About this Manual P/N: 01.54.455327 MPN: 01.54.455327017 Release Date: Jan. 2015 © Copyright EDAN INSTRUMENTS, INC. 2008 - 2015. 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.
information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate 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.......................................
4.1 Alarms Classification ....................................................................................................... 33 4.2 Audible Alarm.................................................................................................................. 33 4.3 Visual Alarm .................................................................................................................... 34 4.4 Choosing the Alarm Display Form ....................................................................
7.2.4 Changing FHR Alarm Limits ................................................................................. 56 7.2.5 Changing FHR Alarm Delay.................................................................................. 56 7.2.6 Testing US Transducers ......................................................................................... 57 7.3 Monitoring FHR with DECG ........................................................................................... 58 7.3.1 Contraindications .....
.9 *Inputting Maternal Information (Mat. Info) ................................................................... 71 7.9.1 Auto ID................................................................................................................... 71 7.9.2 Changing Maternal Information ............................................................................. 71 7.9.3 Switching Mat. Info Inputting On or Off ...............................................................
9.3.2 Choosing HR Source .............................................................................................. 94 9.3.3 Changing HR Beep Volume................................................................................... 94 9.3.4 Enabling HR Trace................................................................................................. 95 9.3.5 Switching the HR Alarm On or Off ....................................................................... 95 9.3.
11.1.3 Features .............................................................................................................. 117 11.2 Installation Guide ......................................................................................................... 118 11.2.1 Opening the Package and Checking ................................................................... 118 11.2.2 Installing Battery ................................................................................................ 118 11.
14.1 Warranty....................................................................................................................... 137 14.2 Contact information ..................................................................................................... 137 Appendix 1 Product Specifications ·························································································· 138 A1.1 Environmental Specifications ..............................................................................
A4.3.3 Measurement Uncertainty ................................................................................. 162 A4.4 Prudent Use Statement ................................................................................................ 163 A4.5 References for Acoustic Output and Safety ................................................................ 163 A4.6 Probe Acoustic Output Parameters List ...................................................................... 164 A4.6.1 Test of Wired Probe ...
F Series 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.
F Series Fetal & Maternal Monitor User Manual Safety Guide 1.2 Features The following table lists the measurements that F6, F6 Express, F9 and F9 Express support. Model F6, F9 F6 Express F9 Express Single-FHR Dual-FHR TOCO FM AFM Opt × Opt MECG × NIBP × MSpO2 × TEMP × Measurement DECG/IUP NOTE: = Standard Opt = Optional × = Not Available 1.
F Series Fetal & Maternal Monitor User Manual Safety Guide does not accept responsibility for safety compliance, reliability and performance if modifications or repairs are carried out by unauthorized personnel. Identical replacement parts must be used.
F Series Fetal & Maternal Monitor User Manual Safety Guide 1.5 Safety Precautions WARNING and CAUTION messages must be observed. To avoid the possibility of injury, observe the following precautions during the operation of the instrument. WARNING For using safety: 1 The monitor or FTS-3 telemetry system (hereinafter called FTS-3) is provided for the use of qualified physicians or personnel professionally trained. 2 Only qualified service engineers can install this equipment.
F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 11 SHOCK HAZARD – Do not connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard.
F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 24 Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, the patient or operator may receive electrical shock or other injury. 25 Disconnect power cord before changing fuses. Replace them with those of the same specifications only.
F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 38 Use the battery only in F6 / F6 Express / F9 / F9 Express. 39 Do not reverse the battery pole or it will cause explosion. 40 Do not unplug the battery when monitoring. 41 Do not heat or throw the battery into a fire. 42 Do not use or leave battery close to fire or other places where the temperature may be above +60 ºC (+140 ºF). 43 Do not immerse, throw, or wet the battery in water/ seawater.
F Series Fetal & Maternal Monitor User Manual Safety Guide WARNING 58 SHOCK HAZARD – The base station and transducers for one patient must be supplied by the same power and do not change the power supply. 59 Please arrange a function test periodically for the system. 60 Do not move the system when it is powered on and do not soak it in any liquid. 61 Please check the transducer, cable and base station periodically. If the transducers are damaged, do not use them in water and repair them in time.
F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION 9 Electromagnetic Interference - Ensure that the environment in which the monitor or FTS-3 is installed is not subject to any source of strong electromagnetic interference, such as CT, radio transmitters, mobile phone base stations, etc. Even though other devices are in accordance with national standard radiation requirements, the monitor or FTS-3 may be interfered.
F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION 21 The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries.
F Series Fetal & Maternal Monitor User Manual Safety Guide CAUTION 12 Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. 13 Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 1.
F Series Fetal & Maternal Monitor User Manual Safety Guide Socket for TEMP Sensor (Type CF applied part) RS232 Interface (DB9 or D-Sub) RJ45 Interface Equipotential Grounding Battery check Alternating Current (a.c.
F Series Fetal & Maternal Monitor User Manual Safety Guide CE marking Disposal method Part Number Serial Number Date Of Manufacture Manufacturer Authorized Representative in the European Community General symbol for recovery/recyclable Caution: Federal (U.S.) Law restricts this device to sale by or on the order of a physician With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No. 601.
F Series Fetal & Maternal Monitor User Manual Safety Guide Ethernet Port (Reserved) Channel Adjustment - 14 -
F9, F9 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.
F9, F9 Express Fetal & Maternal Monitor User Manual Installation Guide 3) Take the battery out from package. Put the battery and the cables into the battery compartment and insert the cable connector into the socket. 4) 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.
F Series Fetal & Maternal Monitor User Manual Installation Guide NOTE: 1 If a rechargeable battery is outfitted, charge it fully each time after using the device to ensure the electric power is enough. 2 After the device is transported or stored for a long time, charge the battery fully before use. Connecting to power supply will charge the battery no matter if the monitor is powered on. 3 Do not pull the battery cables, or the battery may become damaged. 2.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories Chapter 3 Monitor and Accessories 3.1 Overview NOTE: F6/F6 Express differs from F9/F9 Express in LCD size. This manual takes pictures and interfaces of F9/F9 Express as an example, and they may look slightly different from your model.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 16 POWER Switch Figure 3-3 Right Panel 17 Equipotential Grounding Terminal 18 Antenna (Not applicable) 19 USB Socket (Not applicable) 20 Power Socket 21 Handle 22 DB9 Socket Figure 3-4 Rear Panel 23 RJ45Socket 24 Fuses 25 Battery Compartment 26 Wall-mounting Holes Figure 3-5 Bottom Panel 3.1.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories The Monitor is a user-friendly device with operation conducted by a few keys on the front panel and the control knob. Their functions are as follows: (1) *START Function: Start monitoring or return to the main interface Press this key to start monitoring (on the main interface) or return to main interface (in maternal information inputting menu or setup menus).
