ZywieZ3 ECG Monitor Sensor Instruction Manual
- June 13, 2024
- Zywie
Table of Contents
ZywieZ3 ECG Monitor Sensor
Product Information
The ZywieZ3 ECG Monitor is a wireless device manufactured by
Johari Digital Healthcare Ltd. It is intended for use by healthcare
professionals in outpatient settings for recording and displaying
physiological data. The device wirelessly transmits
electrocardiogram (ECG) data to a cellular device for storage,
display, and transmission. The ZywieZ3 sensor can be configured by
authorized persons to modify or ignore operational alerts, but not
to set alerts related to physiological data.
The ZywieZ3 sensor is not intended for use in patients who
require inpatient monitoring or patients whom the attending
physician thinks should be hospitalized. It can only record data
when properly connected to the adhesive on the body. The sensor is
water-resistant but not waterproof, allowing users to shower with
it on following specific guidelines.
Each ZywieZ3 sensor comes with a medical-grade disposable
adhesive. Precautions should be taken to avoid excessive water
exposure to the adhesive. After each use, the used adhesive should
be discarded, and when not in use, it should be secured in the
provided sealed pouch. Before applying the adhesive to the sensor,
both sides of the sensor should be cleaned with an alcohol wipe.
The adhesive pouch should be used within one month to prevent the
hydrogel from drying out and affecting performance.
Potential adverse effects include potential allergic reactions
to acrylic and hydrogel, which are the primary materials of the
adhesive. Prior to using the ZywieZ3 sensor, a patient consultation
with informed consent should be conducted, discussing potential
benefits, options, risks, and contraindications.
Product Usage Instructions
Charging the Sensor
-
Use the provided plug-and-play charging docking station.
-
Place the device on the charging dock as shown in the
image. -
Connect the USB port of the charging dock with the wall
adaptor.
INSTRUCTIONS FOR USE MANUAL
ZywieZ3 ECG Monitor
Instructions for Use Manual
Page 1 of 31
The precautionary instructions for user found in this section and throughout
this manual are indicated by specific symbols. Understand these symbols and
their definitions before operating this equipment. The definitions of these
symbols are as follows:
CAUTION – Text with a “CAUTION” indicator will explain possible Safety
infractions that could have the potential to cause minor to moderate injury or
damage to equipment. WARNING – Text with a “WARNING” indicator will explain
possible Safety infractions that will potentially cause serious injury and
equipment damage. DANGER – Text with a “DANGER” indicator will explain
possible safety infractions that are imminently hazardous situations that
would result in death or serious injury. NO SITTING – Text with a “NO SITTING”
indicator will explain possible Safety infractions that will potentially cause
injury and equipment damage. NO STEPPING ON SURFACE – Text with a “NO STEPPING
ON SURFACE” indicator will explain possible safety infractions that will cause
equipment damage.
NOTE: Throughout this manual, “NOTE” may be found. These NOTEs are helpful
information to aid in the particular area or function being described
Manufactured by Johari Digital Healthcare Ltd. G-582-584, EPIP Boranada,
342012, Jodhpur (Raj.) Mail: info@joharidigital.com Web: www.joharidigital.com
Manufactured for Zywie, Inc. 12000 Findley Road, Suite 360, Johns Creek, GA
30097 Mail: info@zywie.healthcare Web: www.zywie.healthcare
Page 2 of 31
Table of Contents
1 Instructions for Use ………………………………………………………………………………………………………………………. 4 1.1
Warnings ………………………………………………………………………………………………………………………………… 4 1.2
Contraindications…………………………………………………………………………………………………………………..5 1.3
Precautions for ZywieZ3 sensor …………………………………………………………………………………………. 5 1.4
Precautions for ZywieZ3 disposable adhesive …………………………………………………………………. 5 1.5
Precautions for ZywieZ3 docking station …………………… 1.6 Possible Adverse
Effects……………………………………………………………………………………………………….5 1.7 Patient Consultation and
Informed Consent…………………………………………………………………….6
2 Introduction/Operation ……………………………………………………………………………………………………………….. 7 3
Device Description ………………………………………………………………………………………………………………………. 9 4
Accessories ………………………………………………………………………………………………………………………………….. 11 5
Specification………………………………………………………………………………………………………………………………… 13 6 Safety &
Regulatory …………………………………………………………………………………………………………………… 14 7 Clinical
Application …………………………………………………………………………………………………………………….. 22 8 Controls &
Functions…………………………………………………………………………………………………………………. 23 9 Application
Operation……………………………………………………………………………………………………………….. 25 10 Troubleshooting
…………………………………………………………………………………………………………………….. 27 11
Maintenance……………………………………………………………………………………………………………………………. 28 12 Warranty
………………………………………………………………………………………………………………………………….. 29
Page 3 of 31
1 Instructions for Use
ZywieZ3 Sensor is a wireless device intended for use by healthcare
professionals for recording and display of physiological data in outpatient
settings. The physiological electrocardiogram (ECG) data is transmitted
wirelessly to a cellular device for storage, display, and transmission. The
ZywieZ3 sensor can be configured by authorized persons to modify or merge or
ignore any of the operational alerts, but not to set alerts related to
physiological data.
