EDAN INSTRUMENTS FTS3TEDAN, FTS3BEDAN, FTS3UEDAN User Manual
About this Manual
P/N: 01.54.455327
MPN: 01.54.455327017
Release Date: Jan. 2015
© Copyright EDAN INSTRUMENTS, INC. 2008 - 2015. All rights reserved.
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 EDAN
INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, 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 in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Product Information
Product Name: Fetal & Maternal Monitor
Model: F6, F6 Express, F9, F9 Express
Responsibility of the Manufacturer
EDAN 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 EDAN, and
The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
I
information to help qualified technician to maintain and repair some parts, which EDAN may
define as user serviceable.
Terms Used in this Manual
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.
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.
II
Table of Contents
Chapter 1 Safety Guide ················································································································ 1
1.1 Intended Use....................................................................................................................... 1
1.2 Features .............................................................................................................................. 2
1.3 Instruction for Safe Operation ............................................................................................ 2
1.4 Ultrasound Safety Guide .................................................................................................... 3
1.5 Safety Precautions .............................................................................................................. 4
1.6 Definitions and Symbols .................................................................................................. 11
Chapter 2 Installation Guide ······································································································ 15
2.1 Opening and Checking Package ....................................................................................... 15
2.2 Installing Battery .............................................................................................................. 15
2.3 Installing Monitor ............................................................................................................ 16
2.4 Connecting Power Cable .................................................................................................. 17
Chapter 3 Monitor and Accessories ··························································································· 18
3.1 Overview .......................................................................................................................... 18
3.1.1 Keys and Control Knob .......................................................................................... 19
3.1.2 Indicators ................................................................................................................ 21
3.2 Accessories ....................................................................................................................... 22
3.2.1 Ultrasound (US) Transducers ................................................................................. 22
3.2.2 TOCO Transducers ................................................................................................ 22
3.2.3 Belt ......................................................................................................................... 23
3.2.4 Remote Event Marker ............................................................................................ 23
3.2.5 DECG Cable........................................................................................................... 23
3.2.6 Fetal Spiral Electrode ............................................................................................. 24
3.2.7 IUP Cable ............................................................................................................... 24
3.2.8 IUP Catheter ........................................................................................................... 25
3.2.9 ECG Cable ............................................................................................................. 25
3.2.10 SpO2 Sensor ......................................................................................................... 25
3.2.11 NIBP Cuff ............................................................................................................ 26
3.2.12 TEMP Sensor ....................................................................................................... 26
3.3 Screen ............................................................................................................................... 27
3.3.1 Main Interface ........................................................................................................ 27
3.3.2 Setup Interface ....................................................................................................... 30
3.3.3 Touch Screen .......................................................................................................... 31
Chapter 4 Alarms ························································································································ 33
III
4.1 Alarms Classification ....................................................................................................... 33
4.2 Audible Alarm .................................................................................................................. 33
4.3 Visual Alarm .................................................................................................................... 34
4.4 Choosing the Alarm Display Form .................................................................................. 35
4.5 Changing the Alarm Volume ........................................................................................... 35
4.6 *Choosing Alarm Silence Duration ................................................................................. 35
4.7 Choosing Signal Loss Delay ............................................................................................ 35
4.8 Pausing or Resetting the Alarm ........................................................................................ 36
4.9 *Reviewing Alarms .......................................................................................................... 36
4.10 Alarm Treatment Measures ............................................................................................ 37
4.11 Testing Alarms ............................................................................................................... 38
4.12 Patient Alarm Defaults ................................................................................................... 38
Chapter 5 Printing ······················································································································ 40
5.1 *Function Description ...................................................................................................... 40
5.2 Printing Configuration ..................................................................................................... 41
5.2.1 Switching Auto Start Printing On or Off ............................................................... 41
5.2.2 *Choosing the Paper Speed .................................................................................... 41
5.2.3 *Changing the Print Timer ..................................................................................... 41
5.2.4 Switching Print Self-Check On or Off ................................................................... 42
5.2.5 Changing Printing End Volume ............................................................................. 42
5.3 Understanding the Recorder Paper Printout ..................................................................... 42
Chapter 6 Pre-Monitoring Preparation ···················································································· 45
6.1 Loading Recorder paper ................................................................................................... 45
6.2 Switching On .................................................................................................................... 47
6.3 Checking Recorder Paper ................................................................................................. 47
6.4 Adjusting Screen Angle ................................................................................................... 48
6.5 Setting Date and Time ...................................................................................................... 49
6.6 Connecting Transducers ................................................................................................... 49
