F3 Fetal Monitor User Manual Ver 1.4

About this Manual P/N: 01.54.114435-14 Release Date: July 2012 © Copyright EDAN INSTRUMENTS, INC. 2010-2012. All rights reserved.

Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.

Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.

Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death.

I

CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.

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Table of Contents Chapter 1 Safety Guide ................................................................................................................. 1 1.1 Intended Use........................................................................................................................1 1.2 Configuration ......................................................................................................................1 1.3 Instruction for Safe Operation.............................................................................................2 1.4 Ultrasound Safety Guide .....................................................................................................3 1.5 Safety Precautions...............................................................................................................3 1.6 Definitions and Symbols .....................................................................................................7 Chapter 2 Monitor and Accessories............................................................................................ 10 2.1 Opening and Checking Package........................................................................................10 2.2 Overview ...........................................................................................................................10 2.2.1 Keys and Control Knob...........................................................................................12 2.2.2 Indicators.................................................................................................................14 2.3 Accessories........................................................................................................................15 2.3.1 Ultrasound (US) Transducer ...................................................................................15 2.3.2 TOCO Transducer...................................................................................................15 2.3.3 Belt ..........................................................................................................................15 2.3.4 Remote Event Marker .............................................................................................16 2.3.5 DECG Cable............................................................................................................16 2.3.6 Fetal Spiral Electrode..............................................................................................16 2.3.7 IUP Cable ................................................................................................................17 2.3.8 IUP Catheter............................................................................................................17 2.3.9 Fetal Stimulator.......................................................................................................17 2.4 Screen................................................................................................................................18 2.4.1 Main Interface .........................................................................................................18 2.4.2 Setup Interface ........................................................................................................20 Chapter 3 Installation Guide....................................................................................................... 21 3.1 Installing Battery...............................................................................................................21 3.2 Installing Monitor .............................................................................................................22 3.3 Loading Recorder paper....................................................................................................23 3.4 Tearing Off Recorder paper ..............................................................................................25 3.5 Adjusting Screen Angle ....................................................................................................26 3.6 Connecting Transducers....................................................................................................26 3.7 Placing Accessories in the Holder.....................................................................................27 3.8 Connecting Power Cable...................................................................................................28 Chapter 4 Alarms ......................................................................................................................... 29 4.1 Alarms Classification ........................................................................................................29 4.2 Audible Alarm...................................................................................................................29 4.3 Visual Alarm .....................................................................................................................30 4.4 Choosing Alarm Silence Duration ....................................................................................30 4.5 Choosing Alarm Message Form .......................................................................................30 4.6 Changing Alarm Volume ..................................................................................................31 4.7 Choosing Signal Loss Delay .............................................................................................31 4.8 Reviewing Alarms.............................................................................................................31 III

4.9 Alarm Treatment Measures...............................................................................................31 4.10 Testing Alarms ................................................................................................................32 4.11 Patient Alarm Defaults....................................................................................................32 Chapter 5 Printing ....................................................................................................................... 33 5.1 Function Description.........................................................................................................33 5.2 Printing Configuration ......................................................................................................33 5.2.1 Switching Auto Start Printing On or Off ................................................................34 5.2.2 Choosing Paper Speed ............................................................................................34 5.2.3 Changing Print Timer..............................................................................................34 5.2.4 Switching Print Self-Check On or Off ....................................................................35 5.2.5 Switching Paper Advance On or Off ......................................................................35 5.3 Understanding Recorder Paper Printout............................................................................35 Chapter 6 Pre-Monitoring Preparation ..................................................................................... 37 6.1 Confirming Fetal Life .......................................................................................................37 6.2 Switching On.....................................................................................................................37 6.3 Checking Recorder Paper..................................................................................................38 6.4 Setting Date and Time.......................................................................................................38 6.5 Adjusting Volume .............................................................................................................39 Chapter 7 Fetal Monitoring ........................................................................................................ 40 7.1 Monitoring FHR with Ultrasound.....................................................................................40 7.1.1 Parts Required .........................................................................................................40 7.1.2 FHR Monitoring Procedure.....................................................................................40 7.1.3 Switching the FHR Alarm On or Off......................................................................42 7.1.4 Changing FHR Alarm Limits..................................................................................42 7.1.5 Changing FHR Alarm Delay...................................................................................42 7.2 Monitoring FHR with DECG............................................................................................43 7.2.1 Contraindications ....................................................................................................43 7.2.2 Parts Required .........................................................................................................43 7.2.3 Preparing Patient's Skin Prior to Placing Electrodes ..............................................44 7.2.4 Changing DECG Beep Volume ..............................................................................44 7.2.5 Switching the Artifact Suppression On or Off........................................................44 7.2.6 DECG Monitoring Procedure .................................................................................45 7.2.7 Detaching Fetal Spiral Electrode ............................................................................45 7.3 Monitoring Twin FHRs.....................................................................................................46 7.3.1 Monitoring Twins Externally..................................................................................46 7.3.2 Monitoring Internally ..............................................................................................46 7.3.3 Signals Overlap Verification (SOV) .......................................................................46 7.3.4 Changing FHR2 Offset ...........................................................................................47 7.4 Monitoring Uterine Activity Externally............................................................................47 7.4.1 Parts Required .........................................................................................................47 7.4.2 TOCO Monitoring Procedure .................................................................................47 7.4.3 Changing UA Baseline............................................................................................48 7.5 Monitoring Uterine Activity Internally.............................................................................49 7.5.1 Parts Required .........................................................................................................49 7.5.2 IUP Monitoring Procedure......................................................................................49 7.6 Monitoring Fetal Movement .............................................................................................50 7.6.1 Auto Fetal Movement Monitoring (AFM)..............................................................50 IV

