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CADENCE II Fetal Monitor User Manual 

- 66 - 

Appendix 4 Abbreviation 

The abbreviations used in this manual and their full names are listed below: 

Abbreviation Full 

Name 

AC Alternative 

Current 

AFM 

Automatic Fetal Movement [Detection] 

BPM 

Beat(s) Per Minute 

CTG Cardiotocography 

DC Direct 

Current 

DECG Direct 

ECG 

DFHR Direct 

FHR 

ECG Electrocardiogram 

FH Fetal 

Heart 

FHR 

Fetal Heart Rate 

FM Fetal 

Movement 

FS Fetal 

Stimulator 

ICU 

Intensive Care Unit 

ID Identity 

IUP Intra-Uterine 

Pressure 

IUPC Intra-Uterine 

Pressure 

Catheter 

LCD 

Liquid Crystal Display 

MFM 

Manual Fetal Movement [Detection] 

NST Non 

Stress 

Test 

SOV 

Signals Overlap Verification 

TOCO Tocotonometer 

UA Uterine 

Activity 

[TOCO/IUP] 

US Ultrasound 

[Transducer] 

Summary of Contents for CADENCE II

Page 1: ......

Page 2: ...olds 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 installation of the relev...

Page 3: ...Date ECO Version Description 2008 10 31 1 0 1st edition 2009 09 10 ECR QR 9036 1 1 Added key volume adjustment warning notes and abbreviation list Revised SOV position DECG volume and the format of the specification tables ...

Page 4: ...s and Cables 16 3 3 1 Transducers 17 3 3 2 Remote Event Marker 17 3 3 3 Fetal Spiral Electrode 18 3 4 Ordering Information 18 Chapter 4 Alarm 20 4 1 Alarms Classification 20 4 2 Audible Alarm 20 4 3 Visual Alarm 20 4 4 Treatment Measures 21 4 5 Testing Alarms 21 4 6 Alarm Messages 21 4 7 Alarm Defaults 23 Chapter 5 Printing 24 5 1 Function Description 24 5 2 Printing Configuration 25 5 2 1 Switchi...

Page 5: ...toring Internally Optional 37 7 4 3 Signals Overlap Verification SOV 38 7 4 4 Changing FHR2 DECG Offset 38 7 5 Monitoring Uterine Activity UA Externally 39 7 5 1 Parts Required 39 7 5 2 Operation Procedure 39 7 5 3 Changing the UA Baseline 39 7 5 4 Switching the UA Probe Detecting Alarm On or Off 40 7 6 Monitoring Uterine Activity Internally optional 40 7 6 1 Parts Required 40 7 6 2 Directions for...

Page 6: ...ications 56 A1 3 Performance Specifications 57 A1 4 Recorder Specifications 59 A1 5 Lithium ion Battery Specifications 59 A1 6 Low Output Summary Table 60 Appendix 2 Signal Input Output Connector 61 Appendix 3 Troubleshooting 62 A3 1 No Display 62 A3 2 Noise 62 A3 3 Recorder Error 62 A3 4 Ultrasound Monitoring of FHR 63 A3 5 DECG Monitoring of FHR 63 A3 6 Monitoring Contractions External 64 A3 7 M...

Page 7: ...between 5 ºC 41 ºF and 40 ºC 104 ºF 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 A You must check that the equipment cables and transducers do not have visible evidence of damage tha...

Page 8: ...y the operator in the course of the examination The duration of exposure is however fully under the control of the operator Mastery of the examination techniques described in the User Manual will facilitate obtaining the maximum amount of diagnostic information with the minimum amount of exposure The exercising of clinical judgment in the monitoring of low risk patients will avoid unnecessary inso...

Page 9: ...nnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord A SHOCK HAZARD Do not remove the top panel cover during operation or while power is connected A 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 A To ensure the proper working ...

Page 10: ...A Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor A 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 A If liquid leaks of the battery onto your skin or clothes wash well with fresh water immediatel...

Page 11: ...ispose of it properly A 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 f...

Page 12: ...pecial 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 ...

