Product Information

Product Model:
F80/F30

Product Name:
Fetal monitor

Manufacturer Name:

After Service Contact Information:
Guangdong Biolight Meditech Co.,Ltd.
Address: No.2 Innovation First Road, Technical Innovation Coast,
Hi-tech Zone, Zhuhai, P.R. China
Fax: +86-756-3399919
Post code: 519085
Toll-free consultation hot line: +86-400-8818-233
Revision History
This revision number changes whenever the manual is updated due to
software or technical specification change. Contents of this manual are subject
to change without prior notice.

Document No.:

Release time:
J/ CEF80-A-008
Mar.2015
Copyright © 2015 Guangdong Biolight Meditech Co., Ltd. All rights
reserved.
Statement
Manufacturer holds the copyright of this manual, and we are also entitled
to deal with this manual as confidential files. This manual is only used for
operation, maintenance and service of product, someone else can not publish
the manual.
This manual contains exclusive information protected by copyright laws
and we reserve its copyright. Without written approval of manufacturer no
parts of this manual shall be photocopied, Xeroxed or translated into other
languages.
The contents contained in this manual are subject to amendments without
notification.
I
CE mark
EC Representative Name:
Shanghai International Holding Corp. GmbH (Europe)
EC Representative Address:
Eiffestrasse 80, 20537 Hamburg Germany
Manufacturer's Responsibility
Only under the following circumstances will manufacturer be responsible
for the safety, reliability and performance of the instrument:

All the installation, expansion, readjustment, renovation or repairs are
conducted by the personnel certified by manufacturer.

The storage condition, operation condition and electrical status of the
instrument conform to the product specification.

The instrument is used in accordance with the user’s manual.
Cautions and Warnings

The monitor does not contain any parts for self-repair by users. The repair
of the instrument must be conducted by the technical personnel authorized
by manufacturer.

The monitor is neither a therapeutic instrument nor a device that can be
used at home.

Do not touch the patient, bed or the monitor during defibrillation.

Be sure to shut down the system and disconnect all power cables from the
outlets before cleaning the equipment.

Make sure the fetus is alive before using the monitor.

The monitor can not be used underwater.

Be sure the electrical source and grounding environment of the monitor is
stable and safe.