7.6.2 Enabling or Disabling AFM Monitoring.................................................................50 7.6.3 Choosing AFM Mode .............................................................................................51 7.6.4 Manual Fetal Movement Monitoring (MFM) .........................................................51 7.6.5 Changing MFM Volume .........................................................................................51 7.7 Starting Monitoring...........................................................................................................51 7.8 Inputting Maternal Information (Mat. Info)......................................................................52 7.8.1 Auto ID....................................................................................................................52 7.8.2 Changing Maternal Information..............................................................................52 7.8.3 Switching Mat. Info Inputting On or Off ................................................................53 Chapter 8 Understanding Measurement Results ...................................................................... 54 8.1 Changing Screen Display Mode........................................................................................54 8.2 Traces ................................................................................................................................56 8.2.1 Changing Time Scale ..............................................................................................57 8.2.2 Searching for a Patient’s Record.............................................................................57 8.2.3 File Management (Optional) ...................................................................................58 8.2.4 CTG Analysis (Optional) ........................................................................................59 8.2.5 Reviewing ...............................................................................................................62 8.3 Numerics ...........................................................................................................................63 8.4 Alarm Messages ................................................................................................................63 Chapter 9 After Monitoring ........................................................................................................ 65 9.1 Saving Data .......................................................................................................................65 9.2 Completing Monitoring.....................................................................................................65 9.3 Switching Off ....................................................................................................................65 Chapter 10 Maintenance and Cleaning...................................................................................... 66 10.1 Maintenance ....................................................................................................................66 10.1.1 Maintaining Inspection..........................................................................................66 10.1.2 Maintenance of Monitor........................................................................................66 10.1.3 Maintenance of Transducers .................................................................................67 10.1.4 Storage of Recorder Paper ....................................................................................67 10.1.5 Maintenance of Recorder ......................................................................................67 10.2 Cleaning ..........................................................................................................................68 10.2.1 Cleaning of Monitor..............................................................................................68 10.2.2 Cleaning of Accessories........................................................................................69 10.3 Disinfecting .....................................................................................................................70 10.4 Sterilizing ........................................................................................................................70 Chapter 11 Warranty and Service .............................................................................................. 71 11.1 Warranty..........................................................................................................................71 11.2 Contact information ........................................................................................................71 Appendix 1 Product Specifications............................................................................................. 72 A1.1 Environmental Specifications ........................................................................................72 A1.2 Physical Specifications...................................................................................................72 A1.3 Performance Specifications............................................................................................73 A1.4 Recorder Specifications..................................................................................................75 A1.5 Lithium-ion Battery Specifications ................................................................................76 A1.6 Low Output Summary Table..........................................................................................76 Appendix 2 Signal Input/Output Connector ............................................................................. 77 V

Appendix 3 Troubleshooting ....................................................................................................... 78 A3.1 No Display......................................................................................................................78 A3.2 Noise...............................................................................................................................78 A3.3 Recorder Error................................................................................................................78 A3.4 Trouble with Ultrasound FHR Monitoring ....................................................................79 A3.5 Troubles with DECG FHR Monitoring..........................................................................79 A3.6 Troubles with Contractions Monitoring (External)........................................................80 A3.7 Troubles with Contractions Monitoring (Internal).........................................................80 A3.8 Blown Fuses ...................................................................................................................80 A3.9 Paper Jam .......................................................................................................................82 Appendix 4 Abbreviation............................................................................................................. 83 Appendix 5 Ordering Information ............................................................................................. 84 Appendix 6 EMC Information – Guidance and Manufacture’s Declaration......................... 85 A6.1 Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS.............................85 A6.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS .............................86 A6.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING ..............................................................................................................88 A6.4 Recommended Separation Distance...............................................................................90 Appendix 7 Limitations of Ultrasonic Monitoring.................................................................... 91 A7.1 How Does Ultrasound Work ..........................................................................................91 A7.2 Artifacts in Fetal Heart Monitoring................................................................................91 A7.3 Audio Output and Screen Reading.................................................................................93

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F3 Fetal Monitor User Manual

Safety Guide

Chapter 1 Safety Guide NOTE: 1 In order to ensure the operator and the patient’s safety, read through this chapter before using the monitor. 2 This user manual is written to cover the maximum configuration. Therefore, your model may not have some of the parameters and functions described, depending on what you have ordered.

1.1 Intended Use F3 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC. Contraindications: F3 Fetal Monitor is not intended for use in intensive care units, operating rooms or for home use.

1.2 Configuration The standard configuration of the monitor includes FHR1 (fetal heart rate 1), FHR2 (fetal heart rate 2), TOCO, MFM and AFM monitoring. Optionally you can add DECG module to them, providing DFHR (direct fetal heart rate) and IUP (Intra-uterine Pressure) monitoring. A fetal stimulator can be provided to give a mild vibrating stimulation to the fetus. Refer to FS-1 Fetal Stimulator User Manual for details. A DB9 interface and an RJ45 interface are built in the monitor. With them, the monitor can be connected to a computer or the MFM-CNS central monitoring system via 485 network or Ethernet. Optionally, you can order a built-in wireless network module to connect the monitor via wireless network. The monitor adopts a 5.6” LCD, on which the collected data, traces, and numerics are displayed. The built-in thermal recorder prints the fetal traces. Rechargeable lithium-ion batteries are provided for options.

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1.3 Instruction for Safe Operation ‹ The monitor is designed to comply with the international safety requirements IEC/EN 60601-1 for medical electrical equipment. It is class I equipment. ‹ The monitor operates within specifications at ambient temperatures between +5ºC (+41ºF) and +40ºC (+104ºF). Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits. Allow at least 5 cm (2 inches) clearance around the instrument for proper air circulation. ‹ You must check that the equipment, cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use. If damage is evident, replacement is recommended. ‹ The monitor must be serviced only by authorized and qualified personnel. The manufacturer does not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. Identical replacement parts must be used. ‹ Perform periodic safety testing to ensure proper patient safety. This should include leakage current measurement and insulation testing. ‹ The protective categories against electric shock of the patient connections are: 1) Ultrasound (FHR1, FHR2)

2) External TOCO

3) Fetal Movement Mark (FM)

4) Fetal Stimulator (FS)

This symbol indicates that the electric shock defend grade of this applied part is Type BF.

IUP This symbol indicates that the electric shock defend grade of this applied part is Type BF.

DECG This symbol indicates that the electric shock defend grade of this applied part t is Type CF. ‹ The monitor described in this user manual is not protected against: a) The effects of defibrillator shocks b) The effects of defibrillator discharge c) The effects of high frequency currents d) The interference of electrosurgery equipment

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1.4 Ultrasound Safety Guide ‹ Fetal Use The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor. Clinical interpretation of fetal heart rate traces can diagnose fetal and/or maternal problems and complications. ‹ Instructions for Use in Minimizing Patient Exposure The acoustic output of the monitor is internally controlled and can not be varied by the operator in the course of the examination. The duration of exposure is, however, fully under the control of the operator. Mastery of the examination techniques described in the User Manual will facilitate obtaining the maximum amount of diagnostic information with the minimum amount of exposure. The exercising of clinical judgment in the monitoring of low risk patients will avoid unnecessary insonation.

1.5 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the instrument. WARNING For using safety: 1

The monitor is provided for the use of qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation.

2

Installation and service should be performed by qualified and authorized service engineers.

3

This device is not intended for home use.

4

EXPLOSION HAZARD - Do not use the device in the presence of flammable anesthetics due to explosion risk.

5

SHOCK HAZARD – In order to protect the patient and the operator, the monitor case should be grounded. When connecting or disconnecting the grounding wire, be careful not to damage the equipotential grounding terminal.

6

The equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding.

7

The power receptacle must be a three-slot grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor. -3-

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Safety Guide

WARNING 8

Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system.

9

If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.

