Manual - Cardiac Direct
Contents
1. 0 2 11 8 axe BL remem en Ree oe aS RE tet T Teo RS Ae rea a er 6 Z2 General 1101 orma OM tasers Sate ahaa tite and act eae bale NA cede ee Gee ee 6 De DT US T E sete EN EA emcees ascent EAEE ners encase Meanie 6 2 4 010611118 normano esaeen a ice sins a inci a eal dauras lace decal aedubdda deans 7 Chapter 3 Monitor and 36666901169 8 SENON O geen neces E os ee NRE Tv Te RTT Me te On Ea OT Re 8 3 111 PU EB UNON 221 22222 a eee oa eee eee een 8 S MCO 0 12 S MASM ECE 6 6 08 ol eee nee re A er nT a UR POR Ni Re Ae E ANE A 13 3 1 4 Sockets on the Right Side of the Monitor ee ecccccceccecceeeeeeseeeeeeeeeaeeeeeees 15 3 2 11201 8011668 and CADIS c cc cs Sesssunsosetshusacontasadeeeeuuadwesiendse she asaguaaaesaceatpunncsaaeenieaisamces 15 3 2 oN MPASOUNG LT TANSGUCEE cae 15 De POCO Tran GUC Cl sate assed cate sesededupaaeteest E weneereesseaenaa ede 16 FRMO E Mae gree eee enter eee me We See ar come re mer nee eae OIE rE Ee 17 oe OM ley ta kopra ECON Od c PevR ET Mena TOey Tere RNe OrE try MORE TCT T are ire een etry einen one e are 17 Chapter 4 G2. 39 Appendix 3 4 100410166110004 40 ASNODA Y canines a A 40 ASZ NOG reanna bladed E E E diva duaxetboniede wanasdxarhams donated 40 VAN Feo RECOrder ENO senate nee mre tena E rene Noe fe ere 40 A34 Ultrasound Monitoring OF FHR aessresciiiiea aa r siiaeldensduiuae 41 A3 5 Fetal ECG Electrode Monitoring of 41 A3 6 Monitoring Contractions External 2 42 A3 7 Monitoring Contractions Internal sesine eae ean 42 Appendix 4 EMC Information Guidance and Manufacture s Declaration 43 A4 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMG 43 A4 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS ee 44 A4 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not BN aed el Bd DN epee reer tte ere pee trait T E nnmry 45 A4 4 Recommended Separation 1216 13066
3. 10 Cadence Fetal Monitor User Manual 3 PRINT Button Function Enable Disable printing Power on the print indicator status is shut off after self test and no printing When pressing the PRINT button the print indicator will be green and the recorder works If print indicator is still off and the recorder gives out alarm audio the printing function can not be executed and the operation is failed The following reasons may cause the failure of printing Z The monitor is still in the process of self test and the test baseline printing has not been finished After the recorder has finished printing test baseline it begins to print by pressing the PRINT button Just press the PRINT button to end the printing the last row output hasn t been completed The ultrasound transducer or DECG cable connector is off Recorder is out of paper NNN N Recorder failure When pressing the PRINT button once more the print indicator will be off and the recorder will stop working at the moment the recorder may reset after outputting the last row Oe 4 AUTO ZERO Button A070 zero Function 1 Adjust the external TOCO contractions trace value to reference point 10 external monitoring contractions or adjust the IUP trace value to reference point O internal monitoring contractions when the system is not in the status of setting 2 Exit from the setting quickly when the system is in the status of setting
4. AFM Mark Cadence Fetal Monitor User Manual Technique Peak peak detection technique FHR Range 50bpm 210bpm international standard 30bpm 240bpm USA standard Artifact Elimination gt 25bpm changes are ignored Resolution bpm Accuracy 1bpm Input Impedance gt 10M differential dc to 50 60Hz Input Impedance gt 20M Common mode CMRR gt 110dB Noise lt 4uVp Skin Voltage Tolerance 500mV Fetal Input Voltage Range 20uVp to 3mVp Earth Leakage Current lt 10uA 264 VAC applied to transducer Patient Leakage Current lt 10uArms 220V S50Hz Patient Auxiliary Current lt 0 luA dc Dielectric Strength 4000 Vrms Calibration Signal Input 1mv Internal IUP Pressure Range IUP OmmHg 100mmHg Sensitivity 5uV V mmHg Non linear Error 1mmHg Resolution 1 Zero Mode Automatic Manual External TOCO TOCO Range 0 100 135g strength corresponding to 100 Sensitivity 3 7uV V mmHg Non linear Error lt 10 Resolution 1 Zero Mode Automatic Manual Earth Leakage Current lt 10 uA 264 VAC applied to transducer Dielectric Strength gt 4000Vrms Technique Pulsed Doppler ultrasound Range 0 100 Resolution 1 Manual fetal movement mark Boe ae Cadence Fetal Monitor User Manual FHR Alarm When FHR FHR1I FHR2 DECG is less than the lower limit or higher than the upper limit of alarm over the time of alarm delay the monitor will give out audio and LED flashing alarm signal
5. Turn the monitor on and verify that the normal monitoring screen appears on the display Check the TOCO transducer to verify proper attachment to the monitor 2 Acquiring Uterine Activity Data Place another belt around the abdomen Attach the buckle of the TOCO transducer to the belt Do not use aquasonic coupling gel Wipe off any gel present on abdomen around this area Fix the transducer The transducer is retained on the midline half way between the mother 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 falls outside this range the belt may be too tight or too loose If the belt is over tightened the contraction peaks may have a flat top at less than 100 on the TOCO scale If the belt 1s under tightened the position of the transducer may wander and cause unusable readings Readyjust the belt pressure as needed 3 Monitor Adjustments Press the AUTO ZERO button to adjust the value to the baseline This should be done during non contraction intervals WARNING amp Under no circumstances are transducers to be used to monitor patients under water Notes 1 Do not use aquasonic coupling gel on the TOCO transducer or transducer contact area 2 Check the function by TOCO transducer and observe the change of relevant value 5 4 2 Monitoring Contractions Internal Parts
6. When in the status of monitoring after pressing the AUTO ZERO button the symbol U lt will be printed at the trace 5 Volume Control Button Group vp DOWN UP EVENT DOWN BEEP Function 1 For dual configuration press one of the two buttons to select fetal heart audio channel press w 0001 to select fetal heart audio coming from channel 1 press urevent vownecee to select fetal heart audio coming from channel 2 the default fetal heart audio is that of channel 1 k fi hn f 2 Press UE DONA UAE vane DOANE dual configuration to adjust the volume of the loudspeaker up or down 0 10 levels adjustable H 3 When in the setup mode press w bown to adjust the value of parameter selected Up press to increase the sound level or the value of parameter selected Down press to decrease the sound level or the value of parameter selected Notes 1 When volume has reached to its limit press up or down a high frequency Di will 11 Cadence Fetal Monitor User Manual be given out 2 Do not press any button continuously otherwise uncertain result will happen 3 Press any button if succeed the speaker will make a sound of Do If failed the speaker makes no sound 4 For single configuration the Volume Control Button Group of Channel 2 does not work 5 For dual configuration when one Volume Control Button Group is pressed the other fetal audio channel will
7. Do not leave exposed to direct sunlight or ultraviolet light Do not exceed a storage temperature of 40 C Do not exceed a relative humidity of 80 Storage conditions outside these limits may distort the paper and adversely affect the accuracy of grid lines or make the trace unreadable Bye ee Cadence Fetal Monitor User Manual Appendix 1 Product Specifications A1 1 Monitor Physical Characteristics Safety Power Supply Environment Dimensions 330mm x270mm x 100mm Weight 3 5 kg or so 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 Working Voltage a c 100V 240V Line Frequency 50 60Hz Pmax 60VA Fuse T1 6AL 250V Transport and Storage Temperature 10 C 55 C Relative Humidity lt 93 Atmospheric Pressure 700hPa 1060hPa Working Temperature 5 C 40 C Relative Humidity lt 80 Atmospheric Pressure 860hPa 1060hPa _34 Display Printing Signal Interface Ultrasound Cadence Fetal Monitor User Manual Three digits bi
