Home

Manual - EDAN USA

1. Check the connection of the transducer Check the connection of the DECG cable Check the connection of the IUP connecting cable Check if the US transducer 1 is well aimed at the fetus check the woman s condition Check if the US transducer 2 is well aimed at the fetus check the woman s condition Check if the spiral electrode is well attached to the fetus check the woman s condition Check the connection of the spiral electrode Connect the monitor to AC power supply Adjust one of the US transducers until another fetal heart signal is detected CADENCE II Fetal Monitor User Manual 4 7 Alarm Defaults Momsena ops oe US1 US2 DECG Probe Detecting On Off m FHRI FHR2 DECG Signal Quality on off Detecting UA Probe Detecting On Off Toco transducer detecting SOV signals overlap verification 223 CADENCE II Fetal Monitor User Manual Chapter 5 Printing 5 1 Function Description The built in thermal recorder applied in CADENCE II prints continuous FHR1 FHR2 DECG TOCO AFM trends synchronously along with some other symbols A list of date time TOCO type print speed BedID and FHR2 DECG offset at the beginning of the printing The current time every 10 minutes afterward Trends marks FHR1 TOCO ext TOCO int AFM every 8 minutes afterward symbol marks Start Alarm FM event zeroing whenever it happens The monitor supports some other functions liste
2. Ea EX fot M50 78019 Figure 5 2 An example of printing pattern international standard recorder paper Besides the trends some other symbols appear among the trends on the recorder paper This symbol indicates a manual fetal movement and it appears after the patient presses the remote event marker when she feels a fetal movement This symbol indicates a fetal movement 1s detected by the monitor automatically This symbol indicates that the MARK key is pressed to record an event such as the patient turning around taking injection This symbol indicates that the monitor is zeroed by pressing the AUTO ZERO key FHR1 FHRI trend mark The broad trend is FHR1 trend FHRYDECG DECG The narrow trend is FHR2 The narrow tend is FHR2 DECG tends 000 DECG trend e ext TOCO int The TOCO trend from external internal monitoring 20 CADENCE II Fetal Monitor User Manual Chapter 6 Pre Monitoring Preparation 6 1 Confirming Fetal Life Fetal monitoring with ultrasound or DECG can not differentiate a fetal heart rate signal source from a maternal heart rate source in all situations These are some of the signal sources that might be taken as FHR signal source by mistake High maternal heart rate signal Maternal aorta or other large vessels signals Electrical impulse from the maternal heart transmitted through a recently deceased fetus Movement of the deceased fetus during or following maternal
3. for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The CADENCE II Fetal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of CADENCE II 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 II Fetal Monitor including cables than the recommended separation distance calculated from the Conducted RF 3 Vims 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 d ELT Vi 35 WP 80 MHz to 800 MHz 1 ENP 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 69 CADENCE II Fetal Monitor User Manual NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies
4. User Manual EDANUSA CADENCE II Fetal Monitor Version 1 1 Statement This manual will help you understand the operation and maintenance of the product better It is reminded that the product shall be used strictly complying with this manual User s operation failing to comply with this manual may result in malfunction or accident for which the manufacturer can not be held liable The manufacturer owns the copyrights of this manual Without prior written consent of the manufacturer any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing 1n this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of the manufacturer The manufacturer holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer The manufacturer only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by the manufacturer and The electrical instal
5. FHRI Fetal Heart Rate 1 FHR2 Fetal Heart Rate 2 TOCO AFM automatic fetal movement monitoring MFM manual fetal movement monitoring FS fetal stimulator optional DECG direct fetal ECG optional and IUP Intra uterine Pressure optional A 5 7 LCD display is applied by the monitor to display the FHRI FHR2 DECG dual configuration and TOCO IUP trend and numerics Also a built in thermal recorder 1s used to print the trends and other information A rechargeable lithium ion battery is provided for your option A DB interface is built in the monitor With it the monitor can be connected to a computer or the MFM CNS central monitoring system via 485 network Optionally you can order a built in wireless network module to connect the monitor via wireless network The data collected and stored by CADENCE II can be analyzed by the Insight software running on PC or MFM CNS Refer to MFM CNS Central Monitoring System User Manual and the relevant information of wireless network module 10 CADENCE II Fetal Monitor User Manual 3 2 Monitor NOTE The pictures and interfaces in this manual are for reference only Alarm Indicator Display Screen Power Indicator Charging Indicator Keys Recorder m TOCO Transducer Remote Event Marker Ultrasound Transducer Figure 3 1 CADENCE II appearance dual configuration 3 2 1 Display The display of the monitor 1s used to show the information of
6. When more than one alarm 1s active the alarm messages appear in the same area in succession NOTE The alarm message can never be cancelled unless the alarm is switched off 20 CADENCE II Fetal Monitor User Manual 4 4 Treatment Measures When the monitor gives out an alarm and catches your attention you should Check the patient s condition Identify the cause of the alarm Silence the alarm 1f necessary Check if the alarm is terminated when the alarm condition 1s solved 4 5 Testing Alarms To test the functions of visible and audible alarms do the following Switch on the monitor 2 Enable the alarm 3 Set the alarm limits to a small range 4 Stimulate a signal that 1s higher than the upper limit or lower than the lower limit Or disconnect one of the plugs 5 Verify 1f the visible and audible alarms are working properly 4 6 Alarm Messages The table below lists the alarm information that might appear during fetal monitoring and their respective causes and countermeasures Alarm Message Cause Countermeasure Medium Level Alarm The FHR1 measurement result is higher than the preset upper limit or is lower than the preset lower limit over the alarm keep time FHR1 Over limit The FHR2 measurement result is ad Check higher than the preset upper limit or is lower than the preset lower limit over the alarm keep time if the alarm limits are suitable check the woman s condition FHR2 O
7. fetal heart using DECG internally Connect US transducer to FHR1 socket connect DECG cable to DECG socket Monitor one twin with US transducer using procedures described in section 7 2 Monitoring FHR with Ultrasound Monitor the second twin with DECG cable using procedures described in section 7 3 Monitoring x CADENCE II Fetal Monitor User Manual FHR with DECG NOTE If the DECG sound is not switched off the fetal heart sound of the twins will be heard simultaneously 7 4 3 Signals Overlap Verification SOV If the two US transducers are aimed at the same fetal heart or the US transducer is aimed at the fetus that the fetal spiral electrode is attached to an alarm message Signals Overlap will appear on the screen to warn you If you are monitoring FHR externally adjust one of the transducers position to find the second fetal heart If you are monitoring FHR internally adjust the US transducer s position to find the second fetal heart To switch the SOV alarm on or off 1 Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to SOV press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On and Off default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 4 4 Changing FHR2 DECG Offset In order to distinguish FHR1 trend from FHR2 DECG trend FHR2 offset is provided to help you separate the two
8. 2 kV for power Mains power quality should be transient burst supply lines supply lines that of a typical commercial or IEC 61000 4 4 hospital environment Mains power quality should be that of a typical commercial or hospital environment Surge 1 kV line to line 1 kV line to line IEC 61000 4 5 2 kV line to ground 2 kV line to ground 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 UT 596 U1 gt 95 dip in U7 gt 95 dip in U7 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 Uy 60 dip in U7 of the CADENCE Il Fetal for 5 cycles for 5 cycles Monitor requires continued operation during power mains 70 U1 70 U1 interruptions it is recommended 3096 dip in Uy 3096 dip in Uy that the CADENCE Il Fetal for 25 cycles for 25 cycles Monitor be powered from an uninterruptible power supply or lt 5 Us lt 5 Uy 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 U is the a c mains voltage prior to application of the test level 68 CADENCE II Fetal Monitor User Manual A5 3 Electromagnetic Immunity
9. Monitor should assure that it is used in such and environment E RF emissions CISPR 11 RF emission CISPR 11 Harmonic emissions IEC 61000 3 2 fluctuations Voltage flicker emissions IEC 61000 3 3 Oo osa mA NM Electromagnetic environment guidance The CADENCE II Fetal Monitor uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The CADENCE II Fetal Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 267 CADENCE II Fetal Monitor User Manual A5 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The CADENCE II Fetal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of CADENCE II 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 mU mn are covered with synthetic IEC 61000 4 2 B zu 7 aid material the relative humidity should be at least 30 Electrical fast 2 kV for power
10. 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 telephones 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 II Fetal Monitor is used exceeds the applicable RF compliance level above the CADENCE II Fetal Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the CADENCE II Fetal Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 70 CADENCE II Fetal Monitor User Manual A5 4 Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the CADENCE II Fetal Monitor The CADENCE l 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 II Fetal Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable
11. and mobile RF communications equipment transmitters and the CADENCE lII 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 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 71 EDANUSA 4901 Morena Blvd Suite 505 www edanusa com San Deigo CA 92117 Tel 888 850 4597
12. applied part I MARK P3 Socket for Remote Event Marker Type B applied part EXT 1 O Socket for Fetal Stimulator Type B applied part Power Socket o E 90 o o o Soop o m i Dt Pf e e e P N 4 SRELE N Rx only U S CADENCE II Fetal Monitor User Manual Fuse Socket DB9 interface for connection to wireless network module RJ45 Interface Equipotential Grounding System Attention Consult Accompanying Documents Type B Applied Part Type BF Applied Part Type CF Applied Part The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life and that this unit was 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 II Fetal Monitor User Manual Chapter 2 Installation Guidance NOTE Installation must be carried out by qualified personnel authorized by the manufacturer 2 1 Opening the Package and Checking Open the package and take out the monitor and accessories carefully Keep the package for possible future transportation or storage C