6.7 Placing Accessories in the Holder.................................................................................... 50
6.8 Adjusting the Volume ...................................................................................................... 51
Chapter 7 Fetal Monitoring ······································································································· 53
7.1 Confirming Fetal Life ...................................................................................................... 53
7.2 Monitoring FHR with Ultrasound .................................................................................... 53
7.2.1 Parts Required ........................................................................................................ 53
7.2.2 FHR Monitoring Procedure.................................................................................... 54
7.2.3 Switching FHR Alarm On or Off ........................................................................... 55
IV
7.2.4 Changing FHR Alarm Limits ................................................................................. 56
7.2.5 Changing FHR Alarm Delay .................................................................................. 56
7.2.6 Testing US Transducers ......................................................................................... 57
7.3 Monitoring FHR with DECG ........................................................................................... 58
7.3.1 Contraindications ................................................................................................... 58
7.3.2 Parts Required ........................................................................................................ 58
7.3.3 Preparing Patient's Skin Prior to Placing Electrodes ............................................. 58
7.3.4 Changing DECG Beep Volume ............................................................................. 59
7.3.5 Switching the Artifact Suppression On or Off ....................................................... 59
7.3.6 Directions for Using Fetal Spiral Electrode ........................................................... 60
7.3.7 DECG Monitoring Procedure ................................................................................ 60
7.3.8 Detaching Fetal Spiral Electrode ........................................................................... 61
7.4 Monitoring Twin FHRs .................................................................................................... 61
7.4.1 Monitoring Twins Externally ................................................................................. 61
7.4.2 Monitoring Internally ............................................................................................. 62
7.4.3 Signals Overlap Verification (SOV) ...................................................................... 62
7.4.4 Changing FHR2 Offset .......................................................................................... 62
7.5 Monitoring Uterine Activity Externally ........................................................................... 63
7.5.1 Parts Required ........................................................................................................ 63
7.5.2 TOCO Monitoring Procedure ................................................................................ 63
7.5.3 Changing UA Baseline ........................................................................................... 64
7.5.4 Testing TOCO Transducers ................................................................................... 64
7.6 Monitoring Uterine Activity Internally ............................................................................ 65
7.6.1 Parts Required ........................................................................................................ 65
7.6.2 Directions for Use of IUPC .................................................................................... 65
7.6.3 IUP Monitoring Procedure ..................................................................................... 68
7.6.4 Checking Intrauterine Pressure Cable Function ..................................................... 68
7.7 Monitoring Fetal Movement ............................................................................................ 69
7.7.1 Auto Fetal Movement (AFM) Monitoring ............................................................. 69
7.7.2 Enabling or Disabling AFM Trace ......................................................................... 69
7.7.3 Changing AFM Gain .............................................................................................. 69
7.7.4 Choosing AFM Mode ............................................................................................ 70
7.7.5 Choosing FM Source ............................................................................................. 70
7.7.6 Manual Fetal Movement (MFM) Monitoring ........................................................ 70
7.7.7 Changing MFM Volume ........................................................................................ 70
7.8 *Start Monitoring ............................................................................................................. 71
V
7.9 *Inputting Maternal Information (Mat. Info) ................................................................... 71
7.9.1 Auto ID................................................................................................................... 71
7.9.2 Changing Maternal Information ............................................................................. 71
7.9.3 Switching Mat. Info Inputting On or Off ............................................................... 72
Chapter 8 Fetal Monitoring Display (F6/F9) ············································································ 73
8.1 Traces ............................................................................................................................... 73
8.1.1 Changing Time Scale ............................................................................................. 74
8.2 Trace Control Tools ......................................................................................................... 75
8.2.1 Data Saving ............................................................................................................ 75
8.2.2 *Searching for a File .............................................................................................. 75
8.2.3 *Reviewing ............................................................................................................ 76
8.2.4 *CTG Analysis ....................................................................................................... 77
8.2.5 *Marking a Note .................................................................................................... 80
8.3 Numerics .......................................................................................................................... 81
8.3.1 Changing Numeric Window Position (F9) ............................................................ 83
8.4 Fetal Monitoring Alarm Messages ................................................................................... 83
8.4.1 Patient Alarm Messages ......................................................................................... 83
8.4.2 Technical Alarm Messages .................................................................................... 83
Chapter 9 Maternal Monitoring (F6 Express/F9 Express) ····················································· 85
9.1 Maternal ECG Monitoring ............................................................................................... 85
9.1.1 Introduction ............................................................................................................ 85
9.1.2 How to Place 3-lead ECG Cables .......................................................................... 86
9.1.3 ECG Monitoring Procedure ................................................................................... 87
9.1.4 Changing ECG Source ........................................................................................... 87
9.1.5 Changing ECG Gain .............................................................................................. 88
9.1.6 Enabling ECG Calibration ..................................................................................... 88
9.2 Maternal SpO2 Monitoring ............................................................................................... 89
9.2.1 Introduction ............................................................................................................ 89
9.2.2 SpO2 Monitoring Procedure ................................................................................... 91
