Cooper Surgical F9 User Manual
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Cooper Surgical F9 User Manual

Fetal & maternal monitor
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  • Page 3 Statement The manufacturer makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. CooperSurgical, Inc. (hereinafter called CooperSurgical) and the manufacturer assumes no responsibility for any error that may appear in this document, or for incidental or consequential damage in connection with the furnishing, performance or use of this material.

  • Page 4: Table Of Contents

    3.1.1 Buttons ........................14 3.1.2 Indicators........................16 3.1.3 Left Side Panel of the Monitor..................17 3.1.4 Right Side Panel of the F9 Monitor ................17 3.1.5 Rear Panel of the Monitor................... 17 3.1.6 Bottom Panel....................... 18 3.2 Transducers and Cables ......................18 3.2.1 Ultrasound (US) Transducer ..................
  • Page 5 5.3 Understanding the Recorder Paper Printout................32 Chapter 6 Pre-Monitoring Preparation..................35 6.1 Switching On the Monitor..................... 35 6.2 Checking the Recorder Paper....................35 6.3 Adjusting the Screen Angle ....................36 6.4 Setting Date and Time......................37 6.5 Connecting the Transducers....................37 6.6 Adjusting the Volume ......................
  • Page 6 7.10.1 Fetal Monitoring Traces.................... 52 7.10.2 Changing the Time Scale ..................53 7.10.3 Changing the Trace Advancing Mode ..............53 7.10.4 Searching for a Patient ....................54 7.10.5 Reviewing ......................... 54 7.10.6 Making a Note......................55 7.10.7 Fetal Monitoring Values ................... 57 7.10.8 Changing Fetal Numeric Window Position ..............

  • Page 7: Chapter 1 Safety Guidance

    F9 Fetal & Maternal Monitor • User Manual Chapter 1 Safety Guidance NOTE: This User Manual is written to cover features of both the F9 and F9 Express Monitors. Therefore, your model may or may not have some of the parameters and functions described, depending on what you have ordered.

  • Page 8: Ultrasound Safety Guide

    Instructions for Use in Minimizing Patient Exposure The acoustic output of the F9 Monitor is internally controlled and can not be varied by the operator in the course of the examination. The duration of exposure is, however, fully under the control of the operator.

  • Page 9: Safety Precautions

    WARNING Usage Safety Precautions: • The F9 Monitor is provided for use by qualified physicians or professionally trained personnel. They should be familiar with the contents of this User Manual before operation.
  • Page 10 F9 Fetal & Maternal Monitor • User Manual is connected. Only authorized service personnel should remove the unit cover. • The Monitor is not protected against defibrillation. Do not apply it during electro-surgery or MRI; as it might result in harm to the patient or the operator.
  • Page 11 Do not hit with a hammer, step on, throw or drop to cause a strong shock; Do not disassemble or modify the battery. • Use the battery only in the F9 Monitor. Do not connect battery directly to an electrical outlet or cigarette lighter charger.
  • Page 12 • When washing the belts, the water temperature must not exceed 60 ºC (140 ºF). • Electromagnetic Interference - Ensure that the environment in which the F9 Monitor is installed is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phone base stations, etc.

  • Page 13: Chapter 2 Installation

    Battery Installation 1. Carefully place the F9 Monitor upside down on a flat surface covered with cloth or other type of protecting pad. 2. Remove the screws of the battery compartment using a Phillips-head screw driver. Remove the battery compartment cover.
  • Page 14 5. Put the battery and the cables into the battery compartment. 6. Shut the battery compartment cover and secure the screws. Battery Removal Fold the LCD display completely flat before turning the F9 Monitor upside down. Remove the battery in reverse order. - 8 -...

  • Page 15: Loading The Recorder Paper

    Connecting the F9 Monitor to a power supply will charge the battery even if the Monitor is not turned on. 3) Turn off the F9 Monitor and unplug the power cord before installing or removing the battery.
  • Page 16 F9 Fetal & Maternal Monitor • User Manual 4. Unfold two sheets from the top of the pack and pull the end of the paper out of the drawer (make sure the pack in the drawer remains flat). 5. Slide the drawer in until both the latches are locked.

  • Page 17: Connecting The Power Cable

    • Make sure the AC power supply of the Monitor complies with the following specifications: 100 V - 240 VAC, 50/60 Hz. • Connect the power cable provided with the F9 Monitor to the Monitor’s power socket (see Figure 3-5 in Chapter 3). Connect the other end to a hospital grade grounded 3-wire AC outlet.
  • Page 18 F9 Fetal & Maternal Monitor • User Manual DB9 Interface RJ45 Interface Equipotential Grounding System Charge Indicator Alternating Current (a.c.) Stand-by Attention, See instructions for use Type B Applied Part Symbol Type BF Applied Part Symbol Type CF Applied Part Symbol...

