Infobionic 01854 Wireless Ambulatory ECG Monitoring and Detection System User Manual user guide

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Document ID	3023334
Application ID	Qp09jPPZQoSfkinYJFnL1w==
Document Description	user guide
Short Term Confidential	No
Permanent Confidential	No
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Document Type	User Manual
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Filesize	33.88kB (423495 bits)
Date Submitted	2016-06-09 00:00:00
Date Available	2016-12-06 00:00:00
Creation Date	2016-05-20 10:14:35
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Document Lastmod	2016-05-20 10:14:36
Document Title	user guide
Document Creator	Adobe InDesign CC 2015 (Windows)

­
MoMe® Kardia
System Patient Guide
Table of Contents
MoMe® Kardia System Components............................................. 4
Unpacking the MoMe® Kardia System��������������������������������������� 5
Using the MoMe® Kardia System.................................................... 6
Monitoring....................................................................................... 6
Device Controls.............................................................................. 7
Notifications.................................................................................... 9
Charging MoMe® Kardia............................................................1 0
Belt Clip...........................................................................................1 1
Warnings and Cautions ..................................................................1 2
Battery Information..........................................................................1 4
System Specification........................................................................1 5
Electromagnetic Emissions Compliance �������������������������������� 16
page 2
page 3
MoMe® Kardia System Components
MoMe® Kardia Kit Components
No.
Component
Description
MoMe® Kardia
Device
Small, lightweight battery operated device that
collects, stores, and transmits physiological data to
the remote server via built in cellular module
3 wire color
coded lead set
Belt Clip
Used to carry the MoMe® Kardia on your belt or
waistband during the day
Rechargeable
Battery Packs
Battery packs to power the MoMe® Kardia Device.
A fully charged batttery will last for 24 hours and
must be replaced with a charged battery each day
to ensure uninterrupted monitoring
Charger Dock
Used to charge the MoMe® Kardia battery pack
Charger Dock
Power Supply
Used to connect the charger dock to AC wall socket
Electrodes
The MoMe® Kardia leadset snaps
to the electrodes. Electrodes will be
provided by your physician
Attaches to the MoMe® Kardia device and to each
electrode
Inspect all parts before use to ensure nothing is damaged
and/or missing
page 4
Unpacking the MoMe Kardia Device
Upack the MoMe® Kardia Kit and locate components
listed in the Kit Components chart on the previous
page.
Plug in the charger dock and place one of the two
included battery packs in the charger.
Insert the second battery pack into the back of
the MoMe® Kardia Device (for more detailed
instructions, see diagram on page 10). The device
should turn on.
Attach the color-coded leadset to the device.
Place electrodes as indicated on page 6. You are
now monitoring
page 5
figure 2
Monitoring
Once the device is activated and operating normally, the system
requires no intervention to capture or analyze data. However, your
physician should instruct you about the following responsibilities:
• Charge the MoMe® Kardia Battery pack every day
• Report any symptomatic events by pressing the record button
as instructed by your physician
• Return the system to the practice at the end of monitoring
page 6
Press and hold the Record Button
for 3 seconds to record
Device Controls
The MoMe® Kardia Device has three buttons: record, wake, and
volume.
Record: Press the record
button located on the face of the
device to report a symptomatic
event. The screen will display
a solid heart (as seen in figure
4) when the event has been
recorded.
Wake: Press the wake button
at any time to display the
current battery level and lead
connection status.
figure 5
page 7
Volume: Press the volume button to adjust the volume or silence
alerts on the device. To adjust the volume, press up or down on the
volume button. The display will be updated with the current level and
a tone will be played at the current volume for audible feedback of
the volume level. The lowest volume setting mutes the speaker and
can be used when the patients sleep should not be disturbed.
Volume Up
Volume Down
Vibrate
page 8
Notifications
Low Battery: When the battery level is low, the device will play an
audio alert and will display the BATT LOW notification shown below.
