Cooper Surgical F9, F9 Express User Manual
Statement
The manufacturer makes no warranty of any kind with regard to this material, including, but not
limited to the implied warranties of merchantability and fitness for a particular purpose.
CooperSurgical, Inc. (hereinafter called CooperSurgical) and the manufacturer assumes no
responsibility for any error that may appear in this document, or for incidental or consequential
damage in connection with the furnishing, performance or use of this material.
No part of this document may be photocopied, reproduced or translated to another language without prior
written consent of CooperSurgical and the manufacturer.
All information contained in this publication is believed to be correct. CooperSurgical and the manufacturer
shall not be liable for errors contained herein nor for incidental or consequential damages in connection with
the furnishing, performance, or use of this material.
The information contained in this document is subject to change without notice.
Responsibility of the Manufacturer
CooperSurgical and the manufacturer only considers itself responsible for any effect on safety, reliability and
performance of the equipment if:
• Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons
authorized by CooperSurgical.
• The electrical installation of the relevant room complies with national standards, and
• The instrument is used in accordance with the instructions for use.
NOTE: This device is not intended for home use, Intensive Care Unit’s or Operating Rooms.
WARNING : This device is not intended for treatment.
Upon request, CooperSurgical may provide necessary circuit diagrams, and other information to help
qualified technicians to maintain and repair some parts, which CooperSurgical may define as user serviceable.
Using This Label Guide
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal injury or
death.
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.
Copyright © CooperSurgical, Inc. 2010. All rights reserved.
I
Table of Contents
Chapter 1 Safety Guidance...............................................................................................................1
1.1 Intended Use ........................................................................................................................... 1
1.2 Instructions for Safe Operation ............................................................................................... 1
1.3 Ultrasound Safety Guide......................................................................................................... 2
1.4 Safety Precautions................................................................................................................... 3
Chapter 2 Installation........................................................................................................................7
2.1 Opening the Box and Checking .............................................................................................. 7
2.2 Installing the Battery............................................................................................................... 7
2.3 Loading the Recorder Paper.................................................................................................... 9
2.4 Connecting the Power Cable................................................................................................. 11
2.5 Definitions and Symbols....................................................................................................... 11
2.6 Ordering Information ............................................................................................................ 13
Chapter 3 Monitor and Accessories...............................................................................................14
3.1 Major Parts............................................................................................................................ 14
3.1.1 Buttons ........................................................................................................................ 14
3.1.2 Indicators..................................................................................................................... 16
3.1.3 Left Side Panel of the Monitor.................................................................................... 17
3.1.4 Right Side Panel of the F9 Monitor ............................................................................ 17
3.1.5 Rear Panel of the Monitor........................................................................................... 17
3.1.6 Bottom Panel............................................................................................................... 18
3.2 Transducers and Cables ........................................................................................................ 18
3.2.1 Ultrasound (US) Transducer ....................................................................................... 18
3.2.2 TOCO Transducer....................................................................................................... 19
3.2.3 Remote Event Marker ................................................................................................. 20
3.2.4 Fetal Spiral Electrode.................................................................................................. 20
3.3 Screen.................................................................................................................................... 21
3.3.1 Main Interface............................................................................................................. 21
3.3.2 Setup Interface ............................................................................................................24
3.3.3 Touch screen ............................................................................................................... 25
Chapter 4 Alarms.............................................................................................................................26
4.1 Alarm Classification .............................................................................................................26
4.2 Audible Alarm....................................................................................................................... 26
4.3 Visual Alarm ......................................................................................................................... 27
4.4 Choosing the Alarm Display Form ....................................................................................... 27
4.5 Changing the Alarm Volume ................................................................................................ 27
4.6 Reviewing Alarms................................................................................................................. 28
4.7 Alarm Treatment Measures................................................................................................... 28
4.8 Testing Alarms...................................................................................................................... 28
4.9 Patient Alarm Defaults.......................................................................................................... 29
Chapter 5 Printing...........................................................................................................................30
5.1 Function Description............................................................................................................. 30
