Bionet CardioCare 2000 Operation Manual Download Page 7 | Manualshive

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Ver. 2.41

CardioCare2000 Operation Manual

General Precaution on Electric Safety

Check the items listed below before operating the equipment.

-

Be sure that AC power supply line is appropriate to use. (100 - 240V AC).

-

Be sure that the entire connection cable of the system is properly and firmly fixed.

-

Be sure that the equipment is completely grounded. (Otherwise, noise could result.)

Note

The equipment should not be placed in the vicinity of electric generator, X-ray, broadcasting
apparatus to eliminate the electric noise during operation. Otherwise, it may cause incorrect
result.
Self-power line and stabile grounding is important for EKG 2000.
To use same power source with other electric instruments may cause incorrect result.

Note

EKG 2000 is classified as listed below ;



This equipment conforms to Class I, Type-BF. The equipment should be grounded to

protect the patient from electrical shock.



Do not use the equipment in the vicinity of flammable anesthetics and solvents.



The equipment conforms to Class I according to IEC/EN 60601-1 (Safety of Electric

Medical Equipment)



This equipment conforms to Class A according to IEC/EN 60601-1-2 (Electromagnetic

Compatibility Requirements)

Note

Diagnosis has to be confirmed by the doctor.

Note

Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards ( e.g. IEC 950 for data processing equipment
and IEC 601-1 for medical equipment ). Furthermore all configurations shall comply with the
system standard EN 60601-1-1:1993.

Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 601-1-1:1993. If in doubt, consult the technical
service department or your local representative. Diagnosis has to be confirmed by the
doctor.

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Summary of Contents for CardioCare 2000

Page 1: ...CardioCare 2000 OPERATION MANUAL Ver 2 41 www ebionet com ...

Page 2: ...is warranted by Bionet Co Ltd to be free from defects in material and workmanship for one year two years in Europe from date of purchase Warranty repair or replacement will be made by Bionet Service Center at no charge for warranty period if properly used under normal condition in accordance with the instructions for use In the event of a malfunction or failure during warranty period customer shou...

Page 3: ...Ro 31 Gil Guro Gu Seoul 08376 REPUBLIC OF KOREA REPUBLIC OF KOREA Overseas sales dept Tel 82 2 6300 6418 Fax 82 2 6300 6454 E mail sales ebionet com URL http www ebionet com In the event of a malfunction or failure contact Service Dept of Bionet Co Ltd along with the model name serial number date of purchase and explanation of failure If you need the supply circuit diagram component list descripti...

Page 4: ...amage or breakdown that is caused by misuse and failure to maintain the equipment To inform that it may cause no harm in life but lead to injury against the Caution sign Warning To inform that it may cause serious injury or death to the patient property damage material losses against the Warning sign Caution To inform that it may cause no harm in life but lead to injury against the Caution sign No...

Page 5: ...f there are any problems with the equipment please follow the steps below Contact the Bionet Oversea Service Department immediately After gathering the model name Serial Number date of purchase and description of the problem contact Bionet with the information shown below Try to solve the problem over the phone with the service department personnel If the problem cannot be solved over the phone th...

Page 6: ...perating humidity ranges from 30 to 85 Avoid in the vicinity of Electric heater Avoid placing in an area where there is an excessive humidity riseor ventilationproblem Avoid placing in an area where thereis anexcessiveshockor vibration Avoid placing in an area where chemicals are stored or where there is danger of gas leakage Avoid being inserted dust and especially metal material into the equipme...

Page 7: ...d to protect the patient from electrical shock Do not use the equipment in the vicinity of flammable anesthetics and solvents The equipment conforms to Class I according to IEC EN 60601 1 Safety of Electric Medical Equipment This equipment conforms to Class A according to IEC EN 60601 1 2 Electromagnetic Compatibility Requirements Note Diagnosis has to be confirmed by the doctor Note Accessory equ...

Page 8: ...itched off Device part switched on This symbol identifies a safety note Ensure you understand the function of this control before using it Control function is described in he appreciate operation manual Conductor provides a connection between equipment and the potential equalization bur bar of the electrical installation External Signal IN OUT Port EKG Signal Input Port The following symbols are u...

