Edan PDF
Edan PDF
Edan PDF
MPN: 01.54.455327017
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
The electrical installation of the relevant room complies with national standards, and
Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other
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
III
IV
VI
VII
VIII
IX
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.
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1.2 Features
The following table lists the measurements that F6, F6 Express, F9 and F9 Express support.
Model
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
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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:
Electrocardiography (ECG)
Type CF, defibrillation-proof
Temperature (TEMP)
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.
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.
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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.
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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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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.
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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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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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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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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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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.
Reserved.
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RJ45 Interface
Equipotential Grounding
Battery check
Stand-by
Warning
Operating instructions
- 12 -
CE marking
Disposal method
Part Number
Serial Number
Date Of Manufacture
Manufacturer
Caution: Federal (U.S.) Law restricts this device to sale by or on the order of
a physician
Serial Number
- 13 -
Channel Adjustment
- 14 -
If your monitor has been configured with a rechargeable lithium-ion battery, follow these steps to
install the battery:
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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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.
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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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.
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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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
8 Paper Drawer
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
Figure 3-2 Left Panel
28 NIBP Socket
29 TEMP Socket
30 SpO2 Socket
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16 POWER Switch
17 Equipotential Grounding
Terminal
20 Power Socket
21 Handle
22 DB9 Socket
Figure 3-4 Rear Panel 23 RJ45Socket
24 Fuses
25 Battery Compartment
26 Wall-mounting Holes
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The Monitor is a user-friendly device with operation conducted by a few keys on the front panel
and the control knob. Their functions are as follows:
(1) *START
Press this key to start monitoring (on the main interface) or return to main interface (in maternal
information inputting menu or setup menus).
(2) SILENCE
Function: Silence/reset
Press this key to disable the current auditory alarm manifestation, and re-enable the monitor’s
response to new abnormal patient condition.
(4) MARK
Function: Record an event.
Press this key to make an event mark.
(5) PRINT
Function: Start / stop printing
Press this key to toggle between starting and stopping printing.
(6) *CHANNEL
(7) NIBP
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It can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations
on the screen or in the menu are completed by using the control knob.
The highlighted rectangular mark on the screen that moves with the rotation of the control knob is
called “cursor”. Operations can be performed in the position on the screen where the cursor stays.
When the cursor is located on a certain item, you can press the control knob to open its submenu
or confirm the operation. Press the control knob again, and the cursor will be able to move around
on the interface/menus.
Operation Procedure:
a) Rotate the control knob to move the cursor to the item you want;
b) Press the control knob;
c) One of the following three results will be achieved:
A menu pops up on the screen, or the menu is replaced by a new one;
A submenu with several options appears on the right of the item. If this item has more
than 8 options, they will be displayed in more than one page. Select PREV to switch to
the previous page, or select NEXT to switch to the next page.
NOTE:
1 The word “select” hereinafter stands for rotating the control knob cursor to an item
and then pressing the knob.
2 If the key sound is enabled, the monitor gives a normal key sound when the operation
is valid, and gives a sharp “Di” sound when the operation is invalid.
CAUTION
This monitor is a normal medical device. Please avoid violent operations such as
continuously pressing the keys or control knob.
3.1.2 Indicators
There are four groups of indicator on top of the screen and the front panel. From the top down
they are: alarm indicator, CHARGE indicator, AC indicator and Power indicator.
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3.2 Accessories
3.2.1 Ultrasound (US) Transducers
1 US Transducer Sensor
2 Transducer Cable
3 Transducer Connector
2 3
Figure 3-7 US Transducers
1
3 3 Transducer Connector
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3.2.3 Belt
1 Marker Plug
2 Press Key
2
1
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7 Safety Cap
1
2
4
3
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2 Catheter
1
1 ECG Connector
2 ECG Fastener
3 Lead Wire
2
1
3
1 SpO2 Sensor
2 SpO2 Connector
2
1
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1
2
1 NIBP Cuff
1 TEMP Sensor
2 TEMP Connector
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3.3 Screen
3.3.1 Main Interface
Message
Window
Trace/Menu
Window
Numeric
Window
Status Window
According to the content, the main interface is divided into four windows:
According to the content, the main interface is divided into four windows: (1) Message Window
(2) Trace/ Menu Window (3) Numeric Window (4) Status Window.
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a b c d e
a) :
Alarm messages displaying area. When an alarm is active, the message will be displayed
here in yellow. Patient alarms will be displayed on the left and technical alarms in the center.
b) : Paper advancing key. Select this key to advance the paper for 8 cm (PHILIPS
paper) or 7 cm (GE paper).
c) : Display mode switch. F6 Express and F9 Express monitors have three display
modes: maternal-fetal display mode, fetal display mode and maternal display mode. Select
this key, and the display mode will switch to the next one in order.
d) : Mat. Info key. Select this key to open maternal information menu for inputting or
changing the patient’s ID and name.
The background pane bar supports two standards: 30 ~ 240 (American standard) and 50 ~ 210
(International standard).
The green band in between the fetal heart rate panes indicates the preset alarm range (the top
edge is not higher than 180 and the bottom edge is not lower than 100). It makes it easy to
observe if the FHR exceeds the normal range. So you can easily tell if the fetal heart rate is too
low or too high.
The fetal monitoring numerics and maternal vital signs are displayed here.
When the monitor is connected to the FTS-3 system, the signal strength and battery level
of the wireless transducers are displayed.
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f g h i j k l m n o p
f) Power indicator
- AC power supplied.
- no AC power supplied.
g) Battery indicator
The battery is loaded into the monitor with 100% capacity
75% capacity
50% capacity
25% capacity
The battery is almost depleted and needs to recharge immediately.
No battery is loaded.
h) Network connection indicator and device no.
- the monitor is online.
- the monitor is offline.
NOTE:
The network connection indicator is not available if the net version is Insight or
Philips.
i) Audio alarm indicator
- the audible alarm is switched on.
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75% capacity
50% capacity
25% capacity
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Setup Items
Software Version
Function description
In the setup main menu, you have access to all the items other than System. You can select EXIT
to exit from this menu.
The items in this main menu all have submenu(s). To confirm the setting changes in the
submenus, you need to select OK to exit. If you don’t want to store the new settings, select
Cancel, or press the START key to return to the main interface. If no operation is performed in
30 seconds, the menu will return to the upper directory. The change will not be stored.
Once you select OK to confirm the setting changes, the new settings will be stored in the
monitor’s long-term memory. If the monitor is switched on again after being switched off or a
power loss, it will restore the new settings. The setting does not take effect if the system exits
automatically or is shutdown before OK is selected.
For your reference, when the cursor is located at an item in this menu, the monitor provides a
brief function description of this item in a pane with blue frame under the items. For example, the
cursor is located at “System” in the illustration above. Correspondingly, its function “Set system
items of the monitor” is issued in the blue frame pane.
The touch screen is easy to use and operate. It works as a smart control knob. All the operations
of the control knob can be done by gently touching the corresponding position on the screen.
When the touch screen is configured, touching the corresponding menu item is equal to rotating
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the control knob to this item and then pressing it. In the same way, one of the three results with
the control knob will be achieved.
On the main interface, the symbols and might appear right next to the highlighted
item. Touch the symbol to increase the numeric, move to the previous item or move
leftwards. While touching the will decrease the numeric, move to the next item or move
rightwards.
To exit from the submenu, you should touch the item again or touch any place outside the area of
the options.
NOTE:
When touching an item, place the finger or the stylus pen within this item’s cursor pane
to ensure the operating validity. A key sound is heard corresponding to every valid touch,
if the key sound is enabled.
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Chapter 4 Alarms
4.1 Alarms Classification
The monitor has two types of alarm: patient alarm and technical alarm.
Patient alarms indicate the situation of vital sign exceeding its configured limit. Audible alarms
and visual alarms can be disabled excluding ASYSTOLE alarm. The adjustable alarm limits
determine the conditions that trigger the alarm.
Technical alarms indicate that the monitor can not measure and therefore can not detect critical
patient conditions reliably. They cannot be disabled.
In terms of severity, the alarms are divided into three levels: high, medium and low. High level
alarm indicates the condition where the patient’s life is endangered; it is a severe warning, labeled
with the symbol ***; Medium level alarm is a moderate warning, labeled with the symbol **;
low level alarm is a general warning.
The high level alarms have highest priority, and the medium level alarms take the second place. If
more than one type of alarms is active at the same time, the monitor sounds an audible indicator
for the higher level alarms.
If the current audible alarm is temporarily disabled, the alarm indicator displays , with a
remaining time on the right. The audible alarm is enabled again when the time is out, or when the
SILENCE key is pressed.
If the current audible alarm is infinitely disabled, the alarm indicator displays (flashing).
The audible alarm is enabled again when the SILENCE key is pressed.
If Alarm Reset is enabled (see 4.8 Pausing or Resetting the Alarm), and you press the SILENCE
key to disable an audible alarm, the alarm indicator will display . When other alarms present,
the monitor will enable the audible alarm again automatically.
During the silence period, the alarm messages are displayed and the alarm indicator lights up as
usual. You can press the SILENCE key again to enable the audible alarm.
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WARNING
1 Do not rely exclusively on the audible alarm system for patient monitoring.
Adjustment of alarm volume to a low level or off during patient monitoring may result
in patient danger. Remember that the most reliable method of patient monitoring
combines close personal surveillance with correct operation of monitoring
equipment.
2 When the sound pressure of audible alarm is equivalent to the ambient noise, it may
be difficult for the operator to distinguish the audible alarm.
3 Do not disable the audible alarm infinitely for the condition where the patient’s safety
may be endangered.
NOTE:
After you enable the audible alarm again, whether the alarm sound still exists depends
on whether the alarm persists.
- Alarm message: the alarm message appears in the message window of the main interface in
yellow, with patient alarms on the left and technical alarms in the middle.
- Flashing numeric: the numeric of the measurement flashes in grey with a frequency of 2Hz.
When more than one alarm is active, the alarm messages appear in the same area in succession.
WARNING
Setting alarm limits to extreme values may cause the alarm system to become
ineffective. It is recommended to use the default settings.
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The monitor can display a maximum of 100 immediate alarm messages. When the storage is full,
it will delete the earliest alarm message automatically to store the new one.
The monitor can display a maximum of 800 historically physiological alarm and signal overlap
alarm messages. When the total number exceeds 800, the alarms messages cannot be stored.
