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F9 Fetal & Maternal Monitor • User Manual

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Appendix 4 EMC Information – Guidance and

Manufacture’s Declaration

A4.1 Electromagnetic Emissions – for all EQUIPMENT and

SYSTEMS

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 – guidance

RF emissions
CISPR 11

Group 1

The F9 Monitor uses RF energy only for its

internal function. Therefore, its RF emissions are

very low and are not likely to cause any

interference in nearby electronic equipment.

RF emission
CISPR 11

Class A

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Complies

The F9 Monitor is suitable for use in all

establishments, other than domestic and those

directly connected to the public low-voltage power

supply network that supplies buildings used for

domestic purposes.

Содержание F9 Express

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Страница 3: ...e manufacturer only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are car...

Страница 4: ...onitor 17 3 1 6 Bottom Panel 18 3 2 Transducers and Cables 18 3 2 1 Ultrasound US Transducer 18 3 2 2 TOCO Transducer 19 3 2 3 Remote Event Marker 20 3 2 4 Fetal Spiral Electrode 20 3 3 Screen 21 3 3...

Страница 5: ...DECG Monitoring Procedure 44 7 3 6 Detaching the Fetal Spiral Electrode 44 7 4 Monitoring Twin FHRs 44 7 4 1 Monitoring Twins Externally 44 7 4 2 Monitoring Internally 44 7 4 3 Signals Overlap Verific...

Страница 6: ...of the Accessories 64 9 4 Sterilizing 65 Chapter 10 Warranty and Service Policy 66 10 1 Warranty 66 10 2 After Sales Service 66 Appendix 1 Product Specifications 67 A1 1 Monitor 67 A1 2 Transducers an...

Страница 7: ...intensive care units operating rooms or for home use 1 2 Instructions for Safe Operation The F9 Monitor is designed to comply with the international safety requirements IEC EN 60601 1 for Medical Ele...

Страница 8: ...r discharge c The effects of high frequency currents d The interference of electrosurgery equipment 1 3 Ultrasound Safety Guide Fetal Use The F9 Monitor is designed for continuous fetal heart rate mon...

Страница 9: ...receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug from the Monitor to fit a two slot outlet Do not apply this Monitor and other ultr...

Страница 10: ...lt our technical service department or your local CooperSurgical representative Proper Monitoring Safety Precautions This device is not intended for treatment The fetal spiral electrode and intrauteri...

Страница 11: ...a battery with visual damage Proper disposal is required Follow your Local Regulations for disposal CAUTION U S Federal law restricts this device to sale by or on the order of a physician Only qualif...

Страница 12: ...becomes much shorter than usual the battery life is at an end Replace the battery with a new one the same as the one provided or recommended by CooperSurgical When not using the battery for an extende...

Страница 13: ...cking list Check for any mechanical damage Check all the cables and accessories If there is any problem contact us or your local representative immediately 2 2 Installing the Battery If your Monitor i...

Страница 14: ...into the socket 5 Put the battery and the cables into the battery compartment 6 Shut the battery compartment cover and secure the screws Battery Removal Fold the LCD display completely flat before tur...

Страница 15: ...o a power supply will charge the battery even if the Monitor is not turned on 3 Turn off the F9 Monitor and unplug the power cord before installing or removing the battery 2 3 Loading the Recorder Pap...

Страница 16: ...erwise the data will be inaccurate or a paper jam will occur 3 Only use the paper CooperSurgical approved to avoid poor printing quality deflection or a paper jam 4 Keep the drawer closed except when...

Страница 17: ...owered only by the battery 2 5 Definitions and Symbols Socket for Channel 1 Ultrasound Transducer for connection with ultrasound transducer Protection Category B Socket for Channel 2 Ultrasound Transd...

Страница 18: ...BF Applied Part Symbol Type CF Applied Part Symbol Symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life...

Страница 19: ...art List US Transducer 1 pink label Intrauterine Pressure Connecting Cable US Transducer 2 yellow label Intrauterine Pressure Cable TOCO Transducer Disposable Intrauterine Pressure Catheter Remote Eve...

Страница 20: ...ttons 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 monitori...

