EDAN F15 Series User Manual
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EDAN F15 Series User Manual

Fetal & maternal monitor
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Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
1／202

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  • Page 1 Traditional 510(k) of Fetal & Maternal Monitor 014_14.1_F15_Series_User_Manual 1／202...
  • Page 2 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.

  • Page 3: Table Of Contents

    Traditional 510(k) of Fetal & Maternal Monitor Table of Content Chapter1 Safety Guidance ..................1 1.1 Intended Use/Indications for Use ..................1 1.2 Features ..........................1 1.3 Instruction for Safe Operation ....................3 1.4 Safety Precautions ........................ 3 1.5 Safety Information ......................... 2 1.5.1 Protecting Personal Information .................
  • Page 4 Traditional 510(k) of Fetal & Maternal Monitor 3.6.2 Monitoring Numerics ....................36 3.6.2.1 Fetal Monitoring ....................36 3.6.2.2 Maternal Monitoring(F15) ................40 3.6.3 Trace Control Tools ....................42 3.6.3.1 Data Saving ....................43 3.6.3.2 *Searching for a File ..................43 3.6.3.3 * File Management (Optional) ................
  • Page 5 Traditional 510(k) of Fetal & Maternal Monitor 7.2 FHR Monitoring FHR with Ultrasound ................78 7.2.1 Monitoring FHR with Ultrasound Transducer ............79 7.2.2 Changing the FHR Alarm Delay ................81 7.2.3 Testing US Transducers .................... 81 7.3 Monitoring FHR with DECG ....................82 7.3.1 Preparing the Patient's Skin Prior to Placing Electrodes .........
  • Page 6 Traditional 510(k) of Fetal & Maternal Monitor 8.3.2 Choosing HR Source ....................103 8.3.3 Monitor HR with Electrode Sleeve ................104 8.3.4 Changing HR Beep Volume ..................105 8.3.5 Enabling HR Trace ....................106 8.3.6 Signals Overlap Verification ..................106 8.4 Maternal NIBP Monitoring ....................
  • Page 7 Traditional 510(k) of Fetal & Maternal Monitor 11.3.2.3 Disinfecting the ECG Cable Assembly ............128 11.3.2.4 Disinfecting the TOCO Transducer and SpO2 Sensor ......128 11.3.2.5 Disinfecting the TEMP Sensor ..............128 11.3.3 Cleaning and Disinfecting Other Accessories ............128 11.4 Storage ..........................
  • Page 8 Traditional 510(k) of Fetal & Maternal Monitor Appendix 8 Limitations of Ultrasonic Monitoring ..........168 A8.1 How Does Ultrasound Work ................... 168 A8.2 Artifacts in Fetal Heart Monitoring .................. 168 A8.3 Audio Output and Screen Reading ................. 170 Appendix 9 WI-FI Networking and Instructions ........... 172 A9.1 General ...........................

  • Page 9: Features

    F15 series can be compatible with FTS-3 which is a wireless system intended for monitoring physiological parameters including fetal heart rates (FHR), fetal movements (FM), uterine activity. F15 series are intended for monitoring in a bath (FTS-3 only) or shower (FTS-3, and F15 wireless transducers).
  • Page 10 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance Model F15 Air Configuration US Transducer √ √ -FHR-Singleton √ √ -FHR-Twins ● ● -FHR-Triplets √ √ -AFM TOCO Transducer √ √ -TOCO ●...

  • Page 11: Safety Precautions

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance ● ● -WI-FI √ √ -Battery ― = Not Available NOTE: √ = Standard ● = Optional 1.3 Instruction for Safe Operation NOTE: In this manual, Monitor refers to both F15 and F15 air, and is used where the information applies to both models.
  • Page 12 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance For using safety: The monitor is provided for the use of qualified physicians or personnel professionally trained. The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use.
  • Page 13 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance WARNING 16 Connecting any accessory (such as external printer) or other device (such as the computer) to this monitor makes a medical system. In that case, additional safety...
  • Page 14 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance 32 Do not apply the monitor during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 33 ECG cables may be damaged when connected to a patient during defibrillation. Check cables for functionality before using them again.
  • Page 15 53 The IUPC is neither intended nor approved for measuring intrauterine pressure extraovularly; attempting to do so may lead to maternal discomfort or injury. 54 FTS-3 transducers have priority over F15 series US Transducers, DECG Fetal & Maternal Module, TOCO transducer and FECG Fetal&Maternal Module. When FTS-3 transducers get on line, F15 series US Transducers, DECG Fetal &...
  • Page 16 74 Lithium batteries should be charged, used and stored in places far away from static electricity. 75 Only rechargeable button cell supplied or recommended by EDAN can be used. The rechargeable button should be replaced by serviceman authorized by EDAN if needed.

  • Page 17: Chapter1 Safety Guidance

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance CAUTION 11 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.

  • Page 18: Safety Information

    Ensure that all device components maintaining personal information (other than removable media) are physically secure. Ensure that the monitor is connected only to the device authorized/approved by EDAN. Users should operate all EDAN deployed and supported monitors within EDAN authorized specifications, including EDAN approved software, software configuration, security configuration, etc.

  • Page 19: Instruction For Safe Operation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance CAUTION 10 Protect patients’ sensitive information while using the monitor in public places. For information and data displayed on the monitor and saved in the monitor, please pay attention to personal information protection.

  • Page 20: Definitions And Symbols

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance  Set the on or off of Authority Control. When the Authority Control is set to On, it can resist against virus attack.
  • Page 21 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance RJ45 Interface Battery check Alternating Current Direct Current Stand-by Power Supply switch Warning (Background: Yellow; Symbol & outline: Black) Caution Operating instructions Refer to User Manual (Background: Blue;...
  • Page 22 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance Part Number Date Of Manufacture Manufacturer AUTHORISED REPRESENTATIVE EUROPEAN COMMUNITY Disposal method Non-ionizing electromagnetic radiation USB Port Ethernet Port Serial Number Catalogue number Federal (U.S.) Law restricts this device to sale by or on the order of a...
  • Page 23 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Safety Guidance STACKING LIMIT BY NUMBER HANDLE WITH CARE DO NOT STEP ON NOTE: The user manual is printed in black and white. - 7 - 014_14.1_F15_Series_User_Manual...

