Zephyr Technology BH3-M1 Patient Data Transmitter User Manual User s Manualx

Patient

Guide

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2

Patient Guide

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Introduction ................................................................................................................................ 2

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ZephyrLIFE Home Indications for Use ....................................................................................... 2

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ZephyrLIFE Home Intended Use ............................................................................................... 2

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ZephyrLIFE Home Warnings and Cautions ............................................................................... 2

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ZephyrLIFE HealthHub™ .......................................................................................................... 2

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ZephyrLIFE HealthHub Device Options ..................................................................................... 2

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ZephyrLIFE HealthHub Dashboard ........................................................................................... 2

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Measure Blood Pressure (Foracare D40d) ................................................................................ 2

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Measure Blood Pressure (Foracare P20) .................................................................................. 2

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Measure Blood Pressure (Foracare Test N’GO BP) .................................................................. 2

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Measure Blood Glucose (Foracare D40d) ................................................................................. 2

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Measure Blood Glucose (Fora MD) ........................................................................................... 2

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Measure Blood Glucose (Foracare TN’G Voice) ....................................................................... 2

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Measure Weight (Foracare W310 Scale) ................................................................................... 2

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Measure Weight (Foracare TN’G 550 Scale) ............................................................................. 2

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Measure Temperature ............................................................................................................... 2

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Record Feelings ........................................................................................................................ 2

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Zephyr BioModule Intended Use ............................................................................................... 2

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Zephyr BioModule Warnings & Cautions ................................................................................... 2

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Zephyr BioModule Contraindications ......................................................................................... 2

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Prepare BioModule for Use ....................................................................................................... 2

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Skin Preparation ........................................................................................................................ 2

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BioModule Data ......................................................................................................................... 2

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Measure ECG ............................................................................................................................ 2

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BioModule Light Indicators ........................................................................................................ 2

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Onyx® II Model 9560 Finger Pulse Oximeter Indications for Use .............................................. 2

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Onyx® II Model 9560 Finger Pulse Oximeter Contraindications ................................................ 2

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Onyx® II Model 9560 Finger Pulse Oximeter Warnings ............................................................ 2

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Contents

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3

Patient Guide

Measure Blood Oxygen ............................................................................................................. 2

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Accessing the Portal .................................................................................................................. 2

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Navigating the Portal Screens ................................................................................................... 2

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All Patients Tab Parameters ...................................................................................................... 2

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Data Updates – Reading the All Patients Tab ........................................................................... 2

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Dashboard ................................................................................................................................. 2

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History ....................................................................................................................................... 2

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Trends ....................................................................................................................................... 2

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ECG ........................................................................................................................................... 2

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Manage Patient ......................................................................................................................... 2

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Care Circle ................................................................................................................................. 2

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To Replace a Discharged BioModule ........................................................................................ 2

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Care & Cleaning of the BioModule and BioModule Holder ........................................................ 2

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Changing batteries on devices .................................................................................................. 2

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Changing batteries on devices .................................................................................................. 2

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Changing batteries on devices .................................................................................................. 2

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Changing batteries on devices .................................................................................................. 2

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Changing batteries on devices .................................................................................................. 2

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Troubleshooting Tips ................................................................................................................. 2

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Specifications ............................................................................................................................ 2

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Accessories ............................................................................................................................... 2

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Manufacturer’s Declaration and Guidance ................................................................................. 2

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FCC Declaration ........................................................................................................................ 2

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Warranty .................................................................................................................................... 2

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Appendix I Active Patient Monitoring ......................................................................................... 2

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4

Patient Guide

Zephyr Technology

1 Annapolis St.

Suite 200

Annapolis

MD 21401

USA

Zephyr Support

Phone: 1-800-497-4968

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5

Patient Guide

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

Introduction

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6

Patient Guide

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

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for distribution.