  • Page 19: Ordering Information

    The following table describes the accessories that are supplied by or approved by CooperSurgical to be used with the F9 Monitor. The accessories used, such as the rechargeable battery (P/N: HYLB, manufactured by HENGYU) have passed the CE authentication, and have the characteristics specified by their manufacturers.

  • Page 20: Chapter 3 Monitor And Accessories

    3.1 Major Parts 3.1.1 Buttons Figure 3-2: Buttons and Control Knob The F9 Monitor is a user-friendly device that is controlled by a few buttons on the front panel and the Control Knob. Their functions are as follows: START Function: Start monitoring, return to main interface Press this button to start monitoring (on main interface) or return to main interface (in maternal information inputting menu or setup menus).
  • Page 21 F9 Fetal & Maternal Monitor • User Manual SILENCE Function: Disable/Enable audio alarm Press this button once to switch the alarm sound off, but the alarm information displays and indicator flashes as normal; press this button again to switch the sound on again.

  • Page 22: Indicators

    Note: The word “select” hereinafter stands for rotating the control knob cursor to an item and then pressing the knob. CAUTION : This F9 Monitor is a “normal” medical device. Please avoid violent operations such as continuously pressing the buttons or control knob. 3.1.2 Indicators There are four groups of indicators on top of the screen and the front panel.

  • Page 23: Left Side Panel Of The Monitor

    F9 Fetal & Maternal Monitor • User Manual 3.1.3 Left Side Panel of the Monitor Transducer Frame Sockets for Transducers and Cables Figure 3-3: Sockets on the left side of the Monitor NOTE: Sockets for MECG, NIBP, TEMP and SpO2 are only used when these optional features are enabled.

  • Page 24: Bottom Panel

    This multi-crystal, broad beam US transducer is used for monitoring fetal heart rate (FHR). The US transducer operates at a frequency of 1.0 MHz. The FHR transducer on the maternal abdomen transmits a low energy ultrasound wave to the fetal heart and receives the echo signal. The F9 Monitor then calculates the fetal heart rate.

  • Page 25: Toco Transducer

    F9 Fetal & Maternal Monitor • User Manual US transducer 1 has two pink labels; US transducer 2 has two yellow labels. This information is shown on the labels: U:xxxxx: number of this US transducer. MODEL: MS3-109301: Model of this US transducer.

  • Page 26: Remote Event Marker

    F9 Fetal & Maternal Monitor • User Manual There are two blue labels on the TOCO transducer. They include the following information: T:xxxxx: number of this TOCO transducer. MODEL: MS3-31527: Model of this TOCO transducer. PN: MS3-31527: Part number of this TOCO transducer.

  • Page 27: Screen

    NST. During NST, the vibrating operation marks can be displayed /printed on CTG trace when the fetal stimulator is connected to the F9 Monitor by an audio cable. Figure 3-10: Operating control of fetal stimulator 3.3 Screen...
  • Page 28 F9 Fetal & Maternal Monitor • User Manual The main interface of the F9 Monitor displays traces, numeric information menus and monitor status information. The screen background color has four color options: black, green (default), orange and blue. To change the screen color: 1) Select the Setup key on the main interface.
  • Page 29 F9 Fetal & Maternal Monitor • User Manual Numeric Window The fetal monitoring values and maternal vital signs are displayed here. Status Window d) Power indicator - AC power supplied. - no AC power supplied. e) Battery indicator - the battery is loaded; the green pane indicates the charge of the battery.

  • Page 30: Setup Interface

    Once you select OK to confirm the setting changes, the new settings will be stored in the monitor’s long-term memory. If the F9 Monitor is switched on again after being switched off or a power loss, it will restore the new settings.

  • Page 31: Touch Screen

    F9 Fetal & Maternal Monitor • User Manual 3.3.3 Touch screen The touch screen is easy to use and operate. It works as a smart Control Knob. All the operations of the Control Knob can be done by gently touching the corresponding position on the screen.

  • Page 32: Chapter 4 Alarms

    The adjustable alarm limits determine the conditions that trigger the alarm. Technical alarms indicate that the F9 Monitor can not measure and therefore can not reliably detect critical patient conditions. When a patient alarm is switched off, its related technical alarms will be disabled as well.

