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The electrical installation of the relevant room complies with national standards, and

The instrument is used in accordance with the instructions for use.

Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

WARNING

label advises against certain actions or situations that could result in personal

injury or death.

CAUTION

label advises against actions or situations that could damage equipment, produce

inaccurate data, or invalidate a procedure.

NOTE

provides useful information regarding a function or a procedure.

Содержание SE-3 Series

Страница 1: ...Document Name SE 3 SE 300 _ Number 01 54 020055 Version 2 6 Product Model SE 300A SE 300B SE 3 Project Code 2083C000 Signature Originator xiaolijun 2017 10 24 11 14 10 Reviewers lanxiaoyan 2017 10 24...

Страница 2: ......

Страница 3: ...into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual t...

Страница 4: ...de is designed to give key concepts on safety precautions WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label ad...

Страница 5: ...ut the Main Screen 18 3 2 About the System Setup Screen 19 3 3 About the File Manager screen 20 Chapter 4 Operation Preparations 21 4 1 Power and Earthing 21 4 2 Loading Replacing Recorder Paper 22 4...

Страница 6: ...Work Mode 45 8 2 Filter Lead 46 8 3 Record Info Setup 48 8 3 1 Setup 1 48 8 3 2 Setup 2 50 8 4 Patient Information Setup 53 8 5 Transmission Setup 54 8 6 File Setup 55 8 7 Date Sound Setup 56 8 8 Othe...

Страница 7: ...1 Technical Specifications 74 A1 1 Safety Specifications 74 A1 2 Environment Specifications 75 A1 3 Physical Specifications 75 A1 4 Power Supply Specifications 75 A1 5 Performance Specifications 76 A...

Страница 8: ...G with measurements and interpretive statements is offered to clinicians on an advisory basis only WARNING 1 This equipment is not designed for intracardiac use or direct cardiac application 2 This eq...

Страница 9: ...e clause 36 202 101 in the IEC60601 2 25 7 Electrodes of dissimilar metals should not be used it may cause a high polarization voltage 8 EXPLOSION HAZARD Do not use the electrocardiograph in the prese...

Страница 10: ...defibrillator 20 Do not touch accessible parts of electrical equipment and the patient simultaneously 21 In order to avoid being burned please keep the electrodes far away from the radio knife while u...

Страница 11: ...any accessory such as external printer or other device such as the computer to this electrocardiograph makes a medical system In that case additional safety measures should be taken during installatio...

Страница 12: ...ns plug is used as isolation means from supply mains Position the electrocardiograph in a location where the operator can easily access the disconnection device 39 The medical electrical equipment nee...

Страница 13: ...dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispose of them together with house hold garbage At the end of their lives hand the batteries over to...

Страница 14: ...r aging symptom which may impair the safety or the performance 6 Ruptured fuse must only be replaced with that of the same type and rating as the original 1 2 4 Cleaning Disinfection Cautions CAUTION...

Страница 15: ...l Description 1 Output 2 Input 3 DEFIBRILLATION PROOF TYPE CF APPLIED PART 4 Attention consult ACCOMPANYING DOCUMENTS 5 Operating instructions 6 Equipotential grounding 7 Alternating Current 8 ON powe...

Страница 16: ...e of manufacture 18 MANUFACTURER 19 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 20 CE marking 21 Disposal method 22 Caution Federal U S law restricts this device to sale by or on the order of...

Страница 17: ...RHYT OFF RHYT and R R modes can be chosen freely SE 3 SE 300 series can be powered by the mains supply or a built in rechargeable lithium battery Basic type and Net type are optional for each model on...

Страница 18: ...SE 3 SE 300 Series Electrocardiograph User Manual Introduction 11 Figure 2 2 SE 300 series 2 2 Control Panel and Keys Figure 2 3 SE 3 Control Panel and Keys...

Страница 19: ...ery indicator lamp when the device is powered by a built in rechargeable lithium battery the lamp will be lit Battery recharging indicator lamp when the battery is being recharged this lamp will be li...

Страница 20: ...waveform quickly while printing ECG reports WARNING When using the device with a defibrillator after the defibrillator discharges you should press the MODE RST key to reset the waveform quickly NOTE T...

Страница 21: ...On the File Manager screen press these two keys to go to the prev or next page of records 7 PRINT STOP Key Press this key to begin or stop printing ECG reports 8 ON OFF Key SE 3 SE 300 series Press t...