Do not use the monitor in an environment with flammable substance, high
temperature, high humidity, excessive dust or a magnetic and electrical
fields.
(Other contents are specified in this manual)
II
About this manual
This manual contains the instructions necessary to operate the product
safely and in accordance with its function and intended use. Observance of
this manual is a prerequisite for proper product performance and correct
operation and ensures patient and operator safety.
This manual is based on the maximum configuration and therefore some
contents may not apply to your product. If you have any question, please
contact us.
This manual is an integral part of the product. It should always be kept
close to the equipment so that it can be obtained conveniently when needed.
The manual is geared for clinical professionals who are expected to have
a working knowledge of medical procedures, practiced and terminology as
required for monitoring patients.
All illustrations in this manual serve as examples only. They may not
necessarily reflect the setup or data displayed on your product.
Conventions:
‹ Bold Italic text is used in this manual to quote the referenced chapter or
sections.
‹ 【】is used to enclose screen texts.
‹ → is used to indicate operational procedures.
Signs in this manual:
0 Warning: Indicates a potential hazard or unsafe practice that, if
not avoided, will result in death or serious injury.
Caution: Indicates a potential hazard or unsafe practice that, if not
avoided, could result in minor personal injury or product/property
damage.
) Note: Provides application tips or other useful information to ensure
that you get the most from your product.
III
Contents
Chapter 1 General Introduction ....................................................................... 1-1
1.1 Intended Use .............................................................................................................. 1-1
1.2 Product Structure ....................................................................................................... 1-1
1.3 Main Unit................................................................................................................... 1-2
1.4 Equipment Symbols.................................................................................................... 1-8
Chapter 2 Safety ................................................................................................ 2-1
2.1 Safety Information ..................................................................................................... 2-1
2.2 General Safety............................................................................................................ 2-4
2.3 Important Notes for Safety ......................................................................................... 2-5
2.4 Safe Operation Conditions.......................................................................................... 2-8
Chapter 3 Basic Operations .............................................................................. 3-1
3.1 Unpacking and Checking ............................................................................................ 3-1
3.2 Connecting power supply ........................................................................................... 3-2
3.3 Connecting patient cables ........................................................................................... 3-2
3.4 Recording Paper Loading ........................................................................................... 3-3
3.5 Networked Monitoring ............................................................................................... 3-5
3.6 Screen Display ........................................................................................................... 3-5
3.7 General Setting .......................................................................................................... 3-7
Chapter 4 User Interface ................................................................................... 4-1
4.1 Display Style.............................................................................................................. 4-1
4.2 Screen Layout ............................................................................................................ 4-1
Chapter 5 Alarm ................................................................................................ 5-1
5.1 Alarm Category .......................................................................................................... 5-1
5.2 Alarm Level ............................................................................................................... 5-1
5.3 Alarm Indicators......................................................................................................... 5-2
5.4 Alarm Status Symbol .................................................................................................. 5-4
5.5 Setting Alarm Volume ................................................................................................ 5-4
5.6 Parameter Alarm ........................................................................................................ 5-4
5.7 Pausing Alarms .......................................................................................................... 5-5
IV
5.8 Acknowledging Alarms .............................................................................................. 5-6
5.9 When an Alarm Occurs............................................................................................... 5-7
5.10 Testing alarms .......................................................................................................... 5-7
5.11 Alarm when power is lost ......................................................................................... 5-8
Chapter 6 FHR .................................................................................................. 6-1
6.1 Introduction ............................................................................................................... 6-1
6.2 Safety Information ..................................................................................................... 6-1
6.3 Monitoring Procedure................................................................................................. 6-1
6.4 Fetal Parameter Setup................................................................................................. 6-5
Chapter 7 TOCO................................................................................................ 7-1
7.1 Introduction ............................................................................................................... 7-1
7.2 Safety Information ..................................................................................................... 7-1
7.3 Monitoring Procedure................................................................................................. 7-1
7.4 TOCO Value Display .................................................................................................. 7-2
7.5 TOCO setup ............................................................................................................... 7-2
Chapter 8 Fetal Movement (FM) ...................................................................... 8-1
8.1 Introduction ............................................................................................................... 8-1
8.2 Safety Information ..................................................................................................... 8-1
8.3 Monitoring Procedure................................................................................................. 8-1
8.4 FM Display ................................................................................................................ 8-2
8.5 FM Trace ................................................................................................................... 8-2
8.6 FM Setup ................................................................................................................... 8-2
Chapter 9 Battery .............................................................................................. 9-1
9.1 Introduction ............................................................................................................... 9-1
9.2 Battery Installation..................................................................................................... 9-2
9.3 Optimizing Battery Performance ................................................................................ 9-2
9.4 Checking Battery Performance ................................................................................... 9-3
9.5 Disposing Batteries .................................................................................................... 9-3
Chapter 10 Maintenance and Cleaning........................................................... 10-1
10.1 Introduction ........................................................................................................... 10-1
10.2 Cleaning of the Monitor ......................................................................................... 10-1
V
10.3 Cleaning and Sterilizing of Accessories .................................................................. 10-2
Chapter 11 Accessories .................................................................................... 11-1
Appendix A Product Specifications ...................................................................... 1
A.1 Safety Specifications .................................................................................................... 1
A.2 Environmental Specifications ....................................................................................... 1
A.3 Physiological Specifications ......................................................................................... 2
A.4 Power Specifications .................................................................................................... 2
A.5 Hardware Specifications ............................................................................................... 2
A.6 Measurement Specifications ......................................................................................... 5
Appendix B Factory Defaults ............................................................................... 7
Appendix C Alarm messages ................................................................................ 9
Appendix D Guidance and Manufacturer’s Declaration of EMC..................... 10
VI
F80/F30 Fetal Monitor User’s Manual
Chapter 1 General Introduction
1.1 Intended Use
This monitor is applicable for medical institutions to monitor fetal heart
rate, fetal movement and uterine contraction pressure, monitoring information
can be displayed, saved, reviewed and printed.
This monitor can be used in a parturient room, a prenatal care room in a
hospital, for providing medical personnel with the physiological information
of fetuses.
0 Warning:
„
The monitor is intended for use only by clinical professionals or
under their guidance. It must only be used by persons who have
received adequate training in its use. Anyone unauthorized or
untrained must not perform any operations on it.
„
The monitor is not intended for use in ICU room or operating
room.
„
The
monitor
can
not
be
used
during
defibrillation
，
electrosurgery or MRI.
1.2 Product Structure
This fetal monitor is composed of a main unit, a built-in printer and
corresponding functional accessories (ultrasonic sensors, uterine contraction
pressure sensors, a fetal movement marking button, a fetus waker).
1-1
F80/F30 Fetal Monitor User’s Manual
1.3 Main Unit
1.3.1 Front View
‹
F80 Fetal monitor :
1
2
3
4
5
67
8
9
10
11
1-2
12
13
14
F80/F30 Fetal Monitor User’s Manual
‹
F30 Fetal monitor :
1
2
6
3
7
5
14
4
8
9
10
11
12
13
1. Physiological alarm indicating lamp
When a physiological alarm occurs, this lamp will light up as defined
below:
‹
High level alarm: the lamp quickly flashes red.
‹
Medium level alarm: the lamp slowly flashes yellow.
‹
Low level alarm: the lamp lights yellow without flashing.
2. Technical alarm indicating lamp
When a technical alarm occurs, this lamp will light up as defined below:
‹ Low level alarm: the lamp lights blue without flashing.
3. Display screen
4. Printer
5.
Power button
6. Power indicating lamp
It is a LED that lights green and orange, the status of the LED is
specified as follows:
