EDAN CADENCE II User Manual
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EDAN CADENCE II User Manual

EDAN CADENCE II User Manual

Fetal monitor
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  • Page 2 P/N: MS1R-111066-1.1 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.
  • Page 3 Revision History Date ECO# Version Description 2008/10/31 edition Added key volume adjustment, warning notes and abbreviation list. 2009/09/10 ECR-QR-9036 Revised SOV position, DECG volume and the format of the specification tables.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance...................... 1 1.1 Intended Use........................1 1.2 Instruction for Safe Operation..................1 1.3 Ultrasound Safety Guide ....................2 1.4 Safety Precautions ......................2 1.5 Definitions and Symbols ....................5 Chapter 2 Installation Guidance..................... 7 2.1 Opening the Package and Checking................
  • Page 5 Chapter 7 Monitoring ......................31 7.1 Confirming Fetal Life....................31 7.2 Monitoring FHR with Ultrasound ................31 7.2.1 Parts Required ....................31 7.2.2 Operation Procedure..................31 7.2.3 Switching the FHR Alarm On or Off ..............33 7.2.4 Changing the FHR Alarm Limits ..............33 7.2.5 Changing the FHR Alarm Keep Time...............
  • Page 6 7.10.4 Fetal Monitoring Values.................. 49 7.11 Completing Monitoring..................... 49 7.12 Switching Off the Monitor ..................49 Chapter 8 Maintenance, Care and Cleaning ............... 50 8.1 Preventive Maintenance ....................50 8.1.1 Maintaining Inspection..................50 8.1.2 Maintenance of the Monitor................50 8.1.3 Maintenance of the Transducers ............... 51 8.1.4 Storage of Recorder Papers ................

  • Page 7: Chapter 1 Safety Guidance

    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 rooms. It is not intended for use in intensive care units, operating rooms or for home use.

  • Page 8: Ultrasound Safety Guide

    Instructions for Use in Minimizing Patient Exposure The acoustic output of CADENCE II is internally controlled and can not be varied by the operator in the course of the examination. The duration of exposure is, however, fully under the control of the operator.
  • Page 9 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.
  • Page 10 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.

  • Page 11: Definitions And Symbols

    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 connector becomes dirty, wipe it with a dry cloth.
  • Page 12 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.

  • Page 13: Chapter 2 Installation Guidance

    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.

  • Page 14: Connecting The Power Cable

    CADENCE II Fetal Monitor User Manual 2.3 Connecting the Power Cable 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 grounded 3-slot power output special for hospital usage.
  • Page 15 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.

  • Page 16: Chapter 3 Introduction

    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).

  • Page 17: Monitor

    TOCO Transducer Remote Ultrasound Transducer Event Marker Figure 3-1 CADENCE II appearance (dual configuration) 3.2.1 Display The display of the monitor is used to show the information of 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.
  • Page 18 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 Information frame Figure 3-3 Display screen...
  • Page 19 CADENCE II Fetal Monitor User Manual : Time length, the duration of the current monitoring. (2) Trend/Menu Frame The trend/menu frame occupies most space of the screen. During monitoring and playing back, it displays trends; during setting, it displays setup menus.

  • Page 20: Key Functions And Operations

    CADENCE II Fetal Monitor User Manual 3.2.2 Key Functions and Operations 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: SETUP key Function: Enter setup menus.

  • Page 21: Indicators

    CADENCE II Fetal Monitor User Manual During playback this key is invalid. An abnormal audio will be heard when you press it. 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).

  • Page 22: Sockets On The Right Side Of The Monitor

    CADENCE II Fetal Monitor User Manual 3.2.4 Sockets on the Right Side of the Monitor Figure 3-5 Sockets on the right side of the monitor Power Switch: On/Off switch. Fuse: Size: Ф5mm*20mm Model: T1.6AL 250V Power Socket: Input socket for the mains supply 100V-240V~, 50Hz/60Hz.

  • Page 23: Transducers

    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.

  • Page 24: Fetal Spiral Electrode

    CADENCE II Fetal Monitor User Manual Figure 3-9 Remote event marker 3.3.3 Fetal Spiral Electrode 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.
  • Page 25 CADENCE II Fetal Monitor User Manual Coupling Gel (0.25ltr bottle) M50-78001 Fetal Stimulator MS9-17660 DECG Cable MS2-12148 Disposable Fetal Spiral Electrode MS0-02145 Disposable Maternal Attachment Pad Electrode MS0-02146 Intrauterine Pressure Cable Connecting Wire MS1R-107796 Intrauterine Pressure Cable MS1-104152 Disposable Intrauterine Pressure Catheter...

  • Page 26: Chapter 4 Alarm

    CADENCE II Fetal Monitor User Manual Chapter 4 Alarm 4.1 Alarms Classification When a patient’s vital sign exceeds its configured 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.