1.1 Warnings 1.1.1. Do not treat patients without physician evaluation. Safety
of device during pregnancy or delivery has not been established. 1.1.2. Do not
treat over swollen, infected, or inflamed areas or skin eruptions (e.g.,
phlebitis, thrombophlebitis, varicose veins). 1.1.3. Do not wear or use the
sensor during magnetic resonance imaging (MRI), or electro-cautery procedures.
The ZywieZ3 sensor is MR Unsafe. 1.1.4. Exposure of the wireless
communications features of the device, or its accessories, may be interfered
with by other devices that operate on the same frequencies. 1.1.5. Excessive
body tissue, hair, or dry skin may affect the signal quality. 1.1.6. In case
of skin discomfort, remove the sensor immediately. 1.1.7. For best results,
the sensor must be used with the provided adhesives. 1.1.8. No
servicing/maintenance is required while the device is in use. 1.1.9. Before
every use, check the device. Do not use the device if it is damaged. The
continuous use of a damaged unit may cause improper results. 1.1.10. The
device should be used only with the components recommended for use by the
manufacturer. 1.1.11. The performance of the device may be degraded if one or
more of the following occur: -operation outside the manufacturer’s stated
temperature and humidity range. -storage outside the manufacturer’s stated
temperature and humidity range. -mechanical shock (for example, being dropped)
1.1.12. When not in use, store the device in a dry room and protect it against
extreme moisture, heat, lint, dust and direct sunlight. 1.1.13. Never place
any heavy objects on the storage case. 1.1.14. The device only records and
transmits the ECG signal to the paired mobile app. It does not analyze the ECG
recordings or detect the presence of any arrhythmias.
Page 4 of 31
1.2 Contraindications The ZywieZ3 sensor is not intended for use under the
following conditions:
1.2.1 Patients who require inpatient monitoring. 1.2.2 Patients whom the
attending physician thinks should be hospitalized.
1.3 Precautions for ZywieZ3 Sensor The ZywieZ3 sensor can only record data when it is properly connected to the adhesive on your body. The ZywieZ3 sensor is water resistant, but not waterproof. You can shower with the sensor on but please adhere to the following guidelines:
1.3.1 1.3.2 1.3.3 1.3.4 1.3.5 1.3.6 1.3.7
1.3.8
Avoid rubbing soap around the sensor. Avoid excessive water exposure to the sensor. Avoid prolonged, hot showers. Avoid spraying water directly onto the sensor while showering. Prepare the skin before wearing the device to record a good-quality ECG. No servicing or maintenance is required while the device is in use. Any changes or modifications made to this equipment not approved by Zywie, Inc. may void the FCC authorization to operate this equipment. The device is non-sterile. Do not use the device on wounded or irritated skin.
1.4 Precautions for ZywieZ3 Disposable Adhesive Each ZywieZ3 sensor comes with a medical-grade disposable adhesive.
1.4.1 1.4.2 1.4.3 1.4.4
1.4.5
Avoid excessive water exposure to the adhesive. After each use, discard the used adhesive. When not in use, always secure the adhesive in the provided sealed pouch. Before applying the adhesive to the sensor, clean both sides of the sensor with an alcohol wipe (70 % + isopropyl alcohol). After the adhesive pouch is open, use it within one month. Otherwise, the hydrogel may dry out and affect performance.
1.5 Possible Adverse Effects
1.5.1 Skin irritation/hypersensitivity Some patients may experience skin
irritation or hypersensitivity due to the adhesive.
1.5.2 Allergic skin reaction Skin irritation may also cause a possible
allergic skin reaction.