8. 1 47 IV Cadence Fetal Monitor User Manual Chapter 1 Safety Guidance 1 1 Instruction for the Safe Operation Z The CADENCE Fetal Monitor is designed to comply with the international safety requirements IEC EN 60601 1 for medical electrical equipment It is class I equipment Z The CADENCE Fetal Monitor operates within specifications at ambient temperatures between 5 C and 40 C Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits Allow at least 2 inches 5cm clearance around the instrument for proper air circulation Z The user must check that the equipment cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use The recommended inspection interval is once per week or less If damage is evident replacement is recommended before use Z The monitor must be serviced only by authorized and qualified personnel EDAN can not accept responsibility for safety compliance reliability and performance if modifications or repairs are carried out by unauthorized 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 recommended testing i
9. 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people _47 INSTRUMENTS EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipments Park Nanhai Rd 1019 Shekou Nanshan Shenzhen 518067 PR CHINA TEL 86 755 26882220 FAX 86 755 26882223 EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn
10. A1 2 Transducers and Cables Ultrasound Transducer System Pulsed Doppler Weight 160g Cable Length 2 5m Dimension 90mm x65mm Latex free TOCO Transducer System Passive straingauge Weight 150g Cable Length 2 5m Dimension 102mm 50mm Latex free Remote Marker Length 2 5m Weight 56g Bs Cadence Fetal Monitor User Manual A1 3 Acoustic Output Reporting Table Acoustic Output Reporting Table for Track 1 Non Autoscanning Mode Transducer Mode Cadence U1 752 U2291 U2318 Operating Mode Pulsed sinusoid 2MHz Application s Fetal heart monitoring Acoustic Output IspTAg Isppag mW em W cm Global Maximum Value 6 6623E 02 2 6642E 01 2 3909E 01 9 4200E 02 o 2 000 2 000 2 000 30 23 30 23 30 23 Associated Beam xeim 4829 4 829 Acoustic di Parameter mensions tom fae 4 813 4 813 TPO 0699 11296002 120 02 een 1200 oa eeen rosa Operatin p g No operator Control ir adjustable controls Conditions _ 38 Cadence Fetal Monitor User Manual Appendix 2 Signal Input Output Connector Accessory equipment connected to these interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Everybody who connects additional equipment to the signal input connector or signal outpu
11. C 64070 D Electromagnetic Interference Ensure that the environment in which the fetal monitor is installed is not subject to any source of strong electromagnetic interference such as radio transmitters mobile telephones etc Cadence Fetal Monitor User Manual O cauTION The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives 1 4 Definitions and Symbols TOCO TUP Socket for Channel 1 Ultrasound Transducer for connection with ultrasound transducer Protection Category B TOCO IUP Socket TOCO input socket for connection with external contractions TOCO transducer Protection Category 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 Category B Socket for DECG Cable for connection with fetal ECG cable Protection Category CF Socket for Remote Marker for connection with the marker Protection Category B EXT 1 Socket for Marking for connection with the fetal stimulator Protection Category B Power Socket Fuse Socket DB9 interface for connection with wireless network module RJ45 Interface Equipotential Grounding System Attention Consult Accompanying Documents e a gt Ar MA 0123 3b P N SHEER g Rx Only Cadence Fetal Monitor User Ma
12. Required 1 Disposable intrauterine pressure catheter ACCU TRACE IUPC IUPC for short 2 Reusable intrauterine pressure connecting cable connecting cable for short 3 Reusable intrauterine pressure cable IUP cable for short 25 Cadence Fetal Monitor User Manual Directions for Use of IUPC Preparation 1 Gather supplies ACCU TRACE IUPC reusable cable and amniounfusion supplies if needed 2 Open the sterile ACCU TRACE IUPC package Insertion NOTE This product is designed for use with the introducer 3 Using aseptic technique remove the catheter from the package 4 Perform vaginal exam to insure ruptured membranes and adequate dilation 5 Advance the catheter tip to the cervical os along the examination hand using the hand as a guide Do not advance the introducer through the cervix 6 Continue to gently advance the catheter tip through the cervical os and feed the catheter 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 easier insertion do not twist the catheter in the introducer 7 The IUPC may spontaneously fill with amniotic fluid This can be seen 10 the clear lumen of the catheter The filter cap will prevent the amniotic fluid from leaking 8 Slide the introducer out of the vagina along the catheter When the introducer is completely out of the
13. WARNINGA The device should be installed by a qualified service engineer WARNING SHOCK HAZARD Do not remove the top panel covers during operation or while power is connected Only authorized service personnel could remove the unit cover WARNING A Only connect the device to EDAN supplied or recommended accessories A WARNINGA Do not switch on device power until all cables have been properly connected and verified WARNING 4 Do not apply this monitor and other ultrasonic equipment simultaneously on the same patient in case of the possible hazard caused by leakage current superposition Cadence Fetal Monitor User Manual A WARNINGA The fetal spiral electrode and intrauterine pressure catheter are disposable and single use only discard after use A WARNINGA The fetal Spiral electrode should be removed from the patient before performing any electrosurgical procedure A WARNINGA The IUPC is neither intended nor approved for measuring intrauterine pressure extraovularly attempting to do so may lead to maternal discomfort or injury A WARNING Don t touch signal input or output connector and the patient simultaneously A WARNINGAS Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the vali
14. colors Green Red numerical LED display FHR FHR1 FHR2 Three digits bi colors Green Red numerical LED display TOCO IUP Three digits bi colors Green Red numerical LED display DECG One printing status LED Green One power status LED Green One audio alarm LED Green Red One Two FHR signal quality indicator LED Green Orange One TOCO IUP signal quality indicator LED Green Orange One DECG signal quality indicator LED Green Orange Record Paper Z fold thermal Printing Width 112mm Effective Printing Width 104mm Paper Advance Speed 1cm 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 4cm USA standard 2 4cm international standard TOCO IUP Scaling 25 0 85cm USA standard 25 0 6cm international standard Data Accuracy 5 X axis 1 Y axis Record Message Date time TOCO type paper speed FHR type bed No etc RS485 RS232 interface Technique Pulsed Doppler and autocorrelation Pulse Repetition Rate 3 2KHz Pulse Duration 114us Nominal Frequency 2 0MHz Ultrasound Frequency 2 0MHz 10 P lt IMPa Ion lt 10mW cm Ispta lt 100mW cm FHR Range 50bpm 210bpm Resolution 1 bpm Accuracy 2bpm Earth Leakage Current lt 10 uA 264 VAC applied to transducer Dielectric Strength gt 4000Vrms 235 DECG Contraction
15. greater thant 25bpm is not recorded when enabling the DECG arrhythmia logic The recording will resume when beat drops within the limits The monitor will display all the recorded fetal heart beats when disconnecting DECG arrhythmia logic If you have doubts about arrhythmia of the fetus disconnect the DECG arrhythmia logic Prepare the Patient s Skin Prior to Placing Electrodes The skin is a poor conductor of electricity therefore preparation of the patient s skin 1s important to facilitate good electrode contact to skin Z Shave hair from sites if necessary Z Wash sites thoroughly with soap and water Never use ether or pure alcohol because this increases skin impedance Z Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease Detach Fetal Spiral Electrode To detach the fetal spiral electrode rotate it counterclockwise until it is free from the fetal presenting part Do not pull the electrode from the fetal skin 64070 D Do not mistake the higher maternal heart rate for fetal heart rate Eo Cadence Fetal Monitor User Manual Notes 1 2 lf the DECG arrhythmia logic is disconnected during monitoring remember to connect it later lf there is any doubt as to the presence of a fetal heart signal with ECG check with the ultrasound transducer on the mother or with a separate diagnostic instrument The presence of an audible Doppler heart sound at a rate distinct from that
