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EDAN INSTRUMENTS CADENCE User Manual

Fetal monitor
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EDAN INSTRUMENTS, INC
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Manual Ver.: 1.6
Release Date: Aug. 2008
Part No.: MS1R-02284-V1.6

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Summary of Contents for EDAN INSTRUMENTS CADENCE

  • Page 1 EDAN INSTRUMENTS, INC Manual Ver.: 1.6 Release Date: Aug. 2008 Part No.: MS1R-02284-V1.6...
  • Page 2 © Copyright EDAN INSTRUMENTS, INC. 2008. All rights reserved. Statement Edan Instruments, Inc. (hereinafter called EDAN) makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. EDAN assumes no responsibility for any error that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material.
  • Page 3 information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. Using This Label Guide This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance ......................1 1.1 Instruction for the Safe Operation................. 1 1.2 Ultrasound Safety Guide....................2 1.3 Safety Precautions......................2 1.4 Definitions and Symbols....................4 Chapter 2 Introduction......................6 2.1 Intended Use ......................... 6 2.2 General Information...................... 6 2.3 Features .........................
  • Page 5 6.3.2 Cleaning of Fetal ECG Cable................32 6.4 Cleaning of Recorder ....................32 6.5 Cleaning of Belt ......................32 6.6 Sterilization ......................... 32 6.7 Disinfection......................... 33 6.8 Care of Record Paper ....................33 Appendix 1 Product Specifications..................34 A1.1 Monitor........................34 A1.2 Transducers and Cables....................

  • Page 6: Chapter 1 Safety Guidance

    Chapter 1 Safety Guidance 1.1 Instruction for the Safe Operation Z The CADENCE Fetal Monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is class I equipment. Z The CADENCE Fetal Monitor operates within specifications at ambient temperatures between 5°C and 40°C.

  • Page 7: Ultrasound Safety Guide

    Z Instructions for Use in Minimizing Patient Exposure The acoustic output of CADENCE is internally controlled and can not be varied by the operator in the course of the examination. The duration of exposure is, however, fully under the control of the operator.
  • Page 8 Cadence Fetal Monitor User Manual : The fetal spiral electrode and intrauterine pressure catheter are WARNING disposable, and single use only-discard after use. : The fetal spiral electrode should be removed from the patient before WARNING performing any electrosurgical procedure.

  • Page 9: Definitions And Symbols

    Cadence Fetal Monitor User Manual : The device and reusable accessories could be sent back to the CAUTION manufacturer for recycling or proper disposal after their useful lives. 1.4 Definitions and Symbols Socket for Channel 1 Ultrasound Transducer (for connection with...
  • Page 10 Cadence Fetal Monitor User Manual Type B Applied Part Symbol Type BF Applied Part Symbol Type CF Applied Part Symbol This item is compliant with Medical Device Directive 93/42/EEC of June 14, 1993, a directive of the European Economic Community.

  • Page 11: Chapter 2 Introduction

    DB9 interface, and the wireless network module will complete the data transmission of the monitor and the MFM-CNS Obstetrical Central Monitoring System. The data collected and saved by the CADENCE Fetal Monitor can be analyzed and printed by the CADENCE Insight software running on PC.

  • Page 12: Ordering Information

    Z Lightweight, compact size 2.4 Ordering Information Accessories supplied or approved by EDAN can be used with the CADENCE Fetal Monitor. See the following table for details. Accessory (Spare Part)