9.2.3 Enabling SpO2 Trace Printing ................................................................................ 92
9.2.4 Assessing the Validity of a SpO2 Reading ............................................................ 92
9.2.5 SI (Signal Intensity)* ............................................................................................. 93
9.2.6 Switching the SpO2 Alarm On or Off .................................................................... 93
9.2.7 Changing SpO2 Alarm Limits ................................................................................ 93
9.3 Maternal HR Monitoring.................................................................................................. 94
9.3.1 Introduction ............................................................................................................ 94
VI
9.3.2 Choosing HR Source .............................................................................................. 94
9.3.3 Changing HR Beep Volume ................................................................................... 94
9.3.4 Enabling HR Trace ................................................................................................. 95
9.3.5 Switching the HR Alarm On or Off ....................................................................... 95
9.3.6 Changing HR Alarm Limits ................................................................................... 95
9.3.7 Signals Overlap Verification .................................................................................. 95
9.4 Maternal NIBP Monitoring .............................................................................................. 96
9.4.1 Introduction ............................................................................................................ 96
9.4.2 How to Apply NIBP Cuff ...................................................................................... 97
9.4.3 Preparation for NIBP Monitoring .......................................................................... 98
9.4.4 *Auto Measurement ............................................................................................... 99
9.4.5 *Manual Measurement ......................................................................................... 100
9.4.6 Correcting the Measurement ................................................................................ 101
9.4.7 Changing NIBP Unit ............................................................................................ 101
9.4.8 Switching the NIBP Alarm On or Off.................................................................. 101
9.4.9 Changing SYS Alarm Limits ............................................................................... 102
9.4.10 Changing DIA Alarm Limits ............................................................................. 102
9.4.11 *Choosing NIBP Printing Mode ........................................................................ 102
9.4.12 *Calibrating NIBP .............................................................................................. 103
9.5 Maternal TEMP Monitoring .......................................................................................... 103
9.5.1 TEMP Monitoring Procedure ............................................................................... 103
9.5.2 Changing TEMP Unit .......................................................................................... 104
9.5.3 Switching the TEMP Alarm On or Off ................................................................ 104
9.5.4 Changing TEMP Alarm Limits ............................................................................ 104
Chapter 10 Maternal Monitoring Display (F6 Express/F9 Express)···································· 105
10.1 *Display Mode ............................................................................................................. 105
10.2 Maternal Monitoring Traces ........................................................................................ 107
10.3 Maternal Vital Sign List ............................................................................................... 107
10.4 Numerics ...................................................................................................................... 108
10.5 Maternal Monitoring Alarm Messages ........................................................................ 109
10.5.1 Patient Alarm Messages ..................................................................................... 109
10.5.2 Technical Alarm Messages ................................................................................ 110
Chapter 11 FTS-3 Fetal Telemetry System ············································································· 113
11.1 Brief Introduction ......................................................................................................... 113
11.1.1 Base Station ........................................................................................................ 114
11.1.2 US Transducer and TOCO Transducer .............................................................. 117
VII
11.1.3 Features .............................................................................................................. 117
11.2 Installation Guide ......................................................................................................... 118
11.2.1 Opening the Package and Checking ................................................................... 118
11.2.2 Installing Battery ................................................................................................ 118
11.2.3 Installing the System .......................................................................................... 120
11.2.4 Connecting Power Cable .................................................................................... 121
11.2.5 Connect to the Base Station ............................................................................... 122
11.2.6 Configure the Monitor ....................................................................................... 122
11.2.7 Adjusting the Working Channel ......................................................................... 122
11.3 Technical Alarm Messages .......................................................................................... 123
11.4 Basic Operation ............................................................................................................ 124
11.4.1 Charge the Transducer ....................................................................................... 124
11.4.2 Charge the Battery.............................................................................................. 124
11.4.3 Basic Function Test ............................................................................................ 125
11.5 Patient Application ....................................................................................................... 126
11.5.1 General Application ........................................................................................... 126
11.5.2 US Transducer .................................................................................................... 126
11.5.3 Monitor the Ambulatory Patient ........................................................................ 127
11.5.4 Underwater Monitoring ...................................................................................... 127
Chapter 12 After Monitoring ··································································································· 129
12.1 Completing Monitoring ................................................................................................ 129
12.2 Switching Off ............................................................................................................... 129
Chapter 13 Maintenance and Cleaning ··················································································· 130
13.1 Maintenance ................................................................................................................. 130
13.1.1 Maintaining Inspection....................................................................................... 130
13.1.2 Maintenance of Monitor and Base Station ......................................................... 131
13.1.3 Maintenance of Wired and Wireless Transducers ............................................. 131
13.1.4 Storage of Recorder Paper ................................................................................. 131
13.1.5 Cleaning of Recorder ......................................................................................... 131
13.1.6 Maintaining the Battery...................................................................................... 132
13.2 Cleaning ....................................................................................................................... 132
