About this Manual P/N: 01.54.109276-15 Release Date: Apr. 2012 © Copyright EDAN INSTRUMENTS, INC. 2008 - 2012. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable.
CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents Chapter 1 Safety Guide ................................................................................................................ 1 1.1 Intended Use....................................................................................................................... 1 1.2 Features .............................................................................................................................. 2 1.3 Instruction for Safe Operation..........................................
4.10 Testing Alarms ............................................................................................................... 31 4.11 Patient Alarm Defaults................................................................................................... 31 Chapter 5 Printing ...................................................................................................................... 33 5.1 Function Description..................................................................................
7.6.1 Parts Required ........................................................................................................ 54 7.6.2 Directions for Use of IUPC.................................................................................... 54 7.6.3 IUP Monitoring Procedure..................................................................................... 56 7.6.4 Checking Intrauterine Pressure Cable Function..................................................... 57 7.7 Monitoring Fetal Movement ......
9.3.4 Enabling HR Trace................................................................................................. 79 9.3.5 Switching the HR Alarm On or Off ....................................................................... 79 9.3.6 Changing HR Alarm Limits ................................................................................... 80 9.3.7 Signals Overlap Verification.................................................................................. 80 9.4 Maternal NIBP Monitoring .......
13.2 Contact information ..................................................................................................... 101 Appendix 1 Product Specifications.......................................................................................... 102 A1.1 Environmental Specifications ..................................................................................... 102 A1.2 Physical Specifications................................................................................................
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide Chapter 1 Safety Guide CAUTION Federal (U.S.) Law restricts this device to sale by or on the order of a physician. NOTE: 1 In order to ensure the operator and patient’s safety, read through this chapter before using this monitor. 2 This user manual is written to cover the maximum configuration. Therefore, your model may not have some of the parameters and functions described, depending on what you have ordered. 1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide 1.2 Features The following table lists the measurements that F6 and F6 Express support. Model Measurement F6 F6 Express Dual-FHR √ √ TOCO √ √ FM √ √ AFM √ √ Opt × MECG × √ NIBP × √ MSpO2 × √ TEMP × √ DECG/IUP NOTE: √ = Standard Opt = Optional × = Not Available 1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Ultrasound (FHR1, FHR2) External TOCO Fetal Movement Mark (FM) Fetal Stimulator ((FS) Intrauterine Pressure (IUP) Type BF Non-invasive Blood Pressure (NIBP) Arterial Oxygen Saturation (SpO2) Type BF, defibrillation-proof Direct Electrocardiography (DECG) Type CF Electrocardiography (ECG) Temperature (TEMP) Type CF, defibrillation-proof Safety Guide The monitor described in this user manual is not protected against: a) The effects of high frequ
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide WARNING For using safety: 1 The monitor is provided for the use of qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation. 2 Installation and service should only be performed by qualified service engineers authorized by the manufacturer. 3 The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide WARNING 14 Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide WARNING 30 Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. 31 Connect the grounding wire to the equipotential grounding terminal in the main system.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide WARNING 47 Use the battery only in the F6 or F6 Express monitor. 48 If the liquid leak from the battery gets into eyes, do not rub the eyes. Wash them well with clean water and see a doctor immediately. 49 If the liquid leak from the battery spills onto your skin or clothes, wash well with fresh water immediately. 50 Keep the battery away from fire immediately when leakage or foul odor is detected.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide CAUTION 11 Do not use mobile phones nearby in the process of monitoring. 12 The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives. 13 If the terminals of the battery become dirty, wipe with a dry cloth before using the battery. 14 For information on installing and removing the battery from the monitor, thoroughly read the user manual.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide Socket for NIBP Cuff ( Type BF applied part) Socket for SpO2 Transducer ( Type BF applied part) Socket for Maternal ECG Cable ( Type CF applied part) Socket for TEMP Transducer ( Type CF applied part) RS232 Interface (DB9 or D-Sub) RJ45 Interface Equipotential Grounding Terminal Charge Indicator Alternating Current (a.c.
F6 and F6 Express Fetal & Maternal Monitor User Manual Safety Guide Part Number Serial Number Date Of Manufacture Manufacturer Authorized Representative in the European Community Recyclable Federal (U.S.
F6 and F6 Express Fetal & Maternal Monitor User Manual Installation Guide Chapter 2 Installation Guide NOTE: Installation must be carried out by qualified personnel authorized by the manufacturer. 2.1 Opening and Checking Package Visually examine the package prior to unpacking. If any signs of mishandling or damage are detected, contact the carrier to claim for damage. Open the package; take out the monitor and accessories carefully. Keep the package for possible future transportation or storage.
F6 and F6 Express Fetal & Maternal Monitor User Manual Installation Guide 3) Take the battery out from package. Insert the cable connector into the socket. 4) Put the battery and the cables into the battery compartment. 5) 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.
F6 and F6 Express Fetal & Maternal Monitor User Manual Installation Guide 2.3 Installing Monitor The monitor can be placed on a flat surface, or be installed on a wall or a trolley. The service engineer should install the monitor properly. 2.4 Connecting Power Cable Make sure the AC power supply of the monitor complies with the following specification: 100V-240V~, 50Hz/60Hz. Apply the power cable provided with the monitor. Plug one end of the power cable to the power socket of the monitor.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories Chapter 3 Monitor and Accessories 3.1 Overview NOTE: The pictures and interfaces in this manual are for reference only. 1 Keys 2 Transducer 3 Sockets 4 Alarm Indicator 5 Display Screen 6 Control Knob 7 Charge, AC, Power Indicator 8 Paper Drawer Figure 3-1 Appearance (for reference only) 9 Transducer Holder 10 DECG Socket 11 US2 Socket 12 EXT.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 17 Equipotential Grounding Terminal 18 Antenna 19 USB Socket 20 Power Socket 21 Handle 22 DB9 Socket 23 RJ45Socket Figure 3-4 Rear Panel 24 Fuses 25 Battery Compartment 26 Wall-mounting Holes Figure 3-5 Bottom Panel 3.1.1 Keys and Control Knob Figure 3-6 Keys and Control Knob The Monitor is a user-friendly device with operation conducted by a few keys on the front panel and the control knob.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories (2) SILENCE Function: Silence/reset Press this key to disable the current auditory alarm manifestation, and re-enable the monitor’s response to new abnormal patient condition. (3) AUTO ZERO Function: TOCO zero Adjust the external TOCO contractions trace/value to preset unit (external monitoring contractions) or the IUP trace/value to reference point 0 (internal monitoring contractions). (4) MARK Function: Record an event.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories or confirm the operation. Press the control knob again, and the cursor will be able to move around on the interface/menus. Operation Procedure: a) Rotate the control knob to move the cursor to the item you want; b) Press the control knob; c) One of the following three results will be achieved: A menu pops up on the screen, or the menu is replaced by a new one; A submenu with several options appears on the right of the item.