5.2 Printing Configuration ..........................................................................................................30
5.2.1 Switching Auto Start Printing On or Off .................................................................... 31
5.2.2 Choosing the Paper Speed........................................................................................... 31
5.2.3 Changing the Print Timer............................................................................................ 31
5.2.4 Switching Print Self-Check On or Off........................................................................ 31
II
5.3 Understanding the Recorder Paper Printout.......................................................................... 32
Chapter 6 Pre-Monitoring Preparation.........................................................................................35
6.1 Switching On the Monitor..................................................................................................... 35
6.2 Checking the Recorder Paper................................................................................................ 35
6.3 Adjusting the Screen Angle ..................................................................................................36
6.4 Setting Date and Time........................................................................................................... 37
6.5 Connecting the Transducers..................................................................................................37
6.6 Adjusting the Volume ........................................................................................................... 38
Chapter 7 Fetal Monitoring............................................................................................................40
7.1 Confirming Fetal Life ...........................................................................................................40
7.2 Monitoring Fetal Heart Rate (FHR) with Ultrasound........................................................... 40
7.2.1 Parts Required............................................................................................................. 40
7.2.2 FHR Monitoring Procedure ........................................................................................41
7.2.3 Switching the FHR Alarm On or Off.......................................................................... 42
7.2.4 Changing the FHR Alarm Limits................................................................................ 42
7.2.5 Changing the FHR Alarm Delay................................................................................. 42
7.3 Monitoring FHR with DECG (Optional) .............................................................................. 43
7.3.1 Contraindications ........................................................................................................ 43
7.3.2 Parts Required............................................................................................................. 43
7.3.3 Preparing the Patient's Skin Prior to Placing Electrodes ............................................43
7.3.4 Directions for Using Fetal Spiral Electrode................................................................ 43
7.3.5 DECG Monitoring Procedure .....................................................................................44
7.3.6 Detaching the Fetal Spiral Electrode ..........................................................................44
7.4 Monitoring Twin FHRs......................................................................................................... 44
7.4.1 Monitoring Twins Externally...................................................................................... 44
7.4.2 Monitoring Internally.................................................................................................. 44
7.4.3 Signals Overlap Verification (SOV) ........................................................................... 45
7.4.4 Changing FHR2/DFHR Offset.................................................................................... 45
7.5 Monitoring Uterine Activity Externally................................................................................ 45
7.5.1 Parts Required............................................................................................................. 45
7.5.2 TOCO Monitoring Procedure .....................................................................................45
7.5.3 Changing the UA Baseline.......................................................................................... 46
7.6 Monitoring Uterine Activity Internally (Optional) ............................................................... 46
7.6.1 Parts Required............................................................................................................. 46
7.6.2 Directions for Using IUPC.......................................................................................... 46
7.6.3 IUP Monitoring Procedure.......................................................................................... 47
7.6.4 Checking Intrauterine Pressure Cable Function.......................................................... 48
7.7 Monitoring Fetal Movement ................................................................................................. 48
7.7.1 Auto Fetal Movement (AFM) Monitoring.................................................................. 48
7.7.2 Enabling or Disabling AFM Trace.............................................................................. 49
7.7.3 Changing AFM Gain................................................................................................... 49
7.7.4 Manual Fetal Movement (MFM) Monitoring............................................................. 49
7.8 Start Monitoring.................................................................................................................... 49
7.9 Inputting Maternal Information (Mat. Info).......................................................................... 50
7.9.1 Auto ID .......................................................................................................................50
7.9.2 Changing Maternal Information.................................................................................. 50
7.9.3 Switching Mat. Info Entering On or Off..................................................................... 51
7.10 Fetal Monitoring Screen Display ........................................................................................ 51
III
7.10.1 Fetal Monitoring Traces............................................................................................ 52
7.10.2 Changing the Time Scale .......................................................................................... 53
7.10.3 Changing the Trace Advancing Mode ...................................................................... 53
7.10.4 Searching for a Patient .............................................................................................. 54
7.10.5 Reviewing .................................................................................................................54
7.10.6 Making a Note........................................................................................................... 55