  • Page 24: Chapter2 Installation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation Chapter2 Installation WARNING The system installation should be operated by serviceman authorized by the manufacturer. 2.1 Opening the Package and Checking Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage.

  • Page 25: Patient Transfer Within The Hospital

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation Shut the battery compartment cover and fix the screws. (2) Battery Removal Fold the LCD display completely flat before turning the monitor upside down. Remove the battery in reverse order.
  • Page 26 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation 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.

  • Page 27: Connecting Power Cable

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation NOTE: Be careful when inserting paper. Avoid damaging the thermosensitive print head. Make sure the paper is evenly loaded in the drawer. Otherwise the data will be inaccurate or paper jam will happen.

  • Page 28: Installing Transducer Holder Bracket

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation 2.6 Installing Transducer Holder Bracket You can choose to install the transducer holder bracket on the wall or on the trolley. Please refer to MT-811 Trolley (For medical use) Assembling Instruction for method to install it on the trolley.
  • Page 29 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Installation Mark the location of mounting holes of wireless transducer holder bracket on the wall and then use a Ф8 drill to punch the wall.

  • Page 30: Chapter3 Basic Operation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Chapter3 Basic Operation NOTE: The pictures and interfaces in this manual are for reference only. 3.1 Overview F15 Air Figure 3-1 Appearance Alarm Indicator...

  • Page 31: Right Panel

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation F15Air: Figure 3-2 Left Panel Sockets for Transducers and Cables: enables the parameter measurement. 3.1.2 Right Panel F15: F15Air: Figure 3-3 Right Panel...

  • Page 32: Rear Panel

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.1.3 Rear Panel Figure 3-4 Rear Panel RJ45 Socket: it connects the monitor to the central monitoring system (MFM-CNS, MFM-CNS Lite) through Ethernet, which enables MFM-CNS, MFM-CNS Lite to achieve bidirectional communication with the monitor.

  • Page 33: Indicators

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Battery Compartment Handle Loudspeaker Label 3.1.5 Indicators There are four indicators on the top of the screen and the front panel. From the top down they are: alarm indicator, CHARGE indicator, AC indicator and Power indicator.

  • Page 34: Transducers

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.2.1 Transducers Figure 3-6 Wired Transducers 1. Wired US Transducer 2. Wired US Transducer Indicators 3. Wired TOCO Transducer 4. Wired DECG Fetal&Maternal Module Note: The indicators on the wired US transducer are intended to distinguish US transducer 1/2/3.
  • Page 35 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-7 Wireless Transducers 5. Wireless TOCO Transducer 6. Wireless US Transducer 7. Wireless DECG Fetal&Maternal Module CAUTION Degree of protection against harmful ingress of water of the US transducer, TOCO transducer and Fetal&Maternal Module is IPX68.
  • Page 36 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-8 ECG Electrode Sleeve The ECG electrode sleeve is used together with TOCO transducer for MHR monitoring. Figure 3-9 Wireless FECG Fetal&Maternal Module and ECG Leads The FECG cable is configured with remote event marker.

  • Page 37: Remote Event Marker(Optional For F15 Only)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Screen Belt Button Pressure Sensor Symbols Figure 3-10 Front View and Back View of the Wireless FECG Fetal&Maternal Module Figure 3-11 ECG Leads Socket The wireless FECG Fetal&Maternal Module is used with ECG leads and monitor eFHR, HR and...

  • Page 38: Decg Cable

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.2.3 DECG Cable 1 Interface to DECG-IUP integrated cable 2 DECG cable plug Figure 3-13 DECG Cable 3.2.4 DECG-IUP Integrated Cable 1 Interface to IUP catheter...

  • Page 39: Iup Catheter

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.2.6 IUP Catheter 1 Interface to DECG-IUP integrated cable 2 Catheter Figure 3-16 IUP Catheter 3.2.7 ECG Cable 1 Lead Wire 2 ECG Connector...

  • Page 40: Nibp Cuff

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 1 NIBP Cuff 3.2.9 NIBP Cuff 2 Inflation Tube Connector 3 Cuff Extension Tube Figure 3-19 NIBP Cuff Figure 3-20 Cuff Extension Tube 3.2.10 TEMP Sensor...

  • Page 41: Charging Ft20 Telemetry Transmitter

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.3.1 Charging FT20 Telemetry Transmitter There are two methods to charge the FT20 Telemetry Transmitter: Put the FT20 Telemetry Transmitter in the docking slot, for details please refer to 3.4.1 Charging Wireless Transducer.

  • Page 42: Displaying Of Wireless Transducer

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Rechargeable lithium-ion batteries are installed inside the transducers. In the process of monitoring, please pay attention to the battery level of the transducers. Battery level is indicated by the battery icon on the top right corner.

  • Page 43: Close Wireless Transducer

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Description Wireless Signal The wireless signal strength has four degrees: Strength Indicator When the transducer connects to the monitor successfully, a number will appear in the center of the screen, which represents Device Number the device no.

  • Page 44: Monitor The Ambulatory Patient

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation NOTE: 1. Fix the wireless transducers tightly to ensure that they will not shift during movement. 2. It is recommended that the transducer should be placed when the patient stands for better monitoring.
  • Page 45 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Information Fields Measurement Numerics Fileds Waveforms/menu Fields Status Fields Fields Figure 3-24 Main Interface Information Fields The information fields locate on the top of the screen. When an alarm is active, the message will be displayed here.
  • Page 46 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation The battery is almost depleted and needs to recharge immediately No battery is loaded Battery malfunction or battery charging stops due to its high temperature The battery is being charged.
  • Page 47 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Key Fields The key filed locates at bottom of the screen, giving you fast access to functions. (1)*START Function: Start monitoring Press this key to start monitoring (on the main interface).
  • Page 48 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Function: Adjust the brightness of the screen Press this key and the up/down key will be displayed. Press the up/down key to increase or decrease gradually the brightness.

