Gima ABPM User manual

Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. [phone] - fax [phone]
Export: tel. [phone]/221/225 fax [phone]
[e-mail] - [e-mail]
www.gimaitaly.com
GIMA ABPM PULSE RATE MONITOR
WITH SpO2
User Manual
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Contec Medical Systems Co., Ltd
No.24 Huanghe West Road,
Economic & Technical Development Zone,
Qinghuangdao, Hebei Province, 066004, P.R.C.
ATTENTION: The operators must carefully read and completely understand
the present manual before using the product
M-35111-EN-Rev.0.11.11
Shanghai International Trading Corp. GmbH (Hamburg)
Eiffestrasse 80, 20537, Hamburg, Germany
0123
PROFESSIONAL MEDICAL PRODUCTS

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Chapter 1 INTRODUCTION................................................................. 5
1.1 General Information ............................................................ 7
1.2 Button Functions ................................................................ 8
1.3 Interfaces ............................................................................ 9
1.4 Accessories ........................................................................ 9
Chapter 2 GETTING STARTED ......................................................... 10
2.1 Open the Package and Check.......................................... 10
2.2 Dry Battery Installation...................................................... 10
2.3 Power On the Monitor....................................................... 10
2.4 Connect Oximeter Probe .................................................. 11
2.5 Connect NIBP Cuff ........................................................... 11
Chapter 3 FUNCTION INTERFACE................................................... 11
3.1 Main Inferface ................................................................... 11
3.2 System Menu.................................................................... 12
3.2.1 System Setup ................................................................... 13
3.2.2 BP SETUP......................................................................... 14
3.2.3 SpO2SETUP ..................................................................... 15
3.2.4 Patient Information ........................................................... 16
3.2.5 BP TABLE ......................................................................... 16
3.2.6 SpO2TABLE...................................................................... 17
3.2.7 DEMO Function ................................................................ 18
Chapter 4 SpO2MONITORING ......................................................... 19
4.1 What is the SpO2Monitoring ............................................ 19
4.2 Precautions during SpO2/Pulse Monitoring ...................... 20
4.3 Monitoring Procedure ....................................................... 20
4.4 Maintenance and Cleaning ............................................... 21
Chapter 5 NIBP MONITORING ......................................................... 21
5.1 Introduction....................................................................... 21
5.2 NIBP Monitoring ............................................................... 22
5.3 NIBP Message and Explanations ..................................... 24
5.4 Maintenance and Cleaning ............................................... 24
5.5 Transportation and Storage .............................................. 26
5.6 Key of Symbols................................................................. 26
Chapter 6 INSTALLATION OF THE SOFTWARE .............................. 26
6.1 Demand of Editor.............................................................. 26
INDEX

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6.2 Installation of Software ..................................................... 27
Chapter 7 INTRODUCTION TO THE SOFTWARE ............................ 27
7.1 User register ..................................................................... 27
7.2 The main interface ............................................................ 29
7.3 Wear.................................................................................. 29
7.4 Design the measurement plan.......................................... 30
7.5 Data download.................................................................. 32
7.6 Choose patient data to edit .............................................. 32
7.7 Delete data le .................................................................. 33
7.8 Data le backup................................................................ 34
7.9 Edit Blood pressure data .................................................. 35
7.10 Trend Edit.......................................................................... 36
7.11 Display the statistics infomation....................................... 40
7.12 Edit of diagnose information............................................. 41
7.13 Sleep period change......................................................... 41
7.14 BP Thresholds .................................................................. 42
7.15 Histogram ......................................................................... 42
7.16 Piechart............................................................................. 43
7.17 Correlation line.................................................................. 43
7.18 Print report........................................................................ 44
7.19 Help .................................................................................. 46
Chapter 8 TROUBLESHOOTING GUIDE .......................................... 46
Appendix .......................................................................................... 45