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F80/F30 Fetal Monitor User’s Manual
‹ Green: When the AC mains is connected.
‹ Orange: When the AC mains is not connected and monitor is
powered by battery.
‹ Off: When the AC mains is not connected.
7. Battery charging indicating lamp
‹ Light up: When the battery is being charged.
‹ Off: When the battery is fully charged or no battery in monitor.
NIBP measurement button
8.
This botton is invalid.
Alarm pausing/acknowledging button
9.
——Press this button to suspend all alarm indicators of the monitor;
——Long press this button for 2 seconds to acknowledge all active
physiological and technical alarms.
Switch button
10.
Press this button to switch the output of the FHR1 sound or the FHR2
sound during twin monitoring.
Clinical event marking button
11.
The event marking symbol will display on the screen by press this
button.
12.
13.
TOCO Reset Button
Press this button to reset the value back to the specified value.
Print button
After loading the printing paper, press this button to enter the real-time
printing state and to end it by press this button again.
14. Trim Knob
The Trim Knob is used for:
1-4
F80/F30 Fetal Monitor User’s Manual
‹ Turn left or turn right to move the cursor.
‹ Press down to perform an operation, such as open a menu dialog or
select one option.
1.3.2 Side View
‹
F80 Fetal monitor :
Left side:
Right side:
1
2
3
1. Ultrasonic triple-sensor connector
2. FHR2 sensor connector
3. Fetus waker connector
‹
F30 Fetal monitor :
Left side:
Right side:
4
5
6
7
8
1
2
3
9
1-5
F80/F30 Fetal Monitor User’s Manual
1. Fetus waker connector
2. Ultrasonic Triple-Sensor connector
3. FHR2 sensor connector
4. Machine switch
5. Power socket
6. USB socket
7. Wired network connector
8. Serial port
9. Equipotential grounding terminal
Caution: In order to prevent poor contact due to dust accumulated,
please regularly clean the contact point according to actual
application condition. Before cleaning, the monitor must be powered
off. When cleaning, please wipe the point with medical cotton dipped
into medicinal alcohol by use of a nipper.
1.3.3 Bottom View
‹
F80 Fetal monitor :
Battery compartment
‹
F30 Fetal monitor :
Battery compartment
1-6
F80/F30 Fetal Monitor User’s Manual
1.3.4 Rear View
‹
F80 Fetal monitor :
5
‹
4
3
2
1
F30 Fetal monitor :
Handle
1. AC power input connector
2. Equipotential grounding terminal
Base on the requirements of safety and anti-interference, the monitor must
be connected with equipotential grounding system individual. Connect the
equipotential grounding terminal to the equipotential grounding system with
the green and yellow equipotential grounding cable. If the protective earth
system is damaged, the equipotential grounding system can take on the safety
function of protective earth conductor.
3. Serial port
4. USB socket
1-7
F80/F30 Fetal Monitor User’s Manual
Reserved.
5. Wired network connector
Standard RJ45 socket. It is used for connection with the central monitoring
system provided by manufacturer.
1.4 Equipment Symbols
Symbol
Symbol Note
Symbol
Symbol Note
Attention: Consult
accompanying documents
(this manual).
FHR
Short for “ Fetal Heart Rate ”
Non-ionizing radiation
FM
Short for “ Fetal Movement”
TOCO Reset
TOCO
Uterine contraction
Clinical event marking
IPX1
Switch for FHR1/FHR2
SN
Degree
of
protection
against ingress of liquid
Serial number
Network connector
USB socket
Dangerous voltage
Alternating current
Printer button
CE mark
Equipotential grounding
Manufacture date
Symbol for the marking of
electrical and electronics
Manufacturer
devices according to
Directive 2002/96/EC.
Type B applied part
The unit displaying this symbol providing a specified degree of
protection against shock .
1-8
F80/F30 Fetal Monitor User’s Manual
Chapter 2 Safety
2.1 Safety Information
0 Warning:
„
Before putting the system into operation, verify that the monitor,
connecting cables and accessories are in correct working order and
operating condition.
„
To guarantee the safe operation of the monitor, please use the patient
cables and accessories provided or designated by the manufacturer.
Otherwise, different type of the accessories may damage the monitor
and affect the performance of the monitor.
„
Do not open the monitor housings; electric shock hazard may exist.
All servicing and future upgrades must be carried out by the
personnel trained and authorized by manufacturer only.
„
To avoid explosion hazard, do not use the monitor in the presence of
flammable anesthetics or other flammable substance in combination
with air, oxygen-enriched environments, or nitrous oxide.
„
Do not use the monitor in the presence of high voltage device or in the
environment with high quantity of static, otherwise it may bring out
spark due to the instantly discharge.
„
Please connect the monitor to a socket with protective earth. If the
socket does not have protective earth conductor, please do not use the
socket and use battery to provide power to the monitor.
„
When using the monitor with electrosurgical units (ESU), make sure
the patient is safe.
„
Do not come into contact with the patient during defibrillation.
Otherwise serious injury or death could result.
„
To guarantee the safety of patient, summation of the leakage current
should not excess the admit value when patient is connected to more
than one medical electrical equipment.
„
Make sure all the electrodes are connected to the right position on
the body of patient. Be sure that all the electrodes(including neuter
electrode) and patient never come into contact with other conductive
2-1
F80/F30 Fetal Monitor User’s Manual
parts, or with earth.
„
To avoid inadvertent disconnection, route all cables in a way to
prevent a stumbling hazard. Wrap and secure excess cabling to avoid
risk of entanglement or strangulation by patient or personnel.
„
Disposal of the packing materials should observer the applicable
waste control regulations. Keep the packing materials out of
children’s reach.
„
Safety requirements were fully considered when this instrument was
designed. However, the operator should not neglect watching the
machine condition and observing patients. The operator should be
especially careful not to move the instrument and the patient when the
instrument is working.
„
Auxiliary equipment connected to analog and digital interfaces must
be verified in accordance with respective IEC standards (e.g. Medical
Instrument Standard IEC 60601-1).
And all the configurations
should be in conformity with the valid version of IEC 60601-1-1.
Therefore, when configuring the medical system, personnel who
connect auxiliary equipment to signal input and output interfaces
should ensure that the system meet the requirements of the valid
version of IEC 60601-1-1.
„
The monitor can not be applied to heart directly.
„
All the probes, buttons and their connecting cables shall not be dipped
into water or other liquids during normal usage.
„
The monitor should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, the
monitor should be observed to verify normal operation in the
configuration in which it will be used.
„
Class A equipment is intended for use in an industrial environment.
The monitor may be potential difficulties in ensuring electromagnetic
compatibility in other environments, due to conducted as well as
radiated disturbances.
Caution:
„
At the end of its service life, the monitor, as well as its accessories,
must be disposed of in compliance with the guidelines regulating the
2-2
F80/F30 Fetal Monitor User’s Manual
disposal of such products. If you have any questions concerning
disposal of the monitor, please contact us.
„
Magnetic and electrical fields are capable of interfering with the
proper performance of the monitor. For this reason make sure that all
external devices operated in the vicinity of the monitor comply with
the relevant EMC requirements. Mobile phone, X-ray equipment or
MRI devices are a possible source of interference as they may emit
higher levels of electromagnetic radiation.
„
Before connecting the monitor to the power line, check that the
voltage and frequency ratings of the power line are the same as those
indicated on the monitor’s label or in this manual.
„
Always install or carry the monitor properly to avoid damage caused
by drop, impact, strong vibration or other mechanical force.
„
Although the fetal monitor is designed to be firm, dropping and
shaking resistant, and to meet complicated clinical working needs, it
should be handled carefully during its usage, especially, the ultrasonic
probe wafer is ceramic, shall not be dropped, bumped or surface
scratched.
„
Every time after the ultrasonic probe is used, the couplant on its
surface should be wiped away. The user can scrub the probe and the
instrument by using a wet rag dipped with a neutral disinfectant or
detergent.
„
Please do not turn off loudspeaker volume during monitoring, because
fetal heart sound monitoring is very important.
„
The accuracy of fetal heart rate is controlled by the equipment,
cannot be adjusted by the user. If the result of fetal heart rate is not
credible, please verify it by using another method such as by using a
stethoscope, or contact a local agent or the manufacturer for help.
„
The monitor meets the requirement of electromagnetic compatibility
in IEC60601-1-2.
„
The user needs to install and use according to electromagnetism
compatibility information which is attached with it.
„
Portable and mobile RF communication devices may influence the
monitor performance, so the monitor should be kept away from them
during using.
„
Guidance and manufacturer’s declaration stated in the appendix.
2-3
F80/F30 Fetal Monitor User’s Manual
) Note:
„
Put the monitor in a location where you can easily see the screen and
access the operating controls.
„
Keep this manual in the vicinity of the monitor so that it can be
obtained conveniently when needed.
„
The software was developed in compliance with IEC 60601-1-4. The
possibility of hazards arising from software errors is minimized.
„
This manual describes all features and options. Your monitor may not
have all of them.
2.2 General Safety
0 Warning: The monitor is neither a therapeutic instrument nor a
device that can be used at home.
1． Safety precautions for installation
z
Connect the power cord to a properly earthing socket. Avoid putting the
socket used for it in the same loop of such devices as the air conditioners,
which regularly switch between on and off.
z
Avoid putting the monitor in the locations where it easily shakes or
wobbles.
z
Enough space shall be left around the monitor so as to guarantee normal
ventilation.
z
Make sure the ambient temperature and humidity are stable and avoid the
occurrence of condensation in the operation process of the monitor.
0 Warning: Never install the monitor in an environment where
flammable anesthetic gas is present.
2 ． Monitor conforms to the safety requirements of IEC 60601-1:1988+
A1:1991+A2:1995. This monitor is protected against defibrillation effects.
3． Notes on symbols related to safety
2-4
F80/F30 Fetal Monitor User’s Manual
Type B applied part
The unit displaying this symbol providing a specified degree of
protection against shock.
Attention! Please refer to the documents accompanying this
monitor (this manual)!
4． To guarantee the safe operation of the monitor, the monitor is provided
with various replaceable parts, accessories and consuming materials (such as
sensors and their cables, electrode pads). Please use the products provided or
designated by the manufacturer.
5． Monitor only guarantees its safety and accuracy under the condition that it
is connected to the devices provided or designated by manufacturer. If the
monitor is connected to other undesignated electrical equipment or devices,
safety hazards may occur for causes such as the cumulating of the leakage
current.
6． To guarantee the normal and safe operation of the monitor, a preventive
check and maintenance should be conducted for the monitor and its parts
every 6-12 months (including performance check and safety check) to verify
the instrument can work in a safe and proper condition and it is safe to the
medical personnel and the patient and has met the accuracy required by
clinical use.
Caution: The monitor does not contain any parts for self-repair by
users. The repair of the instrument must be conducted by the
technical personnel authorized by manufacturer.
2.3 Important Notes for Safety
„
Patient Number
The monitor can only be applied to one patient at one time.
„
