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BodiMetrics VitalsRx User Manual

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VitalsRx Monitor

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Summary of Contents for BodiMetrics VitalsRx

  • Page 1 User’s Manual VitalsRx Monitor...

  • Page 2: Table Of Contents

    The Basics Introduction Getting Started Using VitalsRx Settings Review Maintenance Accessories Specifications Electromagnetic Compatibility Knowing and Tracking Your Health...

  • Page 3: The Basics

    This manual is based on the maximum configuration of VitalsRx Monitor. Some functions may be not available on your model. 1.1 Safety...
  • Page 4 The VitalsRx is MR unsafe. Do not use this device in an MR  environment as it contains strongly ferromagnetic materials. Do not use the device in a combustible environment (i.e., oxygen-  enriched environment). Never submerge the device in water or other liquids. Do not clean ...

  • Page 5: Introduction

     2. Introduction 2.1 Intended Use The VitalsRx Monitor is intended to be used for measuring, displaying, reviewing and storing of ECG (adults only), oxygen saturation and pulse rate (Continuous data collection and recording is for adult only, spot checking is for adults and pediatrics) and temperature in the home or in healthcare facilities.
  • Page 6 Touch Screen Infrared temperature sensor Internal SpO sensor LED indicator  Off: the monitor is turned off or working in Standby Mode;  Green: the monitor is turned on, and working normally; or when the battery is fully charged;  Blue: the battery is being charged;...
  • Page 7  When the monitor is off, press this button to power it on.  When the monitor is on, press and hold it for 2 seconds to turn it off.  During operation, pressing this button will switch to Main Screen, or Standby Mode, or return to upper menu.
  • Page 8 12. ECG cable with lead wires Connect the cable to the device via micro D USB port, and put the other ends to your left/right wrists or right clavicle/left lower abdomen. 13. SpO external finger sensor Connect the cable to the device via micro D USB port, and put your index finger in with the fingernail facing up against the cable side of the sensor.
  • Page 9 2.4 Standby Mode The device will enter Standby Mode when: No operation is detected for 120 seconds on the screen interface,  the device will automatically switch to the ultra-low power consumption Standby Mode. Pressing the Home button in the Main Screen. ...
  • Page 10 Battery indicator Please refer to Section 7.1 for details. If you failed to respond to the previous reminder event, then that event will be shown in this area. This icon appears when <Quick ECG> is enabled. Please refer to Section 5.4 for details. This icon appears if you have set reminder event.
  • Page 11 Oxygenation and Pulse Rate (from Pulse Oximetry). Buttons  Select button to start a measurement again.  Press button to add voice memo for this measurement.  Press button to play the ECG waveform.  Select button to review previous results. ...

  • Page 12: Getting Started

    MRI unsafe, Presents hazards in all MR environments as device contains strongly ferromagnetic materials. Follow operating instructions No alarm system. Getting Started 3.1 Unpacking Before unpacking, examine the box carefully for signs of damage. If the packing case is intact, open the package and remove the equipment and accessories carefully.
  • Page 13 3.3 Initial Settings The first time when the VitalsRx is powered on, you can follow the steps below to set up your VitalsRx monitor. User Interface Action Tap the language you want the device to use. Then Tap Tap the “+” or “-” button to change the date, month and year.