F6, F6 Express Fetal & Maternal Monitor User Manual Power Indicator Monitor and Accessories On The monitor is powered on. Off The monitor is powered off. 3.2 Accessories The accessories should be connected to the monitor via the sockets on the left side panel. Each accessory has a tab on the connector housing to ensure proper insertion into the appropriate socket on the monitor. 3.2.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.3 Belt Figure 3-9 Belt 3.2.4 Remote Event Marker 1 Marker Plug 2 Press Key 2 1 Figure 3-10 Remote Event Marker 3.2.5 Fetal Stimulator FS-1 Fetal Stimulator is a hand-held device. In order to reduce the time required for the NST when the fetus is asleep, it can be used to give a mild vibrating stimulation to the fetus through the maternal abdomen.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 1 Operating Switch 2 Vibration Rhythm Adjusting Wheel 3 Marker Socket 4 Mode Selecting Switch 5 Vibrating Head 6 Battery Compartment 7 Audio Cable 3.2.6 DECG Cable 1 DECG Cable Plug 2 DECG Cable Connector 1 2 Figure 3-12 DECG Cable 3.2.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.8 IUP Cable 1 2 4 3 Figure 3-14 IUP Connecting Cable Figure 3-15 IUP Cable 1 Interface to IUP Cable 2 Connecting plug 3 Interface to IUP Catheter 4 Interface to Connecting Cable 3.2.9 IUP Catheter 1 Interface to Connecting Cable 2 Catheter 1 2 Figure 3-16 IUP Catheter 3.2.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.11 SpO2 Transducer 1 SpO2 Sensor 2 SpO2 Connector 2 1 Figure 3-18 SpO2 Transducer 3.2.12 NIBP Cuff 1 2 1 NIBP Cuff 2 Cuff Extension Tube Figure 3-19 NIBP Cuff Figure 3-20 Cuff Extension Tube 3.2.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 3.3 Screen 3.3.1 Main Interface 1 3 2 1 Message Window 2 Trace/Menu Window 3 Numeric Window 4 Status Window 4 Figure 3-22 Main Interface The main interface of the monitor displays numbers, traces, menus and monitor status information. The screen background color has four choices: black (default), green, orange and blue. To change the screen color, 1 Select the setup key on the main interface. 2 Select General > Screen Color.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories b) : Alarm reviewing key. Select this key to open the alarm reviewing menu. c) : Paper advancing key. Select this key to advance the paper for 8 cm (PHILIPS paper) or 7 cm (GE paper). d) : Display mode switch. F6 Express monitor has three display modes: maternal-fetal display mode, fetal display mode and maternal display mode. Select this key, and the display mode will switch to the next one in order. e) : Mat. Info key.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories - no battery is loaded. Network connection indicator and device no. i) - the monitor is online. - the monitor is offline. NOTE: The network connection indicator is not available if the net version is Insight or Philips. j) Audio alarm indicator - the audible alarm is switched on. - the audible alarm is switched off infinitely. - the audible alarm is switched off temporarily.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories to exit from this menu. The items in this main menu all have submenu(s). To confirm the setting changes in the submenus, you need to select OK to exit. If you don’t want to store the new settings, select Cancel, or press the START key to return to the main interface. If no operation is performed in 30 seconds, the menu will return to the upper directory. The change will not be stored.
F6, F6 Express Fetal & Maternal Monitor User Manual Monitor and Accessories 3-lead ECG Cable (Snap style, AHA) 01.57.471087 3-lead ECG Cable (Grabber style, IEC) 01.57.471098 3-lead ECG Cable (Grabber style, AHA) 01.57.471095 Disposable ECG Electrode (FDA) 11.57.471060 Disposable ECG Electrode (CE) 11.57.471056 SpO2 Transducer 12.01.109069 NIBP Cuff (Upper Arm Perimeter 25cm-35cm, for Adult) 01.57.40029 NIBP Cuff Extension Tube 01.59.036118 TEMP Transducer 01.15.
F6 and F6 Express Fetal & Maternal Monitor User Manual Alarms Chapter 4 Alarms 4.1 Alarm Classification The monitor has two types of alarm: patient alarm and technical alarm. Patient alarms indicate the situation of vital sign exceeding its configured limit. They can be disabled. The adjustable alarm limits determine the conditions that trigger the alarm. Technical alarms indicate that the monitor can not measure and therefore can not detect critical patient conditions reliably. They cannot be disabled.
F6 and F6 Express Fetal & Maternal Monitor User Manual Alarms 4.3 Visual Alarm When an alarm is active, - Alarm indicator: the alarm indicator lights up: Alarm Category Indicator Color Flashing Frequency Duty Cycle High level alarm red 1.4Hz to 2.8Hz 20% to 60% on Medium level alarm yellow 0.4Hz to 0.