Interference
Do not use mobile phone in the vicinity of the monitor. High level of
electromagnetic radiation emitted from such devices may result in strong
interference with the monitor performance.
„
Protection against ingress of liquid
2-5
F80/F30 Fetal Monitor User’s Manual
To avoid electric shock or device malfunction, liquids must not be allowed
to enter the device. If liquids have entered the device, take it out of service
and have it checked by a service technician before it is used again.
„
Accuracy
If the accuracy of any value displayed on the monitor or printed on a
printout paper is questionable, determine the patient’s vital signs by
alternative means. Verify that the equipment is working correctly.
„
Alarm
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 a hazard to the patient.Remember that the most reliable method
of patient monitoring combines close personal surveillance and correct
operation of monitor.
The functions of the alarm system for monitoring the patient must be
verified at regular intervals.
„
Before Use
Before putting the system into operation, please visually inspect all
connecting cables for signs of damage. Damaged cables and connectors must
be replaced immediately.
Before using the system, the operator must verify that it is in correct
working order and operating condition.
Periodically, and whenever the integrity of the product is in doubt, test all
functions.
„
Cables
Route all cables away from patient’s throat to avoid possible strangulation.
„
Disposal of package
Dispose of the packaging material, please observe the applicable waste
control regulations and keeping it out of children’s reach.
„
Explosion hazard
Do not use this equipment in the presence of flammable anesthetics,
vapors or liquids.
„
Leakage current test
When interfacing with other equipment, a test for leakage current must be
performed by qualified biomedical engineering personnel before using with
patients.
„
Battery
2-6
F80/F30 Fetal Monitor User’s Manual
The device is equipped with a battery. The battery discharges even when
the device is not in use. Store the device with a fully charged battery and take
out the battery, so that the service life of the battery will not be shortened.
„
Disposal of accessories and device
Disposable accessories are intended for single use only. They should not
be reused as performance could degrade or contamination could occur.
The service life of this monitor is 5 years. At the end of its service life, the
monitor, as well as its accessories, must be disposed of in compliance with the
guidelines regulating the disposal of such products. If you have questions
concerning disposal of products, please contact manufacturer or its
representatives.
„
EMC
Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason, make sure that all external devices
operated in the vicinity of the monitor comply with the relevant EMC
requirements. X-ray equipment or MRI devices are a possible source of
interference as they may emit higher levels of electromagnetic radiation. Also,
keep mobile phones or other telecommunication equipment away from the
monitor.
„
Instruction for use
For continuous safe use of the monitor, it is necessary that listed
instructions were followed. However, instructions listed in this manual in no
way can supersede established medical practices concerning patient care.
„
Loss of data
Should the monitor at any time temporarily lose patient data, close patient
observation or alternative monitoring devices should be used until monitor
function is restored.
If the monitor does not automatically resume operation within 60s, restart
the monitor using the power switch. Once monitoring is restored, you should
verify correct monitoring state and alarm function.
If you have any questions, please contact manufacturer or its
representatives.
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F80/F30 Fetal Monitor User’s Manual
2.4 Safe Operation Conditions
Methods of sterilization or Sterilization: not applicable
disinfection recommended by Disinfection: Refer to Maintenance
the manufacturer
Cleaning Chapter
Electromagnetic interference
Electrosurgical interference
damage
Diathermy instruments
influence
and
No mobile telephone nearby
No damage
Displayed values and prints may be disturbed or
erroneous during diathermy
2-8
F80/F30 Fetal Monitor User’s Manual
Chapter 3 Basic Operations
3.1 Unpacking and Checking
1. Unpacking
Before unpacking, examine the packing case carefully for signs of damage.
If any damage is detected, contact the carrier. If the packing case is intact,
open the package.
2. Remove the monitor and accessories carefully.
3. Keep all the packaging materials for future use in transportation or storage.
4. Check the monitor and accessories
Check the monitor and its accessories one by one in accordance with the
packing list. Check to see if the parts have any mechanical damages. In case
of problems, please contact us or our agent.
0 Warning:
„ Keep the packing materials out of children’s reach. Disposal of the
packing materials should observer the applicable waste control
regulations.
„ The monitor might be contaminated during storage and transport.
Before use, please verify whether the packages, especially the
package of disposable accessories, are intact. In case of any
damage, do not apply it to the patient.
„ Please ensure the monitor is working under specified conditions;
otherwise, the technical specifications mentioned in this manual
will not be met, thus possibly leading to damage of equipment and
other unexpected results.
Caution: Please put a monitor onto a horizontal and stable supporting
plane. Avoid putting the monitor in the locations where it easily
shakes or wobbles. Enough space shall be left around the monitor so
as to guarantee normal ventilation.
3-1
F80/F30 Fetal Monitor User’s Manual
3.2 Connecting power supply
3.2.1 AC power supplying
Ensure the AC mains is: AC 100V-240V, 50Hz/60Hz.
Take out the power cables provided with the monitor. Plug the pin of the fan-out in
the AC socket on the rear panel of the monitor and the input end must connected
with the grounding socket which is the dedicated socket of hospital through the
ground wire.
When the AC mains is connected, the power indicating lamp lights up. When the
battery is being charged, the power indicating lamp lights in orange.
Caution:
„
The monitor does not have mains switch. The monitor is switched
completely only by unplugging the power cable from the AC power
source.
„
Connect the monitor to the equipotential grounding system 。 Use the
green/yellow equipotential grounding cable and connect it to the
terminal labeled with the
symbol.
3.2.2 Battery power supplying
The monitor is fitted with inserted battery to ensure its continuous work
after the failure of AC power supply .
Charge the battery before use,ther e is no external char ger. While the monitor
connecting with AC power, the rechargeable battery can be charged. To
make sure the battery is full charged and can be used at any moment, we
recommend connecting the monitor to the AC power source.
Get power supply from battery to support monitoring when excessive
AC interferences are founded during testing in order to reduce the
interference effects among alternating current.
The operating time of a battery refers to product specifications. Please
refer to Battery chapter for the maintenance of battery.
3.3 Connecting patient cables
Plug the patient cable into the patient cable connector on monitor, tighten
the screws beside the plugs.
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3.4 Recording Paper Loading
When recording paper is not loaded or used up, “No Paper” will be
displayed on the monitor’s display in order to remind the user of loading or
changing recording paper.
1. Press and hold the cover button on the front casing of the recorder with
one hand, add a little force to pull out the recorder’s paper container, and take
out folded paper remaining inside the paper container.
Figure 3-1 load recording paper
2. Remove the packing of a new pile of recording paper, place recording
paper into the paper container. Pull recording paper out of the recorder’s
paper outlet by approximately 2cm.
Attention: When you unfold the topmost page of a pile of printing paper from the
outside (the side near to the machine) to the inside (the side near to your body), you can
see the side of paper with thermal sensitive grids; fetal heart rate grids are on the left,
while uterine contraction grids are on the left, as shown on the left of Figure 3-2.
Figure 3-2 load recording paper
3. Push in the paper container, close the recorder cover. And now paper
loading is completed.
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Figure 3-3 load recording paper
Note:
1. The paper container can be pulled out of the paper compartment as well
when the recorder is turned on, as shown in the figure below:
Figure 3-4 load recording paper
2. When loading paper, as shown in the figure below, slightly lift up the paper
container, so that the guide rails on the paper container completely align to the
grooves inside the paper compartment, then gently lower the paper container.
Figure 3-5 load recording paper
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Caution: The keeping of printing paper should meet the following
requirements:
„
Recording paper should be placed in a dry and cool place, prevented
from high temperature, moisture and direct sunlight.
„
Recording paper with recorded waveforms shall not be piled up for a
long time; otherwise recorded waveforms will be copied mutually.
„
Printing can be started only after waveforms appearance on the
screen.
„
Please use recording paper provided by the manufacturer; using other
recording paper may shorten the life of the printer’s thermal
recording head.
3.5 Networked Monitoring
If the user intends to connect the monitor to the central monitoring system,
plug its connecting electrical cable into the network connector at the back of
the monitor.
) Note: This monitor can only be connected to the central monitoring
system provided by manufacturer, do not attempt to connect this
monitor to other central monitoring system.
3.6 Screen Display
The monitor adopts a display screen of high-resolution TFT LCD.
Measurement numerics, waveforms, patient info, alarm area and menu can be
displayed on the screen. Standard screen is shown as follows:
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1
2
3
8
4
7
5
6
1. Patient information area
Display the number and the name of the patient.
2. Alarm state area
The alarm sound is off.
The alarm is suspended and the alarm paused time shown at the
same time.
3. Display area of system state and time
4. Parameter area
It consists of various parameter areas, and shows measurement numerics
for each parameter module. Label displays on the top left corner of each
parameter area.
5. Area of touch smartkeys
Shows smartkeys, these smartkeys are used to conduct some common
operations.
6. System status area
Shows system prompt message, network status icon, battery status icon
and so on. Please refer to Battery chapter for the state of battery.
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7. Waveform area
Shows the waveforms of each physiological parameter. Label displays on
the top left corner of each waveform area.
8. Technical and Physiological alarm area
The left area shows the technical alarm messages and prompt messages.
The middle area shows the medium-level and low-level physiological alarm
messages while the high-level physiological alarm messages shows in the
right area.
3.7 General Setting
3.7.1 System Setup
1. Display Mode
Select【Main Menu】→【System Setup】→【Display Mode】
The display mode can be set to Monitor or Demo mode.
2. Brightness
Select【Main Menu】→【System Setup】→【Brightness】
The screen brightness can be set to a value between 1 and 5. 1 is the
minimum brightness and 5 is the maximum.
3.7.2 Volume Setup
1. Setting the FHR Sound Volume
Select【Vol. Set】smartkey→【FHR Vol.】
The FHR sound volume can be set to silence or a level between 1 and 4. 4
is the maximum volume.
2. Setting the alarm volume
Select【Vol. Set】smartkey→【Alm Vol.】
The alarm volume can be set to silence or a level between 1 and 3. 3 is the
maximum volume.
3.7.3 Setting the System Time
User can configure the system time. The user is advised to set system time
before implementing monitoring. If the configuration is to be conducted
during the process of monitoring, the time for the revision takes effect after