7.10.7 Fetal Monitoring Values ...........................................................................................57
7.10.8 Changing Fetal Numeric Window Position .............................................................. 57
7.10.9 Fetal Monitoring Alarm Messages............................................................................ 58
Chapter 8 After Monitoring............................................................................................................60
8.1 Data Saving ........................................................................................................................... 60
8.2 Completing the Monitoring...................................................................................................60
8.3 Switching Off........................................................................................................................ 60
Chapter 9 Maintenance and Cleaning ...........................................................................................61
9.1 Maintenance .......................................................................................................................... 61
9.1.1 Maintenance Inspections............................................................................................. 61
9.1.2 Maintenance of the Monitor........................................................................................ 61
9.1.3 Maintenance of the Transducers ................................................................................. 62
9.1.4 Storage of Recorder papers......................................................................................... 62
9.1.5 Cleaning of the Recorder ............................................................................................62
9.2 Cleaning ................................................................................................................................ 63
9.2.1 Cleaning of the Monitor.............................................................................................. 63
9.2.2 Cleaning of the Accessories........................................................................................ 64
9.4 Sterilizing .............................................................................................................................. 65
Chapter 10 Warranty and Service Policy......................................................................................66
10.1 Warranty.............................................................................................................................. 66
10.2 After-Sales Service .............................................................................................................66
Appendix 1 Product Specifications.................................................................................................67
A1.1 Monitor............................................................................................................................... 67
A1.2 Transducers and Cables...................................................................................................... 71
A1.3 Rechargeable Lithium-ion Battery..................................................................................... 71
Appendix 2 Signal Input/Output Connector.................................................................................72
Appendix 3 Troubleshooting...........................................................................................................73
A3.1 No Display ......................................................................................................................... 73
A3.2 Noise .................................................................................................................................. 73
A3.3 Recorder Error.................................................................................................................... 73
A3.4 Trouble with Ultrasound FHR Monitoring ........................................................................ 74
A3.5 Trouble with DECG FHR Monitoring ............................................................................... 75
A3.6 Trouble with Contractions Monitoring (External) ............................................................. 75
A3.7 Trouble with Contractions Monitoring (Internal) .............................................................. 76
A3.8 Blown Fuses ....................................................................................................................... 76
Appendix 4 EMC Information – Guidance and Manufacture’s Declaration.............................77
A4.1 Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS................................. 77
A4.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS ................................. 78
A4.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEM that are not
LIFE-SUPPORTING .................................................................................................................. 80
A4.4 Recommended Separation Distance................................................................................... 82
IV
F9 Fetal & Maternal Monitor • User Manual
Chapter 1 Safety Guidance
NOTE: This User Manual is written to cover features of both the F9 and F9 Express
Monitors. Therefore, your model may or may not have some of the parameters and
functions described, depending on what you have ordered.
1.1 Intended Use
The CooperSurgical F9 Series Fetal & Maternal Monitor (hereinafter called F9 Monitor) is intended
for non-invasive monitoring of a fetus during antepartum examination, labor and delivery. It is
intended to be used only by trained and qualified personnel in antepartum examination rooms, labor
and delivery rooms.
The F9 Monitor provides non-stress testing for pregnant women from the 28th week of gestation. It
can externally monitor the Fetal Heart Rates (FHRs) using ultrasound and uterine activity via a
TOCO transducer. Alternatively, it can internally monitor one of the FHRs with Direct
Electrocardiography (DECG) and uterine activity with an Intrauterine Pressure Catheter (IUPC).
Contraindications: The F9 Monitor is not intended for use in intensive care units, operating
rooms or for home use.
1.2 Instructions for Safe Operation
• The F9 Monitor is designed to comply with the international safety requirements IEC/EN
60601-1 for Medical Electrical Equipment. It is Class I equipment.
• The F9 Monitor operates within specifications at ambient temperatures between 5 ºC (41 ºF) and
40 ºC (104 ºF). 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,
replace.
• The F9 Monitor must be serviced only by authorized and qualified personnel. CooperSurgical
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.
• Perform periodic safety testing to ensure proper patient safety. This should include leakage current
measurement and insulation testing. The recommended testing interval is once per year.
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F9 Fetal & Maternal Monitor • User Manual
• The protective categories against electric shock of the patient connections are:
1) Ultrasound (FHR1, FHR2) 2) External TOCO 3) Fetal Movement Mark (FM)
4) Fetal Stimulator (FS)
This symbol indicates that the protection against electric shock of this instrument is Type B.
IUP (Intrauterine Pressure)
This symbol indicates that the protection against electric shock of this instrument is Type BF.