  • Page 33: Visual Alarm

    F9 Fetal & Maternal Monitor • User Manual 4.3 Visual Alarm When an alarm is active, the following 3 visuals occur: - Alarm indicator: the alarm indicator flashes in orange with a frequency of 0.5 Hz if it is a medium level alarm;...

  • Page 34: Reviewing Alarms

    When a new monitoring starts, or after the monitor is switched off, the alarm messages will be cleared. 4.7 Alarm Treatment Measures When the F9 Monitor gives out an alarm, you should: - Check the patient’s condition. - Identify the cause of the alarm.

  • Page 35: Patient Alarm Defaults

    F9 Fetal & Maternal Monitor • User Manual 4.9 Patient Alarm Defaults Alarm Setting Options Default FHR1/FHR2 Alarm On, Off FHR1/FHR2 Lower Limit 50 ~ 205 bpm, adjustable in 5 bpm steps 120 bpm FHR1/FHR2 Upper Limit 55 ~ 210 bpm, adjustable in 5 bpm steps...

  • Page 36: Chapter 5 Printing

    • Remaining time indicating: A print remaining time appears next to the recorder status indicator in the status window, unless the timer is set to Infinite or Present ID. • Fast printing: The recorder prints the data saved in the F9 Monitor at a high speed (up to 25 mm/s).

  • Page 37: Switching Auto Start Printing On Or Off

    F9 Fetal & Maternal Monitor • User Manual 5.2.1 Switching Auto Start Printing On or Off 1) Select the Setup key on the main interface. 2) Select Start Monitor Printing. 3) Select ON (default) or OFF. 4) Select OK. 5.2.2 Choosing the Paper Speed 1) Select the Setup key on the main interface.

  • Page 38: Understanding The Recorder Paper Printout

    FHR pane range 50 ~ 210 bpm indicates the paper style is International Standard. Self-Check Trace – The F9 Monitor prints a self-check trace after being switched on. It is used to check if the recorder paper is properly loaded.
  • Page 39 Figure 5-1: An Example of Recorder Paper with Traces Item Information Description Paper Type There are two types of paper: F9-G and F9-P. Patient The patient’s ID and name. Information The FHR pane range indicates the paper style. Paper Style...
  • Page 40 The paper settings of the monitor. It consists of the paper type and Paper Settings paper style, e.g. “G 50-210”, indicating that the paper type is “F9-G”, and the paper style is International. A list of current date, time, print speed, ID, FHR2 offset, HR, SpO...

  • Page 41: Chapter 6 Pre-Monitoring Preparation

    Press the power switch located on the right panel to turn on the Monitor. The power indicator lights up and start-up music will be heard. You can operate the F9 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.

  • Page 42: Adjusting The Screen Angle

    If the F9 Monitor does not print the baseline, switch on the Print Self-Check and then restart the Monitor.

  • Page 43: Setting Date And Time

    5) Select OK. NOTE: The date and time remain in the F9 Monitor after it is switched off for at least two months. You do not have to reset the date and time before each usage. 6.5 Connecting the Transducers Check for visible damage to the transducers each time before connecting them to the monitor.

  • Page 44: Adjusting The Volume

    Figure 6-2: Connecting the transducer Figure 6-3: Disconnecting the transducer 6.6 Adjusting the Volume The F9 Monitor automatically detects which channel the ultrasound transducer is connected to. The corresponding volume adjustment key of this channel displays , indicating the FH sound is coming out from this channel, for example: ;...
  • Page 45 F9 Fetal & Maternal Monitor • User Manual symbol to decrease the volume. 3) Press the Control Knob again or touch any other place on the screen to confirm the volume level. Adjust the F9 Monitor Event Sound volume: The volume of the sound emitted when pressing keys, and rotating/pressing the control knob is also adjustable.

  • Page 46: Chapter 7 Fetal Monitoring

    F9 Fetal & Maternal Monitor • User Manual Chapter 7 Fetal Monitoring WARNING • The F9 Monitor is not intended for use in intensive care units (ICU), operating rooms or for home use. • The F9 Monitor is not protected against defibrillation. Do not apply it during electro-surgery or MRI;...

  • Page 47: Fhr Monitoring Procedure

    F9 Fetal & Maternal Monitor • User Manual 7.2.2 FHR Monitoring Procedure 1) Place the transducer belts across the bed. Lay the patient on the bed and draw the belts over her abdomen. 2) To acquire the FH signal, search for the location of the fetal heart using a stethoscope or a fetoscope.

