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Manual - Cardiac Direct

1. Bad trace quality or The belt has no elasticity Renew the belt fluctuant TOCO baseline Request the patient to calm Maternal movement down and stay still Frequent fetal movements Delay the monitoring Insure favorable contact for Too high TOCO The body pressure from uterus to patient skin with TOCO sensitivity higher than TOCO transducer is far higher transducer Change the position 100 unit than the average numeric of TOCO transducer if necessary F6 Fetal amp maternal Monitor User Manual A3 7 Troubles with Monitoring Contractions Internal No trend The intrauterine catheter is Wash with disinfector jammed Dry environment or the tip of No pressure change intrauterine catheter is placed when uterine contraction Wash with disinfector or change the position of transducer extraovularly Only see the IUP peak buitre baselne Zero adjustment is wrong Zero the system Move or contact catheter If The trend is a beeline The connector failure trend no fluctuation change intrauterine cable A3 8 Blown Fuses A WARNINGA Switch off the monitor and unplug it before changing the fuse Replace the fuse when it is blown The two fuses of the monitor are located on the bottom panel their specifications are Size DSmm 20mm Model T1 6AL 250V To replace a fuse 3 Fold the LCD display completely flat 4 Carefully place the monitor upside down on a flat surface covered with cloth
2. or C in numeric form for example FHR2 115 lt 120 indicates this is a medium level alarm event the first number is the current measurement result the second number 1s the preset alarm limit The technical alarm messages are displayed in text form for example Fetus EQUIP MALF 4 4 Choosing Alarm Display Form You can change the patient alarm display form 1 Select setup key on the main interface 2 Select Alarm gt Message Form 3 Select Text default or Numeric 4 Select OK 4 5 Changing Alarm Volume You can change the alarm volume 1 Select setup key AA on the main interface 2 Select Alarm gt Alarm Volume 3 Select Low default Medium or High 4 Select OK 4 6 Reviewing Alarms lt lt Review larm gt gt An alarm reviewing menu records a list of up to 30 of PERSE TANTE 2007 11 09 10 44 04 gt FHR2 HIGH 162 gt 160 the most recent patient and technical alarm messages 2007 11 09 10 43 22 FHRZ HIGH 175 gt 160 2007 11 09 10 42 22 FHRZ HIGH 168 gt 160 with date and time information 2007 11 09 10 26 21 FHRZ LOW 100 lt 120 2007 11 09 10 26 06 FHRZ LOW 115 lt 120 2007 11 09 10 23 48 Fetus EQUIP MALF 2007 11 09 10 23 47 Check Paper Select the alarm reviewing key message window to open this menu _24 F6 Fetal amp maternal Monitor User Manual Each page displays 10 alarm records The page mark 1 5 informs you that there are 5 pages
3. year G The protective categories against electric shock of the patient connections are R 1 Ultrasound FHR1 FHR2 2 External TOCO 3 Fetal Movement Mark FM 4 Fetal Stimulator FS This symbol indicates that the electric shock defend grade of this instrument is Type B 1 IUP This symbol indicates that the electric shock defend grade of this instrument is Type BF Y 1 DECG This symbol indicates that the electric shock defend grade of this instrument 1s Type CF The monitor described in this user manual 1s not protected against a The effects of defibrillator shocks b The effects of defibrillator discharge c The effects of high frequency currents d The interference of electrosurgery equipment 1 3 Ultrasound Safety Guide G Fetal Use The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor Clinical interpretation of fetal heart rate traces can diagnose fetal and or maternal problems and complications G Instructions for Use in Minimizing Patient Exposure The acoustic output of the monitor is internally controlled and can not be varied by the operator in the course of the examination The duration of exposure 1s however fully under the control of the operator Mastery of the examination techniques described in the User Manual will facilitate obtaining the maximum amount of diagnostic information with the minimum amount of exposure The exercising of clinical judgment in the
4. 10 3 Disinfecting Clean the equipment before disinfecting The table below lists the allowed disinfectant bases Instrument Disinfectant Glutaraldehyde up to 3 6 Ethanol Surface Disinfectant 1 and 2 Propanol 62 F6 Fetal amp maternal Monitor User Manual Y 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 If any aging or damage is detected replace the damage part s or contact the manufacturer for service before reusing them NOTE The manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details 10 4 Sterilizing Do not sterilize the monitor or the accessories unless this 1s necessary according to your hospital regulation 63 F6 Fetal amp maternal Monitor User Manual Chapter 11 Warranty and After Sales Service 11 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 warran
5. 4 Select ok 5 Select Name 6 Select the required letter for patient s name on the soft keyboard 7 Select ok 8 Select OK Cancel Figure 8 9 Mat Info inputting menu Figure 8 10 Soft keyboard 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 56 F6 Fetal amp maternal Monitor User Manual NOTES 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 3 You can only input English letters for the patient ID and name The input ID appears on both the screen and the recorder paper The name appears only in the archive list 8 9 3 Switching Mat Info Inputting On or Off The Mat Info inputting function allows the menu to pop up automatically after the START key is pressed After you input the mother s information and exit from the menu the monitoring starts immediately To switch the Mat Info Inputting on or off 1 Select setup key on the main interface 2 Select Start Monitor gt Mat Info 3 Select ON or OFF default 4 Select OK _57 F6 Fetal amp maternal Monitor User Manual Chapter 9 After Monitoring 9 1 Data
6. and amnioinfusion supplies if needed 2 Open the sterile ACCU TRACE IUPC package Insertion NOTE This product is designed for use with the introducer 3 4 5 6 T 8 9 Using aseptic technique remove the catheter from the package Perform vaginal exam to ensure ruptured membranes and adequate dilation 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 Continue to gently advance the catheter tip through the cervical os and feed the catheter into the intra amniotic cavity until the 45cm mark is at the introitus If the 45cm mark is not clearly visible stop advancing when the symbol on the catheter meets the introducer NOTE For easier insertion do not twist the catheter in the introducer 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 Slide the introducer out of the vagina along the catheter When the introducer is completely out of the vagina slide thumb between catheter and introducer tab which will begin to separate the introducer from the catheter See figure 8 3 Figure 8 3 Separate the introducer Anchor the catheter in place with one hand and pull the introducer straight back off the catheter See figure 8 4 Figure 8 4 Remove the introducer 52 F6 Fetal amp
