15 00:00:00 |
| Date Available | 2018-03-10 00:00:00 |
| Creation Date | 2017-03-29 10:51:20 |
| Producing Software | Acrobat Distiller 15.0 (Windows) |
| Document Lastmod | 2017-03-29 10:51:20 |
| Document Title | Microsoft Word - User's Manual.docx |
| Document Creator | PScript5.dll Version 5.2.2 |
| Document Author: | angela.still |
Patient Guide Patient Guide Contents Introduction ................................................................................................................................ 2 ZephyrLIFE Home Indications for Use ....................................................................................... 2 ZephyrLIFE Home Intended Use ............................................................................................... 2 ZephyrLIFE Home Warnings and Cautions ............................................................................... 2 ZephyrLIFE HealthHub™ .......................................................................................................... 2 ZephyrLIFE HealthHub Device Options ..................................................................................... 2 ZephyrLIFE HealthHub Dashboard ........................................................................................... 2 Measure Blood Pressure (Foracare D40d) ................................................................................ 2 Measure Blood Pressure (Foracare P20) .................................................................................. 2 Measure Blood Pressure (Foracare Test N’GO BP) .................................................................. 2 Measure Blood Glucose (Foracare D40d) ................................................................................. 2 Measure Blood Glucose (Fora MD) ........................................................................................... 2 Measure Blood Glucose (Foracare TN’G Voice) ....................................................................... 2 Measure Weight (Foracare W310 Scale)................................................................................... 2 Measure Weight (Foracare TN’G 550 Scale)............................................................................. 2 Measure Temperature ............................................................................................................... 2 Record Feelings ........................................................................................................................ 2 Zephyr BioModule Intended Use ............................................................................................... 2 Zephyr BioModule Warnings & Cautions ................................................................................... 2 Zephyr BioModule Contraindications ......................................................................................... 2 Prepare BioModule for Use ....................................................................................................... 2 Skin Preparation ........................................................................................................................ 2 BioModule Data ......................................................................................................................... 2 Measure ECG ............................................................................................................................ 2 BioModule Light Indicators ........................................................................................................ 2 Onyx® II Model 9560 Finger Pulse Oximeter Indications for Use .............................................. 2 Onyx® II Model 9560 Finger Pulse Oximeter Contraindications ................................................ 2 Onyx® II Model 9560 Finger Pulse Oximeter Warnings ............................................................ 2 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Oxygen ............................................................................................................. 2 Accessing the Portal .................................................................................................................. 2 Navigating the Portal Screens ................................................................................................... 2 All Patients Tab Parameters ...................................................................................................... 2 Data Updates – Reading the All Patients Tab ........................................................................... 2 Dashboard ................................................................................................................................. 2 History ....................................................................................................................................... 2 Trends ....................................................................................................................................... 2 ECG ........................................................................................................................................... 2 Manage Patient ......................................................................................................................... 2 Care Circle................................................................................................................................. 2 To Replace a Discharged BioModule ........................................................................................ 