1.5.3 Be careful of potential allergic reactions to acrylic and hydrogel which
are the primary materials of the adhesive.
Page 5 of 31
1.6 Patient Consultation and Informed Consent Prior to using the ZywieZ3
sensor, conduct a patient consultation with informed consent. At that time,
you should also discuss all potential benefits, options, risks of using the
sensor, paying close attention to potential contraindications.
Page 6 of 31
2 Introduction/Operation
The ZywieZ3 Sensor is a wearable three-channel, rechargeable, reusable,
ambulatory medical grade device intended for use in mobile cardiovascular
telemetry. The ZywieZ3 sensor can collect continuous ECG data from the
disposable adhesive adhered to the left chest area. The ZywieZ3 sensor uses a
rechargeable lithium polymer battery to achieve 14 days continuous recording
on a single charge. In case of Bluetooth disconnection, it is capable of
storing patient data for up to 24 hours. The device is intended to be used as
general care for patients within healthcare settings or at home. The device is
not intended to be used on critical care patients and does not replace current
standards of care. The device does not provide interpretive or diagnostic
statements. It is intended to provide physiological information recording for
later viewing by healthcare professionals. Instructions to charge the ZywieZ3
sensor The ZywieZ3 sensor can be charged by placing it on the docking station
as shown in the pictures below:
1. The charging of the sensor is done using a plug-and-play charging docking
station.
2. The user needs to place the device on the charging dock as shown in the
image below, and then connect the USB port with the wall adaptor.
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3. Charging Indication: The ZywieZ3 sensor has red and green LEDs which indicate the charging status as following:
Is the sensor connected to a charger? No Yes Yes
Battery status
Charging Fully charged
Red LED
Off On Off
Green LED
Off Off On
Note:- For the charging purpose, connect the docking station with any IEC 60601 compliant charger or other electrical equipment.
Page 8 of 31
3 Device Description
The ZywieZ3 Sensor is a device for acquisition, storage, and transmission of
physiological data such as electrocardiogram (ECG). The physiological data is
available for view in near-real time from the device (like smart phone, or
watch, etc.) that is paired with the ZywieZ3 Sensor. The healthcare
professionals may be able to view the data either directly on the paired
device or through an application that receives the data in an encrypted form
from the paired device. The sensor uses a disposable ZywieZ3 Adhesive to
maintain contact with the patient’s skin. The hydrogel in the ZywieZ3 Adhesive
senses the electrical signals from patient’s body and conducts it to the
ZywieZ3 Sensor. ZywieZ3 sensor is intended for outpatient monitoring of ECG in
near real-time. All electrode inputs of the ZywieZ3 sensor do not contact
conductive parts including the power supply and earth. The ZywieZ3 Sensor
provides the operational alarm information for the lead on/off status and
battery status. The operational alarms are set to notify of any interruption
in data collection and the overall operational status of the ZywieZ3 Sensor.
The device does not have any alarms that are based on the content of
physiological data recorded, stored, or transmitted. The ZywieZ3 Sensor comes
with a mobile physiological data display application built from a proprietary
software library, using which authorized persons could build their own
applications.
4 Intended Use
ZywieZ3 Sensor is a wireless device intended for use by healthcare
professionals for recording and displaying physiological data in-home or in
healthcare settings. The physiological data includes electrocardiogram (ECG).
This data is transmitted wirelessly to a separate location (such as a mobile
phone) for storage, display, and transmission.
The device is an ambulatory, continuous recording system with intended use as
general care for patients. The device is not intended to be used on critical
care patients and does not replace current standards of care. It is intended
to provide physiological data recordings to be viewed by healthcare
professionals at a later time. The device is not recommended for patients who
use a cardiac pacemaker, defibrillators or other implanted electronic devices.
Page 9 of 31
5 Cybersecurity:
1.1.1.
Device pairing: Ensure the serial number (SN) shown on the paired mobile app matches with the SN printed on back of the ZywieZ3 sensor. Do not connect the mobile app to any unknow devices.
1.1.2.
ZywieZ3 transfers data to the mobile app using low-power Bluetooth wireless communication 5.0 (IEEE 802.15.4-2006) which is secured with LE secure connections using ARM Trust Zone Cryptocell 310 security subsystem including, AES128 encryption and ECDH (Elliptical Curve Diffie-Hellman (ECDH) encryption algorithms. The wireless transmission frequency is in the 2.4 GHz ISM radio frequency band.