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories This function is only available on F6 Express and F9 Express. (8) CONTROL KNOB Function: Adjust volume, setup and review control. It can be pressed like other keys and be rotated clockwise or counterclockwise. All the operations on the screen or in the menu are completed by using the control knob. The highlighted rectangular mark on the screen that moves with the rotation of the control knob is called “cursor”.
F Series Fetal & Maternal Monitor User Manual Indicator Monitor and Accessories Status of Indicator Alarm Indicator Charge Indicator AC Indicator Power Indicator Meaning Flash or light up in yellow An alarm is active. Off No alarm is active. On The battery is being charged. Off No battery or the battery is fully charged. On The monitor is connected to AC power supply. Off The monitor is not connected to AC power supply. On The monitor is powered on. Off The monitor is powered off. 3.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.6 Fetal Spiral Electrode Figure 3-12 Fetal Spiral Electrode 1 Reference Electrode 2 Drive Tube 3 Guide Tube 4 Drive Handle 5 Handle Notch 6 Electrode Wire 7 Safety Cap 3.2.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.8 IUP Catheter 1 Interface to IUP Cable 2 Catheter 1 2 Figure 3-15 IUP Catheter 3.2.9 ECG Cable 1 ECG Connector 2 ECG Fastener 3 Lead Wire 2 1 3 Figure 3-16 3-Lead ECG Cable 3.2.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.2.11 NIBP Cuff 1 2 1 NIBP Cuff 2 Cuff Extension Tube Figure 3-18 NIBP Cuff Figure 3-19 Cuff Extension Tube 3.2.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories 3.3 Screen 3.3.1 Main Interface Message Window Trace/Menu Window Numeric Window Status Window Figure 3-21 Main Interface *Background Color Switch The main interface of the monitor displays numbers, traces, menus and monitor status information. The screen background color has four choices: black, green, orange and blue. To change the screen color, 1 Select the setup key on the main interface. 2 Select General > Screen Color.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories (1) Message Window a b c d e a) : Alarm messages displaying area. When an alarm is active, the message will be displayed here in yellow. Patient alarms will be displayed on the left and technical alarms in the center. b) : Paper advancing key. Select this key to advance the paper for 8 cm (PHILIPS paper) or 7 cm (GE paper). c) : Display mode switch.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories (4) Status Window f g h i j k l m n o p f) Power indicator - AC power supplied. - no AC power supplied. g) Battery indicator The battery is loaded into the monitor with 100% capacity 75% capacity 50% capacity 25% capacity The battery is almost depleted and needs to recharge immediately. No battery is loaded. h) Network connection indicator and device no. - the monitor is online. - the monitor is offline.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories - the current audible alarm is switched off infinitely. - the current audible alarm is switched off temporarily. j) Recorder status indicator - the recorder is in the process of printing. - no printing is going on. k) - Print speed. - Print remaining time. l) m) n) o) - Monitoring timer. It indicates the duration of the current monitoring, and zeroes when the START key is pressed.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories Setup Items Software Version Function description Figure 3-22 Main Setup Menu (F9 Express) In the setup main menu, you have access to all the items other than System. You can select EXIT to exit from this menu. The items in this main menu all have submenu(s). To confirm the setting changes in the submenus, you need to select OK to exit.
F Series Fetal & Maternal Monitor User Manual Monitor and Accessories the control knob to this item and then pressing it. In the same way, one of the three results with the control knob will be achieved. On the main interface, the symbols item. Touch the and might appear right next to the highlighted symbol to increase the numeric, move to the previous item or move leftwards. While touching the rightwards.
F Series Fetal & Maternal Monitor User Manual Alarms Chapter 4 Alarms 4.1 Alarms Classification The monitor has two types of alarm: patient alarm and technical alarm. Patient alarms indicate the situation of vital sign exceeding its configured limit. Audible alarms and visual alarms can be disabled excluding ASYSTOLE alarm. The adjustable alarm limits determine the conditions that trigger the alarm.
F Series Fetal & Maternal Monitor User Manual Alarms WARNING 1 Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in patient danger. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.
F Series Fetal & Maternal Monitor User Manual Alarms 4.4 Choosing the Alarm Display Form You can change the patient alarm display form, 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select Message Form. 4 Select Text (default) or Numeric. 5 Select OK. 4.5 Changing the Alarm Volume You can change the alarm volume, 1 Select the setup key on the main interface. 2 Select Alarm.
F Series Fetal & Maternal Monitor User Manual 1 Select the setup key Alarms on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select Signal Loss Delay. 4 Select 0 (default) ~ 300 seconds. 5 Select OK. 4.8 Pausing or Resetting the Alarm You can enable the function of pausing or resetting audible alarms. 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select Audio Alarm.
F Series Fetal & Maternal Monitor User Manual Alarms Each page displays 10 alarm records. The page mark “1/6” informs you that there are 6 pages and the present one is page 1. To review more records, select the alarm list and then rotate the control knob to switch to the previous or next page. Select OK to exit from this menu. When a new monitoring starts, or after the monitor is switched off, the alarm messages will be cleared.
F Series Fetal & Maternal Monitor User Manual Alarms 4.11 Testing Alarms To test the functions of visible and audible alarms, do the following: 1 Switch on the monitor. 2 Enable the alarm. 3 Set the alarm limits to a small range. 4 Stimulate a signal that is higher than the upper limit or lower than the lower limit. Or disconnect one of the plugs. 5 Verify if the visible and audible alarms are working properly. 4.
F Series Fetal & Maternal Monitor User Manual Alarms 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 40 mmHg ~ 269 mmHg, in increments of 1 90 mmHg SYS High Alarm Limit 41 mmHg ~ 270 mmHg, in increments of 1 160 mmHg SYS Alarm Delay 0 second, not adjustable 0 second SYS Alarm Level Medium, not adjustable Medium DIA Alarm On, Off On DIA Low Alarm Limit 10 mmHg ~ 214 mmHg, in increments of 1
F Series 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).
F Series 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.
F Series 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: 1 Select the setup key on the main interface. 2 Select Recorder > Print Self-Check. 3 Select ON or OFF (default). 4 Select OK. 5.2.5 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 > Print Ending Beep.
F Series Fetal & Maternal Monitor User Manual Printing (4) (13) (1) (8) (14) (5) (6) (9) (2) (11) (7) (10) (3) (12) Figure 5-1 An example of recorder paper with traces 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.
F Series Fetal & Maternal Monitor User Manual Printing 10. SpO2 Mark The trace marked with “SpO2” is the maternal SpO2 trace. 11. NIBP In the real-time printing mode, each NIBP measurement result is printed on the paper in the order of SYS/DIA. 12. Page Mark Each recorder paper pack has 150 pages. When you notice the page mark comes to the end, remember to load new paper in time. 13. CTG Result The CTG analysis results of FHR1 and FHR2. 14.