16. memory After feeding paper again you can press the PRINT button to continue The current printing data will lose when ultrasound transducer or DECG cable connector falls off or power off 3 1 4 Sockets on the Right Side of the Monitor Figure 3 7 Sockets on the right side of the monitor FUSE T1 6AL Power Socket Fuse Socket a AC 100V 240V Power Switch Power Switch O 1 A C mains On Off switch O Off 1 On Fuse Specification Size 5mm 20mm Model T1 6AL 250V Power Socket Input socket for the A C mains supply Rated A C supply voltage is a c 1OOV 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 front panel of the monitor Each cable has a tab located on the connector housing to insure proper insertion into the appropriate socket on the monitor 3 2 1 Ultrasound Transducer This multi crystal broad beam ultrasound transducer is used for monitoring fetal heart rate FHR The ultrasound transducer operates at a frequency of 2 0MHz Put the ultrasound transducer on maternal abdomen to transmit lower energy ultrasound wave to fetal heart then receive the echo signal from it Figure 3 8 Ultrasound transducer Ses i f p m f an ae jam oer Sane lt j 4 aay Lf Oy BF ULTRASONIC Pe TRANSDUCER 60807 CLEARNWITH Labe
17. of the maternal pulse is unequivocal evidence of fetal life After connection of electrodes a few minutes should be allowed for stabilization of the electrode and fetal tissue It is essential that the ECG signal electrode is in good contact with the fetal presenting part Directions for Use of Fetal Spiral Electrode 1 2 3 4 5 6 T 8 Remove from package leaving the electrode wires locked in the handle notch Gently form the guide tube to the desired angle With the patient in the dorsal lithotomy position perform a vaginal examination and clearly identify the fetal presenting part Holding the drive handle ensure the spiral electrode is retracted approximately one inch 2 5 cm from the distal end of the guide tube Place the guide tube firmly against the identified presenting part Maintain pressure against the fetal presenting part with guide and drive tubes 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 occur after one complete rotation Release the electrode wires from the handle notch and straighten them Slide the drive and guide tubes off the electrode wires Insert the safety cap into fetal ECG cable 5 3 Dual Heart Rate Monitoring Simultaneous monitoring of twins using two ultrasound channels see section 5 1 for the operation or using one ultra
18. than the other external surfaces of the monitor Use dry and soft cloth to wipe A WARNING AS Unplug the monitor from the AC power source and detach all accessories before cleaning Do not immerse the unit in water or allow liquids to enter the casing CAUTION 1 Although the monitor is chemically resistant to most common hospital cleansers and non caustic detergents different cleansers are not recommended and may stain the monitor 2 Many cleansers must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor 30 Cadence Fetal Monitor User Manual 3 Don t use strong solvent for example acetone 4 Never use an abrasive such as steel wool or metal polish 5 Do not allow any liquid to enter the product and do not immerse any part of the monitor into any liquid 6 Avoid pouring liquids on the monitor while cleaning 7 Don t remain any cleaning solution on the surface of the monitor Cleanser The following cleaning solutions are recommended for monitor and accessories Sot Soap Temides Byte Acade 1 Moir Cid Fuwwssound Transducer VY dO frocotiansawer VCO 0000 Remote Marker VY S Intrauterine Pressure Cable V Y O y S Notes 1 The monitor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 2 EDAN has no responsibility for the effectiveness of controlling infectious disease using these chemical ag
19. user must check that the equipment cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use The recommended inspection interval is once per week or less If damage is evident replacement is recommended before use 2 Routine Inspection The equipment should undergo periodic safety testing to insure proper patient isolation from leakage currents This should include leakage current measurement and insulation testing The recommended testing interval is once a year or as specified in the institution s test and inspection protocol 3 Mechanical Inspection Make sure all exposed screws are tight Check the external cables for splits cracks or signs of twisting Replace any cable that shows serious damage Pay particular attention to the supply socket AN WARNING 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 possible health hazards 6 2 Care and Cleaning of Monitor Keep the exterior surface of the monitor clean and free of dust and dirt Regular cleaning of the monitor casing and the screen is strongly recommended Use only non caustic detergents such as soap and water to clean the monitor casing Take extra care when cleaning the display surface These are more sensitive to rough handling scratches and breakage
20. E H S E S S 4 4 ee ee ee ee ee ae es Secs 2 ee Ee eee ies He Ee ta ee Figure 3 6 An example of printing pattern international standard record paper CADENCE MFM 2 CADENCE peer et 0 mmHg M50 78019 a gt 0 mmHg a 1 Indicates the alarm status information of monitoring T Indicates the fetal movement event marked by the patient Indicates the event marked by the physician I lt Indicates the information of TOCO zero 14 Cadence Fetal Monitor User Manual Note When paper is used up the recorder will stop printing and the data of waiting printing will be kept in the
21. EDAN INSTRUMENTS INC C 6 0123 O gt U 111 Z 2 O S m pl a R elease _ Aug 2008 MS1R 022 User Menua Copyright Copyright EDAN INSTRUMENTS INC 2008 All rights reserved Statement Edan Instruments Inc hereinafter called EDAN makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose EDAN assumes no responsibility for any error that may appear in this document or for incidental or consequential damage in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without prior written consent of EDAN All information contained in this publication is believed to be correct EDAN shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance 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 rights of others This company does not assume any liability arising out of any infringements of patents or other rights of third parties The information contained in this document is subject to change without notice Responsibility of the Manufacturer EDAN only considers
22. Mains power quality should be mode that of a typical commercial or 2 kV common mode hospital environment Power frequency magnetic fields should be at levels characteristic of a _ typical location in a typical commercial or hospital environment Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 0 5 cycle for 0 5 cycle Mains power quality should be that of a typical commercial or 40 Ur 40 Ur hospital environment If the user 60 dip in Us 60 dip in U7 of the Cadence Fetal Monitor for 5 cycles for 5 cycles requires continued operation during power mains 70 Ur 70 Ur interruptions it is recommended 30 dip in Us 30 dip in Ur that the Cadence Fetal Monitor for 25 cycles for 25 cycles be powered from an uninterruptible power supply or lt 5 Ut lt 5 Ut a battery gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 NOTE Uz is the a c mains voltage prior to application of the test level _44 Cadence Fetal Monitor User Manual A4 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The Cadence Fetal Monitor is intended for use in the electromagnetic environment specified below The customer or the us
23. ace the arrow symbol on the transducer connector on top when connecting them to the monitor 3 Be gentle when connecting and using transducers to avoid mechanical damage to them 20 Cadence Fetal Monitor User Manual Chapter 5 Monitoring 5 1 Ultrasound Monitoring of FHR Ultrasound monitoring is a method to obtain FHR through maternal abdominal wall Put the FHR transducer on maternal abdomen to transmit lower energy ultrasound wave to fetal heart then receive the echo signal from it Ultrasound monitoring can be used for antepartum monitoring Parts Required 1 Ultrasound transducer 2 Aquasonic coupling gel 3 Belt Operation Procedure 1 Preparing the Monitor Turn the monitor on and verify that the normal monitoring screen appears on the display Check the ultrasound transducer to verify proper attachment to the monitor For twins monitoring make sure the second ultrasound transducer is properly connected Set the current heart rate channel to USI and adjust FHR1 volume well Attach the buckle of the ultrasound transducer to the belt Apply aquasonic coupling gel to the face of the transducer 2 Acquiring the Fetal Heart Signal Determine the location of the fetal heart 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 belt can be adjusted which make the patient mo
