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EDAN F9 - User Manual

EDAN F9
215 pages
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EDAN Agile PLM Electronic Signature Information
--Signatures related to this document and performed in EDAN Agile PLM.
文件名称(Document Name):F9说明书_英文
文件编号(Number):01.54.107779
版本(Version):2.9
产品型号(Product Model):F9;F9 Express
项目编码(Project Code):2040A000
签批信息(Signature):
作者(Originator) : 周 睿 (zhourui) 2018-10-15 15:36:46
审核人(Reviewers) : 刘 小倩 (liuxiaoqian) 2018-10-15 17:03:21
审核人(Reviewers) : 唐 林 (tanglin) 2018-10-16 09:10:49
审核人(Reviewers) : 明 镭 (minglei) 2018-10-16 13:54:54
审核人(Reviewers) : 张 冬雪 (zhangdongxue) 2018-10-19 12:04:28
审核人(Reviewers) : 占 皓 (zhanhao) 2018-10-29 09:12:01
审核人(Reviewers) : 余 俊煜 (yujunyu) 2018-10-16 18:54:43
批准人(Approvers) : 夏 欢欢 (xiahuanhuan) 2018-11-02 10:35:44
批准人(Approvers) : 吴 明花 (wuminghua) 2018-11-07 14:20:44
批准人(Approvers) : 冀 伟 (jiwei) 2018-11-02 15:35:48
版权©深圳市理邦精密仪器股份有限公司 (Copyright©Edan Instrument,Inc.)

Table of Contents

Other manuals for EDAN F9

Questions and Answers:

EDAN F9 Specifications

General IconGeneral
FHR Range50-240 bpm
Waterproof LevelIPX1
Parameters MonitoredFHR, TOCO
TOCO Range0-100
Recorder Paper Speed1 cm/min, 2 cm/min, 3 cm/min
BatteryRechargeable lithium battery
Battery Life>4 hours
Power SupplyAC 100-240V, 50/60Hz
Operating Temperature10°C to 40°C
Operating Humidity30% to 75% RH

Summary

Chapter 1 Safety Guidance

1.1 Intended Use;Indications for Use

Defines the intended use and patient population for the F9 and F9 Express monitors.

1.2 Features

Lists the key features and supported measurements for F9 and F9 Express models.

1.3 Instruction for Safe Operation

Provides essential safety guidelines for operating the monitor, including environmental and electrical safety.

1.4 Ultrasound Safety Guide

Details specific safety considerations and instructions related to the use of ultrasound monitoring.

1.5 Safety Precautions

Outlines critical warnings and precautions to prevent injury, shock, and explosion hazards during operation.

1.6 Definitions and Symbols

Explains key terms and symbols used throughout the user manual for clarity.

Chapter 2 Introducing the Monitor

2.1 Installation Guide

Guides qualified personnel through the initial setup and installation process for the monitor.

2.2 Overview

Provides a visual and functional overview of the monitor's front panel, keys, and indicators.

2.3 Accessories

Describes the various transducers and accessories that connect to the monitor for different monitoring functions.

2.4 Screen

Explains the main interface layout, including message, trace, numeric, and status windows.

Chapter 3 Introducing the FTS-3 Fetal Telemetry System

3.1 Brief Introduction

Introduces the FTS-3 system, its purpose, components, and intended use in wireless patient monitoring.

3.2 Installation Guide

Details the installation procedures for the FTS-3 system, including package checking and component setup.

3.3 Basic Operation

Covers essential operational procedures for charging transducers/batteries and general system usage.

Chapter 4 Alarms

4.1 Alarm Classification

Explains the different types of alarms (patient, technical) and their severity levels.

4.2 Audible Alarm

Describes the characteristics of audible alarms, including tones, silencing, and indicator behavior.

4.3 Visual Alarm

Details how visual alarms are displayed, including indicator colors, flashing frequencies, and message content.

4.4 Choosing the Alarm Display Form

Guides users on how to select between text or numeric display formats for patient alarms.

4.5 Changing the Alarm Volume

Explains how to adjust the audible alarm volume to low, medium, or high settings.

4.6 *Choosing Alarm Silence Duration

Allows users to configure the duration for silencing audible alarms, from temporary to infinite.

4.7 Choosing Signal Loss Delay

Describes how to adjust the delay time before a technical alarm is issued for signal loss.

4.8 Pausing or Resetting the Alarm

Explains how to enable functions for pausing or resetting audible alarms using the SILENCE key.

4.9 Switching Transducer Unplugged On or Off

Allows users to enable or disable the alarm for transducer disconnection.

