Use Instructions

10
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11
WARNING: Sources of electromagnetic
radiation like:
• portable and mobile radio frequency
(RF) communications equipment
(e.g. cellular phones, mobile radio),
• radio frequency identification systems
(RFID) devices using one or more of the
following wireless technologies:
o Wi-Fi (IEEE 802.11),
o Bluetooth (IEEE 802.15),
o ZigBee (IEEE 802.15.4),
o WiMAX (IEEE 802.16),
o Ant, etc.,
• base stations for radio
(cellular/cordless) telephones and
land mobile radios, amateur radio,
AM, and FM radio broadcast and TV
broadcast,
• metal detectors,
• diathermy, lithotripsy, electrocautery,
radiofrequency identification (RFID),
near field communication (NFC),
electronic article surveillance (EAS)
can affect the PocketECG transmitter.
MAINTENANCE
The PocketECG transmitter type:
P4TR-AA-ADS,
and
P4-TR-BA-ADS and battery charger type:
PECGC
-III, manufactured by Medicalgorithmics
S.A. are designed for 5 years continuous use if
properly operated. Then
the device should be
recycled according to the local recycling program
or refurbished by
the manufacturer.
CLEANING
& STORING
The outer surface
of the transmitter, ECG lead
wires and transmitter accessories (charger,
batteries) can be wiped with a wet soft cloth and
soft soap dissolved in water or an alcohol
-based
disinfecting
agent (70 % ethanol or 70 %
isopropyl alcohol).
When cleaning or using the equipment, never get
the cables and the connectors wet.
Neither the
device nor the accessories are waterproof.
Should
the PocketECG transmitter or its
accessories get accidentally wet, dry it
immediately (leave
the device with removed
battery cover in the warm room for at least
24
hours).
• Remove the battery from either the transmitter
or charger before storing them. This prevents the
battery from accidental discharge and reduces
the risk of its damage.
SYMBOLS USED ON POCKETECG
ACCESSORIES
Recyclable materials
Indoor use only
Direct current
Alternating current
Date of manufacture
Class II equipment
Serial number
IP02
Minimum Ingress Protection class
provided by protective pouch
FCC Logo (Declaration of Conformity)
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USING POCKETECG IV
1. Safety precautions
• One device is intended to monitor only one
patient at a time.
• It is recommended for the device to work at room
temperature (working temperature is: from 0 ⁰C
to +43 ⁰C (from 32 ⁰F to 109 ⁰F)).
• Air in rooms where the device works should be
free of caustic gasses, steam, and dust. Although
the device is powered from 3.7 VDC and does not
allow for power intake larger than 3 A it is not
guaranteed that it cannot produce a spark which
could initiate the explosion.
• The patient should check with the appropriate
airline carrier to confirm that the PocketECG
transmitter which is similar to a regular mobile
phone may be used on the airplane during
take-off, flight, and landing.
• During handling the device, it is necessary to
avoid excessive stretching and sudden jerking of
cables connecting the PocketECG transmitter
with electrodes placed on the patient’s body. The
ECG cables should not be bent, pulled and
wrapped around the device.
• Parts that wear out and are intended for single
use should be used in accordance with binding
regulations and cannot be re-used. The
electrodes placed on the patient’s body should
be replaced with new ones after no longer than
24 hours if the diagnostic session is to be
continued.
• The manufacturer is not liable for damage caused
by improper use of the device or neglecting
guidelines included in the instructions for use.
• The manufacturer accepts liability only when the
device is used as intended and in accordance with
the instructions for use.
• The ECG cable is permanently attached to the
PocketECG transmitter. In case of damage, do not
repair or replace it, because it may negatively
influence the electromagnetic compatibility of
the device. Damaged ECG cable can be replaced
only by the manufacturer.
• The conductive parts of ECG cables are intended
to be connected only to the ECG electrodes. They
should not be connected to any conductive parts
of any objects including earth.
• The capacity of the PocketECG Li-Ion battery
decreases with normal use over time. The
manufacturer recommends replacing the battery
with a new one after 300 charging cycles or after
2 years of use. Recycle or dispose of used
batteries according to the local regulations.
2. Starting the device
• Slide the battery into its compartment, until it
will snap.
• The device turns on automatically, and it is ready
for starting a new recording session about
30 seconds after the battery is placed in its
compartment.
• A fully charged battery makes it possible to
continuously monitor the patient's ECG and
acceleration signals using the PocketECG
transmitter for at least 24 hours.
CAUTION: Prior to starting a diagnostic
session read the PocketECG IV
instructions for use carefully.
CAUTION: A patient should be trained by
qualified personnel before using the
PocketECG transmitter.
CAUTION: The batteries should be
charged before the first usage.
CAUTION: If no image is displayed within
30 seconds after placing the battery in
the compartment, the battery is fully
discharged or the device does not
operate correctly due to the abnormal
temperature or humidity conditions.
3. Connecting the ECG electrodes
• Remove hair from the place where the electrode
will be attached.
• Wipe the chosen site with a damp cloth/wet
wipes (do not use high-proof alcohol as it may dry
up the epidermis and distort the ECG signal).