7. clearly identify the fetal presenting part 2 Remove the spiral electrode from the package leave the electrode wires locked in the handle notch 47 F6 Fetal amp maternal Monitor User Manual Gently bend the guide tube to the desired angle Hold the drive handle ensure the spiral electrode 1s retracted about one inch 2 5 cm from the distal end of the guide tube Place the guide tube firmly against the identified presenting part Maintain pressure against the fetal presenting part with guide and drive tubes Rotate the drive tube by rotating the drive handle clockwise until gentle resistance 1s encountered Resistance to further rotation and recoil of the drive handle indicates that the spiral electrode 1s well attached to the fetus Release the electrode wires from the handle notch and straighten them Slide the drive and guide tubes off the electrode wires Insert the safety cap into DECG cable Figure 8 2 The well attached fetal spiral electrode 8 3 5 DECG Monitoring Procedure I 2 Perform a vaginal examination to identify the fetal presenting part Prepare the patient s skin using the procedures described in section 8 3 3 Preparing the Patient s Skin Prior to Placing Electrodes Attach the fetal spiral electrode to the fetal presenting part using the procedures described in section 8 3 4 Directions for Using Fetal Spiral Electrode Fix an attachment pad electrode to DECG cable Remove the film on
8. 06 23 14 55 19 4 Figure 3 12 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 setup key on the main interface 2 Select General gt Screen Color 3 Select the required color 4 Select OK According to the content the main interface is divided into four windows 1 Message Window 2 Trace Menu Window 3 Numeric Window 4 Status Window 18 F6 Fetal amp maternal Monitor User Manual 1 Message Window 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 Alarm reviewing key Select this key to open the alarm reviewing menu C BUM Mat Info key Select this key to open maternal information menu for inputting or changing the patient s ID and name d AA Setup key Select this key to open setup main menu 2 Trace Menu Window The trace menu window occupies most space of the screen During monitoring or reviewing it displays traces during setting it displays setup menus The background pane bar supports two standards 30 240 American standard and 50 210 International standard The 120 160 bmp area with the green band in between the fetal heart rate pane makes it eas
9. 18 T om F h i r I 1 1 1 L TE e Ee cm ni e uf a E i Li Qu gt NA nn ee 20 J Figure 3 4 Rear Panel 24 2 x Figure 3 5 Bottom Panel 2d 9 Transducer Holder 10 DECG Socket 11 US2 Socket 12 EXT 1 Socket 13 TOCO IUP Socket 14 US1 Socket 15 MARK Socket 27 28 29 30 Reserved 16 POWER Switch 17 Equipotential Grounding Terminal 18 Antenna 19 USB Socket 20 Power Socket 21 Handle 22 DB9 Socket 23 RJ45Socket 24 Fuses 25 Battery Compartment 26 Wall mounting Holes F6 Fetal amp maternal Monitor User Manual 3 2 1 Keys and Control Knob Figure 3 6 Keys and Control Knob 0000000 START SILENCE AUTO ZERO MARK PRINT CHANNEL MIBP 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 and move back Press this key to start monitoring under the monitoring status or move back to the previous interface under the login status or setting status 2 SILENCE Function Switch on Switch off audible alarm Press this key to switch on or off the audible alarm 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 Fu
10. MARK PRINT NOTES 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 3 Only use the paper the manufacturer approved to avoid poor printing quality deflection or paper jam 4 Keep the drawer closed unless when loading paper or servicing Removing Paper Jam When the recorder does not function or sound properly open the drawer to check for a paper jam Remove the paper jam in this way G Cut the recorder paper from the paper drawer edge G Through the hole on the bottom panel of the paper drawer push the recorder paper up with one finger Remove the paper G Reload paper and then close the drawer a 1g e i p P PRINT CHANNE TTL 31 F6 Fetal amp maternal Monitor User Manual 6 2 Switching On A WARNINGA 1 Check if all the metal parts are linked to the protective earth cord and the cord is working well before powering 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 The power indicator lights up and a start up music will be heard You can operate the monitor after the main interface appears You can choose to swit
11. RN HM MEM EMI LM M MT 59 IO 1 T Maintaining IIS PECUON ut AAA ede tub eo td acts 50 10 12 Waintenance OF MONO sister ERE NET dux aue ito deu vp Eun ad ease 50 TO 1 5 Maintenance or TESDSOUCOES ssaa ea 60 10 1 4 Storage oP Recorder Paper a9 eue iene D Ida tenuta ERU M Ces 60 10 13 Cfeanim of RECON ui 60 A O A N E 61 10 2 L Ckm OP Monitor cta a oe regen hn eter te 61 10 22 Cleans OF ACCESSO CSi dotan 62 10 gt Bi anie EE 62 I SWAT o E E AD 63 Chapter 11 Warranty and After Sales Service eee eee eee eee eene ee eee eee eeee 64 HIVideo 64 A A O da 64 Appendix 1 Product Sp cifications ooo eere ninna allertare 65 PS PRI BI O FOLCO CERRPPEPENS BORE BO SCE RE EE UE MSIE dE LE MIDI E M dE CE 65 AI Low Output sumiiiary bieb iii iii 68 ALS Transducers A AM weiter exe ee hes dca anaes 69 A1 4 Rechargeable Lithium ion Battery eene 69 Appendix 2 Signal Input Output Connector cccccccssssssssscccccccssssssssssccccccccessssssssccooses 70 AppendiX gt Froubleshoome ian 71 ASA dilata 71 PON 71 AS RECOCJEr EOL arrien en On utut toic Loud e Ceu up d endet eu fe oce e Ceu Mp enge u iae 71 A3 4 Trouble with Ultrasound FHR Monitoring T2 A3 5 Troubles with DECG FHR Monitoring ii 22 A3 6 Troubles with Contractions Monitoring External 73 A3 7 Troubles with Monitoring Contractions Internal
12. Saving The monitor automatically saves the data every 2 hours and prior to shutdown including fetal monitoring traces and maternal information The maximum capacity 1s 24 hour data When the monitor is switched on again those data will be loaded You can review them or print them at a high speed A CAUTIONA Switch off the monitor in a normal way as described in section 9 3 Switching Off otherwise the data that is not saved will be lost 9 2 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 Tear off the printed recorder paper along the perforation 9 3 Switching Off 1 Press and hold the POWER switch for at least 3 seconds to switch off the monitor 2 Unplug the power cord A WARNINGA Do not press the POWER switch continuously Allow at least 10 seconds between switching the monitor on and off 58 F6 Fetal amp maternal Monitor User Manual Chapter 10 Maintenance and Cleaning 10 1 Maintenance 10 1 1 Maintaining Inspection 1 Visual Inspection Prior to using the monitor every time do the following inspections G 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 G Check all the outer c