  • Page 49: Main Menu

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.5.2 Main Menu Setup menus are provided to change the monitor configurations and monitoring settings. Press the main menu key on the main interface to open the main menu.

  • Page 50: Monitoring Interface

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.6 Monitoring Interface 3.6.1 Interface Display 3.6.1.1 *Switch Display Mode The monitor has three display modes: maternal-fetal mode (figure 3-26), fetal mode (figure 3-27) and maternal mode (figure 3-28).

  • Page 51: Background Color Switch

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-28 Maternal Mode 3.6.1.2 *Background Color Switch The screen background color has two choices: black and grey (default). To change the screen color, Select the on the main interface.

  • Page 52: Monitoring Numerics

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Select the main menu key on the main interface. Select Date And Time > Time Scale. Select Real Time (default) or Relative Time.
  • Page 53 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation AFM black mark The x-axis of each wave indicates the duration of a detected fetal movement. NOTE: AFM trace is only for reference. Please take the MFM marks as criterion.
  • Page 54 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation FHR3 value, TOCO/IUP value and FM count: FHR1 FHR2 FHR3 TOCO Figure 3-30 Fetal Monitoring Numerics :FHR signal quality. When the quality is poor, it turns into...
  • Page 55 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 7:current UA measurement numeric MFM/AFM: MFM source 0: FM count When monitoring with wireless model, the wireless signal strength icon , and battery level icon of the wireless US transducers, wireless TOCO transducer and wireless DECG Fetal&Maternal...

  • Page 56: Maternal Monitoring(F15)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 3.6.2.2 Maternal Monitoring(F15) Figure 3-31 Maternal Monitoring Traces 1 FHR1 Trace FHR2 Trace FHR3 Trace HR Trace 5 AFM Trace TOCO Trace ECG Trace Waveform Under maternal-fetal monitoring mode, the trace window displays at most nine traces.
  • Page 57 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation The numeric list can be reviewed: select the list, press the symbol to review the previous lists. Besides the fetal numerics, the numeric window of F15 includes maternal vital signs: SpO...

  • Page 58: Trace Control Tools

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation (ECG): The current HR comes from ECG. 67: Current maternal heart rate measurement numeric. TEMP (º C): TEMP unit. When F15 Fetal/Maternal Monitor is connected to FTS-3 Fetal Telemetry System, and transducers are...

  • Page 59: Data Saving

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-35 Trace Control Tools Backward key/Forward 1 Searching Key 3 Alarm Reviewing Key CTG Analyzing Key 3.6.3.1 Data Saving When the START key is pressed, the monitor saves data of the previous ID in a file, and then clears it from the main interface.

  • Page 60: File Management (Optional)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-37 Patient Searching Select ID, input the patient ID with the soft keyboard and select Enter. Select Name, input the patient’s name with the soft keyboard and select Enter.
  • Page 61 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Figure 3-38 File Management If the required record is not on the current page, select Next to view more records. Move the cursor to select the required item, and then select Export in the pop-up item, and the monitor exports this record to the USB disk.

  • Page 62: Reviewing

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation from the monitor. 3.6.3.4 *Reviewing The reviewing keys (backward key) and (forward key) are used to review the traces. The word REVIEW is shown in the background when reviewing the traces.
  • Page 63 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation childbirth. 2 CTG analysis is just an analysis intended to assist the physicians in interpreting the waveforms. Conclusions should be drawn on the basis of the physicians’ diagnosis.

  • Page 64: Marking A Note

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation 2) CTG Analysis Results: The proportion of the signal loss. If it is larger than 10%, analysis SIGNAL LOSS: results cannot be acquired.

  • Page 65: Introduction Of Fts-3 Fetal Telemetry System

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Basic Operation Use the soft keyboard to edit the note content. Select Enter. Select OK. 3.7 Introduction of FTS-3 Fetal Telemetry System F15 is compatible with FTS-3 Fetal Telemetry System which is intended for monitoring in a bath or shower.

  • Page 66: Chapter4 Alarms

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Chapter4 Alarms WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in any single area.

  • Page 67: Visual Alarm

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms in the manner of lighting for one second and pausing for one second. The audible alarm is enabled again only when the SILENCE key is pressed.

  • Page 68: Choosing The Alarm Display Form

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms recommended to use the default settings. 4.5 Choosing the Alarm Display Form You can change the patient alarm display form, Select the main menu key on the main interface.

  • Page 69: To Switch Individual Measurement Alarms On Or Off

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Select Alarm Pause (default) or Alarm Reset. If Alarm Pause is selected: When the monitor gives out alarm sound and you press the SILENCE key, the alarm indicator displays , and the alarm sound is muted.

  • Page 70: Switching Ctg Alarm On Or Off

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms 4.13 Switching CTG Alarm On or Off You can switch “CTG Alarm” on or off: Select the main menu key on the main interface.

  • Page 71: Alarm Treatment Measures

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms NOTE: You can select Main Menu > Alarm > Review Alarms to set up On (by default) or OFF. When the alarm review is enabled, the icon will appear on the main interface.
  • Page 72 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms FHR1/DFHR/FHR2/FHR3 Low 60 bpm ~ 205 bpm, in increments of 5 110 bpm Alarm Limit FHR1/DFHR/FHR2/FHR3 High 65 bpm ~ 210 bpm, in increments of 5...