F6 and F6 Express Fetal & Maternal Monitor User Manual Alarms 4.6 Choosing Alarm Silence Duration You can change the alarm silence duration, 1 Select the setup key on the main interface. 2 Select Alarm > Silence Duration. 3 Select Infinite (default), 1 min, 2 min or 3 min. 4 Select OK. 4.7 Choosing Signal Loss Delay When the fetal signal is lost and this condition continues for a certain time, the monitor issues a technical alarm. This time (signal loss delay) is adjustable.
F6 and F6 Express Fetal & Maternal Monitor User Manual Alarms When the monitor gives out an alarm and catches your attention, you should: - Check the patient’s condition. - Identify the cause of the alarm. - Silence the alarm if necessary. - Check if the alarm is terminated when the alarm condition is solved. When the monitored parameter(s) come(s) back within the adjusted limits, or if the abnormal technical condition does not exist any longer, the monitor stops giving out the alarm. 4.
F6 and F6 Express Fetal & Maternal Monitor User Manual Alarms SpO2 Alarm On, Off On SpO2 Low Alarm Limit 50% ~ 99%, in increments of 1 90% SpO2 High Alarm Limit 51% ~ 100%, in increments of 1 100% SpO2 Alarm Delay 0 second, not adjustable 0 second SpO2 Alarm Level Medium, not adjustable Medium SYS Alarm On, Off On SYS Low Alarm Limit 30 mmHg ~ 269 mmHg, in increments of 1 90 mmHg SYS High Alarm Limit 31 mmHg ~ 270 mmHg, in increments of 1 160 mmHg SYS Alarm Delay 0 second, not adj
F6 and F6 Express Fetal & Maternal Monitor User Manual Printing Chapter 5 Printing 5.1 Function Description The built-in thermal recorder applied in the monitor supports both the American and international standard wide recorder paper. It prints continuous traces synchronously along with marks. The monitor supports some other functions listed below: Auto start printing: If the function is enabled, the recorder starts printing automatically when new monitoring starts (the START key is pressed).
F6 and F6 Express Fetal & Maternal Monitor User Manual Printing 5.2 Printing Configuration NOTE: All the parameters should be well configured before printing starts. You can not change the configuration in the process of printing. 5.2.1 Switching Auto Start Printing On or Off You can switch auto start printing on or off: 1 Select the setup key on the main interface. 2 Select Start Monitoring > PRINT. 3 Select ON or OFF (default). 4 Select OK. 5.2.
F6 and F6 Express Fetal & Maternal Monitor User Manual Printing 5.2.4 Switching Print Self-Check On or Off You can switch on or off the print self-check feature: on the main interface. 1 Select the setup key 2 Select Recorder > Print Self-Check. 3 Select ON or OFF (default). 4 Select OK. 5.2.5 Changing Printing End Volume The monitor gives a tone when printing ends, and this tone volume is adjustable. 1 Select the setup key on the main interface. 2 Select Recorder > Printing End.
F6 and F6 Express Fetal & Maternal Monitor User Manual Printing Item Information Description 1. Self-Check Trace The monitor prints a self-check trace after being switched on. It is used to check if the recorder paper is properly loaded. 2. Paper Settings The paper settings of the monitor. It consists of the paper type and paper style, e.g. “G 50-210”, indicating that the paper type is “F9-G”, and the paper style is International. 3. Paper Type There are two types of paper: F9-G and F9-P.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation Chapter 6 Pre-Monitoring Preparation 6.1 Loading Recorder paper CAUTION 1 Only use the recorder paper provided by the manufacturer, otherwise the recorder may be damaged. This kind of damage is not covered by warranty. 2 Configured with different hardware, the monitor is compatible with both GE and Philips recorder paper. However, the monitor is configured with only one type of paper in the shipment.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 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. NOTE: 1 Be careful when inserting paper. Avoid damaging the thermosensitive print head. 2 Make sure the paper is evenly loaded in the drawer. Otherwise the data will be inaccurate or paper jam will happen.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.2 Switching On WARNING 1 Check if all the metal parts are linked to the protective earth cord and the cord is in good condition before switching on the monitor. 2 If any sign of damage is detected, or the monitor displays some error messages, do not use it on any patient. Contact biomedical engineer in the hospital or our service engineer immediately. Press the POWER switch on the right panel to switch on the monitor.
F6 and F6 Express 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. 6.4 Adjusting Screen Angle The angle between the screen and the top cover of the monitor is adjustable as needed, allowing it to be mounted on a wall or placed on a flat surface.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation 6.5 Setting Date and Time You can change the date and time of the monitor, 1 Select the setup key on the main interface. 2 Select Date and Time. 3 Set the year, month, date, hour, minute and second. The first three numbers are used to set the year, month and date. Their orders vary with the preset Date Format below.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation When disconnecting a transducer, pinch the afterbody of the transducer plug and pull it out slightly. NOTE: Never try to disconnect the transducer by pulling the cable directly. 6.7 Placing Accessories in the Holder In order to protect the accessories, place the not-in-use accessories in the holder. The accessory holder is on the left of the front panel.
F6 and F6 Express Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation and thereby produces interfering signals. Therefore, when monitoring a patient, it is recommended to remove or disconnect the transducer that is not in use. 6.8 Adjusting Volume The monitor automatically detects which channel the ultrasound transducer is connected to.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Chapter 7 Fetal Monitoring WARNING 1 The monitor is not intended for use in intensive care units (ICU), operating rooms or for home use. 2 Do not apply it during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 3 Always check if the alarm settings are appropriate for your patient before starting monitoring. 7.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.2.2 FHR Monitoring Procedure 1) Placing Transducer Belt Place the transducer belts across the bed, ensuring that the belt will be around the abdomen when it is fastened. Lay the patient on the bed. Alternatively, the patient can take a sitting position. Arrange the belt around her abdomen. 2) Determining the Transducer Position - Determine the fetal position using Leopold’s maneuvers.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring NOTE: 1 Do not mistake the high maternal heart rate for fetal heart rate. The fetal pulse can be distinguished from the maternal pulse by feeling the mother’s pulse during the examination. 2 The best quality records will only be obtained if the probe is placed in the optimum position. Positions with strong placental sounds or umbilical blood flow sound should be avoided.