24. aning of Fetal ECG Cable The fetal ECG cables must never be immersed soaked or cleaned with harsh chemicals The recommended cleaning method of the cables is a cloth wipe using ordinary alcohol free hand soap 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 the fetal ECG cables 6 4 Cleaning of Recorder The recorder platen thermal print head and paper sensing mechanism must be cleaned at least once a year or when needed when traces become faint To do this 1 Clean the recorder platen with a lint free cloth and soap water solution 2 With the thermal array using a cotton swab moistened with 70 Isopropyl alcohol based solution 3 Check the paper sensing mechanism is free of dust 6 5 Cleaning of Belt Wash soiled belts with soap and water The water temperature must not exceed 60 C 6 6 Sterilization To avoid extended damage to the equipment sterilization is only recommended when stipulated as necessary in the hospital maintenance schedule Sterilization facilities should be cleaned first Use the following table to choose a sterilant 30 Cadence Fetal Monitor User Manual Ultrasound Transducer TOCO Transducer Intrauterine Pressure Cable Fetal ECG Cable YcauTION 1 Follow the manufacturer s instruction to dilute the solution or adopt the lowest pos
25. be mute automatically 6 EVENT Button Optional vrvevent DOWN BEEP UP EVENT Button Function Record event at the trace If the physician wants to make a label for patient event he she may press this button to mark At the moment the symbol 4 will be printed on the record paper 7 BEEP Button Optional vevevent DOWN BEEP DOWN BEEP Button Function Enable Disable DECG sound 3 1 2 Indicators Figure 3 4 Indicators Y a FHR Indicator of Channel 2 DECG Indicator Z GI Yj ATI TOCO IUP Indicator WE SETUP ALARM AUTO ZERO FHR Indicator of Channel 1 Print Indicator Power ON Indicator UPYEVENT DOWN BEEP ALARM Indicator Table 3 2 Indicator description Green and flash Fetal heart signal quality 16 optimal FHR Indicator including channel Orange and flash Fetal heart signal quality is unacceptable 1 and channel 2 12 Cadence Fetal Monitor User Manual TOCO pressure is at the range from 0 to 100 TOCO Indicator TOCO pressure equals to 0 or is over 100 TOCO transducer is off Intrauterine pressure is at the range from 0 to Green 100 IUP Indicator Intrauterine pressure equals to 0 or is over 100 Off Intrauterine pressure connector is off Print Indicator Green and flash No paper or recorder error Enable audio alarm Disable audio alarm Power ON Indicator 3 1 3 Recorder If the transducers and connectors are connected well press to print The date time FHR type TOCO type paper s
26. d version of the system standard IEC EN 60601 1 1 Everybody who connects additional equipment to the signal input connector or signal 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 consult our technical service department or your local distributor 64070 D Federal U S law restricts this device to sale by or on the order of a physician 64070 D The device is designed for continuous and is ordinary i e not drip or splash proof 6407 D Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment 64070 D Do not operate the unit if it is damp or wet because of condensation or spills Avoid using the equipment immediately after moving it from a cold environment to a warm humid location 64070 Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducers 64070 D Sterility can not be guaranteed if package of fetal spiral electrode is broken or opened V CAUTION Fetal spiral electrode is sterilized by gamma radiation Do not re sterilize YcauTION Do not autoclave or gas sterilize the monitor or any accessory 64070 D Turn off the system power before cleaning 64070 D When washing the belts the water temperature must not exceed 60
27. eeececcccccceceseeeseececeeeeaaeeeseeeeeees 29 SO Alter MONON Os cncesseh ite iacnbersaasieeiatemcer ssh sine laaencerda ss einpelecn rebates iaacsncetdeasmeansauseensees 29 Chapter 6 Maintenance Care and Cleaning ssssssssccccccsssssssssssccccccccssssscssccccssssesees 30 6 Preventive Maintenance srecno ieta ead cas soon Gah aden esses 30 6 2 Care and Cleaning Of MOMIOT riean a mens vaaedeas ad ngestaied anced eased E 30 63 Care and C leanins 91 ACCESSOMES wczicsisssncdaas iteateewniyscidalacinceseautoy sandal E E E 31 023 1 1000108 01 Trans dUC TS nisn conan ae area coin an ceca 32 6 5 2 Cleaning Of Fetal ECG Cape i atcas st ccteiancoiat anes atsbanhaiecniatoeianiehan onetstebeatans a2 0 ean Ol Ine COR CE putsrtyaataled algae panianad ation ubencat ldap arioeaniatianubon at dedalivenaninendeas 32 0 Cle aidin OF DCLG ereen auth aea en een anen E ni aaet us eae 32 COSAINT A 32 OO O A E 33 OSCar ORC 9 WS Pape a TT eee Temenos 33 Appendix 1 Product Specifications ccccccccccccccccccccccccccccscccccccscccccccccccccccccccscsccsssssees 34 POM TM OMA UO eena aero etcetera ee ea staaaare a a eed a Ceeadtqaacenn tienes 34 31 2 Transducers and Caples sciences seers nie eect erat ec eae 37 AAD Acoustic Output Reportin Tale 80 38 Appendix 2 Signal Input Output 0010060 160 200
28. ents Please contact infectious disease experts in your hospital for details 6 3 Care and Cleaning of Accessories Gel must be wiped from the ultrasound transducer after use These precautions will prolong the life of the transducer Although transducers are designed for durability they should be handled with care Rough handling could damage the cover piezoelectric crystals and mechanical movement The cover is made of a soft plastic and contact with hard or sharp objects should be avoided Do not excessively flex the cables A WARNINGA Under no circumstance are transducers to be used to monitor patients under water OCAUTION 1 Be sure that the cleaning solutions and transducers do not exceed a temperature of 45 C 2 Do not autoclave the transducers and cables or heat them above 70 C 31 Cadence Fetal Monitor User Manual 6 3 1 Cleaning of Transducers Follow these steps to clean a transducer 1 Clean the transducer with a cloth soaked in a solution of soap and water or a cleaning solution Do not immerse the transducer in the solution Use only the following cleaning solutions BURATON LIQUID MIKROZID ETHANOL 70 SPORACIDIN CIDEX When using a cleaning solution follow the manufacturer s directions carefully to avoid damaging the transducer NNN N N 2 Wipe the transducer with a cloth damped with water 3 Wipe the transducer with a clean dry cloth to remove any remaining moisture 6 3 2 Cle
29. er of Cadence Fetal Monitor should assure that it is used in such an environment Compliance Electromagnetic environment Immunity test IEC 60601 test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Cadence Fetal Monitor including cables than the recommended Conducted RF 3 Vex separation calculated from the IEC 61000 4 6 150 kHz to 80 MHz equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz J V d e 80 MHz to 800 MHz 1 7 800 MHz to 2 5 GHz 1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co 45 Cadence Fetal Monitor User Manual NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless te
30. erefore its RF Sl al Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 The Cadence Fetal Monitor is suitable for use in Harmonic emissions all establishments other than domestic and IEC 61000 3 2 those directly connected to the public low voltage power supply network that supplies Voltage fluctuations buildi ii flicker emissions Complies A E E E A E SS IEC 61000 3 3 _ 43 Cadence Fetal Monitor User Manual A4 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The Cadence Fetal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of Cadence Fetal Monitor should assure that it is used in such an environment IEC 60601 test Electromagnetic environment Immunity test Compliance level level guidance Floors should be wood Electrostatic concrete or ceramic tile If floor 6 kV contact 6 kV contact discharge ESD Ley a are covered with synthetic IEC 61000 4 2 B i 7 material the relative humidity should be at least 30 Electrical fast 2 kV for power 2V for power supply Mains power quality should be transient burst supply lines lines that of a typical commercial or IEC 61000 4 4 hospital environment 1 kV differential Surge mode IEC 61000 4 5 2 kV common mode 1 kV differential