13.2.1 Cleaning of Monitor and Base Station ............................................................... 132
13.2.2 Cleaning of Accessories ..................................................................................... 133
13.3 Disinfecting .................................................................................................................. 135
13.4 Sterilizing ..................................................................................................................... 136
Chapter 14 Warranty and Service ··························································································· 137
VIII
14.1 Warranty ....................................................................................................................... 137
14.2 Contact information ..................................................................................................... 137
Appendix 1 Product Specifications ·························································································· 138
A1.1 Environmental Specifications ..................................................................................... 138
A1.2 Physical Specifications ................................................................................................ 138
A1.3 Performance Specifications ......................................................................................... 140
A1.4 Recorder Specifications ............................................................................................... 144
A1.5 Rechargeable Lithium-ion Battery .............................................................................. 145
A1.6 Low Output Summary Table ....................................................................................... 146
B FTS-3 Fetal Telemetry System ......................................................................................... 147
B1.1 Environmental Specifications ............................................................................... 147
B1.2 Physical Specifications ......................................................................................... 147
B1.3 Performance Specifications .................................................................................. 148
B1.4 Rechargeable Lithium-ion Battery ....................................................................... 150
B1.5 Low Output Summary Table ................................................................................ 150
Appendix 2 Signal Input/Output Connector ·········································································· 151
Appendix 3 Troubleshooting ···································································································· 153
A3.1 No Display................................................................................................................... 153
A3.2 Noise............................................................................................................................ 153
A3.3 Recorder Error ............................................................................................................. 153
A3.4 Trouble with Ultrasound FHR Monitoring ................................................................. 154
A3.5 Troubles with DECG FHR Monitoring ....................................................................... 154
A3.6 Troubles with Contractions Monitoring (External) ..................................................... 155
A3.7 Troubles with Monitoring Contractions (Internal) ...................................................... 155
A3.8 Big ECG Signal Interference or Thick Baseline ......................................................... 156
A3.9 NIBP and SpO2 No Results ........................................................................................ 156
A3.10 Blown Fuses .............................................................................................................. 156
B FTS-3 Fetal Telemetry System ......................................................................................... 158
B3.1 Troubleshooting .................................................................................................... 158
B3.2 Blown Fuses ......................................................................................................... 158
Appendix 4 Ultrasound Intensity and Safety ········································································· 161
A4.1 Ultrasound in Medicine ............................................................................................... 161
A4.2 Ultrasound Safety and the ALARA Principle ............................................................. 161
A4.3 Explanation of MI/TI .................................................................................................. 161
A4.3.1 MI (Mechanical Index) ...................................................................................... 161
A4.3.2 TI (Thermal Index) ............................................................................................ 162
IX
A4.3.3 Measurement Uncertainty ................................................................................. 162
A4.4 Prudent Use Statement ................................................................................................ 163
A4.5 References for Acoustic Output and Safety ................................................................ 163
A4.6 Probe Acoustic Output Parameters List ...................................................................... 164
A4.6.1 Test of Wired Probe .......................................................................................... 164
A4.6.2 Test of Wireless Probe (FTS-3) ........................................................................ 168
Appendix 5 Abbreviation ·········································································································· 170
Appendix 6 Ordering Information ·························································································· 172
Appendix 7 EMC Information ································································································· 174
A7.1 Electromagnetic Emissions ......................................................................................... 174
A7.2 Electromagnetic Immunity .......................................................................................... 175
A7.3 Electromagnetic Immunity .......................................................................................... 177
A7.4 Recommended Separation Distances .......................................................................... 179
Appendix 8 Limitations of Ultrasonic Monitoring ································································· 180
A8.1 How Does Ultrasound Work ....................................................................................... 180
A8.2 Artifacts in Fetal Heart Monitoring ............................................................................. 180
A8.3 Audio Output and Screen Reading .............................................................................. 182
X
F Series Fetal & Maternal Monitor User Manual Safety Guide
Chapter 1 Safety Guide
CAUTION
Federal (U.S.) Law restricts this device to sale by or on the order of a physician.
NOTE:
1 In order to ensure the operator and patient’s safety, read through this chapter before
using this monitor.
2 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.
3 The functions frequently used are marked with an asterisk
*, for example 4.9
*Reviewing Alarms.
1.1 Indications for Use/ Intended Use
F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):
F6/F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus
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.
F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28
week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a
TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and
uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9
Express):
th
F6 Express/F9 Express Fetal & Maternal 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.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing
th
or fetal monitoring for pregnant women from the 28
solution for maternal vital signs monitoring.
Contraindications:
They are not intended for use in intensive care units, operating rooms or for home use.
- 1 -
week of gestation. In addition, it provides a
F Series Fetal & Maternal Monitor User Manual Safety Guide
1.2 Features
The following table lists the measurements that F6, F6 Express, F9 and F9 Express support.
Model
Measurement
Single-FHR
Dual-FHR
TOCO
FM
AFM
F6, F9
F6 Express
F9 Express
DECG/IUP Opt
MECG ×
NIBP ×
MSpO2 ×
TEMP ×
NOTE: = Standard Opt = Optional × = Not Available
×
Opt
1.3 Instruction for Safe Operation
NOTE:
In this manual, Monitor refers to F6, F6 Express, F9 and F9 Express, and is used
where the information applies to all models.