10 Multiple portable socket-outlets shall not be placed on the floor. 11 Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, the patient or operator may receive electrical shock or other injury. 12 Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC 60601-1 approved to the monitor. The operation or use of non-approved equipment or accessories with the monitor is not tested or supported, and monitor operation and safety are not guaranteed. 13 SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. 14 SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlets supplying the system. 15 Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system. 16 Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the system. 17 Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient, in case of possible hazard caused by leakage current superposition. 18 Do not apply this monitor simultaneously with other PATIENT-connected equipment, such as, a cardiac pacemaker or other electrical stimulators, on a same patient. 19 Do not use the monitor with HF surgical equipment. 20 Do not switch on the monitor until all cables have been properly connected and verified. 21 Do not touch the signal input or output connector and the patient simultaneously. 22 Disconnect power cord before changing fuses. Replace the fuses with those of the same specifications only.

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WARNING 23 SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet hands. Make certain that your hands are clean and dry before touching a power cord. 24 SHOCK HAZARD - Do not remove the top panel cover during operation or while power is connected. Only authorized service personnel could remove the unit cover. 25 The monitor is not protected against defibrillation. Do not apply it during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 26 Only connect accessories supplied or recommended by the manufacturer to the device. 27 Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1. Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. For proper monitoring: 28 Clinical decision making based on the output of the device is left to the discretion of the provider. 29 The fetal spiral electrode and intrauterine pressure catheter are disposable. Discard them after use. 30 The disposable accessories are intended to be used only once. Dispose of them properly after use and do not reuse them. 31 The IUPC is neither intended nor approved for measuring intrauterine pressure extraovularly; attempting to do so may lead to maternal discomfort or injury. 32 Alarms must be set up according to different situations of patients. Make sure that audio sounds can be activated when an alarm occurs. For using the battery: 33 Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read the user manual and safety precautions thoroughly. 34 Do not connect the battery cable connector or battery socket with metal objects, which can result in short circuit. 35 Do not unplug the battery when monitoring. 36 Do not heat or throw the battery into a fire. -5-

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WARNING 37 Do not use or leave battery close to fire or other places where the temperature may be above +60 ºC (+140 ºF). 38 Do not immerse, throw, or wet the battery in water/ seawater. 39 Do not destroy the battery: Do not pierce battery with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the battery. 40 Use the battery only in this Monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger. 41 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately. 42 Do not solder the leading wire and the battery terminal directly. 43 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh water immediately. 44 Keep away from fire immediately when leakage or foul odor is detected. 45 If the battery is not used for a long time, charge it at least once every six months to avoid overdischarge. 46 Stop using the battery if abnormal heat, odor, discoloration, deformation or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor. 47 Do not use a battery with serious scar or deformation. CAUTION 1

Federal (U.S.) law restricts this device to sale by or on the order of a physician.

2

Refer servicing to qualified personnel.

3

The system is designed for continuous operation.

4

Keep the environment clean. Avoid vibration. Keep it far from corrosive medicine, dust area, high-temperature and humid environment.

5

When installing the unit into a cabinet, allow for adequate ventilation, accessibility for servicing, and room for adequate visualization and operation.

6

Electromagnetic Interference - Ensure that the environment in which the monitor is installed is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phone base stations, etc.

7

Do not operate the unit if it is damp or wet because of condensation or spills. Avoid using the equipment immediately after moving it from a cold environment to a warm, humid location.

8

Sterility can not be guaranteed if package of the fetal spiral electrode is broken or opened.

9

The fetal spiral electrode has been sterilized by gamma radiation. Do not re-sterilize.

10 Do not sterilize the monitor or any accessory with autoclave or gas. -6-

F3 Fetal Monitor User Manual

Safety Guide

CAUTION 11 Switch off the monitor and unplug it before cleaning. Cleaning consists of removing all dust from the exterior surface of the equipment with a soft brush or cloth. Use a brush to dislodge any dirt on or around the connectors and panel edges. Remove dirt with a soft cloth, slightly dampened with a mild detergent solution or 70% ethanol or isopropranol. 12 When washing the belts, the water temperature must not exceed +60 ºC (+140 ºF). 13 Do not use mobile phones nearby in the process of monitoring. 14 While the battery is charged, used or stored, keep it away from objects or materials with static electric charges. 15 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery. 16 The recommended charge temperature range is from 0 ºC (+32 ºF) to +40 ºC (+104 ºF). Do not exceed this range. 17 Batteries have life cycles. If the time that the monitor uses the battery becomes much shorter than usual, the battery life is at an end. Replace the battery with a new one the same as the one provided or recommended by the manufacturer. 18 When not using battery for an extended period, remove it from the monitor and store it in a place with low humidity and low temperature. 19 Remove a battery whose life cycle has expired from the monitor immediately. 20 For information on installing and removing the battery from the monitor, thoroughly read the user manual. 21 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product.

1.6 Definitions and Symbols

Socket for ultrasound transducer 1 ( Type BF applied part)

Socket for ultrasound transducer 2 ( Type BF applied part)

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Socket for DECG cable ( inapplicable)

Socket for TOCO transducer ( Type BF applied part) or IUP cable (Type BF applied part)

Socket for Remote Event Marker ( Type BF applied part)

Socket for Fetal Stimulator ( Type BF applied part) Type BF applied part Charge Indicator AC (Alternating Current) Indicator Power Indicator ON/OFF switch for the device Start Alarm silence Auto-zero Event marker Print Channel selection Equipotential Grounding System Fuse Caution Consult instructions for use

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Safety Guide

Antenna USB (Universal Serial Bus) Connection Serial interface Network port The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices. Authorized Representative in the European Community The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. Part Number Serial Number Date Of Manufacture Manufacturer

General symbol for recovery/recyclable Federal (U.S.) Law restricts this device to sale by or on the order of a physician

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F3 Fetal Monitor User Manual

Monitor and Accessories

Chapter 2 Monitor and Accessories 2.1 Opening and Checking Package Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. Open the package; take out the monitor and accessories carefully. Keep the package for possible future transportation or storage. Check the components according to the packing list. ‹ Check for any mechanical damage. ‹ Check all the cables and accessories. If there is any problem, contact the manufacturer or your local distributor immediately.

2.2 Overview 1 1 Alarm Indicator 2

2 LCD

3

3 Keys 4 Control Knob

4

5 Paper Drawer

7

6 Accessory Sockets

8

7 Indicators 8 Paper Drawer Latch 5

6 Figure 2-1 Appearance

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Monitor and Accessories

9 Accessory Holder

Figure 2-2 Left Panel

10 Accessory Sockets

Figure 2-3 Front Panel

11 Power Socket 12 Equipotential Grounding Terminal 13 DB9 Socket 14 RJ45Socket 11

12

13 Figure 2-4 Rear Panel

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14

15

15 USB Socket

F3 Fetal Monitor User Manual

Monitor and Accessories

16 Handle

17 Battery Compartment

Figure 2-5 Bottom Panel

2.2.1 Keys and Control Knob

Figure 2-6 Keys and Control Knob

The monitor is a user-friendly device with operation conducted by a few keys on the front panel and the control knob. Their functions are as follows:

(1) POWER switch Function: Switch on or off the monitor.