  • Page 13: Chapter 3 Monitor And Accessories

    Cadence Fetal Monitor User Manual Chapter 3 Monitor and Accessories Figure 3.1 CADENCE appearance (single (one fetus) configuration) LED Display Model Push Buttons Indicators Recorder Remote Marker TOCO Transducer Ultrasound Transducer 3.1 Monitor 3.1.1 Push Buttons There are several push buttons with different functions on the front panel of the monitor. The diagram is shown as Figure 3.2, and their primary functions are as follows:...
  • Page 14 Cadence Fetal Monitor User Manual (1) SETUP Button Function: Press the button to enter setup mode, the numerical LED display is in red color. The color of the numerical LED may be red or green. While the monitor is in the setup mode, the numerical LED is all red;...
  • Page 15 Cadence Fetal Monitor User Manual Parameter Meaning Adjustable Value 1-4 adjustable; The default is 3, and the interval is AFM Gain 0-100 adjustable; The default is 30, and the AFM Threshold interval is 10 0-60 (minutes) adjustable. The default is 0 minute,...
  • Page 16 Cadence Fetal Monitor User Manual (3) PRINT Button Function: Enable/Disable printing. Power on, the print indicator status is shut off after self-test, and no printing. When pressing the PRINT button, the print indicator will be green and the recorder works. If print indicator is still off, and the recorder gives out alarm audio, the printing function can not be executed and the operation is failed.

  • Page 17: Indicators

    Cadence Fetal Monitor User Manual be given out. 2) Do not press any button continuously, otherwise, uncertain result will happen. 3) Press any button, if succeed, the speaker will make a sound of "Do"; If failed, the speaker makes no sound.

  • Page 18: Recorder

    Cadence Fetal Monitor User Manual Green TOCO pressure is at the range from 0 to 100 TOCO Indicator Orange TOCO pressure equals to 0 or is over 100 TOCO transducer is off Intrauterine pressure is at the range from 0 to...
  • Page 19 Cadence Fetal Monitor User Manual Figure 3.5 An example of printing pattern (USA standard record paper) Figure 3.6 An example of printing pattern (international standard record paper) : Indicates the alarm status information of monitoring. Indicates the fetal movement event marked by the patient.

  • Page 20: Sockets On The Right Side Of The Monitor

    Cadence Fetal Monitor User Manual Note: When paper is used up, the recorder will stop printing and the data of waiting printing will be kept in the memory. After feeding paper again, you can press the PRINT button to continue. The current printing data will lose when ultrasound transducer or DECG cable connector falls off, or power off.

  • Page 21: Toco Transducer

    Cadence Fetal Monitor User Manual Figure 3.9 Label of ultrasound transducer The main information on the label is as follows. PM 2.0: P means pulsed wave, M means multicomponent, 2.0 means central frequency is 2.0 MHz. MS3-01913: EDAN part number for the ultrasound transducer.

  • Page 22: Remote Marker

    Cadence Fetal Monitor User Manual 3.2.3 Remote Marker The remote marker is a hand-held switch operated by patient, shown here. The mother is normally instructed to push down this switch when feeling fetal movement. The remote marker will add an event mark to the record paper.

  • Page 23: Chapter 4 Getting Started

    Connect the DB9 interface of the monitor with one end of RS232, and connect the DB9 interface of the wireless network module with the other end of RS232. When CADENCE Fetal Monitor and the MFM-CNS Obstetrical Central Monitoring System work, the wireless network module will complete the transmission of data between them.
  • Page 24 Cadence Fetal Monitor User Manual the left and the face of the paper downward. Put the paper into the box. 3) Feed the record paper into the slot of the recorder (Figure 4.1) and the paper will go out from the notch automatically.

  • Page 25: Power On The Monitor

    Cadence Fetal Monitor User Manual Removing Paper Jam When the recorder functions or sounds improperly, open the recorder door to check for a paper jam. Removing the paper jam in the following way: Cut the record paper from the paper notch edge.

  • Page 26: Chapter 5 Monitoring

    Cadence Fetal Monitor User Manual Chapter 5 Monitoring 5.1 Ultrasound Monitoring of FHR Ultrasound monitoring is a method to obtain FHR through maternal abdominal wall. Put the FHR transducer on maternal abdomen to transmit lower energy ultrasound wave to fetal heart, then receive the echo signal from it.