  • Page 27: Treatment Measures

    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 if necessary;...
  • Page 28 CADENCE II Fetal Monitor User Manual Low Level Alarm The fetal monitoring board can not Restart the monitor and try again, communicate with system contact the manufacturer if the FM Board fault successfully. connection still fails. DECG board Restart the monitor and try again,...

  • Page 29: Alarm Defaults

    CADENCE II Fetal Monitor User Manual 4.7 Alarm Defaults Alarm Setting Options Default On, Off FHR1/FHR2/DECG Alert 50 bpm ~ 130 bpm, in increments of 5. 120 bpm FHR1/FHR2/DECG Lower Limit 150 bpm ~ 210 bpm, in increments of 5.

  • Page 30: Chapter 5 Printing

    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).

  • Page 31: Printing Configuration

    CADENCE II Fetal Monitor User Manual 5.2 Printing Configuration CAUTION Set 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.

  • Page 32: Examples Of Printing Pattern

    CADENCE II Fetal Monitor User Manual 5.3 Examples of Printing Pattern 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.
  • Page 33 CADENCE II Fetal Monitor User Manual 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 that an alarm is active. This symbol indicates a manual fetal movement, and it appears after the patient presses the remote event marker when she feels a fetal movement.

  • Page 34: Chapter 6 Pre-Monitoring Preparation

    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.

  • Page 35: Setting Date And Time

    CADENCE II Fetal Monitor User Manual 6.3 Setting Date and Time 1 Press the SETUP key 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.

  • Page 36: Adjusting The Volume

    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 channels are connected with US transducers, the fetal heart sound of US1 is heard by default.

  • Page 37: Chapter 7 Monitoring

    CADENCE II Fetal Monitor User Manual Chapter 7 Monitoring WARNING The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use. The monitor is not protected against defibrillation. Do not apply it during electro-surgery or MRI;...
  • Page 38 CADENCE II Fetal Monitor User Manual when it is 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.

  • Page 39: Switching The Fhr Alarm On Or Off

    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 is switched off, the monitor no longer gives any audible or visual warning for this monitoring item.

  • Page 40: Switching The Probe Detecting Alarm On Or Off

    CADENCE II Fetal Monitor User Manual 7.2.6 Switching the Probe Detecting Alarm On or Off The monitor detects if the US transducer is well connected. When the transducer is unplugged, the monitor gives an alarm. You can switch this alarm on or off.

  • Page 41: Parts Required

    CADENCE II Fetal Monitor User Manual 7.3.2 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 is important to facilitate good electrode contact to skin.

  • Page 42: Decg Monitoring Procedure

    CADENCE II Fetal Monitor User Manual 7.3.5 DECG Monitoring Procedure 1 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.

  • Page 43: Changing Decg Volume

    CADENCE II Fetal Monitor User Manual recorded. When the DECG arrhythmia logic is disabled, the monitor records all the fetal heart beats. If you have doubts 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.

  • Page 44: Signals Overlap Verification (Sov)

    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”...

  • Page 45: Monitoring Uterine Activity (Ua) Externally

    CADENCE II Fetal Monitor User Manual 7.5 Monitoring Uterine Activity (UA) Externally 7.5.1 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 is fastened.

  • Page 46: Switching The Ua Probe Detecting Alarm On Or Off

    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.
  • Page 47 CADENCE II Fetal Monitor User Manual Figure 7-3 Separate the introducer 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.

  • Page 48: Operation Procedure

    CADENCE II Fetal Monitor User Manual adequately ruptured and sufficient cervical dilatation assured. 2) Try to insert the catheter opposite the placental site. Do not insert the introducer beyond the cervical OS. Use it with caution when uterine infection is present.

  • Page 49: Checking Intrauterine Pressure Cable Function

    CADENCE II Fetal Monitor User Manual 7.6.4 Checking Intrauterine Pressure Cable Function To test an IUP cable’s function: 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 Verify that the green light is continuously lit (no flashing).

  • Page 50: Enabling/Disabling Afm Trend

    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 FHR1 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.

  • Page 51: Clearing Fm Count

    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.

  • Page 52: Enabling / Disabling Manual Login

    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 CHANNEL key.

  • Page 53: Fetal Monitoring Trends

    CADENCE II Fetal Monitor User Manual 7.10.1 Fetal Monitoring Trends Alarm message 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): FHR1 trend, FHR2/DECG trend, AFM trend and TOCO/IUP trend.

  • Page 54: Trends Loading

    CADENCE II Fetal Monitor User Manual Press the UP key to play the trends forward. The symbol turns into >. Keep pressing it to accelerate until it reaches the maximum speed; the symbol turns into >>>>>. Press the DOWN key to decelerate.

  • Page 55: Fetal Monitoring Values

    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. : FH refreshing rate 169: FHR1 value. US2: FHR2 socket is connected with a US transducer.

  • Page 56: Chapter 8 Maintenance, Care And Cleaning

    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: Check the monitor and accessories to see if there is any visible evidence of damage that may affect patient safety.