DECG (Direct Electrocardiography)
This symbol indicates that the protection against electric shock of this instrument is Type CF.
The monitor described in this User Manual is not protected against:
a) The effects of defibrillator shocks
b) The effects of defibrillator discharge
c) The effects of high frequency currents
d) The interference of electrosurgery equipment
1.3 Ultrasound Safety Guide
Fetal Use
The F9 Monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor.
Clinical interpretation of the fetal heart rate traces can diagnose fetal and/or maternal problems and
complications.
Instructions for Use in Minimizing Patient Exposure
The acoustic output of the F9 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.
Exercising clinical judgment in monitoring low risk patients will avoid unnecessary insonation.
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F9 Fetal & Maternal Monitor • User Manual
1.4 Safety Precautions
WARNING and CAUTION messages must be observed. To avoid the possibility of injury,
observe the following precautions during the operation of the instrument.
WARNING :
Usage Safety Precautions:
• The F9 Monitor is provided for use by qualified physicians or professionally trained
personnel. They should be familiar with the contents of this User Manual before
operation.
• Only qualified service technicians can install this equipment. Only service technicians
authorized by CooperSurgical can open the case.
• This device is not intended for home use, use in Intensive Care Units or Operating Rooms.
• EXPLOSION HAZARD - Do not use the F9 Monitor in a flammable atmosphere.
Equipment is not suitable for use in the presence of flammable anesthetic mixture with
air, with oxygen or with nitrous oxide.
• SHOCK HAZARD - the power receptacle must be a three-wire grounded outlet. A
hospital grade outlet is required. Never adapt the three-prong plug from the Monitor to
fit a two-slot outlet.
• Do not apply this Monitor and other ultrasonic equipment simultaneously on the same
patient, due to the potential of leakage current superposition.
• Do not apply this Monitor simultaneously with other patient-connected equipment, such
as a cardiac pacemaker or other electrical stimulators.
• Do not switch on device power until all cables have been properly connected and
verified.
• Do not touch signal input or output connector and the patient simultaneously.
• Equipment and devices that connect to the Monitor should form an equipotential body
to ensure effective grounding.
• Disconnect power cord before changing fuses. Replace them with those of the same
specifications only.
• 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.
• SHOCK HAZARD - Do not remove the top panel cover during operation or while power
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F9 Fetal & Maternal Monitor • User Manual
is connected. Only aut hor ize d se r vic e pe r son n el s hould remove the unit cover.
• The Monitor is not protected against defibrillation. Do not apply it during elec tro-surgery
or MRI; as it might result in harm to the patient or the operator.
• Only connect accessories supplied or recommended by CooperSurgical to the device.
• 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. Anyone
who connects additional equipment to the signal input connector or signal output
connector configures a medical system, and is therefore responsible 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
CooperSurgical representative.
Proper Monitoring Safety Precautions:
• This device is not intended for treatment.
• The fetal spiral electrode and intrauterine pressure catheter are single use only. Discard
them after use.
• The IUPC is neither intended nor approved for measuring intrauterine pressure
extra-ovularly; attempting to do so may lead to maternal discomfort or injury.
• Alarms must be set up based on different situations. Make sure that audio sounds can
be activated when an alarm occurs.
Battery Safety Precautions:
• Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to
read the User Manual and safety precautions thoroughly.
• Don’t connect the battery cable connector or battery socket with metal objects, which
can result in a short circuit.
• Do not unplug the battery when monitoring.
• Do not heat or throw the battery into a fire.
• Do not use or leave the battery close to fire or other places where the temperature may
be above 60 ºC (140 ºF).
• Do not allow the battery to come in contact with water.
• Do not destroy the battery: Do not pierce battery with a sharp object such as a needle;
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F9 Fetal & Maternal Monitor • User Manual
Do not hit with a hammer, step on, throw or drop to cause a strong shock; Do not
disassemble or modify the battery.
• Use the battery only in the F9 Monitor. Do not connect battery directly to an electrical
outlet or cigarette lighter charger.
• If the liquid from the battery gets into the eyes, do not rub the eyes. Wash them well
with clean water and see a doctor immediately.
• Don’t solder the leading wire directly to the battery terminal.