F6 and F6 Express Fetal & Maternal Monitor User Manual 1 Select the setup key 2 Select Alarm > FHR. Fetal Monitoring on the main interface. 3 Select a value from 60 ~ 205 for Low Alarm Limit. 4 Select a value from 65 ~ 210 for High Alarm Limit. 5 Select OK. 7.2.5 Changing FHR Alarm Delay You can change the FHR alarm delay. The alarm delay indicates how long the measured result continues exceeding its limit before the alarm is triggered. 1 Select the setup key on the main interface.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring The following illustration shows how these parts should be connected: (3) (2) (1) Figure 7-2 Connection for DECG Monitoring 7.3.3 Preparing Patient's Skin Prior to Placing Electrodes The skin is a poor conductor of electricity; therefore preparation of the patient's skin is important to facilitate good electrode contact to skin. 1) Shave hair from electrode sites, if necessary. 2) Wash the sites thoroughly with soap and water.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring artifacts are suppressed and not recorded. When it is off, the artifacts are shown as well as the fetal heartbeats. You can choose to switch the artifact suppression on or off. 1 Select the setup key on the main interface. 2 Select Fetus > Artifact Suppression. 3 Select ON (default) or OFF. 4 Select OK. WARNING When artifact suppression is on, fetal arrhythmia will also be suppressed.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.3.7 DECG Monitoring Procedure 1 Perform a vaginal examination to identify the fetal presenting part. 2 Prepare the patient’s skin using the procedures described in section 7.3.3 Preparing the Patient's Skin Prior to Placing Electrodes. 3 Attach the fetal spiral electrode to the fetal presenting part using the procedures described in section 7.3.6 Directions for Using Fetal Spiral Electrode.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.2 Monitoring FHR with Ultrasound to acquire FHR signals for both channels. Press CHANNEL key to switch the FH sound from one channel to the other. When the two US transducers are fixed, make sure FH sounds from both channels are clear, two FHR traces and two FHR numerics are displayed on the screen. NOTE: To ensure that both transducers stay at the optimum location, each transducer should be fixed with a separate belt. 7.4.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 3 Select -20 bpm (default), 0 bpm or +20bpm. 4 Select OK. This preset FHR2 offset will be printed on the recorder paper every 10 minutes. “FHR2: -20bpm”: the FHR2 trace is 20bpm lower than it really is. “FHR2: +20bpm”: the FHR2 trace is 20bpm higher than it really is. 7.5 Monitoring Uterine Activity Externally 7.5.1 Parts Required 1) TOCO transducer 2) Belt 7.5.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 3) Adjusting the Numeric to Zero Press the AUTO ZERO key to adjust the numeric to the baseline. Make sure this is not done during a contraction. The uterine activity reading at this point should be 30 ~ 90. A flat-top aligned with 100 on the TOCO scale indicates the belt is too tight, and you need to adjust it. Wipe off any gel presents on abdomen around this area.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 4) Check that the value on the display shows this change in pressure. If a TOCO transducer fails the test, repeat this test with another transducer. If the second one passes the test, defect of the first transducer is confirmed. Replace it with a good one. If the second transducer fails the test as well, contact the manufacturer for service. 7.6 Monitoring Uterine Activity Internally (F6) NOTE: This feature is only available on F6.
F6 and F6 Express Fetal & Maternal Monitor User Manual not clearly visible, stop advancing when the introducer. Fetal Monitoring symbol on the catheter meets the NOTE: For easier insertion, do not twist the catheter in the introducer. 7) The IUPC may be spontaneously filled with amniotic fluid. This can be seen in the clear lumen of the catheter. The filter cap will prevent the amniotic fluid from leaking. 8) Slide the introducer out of the vagina along the catheter.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-10 Rezeroing the system 2) During this period, adjust the monitor to zero by pressing AUTO ZERO key. 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.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring ZERO key. Make sure the display numeric and trace are both “0”. 5) Ask the mother to cough. A spike on the trace in response to the cough indicates proper positioning and function of the IUPC. 6) Wash timely during monitoring. A spike on the tracing will respond to the washing. 7.6.4 Checking Intrauterine Pressure Cable Function To test an IUP cable’s function: 1) Disconnect the catheter from the cable.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring AFM monitoring can be switched off; its gain is adjustable. NOTE: AFM monitoring is not available when FHR is monitored by DECG or a cordless ultrasound transducer. 7.7.2 Enabling or Disabling AFM Trace The AFM trace on the screen and recorder paper can be enabled or disabled. 1 Select the setup key on the main interface. 2 Select Fetus > AFM. 3 Select ON or OFF (default). 4 Select OK. 7.7.