Page 9: ...AC Power 20 4 System Installation 21 Installation precautions 21 Power cable connection 21 Patient Cable Connection 22 Recording paper installation 22 5 Menu structure 23 6 System Setting 24 Initial setting 24 Date and time 25 User identification 26 Language 27 Chapter 2 Preparation for ECGs recording 28 1 Electrode positions 29 2 Electrode connection 30 Check before connection 30 Connecting the E...

Page 10: ...nel setting 35 Grid setting 36 Monitoring form setting 37 Monitoring channel setting 38 Diagnosis on off setting 39 Enter Patient Data 40 3 Monitor mode output 46 Output method 46 Output form 46 4 Record mode output 47 10 seconds ECG recording 47 60 seconds ECG recording 48 Output form 49 5 Copy mode output 54 Chapter 4 System control 56 1 Maintenance and Cleaning 57 2 Regular Inspection 58 3 Trou...

Page 11: ...Information 1 Introduction 2 Features of the equipment 3 Equipment description Standard Accessories Options Main Unit LCD Panel Control Panel AC Power 4 System Installation 5 Menu Structure 6 System Settings Initial Setting Date and Time User Identification Language ...

Page 12: ... a visit to patients or during patient transportation 2 Features of the equipment 12 channel ECGs is printed in a various channel form of 3ch 1rhy 6ch 1rhy 12ch rhy 60s 1rhy in A4 sized report form 1 1 channel rhythm is recorded for 60 seconds and printed in A4 sized report form 2 12 channel rhythms are printed simultaneously and continuously in real time 3 Measurement parameters such as heart rat...

Page 13: ...ies are available after opening the packaging box Also check if the main unit and accessories are damaged or harmed Standard accessories EKG2000 Main unit Patient cable 1 EA Limb electrode 1 SET Chest electrode 1SET Operation manual 1EA ECG Gel 1 EA Recording paper 1 EA AC power cable 1 EA Diagnosis guide book 1EA Options Cart Hanger Built in Battery ...

Page 14: ...14 61 Ver 2 41 CardioCare2000 Operation Manual Main Unit Front View Knob Printer door Printer door release button LCD Control panel ...

Page 15: ...15 61 Ver 2 41 CardioCare2000 Operation Manual Rear view Potential equalization stud Main power switch AC power socket RS 232C SERIAL port LAN port Left side view Handle ...

Page 16: ...0 Operation Manual Right side view Patient cable connection port Warning Do NOT disassemble the case of the equipment to avoid the electric shock Refer servicing to Bionet Co Ltd qualified personnel or your local authorized dealer ...

Page 17: ...e LCD are as follows Display ECG signal level out of 5 10 20 aut Auto Gain Display printing speed out of 12 5 25 50 Display base line filter setting on or off Display EMG filter setting on or off Display heart rate Display channel form of the output report out of 3ch 1rhy 6ch 1rhy 12ch rhy 60s 1rhy Display rhythm channel setting out of I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 1 0 1 2 5 O F F O F F 1...

Page 18: ...erational without having an A C power supply When an A C power is supplied the battery indicator will be either red or green depending on the charge level No color will be shown if there is no battery installed in the device Indicate AC power is operated if LED is illuminated green and not in use if LED is off Short keys Select signal level mm mV out of 5 10 20 aut I aVF 10 V1 V6 5 Select printing...

Page 19: ... 10 seconds by pressing key and prints in A4 sized report form after calculating the measurement parameter of the recorded ECGs Print the same report as previously printed one in record mode or prints after changing system setting such as filter signal level output speed channel form rhythm cannel of previously recorded ECGs data in record mode Exit during printing or recording of ECGs Except that...

Page 20: ...the battery battery charge indicator lamp will light up red color If the battery is running low on power three continuous buzzer alarms will sound If this occurs turn off the device and connect the A C power before turning the device back on Required time for charging more than 4 hours Continuous battery operating time 1 hour Caution For the protection of environment do NOT throw wasted battery aw...

Page 21: ...er is turned off and on again Avoid excessive shock or vibration that could result in equipment damage Avoid using in the vicinity of dust and flammable material Power cable connection The equipment operates when the power cable end connect into the EKG2000 power cord Replace the fuse of the equipment if power is not turned on despite that power cord is connected and battery power is in normal con...