Select the alarm reviewing key in the message window to open this menu.
When you review the traces with the word REVIEW shown in the background, the alarm
reviewing menu displays historic alarm review. Otherwise, it displays the immediate alarm
review.
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Each page displays 10 alarm records. The page mark “1/6” informs you that there are 6 pages and
the present one is page 1.
To review more records, select the alarm list and then rotate the control knob to switch to the
previous or next page.
When a new monitoring starts, or after the monitor is switched off, the alarm messages will be
cleared.
NOTE:
You can select Main Menu > General > Review Alarms to set up On (by default) or
OFF. When the alarm review is enabled, the icon will appear in the main interface.
When the monitored parameter(s) come(s) back within the adjusted limits, or if the abnormal
technical condition does not exist any longer, the monitor stops giving out the alarm.
- 37 -
Medium Level
FHR1/FHR2 Low Alarm Limit 60 bpm ~ 205 bpm, in increments of 5 110 bpm
FHR1/FHR2 High Alarm Limit 65 bpm ~ 210 bpm, in increments of 5 160 bpm
- 38 -
SYS High Alarm Limit 41 mmHg ~ 270 mmHg, in increments of 1 160 mmHg
TEMP High Alarm Limit +0.1 ºC ~ +50.0 ºC, in increments of 0.1 +39.0 ºC
NOTE:
The upper limit must be higher than the lower limit. When setting the upper limit, you do
not have access to the options that are lower than the preset lower limit, and vice versa.
- 39 -
Chapter 5 Printing
5.1 *Function Description
The built-in thermal recorder applied in the monitor supports both the American and international
standard wide recorder paper. It prints continuous traces synchronously along with marks.
The monitor supports some other functions listed below:
Auto start printing: If the function is enabled, the recorder starts printing automatically
when new monitoring starts (the START key is pressed). Otherwise you have to press the
PRINT key to start printing.
Printing timer: The printing timer determines the elapsed time for each print. This time is
adjustable. Refer to 5.2.3 Changing the Print Timer.
Fast printing: The recorder prints the data saved in the monitor at a high speed (up to
15mm/s).
Data Caching: When the paper drawer runs out of paper or when it is open, the recorder
stops printing. The data from this time on (at most 60 minutes) will be temporarily saved in
the internal memory. When new paper is loaded and/or the drawer is closed, the saved data
will be printed out at a high speed. When the saved trace has been printed out, the recorder
switches back to continue printing the current data at the normal speed automatically.
NOTE:
1 When the monitor is switched off, the data in the internal memory will be lost.
2 If a printing timer is set, and the time is out when the paper runs out, the CTG
analysis result may disaccord with the printout. Therefore, reload the paper in
time to avoid paper lack.
FHR2 offset: You can set the offset of the FHR2 trace to separate the two FH traces on the
screen and the recorder paper. Refer to 7.4.4 Changing FHR2 Offset.
Print self-check: The recorder prints a baseline for self checking when the monitor is
switched on.
Paper advance: When printing stops, press the paper advancing key to advance the
paper, making sure the paper has a perforation outside the drawer and is easy to be torn off.
NOTE:
The paper advancing key is invalid in the process of printing and paper advancing.
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All the parameters should be well configured before printing starts. You can not change
the configuration in the process of printing.
Different paper speed setting causes different FHR trace appearance on the record
paper. To avoid misinterpretation, we recommend you to set all monitors in your
institution to the same paper speed.
- 41 -
Figure 5-1 is an example of the recorder paper with traces. Comparing it with the monitor screen,
you can find this extra information on it:
- 42 -
(4)
(13)
(1) (14)
(8)
(5)
(6)
(9)
(2) (11)
(7)
(10)
(3) (12)
The paper settings of the monitor. It consists of the paper type and
paper style, e.g. “G 50-210”, indicating that the paper type is “F9-G”,
2. Paper Settings
and the paper style is International. It is printed out to check if the
proper recorder paper is used.
3. Paper Type There are two types of paper: F9-G and F9-P.
5. FHR1 Mark The trace marked with “FHR1” is the FHR1 trace.
6. FHR2 Mark The trace marked with “FHR2” is the FHR2 trace.
A list of current date, time, print speed, ID, Name, FHR2 offset, HR,
Trace
7. SpO2, NIBP (including SYS and DIA) and TEMP is printed at the start
Information List
of the monitoring and every ten minutes afterwards.
- 43 -
10. SpO2 Mark The trace marked with “SpO2” is the maternal SpO2 trace.
Each recorder paper pack has 150 pages. When you notice the page
12. Page Mark
mark comes to the end, remember to load new paper in time.
CTG Analysis
13. The CTG analysis results of FHR1 and FHR2.
Result
It indicates the physiological alarm message and signal overlap alarm
14. Alarm Message
message.
- 44 -
1 Only use the recorder paper provided by the manufacturer, otherwise the recorder
may be damaged. This kind of damage is not covered by warranty.
2 Configured with different hardware, the monitor is compatible with both GE and
Philips recorder paper. However, the monitor is configured with only one type of paper
in the shipment. If you want to use the other type of paper, contact the manufacturer
for service first, otherwise trace excursion or paper jam may occur.
If the monitor is used for the first time or when the paper runs out, you should load paper.
1) Press the two latches on each side of the paper drawer at the same tine and slide the drawer
out carefully.
2) Take out the Z-fold thermosensitive paper and remove the wrapper.
3) Place the pack in the drawer, with the pane facing up and the FHR trace area on the left.
- 45 -
4) Unfold two sheets from the top of the pack and pull the end of the paper out of the drawer
(make sure the pack in the drawer remains flat).
5) Slide the drawer in until both the latches are locked.
NOTE:
1 Be careful when inserting paper. Avoid damaging the thermosensitive print head.
2 Make sure the paper is evenly loaded in the drawer. Otherwise the data will be
inaccurate or paper jam will happen.
3 Only use the paper the manufacturer approved to avoid poor printing quality,
deflection, or paper jam.
4 Keep the drawer closed unless when loading paper or providing a service.
When the recorder does not function or sound properly, open the drawer to check for a paper jam.
Remove the paper jam in this way:
- 46 -
6.2 Switching On
WARNING
1 Check if all the metal parts are linked to the protective earth cord and the cord is in
good condition before switching on the monitor.
2 If any sign of damage is detected, or the monitor displays some error messages, do
not use it on any patient. Contact biomedical engineer in the hospital or our service
engineer immediately.
Press the POWER switch on the right panel to switch on the monitor. The power indicator lights
up and a start-up music will be heard. You can operate the monitor after the main interface
appears.
The recorder prints a baseline and paper settings after start-up (if Print Self-Check is ON).
Check if the paper settings match the paper being used (in the circled area below, P should
correspond to F9-P, and G to F9-G), and then observe the starts and ends of the printed baselines
(illustrated with the arrow). The starts and ends should be printed exactly on the edges of the pane
if the recorder paper is correctly loaded and set. If they do not comply with the edges, reload
paper or ask the service engineer to check the paper settings of the monitor.
- 47 -
If the monitor does not print the baseline, switch on the Print Self-Check function and then
restart the monitor.
NOTE:
Make sure the paper is correctly loaded before the printing starts.
Adjustment method:
Push the hook on top of the screen left to spring it open. Pull the screen forward to adjust to one
of the preset screen angles.
To bring the screen back to flat, pull it all the way forward and then push it back.
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CAUTION
You should set date and time information in advance. After this information is changed,
the monitor starts new monitoring with an auto ID. Therefore, we advise you to restart
the monitor after changing date or time information, and do not perform this operation
when monitoring is in process.
NOTE:
The date and time remain in the monitor for at least two months after it is switched off.
You do not have to set date and time before monitoring each time.
- 49 -
When plugging transducers into the monitor, make sure the arrow symbol of the connector faces
up and put it into the socket.
When disconnecting a transducer, pinch the afterbody of the transducer plug and pull it out
slightly.
NOTE:
Never try to disconnect the transducer by pulling the cable directly.
- 50 -
NOTE:
In the process of monitoring, the transducer that is placed in the holder may be affected
and thereby produces interfering signals. Therefore, when monitoring a patient, it is
recommended to remove or disconnect the transducer that is not in use.
corresponding volume adjustment key of this channel displays , indicating the FH sound is
coming out from this channel; while the other one displays , for example:
- 51 -
The volumes of pressing keys, rotating and pressing the control knob are also adjustable.
- 52 -
WARNING
1 The monitor is not intended for use in intensive care units (ICU), operating rooms or
for home use.
2 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in
harming the patient or the operator.
3 Always check if the alarm settings are appropriate for your patient before starting
monitoring.
- Electrical impulse from the maternal heart transmitted through a recently deceased fetus.
So you need to confirm fetal life by other means before starting to use the fetal monitor, such as
using a fetoscope, stethoscope, Pinard stethoscope or obstetric ultrasonography.
WARNING
Make sure you have confirmed the fetal life by other means before using this monitor for
FHR monitoring.
- 53 -
Place the transducer belts across the bed, ensuring that the belt will be around the abdomen
when it is fastened. Lay the patient on the bed.
Alternatively, the patient can take a sitting position. Arrange the belt around her abdomen.
- Search for the location of the fetal heart using a stethoscope or a fetoscope. The best fetal
heart signal can be obtained through the fetal back.
- Place the transducer below the navel for head presentation and place the transducer above the
navel for breech presentation.
- During parturition, the fetal heart moves downward as the labor progresses. It is
recommended to move the transducer along with the fetus.
Fetal Heart
Pregnancy
Early Parturition
Late Parturition
Apply a certain amount of acoustic gel on the transducer and move the transducer slowly around
the fetus site to even the gel. The best fetal heart signal can be obtained through the fetal back.
Find at least 2 or 3 sites, and choose the one where the clearest, most sonorous and steady fetal
heart sound is heard. When the transducer is connected correctly and communicated well, the
fetal heart signal indicator is full. If the signal is poor, the signal indicator shows as it is and no
FHR data are displayed. When you move the transducer on the abdomen, adjust the speaker
volume so that it can be clearly heard.
When you find clearest and most steady fetal heart sound, wrap the abdomen with the belt over
the transducer. Fix the transducer by pushing its buckle through the overlapping section of the
belt.