• If the liquid leaks from the battery and spills onto your skin or clothes, wash well with
fresh water immediately.
• Keep battery away from flames. If leakage or a foul odor is detected, discontinue use.
• Stop using the battery if abnormal heat, odor, discoloration, deformation or an abnormal
condition is detected during use, charge, or storage. Keep it away from the Monitor .
• Do not use a battery with visual damage.
• Proper disposal is required. Follow your Local Regulations for disposal.
CAUTION :
• U.S. Federal law restricts this device to sale by or on the order of a physician.
• Only qualified personnel shall service the unit.
• The device is designed for continuous operation and is “ordinary” (i.e. not drip or
splash-proof).
• Keep the working environment clean. Avoid vibration. Keep it far from corrosive
medicine, dusty areas, high-temperature and humid environments.
• When installing the unit into a cabinet, allow for adequate ventilation, accessibility for
servicing, and room for adequate visualization and operation.
• Do not operate the unit if it is damp or wet caused by condensation or spills. Avoid
using the equipment immediately after moving it from a cold environment to a warm,
humid location.
• Do not sterilize the Monitor or any accessory with an autoclave or gas.
• Turn 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. Use a brush to dislodge
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F9 Fetal & Maternal Monitor • User Manual
any dirt on or around the connectors and panel edges. Remove dirt with a soft cloth,
slightly dampened with a mild detergent solution or 70% ethanol or isopropranol.
• When washing the belts, the water temperature must not exceed 60 ºC (140 ºF).
• Electromagnetic Interference - Ensure that the environment in which the F9 Monitor
is installed is not subject to any source of strong electromagnetic interference, such as
CT, radio transmitters, mobile phone base stations, etc.
• Do not use mobile phones while monitoring.
• While the battery is charged, used or stored, keep it away from objects or materials with
static electric charges.
• If the terminals of the battery become dirty, wipe with a dry cloth before using the
battery.
• The recommended charge temperature range is from 0º C to 40º C (32º F 104º F). Do
not exceed this range.
• Batteries have life cycles. If the time span that the Monitor runs on the battery becomes
much shorter than usual, the battery life is at an end. Replace the battery with a new
one the same as the one provided or recommended by CooperSurgical.
• When not using the battery for an extended period of time, remove it from the Monitor
and store it in a place with low humidity and low temperature.
• Remove a battery whose life cycle has expired from the Monitor immediately.
• For information on installing and removing the battery from the monitor, thoroughly read
the User Manual.
• The device and accessories are to be disposed of in accordance with all applicable
Federal, State, and local medical/ hazardous waste practices at the end of 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.
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F9 Fetal & Maternal Monitor • User Manual
Chapter 2 Installation
NOTE:
Installation must be carried out by qualified personnel authorized by CooperSurgical. In
order to ensure the operator and patient’s safety, read through this chapter before using this
monitor.
2.1 Opening the Box and Checking
Open the box and take out the F9 Monitor and accessories carefully. Keep the packaging for possible
future transportation or storage. Check the components according to the packing list.
• Check for any mechanical damage.
• Check all the cables and accessories.
If there is any problem, contact us or your local representative immediately.
2.2 Installing the Battery
If your Monitor is configured with the rechargeable lithium-ion battery, follow these steps to install
the battery:
Battery Installation
1. Carefully place the F9 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 Phillips-head screw driver. Remove the
battery compartment cover.
3. Take the battery out of its packaging. Place the battery into the battery compartment with the
cable facing out.
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F9 Fetal & Maternal Monitor • User Manual
4. Plug the cable connector into the socket.
5. Put the battery and the cables into the battery compartment.
6. Shut the battery compartment cover and secure the screws.
Battery Removal
Fold the LCD display completely flat before turning the F9 Monitor upside down. Remove the
battery in reverse order.
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F9 Fetal & Maternal Monitor • User Manual
NOTES:
1) If a rechargeable battery is supplied, charge it fully every time after using the device to
ensure the electric power is adequate.
2) When the battery configuration is provided, after the device is transported or stored, the
battery must be charged. Connecting the F9 Monitor to a power supply will charge the
battery even if the Monitor is not turned on.
3) Turn off the F9 Monitor and unplug the power cord before installing or removing the
battery.