F Series 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.
F Series 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.
F Series 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.
F 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. 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.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation When plugging transducers into the monitor, make sure the arrow symbol of the connector faces up and put it into the socket. 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.
F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation NOTE: In the process of monitoring, the transducer that is placed in the holder may be affected and thereby produces interfering signals. Therefore, when monitoring a patient, it is recommended to remove or disconnect the transducer that is not in use. 6.8 Adjusting the Volume The monitor automatically detects which channel the transducer is connected to.
F Series Fetal & Maternal Monitor User Manual Pre-Monitoring Preparation *Adjust the key volume: The volumes of pressing keys, rotating and pressing the control knob are also adjustable. 1 Select the setup key on the main interface. 2 Select General > Key Volume. 3 Select Low (default), High or OFF. 4 Select OK.
F Series 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 the monitor 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.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Make sure the belt fits the patient snugly but comfortably. Meanwhile, fetus heart beat sound is heard; the FHR trace and numeric are displayed. During long-time monitoring, the gel may dry out as the transducer moves around. Add more gel in time if it is inadequate.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 3 Select FHR. 4 Select ON (default) or OFF for Alarm. 5 Select OK. When the alarm is switched off, an alarm switched-off symbol window. For example: appears in the numeric WARNING Do not switch the alarm off for the condition where the patient’s safety maybe endangered. 7.2.4 Changing FHR Alarm Limits You can change the FHR alarm limits. The alarm limits you set determine the conditions that trigger the alarm.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 4 Select a value from 0 ~ 30 second(s) for Alarm Delay. (The step is 5, and the default value is 10 seconds.) 5 Select OK. WARNING The FHR alarm delay is adjustable between 0 and 30 seconds. 7.2.6 Testing US Transducers To test a US transducer: 1) Switch on the monitor. 2) Connect the US transducer to the fetal monitor.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.3 Monitoring FHR with DECG 7.3.1 Contraindications The fetal spiral electrode can be used when amniotic membranes are adequately ruptured and sufficient cervical dilatation is ensured. The fetal electrode tip is designed to penetrate the epidermis of the fetus; therefore, trauma, hemorrhage and/or infection can occur. The electrode should be used with strict adherence to aseptic technique.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 4) Remove skin scurf and grease. 7.3.4 Changing DECG Beep Volume When the DECG beep is enabled, the monitor gives a beep sound of DECG. To change the DECG beep volume, 1 Select the setup key on the main interface. 2 Select Fetus > DECG Beep. 3 Select 0 (default) ~ 9. 4 Select OK. NOTE: 1 The DECG beep and HR beep share the same audio channel. Once the DECG beep is switched on, the HR beep is disabled (set to level 0) automatically.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.3.6 Directions for Using Fetal Spiral Electrode 1 With the patient in the dorsal lithotomy position, perform a vaginal examination and clearly identify the fetal presenting part. 2 Remove the spiral electrode from the package; leave the electrode wires locked in the handle notch. 3 Gently bend the guide tube to the desired angle. 4 Hold the drive handle, ensure the spiral electrode is retracted about one inch (2.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 5 Remove the film on the back of the electrode and place the electrode on maternal thigh; press it firmly in place. 6 Connect the fetal spiral electrode to the DECG cable. 7 Insert connector of DECG cable into the DECG socket of the monitor. WARNING Do not plug the fetal spiral electrode wire into the power socket. CAUTION Do not mistake the higher maternal heart rate for DECG.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.4.2 Monitoring Internally Alternatively, you can monitor a FH using ultrasound externally, and monitor the second FH using DECG internally. Connect the US transducer to US2 socket; connect DECG cable to DECG socket. Monitor one twin with a US transducer using the procedures described in Section 7.2 Monitoring FHR with Ultrasound. Monitor the other twin with a DECG cable using the procedures described in Section 7.3 Monitoring FHR with DECG.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring “FHR2: -20bpm”: the FHR2 trace is 20bpm lower than it really is. “FHR2: 0bpm”: the FHR2 trace is in its real position. “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.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-6 Testing a TOCO Transducer 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 7.6.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Insertion NOTE: This product is designed for use with the introducer. 3) Using aseptic technique, remove the catheter from the package. 4) Perform vaginal exam to ensure ruptured membranes and adequate dilation. 5) Advance the catheter tip to the cervical os along the examination hand, using the hand as a guide. Do not advance the introducer through the cervix.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Figure 7-10 Secure the adhesive pad to mother Rezeroing the System During Monitoring 1) With the catheter connected to the IUP cable, momentarily pressing the re-zero button on the pressure cable. The green light on the cable will flash for five seconds. Figure 7-11 Rezeroing the system 2) During this period, adjust the monitor to zero by pressing AUTO ZERO key.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.6.3 IUP Monitoring Procedure 1) Insert IUPC using the procedure described in section 7.6.2 Directions for Use of IUPC. 2) Connect the IUPC to the IUP cable. Figure 7-12 Connect catheter to pressure cable 3) Connect the IUP cable to the connecting cable. (They might have already been well connected in the package.) 4) Plug the connecting cable to the TOCO/IUP socket of the monitor.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.7 Monitoring Fetal Movement 7.7.1 Auto Fetal Movement (AFM) Monitoring During fetal heart monitoring with ultrasound, the fetal movement signals are also detected. The fetal movement signals differ from the Doppler heart rate signals in that they have larger extent and lower frequency. The larger extent is because of the bigger scope of moving areas (e.g.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.7.4 Choosing AFM Mode When AFM monitoring is enabled, the AFM monitoring result is displayed either in the form of a trace or black marks. To choose AFM mode, 1 Select the setup key on the main interface. 2 Select Fetus > AFM Mode. 3 Select Trace (default) or Blackmark. 4 Select OK. 7.7.5 Choosing FM Source When AFM monitoring is enabled, the FM has two sources: AFM and MFM.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring 7.8 *Start Monitoring After the START key is pressed, the monitor automatically zeroes the pressure, clears the MFM count and starts monitoring. If the Auto Printing is disabled, press the PRINT key to start printing. 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring The monitoring does not stop when you change maternal information. After you select OK to exit, the new ID takes the 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. 2 If printing starts automatically with the monitoring, the first ID printed on the recorder paper will be the auto-ID. The new ID will be printed 10 minutes later.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display Chapter 8 Fetal Monitoring Display (F6/F9) 8.1 Traces WARNING 1 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. 2 If the data is doubtful, clinicians should make diagnoses based on the real condition.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display TOCO trace The y-axis indicates the numeric of TOCO. The range is 0% ~ 100%. If FHR is monitored using DECG, and the DECG trace is switched on in the hardware setup (only 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.2 Trace Control Tools 1 2 3 4 Figure 8-2 Trace Control Tools 1 Searching Key 2 Reviewing Keys 3 Alarm Reviewing Key 4 CTG Analyzing Key 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display If the required file is not in this list, 2 Select MORE to open the Patient Searching window. Figure 8-4 Patient Searching 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display Select the forward key to review the next traces. The traces start to advance. The amount of the progress symbol “>” on top of the traces indicates the advancing speed. Rotate the control knob clockwise or touch the symbol to increase the speed until it reaches the maximum. Rotate the knob anticlockwise or touch the symbol to decrease the speed until it reaches the minimum. Press the knob or touch any place on the screen to pause.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display WARNING 1 CTG analysis is used for the surveillance of pregnancies and not in delivery room of 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. 3 This analysis describes the fetal heart rate, the tocography and the fetal movements.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 1) CTG Analysis Timer 2) Analysis Results Figure 8-5 CTG Analysis Results Refer to figure 8-5, 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display At the end of the printing, the recorder prints the CTG analysis results of this moment on the recorder paper. Be aware that CTG analysis result is a calculation output. It can be used as a reference to assist medical personnel in making correct diagnosis, instead of replacing it. NOTE: Do not disconnect the ultrasound transducer(s) before the printing stops, otherwise the analysis results will not be printed. 8.2.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 5 Select a note. 6 Use the soft keyboard to edit the note content. 7 Select Enter. 8 Select OK. 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.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 141: FHR1/DFHR measurement numeric. If the US1 socket is not connected with a US transducer and DECG socket is not connected with a DECG cable, nothing displays here; if the transducer/cable is connected but no monitoring is going on, it displays ---. FHR2 180: FHR2 measurement numeric.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display 8.3.1 Changing Numeric Window Position (F9) Especially for F9, the numeric window can be located either on the right of the traces or on top of them. To change its position, 1 Select the setup key on the main interface. 2 Select General > Numeric Window. 3 Select Top or Right (default). 4 Select OK. 8.