(2) START key Function: Start monitoring or return to the main interface During monitoring, press this key to start monitoring (the monitor automatically stops printing data of the last monitoring, checks transducer connection, clears the MFM count and the monitoring timer, zeroes the pressure). When inputting maternal information, or when changing the monitor settings, press this key to return to the main interface. - 12 -

F3 Fetal Monitor User Manual

Monitor and Accessories

(3) SILENCE key Function: Switch on off the alarm sound Press this key to switch on or off the alarm sound. (4) AUTO ZERO key Function: TOCO zero Adjust the external TOCO contractions trace/value to preset unit (external monitoring contractions) or the IUP trace/value to reference point 0 (internal monitoring contractions). (5) MARK key Function: Make record of an event. Press this key to make an event mark. (6) PRINT key Function: Start / stop printing Press this key to toggle between starting and stopping printing. (7) CHANNEL key Function: Switch the channels Press this key, the fetal heart sound toggles between US1 channel and US2 channel. (8) CONTROL KNOB Function: Adjust volume, setup and review control. It can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations on the screen or in the menu are completed by using the control knob. The highlighted rectangular mark on the screen that moves with the rotation of the control knob is called “cursor”. Operations can be performed in the position on the screen where the cursor stays. When the cursor is located on a certain item, you can press the control knob to open its submenu or confirm the operation. Press the control knob again, and the cursor will be able to move around on the interface/menus. Operation Procedure: 1) Rotate the control knob to move the cursor to the item you want; 2) Press the control knob and one of the following three results will be achieved: a) A menu pops up on the screen, or the menu is replaced by a new one; - 13 -

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Monitor and Accessories

b) A submenu with several options appears. If this item has more than 6 options, they will be displayed on more than one page. Select Prev to switch to the previous page, or select Next to switch to the next page. c) The function operates immediately. NOTE: 1 The word “select” hereinafter stands for rotating the control knob cursor to an item then pressing the knob. 2 If the key sound is enabled, the monitor gives a normal key sound when the operation is valid, and gives a sharp “Di” sound when the operation is invalid. CAUTION This monitor is a normal medical device. Please avoid violent operations such as continuously pressing the keys or control knob.

2.2.2 Indicators There are four groups of indicator on top of the screen and the front panel. From the top down they are: alarm indicator, CHARGE indicator, AC indicator and Power indicator. Table 2-1 lists their meanings: Indicator Alarm Indicator

Charge Indicator

AC Indicator

Power Indicator

Status of Indicator

Meaning

Flash or light in orange

An alarm is active.

Off

No alarm is active.

On

The battery is being charged.

Off

No battery is loaded or the battery is fully charged.

On

The monitor is connected to AC power supply.

Off

The monitor is not connected to AC power supply.

On

The monitor is powered on.

Off

The monitor is powered off. Table 2-1 Indicator description

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Monitor and Accessories

2.3 Accessories 2.3.1 Ultrasound (US) Transducer 1 US Transducer (Pink Labeled)

2 1

2 Transducer Cable 3 Transducer Connector 3

Figure 2-7 US Transducer

2.3.2 TOCO Transducer

1 TOCOS Transducer (Blue Labeled)

2 1

2 Transducer Cable 3 Transducer Connector 3

Figure 2-8 TOCO Transducer

2.3.3 Belt

Figure 2-9 Belt

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Monitor and Accessories

2.3.4 Remote Event Marker

1 Marker Plug 2 Press Key

2 1

Figure 2-10 Remote Event Marker

2.3.5 DECG Cable

1 DECG Cable Plug 2 DECG Cable Connector

1

2

Figure 2-11 DECG Cable

2.3.6 Fetal Spiral Electrode

Figure 2-12 Fetal Spiral Electrode 1

Reference Electrode

2

Drive Tube

3

Guide Tube

4

Drive Handle

5

Handle Notch

6

Electrode Wire

7

Safety Cap

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Monitor and Accessories

2.3.7 IUP Cable

1 2 4

3 Figure 2-13 IUP Connecting Cable

Figure 2-14 IUP Cable

1

Interface to IUP Cable

2

Connecting plug

3

Interface to IUP Catheter

4

Interface to Connecting Cable

2.3.8 IUP Catheter

1 Interface to IUP Cable 2 Catheter 1 2 Figure 2-15 IUP Catheter

2.3.9 Fetal Stimulator

Figure 2-16 Fetal Stimulator

NOTE: Refer to User Manual of the fetal stimulator for operation instructions. - 17 -

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Monitor and Accessories

2.4 Screen 2.4.1 Main Interface 1

2

3

4 5 6

7

17 16

15

14

13 12

11

10

9

8

Figure 2-17 Main Interface

Item Screen element 1

Description

Alarm messages displaying area

2

Alarm reviewing key

3

Display mode switch

4

Setup key Fetal heart sound volume adjust/indicator:

5

: the current fetal heart sound comes from this channel. : the fetal heart sound of this channel is mute. Fetal heart signal quality indicator:

6 poor 7, 10

/

acceptable

optimum

Trace review keys

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F3 Fetal Monitor User Manual

Monitor and Accessories

8

MFM/AFM count

9

System time

11

Monitoring timer, the number on the right indicates the duration of the current monitoring.

12

Patient searching / File managing key Network connection/device no. indicator:

13

Online

Offline

(1 stands for the device number.)

NOTE: The network connection indicator is not shown if the net version is Insight or Philips. Recorder status/speed indicator: 14 No printing in progress

Printing in progress

(3 stands for the printing speed: 3 cm/min.) Alarm sound status indicator: 15 Alarm sound is disabled infinitely

Alarm sound on

Alarm sound pause and the remaining time

Battery status indicator. 16 Battery not installed 17

Battery installed (the vertical strips indicate the electric charge) Patient ID (identification)

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F3 Fetal Monitor User Manual

Monitor and Accessories

2.4.2 Setup Interface The setup menu is provided to change the monitor configurations and monitoring settings. Press the Setup key

on the main interface to open this menu.

18

19

Figure 2-18 Setup Menu Item

Screen element

18

Setup Items

19

Function Description

In the setup main menu, you have access to all the items other than System. You can select EXIT to exit from this menu. The items in this main menu all have submenu(s). To confirm the setting changes in the submenus, you need to select OK to exit. If you don’t want to store the new settings, select Cancel, or press the START key to return to the main interface. If no operation is performed in 30 seconds, the menu will return to the upper directory. The change will not be stored. Once you select OK to confirm the setting changes, the new settings will be stored in the monitor’s long-term memory. If the monitor is switched on again after being switched off or a power loss, it will restore the new settings. For your reference, when the cursor is located at an item in this menu, the monitor provides a brief function description of this item in a pane with blue frame under the items. For example, the cursor is located at Star Monitoring in the illustration above. Correspondingly, its function Set new monitoring items is issued in the blue frame pane.

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F3 Fetal Monitor User Manual

Installation Guide

Chapter 3 Installation Guide 3.1 Installing Battery WARNING Switch off the monitor and unplug it before installing or removing the battery. If the monitor is provided with a rechargeable lithium-ion battery, follow these steps to install the battery: (1) Battery Installation 1) Fold the LCD flat and then place the monitor upside down on a flat surface covered with cloth or another type of protecting pad. 2) Remove the screws of the battery compartment using a cross-head screw driver. Remove the battery compartment cover.