13. limit or the monitor can not measure and therefore can not detect critical patient conditions reliably the monitor initiates alarm signals to attract the physician s attention In terms of severity the alarms are divided into two levels medium and low Medium level alarm 1s a severe warning low level alarm 1s a general warning The medium level alarms have higher priority than the low level alarms If both types of alarms are active at the same time the monitor sounds an audible indicator for the medium level alarms 4 2 Audible Alarm When an alarm is active the monitor gives out an alarm sound Medium level alarm a Do tone is repeated three times followed by a pause Low level alarm a Do tone is issued followed by a pause Press the ALARM key on the front panel the audible alarm will toggle between on and off Meanwhile the audible alarm indicator on the main interface toggles between ay and SA However the alarm messages will still be displayed and the alarm indicator will still be lit up when an alarm is active NWARNING Do not disable the audible alarm for the condition where the patient s safety may be endangered 4 3 Visual Alarm When an alarm is active the alarm indicator flashes in orange with a frequency of 0 5Hz if it is a medium level alarm the alarm indicator lights up in orange if it 1s a low level alarm the alarm message appears at the top left corner of the monitoring screen
14. low Connect the monitor to AC power A3 2 Noise Symptom Possible Cause Solution The FHR volume is set to be Adjust the volume down too high Noise Interfered by handset Keep handset other other interfering source MAC source far a A3 3 Recorder Error paperian Wrong feeding paper or Feed paper correctly and keep a paper is affected by damp paper from moist The PRINT key is disabled Press the PRINT key again Recorder does not work Ee Ultrasound transducer or Connect with ultrasound DECG cable connector is transducer or DECG cable unplugged connector 260 CADENCE II Fetal Monitor User Manual A3 4 Ultrasound Monitoring of FHR Phenomenon Possible Cause Monitor FHR with DECG if the membrane is adequately ruptured Adjust the position of the transducer till the better signal is received Loose belt 0 belt Tighten the belt the belt Inconstant trace TUE aquasonic coupling iL ANNE off superfluous aquasonic xS coupling gel Md fetal movements Delay the monitoring the monitoring a LLL NN the patient to calm down Maternal movement and stay still x aquasonic coupling Use recommended aquasonic coupling gel quantity Record maternal heart rate Change the position wrongly ultrasound transducer Thick abdominal wall Improper ultrasound transducer position Doubtful FHR The transducer is not well placed in position and the mixed noise has been recorded
15. lumi LE 63 A3 6 Monitoring Contractions External esses 64 A3 7 Monitoring Contractions Internal sese 64 A3 9 BIOS USCS caste ceca rechts iat n bc beac rans ecto boe tenis bred erate Rem uet 64 Append 4 PENDET 66 Appendix 5 EMC Information Guidance and Manufacture s Declaration 67 A5 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS 67 A5 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS 68 A5 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not PEE TS ee OR TIN enie abate ba aig teats a iiie Den beet io edes id de deta 69 A5 4 Recommended Separation Distance cccccccccsssssssecccceeeecaeeeseeecccseeseaaeeeeeecceeeeaas 71 CADENCE II Fetal Monitor User Manual Chapter 1 Safety Guidance NOTES 1 2 In order to ensure the operator and patient s safety read through this chapter before using this monitor This user manual is written to cover the maximum configuration Therefore your model may not have some of the parameters and functions described depending on what you have ordered 1 1 Intended Use The CADENCE II fetal monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination labor and delivery It is intended to be used only by trained and qualified personnel in antepartum examination rooms labor and delivery r
16. of the screen During monitoring and playing back it displays trends during setting it displays setup menus i Main Interface The background supports two standards 30 240 American standard and 50 210 International standard There are two top horizontal graticules within the FHR trend frame They make it easier for you to estimate 1f the heart rates have exceeded the preset limits The FHRI lower and upper limits determine its range The bottom graticule shows the UA baseline ii Setup Menu The setup menus include Function menu Alarm Configuration menu Fetal Monitor Configuration menu Print Configuration menu Interpartum Configuration menu Auto Monitor menu Date and Time menu and System menu In the setup menus the pane that encircles an item is called the cursor Press the UP key or DOWN key to move the cursor to the previous or next item When it comes to the needed item press the CHANNEL key to stop it This item will be highlighted This item might have several options press the UP key or DOWN key to switch to the previous or next option When the required option appears press the CHANNEL key to confirm the selection By then the cursor will turn into the pane and will be able to move among the items again If no action 1s taken in 30 seconds the system will return to the upper directory Press the SETUP key again to enter the next setup menu Press the AUTO key to return to the main interface quickly 3
17. the monitor menus and collected fetal parameters and trends etc To fit different mounting situations the display can be tilted to one of the four preset positions To tilt the display you need to lift the display forward to the desired angle To fold the display you need to push the display backward to the desired angle Fold the display completely flat when the monitor is mounted on wall el CADENCE II Fetal Monitor User Manual Figure 3 2 To tilt the display The screen display includes three frames 1 information frame 2 trend menu frame 3 parameter frame see Figure 3 3 Trend menu frame Parameter frame TimeLen Information frame ae 0 ge 12 min Figure 3 3 Display screen 1 Information Frame TimeLen lz min The information frame is located at the bottom of the screen which indicates current status of the monitor a aU AC power supplied Se no AC power supplied b C The battery is loaded and the white pane indicates the charge of the battery BG means no battery 1s loaded c E The recorder is printing Ed The recorder stops printing d fal The audible alarm sound i1s activated ER The audible alarm sound is inactivated e Fe The monitor is online ES The monitor is offline ww CADENCE II Fetal Monitor User Manual TimeLen f MARE Time length the duration of the current monitoring 2 Trend Menu Frame The trend menu frame occupies most space
18. 1 Version number of the transducer WATERPROOF means the transducer is waterproof IPX8 means the transducer can work continuously for 5 hours under 1 metre water without being waterlogged W Y CAUTION The waterproof parts of the US TOCO transducer are restricted to the main body and the cable Do not immerse the plug into any liquid in the process of monitoring or cleaning 3 3 2 Remote Event Marker The remote event marker is a hand held switch operated by patient The mother is normally instructed to push down this switch when feeling a fetal movement NLIS CADENCE II Fetal Monitor User Manual Figure 3 9 Remote event marker 3 9 9 Fetal Spiral Electrode safety Cap wy opiral Electrode Reference Electrode Drive Tube Guide Tube Handle Motch Figure 3 10 Spiral electrode 3 4 Ordering Information Accessories supplied or approved by the manufacturer can be used with the monitor See the following table for details The accessories employed by the manufacturer are products having passed the authentication of CE and they have the characteristics specified by their manufacturers Part Number MS3 109301 MS3 31527 MS3 107673 MS2 02264 CADENCE II Fetal Monitor User Manual Disposable Maternal Attachment Pad Electrode MS0 02146 19 CADENCE II Fetal Monitor User Manual Chapter 4 Alarm 4 1 Alarms Classification When a patient s vital sign exceeds its configured
19. 1 1 1 If in doubt consult our technical service department or your local distributor For proper monitoring G C This device is not intended for treatment The fetal spiral electrode and intrauterine pressure catheter are disposable Discard Es C C CADENCE II Fetal Monitor User Manual them after use The IUPC is neither intended nor approved for measuring intrauterine pressure extraovularly attempting to do so may lead to maternal discomfort or injury To avoid delay of treatment alarms must be set according to different conditions of patients Make sure that audio sounds can be heard when an alarm occurs For using the battery C C C C C C C C G C C C C C C Read this manual thoroughly before using the battery Improper operation may cause the battery to get hot catch fire explode be damaged or attenuated in energy Do not heat or throw the battery into fire Do not immerse throw or wet battery in water seawater Do not use leave the battery close to fire or other places where temperatures may be above 60 C 140 F Do not destroy the battery pierce it with a sharp object hit it with a hammer or drop it on a hard ground This may cause battery explosion Do not connect the battery directly to an electric outlet or cigarette lighter charger Do not solder the leading wire and the battery terminal directly otop using the battery if abnormal heat odor discoloration deformation o
20. 2 Physical Specifications Size mm depth x width x 330mm x 270mm x 100mm height Power Supply Operating Voltage MEME LL 14 8V 6600mAh IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 61157 IEC EN 60601 2 37 IEC EN 60601 1 2 2001 A1 Anti electric Shock Type Class I equipment with internal power supply Dimensions and Weight standards Compliance FHRI FHR2 TOCO FM FS B IUP BF DECG C F Degree of Protection against Harmful Ordinary equipment sealed equipment without liquid Ingress of Water proof Degree of Safety in Presence of Equipment not suitable for use in presence of Flammable Gases flammable gases Disinfection Sterilizing Method Refer to this user manual for details 56 Anti electric Shock Degree CADENCE II Fetal Monitor User Manual Working System Continuous running equipment Earth Leakage Current Limit SAC 500 Pan 1000uA Enclosure Leakage Current Limit S F C 100 Pat 500uA Patient Leakage Current Limit Patient Auxiliary Current Limit Display 103 0 W x 79 0 H mm 320 x 240 dots signal DB9 network interface Interface Backlight Cold cathode fluorescent Ultrasound Transducer Cable Length Dimension Weight 180g 2m iind Remote Event Marker A1 3 Performance Specifications Ultrasound Ultrasound Pulse Doppler with autocorrelation Ultrasound Frequency 1 0 10 MHz 57 CADENCE II Fetal Monitor User Manual