The monitor is designed to comply with the international safety requirements IEC/EN
60601-1 for medical electrical equipment. It is class I equipment.
The monitor operates within specifications at ambient temperatures between +5ºC (+41ºF)
and +40ºC (+104ºF). Ambient temperatures that exceed these limits could affect the
accuracy of the instrument and cause damage to the modules and circuits. Allow at least 2
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 use. If damage is
evident, replacement is recommended before use.
The monitor must be serviced only by authorized and qualified personnel. The manufacturer
- 2 -
F Series Fetal & Maternal Monitor User Manual Safety Guide
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.
The protective degree against electric shock of the patient connections is:
Ultrasound (FHR1, FHR2)
External TOCO
Type BF
Fetal Movement Mark (FM)
Intrauterine Pressure (IUP)
Non-invasive Blood Pressure (NIBP)
Type BF, defibrillation-proof
Arterial Oxygen Saturation (SpO
)
2
Direct Electrocardiography (DECG) Type CF
Electrocardiography (ECG)
Type CF, defibrillation-proof
Temperature (TEMP)
The monitor described in this user manual is not protected against:
a) The effects of high frequency currents
b) The interference of electrosurgery equipment
1.4 Ultrasound Safety Guide
Fetal Use
The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor.
Clinical interpretation of fetal heart rate traces can diagnose fetal and/or maternal problems and
complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the monitor 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. 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
insonation.
- 3 -
F Series Fetal & Maternal Monitor User Manual Safety Guide
1.5 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING
For using safety:
1 The monitor or FTS-3 telemetry system (hereinafter called FTS-3) is provided for the
use of qualified physicians or personnel professionally trained.
2 Only qualified service engineers can install this equipment. Only service engineers
authorized by the manufacturer can open the shell.
3 The monitor is not intended for use in intensive care units (ICU), operating rooms or
for home use.
4 Do not switch on the monitor until all cables have been properly connected and
verified.
5 EXPLOSION HAZARD - Do not use the monitor in the presence of flammable
anesthetics or other materials.
6 SHOCK HAZARD - The power receptacle must be a three-wire grounded outlet.
Never adapt the three-prong plug from the monitor to fit a two-slot outlet. A hospital
grade outlet is required. 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.
7 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.
8 Do not touch accessible parts of non-medical electrical equipment and the patient
simultaneously. Do not touch the signal input or output connector and the patient
simultaneously.
9 Accessory equipment connected to the analog and digital 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. Anybody who connects additional equipment to the signal input
connector or signal output connector to configure a medical system must ensure that
the system complies with the requirements of the valid version of the system
standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or
your local distributor.
10 Do not exceed the maximum permitted load when using multiple portable
socket-outlets to supply the system.
- 4 -
F Series Fetal & Maternal Monitor User Manual Safety Guide
WARNING
11 SHOCK HAZARD – Do not connect non-medical electrical equipment, which has
been supplied as a part of the system, directly to the wall outlet when the
non-medical equipment is intended to be supplied by a multiple portable
socket-outlet with an isolation transformer. If multiple instruments are connected to a
patient, the sum of the leakage currents may exceed the limits given in the IEC/EN
60601-1 and may pose a safety hazard. Consult your service personnel.
12 Do not connect any equipment or accessories that are not approved by the
manufacturer or that are not IEC 60601-1 approved to the monitor. The operation or
use of non-approved equipment or accessories with the monitor is not tested or
supported, and monitor operation and safety are not guaranteed.
13 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.
14 The monitor can only be used on one patient at a time.
15 SHOCK HAZARD - Do not remove the top panel cover during operation or while
power is connected. Only authorized service personnel could remove the unit cover.
16 Equipment and devices that connect to the monitor should form an equipotential
body to ensure effective grounding.
17 Only connect accessories supplied or recommended by the manufacturer to the
device.
18 The system should be operated by the doctor or under the doctor’s instructions.
19 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
20 Only MECG, SpO2, NIBP and TEMP applied parts of the monitor are
defibrillation-proof. When a defibrillator is applied, keep other accessories away from
the patient. Otherwise it may result in damaging the monitor or harming the patient.
21 ECG cables may be damaged when connected to a patient during defibrillation.
Check cables for functionality before using them again.
22 After defibrillation, the screen display recovers within 10 seconds if the correct
electrodes are used and applied based on the manufacturers’ instructions.
23 Any non-medical equipment (such as the external printer) is not allowed to be used
within the patient vicinity (1.5m/6ft.).
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F Series Fetal & Maternal Monitor User Manual Safety Guide
WARNING
24 Make sure that the power is turned off and the power cord is disconnected from the
AC socket before connecting or disconnecting equipment. Otherwise, the patient or
operator may receive electrical shock or other injury.
25 Disconnect power cord before changing fuses. Replace them with those of the same
specifications only.
26 Parts and accessories used must meet the requirements of the applicable IEC 601
series safety standards, and/or the system configuration must meet the requirements
of the IEC 60601-1-1 medical electrical systems standard.