3) Take the battery out from package and put it into the compartment. Make sure the battery connector is on the left and the battery label faces down. Battery Connector

Anode & Cathode of Battery Output

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F3 Fetal Monitor User Manual

Installation Guide

WARNING Do not touch the anode and cathode of the battery output together with fingers or metal materials, avoiding hazards to you and the battery caused by the shirt-circuit. 4) Arrange the battery flat in the compartment, and push the strip at the end of the battery into the gap.

5) Shut the battery compartment cover and fix it with the screws. (2) Battery Removal Remove the battery in reverse order. You can pull the strip at the end to take the battery out from the compartment. NOTE: 1 If a rechargeable battery is outfitted, charge it fully each time after using the device to ensure the electric power is enough. 2 When the battery configuration is provided, after the device is transported or stored, the battery must be charged. Connecting to power supply will charge the battery no matter if the monitor is powered on.

3.2 Installing Monitor The monitor should be placed on a flat surface. Alternatively, provided with proper devices, it can be installed on a wall or a trolley. Consult the sales representative for more information. CAUTION Installation must be carried out by qualified personnel authorized by the manufacturer.

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F3 Fetal Monitor User Manual

Installation Guide

3.3 Loading Recorder paper CAUTION 1 Only use the recorder paper provided by the manufacturer, otherwise the recorder may be damaged. This kind of damage is not covered by warranty. 2 Configured with different hardware, the monitor is compatible with both GE and Philips recorder paper. However, only one type of paper is configured with the monitor in the shipment. If you want to use the other type of paper, contact the manufacturer for service first, otherwise trace excursion or paper jam may occur. If the monitor is used for the first time or when the paper runs out, you should load paper. 1) Press the drawer latch on the front panel to flick open the paper drawer cover.

2) Check if there is a paper baffle installed in the left of the drawer. If the baffle is installed, you can only use PHILIPS record papers (01.57.75113 or 01.57.75114), otherwise you can use GE record papers (01.57.75111 or 01.57.75112).

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F3 Fetal Monitor User Manual

Installation Guide

3) Take out the Z-fold thermosensitive paper, remove the wrapper and check if it is the correct paper type. 4) Guide the pack into the drawer underneath the retaining rod, abutting it against the right edge. Make sure the blank side of the paper faces you and the FHR trace area is on the left.

5) Unfold a sheet from the top of the pack and pull its end out of the drawer (make sure the pack in the drawer remains flat).

6) Put the paper drawer cover down and press its end until it clicks locked properly.

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F3 Fetal Monitor User Manual

Installation Guide

CAUTION 1 Be careful when inserting paper. Do not touch the thermosensitive print head or the paper sensor by hand, in case they are damaged by static electricity. 2 Make sure the paper pack in the drawer remains flat when the top sheets are pulled out of the drawer. If paper deflection is detected after the drawer cover is closed, reload paper to prevent trace excursion or paper jam. 3 Keep the drawer closed except when loading paper or providing servicing. 4 Be careful not to trap your fingers when closing the paper drawer cover.

3.4 Tearing Off Recorder paper Perform the following procedure to tear off the recorder paper: on the front panel if the recorder is running.

1)

Press the PRINT key

2)

Pull up the end of the paper (fold the paper if it is very long), and use moderate power to tear it off in an upward motion along the paper-cutting edge.

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Installation Guide

CAUTION Always tear off the paper along the paper-cutting edge or the perforation. Pulling the paper fiercely may damage the printhead or cause misalignment of the paper in the drawer. If you wish to tear off the paper at the perforation all the time, please use the F9-P paper and enable the Paper Advance.

3.5 Adjusting Screen Angle You can fold the screen completely flat, or tilt it to an appropriate angle, allowing the monitor to be placed on a flat surface or mounted on a wall. To tilt or to fold the screen, 1) Push the hook on top of the screen right to spring it open. 2) Hold the centre part of the screen on the top edge and push it forward or backward to the required angle.

3.6 Connecting Transducers Check for visible damages of the transducers every time before connecting them to the monitor. Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid. If damage is found, replace them with good ones at once. When plugging transducers into the monitor, make sure the arrow symbols of the connector is facing up.

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F3 Fetal Monitor User Manual

Installation Guide

Connecting the transducer

Disconnecting the transducer

When disconnecting a transducer, pinch the afterbody of the transducer plug and pull it out gently. NOTE: Never try to disconnect the transducer by pulling the cable directly.

3.7 Placing Accessories in the Holder In order to protect the accessories, place the not-in-use accessories in the holder. The accessory holder is on the left of the front panel. The first hole from the top is for the remote event marker, and the rest three are for the transducers. To place a transducer into the holder, hold the transducer on the edge, and then place the buckle all the way into one of the holes on the holder. Make sure that the transducer cable is on the bottom. To place the remote event marker, put the small end of the marker into the hole as far as it can go.

Placing the transducer

Placing the marker

NOTE: In the process of monitoring, the transducer that is placed in the holder may be affected and thereby produces interfering signals. Therefore, when monitoring a patient, it is recommended to remove or disconnect the transducer that is not in use. - 27 -

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Installation Guide

3.8 Connecting Power Cable ‹ Make sure the AC power supply of the monitor complies with the following specification: 100V-240V~, 50Hz/60Hz. ‹ Apply the power cable provided with the monitor. Plug one end of the power cable to the power socket of the monitor. Connect the other end to a three-slot power output special for hospital usage. ‹ The equipotential grounding terminal is provided for the connection of a potential equalization conductor. Therefore, it is recommended to connect the grounding terminal of the monitor and the power outlet with the grounding wire, making sure the monitor is grounded. WARNING If the protective grounding (protective earth) system is doubtful, the power of the monitor must be supplied by inner power only. NOTE: 1

Make sure the monitor and the power outlet are placed at a place where it is easy to connect and disconnect the power cord.

2

When the supply mains is interrupted, the device switches to inner power and operates normally if the battery is installed. If the battery is not installed, the monitor shuts down and resumes the previous settings at the subsequent operation.

3

After the AC power supply is connected, please wait for at least 2 seconds before pressing the POWER switch to turn on the monitor.

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F3 Fetal Monitor User Manual

Alarms

Chapter 4 Alarms 4.1 Alarms Classification The monitor has two types of alarm: patient alarm and technical alarm. Patient alarms indicate the situation of vital sign exceeding its configured limit. The adjustable alarm limits determine the conditions that trigger the alarm. They can be disabled. Technical alarms indicate that the monitor can not measure and therefore can not detect critical patient conditions reliably. They cannot be disabled. The alarms have two levels: medium and low. Medium level alarm is a serious warning, whose symbol is **; low level alarm is a general warning. The medium level alarms have higher priority than the low level alarms. If both types of alarms are active at the same time, the monitor sounds an audible indicator for the medium level alarms. The system sets all alarm levels, and you can not change them.