21. Adjust the position of the transducer Use the paper recommended by the manufacturer Improper paper Faint trace or no trace Adjusting nuts of the print head Contact the manufacturer for are unbalanced service A3 5 DECG Monitoring of FHR No ECG signal Use a new Spiral electrode Inconstant trend Inconstant display E elefunee Use a new spiral electrode electrode and m The DECG cable has not Fix an attachment pad at the been fixed firmly DECG cable Inconstant trend 2635 CADENCE II Fetal Monitor User Manual A3 6 Monitoring Contractions External Ensure the belt has been used accurately and neither too tight nor too loose The belt is too tight too loose or has no elasticity Poor trend quality or fluctuant UA baseline Maternal movement Relax the patient Fetal movement Wait for a moment Make sure the TOCO transducer is wel contacted with the abdominal skin Reposition of TOCO transducer if necessary The uterus pressure is far higher than the average value Too high TOCO sensitivity higher than 100 unit A3 7 Monitoring Contractions Internal No trend The intrauterine catheter is Wash with disinfector jammed Dry environment or the tip Ne Pro SUr cre eon en of intrauterine catheter is uterine contraction Wash with disinfector or change the position of transducer placed extraovularly Only see the IUP peak but no baseline Zero adjustment is wrong Zero the sys
22. EL key Input the patient s name in the same way Press the CHANNEL to confirm selection 7 Press the AUTO key to exit 7 8 3 Enabling Disabling Manual Login If the manual login 1s enabled the login menu pops up when you press the AUTO key to start monitoring To enable or disable the manual login Press the SETUP key six times to open the Auto Monitor menu 2 Press the UP key or DOWN key to move the cursor to Login press the CHANNEL key 3 Press the UP key or DOWN key to toggle between ON and OFF default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit The monitoring starts immediately after exiting from the menu 7 9 Start Monitoring After the AUTO key is pressed the monitor automatically zeroes the TOCO value clears FM count adjusts fetal heart audio volume to default level zeroes the monitoring time length and starts monitoring If the Auto print 1s switched off press the PRINT key to start printing 7 10 Screen Display usi 169 63 FHREZ Over limit au e 120 4 7 FM TimeLen 12 min 0 Figure 7 9 Fetal monitoring screen display 46 CADENCE II Fetal Monitor User Manual 7 10 1 Fetal Monitoring Trends Alarm message FHRZ Over limit FHR1 Trend FHR2 DECG Trend AFM Trend TOCO IUP Trend Figure 7 10 Fetal monitoring trends During monitoring or playback the trend frame displays four trends at most refer to Figure 7 10 FHRI trend FHR2 DECG trend A
23. FM trend and TOCO IUP trend FHR1 FHR2 DECG trend FHRI trend is the broad one The y axis of the trend indicates the values of FHR whose range is 30 240bpm American standard or 50 210bmp International standard AFM trend The y axis indicates the scope of fetal movement NOTE The AFM trend is only for reference please take the MFM marks as criterion TOCO IUP trend The y axis indicates the value of TOCO IUP whose range is 0 100 7 10 2 Trends Playback The monitor stores data of the latest 12 hours in its long term memory Playback allows you to review them Press the FREEZE key on the main interface a playback symbol amp zi appears in the trend area Now you can press the DOWN key to play the trends backward The symbol turns into lt Keep pressing it to accelerate until it reaches the maximum speed the symbol turns into lt lt lt lt lt Press the UP key to decelerate In this process press the FREEZE key to pause The symbol turns into 7 E again If the PRINT key is pressed at this moment the recorder will print the trends of 20 minutes at most starting from the left edge of the screen zd CADENCE II Fetal Monitor User Manual Press the UP key to play the trends forward The symbol turns into gt Keep pressing it to accelerate until it reaches the maximum speed the symbol turns into gt gt gt gt gt Press the DOWN key to decelerate During playback the current patient monitoring does
24. Parameter Frame Parameter frame lies on the right of the trend frame The monitoring values are displayed here 213 CADENCE II Fetal Monitor User Manual 3 2 2 Key Functions and Operations mee O D O H5 Dg E SETUP ALARM PRINT AUTO ZERO FREEZE AE QO CE5 Co CX CHANNEL DOWN Figure 3 4 Keys CADENCE II Fetal Monitor is a user friendly device with operation conducted by a few keys on the monitor Their functions are as follows 1 SETUP SETUP key Function Enter setup menus There are eight setup menus in the monitor Keep pressing this key the monitor will switch among the eight setup menus and the main interface in turn 2 ALARM ALARM key Function Disable Enable the audible alarm Press this key the audible alarm toggles between on and off 3 PRINT key Function Enable Disable printing Press this key to start printing Press this key again to stop printing 4 AUTO ZERO AUTO ZERO key Function TOCO zero Adjust the external TOCO contractions trend value to preset unit external monitoring contractions or adjust the IUP trend value to the reference point O internal monitoring contractions 5 FREEZE FREEZE key Function Freeze Freeze the advancing real time trends and control playback trends 6 MARK MARK key Function Record an event Press this key to make a patient event 14 CADENCE II Fetal Monitor User Manual During playback this key is invalid An abnormal audio
25. Routine Inspection The overall check of the monitor including safety check and function check should be performed by qualified personnel every 6 to 12 months and each time after service The equipment should undergo periodic safety testing to ensure proper patient isolation from leakage currents This should include leakage current measurement and insulation testing The recommended testing interval 1s once a year or as specified in the institution s test and inspection protocol 3 Mechanical Inspection 1 Make sure all exposed screws are tight 2 Check the external cables for splits cracks or signs of twisting Replace any cable that shows serious damage 3 Pay particular attention to the supply socket NWARNING 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 8 1 2 Maintenance of the Monitor Keep the exterior surface of the monitor clean free of dust and dirt 50 CADENCE II Fetal Monitor User Manual The gathering of dew on the display may occur with abrupt temperature or humidity changes A table environment 1s recommended scratching and damaging the display should be avoided Avoid high voltage and static charge 8 1 3 Maintenance of the Transducers Keep the transducers in a dry environment where the temperature does not ex
26. TE T A A T TETTE 53 A A E A E A A E A E E E E E E ba oe Oe are PURA 54 Chapter SAfter Sales Ser Vice conan RR 55 Appendix 1 Product Specifications sssesececccsssssccecocccssssccceccssssececooccssssscceocsssssssceeeessssssssee 56 A1 1 Environmental Specifications wi ccscccassaatincesdsissvcaxcneactestasasdeassenecdondeasvedsexseaedsavseesteess 56 AT 2 Physical Spectticablols c scent iicisd clas boue tlbe ttt aede buie sto cta Ruetr Ud E adu 56 AT 9 Pertormatnce SPECINCAMONS oes sescsptbms E adit dto ot bad wuts meena iei v opdRSd 37 AT 4 Recorder SpectHoaltOBS iseddaeseoeeuu amita cte ono tradendo cts codem e edunt 59 AT Lithiuim 10n Battery Specifications sono o D EN ED Dd n ts 59 AKo Loyw Outp l Summary Va Die serier eater ed seach ones eee EE o AT ori PE SEES USER 60 Appendix 2 Signal Input Output Connector eee ecce eee eee e e eee eee eese eese esses sne 61 Appendix 5 Troubleshooting eroe eee eoo erae Ee eue o o ER EE EE erae a EFE a POP e Eee E ee ao osooso dotek paisuva 62 A MMNDICIE IT ties edith ane Nadi atari adele ca ado alec tated lth taal dee 62 PNB LN ONS Cerin ieee Sic oss ss as aoa esate 62 PAD 9d COLO CEUIBETEOE ooeino eee ode dieci den otia Misi ae duc deti oim de Uouici docs dur dot oue 62 A34 Ultrasound Monitoring OE FHR 4c eie tet e ette e Mo gu ts ue e pute e anda etica 63 A35 DECO Momitorine Of FHR ei ee reru hid lette AS rcd bi tu tidie tete
27. TO key to exit 7 1 2 Auto Fetal Movement Monitoring AFM During fetal heart monitoring with ultrasound the fetal movement signals are also detected The fetal movement signals differ from the Doppler heart rate signals in that they have larger extent and lower frequency The larger extent 1s because of the bigger scope of moving areas e g the 43 CADENCE II Fetal Monitor User Manual fetal arms or legs lower frequency is because of the lower velocity of the fetal movements compared with those of the fetal heart Only FHRI channel can perform AFM But be aware that when monitoring twins the movements detected by FHR1 may also be caused by the second fetus s movement The movement of the fetus will be detected and displayed in the form of a trend on the screen and the recorder paper You can choose whether to display the AFM trend and change the AFM threshold amp AFM gain 7 1 3 Enabling Disabling AFM I rend To enable or disable the AFM trend 1 Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to AFM Enabled press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On default and Off 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 7 4 Changing AFM Threshold Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to AFMT
28. acental site Do not insert the introducer beyond the cervical OS Use it with caution when uterine infection is present 3 If 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 discomfort or injury CAUTION 1 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 uses it 2 Read Directions For Use of Disposable IUPC 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 NOTE Refer to the instruction on the package for more information about using the IUPC 7 6 3 Operation Procedure 1 2 3 4 5 6 7 Insert IUPC using the procedure described in section 7 6 2 Directions for Use of IUPC Connect the IUPC to the IUP cable See figure 7 7 Figure 7 7 Connect catheter to pressure cable Connect the IUP cable to the connecting cable They might have already been well connected in the package Plug the connecting cable to the TOCO IUP socket of the monitor Momentarily pressing the re zero button on the IUP cable The green light on the cable will flash for five seconds Durin
29. ator description 15 CADENCE II Fetal Monitor User Manual 3 2 4 Sockets on the Right Side of the Monitor Loc is H4 Power Socket Fuse Socket iDOV 240y 2 Figure 3 5 Sockets on the right side of the monitor Power Switch On Off switch Power Switch Fuse Size DSmm 20mm Model T1 6AL 250V Power Socket Input socket for the mains supply 100V 240V 50Hz 60Hz 3 2 5 Base Panel Hanging Hole Label Battery Compartment Figure 3 6 Base panel 3 3 Transducers and Cables The ultrasound transducer s and TOCO transducer IUP cable connector DECG cable connector and fetal remote marker are attached to the front panel of the monitor Each cable has a tab located on the connector housing to ensure proper insertion into the appropriate socket on the monitor lt CADENCE II Fetal Monitor User Manual 3 3 1 Transducers Figure 3 7 Ultrasound US transducer Figure 3 8 TOCO transducer 1 Serial number label of the US transducer pink U xxxxx is the serial number 2 Specification label of the US transducer pink 3 Transducer cable 4 Belt buckle 5 Serial number label of the TOCO transducer blue T xxxxx is the serial number 6 Specification label of the TOCO transducer blue Information on the specification label includes PN MS3 109301 Part number of this US transducer MS3 31527 Part number of this TOCO transducer PW 1 0 pulsed wave the central frequency of the US transducer is 1 0 MHz A
