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Cautions
1.
MoMe
®
Kardia uses cellular phone technology, so the system operation and
data transmission may be affected or interrupted by poor cellular 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.
2.
Use only MoMe
®
Kardia parts and accessories with the MoMe
®
Kardia system.
Using non-MoMe
®
Kardia equipment may result in system malfunction or failure.
3.
Use only with the supplied battery packs, charger dock, and power cord.
4.
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 your physician’s office for a replacement, if needed.
5.
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)
6.
Do not drop or subject MoMe
®
Kardia parts to extreme physical shock.
7.
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.
8.
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.
9.
The MoMe
®
Kardia provided for use in the U.S. will not transmit recorded
data if the patient travels outside of the U.S.
10.
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.
11.
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.
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