  • Page 14: Using Vitalsrx

    Using VitalsRx 4.1 Prior to Use Warnings Use only cables, sensors and other accessories specified in this  manual. The device has no alarms and will not sound if the measurement  reading is too low or too high. Before using ECG Before using Check Vitals or ECG Recorder function, pay attention to the following points in order to obtain precise measurements.
  • Page 15 When connecting external electrodes and/or patient cables, make  sure that the connectors never come into contact with other conductive parts, or with earth. In particular, make sure that all of the ECG electrodes are attached to the patient, to prevent them from contacting conductive parts or earth.
  • Page 16 Do not use the Oximeter outside the specified operating and  storage temperature ranges. The VitalsRx is MR unsafe. Do not use this device in an MR  environment as it contains strongly ferromagnetic materials. Induced current could potentially cause burns. The SpO...
  • Page 17 or skin condition. For patients with poor peripheral blood circulation or sensitive skin, inspect the sensor site more frequently. 4.2 Check Vitals About Check Vitals Warnings Before using this function, please read the Section 4.1.  When using Check Vitals, please ensure you select the right user. ...
  • Page 18 To start a Check Vitals, follow the steps as below. If you have not created user, then please follow the instruction in Section 5.8 to add your user profile. Press the Home button to enter the Main Screen. Tap the <Check Vitals> icon in the middle of the screen. Choose the right user.
  • Page 19 (2) Press the right thumb on the right front electrode. (3) Press the right middle finger on the back electrode. (4) Press the left side electrode to the left palm. Once the device detects stable waveform, it will automatically start the measurement.
  • Page 20 4.3 ECG Recorder About ECG Recorder The ECG recorder offers four different methods to measuring ECG. Tap the icon to switch between two pages. As shown above, from left to right, there are:  Method A: Lead I, right hand to left hand ...
  • Page 21  Press the right thumb on the right electrode;  Press the right forefinger on the back electrode;  For method A, press the left electrode to the left palm;  For method B, press the left electrode to the left lower abdomen; Do not press the device too firmly against your skin, which may result in EMG (electromyography) interference.
  • Page 22  Sit down or stand, stay calm;  Palms facing up, place an electrode in the middle of right wrist;  For method C, place another electrode in the middle of left wrist;  For method D, place another electrode in the left lower abdomen; The display will then show your ECG waveform.
  • Page 23 Display Check Trace To start a Check Trace Wireless Display function, follow the steps as below. In the VitalsRx Main Screen, select < Check Trace > Correctly connect the "Check Trace adaptor", SpO cable and ECG cable with VitalsRx device.
  • Page 24 Choose the device you’re monitoring via SN. When the devices are connected successfully, you can see the waveform and measurement data on both VitalsRx and app. Please see below the displaying screen on app. When you finish measuring, press the Home button to stop monitoring.
  • Page 25 Keep recording for 24 hours or less. During this process, the device will beep if the cable or any electrode is off. 4.5.3 Report on PC VitalsRx Continuous ECG Recording Browser is a PC software to check and print the report.
  • Page 26 About Oximeter The VitalsRx Health Monitor is calibrated to display functional oxygen saturation and pulse rate. The VitalsRx works by shining two light beams into the small blood vessels or capillaries of the finger, reflecting the amount of oxygen in the blood and displaying the measurement.
  • Page 27 Relax your index finger and do exert pressure. When the device detects stable waveform, it will automatically start the measurement. The countdown bar moves from left to right. When the bar is fully filled, the device will show the measurement result.
  • Page 28 Finger nail position If the device is in Standby Mode, press the Home button. Tap the <SpO2> icon. The display will then show your PLETH waveform, SpO and pulse rate. The device will not analysis your data until you press the button.
  • Page 29 4.8 Temperature About thermometer Warnings The thermometer is only designed for the measuring area on the  human body stated in this manual. Check before each use that the lens is intact. If it is damaged,  please contact your retailer or the service address. The device needs to be in the room which the measurement is ...
  • Page 30 severe sweating, flushed skin, fast pulse rate, tendency to collapse, etc. Dirty temperature sensor window will cause low temperature  reading. Clean sensor window to remove dust or dirt in case of doubtful reading. Influences on forehead temperature include but not limited to, ...
  • Page 31 “Bi-Bi” beep, which indicates the measurement is finished. Take down the device, and the screen shows the measurement result. 4.9 Continuous SpO Recording About Sleep SpO2 In order to use the Sleep SpO2 for continuous recording, you will need a wristband.
  • Page 32 Do not use Sleep SpO2 function on babies and children.  If the SpO sensor causes skin sensitivity, change to another finger.  To start a continuously SpO recording, Place the device on your left hand at a proper position. Attach the device to your hand comfortably with the wristband.
  • Page 33 Tap the button to start the SpO recording. During this process, a countdown timer is always displayed at the lower left part. Press Home button or one minute later, the screen will lock. Insert the device into the wrist band cover, and then begin to record.
  • Page 34 screen. If you have not created user, then please follow the instruction in Section 5.8 to add your user profile. Select a user to enter the screen as below. Tap the button to set your target, if needed. Place the device into your pocket. Tap the button to start calculating steps.
  • Page 35 Check Check Vitals Tap the first row to set the repeat interval. Tap the button to change the setting. Tap the second row to set the event. You can define the event by selecting “Self-define”. Once Check Vitals Tap the third row, set the time when the reminder is triggered, then tap to save this reminder.