4.2 Audible Alarm If the audible alarm is not disabled, the alarm indicator displays . When an alarm is active, the monitor gives out a sound. (The sound pressure range is 45dB ~ 85dB.) Medium level alarm: a “Do” tone is repeated three times, and then pauses for 4 seconds. Low level alarm: a “Do” tone is issued, and then pauses for 20 seconds. , the audible alarm toggles between on and off (temporarily or Press the SILENCE key infinitely, you can change the setting). If the audible alarm is temporarily disabled, the alarm indicator displays , with a remaining time on the right. When the time is out, the audible alarm is enabled again automatically. If the audible alarm is infinitely disabled, the alarm indicator displays be enabled again until the SILENCE key

(flashing). It will not

is pressed.

However, the alarm messages will still be displayed and the alarm indicator will still be lighted up when an alarm is active. WARNING Do not disable the audible alarm infinitely for the condition where the patient’s safety may be endangered.

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Alarms

4.3 Visual Alarm When an alarm is active, - Alarm indicator: the alarm indicator lights up. Alarm Category

Indicator Color

Flashing Frequency

Duty Cycle

Medium level alarm

yellow

0.4Hz to 0.8Hz

20% to 60% on

Low level alarm

yellow

Constant (on)

100% on

- Alarm message: the alarm message appears in the alarm message area of the main interface in yellow. - Flashing numeric: the numeric of the measurement flashes in grey with a frequency of 2Hz. When more than one alarm is active, the alarm messages appear in the same area in succession. The patient alarm messages are displayed either: ‹ in text form, for example “** FHR2 LOW”; or ‹ in numeric form, for example “** FHR2 115 < 120”; ** indicates this is a medium level alarm event; the first number is the current measurement result; the second number is the preset alarm limit. The technical alarm messages are displayed in text form, for example “Fetus EQUIP MALF”.

4.4 Choosing Alarm Silence Duration You can choose the alarm silence duration, 1 Select the setup key on the main interface. 2 Select Alarm > Silence Duration. 3 Select Infinite (default), 1 min, 2 min or 3 min. 4 Select OK.

4.5 Choosing Alarm Message Form You can change the patient alarm display form, 1 Select the setup key on the main interface. 2 Select Alarm > Message Form. 3 Select Text (default) or Numeric. 4 Select OK.

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Alarms

4.6 Changing Alarm Volume You can change the alarm volume, 1 Select the setup key on the main interface. 2 Select Alarm > Alarm Volume. 3 Select Low (default), Medium or High. 4 Select OK.

4.7 Choosing Signal Loss Delay When the fetal signal is lost and this condition continues for a certain time, the monitor issues a technical alarm. This time (signal loss delay) is adjustable. To change the signal loss delay, 1 Select the setup key on the main interface. 2 Select Alarm > Signal Loss Delay. 3 Select 0 (default) ~ 300 seconds, in steps of 10s. 4 Select OK.

4.8 Reviewing Alarms An alarm reviewing menu records a list of up to 50 of the most recent patient and technical alarm messages with date and time information.

Select the alarm reviewing key message window to open this menu.

in the

Each page displays 10 alarm records. The page mark “1/5” informs you that there are 5 pages and the present one is page 1. You can select the alarm list and then rotate the control knob to review more alarms. When a new monitoring starts, or after the monitor is switched off, the alarm messages will be cleared.

4.9 Alarm Treatment Measures When the monitor gives out an alarm and catches your attention, you should: - Check the patient’s condition. - Identify the cause of the alarm.

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Alarms

- Silence the alarm if necessary. - Check if the alarm is terminated when the alarm condition is solved.

4.10 Testing Alarms To test the functions of visible and audible alarms, do the following: 1 Switch on the monitor. 2 Enable the alarm. 3 Set the alarm limits to a small range. 4 Stimulate a signal that is higher than the high alarm limit or lower than the low alarm limit. Or disconnect one of the plugs. 5 Verify if the visible and audible alarms are working properly.

4.11 Patient Alarm Defaults Alarm Setting

Options

Default

FHR1/FHR2 Alarm

On, Off

On

FHR1/FHR2 Low alarm limit

60 bpm ~ 205 bpm, in increments of 5

120 bpm

FHR1/FHR2 High alarm limit

65 bpm ~ 210 bpm, in increments of 5

160 bpm

FHR1/FHR2 Alarm Delay

0 ~ 300 second(s), in increments of 5

10 seconds

FHR1/FHR2 Alarm Level

Medium, not adjustable

Medium

NOTE: The high alarm limit must be higher than the low alarm limit. When setting the high alarm limit, you do not have access to the options that are lower than the preset low alarm limit, and vice versa.

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F3 Fetal Monitor User Manual

Printing

Chapter 5 Printing 5.1 Function Description The built-in thermal recorder applied in the monitor supports both the American and international standard wide recorder paper. It prints continuous traces synchronously along with marks. The monitor supports some other functions listed below: ‹ Auto start printing: If the function is enabled, the recorder starts printing automatically when a new monitoring starts (the START key is pressed). Otherwise you have to press the PRINT key to start printing. ‹ Printing timer: The printing timer determines the elapsed time for each print. This time is adjustable. Refer to 5.2.3 Changing the Print Timer. ‹ Fast printing: The recorder prints the data saved in the monitor at a high speed (up to 15mm/s). ‹ Data Caching: When the paper drawer runs out of paper or when it is open, the recorder stops printing. The data from this time on (at most 60 minutes) will be temporarily saved in the internal memory. When new paper is loaded and/or the drawer is closed, the saved data will be printed out at a high speed. After the saved trace has been printed out, the recorder switches back to printing the current data at the normal speed automatically. NOTE: When the monitor is switched off, the data in the internal memory will be lost. ‹ FHR2 offset: You can set the offset of the FHR2 trace to separate the two fetal heart traces on the screen and the recorder paper. Refer to 7.3.4 Changing FHR2/DFHR Offset. ‹ Print self-check: The recorder prints a baseline for self checking when the monitor is switched on. ‹ Paper advance: When printing stops, the paper advances to the next perforation, making it easy to be torn off. Refer to 5.2.5 Switching Paper Advance On or Off.

5.2 Printing Configuration NOTE: All the parameters should be well configured before printing starts. You can not change the configuration in the process of printing.

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Printing

5.2.1 Switching Auto Start Printing On or Off You can switch auto start printing on or off: 1 Select the setup key on the main interface. 2 Select Start Monitoring > PRINT. 3 Select ON or OFF (default). 4 Select OK.

5.2.2 Choosing Paper Speed You can choose a paper speed of 1 cm/min, 2cm/min or 3cm/min: 1 Select the setup key on the main interface. 2 Select Recorder > Print Speed. 3 Select 1 cm/min, 2 cm/min or 3 cm/min (default). 4 Select OK. NOTE: Different paper speed setting causes different FHR trace appearances on the record paper. To avoid misinterpretation, we recommend you to set all monitors in your institution to the same paper speed.