30. ble When nothing is connected it displays Off 17 current UA value FM The FM count comes from the MFM When the FM source is set to AFM it displays AFM 1 FM count 7 11 Completing Monitoring After monitoring 1 Press the PRINT key to stop printing 2 Remove transducers or electrodes from the patient wipe the remaining gel off the patient and the US transducer with a clean soft cloth or tissue 3 Tear off the printed recorder paper along the perforation 7 12 Switching Off the Monitor 1 Press the POWER switch and hold for about 5 seconds 2 Unplug the monitor AN CAUTIONS Do not press the POWER switch continuously Allow at least 10 seconds between switching the monitor on and off 49 CADENCE II Fetal Monitor User Manual Chapter 8 Maintenance Care and Cleaning 8 1 Preventive Maintenance 8 1 1 Maintaining Inspection 1 Visual Inspection Prior to using the monitor every time do the following inspections C Check the monitor and accessories to see if there is any visible evidence of damage that may affect patient safety Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid C Check all the outer cables power socket and power cables C Check if the monitor functions properly If any damage is detected stop using the monitor on the patient Replace the damage part s or contact the manufacturer for service before reusing it 2
31. bts about arrhythmia of the fetus disable the DECG arrhythmia logic To switch DECG arrhythmia logic on or off 1 Press the SETUP key five times to open the Interpartum Configuration menu 2 Press the CHANNEL key when the cursor stays at DECGAntiArt 3 Press the UP key or DOWN key to toggle between On default and Off 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 3 8 Changing DECG Volume The monitor also gives a fetal heart sound when monitoring fetal heart rate with DECG To change DECG volume Press the SETUP key five times to open the Interpartum Configuration menu 2 Press the UP key or DOWN key to move the cursor to DECGVolume press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On and Off default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 4 Dual Heart Rate Monitoring 4 1 Monitoring Twins Externally To monitor twin FHRs externally you need to connect a US transducer to FHRI socket and the second US transducer to FHR2 socket Follow the instructions described in section 7 2 Monitoring FHR with Ultrasound to acquire FHR signals for both channels When two US transducers are fixed make sure fetal heart sound from both channels 1s clear and two FHR trends values are displayed on the screen 7 4 2 Monitoring Internally Optional Alternatively you can monitor a fetal heart using ultrasound externally and monitor the second
32. ceed 45 C 113 F Gel must be wiped from the US 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 parts Contacting the transducers with hard or sharp objects should be avoided Do not excessively flex the cables 8 1 4 Storage of Recorder Papers When storing recorder papers including used paper with trends Do not store them in plastic envelopes Do not expose them to direct sunlight or ultraviolet light Do not exceed a storage temperature of 40 C 104 F 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 trend unreadable 8 1 5 Cleaning of the Recorder The recorder platen thermal print head and paper sensing mechanism must be cleaned at least once a year or when needed when the printed trends become faint To clean the recorder 1 Clean the recorder platen with a lint free cloth dampened in soap water solution 2 Wipe the thermal array using a cotton swab moistened with 70 Isopropyl alcohol based solution 3 Check that the paper sensing mechanism 1s free of dust ay CAUTION Only use the recorder paper provided by the manufacturer or it may damage the recorder This kind of damage is not cove
33. d unnecessary insonation 1 4 Safety Precautions To avoid the possibility of injury observe the following WARNING and CAUTION messages during the operation of the instrument A WARNINGAS For using safety G CADENCE is provided for the use of qualified physicians or personnel professionally trained They should be familiar with the contents of this user manual before operation G Only qualified service engineers can install this equipment Only service engineers authorized by the manufacturer can open the case C This device is not intended for home use C EXPLOSION HAZARD Do not use the monitor in the presence of flammable anesthetics or other materials C C C C C G CADENCE II Fetal Monitor User Manual 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 Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient in case of possible hazard caused by leakage current superposition Do not apply this monitor simultaneously with other PATIENT connected equipment such as a cardiac pacemaker or other electrical stimulators on the same patient Do not switch on device until all cables have been properly connec
34. d below C Auto Start Printing If this function is enabled the recorder starts printing automatically when a new monitoring starts the AUTO key is pressed Otherwise you have to press the PRINT key to start printing C Fixed Length Printing The recorder prints trends of a fixed time length each time A music sound will be heard at the end of the printing This length is adjustable Refer to 5 2 5 Choosing the Printing Time Length C Data Caching When the paper drawer runs out of paper the recorder stops printing The data from this moment on at most 15 minutes will be temporarily saved in the internal memory When new paper is loaded the recorder resumes printing automatically NOTE If both the US transducer and the DECG cable are unplugged or if the monitor is switched off the data in the internal memory will be lost C FHR2 Offset You can set the offset of the FHR2 trend to separate the two FH trends on the screen and the recorder paper Refer to 7 4 4 Changing FHR2 DECG Offset C Print Test The recorder prints a trend for self testing when the monitor is switched on The following factors may cause the printing failure C Pressing the PRINT key frequently You should allow the recorder to print the last row before pressing the key again to start another printing G Neither ultrasound transducer nor DECG cable is connected to the monitor G The recorder runs out of paper G Recorder failure 24 CADENCE II F
35. e into the DECG socket of the monitor 8 Check the setup of DECG arrhythmia logic A WARNINGA Do not plug the fetal spiral electrode wire into the power socket CAUTION Do not mistake the higher maternal heart rate for DECG NOTES 1 If there is any doubt as to the presence of a fetal heart signal with ECG check with the US transducer on the patients abdomen or with a separate diagnostic instrument The presence of an audible Doppler heart sound at a rate distinct from that of the maternal pulse is unequivocal evidence of the fetal life 2 After the electrode is well attached allow a few minutes for the electrode and fetal tissue to become stabilized It is essential that the ECG signal electrode is in good contact with the fetal presenting part 7 3 6 Detaching the 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 Dispose of the used fetal spiral electrode in a proper way Do not use it again 7 3 7 Switching DECG Arrhythmia Logic On or Off When the DECG arrhythmia logic is enabled the monitor only records the transient heart rate change that is smaller than 25bpm If the heart rate change exceeds this limit it will not be n F CADENCE II Fetal Monitor User Manual recorded When the DECG arrhythmia logic 1s disabled the monitor records all the fetal heart beats If you have dou
36. e seen in 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 vagina slide thumb between catheter and introducer tab which will begin to separate the introducer from the catheter See figure 7 3 40 CADENCE II Fetal Monitor User Manual Figure 7 3 Separate the introducer 9 Anchoring the catheter in place with one hand pull the introducer straight back off the catheter See figure 7 4 Figure 7 4 Remove the introducer 10 Remove the liner from the adhesive pad and then adhere the pad to the patient s skin Secure the catheter by placing the catheter attachment strap to the adhesive pad See Figure 7 5 Figure 7 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 7 6 The green light on the cable will flash for five seconds V Ox M dt Figure 7 6 Rezeroing the system 2 During this period adjust the monitor to zero by pressing the AUTO ZERO key NWARNING 1 Before insertion placental position should be confirmed amniotic membranes _A CADENCE II Fetal Monitor User Manual adequately ruptured and sufficient cervical dilatation assured 2 Try to insert the catheter opposite the pl
37. ectric shock of the patient connections are X 1 Ultrasound FHR1 FHR2 2 External TOCO 3 Fetal Movement FM 4 Fetal Stimulator FS This symbol indicates that this is an IEC EN 60601 1 Type B applied part oe CADENCE II Fetal Monitor User Manual IUP This symbol indicates that this is an IEC EN 60601 1 Type BF applied part v DECG This symbol indicates that this is an IEC EN 60601 1 Type CF applied part C 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 1 3 Ultrasound Safety Guide G Fetal Use The CADENCE II Fetal Monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor Clinical interpretation of fetal heart rate trends can diagnose fetal and or maternal problems and complications G Instructions for Use in Minimizing Patient Exposure The acoustic output of CADENCE II 1s 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 avoi
38. etal Monitor User Manual 5 2 Printing Configuration CAUTION oet the recorder well before printing starts You can not change its configuration in the process of printing 5 2 1 Switching Auto Print On and Off 1 Press the SETUP key six times to open the Auto Monitor menu 2 Press the CHANNEL key when the cursor stays at Print 3 Press the UP key or DOWN key to toggle between ON and OFF default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 5 2 2 Choosing the Paper Speed Press the SETUP key four times to open the Print Configuration menu 2 Press the CHANNEL key when the cursor stays at PSpeed 3 Press the UP key or DOWN key to choose the paper speed from 1cm min 2cm min default and 3cm min 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 5 2 3 Choosing the Time Length Press the SETUP key four times to open the Print Configuration menu 2 Press the UP key or DOWN key to move the cursor to Print TimeLen press the CHANNEL key 3 Press the UP key or DOWN key to choose the print time length from 0 250 minute s The default is 0 0 means there is no time limit the recorder will not stop until the PRINT key 1s pressed 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 5 2 4 Switching Print Test On and Off Press the SETUP key four times to open the Print Configuration menu 2 Press the UP key or DOWN key to move the c
39. fectious disease experts in your hospital for details 8 2 2 Cleaning of the Accessories SWARNING Detach the accessory from the monitor before cleaning 52 CADENCE II Fetal Monitor User Manual 1 Cleaning of Transducers and Leads To clean the US transducer TOCO transducer IUP cables and DECG lead follow these steps 1 Wipe them with a soft cloth dampened in cleaning solution 2 Clean them with a soft cloth dampened in water 3 Aur dry them or wipe off the remaining moisture with a soft dry cloth The recommended cleansers for accessories are listed below Accessory Cleansers Ultrasound Transducer BURATON LIQUID TOCO Transducer MIKROZID ETHANOL 70 SPORACIDIN CIDEX DECG Leads IUP cable IUP Mild alcohol free soap water connecting cable CAUTION 1 Be sure the temperature of cleaning solutions does not exceed 45 C 113 F 2 Do not immerse them in any liquid 3 Only clean the outer surface of the connectors make sure no liquid goes into the connector 4 After cleaning no remaining cleanser is allowed on the surface 2 Cleaning of Belt Wash soiled belts with soap and water The water temperature must not exceed 60 C 140 F 8 3 Disinfecting Clean the equipment before disinfecting The table below lists the allowed disinfectant bases Instrument Disinfectant Glutaraldehyde up to 3 6 Surface Disinfectant Ethanol 1 and 2 Propanol YcaAUTION 1 Do not use a
