Lepu Medical ER2-S Bedienungsanleitung

LEPU MEDICAL
0
ECG Recorder
User Manual
1. The basics
Thismanual c ontains theinstructions n ecessary tooperate the
t produc safely inaccordanc e withitsfunction a nd intended
use. O bservanc e of thismanual i sa prerequisite f or proper
produc t performanc e and correct operation and ensures
patient a nd operator s afety.
1.1 Safety
Warnings and CautionaryAdvice
Before u sing thisequipment, please r ead thismanual
carefully a ndfullyunderstand thewarnings and risks.
Thisdevice isnotintended toreplace themedical
diagnosis o f a professional doctor.
Themeasuremen t results of thisdevice arefor reference
onlyand cannot be directly used asa basis f orclinical
treatment.
Wedo notrecommend theuseof thisdevice ifyou have a
pacemak er Or other i mplantable device i nyourbody.
Please follow thedoctoesadvice if necessary.
This devicecannotbe usedwith a defibrillator.
device cannot b eused duringCtor nuclear m agnetic
resonance ( MRI) procedures.
Thisequipmen t must n otbeused in aflammable
environment Keg. oxygen-rich e nvironment).
Thisdevice isnotintended for useby infants weighing
lessthan 10 kg.
DO notswimor submerge t hedevice in thewater. D Onot
immersethedevicein wateror Otherliquids.
2
Themanufactuter shallprovidetheservice personnel with
circuitdiagrams, component partlists,descriptions,
calibration instructions, or otherinformation thatwill
assistservicepersonnel t o repairthe device.
• Repor t tothemanufacturer andthecompetent authority
of theMemberStatein which you're established for any
serious incident that has occurred in relation to the
device.
2. Introduction
2.1 Name and Model
Name: ECG recorder
Model: ER2-S
2.2 Intended Use
The ECG recorder is intended to record, display, store and
transfer single-channelelectrocardiogram(ECG)rhythms at
home or in healthcare environment.
The device doesno analysisby itself and is intended to be
used with a compatible ambulatory ECG (Holter) analysis
system (A1-ECG Tracker) which will analyze the recorded
data.The devicedataand thedata analysisare then reviewed
by trained medical personnelfor the purposeof forming a
clinieal diagnosis.
deviceis intendedfor useby adults' health-conscious
individuals.
The produc t does n otinclude a nalysis anddiagnosis
functions.
The producthasnotbeentestedandit is not intendedfor
pediatricuse.
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Contents
User
Manuale
Manual de .....F.spaö0189-118
Manuel de
Do not useacetone or othervolatile solutionsto cleanthe
device.
Donotstrongly c ollide orcrush thedevice. Ifthecasing
is broken,stopusingit.
Thisdevice cannot b eplaced in a pressure vessel o r gas
sterilizationequipment.
Do not disassemble or modify thedevicewithout
authorizationof themanufacturer, o therwiseit maycause
machine malfunction oraffectthenormal o peration O fthe
device.
Keep thisdevice o utofthereach O fchildren o rpets,
pests.
This deviceshouldnotbe usedon peoplewith sensitive
skin or allergies.
Thisequipment cannot beplaced i nthefollowing
environments: directsunlight, hightemperature, high
humidity. close towater o rfiresources, and high
electromagnetic influence.
Users s hould t rytoavoid sweating. sweat will affect
thecontact b etween theelectrodes andtheskin,affecting
thequality Ofthe measurement.
Users shouldinspect loosened e lectrodes. thatcan
degrade performance Or c ause o ther p roblems
Donotparticipate inviolent o rextensive physical activity
in order to makeappropriatemeasurements.
Themeasurement results of thisdevice cannot d istinguish
all diseases. If yourbodyfeelsunwell, y oushouldconsult
yourdoctorimmediately, in addition tothemeasurement
results Of this device.
3
2.2.1 Contraindications:
The product isnotintended foruse inpatients withcardiac
pacemakers or otherimplantable devices.
2.3 About ECG recorder
2
5
Figure I
Display screen
It can display time,power,waveformandheartlate when
measuring.
Logo on theright
2.
When measuring,theR mark is locatedon theright side
Of the user.
3. LED indicator
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The basics -
1-28
1.1 Safety
29-58
2. Introduction
2.1 Name and Model ......„ .
59-88
2-2 Intended
2.3 About ECG recorder
2.4 Symbols
119-148
2.5 Productsttuctureand composition
3. Using
3.1 BetOre
3.2 Openbox to check
3.3 Boot....
3.4 Measuring
3.5 Data export function
3.6 Charging
4. Maintenance........
4.1 Wananty.... .....
4.2 Battery............„...............
4.3
4.4 Recycling..........„.......
4.5 Problemsolving...............„..... .
Accessories
5.
Specifications
6.
FCC Warnning..„...
7.
Electromagnetic Compatibility
8.
DOnotself-diagnose andtakemedication b ased onthe
measurements O fthis devicewithout consultingyour
doctor. Inparticular, donottake new medications
prior permission.
Thisdevice isnota substitute f orprofessional heartor
Other Organ f unction m easurement
ECGmeasurement requires moreprofessional and
completemeasurements.
ftis device cannot b eusedtodiagnose a disease d irectly.
Please consultyour doctor.
Werecommend
results of themeasurements
doctor if necessary.
Waste ( including t heequipment itselfisscrapped) is
disposed of inaccordance
regulations.
Whenthcambient t emperature is20'C,theminimum and
maximum storage temperature
for useis 2H (the time required).
Thepatient i s theexpected u ser.
DO notpileupthelong tubing atthehead O fthebed, a sit
maywrap around t hehead orneck ofthepatient during
sleep.
Li batteries capacity will decrease after c harge d ischarge
for 300 times.
lhe electrodes
conductive p ansincluding earth.
The product should n otbemaintained whileinuse.
device Shall o nlybemaintained b yqualified
professionals.
Indicator
3
Greenlight
4
Orange
light
Blue light
4. ECG electrodes
Used toconnect thebody surface a nd receive t hehuman
body ECGsignal.
5. Charging interface
Usedto connectthechargingcable.
Table of Contents
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„
-..m. 11
. ..........11
.
..................„... 12
.
15
. 17
........„ 17
. IS
..„.
18
...... ...... 19
...„...... ........m......21
.
without
equipment. Medical
that y ourecord your ECG curve and the
andprovide themtoyour
withrelevant laws and
fromtheproduct toready
(applied p arts) s hould n otcontact other
4
Description
Status
Not activated
OFF
Out of battery
Flashingwith the
• Recordingyour ECG
rhythm of the
heartbeat
Fully charged
Flashingevery S
• In standbymode
seconds
Flashingwith the
rhythm of the • Recordingyour ECG
heartbeat
Charging
On
Low Battery
Flashingevery5
seconds
• In standbymode
Connected to theApp
andreadyto start
recording
Flashingwith the
• Connected to theApp
rhythm of the
andrecordingyour ECG
heartbeat
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19