13. and FHR2 offset is printed Information List at the start of the monitoring and every ten minutes afterwards Each recorder paper pack has 150 pages When you notice the page Page Mark p mark comes to the end remember to load new paper in time 7 Papervendoi F9 G Da due the paper vendor is GE F9 P indicates the paper vendor is Philips 29 F6 Fetal amp maternal Monitor User Manual Chapter 6 Pre Monitoring Preparation 6 1 Loading Recorder paper A CAUTIONA Only use the recorder paper provided by the manufacturer otherwise the recorder may be damaged This kind of damage is not covered by warranty If the monitor is used for the first time or when the paper runs out you should load paper 1 Press the two latches on each side of the paper drawer at the same tine and slide the drawer out carefully r TT ac Dude Sage PU UNT T 2 Take out the Z fold thermosensitive paper and remove the wrapper 3 Place the pack in the drawer with the pane facing up and the green safety area on the left im 7 00000090 RLH Et IP START SILENCE AUTO ZERO MARKER 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 30 F6 Fetal amp maternal Monitor User Manual na o CHANNEL NIRP e A START SILENCE AUTO ZERO
14. and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the F6 Fetal amp maternal Monitor is used exceeds the applicable RF compliance level above the F6 Fetal amp maternal Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the F6 Fetal amp maternal Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 80 F6 Fetal amp maternal Monitor User Manual A5 4 Recommended Separation Distance Recommended separation distances between portable and mobile RF communications equipment and the F6 Fetal amp maternal Monitor The F6 Fetal amp maternal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the F6 Fetal amp maternal Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the F6 Fetal amp maternal Monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to f
15. hee 49 5 4 Momtonn TWyuk PHR peli 49 0 4 Montornes Twins External calati 49 5 42 Montitorine EInteEnally iaa 49 5 4 95 Sipnals Overlap Verification SOV sites diia 50 44 Chane mne EHIRZIDEEIR Ost t OL aa 50 8 5 Monitoring Uterine Activity ExternallY i 50 5 2 1 Parts Requisito 50 8 5 2 POCO Montotino Procedure 2 laid 50 55 5 Chamoun VA Base lhe oer rt e ote Soda v a epe anten teeters 51 8 6 Monitoring Uterine Activity Internally i 2d 50 1 Parts Required aaa iaia 51 5 6 2 Directi ns Tor Use or UPC satis 52 5 0 3 IUP M nitonne Procedure aia io ione 54 8 6 4 Checking Intrauterine Pressure Cable Function sese 54 5 7 Nlonitoruie Fetal Movement eiii dro 55 8 7 1 Auto Fetal Movement Monitoring AFM essere 55 8 7 2 Enabling or Disabling AFM Trace isa 55 8 o Change AFM Gail aereo 55 8 7 4 Manual Fetal Movement Monitoring MEM esee 55 frei Ford MONTOS sa data 56 8 9 Inputting Maternal Information Mat INfO 56 IV Sauro 56 8 9 2 Changing Maternal Information nnne 56 8 9 3 Switching Mat Info Inputting On or Off ccccccecceeeeeeseeeeeeeeeeeeeeeeeees 57 Chapter 9 After Montoro ina 58 Lp 58 92Completin MON ONNO ss 58 IPASVI arci 58 Chapter 10 Maintenance and Cleaning cccsssssssscccccsssssssssssscccccccsssssssssccccsssessssceecs 59 II MEAM
16. key on the main interface 2 Select Recorder gt Print Self Check 3 Select ON or OFF default 4 Select OK 5 3 Understanding Recorder Paper Printout WARNING 1 If there is any difference between the display and the printout take the printout as criterion _27 F6 Fetal amp maternal Monitor User Manual 2 Ifthe data is doubtful clinicians should make diagnoses based on the real condition Figure 5 1 1s an example of the recorder paper with traces Comparing it with the monitor screen you can find this extra information on it Figure 5 1 An Example of recorder paper with traces n E F9 P 7 m e y 210 FERRE 180 pA E aiia fs 4 d pe IS RE sibla mim DIL DIL 5 did Lie PS cipimini FASE EE FESTE PULSE T TSE Es ot eet 1 DE The FHR pane range 30 bpm 240 bpm indicates the paper style is 1 Paper Style American Standard The FHR pane range 50 bom 210 bpm indicates the paper style is International Standard The monitor prints a self check trace after being switched on It is used to check if the recorder paper is properly loaded Self Check Trace FHR2 Mark The trace marked with FHR2 is the FHR2 trace FHR1 Mark The trace marked with FHR1 is the FHR1 trace 28 F6 Fetal amp maternal Monitor User Manual 5 Trace A list of current date time print speed ID
17. monitoring of low risk patients will avoid unnecessary insonation 1 4 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 _2 F6 Fetal amp maternal Monitor User Manual NWARNINGA 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 Only qualified service engineers can install this equipment Only service engineers authorized by the manufacturer can open the shell 3 This device is not intended for home use 4 EXPLOSION HAZARD Do not use the F6 monitor in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur 5 SHOCK HAZARD the power receptacle must be a three wire grounded outlet A hospital grade outlet is required Never adapt the three prong plug from the monitor to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate the monitor 6 Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient in case of possible hazard caused by leakage current superposition 7 Do not apply this monitor simultaneously with other PATIENT connected equipment such as a cardiac pacemaker or ot
18. of the deceased fetus during or following maternal movement So you need to confirm fetal life by other means before starting to use the fetal monitor such as using a fetoscope stethoscope Pinard stethoscope or obstetric ultrasonography 8 2 Monitoring FHR with Ultrasound The ultrasound monitoring is a method to obtain FHR on maternal abdominal wall Place a US transducer Ultrasound transducer on maternal abdomen It transmits low energy ultrasound wave to the fetal heart and receives the echo signal 8 2 1 Parts Required 1 US transducer 2 Aquasonic coupling gel 3 Belt 8 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 1s fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange the belt around her abdomen 44 F6 Fetal amp maternal Monitor User Manual 2 Acquiring FH Signal Search for the location of the fetal heart using a stethoscope or a fetoscope Apply a certain amount of acoustic gel on the transducer and move it slowly around the fetus site until a clear characteristic hoof beat sound of the fetal heart is heard Refer to figure 8 1 for the transducer position Measure TOCO Measure FHR Figure 8 1 Positioning transducers single fetus 3 Fixing the Transducer Wrap the abdomen with the belt over the transducer Fix the transducer by pushi
19. signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt consult our technical service department or your local distributor For proper monitoring 17 This device is not intended for treatment 18 The fetal spiral electrode and intrauterine pressure catheter are disposable Discard them after use 19 The IUPC is neither intended nor approved for measuring intrauterine pressure extraovularly attempting to do so may lead to maternal discomfort or injury 20 Alarms must be set up according to different situations of patients Make sure that audio sounds can be activated when an alarm occurs For using the battery 21 Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly 22 Do not connect the battery cable connector or battery socket with metal objects which can result in short circuit 23 Do not unplug the battery when monitoring 24 Do not heat or throw the battery into a fire 25 Do not use or leave battery close to fire or other places where the temperature may be above 60 C 140 F 26 Do not immerse throw or wet the battery in water seawater 2 Do not destroy the battery Do not pierce battery with a sharp object such as a needle do not hit with a hammer step
20. 1 Anybody who connects additional equipment to the signal input connector or signal output connector to configure a medical system must ensure that the system complies with the requirements of the valid version of the system standard IEC EN 60601 1 1 If in doubt contact our technical service department or your local distributor DB9 Interface Pn Signal impuso dis s qwe oo 6 TA Output 7 TB Output RA Input 8 s m ms RJ45 Interface Reserved 70 F6 Fetal amp maternal Monitor User Manual Appendix 3 Troubleshooting A3 1 No Display Power cable is loose Tighten the power cable Power indicator is off The fuse is blown Change the fuse The battery runs out of power Connect to AC power supply A3 2 Noise Too high volume setup Turn down the volume Interfered by mobile phone or Keep the interfering source far other interfering source away from the monitor A3 3 Recorder Error Phenomenon Possible PossibleCause dn Wi l a loading paper or paper is Load paper ML and keep i dampened paper from moist The recorder is not started Press the PRINT key Run out of paper Load paper Recorder does not work Slide the paper drawer in until The paper drawer is not locked both latches are locked in position EU F6 Fetal amp maternal Monitor User Manual A3 4 Trouble with Ultrasound FHR Monitoring The pregnant woman is too fa
21. 2 Disconnecting the transducer When disconnecting a transducer hold the afterbody of the transducer outshell the shaded part shown in figure 6 2 with fingers and push it in slightly then pull it out Refer to figure 6 2 6 7 Adjusting Volume The monitor automatically detects which channel the ultrasound transducer is connected to The corresponding volume adjustment key of this channel displays Sy indicating the FH sound 1s _ 34 F6 Fetal amp maternal Monitor User Manual USI 137 coming out from this channel for example while the other one displays x for example Press the CHANNEL key to switch the FH sound to the other channel Adjust the default monitoring volume The FH volume returns to the default level after the START key is pressed This default level is adjustable To change this level Select the setup key on the main interface 2 Select Start Monitor Volume 3 Select the volume from 0 9 the step is 1 and the default level is 3 4 Select OK Adjust the real time monitoring volume If the default volume level is not satisfactory during monitoring you can adjust the real time volume of each channel Select the volume adjustment key X on the main interface 2 Rotate the control knob clockwise for one step the volume increases by one level there are ten levels for your choice the green pane of the volume level indicator CANI increases by one at every two steps rotate t
22. 6 Specification label of the TOCO transducer blue Information on the specification label includes PN MS3 109301 Part number of this US transducer PN MS3 31527 Part number of this TOCO transducer PW 1 0 pulsed wave the central frequency of the US transducer is 1 0 MHz A 1 Version number of the transducer WATERPROOF means the transducer is waterproof IPX8 means the transducer can work continuously for 5 hours under 1 metre water without being waterlogged 16 F6 Fetal amp maternal Monitor User Manual E caution The waterproof parts of the US TOCO transducer are restricted to the main body and the cable Do not immerse the plug into any liquid in the process of monitoring or cleaning 3 3 2 Remote Event Marker 1 Key of the remote event marker 2 Plug of the remote event marker Figure 3 9 Remote Event Marker 3 3 3 Fetal Spiral Electrode 1 Reference Electrode 2 Drive Tube 3 Guide Tube 4 Drive Handle 5 Handle Notch 6 Electrode Wire 7 Safety Cap Figure 3 10 Fetal Spiral Electrode 3 3 4 Fetal Stimulator Figure 3 11 Operating control of fetal stimulator 17 F6 Fetal amp maternal Monitor User Manual 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 4 Screen 3 4 1 Main Interface 3 1 Message Window 2 Trace Menu Window 3 Numeric Window 4 Status Window 2009
23. 74 si dui T 74 Appendix 4A DD ECV IAL ON e 75 Appendix 5 EMC Information Guidance and Manufacture s Declaration 76 A5 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS 76 A5 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS LI A5 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not E FESUPRORENGi pianali 79 A5 4 Recommended Separation Distance iii SI F6 Fetal amp maternal Monitor User Manual Chapter 1 Safety Guidance NOTES 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 1 Intended Use The F6 Fetal amp maternal Monitor hereinafter called the monitor is intended for non invasive and invasive monitoring of fetus during antepartum examination labor and delivery It is intended to be used only by trained and qualified personnel in antepartum examination rooms labor and delivery rooms The monitor provides Non stress testing for pregnant women from the 28th week of gestation It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer Alternatively it can interna
