Fazzini FM5000C Manuale utente

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

FM5000C - FM5000PLUS

0123

Maternal/Fetal Monitor

User Manual

IMPORTANTE

Leggere attentamente le istruzioni prima dell’utilizzo.

WARNING

Read the instructions carefully before using the device.

IMPORTANT

Lisez attentivement la notice avant l’emploi.

IMPORTANTE

Lea atentamente las instrucciones antes de utilizar el aparato.

IMPORTANTE

Ler atentamente as instruções antes de utilizar o aparelho.

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

Preface

Thank you for purchasing our FM5000 maternal/ fetal patient monitor! This manual gives detailed description to

the Monitor concerning its performance, operation, safety guide, and precautions. Reading through this manual

is the first step to get familiar with the equipment and make the best use of it.

Following symbols indicates some important notes that you have to pay special attention to:

Warning

Points to be noted to avoid injury to the patient and the operator.

Note

Important points to be noted.

Intended Use

This product is intended to be used in surgeries, ICU wards, CCU wards and other places requiring monitoring

for patients. It can display in real time the fetal heart rate (FHR), TOCO, fetal movement mark, maternal heart

rate, ECG, non-invasive blood pressure (NIBP), SpO2, pulse rate, RESP, and TEMP etc.

Working Environment

1. Working temperature: 5℃~40℃

2. Relative humidity: ≤80%

3. Atmospheric pressure: 860hPa~1060hPa

4. Supply voltage: 220V ±22V

5. Power frequency: 50Hz ± 1Hz

Storage Temperature

1. Ambient temperature: -20℃~55℃

2. Relative humidity: ≤95%

3. Atmospheric pressure: 50kPa~106kPa

Please read through this Manual carefully before use.

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FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

Contents

Chapter 1 Safety Guide..........................................................................................................................1-1

1.1 Safety

Information......................................................................................................................

1-1

1.2

Symbols

......................................................................................................................................1-3

Chapter 2 Overview ...............................................................................................................................2-1

2.1 Intended Use...............................................................................................................................2-1

2.2

Components

................................................................................................................................2-1

2.3

Contraindictions .........................................................................................................................

2-1

2.4 Appearance

Introduction............................................................................................................

2-2

2.4.1 Front V

ew......................................................................................................................2-2

2.4.2

RightView.......................................................................................................................

2-3

2.4.3

LeftVi

ew.........................................................................................................................2-3

2.4.4

RearVi

ew........................................................................................................................2-3

2.4.5 BottomV

ew...................................................................................................................2-4

2.5 On-screen

Display......................................................................................................................

2-4

Chapter 3 Installation ............................................................................................................................3-1

3.1 Unpack and

k......................................................................................................................3-1

3.2 Connect theAC Power Cord......................................................................................................3-1

3.3 Turn on the Monitor...................................................................................................................3-1

3.4 Connect the Sensors ...................................................................................................................3-2

Chapter 4 Patient Safety........................................................................................................................4-1

4.1 Safety Instruction .......................................................................................................................4-1

4.2 Enviroment

Requirements

..........................................................................................................4-1

4.3 Grounding protection .................................................................................................................4-1

4.4 Equipotential

Grounding ............................................................................................................

4-2

4.5

Conde

nsa

tion

..............................................................................................................................4-2

Chapter 5 Basic Operations...................................................................................................................5-1

5.1 Using the Main Menu.................................................................................................................5-1

5.2 General Settings .........................................................................................................................5-1

5.2.1 Setting the System

time

..................................................................................................5-1

5.2.2 Changing System

Language

...........................................................................................5-2

5.2.3 AdjustingAlarm Vo

lume

................................................................................................5-2

5.2.4 AdjustingHeartbeatVolume ...........................................................................................5-2

5.2.5 AdjustingFHR Volume...................................................................................................5-2

5.2.6 Adjusting Key Volume...................................................................................................5-2

5.2.7 Adjusting Screen Brightness..........................................................................................5-2

5.3 Module Setup.............................................................................................................................5-3

5.4 Monitor Infor

mation

...................................................................................................................5-3

5.5 Demo F

unction

...........................................................................................................................5-3

5.6 Locking the Touch

Scree

n..........................................................................................................5-3

5.7 Network

Settings

........................................................................................................................5-4

5.8 Freezing

Waveform ....................................................................................................................