  • Page 48: Switching The Fhr Alarm On Or Off

    7.2.3 Switching the FHR Alarm On or Off Always check if the alarm settings are appropriate for your patient before starting to monitor. If the fetal heart alarm is switched off, the F9 Monitor will no longer give any audible or visual warning for this monitoring item.

  • Page 49: Monitoring Fhr With Decg (Optional)

    F9 Fetal & Maternal Monitor • User Manual 7.3 Monitoring FHR with DECG (Optional) 7.3.1 Contraindications The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and sufficient cervical dilatation is ensured. The fetal electrode tip is designed to penetrate the epidermis of the fetus;...

  • Page 50: Decg Monitoring Procedure

    F9 Fetal & Maternal Monitor • User Manual 7.3.5 DECG Monitoring Procedure Please refer to the manufactures directions for the Fetal Spiral Electrode. WARNING : Do not plug the fetal spiral electrode wire in to the power socket. CAUTION : Do not mistake the higher maternal heart rate for DECG.

  • Page 51: Signals Overlap Verification (Sov)

    7.4.3 Signals Overlap Verification (SOV) When monitoring twins, there are possibilities that one twin’s FHR signal is mistaken for the other one’s signal. The F9 Monitor provides a signal overlap verification (SOV) function to reduce these possibilities. In the process of monitoring, if the SOV detects signals overlapping, an alarm message “Signals Overlap (FHR1, FHR2/DFHR)”...

  • Page 52: Changing The Ua Baseline

    F9 Fetal & Maternal Monitor • User Manual 2) Set the TOCO baseline. Place the transducer on the patient’s fundus to get an optimum recording of uterine activity. Refer to Figure 7-1 for the TOCO transducer position. Wrap the abdomen with the belt over the transducer. Fix the transducer by pushing its buckle through the overlapping section of the belt.

  • Page 53: Iup Monitoring Procedure

    (See Figure 7-2). The green light on the cable will flash for five seconds. Figure 7-2: Rezeroing the system 3) During that time, adjust the F9 Monitor to zero by pressing the AUTO ZERO button. WARNING • Before insertion, the placental position should be confirmed, amniotic membranes are adequately ruptured and sufficient cervical dilatation is assured.

  • Page 54: Checking Intrauterine Pressure Cable Function

    5) Momentarily pressing the re-zero button on the IUP cable. The green light on the cable will flash for five seconds. During that time, zero the F9 Monitor by pressing the AUTO ZERO button. Make sure the display value and the trace are both “0”.

  • Page 55: Enabling Or Disabling Afm Trace

    7.8 Start Monitoring After pressing the START button, the F9 Monitor automatically zeroes the pressure, clears the MFM count and starts monitoring. If the Auto start printing function is disabled, press the PRINT button to start printing.

  • Page 56: Inputting Maternal Information (Mat. Info)

    ID takes the place of the old one for this patient. CAUTION Pressing the START key separates two patients. The F9 Monitor only displays the most recent ID for the same patient. If printing starts automatically with the monitoring, the first ID printed on the recorder paper will be the auto-ID.

  • Page 57: Switching Mat. Info Entering On Or Off

    F9 Fetal & Maternal Monitor • User Manual For the non-English system, more letters are provided for inputting the name. Select the key on the bottom left corner to toggle between them. 7.9.3 Switching Mat. Info Entering On or Off If the Mat.

  • Page 58: Fetal Monitoring Traces

    F9 Fetal & Maternal Monitor • User Manual 7.10.1 Fetal Monitoring Traces WARNING : Due to the LCD size, resolution and system settings, the traces displayed on the screen may look different from the recorder printout. Take the printout as criterion when making diagnoses.

  • Page 59: Changing The Time Scale

    7.10.3 Changing the Trace Advancing Mode Trace advances as time passes by when the F9 Monitor receives valid data. If no valid data is received, the screen will either advance with Auto or Valid. Auto means the screen keeps advancing as time passes by;...

  • Page 60: Searching For A Patient

    F9 Fetal & Maternal Monitor • User Manual 7.10.4 Searching for a Patient The searching key under the traces is used to search for a patient’s data saved in the monitor. To search for a patient, 1 Select the searching key to open the patient list. It contains six sets of most recent patient’s ID and name.