24. EDAN INSTRUMENTS INC C 0123 IOUO BUI BUI V 839 1 User Manuel Manual Ver 1 1 Release Date Aug 2009 Part No MS1R 112839 V1 1 Copyright Copyright EDAN INSTRUMENTS INC 2009 AII rights reserved Statement This manual will help you understand the operation and maintenance of the product better It 1s 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 EDAN owns the copyrights of this manual Without prior written consent of EDAN any materials contained in this manual shall not be photocopied reproduced or translated into other languages Materials protected by the copyright law including but not limited to confidential information such as technical information and patent information are contained in this manual the user shall not disclose such information to any irrelevant third party The user shall understand that nothing in this manual grants him expressly or implicitly any right or license to use any of the intellectual properties of EDAN EDAN holds the rights to modify update and ultimately explain this manual Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions r
25. 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 Adjustment method Push the hook on top of the screen left to spring it open Pull the screen forward to adjust to the preset screen angles of 31 44 or 53 degrees 2 33 F6 Fetal amp maternal Monitor User Manual 6 5 Setting Date and Time You can change the date and time of the monitor 1 Select 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 4 Select Date Format for the format of the date there are three options yyyy mm dd default mm dd yyyy and dd mm yyyy 5 Select OK NOTE The date and time remain in the monitor for at least two months after it is switched off You do not have to set date and time before monitoring each time 6 6 Connecting Transducers Check for visible damages of the transducers every time before connecting them to the monitor Pay special attention to the cracks on the transducers and cables before immersing them into conductive fluid If damage is found replace them with good ones at once When plugging transducers into the monitor make sure the arrow symbol of the connector 1s facing up refer to figure 6 1 Figure 6 1 Connecting the transducer Figure 6
26. W x 132 48 mm H Module Size 235 0 mm W x 145 8 mm H x 6 1mm D Surface treatment Anti glare Color Arrangement RGB Stripe Interface Digital Viewing angle 65 Horizontal 45 65 Vertical Response Time TrR 15ms typ TrD 20ms Typ Contrast Ratio 300 1 Typ Brightness 350 cd m2 Typ Backlight power consumption 4 098W Typ Panel power consumption 250mW Typ Weight 332g 10 Recorder Paper Z fold thermosensitive compatible with GE and PHILIPS recorder papers Paper width 152mm GE 150mm PHILIPS Effective printing width 110mm American Standard 120mm International Standard FHR printout width 70mm American Standard 80mm International Standard 66 Signal Interface F6 Fetal amp maternal Monitor User Manual FHR scaling 30bpm cm American Standard 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 Accuracy of data 5 X axis Accuracy of data 1 Y axis Resolution 8 dots mm Record Information FHR1 trace mark FHR2 DECG trace mark TOCO IUP trace AFM trace fetal movement mark event mark AUTO zero symbol date time printing speed ID and FHR2 Offset etc Auto data saving 24 hour data Archive storage 3 000 minute data DB9 network interface RJ45 interface Technique Ultrasound Pul
27. ables power socket and power cables G Check if the monitor functions properly If any damage is detected stop using the monitor on the patient Replace the damage part s or contact the manufacturer for service before reusing it 2 Routine Inspection The overall check of the monitor including safety check and function check should be performed by qualified personnel every 6 to 12 months and each time after service The equipment should undergo periodic safety testing to ensure proper patient isolation from leakage currents This should include leakage current measurement and insulation testing The recommended testing interval is once a year or as specified in the institution s test and inspection protocol 3 Mechanical Inspection Make sure all exposed screws are tight Check the external cables for splits cracks or signs of twisting Replace any cable that shows serious damage Pay particular attention to the supply socket A WARNINGA Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards 10 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 _ 59 F6 Fetal amp maternal Monitor User Manual table environment 1
28. acteristics specified by their manufacturers 21 F6 Fetal amp maternal Monitor User Manual Thermosensitive Paper GE International M25R 75112 Thermosensitive Paper Philips American M25R 75113 Thermosensitive Paper Philips International M25R 75114 Fuse T1 6AL 250V M21 64010 Rechargeable Lithium ion Battery M21R 064118 A CAUTION Only connect the accessories supplied or recommended by the manufacturer to the monitor OO ns F6 Fetal amp maternal Monitor User Manual 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 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 When a patient alarm is switched off the technical alarms relative to it will be disabled as well The alarms have two levels middle and low Middle level alarm is a serious warning whose symbol is low level alarm is a general warning The middle level alarms have higher priority than the low level alarms If both types of alarms are active at the same time the monitor sounds an audible indicator for the middle level alarms The system sets all patient alarms as middle level and all technical alarms as low level a
29. and the present one is page 1 You can select the alarms list and then rotate the control knob to review more alarms 4 7 Alarm Treatment Measures 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 1f necessary Check if the alarm 1s terminated when the alarm condition 1s solved 4 8 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 9 Patient Alarm Defaults FHR1 FHR2 Lower Limit 120 bpm FHRUFHR2 Upper Limi 160 bpm FHR1 FHR2 Alarm Delay 0 300 second s in increments of 5 FHR1 FHR2 Alarm Level Medium not adjustable NOTE The upper limit must be higher than the lower limit When setting the upper limit you do not have access to the options that are lower than the preset lower limit and vice versa 25 F6 Fetal amp maternal Monitor User Manual 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 mon