the current window is exited.
To set the date and time:
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1. Select【Main Menu】smartkey→【System Time】.
2. Select Year/Month/Day/Hour/Min/Sec to set the system time.
3. The time format is 24 hour change.
Caution: Changing the date or time will affect the storage of trends
and events, it may result in data loss.
3.7.4 Color Setup
On the monitor, you can select to set the color of each parameter displayed
on the main menu in order to felicitate the distinguishing of various
parameters.
1. Select【Color Setup】on the main menu.
2. You can set the colors of parameters such as FHR1/FHR2/TOCO/FM.
3. 10 colors are available for each parameter.
3.7.5 Print Setup
On the monitor, you can select to set the monitor's printing.
Select【Print Setup】on the main menu.
1. Print Speed
By selecting【 Print Speed】 , you can set the printer’s print speed;
selectable print speeds are 1cm/min, 2cm/min and 3cm/min.
2. Print Density
By selecting 【Print Density】, you can set the printer’s printing density;
selectable printing densities are 1 to 5; 1 is the minimum density, while 5 is
the maximum density.
3. Timing Print
By selecting【Timing Print】, you can set the printer’s timed printing
function; selectable times are: Off, 10min, 20min, 30min and 40min.
4. Print Score
By selecting 【Print Score】, you can set the On and Off of the automatic
printing CTG scoring function.
5. Scoring Select
By selecting 【Score Select】, you can select the FHR channels to be
scored.
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3.7.6 Maternal Information
On the monitor, you can select to set the maternal information.
Select the【Mat Info】smartkey to set the name, age, gestational weeks,
gestational days and fetal number of the pregnant woman.
3.7.7 Data Review
The monitor is provided with a data review function. Select the【Data
Review】button on the touch screen and then press the rotary coding disc to
enter into the data review screen.
The data have recorded the number, name, age, fetal number, date and
time with respect to the pregnant woman. If there are several pages of stored
data, you can use【Page Up】and【Page Down】to turn pages, and 【Delete】
to delete all the stored data, be caution when you use it.
When you select a record, a dialog box will pop up on the screen; you can
select:
【 Enter 】 to view recorded contents (fetal heart rate curve, uterine
contraction curve, fetal movement curve);
【Exit】to return to the data review screen.
After you have selected【Enter】, you will enter into the review screen of
this record; similarly, if there are several pages of data, you can use【Page
Up】and【Page Down】to turn pages. By selecting【CTG】, you can carry out
print score output on this record.
Caution:CTG scoring can be carried out only when the monitoring
duration exceeds 20 minutes; otherwise 【CTG】 will be shielded,
inoperable.
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Chapter 4 User Interface
4.1 Display Style
Display style of user interface can be set according to your need.
Including:
——Screen brightness:
——Display color of wave and parameter:
4.1.1 Screen Brightness
Select【Main Menu】→【System Setup】→【Brightness】
You can set the brightness to a value between 1 and 5. 1 is the minimum
brightness and 5 is the maximum.
4.1.2 Parameter Color
1. Select【Main Menu】→【Color Setup】.
2. Click the color block of corresponding parameter, and then select the color
according to your need from the popped menu.
4.2 Screen Layout
You can set the screen layout as required. The setting method is as
follows:
1. Select the【Main Menu】→【Screen Layout】.
2. Select one screen according to your need.
The following are the display interface of screens, which may differ from
those on your monitor.
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„ Fetal Screen
To enter fetal screen:
Select【Main Menu】smartkey→【Screen Layout】→【Fetal Screen】.
„ Big Numerics (F)(applicable to F30)
You can display the Big Numerics(F) by the method as follows:
¾ Select【 Main Menu】smartkey→【Screen Layout】→【Big Numerics(F)】
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„ Fetal Cascade(applicable to F80)
You can display the Fetal Cascade by the method as follows:
¾ Select【Main Menu】smartkey→【Screen Layout】→【Fetal Cascade】
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Chapter 5 Alarm
Alarm refers to a prompt that is given by the monitor for medical
personnel through visual, audible and other means when a vital sign appears
abnormal or the monitor occurs technical problem.
5.1 Alarm Category
According to character of alarm, the monitor’s alarms can be classified
into three categories: physiological alarms, technical alarms and prompt
messages.
„ Physiological alarms
Physiological alarms are triggered by a monitored parameter value that
violates set alarm limits or an abnormal patient condition. Physiological alarm
message are displayed in the physiological alarm area.
„ Technical alarms
Technical alarms are triggered by a device malfunction due to improper
operation or system problems. The problems may result in system abnormal
operation or irresponsible monitoring parameters. Technical alarm message
are displayed in the technical alarm area.
„ Prompt messages
As a matter of fact, prompt messages are not alarm messages. Apart from
the physiological and technical alarm messages, the monitor will show some
message to indicate the system status.
5.2 Alarm Level
According to severity of alarm, the monitor’s physiological alarms are
classified into three categories: high level alarms, medium level alarms and
low level alarms.
„ High level alarms: Indicate that the patient is in a life threatening situation
and an emergency treatment is necessary. This is the highest level alarm.
„ Medium level alarms: Indicate that the patient’s vital signs appear
abnormal and an immediate treatment is required.
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„ Low level alarm: Indicate that the patient’s vital signs appear abnormal and
an immediate treatment may be required.
The levels of some physiological alarms are predefined before the monitor
leaves the factory and can not be changed by users. While some levels of
physiological alarms can be changed by users.
The monitor’s technical alarms are classified into categories: low level.
The levels of technical alarms are predefined before the monitor leaves the
factory and can not be changed by users.
5.3 Alarm Indicators
When an alarm occurs, the monitor will indicate it through the following
means:
„ Alarm tone: According to alarm level, speaker in the monitor gives alarm
sound in different tone.
„ Alarm lamp: According to alarm level, alarm lamp on monitor flashes in
different color and speed.
„ Alarm message: Alarm messages are displayed on the screen.
Caution:
„ The concrete presentation of each alarm prompt is related to
the alarm level.
„ The alarm system is real-time alarming.
5.3.1 Alarm Tone
The different level alarms are indicated by the system in following
different audio ways:
Alarm level
Audible prompt
High
“DO-DO-DO------DO-DO, DO-DO-DO------DO-DO”
Medium
“DO-DO-DO”
Low
“DO-”
Caution: For alarm pressure in different alarm levels, alarm pressure
in medium level can not be over than the one in high level. Alarm
pressure in low level can not be over than the one in medium level.
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5.3.2 Alarm Lamp
When a physiological alarm occurs, the alarm levels are indicated in the
following different visual ways:
Alarm level
Visual prompt
High
Alarm lamp flashes in red with 2 Hz.
Medium
Alarm lamp flashes in yellow with 0.5 Hz.
Low
Alarm lamp lights on in yellow without flashing.
When a technical alarm occurs, the alarm levels are indicated in following
different visual ways:
Alarm level
Low
Visual prompt
Alarm lamp lights on in blue without flashing.
Caution: When multiple alarms of different levels occur at the same
time, the monitor will select the alarm of the highest level and give
visual and audible alarm indications.
5.3.3 Alarm Message
‹ Physiological alarm
1) Physiological alarm messages are displayed in the physiological alarm area.
2) The “*” symbol before the alarm message match the alarm level as follows:
High level alarms: ***
Medium level alarms: **
Low level alarms: *
3) The system uses different background colors for the alarm message to
match the alarm level:
High level alarms: red
Medium level alarms: yellow
Low level alarms: yellow
‹ Technical alarm
1) Technical alarm messages are displayed in the technical alarm area.
2) The “*” symbol before the alarm message match the alarm level as follows:
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Low level alarms: *
3) The background color for the alarm message is blue.
‹ Prompt messages
1) Prompt messages are displayed in technical alarm area or the corresponding
parameter area.
2) The background color for the technical alarm area is blue, parameter area
have no color and visual and audible alarm indication.
‹ When multiple alarms occur at the same time, the alarm messages will be
displayed in the alarm area in turn.
5.4 Alarm Status Symbol
The alarm sound is off.
The alarm is suspended.
The parameter alarm is off.
5.5 Setting Alarm Volume
Select 【Vol. Set】→【Alm Vol.】 to set the alarm volume of system.
The alarm volume can be set to silence or a value between 1 and 3. 3 is the
maximum volume.
When the alarm volume is set to be silence, other alarm mode works
normally except the alarm tone, and the
button will show at the top of
the screen.
5.6 Parameter Alarm
The alarm setting of parameter is independent from each other. You can
select【 Main Menu】smartkey→【 Fetal Alm Setup】to set the parameter alarm
limit, alarm status.
For the parameters whose alarm switch is set to ON, the alarm will be
triggered when at least one of them exceeds alarm limit. The following actions
take place:
1. Trigger audible and visual alarm according to alarm level;
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2. Alarm message is displayed in the physiological alarm area.
5.6.1 Alarm Switch and Level
You can select 【Main Menu】smartkey→【Fetal Alm Setup】→【Alm
Level】to set the alarm switch and alarm level of them; when a parameter
alarm is off, a symbol “
” will be displayed near the parameter. If the alarm
is turned on, the symbol will disappear.
Select【Alm Level】in the setting menu of each parameter, you can view
and set the alarm levels of present parameters. The level can be set to【Low】,
【Med】or【High】.
5.6.2 Alarm Limit
„
Setting All Alarm Limits
Select【Main Menu】smartkey→【Fetal Alm Setup】→【Hi Lmt】/【Lo
Lmt】to set the alarm limits of all present parameters. The alarm limit is
adjustable, Physiological alarm will be triggered when the measuring value
exceeds the set limit.
0 Warning:
„
Medical personnel should set the alarm limits of parameters in line
with the clinical environment and existing clinical experience. Before
monitoring, please confirm whether the alarm setting is suitable for
the monitored patient.
„
In any single zone (such as patient room or delivery room), that
different alarm settings are used in the same or similar equipment will
make a potential hazard.
5.7 Pausing Alarms
By pressing the
button on the monitor's front panel, you can pause
all the alarm prompts on the monitor.
The alarm pausing time is displayed at the top of the screen, and the
symbol is displayed in this prompt zone. The alarm pausing time is fixed
to 2min, and there should be a countdown time (e.g. 1:56) displayed on the
screen.
When the alarm pausing time is up, the monitor will cancel alarm pausing
automatically. Pressing the
button during alarm pausing can cancel
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alarm pausing manually.
Physiological Alarm Pausing
——All the light and sound alarms are paused.
——Alarm messages in the physiological alarm message area will not be
displayed.
——During alarm pausing, it a new alarm occurs, it is still not issued.
After the system has returned to its normal state, whether or not an alarm
exists depends on whether or not the alarm condition is met.
Technical Alarm Pausing
——The sound alarm is paused.
——Alarm messages in the light alarm and technical alarm message area are
unchanged, still displayed.
——If a new technical occurs during alarm pausing, the system exits pausing
and returns to the normal condition.
After the system has returned to its normal state, whether or not an alarm
exists depends on whether or not the alarm condition is met.
5.8 Acknowledging Alarms
Long press the button