5.2.3 Changing Print Timer You can choose different time lengths for the print timer: 1 Select the setup key

on the main interface.

2 Select Recorder > Timer. 3 Set timer to 10 ~ 90 (minutes, the step is 5) Present ID or Infinite. For a fixed time, the recorder stops when the time is up. For Present ID and Infinite, it prints the traces of the present patient, and stops automatically when another patient’s traces come up. If there is no ID on the current reviewing screen, the recorder with Present ID setting starts printing from the beginning of this ID, and with a fixed timer or Infinite setting, it starts printing from the left border of the screen. Whatever the setting is, the recorder stops when the PRINT key is pressed in midway. 4 Select OK.

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Printing

5.2.4 Switching Print Self-Check On or Off You can switch print self-check on or off: 1 Select the setup key on the main interface. 2 Select Recorder > Print Self-Check. 3 Select ON or OFF (default). 4 Select OK.

5.2.5 Switching Paper Advance On or Off You can switch paper advance on or off: 1 Select the setup key on the main interface. 2 Select Recorder > Paper Advance. 3 Select ON or OFF (default). 4 Select OK. NOTE: This option is available only when the paper type is PHILIPS.

5.3 Understanding Recorder Paper Printout WARNING 1 If there is any difference between the display and the printout, the printout should prevail. 2 If the data is doubtful, clinicians should make diagnoses based on the real condition. Figure 5-1 is an example of the recorder paper with traces. Comparing it with the monitor screen, you can find this extra information on it:

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F3 Fetal Monitor User Manual

Printing

1 2

6 7

3

4 5

8 Figure 5-1 An example of recorder paper with traces

Item

Information

Description

1

Patient Information

The patient’s ID and name.

2

Self-Check Trace

The monitor prints a self-check trace after being switched on. It is used to check if the recorder paper is properly loaded.

3

Paper Style

The FHR pane range 30 bpm ~ 240 bpm indicates the paper style is American Standard. The FHR pane range 50 bpm ~ 210 bpm indicates the paper style is International Standard.

4

Paper Type

There are two types of paper: F9-G and F9-P.

5

Trace Information List

A list of current date, time, print speed and FHR2 offset is printed at the start of the monitoring and every ten minutes afterwards.

6

FHR1 Mark

The trace marked with “FHR1” is the FHR1 trace.

7

FHR2 Mark

The trace marked with “FHR2” is the FHR2 trace.

8

Page Mark

Each recorder paper pack has 150 pages. When you notice the page mark comes to the end, remember to load new paper in time.

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F3 Fetal Monitor User Manual

Pre-Monitoring Preparation

Chapter 6 Pre-Monitoring Preparation 6.1 Confirming Fetal Life Fetal monitoring with ultrasound or DECG can not differentiate a fetal heart rate signal source from a maternal heart rate source in all situations. These are some of the signal sources that might be taken as FHR signal source by mistake: - High maternal heart rate signal. - Maternal aorta or other large vessels signals. - Electrical impulse from the maternal heart transmitted through a recently deceased fetus. - Movement of the deceased fetus during or following maternal movement. So you need to confirm fetal life by other means before starting to use the fetal monitor, such as using a fetoscope, stethoscope, Pinard stethoscope or obstetric ultrasonography.

6.2 Switching On WARNING 1 Check if all the metal parts are linked to the protective earth cord and the cord is in good condition before switching on the monitor. 2 If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient. Contact biomedical engineer in the hospital or our service engineer immediately.

Press the POWER switch on the front panel to switch on the monitor. The power indicator lights up and a start-up music will be heard. You can operate the monitor after the main interface appears. You can choose to switch the start-up music on or off, 1 Select the setup key on the main interface. 2 Select General > Start-up Music. 3 Select ON (default) or OFF. 4 Select OK.

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F3 Fetal Monitor User Manual

Pre-Monitoring Preparation

6.3 Checking Recorder Paper The monitor provides the print self-check function to check if the recorder paper is correctly loaded and set. The recorder prints a baseline after start-up (if Print Self-Check in the menu is ON). Observe the starts and ends of the printed baselines (illustrated with the arrow). The starts and ends should be printed exactly on the edges of the pane if the recorder paper is correctly loaded and set. If they do not comply with the edges, reload paper or ask the service engineer to check the paper settings of the monitor.

If the monitor does not print the baseline, switch on the Print Self-Check and then restart the monitor. NOTE: Make sure the paper is correctly loaded before starting printing.

6.4 Setting Date and Time You can change the date and time of the monitor, 1 Select the setup key on the main interface. 2 Select Date And Time. 3 From left to right, the figures are used to set the year, month, date, hour, minute and second. 4 Select Date Format for the format of the date; there are three options: yyyy-mm-dd (default), mm/dd/yyyy and dd/mm/yyyy. 5 Select OK. CAUTION You should set date and time information in advance. After this information is changed, the monitor starts new monitoring with an auto ID. Therefore, we advise you to restart the monitor after changing date or time information, and do not perform this operation when monitoring is in process.

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F3 Fetal Monitor User Manual

Pre-Monitoring Preparation

6.5 Adjusting Volume The monitor automatically detects which channel the ultrasound transducer is connected to. The corresponding volume adjustment key of this channel displays

, indicating the fetal heart

sound is coming out from this channel; while the other one displays

, for example:

. Press the CHANNEL key

to switch the fetal heart sound to the other channel.

Adjust the default monitoring volume: The fetal heart volume returns to the default level after the START key default level is adjustable. To change this level,

is pressed. This

1 Select the setup key

on the main interface. 2 Select Start Monitoring > Volume. 3 Select the volume from 1 ~ 10 in increments of 1. The default level is 3. 4 Select OK. Adjust the real-time monitoring volume: If the default volume level is not satisfactory during monitoring, you can adjust the real-time volume of each channel. 1 Select the volume adjustment key on the main interface. 2 Rotate the control knob clockwise for one step, the volume increases by one level, there are ten levels for your choice; the volume level indicator increases by one at every two steps; rotate the knob anticlockwise to decrease the volume. 3 Press the knob again to confirm the selection. Adjust the key volume: The volumes of pressing keys, rotating and pressing the control knob are also adjustable. 1 Select the setup key on the main interface. 2 Select General > Key Volume. 3 Select Low (default), High or OFF. 4 Select OK.

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F3 Fetal Monitor User Manual

Fetal Monitoring

Chapter 7 Fetal Monitoring WARNING 1 The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use. 2 The monitor is not protected against defibrillation. Do not apply it during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 3 Always check if the alarm settings are appropriate for your patient before starting monitoring.

7.1 Monitoring FHR with Ultrasound The ultrasound monitoring is a method to obtain FHR on maternal abdominal wall. Place a US transducer (Ultrasound transducer) on maternal abdomen. It transmits low energy ultrasound wave to the fetal heart, and receives the echo signal. WARNING Make sure you have confirmed the fetal life by other means before using this monitor for FHR monitoring.