30. ange the AFM gain The AFM gain affects overall numeric and scope of the AFM trace 1 Select setup key on the main interface 2 Select Fetus gt AFM Gain 3 Select 1 2 3 default or 4 4 Select OK 8 7 4 Manual Fetal Movement Monitoring MFM MFM result comes from the patient s feeling of fetal movement The count will be displayed on the screen in MFM numeric area 1 Insert the FM marker connector into the MARK socket on the monitor 2 Let the patient hold the marker in hand ask her to press the top key of it when a fetal _55 F6 Fetal amp maternal Monitor User Manual movement is felt Continuous movements in 5 seconds are considered to be one movement and only press the key once 8 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 start printing is disabled press the PRINT key to start printing 8 9 Inputting Maternal Information Mat Info 8 9 1 Auto ID After you press the START key the system creates an auto ID for the present patient Gf Mat Info inputting is switched off The auto ID consists of the date and time when the monitoring starts 8 9 2 Changing Maternal Information You can change the patient s information after the monitoring starts 1 Select Mat Info key mx acm on the main interface 2 Select ID 3 Select the required number for patient s ID on the soft keyboard
31. appear on the screen to warn you Checking the patient and reposition of transducers might be needed 8 4 4 Changing FHR2 DFHR Offset In order to distinguish FHRI trace from FHR2 DFHR trace FHR2 DFHR offset is provided to help you separate the two traces by an offset of 20 bpm or 20 bpm To change the FHR2 DECG offset 1 Select setup key on the main interface 2 Select Recorder gt FHR2 Offset 3 Select 20 bpm default 0 bpm or 20bpm 4 Select OK This preset FHR2 DFHR offset will be printed on the recorder paper every 10 minutes FHR2 DFHR 20bpm the FHR2 DFHR trace is 20bpm lower than it really is FHR2 DFHR 20bpm the FHR2 DFHR trace is 20bpm higher than it really is 8 5 Monitoring Uterine Activity Externally 8 5 1 Parts Required 1 TOCO transducer 2 Belt 8 5 2 TOCO Monitoring Procedure 1 Placing Transducer Belt Place the transducer belts across the bed ensuring that the belt will be around the abdomen when it 1s fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange the belt around her abdomen 50 F6 Fetal amp maternal Monitor User Manual 2 Fixing the Transducer Refer to figure 8 1 for the TOCO transducer position Wipe any gel remaining on abdomen around this area Place the transducer on the patient s fundus to get optimum recording of uterine activity Wrap the abdomen with the belt over the transducer Fix the transducer
32. ashing 3 If the light does not illuminate replace the cable NOTE If the light is flashing verify that the cable check plug is inserted completely into the cable A WARNINGA The cable test function is not intended to check the accuracy of the system only to confirm cable function _54 F6 Fetal amp maternal Monitor User Manual 8 7 Monitoring Fetal Movement 8 1 Auto Fetal Movement Monitoring AFM 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 1s because of the bigger scope of moving areas e g the fetal arms or legs lower frequency is because of the lower velocity of the fetal movements compared with those of the fetal heart Only USI channel can perform AFM But be aware that when monitoring twins the movements detected by USI may also be caused by the second fetus s movement The movement of the fetus will be detected and displayed in the form of a trace on the screen and the recorder paper AFM monitoring can be switched off its gain 1s adjustable 8 7 2 Enabling or Disabling AFM Trace The AFM trace on the screen and recorder paper can be enabled or disabled 1 Select setup key AA on the main interface 2 Select Fetus gt AFM 3 Select ON or OFF default 4 Select OK 8 7 3 Changing AFM Gain You can ch
33. ble gases Disinfection Sterilizing Method Refer to this user manual for details EMC Group Class A Working System Continuous running equipment Earth Leakage Current Limit N C SEG 500uA 1000A Enclosure Leakage Current Limit N C S F C 100uA 500uA Patient Leakage Current Limit N C S F C d c 10uA 50uA a c 10uA 50uA Patient Auxiliary Current Limit N C S F C d c 10uA 50uA a c 10A 50uA Operating Voltage 100V 240V Operating Frequency 50Hz 60Hz Input Power 110VA Battery 14 8V 4400mAh Lithium ion Battery Power Supply 65 F6 Fetal amp maternal Monitor User Manual ees Fetal amp maternal Monitor User Manual Working Environment Temperature 5 C 40 C 41 F 104 F Relative Humidity 25 80 non condensing Atmospheric Pressure 860hPa 1060hPa Transport and Storage Temperature 20 C 55 C 4 F 131 F Relative Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa Working Temperature 0 C 40 C 32 F 104 F Relative Humidity lt 95 40 C 4104 F Altitude 500m 3000m Transducers Transport and Storage Temperature 40 C 60 C 40 F 140 F Relative Humidity lt 90 60 C 140 F Altitude 500m 3000m Display LCD Size 10 2 Diagonal Resolution 800 x 3 RGB x 480 Display Mode Normally white Transmissive Pixel Pitch 0 0925 mm W x 0 276 mm H Active Area 222 0 mm
34. bpm 210 bmp International standard AFM trace The y axis indicates the scope of fetal movement NOTE The AFM trace is only for reference please take the MFM marks as criterion TOCO trace The y axis indicates the numeric of TOCO The range is 0 100 Besides some other symbols appear among the traces This symbol indicates the new monitoring starts T This symbol indicates a manual fetal movement and it appears after the patient presses the FM marker when she feels a fetal movement l This symbol indicates the MARK key is pressed to record an event such as the patient turning around taking injection xx This symbol indicates the monitor is zeroed by pressing AUTO ZERO key 7 1 1 Changing Time Scale The fetal monitoring traces share the same time scale which displays the time every two minutes This scale 1s either in real time format or relative time format Real time 1s the time of the monitor Relative time records the elapsed time for the current monitoring To change this time format Select setup key ACA on the main interface 2 Select Date And Time gt Time Scale 3 Select Real Time default or Relative Time 4 Select OK NOTE The real time contains only the hour and minute but no second As a result the time scale may correspond to the 0 59th second of the system time Do not mistake the time scale for the exact time LB F6 Fetal amp maternal Monitor User Manual 7 1 2 Changi
35. by pushing its buckle through the overlapping section of the belt Make sure the belt fits the patient snugly but comfortably 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 NOTES 1 Do not apply aquasonic coupling gel on a TOCO transducer or its contact area 2 Check the function of the TOCO transducer by applying pressure on it to see if this is displayed on the screen 8 5 3 Changing UA Baseline You can change the UA baseline 1 Select setup key on the main interface 2 Select Fetus gt UA Baseline 3 Select 5 10 default 15 or 20 4 Select OK NOTE If your monitor has been configured with IUP the baseline will be 10 and not adjustable 8 6 Monitoring Uterine Activity Internally 8 6 1 Parts Required 1 Disposable intrauterine pressure catheter ACCU TRACE IUPC IUPC for short 2 Reusable intrauterine pressure connecting cable connecting cable for short 3 Reusable intrauterine pressure cable IUP cable for short 51 F6 Fetal amp maternal Monitor User Manual 8 6 2 Directions for Use of IUPC Preparation 1 Gather supplies ACCU TRACE IUPC reusable cable