Page 10 of 31
6 Accessories
The ZywieZ3 sensor kit has the following accessories.
No
Item
Qty
Specification
Patient Contacting
ZywieZ3 1.
sensor
Weight – 27 gm
1
Height – 14.5 mm
No contact
Dia – 51.26 mm
Remark
ZywieZ3 2.
Adhesive
Length 10.2 cm
Breadth 11.5 cm
1
Height 0.07 cm Left Chest Area
(without the
release liner)
Disposable
3. adhesive
1
Package Size 15 x
NA
pouch
20.5 cm
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Width – 56.2 mm
Length – 64 mm
Docking 4.
Height – 14.4 mm 1
NA
station
Android phone,
Cellular
v8+, BLE 5, RAM
5. device
1
1GB+, Storage
NA
8GB+ Android 11
Version
USB Type A, TPE
USB charging
1
coated White
NA
cable
Length 1.5 Meter
Cellular
1
NA
NA
device holster
Note For the charging purpose, connect the docking station with any IEC 60601
compliance charger or other electrical equipment.
Page 12 of 31
7 Specification
Device Specification:
Dimensions Net Weight Power Input Battery Electrical Class Electrotherapy
Electrical Class Operating Temperatures Storage Temperatures Atmospheric
Pressure Humidity Range
: 51.26 x 14.5mm : 27 gm : 5V DC, 500 mA : Lithium Polymer 3.85V, 665 mAh :
Class B : Class II : 50° F – 113° F (10° C – 45° C)
: 50° F – 122° F (10° C – 50° C) : 70 – 106 kPa : 10% – 95%
Technical Specification:
ECG Channels
Sample Rate Data resolution Frequency Response
Duration of recording
Device memory duration Input Impedance CMRR Wireless Transmission Device
placement position IP rating Battery Specifications
– Type – Life Wireless Transmission – Service – Bands
3
200 Hz 16 bits 0.5 40 Hz 14 days continuous recording with single charge 24
hours >10MOhms 60 2.4GHz ISM Band (2.402 2.480 GHz Utilized) Left upper
chest area IP 55
Lithium Polymer Charging/Discharge cycle life 500 times
– Bluetooth – 2.4 GHz ISM spectrum band (2400 to 2483.5 MHz)
Page 13 of 31
8 Safety & Regulatory
Device, when properly used by trained personnel, is a safe and effective
instrument for the indicated clinical treatments. Keep in mind that safe
operation requires a thorough understanding of the system and safety features
as described in this operator manual. Manufacturer does not make
recommendations regarding the practice of medicine. Individual treatments
should be based on clinical training, clinical observation, and appropriate
clinical endpoints. 8.1. Operational Training The ZywieZ3 sensor should be
operated only by qualified personnel who have received appropriate training in
the use of the system.
WARNING Do not allow untrained or unqualified personnel to use the system at
any time. WARNING Failure to follow all applicable instructions for the user
may result in serious injury. CAUTION Do not attempt to use this system until
you have been properly trained on system operation by certified personnel and
have thoroughly read and comprehended this manual and the accompanying
treatment guidelines. 8.2. Operational Safety
WARNING System failure could result in an unintended increase of output power.
WARNING Device is sensitive instruments and should not be dropped. If a device
is dropped, carefully examine it for any physical damage prior to use.
WARNING Device components should remain separated from other medical equipment
to avoid inadvertent electrical coupling between devices. Inadvertent
activation may cause injury to patient and/or user or equipment damage.
WARNING No modification of the device system is allowed.
Page 14 of 31
CAUTION
The use of the system can interfere with and adversely affect the operation of
other electromagnetic equipment.
CAUTION
Do not operate the unit in an environment of short-wave diathermy use.
CAUTION
Prior to each use of the system, inspect the device components and cables for
any damage, excessive wear, or crimping that could affect system performance
or safe operation.
CAUTION
Device is designed to be operated exclusively as a unit. Only use accessories
provided by Manufacturer.
CAUTION
Manufacturer cannot verify the safety of single use accessories that have been
reprocessed or reused.
8.3. Additional Safety Consideration WARNING
Do not tamper with the system. The device battery poses a fire or chemical
burn hazard, if mistreated.
WARNING
Only an authorized Manufacturer Service Representative should perform service
on any console or handpiece.
WARNING
Do not attempt to perform maintenance other than that which is outlined in
this operator manual.
WARNING
Do not connect wet components to the device.