  • Page 73: Alarm Messages

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms MAP Alarm Delay 0 second, not adjustable 0 second MAP Alarm Priority Medium, not adjustable Medium TEMP Alarm On, Off TEMP Low Alarm Limit 0 º...
  • Page 74 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms CTG Alarm(Medium Priority) There minutes Check the patient’s and fetus’s current **FHR1/FHR2/FHR3 variability ≤ 2bpm within 21 Low Variability condition. min. Check the patient’s and fetus’s current **FHR1/FHR2/FHR3 Delayed deceleration >0 within...
  • Page 75 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms CTG Alarm(Low Priority) Delayed deceleration FHR1/FHR2/FHR3 detected when maternal and Check the patient’s and fetus’s current Suspected Delayed fetal heart rate are close, and condition.
  • Page 76 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms transducer. Low Priority There is no paper in the paper Check Paper Load paper and/ or close the drawer. drawer or the drawer is open.
  • Page 77 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Check whether the ambulating mother The wireless signal of wireless TOCO Wireless Signal has reached the limit of the active signal TOCO is too weak for the...

  • Page 78: Maternal Monitoring Alarm Messages

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms transducer Connect US transducer 3 with the Probe MALF (FHR3) disconnected with the monitor monitor DECG&IUP transducer Connect DECG&IUP transducer with the Probe MALF (DECG)
  • Page 79 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Patient Alarm Messages Alarm Message Cause Countermeasure High Priority No QRS wave is detected by TOCO&MECG transducer in 4 Check the patient’s condition and take...
  • Page 80 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Low Priority US transducer 1 has picked up Signals Overlap Reposition the US transducer 1 until the the maternal heart signal; the (FHR1, HR) fetal heart signal is detected.
  • Page 81 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Restart the monitor and try again, contact FT20 is disconnected with the FT20 MALF the manufacturer if the connection still monitor fails. The current network environment...

  • Page 82: Technical Alarm Messages

    4.18.3 FTS-3 Technical Alarm Messages When FTS-3 is connected to F15 series fetal/maternal monitor, the monitor gives technical alarms for the situations that need the physicians to pay attention to during wireless monitoring, the alarm messages are listed below.

  • Page 83: Alarm Bilateral Control

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Alarms Alarm Message Cause Countermeasure Medium Priority The battery indicator is Please charge the US1 The battery level battery power is too low to support transducer immediately.

  • Page 84: Chapter5 Printing

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Printing Chapter5 Printing 5.1 *Function Description The built-in thermal recorder applied in the monitor supports both the American and international standard wide recorder paper. prints...

  • Page 85: Printing Configuration

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Printing 5.2 Printing Configuration NOTE: All the parameters should be well configured before printing starts. You cannot change the configuration in the process of printing.

  • Page 86: Changing Title Print Cycle

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Printing Select the main menu key on the main interface. Select Recorder > Print Ending Beep. Select High, Low (default) or OFF. Select OK. 5.2.6 Changing Title Print Cycle Select the main menu key on the main interface.
  • Page 87 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Printing (14) (15) (10) (12) (11) (13) Figure 5-1 an example of recorder paper with traces Item Information Description The monitor prints a self-check trace after being switched on. It is used Self-Check Trace to check if the recorder paper is properly loaded.
  • Page 88 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Printing Each recorder paper pack has 150 pages. When you notice the page Page Mark mark comes to the end, remember to load new paper in time.

  • Page 89: Chapter6 Pre-Monitoring Preparation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation Chapter6 Pre-Monitoring Preparation 6.1 Switching On the Monitor 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.

  • Page 90: Adjusting The Screen Angle

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation If the monitor does not print the baseline, switch on the Print Self-Check function and then restart the monitor. NOTE: Make sure the paper is correctly loaded before the printing starts.

  • Page 91: Setting Screen Brightness

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.4 Setting Screen Brightness You can adjust the brightness of the screen, Select the brightness key on the main interface or Select the main menu key on the main interface.

  • Page 92: Connecting Transducers

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation service life. Please contact the service personnel or your local distributor. NOTE: The date and time remain in the monitor for at least two months after it is switched off. You do not have to set date and time each time before monitoring.
  • Page 93 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation The FH volume returns to a default level after the START key is pressed. This default level is adjustable. To change this level, 1 Select the main menu key on the main interface.

  • Page 94: Chapter7 Fetal Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Chapter7 Fetal Monitoring WARNING 1 The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use.

  • Page 95: Monitoring Fhr With Ultrasound Transducer

    If AFM is enabled, please fix the transducer with a belt, suggest to reduce maternal movement and walking, and do not pat the abdomen. Using coupling gel not approved by EDAN may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty.
  • Page 96 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Fetal Heart Pregnancy Early Parturition Late Parturition Figure 7-1 Positioning Ultrasound Transducer (single fetus) Acquiring Fetal Heart Signal Apply a certain amount of acoustic gel on the transducer and move the transducer slowly around the fetus site to even the gel.

  • Page 97: Changing The Fhr Alarm Delay

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring comfortable. During long-time monitoring, the gel may dry out as the transducer moves around. Add more gel in time if it is inadequate.

  • Page 98: Monitoring Fhr With Decg

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-2 Testing a US Transducer Check that the value on the display shows this change in FHR. If a US transducer fails the test, repeat this test with another transducer. If the second one passes the test, defect of the first transducer is confirmed.

  • Page 99: Decg Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Hold the drive handle, ensure the spiral electrode is retracted about one inch (2.5 cm) from the distal end of the guide tube.

  • Page 100: Changing Decg Beep Volume

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring The filter of AC power supply can be configured by selecting System>Factory Configuration>Line Frequency>50(default) or 60. Please select it according to the current AC frequency.

  • Page 101: Decg Gain And Display

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Select 0 (default) ~ 9. Select OK. NOTE: 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 OFF) automatically.

  • Page 102: Monitoring Internally

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring NOTE: To ensure that both transducers stay at the optimum location, each transducer should be fixed with a separate belt. 7.4.2 Monitoring Internally Alternatively, you can monitor a FH using ultrasound externally, and monitor the second FH using DECG internally.

  • Page 103: Monitoring Triple Fhrs

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.5 Monitoring Triple FHRs 7.5.1 Monitoring Triplets Externally To monitor triple FHRs externally, you need to connect three US transducers to fetal monitoring socket of the monitor.