When the battery level is low the screen will
display BATT LOW
figure 7
page 9
Charging the MoMe® Kardia Battery Pack
To charge the MoMe® Kardia Battery Pack, follow these steps:
• First, remove the battery pack by sliding the lock and pulling
the battery from the MoMe® Kardia Device
• Place battery pack in the charging dock. When the charge is
complete, the indicator light will turn green.
• 
The battery must be replaced once daily. Promptly recharge
the battery pack after replacing depleted battery.
• To replace battery, use the slide lock lever to release and insert
the battery, as shown below in figure 8
line up battery
pack
insert tabs
push down and
in to slide lock
over
figure 8
page 10
Belt Clip
The MoMe® Kardia Device must be used with the included Belt Clip
.Slide the device up and into the belt clip holster to secure the device
in place then slide the clip over your belt or waistband with the leadset
attachment facing upwards.
figure 9
page 11
Warnings
•
•
•
•
•
•
•
•
•
•
•
•
 arning: MoMe® Kardia is not intended for use on infants weighing less than
10 kg (22 lb).
Warning: Use only specified MoMe® Kardia cables and accessories. Use of
any other cables and accessories may negatively affect EMC performance
resulting in increased emissions and decreased immunity.
Warning: Use only specified MoMe® Kardia accessories. Use of any other
accessories may result in non-compliance.
Warning: MoMe® Kardia is not intended for use as an emergency medical
response system.
Patients should be instructed that if they experience
symptoms of concern they need to seek immediate medical attention.
Warning: The MoMe® Kardia Device is not defibrillation-proof. Remove MoMe®
Kardia Device and disconnect patient leads before external defibrillation.
Warning: Do not service or repair any components of the MoMe® Kardia system.
Removal or tampering of the lead wires or any other component may alter
device performance and cause device malfunction or failure. Contact MoMe®
Kardia Technical Support at 1.844.401.9725 for product repair or replacement.
Warning: The MoMe® Kardia system may be affected by equipment even if the
equipment is CISPR compliant.
Warning: The MoMe® Kardia system should not be used in the presence of
flammable anesthetics.
Warning: The MoMe® Kardia contains a cellphone. If the patient has an
implantable device, they should be instructed to follow their implantable device
manufacturer’s recommendations for use with a cellphone.
Warning : Never attempt to repair or service any MoMe® Kardia equipment.
Repairs by untrained, unauthorized individuals may damage the equipment or
cause system malfunction.
Warning : The MoMe® Kardia is not intended to be used in an Oxygen rich
environment.
Warning : Electrodes may cause skin irritation or breakdown. We recommend that
standard FDA approved Ag/AgCL ambulatory monitoring electrode patches be used
and that the patient be instructed on what to do if skin irritation occurs.ff
Cautions
1.
 oMe® Kardia uses cellular phone technology, so the system operation
and data transmission may be affected or interrupted by poor cellular
page 12
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
coverage or electromagnetic interference. If data transmission is interrupted,
MoMe® Kardia will automatically cache the data until cellular coverage or
communication between the two devices is restored and then send the stored
data.
Use only MoMe® Kardia parts and accessories with the MoMe® Kardia
system. Using non-MoMe® Kardia equipment may result in system
malfunction or failure.
Use only with the supplied battery packs, charging dock, and wall adapter.
Prior to setting up a new patient with MoMe® Kardia, carefully inspect all
system components for defects or damage. Check lead wires for cracks or
fraying in the wiring, and cracks around the connector and snap leads. Do not
use the MoMe® Kardia system if any component appears defective, damaged,
or worn (e.g. cracks, dents, chips, cuts, kinks, or crushed or elongated
sections), as this may result in system malfunction or failure. Contact MoMe®
Kardia Technical Support at 1.844.401.9725 for a replacement, if needed.
MoMe® Kardia is not waterproof.:
— Protect all MoMe® Kardia parts from water, liquids or moisture which
will damage equipment and affect system operation;
— 
Do not immerse any part of the MoMe® Kardia system in water or
fluids. Do not spray device with cleaners or other liquids;
— 
Never bathe, shower, or swim while wearing the MoMe® Kardia
Device (while bathing or swimming, store MoMe® Kardia equipment
in a safe, dry location)
Do not drop or subject MoMe® Kardia parts to extreme physical shock.