36. by using reviewing keys Move the cursor away from the trace control tools to return to the real time main interface Deleting an archive To delete an archive select the archive opening key on the main interface Select the Archive and then choose Delete to delete the archive 7 2 4 Auto Measuring The auto measurement feature of the monitor provides baseline acceleration peak and deceleration peak of a FHR trace NOTE The auto measurement results are provided for reference only Measuring the FHH1 trace Load the traces to the main interface by using reviewing keys and then select the auto measuring key EH Un The following information 1s shown on the trace figure 7 4 Baseline A line is drawn in the central section of FHRI trace indicating FHRI baseline Acceleration peak If the acceleration is larger than 15 bpm and lasts longer than 15 seconds its amplitude and start time is marked above the peak in the format of X hh mm ss Deceleration peak If the deceleration is larger than 15 bpm and lasts longer than 20 seconds its amplitude and start time is marked under the peak in the format of X hh mm ss 40 F6 Fetal amp maternal Monitor User Manual Figure 7 4 Auto measuring FHR1 Measuring the FHR2 trace Press the auto measuring key again the monitor measures the FHR2 trace The auto measuring feature can only be applied to the reviewed FHR traces The information disappears
37. ch the start up music on or off 1 Select setup key on the main interface 2 Select General gt Start up Music 3 Select ON default or OFF 4 Select OK NOTES 1 Check all the functions to make sure that the monitor is in good condition 2 Ifthe monitor has a great amount of data saved in its long term memory it will take a few seconds to load them after start up When you notice the message Loading data please wait on the screen do not operate the monitor until the main interface appears The message Load failed indicates that the data have been damaged and therefore can not be loaded 6 3 Checking Recorder Paper The monitor provides the print self check function to check if the recorder paper is correctly loaded and set The recorder prints a baseline after start up if Print Self Check in the menu is ON Observe the starts and ends of the printed baselines illustrated with the arrow The starts and ends should be printed exactly on the edges of the pane if the recorder paper is correctly loaded and set If they do not comply with the edges reload paper or ask the service engineer to check the paper settings of the monitor 2 35 F6 Fetal amp maternal Monitor User Manual If the monitor does not print the baseline switch on the Print Self Check and then restart the monitor NOTE Make sure the paper is correctly loaded before starting printing 6 4 Adjusting Screen Angle
38. content in the pane can be changed while rotating the control knob At this time rotate the knob until the needed item appears press the knob to confirm selection G The function operates immediately NOTE The word select hereinafter stands for rotating the control knob cursor to an item then pressing the knob CAUTION This monitor is a normal medical device Please avoid violent operations such as continuously pressing the keys or control knob 3 2 2 Indicators There are four groups of indicator on top of the screen and the front panel From the top down they are alarm indicator CHARGE indicator AC indicator and Power indicator Table 3 1 lists their meanings Table 3 1 Indicator description Alarm Indicator _15 F6 Fetal amp maternal Monitor User Manual The battery is being charged Charge Indicator No battery is loaded or the battery is fully charged The monitor is connected to AC power supply AC Indicator The monitor is not connected to AC power supply The monitor is powered on Power Indicator The monitor is powered off 3 3 Accessories 3 3 1 Transducers Cu Figure 3 7 Ultrasound US transducer Figure 3 8 TOCO transducer 1 Serial number label of the US transducer pink U xxxxx is the serial number 2 Specification label of the US transducer pink 3 Transducer cable 4 Belt buckle 5 Serial number label of the TOCO transducer blue T xxxxx is the serial number
39. e adjustments modifications or repairs are carried out by persons authorized by EDAN and The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use Upon request EDAN may provide with compensation necessary circuit diagrams and other information to help qualified technician to maintain and repair some parts which EDAN may define as user serviceable Using This Label Guide This guide is designed to give key concepts on safety precautions AN WARNINGS A WARNING label advises against certain actions or situations that could result in personal injury or death Y 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 Revision History Corrected grammar and punctuation Revised interface and cursor and added archive managing auto measuring according to the V1 4 software 2009 08 14 ECO F9 9003 V1 1 II Table of Contents Chapter LE Safety Guidant Esasi EE E EE 1 T1 Intended US E E I 2 Enstruction dot Sale Operaio ala l 3 Ultrasound Saler Md Ae anor dea 2 A Salely Procal ioi ii 2 1 5 Denntrons and Symbol Snae Liliana ap 6 Chapter 2 Installation Guidant aan 9 21 Openin and Checkne Packard ida 9 22 Wiis tain DAME ia 9 23 Connecting Power Cable s
40. er connection of the Restart the monitor and try again contact the manufacturer if the connection still fails Connect the monitor to AC power supply Load paper and or close the drawer Adjust one of the US transducers until another fetal heart signal is detected Adjust the US transducer until another fetal heart signal is detected Check the connection of the spiral electrode Check the connection of the DECG cable Check if the spiral electrode is well attached to the fetus check the woman s condition F6 Fetal amp maternal Monitor User Manual Chapter 8 Fetal Monitoring NWARNING 1 The monitor is not intended for use in intensive care units ICU operating rooms or for home use 2 The monitor is not protected against defibrillation 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 8 1 Confirming Fetal Life Fetal monitoring with ultrasound or DECG can not differentiate a fetal heart rate signal source from a maternal heart rate source in all situations These are some of the signal sources that might be taken as FHR signal source by mistake High maternal heart rate signal Maternal aorta or other large vessels signals Electrical impulse from the maternal heart transmitted through a recently deceased fetus Movement