2 Care & Cleaning of the BioModule and BioModule Holder ........................................................ 2 Changing batteries on devices .................................................................................................. 2 Changing batteries on devices .................................................................................................. 2 Changing batteries on devices .................................................................................................. 2 Changing batteries on devices .................................................................................................. 2 Changing batteries on devices .................................................................................................. 2 Troubleshooting Tips ................................................................................................................. 2 Specifications ............................................................................................................................ 2 Accessories ............................................................................................................................... 2 Manufacturer’s Declaration and Guidance................................................................................. 2 FCC Declaration ........................................................................................................................ 2 Warranty .................................................................................................................................... 2 Appendix I Active Patient Monitoring ......................................................................................... 2 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Zephyr Technology 1 Annapolis St. Suite 200 Annapolis MD 21401 USA Zephyr Support Phone: 1-800-497-4968 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Introduction Overview This manual describes the features, setup and operation of the ZephyrLIFE Home remote patient monitoring system, comprising the Zephyr BioModule, HealthHub and associated sensors. A companion Quick Reference Guide is provided for clinician use. Intended Audience This manual provides information to patients in low-acuity hospital-type or home settings, for preparation and maintenance of the system. Before operating, thoroughly read this manual. Safety Symbols Symbol Definition Warning: warnings alert users to potential serious outcomes (injury or adverse events) to the patient, operator or environment Caution: cautions inform users to exercise appropriate care for safe and effective use of the product. Note: Notes provide additional guidelines or information 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE Home Indications for Use ZephyrLIFE Home is indicated to receive, transmit, collect, accumulate and display a patient’s physiologic signals and other data from a remote location to the healthcare practitioner. External sensors supply this device with physiologic information such as, but not limited to: Blood pressure Blood glucose Blood oxygen saturation Temperature Heart Rate Respiration Rate Position for distribution. 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE Home Intended Use 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE Home Warnings and Cautions 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE HealthHub™ Press and Hold side button to power ON/OFF. Press briefly to turn screen off, and again to turn the screen on. ZephyrLIFE will keep running in the background. Tap the icon to start ZephyrLIFE. The images shown in this guide are for education purposes only Tap the screensaver screen to return to the dashboard Keep the HealthHub connected to a charge unit when indoors During operation, always keep the HealthHub within 10 yards of the BioModule and external sensors. 10 yards 9700.0205.v7b ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE HealthHub Device Options HealthHub 5-inch screen HealthHub 8-inch screen 9700.0205.v7b 10 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ZephyrLIFE HealthHub Dashboard Zephyr BioModule Heart Rate Respiration Rate Calories Activity Minutes Battery level HealthHub Battery Level Blood Pressure Blood Glucose Temperature Blood Oxygen Weight Heart Rate Respiration Rate Activity Minutes Calories Expended BioModule Battery Not implemented Blood Pressure Temperature Blood Glucose Weight Blood Oxygen (SpO2) ECG request button 9700.0205.v7b 11 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Pressure (Foracare D40d) Apply cuff to the arm and start measurement on the device, by pressing the On/OFF button. Follow the voice prompt for instructions. When complete the new measurement will display with the time it was taken. Detailed instructions for measuring blood pressure and taking test measurements are included in the blood pressure monitor user manual Check the Blood Pressure monitor user manual for warnings and cautions on its use 9700.0205.v7b 12 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Pressure (Foracare P20) Apply cuff to the arm and start measurement on the device, by pressing the On/OFF button. Follow the voice prompt for instructions. When complete the new measurement will display with the time it was taken. Detailed instructions for measuring blood pressure and taking test measurements are included in the blood pressure monitor user manual Check the Blood Pressure monitor user