The MoMe® Kardia system uses and generates radio frequency energy, so it
may cause harmful interference to radio communication if not used according
to instructions.
The user should take precautions regarding electromagnetic compatibility, the
MoMe® Kardia system needs to be used according to the EMC information
provided in this IFU.
The MoMe® Kardia provided for use in the U.S. will not transmit recorded
data if the patient travels outside of the U.S.
Do not use the MoMe® Kardia system in conditions that are:
— Below 32°F (0°C) or above 104°F (40°C);
— 
Less than 15% or greater than 93% non-condensing atmospheric
humidity.
Do not store or transport MoMe® Kardia in conditions that are:
— Below -25°C or above 70°C;
— 
Less than 15% or greater than 93% non-condensing atmospheric
humidity.
Keep the system out of reach of children and pets.
page 13
Battery Information
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Do not dismantle, open or shred secondary cells or batteries.
Do not expose cells or batteries to heat or fire. Avoid storage in direct sunlight.
Do not short-circuit a cell or a battery. Do not store cells or batteries haphazardly
in a box or drawer where they may short-circuit each other or be short-circuited
by other metal objects.
Do not remove a cell or battery from its original packaging until required for use.
Do not subject cells or batteries to mechanical shock.
In the event of a cell leaking, do not allow the liquid to come in contact with the
skin or eyes. If contact has been made, wash the affected area with copious
amounts of water and seek medical advice.
Do not use any charger other than that specifically provided for use with the
equipment.
Observe the plus (+) and minus (–) marks on the cell, battery and equipment
and ensure correct use.
Do not use any cell or battery which is not designed for use with the equipment.
Battery usage by children should be supervised.
Keep cells and batteries clean and dry.
Wipe the cell or battery terminals with a clean dry cloth if they become dirty.
Secondary cells and batteries need to be charged before use. Always use
the correct charger and refer to the manufacturer’s instructions or equipment
manual for proper charging instructions.
Do not leave a battery on prolonged charge when not in use.
After extended periods of storage, it may be necessary to charge and discharge
the cells or batteries several times to obtain maximum performance.
Retain the original product literature for future reference.
Use only the cell or battery in the application for which it was intended.
Dispose of properly.
page 14
System Specifications
MoMe® Kardia Device Specification
Specification
Battery Life
Operating Temperature
Storage Temperature (power off )
Operating Humidity
MoMe® Kardia Device
Provides 24 hours of function
before recharging
5°C to 40°C
-25°C to 70°C
15% to 93% non-condensing
Storage Humidity
Operating Pressure
ECG
Sampling Rate
Digital Resolution
200 Hz
5uV
Input Dynamic Range
+/- 10 mV
Input Offset Dynamic Range
+/- 300 mV
Input Impedence
> 3 MOhm
Peak Current Injection
24 nA (Lead off circuit) DC
RMS Current Injection
29 microA
Data Storage Capacity
Minimum 30 days
Dimensions
Weight
Communication Means
Ingress Protection Rating
108 mm x 67 mm x 17 mm max
80 +/- 5 g
HSPA+, UMTS, GPRS, EDGE
800/850, AWS1700, 1900
IPX0
Display
Type: LED Matrix, Size: 24 X 7
Memory
Internal microSD card up to 32
GB, Not user accessible
Battery
Li-Ion 1900mAh battery pack,
Min 24 hour battery life
page 15
Electromagnetic Emissions Compliance
The MoMe® Kardia device has been tested and found to comply
with the limits for medical devices to the IEC 60601-1-2:2007. These
limits are designed to provide reasonable protection against harmful
interference in a typical installation.
1.
2.
T his device radiates radio frequency energy in normal use and,
if not installed and used in accordance with instructions in this
manual, may cause harmful interferences to other devices in the
vicinity. If this device does cause harmful interference to other
devices, the user is encouraged to try to correct the interference
by one or more of following measures:
— Reorient or relocate the other device/s
— 
Increase the separation distances between this device
and other device/s
— Consult the manufacturer/s of other device/s or call service
for help
The device performance may be affected by heavy electrical
equipment or other sources of electromagnetic interference.