Страница 21: ...asound transducers are connected to the monitor press this button to switch the audio to US2 press it again to switch the audio back to US1 NIBP Non Invasive Blood Pressure Function Start or stop a NI...

Страница 22: ...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 Indicato...

Страница 23: ...are only used when these optional features are enabled 3 1 4 Right Side Panel of the F9 Monitor Figure 3 4 Right side of the Monitor 3 1 5 Rear Panel of the Monitor Figure 3 5 Rear panel of the monito...

Страница 24: ...e proper insertion into the appropriate socket on the monitor 3 2 1 Ultrasound US Transducer This multi crystal broad beam US transducer is used for monitoring fetal heart rate FHR The US transducer o...

Страница 25: ...rasound transducer WATERPROOF means this transducer is waterproof IPX8 means this transducer can work continuously for 5 hours under 1 meter of water without being waterlogged CAUTION The waterproof p...

Страница 26: ...ducer can work continuously for 5 hours under 1 meter of water without being waterlogged CAUTION The waterproof parts of the TOCO transducer are restricted to the main body and the cable Do not immers...

Страница 27: ...fetus through the maternal abdomen This can reduce the time required for the NST During NST the vibrating operation marks can be displayed printed on CTG trace when the fetal stimulator is connected t...

Страница 28: ...tive the message will be displayed here in red Patient alarms will be displayed on the left and technical alarms in the center Alarm reviewing key Select this key to open the alarm review menu b Mat I...

Страница 29: ...e of the battery no battery is loaded f Network connection indicator and device no the Monitor is online the Monitor is offline NOTE The network connection indicator is not available if the net versio...

Страница 30: ...TART key or touch setup key with touch screen to return to the main interface If no action is taken in 30 seconds the menu will return to the upper directory The change will not be stored Once you sel...

Страница 31: ...ssing it In the same way one of the three results with the Control Knob will be achieved On the main interface the symbols and might appear right next to the pane Touch the symbol to increase the nume...

Страница 32: ...al 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 alarm...

Страница 33: ...ctive 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 t...

Страница 34: ...Select OK to exit from this menu 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 alar...

Страница 35: ...20 bpm FHR1 FHR2 Upper Limit 55 210 bpm adjustable in 5 bpm steps 160 bpm FHR1 FHR2 Alarm Delay 0 300 second s adjustable in 5 second steps 10 seconds FHR1 FHR2 Alarm Level Medium not adjustable Mediu...

Страница 36: ...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 Data Caching When the paper drawer is out of paper or when it is open the...

Страница 37: ...ct Recorder Timer 3 Set the timer to Infinite default Present ID or 10 90 minutes the increment is 5 Infinite means that the recorder will not stop printing until the PRINT key is pressed Present ID m...

Страница 38: ...Style The FHR pane range 30 240 bpm indicates the paper style is American Standard The FHR pane range 50 210 bpm indicates the paper style is International Standard Self Check Trace The F9 Monitor pr...

Страница 39: ...There are two types of paper F9 G and F9 P 2 Patient Information The patient s ID and name 3 Paper Style The FHR pane range indicates the paper style American style 30 240 International style 50 210...

Страница 40: ...ting that the paper type is F9 G and the paper style is International 8 Trace Information List A list of current date time print speed ID FHR2 offset HR SpO2 and TEMP is printed at the start of the mo...

Страница 41: ...t or OFF 4 Select OK NOTE Check all the functions to make sure that the F9 Monitor is in good condition NOTE If the F9 Monitor has a large amount of data saved in its long term memory it will take a f...

Страница 42: ...per is correctly loaded before starting to print 6 3 Adjusting the Screen Angle The angle between the screen and the top cover of the F9 Monitor is adjustable as needed allowing it to be mounted on a...

Страница 43: ...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 befo...

Страница 44: ...rns to the default level after the START key is pressed This default level is adjustable To change this level 1 Select the Setup key on the main interface 2 Select Start Monitor Volume 3 Select the vo...

Страница 45: ...ther 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 adjustab...

Страница 46: ...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 decease...