Page 13: ...tallation A Carefully place the monitor upside down on a flat surface covered with cloth or other types of protecting pad A Remove the screw of the battery compartment A Remove the battery compartment cover A Take the battery out from package Place the battery into the compartment with the wired direction on the outside A Insert the cable connector into the socket A Close the battery compartment c...

Page 14: ... 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 Figure 2 1 D...

Page 15: ...or DECG cable connector falls off 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 ...

Page 16: ... FHR2 DECG dual configuration and TOCO IUP trend and numerics Also a built in thermal recorder is used to print the trends and other information A rechargeable lithium ion battery is provided for your option A DB9 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...

Page 17: ... 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 Display Screen Charging Indicator Keys Recorder ...

Page 18: ...ocated at the bottom of the screen which indicates current status of the monitor a AC power supplied no AC power supplied b The battery is loaded and the white pane indicates the charge of the battery means no battery is loaded c The recorder is printing The recorder stops printing d The audible alarm sound is activated The audible alarm sound is inactivated e The monitor is online The monitor is ...

Page 19: ...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...

Page 20: ...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 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 re...

Page 21: ...e 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 ...

Page 22: ... for the mains supply 100V 240V 50Hz 60Hz 3 2 5 Base Panel 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 Hanging ...

Page 23: ...his 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 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 CAUTION The waterproof parts of the US TOCO transducer are restricted to t...

Page 24: ...proved 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 Accessory Part Number Ultrasound Transducer MS3 109301 TOCO Transducer MS3 31527 Remote Event Marker MS3 107673 Belt MS2 02264 ...

Page 25: ...terine Pressure Cable Connecting Wire MS1R 107796 Intrauterine Pressure Cable MS1 104152 Disposable Intrauterine Pressure Catheter MS1 104153 Rechargeable Lithium ion Battery M21 064117 Thermosensitive Paper American Standard MS1 01921 Thermosensitive Paper European Standard M50R 78019 Fuse T1 6AL 250V M21 64010 Power Cord American Standard M13 36015 Power Cord European Standard M13R 36014 Recharg...

Page 26: ... 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 and However the alarm messages will still be displayed and the alarm indicator will still be lit up when an alarm is active W...

Page 27: ...lugs 5 Verify if 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 FHR1 Over limit The FHR1 measurement result is higher than the preset upper limit or is lower than the preset lower limit ov...

Page 28: ... Check the connection of the IUP connecting cable US1 quality bad FHR1 signal is too weak for the system to process analysis Check if the US transducer 1 is well aimed at the fetus check the woman s condition US2 quality bad FHR2 signal is too weak for the system to process analysis Check if the US transducer 2 is well aimed at the fetus check the woman s condition DECG quality bad DECG signal is ...

Page 29: ... bpm in increments of 5 120 bpm FHR1 FHR2 DECG Upper Limit 150 bpm 210 bpm in increments of 5 160 bpm FHR1 FHR2 DECG Keep Time 0 30 second s in increments of 5 30 seconds US1 US2 DECG Probe Detecting On Off On FHR1 FHR2 DECG Signal Quality Detecting On Off On UA Probe Detecting Toco transducer detecting On Off On SOV signals overlap verification On Off Off ...

Page 30: ...ard at the end of the printing This length is adjustable Refer to 5 2 3 Choosing the Printing Time Length A 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 c...

Page 31: ...m 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 1 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 ...

Page 32: ...e 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 Figure 5 1 An example of printing pattern American standard recorder paper ...

Page 33: ...he patient presses the remote event marker when she feels a fetal movement This symbol indicates a fetal movement is 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 FHR1 trend mark The broad trend is FHR1...

Page 34: ...witching On the Monitor WARNING 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 swi...

Page 35: ...ter 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 int...

Page 36: ...he 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 is 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 ...

Page 37: ...gnal 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 ...

Page 38: ...ut comfortably Meanwhile fetus heart sound is heard clearly and the FHR trace and value are displayed on the screen CAUTION Do not mistake the higher maternal heart rate for fetal heart rate NOTES 1 The best quality records will only be obtained if the transducer is placed in the optimum position 2 Positions with strong placental sounds or umbilical blood flow sound should be avoided 3 If the fetu...