F6 and F6 Express Fetal & Maternal Monitor User Manual 1 Select the setup key Fetal Monitoring on the main interface. 2 Select Fetus > AFM Threshold. 3 Select a value from 0 ~ 100 for AFM Threshold, and the default is 20. 4 Select OK. 7.7.6 Choosing FM Source When AFM monitoring is enabled, the FM has two sources: AFM and MFM. To choose the FM source, 1 Select the setup key on the main interface. 2 Select Fetus > FM Source. 3 Select MFM (default) or AFM. 4 Select OK. 7.7.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring 7.9 Inputting Maternal Information (Mat. Info) 7.9.1 Auto ID After you press the START key, the system creates an auto-ID for the present patient. (if Mat. Info inputting is switched off.) The auto-ID consists of the date and time when the monitoring starts. 7.9.2 Changing Maternal Information You can change the patient’s information after the monitoring starts: 1 Select Mat. Info key on the main interface. Figure 7-13 Mat.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring paper will be the auto-ID. The new ID will be printed 10 minutes later. 3 The ID and name are shown on the screen, the paper printout and the archive list. 4 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 Inputting On or Off The Mat.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display Chapter 8 Fetal Monitoring Display (F6) 8.1 Traces WARNING Due to the LCD size, resolution and system settings, the traces displayed on the screen may look different from the recorder printout. The printout should prevail when making diagnoses.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display service engineers have access to it), a DECG trace is shown underneath other traces on the screen. Besides, some other symbols appear among the traces: This symbol indicates the new monitoring starts. This symbol indicates a manual fetal movement, and it appears after the patient presses the FM marker when she feels a fetal movement.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.2.1 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. The main interface only displays the new patient’s data. During monitoring, the data is saved every 10 minutes. All data of the same patient is saved in a file (the maximum duration is 24 hours, the rest data is saved in another file.) The files are stored in the monitor.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 3 Select ID, input the patient ID with the soft keyboard and select Enter. 4 Select Name, input the patient’s name with the soft keyboard and select Enter. NOTE: You can input only a part of the patient ID or name. However, the more information you input, the more accurate result you will get. 5 Select Search. The files with the matched information are listed in the window.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display However, when printing traces in a file, the SpO2 trace cannot be printed. 3 You must pause before printing starts. Printing in the process of playback might result in failure information on the paper. 4 After the reviewed data has been printed out, the recorder does not switch back to real-time printing automatically. 8.2.4 CTG Analysis CTG analysis aims at a real-time trace, providing some reference data for the physicians.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 1) CTG Analysis Timer 2) Analysis Results Figure 8-5 CTG Analysis Results Refer to figure 8-6, the CTG analysis results on the screen include: 1) CTG Analysis Timer: The CTG analysis timer starts when the recorder starts printing; it stops when the timer reaches 60 minutes (the timer turns into >60) and resets when the recorder stops printing. 2) CTG Analysis Results: SIGNAL LOSS: the proportion of the signal loss.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display NOTE: Do not disconnect the ultrasound transducer(s) before the printing stops, otherwise the analysis results will not be printed. 8.2.5 Marking a Note When there is a significant event, you can press the MARK key on the front panel to add a note. will appear on both the main interface and the recorder paper. An event mark However, an event mark cannot clearly indicate an event.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.3 Numerics FHR1 FHR2 TOCO MFM Figure 8-6 Fetal Monitoring Numerics The fetal monitoring values in the numeric window include FHR1/DFHR value, FHR2 value, TOCO/IUP value and FM count: FHR1/DFHR : FHR signal quality. When the quality is poor, it turns into . : FH refreshing rate : FH sound volume adjusting key : FH sound volume indicator 137: FHR1/DFHR measurement numeric.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.4 Fetal Monitoring Alarm Messages During fetal monitoring, the monitor gives alarms for the situations that need the physicians to pay attention to. The alarm messages are listed below. 8.4.1 Patient Alarm Messages Alarm Message Source Cause Countermeasure US FHR1 or FHR2 measuring result (xxx) is higher than the set upper limit (yyy) over the alarm delay time.
F6 and F6 Express Fetal & Maternal Monitor User Manual Fetal Monitoring Display DECG LEADS OFF DECG The spiral electrode is not well connected. Check the connection of the spiral electrode. DECG UNPLUGGED DECG The DECG lead is not well connected to the monitor. Check the connection of the DECG cable. DECG SIGNAL LOSS DECG DECG signal is too weak for the system to analyze. DECG EQUIP MALF DECG The DECG board can not communicate with the system successfully.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Chapter 9 Maternal Monitoring (F6 Express) WARNING 1 Do not apply it during electro-surgery or MRI; otherwise it might result in harming the patient or the operator. 2 Always check if the alarm settings are appropriate for your patient before starting monitoring. 3 Check for any fault of the transducers before applying them to the patient. NOTE: This feature is only available on F6 Express. 9.1 Maternal ECG Monitoring 9.1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform. A good ECG signal should be – 1) With normal QRS wave. 2) Tall and narrow with no notches. 3) With tall R-wave completely above the baseline. 4) With T-wave less than one-third of the R-wave height. 5) With P-wave much smaller than the T-wave. R T P Q S Figure 9-1 Standard ECG Waveform 9.1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: 1 To ensure patient’s safety, all leads must be attached to the patient. 2 Check everyday if the skin is irritated from attachment of electrodes, if so, change for new electrodes or change their sites every 24 hours. 3 Recycle or dispose the used electrodes properly to protect the environment. 9.1.3 ECG Monitoring Procedure 1) Prepare the skin for ECG monitoring. Refer to section 7.3.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.1.6 Enabling ECG Calibration When windage of the ECG waveform is suspected, enable ECG calibration to validate the wave. 1 Select the setup key on the main interface. 2 Select Mother > ECG Calibration. 3 Select Calibration or OFF (default). 4 Select OK. The monitor creates a square wave in the ECG area. Compare the square wave with the ECG guage. If the error is larger than 0.5mm, change the ECG gain.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 1 Do not put the SpO2 sensor on the extremities with arterial catheter or venous syringe. 2 Do not perform SpO2 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 SpO2 numeric.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 5) Intravascular dye injections. 6) Improper sensor application. 7) Sensor temperature. (Maintain the temperature between +28 °C (+82.4 °F) and +41 °C (+105.8 °F) for best operation) 8) Placement of the sensor, such as on an extremity that has a NIBP cuff, arterial catheter, or intravascular line. 9) Significant concentrations of dysfunctional hemoglobin, such as carboxyhemoglobin and methemoglobin.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.2.3 Enabling SpO2 Trace Printing The real-time SpO2 measurement result is displayed in the parameter area of the main interface. You can choose to print them as a continuous trace on the recorder paper (refer to figure 5-1). To enable or disable SpO2 trace printing, 1 Select the setup key on the main interface. 2 Select Recorder > SpO2 Trace. 3 Select ON or OFF (default). 4 Select OK. 9.2.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3.2 Choosing HR Source You can change the HR source. 1 Select the setup key on the main interface. 2 Select Mother > HR Source. 3 Select ECG (default) or Pulse. 4 Select OK. 9.3.3 Changing HR Beep Volume When the HR beep is enabled, the monitor gives a beep sound of maternal heart. To change the HR beep volume, 1 Select the setup key on the main interface. 2 Select Mother > HR Beep. 3 Select OFF (default), Low or High.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3.6 Changing HR Alarm Limits You can change the HR alarm limits. 1 Select the setup key on the main interface. 2 Select Alarm > HR. 3 Select a value from 30 ~ 239 for Low Alarm Limit. 4 Select a value from 31 ~ 240 for High Alarm Limit. 5 Select OK. 9.3.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: The monitor is intended to measure NIBP for adults only. Measurement Limitations 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.