31. ettine Started siscseccsu sissy cvsevved e a a a a a as 18 AJ Opemine Packace and CWeCKaa wave cot iarssctenac he cease 18 Ai ONEC NETO we Dle aaa E TE T 18 d 1 011116006 01 NEIWOLK arreen a a E 18 OMMC CE WU Nl eaa E a a O 18 4 5 Connect with Wireless Network Module ec cccccssccesccsscesccesccesceescescesscesces 18 4 6 Feeding Paper and Removing Paper Jam ccccccccssssssseccececeeeeeesesecceeeeeeaeeeeseeeeeees 18 A POWEE Ol ihe MONO aoan tenant esteecscisun canteen R A sss 20 4 8 Connect Transducers and Cables 0 20 11811161 Monitorin sessista aena aKa ea LEA OaE a AAE NEE a KESAS 21 2 Uitrasound Monitorim 01 EHR aseina a a a a ZA 5 2 Fetal ECG Electrode Monitoring of FHR 2 0 cccccccccccccssssseseeeeeeeeeeeaeeesseeceeeeeeeeeeeeees 2 3 D al Heat Rate MIO I LON seroma sp eteedan ainda cetawiaberd recuse aeeeananeceoee 24 4 Montornes URIMEACHVIY coisa tt ccna a teeta E a ena ue ent 25 5 4 1 Monitoring Contractions External esesesssooeeessssssssoerressssssssereressssseeeeeees 25 5 4 2 Monitoring Contractions Internal 1 1 25 5 5 Remote Marker Recording of Fetal Movement cc
32. g gel sel Fetal movement Wait for a moment then monitor Maternal movement Relax patient s spirit Use recommended coupling gel Change the position l o _ Improper position of ultrasound Signal indicator is transducer ultrasound transducer till Pe orange continuously m indicator 19 green FHR is FHR is less than 50bpm than FHR is less than 50bpm Record maternal heart rate 00 position wrongly ultrasound poet The ultrasound transducer is not placed well on the abdomen Change the position of and the mixed noise has been ultrasound transducer recorded Use paper recommended Feint trace or no trace Improper paper by manufacturer A3 5 Fetal ECG Electrode Monitoring of FHR No ECG signal Use a new spiral electrode Inconstant trace contact reference Megostant gapay Use a new spiral electrode RA and aa Improper ultrasound transducer position Doubtful FHR monen ee The ECG cable has not been Fix an attachment pad at the fixed firmly fetal ECG cable Signal indicator is Insure that DECG arrhythmia Fetal arrhythmia orange continuously logic has been disconnected _4 Cadence Fetal Monitor User Manual A3 6 Monitoring Contractions External Ensure the belt has been used accurately and neither too tight nor too loose Too tight or too loose belt or no elasticity Worse trace quality or fluctuant TOCO baseline Maternal Movement Relax patient s spirit Fetal Movement Wait for a mo
33. itself responsible for any effect on safety reliability and performance of the equipment 1f Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use NOTE This device is not intended for home use A WARNINGA This device is not intended for treatment Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Using This Label Guide This guide is designed to give key concepts on safety precautions A WARNINGA A WARNING label advises against certain actions or situations that could result in personal injury or death CAUTION A CAUTION label advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure NOTE A NOTE provides useful information regarding a function or a procedure JI Table of Contents Chapter Safety Gund ane scosse ee a E E 1 1 1 Instruction Tor the Safe Operation aterri E E O kuch Gde 1 L2 Ultasound Saey Gudernes r E E 2 2 Loa Pree LONS ar ie a EE 2 ka 1261101110108 and S ymboeni a ieyGaetelant ar asda eae 4 Chapter 11160000001
34. l SN U1234 serial number it is a letter U with four digits _15 Cadence Fetal Monitor User Manual Figure 3 9 Label of ultrasound transducer ULTRASONIC TRANSDUCER DO NOT amp CLEARN WITH IMMERSE SOAP AND IN WATER WATER ONLY CADENCE MS3 01913 A1 PM2 0 The main information on the label is as follows PM 2 0 P means pulsed wave M means multicomponent 2 0 means central frequency is 2 0 MHz MS3 01913 EDAN part number for the ultrasound transducer A1 Version number for the ultrasound transducer DO NOT IMMERSE IN WATER CLEAN WITH SOAP AND WATER ONLY the CAUTION message 3 2 2 TOCO Transducer This 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 uterine contractions It gives a subjective indication of contractions pressure Figure 3 10 TOCO transducer 0 E Di sa ah CADENCE Sosem TOCO TRANSDUCER Label DO NOT IMMERSE IN WATER CLEAN WITH SOAP AND WATER ONLY SN T1234 serial number it is a letter T with four digits ae SS d a 7 Figure 3 11 Label of TOCO transducer CADENCE MS3 01916 A1 TOCO C TRANSDUCER DO NOT IMMERSE IN WATER CLEAN WITH SOAP AND WATER ONLY The main information on the label is as follows MS3 01916 EDAN part
35. lephones and land mobile radios amateur radio AM and FM radio broadcast 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 measured field strength in the location in which the Cadence Fetal Monitor is used exceeds the applicable RF compliance level above the Cadence Fetal Monitor should be observed to verify normal operation lf abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Cadence Fetal Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 46 Cadence Fetal Monitor User Manual A4 4 Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the Cadence Fetal Monitor The Cadence Fetal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Cadence Fetal Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Cadence Fetal Monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of 150 kHz to
36. ment then monitor The body pressure from Too high TOCO uterus to TOCO sensitivity higher than transducer is far higher 100 unit 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 Possible Possible Cause 0 Solution 00000 intrauterine No trace 5 Wash with disinfector ais is jammed Dry environment or No pressure change when the tip of intrauterine Wash with disinfector or change the uterine contraction catheter is placed position of transducer extraovularly Only see the IUP peak but Zero adjustment is Zero the system no baseline wrong Move or contact catheter If trace no The trace is a beeline The connector failure fluctuation change intrauterine cable 42 Cadence Fetal Monitor User Manual Appendix 4 EMC Information Guidance and Manufacture s Declaration A4 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The Cadence Fetal Monitor is intended for use in the electromagnetic environment specified below The customer of the user of the Cadence Fetal Monitor should assure that it is used in such and environment Emissiontest Compliance Electromagnetic environment guidance The Cadence Fetal Monitor uses RF energy only 0 for its internal function Th
37. moving Paper Jam When the recorder functions or sounds improperly open the recorder door to check for a paper jam Removing the paper jam in the following way Z Cut the record paper from the paper notch edge Z Open the door of recorder and revolve the left gear of the recorder Z Pull the paper from below Z Reload the paper 4 7 Power on the Monitor A WARNINGA 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 service engineer immediately Turn the power switch ON you can hear the short sound of Do and see that the power ON indicator is lit The 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 and you can perform normal monitoring now After self test the numeral LED will display as Figure 4 3 dual configuration Figure 4 3 Numeral LED display status after self test external TOCO ts Yj E 10 U Yj Yj Yj 4 8 Connect Transducers and Cables Prior to every time use check for visible damages of the transducers and cables If damage is found replace them at once Connect all the necessary transducers and cables between the monitor and the patient Note 1 Only connect the transducers and cables supplied by EDAN to the monitor 2 Pl
38. n 2 Positions with strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate should be avoided 3 If the fetus is in the cephalic position and the mother is supine the clearest heart sound will normally be found on the midline below the umbilicus During monitoring prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension Sitting up or lateral positions are preferable and may be more comfortable to the mother 4 It is not possible to FHR unless an audible fetal heart signal is present The fetal pulse can be distinguished from the 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 adequately ruptured and sufficient cervical dilatation assured The fetal electrode tip is designed to penetrate the epidermis of the fetus therefore trauma hemorrhage and or infection can occur The electrode should be used with strict adherence to aseptic technique The fetal spiral electrode should not be applied to the fetal face fontanels or genitalia Do not apply when placenta previa is present when the mother has visible genital herpes lesions or reports symptoms of prodromal lesions when the mother is HIV sero positive when mother is a confirmed carrier of hemophilia and the fetus 16 affected or of unknown status or when it is no