Page 22: ...ar of the equipment Connect the limb electrodes to the N F R L lead and chest electrodes to C1 C2 C3 C4 C5 C6 of the patient cable Recording paper installation Printer door open if printer release button at the side of EKG 2000 is pushed in the right Place the recording paper with the signal recording side up and push back to close ...

Page 23: ... mode Menu mode is activated by pressing key in preparation mode and following window displays on the LCD PAT FLT PRN SYS PATient Info First line indicates menu selection and second line indicates an explanation of the menu items or selected value Press key to move the focus Press key to select the focused menu items Press ESC key of control panel to move the menu above Menu structure is as follow...

Page 24: ... following window message appears on the LCD for 1sec and system sets to initialize FACTORY MODE initialize Initialized details are as follows Date DATE 2000 00 00 fixed Time TIME 00 00 00 Signal level SENS 10mm mV Display speed SPD 25mm s Grid GRID Off Channel form FORM 6ch 1rhy Rhythm lead LEAD II Base line filter BASE On EMG filer MUSC Off AC noise filter AC 60hz Low pass filter 40hz ...

Page 25: ...E Select Number is entered by pressing 0 9 numeric key in the current cursor position and cursor automatically moves to the right To exit the date setting press key or ESC key that moves to the menu above To set the time of EKG2000 move the menu to SYS TIME TIME SETUP as shown above Then enter the time in the same way date is entered DATE TIME HOSP 2000 03 01 DATE SETUP 2000 03 01 ESC ...

Page 26: ...ct the required character in the current cursor position As for 1ABC key the key toggles in the order of A B C 1 A whenever pressing that key So if you want to enter B character press key to input B after pressing the 1ABC key 2 times in the current cursor position Then moves the cursor to the next To exit the hospital name setting press key or ESC key that moves to the menu above To enter the use...

Page 27: ...e power on You will then be redirected to the Language menu In the Language menu press a number key 1 through 7 to select a desired language 1 English 2 Chinese 3 German 4 French 5 Russian 6 Spanish and 7 Italian After selecting a language press the key and the selected language will be applied to the system Language Set ENGLISH ...

Page 28: ...rdioCare2000 Operation Manual Chapter 2 Preparation for ECGs recording 1 Electrode positions 2 Electrode Connection Check before connection Connecting the Electrodes Connecting the patient cable Lead off troubleshooting ...

Page 29: ...lectrode positions To record the 12 standard leads ECGs I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 connect the electrodes to the patient as follows Electrode positions for limb leads are as follows N RL Right leg F LL Left leg R RA Right arm L LA Left arm ...

Page 30: ...rovided from Bionet Co Ltd Otherwise Bionet Co Ltd takes no responsibility for accidents Lead Off troubleshooting If lead connection status is O K READY indicator lamp lights up when power switch is turned on If indicator lamp still does not light up after 10 seconds it indicates lead off status You can detect which one of leads is in lead off status from operating MONITOR mode output Lead off sta...

Page 31: ...ral Information Signal Level Setting Signal Display Setting Filter Setting Channel Form Setting Rhythm Lead Setting Grid Setting Monitoring Form Setting Monitoring Channel Setting Diagnosis on off setting Enter patient data 3 Monitor Mode Output Output Method Output Form 4 Record Mode Output 5 Copy Mode Output ...

Page 32: ...l take necessary steps according to Lead off troubleshooting of Chapter 2 6 Press COPY key to print the same report as previously printed one Press key to exit during printing or recording of ECGs For a convenient operation memorize the short keys described below MONITOR Displays real time ECGs from the patient continuously or monitoring the patient ECGs for long time RECORD Records ECGs for 10 se...

Page 33: ... mV 10mm mV 20mm mV and aut Auto gain control which sets I II III aVR aVL aVF to 10mm mV V1 V2 V3 V4 V5 V6 to 5mm mV As for 5mm mV it indicates that the amplitude of 1mV pulse is amplified into 5mm To change the signal level press SENS key to select the required one SENS key toggles between 5 10 20 aut that are displayed on the LCD The selected setting is shown on the bottom line of the output rep...

Page 34: ...ignal is induced from muscle and internal organs of the patient For clear ECG signal output it is necessary to eliminate EMG signal interference EMG filter can be set by pressing MUSC key MUSC key switches on or off On or off indicates EMG filter is applied or not The selected setting is shown on the bottom line of the output form indicated by Cut off EMG Low pass filter can be selected to optimiz...