8.4 Regulatory The device is a Class II medical device in the US It complies
with the following:
· US FDA 21 CFR 870.2910, · FCC part 15 · IEC 60601-1 · IEC 60601-1-2 · IEC
60601-2-47
Page 15 of 31
8.5. EMI-EMC, FCC Declaration Statement
FCC ID: 2BAK3Z3E
FCC Compliance Statements: This device has been tested and found to comply
with the limits for a Class B digital device, pursuant to part 15 of the FCC
Rules. These limits are designed to provide reasonable protection against
harmful interference in a residential installation. The operation is subject
to the following two conditions:
1. This device may not cause harmful interference. 2. This device must accept
any interference received, including, an interference that may
cause undesired operation.
Caution Statements:
Any changes or modifications not expressly approved by the party responsible
for compliance could void the user’s authority to operate this equipment.
INFORMATION TO THE USER For a Class B digital device or peripheral, the
instructions furnished to the user shall include the following or similar
statement, placed in a prominent location in the text of the manual: NOTE:
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more
of the following measures: · Reorient or relocate the receiving antenna. ·
Increase the separation between the equipment and receiver. · Connect the
equipment into an outlet on a circuit different from that to which the
receiver is
connected. Consult the dealer or an experienced radio/TV technician for help.
Separation Distance The minimum separation distance between the Antenna and
the surface is 1.19mm.
Page 16 of 31
ELECTROMAGNETIC COMPATIBILITY
ZywieZ3 ECG Monitor complies with the requirements of IEC 60601-1-2:2014 (EMC
Collateral standard) including the radiated RF field strength 10 V/m & RF
frequencies from 80 MHz to 2.7 GHz . However, even at this level of device
immunity, certain transmitting devices (cellular phones, two-way radios,
cordless phones, paging transmitters, RFID devices etc.) emit radio
frequencies that could interrupt equipment operation if operated in a range
too close to the equipment. Users should be aware of possible radio frequency
interference if the handheld device is operated close to the equipment.
Portable and mobile RF communications equipment may affect the normal function
of the ZywieZ3 ECG Monitor.
Do not use cables or accessories other than those provided with the ZywieZ3
ECG Monitor, as this may result in increased electromagnetic emissions or
decreased immunity to such emissions.
Handheld and mobile RF communications equipment may affect the normal function
of the ZywieZ3 ECG Monitor.
Do not use cables or accessories other than those provided with the ZywieZ3
ECG Monitor, as this may result in increased electromagnetic emissions or
decreased immunity to such emissions.
Test IEC 60601-1:2005+AMD1:2012
Electrical Safety environment guidance Medical Electrical Equipment Safety standards,
IEC 60601-2-10:2012+AMD1:2016 Part 2: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-1-11:2015
Part 1-11: General requirements for basic safety and essential performance — Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Page 17 of 31
GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the ZywieZ3® Sensor & Adhesive 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 ZywieZ3 sensor, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency
of the transmitter.
RECOMMENDED SEPARATION DISTANCE
Radiated RF IEC 61000-4-3
10 V/m
10 V/m
80 MHz to 2.5 GHz 80 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 the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of equipment marked with the following
symbol:
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 strength from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcasts and TV broadcasts cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the ZywieZ3 sensor is used
exceeds the applicable RF compliance level above,
the ZywieZ3 sensor should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as
reorienting or relocating the ZywieZ3 Sensor.
B ) Over the frequency range 150 kHz to 80 MHz, field strength should be less
than [V1] V/m.
Page 18 of 31
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ZywieZ3 ECG Monitor
The ZywieZ3 ECG Monitor device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the ZywieZ3 ECG Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ZywieZ3 ECG Monitor as recommended below, according to the maximum output power of the communications equipment.
Separation distance (m) according to the frequency of the transmitter
Rated maximum output power (W) of
transmitter
150 kHz to 80 MHz d = 1.17 P
80 MHz to 800 MHz d = 1.17 P
800 MHz to 2.7 GHz d= 2.33 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1
1.17
1.17
2.33
10
3.70
3.70
7.37
100
11.70
11.70
23.30
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.
Guidance and manufacturing’s declaration electromagnetic Immunity The Model
ZywieZ3 ECG Monitor is intended for use in the electromagnetic environment
specified below. The customer or the user of the model ZywieZ3 ECG Monitor
should assure that it is used in such an environment.