4.10 *Reviewing Alarms

Details how to access and review immediate and historical alarm messages on the monitor.

4.11 Alarm Treatment Measures

Provides guidance on immediate actions to take when an alarm occurs, including patient checks and alarm silencing.

4.12 Testing Alarms

Outlines the procedure for testing the functionality of both visible and audible alarms.

4.13 Patient Alarm Defaults

Lists the default settings for various patient alarm parameters and limits.

4.14 Alarm Messages

Details specific patient and technical alarm messages, their causes, and recommended countermeasures.

Chapter 5 Printing

5.1 *Function Description

Describes the capabilities of the built-in thermal recorder, including trace printing and information logging.

5.2 Printing Configuration

Covers settings for auto start printing, paper speed, print timer, and self-check functions.

5.3 Understanding Recorder Paper Printout

Explains how to interpret the information and traces printed on the recorder paper.

Chapter 6 Pre-Monitoring Preparation

6.1 Loading Recorder paper

Provides step-by-step instructions for loading the Z-fold thermosensitive paper into the monitor's recorder.

6.2 Switching On the Monitor

Details the procedure for powering on the monitor and checking its initial status and functions.

6.3 Checking the Recorder Paper

Explains how to verify the correct loading and setting of the recorder paper using the print self-check function.

6.4 Adjusting the Screen Angle

Describes how to adjust the monitor's screen angle for optimal viewing and positioning.

6.5 Setting Date and Time

Guides users through changing the monitor's date, time, and date format settings for accurate record keeping.

6.6 Connecting Transducers

Provides instructions on how to properly connect various transducers to the monitor's input sockets.

6.7 Placing Accessories in the Holder

Explains how to store unused accessories, such as transducers and event markers, in the designated holder.

6.8 Adjusting the Volume

Covers how to adjust the default and real-time monitoring volume levels for fetal heart sounds.

Chapter 7 Fetal Monitoring

7.1 Confirming Fetal Life

Discusses potential sources of confusion for FHR signals and methods to confirm fetal life before monitoring.

7.2 Monitoring FHR with Ultrasound

Details the procedure for monitoring Fetal Heart Rate (FHR) using ultrasound transducers, including positioning and signal acquisition.

7.3 Monitoring FHR with DECG

Explains the process of monitoring FHR using Direct ECG (DECG), including contraindications and electrode placement.

7.4 Monitoring Twin FHRs

Describes methods for monitoring FHR from multiple fetuses, both externally and internally.

7.5 Monitoring Uterine Activity Externally

Covers the procedure for monitoring uterine activity (TOCO) externally using transducers and belts.

7.6 Monitoring Uterine Activity Internally

Explains the process of monitoring uterine activity internally using an IUPC catheter and related cables.

7.7 Monitoring Fetal Movement

Details how to monitor fetal movement (AFM and MFM) using the monitor's features and accessories.

7.8 *Start Monitoring

Describes the action of initiating a monitoring session, including automatic zeroing and start printing.

7.9 *Inputting Maternal Information (Mat. Info)

Guides users on how to input and manage patient information, including auto-ID and manual entry.

Chapter 8 Fetal Monitoring Display (F9)

8.1 Traces

Explains the display of fetal monitoring traces (FHR, TOCO, AFM) on the monitor screen and their interpretation.

8.2 Trace Control Tools

Covers tools for managing and reviewing trace data, including searching, data saving, and file management.

8.3 Numerics

Describes the display of numerical data for fetal monitoring parameters like FHR, TOCO, and FM count.

Chapter 9 Maternal Monitoring (F9 Express)

9.1 Maternal ECG Monitoring

Details how to perform maternal ECG monitoring, including cable placement and signal quality.

9.2 Maternal SpO2 Monitoring

Explains the procedure for monitoring maternal oxygen saturation (SpO2) and pulse rate using a sensor.

9.3 Maternal HR Monitoring

Covers monitoring maternal heart rate (MHR) using ECG or SpO2 sources and managing HR beep volume.

9.4 Maternal NIBP Monitoring

Outlines the process for measuring maternal non-invasive blood pressure (NIBP), including cuff application and measurement modes.

9.5 Maternal TEMP Monitoring

Describes how to perform maternal temperature monitoring using a TEMP sensor and manage settings.

Chapter 10 Maternal Monitoring Display (F9 Express)

10.1 *Display Mode

Explains how to switch between different display modes (maternal-fetal, fetal, maternal) on the F9 Express.