7.1.1 Parts Required 1)

US transducer

2)

Aquasonic coupling gel

3) Belt

7.1.2 FHR Monitoring Procedure 1) Placing Transducer Belt Place the transducer belts across the bed, ensuring that the belt will be around the abdomen when it is fastened. Lay the patient on the bed. Alternatively, the patient can take a sitting position. Arrange the belt around her abdomen. 2) Determining the Transducer Position - Determine the fetal position using Leopold’s maneuvers. - Search for the location of the fetal heart using a stethoscope or a fetoscope. The best fetal heart signal can be obtained through the fetal back.

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F3 Fetal Monitor User Manual

Fetal Monitoring

Fetal Heart Pregnancy Early Parturition Late Parturition

Figure 7-1 Positioning Ultrasound Transducer (single fetus)

- During parturition, the fetal heart moves downward as the labor progresses. It is recommended to move the transducer along with the fetus. 3) Acquiring Fetal Heart Signal Apply a certain amount of acoustic gel on the transducer and move it slowly around the fetus site. The best fetal heart signal can be obtained through the fetal back. Find at least 2 or 3 sites, and choose the one where the clearest, most sonorous and steady fetal heart sound is heard. 4) Fixing the Transducer Wrap the abdomen with the belt over the transducer. Fix the transducer by pushing its buckle through the overlapping section of the belt. Make sure the belt fits the patient snugly but comfortably. Meanwhile, fetus heart beat sound is heard; the FHR trace and numeric are displayed on the screen. 5) Confirming that the Fetus is the Signal Source Ultrasound Doppler technology is utilized to observe the fetal heart rate externally, there are possibilities that maternal heart rate signal is mistaken for FHR signal. It is highly recommended to confirm that the fetus is the signal source continuously. You can feel the maternal pulse at the same time. If the maternal heart signal is misidentified as the fetal heart signal, Repositioning of the transducer is needed. NOTE: 1 Do not mistake the high maternal heart rate for fetal heart rate. The fetal pulse can be distinguished from the maternal pulse by feeling the mother’s pulse during the examination. 2 The best quality records will only be obtained if the probe is placed in the optimum position. Positions with strong placental sounds or umbilical blood flow sound should be avoided. 3 If the fetus is in the cephalic presentation and the mother is supine, the clearest heart sound will normally be found on the midline below the umbilicus. During monitoring, - 41 -

F3 Fetal Monitor User Manual

Fetal Monitoring

the pregnant woman’s prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension. Sitting up or lateral positions are preferable and may be more comfortable. 4 During long-time monitoring, the gel may dry out as the transducer moves around. Add more gel in time if it is inadequate. 5 It is impossible to examine FHR unless a clear fetal heart signal is detected.

7.1.3 Switching the FHR Alarm On or Off You can choose to switch the FHR alarm on or off. If the fetal heart alarm is switched off, the monitor will no longer give any audible or visual warning for this monitoring item. 1 Select the setup key on the main interface. 2 Select Alarm > FHR > Alarm. 3 Select ON (default) or OFF. 4 Select OK.

If FHR alarm is switched off, an alarm switched-off symbol message area on the main interface. For example:

will appear in the alarm

WARNING Do not switch the alarm off for the condition where the patient’s safety maybe endangered.

7.1.4 Changing FHR Alarm Limits You can change the FHR alarm limits. The alarm limits you set determine the conditions that trigger the alarm. 1 Select the setup key on the main interface. 2 Select Alarm > FHR. 3 Select a value from 60 ~ 205 for low alarm limit. 4 Select a value from 65 ~ 210 for high alarm limit. 5 Select OK.

7.1.5 Changing FHR Alarm Delay You can change the FHR alarm delay. The alarm delay indicates how long the measured result continues exceeding its limit before the alarm is triggered. - 42 -

F3 Fetal Monitor User Manual

Fetal Monitoring

1 Select the setup key on the main interface. 2 Select Alarm > FHR > Alarm Delay. 3 Select a value from 0 ~ 300. 4 Select OK. WARNING The FHR alarm delay is adjustable between 0 and 300 seconds. In order to notify the physicians of the condition where attention should be paid, set the alarm delay properly for each patient.

7.2 Monitoring FHR with DECG 7.2.1 Contraindications The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and sufficient cervical dilatation is ensured. The fetal electrode tip is designed to penetrate the epidermis of the fetus; therefore, trauma, hemorrhage and/or infection can occur. The electrode should be used with strict adherence to aseptic technique. The fetal spiral electrode should not be applied to the fetal face, fontanels or genitalia. Do not apply the fetal spiral electrode when placenta previa is present; when the mother has visible genital herpes lesions or reports symptoms of prodromal lesions; when the mother is HIV sero-positive; when mother is a confirmed carrier of hemophilia and the fetus is affected or of unknown status; or when it is not possible to identify fetal presenting part where application is being considered. This method is not recommended when fetus is extremely premature, or in the presence of a maternal infection such as Hepatitis B, Group B hemolytic strep, syphilis or gonorrhea, unless a clear benefit to the fetus or mother can be established.

7.2.2 Parts Required 1) DECG cable

2) Fetal spiral electrode

3) Disposable maternal attachment pad electrode

The following illustration shows how these parts should be connected: (3) (2)

(1)

Figure 7-2 Connection for DECG Monitoring - 43 -

F3 Fetal Monitor User Manual

Fetal Monitoring

7.2.3 Preparing Patient's Skin Prior to Placing Electrodes The skin is a poor conductor of electricity; therefore preparation of the patient's skin is important to facilitate good electrode contact to skin. 1) Shave hair from electrode sites, if necessary. 2) Wash the sites thoroughly with soap and water. (Do not use ether or pure alcohol, which will increase skin impedance) 3) Rub the skin briskly to increase capillary blood flow in the tissues. 4) Remove skin scurf and grease.

7.2.4 Changing DECG Beep Volume When the DECG beep is enabled, the monitor gives a beep sound of DECG. To change the DECG beep volume, 1 Select the setup key

on the main interface.

2 Select Fetus > DECG Beep. 3 Select 0 (default) ~ 9. 4 Select OK. NOTE: 1 The DECG beep and HR beep share the same audio channel. Once the DECG beep is switched on, the HR beep is disabled (set to level 0) automatically. 2 Once the DECG/HR beep volume is changed, the sound switches to channel 1 automatically. Therefore, it is advised against changing DECG/HR beep volume in the monitoring process.

7.2.5 Switching the Artifact Suppression On or Off When monitoring FHR with DECG, artifacts may occur due to bad connection of the spiral electrode, excessive motion of the mother, electromyographic interference etc.. The Artifact Suppression feature is designed to eliminate the interference. When artifact suppression is on, artifacts are suppressed and not recorded. When it is off, the artifacts are shown as well as the fetal heartbeats. You can choose to switch the artifact suppression on or off. 1 Select the setup key

on the main interface.

2 Select Fetus > Artifact Suppression. 3 Select ON (default) or OFF. 4 Select OK.

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