manual for warnings and cautions on its use 9700.0205.v7b 13 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Pressure (Foracare Test N’GO BP) Apply cuff to the arm and start measurement on the device, by pressing the On/OFF button on the top edge of the device. When complete the new measurement will display with the time it was taken. Detailed instructions for measuring blood pressure and taking test measurements are included in the blood pressure monitor user manual Check the Blood Pressure monitor user manual for warnings and cautions on its use 9700.0205.v7b 14 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Glucose (Foracare D40d) Insert test strip carefully and wait until the glucometer prompts for the blood drop. Take a blood sample using the lancing device as instructed. Place the blood drop on the strip. The glucometer will count down while testing and display the result. The result will display on the HealthHub automatically, with the time it was taken. Use the side button to eject the Glucose strip. As the lancet and test strip may be biohazards, please discard carefully according to your local regulations. Detailed instructions for obtaining a blood sample, using the glucometer, troubleshooting and taking test measurements are included in the glucometer user manual. Check the Blood Glucose monitor user manual for warnings and cautions on its use 9700.0205.v7b 15 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Glucose (Fora MD) Insert test strip carefully and wait until the glucometer prompts for the blood drop. Take a blood sample using the lancing device as instructed. Place the blood drop on the strip. The glucometer will count down while testing and display the result. The result will display on the HealthHub automatically, with the time it was taken. Use the top button to eject the Glucose strip. As the lancet and test strip may be biohazards, please discard carefully according to your local regulations. Detailed instructions for obtaining a blood sample, using the glucometer, troubleshooting and taking test measurements are included in the glucometer user manual. Check the Blood Glucose monitor user manual for warnings and cautions on its use 9700.0205.v7b 16 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Glucose (Foracare TN’G Voice) Insert test strip carefully and wait until the glucometer prompts for the blood drop. Take a blood sample using the lancing device as instructed. Place the blood drop on the strip. The glucometer will count down while testing and display the result. The result will display on the HealthHub automatically, with the time it was taken. Use the side button to eject the Glucose strip. As the lancet and test strip may be biohazards, please discard carefully according to your local regulations. Detailed instructions for obtaining a blood sample, using the glucometer, troubleshooting and taking test measurements are included in the glucometer user manual. Check the Blood Glucose monitor user manual for warnings and cautions on its use 9700.0205.v7b 17 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Weight (Foracare W310 Scale) Turn on the scale by using the center button or by tapping the weigh platform – wait for the number ‘0.0’ to be displayed. Step on the scale and wait for weight to be displayed and stop flashing. The weight will display on the HealthHub automatically, with the time it was taken. Detailed instructions for setting up the scale and troubleshooting are included in the weigh scale user manual. Check the Weigh Scale user manual for warnings and cautions on its use 9700.0205.v7b 18 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Weight (Foracare TN’G 550 Scale) Turn on the scale by using the center button or by tapping the weigh platform – wait for the number ‘0.0’ to be displayed. Step on the scale and wait for weight to be displayed and stop flashing. The weight will display on the HealthHub automatically, with the time it was taken. Detailed instructions for setting up the scale and troubleshooting are included in the weigh scale user manual. Check the Weigh Scale user manual for warnings and cautions on its use 9700.0205.v7b 19 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Temperature Fit a new cover on the ear probe. Use only covers supplied by the manufacturer. [After taking a reading, dispose of the cover using the eject button]. Turn on the thermometer using the front button below the display screen. A beep will sound. Insert probe gently into ear canal and press the rear button. Hold until another beep indicates temperature taken. The result will display on the HeathHub automatically along with the time it was taken Detailed instructions for obtaining temperature, using the thermometer, troubleshooting and taking test measurements are included in the thermometer user manual. Check the Thermometer user manual for warnings and cautions on its use 9700.0205.v7b 20 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Record Feelings Swipe the ZephyrLIFE dashboard from left to right to access the Feelings screen. Use the sliders to give an indication of your feelings. This is a subjective view for yourself only. Use the Submit button to send information to the ZephyrLIFE portal. Actual screen appearance may vary. Swipe the Feelings screen in the opposite direction to return to the dashboard, or use the back button. 