27 Connect the grounding wire to the equipotential grounding terminal in the main
system. If it is not evident from the instrument specifications whether a particular
instrument combination is hazardous or not, for example due to summation of
leakage currents, you should consult the manufacturer or an expert in the field, to
ensure that the necessary safety of all instruments concerned will not be impaired by
the proposed combination.
For proper monitoring:
28 The monitor is not intended for treatment.
29 Alarms must be set up according to different situations of patients. Make sure that
audio sounds can be activated when an alarm occurs.
30 Do not perform NIBP measurements on patients with sickle-cell disease or under
any condition where the skin is damaged or expected to be damaged.
31 Clinical decision making based on the output of the device is left to the discretion of
the provider.
32 Do not put the sensor on extremities with arterial catheter or venous syringe.
33 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place.
This could cause tissue damage around the catheter when infusion is slowed or
blocked during cuff inflation.
34 The fetal spiral electrode and intrauterine pressure catheter are disposable. Discard
them after use.
35 The disposable accessories are intended to be used only once. Dispose of them
properly after use and do not reuse them.
36 The IUPC is neither intended nor approved for measuring intrauterine pressure
extraovularly; attempting to do so may lead to maternal discomfort or injury.
For using the battery:
37 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure
to read the user manual and safety precautions thoroughly.
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F Series Fetal & Maternal Monitor User Manual Safety Guide
WARNING
38 Use the battery only in F6 / F6 Express / F9 / F9 Express.
39 Do not reverse the battery pole or it will cause explosion.
40 Do not unplug the battery when monitoring.
41 Do not heat or throw the battery into a fire.
42 Do not use or leave battery close to fire or other places where the temperature may
be above +60 ºC (+140 ºF).
43 Do not immerse, throw, or wet the battery in water/ seawater.
44 Do not destroy the battery: Do not pierce battery with a sharp object such as a
needle. Do not hit with a hammer, step on or throw or drop to cause strong shock.
Do not disassemble or modify the battery.
45 Do not short-circuit the battery by connecting the battery cable connector or battery
socket with metal objects or solder.
46 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh
water immediately.
47 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well
with clean water and see a doctor immediately.
48 Do not solder the leading wire and the battery terminal directly.
49 Keep the battery away from fire immediately when leakage or foul odor is detected.
50 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.
51 Do not use a battery with serious scar or deformation.
52 Remove the battery and store it at a cool and dry environment if the monitor is not
used for a long time.
53 Unplug the monitor before installing and removing the battery.
54 Do not connect the battery directly to an electric outlet or cigarette lighter charger.
55 Batteries have life cycles. If the time that the monitor using battery becomes much
shorter than usual, the battery life is at an end. Replace the battery with a new one
of the same specification as the one provided or recommended by the manufacturer.
56 If the battery is stored alone and not used for a long time, we recommend that the
battery should be charged at least once every 6 months to prevent overdischarge.
In addition, when you use the FTS-3 fetal telemetry system, please pay attention to the
warnings as follows:
57 The system should be operated by the doctor or under the doctor’s instructions.
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F Series Fetal & Maternal Monitor User Manual Safety Guide
WARNING
58 SHOCK HAZARD – The base station and transducers for one patient must be
supplied by the same power and do not change the power supply.
59 Please arrange a function test periodically for the system.
60 Do not move the system when it is powered on and do not soak it in any liquid.
61 Please check the transducer, cable and base station periodically. If the transducers
are damaged, do not use them in water and repair them in time.
62 If the transducer has been beaten or knocked, please check whether the cover is
airproof or damaged. If you have any doubt, please contact the manufacturer or local
agent.
63 If the battery in the base station is stored alone and not used for a long time, we
recommend that the battery should be charged at least once every 6 months to
prevent overdischarge.
64 The battery in the wireless transducer should be replaced by the serviceman
authorized by EDAN.
65 The wireless transducer has priority over the wired transducer. When the wireless
transducer is working, the wired transducer will be turned off automatically. Do not
use the wireless transducer and the wired transducer at the same time.
CAUTION
1 The device is designed for continuous operation. Avoid liquid splashing on the
device.
2 Refer servicing to qualified personnel.
3 Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine,
dust area, high-temperature and humid environment.
4 When installing the unit into a cabinet, allow for adequate ventilation, accessibility for
servicing, and room for adequate visualization and operation.
5 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.
6 Do not sterilize the monitor or any accessory with autoclave or gas.
7 Switch off the system power before cleaning. Cleaning consists of removing all dust
from the exterior surface of the equipment with a soft brush or cloth.
8 Only the sensor and cable of US/TOCO transducers are watertight. Pay attention not
let any liquid enter the transducer plug.
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F Series Fetal & Maternal Monitor User Manual Safety Guide
CAUTION
9 Electromagnetic Interference - Ensure that the environment in which the monitor
or FTS-3 is installed is not subject to any source of strong electromagnetic
interference, such as CT, radio transmitters, mobile phone base stations, etc. Even
though other devices are in accordance with national standard radiation
requirements, the monitor or FTS-3 may be interfered.
