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F9 Express
EDAN F9 Express User Manual
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F9
,
F9 Expres
s Fet
al & Maternal M
onitor Us
er Manual
Ultrasound I
ntensity
and Safety
- 188 -
parameter speci
fied in T
RACK1 o
f FDA Guidanc
e
TRACK1 param
eter
NOTE
p
r
.3
Derated Peak-
rare-
factional
Acoustic Press
ure
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0
Output Power
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sp
z
sp
=z
B.3
, Depth
for Bone
Therm
al Index
f
c
Center F
requency
,
Acoustic
x
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-6dB Beam
width
y
-6
PD
Pulse Durati
on
PRF
Pulse Repeti
tion Frequency
MI
Mechanical I
ndex
I
SPT
A
.3
Derated Spati
al-peak
T
em
poral-average I
ntensity
I
SPP
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.3
Derated Spati
al-peak Pulse-
average I
ntensity
Az
.
Aperture X wi
dth
Y
Dim
eter
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ED
S
Entrance Dim
ensions Of
The Scan
E
BD
Entrance Beam
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ions
198
200
Table of Contents
Default Chapter
5
Table of Contents
5
Chapter 1 Safety Guidance
12
Intended Use/Indications for Use
12
Features
13
Instruction for Safe Operation
13
Ultrasound Safety Guide
14
Safety Precautions
15
Definitions and Symbols
22
Chapter 2 Introducing the Monitor
26
Installation Guide
26
Opening the Package and Checking
26
Installing Battery
26
Installing Monitor
28
Connecting Power Cable
28
Overview
29
Keys
31
Indicators
33
Accessories
33
Ultrasound (US) Transducers
34
TOCO Transducers
34
Belt
34
Remote Event Marker
35
Fetal Stimulator
35
DECG Cable
36
Fetal Spiral Electrode
36
IUP Cable
36
IUP Catheter
37
ECG Cable
37
Spo Sensor
37
NIBP Cuff
38
TEMP Sensor
38
Screen
39
Main Interface
39
Setup Interface
42
Touch Screen
43
Chapter 3 Introducing the FTS-3 Fetal Telemetry System
45
Brief Introduction
45
Base Station
46
Transducers
49
Accessories
50
Features
51
Installation Guide
51
Opening the Package and Checking
51
Installing Battery
52
Installing the System
54
Connecting Power Cable
54
Configuration
55
Connecting to the Monitor
55
Adjusting the Working Channel
55
Basic Operation
56
Charge the Transducer
56
Charge the Battery
56
General Application
58
Relocation of the Transducers
59
Monitor the Ambulatory Patient
59
Underwater Monitoring
60
Priority
61
Basic Function Test
61
Chapter 4 Alarms
63
Alarm Classification
63
Audible Alarm
63
Visual Alarm
64
Choosing the Alarm Display Form
65
Changing the Alarm Volume
65
Choosing Alarm Silence Duration
65
Choosing Signal Loss Delay
66
Pausing or Resetting the Alarm
66
Switching Transducer Unplugged on or off
66
Reviewing Alarms
66
Alarm Treatment Measures
67
Testing Alarms
68
Patient Alarm Defaults
68
Alarm Messages
70
Fetal Monitoring Alarm Messages
70
Maternal Monitoring Alarm Messages
72
Technical Alarm Messages
75
Alarm Bilateral Control
75
Chapter 5 Printing
77
Function Description
77
Printing Configuration
78
Switching Auto Start Printing on or off
78
Choosing the Paper Speed
78
Changing the Print Timer
78
Switching Print Self-Check on or off
79
Changing Printing End Volume
79
Changing Title Print Cycle
79
Switching Maternal Monitor Information on or off
79
Understanding Recorder Paper Printout
80
Chapter 6 Pre-Monitoring Preparation
82
Loading Recorder Paper
82
Switching on the Monitor
84
Checking the Recorder Paper
84
Adjusting the Screen Angle
85
Setting Date and Time
86
Connecting Transducers
87
Placing Accessories in the Holder
87
Adjusting the Volume
88
Chapter 7 Fetal Monitoring
90
Confirming Fetal Life
90
Monitoring FHR with Ultrasound
90
Monitoring FHR with Wired Ultrasound Transducer
91
Monitoring FHR with Wireless Ultrasound Transducer
93
Switching the FHR Alarm on or off
93
Changing the FHR Alarm Limits
94
Changing the FHR Alarm Delay
94
Testing US Transducers
95
Monitoring FHR with DECG
96
Contraindications
96
Preparing the Patient's Skin Prior to Placing Electrodes
96
Directions for Using Fetal Spiral Electrode
96
Wired DECG Monitoring
97
Wireless DECG Monitoring
98
Changing DECG Beep Volume
99
DECG Gain and Display
100
Switching the Artifact Suppression on or off
100
Detaching the Fetal Spiral Electrode
100
Monitoring Twin Fhrs
101
Monitoring Twins Externally
101
Monitoring Internally
101
Signals Overlap Verification (SOV)
101
Changing FHR2 Offset
101
Monitoring Uterine Activity Externally
102
Wired TOCO Monitoring
102
Wireless TOCO Monitoring
103
Changing the UA Baseline
104
Testing TOCO Transducers
104
Monitoring Uterine Activity Internally
105
Parts Required
105
Directions for Use of IUPC
105
IUP Monitoring Procedure
107
Checking Intrauterine Pressure Cable Function
108
Monitoring Fetal Movement
108
Auto Fetal Movement (AFM) Monitoring
108