Страница 22: ...nd the USB interface Figure 2 5 SE 300 series The net port optional only for Net type is on the back of the main unit shown in the following figure Only the electrocardiograph with net port can suppor...

Страница 23: ...ly specifications WARNING Only qualified installation or service engineer can shift the mains supply shift switch according to local mains supply specifications 2 Fuse There are two fuses of the same...

Страница 24: ...AUTO RHYT OFF RHYT and R R modes Measurement function and interpretation function are optional System Setup Screen for parameter settings Built in rechargeable lithium battery with large capacity Hin...

Страница 25: ...n Screen On the main screen press the up and down arrows to move the cursor to the items that need to be modified and press the left and right arrows to modify the value Figure 3 1 Main Screen The Mai...

Страница 26: ...O Module Error Overload Lead Name When the leads are off the lead names will be highlighted For details please refer to Chapter 10 Hint Information L 25mm s Speed M 10mm mV Sensitivity N 100Hz Filter...

Страница 27: ...ort and Return buttons and then press the MENU key to conform the operation Press RECALL again to return to the main screen Press the Left or Right arrow to move the cursor to Select button and press...

Страница 28: ...s on the left side of the unit If the mains supply is used connect the power cord to the socket first and then connect the power cord to the hospital grade outlet Operating voltage 100V 115V 220V 240V...

Страница 29: ...refer to the maintenance section for how to recharge the battery When the battery is being recharged SE 3 SE 300 series can be powered by the mains supply at the same time WARNING The potential equali...

Страница 30: ...mainder paper from the roller if necessary 3 Take off the wrapper of the new thermal paper roll and then put the paper roll through the roller 4 Place the paper and the roller gently in the recorder w...

Страница 31: ...tient 4 3 1 Instructing the Patient Before attaching the electrodes greet the patient and explain the procedure Explaining the procedure decreases the patient s anxiety Reassure the patient that the p...

Страница 32: ...ater 3 Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead dry skin cells and oils 4 4 Connecting the Patient Cable to the Electrocardiograph and Elect...

Страница 33: ...trodes to the Patient There are two types of electrode for you to choose one is the reusable electrodes and the other is the disposable electrodes The uses of the two types of electrode are as shown b...

Страница 34: ...Chest 3 C3 White green V3 Brown green Chest 4 C4 White brown V4 Brown blue Chest 5 C5 White black V5 Brown orange Chest 6 C6 White violet V6 Brown violet As the following figure shows the positions o...

Страница 35: ...electrodes in the same way NOTE Long time measurement with a strong negative pressure on the suction bulb may cause reddening of the skin When using the electrode on small children or patients with d...

Страница 36: ...A R Right deltoid LA L Left deltoid RL N or RF Above right ankle Alternate placement upper leg as close to torso as possible LL F Above left ankle Alternate placement upper leg as close to torso as po...

Страница 37: ...istance between the patient and the electrode In order to get a high quality ECG the skin electrode resistance must be minimized when you attach electrodes to patients CAUTION The disposable electrode...

Страница 38: ...t should be used When the battery capacity is low recharge the battery before use 3 Patient Cable Check whether the patient cable is connected to the unit firmly and keep it far away from the power co...

Страница 39: ...upply indicator lamp is lit Then press the ON OFF key on the control panel to turn on the unit Then SE 3 SE 300 series is ready for use When a built in rechargeable lithium battery is used press the O...

Страница 40: ...rent window 5 Press Return or RECALL to return to the main screen 2 Move the cursor to the patient symbol Press the Left or Right arrow to enter the patient information window on the Main Screen 1 Pre...

Страница 41: ...recorder paper before printing the ECG signals of the next lead group Moreover a 1mV calibration mark will be printed at the beginning of ECG reports The switch orders of lead groups are listed in Tab...

Страница 42: ...itivity 3 Set the suitable speed value and filter value 4 Or press the MENU key to open the System Setup Screen to set the detailed settings Press the Return to return to the Main Screen 5 Press the L...

Страница 43: ...R mode which will be displayed in the bottom right corner of the LCD screen 2 Press the SENS key to set the sensitivity 3 Set the suitable speed value and filter value 4 Press the PRINT STOP key to b...

Страница 44: ...of the average integrated ECG vectors RV5 SV1 The maximum of the amplitude of R or R wave of one selected dominant beat from lead V5 The maximum absolute value of the amplitude of S or S wave of one...