F Series Fetal & Maternal Monitor User Manual Fetal Monitoring Display Monitor There is no paper in the paper drawer or the drawer is open. Load paper and/ or close the drawer. US US transducer 1 or US transducer 2 is not well connected. Or wireless US signal is not detected. Check the connection of the transducer. US FHR1 or FHR2 signal is too weak for the system to analyze.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Chapter 9 Maternal Monitoring (F6 Express/F9 Express) WARNING 1 Do not apply the monitor 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 and F9 Express. 9.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 3 ECG accessories are not suitable for DIRECT CARDIAC APPLICATION (Refer to IEC60601-1 for more information about the definition of DIRECT CARDIAC APPLICATION). CAUTION A different type of electrodes may produce higher offset voltage. Therefore, only use the ECG leads supplied by the manufacturer when using the monitor for ECG monitoring.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Figure 9-2 Placing 3-lead ECG Cable NOTE: 1 To ensure patient’s safety, all leads must be attached to the patient. 2 Check everyday if the skin is irritated from ECG 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.
F Series Fetal & Maternal Monitor User Manual 1 Select the setup key Maternal Monitoring on the main interface. 2 Select Mother > Lead. 3 Select I, II (default) or III. 4 Select OK. 9.1.5 Changing ECG Gain You can change the ECG gain. The ECG gain affects overall numeric and scope of the ECG waveform. 1 Select the setup key on the main interface. 2 Select Mother > Gain. 3 Select X1/4, X1/2, X1 (default), X2 or Auto. ‘Auto’ means the monitor adjusts the gain automatically.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.2 Maternal SpO2 Monitoring 9.2.1 Introduction The monitor provides continuous monitoring of functional arterial oxygen saturation (SpO2) and pulse rate(PR) for pregnant women. SpO2 Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring WARNING 3 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. 4 Prolonged and continuous monitoring may increase jeopardy of unexpected change of dermal condition such as abnormal sensitivity, rubescence, vesicle, repressive putrescence, and so on.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: 1 The nail should cover the light but not too long. 2 The cable should be placed on the backside of the hand. 3 Avoid external light sources such as radiated rays or ultrared rays. 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).
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.2.5 SI (Signal Intensity)* *Only applicable to the EDAN module The signal intensity (SI) shows perfusion in numeric, and it reflects the pulse intensity of the measurement site. The SI ranges from 0 to 10, with a larger value indicating the more intense signal. When the SI value reaches 10, the signal quality is optimal.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3 Maternal HR Monitoring 9.3.1 Introduction Maternal heart rate (HR) monitoring does not need an extra accessory. When you perform ECG or SpO2 (Pulse) monitoring, the HR result can be acquired at the same time. When monitoring ECG and SpO2 at the same time, you can choose the HR source. If only one of them is being performed, the source will automatically switch to the available one (the screen reading should prevail). 9.3.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.3.4 Enabling HR Trace The real-time HR measurement result is displayed in the parameter area of the main interface. Also, you can choose to display and print those as a continuous trace on the recorder paper (refer to figure 5-1). To enable or disable HR trace printing, 1 Select the setup key on the main interface. 2 Select Recorder > HR Trace. 3 Select ON or OFF (default). 4 Select OK. 9.3.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring In the process of monitoring, if the SOV detects signals overlapping, an alarm message “Signals Overlap (FHR1/FHR2, HR)” will appear on the screen to warn you. Checking the patient and reposition of sensors might be needed. 9.4 Maternal NIBP Monitoring 9.4.1 Introduction The monitor measures blood pressure using the oscillometric method.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 1) Select appropriate cuff for the patient. The table below lists the reference size: Type Limb Perimeter Cuff Size Upper Arm (Adult 1) 27 cm ~ 35 cm 14.5 cm Upper Arm (Adult 2) 34 cm ~ 43 cm 18 cm Air Hose Length 3m 2) Squeeze the cuff to discharge the air. 3) Apply the cuff to the patient; make sure that the index line is placed in the appointed range and the symbol is over the appropriate artery (Refer to figure 9-4).
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 3. Wait for five minutes until the first reading is taken. NOTES: Please roll up the sleeve and keep the patient’s arm bare or it will cause the inaccurate measurements. 1) Wrap the cuff on a bare arm. 2) Insert the cuff plug into NIBP socket on the monitor. 3) Apply the NIBP cuff to the patient’s arm or leg following the instructions described in section 9.4.2 How to Apply NIBP Cuff. 4) Connect the cuff to the air hose.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 5 Press NIBP key on the front panel to start an Auto measurement. 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. The monitor will measure NIBP only when the UC is lower than 50, and it will then start timing for the Auto measurement.