  • Page 104: Monitoring Uterine Activity Externally

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Select -20 bpm (default), 0 bpm or +20bpm. Select OK. This preset FHR2 offset will be printed on the recorder paper every 10 minutes (Default)/20min/30min/60min (optional).

  • Page 105: Changing The Ua Baseline

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Place the transducer Place the transducer on fetal buttocks for fetal back delivery Figure 7-6 Positioning TOCO Transducer Wrap the abdomen with the belt over the transducer. Fix the transducer by pushing its buckle through the overlapping section of the belt.

  • Page 106: Monitoring Uterine Activity Internally

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Switch on the monitor. Connect the TOCO transducer to the fetal monitor. Gently press the center of the transducer. Figure 7-7 Testing a TOCO Transducer Check that the value on the display shows this change in pressure.
  • Page 107 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring This product is designed for use with the introducer. Using aseptic technique, remove the catheter from the package. Perform vaginal exam to ensure ruptured membranes and adequate dilation.

  • Page 108: Iup Monitoring Procedure

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring WARNING 1 Before insertion of IUPC, placental position should be confirmed, amniotic membranes are adequately ruptured and sufficient cervical dilatation is assured. 2 Try to insert the catheter opposite the placental site. Do not insert the introducer beyond the cervical OS.

  • Page 109: Enabling Or Disabling Afm Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.8.2 Enabling or Disabling AFM Monitoring To enable or disable AFM monitoring, Select the main menu key on the main interface. Select Fetus > AFM.

  • Page 110: Start Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring Select the main menu key on the main interface. Select Fetus > MFM Volume. Select Low or High (default). Select OK. 7.9 *Start Monitoring After the START key is pressed, the monitor automatically zeroes the pressure, clears the FM count and starts monitoring.

  • Page 111: Id Entry With A Scanner

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Fetal Monitoring new ID takes place of the old one for this patient. NOTE: 1 Pressing the START key separates two patients. The monitor only displays the most recent ID for the same patient.

  • Page 112: Chapter8 Maternal Monitoring

    A different type of electrode may produce higher offset voltage. Therefore, only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring. Please use EDAN approved disposable electrodes with legal and valid medical device qualification.

  • Page 113: How To Place 3-Lead Ecg Cables

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring With normal QRS wave. Tall and narrow with no notches. With tall R-wave completely above the baseline. With T-wave less than one-third of the R-wave height.

  • Page 114: Ecg Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring R (RA) Red (White) L (LA) N(RL) Yellow (Black) Black(Green) Figure 8-3 Placing 3-lead ECG Cable (obtain wave of II lead) NOTE: To ensure patient’s safety, all leads must be attached to the patient.

  • Page 115: Changing Ecg Gain

    The F15 monitor is compatible with the SpO transducers supplied by EDAN only. The SpO transducer manufactured by EDAN can only be used with the F15 monitor. Compatibility should be checked prior to use. Otherwise the monitor performance can be degraded.
  • Page 116 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring Do not perform SpO measuring and NIBP measuring on the same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO numeric.

  • Page 117: Monitoring Procedure

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring Sensor temperature. (Maintain the temperature between +28 ℃ (+82.4 ° F) and +41 ℃ (+105.8 ° F) for best operation) Placement of the sensor, such as on an extremity that has a NIBP cuff, arterial catheter, or intravascular line.

  • Page 118: Signal Intensity)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.

  • Page 119: Maternal Hr Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring 8.3 Maternal HR Monitoring 8.3.1 Introduction Maternal heart rate (MHR) monitoring does not need an extra accessory. When you perform ECG or (Pulse) monitoring, the MHR result can be acquired at the same time.

  • Page 120: Monitor Hr With Electrode Sleeve

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring 8.3.3 Monitor HR with Electrode Sleeve  Principle Introduction The HR monitoring is based on the obtaining of ECG signal on the abdomen. The three meal electrodes of MECG-R electrode sleeve correspond to lead L, N and R of the ECG leads.

  • Page 121: Changing Hr Beep Volume

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring X4. When a good signal is obtained, the ECG signal with regular rhythms will appear in the ECG waveform display area, and the wireless transducer signal quality icon will become full in 3~5s. If effective ECG signal is not obtained or the ECG signal is not obvious, the accuracy and stability of HR calculation will be influenced.

  • Page 122: Enabling Hr Trace

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring To change the HR beep volume, Select the main menu key on the main interface. Select Mother > HR Beep. Select OFF (default), Low or High.
  • Page 123 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean artery pressure), and then diminish.

  • Page 124: How To Apply Nibp Cuff

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring To different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure pulse. In those circumstances where the patient's condition makes it difficult to detect, the measurement becomes unreliable and the measuring time increases.

  • Page 125: Measurement Procedures

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring Figure 8-9 Applying the Cuff 8.4.3 Measurement Procedures To obtain accurate measurements, the following operating steps need to be observed: Ensure the patient position in normal use, including...

  • Page 126: Manual Measurement

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring NOTE: The monitor checks uterine contract (UC) pressure when the NIBP key is pressed. If the UC is over 50, a prompt “Intense UC, can't measure NIBP now.” is issued, and the monitor will check the UC every 30 seconds.

  • Page 127: Choosing Nibp Printing Mode

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring Select OK. Note: When the network version is ETHERNET 1.4 and above,if the fetal monitor gets on line, the central station will control to make the NIBP unit of the fetal monitor in concert with that of the central station.

  • Page 128: Changing Temp Unit

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual After Monitoring CAUTION Be cautious when taking and putting the TEMP sensor. Do not pull the cable too tight or it might cause mechanical damage.

  • Page 129: Chapter9 Monitoring Mother And Fetus Using Fecg

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG Chapter9 Monitoring Mother and Fetus Using FECG FECG is only indicated for use on women who are at >36 completed weeks, with singleton pregnancies.

