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Cadence Fetal Monitor User Manual

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Appendix 1 Product Specifications

A1.1 Monitor

Physical
Characteristics

Dimensions: 330mm x270mm x100mm

Weight: 3.5 kg or so

Safety

Comply with: IEC/EN 60601-1, IEC/EN 60601-1-2

Anti-electric Shock Type: Class I equipment without internal power

supply

Anti-electric Shock Degree:

FHR1, FHR2, TOCO, MARK, FS B

IUP BF

DECG CF

Degree of Protection against Harmful Ingress of Water: Non-protected

Degree of Safety in Presence of Flammable Gases: Equipment not
suitable for use in presence of flammable gases

Disinfection/Sterilizing Method: Refer to this user manual for details

EMC: Group I Class A

Working System: Continuous running equipment

Power Supply

Working Voltage: a.c.100V-240V

Line Frequency: 50/60Hz

Pmax = 60VA

Fuse: T1.6AL 250V

Environment

Transport and Storage

Temperature: -10

C~55

Relative Humidity:

≤

93%

Atmospheric Pressure: 700hPa-1060hPa

Working

Temperature: 5

C~40

Relative Humidity:

≤

80%

Atmospheric Pressure: 860hPa-1060hPa

Содержание CADENCE

Страница 1: ...EDAN INSTRUMENTS INC Manual Ver 1 6 Release Date Aug 2008 Part No MS1R 02284 V1 6 CADEN CE...

Страница 2: ...rformance or use of this material This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of this company nor the right...

Страница 3: ...ive 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 advises against actio...

Страница 4: ...tting Started 18 4 1 Open the Package and Check 18 4 2 Connect the Power Cable 18 4 3 Connect with Network 18 4 4 Connect with PC 18 4 5 Connect with Wireless Network Module 18 4 6 Feeding Paper and R...

Страница 5: ...ting 40 A3 1 No Display 40 A3 2 Noise 40 A3 3 Recorder Error 40 A3 4 Ultrasound Monitoring of FHR 41 A3 5 Fetal ECG Electrode Monitoring of FHR 41 A3 6 Monitoring Contractions External 42 A3 7 Monitor...

Страница 6: ...thorized personnel Identical replacement parts must be used Z Perform periodic safety testing to insure proper patient safety This should include leakage current measurement and insulation testing The...

Страница 7: ...nitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur WARNING SHOCK HAZARD the power receptacle must be a three wire grounded outlet A hospital gra...

Страница 8: ...1 If in doubt consult our technical service department or your local distributor CAUTION Federal U S law restricts this device to sale by or on the order of a physician CAUTION The device is designed...

Страница 9: ...ry B IUP input socket for connection with intrauterine pressure connector Protection Category BF Socket for Channel 2 Ultrasound Transducer for connection with ultrasound transducer Protection Categor...

Страница 10: ...nsisting of two parts see below It indicates that the equipment should be sent to the special agencies according to local regulation for separate collection after its useful life It indicates that the...

Страница 11: ...ontractions TOCO transducer with a recorder CADENCE Fetal Monitor is a complete monitoring system for use during the management of labor IUP and DECG as options It provides accurate and reliable monit...

Страница 12: ...DENCE Fetal Monitor See the following table for details Accessory Spare Part Manufacturer and Part Number Ultrasound Transducer EDAN MS3 01913 TOCO Transducer EDAN MS3 01916 Remote Marker EDAN MS3 107...

Страница 13: ...ons on the front panel of the monitor The diagram is shown as Figure 3 2 and their primary functions are as follows Figure 3 2 Push buttons LED Display Model Indicators Recorder Remote Marker Ultrasou...

Страница 14: ...tton to enter setup mode the first showing is as follows Figure 3 3 Parameter setup display Then press to adjust the value up or down The parameters and the adjustable ranges are given in the followin...

Страница 15: ...larm over the time of alarm delay alarm signal will be given out Parameter Meaning Adjustable Value 12 AFM Gain 1 4 adjustable The default is 3 and the interval is 1 13 AFM Threshold 0 100 adjustable...

Страница 16: ...ay reset after outputting the last row 4 AUTO ZERO Button Function 1 Adjust the external TOCO contractions trace value to reference point 10 external monitoring contractions or adjust the IUP trace va...

Страница 17: ...t event he she may press this button to mark At the moment the symbol will be printed on the record paper 7 BEEP Button Optional DOWN BEEP Button Function Enable Disable DECG sound 3 1 2 Indicators Fi...

Страница 18: ...FHR2 DECG printing trace offset 20bpm 0bpm or 20bpm which means that FHR2 DECG trace is 20bpm lower than its actual position or actual position or 20bpm higher than its actual position so 20bpm should...

Страница 19: ...ard record paper Figure 3 6 An example of printing pattern international standard record paper Indicates the alarm status information of monitoring Indicates the fetal movement event marked by the pat...

Страница 20: ...tage is a c 100V 240V Alternating current 3 2 Transducers and Cables The ultrasound transducer s and TOCO transducer IUP cable connector DECG cable connector and remote marker are attached to the fron...

Страница 21: ...is transducer is a tocotonometer whose central section is depressed by the forward displacement of the abdominal muscles during a contraction It is used for assessment of frequency and duration of ute...