Страница 47: ...mfortably When the fetal heart beat sound is detected the FHR trace and numeric value are displayed on the screen NOTES 1 Do not mistake high maternal heart rate for fetal heart rate 2 The best qualit...

Страница 48: ...e condition where the patient s safety may be endangered 7 2 4 Changing the FHR Alarm Limits The alarm limits you set determine the parameters that trigger the alarm 1 Select the Setup key on the main...

Страница 49: ...not possible to identify fetal presenting part where application is being considered This method is not recommended when the fetus is extremely premature or in the presence of a maternal infection su...

Страница 50: ...aching the Fetal Spiral Electrode To detach the fetal spiral electrode rotate it counterclockwise until it is free from the fetal presenting part Do not pull the electrode from the fetal skin forceful...

Страница 51: ...itoring if the SOV detects signals overlapping an alarm message Signals Overlap FHR1 FHR2 DFHR will appear on the screen to warn you It may be necessary to check the patient and reposition the transdu...

Страница 52: ...Wipe off any gel present on the abdomen around this area NOTES 1 Do not apply ultrasound coupling gel on a TOCO transducer or its contact area 2 Check the function of the TOCO transducer by applying...

Страница 53: ...OS Use with caution when a uterine infection is present If resistance is met at any time during insertion withdraw the catheter slightly and try at a different angle Forced insertion may result in pa...

Страница 54: ...tion 1 Disconnect the catheter from the cable Insert the cable check plug into the catheter end of the cable See Figure 7 4 Figure 7 4 Test the Pressure Cable 2 Verify that the green light is continuo...

Страница 55: ...race 1 Select the Setup key on the main interface 2 Select Fetus AFM Gain 3 Select 1 2 3 default or 4 4 Select OK 7 7 4 Manual Fetal Movement MFM Monitoring The MFM monitoring result comes from the pa...

Страница 56: ...ID on the touch screen keyboard 4 Select Ok 5 Select Name 6 Enter the required letters for the patient s name on the touch screen keyboard 7 Select Ok 8 Select OK Figure 7 5 Mat Info inputting menu 7...

Страница 57: ...entering function is switched on the menu will pop up for you to input the ID and name for the patient after the START key is pressed The monitoring starts immediately after you exit from the menu To...

Страница 58: ...isplays four traces at most refer to Figure 7 8 FHR1 trace FHR2 trace dual configuration AFM trace and TOCO trace FHR1 FHR2 trace The y axis of the trace indicates the values of FHR whose range is 30...

Страница 59: ...urrent monitoring To change this time format 1 Select the Setup key on the main interface 2 Select Date And Time Time Scale 3 Select Real Time default or Relative Time 4 Select OK NOTE The real time c...

Страница 60: ...Patient Searching window 3 Select ID input the patient ID with the soft keyboard and select Ok 4 Select Name input the patient s name with the soft keyboard and select Ok NOTE You can input only a pa...

Страница 61: ...the screen at a high speed X indicates the proportion of current traces positioned in the entire reviewable traces Move the cursor to any item other than reviewing keys searching key or touch any pla...

Страница 62: ...ed press the MARK key on the front panel to open the smart note list choose an event catalog and then choose an annotation from the list The annotation of this event will be printed in the top area of...

Страница 63: ...lect Top or Right default 4 Select OK FH refreshing rate FH sound volume adjustment key FH sound volume indicator FHR1 141 FHR1 measurement value If the US1 socket is not connected with a US transduce...

Страница 64: ...l US1 UNPLUGGED or US2 UNPLUGGED US transducer 1 or US transducer 2 is not securely connected Check the connection of the transducer US1 SIGNAL LOSS or US2 SIGNAL LOSS FHR1 or FHR2 signal is too weak...

Страница 65: ...oned at the fetus that the spiral electrode is attached to the signals overlap Adjust the US transducer until another fetal heart signal is detected DECG LEADS OFF The spiral electrode is not securely...

Страница 66: ...in Section 8 3 otherwise the unsaved data will be lost 8 2 Completing the Monitoring After monitoring is completed 1 Remove transducers or electrodes from the patient Wipe the remaining gel off the pa...