F6 and F6 Express Fetal & Maternal Monitor User Manual Thigh (Adult) 46 cm ~ 66 cm Maternal Monitoring 21 cm 2) Squeeze the cuff to discharge the air. 3) Apply the cuff to the patient; make sure that the symbol "Φ" is over the appropriate artery (Refer to figure 9-4). Ensure that the cuff is not wrapped too tightly around the limb. Excessive tightness may cause discoloration and eventual ischemia of the extremities. Figure 9-4 Applying the Cuff 9.4.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: After the NIBP key is pressed, the system checks uterine pressure. If the pressure is higher than 50, it will automatically delay the NIBP measuring for 20 seconds. To stop the current measurement Press the NIBP key anytime during the current measurement to stop it. Another measurement will start after the time interval.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 9.4.6 Correcting the Measurement To correct the measurement if the limb is not at heart level, add 0.75 mmHg (0.10 kPa) for each inch higher. deduct 0.75 mmHg (0.10 kPa) for each inch lower. 9.4.7 Changing NIBP Unit You can change the NIBP unit. 1 Select the setup key on the main interface. 2 Select Mother > Unit (NIBP Setup). 3 Select mmHg (default) or kPa. 4 Select OK. 9.4.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring 4 Select a value from 11 ~ 245 for High Alarm Limit. 5 Select OK. 9.4.11 Changing MAP Alarm Limits You can change the MAP alarm limits. on the main interface. 1 Select the setup key 2 Select Alarm > MAP. 3 Select a value from 20 ~ 254 for Low Alarm Limit. 4 Select a value from 21 ~ 255 for High Alarm Limit. 5 Select OK. 9.4.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring CAUTION Be cautious when taking and putting the TEMP transducer. Do not pull the cable too tight or it might cause mechanical damage. 9.5.2 Changing TEMP Unit You can change the TEMP unit. 1 Select the setup key on the main interface. 2 Select Mother > Unit (TEMP Setup). 3 Select ºC (default) or ºF. 4 Select OK. 9.5.3 Switching the TEMP Alarm On or Off You can choose to switch the TEMP alarm on or off.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display Chapter 10 Maternal Monitoring Display (F6 Express) 10.1 Display Mode F6 Express has three display modes: maternal-fetal display (figure 10-1), fetal display (figure 10-2) and maternal display (figure 10-3). To change the display mode, select the display mode switch display mode will switch among the three modes. Figure 10-1 Maternal-Fetal Display mode - 87 - on the main interface.
F6 and F6 Express Fetal & Maternal Monitor User Manual Figure 10-2 Fetal Display Mode Figure 10-3 Maternal Display Mode - 88 - Maternal Monitoring Display
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display 10.2 Maternal Monitoring Traces ECG Waveform Maternal Vital Sign List SpO2 waveform Figure 10-4 Maternal Monitoring Traces F6 Express displays both maternal monitoring traces and fetal monitoring traces on the same screen. The maternal monitoring traces include ECG waveform and SpO2 waveform. The fetal monitoring traces are the same as traces of F6, refer to 8.1 Fetal Monitoring Traces for more information. 10.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-6 Maternal Vital Sign List The maternal vital sign list can be reviewed: select the list and then rotate the control knob to review the previous lists. 10.4 Numerics Besides the fetal numerics, the numeric window of F6 Express includes maternal vital signs: SpO2, NIBP, HR and TEMP: FHR1 FHR2 MFM TOCO SpO2 NIBP TEMP HR Figure 10-7 Numeric Window SpO2 99: Current SpO2 measurement numeric.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display (ECG)/(Pulse): The current HR source. 81: Current maternal heart rate measurement numeric. HR (ºC)/(ºF): TEMP unit. 37.2: Current TEMP measurement numeric. TEMP 10.5 Maternal Monitoring Alarm Messages Besides the fetal monitoring alarms, F6 Express also gives alarms for the situations that occur during maternal monitoring. The alarm messages are listed below. 10.5.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display 10.5.2 Technical Alarm Messages Alarm Message Source Cause Countermeasure ECG ECG signal exceeds measurement limits. Signals Overlap (FHR1, HR) US+ECG /Pulse US transducer 1 has picked up the maternal heart signal; the signals overlap. Reposition the US transducer 1 until the fetal heart signal is detected.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maternal Monitoring Display NIBP A different cuff other than the one supplied by the manufacturer is used. Use the cuff supplied by the manufacturer. NIBP The cuff, hose and (or) connector are (is) damaged. Check and replace the leaking part(s). Contact the manufacturer for service if required. NIBP Cuff is too loose or the patient pulse is too weak. Use other methods measure NIBP.