39. nitored in the comfortable Situation and the fetal heart rate value will be shown in the screen 3 Acquiring Twins Heart Rates Signal Follow the step 2 mentioned above to acquire the heart rate for the first fetus Set the current heart rate channel to US2 and adjust FHR2 volume well so that the second heart sounds can be heard Determine the location of the second fetal signal using palpation or a fetoscope Apply aquasonic coupling gel to the face of the transducer Place the second ultrasound transducer on the abdomen over fetal site and move it slowly until the characteristic hoof beat sound of the second fetal heart is heard The elasticity of belt can be adjusted which make the patient monitored in the comfortable situation Also verify the position of transducer one has not changed Verify the monitor is displaying fetal heart rate values for both fetuses The signal quality can be reflected by the color of fetal signal quality indicator _2 1 Cadence Fetal Monitor User Manual Good green and flash Poor orange and flash 4 Monitor Adjustments Readjust the volume settings for the desired loudness Figure 5 1 Ultrasound transducer amp TOCO transducer positioning f aw e Measure TOCO WS Sr A Measure FHR N POS Do not mistake the higher maternal heart rate for fetal heart rate Notes 1 The best quality records will only be obtained if the transducer is placed in the optimum positio
40. nterval is once per year Z The protective categories against electric shock of the patient connections are A 1 FHAHR1I 2 FHR2 3 TOCO 4 MARK SFS This symbol indicates that the instrument is IEC EN 60601 1 Type B equipment Type B protection means that these patient connections will comply with permitted leakage currents dielectric strengths and protective earthing limits of IEC EN 60601 1 IUP This symbol indicates that the instrument is IEC EN 60601 1 Type BF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock 2 DECG This symbol indicates that the instrument is IEC EN 60601 1 Type CF equipment The unit displaying this symbol contains an F Type isolated floating patient applied part providing a high degree of protection against shock Z The monitor described in this user manual is not protected against a The effects of defibrillator shocks b The effects of defibrillator discharge c The effects of high frequency currents d The interference of electrosurgery equipment Cadence Fetal Monitor User Manual 1 2 Ultrasound Safety Guide Z Fetal Use The CADENCE Fetal Monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor Clinical interpretation of fetal heart rate patterns can diagnose fetal and or maternal problems and complications Z Instructions for Use in Minimizing Patient Exp
41. nual Type B Applied Part Symbol Type BF Applied Part Symbol Type CF Applied Part Symbol This item is compliant with Medical Device Directive 93 42 EEC of June 14 1993 a directive of the European Economic Community This symbol consisting 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 equipment is put on the market after 13 August 2005 Part Number Serial Number Date Of Manufacture Manufacturer Authorized Representative in the European Community Recycle Federal U S law restricts this device to sale by or on the order of a physician Cadence Fetal Monitor User Manual Chapter 2 Introduction The CADENCE Fetal Monitor can provide different configurations according to different user requirements FHRI 051 FHR2 US2 optional TOCO MARK remote marker AFM automatic fetal movement mark optional FS fetal stimulator optional DECG direct fetal ECG optional and IUP intra uterine pressure optional The user can select the monitors according to requirements Note This user manual is written to cover all options Therefore your model may or may not have some of the parameters and functions described depending on what was ordered See FS 1 Fetal Stimulator User Manual for detailed information of fetal stimulator 2 1 Intended Use CADENCE Fetal Moni
42. number for the TOCO transducer Al Version number for the TOCO transducer DO NOT IMMERSE IN WATER CLEAN WITH SOAP AND WATER ONLY the CAUTION message _16 Cadence Fetal Monitor User Manual 3 2 3 Remote Marker The remote marker is a 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 Figure 3 12 Remote marker 3 2 4 Fetal Spiral Electrode Figure 3 13 Spiral electrode Safety Cap Spiral Electrode SY Flectrode Wires _ Reference Electrode ie SS XS Drive Handle Drive Tube K _ Guide Tube Handle Notch _17 Cadence Fetal Monitor User Manual Chapter 4 Getting Started Note To ensure that the monitor works properly please read this chapter and Chapter 1 Safety Guidance and follow the steps before using the monitor 4 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 Z Check for any mechanical damage Z Check all the cables and accessories If there is any problem contact us or your local distributor immediately 4 2 Connect the Power Cable Z Make sure the AC power supply of the monitor complies with the following specification a c LOOV 240V 50 60 Hz Z Apply the po
43. onitor 3 1 1 Push Buttons There are several push buttons with different functions 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 ALARM Button PRINT Button SETUP Button Bet AUTO ZERO Button SETUP ALARM PRINT AUTO ZERO ip A Se BEEP Button UP DOWN URE ENT DQWN BEEP EVENT Button FHR Volume Control Button Group of Channel 2 FHR Volume Control Button Group of Channel 1 Cadence Fetal Monitor User Manual a gr 1 SETUP Button setur Function Press the button to enter setup mode the numerical LED display is in red color The color of the numerical LED may be red or green While the monitor is in the setup mode the numerical LED is all red while the monitor is in the monitoring mode without physiological parameter alarm the numerical LED is green but if parameter such as FHR is in alarm situation the color of the alarmed parameter is displayed in red until the alarm disappears Pressing this button will activate the function of setting parameters step by step such as bed No printing speed system date time etc Press the button to enter setup mode the first showing 1s as follows Figure 3 3 Parameter setup display Adjust the value Then press to adjust the value up or down The parameters and the adjustable ranges are given in the following table Table 3 1 Parameters and adjus
44. ort or injury CAUTION D Z Since procedures vary according to hospital needs preferences it is the responsibility of the hospital staff to determine exact policies and procedures for both monitoring and amnioinfusion The safe and effective use of the IUPC depends on the skill of the clinician who applies use it Z Read Directions For Use of Disposable UPC prior to insertion The Product has been sterilized by gamma radiation and is sterilized and non pyrogenic unless package is broken or open Do not re sterilize it 77 Cadence Fetal Monitor User Manual NOTE Refer to the instruction on the package for more information about using the IUPC Operation Procedure 1 Insert IUPC using the procedure described in s Directions For Use of Disposable IUPC 2 Connect the IUPC to the IUP cable See figure 5 7 Figure 5 7 Connect catheter to pressure cable 3 Connect the IUP cable to the connecting cable They might have already been well connected in the package 4 Plug the connecting cable to the TOCO IUP socket of the monitor 5 Momentarily pressing the re zero button on the IUP cable The green light on the cable will 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 cough indicates proper positioning and function of the IUPC 7 Wash timely du
45. osure The acoustic output of CADENCE is internally controlled and can not be varied by the operator in the course of the examination The duration of exposure is however fully under the control of the operator Mastery of the examination techniques described in the User Manual will facilitate obtaining the maximum amount of diagnostic information with the minimum amount of exposure The exercising of clinical judgment in the monitoring of low risk patients will avoid unnecessary insonation 1 3 Safety Precautions WARNING and CAUTION messages must be observed To avoid the possibility of injury observe the following precautions during the operation of the instrument A WARNINGA EXPLOSION HAZARD Do not use the CADENCE Fetal Monitor 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 grade outlet is required Never adapt the three prong plug from the monitor to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate the monitor A WARNINGA Disconnect power cord before changing fuse Replace with the same rating and type only A WARNINGA SHOCK HAZARD Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord A