  • Page 36: Settings

     Tap the button, and then “Yes” to delete a reminder. 4.12 HRV To start an HRV recording, Tap <HRV> icon in the Main Screen. Press User name or add a new one. Before beginning, sit down, relax, hold device gently as shown and rest your hands on a table.
  • Page 37 Press the Home button to enter the Main Screen. Tap the <Settings> icon to open the menu as below. In the Settings menu, you can  button to page up or down  to close the Settings menu 5.2 Changing Sound Volume In the Settings menu, tap the <Volume>...
  • Page 38 In the Settings menu, choose <Name Management>. Tap a “+” button to open the menu below. Tap each button to edit corresponding information. to return the < Name Management > menu. To edit the information of a user: In the Settings menu, choose <Name Management>. Choose the user that you want to edit.
  • Page 39 5.4 Setting Date & Time In the Settings menu, Chose <Date & Time>. Tap “+” or “-” button to change the date, then Tap Tap “+” or “-” button to change the time. to finish the setting. 5.5 Enabling/Disabling Quick ECG In the Settings menu, tap <Quick ECG>...

  • Page 40: Review

    Choose <About> in the <Settings> menu to identify the software version of your device. 5.9 Turning On/Off Bluetooth VitalsRx has built-in Bluetooth wireless connectivity, which enables exporting measured records from the device to mobile devices. To turn on the Bluetooth: Press the Home button to enter Main Screen.
  • Page 41 6.1 Review Check Vitals To review Check Vitals records, In the <Data Review> menu, select <DailyCheck>. Choose the right user to open the list as below, then select one record to review more information as below. In this menu, you can: ...
  • Page 42 When the ECG waveform is being replayed, you can  to change the waveform amplitude. Select  Select to pause it.  Select to return Check Vitals list. After the ECG waveform is replayed, it will automatically return to the previous interface. Before that, you will hear the voice memo if you added the voice memo for this measurement.
  • Page 43 6.3 Review Oximeter To review Oximeter records, in the <Data Review> menu, select <Oximeter>. 6.4 Review Thermometer To review Thermometer records, in the <Data Review> menu, select <Thermometer>. 6.5 Review Sleep SpO2 To review the records, in the <Data Review> menu, select <Sleep SpO2>.
  • Page 44 Realtime Wireless Display With Realtime Wireless Display adapter, VitalsRx supports continuously real-time ECG and Spo2 data transfer by Bluetooth. Real-time waveform, HR, SpO2, PI and PR value can be sent to mobile pad. Please be noted that:  Realtime Wireless Display adapter is required if you want to use this function.
  • Page 45 Real time Wireless Display adaptor External SpO2 cable Turn on the Bluetooth on your pad, open <VitalsRx Realtime Wireless Display> app and it will search the VitalsRx device. Choose the device you’re monitoring via SN. When the devices are connected, waveform and data will display on both...
  • Page 46 When you finish measuring, press the Home button to stop monitoring.

  • Page 47: Maintenance

    Maintenance Warnings Have the device repaired by authorized service centers only,  otherwise its warranty is invalid. 7.1 Warranty The product is warranted to be free from defects in materials and workmanship within warranty period when used in accordance with the provided instructions.

  • Page 48: Care And Cleaning

    To charge the battery, Connect the smaller end of the charging cable to the multi- functional connector, as shown below. Connect the other end of the USB charging cable to the USB charging port. Please make sure that the LED is blue, and press the Home button to enter the Main Screen, if needed.