F Series Fetal & Maternal Monitor User Manual 2 Maternal Monitoring 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. Please wait and do not attempt to measure NIBP until the UC is lower than 50. CAUTION 1 Do not squeeze the rubber tube on the cuff.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 9.4.9 Changing SYS Alarm Limits You can change the SYS alarm limits. 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select SYS. 4 Select a value from 40 ~ 269 for Low Alarm Limit. (The step is 1, and the default value is 90 mmHg.) 5 Select a value from 41 ~ 270 for High Alarm Limit. (The step is 1, and the default value is 160 mmHg.) 6 Select OK. 9.4.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring NOTE: The NIBP measurement results during the period of paper lacking and fast printing after new paper is loaded will not be saved or printed. Therefore, do not perform NIBP measurements during this period. 9.4.12 *Calibrating NIBP NIBP is not user-calibrated. Cuff-pressure sensors must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. 9.5 Maternal TEMP Monitoring 9.5.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring 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. 1 Select the setup key on the main interface. 2 Select Alarm. On the displayed Password box, enter 9999, then select Enter. 3 Select TEMP.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Chapter 10 Maternal Monitoring Display (F6 Express/F9 Express) 10.1 *Display Mode F6 Express and F9 Express have 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 - 105 - on the main interface.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-2 Fetal Display Mode Figure 10-3 Maternal Display Mode - 106 -
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display 10.2 Maternal Monitoring Traces 1 2 3 4 5 6 7 Figure 10-4 Maternal Monitoring Traces 1 FHR1 Trace 2 FHR2 Trace 3 HR Trace 5 TOCO Trace 6 ECG Trace 7 SpO2 Waveform 4 AFM Trace F6 Express and F9 Express display both maternal monitoring traces and fetal monitoring traces on the same screen. The maternal monitoring traces include ECG waveform and SpO2 waveform.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display Figure 10-5 Maternal NIBP List In maternal display mode, the list contains the time, HR, SpO2, SYS, DIA and TEMP numerics. The numerics are recorded every minute. 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.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display 99: Current SpO2 measurement numeric. SpO2 : SpO2 indicator. SI: Signal intensity. 09:15: Time when the NIBP measurement starts. NIBP mmHg/kPa: NIBP unit. From left to right in turn: systolic pressure (118) and diastolic pressure (73). (manual)/(Auto): The current NIBP measurement mode. HR (ECG)/(Pulse): The current HR source. 60: Current maternal heart rate measurement numeric. TEMP (ºC)/(ºF): TEMP unit. 37.
F Series Fetal & Maternal Monitor User Manual Maternal Monitoring Display **SYS HIGH or **SYS xxx > yyy NIBP SYS result (xxx) is higher than the upper limit (yyy). **SYS LOW or **SYS xxx < yyy NIBP SYS result (xxx) is lower than the upper limit (yyy). **DIA HIGH or **DIA xxx > yyy NIBP DIA result (xxx) is higher than the upper limit (yyy). **DIA LOW or **DIA xxx < yyy NIBP DIA result (xxx) is lower than the upper limit (yyy).
F Series Fetal & Maternal Monitor User Manual ECG MALF EQUIP HR EXCEEDS MEASUREMENT RANGE NIBP MALF EQUIP Maternal Monitoring Display ECG The ECG board can not communicate with the system successfully. Restart the monitor and try again, contact the manufacturer if the connection still fails. ECG/ Pulse The heart rate exceeds measurement limits. Check the connection of the ECG leads/SpO2 sensor and the patient’s condition. NIBP The NIBP board can not communicate with the system successfully.
F Series Fetal & Maternal Monitor User Manual SpO2 OFF SpO2 MALF SENSOR EQUIP TEMP UNPLUGGED TEMP Calibration Failed Maternal Monitoring Display sensor SpO2 connected. SpO2 The SpO2 board can not communicate with the system successfully. Restart the monitor and try again, contact the manufacturer if the connection still fails. TEMP TEMP sensor connected. Check the connection TEMP sensor. TEMP is is not not well Check the connection of SpO2 sensor and finger placement.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System Chapter 11 FTS-3 Fetal Telemetry System 11.1 Brief Introduction FTS-3 Fetal Telemetry System (hereinafter called FTS-3) provides non-invasive monitoring for the fetal heart rate (FHR) and testing TOCO for the pregnant women from the 28th week of gestation. When connected to a compatible fetal monitor, FTS-3 provides wireless patient monitoring in the antepartum period and during labor and delivery.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.1.1 Base Station 6 1 2 3 4 5 Figure 2-1 Top Panel Name Description 1 Docking Slot Place, charge and manage the transducer. 2 Power Indicator When you turn the power supply, the indicator is on. 3 AC Indicator When AC power is supplied, the indicator is on. 4 Battery Indicator When the base station battery is charging, the indicator is on. When the battery is in low level, it is flashing.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 7 8 10 9 11 12 Figure 2-2 Rear Panel Name Description 7 AC Outlet AC outlet. 8 Communication Socket Communicate to the bedside monitor. 9 Emission Slot Emit the heat. 10 Channel Adjustment Button Adjust the channel. 11 USB port Reserved 12 Ethernet port Reserved 13 Figure 2-3 Right Panel Name 13 Power Switch Description Turn on or turn off the base station.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System CAUTION 1. This monitor is a normal medical device. Please avoid violent operations such as continuously pressing the power switch. 2. When the transducer is taken up, please do not power off the base station. 14 Figure 2-4 Bottom Name 14 Battery Compartment Description Install the battery.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.1.2 US Transducer and TOCO Transducer 18 19 16 17 15 US transducer TOCO transducer Name Description 15 Transducer Tied to the pregnant women. 16 Transducer Type Indicate the transducer type. 17 System Working Channel Indicate the system working channel. 18 Signal Indicator Indicate wireless signal strength. 19 Battery Indicator Indicate battery level. 11.1.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.2 Installation Guide WARNING The system installation should be operated by serviceman authorized by the manufacturer. 11.2.1 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. Open the package; take out the base station and accessories carefully.
F9, F9 Express Fetal & Maternal Monitor User Manual c) FTS-3 Fetal Telemetry System Take the battery out from package and put it into the compartment. Make sure the battery connector is on the left and the battery label faces down. Anode & Cathode of Battery Output Battery Connector WARNING Do not touch the anode and cathode of the battery output together with fingers or metal materials, avoiding hazards to you and the battery caused by the short-circuit.