9700.0205.v7b 21 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Zephyr BioModule Intended Use 9700.0205.v7b 22 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Zephyr BioModule Warnings & Cautions 9700.0205.v7b 23 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide 9700.0205.v7b 24 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide A quality ECG signal requires that fresh electrode patches and evaluation of skin integrity should occur every 24 hours, or per Care Area guidelines. BioModule holder should be disposed of as per care area policy and product instructions. 9700.0205.v7b 25 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Zephyr BioModule Contraindications Not for use with patients fitted with an implanted cardiac device such as an internal pacemaker or automatic defibrillator. 9700.0205.v7b 26 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Prepare BioModule for Use a) Obtain your clean and charged BioModule from the charging cradle b) Clean BioModule using instructions found in this guide c) Snap the BioModule into the BioModule holder (larger notch in the upper rim). BioModule ‘Zephyr’ logo at the bottom of the holder. d) To remove, press the BioModule holder from the rear as shown. e) Verify that the electrode expiration date has not passed and the gel is moist. Keep the electrode package in a zip top bag after opening to keep electrodes moist. f) Snap two (2) electrodes to the holder. It is ready to apply. g) Press and hold the device center firmly to turn it on. The red light will light up and the blue light will flash. Recommended electrodes: Covidien Kendall™ 530 Foam 9700.0205.v7b 27 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Skin Preparation a) Select the area to prepare as indicated in the figure. b) Clip hair to make sure electrodes adhere to the skin. c) Wash skin with soap and water to remove dirt, lotions and dry skin cells. Rinse well. d) Dry the area with a cloth to remove any hair or soap. e) Peel the backing from the electrodes. f) Apply firmly in line with the breast bone as shown, between the sternal notch and the xiphoid process. g) The BioPatch may be removed at any time without risk to the wearer. Replace electrodes daily or as instructed. Note: For best signal electrodes should be changed as directed by your prescribing clinician. If the electrode causes skin irritation, please notify your care giver. 9700.0205.v7b 28 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide BioModule Data Heart Rate in beats per minute Should appear after ~ 1 minute Green flashing LED on BioModule No heart rate is indicated by ‘- - ‘ on the display. Breathing Rate in breaths per minute No breath rate is reported during the first minute If after the second minute no breath rate is reported, alternative methods should be considered. No breath rate is indicated by ‘- - ‘ on the display. Minutes of activity while wearing BioModule Walking effort or equivalent Resets at midnight each day Calories burned while wearing BioModule Resets at midnight each day BioModule battery – percentage full charge remaining Time Stamp – the date and time the last BioModule information was uploaded to the portal – every 15 minutes Once the BioModule is attached to the patient and flashing green, the device is functioning properly. This may take up to a minute. 9700.0205.v7b 29 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure ECG Sit down and remain still while taking ECG. Touch the ECG button to request a new ECG strip. Touch the ECG button on the phone screen. The ECG screen will display. Be careful not to touch the screen again as it will stop the ECG from being acquired. If the BioModule has recently been applied, a message may display asking you to wait 1 minute. ECG will be displayed, with time measurement taken, and uploaded to the web portal. Touch the screen again to return to the main screen (or the back button). If you experience chest pain, or signs and symptoms of an acute problem, call 911 or follow the instructions of your physician 9700.0205.v7b 30 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide BioModule Light Indicators a) GREEN: flashing – working normally. Data is transmitting. b) BLUE: flashing – loss of Bluetooth signal. Move closer to the HealthHub. Confirm HealthHub application is running. c) ORANGE: Flashing – low battery. Recharge in cradle. d) RED: constant – No heart rate detected. Check electrode connection. Re-prep skin and apply fresh electrodes if necessary. In Charging Cradle: a) Flashing Orange = Charging (1 hr to 90%) b) Constant Orange = Charged (3 hrs to 100%) Ready to use. Once the BioModule is attached to the patient and flashing green, the device is functioning properly. This may take up to a minute. 9700.0205.v7b 31 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Onyx® II Model 9560 Finger Pulse Oximeter Indications for Use The Nonin Onyx II Finger Pulse Oximeter is a small, lightweight, wireless device indicated for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The device’s intended use environments include hospitals, clinics, long-term care facilities, skilled nursing facilities, emergency medical services and home healthcare services Federal Law restricts this device to sale by or on the order of a licensed practitioner. 