Enabling or Disabling AFM Monitoring
109
Choosing AFM Mode
109
Choosing FM Source
109
Manual Fetal Movement (MFM) Monitoring
109
Changing MFM Volume
110
Start Monitoring
110
Inputting Maternal Information (Mat. Info)
110
Auto ID
110
Changing Maternal Information
110
Switching Mat. Info Inputting on or off
111
Chapter 8 Fetal Monitoring Display (F9)
113
Traces
113
Changing Time Scale
115
Trace Control Tools
115
Data Saving
116
Searching for a File
116
File Management (Optional)
117
Reviewing
119
CTG Analysis
120
Marking a Note
122
Numerics
123
Changing Numeric Window Position (F9)
124
Chapter 9 Maternal Monitoring (F9 Express)
125
Maternal ECG Monitoring
125
Introduction
125
How to Place 3-Lead ECG Cables
126
How to Place 2-Lead FTS-3 MECG Cables
127
Wired ECG Monitoring
129
Wireless ECG Monitoring
129
Changing ECG Source
130
Changing ECG Gain
130
Enabling ECG Calibration
130
Maternal Spo Monitoring
131
Spo Monitoring Procedure
134
Enabling Spo Trace Printing
134
Assessing the Validity of a Spo2 Reading
135
Signal Intensity)
135
Switching the Spo 2 Alarm on or off
136
Changing Spo 2 Alarm Limits
136
Maternal HR Monitoring
136
Introduction
136
Choosing HR Source
136
Changing HR Beep Volume
137
Enabling HR Trace
137
Switching the HR Alarm on or off
137
Changing HR Alarm Limits
138
Signals Overlap Verification
138
Maternal NIBP Monitoring
138
Introduction
138
How to Apply NIBP Cuff
140
Preparation for NIBP Monitoring
141
Auto Measurement
142
Manual Measurement
142
Correcting the Measurement
143
Changing NIBP Unit
143
Switching the NIBP Alarm on or off
144
Changing SYS Alarm Limits
144
Changing DIA Alarm Limits
144
Changing MAP Alarm Limits
145
Choosing NIBP Printing Mode
145
Calibrating NIBP
145
Maternal TEMP Monitoring
146
TEMP Monitoring Procedure
146
Changing TEMP Unit
146
Switching the TEMP Alarm on or off
147
Changing TEMP Alarm Limits
147
Chapter 10 Maternal Monitoring Display (F9 Express)
148
Display Mode
148
Maternal Monitoring Traces
151
Maternal Vital Sign List
151
Numerics
152
Chapter 11 After Monitoring
156
Completing Monitoring
156
Switching off
156
Chapter 12 Maintenance and Cleaning
157
Maintenance
157
Maintaining Inspection
157
Maintenance of Monitor and Base Station
158
Maintenance of Wired and Wireless Transducers
158
Storage of Recorder Paper
158
Cleaning of Recorder
159
Maintaining the Battery
159
Cleaning
159
Cleaning of Monitor and Base Station
159
Cleaning of Accessories
160
Disinfecting
162
Sterilizing
163
Chapter 13 Warranty and Service
164
Warranty
164
Contact Information
164
Appendix 1 Product Specifications
165
A F9, F9 Express Fetal/Maternal Monitor
165
A1.1 Environmental Specifications
165
A1.2 Physical Specifications
165
A1.3 Performance Specifications
167
A1.4 Recorder Specifications
172
A1.5 Rechargeable Lithium-Ion Battery
173
A1.6 Low Output Summary Table
173
B FTS-3 Fetal Telemetry System
174
B1.1 Environmental Specifications
174
B1.2 Physical Specifications
174
B1.3 Performance Specifications
176
B1.4 Rechargeable Lithium-Ion Battery
179
B1.5 Low Output Summary Table
179
Appendix 2 Signal Input/ Output Connector
181
Appendix 3 Troubleshooting
183
A F9, F9 Express Fetal/Maternal Monitor
183
A3.1 no Display
183
A3.2 Noise
183
A3.3 Recorder Error
183
A3.4 Trouble with Ultrasound FHR Monitoring
184
A3.5 Troubles with DECG Monitoring
184
A3.6 Troubles with Contractions Monitoring (External)
185
A3.7 Troubles with Contractions Monitoring (Internal)
185
A3.8 Big ECG Signal Interference or Thick Baseline
185
A3.9 NIBP and Spo2 no Results
186
A3.10 Blown Fuses
186
B FTS-3 Fetal Telemetry System
188
B3.1 Troubleshooting
188
B3.2 Blown Fuses
188
Appendix 4 Ultrasound Intensity and Safety
191
A4.1 Ultrasound in Medicine
191
A4.2 Ultrasound Safety and the ALARA Principle
191
A4.3 Explanation of MI/TI
191
A4.3.1 MI (Mechanical Index)
191
A4.3.2 TI (Thermal Index)
192
A4.3.3 Measurement Uncertainty
192
A4.4 Prudent Use Statement
193
A4.5 References for Acoustic Output and Safety
193
A4.6 Transducer Acoustic Output Parameters List
194
A4.6.1 Test of Wired Transducer
194
A4.6.2 Test of Wireless Transducer (FTS-3)
195
A4.6.3 Standard Parameter Equal Contrast List
198
Appendix 5 Abbreviation
200
Appendix 6 Ordering Information
202
Appendix 7 EMC Information
205
A7.1 Electromagnetic Emissions
205
A7.2 Electromagnetic Immunity
206
A7.3 Electromagnetic Immunity
208
A7.4 Recommended Separation Distances
211
Appendix 8 Limitations of Ultrasonic Monitoring
212
A8.1 How Does Ultrasound Work
212
A8.2 Artifacts in Fetal Heart Monitoring
212
A8.3 Audio Output and Screen Reading
214
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EDAN F9 Express Specifications
General
Brand
EDAN
Model
F9 Express
Category
Medical Equipment
Language
English
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