  • Page 49: Trouble Shooting

    directly on or into the device. 7.4 Trouble Shooting Problem Possible Cause Solution The device does not 1. The battery may be 1. Charge the battery turn on. low. and try again. 2. The device might be 2. Please contact with damaged your local distributor.
  • Page 50 occurred. failure. measure again. If the error persists, mark down the error number and contact with your local distributor. No voice during ECG and The speaker is muted. Unmuted the speaker measurement. in the Settings menu. value is too low 1.

  • Page 51: Accessories

    Accessories Warnings Use accessories specified in this chapter. Using other accessories  may cause damage to the device or not meet the claimed specifications. Part Number Description 540-00758-00 ECG cable with 2 lead wires, snap 540-00193-00 finger sensor, 25 cm, FP-10...

  • Page 52: Specifications

    Specifications Environmental Item Operating Storage Temperature 5 to 45°C -25 to 70°C Relative humidity (noncondensing) 10% to 95% 10% to 95% Barometric 700 to 1060 hPa 700 to 1060 hPa Degree of dust & water resistance IP22 Drop test 1.0 m Physical Size 88×56×13 mm...
  • Page 53 Standby mode: > 3 months Charge time Less than 2 hours to 90% Integrated ECG electrodes Lead type External ECG cable and electrodes Lead set Lead I, lead II Sampling rate 500 Hz Sampling accuracy 16 bit 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV Display Gain 10 mm/mV, 20 mm/mV Sweep speed...
  • Page 54 adult volunteers by comparing to arterial blood samples measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-oximeter measurements. display range 0% to 100% Integrated External Range...
  • Page 55 Total duration, <90% STAT, Average saturation, Measurement summary Lowest saturation Pedometer Range 0 to 99999 steps Distance 0.00 to 999.99 miles Timer 0 to 1999 minutes Calories 0.00 to 9999.99 kcal 0.00 to 199.99 oz Reminder No. of reminder Reminder event Wake up, Check me, Medicine, Self-define Review Data review...
  • Page 56 -SaO ) by SaO using the VitalsRx Monitor with a linear regression fit and upper 95% and lower 95% limits of agreement. Each sample data point is identified by subject from a clinical study in non-motion conditions. Clinical study was performed using healthy adult subjects.
  • Page 57 VitalsRx Monitor with integrated sensor VitalsRx with sensor FP10...

  • Page 58: Electromagnetic Compatibility

    10. Electromagnetic Compatibility The device meets the requirements of IEC 60601-1-2. All the accessories also meet the requirements of IEC 60601-1-2 when in use with this device. Warnings Using accessories other than those specified in this manual may  result in increased electromagnetic emission or decreased electromagnetic immunity of the equipment.
  • Page 59 Guidance and Declaration - Electromagnetic Emissions The Health Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emission tests Compliance Electromagnetic environment - guidance The device uses RF energy only for its internal function.
  • Page 60 ± 1 kV for input/output ± 1 kV for input/output lines lines ± 1 kV line(s) to ± 1 kV line(s) to Surge line(s) line(s) IEC 61000-4-5 ± 2 kV line(s) to ± 2 kV line(s) to earth earth <5 % UT <5 % UT (>95 % dip in UT) (>95 % dip in UT)
  • Page 61 Guidance and Declaration - Electromagnetic Immunity The Health Monitor is intended for use in the specified electromagnetic environment. The customer or the user of the Health Monitor should assure that it is used in such an environment as described below. Immunity IEC60601 test...
  • Page 62 The Health Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Health Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment.
  • Page 63 VitalsRx Monitor Bodimetrics LLC 1601 N.Sepulveda Blvd., Ste 839 Manhattan Beach, CA 90266 www.bodimetrics.com PN 255-00789-00 Version: B Contents of this manual are subject to changes without prior notice. ©Copyright 2018 Shenzhen Viatom Technology Co., Ltd. All rights reserved. Knowing and Tracking Your Health...

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