- 54 -
Make sure the belt fits the patient snugly but comfortably. Meanwhile, fetus heart beat sound is
heard; the FHR trace and numeric are displayed. During long-time monitoring, the gel may dry
out as the transducer moves around. Add more gel in time if it is inadequate.
Ultrasound Doppler technology is utilized to observe the fetal heart rate externally, there are
possibilities that maternal heart rate signal is mistaken for FHR signal. It is highly
recommended to confirm that the fetus is the signal source continuously. You can feel the
maternal pulse at the same time.
If the maternal heart signal is misidentified as the fetal heart signal, Repositioning of the
transducer is needed.
NOTE:
1 Do not mistake the high maternal heart rate for fetal heart rate. The fetal pulse can be
distinguished from the maternal pulse by feeling the mother’s pulse during the
examination.
2 The best quality records will only be obtained if the probe is placed in the optimum
position. Positions with strong placental sounds or umbilical blood flow sound should
be avoided.
3 If the fetus is in the cephalic presentation and the mother is supine, the clearest heart
sound will normally be found on the midline below the umbilicus. During monitoring,
the patient’s prolonged lying in the supine position should be avoided owing to the
possibility of supine hypotension. Sitting up or lateral positions are preferable and
may be more comfortable.
5 During long-time monitoring, the gel may dry out as the transducer moves around.
Add more gel in time if it is inadequate.
6 When applied to the patient, the ultrasound transducer may warm slightly (less than
1°C (1.8ºF) above ambient temperature). When NOT applied, the ultrasound
transducer may warm slightly (less than 2°C (3.6ºF) above ambient temperature).
You can choose to switch the FHR alarm on or off. If the fetal heart alarm is switched off, the
monitor will no longer give any audible or visual warning for this monitoring item.
- 55 -
3 Select FHR.
4 Select ON (default) or OFF for Alarm.
5 Select OK.
When the alarm is switched off, an alarm switched-off symbol appears in the numeric
window. For example:
WARNING
Do not switch the alarm off for the condition where the patient’s safety maybe
endangered.
- 56 -
4 Select a value from 0 ~ 30 second(s) for Alarm Delay. (The step is 5, and the default
value is 10 seconds.)
5 Select OK.
WARNING
The FHR alarm delay is adjustable between 0 and 30 seconds.
3) Hold the transducer with one hand, and gently touch the center of the transducer
4) Check that the value on the display shows this change in FHR.
If a US transducer fails the test, repeat this test with another transducer. If the second one passes
the test, defect of the first transducer is confirmed. Replace it with a good one. If the second
transducer fails the test as well, contact the manufacturer for service.
- 57 -
7.3.1 Contraindications
The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and
sufficient cervical dilatation is ensured. The fetal electrode tip is designed to penetrate the
epidermis of the fetus; therefore, trauma, hemorrhage and/or infection can occur. The electrode
should be used with strict adherence to aseptic technique.
The fetal spiral electrode should not be applied to the fetal face, fontanels or genitalia.
Do not apply the fetal spiral electrode when placenta previa is present; when the mother has
visible genital herpes lesions or reports symptoms of prodromal lesions; when the mother is HIV
sero-positive; when mother is a confirmed carrier of hemophilia and the fetus is affected or of
unknown status; or when it is not possible to identify fetal presenting part where application is
being considered. This method is not recommended when fetus is extremely premature, or in the
presence of a maternal infection such as Hepatitis B, Group B hemolytic strep, syphilis or
gonorrhea, unless a clear benefit to the fetus or mother can be established.
(3)
(2) (1)
2) Wash the sites thoroughly with soap and water. (Do not use ether or pure alcohol, which will
increase skin impedance)
3) Rub the skin briskly to increase capillary blood flow in the tissues.
- 58 -
NOTE:
1 The DECG beep and HR beep share the same audio channel. Once the DECG beep
is switched on, the HR beep is disabled (set to level 0) automatically.
2 Once the DECG/HR beep volume is changed, the sound switches to channel 1
automatically. Therefore, it is advised against changing DECG/HR beep volume in the
monitoring process.
WARNING
When artifact suppression is on, fetal arrhythmia will also be suppressed. Therefore, if
fetal arrhythmia is suspected, switch artifact suppression off.
- 59 -
2 Remove the spiral electrode from the package; leave the electrode wires locked in the
handle notch.
4 Hold the drive handle, ensure the spiral electrode is retracted about one inch (2.5 cm)
from the distal end of the guide tube.
5 Place the guide tube firmly against the identified presenting part.
6 Maintain pressure against the fetal presenting part with guide and drive tubes. Rotate the
drive tube by rotating the drive handle clockwise until gentle resistance is encountered.
Resistance to further rotation and recoil of the drive handle indicates that the spiral
electrode is well attached to the fetus.
7 Release the electrode wires from the handle notch and straighten them. Slide the drive
and guide tubes off the electrode wires.
2 Prepare the patient’s skin using the procedures described in section 7.3.3 Preparing
Patient's Skin Prior to Placing Electrodes.
3 Attach the fetal spiral electrode to the fetal presenting part using the procedures
described in section 7.3.6 Directions for Using Fetal Spiral Electrode.
- 60 -
5 Remove the film on the back of the electrode and place the electrode on maternal thigh;
press it firmly in place.
7 Insert connector of DECG cable into the DECG socket of the monitor.
WARNING
Do not plug the fetal spiral electrode wire into the power socket.
CAUTION
Do not mistake the higher maternal heart rate for DECG.
NOTE:
1 If there is any doubt as to the presence of a fetal heart signal with ECG, check with
the US transducer on the patient’s abdomen or with a separate diagnostic instrument.
The presence of an audible heart sound at a rate distinct from that of the maternal
pulse is unequivocal evidence of the fetal life.
2 After the electrode is well attached, allow a few minutes for the electrode and fetal
tissue to become stabilized. It is essential that the ECG signal electrode is in good
contact with the fetal presenting part.
When the two US transducers are fixed, make sure FH sounds from both channels are clear, two
FHR traces and two FHR numerics are displayed on the screen.
NOTE:
To ensure that both transducers stay at the optimum location, each transducer should be
fixed with a separate belt.
- 61 -
Connect the US transducer to US2 socket; connect DECG cable to DECG socket.
Monitor one twin with a US transducer using the procedures described in Section 7.2 Monitoring
FHR with Ultrasound.
Monitor the other twin with a DECG cable using the procedures described in Section 7.3
Monitoring FHR with DECG.
CAUTION
The US transducer must be connected to US2 socket. If the US transducer connects to
US1 socket while DECG cable is connected to DECG socket, the FHR trace and
numeric from US1 will not be displayed.
In the process of monitoring, if the SOV detects signals overlapping, an alarm message “Signals
Overlap (FHR1/DFHR, FHR2)” will appear on the screen to warn you. Checking the patient and
reposition of transducers might be needed.
This preset FHR2 offset will be printed on the recorder paper every 10 minutes.
- 62 -
“FHR2: -20bpm”: the FHR2 trace is 20bpm lower than it really is.
“FHR2: 20bpm”: the FHR2 trace is 20bpm higher than it really is.
Place the transducer belts across the bed, ensuring that the belt will be around the abdomen
when it is fastened. Lay the patient on the bed.
Alternatively, the patient can take a sitting position. Arrange the belt around her abdomen.
Wrap the abdomen with the belt over the transducer. Fix the transducer by pushing its buckle
through the overlapping section of the belt. Make sure the belt fits the patient snugly but
comfortably.
- 63 -
Press the AUTO ZERO key to adjust the numeric to the baseline. Make sure this is not done
during a contraction.
The uterine activity reading at this point should be 30 ~ 90. A flat-top aligned with 100 on
the TOCO scale indicates the belt is too tight, and you need to adjust it.
NOTE:
1 Do not apply aquasonic coupling gel on a TOCO transducer or its contact area.
2 Check the function of the TOCO transducer by applying pressure on it to see if this is
displayed on the screen.
NOTE:
If the monitor has been configured with IUP, the IUP baseline is 0 and it is not adjustable.
The TOCO baseline is adjustable.
- 64 -
4) Check that the value on the display shows this change in pressure.
If a TOCO transducer fails the test, repeat this test with another transducer. If the second one
passes the test, defect of the first transducer is confirmed. Replace it with a good one. If the
second transducer fails the test as well, contact the manufacturer for service.
- 65 -
Insertion
NOTE:
This product is designed for use with the introducer.
3) Using aseptic technique, remove the catheter from the package.
4) Perform vaginal exam to ensure ruptured membranes and adequate dilation.
5) Advance the catheter tip to the cervical os along the examination hand, using the hand
as a guide. Do not advance the introducer through the cervix.
6) Continue to gently advance the catheter tip through the cervical os and feed the catheter
into the intra-amniotic cavity until the 45cm mark is at the introitus. If the 45cm mark is
not clearly visible, stop advancing when the symbol on the catheter meets the
introducer.
NOTE:
For easier insertion, do not twist the catheter in the introducer.
7) The IUPC may be spontaneously filled with amniotic fluid. This can be seen in the clear
lumen of the catheter. The filter cap will prevent the amniotic fluid from leaking.
8) Slide the introducer out of the vagina along the catheter. When the introducer is
completely out of the vagina, slide thumb between catheter and introducer tab, which
will begin to separate the introducer from the catheter.
9) Anchor the catheter in place with one hand, and pull the introducer straight back off the
catheter.
10) Remove the liner from the adhesive pad, and then adhere the pad to the patient’s skin.
Secure the catheter by placing the catheter attachment strap to the adhesive pad.
- 66 -
Figure 7-11 Rezeroing the system
2) During this period, adjust the monitor to zero by pressing AUTO ZERO key.
WARNING
1 Before insertion of IUPC, placental position should be confirmed, amniotic
membranes are adequately ruptured and sufficient cervical dilatation is assured.
2 Try to insert the catheter opposite the placental site. Do not insert the introducer
beyond the cervical OS. Use it with caution when uterine infection is present.
3 If resistance is met at any time during insertion, withdraw the catheter slightly and try
at a different angle. Forced insertion may result in patient’s discomfort or injury.
CAUTION
1 Since procedures vary according to hospital needs/preferences, it is the responsibility
of the hospital staff to determine exact policies and procedures for both monitoring
and amnioinfusion. The safe and effective use of the IUPC depends on the skill of the
clinician who applies/uses it.