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Chapter1
INTRODUCTION
• Foranoverallintroductiontothemonitor,pleaserefertoGeneral
Information.
• Forbasicoperatinginstructions,pleaserefertoButtonFunction.
• Forallocationofinterfacesockets,pleaserefertoInterfaces.
Warning
Possible explosion hazard if used in the presence of ammable
anestheticsorotherammablesubstanceincombinationwithair,
oxygen-enrichedenvironments,ornitrousoxide.
Warning
Youmustverifyifthedeviceandaccessoriescanfunctionsafely
and normally before use.
Warning
Ensurethattheenvironmentinwhichthedeviceisoperatedisnot
subjecttoanysourcesofstrongelectromagneticinterference,such
asradiotransmitters,mobiletelephones,etc.KeepthemfarawayHigh
levelelectromagneticradiationemittedfromsuchdevicesmaygreatly
affect the monitor performance.
Warning
The disposal of scrap instrument and its accessories and packings
(includingbattery,plasticbags,foamsandpaperboxes)shouldfollow
the local laws and regulations.
Warning
Pleasechoosetheaccessoriesandprobewhichareapproved
ormanufacturedbythemanufacturer,orelseitmaydamagethedevice.
Warning
Disposeofthepackagingmaterial,observingtheapplicablewaste
control regulations and keeping it out of children’s reach.
Warning
The monitor is only for use on one patient at a time.
Warning
It is recommended that you check if there is any damage on the
monitorortheaccessoriesregularly,ifyoundanydamage,stop
usingit,andcontactthebiomedicalengineerofthehospitalorour
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CustomerServiceimmediately.
Inaddition,theoverallcheckofmonitor,includingthesafetycheck
suchastheleakagecurrent,shouldbeperformedonlybyqualied
personnelonceevery12months.
Note
Please choose the computer which should be ensured compliance
withtherequirementsofIEC60950,orelseitmaydamagethedevice.
Note
ThesoftwarewasdevelopedperIEC60601-1-4.Thepossibility
of hazards arising from errors in the software program is minimized.
Caution
Attheendofitsservicelife,theproductdescribedinthismanual,
aswellasitsaccessories,mustbedisposedofincompliancewith
theguidelinesregulationthedisposalofsuchproducts.Ifyouhave
questionsconcerningdisposaloftheproduct,pleasecontactus
oritsrepresentatives.
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1.1 General Information
Environment:
Temperature
  Working 5~40(°C)
  TransportandStorage -20~60(°C)
Humidity
Working ≤ 80 %
Transport and Storage ≤ 95 %
Altitude
  Working -500to4,600m(-1,600to15,000ft)
  TransportandStorage -500to13,100m(-1,600to43,000ft)
 PowerSupply 3(V)DC
Pmax = 2.56VA
General instruction
Themonitornotonlymeasuretheambulatorybloodpressure,butalso
monitor the parameters of NIBP and SpO2. But it is applicable for adult only.
It integrates parameter measuring modules function and display function
inonedevice,featuringincompactness,lightweight.
The POWER switch is on the front panel. The RUN indicator and the ALARM
indicatorashonetimewhenthedeviceispoweredon.TheALARM
indicator ashes when alarm occurs. The sockets of the sensors are
at the top. USB is at the bottom of monitor.
Thismonitorisauser-friendlydevicewithoperationsconductedby
a few buttons on the front panel. Refer to Button Functions for details.
Measuring the ambulatory blood pressure function:
Inthismode,themonitorcanwork24hourscontinuously.Themonitor
havethecapableofrecordingupto4800measurements,thestoredreadings
in the monitor are downloaded into the computer to proceed the function
includingeditingthedata,editingthetrendgraph,statistic,displaying
theinformation,editingthediagnosticinformation,settingtheparameters
andprintingandsoon.However,thismonitorcannottransmitdata
real-time in the process of measuring.
Monitoring function:
NIBP
- Fromlefttoright,thereareSystolicpressure,Meanpressure
 andDiastolicpressure(unit:mmHgorkPa)
SpO2
- SpO2(unit:%)
- PulseRate(unit:beats/minute)(When“BOTH”itemisselected)
Note
Inthismode,thelengthofworkingtimecontinuouslyisdecidedbythe
intervalofmeasurementsetbytheuser.
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It is useful that the software at the state of monitoring as the ambulatory
blood pressure.
Refer to Software Functions for details.
1.2 Button Functions
All the operations to the monitor are through the buttons at the bottom
ofthepanel.Thenamesofthebuttonsareabovethem.Theyare:
POWER
Press the button and the system will start.
Note
Whenthebatteryislow,thealarmoccurs.
MENU
Whateverlevelsofmenuthesystemisin,pressthebuttonand
the system immediately executes a certain function.
UP
Press the button to select the menu item and modify the setup.
DOWN
Press the button to select the menu item and modify the setup.
In the main interface press this button less than 1second to enter alarm
pausestatus.Press“DOWN”for1secondtoenterthesilencestatus
and a symbol appears at main screen. When the system
isinsilencestatus,anynewlygeneratedalarmwilldischarge
thesilencestatusandmakethesystemgivenormalalarmstatus.
Note
PulsetonewillbeheardinSilencestatus,IfnewalarmoccursinAlarm
Silencestatus,thesystemwilldischargeSilencestatusautomatically,
or the silence status will be discharged automatically 1 minute later.
NIBP
Press to inate the cuff to start a blood pressure measurement. When
measuring,presstocancelthemeasurementanddeatethecuff.
Method to use the button to operate in the screen:
TherectangularmarkinthescreenthatmoveswiththeUPbuttonorDOWN
buttoniscalled“cursor”.Operationcanbeperformedatanyposition
at which the cursor can stay.
Whentheitemisnottoselect,thecursoriswhite;whenpressMENU
toselecttheitem,thecursorbecomered.
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1.3 Interfaces
Fortheconvenienceofoperation,thedifferentkindsofinterfaces
are in different parts of the monitor.
At the top is the Socket for SpO2Sensor and socket for NIBP cuff
1the Socket for NIBP cuff
2the Socket for SpO2Sensor
AtthebottomisthesocketforUSB,asshowninFigure1.3.2.
①the Socket for USB
1.4 Accessories
A a cuff for adult
B a usb data line
C a oximeter probe (Model: SpO2-01-DR)
Dadisk(PCsoftware)
E a pouch
F a user manual
Warning
Please use the accessories supplied by the manufacturer or replace
theaccessoriesaccordingtotherequirementsofthemanufacturer
inordertoavoidmakingharmstopatients.
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Figure 1.3.1
Top
Figure 1.3.2
Bottom
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Chapter 2
GETTING STARTED
• Openthepackageandcheck
• Drybatteryinstallation
• Poweronthemonitor
• Connectpatientsensors
2.1 Open the Package and Check
Open the package and take out the monitor and accessories carefully.
Keep the package for possible future transportation or storage.
Check the components according to the packing list.
• Checkforanymechanicaldamage.
• Checkallthecables,modulesandaccessories.
Ifthereisanyproblem,contactthedistributorimmediately.
2.2 Dry battery installation
The monitor will be supplied with two ‘AA’ alkaline batteries or high capacity.
Before using the monitor you shall put the battery in the box of battery.
Note
Whenyoudon’tusethemonitor,youwilltakeoutthedrybattery.
2.3 Power on the monitor
PressPOWERtopoweronthemonitor.Theindicatorwillash,thesystem
willentermonitoringscreenofmonitoringorABPM,andyoucanperform
normal monitoring now. Refer to System Menu for details.
Warning
Ifanysignofdamageisdetected,orthemonitordisplayssomeerror
messages,donotuseitonanypatient.Contactbiomedicalengineer
inthehospitalorourCustomerServiceCenterimmediately.
Note
Check all the functions that may be used to monitor and make sure that
the monitor is in good status.
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2.4 Connect Oximeter Probe
Note
Forinformationoncorrectconnection,refertoFigure2.4
2.5 Connect NIBP Cuff
Connect NIBP extension conduit between the monitor and the patient.
Note
Forinformationoncorrectconnection,refertoFigure2.5.
Chapter3
FUNCTION INTERFACE
• MainInterface
• SystemMenu
3.1 Main Interface
PressPOWERtopoweronthemonitor,Theindicatorwillash,thesystem
will enter the main interface successfully.
ABPM : If there is no key-press operation within the time set in the
BACKLIGHTTIMEitem,themonitorwillenterstandbymode.
RUNindicatorlightashesonceeveryother2seconds,indicating
the monitor is under working mode.
Monitoring Mode: BACKLIGHT TIME item setup is of no effect. The backlight
is bright all the time.
The ‘04’ will be displayed in the middle of the speaker and battery when
the power is low.
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Figure 2.4
THE SpO2PROBE
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Figure 2.5
THE CUFF