9700.0205.v7b 32 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Onyx® II Model 9560 Finger Pulse Oximeter Contraindications Do not use the device in an MR environment, in an explosive atmosphere, or on infant or neonatal patients. This device is not defibrillation proof per IEC 60601-1 9700.0205.v7b 33 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Onyx® II Model 9560 Finger Pulse Oximeter Warnings Further information can be found in the Onyx II® User Manual 9700.0205.v7b 34 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Measure Blood Oxygen Insert index finger in sensor. Wait until the red lines on the top row stop flashing. Do not wear dark nail varnish when using the oximeter as this will affect its ability to take a reading. The reading will display on the HealthHub automatically, with the time it was taken. Detailed instructions for taking blood oxygen measurements and troubleshooting are included in the pulse oximeter user manual. Please check the Pulse Oximeter user manual for warnings and cautions on its use 9700.0205.v7b 35 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Accessing the Portal Go to the web address supplied by your administrator Use the login form on the right You will need to use the Username and Password provided to you When you have finished accessing the portal, log out by clicking Logout at the top of the screen Supported web browser is Chrome 9700.0205.v7b 36 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Navigating the Portal Screens Use the tabs at the top of each screen. In the All Patients tab select the patient name to open the specific patient Dashboard tab. Auto Sort – (default) – highest (red, yellow) alert patients at the top. Alpha Sort – alphabetical order by last name. Help – provides access to the Quick Reference 9700.0205.v7b 37 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide All Patients Tab Parameters Update Time Data Description/Units Heart Rate Beats/minute Respiration Rate Breaths/minute Activity Minutes Minutes of activity since midnight – resets at zero every midnight Posture Icon: Walk, upright, lying down Calories Calories expended during the selected time period Blood Pressure Systolic/Diastolic in mmHg Last measurement SpO2 Peripheral blood oxygen saturation (%) [Values are individually timestamped] Weight lbs Blood Glucose mg/dL Temperature Degrees Fahrenheit Once per minute for initial 15 min after power-on, then every 15 min OR Last alert generated [Last Update value] 9700.0205.v7b 38 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Data Updates – Reading the All Patients Tab Active Alerted subject/invitees are show at the top of the list. BioModule Data updated every 15 minutes. External sensor readings show time and date of last measurement. ‘- -‘ displays if no valid measurement taken using an external sensor. Blue cell – a measurement has been missed inside a period set in the portal. Blue row – no data for 1/3/7 days, set in the portal. You will only see this screen unless invited to the Care Circle of another patient. 9700.0205.v7b 39 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Dashboard Display latest data OR cursor location on trend graph. Select the patient’s name from the list on the left (single entry in example). Select Start and End dates and time span button. Defaults: Previous 7 days/daily. Drag flags above graph to zoom in. Mouse over graph data point to show recorded values. No mouse = last received value. Expand any graph using the to show sweep scale. arrow Green/yellow/red coloring reflects alert thresholds set for each vital sign. 9700.0205.v7b 40 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide History Each row shows the same data shown on the All Patients tab. Select time interval to display. Show or hide alerts. Alerting cells are red or yellow. Alert Column Indicator – use to clear a single alert for that column. 9700.0205.v7b Alert 41 ©2016 Zephyr Technology, All Rights Reserved Cleared Alert 24-NOV-2016 Patient Guide Trends Patient history as a line graph. Select time interval to display. Select icons to show or hide graphs Grey icon = graph not displayed Mouse over any data point on graph to show recorded values in a callout. 9700.0205.v7b 42 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide ECG ECG strips are generated by button request on screen (authorization required), or automatically when a Heart Rate or Breathing Rate alert is triggered or when submitted by patient on the HealthHub. Thumbnail frame colors o White = manual request or submit o Yellow/Red = auto by alert trigger Select from thumbnail archive or REQUEST NEW ECG by clicking on button Set vertical scale (mV) of the strip paper Data are 3 x 10 second strips – 15 seconds before & after request or trigger. Use the ECG Report button to generate a report 9700.0205.v7b 43 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Manage Patient Patient Demographics Update personal details Email will be the patient’s own login You may have been given permission to change your alert thresholds, or they may be inactive. Alerts display as colored cells in the Portal. Alerts are for information only; they are not warnings. You should consult your clinician before changing any alert levels. Emergency Contact details are at the foot of the page Alerts are generated to inform a credentialed caregiver and are not intended by the manufacturer to suggest any action to the caregiver or user. An alert is for information only – it is not an alarm. 9700.0205.v7b 44 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Care Circle Update all Patient details in the My Profile section. INVITE A FRIEND A patient logged in to the portal can use the Admin tab to send an email invite to a friend to register to view their data. Clinicians do not see this view. An email invitation will be sent to the friend, with a link to a registration page. The patient can use their Admin tab to set what their friend can see when logged in to the portal. 