  • Page 130: Parts Required

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG WARNING If montoring TOCO with the pressure sensor, inspect patient skin before applying the transducer. If the skin quality is poor, especially when the skin is damaged or irritated, please change a site to apply the transducer.

  • Page 131: Electrode Placement

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG ×3 CAUTION Please be gentle during skin preparation to avoid skin injury. 9.2.4 Electrode Placement FECG adopts 6-lead cables. The table below lists the names and position of the ECG leads.

  • Page 132: Connecting The Ecg Leads To The Electrodes

    Monitoring can only be started when all the ECG leads are connected correctly and signal is normal. CAUTION Please use EDAN approved disposable electrodes with legal and valid medical device qualification. 9.2.6 Placing the Transducer When monitoring uterine activity by pressure sensor of the transducer, put the transducer on the patient’s fundus, which is flat and solid.

  • Page 133: Electrode Checking

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG deflections from baseline may represent electrical activity in myometrium that is not sufficiently organized to cause the uterine smooth muscle to contract.

  • Page 134: Changing Ecg Gain

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG ‘Select OK. Suggest to select X32 at the beginning of the monitoring, and then adjust the gain according to the actual displayed waveform to reach the best effect.
  • Page 135 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Monitoring Mother and Ferus Using FECG Figure 9-3 Maternal Monitoring Interface - 119 - 014_14.1_F15_Series_User_Manual 135／202...

  • Page 136: Chapter10 After Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter10 After Monitoring 10.1 Completing Monitoring After monitoring, Remove transducers or electrodes from the patient; wipe the remaining gel off the patient and the transducer with a clean soft cloth or tissue.

  • Page 137: Chapter11 Maintenance And Cleaning

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter11 Maintenance and Cleaning 11.1 Maintenance 11.1.1 Maintaining Inspection (1) Visual Inspection Prior to using the monitor every time, do the following inspections: ...

  • Page 138: Storage Of Recorder Paper

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning residual coupling gel. The transducers are delicate and sensitive. Please handle them with care and try to avoid dropping on to the ground or any hard surfaces.

  • Page 139: Checking Battery Performance

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 11.1.6.1 Checking Battery Performance The performance of rechargeable batteries may deteriorate over time. If you suspect that the battery may have failed, check the battery performance.

  • Page 140: Cleaning The Monitor

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning WARNING Use only recommended cleaning substances and disinfectants listed in this manual. Others may cause damage (not covered by warranty), reduce product lifetime or cause safety hazards.

  • Page 141: Cleaning The Reusable Accessories

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 11.2.2 Cleaning the Reusable Accessories 11.2.2.1 Cleaning the Ultrasound Transducer 1. Disconnect the transducer from the monitor. 2. Wear sterile protective gloves to prevent infection.

  • Page 142: Cleaning The Ecg Cable Assembly

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Adjust the bladder until it is in position. CAUTION 1 Do not squeeze the rubber tube on the cuff. 2 Do not dry-clean the cuff.

  • Page 143: Disinfecting The Monitor

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 11.3.1 Disinfecting the Monitor To disinfect the monitor, follow these steps: Switch off the monitor and disconnect it from the power line.

  • Page 144: Disinfecting The Nibp Cuff

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 7. Inspect the transducer to ensure that there is no damage. 11.3.2.2 Disinfecting the NIBP Cuff Disinfecting the Cuff: Take out the air bladder before disinfection.
  • Page 145 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Atmospheric Temp.: -20 º C〜+55 º C Relative Humidity: 15%~95% (Non-condensing) Atmospheric Pressure: 70kPa ~ 106kPa. - 129 - 014_14.1_F15_Series_User_Manual 145／202...

  • Page 146: Chapter12 Warranty And Service

    EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired.

  • Page 147: Appendix 1 Product Specifications

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton Appendix 1 Product Specifications A F15 Fetal/Maternal Monitor A1.1 Environmental Specifications The monitor may not meet the performance specifications given here if stored or used outside the specified temperature and humidity ranges.
  • Page 148 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton SpO2, NIBP , TEMP CF (Defibrillating-proof) Main Unit: IPX2, protected against vertically falling water drops when enclosure tilted up to 15 (provided recorder drawer is shut and the...

  • Page 149: A1.3 Performance Specifications

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton ◆Wireless transducer≤150g Weight ◆Wired transducer≤150g (not including the wire) Cable Length 2.5m Withstands a 1.5 m drop at least 3 times to concrete surface with...
  • Page 150 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton Isppa.3<190W/cm Ispta.3<94mW/cm Iob≤3.6 mW/cm *Ultrasound Output Isata≤.6 mW/cm TI<1.0 MI<1.0 When applied to the patient, the ultrasound transducer may warm slightly (less than 10℃...
  • Page 151 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton *Accuracy ± 3mmHg *Display Range 0 ~ 999 *FM Mode Automatic/Manual MFM & AFM *AFM Mode Trace (default) or Black Mark AMF Technique...
  • Page 152 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton maximum recommended 1.5mV T-Wave amplitude *Measurement Range 50% ~ 100% (EDAN) *Measurement 50% ~ 100% Range(Nellcor) Resolution *Measuring Accuracy 70% ~ 100% ± 2%...
  • Page 153 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton (2.7kPa~31.3 kPa) Systolic pressure, Diastolic pressure, Mean *Alarm pressure Alarm Software Over Voltage (297  3) mmHg [(39.6  0.4) kPa] Protection Hardware Over Voltage (320 ...

  • Page 154: A1.4 Recorder Specifications

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton Resolution 1bpm * Accuracy ± 1bpm * Measurement Range 30~240bpm Signal Range 5uV~3mV QRS Wave Width 30ms~60ms Differential Input >2.5MΩ Impedance Electrode Offset Potential ±...

  • Page 155: A1.5 Rechargeable Lithium-Ion Battery

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton 30bpm/cm (American Standard) FHR scaling 20bpm/cm (International Standard) TOCO printout width 40mm TOCO scaling 25%/cm Printing speed Standard Speed(Real-Time Traces) 1 cm/min, 2 cm/min, 3 cm/min...