40. g this time zero the monitor by pressing the AUTO ZERO key Make sure the display value and trend are both 0 Ask the mother to cough A spike on the trend in response to the cough indicates proper positioning and function of the IUPC Wash timely during monitoring A spike on the tracing will respond to the washing 42 CADENCE II Fetal Monitor User Manual 7 6 4 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 7 8 Figure 7 8 Test the Pressure Cable 2 Verify that the green light is continuously lit no flashing 3 Ifthe 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 NWARNING The cable test function is not meant to check the accuracy of the system only to confirm cable function 7 1 Fetal Movement Monitoring The fetal movement count on the main interface comes either from ultrasound AFM or remote event marker Manual 7 1 Choosing the FM Source Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to FMSource press the CHANNEL key 3 Press the UP key or DOWN key to toggle between Manual default and AFM 4 Press the CHANNEL key to confirm selection 5 Press the AU
41. he patient will be printed on the recorder paper Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the CHANNEL key when the cursor stays at BedID 3 Press the UP key or DOWN key to choose the bed ID from 1 99 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 8 2 Inputting Patient s Information It s recommended to input the patient s information This information will appear beneath the loaded trends Press the SETUP key once to open the Function menu 2 Press the CHANNEL key when the cursor stays at Login 3 An ID that 1s composed of time or the previous ID appears in the ID area Press the CHANNEL key the cursor moves to the symbols area below Press the UP key or DOWN key to move the cursor left or right Press the FREEZE key to move the cursor up and down Press the CHANNEL key at the symbol to delete an inputted symbol Press the CHANNEL key at the symbol to finish inputting You can input 10 characters at most 4 Press the UP key or DOWN key to move the cursor to NAME press the CHANNEL key Input the patient s name in the same way You can input 10 characters at most _45 CADENCE II Fetal Monitor User Manual 5 Press the UP key or DOWN key to move the cursor to GesWeek press the CHANNEL key Input the patient s name in the same way Press the CHANNEL to confirm selection 6 Press the UP key or DOWN key to move the cursor to GesDay press the CHANN
42. heck the components according to the packing list C Check for any mechanical damage G Check all the cables and accessories If there 1s any problem contact us or your local distributor immediately 2 2 Installing Battery ANWARNING owitch off the monitor and unplug it before installing or removing the battery 1 Battery Installation C Carefully place the monitor upside down on a flat surface covered with cloth or other types of protecting pad C Remove the screw of the battery compartment G Remove the battery compartment cover C Take the battery out from package Place the battery into the compartment with the wired direction on the outside G Insert the cable connector into the socket C Close the battery compartment cover and fix it with the screw 2 Battery Removal The steps of battery removal are opposite to those of battery installation NOTES 1 When a battery is configured after the device is transported or stored the battery must be charged Connecting the monitor to AC power supply will charge the battery no matter if the monitor is powered on 2 Ifa rechargeable battery is configured charge it fully each time after use to ensure the electric power is enough CADENCE II Fetal Monitor User Manual 2 3 Connecting the Power Cable G Use the power cord provided with the monitor Put the connector of the power cord into the power socket on the monitor Put the plug of the power cord into a gro
43. hreshold press the CHANNEL key 3 Press the UP key or DOWN key to choose the threshold from 0 100 the default value is 30 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 7 5 Changing AFM Gain Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to AFMGain press the CHANNEL key 3 Press the UP key or DOWN key to choose the gain from 1 2 3 and 4 default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 6 Manual Fetal Movement Monitoring MFM MFM result comes from the patient s feeling of fetal movement The MFM symbol I will be printed on the recorder paper 44 CADENCE II Fetal Monitor User Manual 1 Insert the remote event marker connector into the MARK socket on the monitor 2 Let the patient hold the marker in hand ask her to press the top key of it when a fetal movement is felt Continuous movements in 5 seconds are considered to be one movement and only press the key once 7 7 7 Clearing FM Count When you want to clear the FM count you can either press the AUTO key to start a new monitoring or 1 Press the SETUP key once to open the Function menu 2 Press the UP key or DOWN key to move the cursor to ClearFM 3 Press the CHANNEL key to confirm selection 4 Press the AUTO key to exit 7 8 Login 7 8 1 nputting Patient s Bed ID The bed ID you input for t
44. iee 45 7 8 2 Inputting Patient s Information sensensa aai a a S 45 7 8 3 Enabling Disabling Manual Login an E AS 46 FIMEN ONONE Cocos esca a a utendi sc coetui en ioco tutes dcs coton a 46 T MOSS CLE EMIS PLAY uester feo e cab teu eect eee tenet ona fecu D EU duc ihe diee Eu 46 T I0 A FG Cal MOntortno TEGDOS ad E nt decis tue tod t ma M Ended ameti 47 710 2 Trends Play Dac Koo utentes Rete deti Minetiva Que ben utes a eie tunt ipeum 47 JT AOD ERC MOS 30 QOIS Loto cete ito tebo lut ihn eo Satan etidete tetto der ei Sectio ee bibens duode tea pains 48 3 10 4 Eetal Monttorimp Values ecd aque ene quisbe tat edu e qui bet dudas 49 7 Ad Completing MOTLOFIDS ert setae E rend vetns amende 49 I2 ovien Orr the Mono corp aet eet tnde mae ever UN 49 Chapter 8 Maintenance Care and Cleaning eee e eee eee eee ee eee eee ee eee eee eeee 50 6 Preventive Malin enanee eere Voice aeta e it edt m ae ee te dirmi as 50 S L L Maintaining TS pS Ct Oli vases cn io i ha doe nea eee ha et td eren PEE deret UU RE ntque 50 61 2 Maintenance OF the MODIOE o o PEE NOR EU PI PET TURAE ND UEEE 50 5 1 3 Maintenance Of the T ransqucers wcrc terse ieee eos es 51 S A Storage Or Recorder Papets assesses doe ila Un RUBRI tae x Nestle Heads 51 S Clheaninccorthe ReCOEGOE er a 51 OC NTN RN CE 52 2 1 Cleaninc ob Ihe MOBILE soe ene eet A steduimius 22 6 2 2 Gleaming OF INE ACCESSOMES uai el vast dro eM a bis 52 S S USIP CC UNE oieri a
45. ke sure the belt fits the patient snugly but comfortably 3 Adjust the Value to Zero Press the AUTO ZERO key to adjust the value to the baseline Make sure this 1s not done during a contraction The uterine activity reading at this point should be 30 90 If the numeric exceeds this range it indicates the belt is too tight or too loose The too tight belt may cause a flat top aligned with 100 on the TOCO scale and the transducer would slide 1f the belt 1s too loose You need to adjust it NOTES 1 Do not apply aquasonic coupling gel on a TOCO transducer or its contact area 2 Check the function of the TOCO transducer by applying pressure on it to see if this is displayed on the screen 5 3 Changing the UA Baseline 1 Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to UABaseline press the CHANNEL key 3 Press the UP key or DOWN key to choose the baseline from 5 10 default 15 and 20 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 280 CADENCE II Fetal Monitor User Manual 7 5 4 Switching the UA Probe Detecting Alarm On or Off The monitor detects if the TOCO transducer is well connected When the transducer is unplugged the monitor gives an alarm You can switch this alarm on or off Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to UAPr
46. lation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request the manufacturer may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which the manufacturer may define as user serviceable Using This Label Guide This guide 1s designed to give key concepts on safety precautions NWARNING 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 Revision History Added key volume adjustment warning notes and abbreviation list 2009 09 10 EGR QR 9036 i Revised SOV position DECG volume and the format of the specification tables II Table of Contents Chapter 1 Safety EInBlICc E 1 MCI AU a E O enc tines l 2 I sttucHoBn tor Sale Operat Omes E d oon a dida fortu dae ci ed eU l 1 3 Ultrasound Safety Guide essre p de en doe aeee a E a Eiaa 2 Id Safe Preeautiolls sorier A T Dd Ip DI ned 2 1 5 Definitions and 5ymbolsas d E ber o ost E dose aislada beds 5 Chapter Z Installation Guidance sicciscaccscisesicecsstacsecsdsscencastecensudesesncascoesecuassceecactossssuden
47. m On or Off eeeeeessssssssssssseeeeeeeeeeennnnnnn 33 7 2 4 hanome the BEDR Alar LIMIS oe eer REPE ERUNE R US 33 7 2 Chanpgme the PHAR Alarm Keep Time costes cs ERR DUE SER ew 33 7 2 6 Switching the Probe Detecting Alarm On or Off eeeeeeeeeesses 34 7 2 7 Switching the FHR Signal Quality Alarm On or Off 34 7 3 Monitoring FHR with DECG optional ssssnssssesssseecssorressrssnssssssssseeccssorrerrsnsnsssssss 34 T 1 COMMING ICAUIONS sogan E EE REE 34 RS PIS REGUE d aa HE 35 7 3 3 Preparing the Patient s Skin Prior to Placing Electrodes 35 7 3 4 Directions for Use of Fetal Spiral Electrode 0 0 0 eccccccccccecceeessseeeeeeeeeeeeees 35 TOS DBCCO MOBILIS T EOCECOUEGa e oet oec t mo a a esdess 36 7 3 6 Detaching the Fetal Spiral Electrode sssssseeeeeeeeeeeeene 36 7 3 7 Switching DECG Arrhythmia Logic On or Off seen 36 729 6 Changing DECO VOIUHIG o p RH qd DUM un CUM 37 TA Dual Heart Fea be VOLO TING asinen so vate E A E d dnt seit dcus 37 TAA Monitoring TWINS BXICEHAlly uoce a A AO el trs 37 7 4 2 Monitoring Internally Optional Jaossa ia E EER S 37 7 4 3 Signals Overlap Verification SOV sessseesesesesssseeeeeeeeeeneeeennnnnnn nnns 38 TAAL mane PEHRZ DECG O BSeU5 2200 940 9 0 090 0 02 8 2000 1 000
48. movement So you need to confirm fetal life by other means before starting to use the fetal monitor such as using a fetoscope stethoscope Pinard stethoscope or obstetric ultrasonography 6 2 Switching On the Monitor NWARNING 1 Check if all the metal parts are linked to the protective earth cord and the cord is working well before powering on the monitor 2 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 Press the POWER switch on the right panel to switch on the monitor The power indicator lights up and a switching on sound is heard You can operate the monitor after the main interface appears The recorder prints a baseline after the monitor is switched on Observe the turning points of the printed baselines they should be printed exactly on the thick scale lines if the recorder paper is UOR TNL ADOD AY TA T BER ARE a i HUTT ea EMIRE amii Pn THREE AH GEHEN HTH If they do not comply with the lines reload paper or ask the service engineer to check the paper settings of the monitor D Make sure the paper is correctly loaded before starting printing correctly loaded and set e e CAUTION _ 28 CADENCE II Fetal Monitor User Manual 6 3 Setting Date and Time Press the SETUP key