46. peed bed No and the offset of FHR2 DECG trace etc will be printed at the beginning of the paper The offset of FHR2 DECG trace 19 the preset FHR2 DECG printing trace offset 20bpm Obpm 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 be added unchanged 20bpm should be subtracted when calculating the numerical value of FHR2 DECG After printing the information mentioned above FHR1 FHR2 DECG AFM TOCO ext TOCO int will be printed at the relevant trace In the process of later printing the recorder will print system time once every 10 minutes and FHRI FHR2 DECG AFM TOCO ext TOCO int once every 8 minutes see Figure 3 5 and Figure 3 6 FHR2 DECG trace 19 a broad one If pressing the AUTO ZERO button the symbol of TOCO zero is printed If the EVENT button is pressed the symbol of will be printed at the trace If alarm occurs the symbol 44 will be printed at the trace Please set all parameters well before printing and do not try to change the setup in the process of printing Note The printing soeed and FHR2 DECG printing trace offset can not be changed in the process of printing _13 Cadence Fetal Monitor User Manual Figure 3 5 An example of printing pattern USA standard record paper MFM 2 CADENCE MFM 2 CADENCE 240 EEEE
47. ptional 1 Enable DECG arrhythmia logic 25bpm anti artificial 0 Disable DECG arrhythmia logic The default is 1 1 2 3 optional 1 Lead I 2 Lead II 3 Lead III ECG Leads Selection The default is 2 Note The parameter 16 to 18 are only be set by the manufacturer or service engineer and can not be operated by the user DECG Arrhythmia Logic Judgment 12 13 14 15 16 17 18 19 20 21 2 Press AUTO ZERO button to exit from the setting quickly Note When no operation happened within 30 seconds in the setup mode the monitor will be switched to the monitoring status of displaying FHR1 FHR2 DECG and TOCO IUP automatically i 2 ALARM Button Atarn Function Enable Disable audio alarm when FHR is in alarm situation Power on the alarm indicator status is shut off no audio alarm Press the button to enable audio alarm the alarm indicator will become green when FHR FHR1 FHR2 DECG is in alarm situation alarm sound Di Di Di appears and alarm indicator becomes red and flash Press the button again to silence audio alarm the alarm indicator is shut off When FHR FHR1 FHR2 DECG is in alarm situation alarm sound does not appear but alarm indicator becomes red and flash When alarm condition disappears the alarm indicator will be off When FHR FHR1 FHR2 DECG is less than the lower limit or higher than the upper limit of alarm over the time of alarm delay alarm signal will be given out
48. ring monitoring A spike on the tracing will respond to the washing Checking Intrauterine Pressure Cable Function To test an IUP cable s function 1 Disconnect the catheter from the cable Insert the cable check plug into the catheter end of the cable See Figure 5 8 Figure 5 8 Test the Pressure Cable 2 Verify that the green light is continuously lit no flashing 3 If the light does not illuminate replace the cable NOTE If the light is flashing verify that the cable check plug is inserted completely into the cable _ 28 Cadence Fetal Monitor User Manual A WARNINGAS The cable test function is not meant to check the accuracy of the system only to confirm cable function 5 5 Remote Marker Recording of Fetal Movement Insert the remote marker cable into its socket When FHR is monitored 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 T of fetal movement will be printed on the record paper 5 6 After Monitoring Operation after Monitoring 1 Remove transducers electrodes etc from patient Wipe transducer with a soft cloth to remove remaining aquasonic coupling gel 2 Tear the paper at the folding place 3 Switch off the power of the monitor 29 Cadence Fetal Monitor User Manual Chapter 6 Maintenance Care and Cleaning 6 1 Preventive Maintenance 1 Visual Inspection The
49. sible density Do not let liquid enter the monitor 2 00 No part of this monitor can be subjected to immersion in liquid N Do not pour liquid onto the monitor during sterilization O1 Use a moistened cloth to wipe up any agent remained on the monitor 6 7 Disinfection To avoid extended damage to the equipment disinfection is only recommended when stipulated as necessary in the hospital maintenance schedule Disinfection facilities should be cleaned first Do not use Povodine Sagrotan Mucovit or strong solvent Do not use strong oxidant for example bleaching powder Do not use bleaching powder with sodium hypochlorite Do not 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 monitor transducer and cable A WARNING Do not autoclave the transducers or heat them 64070 D Check carefully after cleaning sterilization or disinfection of monitor and accessories If aging and damage are found please do not use them to monitor Note 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 6 8 Care of Record Paper When storing recorder paper including used paper with traces Do not store 10 plastic envelopes
50. sound channel see section 5 1 for the operation and the DECG during labor channel see section 5 2 for the operation Notes 1 2 3 4 5 The monitoring results are two different fetal heart rates If the two channels record the same fetal heart rate one ultrasound transducer must be moved till the second fetal heart rate is found In order to distinguish the two fetal heart rates recorded by different channels the offset of FHR2 DECG trace is the printing trace offset preset If two ultrasound channels are used to monitor the twins only the audio signals of one fetus can be heard The audio signal for each fetus can be heard by selecting the appropriate channel with the Volume Control Button Group lf one ultrasound channel and the DECG channel are used to monitor the twins only the volume of channel 1 FHR can be adjusted Avoid mistaking maternal heart rate for the fetal heart rate 24 Cadence Fetal Monitor User Manual 5 4 Monitoring Uterine Activity Use a TOCO transducer to external measure uterine activity or use an intrauterine pressure catheter to internal measure uterine activity Only ruptured membranes and adequate dilation can the internal contractions be monitored 5 4 1 Monitoring Contractions External Monitoring of the external contractions is obtained through TOCO transducer on abdominal wall Parts Required 1 TOCO transducer 2 Belt Operation Procedure 1 Preparing the Monitor
51. t possible to identify fetal presenting part where application is being considered Application when fetus is extremely premature or in the presence of a maternal infection such as Hepatitis B Group B hemolytic strep syphilis or gonorrhea is not recommended but may be acceptable if a clear benefit to the fetus or mother can be established 09 _ Cadence Fetal Monitor User Manual Parts Required 1 Fetal ECG cable 2 Disposable fetal spiral electrode 3 Attachment pad Operation Procedure 1 Perform a vaginal examination and clearly identify the fetal presenting part Using a sterile technique to attach the fetal spiral electrode to the fetal presenting part as described in the Directions for Use of Fetal Spiral Electrode at this section Figure 5 2 Connection for fetal spiral electrode 1 A WARNING Do not plug the fetal spiral electrode wire into the power socket 2 Fix an attachment pad at fetal ECG cable 3 Thoroughly clean is on patient s thigh and ensure that it is dry Remove the release liner from the back of the pad Place the pad on maternal thigh and press firmly 10 place Read Prepare the Patient s Skin Prior to Placing Electrodes at this section first 4 Connect fetal spiral electrode with fetal ECG cable 5 Switch on the power of the monitor 6 Insert connector of fetal ECG cable into the DECG socket at the monitor 7 Check setup of DECG arrhythmia logic The transient heart rate change that equals to or is
