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Electrocardiograph
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1. Sensitivity Auto 2 5 5 10 20 40 mm mvV 5 Input Impedance gt 50M 10Hz Input Circuit Current lt 50nA Input Voltage Range k 5 mVpp ECG Unit karaton voae _ Voltage ImV 2 Depolarization Voltage Voltage 700m V Noise k12 Vp p EMG Filter 25 35 45Hz Filter ADS Filter Yes No Sate t Filter Yes No 50 60Hz CMRR is 2120dB Patient Leakage Current lt 10 A a c Dielectric Strength 4000Vv rm Distributed by DELTAS YSTECH Romania Electrocardiograph portable MODEL T12 Safety Standards Classification Dimensions Net Weight Display IEC 60601 1 1988 A1 1991 A2 1995 GB9706 1 2007 IEC 60601 2 25 1993 A1 1999 GB10793 2000 EN 60601 1 4 1999 EN 60601 2 51 2003 IEC 60601 1 2 2007 YY1139 2000 Anti electric shock type Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Amendment 1 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analyzing single channel and multichannel electrocardiograph Medical electrical equipment Part 1 General requir
2. MODEL 1201G Overview Standard Cabrera 12 Leads 4 3 LCD Color Screen Ste Simultaneously 12 Leads Acquisition ae Manual auto 1CH 2CH 1CH 1R oa disni i isplay NNG 7 Manual auto 1 Channel x Simultaneously Printing without distortion Electrode Disconnection Alarm Diagram Automatic measurement amp analysis 60seconds arrhythmia analysis Security type I type CF System Inputs amp Outputs RS 232 USB2 0 RJ 45 SD Interface Audio Output Interface Standard Package 1203G ECG Machine with battery Patient Cable Chest Electrodes Limb Electrodes Thermal Printing Paper Power Cord GroundingWire User Manual Paper Axis Optional Accessories Series Electrodes Thermal Printing Paper SD Memory Card Lithium Battery Workstation Software Workstation Trolley Laser Inkjet Printer Paper Axis Technique Specification Sampling rate 8000Hz 1ms Frequency Response 0 05 150Hz 3dB Time Constant 2 3 2s CMRR gt 100dB Patient Leakage Current lt 10uA Input Mode floating input Input Circuit lt 504A Noise Level lt uVp p Sensitivity valve 20 uV Polarization Voltage 600mV Calibration Voltage 1mV 2 Continuous Operating AC gt 10h amp DC 2 3h A D shift 20 Input Impedance 50 MQ Sensitivity 1 25 2 5 5 10 20 40 mm mV 2 6levels automatic adjustment Paper Speed 5 6 25 10 12 5 25 50mm s 3 6 levels adjustment RecordingMode Thermal array printe
3. Range Accuracy External Input Output Optional Communication Interface Charge current standard lt 0 3C5A 1320mA Charge voltage standard 16 8 0 1V Cycle life 2500 times 70VA max T2A AC 250V 5x20 Thermal dot matrix printer Rolled or folded thermo sensitive paper Roll thermo sensitive paper 210 216 mm Z fold thermo sensitive paper 210x90 mm Roll thermo sensitive paper 200 206 mm Z fold thermo sensitive paper 200x90 mm 5 mm s 6 25 mm s 10 mm s 12 5 mm s 25mm s 50mm s 3 5 Peak peak detection 30BPM 215BPM 1BPM Input impedance 2100k Sensitivity 1Omm V 5 Output impedances100 Sensitivity 1V mV 5 Input Single ended Output Single ended RS232 serial port USB Leads 12 standard leads lead change manually automatically ECG Unit Patient Leakage Current 10 A a c Dielectric Strength 4000V rms Acquisition Mode 12 lead acquisition simultaneously Input Circuit Floating protection against defibrillator effect A D switch 24 bit Time Constant gt 3 2s Frequency Response 0 05Hz 165Hz Sensitivity Auto 2 5 5 10 20 40 mm mvV 5 Input Impedance gt 50M 10Hz Input Circuit Current lt 50nA Input Voltage Range k 5 mVpp Calibration Voltage ImV 2 Depolarization Voltage 700mV Noise k12 Vp p EMG Filter 25 35 45Hz Filter ADS Filter Yes No HUM Filter Yes No 50 60Hz CMRR gt 120dB Distributed by DELTASYSTECH