49. nels are connected with US transducers the fetal heart sound of USI is heard by default You can press the CHANNEL key to switch the sound to US2 Adjust the default monitoring volume The fetal heart sound volume returns to a default level in new monitoring after the AUTO key is pressed This default level is adjustable To change this level 1 Press the SETUP key six times to open the Auto Monitor menu 2 Press the UP key or DOWN key to move the cursor to Volume press the CHANNEL key 3 Press the UP key or DOWN key to choose the volume from 0 9 the default is 3 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit Adjust the real time monitoring volume If the default volume 1s not satisfactory during monitoring you can press the UP key or DOWN key to increase or decrease the volume of the current channel Press the CHANNEL key and adjust the volume of the other channel in the same way Adjust the key volume When a key is pressed the monitor gives a D1 sound This volume is also adjustable Press the SETUP key three times to open the Fetal Monitor Configuration menu 2 Press the UP key or DOWN key to move the cursor to Key Volume press the CHANNEL key 3 Press the UP key or DOWN key to choose the key volume from High Low default and Off 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit NOTE When the monitor does not execute the function of a key it give
50. ng can be used for antepartum monitoring 2 1 Parts Required 1 US transducer 2 Aquasonic coupling gel 3 Belt 7 2 2 Operation Procedure 1 Placing Transducer Belt Place the transducer belts across the bed ensuring that the belt will be around the abdomen 20 CADENCE II Fetal Monitor User Manual when it 1s fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange the belt around her abdomen 2 Acquiring FH Signal Search for the location of the fetal heart using a stethoscope or a fetoscope Apply a certain amount of acoustic gel on the transducer and move it slowly around the fetus site until a clear characteristic hoof beat sound of the fetal heart is heard Refer to figure 7 1 for the transducer position Measure TOCO Measure FHR Figure 7 1 Ultrasound transducer amp TOCO transducer positioning single fetus 3 Fixing the Transducer Wrap the abdomen with the belt over the transducer Fix the transducer by pushing its buckle through the overlapping section of the belt Make sure the belt fits the patient snugly but comfortably Meanwhile fetus heart sound is heard clearly and the FHR trace and value are displayed on the screen L CAUTION Do not mistake the higher maternal heart rate for fetal heart rate NOTES 1 2 The best quality records will only be obtained if the transducer is placed in the optimum position Positions with strong placen
51. ng part Holding the drive handle ensure the spiral electrode 1s 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 1s 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 DECG cable Figure 7 2 Connection for fetal spiral electrode i CADENCE II Fetal Monitor User Manual 7 3 5 DECG Monitoring Procedure Perform a vaginal examination to identify the fetal presenting part 2 Prepare the patient s skin using the procedures described in section 7 3 3 Preparing the Patient s Skin Prior to Placing Electrodes 3 Attach the fetal spiral electrode to the fetal presenting part using the procedures described in section 7 3 4 Directions for Use of Fetal Spiral Electrode 4 Fixan attachment pad electrode to DECG cable 5 Remove the film on the back of the electrode and place the electrode on maternal thigh press it firmly in place 6 Connect the fetal spiral electrode to the DECG cable 7 Insert connector of DECG cabl
52. ng the print head CADENCE II Fetal Monitor User Manual 3 Make sure the paper coming out from the notch aligns with the notch edges Otherwise the trend printed on the recorder paper will be inaccurate or paper jam may happen 4 Only use the manufacturer approved paper to avoid poor printing quality deflection and paper jam 5 The printing function cannot be executed when ultrasound transducer or DECG cable connector falls off L 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 Figure 2 2 Diagram of feeding paper correctly NOTE Be careful when feeding paper Avoid damaging the thermosensitive print head Unless feeding paper or shooting troubles do not leave the recorder compartment open Removing Paper Jam When the recorder does not function or sound properly open the paper compartment to check for a paper jam Remove the paper jam in this way G Cut the recorder paper from the paper notch edge G Open the paper compartment and then rotate the gear of the recorder G Remove the rest of the paper G Feed the paper again CADENCE II Fetal Monitor User Manual Chapter 3 Introduction 3 1 Functions The CADENCE II Fetal Monitor can provide different configurations according to different user requirements
53. not stop The fetal heart sound and FHR values are all real time information of the patient During playback pause press the FREEZE key to return to real time monitoring NCAUTION Playback must pause before printing starts Printing in the process of playback might result in failure information on the paper NOTE The process of playback does not bear the limit of returning to the upper directory interface if no operation is performed within 30 seconds 7 10 3 Trends Loading When the 12 hour data stored in the monitor is loaded the trends occupy the whole screen and the patient s information appears beneath them To load the trends Press the SETUP key once to open the Function menu 2 Press the UP key or the DOWN key to move the cursor to Load 3 Press the CHANNEL key to confirm selection Review them in the same way as playback The information of the patient will be updated synchronously Figure 7 11 An example of loaded trends 48 CADENCE II Fetal Monitor User Manual 7 10 4 Fetal Monitoring Values US1 FHR1 socket is connected with a US transducer When nothing is connected it displays Off Ld FH refreshing rate 169 FHR1 value US2 FHR2 socket is connected with a US transducer When DECG cable is connected to the DECG socket it displays DECG When nothing is connected it displays Off 63 FHR2 DECG value TOCO The TOCO IUP socket is connected with a TOCO transducer or DECG connecting ca
54. ny disinfectant containing additional active ingredients other than those listed _ 53 CADENCE Il Fetal Monitor User Manual 2 Follow the manufacturer s instruction to dilute the solution or adopt the lowest possible density 3 Do not immerse any part of the monitor or any accessory into liquid 4 After disinfection no remaining disinfectant is allowed on the surface 5 Check if the monitor and accessories are in good condition If any aging or damage is detected replace the damage part s or contact the manufacturer for service before reusing them NOTE The manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details 8 4 Sterilizing Do not sterilize the monitor or the accessories unless this is necessary according to your hospital regulation 54 CADENCE II Fetal Monitor User Manual Chapter 9 After Sales Service If you have any question about maintenance technical specifications or malfunctions of devices contact the manufacturer or distributor 55 CADENCE II Fetal Monitor User Manual Appendix 1 Product Specifications A1 1 Environmental Specifications Worki MER Relative Humidity 25 80 non condensing Atmospheric Pressure 860hPa 1060hPa Transport and Storage l m l Relative Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa A1
55. obe press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On and Off default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 6 Monitoring Uterine Activity Internally optional 7 6 1 Parts 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 7 6 2 Directions for Use of IUPC Preparation 1 Gather supplies ACCU TRACE IUPC reusable cable and amnioinfusion 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 ensure 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 b
56. occi e uto uooauss 38 7 5 Monitoring Uterine Activity UA Externally eeeessssssseseeeeeeeeeeennnnnnnn 39 SR MEC NI Selbst 39 Te 52 OPOE PrOCE QUEE oeste t tomtom ons Poo ae centu d Sm ts 39 T Changine the UA Baseline eae coeno iei ttn ete tdi vet ubican iudi 39 7 5 4 Switching the UA Probe Detecting Alarm On or Off eeesessss 40 7 6 Monitoring Uterine Activity Internally optional eeeeeeeeeeee 40 POLCE S DECUIT C Ule oocseutcs erent rere ne mR Ma eI a eee eee 40 TEL Directions TOF C Se OL TUR 2 tata sitet oti cdioe est ututisemucs iod pite dedioe edt ees 40 TOS Operation PrOCE QUEE uus tom pla TI E ia ae un copie 42 7 6 4 Checking Intrauterine Pressure Cable Function seseeeeeesse 43 T Petal Movement MOonttottlig 4 iecit ena I HN eno pM dae 43 TT E Choosmp the ENISOUEDGS i ooo osa a co tuc cuo fuo dob ed d I eok tne dou 43 7 7 2 Auto Fetal Movement Monitoring AFM eessssseeeeeeeeeeeenenennnnnnn 43 T 553 enabling Disab ite AFM Tru uec nes ate ton Ste ge pat tice esten 44 RAC hanane AFM Threspnolklessc aset et ease sues E e pee oie atthe E tied 44 LLY HENE AD NECI Salsas rae tases hse i6t23d91s iuto iviseue aise tulei o cota al i otto rase sata 44 7 7 6 Manual Fetal Movement Monitoring MFM essere 44 FREERIDE RUE GOVT TEST TEES 45 odo rp 45 75 input Patents Bed DD oc dep pedet pavo ES oerte idit pae euta
57. ooms It is not intended for use in intensive care units operating rooms or for home use 1 2 Instruction for Safe Operation C C C The CADENCE II Fetal Monitor hereinafter called CADENCE II is designed to comply with the international safety requirements IEC EN 60601 1 for medical electrical equipment It is class I equipment CADENCE II operates within specifications at ambient temperatures between 5 C 41 F and 40 C 104 F after it is powered on for one minute Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits Allow at least two inches 5 cm clearance around the instrument for proper air circulation You must check that the equipment cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before each use If damage is evident replacement 1s recommended before use The monitor must be serviced only by authorized and qualified personnel The manufacturer does 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 Perform periodic safety testing to ensure proper patient safety This should include leakage current measurement and insulation testing The recommended testing interval 1s once per year The protective categories against el
58. or becomes dirty wipe it with a dry cloth The recommended charge temperature range is from 0 C 32 F to 40 C 104 F Do not exceed these ranges Batteries have life cycles If the time that the monitor uses the battery becomes much shorter than usual the battery life is at an end Replace the battery with a new one the same as the one provided or recommended by the manufacturer When not using battery for an extended period or any peculiar smell distortion or discoloration is detected remove it from the monitor and dispose of it properly The device and accessories are to be disposed of according to local regulations after their useful lives Alternatively they can be returned to the dealer or the manufacturer for recycling or proper disposal Batteries are hazardous waste Do NOT dispose them together with house hold garbage At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product 1 5 Definitions and Symbols applied part lr Pa f N i FHR1 Socket for ultrasound transducer 1 Type B applied part TOCO IUP Socket for TOCO transducer Type B applied part or IUP cable Type BF Y Socket for ultrasound transducer 2 Type B applied part Socket for DECG cable Type CF