52. t 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 consult our technical service department or your local distributor RJ45 DB9 Interface 1 RJ45 Interface RJ45 interface is 1500V AC isolated intensity and the maximum voltage applied should not exceed 15V DC Input Output 2 DB9 Interface 1 5 0 e Input Output 00000 6 9 39 Cadence Fetal Monitor User Manual Appendix 3 Troubleshooting A3 1 No Display Possible Cause Solution 00000 ON indicator 1s Power cable is loose Tighten it and check the fuse A3 2 Noise Too high volume sets Adjust the volume down Interfered by handset or other Keep the handset or other interfering source interfering source far away A3 3 Recorder Error Wrong feeding paper or paper is Feed paper correctly and keep affected with damp paper from moist PRINT button is disabled Press the PRINT button again Paper jam Recorder does not work Out of paper Feed paper Connect with ultrasound transducer or DECG cable connector Ultrasound transducer or DECG cable connector 18 off _ 40 Cadence Fetal Monitor User Manual A3 4 Ultrasound Monitoring of FHR the position ultrasound transducer till he signal indicator is green Tighten belt constant display l Wipe off superfluous coupling Superfluous couplin
53. table values Printing Speed 1 1cm min 2 2cm min 3 3cm min optional Hour 0 23 adjustable 06 Year 0 99 e 2000 2099 adjustable aoe 160bpm 180bpm adjustable the default is i oceania ian 160bpm and the interval is 1Obpm 10 ower anor Alcan 90bpm 120bpm adjustable the default is 120bpm and the interval is 10bpm 11 Aare Dela 10 40 seconds adjustable The default is 30 M seconds and the interval is 5 seconds Cadence Fetal Monitor User Manual AEM Gain adjustable The default 1s 3 and the interval is AEM Threshold 0 100 adjustable The default is 30 and the interval is 10 Panino eee 0 60 minutes adjustable The default is 0 minute 8 and the interval is 10 FHR2 DECG Printing 0 2 adjustable 0 no offset 1 20bpm 2 Trace Offset 20bpm and the default is 0 1 2 optional 1 international standard record paper and the range is 50bpm 210bpm Record Paper Type 20bpm cm 2 USA standard record paper and the range is 30bpm 240bpm 30bpm cm The default is 2 noo 0 1 2 are optional 0 RS485 network protocol Network Protocol V1 0 1 RS485 network protocol V1 1 2 Insight protocol V1 2 The default is 1 Derce Con anaon 0 1 2 optional 0 single 1 dual 2 IUP and 8 DECG The default is 0 DECG Calculation 1 2 optional 1 Transient calculation mode 2 Mode Twice average calculation mode The default is 1 l 2 optional 1 SObpm 210bpm 2 EA 30bpm 240bpm The default is 2 1 0 o
54. tch automatically Figure 4 1 Diagram of feeding paper Paper Advance Slot Handle The side without print scale will face to user 4 Adjust the paper length by the gear beside the handle if required 5 If the paper is slantwise you must pull the handle up and push the gear to force the paper out push the handle down and feed paper again 6 After closing the cover make sure that the paper can go out from the paper notch 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 notch should be aligned otherwise the data will be inaccurate or paper jam will happen 3 Only use EDAN approved paper to avoid poor printing quality deflection or paper jam 4 The printing function can t be executed when ultrasound transducer or DECG cable connector falls off Figure 4 2 Diagram of feeding paper correctly i Please make sure the paper is loaded correctly o The green Safety Band is at the left side o The blank side is faced toward the operator 2 Guide the paper into the print head the paper should be aligned with the guide notch at both sides Note Be careful when inserting paper Avoid damaging the thermosensitive print head Unless inserting paper or shooting troubles do not leave the recorder door open 19 Cadence Fetal Monitor User Manual Re
55. the CADENCE Insight software running on PC 2 3 Features Z Basic function FHR1 channel 1 FHR2 channel 2 optional TOCO IUP optional DECG optional Automatic fetal movement mark optional Nine crystals broad band pulsed wave transducer High brightness bi color numerical LED display Built in long life thermal recorder Advanced autocorrelation digital signal processing technique Signal quality indicator and alarm function NNNWN WN N Cadence Fetal Monitor User Manual TOCO zero Recorder can be stopped by the user programmable timer Built in DB9 RJ45 interface DECG arrhythmia logic judgment DECG range optional Wireless network module optional Vibrating operation marks can be recorded on CTG trends when connected with a fetal stimulator by an audio cable optional the dual configuration hasn t this option Z Lightweight compact size NNNNWN NN 2 4 Ordering Information Accessories supplied or approved by EDAN can be used with the CADENCE Fetal Monitor See the following table for details Manufacturer and Part Number Parker Aquasonic 100 01943 or M50 78001 TYCO 40000021 MS1 104153 TYCO 31479549 MS0 02145 TYCO 50000095 MS0 02146 Cadence Fetal Monitor User Manual Chapter 3 Monitor and Accessories Figure 3 1 CADENCE appearance single one fetus configuration LED Display Model Push Buttons Indicators Recorder Remote Marker TOCO Transducer Ultrasound Transducer 3 1 M
56. tor can acquire fetal heart rate FHR1 of channel 1 FHR2 of channel 2 maternal uterine contraction TOCO abdomen pressure when pregnancies over 28 weeks The CADENCE Fetal Monitor can be used for monitoring fetal heart rate during the antepartum period for NST Non stress Test and CST Contraction Stress Test Dual Heart Rate Monitoring allows simultaneous monitoring of two heart rates for twins This is achieved by using the facilities of two ultrasound transducers and an external contractions 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 monitoring information offering non invasive ultrasound external TOCO facilities DECG direct fetal ECG and Intra uterine Pressure IUP measurements 2 2 General Information CADENCE Fetal Monitor provides accurate and reliable monitoring information using non invasive ultrasound Doppler external TOCO technique and direct fetal ECG technique RJ45 interface is built and the monitor can be connected with MFM CNS Obstetrical Central Monitoring System via it The monitor can be connected to the wireless network module via a 12139 interface and the wireless network module will complete the data transmission of the monitor and the MFM CNS Obstetrical Central Monitoring System The data collected and saved by the CADENCE Fetal Monitor can be analyzed and printed by
57. vagina slide thumb between catheter and introducer tab which will begin to separate the introducer from the catheter See figure 5 3 Figure 5 3 Separate the introducer CL 4H 7 9 Anchoring the catheter in place with one hand pull the introducer straight back off the catheter See figure 5 4 Figure 5 4 Remove the introducer 36 Cadence Fetal Monitor User Manual 10 Remove the liner from the adhesive pad then adhere the pad to the patient s skin Secure the catheter by placing the catheter attachment strap to the adhesive pad See Figure 5 5 Figure 5 5 Secure the adhesive pad to mother Rezeroing the System During Monitoring 1 With the catheter connected to the IUP cable momentarily pressing the re zero button on the pressure cable See Figure 5 6 The green light on the cable will flash for five seconds Figure 5 6 Rezeroing the system 2 During this five seconds adjust the monitor to zero by pressing AUTO key A WARNINGAS Z Before insertion placental position should be confirmed amniotic membranes adequately ruptured 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 is present Z f resistance is met at any time during insertion withdraw the catheter slightly and try at a different angle Forced insertion may result in patient s discomf
58. wer cable provided with the monitor Plug one end of the power cable to the power socket of the monitor see Figure 3 7 Connect the other end 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 cable into the RJ45 interface of the monitor 4 4 Connect with PC Connect RJ45 interface of the monitor with PC via special RS232 cable provided by EDAN 4 5 Connect with Wireless Network Module Connect the DB9 interface of the monitor with one end of RS232 and connect the DB9 interface of the wireless network module with the other end of RS232 When CADENCE Fetal Monitor and the MFM CNS Obstetrical Central Monitoring System work the wireless network module will complete the transmission of data between them 4 6 Feeding Paper and Removing Paper Jam Feeding Paper If the paper is used up or paper jam happens you have to feed paper into the recorder the operation procedure is as follows 1 Push the cee position simultaneously on both sides of the recorder cover to open it 2 Take out the Z type thermosensitive paper from the wrapper Put the green safety band to 18 Cadence Fetal Monitor User Manual the left and the face of the paper downward Put the paper into the box 3 Feed the record paper into the slot of the recorder Figure 4 1 and the paper will go out from the no
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