4. Romania Electrocardiograph portable MODEL 1112M Safety Standards Classification MDD93 42 EEC IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 2 25 1993 A1 1999 IEC 60601 1 2 2007 EN 60601 1 4 1999 EN 1S014971 2007 YY1139 2000 Anti electric shock type Anti electric shock degree Degree of protection against harmful ingress of water Medical Device Directive Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Amendment 1 Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical devices Application of risk management to medical devices Single and multichannel electrocardiograph Class 1 with internal power supply Type CF with defibrillator protection Ordinary equipment Sealed equipment without liquid proof Degree of safety of application in Equipment not suitable for use in the the presence of flammable gas presence of flammable gas Working Mode EMC Continuous operation Group1 Class B pimensi Net Weight Display Environment Power Supply Recorder HR Recognition Extern
5. 01 1 1988 A1 1991 A2 1995 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 2 25 1993 A1 1999 Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Amendment 1 IEC 60601 1 2 2007 Safety Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests Standards EN 60601 1 4 1999 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems EN 60601 2 51 2003 Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analyzing single channel and multi channel electrocardiograph EN 1S014971 2007 Medical devices Application of risk arrangement to medical devices YY1139 2000 Single and multi channel electrocardiograph Electrocardiograph portable MODEL 1103G Safety Standards Classification Recorder MDD93 42 EEC IEC 60601 1 1988 A1 1991 A2 1995 IEC 60601 2 25 1993 A1 1999 IEC 60601 1 2 2007 EN 60601 1 4 1999 EN 60601 2 51 2003 EN 1S014971 2007 YY1139 2000 Anti electric shock type Anti electric shock degre Degree of protection aga harmful ingress of water Medical Device Di
6. 0Hz Rated input power 90VA Rated output voltage 19V External DC power supply Rated output current 3 5A Rated voltage 14 4V Discharge cut off voltage 11V Working 5 C 40 C 25 85 700hPa 1060hPa Power Supply PN Rated capacity 4400mAh Built in rechargeable Battery Pack Charge mode Constant current voltage Charge current standard lt 0 3C5A 1320mA Charge voltage standard 16 8 0 1V Cycle life 2500 times Power Consumption 70VA max Fuse T2A AC 250V 5x20 Record Mode Thermal dot matrix printer Recording Paper Rolled or folded thermo sensitive paper Roll thermo sensitive paper 210 216 mm papchwigen Z fold thermo sensitive paper 210x90 mm Recorder Effective width Roll thermo sensitive paper 200 206 mm Z fold thermo sensitive paper 200x90 mm Paper Speed 5 mm s 6 25 mm s 10 mm s 12 5 mm s 25mm s 50mm s 3 Accuracy of data 5 Technique Peak peak detection HR Recognition HR Range Accuracy External Input Output Optional Communication Interface 30BPM 215BPM 1BPM Input Single ended Input impedance 2100k Sensitivity 10mm V 5 Output impedance lt 100 Output Single ended RS232 serial port USB Sensitivity 1V mV 5 Leads 12 standard leads lead change manually automatically Acquisition Mode h2 lead acquisition simultaneously Input Circuit Floating protection against defibrillator effect A D switch 24 bit Time Constant 23 25 Frequency Response 0 05Hz 165Hz
7. 25 Particular requirements for the safety of electrocardiographs Amendment 1 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analyzing single channel and multichannel electrocardiograph Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests Single and multichannel electrocardiograph Anti electric shock type Class 1 with internal power supply Anti electric shock degree Type CF with defibrillator protection Degree of protection against Ordinary equipment Sealed equipment harmful ingress of water without liquid proof Degree of safety of application in Equipment not suitable for use in the the presence of flammable gas presence of flammable gas Working Mode Signal Input amp Output EMC Continuous operation With a signal input and output part Group1 Class B 338mmx280mmx85mm About 5kgs T10 10 2 inches 1024x600 multicolor LCD Screen T12 12 1 inches 800x600 multicolor LCD Screen Transport Storage Temperature 20 C 55 C 10 C 40 C Environment 5 Relative Humidity 25 95 25 85 Atmospheric Pressure 700hPa 1060hPa 700hPa 1060hPa Rated voltage 100V 240V AC Power Supply Rated frequency 50 6