10.2 Maternal Monitoring Traces

Details the display of maternal monitoring traces like ECG and SpO2 waveforms on the screen.

10.3 Maternal Vital Sign List

Describes the list that records recent maternal vital signs and their measurement times.

10.4 Numerics

Explains the display of maternal vital signs (SpO2, NIBP, HR, TEMP) in the monitor's numeric window.

Chapter 11 After Monitoring

11.1 Completing Monitoring

Provides steps for finishing a monitoring session, including removing transducers and stopping printing.

11.2 Switching Off

Details the procedure for safely powering down the monitor by holding the power switch and unplugging the cord.

Chapter 12 Maintenance and Cleaning

12.1 Maintenance

Covers routine inspections, safety checks, and mechanical checks for the monitor and accessories.

12.2 Cleaning

Provides guidelines for cleaning the monitor, base station, and accessories to prevent infection and maintain hygiene.

12.3 Disinfecting

Outlines the process and recommended disinfectants for cleaning transducers, leads, and other components.

12.4 Sterilizing

Addresses the conditions under which sterilization may be necessary for the monitor and accessories, as per hospital regulations.

Chapter 13 Warranty and Service

13.1 Warranty

Details the terms and conditions of EDAN's product warranty, including exclusions and claims procedures.

13.2 Contact information

Provides contact details for obtaining maintenance support, technical specifications, or reporting malfunctions.

Appendix 1 Product Specifications

A F9, F9 Express Fetal;Maternal Monitor

Lists detailed environmental, physical, and performance specifications for the F9 and F9 Express monitors.

B FTS-3 Fetal Telemetry System

Provides environmental, physical, performance, and compliance specifications for the FTS-3 Fetal Telemetry System.

Appendix 2 Signal Input; Output Connector

DB9 Interface

Details the pinout and signal assignments for the DB9 serial interface connector.

D-Sub Interface

Lists the pinout and signal assignments for the D-Sub connector used for system interfaces.

RJ45 Interface

Describes the pinout and signal assignments for the RJ45 Ethernet port.

Appendix 3 Troubleshooting

A F9, F9 Express Fetal;Maternal Monitor

Lists common phenomena, possible causes, and solutions for troubleshooting the F9 and F9 Express monitors.

B FTS-3 Fetal Telemetry System

Provides troubleshooting guidance for the FTS-3 system, covering power, signal, and fuse issues.

Appendix 4 Ultrasound Intensity and Safety

A4.1 Ultrasound in Medicine

Discusses the role and benefits of diagnostic ultrasound in medical practice and the importance of safety.

A4.2 Ultrasound Safety and the ALARA Principle

Explains ultrasound safety principles, including tissue warming and the ALARA principle for minimizing exposure.

A4.3 Explanation of MI;TI

Defines Mechanical Index (MI) and Thermal Index (TI) and their significance in assessing ultrasound bioeffects.

A4.4 Prudent Use Statement

Emphasizes the importance of using diagnostic ultrasound prudently and avoiding high acoustic output and long exposure times.

A4.5 References for Acoustic Output and Safety

Lists relevant standards and publications concerning ultrasound safety and acoustic output.

A4.6 Transducer Acoustic Output Parameters List

Presents tables detailing acoustic output parameters for wired and wireless transducers as per IEC60601-2-37.

Appendix 5 Abbreviation

Abbreviations Used in Manual

Provides a list of abbreviations used in the manual and their corresponding full names for reference.

Appendix 6 Ordering Information

Accessories and Configurations

Lists standard and optional accessories, their part numbers, and specifications for ordering.

Appendix 7 EMC Information

A7.1 Electromagnetic Emissions

Details the guidance and manufacturer's declaration regarding electromagnetic emission compliance for the monitors.

A7.2 Electromagnetic Immunity

Provides guidance on electromagnetic immunity levels and recommended environments for operating the monitors.

A7.3 Electromagnetic Immunity

Outlines specific immunity test levels and recommended separation distances for RF communications equipment.

A7.4 Recommended Separation Distances

Specifies recommended minimum distances between the monitor and RF transmitting equipment to prevent interference.

Appendix 8 Limitations of Ultrasonic Monitoring

A8.1 How Does Ultrasound Work

Explains the fundamental principles of how ultrasound technology functions in medical diagnostic imaging.

A8.2 Artifacts in Fetal Heart Monitoring

Discusses common artifacts in FHR monitoring (doubling, halving, drop out) and their interpretation.

A8.3 Audio Output and Screen Reading

Addresses discrepancies between audio output and screen readings, and potential causes for differences.

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