ZephyrLIFE Home Indications for Use

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Patient Guide

ZephyrLIFE Home Intended Use

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8

Patient Guide

ZephyrLIFE Home Warnings and Cautions

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9

Patient Guide

 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

ZephyrLIFE HealthHub™

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10

Patient Guide

HealthHub 8-inch

screen

HealthHub 5-inch

screen

Zeph

y

rLIFE HealthHub Device Options

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11

Patient Guide

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Heart Rate Respiration Rate

Activity Minutes Calories Expended

BioModule Battery Not implemented

Blood Pressure Temperature

Blood Glucose Weight

Blood Oxygen (SpO

2

) ECG request button

Zephyr BioModule

Heart Rate

Respiration Rate

Calories

Activity Minutes

Battery level

HealthHub

Battery

Level

Temperature

Weight

Blood Pressure

Blood Glucose

Blood Oxygen

ZephyrLIFE HealthHub Dashboard

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12

Patient Guide

 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

Measure Blood Pressure (Foracare D40d)

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13

Patient Guide

 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

Measure Blood Pressure (Foracare P20)

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14

Patient Guide

 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

Measure Blood Pressure (Foracare Test N’GO BP)

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Patient Guide

 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

Measure Blood Glucose (Foracare D40d)

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16

Patient Guide

 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

Measure Blood Glucose (Fora MD)

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Patient Guide

 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

Measure Blood Glucose (Foracare TN’G Voice)

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Patient Guide

 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

Measure Weight (Foracare W310 Scale)

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Patient Guide

 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

Measure Weight (Foracare TN’G 550 Scale)

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20

Patient Guide

 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

Measure Temperature

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21

Patient Guide

 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.

 Swipe the Feelings screen in the

opposite direction to return to the

dashboard, or use the back

button.

A

ctual screen appearance may vary.

Record Feelings

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Patient Guide

Zephyr BioModule Intended Use

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Patient Guide

Zephyr BioModule Warnings & Cautions

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Patient Guide

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25

Patient Guide

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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.

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26

Patient Guide

Not for use with patients fitted with an implanted cardiac device

such as an internal pacemaker or automatic defibrillator.

Zephyr BioModule Contraindications

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Patient Guide

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

Prepare BioModule for Use

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28

Patient Guide

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.

Skin Preparation

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Patient Guide

 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.

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 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.

BioModule Data

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Patient Guide

 Sit down and remain still while taking

ECG.

 Touch the ECG button to request a

new ECG strip.

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 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).

Touch the ECG

button on the

phone screen.

If you experience chest pain, or signs and symptoms of an acute

problem, call 911 or follow the instructions of your physician

Measure ECG

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31

Patient Guide

a) GREEN: flashing – working normally. Data is

transmitting.

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b) BLUE: flashing – loss of Bluetooth signal. Move

closer to the HealthHub. Confirm HealthHub

application is running.

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c) ORANGE: Flashing – low battery. Recharge in

cradle.

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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.

BioModule Light Indicators

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Patient Guide

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.

Onyx® II Model 9560 Finger Pulse Oximeter Indications for Use

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Patient Guide

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

Onyx® II Model 9560 Finger Pulse Oximeter Contraindications

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34

Patient Guide

Further information can be found in the Onyx II® User Manual

Onyx® II Model 9560 Finger Pulse Oximeter Warnings

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35

Patient Guide

 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

Measure Blood Oxygen

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Patient Guide

 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

Accessing the Portal

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37

Patient Guide

 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

Navigating the Portal Screens

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Patient Guide

Update Time Data Description/Units

Once per minute for initial

15 min

after power-on, then every

15 min

OR

Last alert generated

[Last Update value]

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

[Values are individually

timestamped]

SpO

2

Peripheral blood oxygen saturation

(%)

Weight lbs

Blood Glucose mg/dL

Temperature Degrees Fahrenheit

All Patients Tab Parameters

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39

Patient Guide

 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.

Data Updates – Reading the All Patients Tab

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Patient Guide

 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.

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 Mouse over graph data point to show

recorded values.

 No mouse = last received value.

 Expand any graph using the arrow

to show sweep scale.

 Green/yellow/red coloring reflects alert

thresholds set for each vital sign.

Dashboard

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41

Patient Guide

 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.

A

lert Cleared

Alert

History

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42

Patient Guide

 Patient history as a line graph.

 Select time interval to display.

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 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.

Trends

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Patient Guide

 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

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 Data are 3 x 10 second strips – 15

seconds before & after request or

trigger.

 Use the ECG Report button to

generate a report

ECG

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44

Patient Guide

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.