59. or to Probe FHR1 Alert or FHR2 Alert press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On and Off default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 2 7 Switching the FHR Signal Quality Alarm On or Off When the FHR signal from the US transducer is too weak for the system to process analysis the monitor gives an alarm You can switch this alarm on or off Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to Quality FHRI Alert or FHR2 Alert press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On and Off default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 7 3 Monitoring FHR with DECG optional 7 3 1 Contraindications The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and sufficient cervical dilatation 1s ensured The fetal electrode tip 1s 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 the fetal spiral electrode 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 m
60. other 1s a confirmed carrier of hemophilia and the fetus 1s affected or of unknown status or when it 1s not possible to identify fetal presenting part where application 1s being considered This method is not recommended when fetus is extremely premature or in the presence of a maternal infection such as Hepatitis B Group B hemolytic strep syphilis or gonorrhea unless a clear benefit to the fetus or mother can be established A CADENCE II Fetal Monitor User Manual 3 2 Parts Required 1 DECG cable 2 Disposable fetal spiral electrode 3 Disposable maternal attachment pad electrode 7 3 3 Preparing 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 C C C Shave hair from sites 1f necessary Wash sites thoroughly with soap and water Never use ether or pure alcohol because this increases skin impedance Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease 7 3 4 Directions for Use of Fetal Spiral Electrode 1 2 3 4 5 6 7 8 Remove the fetal spiral electrode from package leaving the electrode wires locked in the handle notch Gently bend the guide tube to the desired angle With the patient in the dorsal lithotomy position perform a vaginal examination and clearly identify the fetal presenti
61. p 1 MPa Ij 10 mW cm Ispta 100 mW em FHR Measurement Range 50 bpm 240 bpm Resolution 1 bpm 2 bpm gt 4000Vrms Accuracy Dielectric Strength ISATA the transducer face 1 865 mW cm7 Entrance beam 6 08 cm Measurement uncertainties for ISATA 26 6 Measurement uncertainties for ultrasonic power 26 6 Peak peak detection technique DECG 30bpm 240bpm gt 10M Differential DC50 60Hz gt 20M Common Mode 58 CADENCE II Fetal Monitor User Manual AFM Pulsed Doppler ultrasound Range 0 100 Resolution 1 Manual fetal movement mark A1 4 Recorder Specifications Icm min 2cm min and 3cm min optional 7cm USA standard 8cm international standard 30bpm cm USA standard 20bpm cm international standard 3 4cm USA standard 2 4cm international standard TOCO IUP Scaling 25 0 85cm USA standard 25 0 6cm international standard Record Message Date time TOCO type paper speed FHR type bed No etc A1 5 Lithium ion Battery Specifications Necessary Charge time 6 hours MX _ 59 CADENCE II Fetal Monitor User Manual The Maximum Charge 2000mA Current Continuously Short Term within 1 month 20 C to 60 C 4 F to 140 F Middle Term within 3 months 20 C to 45 C 4 F to 113 F Long Term within 1 year 20 C to 20 C 4 F to 68 F Storage During storage recharge the battery at least every six months Cha
62. r abnormal condition is detected during use charge or storage Keep it away from the monitor If liquid leaking from the battery splashes into your eyes do not rub them Wash them well with clean water and see a doctor immediately If liquid leaks of the battery onto your skin or clothes wash well with fresh water immediately Use the battery only in CADENCE II CAUTION Federal U S law restricts this device to sale by or on the order of a physician The device is designed for continuous operation and is ordinary i e not drip or splash proof Keep it far from corrosive medicine dust area high temperature and humid environment 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 oterility can not be guaranteed if the package of the fetal spiral electrode is broken or opened Do not sterilize the monitor or any accessory 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 G G G G G C CADENCE II Fetal Monitor User Manual While the battery is charged used or stored keep it away from objects or materials with static electric charges Do not short circuit the battery socket or the battery plug If the battery connect
63. red by warranty 5 CADENCE II Fetal Monitor User Manual 8 2 Cleaning In order to avoid infection clean and disinfect the monitor and accessories after each use 8 2 1 Cleaning of the Monitor NWARNING Unplug the monitor from the AC power source and detach all accessories before cleaning Clean the monitor enclosure with a soft cloth and diluent non caustic detergents such as soft soap water Tensides Ethylate and Acetaldehyde Clean the screen with a dry soft cloth CAUTION 1 Although the monitor is chemically resistant to most common hospital cleaners and non caustic detergents other cleaners 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 3 Don t use strong or chemical solvents such as acetone acidic or alkali solutions 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 Do not remain any cleaning solution on the surface of the monitor NOTES 1 The monitor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth 2 The manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact in
64. rge State When 20 50 Leav ng Factory A1 6 Low Output Summary Table Low Output Summary Table for systems with no transducers having global maximum index values exceeding 1 0 System CADENCE series Fetal Monitor Ispta 3 Ipa 3 MI max Transducer Model mW cm TI Type TI Value W jem PW 1 0 MHz 60 CADENCE II 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 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 1n doubt contact our technical service department or your local distributor DB Interface 1 5 Signal Input Output oo0aa g P P oooQ B g E XM CADENCE II Fetal Monitor User Manual Appendix 3 Troubleshooting A3 1 No Display Tighten the power cable and check the fuse or check the battery Power cable is loose and no Exe P indi is off ower indicator is o The fuse s is are blown fuse s is are blown Replace the fuse s The battery is
65. s a Do sound 30 CADENCE II Fetal Monitor User Manual Chapter 7 Monitoring NWARNING 1 The monitor is not intended for use in intensive care units ICU operating rooms or for home use 2 The monitor is not protected against defibrillation Do not apply it during electro surgery or MRI otherwise it might result in harming the patient or the operator 3 Always check if the alarm settings are appropriate for your patient before starting monitoring 7 1 Confirming Fetal Life Fetal monitoring with ultrasound or DECG can not differentiate a fetal heart rate signal source from a maternal heart rate source in all situations These are some of the signal sources that might be taken as FHR signal source by mistake High maternal heart rate signal Maternal aorta or other large vessels signals Electrical impulse from the maternal heart transmitted through a recently deceased fetus Movement of the deceased fetus during or following maternal movement So you need to confirm fetal life by other means before starting to use the fetal monitor such as using a fetoscope stethoscope Pinard stethoscope or obstetric ultrasonography 7 2 Monitoring FHR with Ultrasound The ultrasound monitoring 1s a method to obtain FHR through maternal abdominal wall Place a US transducer US transducer on maternal abdomen to transmit lower energy ultrasound wave to fetal heart and then receive the echo signal Ultrasound monitori
66. se E etos muda ett 21 Ao PVT CLANS is apace cacti teat pata yt cca Nd deu teeta tip a a aA 23 Chapter 5 PEInUDBP oon ni Er EP RET EMetE ore isa 24 L E ncion DescEDLIOD o E CE EIE itis E ORE LEAN EEUU esas 24 35 2 Priitino CON ouri Ol ves tei diatutcie uictis ui ed bxDudu ce Sub scenes treu cates ns Sab but ete one dose 25 3 2 1 Switching Auto Print Omand OTT oot ob Ee etd E Fi ew 25 3 2 2 CHOOSING TNE Paper Dee o aeu sen n a A tot ont miuteteno ied aes 25 5 2 C hoosmp the Time LSU ie iecore teen er noatri te etam der nli etae es E i 25 5 2 4 Switching Print Test On and O wees o oa oM det 25 5 9 B xamples or Prints Pall ri eats oue co e pb o oa amies ett ME 26 Chapter 6 Pre Monitoring Preparation e eee eee eee eee eee tete tette esee ees sees ee 28 SM C onirun Fetal Life NERO NS T 28 6 2 Switching On the Monitor eese nennen nen 28 0 mete Date dnd Lies oo eost odo a c does LoE Speo esas 29 o6dConnecHhg Transducels md io epus voted lat v ptuetdy iab Vt ioc dE dante eae 29 o0 Adjus nps the Volu eee ete Ra PUR Hived ren iet Masa PAD reri ufo Maas 30 Chapter 7 Monitoria cose esee RR EUR eE EINER INE ES IR EP IAN IUE PN 3l FE Consilii t rM Ec LEE 3l 7 2 Monitoring FHR with Ultrasound ied b ERE EEEEEEEX ERA GAS IS DUE CREER PEE T 31 2c L Doris Ie quite esana E fu etai aise eee 3l Ped 2 CCT AMON PROC COILS etree Saas Date Pott deb oM etat ttai estas 3l 7 2 3 Switching the FHR Alar
67. sescescetexe 7 2d Opening the Package and Checklfi9 ote epp ehe teo es setate TAE J ee MING AL B ae e RO RE E EE 7 2 9 Connecins tie POW er ale nena OA 8 P DEAE Pipe deere ee I et eno nee ere meditatus mi ene ne edid bet 8 Chapter S Mmr oduct ossessi eieaa aae AE LESENA aaa E EE aoaea roie 10 IAL PIMA PLO INS RET TU T Tm 10 9 2 MODON te c LS 11 Dele DIS ay orarie eT a TA A T E Ti 11 3 2 2 Key Functions and Operation Secimi ne E T A S 14 5 2 CIC ALONG ce O Oe A 15 3 2 4 Sockets on the Right Side of the Monitor eesssssseeeeeeeeeeeennn 16 S i AO IPAE hate thias wate Saree nc haha E cemento tiet Puoi ast ates eee 16 229 Transducers and Cables ieu ep ui p tno uM tO D p ae eee ee ieee 16 SS NDS EET 7 2 3 2 ISemmote Event IMOUKOE coro ive E tate cna IRE ti me astutus CE etpH M isa 17 3 35 Petal Spital BlectfOOessetisovesciftotes desto iae potuto hien oct tans pA adiu 18 2 4 Ordetrinp Orma OM ccelestis ed eqeast a deuauu toot axe ad dte quasi ag desde 18 Chapter d ATarFBLus o o tino eo ed E esc Eee bU va ISP Sed EEEE 20 A T Alarms Classica oi erea aa benc edi asiste ET c Dedit asiste i ep 20 2 2 AUOIDIC TAE sedem ciat ER Prestiti eae ea ete eee 20 2 5 VISUAL NIAE ope ce i re ae ehe qur etit tec vor iet ug ete vedete lier n UU tite be edi e uda 20 AP Treatment Vie ds UOS poi tm ninth De T siete asi n ADEM dto tSedAMtUtE 2 2 5 l est ATIN oes oso a ed oun du aet ketIa Md det acu tense 21 FOEN SS DOS dta itti tho
68. seven times to open the Date and Time menu 2 Press the CHANNEL key when the cursor stays at Year 3 Press the UP key or DOWN key to choose the year 4 Press the CHANNEL key to confirm selection 5 In the same way choose the month from 12 the day from 1 31 depending on the year and month the hour in 24 hour format from 0 23 the minute from 0 59 and the second from 0 59 6 Press the AUTO key to exit NOTE The date and time remain in the monitor for at least two months after it switches off You do not have to set date and time before monitoring each time 6 4 Connecting Transducers Check for visible damages of the transducers before connecting them to the monitor every time Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid If damage is found replace them with good ones at once When plugging transducers into the sockets make sure the arrow symbol of the connector is facing up refer to figure 6 1 Figure 6 1 Connecting the transducer When disconnecting a transducer hold the afterbody of the transducer outshell the shaded part shown in figure 6 2 with fingers and push it in slightly and then pull it out Refer to figure 6 2 Figure 6 2 Disconnecting the transducer 29 CADENCE II Fetal Monitor User Manual 6 5 Adjusting the Volume The monitor automatically detects which channel the ultrasound transducer is connected to If both chan