  • Page 156: A1.6 Wifi Specifications

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton Type Rechargeable Lithium-ion Battery ≥8 hours (new battery used in fully charged) Continual Working Time Necessary charge time ≤5 hours (stand by or power off status) from "out of power"...

  • Page 157: A1.8 Interface Specifications

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Product Specificaiton A1.8 Interface Specifications A1.8.1 USB Interfaces Number of USB Interfaces Standard: 2 Drive Mode HOST interface, USB 2.0 protocol Power Supply 5 .3VDC± 5%, 1500 mA Max.

  • Page 158: Appendix 2 Signal Input/ Output Connector

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Signal Input/Output Connector 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).

  • Page 159: Appendix 3 Troubleshooting

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Troubleshooting Appendix 3 Troubleshooting A3.1 No Display Phenomenon Possible Cause Solution Power cable is loose. Tighten the power cable. Power indicator is off. The battery runs out of power.

  • Page 160: A3.5 Trouble With Ultrasound Fhr Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Troubleshooting Reset time and date and note the difference between Daylight Time incorrectly set Saving Time Winter Standard Time(See 6.5) Incorrect time and date The battery needs service. Call Battery fault the service personnel.

  • Page 161: A3.7 Troubles With Contractions Monitoring (External)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Troubleshooting The DECG cable has not been Fix an attachment pad at the Inconstant trend fixed firmly DECG cable. A3.7 Troubles with Contractions Monitoring (External)

  • Page 162: A 3.10Troubles With Hr Monitoring With Electrode Sleeve

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Troubleshooting special ground wire Check if the special ground wire connecting with monitor is not connecting with monitor properly earthed. earthed. Improper positions Place the ECG electrodes per electrodes suggested positions.

  • Page 163: A3.10 No Nibp And Spo2 Results

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A3.10 No NIBP and SpO2 Results Phenomenon Possible Cause Solution The NIBP cuff is not properly Check if the NIBP cuff is properly...

  • Page 164: Appendix 4 Ultrasound Intensity And Safety

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Appendix 4 Ultrasound Intensity and Safety A4.1 Ultrasound in Medicine The use of diagnostic ultrasound has proved to be a valuable tool in medical practice. Given its known benefits for non-invasive investigations and medical diagnosis, including investigation of the human fetus, the question of clinical safety with regards to ultrasound intensity arises.

  • Page 165: A4.3.3 Measurement Uncertainty

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety TIB (Bone Thermal Index): It provides an estimate of potential temperature rise when the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone.

  • Page 166: A4.6 Transducer Acoustic Output Parameters List

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A4.6 Transducer Acoustic Output Parameters List A4.6.1 Test of Wired Transducer(F15) Acoustic output reporting table (IEC60601-2-37:2007+AMD1:2015, table 201.103) Transducer Model: US-TF Nominal Frequency: 1.0MHz...
  • Page 167 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety (Hz) 2000.00 2000.00 (cm) Φ3.46 Ele. (cm) Φ3.46 Focus(mm) Fixed Operating Control Depth(mm) Fixed Conditions Frequency(MHz) Acoustic output reporting table (IEC60601-2-37:2007+AMD1:2015, table 201.103) Transducer Model: US-SF Nominal Frequency: 1.0MHz...

  • Page 168: A4.6.2 Test Of Wireless Transducer(F15 Air)

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety (usec) 91.78 91.78 (Hz) 2000.00 2000.00 Φ2.65 (cm) Ele. (cm) Φ2.65 Focus(mm) Fixed Operating Control Depth(mm) Fixed Conditions Frequency(MHz) A4.6.2 Test of Wireless Transducer(F15 Air) Acoustic output reporting table (IEC60601-2-37:2007+AMD1:2015, table 201.103)
  • Page 169 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Nominal Frequency: 1.0MHz Operating Mode: PW Mode SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.045 21.18 0.12 (MPa) 0.045 (mW) 11.41...

  • Page 170: A4.6.3 Standard Parameter Equal Contrast List

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Nominal Frequency: 1.0MHz Operating Mode: PW Mode SPTA.3 SPPA.3 Acoustic Output (mW/cm (W/cm Global Maximum Value 0.036 13.57 0.075 (MPa) 0.036 (mW) 11.38...
  • Page 171 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Attenuated Pulse-average Intensity at the point of at max MI pi.α Maximum MI -12dB Output Beam Area aprt Mechanical Index Soft Tissue Thermal Index...

  • Page 172: Appendix 5 Abbreviation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Abbreviation Appendix 5 Abbreviation The abbreviations used in this manual and their full names are listed below: Abbreviation Full Name Alternative Current Automatic Fetal Movement [Detection]...
  • Page 173 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Abbreviation Short-Term Variation Systolic Blood Pressure TEMP Temperature TOCO Tocotonometer Uterine Activity [TOCO/IUP] Ultrasound [Transducer] - 157 - 014_14.1_F15_Series_User_Manual 173／202...

  • Page 174: Appendix 6 Ordering Information

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ordering Information Appendix 6 Ordering Information Accessories (standard and optional configuration) supplied or approved by the manufacturer can be used with the monitors. See the following table for details.
  • Page 175 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ordering Information 01.57.078001 Ultrasound Gel PARKER 01.57.471447 Belt 1400mm*58mm 02.01.210095 Remote Event Marker 02.01.210095 REM,2.6m 02.01.210120 SpO2 Sensor DB9,SH1,adult, 1m, reusable D Type 7Pin,SH1,adult, 1m, 02.57.225039...
  • Page 176 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual Ordering Information 01.57.471868 Thermosensitive Paper Phillips, IEC Standard 01.13.037122 Power Cord AHA Standard ID996, Rechargeable 01.21.064381 Battery 5100mAh Lithium-ion Battery , Switching Power UES18LCP-050300SP 01.21.064414...