8. Electrocardiograph portable MODEL 1206 Overview Standard Cabrera 12 Leads 7 LCD Color Screen Simultaneously 12 Leads Acquisition Manual auto 3CH 3CH 1R 3CH 2R 6CH 6CH 1R display Manual auto 6 Channels Simultaneously Printing without distortion Electrode Disconnection Alarm Diagram Automatic measurement amp analysis 5minutes arrhythmia analysis Security type I type CF Quality Standards ISO9001 15013485 CMD CCC Standard Package 1206 ECG Machine with battery Patient Cable Chest Electrodes Limb Electrodes Thermal Printing Paper Power Cord Grounding Wire User Manual Paper Axis Optional Accessories Series Electrodes Thermal Printing Paper SD Memory Card Lithium Battery Workstation Software Workstation Trolley Laser Inkjet Printer Paper Axis Technique Specification Sampling rate 8000Hz 1ms Frequency Response 0 05 150Hz 3dB Time Constant 2 3 2s CMRR gt 100dB Patient Leakage Current lt 10uA Input Mode floating input Input Circuit lt 504A Noise Level lt uVp p Sensitivity valve 20 uV Polarization Voltage 600mV Calibration Voltage 1mV 2 Continuous Operating AC 10h amp DC 2 3h A D shift 20 Input Impedance 50 MQ Sensitivity 1 25 2 5 5 10 20 40 mm mV 2 6levels automatic adjustment Paper Speed 5 6 25 10 12 5 25 50mm s 3 6 levels adjustment Recording Mode Thermal array printer 8 dot mm Vertical 40 do
9. al Input Output Optional Communication Interface 338mmx280mmx85mm 3 5kgs 7 0 inches 800x480 color LCD Transport Temperature 20 C 55 C Relative Humidity 25 95 Atmospheric Pressure 700hPa 1060hPa Storage 10 C 40 C 25 85 700hPa 1060hPa Rated voltage 100V 240V Mains Supply Rated frequency 50 60Hz Rated input power 75VA External DC Rated output voltage 19V power supply Rated output current 3 5A Rated voltage 14 4V Discharge cut off voltage2 11V Rated capacity 4400mAh Built in rechargeable Battery Pack Working 5 C 40 C 25 85 700hPa 1060hPa Charge mode Constant current voltage Charge current standard lt 0 3C5A 1320mA Charge voltage standard 16 8 0 1V Cycle life gt 500 times Fuse T2A AC 250V 5x20 Record Mode Thermal dot matrix printer Recording Paper Rolled or folded thermo sensitive paper Paper Width Rolled paper 210 216 mm folded paper 210mmx90mm Effective width Rolled paper 200 206mm folded paper 200mmx90mm Paper Speed 5 mm s 6 25 mm s 10mm s 12 5 mm s 25mm s 50mm s 3 Technique Peak peak detection HR Range 30BPM 215BPM Accuracy 1BPM Output Single ended Input Single ended RS232 serial port USB Input impedance 2100k Sensitivity 1Omm V 5 Output impedancesi100 Sensitivity 1V mV 5 Leads ECG Unit 12 standard leads lead change manually automatically Acquisition Mode Input Circuit 12 lead acquisiti
10. ements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests Single and multichannel electrocardiograph Class 1 with internal power supply Anti electric shock degree Type CF with defibrillator protection Degree of protection against Ordinary equipment Sealed equipment harmful ingress of water without liquid proof Degree of safety of application in Equipment not suitable for use in the the presence of flammable gas presence of flammable gas Working Mode Signal Input amp Output EMC 338mmx280mmx85mm About 5kgs Continuous operation With a signal input and output part Group1 Class B T10 10 2 inches 1024x600 multicolor LCD Screen T12 12 1 inches 800x600 multicolor LCD Screen Temperature Environment Relative Humidity Transport Storage Working 20 C 55 C 10 C 40 C 5 C 40 C 25 95 25 85 25 85 Atmospheric Pressure 700hPa 1060hPa 700hPa 1060hPa 700hPa 1060hPa AC Power Supply Rated voltage 100V 240V Rated frequency 50 60Hz Rated input power 90VA Rated output voltage 19V External DC power supply Power Supply Rated output current 3 5A Rated voltage 14 4V Discharge cut off voltage2 11V Rated capacity 4400mAh Built in rechargeable Battery Pack Charge mode Constant current voltage Power Consumption Fuse Record Mode Recording Paper Paper Width Recorder Effective width Paper Speed Accuracy of data Technique HR Recognition HR