2 The Product has been sterilized by gamma radiation and is sterilized and
non-pyrogenic unless package is broken or open. Do not re-sterilize it.
NOTE:
Refer to the instruction on the package for more information about using the IUPC.
- 67 -
Figure 7-12 Connect catheter to pressure cable
3) Connect the IUP cable to the connecting cable. (They might have already been well
connected in the package.)
4) Plug the connecting cable to the TOCO/IUP socket of the monitor.
5) Momentarily pressing the re-zero button on the IUP cable. The green light on the cable
will flash for five seconds. During this period, zero the monitor by pressing the AUTO
ZERO key. Make sure the display numeric and trace are both “0”.
6) Ask the mother to cough. A spike on the trace in response to the cough indicates proper
positioning and function of the IUPC.
7) Wash timely during monitoring. A spike on the tracing will respond to the washing.
Figure 7-13 Test the pressure cable
NOTE:
1 If the light is flashing, verify that the cable check plug is inserted completely into the
cable.
2 The cable test function is not intended to check the accuracy of the system, only to
confirm cable function.
- 68 -
Only US1 channel can perform AFM. But be aware that when monitoring twins, the movements
detected by US1 may also be caused by the second fetus’s movement.
The movement of the fetus will be detected and displayed in the form of a trace on the screen and
the recorder paper.
NOTE:
- 69 -
1) Insert the FM marker connector into the MARK socket on the monitor.
2) Let the patient hold the marker in hand; ask her to press the top key of it when a fetal
movement is felt. Continuous movements in 5 seconds are considered to be one
movement and only press the key once.
- 70 -
If the Auto Printing is disabled, press the PRINT key to start printing.
2 Select ID.
The monitoring does not stop when you change maternal information. After you select OK to exit,
the new ID takes the place of the old one for this patient.
NOTE:
1 Pressing the START key separates two patients. The monitor only displays the most
recent ID for the same patient.
2 If printing starts automatically with the monitoring, the first ID printed on the recorder
paper will be the auto-ID. The new ID will be printed 10 minutes later.
3 The ID and name are shown on the screen, the paper printout and the archive list.
4 For the non-English system, more letters are provided for inputting the name. Select
the key on the bottom left corner to toggle between them.
- 72 -
1
2
1 FHR1 Trace
2 FHR2 Trace
3 AFM Trace
3 4 TOCO Trace
4 5 Trace Control Tools
During monitoring or reviewing, the trace window displays four traces: FHR1 trace, FHR2 trace
(dual configuration), AFM trace and TOCO trace.
FHR1/FHR2 trace
The y-axis of the trace indicates the numerics of FHR. The range is 30 bpm ~ 240 bpm
(American standard) or 50 bpm ~ 210 bpm (International standard).
AFM trace
The y-axis indicates the scope of fetal movement.
NOTE:
AFM trace is only for reference, please take the MFM marks as criterion.
- 73 -
TOCO trace
If FHR is monitored using DECG, and the DECG trace is switched on in the hardware setup (only
service engineers have access to it), a DECG trace is shown underneath other traces on the
screen.
This symbol indicates the MARK key is pressed to record an event, such as the
patient turning around, taking injection.
This symbol indicates the monitor is zeroed by pressing AUTO ZERO key.
NOTE:
The real time contains only the hour and minute, but no second. As a result, the time
scale may correspond to the 0 ~ 59th second of the system time. Do not mistake the time
scale for the exact time.
- 74 -
1 2 3 4
The files are stored in the monitor. When the data amount reaches the maximum capacity (300
files or approximately 60-hour), the monitor deletes the oldest file(s) automatically.
The searching key under the traces is used to search for a patient’s data file saved
in the monitor.
1 Select the searching key to open the file list. It contains six sets of most recent patient’s ID,
name and start time of monitoring. Select the required item, this file is loaded to the main
interface immediately.
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3 Select ID, input the patient ID with the soft keyboard and select Enter.
4 Select Name, input the patient’s name with the soft keyboard and select Enter.
NOTE:
You can input only a part of the patient ID or name. However, the more information you
input, the more accurate result you will get.
5 Select Search. The files with the matched information are listed in the window.
6 Select the required item, this file is loaded to the main interface immediately. You can review
the traces backward or forward.
8.2.3 *Reviewing
The reviewing keys (backward key) and (forward key) are used
to review the traces. The word REVIEW is shown in the background when reviewing the traces.
Select the backward key to review the previous traces. The traces start to retreat. The amount of
the progress symbol “<” on top of the traces indicates the retreating speed. Rotate the control
knob anticlockwise or touch the symbol to increase the speed until it reaches the maximum.
Rotate the knob clockwise or touch the symbol to decrease the speed until it reaches the
minimum. Press the knob or touch any place on the screen to pause.
- 76 -
Select the forward key to review the next traces. The traces start to advance. The amount of the
progress symbol “>” on top of the traces indicates the advancing speed. Rotate the control knob
clockwise or touch the symbol to increase the speed until it reaches the maximum. Rotate
the knob anticlockwise or touch the symbol to decrease the speed until it reaches the
minimum. Press the knob or touch any place on the screen to pause.
When the reviewing is paused, the progress symbol turns to <--X%-->. If the PRINT key is
pressed at this moment, the recorder will print the traces starting from the left edge of the screen
at a high speed.
X% indicates the proportion of current traces positioned in the whole reviewable traces.
Move the cursor away from the trace control tools, or touch any place out of the trace window on
the screen to return to the real-time main interface. If no operation is performed in 10 seconds,
the monitor switches to real-time interface automatically, unless the printing is in process.
When reviewing the traces, the monitor does not stop. The FH sound and numerics are all real
time information of the current patient.
WARNING
The reviewing printout is provided for reference only. Please take the real-time printout
as criterion when making diagnoses.
NOTE:
1 The main interface only displays traces and patient information of one file. If you want
to review another file you should search for the file and load it.
2 For a real-time monitoring patient, you can print all her traces, including SpO2 trace.
However, when printing traces in a file, the SpO2 trace cannot be printed.
3 You must pause before printing starts. Printing in the process of playback might result
in failure information on the paper.
4 After the reviewed data has been printed out, the recorder does not switch back to
real-time printing automatically.
- 77 -
WARNING
1 CTG analysis is used for the surveillance of pregnancies and not in delivery room of
childbirth.
2 CTG analysis is just an analysis intended to assist the physicians in interpreting the
waveforms. Conclusions should be drawn on the basis of the physicians’ diagnosis.
3 This analysis describes the fetal heart rate, the tocography and the fetal movements.
It’s the responsibility of qualified medical staff to do the diagnostic interpretation of the
waveform.
A CTG analysis key appears on the main interface, indicating that CTG analysis is
enabled.
1 CTG analyze starts after the real-time trace has been printed for 10 minutes.
After the real-time trace is printed for 10 minutes, select the CTG analysis key on
the main interface. The analysis result window opens.
- 78 -
1) CTG Analysis
Timer
2) Analysis Results
Refer to figure 8-5, the CTG analysis results on the screen include:
The CTG analysis timer starts when the recorder starts printing; it stops when the timer
reaches 60 minutes (the timer turns into >60) and resets when the recorder stops printing.
BASAL HEART the average FHR in 10 minutes when it is not influenced by fetal
RATE: movement or contractions.
the acceleration time, including the acceleration with amplitude
larger than 10bpm and lasts more than 10 seconds, and the
ACCELERATIONS:
acceleration with amplitude larger than 15bpm and lasts more than
15 seconds.
DECELERATIONS: the deceleration time.
SHORT TERM
the short-term variation analysis result.
VARIATION:
LONG TERM
the long-term variation analysis result.
VARIATION:
ANALYSIS START: the start time of the analysis.
ANALYSIS END: the finishing time of the analysis.
During 10 to 60-minute of the timer, the monitor gives CTG analysis results every minute.
- 79 -
At the end of the printing, the recorder prints the CTG analysis results of this moment on the
recorder paper.
Be aware that CTG analysis result is a calculation output. It can be used as a reference to assist
medical personnel in making correct diagnosis, instead of replacing it.
NOTE:
Do not disconnect the ultrasound transducer(s) before the printing stops, otherwise the
analysis results will not be printed.
However, an event mark cannot clearly indicate an event. Smart Notes provides a list of
annotation for the events, including events that relate to drugs, positions, membranes, procedures,
antenatal, reasons and others. This feature is only available on F9 and F9 Express.
A smart note editing key appears next to the Smart Notes item.
The annotation of this event will be printed in the top area of recorder paper during real-time
printing.
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5 Select a note.
6 Use the soft keyboard to edit the note content.
7 Select Enter.
8 Select OK.
8.3 Numerics
FHR1
FHR2
TOCO
MFM
The fetal monitoring values in the numeric window include FHR1/DFHR value, FHR2 value,
TOCO/IUP value and FM count:
FHR1/DFHR : FHR signal quality. When the quality is poor, it turns into .
: FH refreshing rate
- 81 -
TOCO/IUP
(10)/(0): UA baseline
FM
MFM/AFM: FM source
3: FM count
When F9, F9 Express Fetal/Maternal Monitor is connected to FTS-3 Telemetry System, the
wireless US transducer and TOCO transducer signal strength and battery level are
displayed in the numeric window.
Figure 8-7
- 82 -
Medium Level
Medium Level
Low Level
- 83 -
US transducer 1 is aimed at
US + Adjust the US transducer
Signals Overlap the fetus that the spiral
until another fetal heart
(DFHR, FHR2) DECG electrode is attached to; the
signal is detected.
signals overlap.
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NOTE:
WARNING
1 When connecting the cables and electrodes, make sure no conductive part is in
contact with the ground. Verify that all ECG electrodes, including neutral electrodes,
are securely attached to the patient.
2 The electrodes should be made of the same metal materials.
- 85 -
WARNING
3 ECG accessories are not suitable for DIRECT CARDIAC APPLICATION (Refer to
IEC60601-1 for more information about the definition of DIRECT CARDIAC
APPLICATION).
CAUTION
A different type of electrodes may produce higher offset voltage. Therefore, only use the
ECG leads supplied by the manufacturer when using the monitor for ECG monitoring.
NOTE:
Interference from a non-grounded instrument near the patient and ESU interference can
cause inaccuracy of the waveform.