10 Electromagnetic Interference - Do not use mobile phones nearby in the process of
monitoring.
11 Electromagnetic Interference - Fetal parameters, especially ultrasound and ECG,
are sensitive measurements involving small signals, and the monitoring equipment
contains very sensitive high gain front-end amplifiers. Immunity levels for radiated
RF electromagnetic fields and conducted disturbances induced by RF fields are
subject to technological limitations. To ensure that external electromagnetic fields do
not cause erroneous measurements, it is recommended to avoid the use of
electrically radiating equipment in close proximity to these measurements.
12 Electromagnetic Interference - The monitor or FTS-3 system should not be used
adjacent to or stacked with other equipment, refer to section A7.4 Recommended
Separation Distances.
13 Electromagnetic interference is not unique to this system but is characteristic of fetal
patient monitoring equipment in use today. This performance is due to very sensitive
high gain front-end amplifiers required to process the small physiological signals
from the patient. Among the various monitoring systems already in clinical use,
interference from electromagnetic sources is rarely a problem.
14 The medical electrical equipment needs to be installed and put into service
according to Appendix 7 EMC Information.
15 Portable and mobile RF communications equipment can affect medical electrical
equipment, refer to section A7.4 Recommended Separation Distances.
16 Sterility cannot be guaranteed if package of the fetal spiral electrode is broken or
opened.
17 The fetal spiral electrode has been sterilized by gamma radiation. Do not re-sterilize.
18 The device and reusable accessories could be sent back to the manufacturer for
recycling or proper disposal after their useful lives.
19 If the terminals of the battery become dirty, wipe with a dry cloth before using the
battery.
20 For information on installing and removing the battery from the monitor, thoroughly
read the user manual.
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F Series Fetal & Maternal Monitor User Manual Safety Guide
CAUTION
21 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.
22 Batteries have life cycles. If the time that the monitor and the FTS-3 system using
battery becomes much shorter than usual, the battery life is at an end. Please
contact the manufacturer to replace the battery with a new one of the same
specifications as the one provided or recommended by the manufacturer.
In addition, when you use the FTS-3 fetal telemetry system, please pay attention to the
cautions as follows:
1 The wireless transducers are IPX8 waterproof, but the base station should be kept
non-soaked and non-condensing. The system may be condensing during
transportation in high humidity or low temperature.
2 The water temperature must not exceed +60 ºC (+140 ºF) when you wash the belt.
3 The use of accessories and cables other than those specified may result in
increased electromagnetic emissions or decreased electromagnetic immunity of the
system.
4 This equipment generates, uses and radiates radio-frequency energy, and if it is not
installed and used in accordance with its accompanying documentation, it may
cause interference to radio communications.
5 When the battery is charged, used or stored, keep it away from objects or materials
with static electric charges.
6 If the terminals of the battery become dirty, wipe with a dry cloth before using the
battery.
7 The recommended charging temperature for the battery is between 0°C ~ +40°C.
Please do not exceed the temperature range.
8 Batteries have life cycles. If the time that FTS-3 using battery becomes much shorter
than usual, the battery life is at an end. Please contact the manufacturer to replace
the battery with a new one of the same specification as the one provided or
recommended by the manufacturer.
9 Remove the battery in the base station and store it at a cool and dry environment if
the system is not used for a long time.
10 Please remove the battery out of the transducer at the end of their life.
11 Please read the user manual carefully when you install or remove the battery.
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F Series Fetal & Maternal Monitor User Manual Safety Guide
CAUTION
12 Operation is subject to the following two conditions: (1) This device may not cause
harmful interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
13 Any Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
1.6 Definitions and Symbols
Socket for ultrasound transducer 1 (Type BF applied part)
Socket for ultrasound transducer 2 (Type BF applied part)
Socket for DECG cable (Type CF applied part)
Socket for TOCO transducer or IUP cable (Type BF applied part)
Socket for Remote Event Marker (Type BF applied part)
Reserved.
Socket for NIBP Cuff (Type BF applied part)
Socket for SpO
Sensor (Type BF applied part)
2
Socket for Maternal ECG Cable (Type CF applied part)
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F Series Fetal & Maternal Monitor User Manual Safety Guide
Socket for TEMP Sensor (Type CF applied part)
RS232 Interface (DB9 or D-Sub)
RJ45 Interface
Equipotential Grounding
Battery check
Alternating Current (a.c.)