F6 and F6 Express Fetal & Maternal Monitor User Manual After Monitoring Chapter 11 After Monitoring 11.1 Completing Monitoring After monitoring, 1) Remove transducers or electrodes from the patient; wipe the remaining gel off the patient and the transducer with a clean soft cloth or tissue. 2) Press the PRINT key to stop printing, and press the paper advancing key advance the paper. 3) Wait the paper to stop and then tear it off along the perforation.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter 12 Maintenance and Cleaning 12.1 Maintenance 12.1.1 Maintaining Inspection (1) Visual Inspection Prior to using the monitor every time, do the following inspections: Check the monitor and accessories to see if there is any visible evidence of damage that may affect patient safety. Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning 12.1.2 Maintenance of Monitor Keep the exterior surface of the monitor clean, free of dust and dirt. The gathering of dew on the screen may occur with abrupt temperature or humidity changes. A table environment is recommended. Stop using the monitor and contact the service personnel immediately if accidental wetting occurs. Scratching and damaging the screen should be avoided. 12.1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning 12.1.6 Maintaining the Battery It is required to follow the instructions in this user manual during installation, storage and maintenance of the battery. When the battery is charged, used or stored, keep it away from objects or materials with static electric charges. The recommended charge temperature range is from 0 ºC (+32 ºF) to +40 ºC (+104 ºF). Do not exceed this range.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 5 Do not allow any liquid to enter the product, and do not immerse any part of the monitor into any liquid. 6 Avoid pouring liquids on the monitor while cleaning. 7 Do not allow any remaining solution on the surface of the monitor. NOTE: 1 The monitor surface can be cleaned with hospital-grade ethanol and dried in air or with crisp and clean cloth.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 4 Only clean the outer surface of the connectors, make sure no liquid goes into the connector. 5 After cleaning, no remaining cleanser is allowed on the surface. (2) Cleaning of Belt Wash soiled belts with soap and water. The water temperature must not exceed +60 ºC (+140 ºF). (3) Cleaning of NIBP Cuff The cuff can also be machine-washed or hand-washed. Hand-washing will prolong the life of the cuff.
F6 and F6 Express Fetal & Maternal Monitor User Manual Maintenance and Cleaning 12.3 Disinfecting Clean the equipment before disinfecting.
F6 and F6 Express Fetal & Maternal Monitor User Manual Warranty and Service Chapter 13 Warranty and Service 13.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance.
F6 and F6 Express Fetal & Maternal Monitor User Manual Product Specifications Appendix 1 Product Specifications A1.1 Environmental Specifications Working Transport and Storage Temperature: +5 ºC ~ + 40 ºC ( +41 ºF ~ +104 ºF) Relative Humidity: 25% ~ 80% (non-condensing) Atmospheric Pressure: 860hPa ~ 1060hPa Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF) Relative Humidity: 25% ~ 93% (non-condensing) Atmospheric Pressure: 700hPa ~ 1060hPa A1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Product Specifications US/TOCO Transducers: IPX8 Other Accessories: No liquid ingress protection Disinfection/Sterilizing Method: Refer to this user manual for details EMC Group I Class A Working System Continuous running equipment Display LCD Size: 10.1” (Diagonal) Resolution: 800 × 3 (RGB) × 480 Display Mode: Normally white, Transmissive Pixel Pitch: 0.0925 mm(W) × 0.276 mm (H) Active Area: 222.0 mm(W) × 132.
F6 and F6 Express Fetal & Maternal Monitor User Manual Product Specifications TOCO Transducer Cable Length: 2.5 m Weight: 180 g Dimension: 88 mm × 35 mm Remote Event Marker Length: 2.5 m Weight: 56 g ECG Cable Length: 3m Weight: 213 g SpO2 Cable Length: 2.4 m Weight: 68 g NIBP Cable Length: 3.3 m Weight: 194 g TEMP Cable Length: 3m Weight: 55 g A1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Technique: DFHR Range: DECG TOCO IUP AFM Marking ECG Product Specifications Peak-peak detection technique Measurement 30bpm ~ 240bpm Resolution: 1bpm Accuracy: ±1bpm Input Impedance: > 10M (Differential, DC50/60Hz) Input Impedance: > 20M (Common Mode) CMRR: > 110dB Noise: < 4µVp Skin Voltage Tolerance: ±500mV Fetal Input Current: 20µVp-3mVp Voltage TOCO Range: 0% ~ 100% Non-linear Error: ±10% Resolution: 1% Zero Mode:
F6 and F6 Express Fetal & Maternal Monitor User Manual N.C. Patient Auxiliary Current d.c. 10µA (Limit) a.c. 10µA ECG Product Specifications S.F.C. 50µA 50µA Differential Input Impedance >5MΩ Display Sensitivity 2.5mm/mV (×0.25), 5mm/mV (×0.5), 10mm/mV (×1), 20mm/mV (×2), AUTO gain Sweep speed 25mm/s d.c.
F6 and F6 Express Fetal & Maternal Monitor User Manual SpO2 PR Measuring Accuracy: ±2 bpm Data update period: 2s Product Specifications Wave length Red light (660±3) nm Infrared light (905±5) nm Emitted light energy Not more than 15 mW Measurement Range: Systolic pressure: 40mmHg ~ 270mmHg Diastolic pressure: 10mmHg ~ 215mmHg Mean pressure: 20mmHg ~ 235mmHg NIBP Measuring Time: ≤ 120 seconds (for adult) Software Over Voltage Limit: ≤ 297mmHg Hardware Over Voltage Protection: (325 ±
F6 and F6 Express Fetal & Maternal Monitor User Manual Product Specifications 70mm (American Standard) FHR printout width: 80mm (International Standard) 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 Fast Print Speed (Stored Traces): Up to 25mm/sec Paper Advancing: 20mm/sec Accuracy of data: ± 5% (X axis) ± 1% (Y axis) Resolution: 8
F6 and F6 Express Fetal & Maternal Monitor User Manual Storage Temperature: Product Specifications Short Term (≤ 1 month): -20 ºC ~ +60 ºC (-4 ºF ~ +140 ºF) Medium Term (≤ 3 months): -20 ºC ~ +45 ºC (-4 ºF ~ +113 ºF) Long Term (≤ 1 year): -20 ºC ~ +20 ºC (-4 ºF ~ +68 ºF) During storage, recharge the battery at least every six months. Cycle Life: ≥ 500 times A1.6 Low Output Summary Table Low Output Summary Table (for systems with no transducers having global maximum index values exceeding 1.