5-4

Chapter 6 Patient Management ............................................................................................................6-1

6.1 Admitting Patient.......................................................................................................................6-1

6.1.1 Discharging Patient ........................................................................................................6-2

6.2 Patient Case

Management ..........................................................................................................

6-2

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FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

6.2.3 Import or Export Patient Case via USB Flash Disk .......................................................6-3

Chapter 7 User Screens..........................................................................................................................7-1

7.1

Overview

....................................................................................................................................7-1

7.1.1 Fetal Monitoring

Screen

.................................................................................................7-1

7.1.2 Mother/Fetus Monitoring Screen ...................................................................................7-2

7.1.3 Mother Monitoring

Screen.............................................................................................

7-2

7.1.4 List

Scree

n......................................................................................................................7-3

7.1.5 Trend

Screen...................................................................................................................

7-4

7.1.6

OxyCRGScreen ..............................................................................................................

7-5

7.1.7 Big F

ontScree

n...............................................................................................................7-6

7.2 Swipe the

Screen........................................................................................................................

7-6

7.3 TailoringYour Screens...............................................................................................................7-7

7.3.1 Changing the WaveformSweep

Speed...........................................................................

7-7

7.3.2 Setting the

DisplayColor ................................................................................................

7-7

7.3.3 Setting the WaveformDisplay

Style...............................................................................

7-7

7.3.4 Waveform Exchange ......................................................................................................7-7

Chapter 8 Alarm.....................................................................................................................................8-1

8.1 Alarm

.................................................................................................................................8-1

8.2 Alarm

Level

................................................................................................................................8-1

8.3 Alarm Mode ...............................................................................................................................8-2

8.3.1 Visual

Alarm...................................................................................................................

8-2

8.3.2 Audio

Alarm

...................................................................................................................8-2

8.3.3 Alarm Message...............................................................................................................8-3

8.3.4 Alarm Parameter

Flashing

..............................................................................................8-3

8.4 Adjusting theAlarm

Volume......................................................................................................

8-3

8.4.1 Adjusting the MinimumAlarm Volume.........................................................................8-3

8.4.2 Adusting theAlarmVolume...........................................................................................8-3

8.4.3 Setting the Reminder

Tone .............................................................................................

8-4

8.5 Alarm

Settings

............................................................................................................................8-4

8.5.1 Setting the Alarm

Level..................................................................................................

8-4

8.5.2 Setting the Alarm

Limit

..................................................................................................8-5

8.5.3 Alarm

Recording............................................................................................................

8-6

8.5.4 Setting the Alarm Delay

Time........................................................................................

8-7

8.6 Pausing

Alarm

s...........................................................................................................................8-7

8.6.1 Setting the MaximumAlarm Pause

Time

.......................................................................8-7

8.6.2 Setting the Alarm Pause Time ........................................................................................8-7

8.7 Switching off

Alarms..................................................................................................................

8-8

8.7.1 Switching off Individual Parameter

Alarm.....................................................................

8-8

8.7.2 Switching off All Parameter

Alarms...............................................................................

8-8

8.8 Latching

Alarms.........................................................................................................................

8-9

8.9 Alarm

Reset

................................................................................................................................8-9

8.10 Alarm Presets .............................................................................................................................8-9

8.11 Check theAlarm

System..........................................................................................................

8-10

Chapter 9 Battery...................................................................................................................................9-1

9.1 General In

troduction...........................................................................................................

........9-1

9.2 Low Battery

Alarm

.....................................................................................................................9-1

9.3 Power

Management

....................................................................................................................9-2

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FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

9.6 Battery

Rec

very

........................................................................................................................9-3

Chapter 10 Review .................................................................................................................................10-1

10.1 Trend GraphReview .................................................................................................................10-1

10.2 Trend Table

Review..................................................................................................................

10-2

10.3 NIBPMeasurement

Review

......................................................................................................10-3

10.4 Alarm Event

Review................................................................................................................

10-4

10.5 Waveform

Review

....................................................................................................................10-5

Chapter 11 Printing................................................................................................................................11-1

11.1 Loading Recording

Paper

.........................................................................................................11-1

11.2

Printing

.....................................................................................................................................11-2

11.2.1 Real-time Printing ........................................................................................................11-2

11.2.2 Frozen printing.............................................................................................................11-2

11.2.3 Stored Patient Case

Printing

.........................................................................................11-3

11.2.4 Printing Settings...........................................................................................................11-3

11.3 Score Criterion .........................................................................................................................11-4

Chapter 12 Cleaningand Disinfection...................................................................................................12-1

12.1

Overview

..................................................................................................................................12-1

12.2 Cleaning and Disinfection of the Monitor and

Accessories .....................................................