Страница 22: ...hand held switch operated by patient shown here The mother is normally instructed to push down this switch when feeling fetal movement The remote marker will add an event mark to the record paper Figu...

Страница 23: ...nd of the power cable to a grounded 3 phase power output special for hospital usage Z Connect to the ground wire if necessary 4 3 Connect with Network If the network has been ready insert the network...

Страница 24: ...Notes 1 When feeding paper the black handle must be down If jam happens pull up the handle first and push the gear to force the paper out Then feed the paper again 2 The paper going out from the notc...

Страница 25: ...e numeral LED will flash in red color and green color to test it At the same time the system will print a test baseline About ten seconds or so the system will enter monitoring screen after self test...

Страница 26: ...using palpation or a fetoscope Place the ultrasound transducer on the abdomen over fetal site and move it slowly until the characteristic hoof beat sound of the fetal heart is heard The elasticity of...

Страница 27: ...e maternal pulse by feeling the mother s pulse during the examination 5 2 Fetal ECG Electrode Monitoring of FHR Contraindications The fetal spiral electrode can be used when amniotic membranes adequat...

Страница 28: ...CG socket at the monitor 7 Check setup of DECG arrhythmia logic The transient heart rate change that equals to or is greater than 25bpm is not recorded when enabling the DECG arrhythmia logic The reco...

Страница 29: ...s Turn the drive tube by rotating the drive handle clockwise until gentle resistance is encountered Resistance to further rotation and recoil of the drive handle indicates attachment This will usually...

Страница 30: ...s fundus and the umbilicus see Figure 5 1 for the positioning of the external TOCO The uterine activity reading at this point should be greater than 30 units and less than 90 units If the reading fall...

Страница 31: ...atheter into the intra amniotic cavity until the 45cm mark is at the introitus If the 45cm mark is not clearly visible stop advancing when the symbol on the catheter meets the introducer NOTE For easi...

Страница 32: ...ptured and sufficient cervical dilatation assured Z Try to insert the catheter opposite the placental site Do not insert the introducer beyond the cervical OS Use with caution when uterine infection i...

Страница 33: ...ll flash for five seconds During this time zero the monitor by pressing the AUTO key Make sure the display value and trace are both 0 6 Ask the mother to cough A spike on the trace in response to the...

Страница 34: ...red the mother takes the remote maker in her hand She operates the hand held remote marker press switch when sensing fetal movement At the moment the symbol of fetal movement will be printed on the re...

Страница 35: ...G Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and p...

Страница 36: ...and clean cloth 2 EDAN has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details...

Страница 37: ...oap or USP green soap tincture After cleaning the cables they should be wiped with water using a clean damp cloth and then with a clean dry cloth Do not autoclave Ethylene Oxide EtO or stem sterilize...

Страница 38: ...t use sterilant with iodide Many cleansers must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor Do not use EtO gas or formaldehyde to disinfect the m...

Страница 39: ...st Harmful Ingress of Water Non protected Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Disinfection Sterilizing Method Refer to this us...

Страница 40: ...cm min 2cm min and 3cm min optional FHR DECG Printout Width 7cm USA standard 8cm international standard FHR DECG Scaling 30bpm cm USA standard 20bpm cm international standard TOCO IUP Printout Width 3...

Страница 41: ...applied to transducer Patient Leakage Current 10uArms 220V 50Hz Patient Auxiliary Current 0 1uA dc Dielectric Strength 4000Vrms Calibration Signal Input 1mv Contraction Internal IUP Pressure Range IUP...

Страница 42: ...of alarm delay the monitor will give out audio and LED flashing alarm signal A1 2 Transducers and Cables Ultrasound Transducer System Pulsed Doppler Weight 160g Cable Length 2 5m Dimension 90mm 65mm...

Страница 43: ...rt monitoring Acoustic Output MI ISPTA 3 mW cm 2 ISPPA 3 W cm 2 Global Maximum Value 6 6623E 02 2 6642E 01 2 3909E 01 Pr 3 Mpa 9 4220E 02 W0 mW 6 972 6 972 fc MHz 2 000 2 000 2 000 Zsp mm 30 23 30 23...

Страница 44: ...gnal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt c...

Страница 45: ...se Interfered by handset or other interfering source Keep the handset or other interfering source far away A3 3 Recorder Error Symptom Possible Cause Solution Paper jam Wrong feeding paper or paper is...

Страница 46: ...indicator is green Signal indicator is orange continuously FHR is less than 50bpm No Record maternal heart rate wrongly Change the position of ultrasound transducer Doubtful FHR The ultrasound transd...

Страница 47: ...ar higher than the averaged value Insure favorable contact for patient skin with TOCO transducer Change the position of TOCO transducer if necessary A3 7 Monitoring Contractions Internal Symptom Possi...

Страница 48: ...nt Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Cadence Fetal Monitor uses RF energy only for its internal function Therefore its RF emissions are ve...

Страница 49: ...differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Power frequency 50Hz 60Hz magnetic field...

Страница 50: ...rms 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the Cadence Fetal Monitor including cables than the recommended separation distance calculated from th...

Страница 51: ...ast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the m...

Страница 52: ...nt Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P V d 1 5 3 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 5 GHz P E d 1 7 0 01...

Страница 53: ...hai Rd 1019 Shekou Nanshan Shenzhen 518067 P R CHINA TEL 86 755 26882220 FAX 86 755 26882223 EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany T...

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