11. ional Communication Interface ECG Unit Output Single ended Leads Acquisition Mode Input Circuit A D switch Time Constant Frequency Response Sensitivity Input Impedance Input Circuit Current Input Voltage Range Calibration Voltage Depolarization Voltage Noise Filter CMRR Patient Leakage Current Dielectric Strength Distributed by DELTAS YSTECH Romania 6 25 12 5 25 50mm s 3 5 X axis 5 Y axis Peak peak detection 30BPM 215BPM 1BPM Input impedance 2100k Sensitivity 10mm V 5 Output impedancesi100 Sensitivity 1V mV 5 RS232 serial port USB 12 standard leads lead change manually automatically 12 lead acquisition simultaneously Floating protection against defibrillator effect 12 bit 23 25 0 05Hz 165Hz Auto 2 5 5 10 20 40 mm mvV 5 gt 50M 10Hz lt 50nA lt 5 mVpp ImV 2 500m V lt 13 Vp p EMG Filter 25 45Hz ADS Filter Yes No HUM Filter Yes No gt 100dB lt 10 A a c 4000V rms Electrocardiograph portable Safety Standards Classification Dimensions Net Weight Display IEC 60601 1 1988 A1 1991 A2 1995 GB9706 1 2007 IEC 60601 2 25 1993 A1 1999 GB10793 2000 EN 60601 1 4 1999 EN 60601 2 51 2003 IEC 60601 1 2 2007 YY1139 2000 MODEL T10 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 2
12. mV Calibration Voltage ImV 2 Continuous Operating AC gt 10h amp DC gt 3h A D shift 20 Input Impedance 50 MQ Sensitivity 1 25 2 5 5 10 20 40 auto mm mV 2 6levels automatic adjustment Paper Speed 5 6 25 10 12 5 25 50mm s 3 6 levels adjustment RecordingMode Thermal array printer 8 dot mm Vertical 40 dot mm Horizontal 25mm s Paper Size 210mmx20m or 216mmx20m thermal roll paper Filter AC 50 60Hz 20dB EMG 25 35Hz 3dB Drift 0 15Hz 0 5Hz High Frequency 70Hz 100Hz 150Hz Distributed by DELTAS YSTECH Romania Electrocardiograph portable MODEL 1201 Features Simultaneous acquisition of 12 lead ECG data 12 leads waveform display and print by segment Mey 4 3 inch LCD screen PA Manual Auto 1CH 2CH 1CH 1R printing 60 Sec arrhythmia waveform Analysis 295 2 Ft 100 ECG data storage SD card support Alarm of electrodes breaking off body diagram indicate the unconnected lead area V1 V3 V5 chest lead examination mode easy operation It can record one case ECG data in 9 seconds It is very useful for the large scale Examination Voice prompts allowing the operator with intuitive more reliable Standard configurations Main machine 1 unit Patient cable 1 unit Limb electrode Adult 1set 4pcs Chest electrode Adult 1set 6pcs Power cable 1unit Distributed by DELTAS YSTECH Romania Electrocardiograph portable
13. ollateral standard Electromagnetic compatibility Requirements and tests Standards EN 60601 1 4 1999 Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems EN 60601 2 51 2003 Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analyzing single channel and multi channel electrocardiograph EN 1S014971 2007 Medical devices Application of risk arrangement to medical devices YY1139 2000 Single and multi channel electrocardiograph Distributed by DELTAS YSTECH Romania Electrocardiograph portable Features Leads 12 standard leads lead chan A D switch 12 bit Time Constant 23 2s Input Impedance 250M 10Hz Input Circuit Current lt 50nA Input Voltage Range 5 mVpp Calibration Voltage 1mV 2 Depolarization Voltage 500m V Noise lt 15 Vp p Filter EMG Filter 25 45Hz ADS Filter Yes No HUM Filter Yes No CMRR 2100dB Patient Leakage Current lt 10 A a c Dielectric Strength 4000V rms MODEL 1106L with RS232 Interface ge manually automatically Acquisition Mode 12 lead acquisition simultaneously Input Circuit Floating protection against defibrillator effect Frequency Response 0 05Hz 165Hz Sensitivity Auto 2 5 5 10 20 40 mm mV 5 MDD93 42 EEC Medical Device Directive IEC 606
14. on simultaneously Floating protection against defibrillator effect A D switch Time Constant Frequency Response 12 bit 23 25 0 05Hz 165Hz Sensitivity Input Impedance Auto 2 5 5 10 20 40 mm mvV 5 gt 50M 10Hz Input Circuit Current Input Voltage Range Calibration Voltage lt 50nA 5 mVpp ImV 2 Depolarization Voltage Noise 700m V lt 15 Vp p EMG Filter 25 35Hz Patient Leakage Current Filter ADS Filter Yes No HUM Filter Yes No CMRR gt 100dB lt 10 A a c 4000V rms Dielectric Strength Distributed by DELTAS YSTECH Romania