Page 19 of 31
Immunity test
IEC 60601 test level Compliance level Electromagnetic environment Guidance
Electrostatic discharge ± 8 kV Contact (ESD)
IEC 61000-4-2
± 15 kV air
± 8 kV Contact ± 15 kV air
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electric fast transient / ± 2.0 kV/100 kHz burst IEC 61000-4-4 (AC Power port)
± 2.0 kV/100 kHz Mains power quality should be (AC Power port) that of a
typical commercial or
hospital environment
Surge IEC 61000-4-5
0.5, 1 kV
± 1kV differential The mains power quality should
(Differential mode) mode
be that of a typical commercial or
Line 2 kV
to Line 0.5, (Common
1,
±
2kV
common
mode) Line to Gnd mode
hospital environment.
Phase Angle:
0°,90°,270°
Conducted RF IEC 61000-4-3
ISM band between 0.15 – 80MHz: 6V rms,
ISM band between Mains power quality should be
0.15 – 80MHz: 6V that of a typical commercial or
rms,
hospital environment. If the user
of the Model ZywieZ3 ECG
continue operation during power
mains interruptions, it is
recommended that the Model
ZywieZ3 ECG Monitor be
powered from an uninterruptible
power supply.
Voltage dips, short 5 % UT (>95% dip in <5 % UT (>95% Mains power quality should be
interruptions and
UT) For 0,5 cycle dip in UT) For 0,5 that of a typical commercial or
voltage variations on 40 % UT (60 % dip
power supply input lines in UT) For 5 cycles
IEC 61000-4-11
70 % UT
cycle
hospital environment. If the user
40
%
UT
(60
%
dip
of the Model ZywieZ3 ECG continue operation during power
in UT) For 5 cycles mains interruptions, it is
(30 % dip in UT) For 70 % UT
25 cycles
(30 % dip in UT)
For 25 cycles <5 % UT (>95% dip
recommended that the Model ZywieZ3 ECG Monitor be powered from an uninterruptible power supply.
in UT) For 5 s
<5 % UT (>95%
dip in UT) For 5 s
Page 20 of 31
Power frequency (50/60Hz) Magnetic field
IEC 61000-4-8
30 A/m
30 A/m
If the display is distorted, it may be necessary to position the Model ZywieZ3 ECG Monitor farther from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.
NOTE: UT is the a.c mains voltage before application of the test level.
Guidance and manufacturing’s declaration electromagnetic emissions
The Model ZywieZ3 ECG Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model ZywieZ3 ECG Monitor should assure that it is used in such an environment
Emission test
Compliance Electromagnetic environment guidance
RF emission CISPR 11
Group 1
The Model ZywieZ3 ECG Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause ant interference in nearby electronic equipment.
RF emissions CISPR 11 Harmonic emission IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC61000-3-3
Class B Class B Complies
The Model ZywieZ3 ECG Monitor is suitable for use in all establishments, including the domestic establishment and those directly connected to the public lowvoltage power supply network that supplies building used for domestic purposes.
Radiated RF IEC 61000-4-3
Group 1
The Model ZywieZ3 ECG Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause ant interference in nearby electronic equipment.
Page 21 of 31
9 Clinical Application
The ZywieZ3 sensor is intended for use to monitor patients including, but not
limited to, a) Patients diagnosed with non-life-threatening arrhythmias. b)
Patients with symptoms that may be due to cardiac arrhythmias. c) Patients who
are at a high risk of having cardiac disease. d) Patients recovering from
cardiac surgery who are indicated for outpatient arrhythmia monitoring.
The ECG data is transmitted to the paired cellular device via Bluetooth for a
later viewing by healthcare professionals. Data from this device may be used
by another device to analyze or report cardiac arrhythmias.
Page 22 of 31
10 Controls & Functions
The ZywieZ3 sensor records the ECG signals sensed by the adhesive on the body.
ECG data is transmitted wirelessly via BLE to the Zywie SDK. The SDK posts
data to the Zywie Mobile App. The App can upload the data to Cloud for further
processing. The workflow is summarized in Fig. 1.
Fig. 1 Basic system workflow process The ZywieZ3 sensor records and transmits
the ECG data wirelessly to a paired device. It does not have any on-board
algorithm or software to detect the heart rate or arrhythmias. The device does
not provide interpretive or diagnostic statements.
The system block diagram of the ZywieZ3 sensor is shown in Fig. 2 and the
description of system modules is given in the section below.