F6 and F6 Express Fetal & Maternal Monitor User Manual 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). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1.
F6 and F6 Express Fetal & Maternal Monitor User Manual Input/Output Connector RJ45 Interface Pin Signal Input/Output 1 TD+ Output 2 TD- Output 3 RD+ Input 4 Reserved 5 Reserved 6 RD- 7 Reserved 8 Reserved Input CAUTION Only the PC or telemetry system recommended by the manufacturer can be connected to the signal input/output interface of the monitor. Other equipment is forbidden.
F6 and F6 Express Fetal & Maternal Monitor User Manual Troubleshooting Appendix 3 Troubleshooting A3.1 No Display Phenomenon Power indicator is off. Possible Cause Solution Power cable is loose. Tighten the power cable. The fuse is blown. Change the fuse. The battery runs out of power. Connect to AC power supply. A3.2 Noise Phenomenon Possible Cause Too high volume setup. Noise Interfered by mobile phone or other electromagnetic interference source. Solution Turn down the volume.
F6 and F6 Express Fetal & Maternal Monitor User Manual Troubleshooting A3.4 Trouble with Ultrasound FHR Monitoring Phenomenon Inconstant trace / display Possible Cause Solution The patient is overweighted. Monitor FHR with DECG. Improper ultrasound transducer position. Adjust the position of the transducer till the better signal is received. Loose belt. Tighten the belt. Superfluous aquasonic coupling gel. Wipe off superfluous aquasonic coupling gel. Frequent fetal movements.
F6 and F6 Express Fetal & Maternal Monitor User Manual Troubleshooting A3.6 Troubles with Contractions Monitoring (External) Phenomenon Possible Cause Bad trace quality or fluctuant TOCO baseline Too high TOCO sensitivity (higher than 100 unit) Solution The belt is too tight or too loose. Adjust the belt. The belt has no elasticity. Renew the belt. Maternal movement. Request the patient to calm down and stay still. Frequent fetal movements. Delay the monitoring.
F6 and F6 Express Fetal & Maternal Monitor User Manual Troubleshooting Power socket has no standard ground wire. Check if power socket has standard ground wire. The special ground wire connecting with monitor is not properly earthed. Check if the special ground wire connecting with monitor is earthed. A3.9 NIBP and SpO2 No Results Phenomenon NIBP and SpO2 have no results Possible Cause Solution The NIBP cuff is not properly wrapped to the position of patient's arm.
F6 and F6 Express Fetal & Maternal Monitor User Manual 5 Troubleshooting Push the new fuse into the socket for about 1 mm and then screw it clockwise back in position.
F6 and F6 Express Fetal & Maternal Monitor User Manual Appendix 4 Abbreviation The abbreviations used in this manual and their full names are listed below: Abbreviation Full Name AC Alternative Current AFM Automatic Fetal Movement [Detection] BPM Beat(s) Per Minute CTG Cardiotocography DC Direct Current DIA Diastolic Blood Pressure ECG Electrocardiogram FH Fetal Heart FHR Fetal Heart Rate FM Fetal Movement FS Fetal Stimulator HR Heart Rate ICU Intensive Care Unit ID Identity L
F6 and F6 Express Fetal & Maternal Monitor User Manual Appendix 5 EMC Information EMC Information – Guidance Manufacture’s Declaration and A5.1 Electromagnetic Emissions – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The F6/F6 Express Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below.
F6 and F6 Express Fetal & Maternal Monitor User Manual EMC Information A5.2 Electromagnetic Immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The F6/F6 Express Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F6/F6 Express Fetal & maternal Monitor should assure that it is used in such an environment.
F6 and F6 Express Fetal & Maternal Monitor User Manual Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 < 5% UT (> 95% dip in UT) for 0.5 cycle < 5% UT (> 95% dip in UT) for 0.
F6 and F6 Express Fetal & Maternal Monitor User Manual EMC Information A5.3 Electromagnetic Immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING Guidance and manufacture’s declaration – electromagnetic immunity The F6/F6 Express Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F6/F6 Express Fetal & maternal Monitor should assure that it is used in such an environment.
F6 and F6 Express Fetal & Maternal Monitor User Manual EMC Information NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
F6 and F6 Express Fetal & Maternal Monitor User Manual EMC Information A5.4 Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the F6/F6 Express Fetal & maternal Monitor The F6/F6 Express Fetal & maternal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
F6 and F6 Express Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring Appendix 6 Limitations of Ultrasonic Monitoring A6.1 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. If the object moves away from the sound source, the frequency of the echo decreases. This is called “Doppler Effect”.
F6 and F6 Express Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring (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. As a result, a heart rate trace that is half the actual heart rate is produced. This often happens during tachycardia, representing an abrupt switch of the trace to half the actual heart rate.
F6 and F6 Express Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring Stethoscopy should be applied when sudden changes in baseline are detected. If the amniotic membrane rupture and cervical dilatation are sufficient, consider using a spiral electrode to obtain precise FHR with direct fetal ECG as the signal source.
F6 and F6 Express Fetal & Maternal Monitor User Manual Connection of T840 Telemetry System Appendix 7 Connection of T840 Telemetry System The T840 telemetry system of Rimkus Medixintechnik is compatible for use with F6 and F6 Express. This appendix introduces how to connect the T840 telemetry system to F6 and F6 Express, and how the monitors display the monitoring results. The operation and maintenance of the T840 are described in OPERATOR’S MANUAL of T840 telemetry system.
F6 and F6 Express Fetal & Maternal Monitor User Manual Connection of T840 Telemetry System 1. Put the D-Sub convex socket of the signal cable into the D-Sub interface of the monitor. 2. Put the DB15 convex socket of the signal cable into the DB15 interface of the receiver unit. CAUTION 1 DECG cable shares the US1 channel with the telemetry system but has higher priority. Therefore, do not connect the DECG cable to the monitor when using the telemetry system.