2.3 Loading the Recorder Paper
Use the following procedure to load Recorder the paper.
1. Press the two latches on each side of the paper drawer at the same time and slide the drawer out
carefully.
2. Remove the wrapper from the “Z” type thermosensitive paper.
3. Place the paper in the drawer, with the pane facing up and the green safety area on the left.
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F9 Fetal & Maternal Monitor • User Manual
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.
NOTES:
1) Be careful when inserting paper. Avoid damaging the thermosensitive print head.
2) The paper going out from the drawer should be aligned. Otherwise the data will be
inaccurate or a paper jam will occur.
3) Only use the paper CooperSurgical approved to avoid poor printing quality, deflection, or
a paper jam.
4) Keep the drawer closed except when loading paper or servicing.
Removing a Paper Jam
When the recorder does not function properly, open the drawer to check for a paper jam. Remove the
paper jam as follows:
1. Cut the recorder paper from the paper drawer edge.
2. Push the recorder paper up with one finger through the hole on the bottom panel of the paper
drawer. Remove the paper.
3. Reload the paper and then close the drawer.
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F9 Fetal & Maternal Monitor • User Manual
2.4 Connecting the Power Cable
• Make sure the AC power supply of the Monitor complies with the following specifications: 100
V - 240 VAC, 50/60 Hz.
• Connect the power cable provided with the F9 Monitor to the Monitor’s power socket (see
Figure 3-5 in Chapter 3). Connect the other end to a hospital grade grounded 3-wire AC outlet.
WARNING : If the protective grounding (protective earth) system is
in question, the F9 Monitor must be powered only by the battery.
2.5 Definitions and Symbols
Socket for Channel 1 Ultrasound Transducer (for connection with ultrasound
transducer, Protection Category B)
Socket for Channel 2 Ultrasound Transducer (for connection with ultrasound
transducer, Protection Category B)
DECG Socket (for connection with DECG cable, Protection Category CF)
TOCO/IUP Socket (TOCO input socket-for connection with external
contractions (TOCO) transducer, Protection Category B/ IUP input socket, for
connection with intrauterine pressure connector, Protection Category BF)
Socket for Remote Event Marker (for connection with the marker, Protection
Category B)
Socket for Fetal Stimulator (reserved)
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DB9 Interface
F9 Fetal & Maternal Monitor • User Manual
RJ45 Interface
Equipotential Grounding System
Charge Indicator
Alternating Current (a.c.)
Stand-by
Attention, See instructions for use
Type B Applied Part Symbol
Type BF Applied Part Symbol
Type CF Applied Part Symbol
Rx Only
Symbol indicates that the device should be sent to the special agencies
according to local regulations for separate collection after its useful life and
that this unit was put on the market after August 13, 2005.
Reorder Number
Serial Number
Date of Manufacture
Manufacturer
Recycle
US Federal law restricts this device to sale by or on the order of a physician
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F9 Fetal & Maternal Monitor • User Manual
2.6 Ordering Information
The following table describes the accessories that are supplied by or approved by CooperSurgical to
be used with the F9 Monitor. The accessories used, such as the rechargeable battery (P/N: HYLB,
manufactured by HENGYU) have passed the CE authentication, and have the characteristics
specified by their manufacturers. Call CooperSurgical Customer Service at 800-243-2974 or
203-601-9818 for part numbers and pricing.
Accessory (Spare Part) List
US Transducer 1 (pink label) Intrauterine Pressure Connecting Cable
US Transducer 2 (yellow label) Intrauterine Pressure Cable
TOCO Transducer Disposable Intrauterine Pressure Catheter
Remote Event Marker Thermosensitive Paper (GE-American)
Belt Thermosensitive Paper (GE-International)
Aquasonic Coupling Gel (0.25ltr bottle) Thermosensitive Paper (Philips-American)
Fetal Stimulator Thermosensitive Paper (Philips-International)
DECG Cable
Disposable Fetal Spiral Electrode Fuse T1.6AL 250V
Disposable Maternal Attachment Pad Electrode Rechargeable Lithium-ion Battery
Power Cord (American Standard)
WARNING : Only connect the accessories supplied or recommended by
CooperSurgical to the F9 Monitor.