Stand-by
Caution, consult ACCOMPANYING DOCUMENTS
Warning
Operating instructions
IPX1
IPX8
Follow instructions for use
Type BF applied part
Defibrillation-proof type BF applied part
Type CF applied part
Defibrillation-proof type CF applied part
Protected against vertically falling water drops
Protected against the effects of continuous immersion in water
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F Series Fetal & Maternal Monitor User Manual Safety Guide
CE marking
Disposal method
Part Number
Serial Number
Date Of Manufacture
Manufacturer
Authorized Representative in the European Community
General symbol for recovery/recyclable
Caution: Federal (U.S.) Law restricts this device to sale by or on the order of
a physician
With respect to electrical shock, fire and mechanical hazards only in
accordance with UL 60601-1and CAN/CSA C22.2 No. 601.1
FTS-3 Fetal Telemetry System
Non-ionizing electromagnetic radiation
Serial Number
Wireless Transducer Working Indicator
USB Port (Reserved)
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F Series Fetal & Maternal Monitor User Manual Safety Guide
Ethernet Port (Reserved)
Channel Adjustment
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F9, F9 Express Fetal & Maternal Monitor User Manual Installation Guide
Chapter 2 Installation Guide
NOTE:
Installation must be carried out by qualified personnel authorized by the manufacturer.
2.1 Opening and Checking Package
Visually examine the package prior to unpacking. If any signs of mishandling or damage are
detected, contact the carrier to claim for damage.
Open the package; take out the monitor and accessories carefully. Keep the package for possible
future transportation or storage. Check the components according to the packing list.
Check for any mechanical damage.
Check all the cables and accessories.
If there is any problem, contact us or your local distributor immediately.
2.2 Installing Battery
WARNING
Switch off the monitor and unplug it before installing or removing the battery.
If your monitor has been configured with a rechargeable lithium-ion battery, follow these steps to
install the battery:
(1) Battery Installation
1) Carefully place the monitor upside down on a flat surface covered with cloth or other type of
protecting pad.
2) Remove the screws of the battery compartment using a cross-head screw driver. Remove the
battery compartment cover.
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F9, F9 Express Fetal & Maternal Monitor User Manual Installation Guide
3) Take the battery out from package. Put the battery and the cables into the battery
compartment and insert the cable connector into the socket.
4) Shut the battery compartment cover and fix the screws.
(2) Battery Removal
Fold the LCD display completely flat before turning the monitor upside down. Remove the
battery in reverse order. To remove the battery, hold the two bands of the battery tight, shake it
loose and pull it out with force.
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F Series Fetal & Maternal Monitor User Manual Installation Guide
NOTE:
1 If a rechargeable battery is outfitted, charge it fully each time after using the device to
ensure the electric power is enough.
2 After the device is transported or stored for a long time, charge the battery fully before
use. Connecting to power supply will charge the battery no matter if the monitor is
powered on.
3 Do not pull the battery cables, or the battery may become damaged.
2.3 Installing Monitor
The monitor can be placed on a flat surface, or be installed on a wall or a trolley. The service
engineer should install the monitor properly.
2.4 Connecting Power Cable
Make sure the AC power supply of the monitor complies with the following specification:
100V-240V~, 50Hz/60Hz.
Apply the power cable provided with the monitor. Plug one end of the power cable to the
power socket of the monitor. Connect the other end to a three-slot power output special for
hospital usage.
The equipotential grounding terminal is provided for the connection of a potential
equalization conductor. Therefore, it is recommended to connect the grounding terminal of
the monitor and the power outlet with the grounding wire, making sure the monitor is
grounded.
WARNING
If the protective grounding (protective earth) system is doubtful, the power of the monitor
must be supplied by internal power supply only.
NOTE:
1 Make sure the monitor and the power outlet are placed at a place where it is easy to
connect and disconnect the power cord.
2 When the supply mains is interrupted, the device switches to internal power supply
and operates normally if the battery is installed. If the battery is not installed, the
monitor shuts down and resumes the previous settings at the subsequent operation.
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F Series Fetal & Maternal Monitor User Manual Monitor and Accessories
p
Chapter 3 Monitor and Accessories
3.1 Overview
NOTE:
F6/F6 Express differs from F9/F9 Express in LCD size. This manual takes pictures and
interfaces of F9/F9 Express as an example, and they may look slightly different from
your model.
1 Keys
2 Transducer
3 Sockets
4 Alarm Indicator
5 Display Screen
6 Control Knob
7 Charge, AC, Power Indicator
8 Paper Drawer
Figure 3-1 Appearance (for reference only)
Figure 3-2 Left Panel
9 Transducer Holder
10 DECG Socket
11 US2 Socket
12 EXT.1 Socket
13 TOCO/IUP Socket
14 US1 Socket
15 MARK Socket
27 MECG Socket
28 NIBP Socket
29 TEMP Socket
30 S
O2 Socket
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F Series Fetal & Maternal Monitor User Manual Monitor and Accessories
6
16 POWER Switch
Figure 3-3 Right Panel
17 Equipotential Grounding
Terminal
18 Antenna (Not applicable)
19 USB Socket (Not applicable)
20 Power Socket
21 Handle
Figure 3-4 Rear Panel
Figure 3-5 Bottom Panel
22 DB9 Socket
23 RJ45Socket
24 Fuses
25 Battery Compartment
2
Wall-mounting Holes
3.1.1 Keys and Control Knob
Figure 3-6 Keys and Control Knob
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