Страница 45: ...CG 38 Bottom Information 0 67 100Hz 0 67Hz DFT Filter 100Hz Lowpass Filter AC50 50Hz AC Filter 25mm s Paper Speed 10mm mV Gain 60 Heart Rate Electrocardiograph Model V1 0 Software Version SEMIP V1 7 A...

Страница 46: ...When there is no space for more records to be stored in the File Manager the message MemFull will be displayed 7 1 Transmitting ECG Records to the PC NOTE To transmit ECG records to the PC Smart ECG V...

Страница 47: ...ager screen a 1 Select the TransAll button and then press the MENU key to confirm the operation NOTE Please make sure the settings of Auto Transmission and Transmission Mode in Transmission is correct...

Страница 48: ...of the Smart ECG Viewer software Set the Server IP to the IP of Smart ECG Viewer Set the first three numbers of the Local IP to the first three numbers of the IP of Smart ECG Viewer The last number of...

Страница 49: ...ital letters You should not change the name of records in the ECGDATA folder During the transmission from the U disk to the electrocardiograph if something wrong happens the electrocardiograph will gi...

Страница 50: ...e U disk should not be pulled out 3 Only the U disk with FAT format can be used 7 3 Deleting Patient Records 1 Press the RECALL key to open the File Manager screen a 2 If you want to delete all the re...

Страница 51: ...ed out pressing the 1mV Copy key can print the ECG report which was printed out last time Pressing the PRINT STOP key can stop printing the ECG report NOTE After an ECG report is printed out in the AU...

Страница 52: ...ou can press the lead switch button to switch the lead group In the OFF AUTO or OFF RHYT mode the electrocardiograph samples ECG signal as well as save the patient record but doesn t print ECG report...

Страница 53: ...ilter is used to suppress interference of AC power supply NOTE AC frequency can be set to 50Hz or 60Hz on the Advanced Setup screen according to local mains supply specifications DFT Filter Choose fro...

Страница 54: ...be printed in the ECG reports In the rhythm mode When Rhythm Style is set to Single Lead 60s wave of the rhythm lead selected in the Rhythm Lead1 list box will be printed in the ECG reports When Rhyth...

Страница 55: ...waves of lead V1 V2 V3 V4 V5 and V6 will be printed in 3 groups of 2 When Record Style is set to 1Ch 1R ECG waves of all leads will be printed one by one in a sequence with ECG waves of one rhythm lea...

Страница 56: ...e acquires ECG signals from patients undergoing short term resting test The time range can be 2 5s 5s or 10s Manual REC Style Choose from 3 channels 6 channels and 12 channels the default value is 12...

Страница 57: ...Horizontal Select Horizontal the baselines of the lead groups are adjusted simultaneously and the baselines of the leads in the same row are on the same line Select Auto the baselines of the lead gro...

Страница 58: ...Off the default value is On When it is set to On the Minnesota Code will be printed in the ECG report Device No Choose from On or Off the default value is On When it is set to On the Device No will b...

Страница 59: ...F Report 3 USB printing is ineffective in the auto mode OFF AUTO RHYT mode and OFF RHYT mode 4 Make sure that paper is installed in the USB printer before printing Error may occur if no paper is loade...

Страница 60: ...t the patient ID can be automatically generated according to the time Entering the patient ID manually is not supported ID Hint Choose from On or Off the default value is Off In the auto rhythm mode w...

Страница 61: ...mart ECG Viewer software produced by the manufacturer must be installed in the PC You should log into the Smart ECG Viewer software before transmission 2 To transmit ECG data to the PC in DICOM SCP FD...

Страница 62: ...k For details please refer to Section 7 1 1 Transmitting ECG Data in DAT Format NOTE If WIFI is enabled and Auto Get IP is selected in the WIFI Setup window IP addresses can be acquired automatically...

Страница 63: ...ivate the SCP FDA XML DICOM function on the Advanced Setup screen For details please contact the manufacturer or the local distributor Del After Trans Or Export Choose from On or Off the default value...

Страница 64: ...the electrocardiograph gives a short sound when you press keys on the keyboard Select Off there is no sound QRS Volume Choose from On or Off the default value is On Select On the electrocardiograph g...

Страница 65: ...power off time be effective Institution Input the institution name manually within 40 ASCII characters NOTE The total number of supported characters may be fewer if special Latin characters are entere...