12-1

12.2.1 Cleaning and Disinfection of the Cuff..........................................................................12-3

12.2.2 Cleaning the

Belt

..........................................................................................................12-4

Chapter 13 Maintenance........................................................................................................................13-1

13.1 Maintenance

Check..................................................................................................................

13-1

13.2 Maintenance

Schedule..............................................................................................................

13-1

13.3 ECG

calibration

........................................................................................................................13-2

13.4 NIBPAir Leakage

Test

.............................................................................................................13-2

13.5 NIBP

Calibration

......................................................................................................................13-3

13.6 Touch Screen

Calibration .........................................................................................................

13-4

Chapter 14 Fetus Monitoring................................................................................................................14-1

14.1 Difference betweenAntepartum and IntrapartumMonitor......................................................14-1

14.1.1 AntepartumMonitoring

Principles

...............................................................................14-1

14.1.2 Terms about

Monitor

....................................................................................................14-1

14.2 FHR

Monitoring

.......................................................................................................................14-2

14.2.1 Connect the FHR Transducer .......................................................................................14-2

14.2.2 Cross-Channel Verification ..........................................................................................14-3

14.2.3 Trace Se

parati

on...........................................................................................................14-3

14.2.4 FHR Settings................................................................................................................14-4

14.2.4.1 Setting the Source of Maternal Heart Rate ......................................................................... 14-4

14.2.4.2 Setting the FHR Sound Channel......................................................................................... 14-5

14.3 TOCO

Monitori

ng....................................................................................................................14-5

10.2.1 Connect the TOCO Transducer....................................................................................14-6

14.3.1 Setting the TOCO Zero

Value.......................................................................................

14-6

14.4 FM

Counting ............................................................................................................................

14-7

14.4.1 Counting FM manually................................................................................................14-7

14.4.2 Counting FM

automatically..........................................................................................

14-7

14.4.3 Setting the FM Sensitivity

Threshold

...........................................................................14-7

14.4.4 Setting the FM Counting Mode....................................................................................14-8

14.5

Fetus-awakening

Acoustic

Stimulator

......................................................................................14-8

VII

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

Chapter 15 ECG Monitoring.................................................................................................................15-1

15.1

Overview

..................................................................................................................................15-1

15.2 ECG Display............................................................................................................................15-1

15.3 Safety

Information....................................................................................................................

15-2

15.4 Steps of

Monitoring..................................................................................................................

15-3

15.4.1............................................................................................................................................15-3

15.4.1 Preparation ...................................................................................................................15-3

15.4.2 Placement of ECG

Electrodes ......................................................................................

15-3

15.4.2.1 Identifiers and Color Code of Electrodes............................................................................ 15-3

15.4.2.2 Placement of 3-lead ECG Electrodes.................................................................................. 15-4

15.4.2.3 Placement of 5-lead ECG Electrodes.................................................................................. 15-4

15.4.2.4 Placement of Reformed 12-lead ECG Electrodes............................................................... 15-6

15.4.2.5 ECG Lead Connection Recommended for Surgical Patients.............................................. 15-7

15.5 Waveform

quality.....................................................................................................................

15-7

15.6 ECG

Settings

............................................................................................................................15-8

15.6.1 Setting the Lead

Type...................................................................................................

15-8

15.6.2 Setting the Lead Name.................................................................................................15-8

15.6.3 Setting the Ga

............................................................................................................15-9

15.6.4 Setting the Filter Mode.................................................................................................15-9

15.6.5 Setting the Calculation

Channel...................................................................................

15-9

15.6.6 Setting the No

tch

........................................................................................................15-10

15.7 ST Segment Analysis .............................................................................................................15-10

15.7.1 About ST Segment Analysis ......................................................................................15-10

15.7.2 Impact on

ST-segment................................................................................................

15-10

15.7.3 Enabling ST SegmentAnalysis ..................................................................................15-11

15.7.4 Adjusting the ST Segment Analysis Point .................................................................15-11

15.8 Arrhythmia Analysis ..............................................................................................................15-12

15.8.1 EnablingArrhythmia Analysis ...................................................................................15-13

15.8.2 Arrhythmia Alarm Settings........................................................................................15-13

15.8.3 Arrhythmia

Relearning

...............................................................................................15-13

15.8.4 Arrhythmia

Review....................................................................................................