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The main interface is shown as the follow:
Note
Whentheregisterisfull,willbeappearanceatthetopofscreen.
Thenoteofthelastvalueneedstobecleared.
3.2 System Menu
Press the MENU button on the panel to call up the [SYSTEM MENU].
You can perform option operations by using UP and DOWN buttons.
Figure 3.1.1
ABPM main menu
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Figure 3.1.2
Monitoring main menu

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[PMBPSETUP],[PMSpO2SETUP] and [SpO2TABLE] are gray in the mode
of ABPM. They cannot be set up.
3.2.1 System Setup
Select the SYSTEM SETUP item in the [SYSTEM MENU].
The following menu will pop up.
Users can set up the system time by selecting the [TIME] item.
Ifusersselect[YES]inthe[DEFAULT]item,themonitorwillcomeback
to factory default.
Inthe[LANGUAGE]item,userscanselectthewordsshowninChinese
or English in the screen.
Figure 3.2
System menu
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Figure 3.2.1
System setup

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Ifusersselect[ON]inthe[ALARM]item,theloudspeakerturnson.
willbeappearedinthemainmonitoringinterface.Ontheotherhand,
whenusersselect[OFF],theloudspeakerturnsoff,
will turns up.
Inthe[NEWPATIENT]item,ifusersselect[OFF],the“Clearthelastvalue?
“dialogboxwillappear.
Select[YES]againwilldeletethemeasurerecordofthelastpatient,then
select[NO]backtothe[SYSTEMSETUPMENU].Else,selecting[NO]
atrst,themonitorwilldonothing.Pleasepayattentiontothisfunction.
Users can select PM or ABPM in the [FUNCTION SELECT] item
and correspond measures will be taken.
Inthe[BACKLIGHTTIME]item,userscanmakeitfrom5to120seconds
with 5 seconds per step. Its function is to control the backlight time
of the main interface in ABPM.
UndertheABPM,[DEFAULT],[ALARM]and[NEWPATIENT]cannot
be set up.
3.2.2 BP SETUP
Select[PMBPSETUP]inthe[“SYSTEMMENU”].Thefollowingmenuwill
pop up.
Whenusersselect[ON]inthe[AUTOMEASURE]item,theMonitorwillme-
asure blood pressure according to the time selected in the [INTERVAL] item.
When[OFF]isselected,manualmeasureisneeded,simultaneously[INTER-
VAL] item turns gray and cannot be set up.
Theintervaltime(Unit:minute)setupinthe[INTERVAL]itemcanbeselected
fromthefollowingoptions:5,10,15,20,30,45,60,90.
Figure 3.2.2
BP setup

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Thealarmisonoroffaccordingtothehighandlowlimitswhichhavebeen
set up. When the pressure higher than the high limit or lower than the low
limit,thealarmwilloccur.[SYSALM],[MEANALM]and[DIAALM]canbe
processed separately.
The adjustable ranges of the high and low limits of the alarm are as follows:
DIA ALM: 40~270 mmHg
SYS ALM: 10~215 mmHg
MEAN ALM: 20~235 mmHg
3.2.3 SpO2SETUP
Select [PM SpO2SETUP]inthe“SYSTEMMENU”.
The following menu will pop up.
Forthe[PULSESOUND]item,youcanchooseitsstate.Whenitis“ON”,
pulse sound plays while the monitor measure the ambulatory blood pressure.
Whenitis“OFF”,pulsesounddosen’tplaywhilethemonitormeasurethe
ambulatory blood pressure.
For the [SpO2ALMHI/LO]item,youcansetup[SpO2ALM H] and [SpO2ALM
LO].Alarmoccurs,whenSpO2valueoverows.
Forthe[PRALMHI/LO]item,youcansetup[PRALMHI]and[SpO2ALM
LO].Alarmoccurs,whenPRvalueoverows.
SpO2and PR ALARM analysis alarm limits:
Figure 3.2.3
SpO2setup
PARAMETERS Max. HI Min. LO Step
SpO2100 0 1
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3.2.4 Patient Information
Pickthe[ABPMINF0]iteminthe“SYSTEMMENU”tocallupthefollowing
menu.
Theinformationinthisinterfacecan’tbechanged,untilreinstall
the parameter in software.
3.2.5 BP TABLE
Pickthe[BPTABLE]iteminthe“SYSTEMMENU”tocallupthefollowing
menu.
[total]:thenumberisthetotalofalldatahavebeenmeasuredfromaccessing
thisinterfacethersttime.Thesequencenumberofthecurrentrstlinewill
Figure 3.2.4
ABPM infor
Figure 3.2.5.1
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bedisplayedwhenchangingthedataorturningoverpages.Everypagecan
contain 10 data at most.
Select the [change] item to enter the [Change The Number] menu:
Whenthenumberwhichyouinputismorethanthetotal,itwillprompt“>
total”.Bloodpressuremeasureonetimeper5minutes,andthemostnumber
of times is 4896.
3.2.6 SpO2TABLE
Pick the [SpO2TABLE]iteminthe“SYSTEMMENU”tocallupthefollowing
menu.
Figure 3.2.5.2
Change
Figure 3.2.6.1
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[total]:thenumberisthetotalofalldatahavebeenmeasured,while
accessingthisinterfaceforthersttime.Thesequencenumberoftherst
linecurrentlywillbedisplayed,whilechangingthedataorturningoverpage.
Everypagecancontain10dataatmost.
Select the [change] item to enter the [Change The Number] menu:
Whenthenumberwhichyouinputismorethanthetotal,itwillprompt
“>total”.Thebloodpressureismeasuredonceper1s,andthemostnumber
of times is 183000.
3.2.7 DEMO function
Selectthe[DEMO]itemtoenterDEMOstatus.IntheDEMOstatus,pressthe
“MENUKEY”,andsystemreturnstothe“MAINMENU”.
Figure 3.2.6.2
Change
Figure 3.2.7
Demo