F9, F9 Express Fetal & Maternal Monitor User Manual e) FTS-3 Fetal Telemetry System Shut the battery compartment cover and fix it with the screws. (2) Battery Removal Remove the battery in reverse order. You can pull the strip at the end to take the battery out from the compartment. NOTE: 1 If a rechargeable battery is outfitted, charge it fully each time after using the device to ensure the electric power is enough.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System CAUTION 3. This equipment has been tested and found to comply with the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 11.2.5 Connect to the Base Station 1. Power on the base station. 2. Connect one end of the signal cable to the base station and the other end to the monitor input socket. 3. Put the transducer back into the docking slot. The system can support 2 US transducers and 1 TOCO transducer at most. Please do not exceed the maximum number of the transducer.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System NOTE: The working channel number used by a system cannot be duplicate with that used by a device of the same type. 11.3 Technical Alarm Messages When FTS-3 is connected to F9 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.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System connected to the base station. Wireless US2 SIGNAL LOSS FHR2 signal is too weak for the system to analyze. Wireless TOCO SIGNAL LOSS TOCO signal is too weak for the system to analyze. Check if the Wireless US2 transducer is aimed at the fetal heart; check if the patient moves out of the base station RF range, if the transducer is well connected to the base station.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System water and coupling gel during charging. When you charge the battery, the screen will display as follows: x Full charging icon: fully charged. x Increasing charging icon: charging x No charging icon: the transducer place in the docking slot incorrectly. x If the screen displays ERROR, it indicates that the transducer is not connected well or you place the transducer from the other system by mistake. It takes about 3.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System 7. Touch the measuring area of the TOCO transducer gently: x The fetal monitor displays TOCO value change. 8. Install the US transducer to charge: x The US transducer screen displays charging interface and charging state. x The US transducer indicator is off. x The fetal monitor screen is no display. 9. Install the TOCO transducer to charge: x The TOCO transducer screen displays charging interface and charging state.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System (less than 3°C (5.4ºF) above ambient temperature). 2. When NOT applied, the wireless ultrasound transducer may warm slightly (less than 3°C (5.4ºF) above ambient temperature). 11.5.3 Monitor the Ambulatory Patient FTS-3 is suitable for ambulatory patients. You can take out the transducer from the docking slot and fix the transducer on the location where the best fetal heart signal is received.
F9, F9 Express Fetal & Maternal Monitor User Manual FTS-3 Fetal Telemetry System Caution 1. Please avoid flushing the transducer during underwater monitoring, or it may cause wireless signal interference. 2. The transducers are watertight to a depth of 1.1 meter for 24 hours, but base station is not waterproof. Please do not splash water about the station or soak it into any liquid. 3. Underwater monitoring may influence the TOCO baseline in virtue of water temperature and depth or other reasons.
F Series Fetal & Maternal Monitor User Manual After Monitoring Chapter 12 After Monitoring 12.1 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.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning Chapter 13 Maintenance and Cleaning 13.1 Maintenance 13.1.1 Maintaining Inspection (1) Visual Inspection Prior to using the monitor or FTS-3 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.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 13.1.2 Maintenance of Monitor and Base Station Keep the exterior surface of the monitor and the base station clean, free of dust and dirt. The gathering of dew on the screen may occur with abrupt temperature or humidity changes. A stable environment is recommended. Stop using the monitor or the base station and contact the service personnel immediately if accidental wetting occurs. Scratching and damaging the screen should be avoided.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning 1) Clean the recorder platen with a lint-free cloth dampened in soap/water solution. 2) Wipe the thermal array using a cotton swab moistened with 70% Isopropyl alcohol-based solution. 3) Check that the paper sensing mechanism is free of dust. WARNING Switch off the monitor and remove the power cord prior to recorder cleaning. 13.1.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Although the monitor and the base station are chemically resistant to most common hospital cleaners and non-caustic detergents, different cleaners are not recommended and may stain the monitor. 2 Many cleansers must be diluted before use. Follow the manufacturer’s directions carefully to avoid damaging the monitor and the base station. 3 Do not use strong solvent, for example, acetone.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 The waterproof parts of the transducer are restricted to the main body and the cable. Do not immerse the plug into water during the process of monitoring or cleaning. 2 Be sure the temperature of cleaning solutions does not exceed +45 ºC (+113 ºF). 3 Only wipe the outer surface of accessories. Do not immerse them in any liquid. 4 Make sure no liquid enters the connector.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Do not squeeze the rubber tube on the cuff. 2 Do not dry-clean the cuff. 3 Only clean the outer surface of the connectors, make sure no liquid goes into the connector. 4 When the reusable cuff is not connected with the monitor, or being cleaned, always place the cover on the rubber tube to avoid liquid permeation. 13.3 Disinfecting To disinfect the transducers and leads, follow these steps: 1) Clean the accessories.
F Series Fetal & Maternal Monitor User Manual Maintenance and Cleaning CAUTION 1 Do not use any disinfectant containing additional active ingredients other than those listed. 2 Follow the manufacturer’s instruction to dilute the solution, or adopt the lowest possible density. 3 Do not immerse any part of the monitor or any accessory into liquid. 4 After disinfection, no remaining disinfectant is allowed on the surface. 5 Check if the monitor and accessories are in good condition.
F Series Fetal & Maternal Monitor User Manual Warranty and Service Chapter 14 Warranty and Service 14.1 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. c) damage caused by alteration or repair by anyone not authorized by EDAN.
F Series Fetal & Maternal Monitor User Manual Product Specifications Appendix 1 Product Specifications 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.
F Series Fetal & Maternal Monitor User Manual Product Specifications IEC 80601-2-30, ISO 80601-2-61, ISO 80601-2-56, EN 12470-4, AAMI/ANSI EC13 Anti-electric Shock Type Anti-electric Shock Degree Class I equipment with internal power supply FHR1, FHR2, TOCO, FM, IUP BF SpO2, NIBP BF (Defibrillating-proof) DECG CF ECG, TEMP CF (Defibrillating-proof) Main Unit: IPX1, protected against vertically falling water Degree of Protection against drops(provided recorder drawer is shut and the monitor is no
F Series Fetal & Maternal Monitor User Manual Dimension: Product Specifications 88 mm × 35 mm 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.
F Series Fetal & Maternal Monitor User Manual Product Specifications Isppa.3<190W/cm2 Ispta.3<94mW/cm2 Max Output Power <15mW Effective Radiating Area: 942 mm2 ± 15% FHR Measurement Range: 50 bpm ~ 240 bpm Resolution: 1 bpm ±2 bpm (F6/F6 Express) Accuracy: ±1 bpm (F9/F9 Express) Dielectric Strength: 4000Vrms Maximum transducer temperature rise during Less than 5 qC (9ºF) use: Expanded uncertainty of U=0.4qC (0.
F Series Fetal & Maternal Monitor User Manual Product Specifications Non-linear Error: ± 3mmHg Resolution: 1% Zero Mode: Manual Fetal Movement Technique: Pulsed Doppler ultrasound FM Mode Automatic/Manual AFM Mode Trace or blackmark Display Range 0-999 HR Measurement Range: 30 bpm ~ 240 bpm Input Signal Range: ±8 mV PP HR Measuring Accuracy: ±2 bpm ECG Waveform: Manual control ECG waveform display ECG falls off: Detect automatically N.C. Patient Leakage Current (Limit) ECG S.F.C.