15. r 8 dot mm Vertical 40 dot mm Horizontal 25mm s Paper Size 5 0mmx20m thermal roll paper Filter AC 50 60Hz 20dB EMG 25 35Hz 3dB Drift 0 15Hz 0 5Hz High Frequency 70Hz 100Hz 150Hz Quality Standards ISO9001 15013485 CMD CCC Distributed by DELTASYSTECH Romania Electrocardiograph portable MODEL 1103L Features A D switch 12 bit Time Constant 23 2s Input Impedance 250M 10Hz Input Circuit Current lt 50nA Input Voltage Range 5 mVpp Calibration Voltage 1mV 2 Depolarization Voltage 500m V Noise lt 15 Vp p Filter EMG Filter 25 45Hz ADS Filter Yes No HUM Filter Yes No CMRR 2100dB Patient Leakage Current lt 10 A a c Dielectric Strength 4000V rms Leads 12 standard leads lead change manually automatically Acquisition Mode 12 lead acquisition simultaneously Input Circuit Floating protection against defibrillator effect Frequency Response 0 05Hz 165Hz Sensitivity Auto 2 5 5 10 20 40 mm mV 5 MDD93 42 EEC Medical Device Directive IEC 60601 1 1988 A1 1991 A2 1995 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 2 25 1993 A1 1999 Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Amendment 1 IEC 60601 1 2 2007 Safety Medical electrical equipment Part 1 General requirements for safety 2 C
16. rective Medical electrical equipment Part 1 General requirements for basic safety and essential performance Medical electrical equipment Part 2 25 Particular requirements for the safety of electrocardiographs Amendment 1 Medical electrical equipment Part 1 General requirements for safety 2 Collateral standard Electromagnetic compatibility Requirements and tests Medical electrical equipment Part 1 4 General requirements for safety Collateral standard Programmable electrical medical systems Medical electrical equipment Part 2 51 Particular requirements for safety including essential performance of recording and analyzing single channel and multi channel electrocardiograph Medical devices Application of risk management to medical devices Single and multi channel electrocardiograph Class 1 with internal power supply e Type CF with defibrillator protection inst Ordinary equipment Sealed equipment without liquid proof Degree of safety of application in Equipment not suitable for use in the the presence of flammab Working Mode EMC Record Mode Recording Paper Paper Width Recording Width le gas presence of flammable gas Continuous operation Group1 Class B Thermal dot matrix printer Rolled or folded thermo sensitive paper 210 216mm 200 206mm HR Recognition Paper Speed Accuracy of data Technique HR Range Accuracy Input Single ended External Input Output Opt
17. t mm Horizontal 25mm s Paper Size 112mmx20m thermal roll paper Filter AC 50 60Hz 20dB EMG 25 35Hz 3dB Drift 0 15Hz 0 5Hz High Frequency 70Hz 100Hz 150Hz Distributed by DELTAS YSTECH Romania Electrocardiograph portable MODEL 1212 Overview Standard Cabrera 12 Leads 9 LCD Color Touch Screen Simultaneously 12 Leads Acquisition Manual auto 3CH 3R 6CH 6CH 1R 12CH 12CH 1R display Manual auto 12 Channels Simultaneously Printing without distortion Electrode Disconnection Alarm Diagram Automatic measurement amp analysis Iminute 5minutes arrhythmia analysis Security type I type CF Quality Standards ISO9001 15013485 CMD CCC System Inputs amp Outputs RS 232 USB2 0 RJ 45 SD Interface Audio Output Interface Standard Package 1212 ECG Machine with battery Patient Cable Chest Electrodes Limb Electrodes Thermal Printing Paper Power Cord Grounding Wire User Manual Paper Axis Optional Accessories Series Electrodes Thermal Printing Paper SD Memory Card Lithium Battery Workstation Software Workstation Trolley Laser Inkjet Printer Paper Axis Technique Specification Sampling rate 8000Hz 1ms Frequency Response 0 05 150Hz 3dB Time Constant 2 3 2s CMRR gt 100dB Patient Leakage Current lt 10uA Input Mode floating input Input Circuit lt 50A Noise Level lt uVp p Sensitivity valve 20 uV Polarization Voltage 600
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