  • Page 27: Fetal Ecg Electrode Monitoring Of Fhr

    Cadence Fetal Monitor User Manual Good: green and flash Poor: orange and flash 4) Monitor Adjustments Readjust the volume settings for the desired loudness. Figure 5.1 Ultrasound transducer & TOCO transducer positioning Measure TOCO Measure FHR : Do not mistake the higher maternal heart rate for fetal heart rate.
  • Page 28 Cadence Fetal Monitor User Manual Parts Required 1) Fetal ECG cable 2) Disposable fetal spiral electrode 3) Attachment pad Operation Procedure Perform a vaginal examination and clearly identify the fetal presenting part. Using a sterile technique to attach the fetal spiral electrode to the fetal presenting part as described in the Directions for Use of Fetal Spiral Electrode at this section.

  • Page 29: Dual Heart Rate Monitoring

    Cadence Fetal Monitor User Manual Notes: 1) If the DECG arrhythmia logic is disconnected during monitoring, remember to connect it later. 2) If there is any doubt as to the presence of a fetal heart signal with ECG, check with the ultrasound transducer on the mother or with a separate diagnostic instrument.

  • Page 30: Monitoring Uterine Activity

    Cadence Fetal Monitor User Manual 5.4 Monitoring Uterine Activity Use a TOCO transducer to external measure uterine activity, or use an intrauterine pressure catheter to internal measure uterine activity (Only ruptured membranes and adequate dilation can the internal contractions be monitored).
  • Page 31 Cadence Fetal Monitor User Manual Directions for Use of IUPC Preparation Gather supplies: ACCU-TRACE IUPC, reusable cable, and amniounfusion supplies if needed. Open the sterile ACCU-TRACE IUPC package. Insertion NOTE: This product is designed for use with the introducer. Using aseptic technique, remove the catheter from the package.
  • Page 32 Cadence Fetal Monitor User Manual 10) Remove the liner from the adhesive pad, then adhere the pad to the patient’s skin. Secure the catheter by placing the catheter attachment strap to the adhesive pad. (See Figure 5-5). Figure 5-5 Secure the adhesive pad to mother...
  • Page 33 Cadence Fetal Monitor User Manual NOTE: Refer to the instruction on the package for more information about using the IUPC. Operation Procedure Insert IUPC using the procedure described in s Directions For Use of Disposable IUPC. Connect the IUPC to the IUP cable. (See figure 5-7) Figure 5-7 Connect catheter to pressure cable Connect the IUP cable to the connecting cable.

  • Page 34: Remote Marker Recording Of Fetal Movement

    Cadence Fetal Monitor User Manual WARNING The cable test function is not meant to check the accuracy of the system, only to confirm cable function. 5.5 Remote Marker Recording of Fetal Movement Insert the remote marker cable into its socket. When FHR is monitored, the mother takes the remote maker in her hand.

  • Page 35: Chapter 6 Maintenance, Care And Cleaning

    Cadence Fetal Monitor User Manual Chapter 6 Maintenance, Care and Cleaning 6.1 Preventive Maintenance (1) Visual Inspection The user must check that the equipment, cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use. The recommended inspection interval is once per week or less.

  • Page 36: Care And Cleaning Of Accessories

    Cadence Fetal Monitor User Manual 3) Don’t use strong solvent, for example, acetone. 4) Never use an abrasive such as steel wool or metal polish. 5) Do not allow any liquid to enter the product, and do not immerse any part of the monitor into any liquid.

  • Page 37: Cleaning Of Transducers

    Cadence Fetal Monitor User Manual 6.3.1 Cleaning of Transducers Follow these steps to clean a transducer: 1) Clean the transducer with a cloth soaked in a solution of soap and water, or a cleaning solution. Do not immerse the transducer in the solution. Use only the following cleaning...

  • Page 38: Disinfection

    Cadence Fetal Monitor User Manual Ultrasound Transducer √ √ TOCO Transducer √ √ Intrauterine Pressure Cable √ √ Fetal ECG Cable √ √ CAUTION 1) Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest possible density. 2) Do not let liquid enter the monitor.