69. tal sounds or umbilical blood flow sound should be avoided 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 examining the pregnant woman s 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 It is impossible to examine 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 2 00 CADENCE II Fetal Monitor User Manual 7 2 3 Switching the FHR Alarm On or Off Always check if the alarm settings are appropriate for your patient before starting a monitoring If the fetal heart alarm 1s switched off the monitor no longer gives any audible or visual warning for this monitoring item Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to Enabled FHR1 Alert or FHR2 Alert press the CHANNEL key 3 Press the UP key or DOWN key to toggle between On default and Off 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit NWARNING Do not switch off the FHR alarm for the condition where the patients safety may be endangered 7 2 4 Changing the FHR Alarm Limits The alarm limits you set determine the condi
70. ted and verified Do not touch the signal input or output connector and the patient simultaneously Equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding Disconnect the power cord before changing fuses Replace them with those of the same specifications only 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 SHOCK HAZARD Do not remove the top panel cover during operation or while power is connected The monitor is not protected against defibrillation Do not apply it during electro surgery or MRI otherwise it might result in harming the patient or the operator To ensure the proper working of the monitor only connect accessories supplied or recommended by the manufacturer to the device Accessory equipment connected to the analog and digital interfaces must be validated 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 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 6060
71. tem Move or reposition the catheter If the trend still displays no fluctuation change intrauterine cable The trend is in a beeline The connector failure A3 8 Blown Fuses SWARNING owitch off the monitor and unplug it before changing the fuse Replace the fuse when it 1s blown The two fuses of CADENCE II monitor are located on the right panel their specifications are Size DSmm 20mm Model T1 6AL 250V 64 CADENCE II Fetal Monitor User Manual To replace a fuse C Place the monitor on a flat surface G With a flat head screw driver push the fuse in for about 1 mm and then unscrew it anticlockwise G Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications C Push the new fuse into the socket for about 1 mm and then screw it clockwise back in position 65 CADENCE II Fetal Monitor User Manual Appendix 4 Abbreviation The abbreviations used in this manual and their full names are listed below Abbreviation FullName woo mmy O 66 CADENCE II Fetal Monitor User Manual Appendix 5 EMC Information Guidance and Manufacture s Declaration A5 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The CADENCE l Fetal Monitor is intended for use in the electromagnetic environment specified below The customer of the user of the CADENCE II Fetal
72. tions that trigger the alarm Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to Lower FHRI Alert or FHR2 Alert press the CHANNEL key 3 Press the UP key or DOWN key to choose the lower limit from 50 130 bpm 4 Press the CHANNEL key to confirm selection 5 Press the UP key or DOWN key to move the cursor to Upper FHRI Alert or FHR2 Alert press the CHANNEL key 6 Press the UP key or DOWN key to choose the upper limit from 150 210 bpm 7 Press the CHANNEL key to confirm selection 8 Press the AUTO key to exit 7 2 5 Changing the FHR Alarm Keep Time The alarm keep time indicates how long the measurement result continues exceeding its limit before the alarm is triggered Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the cursor to Keep FHRI Alert or FHR2 Alert press the CHANNEL key 6 Press the UP key or DOWN key to choose the keep time from 0 30 second s 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 0 CADENCE II Fetal Monitor User Manual 7 2 6 Switching the Probe Detecting Alarm On or Off The monitor detects 1f the US transducer is well connected When the transducer is unplugged the monitor gives an alarm You can switch this alarm on or off 1 Press the SETUP key twice to open the Alarm Configuration menu 2 Press the UP key or DOWN key to move the curs
73. trends by an offset of 20 bpm or 20 bpm Press the SETUP key four times to open the Print Configuration menu 2 Press the UP key or DOWN key to move the cursor to FHR2Offset press the CHANNEL key 3 Press the UP key or DOWN key to choose the offset from 20 bpm 0 bpm and 20 bpm 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit This preset FHR2 offset will be printed on the recorder paper FHR2 20bpm means the FHR2 DECG trend is 20bpm lower than it really 1s FHR2 Obpm means the FHR2 DECG trend is staying at where it really 1s FHR2 20bpm means the FHR2 DECG trend is 20bpm higher than it really is _ 38 CADENCE II Fetal Monitor User Manual 7 5 Monitoring Uterine Activity UA Externally 5 1 Parts Required 1 TOCO transducer 2 Belt 7 5 2 Operation Procedure 1 Placing Transducer Belt Place the transducer belts across the bed ensuring that the belt will be around the abdomen when it 1s fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange the belt around her abdomen 2 Fixing the Transducer Refer to figure 7 1 for the TOCO transducer position Wipe off any gel remaining on abdomen around this area Place the transducer on the patient s fundus to get optimum recording of uterine activity Wrap the abdomen with the belt over the transducer Fix the transducer by pushing its buckle through the overlapping section of the belt Ma
74. unded 3 slot power output special for hospital usage C Make sure the AC power supply complies with the following specification 100V 240V 50Hz 60 Hz NWARNING If the protective grounding protective earth system is doubtful the monitor must be powered only by the inner power 2 4 Feeding Paper Feeding Paper If the paper is used up or a paper jam happens you have to feed paper The operation procedure 1s as follows 1 Press the coe position simultaneously on both sides of the recorder cover to open the paper compartment 2 Take out the Z fold thermosensitive paper from the wrapper Place the pack in the compartment with the pane facing down and the green safety area on the left 3 Feed the recorder paper into the paper advance slot Figure 2 1 The paper will come out from the notch automatically Adjust the paper length by rotating the gear on the left of the handle if required Paper advance slot Handle The side without print scale faces up Figure 2 1 Diagram of feeding paper 4 Ifthe paper is slantwise pull the handle up and rotate the gear to force the paper out Push the handle down and then feed paper again 5 After closing the cover make sure that the paper can come out from the paper notch NOTES 1 When feeding paper the black handle must be down If a paper jam happens pull up the handle first and then push the gear to force the paper out 2 Feed the paper gently and avoid touchi
75. ursor to PrintTest press the CHANNEL key 3 Press the UP key or DOWN key to toggle between ON and OFF default 4 Press the CHANNEL key to confirm selection 5 Press the AUTO key to exit 25 CADENCE II Fetal Monitor User Manual 5 3 Examples of Printing Pattern V CAUTION 1 If there is any difference between the display and the printout take the printout as criterion 2 If the data is doubtful clinicians should use other methods to verify the results or make diagnoses based on the real condition MFM E ERDENCE MFM 2 CADENC 22407 wai i ne en i 210s i pose ESL AE E E RA ESI U cue eet ao o we I F AA rotes ry tae ee ae ee s gee ee ne er Bee ieee aes ae DES SE SA 006 cP IM I MG e 1 3 p FE a gt secer enem E EELSE AAN METE ME SRI Forme creme Do caer a CES e X ETEEN Peat EE SOE MAIS MO Ign Ga aT Seer ess aad Sie Ae tt S ee Sr ui RUE mat o Figure 5 1 An example of printing pattern American standard recorder paper 26s CADENCE II Fetal Monitor User Manual CADENCE l MFM 2 CADENCE
76. ver limit The DECG measurement result is higher than the preset upper limit or is lower than the preset lower limit over the alarm delay time DECG Over limit eI Low Level Alarm CADENCE II Fetal Monitor User Manual FM Board fault DECG Board fault US1 probe off US1 quality bad US2 quality bad DECG quality bad DECG lead off Low battery energy oignals Overlap The fetal monitoring board can not communicate with the system successfully The DECG board can not communicate with the system successfully Ultrasound transducer 1 is not well connected Ultrasound transducer 2 is not well connected TOCO transducer is not well connected The DECG lead is not well connected to the monitor The IUP connecting cable is not well connected to the monitor FHR1 signal is too weak for the system to process analysis FHR2 signal is too weak for the system to process analysis DECG signal is too weak for the system to process analysis The spiral electrode is not well connected The battery power is too low to support further work of the monitor The two US transducers are aimed at the same fetal heart or the US transducer is aimed at the fetus that the fetal spiral electrode is attached to 99 Restart the monitor and try again contact the manufacturer if the connection still fails Restart the monitor and try again contact the manufacturer if the connection still fails
77. will be heard when you press it 7 auto AUTO key Function Start monitoring or return to the main interface Press this key to start monitoring on the main interface or return to main interface in setup menus 8 CHANNEL CHANNEL key Function 1 If USI socket and US2 socket are separately connected with an ultrasound transducer during monitoring press this key the fetal heart sound will toggle between USI and US2 The default fetal heart sound comes from US1 2 In the setup menus when the cursor is located at the required item press this key to confirm selection 9 up DOWN UPkey DOWN key Function 1 During monitoring press the UP key to increase the fetal heart sound volume of the current channel press the DOWN key to decrease the fetal heart sound volume of the current channel 2 During playback press the UP key to play backward press the DOWN key to play forward 3 In the setup menus press the UP key to move the cursor downward among the menu items press the DOWN key to move the cursor upward among the menu items 4 In the setup menus if an item 1s highlighted press the UP key to adjust the item value to the previous available option press the DOWN key to adjust the item value to the next available option 3 2 3 Indicators Alarm Indicator Power Indicator The monitor is powered off The battery is being charged Charging Indicator No battery or electric charge is full Table 3 1 Indic

Manual - EDAN USA

Contents

Download Pdf Manuals

Related Search

Related Contents