9700.0205.v7b 45 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide To Replace a Discharged BioModule Remove the BioModule from the subject. Turn off the BioModule by pressing the center for five seconds or until all the lights turn off. Remove the BioModule from the holder by pressing firmly on the back while retracting on the snap wings as shown. Insert the BioModule in the charging cradle, making sure the crescent notch is upward as shown. The cradle is powered by a wall plug adaptor. A full charge of a fully-depleted battery will take approximately 3 hours. A solid non-flashing orange light means fully charged. Patient 9700.0205.v7b 46 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Care & Cleaning of the BioModule and BioModule Holder The BioModule holder is for single patient use and can be reused by that patient. ECG electrodes may be disposed in general home waste. The BioModule and BioModule Holder are reusable and should be surface cleaned with one of the products below. Wipe BioModule and BioModule Holder with a cloth soaked in bleach or peroxide solution. Let air dry. Recommended cleaning product options Sani-Cloth HB Sodium Hypochlorite (8.25% bleach, diluted 1:10 to 1:100) Hydrogen Peroxide (3% solution) Sani-Cloth is a registered trade mark of Professional Disposables International, Inc. Sani-Cloth HB® Bleach Hydrogen Peroxide Consult the instructions supplied with each cleaning product for appropriate cleaning procedure 9700.0205.v7b 47 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Changing batteries on devices Fora D40 Blood Pressure/Glucometer. 4 x AA batteries. Flashing battery symbol means batteries are low. Flashing battery = low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded and a message displayed on the HealthHub. Repeat to take a valid measurement. Fora IR20 Thermometer. 2 x AA batteries. Constant battery symbol means batteries are low. After battery replacement, take a measurement. The first measurement after changing batteries will be discarded and a message displayed on the HealthHub. Repeat to take a valid measurement. Battery icon = low power For detailed instructions on changing the batteries in optional sensors, please read the manufacturer’s manual 9700.0205.v7b 48 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Changing batteries on devices Fora W310 Weight Scale. 4 x AA batteries. “Lo” display means batteries are low. “Lo” = low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. Nonin 9560 Pulse Oximeter 2 x AAA batteries. Flashing display means batteries are low. Squeeze as shown to release battery compartment. Flashing display = low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. For detailed instructions on changing the batteries in optional sensors, please read the manufacturer’s manual 9700.0205.v7b 49 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Changing batteries on devices ForaTN’G 550 Weight Scale. 4 x AA batteries. “Lo” display means batteries are low. “Lo” = low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. Fora MD Glucometer 2 x AAA batteries. Low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. For detailed instructions on changing the batteries in optional sensors, please read the manufacturer’s manual 9700.0205.v7b 50 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Changing batteries on devices Fora Test N’GO Voice. 2 x AAA batteries. Low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. For a P20 Blood Pressure Monitor 4 x AAA batteries. After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. Low power For detailed instructions on changing the batteries in optional sensors, please read the manufacturer’s manual 9700.0205.v7b 51 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Changing batteries on devices Fora Test N’GO BP. 4 x AAA batteries. Low power After battery replacement, take a measurement. The first measurement after changing batteries will be discarded. Repeat to take a valid measurement. For detailed instructions on changing the batteries in optional sensors, please read the manufacturer’s manual 9700.0205.v7b 52 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Troubleshooting Tips Question How do I know if the BioModule is fully charged? What to do The orange light is steady, not flashing when in the charging hub or cradle. See BioModule Light Indicators page. How long does it take to charge? 1 hour for 90% charge and 3 hours for 100%. See BioModule Light Indicators page. What does it mean if the red light on the BioModule is constantly on? A steady red light indicates no heart rate was detected – check that the BioModule holder is firmly attached to the electrodes and that the electrodes are securely attached your chest. See Page 32 What does a flashing blue light mean? A flashing blue light indicates a loss of radio transmission from the BioModule to the HealthHub. Move closer to the HealthHub, or locate it in a more central room of your home. See BioModule Light Indicators page. Is it important to place the BioModule in the pictured positions? Yes, to get the most accurate data it is very important to position as shown. See Skin Preparation page. What do I do with my HealthHub while wearing the BioModule? Keep it in the base plugged into an outlet in the same room, or carry the HealthHub with you if you go outside. Make sure the HealthHub is charged before leaving. The HealthHub can lose communication with the BioModule if separated by more than 10 yards. A message appears on the HealthHub “No Internet Connection Available”. Make sure that the HealthHub has wireless data connectivity. Re-start the HealthHub and the ZephyrLIFE application. A message appears on the HealthHub “ZephyrLIFE Patient isn’t responding, do you want to close it?” Re-start the HealthHub and the ZephyrLIFE application. Different values are shown on the HealthHub from the peripheral device Repeat measurement. HealthHub and portal do not display data from the Fora device after multiple measurements Remove and reinsert the batteries from Fora device and take measurement. The first measurement will be discarded, take a second measurement. 