  • Page 57: Maintenance Of The Transducers

    CADENCE II Fetal Monitor User Manual The gathering of dew on the display may occur with abrupt temperature or humidity changes. A table environment is recommended. Scratching and damaging the display should be avoided. Avoid high voltage and static charge.

  • Page 58: Cleaning

    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 WARNING Unplug the monitor from the AC power source and detach all accessories before cleaning.

  • Page 59: Disinfecting

    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;...

  • Page 60: Sterilizing

    CADENCE II 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.

  • Page 61: Chapter 9 After-Sales Service

    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 -...

  • Page 62: Appendix 1 Product Specifications

    CADENCE II Fetal Monitor User Manual Appendix 1 Product Specifications A1.1 Environmental Specifications Temperature: +5 ºC ~+ 40 ºC ( +41 ºF ~ +104 ºF) Working Relative Humidity: 25% ~ 80% (non-condensing) Atmospheric Pressure: 860hPa ~ 1060hPa Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF)

  • Page 63: A1.3 Performance Specifications

    CADENCE II Fetal Monitor User Manual Working System Continuous running equipment Earth Leakage Current (Limit) N.C. S.F.C. 500µA 1000µA Enclosure Leakage Current (Limit) N.C. S.F.C. 100µA 500µA Patient Leakage Current (Limit) N.C. S.F.C. d.c. 10µA 50µA a.c. 10µA 50µA Patient Auxiliary Current (Limit) N.C.
  • Page 64 CADENCE II Fetal Monitor User Manual p- <1 MPa <10 mW/cm <100 mW/cm spta FHR Measurement Range: 50 bpm ~ 240 bpm Resolution: 1 bpm Accuracy: ±2 bpm Dielectric Strength: > 4000Vrms ISATA@ the transducer face: 1.865 mW/cm Entrance beam: 6.08 cm Measurement uncertainties for ISATA: +26.6%...

  • Page 65: A1.4 Recorder Specifications

    CADENCE II Fetal Monitor User Manual Technique: Pulsed Doppler ultrasound Range: 0% ~ 100%, Resolution: Marking Manual fetal movement mark A1.4 Recorder Specifications Recorder paper: Z-fold, thermal Printing Width: 112mm Effective Printing Width: 104mm Paper Advance Speed: 1cm/min, 2cm/min and 3cm/min optional...

  • Page 66: A1.6 Low Output Summary Table

    CADENCE II Fetal Monitor User Manual Maximum Charge 2000mA Current Continuously Short Term (within 1 month): -20 ºC to 60 ºC (-4 ºF to 140 ºF) Middle Term (within 3 months): -20 ºC to 45 ºC (-4 ºF to 113 ºF)

  • Page 67: Appendix 2 Signal Input/Output Connector

    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.

  • Page 68: Appendix 3 Troubleshooting

    CADENCE II Fetal Monitor User Manual Appendix 3 Troubleshooting A3.1 No Display Symptom Possible Cause Solution Tighten the power cable and Power cable is loose and no check the fuse, or check the battery battery Power indicator is off The fuse(s) is (are) blown.

  • Page 69: A3.4 Ultrasound Monitoring Of Fhr

    CADENCE II Fetal Monitor User Manual A3.4 Ultrasound Monitoring of FHR Phenomenon Possible Cause Solution Monitor FHR with DECG if the Thick abdominal wall membrane is adequately ruptured. Adjust position Improper ultrasound transducer transducer till the better signal is position.

  • Page 70: A3.6 Monitoring Contractions (External)

    Switch off the monitor and unplug it before changing the fuse. Replace the fuse when it is blown. The two fuses of CADENCE II monitor are located on the right panel, their specifications are: Size: Ф5mm*20mm; Model: T1.6AL 250V. - 64 -...
  • Page 71 CADENCE II Fetal Monitor User Manual To replace a fuse: Place the monitor on a flat surface. With a flat-head screw driver, push the fuse in for about 1 mm and then unscrew it anticlockwise. Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications.

  • Page 72: Appendix 4 Abbreviation

    CADENCE II Fetal Monitor User Manual Appendix 4 Abbreviation The abbreviations used in this manual and their full names are listed below: Abbreviation Full Name Alternative Current Automatic Fetal Movement [Detection] Beat(s) Per Minute Cardiotocography Direct Current DECG Direct ECG...

  • Page 73: Appendix 5 Emc Information - Guidance And Manufacture's Declaration

    Guidance and manufacture’s declaration – electromagnetic emission The CADENCE II Fetal Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the CADENCE II Fetal Monitor should assure that it is used in such and environment.

  • Page 74: 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.

  • Page 75: A5.3 Electromagnetic Immunity - 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.
  • Page 76 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.

  • Page 77: A5.4 Recommended Separation Distance

    The CADENCE II 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 and mobile RF communications equipment (transmitters) and the CADENCE II Fetal Monitor as recommended below, according to the maximum output power of the communications equipment.

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