Страница 66: ...equipped in the electrocardiograph through which the electrocardiograph can send rhythm lead signals to the external equipment Choose from Off Standard or Triggered the default value is Off Select St...

Страница 67: ...ilt in battery is used press the ON OFF key directly to turn off the unit When the mains supply is used press the ON OFF key and then press the mains switch on the left side of the unit Pull out the p...

Страница 68: ...ack signs while the paper style is set as Folded on the System Setup Screen BAT WEAK The built in battery is weak Demo The system is in the demonstration mode Sampling Analyzing Recording ECG signals...

Страница 69: ...r out of the paper tray tear the pages with rumples and then put the paper in the paper tray again adjust the position of the paper carefully and close the casing If the above mentioned situation is n...

Страница 70: ...ch means that the ECG is transmitting the data to the PC please wait a few seconds You can start the printing after the data has been transmitted If the problem still exists please contact the manufac...

Страница 71: ...layed the hint Lead Off What should I do A1 The leads are not connected well Please check whether the electrodes are connected to the patient skin well and then make sure that the patient cable socket...

Страница 72: ...nded cleaning agents and disinfectants listed in this manual Others may cause damage not covered by warranty reduce product lifetime or cause safety hazards Always dilute according to the manufacturer...

Страница 73: ...ed with tap water after cleaning until no visible cleaning agent remains 4 Dry the electrocardiograph patient cable and reusable electrodes in a ventilated and cool place CAUTION Any remainder of clea...

Страница 74: ...or at least 30 minutes in a ventilated and cool place 12 4 Care and Maintenance 12 4 1 Recharge and Replacement of Battery 1 Capacity Identification The battery capacity can be identified according to...

Страница 75: ...ea avoiding excessive temperature humidity and sunshine Do not put the recorder paper under fluorescence for a long time Make sure that there is no polyvinyl chloride or other chemicals in the storage...

Страница 76: ...part of the responsible individual hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failures and possible health hazards 1 M...

Страница 77: ...sunshine and excessive temperature After long term use the surfaces of electrodes will be oxidized because of erosion and other causes By this time electrodes should be replaced to achieve high quali...

Страница 78: ...s Table 13 1 Standard Accessories List Accessory Part Number Power cord European 01 13 036638 Power cord American 01 13 037122 Patient Cable European 01 57 107402 01 57 471500 01 57 471613 01 57 47187...

Страница 79: ...et Adapters 01 57 040173 Adult Disposable Adhesive Electrodes 01 57 471056 Pediatric Disposable Adhesive Electrodes 01 57 471057 Disposable Resting electrodes 01 57 471031 Thermal Recorder Paper Folde...

Страница 80: ...EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty is determined to be defective because of defective materia...

Страница 81: ...ectric shock degree Type CF Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof Disinfection sterilization method Refer to the user manual fo...

Страница 82: ...lbs Excluding recorder paper and battery Display 3 5 320 240 LCD Screen black and white screen is for configuration A color screen is for configuration B A1 4 Power Supply Specifications Mains Supply...

Страница 83: ...Paper Speed 5mm s 6 25mm s 10mm s 12 5mm s 25mm s 50mm s 3 Accuracy of data 5 x axis 5 y axis HR Recognition Technique Peak Peak Detection HR Range 30 bpm 300 bpm Accuracy 1 bpm ECG Unit Leads Standa...

Страница 84: ...5Hz 35Hz 45Hz OFF LOWPASS Filter 150Hz 100Hz 75Hz CMRR 110dB 115dB optional with DE12 ECG board Sampling Frequency 1000Hz Pacemaker Detection Optional with DE12 ECG board Amplitude 2mV 700mV Width 0 1...

Страница 85: ...stic and those directly connected to the public low voltage power supply network that supplies building used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker...

Страница 86: ...1000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 7...

Страница 87: ...s 150 kHz to 80 MHz 3 Vrms P d 2 1 Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m P d 2 1 80 MHz to 800 MHz P d 3 2 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transm...

Страница 88: ...rbances are controlled The customer or the user of the electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications...

Страница 89: ...am Electrocardiograph HR Heart Rate aVF Left Foot Augmented Lead aVL Left Arm Augmented Lead aVR Right Arm Augmented Lead LA Left Arm LL Left Leg RA Right Arm RL Right Leg ID Identification AC Alterna...

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