9700.0205.v7b 53 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Specifications BioModule Prescription Device Heart Rate Breathing Rate 30 – 240 bpm ±1bpm static (R-R interval) 5 – 50 brpm ±1brpm static Battery Performance Type Operating Rechargeable Lithium Polymer, 3.6 – 4.2V 24 hours minimum when new and fully charged Place in charger 24 hours if unused for 3 months. Charge periodically if unused to avoid full discharge state Battery Charging Charge Time Single Device Charge cradle 5 Device Charge cradle Classifications per IEC 60601-1 Installation & Use Degree of Protection Supply Connection ECG type (BH3-M1) ECG type (BH3-M2) 1 hr to 90% capacity, 3 hrs to 100% capacity USB connector provided AC Adaptor, 100-240V input 5V/0.5A output 100-240V input, 7.5V /3.0A output power supply provided Portable, body-worn Type CF-Applied Part Internally powered Ambulatory Electro Cardio Graph (AECG Type 3) as per ANSI/AAMI EC38:1998 compliance Ambulatory Electro Cardio Graph (AECG) as per IEC 60601-2-47: 2012 compliance Transmitter Bluetooth Compliance Operating Frequency Output Power Antenna type Operating Range Modulation Type FCC ID Version 2.1 + EDR 2.4 - 2.4835 GHz 10 dBm Internal 10 yards FSK VZ6-BH3 Electromagnetic Compliance Emissions Immunity IEC 60601-1-2:2007 IEC 60601-1-2:2007 Environmental (Operating) Temperature Temperature - charging Relative Humidity Ingress Protection 9700.0205.v7b -20º C to +45º C (-4º F to 113º F) inclusive 0º C to +45º C (32º F to 113º F) inclusive 15% to 95% non-condensing IP67 – protected from dust and against the effect of immersion in water to depth between 15 cm and 1 meter (6 in to 3 ft) 54 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Environmental (Storage & Transportation) Temperature Relative Humidity Atmospheric Pressure -20º C to +45º C (-4º F to 113º F) inclusive 15% to 95% non-condensing 12kPa to 107kPa Service Life BioModule Battery Maintenance BioModule Holder ECG electrodes 300 charge cycles minimum Other than cleaning and charging, no other maintenance is required. Single Patient use Single use Disposal Return Local Disposal WEEE The BioModule, charge cradle and BioModule holder contain no hazardous components. All electrical components are lead-free. Zephyr Technology will undertake to dispose of any end-of-life components which are returned to their facility. Where specific provision is made in a particular region for disposal and recycling of electrical goods, Zephyr advises following local guidelines for conscientious disposal of equipment. Zephyr BioModule is WEEE compliant Dimensions BioModule Holder 48 x 46 x 10 mm (1.9 x 1.8 x 0.4 in) 90 x 50 x 10 mm (3.5 x 2.0 x 0.4 in) BioModule 18 grams (0.63 oz) Holder 14 grams (0.49 oz) Weight 9700.0205.v7b 55 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Symbols on Device Blue LED – Bluetooth transmit status/error Orange LED – low battery indication/charging indication Red LED – Heart Rate detection status/error Green LED – normal operations indication Symbols on Device Label Manufacturer’s designation for device Device Model Device Serial Number XXXXXX Consult user manual before use Type CF-Applied Part IP67 Ingress Protection Rating Device Type [Ambulatory ECG Type 3] WEEE Europe Contains radio transmitter (non-ionizing radiation) FCC radio emissions compliance FCC ID 9700.0205.v7b Zephyr BioModule ID 56 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Symbols on Shipping Label Prescription-only device Read instruction manual (this manual) before use Transport atmospheric pressure range 12kPa – 107 kPa Transport humidity range 15 – 95% RH Transport temperature range -4º - 113ºF / -20º - 45ºC Keep dry 9700.0205.v7b 57 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Accessories The Zephyr BioModule should only be used in conjunction with the following accessories, supplied with the system kit: Component Part Number Description Zephyr BioModule BH3-M1 9607.0216 Zephyr BioModule Zephyr BioModule BH3-M2 9607.0296 Zephyr BioModule BioModule Holder 9607.0207 White holder, stainless steel snaps Single charge cradle 9800.0221 White single BioModule charge cradle USB cable 0015.0051 USB cable for single BioModule charge cradle USB A/C Adaptor 0010.0119 AC adaptor for single BioModule cradle 5 Device charge cradle 9607.0215 White charge cradle for 5 BioModules with power supply Nonin 9560BT Onyx II 9607.0231 Pulse Oximeter SpO2 sensor Foracare W310b 9607.0223 Weigh Scale Foracare TN’G 550 9607.0282 Weigh Scale Foracare IR20b 9607.0230 Infrared Ear Thermometer Foracare IR20b V4 9607.0285 Infrared Ear Thermometer Foracare D40d 9607.0222 Blood Pressure / Blood Glucometer sensor Foracare D40d V4 9607.294 Blood Pressure / Blood Glucometer sensor Lancet Pen 9607.0233 Foracare Lancet Pen