Page 39: ...arm 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 Lower FHR1 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 FHR1 Alert or FHR2 Alert press the CHANNEL key 6...

Page 40: ...efault 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 is ensured The fetal electrode tip is designed to penetrate the epidermis of the fetus therefore trauma hemorrhage and or infection can...

Page 41: ...ires locked in the handle notch 2 Gently bend the guide tube to the desired angle 3 With the patient in the dorsal lithotomy position perform a vaginal examination and clearly identify the fetal presenting part 4 Holding the drive handle ensure the spiral electrode is retracted approximately one inch 2 5 cm from the distal end of the guide tube 5 Place the guide tube firmly against the identified ...

Page 42: ...r 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 patient s 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 m...

Page 43: ...y 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 7 4 1 Monitoring Twins Externally To monitor twin FHRs externally you need to connect a US transducer to FHR1 socket and the second US transducer to FHR2 socket Follow the instructions described in section 7 2 Monitoring FHR ...

Page 44: ... 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 trends by an offset of 20 bpm or 20 bpm 1 Press the SETUP key fo...

Page 45: ...ent snugly but comfortably 3 Adjust the Value to Zero Press the AUTO ZERO key to adjust the value to the baseline Make sure this is 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 wou...

Page 46: ...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 c...

Page 47: ... 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 Figure 7 6 Rezeroing the system 2 During this period adjust t...

Page 48: ...rilized 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 Insert IUPC using the procedure described in section 7 6 2 Directions for Use of IUPC 2 Connect the IUPC to the IUP cable See figure 7 7 Figure 7 7 Connect catheter t...

Page 49: ...n 7 7 Fetal Movement Monitoring The fetal movement count on the main interface comes either from ultrasound AFM or remote event marker Manual 7 7 1 Choosing the FM Source 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 FMSource press the CHANNEL key 3 Press the UP key or DOWN key to toggle between Manual default an...

Page 50: ... 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 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 AFMThreshold press the CHANNEL key 3 Press the UP key or DOWN key to choose the threshold from 0 100 the defaul...

Page 51: ...tion 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 1 Press the SETUP key once to open the Function menu 2...

Page 52: ... enable or disable the manual login 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 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 Monitor...

Page 53: ...n 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 appears in the trend area Now you can press the DOWN key to play the trends backward The symbol turns into Keep pressing it to ac...

Page 54: ...ng 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 t...

Page 55: ...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 pri...

Page 56: ...ty 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 is once a year or as specified in the institution s test and inspe...

Page 57: ...der 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 ºC 104 ºF 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 unreadabl...

Page 58: ...re 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 remai...

Page 59: ...cting cable Mild alcohol free soap water CAUTION 1 Be sure the temperature of cleaning solutions does not exceed 45 ºC 113 ºF 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 m...

Page 60: ...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 sterili...

Page 61: ...ADENCE II Fetal Monitor User Manual 55 Chapter 9 After Sales Service If you have any question about maintenance technical specifications or malfunctions of devices contact the manufacturer or distributor ...

Page 62: ... 3 6 kg Operating Voltage 100V 240V Operating Frequency 50Hz 60Hz Input Power 60VA Power Supply Battery 14 8V 6600mAh Standards Compliance 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 Anti electric Shock Degree FHR1 FHR2 TOCO FM FS B IUP BF DECG CF Degree of Protection agai...

Page 63: ...CD Size 5 7 Active Area 103 0 W x 79 0 H mm 320 x 240 dots Resolution 85 dots per inch Display Backlight Cold cathode fluorescent Signal Interface DB9 network interface Ultrasound Transducer Weight 190g Cable Length 2 5m Dimension 88mm 35mm TOCO Transducer Weight 180g Cable Length 2 5m Dimension 88mm 35mm Remote Event Marker Length 2 5m Weight 56g A1 3 Performance Specifications Technique Ultrasou...