  • Page 177: Appendix 7 Emc Information

    The F15 Series Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer of the user of the F15 Series Fetal & Maternal Monitors should assure that it is used in such and environment.

  • Page 178: A7.2 Electromagnetic Immunity

    Guidance and manufacture’s declaration – electromagnetic immunity The F15 Series Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of F15 Series Fetal & Maternal Monitors should assure that it is used in such an environment.
  • Page 179 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual EMC Information Mains power quality should be 0 % U 0,5 cycle 0 % U 0,5 cycle that of a typical commercial or At 0° , 45° , 90° , 135° , At 0°...
  • Page 180 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual EMC Information Test Levels RFID Specification Frequency Test level (RMS) Result ISO 14223 134.2 kHz 65 A/m Complies ISO/IEC 14443-3 (Type A) 13.56 MHz 7.5 A/m...

  • Page 181: A7.3 Electromagnetic Immunity

    The F15 Series Fetal & Maternal Monitors are intended for use in the electromagnetic environment specified below. The customer or the user of F15 Series Express Fetal & Maternal Monitors should assure that it is used in such an environment.
  • Page 182 If the measured field strength in the location in which the F15 Series Fetal & Maternal Monitors are used exceeds the applicable RF compliance level above, the F15 Series Fetal & Maternal Monitors should be observed to verify normal operation.

  • Page 183: A7.4 Recommended Separation Distances

    The F15 Series Fetal & Maternal Monitors are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the F15 Series Fetal & Maternal Monitors can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the F15 Series Fetal &...

  • Page 184: Appendix 8 Limitations Of Ultrasonic Monitoring

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions Appendix 8 Limitations of Ultrasonic Monitoring A8.1 How Does Ultrasound Work When the ultrasound waves strike an object, they bounce back and create an echo. If the object moves toward the sound source, the frequency of the echo increases.
  • Page 185 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions (3) Halving: When the FHR increases to 180 bpm or higher, it is possible for the monitor to mistake the two separate hearbeats for the diastole and systole of a single heartbeat.

  • Page 186: A8.3 Audio Output And Screen Reading

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions electrode to obtain precise FHR with direct fetal ECG as the signal source. (4) Erratic Traces / Drop out When the fetal heart moves partially out of the ultrasound wave path, the transducer receives mixed or weak signals, and thereby the monitor presents erratic traces.
  • Page 187 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions the high-frequency signals, so fetal heart sound is heard. On the other hand, the autocorrelation algorithm computes the stronger signal source and thereby the maternal heart/pulse rate is displayed.

  • Page 188: Appendix 9 Wi-Fi Networking And Instructions

    WI-FI Networking and Instructions Appendix 9 WI-FI Networking and Instructions A9.1 General In order to standardize the implementation of the national network construction project of EDAN and unify the technical standards and requirements for construction work, this specification is specially formulated.

  • Page 189: A9.3 Network Installation Process

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions A9.3 Network Installation Process Wireless Network Installation The salesman provides the floor plan and collects the network coverage and Site Survey...
  • Page 190 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions laptops with WirelessMon or Android phones with inSSIDer software. After arriving at the construction site, the sales or after-sales engineer immediately contact the...

  • Page 191: A9.5 Network Design And Implementation

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions Network Plan Network of XX Hospital Note 1: 1. The wireless signal shall cover all marked labour rooms and delivery rooms.
  • Page 192 Please pay attention that Edan recommends to use AP DLINK DAP2230 for Wi-Fi networking between monitor and central station, and the signal strength observed on the monitor end should be no less than -45dB.
  • Page 193 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions Instruction: WiFi has a total of 14 channels, as shown in the figure above: IEEE 802.11b/g standard works in 2.4G frequency band, frequency range is 2.400-2.4835GHz. A total 83.5M bandwidth is divided into 14 sub-channels, and each sub-channel width is 22MHz.
  • Page 194 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions The above picture is a network scanned by a notebook. The AP is set to channel 3, so there is no AP on the channel, and the adjacent channel signal is also weak.
  • Page 195 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions As shown in the above figure, channel 1 and 6 strongly interfere with the AP. In this case, the hospital needs to adjust the channel that interferes with the AP, remove or close the AP. Otherwise, dropouts will happen during data transmission.

  • Page 196: A9.5.2 Wireless Model Network Design

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions Ping 32-byte data from 192.168.1.166: Response from 192.168.1.166: byte=32, time=62ms, TTL=128 Response from 192.168.1.166: byte=32, time=29ms, TTL=128 Response from 192.168.1.166: byte=32, time=46ms, TTL=128 Response from 192.168.1.166: byte=32, time=39ms, TTL=128...
  • Page 197 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions occupancy exceeds 50% to ensure that sufficient bandwidth can be used in the channel for the monitor so as to avoid frequent disconnection and interference.
  • Page 198 It is recommended to use EDAN-verified network equipment. This verification includes network architecture, device model, firmware version, and specific configuration. EDAN allows the use of higher-version network device firmware, but EDAN does not recommend the use of firmware versions - 182 - 014_14.1_F15_Series_User_Manual...
  • Page 199 Operation of the monitor may be risky if adopting network equipment of which compatibility is not certified by EDAN. In this case, EDAN recommends that the customer test run the monitor for at least 24 hours to confirm that there is no problem with the compatibility.

  • Page 200: A9.6 Continuous Transmission From Disconnection Of Wireless Transducer

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions A9.6 Continuous Transmission from Disconnection of Wireless Transducer There might be WIFI disconnection between wireless transducer and the monitor in following situations: ...

  • Page 201: A9.7 Connecting The Monitor To Mfm-Cns/ Mfm-Cns Lite

    Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions A9.7 Connecting the Monitor to MFM-CNS/ MFM-CNS Lite The monitor can be connected to the central monitoring system through the network: 1.
  • Page 202 Traditional 510(k) of Fetal & Maternal Monitor F15 Series Fetal & Maternal Monitor User Manual WI-FI Networking and Instructions 014_14.1_F15_Series_User_Manual 202／202...

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