Page 35: ...or 10 seconds in lower part of the output form As for 12ch rhy 12 channel rhythms are simultaneously and continuously recorded in the order of I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 As for 60s 1rhy 1 channel rhythm is recorded with 6 lines 10 seconds to every line for 60 seconds To set the channel form press FORM key FORM key toggles between 3ch 1rhy 6ch 1rhy 12ch rhy 60s 1rhy that are displayed o...

Page 36: ...e of using standard ECG recording paper supplied from Bionet Co Ltd instead of using fax sheet grid setting should be off because grid is already marked on recording paper To set the grid moves the menu to GRID as following steps key switches on or off If set to on grid is recorded on the recording paper If set to off grid is not recorded on the recording paper PAT FLT PRN SYS PRiNter setup SENS S...

Page 37: ... monitoring form moves the menu to MONI as following steps key switches continue or A4 report If set to continue the lead will be printed out continuously until you press the key on the control panel If set to A4 report print out the 10 second data in the form of A4 paper PAT FLT PRN SYS PRiNter setup FORM LEAD MONI CONTINUE ...

Page 38: ...toring channel moves the menu to M CH as following steps key switches 3 6 and 12 If set to 3 print 3 channels at the same time I III aVR aVF V1 V3 V4 V6 If you want to change the channel press the on the control panel If set to 6 print 6 channels at the same time I aVF V1 V6 If you want to change the channel press the on the control panel If set to 12 print 12 channels at the same time I V6 PAT FL...

Page 39: ...se the result of diagnosis is printed out or not on the report To set the diagnosis moves the menu to DIAG as following steps key switches on or off If you set up ON the result of diagnosis is printed out and if you set up OFF the result of diagnosis is not printed out on the report PAT FLT PRN SYS PRiNter setup M CH DIAG On ...

Page 40: ...atient data First move the menu to patient data menu by pressing PAT key Second move the menu to ID as following steps When there are previous patient data following window appears on the LCD whether to change data of the previously recorded one or to select new patient Select ID PAT FLT PRN SYS PATient info ID NAME AGE New Patient yes no ID NAME AGE Enter ID Select Yes Select No ...

Page 41: ... to ENTER ID for new patient data entry Previous patient data are displayed on the LCD as follows with selecting no Select No Select ID To enter patient ID move the menu to ENTER ID as following steps Select ID New Patient yes no ID NAME AGE 12345678 Enter ID 12345678_ PAT FLT PRN SYS PATient info ID NAME AGE Enter ID 12345678_ ...

Page 42: ...ent name move the menu to ENTER NAME as following steps Select PAT Select Name Patient name can be entered in up to 16 characters To enter the name select the required character in the current cursor position As for 1ABC key the key toggles in the order of A B C 1 A whenever pressing that key So if you want to enter B character press key to input B after pressing the 1ABC key two times in the curr...

Page 43: ...ct Age Age can be entered in up to 3 figures Age is entered by the unit of year Age is entered with pressing 0 9 numeric key in the current cursor position and cursor automatically moves to the right To exit Age press key or ESC key that moves to the menu above PAT FLT PRN SYS PATient info ID NAME AGE Enter Age years ...

Page 44: ...t move the menu to ENTER HEIGHT as following step Select PAT Select HEI Height can be entered in up to 3 figures Height is entered by the unit of cm Height is entered with pressing 0 9 numeric key in the current cursor position and cursor automatically moves to the right To exit height press key or ESC key that moves to the menu above PAT FLT PRN SYS PATient info SEX HEI WEI Enter Sex male female ...

Page 45: ...t WEI Weight can be entered in up to 3 figures Weight is entered by the unit of kg Weight is entered with pressing 0 9 numeric key in the current cursor position and cursor automatically moves to the right To exit Weight press key or ESC key that moves to the menu above PAT FLT PRN SYS PATient info SEX HEI WEI Enter Weight _ kg ...

Page 46: ...od Filter setting value is fixed Set the required printing speed and signal level and press MON key Then the system starts printing according to the selected speed with the following message on the LCD Press key or key to stop printing Then system stops printing and displays system setting after indicating following message for 1 second on the LCD Output form In monitor mode output 12 channel rhyt...