  • Page 39: Appendix 1 Product Specifications

    Cadence Fetal Monitor User Manual Appendix 1 Product Specifications A1.1 Monitor Physical Dimensions: 330mm x270mm x100mm Characteristics Weight: 3.5 kg or so Safety Comply with: IEC/EN 60601-1, IEC/EN 60601-1-2 Anti-electric Shock Type: Class I equipment without internal power supply Anti-electric Shock Degree:...
  • Page 40 Cadence Fetal Monitor User Manual Display Three digits bi-colors (Green/Red) numerical LED display FHR (FHR1/FHR2) Three digits bi-colors (Green/Red) numerical LED display TOCO/IUP Three digits bi-colors (Green/Red) numerical LED display DECG One printing status LED (Green) One power status LED (Green)
  • Page 41 Cadence Fetal Monitor User Manual DECG Technique: Peak-peak detection technique FHR Range: 50bpm-210bpm (international standard) 30bpm-240bpm (USA standard) Artifact Elimination > ±25bpm changes are ignored Resolution: 1bpm Accuracy: ±1bpm Input Impedance: >10M (differential, dc to 50/60Hz) Input Impedance: >20M (Common mode) CMRR: >110dB...

  • Page 42: A1.2 Transducers And Cables

    Cadence Fetal Monitor User Manual FHR Alarm When FHR (FHR1/FHR2/DECG) is less than the lower limit or higher than the upper limit of alarm over the time of alarm delay, the monitor will give out audio and LED flashing alarm signal.

  • Page 43: A1.3 Acoustic Output Reporting Table

    Cadence Fetal Monitor User Manual A1.3 Acoustic Output Reporting Table Acoustic Output Reporting Table for Track 1 Non-Autoscanning Mode Cadence U1752, U2291, U2318 Transducer Mode： Pulsed sinusoid, 2MHz Operating Mode： Fetal heart monitoring Application(s)： SPTA.3 SPPA.3 Acoustic Output mW/cm W/cm 6.6623E-02...

  • Page 44: Appendix 2 Signal Input/Output Connector

    Cadence Fetal Monitor User Manual Appendix 2 Signal Input/Output Connector Accessory equipment connected to these interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1.

  • Page 45: Appendix 3 Troubleshooting

    Cadence Fetal Monitor User Manual Appendix 3 Troubleshooting A3.1 No Display Symptom Possible Cause Solution Power ON indicator is Power cable is loose Tighten it and check the fuse A3.2 Noise Symptom Possible Cause Solution Too high volume sets Adjust the volume down...

  • Page 46: A3.4 Ultrasound Monitoring Of Fhr

    Cadence Fetal Monitor User Manual A3.4 Ultrasound Monitoring of FHR Symptom Possible Cause Solution Wrong FHR The pregnant woman is too fat Change position Improper ultrasound transducer ultrasound transducer till the position signal indicator is green Inconstant trace Loose belt...

  • Page 47: A3.6 Monitoring Contractions (External)

    Cadence Fetal Monitor User Manual A3.6 Monitoring Contractions (External) Symptom Possible Cause Solution Ensure the belt has been used Too tight or too loose accurately and neither too tight, nor belt or no elasticity too loose Worse trace quality or...

  • Page 48: Appendix 4 Emc Information - Guidance And Manufacture's Declaration

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

  • Page 49: A4.2 Electromagnetic Immunity - For All Equipment And Systems

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

  • Page 50: A4.3 Electromagnetic Immunity - For Equipment And System That Are Not Life-Supporting

    Guidance and manufacture’s declaration – electromagnetic immunity The Cadence Fetal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of Cadence Fetal Monitor should assure that it is used in such an environment.
  • Page 51 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Cadence Fetal Monitor is used exceeds the applicable RF compliance level above, the Cadence Fetal Monitor should be observed to verify normal operation.

  • Page 52: A4.4 Recommended Separation Distance

    The Cadence Fetal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Cadence Fetal Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Cadence Fetal Monitor as recommended below, according to the maximum output power of the communications equipment.
  • Page 53 EDAN INSTRUMENTS, INC. 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. CHINA TEL: +86-755-26882220 FAX: +86-755-26882223 EC REPRESENTATIVE Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, D-20537 Hamburg Germany TEL: +49-40-2513175 FAX: +49-40-255726 E-mail: antonjin@yahoo.com.cn...

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