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F9 Fetal & Maternal Monitor • User Manual
Chapter 3 Monitor and Accessories
Figure 3-1: The CooperSurgical F9 Fetal Monitor
3.1 Major Parts
3.1.1 Buttons
Figure 3-2: Buttons and Control Knob
The F9 Monitor is a user-friendly device that is controlled by a few buttons on the front panel and
the Control Knob. Their functions are as follows:
START
Function: Start monitoring, return to main interface
Press this button to start monitoring (on main interface) or return to main interface (in maternal
information inputting menu or setup menus).
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F9 Fetal & Maternal Monitor • User Manual
SILENCE
Function: Disable/Enable audio alarm
Press this button once to switch the alarm sound off, but the alarm information displays and
indicator flashes as normal; press this button again to switch the sound on again.
AUTO ZERO
Function: TOCO/IUP zero
Adjust the external TOCO contractions trace/value to preset unit (external monitoring contractions)
or the IUP trace/ value to reference point 0 (internal monitoring contractions).
MARK
Function: Record an event
Press this key to mark a patient event or open the smart note list.
PRINT
Function: Start / stop printing
Press this button to toggle between starting and stopping printing.
CHANNEL
Function: Switch the channels
The default fetal heart audio is US1. When two ultrasound transducers are connected to the monitor,
press this button to switch the audio to US2; press it again to switch the audio back to US1.
NIBP (Non-Invasive Blood Pressure)
Function: Start or stop a NIBP measurement.
This button is not active unless the optional NIBP feature is enabled.
CONTROL KNOB
Rotate Control Knob
Press Control Knob
Function: Adjust volume, setup and playback control.
The knob can be rotated clockwise or counterclockwise and be pressed like other buttons. All
operations on the screen or in the menu can be completed by using the control knob.
The rectangular mark on the screen that moves with the rotation of the control knob is referred to
as the “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
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F9 Fetal & Maternal Monitor • User Manual
the interface/menus.
Control Knob Operating Procedure:
a) Rotate the control knob to move the cursor to the required item.
b) Press the control knob.
c) One of the following three results will be achieved:
• A new menu pops up. Operate the control knob in the new menu in the same way.
• 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.
• The function operates immediately.
Note: The word “select” hereinafter stands for rotating the control knob cursor to an
item and then pressing the knob.
CAUTION : This F9 Monitor is a “normal” medical device. Please avoid violent
operations such as continuously pressing the buttons or control knob.
3.1.2 Indicators
There are four groups of indicators on top of the screen and the front panel. From the top to bottom
they are: Alarm Indicator, Charge Indicator, AC indicator and Power indicator. Table 3-1 lists their
meanings:
Indicator Status of Indicator Meaning
Alarm Indicator
Charge Indicator
AC Indicator
Flash or light up in
orange
Off No alarm is active
On The battery is being charged
Off No battery or the battery is fully charged
On The Monitor is connected to AC power supply.
Off
An alarm is active
The Monitor is not connected to AC power
supply.
Power Indicator
On
Off
Table 3-1: Indicator Descriptions
The Monitor is powered on.
The Monitor is powered off.
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F9 Fetal & Maternal Monitor • User Manual
3.1.3 Left Side Panel of the Monitor
Transducer Frame
Sockets for Transducers
and Cables
Figure 3-3: Sockets on the left side of the Monitor
NOTE: Sockets for MECG, NIBP, TEMP and SpO2 are only used when these optional
features are enabled.
3.1.4 Right Side Panel of the F9 Monitor
Figure 3-4: Right side of the Monitor
Power Switch
3.1.5 Rear Panel of the Monitor
Equipotential
Grounding Terminal
Power Socket
Figure 3-5: Rear panel of the monitor
Handle
Antenna
DB9
Interface
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USB
Interface
RJ45
Interface
3.1.6 Bottom Panel
F9 Fetal & Maternal Monitor • User Manual
Battery
Compartment
Fuses
Figure 3-6: Bottom panel
Hanging Holes
Bottom Label
3.2 Transducers and Cables
The ultrasound transducer(s), TOCO transducer, IUP cable and remote event marker should be
connected to the left side panel of the monitor. Each cable has a tab on the connector housing to
insure proper insertion into the appropriate socket on the monitor.