Guidance and Manufacturer’s Declaration Electromagnetic emissions
The MoMe® Kardia is intended for use in the electromagnetic environment specified below. The
customer or the user of MoMe® Kardia should assure that it is used in such an environment
Emissions Test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The MoMe® Kardia 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
RF emissions
CISPR 11
Class B
The MoMe® Kardia is suitable for use in all
establishments, including domestic establishments
and those directly connected to the public lowvoltage power supply network that supplies
buildings used for domestic purposes.
page 16
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The MoMe® Kardia is intended for use in the electromagnetic environment specified below. The
customer or the user of MoMe® Kardia should assure that it is used in such an environment
Immunity
Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Envioronment Guidance
±6 kV contact
±8 kV air
±6 kV contact
±8 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%.
Electrical fast
transient/
burst
+/- 2 kV for power
supply lines
+/- 1 kV for input/
output lines
Not applicable
Surge IEC
61000-4-5
+/- 1 kV line(s)
to line(s)
+/- 2 kV lines(s)
to earth
Not applicable
Electrostatic
discharge
(ESD)
IEC 610004-2
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 610004-11
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
Not applicable
<5% UT
(>95% dip in
UT) for 5s
page 17
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The MoMe® Kardia is intended for use in the electromagnetic environment specified below. The
customer or the user of MoMe® Kardia should assure that it is used in such an environment
Power
frequency
(50/60 Hz)
magnetic field
IEC 610004-8
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.
Portable and mobile RF communications
equipment should be used no closer to
any part of the unit, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended Separation Distance:
Conducted
RF
IEC 610004-6
Radiated RF
IEC 610004-3
3 Vrms
Not applicable
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Not applicable
3 V/m
d = 1.2 √ P 80 MHz to 800 MHz
d = 2.3 √ P 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, should be less than the
compliance level in each frequency range.
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 strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
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 unit is used exceeds the applicable RF compliance level
above, then the unit should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the unit.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
page 18
Recommended seperation distances between portable and
mobile RF communications equipment and MoMe® Kardia
System
The MoMe® Kardia is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The user of the MoMe® Kardia can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MoMe® Kardia as recommended below, according to the
maximum output power of the communications equipment
Seperation distance according to frequency of transmit
Rated maximum ouput
power of transmitter
150 kHz
to 80 MHz
d = 1.2 √ P
0.01
80 MHz
to 800 MHz
d = 1.2 √ P
800 MHz
to 2,5 GHz
d = 2.3 √ P
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
page 19
SAR Exposure Information
This device is designed and manufactured not to exceed the emission limits for
exposure to radio frequency (RF) energy set by the Federal Communications
Commission of the U.S. Government.
The exposure standard employs a unit of measurement known as the Specific
Absorption Rate, or SAR. The SAR limit relevant for the application described in
the manual is 1.6W/kg. Tests for SAR are conducted using standard operating
positions accepted by the FCC with the device transmitting at its highest
certified power level in all tested frequency bands.
Although the SAR is determined at the highest certified power level, the actual
SAR level of the equipment while operating can be well below the maximum
value. This is because the device is designed to operate at multiple power levels
so as to use only the power required to reach the network. In general, the closer
you are to a wireless base station antenna, the lower the power output.
Equipment Authorization has been granted to this device with the reported
SAR level(s) evaluated as in compliance with the FCC RF exposure guidelines.
SAR information on this equipment is on file with the FCC and can be found
under the Display Grant section of www.fcc.gov/oet/ea/fccid after searching on
the FCC ID as printed on the equipment.
This device has been tested to comply with FCC radiation exposure limits set
forth for an uncontrolled environment when used for the documented intended
purpose and when operated as shown in the user instructions provided with
this product, i.e. when carried with the belt clip coming with the product as a
bundled accessory.
The MoMe® Kardia Device must be used with the included Belt Clip
to keep a safe minimum distance towards your body (6mm), ensuring
compliance with regulatory limits regarding human exposure to radio
frequency radiation.
page 20

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