  • Page 61: Making A Note

    F9 Fetal & Maternal Monitor • User Manual progress symbol “<” on top of the traces indicates the retreating speed. Rotate the control knob counter-clockwise or touch the symbol to increase the speed until it reaches the maximum. Rotate the knob clockwise or touch the symbol to decrease the speed until it reaches the minimum.
  • Page 62 F9 Fetal & Maternal Monitor • User Manual reasons and others. - Enabling/disabling Smart Notes To enable or disable Smart Notes, 1) Select the setup key on the main interface. 2) Select General Setup > Smart Notes. 3) Select ON or OFF (default).

  • Page 63: Fetal Monitoring Values

    3: MFM count 7.10.8 Changing Fetal Numeric Window Position For the F9 Monitor, the fetal numeric value window can be located either on the right of the traces or on top of them. To change its position, 1) Select the Setup key on the main interface.

  • Page 64: Fetal Monitoring Alarm Messages

    F9 Fetal & Maternal Monitor • User Manual 7.10.9 Fetal Monitoring Alarm Messages This table lists the alarm information that might appear during fetal monitoring, their respective causes and countermeasures. Alarm Message Cause Countermeasure Patient Alarm (Medium Level) **FHR1 HIGH or FHR1 or FHR2 measuring result ** FHR1 xxx >...
  • Page 65 F9 Fetal & Maternal Monitor • User Manual Alarm Message Cause Countermeasure US transducer 1 and US Signals Overlap Adjust one of the US transducers transducer 2 are positioned at (FHR1, FHR2) until another fetal heart signal is the same fetal heart; the signals detected.

  • Page 66: Chapter 8 After Monitoring

    The F9 Monitor automatically saves the data every 2 hours and prior to shutdown. The maximum capacity is 24-hour data. When the F9 Monitor is turned on again, the saved data will be loaded. You can review them or print them at a high speed.

  • Page 67: Chapter 9 Maintenance And Cleaning

    Prior to using the Monitor, perform the following inspections: • Check the F9 Monitor and accessories to see if there is any visible evidence of damage that may affect patient safety. Pay special attention to the seams on the transducers and cables before immersing them into conductive fluid.

  • Page 68: Maintenance Of The Transducers

    F9 Fetal & Maternal Monitor • User Manual The appearance of moisture on the screen may occur with abrupt temperature or humidity changes. A stable environment is recommended. Scratching and damaging the screen should be avoided. Operate the touch screen with the special stylus pen or finger. Sharp edged or hard items like ball point pens are not recommended.

  • Page 69: Cleaning

    F9 Fetal & Maternal Monitor • User Manual 9.2 Cleaning In order to avoid contamination, clean and disinfect the F9 Monitor and accessories after each use. 9.2.1 Cleaning of the Monitor Regular cleaning of the F9 Monitor casing and the screen is strongly recommended.

  • Page 70: Cleaning Of The Accessories

    F9 Fetal & Maternal Monitor • User Manual 9.2.2 Cleaning of the Accessories Cleaning of Transducers and ECG Leads To clean the US transducer, TOCO transducer, IUP Probe and DECG Lead, follow these steps: 1) Wipe them with a soft cloth dampened in cleaning solution;...

  • Page 71: Sterilizing

    NOTE: CooperSurgical has no responsibility for the effectiveness of controlling infectious disease using these chemical agents. Please contact infectious disease experts in your hospital for details. 9.4 Sterilizing Do not sterilize the F9 Monitor or the accessories, unless this is necessary according to your hospital regulation. - 65 -...

  • Page 72: Chapter 10 Warranty And Service Policy

    F9 Fetal & Maternal Monitor • User Manual Chapter 10 Warranty and Service Policy 10.1 Warranty CooperSurgical’s obligation under this warranty is limited to repairing, at CooperSurgical’s option, any part, which upon CooperSurgical's examination proves defective. If the product doesn’t function as warranted during the 1 year warranty period, we will repair or replace it without charge.