Fig. 2 Block diagram of the ZywieZ3 sensor Power management: A rechargeable
battery with a 665 mAh capacity and 3.85 V output is used to power the sensor.
Power management circuits converts a 5.0 VDC input into 4.4V output to charge
the battery. The minimum required current to charge the sensor is 500 mA. The
power management circuit also transfers the energy from the battery to power
the ECG sensor, storage chips, microcontroller, and accelerometer sensor.
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Sensor: The ZywieZ3 has a 24-bit ECG sensing chip to sample the ECG data from
lead I and lead II or only lead III (if lead I and II are off). The sampling
frequency of ECG is 200 Hz. Storage: If the Bluetooth communication is
disconnected, the flash memory can store the sampled ECG data up to a duration
of 24 hours. The data is over-written if the disconnection is beyond 24 hours.
Communication: Device status and ECG data are processed and sent to the paired
mobile via a wireless low-power Bluetooth communication with the
microcontroller. The microcontroller communicates with the ECG sensor using
SPI protocols. The sampled data is transferred between the microcontroller and
flash memory using fast Quad-SPI (QSPI) communication. Zywie provides ECG
diagnostic services and NOT emergency medical services. If at any time during
the study you think you are having a medical emergency, call your doctor, go
to the emergency department, or call 911 immediately.
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11 Application Operation
Upon successful installation of the firmware and app, proceed with pairing the
app with a sensor data collection.
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Both the sensor and the phone need to be charged and remain within 25 feet of
each other to ensure data upload is not delayed or lost. · Sensor: Charge
fully once every 14 days or based on the low battery warning on the
app. To charge the sensor, place it in the charger provider by aligning the
four snaps on the sensor with the four pins on the charger. Connect the USB
adapter and plug it into the wall. The red light on the side of the sensor
indicates that the sensor is still charging. When it changes to green light
indicates charging is complete. The sensor cannot be charged when users are
wearing it. · Phone: Leave the phone on and charge overnight, every night.
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12 Troubleshooting
If the device is not charging or the device is not working, please contact the
authorized maintenance personnel.
Symptom
Possible Causes
Solutions
Artifact data
1. This device might be damaged.
2. This device might not be worn correctly.
3. The operation temperature is too high or too low.
4. Improper or no skin preparation.
5. Incorrect attachment of adhesive.
1. Contact your device provider.
2. Recheck device’s location or
contact with skin.
3. Use this device under
instructed
operation
temperature.
4. Prepare the skin before
application.
5. Follow the instructions to
attach the adhesive.
No data or intermittent data received by mobile app or
No BLE signal
or
data
transmission
latency
1. Bluetooth turned off in the
mobile app-installed device.
2. Out of connection range.
3. Interference from other RF
emitters, such as RFID metal
detectors,
medical
equipment, etc, in the
vicinity.
1. Enable Bluetooth. 2. Move the sensor close to the
mobile app-installed device. 3. The sensor battery is low,
charge it. 4. Restart the mobile app-
installed device. 5. Move far away from any
electronic equipment or change rooms or move to an open space.
Charging Indication
ZywieZ3 sensor has red and green LEDs which indicate the charging status as following:
Is the sensor connected to a charger? No Yes Yes
Battery status
Charging Fully charged
Red LED
Off On Off
Green LED
Off Off On
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13 Maintenance
13.1 Cleaning of ZywieZ3 sensor A patient should adhere to the following
guidelines to remove the adhesive and clean the sensor:
1. Remove the sensor from chest by pulling the tab of the adhesive. 2. Clean
with 70% alcohol wipes included in the kit and remove any adhesive residue on
the sensor. 3. Wait for the sensor to dry completely. The sensor should be
clean, dry and free of any
adhesive residue before applying it to a new adhesive.
13.2 Storage of ZywieZ3 sensor · It is recommended to store the sensor in a
clean place. · When passing through the airport security, if wearing the
device, take it off from your body and allow TSA officers to screen the
device. · To charge the device in other countries, make sure to use the
correct adapter for the standard USB (Universal Serial Bus) outlet.
13.3 Care for Disposable Adhesives: Each ZywieZ3 sensor comes with its
medical-grade disposable adhesives. Adhesives can be used for up to 14 days.