Manage Patient

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Patient Guide

 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.

Care Circle

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46

Patient Guide

 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

To Replace a Discharged BioModule

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47

Patient Guide

 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.



Bleach

Sani-Cloth

HB®

Hydrogen

Peroxide

Consult the instructions supplied with each cleaning product for

appropriate cleaning procedure

Care & Cleaning of the BioModule and BioModule Holder

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48

Patient Guide

 Fora D40 Blood

Pressure/Glucometer.

 4 x AA batteries.

 Flashing 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.

 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.

Flashing battery = low

power

Battery icon = low

power

For detailed instructions on changing the batteries in optional sensors,

please read the manufacturer’s manual

Changing batteries on devices

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49

Patient Guide

 Fora W310 Weight Scale.

 4 x AA batteries.

 “Lo” display means batteries are low.

 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.

 After battery replacement, take a

measurement.

 The first measurement after

changing batteries will be discarded.

 Repeat to take a valid measurement.

“Lo” = low power

Flashing display = low

power

For detailed instructions on changing the batteries in optional sensors,

please read the manufacturer’s manual

Changing batteries on devices

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50

Patient Guide

 ForaTN’G 550 Weight Scale.

 4 x AA batteries.

 “Lo” display means batteries are low.

 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.

 After battery replacement, take a

measurement.

 The first measurement after

changing batteries will be discarded.

 Repeat to take a valid measurement.

“Lo” = low power

Low power

For detailed instructions on changing the batteries in optional sensors,

please read the manufacturer’s manual

Changing batteries on devices

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51

Patient Guide

 Fora Test N’GO Voice.

 2 x AAA batteries.

 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

Changing batteries on devices



52

Patient Guide

 Fora Test N’GO BP.

 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

Changing batteries on devices



53

Patient Guide

Question What to do

How do I know if the BioModule is fully

charged?

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.

Troubleshooting Tips

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54

Patient Guide

BioModule Prescription Device

Heart Rate 30 – 240 bpm ±1bpm static (R-R interval)

Breathing Rate 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

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

Classifications per IEC 60601-1

Installation & Use

Degree of Protection

Supply Connection

Portable, body-worn

Type CF-Applied Part

Internally powered

ECG type (BH3-M1)

ECG type (BH3-M2)

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 IEC 60601-1-2:2007

Immunity IEC 60601-1-2:2007

Environmental (Operating)

Temperature -20º C to +45º C (-4º F to 113º F) inclusive

Temperature - charging 0º C to +45º C (32º F to 113º F) inclusive

Relative Humidity 15% to 95% non-condensing

Ingress Protection 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)

Specifications



55

Patient Guide

Environmental (Storage & Transportation)

Temperature -20º C to +45º C (-4º F to 113º F) inclusive

Relative Humidity 15% to 95% non-condensing

Atmospheric Pressure 12kPa to 107kPa

Service Life

BioModule Battery 300 charge cycles minimum

Maintenance Other than cleaning and charging, no other maintenance is

required.

BioModule Holder Single Patient use

ECG electrodes Single use

Disposal

Return 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.

Local Disposal 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.

WEEE Zephyr BioModule is WEEE compliant

Dimensions

BioModule 48 x 46 x 10 mm (1.9 x 1.8 x 0.4 in)

Holder 90 x 50 x 10 mm (3.5 x 2.0 x 0.4 in)

Weight

BioModule 18 grams (0.63 oz)

Holder 14 grams (0.49 oz)



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56

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

Zephyr BioModule ID



57

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



58

Patient Guide

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 SpO

2

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

Accessories



59

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



60

Patient Guide



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

CISPR 11

Group 1,

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

Manufacturer’s Declaration and Guidance

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61

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.



62

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

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 KHz to 80

MHz

3 V/m

80 MHz to 2.5 GHz

Not

applicable

3 V/m

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

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

survey

a

should be less than compliance level

in each frequency range

b

Interference may occur in the vicinity or

equipment marked with the following symbol:



63

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.

a

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.

b

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 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23



64

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.

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.

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.

Warranty

FCC Declaration

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65

Patient Guide

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.

Appendix I Active Patient Monitoring

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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