for D40d Foracare P20 9607.0286 Foracare Test N’Go Blood Pressure Cuff Fora MD 9607.0289 Blood Glucose Sensor For a TN’G Voice 9607.0283 Blood Glucose Sensor ZephyrLIFE HealthHub 5” 9607.0278 ZephyrLIFE HealthHub and installed software ZephyrLIFE HealthHub 7” 9607.0277 ZephyrLIFE HealthHub and installed software 9700.0205.v7b 58 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Component Part Number Description BP Cuff Large 9607.0107 Large BP cuff for D40d BP Cuff Wide Range 9607.0108 Wide Range BP cuff for D40d BP Cuff Small 9607.0109 Small BP cuff for D40d ECG Electrode 9607.0104 Covidien™ Kendall™ 530 Foam Electrode, pack of 30 IR20b Lens Filter 9607.0235 Pack of single-use lens filters for ear thermometer IR20b V4 Lens Filter 9607.0292 Pack of single-use lens filters for ear thermometer BG Test Strips 9607.0232 Pack Test Strips for D40d blood glucose BG Test Strips 9607.0291 Pack 50 Test Strips for Fora MD blood glucose BG Test Strips 9607.0284 Pack 50 Test Strips for Fora TN’G Voice blood glucose Lancets 9607.0234 Pack Foracare lancets for lancet pen Control Solution 9607.0237 Blood control solution for D40d glucometer calibration Control Solution 9607.0287 Blood control solution GDH Control Solution 9607.0288 Blood control solution GOD 9700.0205.v7b 59 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Manufacturer’s Declaration and Guidance Electromagnetic Emissions Electromagnetic Emissions Guidelines and Compliance Guidance and Manufacturer’s Declaration—Electromagnetic Emissions (IEC 60601-1-2:2007, Table 1) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of the BioModule should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF emission Group 1, CISPR 11 Class B BioModule uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Harmonic Emission IEC 61000-3-2 N/A N/A Voltage fluctuation/ flicker emissions IEC 61000-3-3 N/A N/A 9700.0205.v7b 60 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Electromagnetic Immunity Electromagnetic Immunity Guidelines and Compliance Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC 60601-1-2:2007, Table 2) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of BioModule should assure that it is used in such an environment. Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) IEC 61000-4-2 ± 6 kV contact ± 8 kV air ± 6 kV contact ± 8 kV air Floor should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 9700.0205.v7b 61 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Recommended Separation Distance Calculations Guidance and Manufacturer’s Declaration—Electromagnetic Immunity (IEC 60601-1-2:2007, Table 4) The BioModule is intended for use in the electromagnetic environment specified below. The customer or the user of BioModule should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the BioModule, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 3 Vrms 150 KHz to 80 MHz Not applicable 3 V/m 80 MHz to 2.5 GHz 3 V/m 1.2√ 80 MHz to 800 MHz 2.3√ 800 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 d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than compliance level in each frequency rangeb Interference may occur in the vicinity or equipment marked with the following symbol: 9700.0205.v7b 62 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Note 1 At 80 MHz and 800 MHz, 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. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM 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 measured field strength in the location in which the BioModule is used exceeds the applicable RF compliance level above, the BioModule should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the BioModule. Over the frequency range 150 kHz to 80 MHz, fields strengths should be less than 3 V/m Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and BioModule The BioModule is intended for use an electromagnetic environment specified below in which radiated RF disturbances are controlled. The customer or user of the BioModule can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BioModule as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W (watts) Separation distance according to frequency of transmitter m (meters) 150 kHz to 80 MHz 1.2√ 80 MHz to 800 MHz 1.2√ 800 MHz to 2.5 GHz 2.3√ 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 9700.0205.v7b 63 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide 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. FCC Declaration NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. This device complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Any computer used in conjunction with this device must be covered by a Declaration of Conformity or must be FCC certified in its own right. Warranty The product is tested and validated with the components which are supplied with the ZephyrLIFE Home Kit. Substituting any portion of the kit may alter functionality of the kit. Use only parts which are supplied with the kit. Changes or modifications to the BioModule and/or BioModule Holder may void the user’s authority to operate this equipment. 9700.0205.v7b 64 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016 Patient Guide Appendix I Active Patient Monitoring A device is considered used for active patient monitoring when it is: relied upon for information necessary to make an immediate medical decision, or used for continuous patient monitoring. 9700.0205.v7b 65 ©2016 Zephyr Technology, All Rights Reserved 24-NOV-2016
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