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Warnings
1. Warning: MoMe
®
Kardia is not intended for use on infants weighing less
than 10kg (22 lb).
2. 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.
3. Warning: Use only specified MoMe
®
Kardia accessories. Use of any other
accessories may result in non-compliance.
4.
Warning:
To avoid possible strangulation, route all cables away from the
patient's throat.
5. Warning: The MoMe
®
Kardia Device is not defibrillation-proof. Remove MoMe
®
Kardia Device and disconnect patient leads before external defibrillation.
6. 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 your physician’s office for product repair or replacement.
7. Warning: The MoMe
®
Kardia system may be affected by equipment even
if the equipment is CISPR compliant.
8. Warning: The MoMe
®
Kardia system should not be used in the presence
of flammable anesthetics.
9. 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.
10. Warning: Never attempt to repair or service any MoMe
®
Kardia equipment.
Repairs by untrained, unauthorized individuals may damage the equipment
or cause system malfunction.
11. Warning: The MoMe
®
Kardia is not intended to be used in an Oxygen rich
environment.
12. 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.
13. Keep the system out of reach of children and pets
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