A good ECG signal should be –
P T
Q
S
RA White R Red Near the right shoulder, right below the clavicle
LA Black L Yellow Near the left shoulder, right below the clavicle
- 86 -
Figure 9-2 Placing 3-lead ECG Cable
NOTE:
2) Insert the ECG cable connector into the MECG socket on the monitor.
4) Peel the protection membrane off the back of ECG electrodes and attach electrodes to the
patient. Refer to section 9.1.2 How to Place 3-lead ECG Cables for electrodes’ sites.
NOTE:
After the monitor is switched on, if electrodes are not well attached or fell off, alarm
message “ECG LEADS OFF” will appear on the screen to draw your attention.
If the electrodes are tightly attached to the patient but ECG waveform is not accurate, switch
ECG source to another lead by performing the following procedures:
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The monitor creates a square wave in the ECG area. Compare the square wave with the ECG
gauge. If the error is larger than 0.5mm, change the ECG gain.
ECG Gauge
When the error is smaller than 0.5mm, calibration is completed. Disable ECG calibration in the
same directory.
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1 Before monitoring, check whether the sensor cable is normal. If any sign of damage in
the SpO2 sensor is detected, do not use the sensor. Return it to the manufacturer for
service.
2 Do not put the SpO2 sensor on the extremities with arterial catheter or venous syringe.
- 89 -
WARNING
3 Do not perform SpO2 measuring and NIBP measuring on the same arm at one time,
because obstruction of blood flow during NIBP measuring may adversely affect the
reading of SpO2 numeric.
5 The maximum application time of the SpO2 sensor at a single site is 4 hours. Check
the sensor placement every 2 to 3 hours and move it when the skin deteriorates.
More frequent examinations may be required for different patients.
6 Setting the SpO2 higher alarm limit to 100% is equivalent to switching off the alarm on
higher limit. High oxygen levels may predispose a premature infant to retrolental
fibroplasia. Therefore, the higher alarm limit for oxygen saturation must be carefully
selected in accordance with commonly accepted clinical practices.
CAUTION
Compatibility between the monitor and sensor should be verified before use to avoid
injuring the patient or operator.
NOTE:
2 A functional tester cannot be used to assess the accuracy of the SpO2 sensor or the
monitor.
Measurement Limits -
1) Magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.
3) Low perfusion.
4) High-frequency electrical noise, including noise created by the host system, or noise from
external sources, such as electrosurgical apparatus, which is admitted by the host system.
- 90 -
7) Sensor temperature. (Maintain the temperature between +28 °C (+82.4 °F) and +41 °C
(+105.8 °F) for best operation)
8) Placement of the sensor, such as on an extremity that has a NIBP cuff, arterial catheter, or
intravascular line.
10) External illumination more than 5,000 lumens/square meter (typical office lighting). (Cover
the sensor site with opaque materials is recommended.)
b) Apply the sensor as directed, and observe all warnings and cautions presented in the sensor
user manual.
c) Clean and remove any substances, such as nail polish, from the application site.
d) Periodically check to ensure that the sensor remains properly positioned on the patient.
1) Insert the SpO2 sensor plug into the SpO2 socket on the monitor.
2) Place the forefinger, middle finger or third finger into the SpO2 sensor, refer to figure 9-3.
Figure 9-3 Placement of the Finger for SpO2 Measuring
- 91 -
NOTE:
1 The nail should cover the light but not too long.
2 The cable should be placed on the backside of the hand.
3 Avoid external light sources such as radiated rays or ultrared rays.
NOTE:
1 The SpO2 accuracy has been validated in human studies against arterial blood
sample reference measured with a CO-oximeter. Pulse oximeter measurements are
statistically distributed, only about two-thirds of the measurements can be expected
to fall within the specified accuracy compared to CO-oximeter measurements. The
volunteer population in the studies composed of local healthy men and women from
age 19 to 37, with variations of skin pigmentations. The SpO2 accuracy is as follows:
±2% for 90%-100% and ±4% for 70%-90%.
2 The pulse rate accuracy is obtained by comparison to the pulse rate generated with
an arterial oxygen simulator (also an electronic pulse simulator).
3 Generally, the quality of the SpO2 pleth wave reflects the quality of the light signals
obtained by the sensor. A wave of poor quality manifests a decline of the signal
validity. On the other hand, the stability of the SpO2 values also reflects the signal
quality. Different from varying SpO2 readings caused by physiological factors,
unstable SpO2 readings are resulted from the sensor’s receiving signals with
interference. The problems mentioned above may be caused by patient movement,
wrong sensor placement or sensor malfunction. To obtain valid SpO2 readings, try to
limit patient movement, check the placement of the sensor, measure another site or
replace the sensor.
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The signal intensity (SI) shows perfusion in numeric, and it reflects the pulse intensity of the
measurement site. The SI ranges from 0 to 10, with a larger value indicating the more intense
signal. When the SI value reaches 10, the signal quality is optimal. If the SI value is less than 2, it
indicates that the pulse at the current site is weak, and you should change the measurement site.
- 93 -
When monitoring ECG and SpO2 at the same time, you can choose the HR source. If only one of
them is being performed, the source will automatically switch to the available one (the screen
reading should prevail).
NOTE:
1 The DECG beep and HR beep share the same audio channel. Once the HR beep is
switched on, the DECG beep is disabled (set to OFF) automatically.
2 Once the DECG/HR beep volume is changed, the sound switches to channel 1
automatically. Therefore, it is advised against changing DECG/HR beep volume in the
monitoring process.
- 94 -
- 95 -
In the process of monitoring, if the SOV detects signals overlapping, an alarm message “Signals
Overlap (FHR1/FHR2, HR)” will appear on the screen to warn you. Checking the patient and
reposition of sensors might be needed.
Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff
deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks
through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase
in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.
There are two modes available: Manual and Auto. In manual mode, NIBP is measured once on
each demand. In auto mode, NIBP is measured repeatedly after a preset time interval. This
interval is adjustable. You can perform a manual measurement during an Auto measurement
interval.
In both modes, systolic pressure (SYS) and diastolic pressure (DIA) are measured and displayed.
The blood pressure measurements determined with this device comply with the American
National Standard for Electronic or Automated Sphygmomanometers (ANSI/AAMI/ISO
81060-2:2009, ANSI/AAMI SP10:2002) in relation to mean error and standard deviation.
WARNING
1 Check for any fault of the cuff before start monitoring.
2 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, such as on the arm
on the side of a mastectomy.
3 Pressurization of the cuff can temporarily cause loss of function of simultaneously
used monitor on the same limb.
4 If liquid is splashed on or into the main unit inadvertently, or enters the conduit, stop
using the monitor and contact the manufacturer for service immediately.
5 For a thrombasthemia patient, it is important to determine whether the measurement
of blood pressure shall be done automatically. The determination should be based on
clinical evaluation.
6 Do not apply the cuff to a limb that has an intravenous infusion or catheter in place
frequently. This could cause tissue damage around the catheter when infusion is
slowed or blocked during cuff inflation.
7 Make sure that the air conduit connecting the blood pressure cuff and the monitor is
neither blocked nor tangled.
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NOTE:
The monitor is intended to measure NIBP for adults only.
Measurement Limitations -
To different patient conditions, the oscillometric measurement has certain limitations. The
measurement is in search of regular arterial pressure pulse. In those circumstances where the
patient's condition makes it difficult to detect, the measurement becomes unreliable and the
measuring time increases. You should be aware that the following conditions could interfere
with the measurement, making the measurement unreliable or longer to derive. In some cases,
the patient's condition will make a measurement impossible.
1) Patient Movement
Measurements will be unreliable or may not be possible if the patient is moving, shivering or
having convulsions. These motions may interfere with the detection of the arterial pressure
pulses. In addition, the measurement time will be prolonged.
2) Cardiac Arrhythmia
Measurements will be unreliable and may not be possible if the patient's cardiac arrhythmia
has caused an irregular heartbeat. The measuring time thus will be prolonged.
3) Heart-lung Machine
4) Pressure Changes
Measurements will be unreliable and may not be possible if the patient's blood pressure is
changing rapidly over the period of time during which the arterial pressure pulses are being
analyzed to obtain the measurement.
5) Severe Shock
If the patient is in severe shock or hypothermia, measurements will be unreliable since reduced
blood flow to the peripheries will cause reduced pulsation of the arteries.
Measurements can not be done to a patient whose heart rate is lower than 40 bpm or higher
than 240 bpm.
- 97 -
3) Apply the cuff to the patient; make sure that the index line is placed in the appointed range and
the symbol is over the appropriate artery (Refer to figure 9-4). If the index line is not in the
appointed range, please replace for a proper one. Ensure that the cuff is not wrapped too
tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of
the extremities.
Index Line
Appointed
Region
comfortably seated
legs uncrossed
middle of the cuff at the level of the right atrium of the heart
- 98 -
NOTES:
Please roll up the sleeve and keep the patient’s arm bare or it will cause the inaccurate
measurements.
3) Apply the NIBP cuff to the patient’s arm or leg following the instructions described in section
9.4.2 How to Apply NIBP Cuff.
4) Connect the cuff to the air hose. The limb chosen for taking the measurement should be placed
at the same level as the patient's heart. If this is not possible, correct the measurement using
the formula described in section 9.4.6 Correcting the Measurement.
- 99 -
The monitor checks uterine contract (UC) pressure when the NIBP key is pressed. If the
UC is over 50, a prompt “Intense UC, can't measure NIBP now.” is issued, and the
monitor will check the UC every 30 seconds. The monitor will measure NIBP only when
the UC is lower than 50, and it will then start timing for the Auto measurement.
Press the NIBP key anytime during the current measurement to stop it. Another measurement
will start after the time interval.
WARNING
Prolonged NIBP measurements in automatic mode may be associated with purplish
patches, ischemia and neurologic damage in the limb wearing the cuff. When monitoring
a patient, examine the extremities of the limb frequently for normal color, warmth and
sensitivity. If any abnormality is observed, stop the NIBP measurement.
Press the NIBP key anytime during the measurement to stop it.
The monitor will restart timing for the Auto measurement and resume measuring after the time
interval.
NOTE:
1 If you are in doubt about the accuracy of any reading(s), check the patient's vital
signs by an alternative method before checking the functioning of the monitor.
- 100 -
2 The monitor checks uterine contract (UC) pressure when the NIBP key is pressed. If
the UC is over 50, a prompt “Intense UC, can't measure NIBP now.” is issued.