on the front panel of the monitor for
2seconds, you can acknowledge all active physiological and technical alarms:
Acknowledging physiological alarm
——The visual alarm and audible alarm are all shut off.
——The sign “√” is added in front of the acknowledged physiological alarm
message.
After acknowledging the alarms, if a new physiological alarm occurs, the
monitor will enable the visual and audible alarm once again to the normal state .
Acknowledging technical alarm
——The audible alarm is shut off.
——The visual alarm is keep on.
——The sign “√” is added in front of the acknowledged technical alarm
message, but the alarm of lead-off/sensor-off turns into a prompt message.
After acknowledging the alarms, if a new technical alarm occurs, the
monitor will enable the visual and audible alarm once again to the normal
state .
If handlers take off the sensor, probe or module on purpose, the function of
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acknowledging the alarms can be used to restrain the alarm indication of
lead-off/sensor-off , and turns it into a prompt message.
5.9 When an Alarm Occurs
) Note: When an alarm occurs, you should always check the patient’s
condition first.
Check the alarm message appeared on the screen. It is needed to identify
the alarm and action appropriately, according to the cause of the alarm.
1. Check the patient’s condition.
2. Identify alarming parameter and alarm category.
3. Identify the cause of the alarm.
4. Silence the alarm, if necessary.
5. When cause of alarm has been over, check that the alarm system is
working properly.
You will find the alarm messages for the individual parameter in
Appendix C Alarm message.
5.10 Testing alarms
In general, to test the functioning of visible and audible alarms, do the
following:
1.
Enable the alarm.
2.
Set the alarm limits.
3.
Measure or simulate the parameter that is out of range, or signal loss.
4.
Verify that the visible and audible alarms are working.
As an example, to test the FHR alarms:
1.
Connect the US transducer to a fetal sensor socket.
2.
Enable the FHR alerting .
3.
Set the high alert limit to 150 bpm respectively, and the low alert limit to
110 bpm respectively.
4.
Generate a fetal heart rate of approximately 180 bpm (3 beats per second)
for more that one minute.
5.
Verify the functioning of the visible and audible alarm.
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5.11 Alarm when power is lost
After a loss of power, the alarm settings prior to the power loss are
restored. If you want to restore either the alarm settings from the default
settings, please enter the alarm setting menu to select the setting.
If power is lost for less than one minute, the alarm settings prior to the
power loss are restored.
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Chapter 6 FHR
6.1 Introduction
Fetal heart rate is regulated by sympathetic and parasympathetic nerves, a
monitoring curve formed by instant fetal heart changing described by a signal.
For in vitro signal fetal heart rate monitoring, you can install an ultrasonic
sensor on the auxiliary belt wrapping around the mother’s abdomen. The
ultrasonic sensor will emit low energy ultrasonic beams to the fetus’s heart,
and detect the reflected signal. The monitor can also detect fetal movement
and plot out a fetal movement profile (FMP) on the trace curve.
If you want to monitor the fetal heart rates of twin, you will need two
ultrasonic sensors.
6.2 Safety Information
0 Warning:
„
When you use ultrasound to monitor a fetus, if ultrasonic imaging or
Doppler blood flow measuring is carried out concurrently, it may
cause false FHR readings, and trace recording distortion.
„
Current fetal monitoring technology cannot always distinguish the
fetal heart rate signal source from the maternal heart rate signal
source under all circumstances. Therefore, you must use another
method (e.g. fetal movement percussion or fetal heart sound
auscultation by using a stethoscope or fetal stethoscope) to verify that
the fetus is still alive before carrying out fetal monitoring. If you hear
no fetal heart sounds or feel no fetal movements, verify whether the
fetus is still alive by means of ultrasonic obstetrical examination.
6.3 Monitoring Procedure
6.3.1 Monitoring Preparation
1. After installation of the monitor, press the power button to turn on main
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unit and start the running of the machine, then the main operating screen
appears.
2. Prepare a probe, an ultrasonic couplant and a bandage.
3. Insert the needed probe and fetal movement marking button into the
fetal monitor. Probe connection is unique; if the probe is inserted to a wrong
receptacle, it cannot fit into the receptacle properly.
) Note:
„
If you prepare only for fetal heart rate monitoring, place a bandage
on the bed, then let the pregnant woman lie down; if you prepare for
concurrent fetal heart rate and uterine contraction pressure
monitoring, place two bandages on the bed, then let the pregnant
woman lie down.
The bandages are used to bind probes to the
pregnant woman’s abdomen.
6.3.2 Ultrasonic Sensor Placement
1. Ask the pregnant woman to take a body position (usually semi-supine
position) conducive to monitoring.
2. Pass a bandage through from underneath the waist (two bandages are
needed for monitoring fetal heart rate and uterine contraction pressure).
3. Coat an appropriate amount of couplant onto the surface of an
ultrasonic probe, place the probe onto the pregnant woman’s abdomen; the
couplant should enable the probe to nicely contact the pregnant woman’s
abdomen. The ultrasonic signal will be the best when the probe is positioned
at the upper rear position of the left shoulder of the fetus; place the probe and
then move and adjust the probe slowly to find the best position, at which the
fetal heart beating sound from the loudspeaker will be strongest and the screen
displays continuous fetal heart rate.
4. After the probe finds the best position, keep it at this position, fasten the
bandage. If the probe moves, adjust the probe’s position again to seek for the
best signal.
5. During monitoring, please do not turn off the loudspeaker’s volume;
when the fetal heart rate signal is very weak, you can hardly hear the fetal
heart sound produced by the loudspeaker, be cautious that the digital fetal
heart rate displayed on the screen now might be meaningless.
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6. Having fixed the ultrasonic probe, adjust the volume to a volume you
think appropriate.
7. The fetal heart monitoring probe’s best position might change during
monitoring for a long time. The reasons are fetus squirming, the pregnant
woman turning sideways and the bandage sliding, etc. If the probe’s position
deviates too seriously, there may be such a sign as no sound or no heart rate
curve or the detection precision may be affected.
In order to reduce and avoid the occurrence of similar circumstances, do
the followings steps properly:
¾ Accurately find the best position for fetal heart monitoring, which is a basic
skill.
¾ It is required that the pregnant woman’s lying posture be natural and
comfortable.
¾ The bandage should be reliably bound to an appropriately tightness.
¾ The ultrasonic couplant should be appropriate.
¾ During monitoring, the operator should be earnest and responsible, carry
out patrolling inspection once every few minutes, readjust the probe's
position if finding that the fetal hear sound diminishes significantly.
0 Warning:
„
Using an unapproved ultrasonic couplant may result in signal quality
deterioration, and damage the sensor; such a damage is not included
in warranty terms.
„
Check the mother’s pulse regularly, and compare it with the signal
produced by the monitor’s loudspeaker to ensure the fetal heart rate
during monitoring. Do not mistake the doubled or accelerated
maternal heart rate as the fetal heart rate.
„
During monitoring, please do not turn off the loudspeaker’s volume;
when the fetal heart rate signal is very weak, you can hardly hear the
fetal heart sound produced by the loudspeaker, note that the digital
fetal heart rate displayed on the screen now might be meaningless.
) Note:
„
When placed on the body of the pregnant woman, the ultrasonic
sensor will have a slight temperature rise (which will not be 1℃ /1.8℉
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higher than the ambient temperature).
„
The waterproof rating of the ultrasonic sensor used for this monitor is
IPX1; the sensor is a dripping liquid proof enclosed device; be careful
not to let it splashed by water.
6.3.3 Fetus waker
If your machine is equipped with a fetus waker, when you need to use it,
you need to connect the plug on one end of the audio cable to the fetus waker
receptacle. When the monitoring is in a turned-on condition, the screen will
display the
„
symbol of the fetus waker.
Mode Setting
Whenever you press the Mode button once, the fetus waker will switch
alternatively between the 3-times mode (the device will stop vibrating
automatically after it has vibrated 3 times) and the continuous mode.
„
Vibrating Rhythm Adjustment
Vibration is produced intermittently during operation.
The vibrating rhythm adjusting knob adjusts the repeating cycle of
intermittent vibration.
„
Operating
Apply the surface of the instrument’s vibrating head to the mother’s
abdomen and press the power switch, there will be vibration; press the power
switch again to stop vibrating.
„
Battery Loading
Batteries were not loaded into the battery holder when the fetus waker was
purchased; before using, you need to load batteries and close the battery
holder cover.
Attention:
¾ Please do not use new and old batteries or different types of batteries in
a mixed way.
¾ Please do not dismantle batteries, less doing so might result in a battery
fluid leak or a battery rupture.
¾ If the instrument is not used for a long time, take batteries out in a
timely manner.
„
This device is provided with the following characteristics:
Light, small, convenient for carrying;
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The 3-times mode and the continuous mode are optional;
The vibrating rhythm is adjustable;
The device can be connected to the fetal monitor, and record a stimulation
mark on the recorded trace;
Two alkaline batteries (1.5V) are used for power supplying; low power
consumption: the recommended model can be used 7000 times under the
3-times mode.
6.3.4 Fetal Heart Rate Display
The monitor can display two channels of fetal heart numerical values; you
can hear only the fetal sound from one ultrasonic sensor at a time; after you
have selected the fetal heart sound for one channel, you can see the sound
making source symbol by the FHR numerical value marked for that channel.
FHR Volume
FHR channel
Trace separation
value
FHR signal
FHR value
FHR unit
6.4 Fetal Parameter Setup
Select【Main Menu】→【Fetal Param.】to set fetal parameters.
„
Trace Separation (Trace Offset)
When more than one fetal heart rate is measure, fetal heart rate 2 is moved
down to a corresponding position, while the baseline of fetal heart rate 1
always remains unchanged. Select trace separation, which can help you
identify baseline similar traces; options: 20bpm, 30bpm and 40bpm.
„
FHR Channel (FHR Chan.)
This monitor support twins monitor. By selecting Fetal Heart Sound
Channel, you can switch between two fetal heart sound channels to select
Fetal Heart Sound 1 or Fetal Heart Sound 2. Return to the main screen after
selection, you can then monitor the fetal heart sound of the corresponding
channel.
„
Alarm Delay
Alarm delay options: Off, 5s, 10s, 15s and 20s.
„
TOCO Reset
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Options: 0, 5, 10 and 15.
„
FM Count
Options: Manual and automatic.
„
FM Strength Trace
Options: Off and On.
„
FM Threshold
Options: 30, 40, 50, 60 and 70.
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Chapter 7 TOCO
7.1 Introduction
Uterine contraction is an important characteristic of imminent giving birth ,
in short, uterine contract is the regular contraction of the uterus . At the
beginning, the uterine contraction is irregular and its strength is weak, then
the uterine contraction gradually becomes regular while its strength becomes
stronger and stronger, and the duration becomes longer while the interval time
is shortened.
You can use a uterine contraction pressure sensor to detect uterine
activities in vitro.
Using the monitor to measure uterine contract pressure is one of important