F Series Fetal & Maternal Monitor User Manual Product Specifications According with Sect.4.1.2.
F Series Fetal & Maternal Monitor User Manual Product Specifications Infrared light (905r10) nm Emitted light energy < 15 mW Information about the wave length range can be especially useful to clinicians (for instance, when photodynamic therapy is performed.
F Series Fetal & Maternal Monitor User Manual Product Specifications 110mm (American Standard) Effective printing width: 120mm (International Standard) 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 15mm/sec Accuracy of dat
F Series Fetal & Maternal Monitor User Manual Product Specifications A1.6 Low Output Summary Table Low Output Summary Table (for systems with no transducers having global maximum index values exceeding 1.0) System: Fetal & maternal Monitor Transducer Model Ispta.3 2 (mW/cm ) PW1.0MHz (F6/F6 Express US Transducer) 1.288 PW1.0MHz (F9/F9 Express US Transducer) TI Type TI Value TIS 0.006149 TIB 0.04687 TIS 0.008761 TIB 0.05723 1.817 - 146 - MI Ipa.3@MImax (W/cm2) 0.01405 0.007225 0.
F Series Fetal & Maternal Monitor User Manual Product Specifications B FTS-3 Fetal Telemetry System B1.1 Environmental Specifications Temperature: +5 ºC ~ +40 ºC (+41ºF ~ +104ºF) Relative Humidity: 15% ~ 93% Atmospheric Pressure: 860hPa ~ 1060hPa Temperature: -20 ºC ~ +55 ºC (-4ºF ~ +131 ºF) Relative Humidity: 15% ~ 93% Atmospheric Pressure: 700hPa ~ 1060hPa Working Transport and Storage (non-condensing) (non-condensing) B1.
F Series Fetal & Maternal Monitor User Manual Product Specifications Disinfection/Sterilizing Method Refer to this user manual for details EMC CISPR11 Group 1 Class A Ground (Limit): Leakage Enclosure Leakage Current (Limit) Patient Leakage (Limit): N.C. S.F.C. 500μA 1000μA N.C. S.F.C. Current 100μA 500μA N.C. S.F.C. 10μA 50μA Current d.c. a.c. Patient Auxiliary (Limit): Current d.c. a.c. 100μA 500μA N.C. S.F.C. 10μA 50μA 100μA 500μA Base Station Weight: 1.
F Series Fetal & Maternal Monitor User Manual Product Specifications p_< 1 MPa Iob<10 mW/cm2 Ispta<100 mW/cm2 FHR Measurement Range: 50 bpm ̚ 240 bpm Resolution: 1 bpm Accuracy: ±2 bpm Dielectric Strength: 4000 Vrms TOCO TOCO Range: 0% ~ 100% Non-linear Error: ±10% Baseline Drift due Temperature Changes to 1 unit/min/°C (free air) 5 units/min/°C (underwater) Resolution: 1% Zero Mode: Automatic/ Manual Dielectric Strength: 4000 Vrms RF Index Transmission Power: < 10mW e.r.
F Series Fetal & Maternal Monitor User Manual Product Specifications B1.4 Rechargeable Lithium-ion Battery Base Station Battery Nominal Capacity: 5000 mAh Continuous Time: 40 Hours Work Nominal Voltage: 14.8 V Necessary Time: 14 Hours Charge >300 times Cycle Life: Transducer Battery Nominal Capacity: 1600 mAh Charge (Standard): Current 700 mA Continuous Time: Work >16 Hours Nominal Voltage: 3.7 V Charge (Standard): (4.2±0.1) V Voltage Cycle Life: 500 times B1.
F 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). Furthermore all configurations shall comply with the valid version of the system standard IEC/EN 60601-1-1.
F Series Fetal & Maternal Monitor User Manual RJ45 Interface Signal Input/Output Connector 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 recommended by the manufacturer can be connected to the signal input/output interface of the monitor. Other equipment is forbidden.
F Series 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.
F Series Fetal & Maternal Monitor User Manual Troubleshooting A3.4 Trouble with Ultrasound FHR Monitoring Phenomenon Inconstant trace / display Possible Cause 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. Delay the monitoring.
F Series Fetal & Maternal Monitor User Manual Inconstant trend Troubleshooting The DECG cable has not been fixed firmly Fix an attachment pad at the DECG cable. A3.6 Troubles with Contractions Monitoring (External) Phenomenon Bad trace quality or fluctuant TOCO baseline Too high TOCO sensitivity (higher than 100 unit) Possible Cause Solution The belt is too tight or too loose. Adjust the belt. The belt has no elasticity. Renew the belt. Maternal movement.
F Series Fetal & Maternal Monitor User Manual Troubleshooting A3.8 Big ECG Signal Interference or Thick Baseline Phenomenon Big ECG interference or baseline signal thick Possible Cause Solution Abnormal electrodes placing or electrodes invalidation. Check the electrodes placing and the period of validity of electrodes. The cable connector is not well connected. Check the connection of cable connector. Power socket has no standard ground wire. Check if power socket standard ground wire.
F Series Fetal & Maternal Monitor User Manual Troubleshooting To replace a fuse: 1 Fold the LCD display completely flat. 2 Carefully place the monitor upside down on a flat surface covered with cloth or other protecting pad. 3 With a flat-head screw driver, push the fuse in for about 1 mm and then unscrew it anticlockwise. 4 Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety B FTS-3 Fetal Telemetry System B3.1 Troubleshooting Phenomenon Possible Cause ķ It runs out of power. Solution ķ Recharge the transducer. Take out the US transducer, ĸ The base station cannot ĸ Put it back in the docking slot and take it up again. If but it cannot power on. communicate with the the problem persists, transducer by RF. restart the base station.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety To replace a fuse: 1) Place the base station on a flat surface and remove the power cord. 2) Reverse the base station and pull the fuse container out as far as it can go. 3) Use a screw driver or a pair of pliers to push the fuse up from the bottom of the container. 4) Take the fuse out and replace it with a new one that is supplied by the manufacturer or of the same specifications.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety 5) Push the fuse container all the way back in position.
F 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.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety MI = Pr, ǩ fawf CMI CMI = 1 (MPa / MHz ) A4.3.2 TI (Thermal Index) Heating of tissues is caused by absorption of ultrasound when the ultrasound energy is applied. The temperature rise is determined by the acoustic intensity, exposed area and thermophysical properties of the tissue. In order to indicate the potential for temperature rise caused by thermal effects, the AIUM and NEMA formulate thermal index (TI).