  • Page 73: Appendix 1 Product Specifications

    F9 Fetal & Maternal Monitor • User Manual Appendix 1 Product Specifications A1.1 Monitor Dimensions: 347 mm x 330 mm x 126 mm (13.7“ x 13“ x 5“) Physical Weight: about 6 kg (13 lbs) Characteristics Safety Complies with: IEC 60601-1:1988+A1+A2, EN 60601-1:1990+A1+A2, IEC/EN 61157,...
  • Page 74 F9 Fetal & Maternal Monitor • User Manual Environment Working (con’t) Temperature: 0 ºC ~ 40 ºC ( 32 ºF ~ 104 ºF) Relative Humidity: < 95% @ 40 ºC Altitude: -500m ~ 3000m Transducers Transport and Storage Temperature: -40 ºC ~ 60 ºC (-40ºF ~ 140 ºF) Relative Humidity: <...
  • Page 75 F9 Fetal & Maternal Monitor • User Manual Recorder Accuracy of data: ± 5% (X axis) Accuracy of data: ± 1% (Y axis) (con’t) Resolution: 8 dots/mm Record Information: FHR1 trace/mark, FHR2/DECG trace/mark, TOCO/IUP trace, AFM trace, fetal movement mark, doctor event mark (and annotation), AUTO-zero symbol, date, time, printing speed, ID, name, FHR2 Offset etc.
  • Page 76 F9 Fetal & Maternal Monitor • User Manual Technique: Peak-peak detection technique DECG DFHR Measurement Range: 30 bpm ~ 240 bpm (Direct Electro- cardiography) Resolution: 1 bpm Accuracy: ±1 bpm Input Impedance: > 10 M (Differential, DC50/60Hz) Input Impedance: > 20 M (Common Mode) CMRR: >...

  • Page 77: A1.2 Transducers And Cables

    F9 Fetal & Maternal Monitor • User Manual A1.2 Transducers and Cables Weight: 190 g (6.7 oz) Ultrasound Cable Length: 2.5 m (8 ft) Transducer Dimension: 88 mm×35 mm (3.5” x 1.4”) Weight: 180 g (6.35 oz) TOCO Cable Length: 2.5 m (8 ft)

  • Page 78: Appendix 2 Signal Input/Output Connector

    F9 Fetal & Maternal Monitor • User Manual Appendix 2 Signal Input/Output Connector Accessory equipment connected to these 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.

  • Page 79: Appendix 3 Troubleshooting

    F9 Fetal & Maternal Monitor • User Manual Appendix 3 Troubleshooting A3.1 No Display Error Condition Possible Cause Corrective Action Power cable is loose Tighten the power cable Power indicator is off The fuse is blown Change the fuse The battery has run out of power Connect to AC power supply A3.2 Noise...

  • Page 80: A3.4 Trouble With Ultrasound Fhr Monitoring

    F9 Fetal & Maternal Monitor • User Manual A3.4 Trouble with Ultrasound FHR Monitoring Error Condition Possible Cause Corrective Action Monitor FHR with DECG, if The pregnant woman is too obese applicable Adjust the position of the Improper ultrasound transducer...

  • Page 81: A3.5 Trouble With Decg Fhr Monitoring

    F9 Fetal & Maternal Monitor • User Manual A3.5 Trouble with DECG FHR Monitoring Error Condition Possible Cause Corrective Action No ECG signal Use a new spiral electrode Inconsistent trend Inconsistent display Bad contact of reference Use a new spiral electrode...

  • Page 82: A3.7 Trouble With Contractions Monitoring (Internal)

    To replace a fuse: 1) Fold the LCD display completely flat. 2) Carefully place the F9 Monitor upside down on a flat surface covered with cloth or other protecting pad. 3) With a flat-head screw driver, push the fuse in for about 1 mm then unscrew it counter-clockwise.

  • Page 83: Appendix 4 Emc Information - Guidance And Manufacture's Declaration

    Guidance and manufacture’s declaration – electromagnetic emission The F9 Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the F9 Monitor should assure that it is used in such and environment. Emission test Compliance Electromagnetic environment –...

  • Page 84: A4.2 Electromagnetic Immunity - For All Equipment And Systems

    Guidance and manufacture’s declaration – electromagnetic immunity The F9 Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F9 Monitor should assure that it is used in such an environment. IEC 60601 test...
  • Page 85 F9 Fetal & Maternal Monitor • User Manual IEC 60601 test Electromagnetic environment Immunity test Compliance level level - guidance < 5% U < 5% U (> 95% dip in U (> 95% dip in U for 0.5 cycle for 0.5 cycle...

  • Page 86: A4.3 Electromagnetic Immunity - For Equipment And System That Are Not Life-Supporting

    Guidance and manufacture’s declaration – electromagnetic immunity The F9 Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F9 Monitor should assure that it is used in such an environment. Compliance Electromagnetic environment -...
  • Page 87 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the F9 Monitor is used exceeds the applicable RF compliance level above, the F9 Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the F9 Fetal Monitor.

  • Page 88: A4.4 Recommended Separation Distance

    RF communications equipment and the F9 Fetal Monitor The F9 Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the F9 Monitor can help prevent...
  • Page 89 F9 Fetal & Maternal Monitor • User Manual NOTES: - 83 -...

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