Page 64: ...c power 26 6 Technique Peak peak detection technique DFHR Measurement Range 30bpm 240bpm Resolution 1bpm Accuracy 1bpm Input Impedance 10M Differential DC50 60Hz Input Impedance 20M Common Mode CMRR 110dB Noise 4µVp Skin Voltage Tolerance 500mV DECG Fetal Input Voltage Current 20µVp 3mVp TOCO Range 0 100 Non linear Error 10 Resolution 1 Zero Mode Automatic Manual TOCO Dielectric Strength 4000Vrms ...

Page 65: ...d 20bpm cm international standard TOCO IUP Printout Width 3 4cm USA standard 2 4cm international standard TOCO IUP Scaling 25 0 85cm USA standard 25 0 6cm international standard Data Accuracy 5 X axis 1 Y axis Record Message Date time TOCO type paper speed FHR type bed No etc A1 5 Lithium ion Battery Specifications Operating Temperature 20 C to 35 C 4 F to 95 F Relative Humidity 65 20 Nominal Capa...

Page 66: ...ºC to 20 ºC 4 ºF to 68 ºF During storage recharge the battery at least every six months Charge State When Leaving Factory 20 50 Cycle Life 500 times 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 Transducer Model Ispta 3 mW cm2 TI Type TI Value MI Ipa 3 MImax W cm2 TIS 0 055...

Page 67: ...lid version of the system standard IEC EN 60601 1 1 Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt contact our technical service department or your local distributor DB9...

Page 68: ... Cause Solution The FHR volume is set to be too high Adjust the volume down Noise Interfered by handset or other interfering source Keep the handset or other interfering source far away A3 3 Recorder Error Symptom Possible Cause Solution Paper jam Wrong feeding paper or paper is affected by damp Feed paper correctly and keep paper from moist The PRINT key is disabled Press the PRINT key again Out ...

Page 69: ...sonic coupling gel Use recommended aquasonic coupling gel quantity Record maternal heart rate wrongly Change the position of the ultrasound transducer Doubtful FHR The transducer is not well placed in position and the mixed noise has been recorded Adjust the position of the transducer Improper paper Use the paper recommended by the manufacturer Faint trace or no trace Adjusting nuts of the print h...

Page 70: ...itoring Contractions Internal Symptom Possible Cause Solution No trend The intrauterine catheter is jammed Wash with disinfector No pressure change when uterine contraction Dry environment or the tip of intrauterine catheter is placed extraovularly Wash with disinfector or change the position of transducer Only see the IUP peak but no baseline Zero adjustment is wrong Zero the system The trend is ...

Page 71: ... flat head screw driver push the fuse in for about 1 mm and then unscrew it anticlockwise A Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications A Push the new fuse into the socket for about 1 mm and then screw it clockwise back in position ...

Page 72: ... Cardiotocography DC Direct Current DECG Direct ECG DFHR Direct FHR ECG Electrocardiogram FH Fetal Heart FHR Fetal Heart Rate FM Fetal Movement FS Fetal Stimulator ICU Intensive Care Unit ID Identity IUP Intra Uterine Pressure IUPC Intra Uterine Pressure Catheter LCD Liquid Crystal Display MFM Manual Fetal Movement Detection NST Non Stress Test SOV Signals Overlap Verification TOCO Tocotonometer U...

Page 73: ...nment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 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 RF emission CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IE...

Page 74: ...5 1 kV line to line 2 kV line to ground 1 kV line to line 2 kV line to ground Mains power quality should be that of a typical commercial or hospital environment Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Voltage dips short interruptions and...

Page 75: ...z 3Vrms 3 V m 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 equation applicable to the frequency of the transmitter Recommended separation distance P V d 1 5 3 P E d 1 5 3 80 MHz to 800 MHz P E d 1 7 800 MHz to 2 5 GHz Where P is the maximum output po...

Page 76: ...t 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 ope...

Page 77: ...s equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P V d 1 5 3 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 5 GHz P E d 1 7 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 1 2 1 2 2 3 10 3 7 3 7 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters ...

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