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety pressure values and ± 14.52 percent for the Mechanical Index. A4.4 Prudent Use Statement Although no confirmed bioeffects on patients caused by exposure from present diagnostic ultrasound equipment have ever been reported, the potential exists that such bioeffects may be identified in the future. Therefore, the ultrasound should be used prudently.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety A4.6 Probe Acoustic Output Parameters List A4.6.1 Test of Wired Probe Acoustic Output Reporting Table (F9/F9 Express) Operating Mode: PW mode Working Frequency: 1.0MHz TIS Index Label MI Global Maximum Index Value P Associated Acoustic Parameters 0.01567 (MPa) Pr.a Aaprt>1 Non-scan 0.008761 0.05723 N/A 11.52 N/A 0.01567 1.84 Zs (cm) 13.95 Zbp (cm) 5.188 Zb (cm) 13.60 Z at max Ipi.a (cm) td prr 13.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Operating Mode: PW mode Working Frequency: 1.0MHz Acoustic Output MI Global Maximum Value 0.01567 (MPa) Pr.3 W0 Associated Acoustic Parameter Isppa.3 Ispta.3 2 (mW/cm ) (W/cm2) 1.817 0.01025 11.52 11.52 0.01567 (mW) fc (MHz) 1.00 1.00 1.00 Zsp (cm) 13.65 13.65 13.65 Beam X-6 (cm) 0.5795 0.5795 dimensions Y-6 (cm) 0.6061 0.6061 PD (usec) PRF EDB (Hz) 88.72 88.72 2000 2000 Az (cm) 3.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Acoustic Output Reporting Table (F6/F6 Express) Operating Mode: PW mode Working Frequency: 1.0MHz TIS Index Label MI Global Maximum Index Value P Associated Acoustic Parameters Aaprt>1 0.006149 0.04687 N/A 10.70 N/A 0.01405 1.29 Zs (cm) 13.45 Zbp (cm) 4.236 Zb (cm) 13.35 Z at max Ipi.a (cm) td prr 13.45 13.45 (cm) 2.04 (MHz) Dim of Aaprt TIC Non-sca n Min of [Pa(Zs),Ita.a(Zs)] (mW) fawf 1.
F Series Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety Operating Mode: PW mode Working Frequency: 1.0MHz Acoustic Output MI Global Maximum Value 0.01405 (MPa) Pr.3 W0 Associated Acoustic Parameter Isppa.3 Ispta.3 2 (mW/cm ) (W/cm2) 1.288 0.007225 10.70 10.70 0.01405 (mW) fc (MHz) 1.00 1.00 1.00 Zsp (cm) 13.30 13.30 13.30 Beam X-6 (cm) 0.7092 0.7092 dimensions Y-6 (cm) 0.7766 0.7766 PD (usec) PRF EDB (Hz) 89.36 89.36 2000 2000 Az (cm) 2.
F Series Fetal & Maternal Monitor User Manual Abbreviation A4.6.2 Test of Wireless Probe (FTS-3) Acoustic Output Reporting Table Operating Mode: PW mode Working Frequency: 1.0MHz TIS Index Label MI Global Maximum Index Value (MPa) Pr.a P Associated Acoustic Parameters 0.01087 Aaprt>1 Non-scan 0.002949 0.01939 N/A 3.496 N/A 0.01087 0.62 Zs (cm) 12.50 Zbp (cm) 5.188 Zb (cm) 11.95 Z at max Ipi.a (cm) td prr 12.10 12.10 (cm) 1.77 (MHz) Dim of Aaprt 1.00 1.00 1.
F Series Fetal & Maternal Monitor User Manual Abbreviation Operating Mode: PW mode Working Frequency: 1.0MHz Acoustic Output MI Global Maximum Value 0.01087 (MPa) Pr.3 W0 Associated Acoustic Parameter Ispta.3 Isppa.3 (mW/cm2) (W/cm2) 0.6186 0.003412 3.496 3.496 0.01087 (mW) fc (MHz) 1.00 1.00 1.00 Zsp (cm) 11.80 11.80 11.80 Beam X-6 (cm) 0.5663 0.5663 dimensions Y-6 (cm) 0.5437 0.5437 PD (usec) PRF EDB (Hz) 90.65 90.65 2000 2000 Az (cm) 3.46 Ele (cm) 3.
F 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 AC Alternative Current AFM Automatic Fetal Movement [Detection] BPM Beat(s) Per Minute CTG Cardiotocography DC Direct Current DECG Direct ECG DFHR Direct FHR DIA Diastolic Blood Pressure ECG Electrocardiogram FH Fetal Heart FHR Fetal Heart Rate FM Fetal Movement FS Fetal Stimulator HR Heart Rate
F Series Fetal & Maternal Monitor User Manual Abbreviation STV Short-Term Variation SYS Systolic Blood Pressure TEMP Temperature TOCO Tocotonometer UA Uterine Activity [TOCO] US Ultrasound [Transducer] - 171 -
F 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 monitor. See the following table for details. The accessories employed by us, such as the rechargeable battery, are products having passed the authentication of CE, and they have the characteristics specified by their manufacturers.
F Series Fetal & Maternal Monitor User Manual Ordering Information Disposable ECG Electrode (US) 01.57.471276 SpO2 Sensor 02.01.109069 NIBP Cuff (Upper Arm Perimeter 27cm-35cm, for Adult) 01.57.471330 NIBP Cuff Extension Tube 01.57.471005 TEMP Sensor 01.15.040187 Thermosensitive Recorder Paper (GE-American) 01.57.75111 Thermosensitive Recorder Paper (GE-International) 01.57.75112 Thermosensitive Recorder Paper (Philips-American) 01.57.
F Series Fetal & Maternal Monitor User Manual EMC Information Appendix 7 EMC Information A7.1 Electromagnetic Emissions Guidance and manufacture’s declaration – electromagnetic emission The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer of the user of the F Series Fetal & maternal Monitor should assure that it is used in such and environment.
F Series Fetal & Maternal Monitor User Manual EMC Information A7.2 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F Series Fetal & maternal Monitor should assure that it is used in such an environment.
F Series Fetal & Maternal Monitor User Manual Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 EMC Information < 5% UT < 5% UT (> 95% dip in UT) (> 95% dip in UT) for 0.5 cycle for 0.
F Series Fetal & Maternal Monitor User Manual EMC Information A7.3 Electromagnetic Immunity Guidance and manufacture’s declaration – electromagnetic immunity The F Series Fetal & maternal Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of F Series Fetal & maternal Monitor should assure that it is used in such an environment.
F Series 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.
F Series Fetal & Maternal Monitor User Manual EMC Information A7.4 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the F Series Fetal & maternal Monitor The F Series Fetal & maternal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
F Series Fetal & Maternal Monitor User Manual Limitations of Ultrasonic Monitoring 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. If the object moves away from the sound source, the frequency of the echo decreases. This is called “Doppler Effect”.
F Series 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. The clinicians may interpret it as a “deceleration”.
F Series 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.