Page 47: ...y 12ch rhy Then the system starts recording data for 10 seconds on the memory with the following message indicates recording time on the LCD After recording data for 10 seconds the system starts applying the selected filter and calculating the measurement parameter of the recorded ECGs with the following message on the LCD After data processing the system starts printing with the following message...

Page 48: ...ata for 60 seconds the system starts applying the selected filter and calculates the heart rate of the recorded ECGs with the following message on the LCD After data processing the system starts printing with the following message on the LCD Press key to exit during recording or printing data Then system stops recording or printing and displays system setting after indicating following message for...

Page 49: ...49 61 Ver 2 41 CardioCare2000 Operation Manual Output form The printing forms are described and the example of printing form by each channel form is provided below RHYTHM REPORT FORM ...

Page 50: ...50 61 Ver 2 41 CardioCare2000 Operation Manual RECORD REPORT FORM 3ch 1rhy ...

Page 51: ...51 61 Ver 2 41 CardioCare2000 Operation Manual RECORD REPORT FORM 6ch 1rhy ...

Page 52: ...52 61 Ver 2 41 CardioCare2000 Operation Manual RECORD REPORT FORM 12ch rhy ...

Page 53: ...53 61 Ver 2 41 CardioCare2000 Operation Manual RECORD REPORT FORM 60s 1rhy Output form These are the explanation of the output form and examples according to each channel form ...

Page 54: ...rinting system displays system setting after indicating following message for 1 second on the LCD If filter setting is changed to the previously recorded ECG data the system starts applying changed filter with the following message on the LCD After filter processing the system starts printing with the following message on the LCD After printing is finished the system displays system setting after ...

Page 55: ...re attached to the patient to prevent them from contacting conductive parts or earth Warning Use the provided ECG patient cable for measuring ECG in the operating room Patient cable cannot be used for measuring respiration Caution Do not use EKG3000 in combination with any Electro Surgical ES equipment Caution Users must use same type of electrode or any other biocompatibility certified ones that ...

Page 56: ...56 61 Ver 2 41 CardioCare2000 Operation Manual Chapter 4 System control 1 Maintenance and Cleaning 2 Regular Inspection 3 Troubleshooting ...

Page 57: ...warm water 40 C 104 F Wipe with absorbent cotton soaked with clinical alcohol once a month Do not under any circumstance immerse the equipment and ECG cable into cleaning liquids or detergents Do not insert any kind of liquids into the equipment and ECG cable Disposal of your old appliance 1 When this crossed out wheeled bin symbol is attached to a product it means the product is covered by the Eu...

Page 58: ...perate again after closing firmly 3 In case that buzzer alarms three times in series when system is on battery power following message appears on the LCD This indicates that the battery is almost discharged Turn the system power off and connect the ac power source Then turn the system power on again 4 In case that ECGs is interfered with power noise First move the menu to FLT AC and check if AC is...

Page 59: ... char LCD Display Registration Resolution Vertical 8 points mm Horizontal 25 m at 25 mm S Paper type Thermal roll paper Paper width A4 210 mm or 8 5 Length A4 300 mm or 11 Keyboard Membrane keyboard Electrical Power supply AC or built in Battery option Voltage rating 100 240Vac 50 60 Hz Environment Operating Temperature 15 C to 30 C 59 F to 86 F Storage Temperature 10 C to 60 C 14 F to 140 F Opera...

Page 60: ...purchase Two years in Europe Date of purchase Customer Hospital Address Name Tel Sales Agency Manufacturer Thank you for purchasing CardioCare 2000 This product is manufactured and passed through strict quality control and thorough inspection Compensation standard concerning repair replacement refund of the product complies with Consumer s protection law noticed by Economic Planning Dept ...

Page 61: ...bionet com U S A sales service representative Bionet America Inc 2691 Dow Ave Suite B Tustin CA 92780 U S A Toll Free 1 877 924 6638 FAX 1 714 734 1761 e mail support bionetus com Website www bionetus com European sales service representative MGB Endoskopische Geräte GmbH Berlin Schwarzschildstraße 6 D 12489 Berlin Germany Tel 49 0 306392 7000 Fax 49 0 306392 7011 e mail sales mgb berlin de Websit...

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