15-13

Chapter 16 RESPMonitoring ...............................................................................................................16-1

16.1

Overview

..................................................................................................................................16-1

16.2 RESP Di

splay

...........................................................................................................................16-1

16.3 Placing Electrodes for RESP Measurement .............................................................................16-1

16.4 RESP

Settings

...........................................................................................................................16-2

16.4.1 Setting the Ga

............................................................................................................16-2

16.4.2 Setting

theApneaAlarmTime

........................................................................................16-3

16.4.3 Setting the RESP Lead .................................................................................................16-3

16.4.4 Setting the RESP

Filter.................................................................................................

16-3

Chapter 17 SpO2 Monitoring.................................................................................................................17-1

17.1

Overview

..................................................................................................................................17-1

17.1.1 Principle of Measuring SpO2........................................................................................17-1

17.1.2 Recognition of the type of SpO2 Sensor......................................................................17-1

17.2 SpO2/PR Display.....................................................................................................................17-2

17.3 Safety

Information....................................................................................................................

17-2

17.4 Steps of

Monitoring..................................................................................................................

17-3

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FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

17.6.1 Setting

theIntelligent

Alarm .........................................................................................17-5

17.6.2 Setting the Pulse Sound................................................................................................17-6

17.6.3 Setting the Signal IQ ....................................................................................................17-7

17.6.4 Setting the Average

Time..............................................................................................

17-7

17.6.5 Setting the Quick SpO2.................................................................................................17-7

17.6.6 Setting the Calculation Sensitivity...............................................................................17-7

17.7 SPO2 Accuracy

Test

.................................................................................................................17-8

17.8 Low Perfusion Accuracy

Test...................................................................................................

17-8

17.9 PR AccuracyTest .....................................................................................................................17-9

17.10 Masimo

Information

.............................................................................................................17-9

Chapter 18 NIBP Monitoring................................................................................................................18-1

18.1

Overview

..................................................................................................................................18-1

18.2 NIBP Display ...........................................................................................................................18-1

18.3 Safety

Information....................................................................................................................

18-2

18.4 NIBP

Measurement ..................................................................................................................

18-2

18.4.1 Measurement

Steps.......................................................................................................

18-2

18.4.2 Operation

Prompt .........................................................................................................

18-4

18.4.3 Measurement

Limitations

.............................................................................................18-5

18.5 NIBP

Settings

...........................................................................................................................18-6

18.5.1 Setting the Measure Mode............................................................................................18-6

18.5.2 Setting the Interval

Time ..............................................................................................

18-6

18.5.3 Setting the Pressure Unit..............................................................................................18-6

18.5.4 Setting the Pre-inflation

Value......................................................................................

18-6

18.6 NIBP

Reset

...............................................................................................................................18-7

Chapter 19 TEMPMonitoring..............................................................................................................19-1

19.1

Overview

..................................................................................................................................19-1

19.2 TEMP

Displa

y..........................................................................................................................19-1

19.3 Safety

Information....................................................................................................................

19-1

19.4 Steps of TEMP Meas

ureme

...................................................................................................19-2

19.5 Setting the TEMP Unit.............................................................................................................19-2

Appendix I Accessories...................................................................................................................I-1

Appendix II Product

Specification................................................................................................

II-1

Appendix III System Alarm

Message...........................................................................................

III-1

Appendix IV Factory Default

Settings

..........................................................................................IV-1

Appendix V

EMC

...........................................................................................................................

V-1

1-1

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

User manual of Specialized Fetal

Materna!Monitor

BLANK

Chapter 1 Safety Guide

1.1 Safety Information

Warning

To warn you of the conditions where serious consequence, disadvantageous matters or danger

may occur. Failure to comply with the warning will result in severe personal injury or death of the

user or the patient.

Caution

To indicate potential danger or unsafe operation. If not avoided, it may lead to mild personal

injury, product malfunction, damages or property loss. It may also give rise to more severe harm.

Attention

It emphasizes primary warnings or provides descriptions or explanations so that this product

can be used in a better way.

Warning

This monitor is used for monitoring the clinical patients, and only the doctors and nurses who are

qualified through training can use this monitor.

Check whether this instrument and its accessories can work normally and safely prior to use.

The alarm volume and alarm limits shall be set for different patients. When a patient is

monitored, the audible alarm system cannot be merely depended on. If the alarm volume is set too

low or is completely turned off, the alarm will not be heard and the patient will be endangered.