Please wait and do not attempt to measure NIBP until the UC is lower than 50.
CAUTION
1 Do not squeeze the rubber tube on the cuff.
2 If liquid is inadvertently splashed on the equipment or its accessories, or may enter
the conduit or inside the monitor, contact local service center.
- 101 -
- 102 -
NOTE:
The NIBP measurement results during the period of paper lacking and fast printing after
new paper is loaded will not be saved or printed. Therefore, do not perform NIBP
measurements during this period.
2) Apply the sensor firmly underneath the patient’s axilla. It takes 5 minutes for the temperature
measurement to stabilize.
WARNING
1 Check if the TEMP sensor functions properly prior to use.
2 Do not apply the TEMP sensor to the mouth or the rectum.
CAUTION
Be cautious when taking and putting the TEMP sensor. Do not pull the cable too tight or
it might cause mechanical damage.
The transient response time for the continuous TEMP sensor is not larger than 30s. The
laboratory method used to test the response time is as follows:
1. Prepare two reference temperature sources. The first one with a constant temperature of 25ºC
(77ºF) and the second one with a constant temperature of 27ºC (80.6ºF).
2. Put the TEMP sensor to the first reference temperature source until the temperature reading
reaches 25ºC (77ºF).
3. Move the TEMP sensor to the second reference temperature source. Note the time (t1) from
the TEMP sensor being moved in to the temperature reading reaching 27ºC (80.6ºF).
4. When the temperature reading is stable, move the TEMP sensor back to the first reference
temperature source. Note the time (t2) from the TEMP sensor being moved in to the
temperature reading falling to 25ºC (77ºF).
5. The larger value of t1 and t2 is the response time.
- 103 -
- 104 -
F6 Express and F9 Express have three display modes: maternal-fetal display (figure 10-1), fetal
display (figure 10-2) and maternal display (figure 10-3).
To change the display mode, select the display mode switch on the main interface. The
display mode will switch among the three modes.
- 105 -
- 106 -
F6 Express and F9 Express display both maternal monitoring traces and fetal monitoring traces
on the same screen. The maternal monitoring traces include ECG waveform and SpO2 waveform.
The fetal monitoring traces are the same as traces of F6/F9, refer to 8.1 Fetal Monitoring Traces
for more information.
In maternal-fetal display mode, the list contains the time, SYS and DIA numerics of every
measurement.
- 107 -
In maternal display mode, the list contains the time, HR, SpO2, SYS, DIA and TEMP numerics.
The numerics are recorded every minute.
The maternal vital sign list can be reviewed: select the list and then rotate the control knob to
review the previous lists.
10.4 Numerics
Besides the fetal numerics, the numeric window of F6 Express / F9 Express includes maternal
vital signs: SpO2, NIBP, HR and TEMP:
FHR1
FHR2
TOCO MFM
SpO2
NIBP
HR TEMP
- 108 -
: SpO2 indicator.
SI: Signal intensity.
NIBP 09:15: Time when the NIBP measurement starts.
mmHg/kPa: NIBP unit.
From left to right in turn: systolic pressure (118) and diastolic pressure
(73).
(manual)/(Auto): The current NIBP measurement mode.
HR
(ECG)/(Pulse): The current HR source.
TEMP
(ºC)/(ºF): TEMP unit.
High Level
- 109 -
**DIA HIGH or DIA result (xxx) is higher than the Check if the alarm limits are
NIBP
**DIA xxx > yyy upper limit (yyy). suitable; check the patient’s
condition.
**DIA LOW or DIA result (xxx) is lower than the
NIBP
**DIA xxx < yyy upper limit (yyy).
**TEMP HIGH or TEMP result (xxx) is higher than
TEMP
**TEMP xxx > yyy the upper limit (yyy).
**TEMP LOW or TEMP result (xxx) is lower than
TEMP
**TEMP xxx < yyy the upper limit (yyy).
High Level
US transducer 1 and US
Signals Overlap Reposition the US
US+ECG transducer 2 have picked up the
(FHR1, FHR2, transducers until the fetal
/Pulse maternal heart signal; the signals
HR) heart signals are detected.
overlap.
- 110 -
NIBP SIGNAL Cuff is too loose or the patient Use other methods to
NIBP
LOSS pulse is too weak. measure NIBP.
Large signal noise or irregular
NIBP SIGNAL Keep the arm that is wrapped
NIBP pulse rate caused by excessive
INTERFERED with the cuff still.
motions of the patient.
NIBP EXCEEDS Check the connection of the
The blood pressure exceeds the
MEASUREMENT NIBP cuff and the patient’s
measurement limits.
RANGE condition.
- 111 -
- 112 -
Device FCC ID
Base Station SMQFTS3BEDAN
US Transducer SMQFTS3UEDAN
TOCO Transducer SMQFTS3TEDAN
- 113 -
3 4 5
Name Description
2 Power Indicator When you turn the power supply, the indicator is on.
WARNING
The charging point is specially used for charging the medical equipment and please do
not touch the charging point and the patient at the same time.
- 114 -
7 8
10 11 12
9
Figure 2-2 Rear Panel
Name Description
7 AC Outlet AC outlet.
Channel Adjustment
10 Adjust the channel.
Button
13
Name Description
- 115 -
CAUTION
1. This monitor is a normal medical device. Please avoid violent operations such as
continuously pressing the power switch.
2. When the transducer is taken up, please do not power off the base station.
14
Name Description
Battery
14 Install the battery.
Compartment
- 116 -
18 19
16
17
15
Name Description
System Working
17 Indicate the system working channel.
Channel
11.1.3 Features
x Long work distance and free to walk in a great range
x Wireless transducers
x Low power consumption and working for long time
x Rechargeable transducers
x Cabinet, portable and waterproof transducers
x Provide rechargeable battery for base station
- 117 -
WARNING
The system installation should be operated by serviceman authorized by the
manufacturer.
Open the package; take out the base station and accessories carefully. Keep the package for
possible future transportation or storage. Check the components according to the packing list.
WARNING
Switch off FTS-3 and unplug it before installing or removing the battery.
NOTE:
1 If the system is provided with a rechargeable base station battery, please charge the
battery after each transportation and storage.
2 Please charge the battery to the full after each use. When the system is powered on
with the AC power supply, the battery is charging. Please do not interrupt the
charging and wait until the battery is fully charged.
If the system is provided with a rechargeable lithium-ion battery, follow these steps to install the
battery:
a) Place FTS-3 upside down on a flat surface covered with cloth or another type of protecting
pad.
b) Remove the screws of the battery compartment using a cross-head screw driver. Remove the
battery compartment cover.
- 118 -
c) Take the battery out from package and put it into the compartment. Make sure the battery
connector is on the left and the battery label faces down.
Battery Connector
WARNING
Do not touch the anode and cathode of the battery output together with fingers or metal
materials, avoiding hazards to you and the battery caused by the short-circuit.
d) Arrange the battery flat in the compartment, and push the strip at the end of the battery into
the gap.
- 119 -
e) Shut the battery compartment cover and fix it with the screws.
Remove the battery in reverse order. You can pull the strip at the end to take the battery out from
the compartment.
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 When the battery configuration is provided, after the device is transported or stored,
the battery must be charged.
CAUTION
1. Installation must be carried out by qualified personnel authorized by the
manufacturer.
2. If you choose to install FTS-3 on the wall, the ceiling or other locations, it is the
user’s responsibility to ensure their integrity and solidity evaluated by a registered,
professional structural or mechanical engineer and compliance with all local
regulations. The manufacturer will not be responsible for the failure and loss of any
improper installation.
- 120 -
CAUTION
3. This equipment has been tested and found to comply with the FCC Rules. These
limits are designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates uses and can radiate radio
frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no
guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to
correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help.
4. Operation of this equipment requires the prior coordination with a frequency
coordinator designated by the FCC for the Wireless Medical Telemetry Service.
WARNING
If the protective grounding (protective earth) system is doubtful, the power of the system
must be supplied by internal power supply only.
NOTE:
1 Make sure the system 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 are interrupted, the device switches to internal power supply
and operates normally if the battery is installed. If the battery is not installed, the
system shuts down and resumes the previous settings at the subsequent operation.
3 After the AC power supply is connected, please wait for at least 2 seconds before
pressing the POWER switch to turn on the system.
- 121 -
NOTE:
If the system is provided with transducer protection cover, please do not take up the
cover during monitoring.
NOTE:
1. Detailed operations please refer to 7.2.2 FHR Monitoring Procedure.
2. If the working status indicator is on, please do not put the uncharged transducer in
the docking slot.
3. The transducer has been taken first displays US1 on the screen, and that taken later
displays US2. Please do not take two US transducers simultaneously and wait at 2
seconds to take the other one.
- 122 -
NOTE:
The working channel number used by a system cannot be duplicate with that used by a
device of the same type.
Medium Level
** Wireless US2 The battery power is too low to Please charge the US2
Transducer Battery support further work of the transducer immediately.
Low transducer.
** Wireless TOCO The battery power is too low to Please charge the TOCO
Transducer Battery support further work of the transducer immediately.
Low transducer.
Low Level
Check if the Wireless US1
transducer is aimed at the fetal
Wireless US1 SIGNAL FHR1 signal is too weak for the heart; check if the patient moves
LOSS system to analyze. out of the base station RF
range, if the transducer is well
- 123 -
Caution
Please wait for 2 minutes to use the transducers after charging.
: It is fully charged.
: It is in low level. Please charge the battery. There is alarm information on the screen.
Caution
When in indicates the power is low, please charge the battery immediately or the
monitoring will be interrupted.
Please wipe the transducer and the charging point with a dry cloth before charging the transducer.
Please do not scratch the charging point.
The battery is installed in the transducer. If the base station is supplied by AC, the battery will be
charged automatically when it is placed in the docking slot. Please keep the transducer free of
- 124 -
It takes about 3.5 hours to charge the battery. It is recommended to place the transducer in the
docking slot when the transducer is not used for a long time.
Install the transducer in the base station and the transducer icon will display on the screen.
At the end of their life hand the batteries over to the applicable collection points for the recycling
of waste batteries. If the battery charging time decreases sharply, the battery is considered as
obsolete battery. Please use the battery provided by the manufacturer and disposes the battery
according to the local regulations.