means for protecting the fetus and the mother.
7.2 Safety Information
0 Warning:
„
The amplitude and sensitivity of a uterine contraction pressure sensor
depend on many factors, such as sensor position, patient stature, and
abdominal belt tightness.
„
The uterine contraction pressure sensor should never be coated with
an ultrasonic couplant, less the couplant might damage the uterine
contraction pressure probe, or more seriously, cause a safety danger.
The probe should be kept away from moisture when it is not used.
) Note:
„
During monitoring you need to adjust the zero point of uterine
contraction pressure: You need to carry out uterine contraction
pressure zeroing whenever you find that the zero point changes
significantly over a certain period of time.
7.3 Monitoring Procedure
1. Pass a bandage through the back of the pressure probe, place the sensor
7-1
F80/F30 Fetal Monitor User’s Manual
at the pregnant woman’s uterine fundus and fix the bandage, the tightness of
the bandage should be appropriate when adjusting the position.
2. Press the uterine contract pressure reset button (“
”), then the uterine
contraction reset value is displayed at the uterine contraction position on the
screen.
7.4 TOCO Value Display
The monitor can display the uterine contraction pressure value, and the
uterine contraction pressure reset value, which is adjustable.
Label
TOCO resetting value
TOCO value
7.5 TOCO setup
TOCO Reset setting
Select 【Fetal Param.】on the main menu, then select【TOCO Reset】
to set a numerical value as needed.
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F80/F30 Fetal Monitor User’s Manual
Chapter 8 Fetal Movement (FM)
8.1 Introduction
Fetal movement refers to the movement of the fetus inside the uterine
cavity, which impact the uterine wall.
After 4 months of pregnancy, i.e. starting from the 5th month, the mother
can obviously feel the movement of the fetus. The fetus stretches his/her
hands or kicks his/her legs inside the uterus, which impacts the uterine wall, is
called as fetal movement. The number of times, frequency and strength of
fetal movements indicate the safety/danger of the fetus. Fetal movement is the
movement of the fetus inside the mother’s uterus.
Fetal movement marking options include such two modes as manual and
automatic.
8.2 Safety Information
) Note:
„
The number of times of fetal movement is not constant. Weeks 28～38
of pregnancy are a fetal movement active period, later, fetal
movement gradually weakens, until delivery. The pregnant woman’s
movements, postures and moods, as well as loud noises, high intensity
light beams and abdomen touches etc, can all cause the changing of
fetal movement.
8.3 Monitoring Procedure
Automatic fetal movement: After you have selected the automatic fetal
movement mode, the monitor will monitor fetal movements on corresponding
channel while it monitors fetal heart rate.
Manual fetal movement: If you need to record fetal movements manually,
let the examinee (the pregnant woman) hold the fetal movement button
connected to the instrument, and ask her to press the button once whenever
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F80/F30 Fetal Monitor User’s Manual
there is a fetal movement. Detected fetal movement signals will be marked on
corresponding position on plotting paper.
This instrument has such two modes as manual recording and automatic
recording for fetal movements.
8.4 FM Display
FM method
FM count
8.5 FM Trace
Fetal movement parameters detect fetal movements via the ultrasonic
sensor connected to the monitor. You can select the On/Off setting of the FM
trace in fetal parameters.
When the setting is On, the FM trace will be triggered automatically after
the ultrasonic sensor is connected.
8.6 FM Setup
„
FM Count
Select 【Fetal Param.】on the main menu, then select【 FM Count】to set
a manual or automatic counting mode as needed.
„
FM Strength Trace
Select 【Fetal Param.】on the main menu, then select【FM Strength
Trace】to turn on or off the fetal movement strength trace.
„
FM Threshold
Select 【Fetal Param.】on the main menu, then select【FM Threshold】
to select a corresponding numerical value.
8-2
F80/F30 Fetal Monitor User’s Manual
Chapter 9 Battery
9.1 Introduction
The monitor can be fitted with rechargeable battery to ensure its
continuous work after the failure of alternating current power supply, and it
needs no special maintenance under the normal condition. While the monitor
connecting with alternating current power, no matter whether the monitor is
operating or not, the battery always can be charged. In the event of sudden
being powered off, the monitor will automatically get power supply from
battery without interruption of monitoring work.
Indicative message under the screen will display battery states:
Indicates that the battery is fully charged.
Indicates that the battery is three quarters charged.
Indicates that the battery is half charged.
Indicates that the battery is one quarters charged.
Indicates that the battery is almost depleted and need to be
charged immediately.
The power supply of battery can only function for a certain period.
Excessively low voltage of battery will trigger a technical alarm and the
“Battery Low” message will be displayed. At this moment, the monitor shall
immediately connect with alternating current power supply to charge the
battery.
Caution: Remove the batteries prior to shipping or if the monitor is
not likely to be used for an extended period of time.
0 Warning:
„ Use only batteries specified in this manual.
„ Keep the batteries out of children’s reach.
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F80/F30 Fetal Monitor User’s Manual
9.2 Battery Installation
The battery compartment is located at the bottom of the monitor, please
refer to the following steps for battery installation or replacement:
1. Turn off the power supply for the monitor, disconnect the power cord and
other connecting wires.
2. Use a screwdriver to unscrew the fixing screws above the battery door,
open the battery door and take out the old batteries.
3. Place new batteries into the battery compartment in the marked direction,
and press batteries down, ensure the close contacting between batteries and
polar slices.
4. Reinstall the battery door.
5. Connect the monitor to an AC power supply, and check whether the
monitor’s battery status indicator displays a normal condition.
9.3 Optimizing Battery Performance
A battery needs at least two optimizing cycles when it is put into use for
the first time. A battery cycle is one complete, uninterrupted charge of the
battery, followed by a complete, uninterrupted discharge of the battery. A
battery should be conditioned regularly to maintain its useful life. Condition a
battery once when it is used or stored for two months, or when its run time
becomes noticeably shorter.
To optimize a battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring and
measuring procedures.
2. Place the battery in need of optimizing into the battery compartment to the
monitor.
3. Place the monitor in the charger stand and connect the AC mains. Allow
the battery to be charged uninterruptedly for above 6 hours.
4. Remove the AC mains and allow the monitor to run from the battery until
it shuts off.
5. Replace the monitor in the charger stand and connect the AC mains. Allow
the battery to be charged uninterruptedly for above 6 hours.
6. The optimizing of the battery is over.
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F80/F30 Fetal Monitor User’s Manual
9.4 Checking Battery Performance
The performance of a battery may deteriorate over time. To check the
performance of a battery, follow this procedure:
1. Disconnect the monitor from the patient and stop all monitoring and
measuring procedures.
2. Place the monitor in the charger stand and connect the AC mains. Allow
the battery to be charged uninterruptedly for above 6 hours.
3. Disconnect AC mains and allow the monitor to run on the battery until it
shuts off.
4. The operating time of a battery reflects its performance directly.
Caution:
The
operating
time
of
a
battery
depends
on
the
configuration and operation of the monitor. FHR measurement and
using of recorder will deplete the battery faster than other
parameters’ measurement.
9.5 Disposing Batteries
Batteries that are damaged or depleted should be replaced and discarded
properly. Dispose of used batteries according to local regulations.
Caution: The service life of battery depends on the service time and
frequency. This monitor battery can be charged and discharged for
300 times generally.
0 Warning: Do not disassemble batteries, or dispose of them in fire, or
cause them to short circuit. They may ignite, explode, or leak, causing
personal injury.
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F80/F30 Fetal Monitor User’s Manual
Chapter 10 Maintenance and Cleaning
10.1 Introduction
Keep your equipment and accessories free of dust and dirt. To avoid
damage to the equipment, follow these rules:
1. Always dilute according the manufacturer’s instructions or use lowest
possible concentration.
2. Do not immerse part of the equipment in the liquid.
3. Do not pour liquid onto the equipment or accessories.
4. Do not allow liquid to enter the case.
5. Never use abrasive materials (such as steel wool or silver polish), or
erosive cleaners (such as acetone or acetone-based cleaners).
In order to ensure the normal service life of the equipment, safty tests
should be taken in a cycle of 6-12 months, main contents to be tested are as
follows:
1. Verify the equipment functions according to the operating manual;
2. Check if the monitor or any accessory is damaged;
3. Run the related safety tests according to the requirements of IEC60601-1
and IEC60601-2-37.
0 Warning: Be sure to shut down the system and disconnect all power
cables from the outlets before cleaning the equipment.
Caution: If you spill liquid onto the equipment or accessories, contact
us or your service personnel.
10.2 Cleaning of the Monitor
Common detergent and non-corrosive disinfectant used in hospital can be
applied to clean monitor, however you must be aware that many kinds of
detergents must be diluted prior to utilization, and please use it according to
the instruction of detergent manufacturer.
Avoid the use of alcohols, amino or acetonyl detergent.
10-1
F80/F30 Fetal Monitor User’s Manual
The enclosure and screen of monitor shall be free of dust, and they can be
wiped with lint-free soft cloth or sponge soaked in detergent. While cleaning,
be careful and do not spill liquid onto the instrument and keep any liquid out
of it. When wiping the side panel of monitor, you must be especially careful to
keep water out of all kinds of cable and outlet on the panel.
Do not use abrasive material including wire brush or metal brightener
during cleaning because this material will damage the panel and monitor
screen.
Do not submerge the monitor in liquid.
While cable or plug of attachment accidentally gets wet, please rinse it
with distilled water or deionized water and dry it in the environment of
temperature 40℃ to 80℃ for at least one hour.
10.3 Cleaning and Sterilizing of Accessories
1． Ultrasonic Sensor
Recommended disinfectants includes glutaraldehyde solution, ethanol
solution, 1- and 2-propanol solution.
a） Before disinfection, please clean sensor surface;
b） Use a hair free soft rag dipped with an appropriate amount of clear water
or mild soap water to clean sensor surfaces;
c） Use a hair free soft rag dipped with an appropriate amount of disinfectant
to clean the sensor;
d） Use a hair free soft rag dipped with clear water to wipe away disinfectant
remaining on the sensor;
e） Place the sensor in a shady and cool environment for drying.
Attention:
Never mix the disinfectants, less they might produce a dangerous gas.
Use soap water to wash a repeatedly usable abdominal belt and the water
temperature shall not exceed 60℃.
Never use high pressure, rays or steam to disinfect the sensor.
Never soak the sensor directly in a liquid.
In order to prevent long term damage caused to the sensor, we recommend
that you disinfect the product only when you think it necessary according to
hospital stipulations
Do not clean and reuse disposable sensor.
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F80/F30 Fetal Monitor User’s Manual
Caution:
„ Check patient cables and wires on a regular basis in order to make sure
that their integrity and conductivity are good
„ Replace such a damaged or aging cable or wire in a timely manner.