The most reliable patient monitoring method shall be keeping the patient under close surveillance.

This instrument can only be connected to a power socket with protective grounding. If the

power socket is not connected to grounding conductor, do not use this socket, but use the battery

for power supply.

Do not open the enclosure of this instrument to avoid the possible electric shock. The

maintenance and upgrading of this instrument must be conducted by the service personnel trained

and authorized by our company.

The disposal of packaging materials shall comply with the local laws and regulations or the

waste disposal rules and regulations of the hospital. Keep the packaging materials out of the

reach of the children.

1-2

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

Do not use this instrument at the place where there are flammable articles such as anesthetic

to prevent explosion or fire from happening.

Please carefully install the power lines and the cables for various accessories to avoid

entanglement or potential strangulation and keep the patient free from electrical interference.

Do not use mobile phone near the monitor, because the mobile phone will generate a very

strong radiation field and disturb the functions of the monitor.

For the patient with pacemaker, cardiotachometer might measure the pacing pulsein case of

cardiac arrest or arrhythmia. Do not completely rely on the alarm of cardiotachometer. The

patient with pacemaker shall be closely monitored.

The operators shall not touch the patients, tables and instruments during defibrillation.Before

reusing thecables, check whether their functionsare normal.

The equipment connected with the monitor shall form an equipotential body (the protective

grounding wire is effectively connected).

When the monitor is used in conjunction with electrosurgery unit, the user (doctor or nurse)

shall ensure the patients’ safety.

The physiological waveforms, physiological parameters and alarm message, etc. displayed by

this monitor shall be for the doctors’ reference only and cannot be directly used as the clinical

treatment basis.

The electromagnetic field will affect the performance of this monitor, so the use of the other

equipments, for example Mobile phone, X-ray or MRI equipment, near this monitor must

meet corresponding EMC requirements, because they will transmit high-strength

electromagnetic radiation.

Conductive parts of electrodes and associated connectors for applied parts, including the

neutral electrode, should not contact any other conductive parts including earth.

This is not a treatment device.

Do not posit the equipment to make it difficult to operate the power plug which uses to isolate

the equipment circuits electrically from the supply mains.

The installation and replacement of fuse should be performed by trained and qualified

serviceman.

The use of this monitor is restricted to one patient at a time.

When the monitor is used with HF surgical equipment, the transducer and the cables must be

avoided conductive connection to the HF equipment to protect against burns to the patient.

After defibrillation, the ECG wave will recover within 5s, others will recover within 10s.

Caution

To avoid damage to this instrument and guarantee patient safety, please use the accessories

designated in this user manual.

Please properly install or move this instrument and prevent the instrument from being

damaged due to fall, collision, strong vibration or other external mechanical forces.

Before the instrument is switched on, please confirm that the power supply used meets the

requirements for power supply voltage and frequency designated in the nameplate label or in

the user manual of this instrument.

When this instrument and its accessories are about to exceed the service life, they must be

disposed of according to local relevant laws and regulations or the rules and regulations of the

hospital.

1-3

FM5000C - FM5000PLUS

Maternal/Fetal Monitor

User Manual

Attention

Please install

maintenance.

the equipment in a place that is

convenient

for observation, operation and

This user manual is based on the maximum configuration, and therefore some contents may

not apply to your monitor.

Please place this user manual near the instrumentfor easy and timely reference.

This instrument cannot be used at home.

The service life of the monitor is 5 years.

The analysis report is for reference only and the doctor should sign to ensure the correctness.

1.2 Symbols

(1) Product Symbols

Caution

Refer to instruction

manual/booklet

Defibrillation-prooftype

applied

part

Defibrillation-prooftype

applied

part

Battery indicator

Dateof manufacture

On/Off key

Serial number

AC power indicator

Equipotential

Freeze key

Network

Alarm reset key

NIBP start key

key

TOCO zero key

Europeancommunity

representative

The monitor is Protectedfrom

vertically falling water drops

Manufacturer

IP67

The transducers are

dust-tight

and protected against

the

effects of

temporary

immersion in

water

Separate collection

for

electric and

electronic

equipment

Conformité

Européenne

Complies with medical

device

directive

93/42/EEC

Warning: Only use the ECG cable provided by Our company. Other types of

ECG

cable may decrease the defibrillation energy delivered to the

patient.

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