- 125 -
WARNING
If the patient is monitored underwater, please place the transducer when she is ready.
11.5.2 US Transducer
Apply the coupling gel to the transducer:
x Underwater monitoring requires less coupling gel or no coupling gel.
x Move the transducer to get the desire fetal heart and belt it to the belly.
NOTE:
1. When applied to the patient, the wireless ultrasound transducer may warm slightly
- 126 -
Caution
Please do not mistake the patient’s steps for the fetal heartbeats.
- 127 -
Caution
1. Please avoid flushing the transducer during underwater monitoring, or it may cause
wireless signal interference.
2. The transducers are watertight to a depth of 1.1 meter for 24 hours, but base station
is not waterproof. Please do not splash water about the station or soak it into any
liquid.
3. Underwater monitoring may influence the TOCO baseline in virtue of water
temperature and depth or other reasons. Please adjust the TOCO baseline until the
pressure of the transducer in water is steady and keep checking it.
4. A metal bath tub and underwater monitoring both reduce the operating range.
RF Exposure statement
The devices has been tested and meets applicable limits for Radio Frequency (RF)
exposure.
FCC statement
This device complies with part 15 of the FCC Rules. 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.
- 128 -
2) Press the PRINT key to stop printing, and press the paper advancing key to
advance the paper.
3) Wait the paper to stop and then tear it off along the perforation.
NOTE:
After the fetus is delivered in the labor, the monitor may pick up signals of the umbilical
cord and display a trace/numeric. To avoid misinterpretation, it is recommended to
remove the transducers from the patient and switch off the monitor immediately after the
fetus is delivered.
CAUTION
Do not press the POWER switch continuously. Allow at least 10 seconds between
switching the monitor on and off.
- 129 -
Prior to using the monitor or FTS-3 every time, do the following inspections:
Check the monitor and accessories to see if there is any visible evidence of damage that
may affect patient safety. Pay special attention to the cracks on the transducers and
cables before immersing them into conductive fluid.
Check all the outer cables, power socket and power cables.
Check if the monitor functions properly.
If any damage is detected, stop using the monitor or FTS-3 on the patient. Replace the damage
part(s) or contact the manufacturer for service before reusing it.
WARNING
Failure on the part of the responsible individual hospital or institution employing the use
of this equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
CAUTION
Besides the maintenance requirements recommended in this manual, comply with local
regulations on maintenance and measurement.
- 130 -
In case of unsuccessful charge or poor contact, please use detergent with abrasive effect to rub the
electrodes of the transducers in order to clear away the oxide of coupling gel.
Storage conditions outside these limits may distort the paper and adversely affect the accuracy of
grid lines or make the trace unreadable.
- 131 -
1) Clean the recorder platen with a lint-free cloth dampened in soap/water solution.
2) Wipe the thermal array using a cotton swab moistened with 70% Isopropyl alcohol-based
solution.
WARNING
Switch off the monitor and remove the power cord prior to recorder cleaning.
13.2 Cleaning
In order to avoid infection, clean and disinfect the monitor and accessories after each use.
WARNING
1 Unplug the monitor and the base station from the AC power source and detach all
accessories before cleaning. Do not immerse the unit in water or allow liquids to enter
the case.
2 If liquid is splashed on or into the main unit inadvertently, or enters the conduit, stop
using the monitor and contact the manufacturer for service immediately.
The solutions recommended for monitor cleaning are: mild near neutral detergent, ethanol 75%
and isopropanol 70%.
Clean the monitor and the base station enclosure with soft cloth and diluent non-caustic
detergents recommended above.
Clean the screen and the charging point in the docking slot with a dry soft cloth.
- 132 -
CAUTION
1 Although the monitor and the base station are chemically resistant to most common
hospital cleaners and non-caustic detergents, different cleaners are not
recommended and may stain the monitor.
2 Many cleansers must be diluted before use. Follow the manufacturer’s directions
carefully to avoid damaging the monitor and the base station.
3 Do not 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.
6 Avoid pouring liquids on the monitor while cleaning.
7 Do not allow any remaining solution on the surface of the monitor.
NOTE:
1 The monitor surface can be cleaned with hospital-grade ethanol and dried in air or
with crisp and clean cloth.
2 The manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in
your hospital for details.
Ultrasound Transducer
TOCO Transducer Mild near neutral detergent Ethanol 75% Isopropanol 70%
(Including the wireless)
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CAUTION
1 The waterproof parts of the transducer are restricted to the main body and the cable.
Do not immerse the plug into water during the process of monitoring or cleaning.
2 Be sure the temperature of cleaning solutions does not exceed +45 ºC (+113 ºF).
3 Only wipe the outer surface of accessories. Do not immerse them in any liquid.
4 Make sure no liquid enters the connector.
5 When you clean the TEMP transducer, take the head in one hand and clean with the
soft cloth in the other hand.
6 After cleaning, no remaining cleanser is allowed on the surface.
7 Please clean the charging point periodically or it will not be charged.
Remove the latex rubber bag before washing; for machine-washing, close the Velcro fastening.
Allow the cuff to dry thoroughly after washing; then reinsert the rubber bag.
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CAUTION
13.3 Disinfecting
To disinfect the transducers and leads, follow these steps:
1) Clean the accessories.
2) Wipe them with a soft cloth dampened in the recommended disinfectant.
3) Wipe them clean with a soft cloth dampened in water.
4) Air-dry them or wipe the remaining moisture with a soft dry cloth.
The table below lists the allowed disinfectant bases:
Type Recommended
Fetal/Maternal Monitor
Base Station
US and TOCO Transducers
(the wired and wireless)
Ethanol 75%
Remote Event Marker
Isopropanol 70%
DECG Cable
IUP Cable
ECG Leads
SpO2 Transducer
TEMP Transducer
NIBP Cuff Ethanol 75%
Isopropanol 70%
NIBP Cuff Extension Tube
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CAUTION
1 Do not use any disinfectant containing additional active ingredients other than those
listed.
2 Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest
possible density.
3 Do not immerse any part of the monitor or any accessory into liquid.
4 After disinfection, no remaining disinfectant is allowed on the surface.
5 Check if the monitor and accessories are in good condition. If any aging or damage is
detected (e.g. the belt loses its elasticity), replace the damage part(s) or contact the
manufacturer for service before reusing them.
6 Please do not light the TOCO transducer with ultraviolet light for a long time.
NOTE:
The manufacturer has no responsibility for the effectiveness of controlling infectious
disease using these chemical agents. Please contact infectious disease experts in your
hospital for details.
13.4 Sterilizing
Do not sterilize the monitor, the base station or the accessories, unless this is necessary according
to your hospital regulation.
NOTE:
Check if the monitor, the base station, cables and accessories function well. If any
problem is detected, please contact the manufacturer for service before reusing them.
Checking Item Checking Method
Visual Inspect the monitor, base station and cables etc. for any damage.
Power On Power on the monitor. Does it boot up successfully without errors and enter the
main menu?
Functionality Test After power up, check whether the AC power indicator and battery status
indicator in the bottom left of the screen display as stated in 3.3.1 section.
Performance Please check the US transducer and TOCO transducer according to 7.2.6
Testing US Transducers and 7.5.4 Testing TOCO Transducers. FTS-3 wireless
transducers also can be tested accordingly.
System When the monitor is connected to FTS-3, please check whether the base
station working channel and its battery status indicator in the bottom right of the
screen display as stated in 3.3.1 section.
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Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
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IEC 80601-2-30,
ISO 80601-2-61,
ISO 80601-2-56,
EN 12470-4,
AAMI/ANSI EC13
Degree of Safety in Presence of Equipment not suitable for use in presence of flammable
Flammable Gases gases
Signal Interface
Ultrasound Transducer
Cable Length: 2.5m
Weight: 190 g
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Dimension: 88 mm × 35 mm
TOCO Transducer
Cable Length: 2.5 m
Weight: 180 g
Dimension: 88 mm × 35 mm
Remote Event Marker
Length: 2.5 m
Weight: 56 g
ECG
Cable Length: 3m
Weight: 213 g
SpO2
Cable Length: 2.4 m
Weight: 68 g
NIBP
Cable Length: 3.3 m
Weight: 194 g
TEMP
Cable Length: 3m
Weight: 55 g
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Isppa.3<190W/cm2
Ispta.3<94mW/cm2
Max Output Power <15mW
Effective Radiating Area: 942 mm2 ± 15%
FHR Measurement Range: 50 bpm ~ 240 bpm
Resolution: 1 bpm
±2 bpm (F6/F6 Express)
Accuracy:
±1 bpm (F9/F9 Express)
Dielectric Strength: 4000Vrms
Maximum transducer
temperature rise during Less than 5 qC (9ºF)
use:
Expanded uncertainty of
U=0.4qC (0.72ºF), k=2
temperature test:
Technique: Peak-peak detection technique
DFHR Measurement
30bpm ~ 240bpm
Range:
Resolution: 1bpm
Accuracy: ±1bpm
Input Impedance: > 10M (Differential, DC50/60Hz)
DECG
Input Impedance: > 20M (Common Mode)
CMRR: > 110dB
Noise: < 4μVp
Skin Voltage Tolerance: ±500mV
Fetal Input Voltage
20μVp-3mVp
Current:
TOCO Range: 0% ~ 100%
Non-linear Error: ±10%
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FM Mode Automatic/Manual
Display
0-999
Range
HR Measurement Range: 30 bpm ~ 240 bpm
Input Signal Range: ±8 mV PP
HR Measuring Accuracy: ±2 bpm
ECG Waveform: Manual control ECG waveform display
ECG falls off: Detect automatically
N.C. S.F.C.
Patient Leakage Current
d.c. 10μA 50μA
(Limit)
a.c. 10μA 50μA
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- 143 -
Resolution: 1 mmHg
Measuring Accuracy
Position: Axilla
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(for systems with no transducers having global maximum index values exceeding 1.0)
System: Fetal & maternal Monitor
Ispta.3 Ipa.3@MImax
Transducer Model 2
TI Type TI Value MI
(mW/cm ) (W/cm2)
PW1.0MHz TIS 0.006149
(F6/F6 Express US 1.288 0.01405 0.007225
TIB 0.04687
Transducer)
PW1.0MHz TIS 0.008761
(F9/F9 Express US 1.817 0.01567 0.01025
Transducer) TIB 0.05723
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Battery: 14.8VDC/5000mAh
IEC 60601-1:2005,
EN 60601-1:2006/AC:2010,
IEC 60601-1-2:2007,
Standards Compliance
EN 60601-1-2:2007/AC:2010,
IEC/EN 60601-2-37.