„ Untangle the lead wires whenever possible while be used and never pull
then forcefully.
0 Warning: Never use EtO, Phenyl, amino or Iodine based for
disinfection.
Caution: Sterilization maybe do some harm to monitor, it is suggested
that the sterilization be performed only when your hospital considers
it necessary in line with maintenance plan. Clean equipment before
sterilization.
) Note: The electric schematic and element list can only be offered to
the eligible service center or personnel.
10-3
F80/F30 Fetal Monitor User’s Manual
Chapter 11 Accessories
0 Warning:
„
Use only accessories specified in this manual. Using other accessories
may cause damage to the monitor.
„
Disposable accessories are designed for single-patient use only. Reuse
of them may cause a risk of contamination and affect the
measurement accuracy.
„
Check the accessories and their packages for any sign of damage. Do
not use them if any damage is detected.
Accessories
Specification
PN
Reusable
Triple sensor
Including FHR1, TOCO sensor
15-100-0113
and FM sensor
Twins Ultrasonic sensor
Reusable （ FHR2)
15-100-0114
Fetus waker
Reusable
15-100-0115
11-1
F80/F30 Fetal Monitor User’s Manual
Appendix A Product Specifications
A.1 Safety Specifications
According to the MDD 93/42/EEC, the monitor is Type Ⅱa equipment.
Classified according to the IEC60601-1 is as follows:
Classification of
protection against
Class I, internally and externally powered equipment
electric shock
Degree of protection
against electric
Type B applied part
shock
Degree of protection
against ingress of
IPX1
liquid
Degree of protection
Non- AGP equipment. Equipment is not suitable for
against hazards of
use in the presence of flammable anesthetic mixture
explosion
with air or with oxygen or nitrous oxide
Mode of operation
Continuous
EMC
Group 1, class A
A.2 Environmental Specifications
Operating temperature
5℃ to 40℃
Operating humidity
15% to 85% (non condensing)
Operating atmospheric pressure
700hPa to 1060hPa
Transportation and storage temperature
-20℃ to +55℃
Transportation and storage humidity
10% to 93% (non condensing)
Transportation and storage atmospheric
pressure
1
500hPa to 1060 hPa
F80/F30 Fetal Monitor User’s Manual
A.3 Physiological Specifications
Size(W×H×D)
Weight
F80: 383mm×367mm×124mm
F30: 332mm×295mm×144mm
F80: ≤6kg
F30: ≤5kg
A.4 Power Specifications
Input voltage
100V-240V AC
Frequency
50Hz/60Hz
Input current
1.0A~0.5A
Standard
requirement
According to IEC 60601-1, IEC 60601-1-2
A.5 Hardware Specifications
A.5.1 Display
Mainframe display
Type
Color TFT LCD
Size（diagonal)
F80: 12.1 inch
F30: 7.0 inch
Resolution
F80: 800×600 pixels
F30: 800×480 pixels
A.5.2 Recorder
Type
Thermal dot array
Resolution
8 dots/mm
Paper width
152 mm, Z type paper
Paper length
13.5 m
Recording speed
Real-time recording : 1cm/min, 2cm/min, 3cm/min
Review of fast recording: up to 25mm/s
Speed accuracy of
printing
≤ ±5%
2
F80/F30 Fetal Monitor User’s Manual
Recording trace
FHR trace for twins, TOCO trace, and FM trace
optional
Recording way
Real-time printing, history data printing
A.5.3 Battery
Type
Rechargeable lithium ion battery
Model
LB-08
Size
106m×78mm×21.5mm
Weight
<360 g
Quantity
1
Rated voltage
11.1 VDC
Charge method
Constant current/Constant voltage
Voltage to stop
charging
12.6V±0.05V
Voltage to stop
discharging
9.5V±0.3V
Charge current
0.8A～1.5A
Capability
4000 mAh
4 hours
Under the circumstance of using a new and fully
Operating time
charged battery at 25 ℃ ambient temperature and
working on the typical config(connecting a FHR
sensor, and the printer keeping on printing).
Charge time
6h to 100%(Standby)
Turn off delay
5 min -15 min after the low battery alarm first occurs.
Indicator of battery
capability
With
3
F80/F30 Fetal Monitor User’s Manual
A.5.4 Mainframe LED
including physiological
indicating lamp
Alarm indicating lamp
and
technical
alarm
physiological alarm indicating lamp:1 (Yellow/Red)
technical alarm indicating lamp: 1 (Blue)
AC/Battery indicating lamp: 1 (Green/Orange)
Power indicating lamp
When powered with AC, it lights green while turn
on and off the monitor
When powered with battery, it lights orange only
while turn on the monitor
Battery charging
indicating lamp
1 (Yellow)
A.5.5 Audio indicating
Speaker
Alarm pressure
FHR Sound
Alarm tones meet the requirement of IEC 60601-1-8.
45 dB to 85 dB. Testing place is 1 meter from the
tone
Output the FHR sound from monitoring channel
A.5.6 Input device
Button
6, power switch, FHR sound channel, pausing
Function button
alarm/acknowledging
alarm,
event, TOCO reset, print
Knob
Type
Mechanical
Other
Keyboard input
Optional
4
Mark
for
clinical
F80/F30 Fetal Monitor User’s Manual
A.5.7 Connectors
Power
F80: 1 AC power inlet
F30: 1 DC +15V inlet
Wired network
1 standard RJ45 interface
USB
Reserved
RS232
1 standard RS232 connector
A.5.8 Data Storage
Data storage
Store and review CTG for 24h
A.6 Measurement Specifications
A.6.1 FHR
Measurement method
Ultrasound Pulsed Doppler
Transducer
9 crystals
Ultrasonic intensity
< 5mW/cm 2
Ultrasonic frequency
1.0MHz, deviation less than ±10％
Measurement range
50~210bpm
Accuracy
±2bpm
Resolution
1bpm
Ultrasonic output parameter
Peak-negative acoustic pressure（P-）
（0.03 ± 0.0022）MPa
Output beam intensity（I ob ）
（0.59±0.045）mW/cm2
Spatial-peak temporal average
（0.85 ±0.064）mW/cm2
intensity （I spta ）
A.6.2 TOCO
Measurement method
Strain Gauge Sensor Element
Measurement range
0~100 units (relative to %)
Resolution
1% (1 unit)
5
F80/F30 Fetal Monitor User’s Manual
Nonlinear accuracy
≤ ±10%
TOCO baseline
0, 5, 10, 15
A.6.3 FM
Auto FM
Measurement method
Doppler ultrasound
FM intensity measurement range
0-40 (%) relative range
Manual FM
Measurement method
Press the FM button by pregnant women
6
F80/F30 Fetal Monitor User’s Manual
Appendix B Factory Defaults
This section lists the most important factory default settings. These settings are not
user-adjustable. However, you can restore the factory default settings of the monitor
and EMS if necessary.
„
„
„
„
„
Volume Setup
Main Menu Item
Factory Defaults
FHR Sound Volume
3
Alarm Volume
3
Screen Layout
Main Menu Item
Factory Defaults
F80 Interface layout
Fetal Screen
F30 Interface layout
Fetal Screen
System Setup
Main Menu Item
Factory Defaults
Display Mode
Monitor
Brightness
3
Color Setup
Main Menu Item
Factory Defaults
FHR1
red
FHR2
pink
TOCO
bottle green
FM
yellow
Print Setup
Main Menu Item
Factory Defaults
Print Speed
3cm/min
Print Density
3
Timing Print
30min
7
F80/F30 Fetal Monitor User’s Manual
„
Print Score
On(when have Scoring Module)
Scoring Select
FHR1
Fetal Param
Main Menu Item
Factory Defaults
Trace Separation
20bpm
FHR Channel
FHR1
Alarm Delay
Off
TOCO Reset
5
FM Count
Manual
FM Strength Trace
On
FM Threshold
50
8
F80/F30 Fetal Monitor User’s Manual
Appendix C Alarm messages
C.1 Physiological alarm messages
Prompt messages
Cause
Level
FHR1 low
FHR1 measuring value is below the low
alarm limit
User-Selectable
FHR1 high
FHR1 measuring value is above the high
alarm limit
User-Selectable
FHR2 low
FHR2 measuring value is below the low
alarm limit
User-Selectable
FHR2 high
FHR2 measuring value is above the high
alarm limit
User-Selectable
C.2 Technical alarm messages
Prompt messages
Cause
Level
Battery Low
Voltage of battery is too low
Low
Out of Paper
No paper in the recorder when recording
Low
Printer Panel Open
the recorder door is open
Low
FHR Overlap
Use the same sensor to monitor a twin
Low
FHR sensor off
FHR Triple-sensor falls off from the monitor
Low
9
F80/F30 Fetal Monitor User’s Manual
Appendix D Guidance and Manufacturer’s
Declaration of EMC
Guidance and manufacturer’s declaration – electromagnetic emissionsfor all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration –electromagnetic emissions
The Fetal monitor F80/F30 is intended for use in the electromagnetic environment specified below. The
customer or the user of the SECP-II should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
Compliance
Electromagnetic environment - guidance
Group 1
The Fetal monitor F80/F30 uses RF energy only for its
internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
The Fetal monitor F80/F30 is suitable for use in all
establishments other than domestic and those directly
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
10
F80/F30 Fetal Monitor User’s Manual
Guidance and manufacturer’s declaration – electromagnetic immunity –
for all EQUIPMENT and SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fetal monitor F80/F30 is intended for use in the electromagnetic environment specified
below.
The customer or the user of the monitor should assure that it is used in such an
environment.
Electromagnetic
IEC 60601 test
Immunity test
Compliance level
environment –
level
guidance
Electrostatic
±6 kV contact ± 6 kV contact
Floors should be wood,
discharge (ESD)
±8 kV air
± 8 kV air
concrete or ceramic tile. If
floors are covered with
IEC 61000-4-2
synthetic material, the relative
humidity should be at least 30
%.
Electrical fast
±1 kV for power ±1 kV for power
Mains power quality should
transient/burst
supply lines
supply lines
be that of a typical
IEC 61000-4-4
commercial or hospital
environment.
Surge
± 1 kV line(s) to ± 1 kV line(s) to
Mains power quality should
line(s)
line(s)
be that of a typical
IEC 61000-4-5
± 2 kV line(s) to ± 2 kV line(s) to commercial or hospital
earth
earth
environment.
Voltage
dips,
short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in
UT)
for 0,5 cycle
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 s
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
11
Mains power quality should
be that of a typical
commercial
or
hospital
environment. If the user of the
monitor requires continued
operation during power mains
interruptions,
it
is
recommended that the monitor
be
powered
from
an
uninterruptible power supply
or a battery.
F80/F30 Fetal Monitor User’s Manual
3 A/m
3 A/m
Power frequency magnetic
fields
should
be
at
levels
magnetic field
characteristic of a typical
IEC 61000-4-8
location
in
a
typical
commercial
or
hospital
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.
Power frequency
(50/60 Hz)
Caution: The fetal heart rate measurement is very sensitive measurement.
Technological limitations do not allow higher immunity levels than ±1 kV for
EFT. Immunity for EFT above ±1 kV may cause erroneous measurements.
12
F80/F30 Fetal Monitor User’s Manual
Guidance and manufacturer’s declaration – electromagnetic immunity –
for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration – electromagnetic immunity
The Fetal monitor F80/F30 is intended for use in the electromagnetic environment specified below.
The customer or the user of the monitor should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic
environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the monitor, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3Vrms
150kHz to 80MHz
3Vrms
Radiated RF
IEC 61000-4-3
3V/m
80MHz to 2.5GHz
3V/m
d = 1.2 P
d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey, ashould be less than the compliance
level in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80MHz and 800MHz, 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.
13
F80/F30 Fetal Monitor User’s Manual
a
b
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 monitor is used exceeds the applicable RF compliance level above, the monitor should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the monitor.
Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
Recommended separation distances between portable and mobile
RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the monitor
The Fetal monitor F80/F30 is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the monitor can help
prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the monitor as recommended
below, according to the maximum output power of the communications equipment.
Rated
Separation distance according to frequency of transmitter
maximum
m
output power
150kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
of transmitter
d = 1.2 P
d = 1.2 P
d =2.3 P
W
0.01
0.1
1
10
100
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
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 80MHz and 800MHz, 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.
14
Product name: Fetal monitor
Product type: F80/F30
Manufacturer: Guangdong Biolight Meditech Co., Ltd.
Address: No.2 Innovation First Road, Technical Innovation Coast, Hi-tech
Zone, Zhuhai, P.R. China
Fax: +86-756-3399919
Post code: 519085
Toll-free consultation hot line: +86-400-8818-233
PN: 22-045-0012