Страница 67: ...ding safety check and function check should be performed by qualified personnel every 6 to 12 months and each time after service The equipment should undergo periodic safety testing to ensure proper p...

Страница 68: ...ng the transducers with hard or sharp objects should be avoided Do not excessively flex the cables 9 1 4 Storage of Recorder papers When storing recorder paper including the printed paper with traces...

Страница 69: ...solvents acidic or alkali solutions CAUTION 1 Although the F9 Monitor is chemically resistant to most common hospital cleaners and non caustic detergents different cleaners are not recommended and may...

Страница 70: ...ZID ETHANOL 70 SPORACIDIN CIDEX DECG Cable Mild alcohol free soapy water IUP Cable Mild alcohol free soapy water CAUTION 1 Be sure the temperature of the cleaning solution does not exceed 45 C 113 F 2...

Страница 71: ...remaining disinfectant is on the surface 5 Check that the F9 Monitor and accessories are in good condition If any aging or damage is detected replace the damaged part s or contact CooperSurgical for s...

Страница 72: ...ing instructions due to defects in materials and workmanship If CooperSurgical receives notice of such defects during the warranty period that begins on the date of shipment CooperSurgical shall repai...

Страница 73: ...equipment sealed equipment without liquid proof Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or n...

Страница 74: ...yp Support Color 262 144 RGB 6 bit Driver Input Voltage 3 3V Power 7 8 Watt typ Electric Interface LVDS Angle of View Horizontal K 10 Right 70 K Contrast Ratio Left 70 Vertical K 10 Top 60 K Contrast...

Страница 75: ...que Mode Pulse Repetition Rate Pulse Duration Ultrasound Frequency p 1 MPa Iob 10 mW cm2 Ispta 100 mW cm2 FHR Measurement Range Resolution Accuracy Earth Leakage Current Dielectric Strength Ultrasound...

Страница 76: ...ed to transducer DECG Direct Electro cardiography Patient Leakage Current Limit Patient Auxiliary Current Limit N C S F C d c 10 uA 50 uA a c 10 uA 50 uA TOCO TOCO Range 0 100 Sensitivity 3 7 uV V g N...

Страница 77: ...ble Lithium ion Battery Continual Working Time 2 4 hours depending on the configuration Nominal Capacity 4400 mAh Nominal Voltage 14 8V Charge Mode Constant current constant voltage Charge Current Sta...

Страница 78: ...additional equipment to the signal input connector or signal output connector configures a medical system and is therefore responsible that the system complies with the requirements of the valid vers...

Страница 79: ...Corrective Action Volume set too high Turn down the volume Noise Interference from mobile phone or other source Keep the interfering source far away from the monitor A3 3 Recorder Error Error Conditio...

Страница 80: ...monitoring Maternal movement Request the patient to reduce movements Inconstant trace display Inadequate ultrasound coupling gel Add ultrasound coupling gel Recording maternal heart rate inadvertentl...

Страница 81: ...A3 6 Trouble with Contractions Monitoring External Error Condition Possible Cause Corrective Action The belt is too tight or too loose Adjust the belt The belt has no elasticity Replace the belt Mater...

Страница 82: ...fluctuating change intrauterine cable A3 8 Blown Fuses Replace the blown fuse when needed The two fuses of the F9 Monitor are located on the bottom panel Their specifications are Size 5 mm 20 mm Mode...

Страница 83: ...ment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The F9 Monitor uses RF energy only for its internal function Therefore its RF emissions are very low an...

Страница 84: ...ct 8 kV air Floors should be wood concrete or ceramic tile If floor is covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV fo...

Страница 85: ...for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Mains power quality should be tha...

Страница 86: ...3 V m Portable and mobile RF communications equipment should be used no closer to any part of the F9 Monitor including cables than the recommended separation distance calculated from the equation app...

Страница 87: ...nsmitters 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 Mon...

Страница 88: ...ccording to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P V d 1 5 3 80 MHz to 800 MHz P E d 1 5 3 800 MHz to 2 5 GHz P E d 1 7 0 01 0 12 0 12 0 23 0 1 0 37...

Страница 89: ...F9 Fetal Maternal Monitor User Manual 83 NOTES...

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