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Note
Inclinicalapplication,thisfunctionisforbiddenbecausetheDEMO
willmisleadthemedicalstafftotreattheDEMOwaveformand
parameterastheactualdataofthepatient,whichmayresult
in the delay of treatment or mistreatment.
Whenitisambulatorybloodpressurestate,[PMBPSETUP]、[PMSpO2
SETUP]and[TABLE]can’tbechangedinthe“MAINMENU”.
Chapter 4
SpO2MONITORING
4.1 What is the SpO2 Monitoring
SpO2Plethysmogram measurement is employed to determine the oxygen
saturationofhemoglobininthearterialblood.If,forexample,97%
hemoglobin molecules in the red blood cells of the arterial blood combine
withoxygen,thenthebloodhasaSpO2oxygen saturation of 97%.
The SpO2numeric on the monitor will read 97%. The SpO2numeric shows
thepercentageofhemoglobinmoleculeswhichhavecombinedwithoxygen
molecules to form oxyhemoglobin. The SpO2/PLETH parameter can also
provideapulseratesignalandaplethysmogramwave.
How the SpO2/ PLETH Parameter Works
• Arterialoxygensaturationismeasuredbyamethodcalledpulseoximeter.
 Itisacontinuous,non-invasivemethodbasedonthedifferentabsorption
spectra of reduced hemoglobin and oxyhemoglobin. It measures how
 muchlight,sentfromlightsourcesononesideofthesensor,is
 transmittedthroughpatienttissue(suchasangeroranear),toareceiver
on the other side.
 Thesensormeasurementwavelengthsarenominally660nmforthe
Red LED and 940nm for Infrared LED. Maximum optical power output
for LED is 4 mW.
• Theamountoflighttransmitteddependsonmanyfactors,mostofwhich
 areconstant.However,oneofthesefactors,thebloodowinthearteries,
 varieswithtime,becauseitispulsating.Bymeasuringthelightabsorption
 duringapulsation,itispossibletoderivetheoxygensaturation
 ofthearterialblood.DetectingthepulsationgivesaPLETHwaveform
and pulse rate signal.
• TheSpO2valueandthePLETHwaveformcanbedisplayedinthemain
screen.
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Warning
ES(Electrosurgery)equipmentwireandSpO2cable must not be
tangled up.
Warning
Donotputthesensoronextremitieswitharterialcatheterorvenous
syringe.
Note
Do not perform SpO2measuring and NIBP measuring on same arm
atonetime,becauseobstructionofbloodowduringNIBPmeasuring
mayadverselyaffectthereadingofSpO2value.
4.2 Precautions during SpO2/Pulse Monitoring
Note
、Makesurethenailcoversthelightwindow;
① The wire should be on the backside of the hand.
Note
SpO2waveformisnotproportionaltothepulsevolume.
Warning
Do not use the SpO2sensor once the package or the sensor is found
damaged.Instead,youshallreturnittothevendor.
Warning
Prolonged and continuous monitoring may increase jeopardy
ofunexpectedchangeofdermalconditionsuchasabnormalsensitivity,
rubescence,vesicle,repressiveputrescence,andsoon.Itisespecially
important to check the sensor placement of neonate and patient of poor
perfusion or immature dermogram by light collimation and proper
attaching strictly according to changes of the skin. Check per 2~3 hours
thesensorplacementandmoveitwhentheskindeteriorates.
Morefrequentexaminationsmayberequiredfordifferentpatients.
4.3 Monitoring Procedure
SpO2plethysmogram measurement
1. Switch on the monitor.
2. Attach the sensor to the appropriate site of the patient nger.
3. Plug the connector of the sensor extension cable into the SpO2socket, 
please pay attention to the direction of the sensor.
4.PleasepulloutthesensorWhenmeasureisover.
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