FCC 47 CFR Part 95
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Disinfection/Sterilizing
Refer to this user manual for details
Method
EMC CISPR11 Group 1 Class A
N.C. S.F.C.
Ground Leakage Current
(Limit): 500μA 1000μA
N.C. S.F.C.
Enclosure Leakage Current
(Limit) 100μA 500μA
N.C. S.F.C.
Patient Leakage Current d.c. 10μA 50μA
(Limit):
a.c. 100μA 500μA
N.C. S.F.C.
Patient Auxiliary Current d.c. 10μA 50μA
(Limit):
a.c. 100μA 500μA
Base Station
Weight: 1.8 kg
US Transducer
TOCO Transducer
Pulse Duration: 92 μs
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p_< 1 MPa
Iob<10 mW/cm2
Ispta<100 mW/cm2
Resolution: 1 bpm
Accuracy: ±2 bpm
Resolution: 1%
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Transducer Battery
Charge Current
700 mA
(Standard):
Continuous Work
>16 Hours
Time:
Charge Voltage
(4.2±0.1) V
(Standard):
(for systems with no transducers having global maximum index values exceeding 1.0)
System: Fetal Telemetry System
Ispta.3 Ipa.3@MImax
Transducer Model TI Type TI Value MI
(mW/cm2) (W/cm2)
TIS 0.002949
PW1.0MHz 0.6186 0.01087 0.003412
TIB 0.01939
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- 151 -
CAUTION
Only the PC recommended by the manufacturer can be connected to the signal
input/output interface of the monitor. Other equipment is forbidden.
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Appendix 3 Troubleshooting
A3.1 No Display
A3.2 Noise
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- 154 -
The DECG cable has not been Fix an attachment pad at the
Inconstant trend
fixed firmly DECG cable.
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WARNING
Switch off the monitor and unplug it before changing the fuse.
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To replace a fuse:
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B3.1 Troubleshooting
Phenomenon Possible Cause Solution
ķ Recharge the transducer.
ķ It runs out of power.
Take out the US transducer, ĸ The base station cannot ĸ Put it back in the docking
but it cannot power on. slot and take it up again. If
communicate with the
the problem persists,
transducer by RF.
restart the base station.
The wireless connection
ķ Loose or damaged
indicator is green but the
cable to the monitor ķ Tighten or repair the cable.
fetal monitor shows no
socket
signal.
ķ Check the transducer
ķ Transducer is placed
position.
incorrectly.
ĸ Tighten the transducer and
ĸ Transducer slides.
FHR or TOCO record apply little coupling gel.
interrupts. Ĺ The patient walks in
Ĺ Ask the patient to walk
strong tramps.
slightly.
ĺ RF interference or out
ĺ Ask the patent to walk in
of prescriptive area.
the prescriptive area.
ķ The transducer does not
ķ Press the transducer to
The battery icon does not connect to the charging
touch the charging point.
display when charging point tightly.
the battery. ĸ Ensure the base station is
ĸ The base station is not
not supplied by AC power.
supplied by AC power.
ķ Clean the transducer
The charging board or
ķ It is wet or polluted by before charging. Replace
charging point is
the coupling gel. the charging point if
corrosive.
necessary.
WARNING
Switch off the base station and remove the power cord before changing the fuse.
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To replace a fuse:
1) Place the base station on a flat surface and remove the power cord.
2) Reverse the base station and pull the fuse container out as far as it can go.
3) Use a screw driver or a pair of pliers to push the fuse up from the bottom of the
container.
4) Take the fuse out and replace it with a new one that is supplied by the manufacturer or
of the same specifications.
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- 160 -
There is no easy answer to the question of safety surrounding the use of diagnostic ultrasound
equipment. Application of the ALARA (As Low As Reasonably Achievable) principle serves as a
rule-of-thumb that will help you to get reasonable results with the lowest possible ultrasonic
output.
The American Institute of Ultrasound in Medicine (AIUM) states that given its track record of
over 25 years of use and no confirmed biological effects on patients or instrument operators, the
benefits of the prudent use of diagnostic ultrasound clearly outweigh any risks.
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MI = Pr, ǩ
fawf CMI
CMI = 1 (MPa / MHz )
- 162 -
- 163 -
- 164 -
Operating Control
Fixed
Conditions
- 165 -
- 166 -
Operating Control
Fixed
Conditions
- 167 -
- 168 -
Operating Control
Fixed
Conditions
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Appendix 5 Abbreviation
The abbreviations used in this manual and their full names are listed below:
AC Alternative Current
CTG Cardiotocography
DC Direct Current
ECG Electrocardiogram
FH Fetal Heart
FM Fetal Movement
FS Fetal Stimulator
HR Heart Rate
ID Identity
PR Pulse Rate
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TEMP Temperature
TOCO Tocotonometer
US Ultrasound [Transducer]
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Accessories (standard and optional configuration) supplied or approved by the manufacturer can
be used with the monitor. See the following table for details. The accessories employed by us,
such as the rechargeable battery, are products having passed the authentication of CE, and they
have the characteristics specified by their manufacturers. The materials with which the patient
can come into contact conform to the standard of ISO 10993.
Belt 01.57.471447
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CAUTION
Replacement of all above accessories can be performed by the operator. But only the
accessories supplied or recommended by the manufacturer are allowed connected to
the monitor.
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The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment
specified below. The customer of the user of the F Series Fetal & maternal Monitor should assure
that it is used in such and environment.
RF emission
Class A
CISPR 11 The F Series Fetal & maternal Monitor is
Harmonic emissions suitable for use in all establishments, other than
Class A
IEC 61000-3-2 domestic and those directly connected to the
public low-voltage power supply network that
Voltage fluctuations/
flicker emissions supplies buildings used for domestic purposes.
Complies
IEC 61000-3-3
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r 2 kV for power
Electrical fast r 2kV for power Mains power quality should be
supply lines
transient/burst supply lines that of a typical commercial or
r 1 kV for hospital environment.
IEC 61000-4-4 Not applicable
input/output lines
r 1 kV line(s) to r 1 kV differential
Surge line(s) mode Mains power quality should be
that of a typical commercial or
IEC 61000-4-5 r 2 kV line(s) to r 2 kV common hospital environment.
ground mode
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< 5% UT < 5% UT
< 5% UT < 5% UT
NOTE: UT is the a.c. mains voltage prior to application of the test level.
- 176 -
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NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in
the location in which the F Series Fetal & maternal Monitor is used exceeds the applicable RF
compliance level above, the F Series Fetal & maternal Monitor should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the F Series Fetal & maternal Monitor.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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The F Series Fetal & maternal Monitor is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the F Series Fetal & maternal
Monitor can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the F Series Fetal & maternal
Monitor as recommended below, according to the maximum output power of the communications
equipment.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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The ultrasound process involves placing a small device called a transducer, against the skin of the
patient near the region of interest. The ultrasound transducer combines functions of emitting and
receiving ultrasounds in one device. This transducer produces a stream of inaudible, high
frequency sound waves which penetrate into the body and bounce off the organs inside. It detects
sound waves as they bounce off or echo back from the internal structures and contours of the
organs. The movement of the organs produces the Doppler Effect, and this movement can be
measured and described by measuring the echo.
In fetal monitoring, the ultrasound transducer produces a stream of sound waves which penetrate
into the maternal abdomen and bounce off the fetal heart. Then the transducer receives the echoes
and transfers them to the monitor, which turns the signal into fetal heart beating sound and fetal
heart rate trace.
The transducer detects sound waves as they bounce off or echo back from the fetal heart.
However, the sound waves bouncing off from maternal blood vessels may be detected by the
transducer and then be processed by the monitor as well. As a result, artifacts may be produced.
The artifacts, if not correctly interpreted, may cause the physicians to perform unnecessary
interventions, or to fail to detect the fetal distress and the need for interventions.
(2) Doubling:
When the FHR drops to 120 bpm or lower, the diastole and systole become far apart, thereby the
monitor may mistake these two movements of a single heartbeat for two separate heartbeats. As a
result, a heart rate trace that is double the actual heart rate is produced. This often happens during
severe decelerations and bradycardia, representing an abrupt switch of the trace to double the
actual heart rate.
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(3) Halving:
When the FHR increases to 180 bpm or higher, it is possible for the monitor to mistake the two
separate hearbeats for the diastole and systole of a single heartbeat. As a result, a heart rate trace
that is half the actual heart rate is produced. This often happens during tachycardia, representing
an abrupt switch of the trace to half the actual heart rate. The clinicians may interpret it as a
“deceleration”.
However, the heart beat sound from the monitor speaker is still reliable even when doubling or
halving is occurring.
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If the amniotic membrane rupture and cervical dilatation are sufficient, consider using a spiral
electrode to obtain precise FHR with direct fetal ECG as the signal source.
When the fetal heart moves partially out of the ultrasound wave path, the transducer receives
mixed or weak signals, and thereby the monitor presents erratic traces. When the fetal heart
moves fully out of the path, inadequate consecutive and periodic signals are received, and no
trace is represented.
Erratic traces and transitory episodes of drop out are common, especially when the fetus or/and
mother move(s). If they exist for an extended period, it indicates that the transducer is not aimed
at the fetus. Repositioning of the transducer is needed.
When the fetal heart moves partially out of the ultrasound wave path, the transducer receives
weaker FHR signal and other stronger signals (usually maternal heart/pulse rate). After the
signals are transmitted to the monitor, the audio system and the video system of the monitor
process the signals separately. On one hand, the audio circuit filters the low-frequency signals and
gives audio output of the high-frequency signals, so fetal heart sound is heard. On the other hand,
the autocorrelation algorithm computes the stronger signal source and thereby the maternal
heart/pulse rate is displayed. As a result, the audio output differs from the screen reading.
In a word, the abnormalities listed above (artifacts, sound and reading differences) are caused by
the limitations of ultrasonic monitoring technique. Fortunately they rarely occur. But a good
understanding of how to detect them and what countermeasures should be taken will help obtain
better fetal monitoring effect.
We hope you find this information useful. If you have any questions about fetal monitoring,
please contact our sales representatives and perinatal specialists.
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