However, some users may want to change the adhesives before the intended
duration depending on comfortability. The adhesives are packaged in a non-
sterile foil pouch. The shelf life is set at 2 years from the time they are
packaged. A user should adhere to the following guidelines to use the
adhesive:
· After each use, discard the used adhesive. · Do not re-apply the adhesive
once removed from the skin. · Keep the foil pouch closed to not let the
adhesives dry. · Before applying a new adhesive, clean both sides of the
sensor with an alcohol wipe. · The adhesive should be stored in a room
temperature between -40 to 80 °C.
13.4 Skin Care The skin should be clean, dry, and free of hair. Clean the
left, upper middle chest area with a 70%+ alcohol swab. Shave area if needed.
Let it dry completely.
13.5 Service Shelf life of the device is 5 Years. The device is non-
serviceable & non-repairable. Faulty units should be sent back to the Zywie
team or disposed of as per the local regulations.
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14 Warranty
This product warranty extends to the original consumer/ purchaser of the
product.14.1 Warranty Coverage & Disclaimers
This product is warranted to be free from defects in materials and workmanship
for one (1) year. This warranty ceases if the product has been damaged by
accident, in shipment, unreasonable use, misuse, neglect, improper service,
repair by unauthorized personnel or cause not arising out of defect in
materials or workmanship. This warranty does not extend to any units which are
used in violation of the guidelines outlined in this manual, or to units that
have been altered or modified, or to damage to products or parts which have
had the serial number removed, altered or defaced or rendered illegible.
14.2 Legal Remedies This warranty gives you specific legal rights, and you may
also have other rights that vary from state to state.
14.3 Warranty Performance During the above one-year warranty period, a product
with a defect will be repaired or replaced with a reconditioned comparable
unit at the distributor’s option when the product is returned to the
distributor. The repaired or replacement product will be in the warranty for
the balance of the one-year warranty period and an additional one-month
period. No charge will be made for such repair or replacement.
14.4 Customer Service For in-warranty service for a product covered under the
warranty period, no charge is made for service and return postage. Please
return the product insured, packed with sufficient protection, postage
insurance, prepaid to the address. The customer’s duty/brokerage fee, if any,
must be paid by the consumer.
14.5 Out of warranty service There will be charges rendered for repairs made
to the product after the expiration of the one (1) year warranty period after
purchaser is advised appropriately. The distributor cannot assume
responsibility for loss or damage during shipment. For your protection,
carefully pack the product for shipment and insure it with the carrier. Ensure
that you return the unit and accessories related to your problem and also that
you indicate the full return address. Also, send a copy of the sales receipt
or other proof of purchase to determine warranty status. C.O.D. shipments
cannot be accepted.
Please send the above warranty information and in the case replacement of any
accessory is needed to the following address:
Please call 877-858-7200 or email
customer.service@zywie.healthcare for any questions and support.
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List of Accessories: (In case of replacement or ordering)
Sr.#
Description
1
1. ZywieZ3 sensor
2
Pouch of disposable adhesive
3
Docking station to charge the sensor
Part number 70FG68000 Z3ADH xxxxxx 40CME01282
A statement that the MANUFACTURER will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will assist SERVICE PERSONNEL to repair those parts of the EQUIPMENT that are designated by the MANUFACTURER as repairable by SERVICE PERSONNEL
JOHARI DIGITAL HEALTHCARE LTD. G-582-584, EPIP, BORANADA, JODHPUR 342012
(RAJ.) INDIA TOLL FREE: 1800-102-8684 | Email : info@joharidigital.com
www.joharidigital.com
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Back Cover Page
Manufactured by Johari Digital Healthcare Ltd. G-582-584, EPIP, Boranda,
Jodhpur 342012 (RAJ.) India Toll Free: 1800-102-8684 Mail:
info@joharidigital.com Web: www.joharidigital.com
Manufactured for Zywie, Inc. 12000 Findley Road, Suite 360, Johns Creek, GA
(30097), USA Mail: info@zywie.healthcare Web: www.zywie.healthcare
DRW# XXXXXXXX, Ver.-X.X.X Date: DD/MM/YYYY
All rights reserved. Although every care has been taken to provide accurate
and up-to-date information, no responsibility can be accepted for any mistakes
or misprints contained in this catalogue. The products and their
specifications, as shown in this catalogue, may change without notice. The
images are shown for illustrative purposes only and may include accessories
that are not supplied as standard.
MADE IN INDIA
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References
- Medical Device Manufacturing Company - Johari Digital Healthcare Ltd
- Medical Device Manufacturing Company - Johari Digital Healthcare Ltd
- Wearable heart monitors, holter heart monitor, cardiac monitors, arrhythmias