3.2.1 Ultrasound (US) Transducer
This multi-crystal, broad beam US transducer is used for monitoring fetal heart rate (FHR). The US
transducer operates at a frequency of 1.0 MHz. The FHR transducer on the maternal abdomen
transmits a low energy ultrasound wave to the fetal heart and receives the echo signal. The F9
Monitor then calculates the fetal heart rate.
Figure 3-7: Ultrasound transducer
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F9 Fetal & Maternal Monitor • User Manual
US transducer 1 has two pink labels; US transducer 2 has two yellow labels. This information is
shown on the labels:
U:xxxxx: number of this US transducer.
MODEL: MS3-109301: Model of this US transducer.
PN: MS3-31528: Part number of the US transducer 1.
PN: MS3-107705: Part number of the US transducer 2.
PW 1.0: PW means pulsed wave, 1.0 means central frequency is 1.0 MHz.
A/1: Version number of the ultrasound transducer.
WATERPROOF: means this transducer is waterproof.
IPX8: means this transducer can work continuously for 5 hours under 1-meter of water without
being waterlogged.
CAUTION : The waterproof parts of the ultrasound transducer are restricted to
the main body and the cable. Do not immerse the plug into water
during the process of monitoring or cleaning.
3.2.2 TOCO Transducer
This transducer is a toco tonometer whose central section is depressed by the forward displacement
of the abdominal muscles during a contraction. It is used for assessment of frequency and duration of
uterine contractions.
Figure 3-8: TOCO transducer
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F9 Fetal & Maternal Monitor • User Manual
There are two blue labels on the TOCO transducer. They include the following information:
T:xxxxx: number of this TOCO transducer.
MODEL: MS3-31527: Model of this TOCO transducer.
PN: MS3-31527: Part number of this TOCO transducer.
A/1: Version number of the TOCO transducer.
WATERPROOF: means this transducer is waterproof.
IPX8: means this transducer can work continuously for 5 hours under 1-meter of water without
being waterlogged.
CAUTION : The waterproof parts of the TOCO transducer are restricted to the
main body and the cable. Do not immerse the connector into water
during the process of monitoring or cleaning.
3.2.3 Remote Event Marker
The remote event marker is a hand-held device used by the pregnant woman to detect and mark fetal
movement from the mother’s perspective.
Figure 3-9: Remote Event Marker
3.2.4 Fetal Spiral Electrode
Please refer to manufactures instructions when using a fetal spiral electrode.
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F9 Fetal & Maternal Monitor • User Manual
3.2.5 Fetal Stimulator
The FS-1 Fetal Stimulator is a hand-held device. It can be used to observe changes in the fetal heart
rate by giving a mild vibrating stimulation to the fetus through the maternal abdomen. This can
reduce the time required for the NST.
During NST, the vibrating operation marks can be displayed /printed on CTG trace when the fetal
stimulator is connected to the F9 Monitor by an audio cable.
Figure 3-10: Operating control of fetal stimulator
3.3 Screen
3.3.1 Main Interface
Message Window
Trace/Menu Window
Setup Key
Numeric Window
Figure 3-11: Main Interface
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Status Window
F9 Fetal & Maternal Monitor • User Manual
The main interface of the F9 Monitor displays traces, numeric information menus and monitor status
information. The screen background color has four color options: black, green (default), orange and
blue.
To change the screen color:
1) Select the Setup key on the main interface.
2) Select General Screen Color.
3) Select the required color.
4) Select OK.
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.
Message Window
a) :
Alarm messages displaying area. When an alarm is active, the message will be displayed here
in red. Patient alarms will be displayed on the left and technical alarms in the center.
Alarm reviewing key. Select this key to open the alarm review menu.
b) : Mat. Info key. Select this key to open the maternal information menu to input or
change the patient’s ID and name.
c)
: Setup key. Select this key to open the Setup main menu.
Trace/Menu Window
The trace/menu window occupies the main portion of the screen. During monitoring or reviewing,
it displays traces; during system configuration, it displays Setup menus.
The background pane bar supports two standards: 30 ~ 240 (American standard) and 50 ~ 210
(International standard).
The 120 ~ 160 bpm area with the green background in between the fetal heart rate pane makes it
easy to observe if the FHR exceeds this range.
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