41. ersion 1 4 3 In the setup main menu you have access to all the items other than System You can select EXIT to exit from this menu 20 F6 Fetal amp maternal Monitor User Manual 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 Once you select OK to confirm the setting changes the new settings will be stored in the monitor s long term memory If the monitor is switched on again after being switched off or a power loss it will restore the new settings For your reference when the cursor is located at an item in this menu the monitor provides a brief function description of this item in a pane with blue frame under the items For example the cursor is located at System in the illustration above Correspondingly its function Set system items of the monitor is issued in the blue frame pane 3 5 Ordering Information Accessories supplied or approved by EDAN can be used with the F6 monitor See the following table for details The accessories employed by us such as the rechargeable battery model No HYLB manufactured by HENGYU are products having passed the authentication of CE and they have the char
42. gnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment Power frequency 50Hz 60Hz magnetic field IEC61000 4 8 mas ie F6 Fetal amp maternal Monitor User Manual lt 5 UT lt 5 UT gt 95 dip in U7 gt 95 dip in Ur for 0 5 cycle for 0 5 cycle Mains power quality should be that of a typical commercial or 40 U1 40 U1 hospital environment If the user 60 dip in Ur 60 dip in Ur of the F6 Fetal amp maternal for 5 cycles for 5 cycles Monitor requires continued operation during power mains 70 Uy 70 Uy interruptions it is recommended 30 dip in Ur 30 dip in Ur that the F6 Fetal amp maternal for 25 cycles for 25 cycles Monitor be powered from an uninterruptible power supply or lt 5 Us lt 5 Uy a battery gt 95 dip in Uy gt 95 dip in Ur for 5 sec for 5 sec NOTE Ur is the a c mains voltage prior to application of the test level Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 _ 78 F6 Fetal amp maternal Monitor User Manual A5 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The F6 Fetal amp maternal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of F6 Fetal amp maternal Monit
43. guration of F6 monitor includes FHRI fetal heart rate 1 FHR2 fetal heart rate 2 TOCO MFM and AFM monitoring That is to say F6 FHR1 FHR2 TOCO MEM AFM Optionally you can add DECG module to F6 providing DFHR direct fetal heart rate and IUP Intra uterine Pressure monitoring That is to say F6_optional F6 DFHR IUP A fetal stimulator can be provided to give a mild vibrating stimulation to the fetus Refer to FS 1 Fetal Stimulator User Manual for details A DB interface and an RJ45 interface are built in the monitor With them F6 monitor can be connected to a computer or the MFM CNS central monitoring system via 485 network or Ethernet Optionally you can order a built in wireless network module to connect the monitor via wireless network F6 monitor adopts a 10 2 LCD on which the collected data traces and numerics are displayed The built in thermal recorder prints the fetal traces Rechargeable lithium ion battery is provided for options 3 2 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 F6 Appearance for reference only 12 F6 Fetal amp maternal Monitor User Manual d 27 28 10 1112 2d 30 13 14 15 Figure 3 2 Left Panel FIERE Wwe 1 hr LETS EHE IA AAA aim UM 7 Figure 3 3 Right Panel 18
44. he knob anticlockwise to decrease the volume 3 Press the knob again to confirm the volume level Adjust the key volume The volumes of pressing keys rotating and pressing the control knob are also adjustable Select the setup key on the main interface 2 Select Fetus Beep Volume 3 Select Low default High or OFF 4 Select OK 35 F6 Fetal amp maternal Monitor User Manual Chapter 7 Understanding Measurement Results 100 gt i o dL o A A co 150 _ AA uw Xu S RR A o el ey mnis ENE ALA tN A E Sr me n RON MI 190 i A E co dictura cas A T a L PEPE at MA aa ios a Po 2009 06 23 14 56 31 Figure 7 1 F6 screen display 7 1 Traces A WARNINGA Due to the LCD size resolution and system settings the traces displayed on the screen may look different from the recorder printout Take the printout as criterion when making diagnoses amp 100 gt x CERTE E E A A A PAN 1 FHR2 Trace Fen OA OP Pe am ot pat o We AX EM p e PIN PS AT cg AA ERE NS 2 FHR1 Trace 3 AFM Trace 4 TOCO Trace Figure 7 2 Traces 36 F6 Fetal amp maternal Monitor User Manual During monitoring or reviewing the trace window displays four traces at most FHRI trace FHR2 trace dual configuration AFM trace and TOCO trace FHRI FHR2 trace The y axis of the trace indicates the numerics of FHR The range is 30 bpm 240 bpm American standard or 50
45. hen the monitor is switched on 5 2 Printing Configuration A CAUTIONA 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 setup key AA on the main interface _ 26 F6 Fetal amp maternal Monitor User Manual 2 Select Start Monitor gt Printing 3 Select ON or OFF default 4 Select OK 5 2 2 Choosing Paper Speed You can choose a paper speed of 1 cm min 2cm min or 3cm min 1 Select setup key on the main interface 2 Select Recorder gt Print Speed 3 Select 1 cm min 2 cm min or 3 cm min default 4 Select OK 5 2 3 Changing Print Timer You can choose different time length for the print timer 1 Select setup key on the main interface 2 Select Recorder gt Timer 3 Set timer to Infinite default Present ID or 10 90 minutes the step is 5 Infinite means the recorder will not stop printing until the PRINT key is pressed Present ID means the recorder will only print the traces for the patient with the present ID It will stop when her traces come to the end If the current page of the screen display includes more than one patient traces of the one on the right end of the page will be the printed 4 Select OK 5 2 4 Switching Print Self Check On or Off You can switch print self check on or off 1 Select setup
46. her electrical stimulators on a same patient 8 Do not switch on device power until all cables have been properly connected and verified 9 Do not touch signal input or output connector and the patient simultaneously 10 Equipment and devices that connect to the monitor should form an equipotential body to ensure effective grounding 11 Disconnect power cord before changing fuses Replace them with those of the same specifications only 12 SHOCK HAZARD Do not attempt to connect or disconnect a power cord with wet hands Make certain that your hands are clean and dry before touching a power cord 13 SHOCK HAZARD Do not remove the top panel cover during operation or while power is connected Only authorized service personnel could remove the unit cover 14 The monitor is not protected against defibrillation Do not apply it during electro surgery or MRI otherwise it might result in harming the patient or the operator 15 Only connect accessories supplied or recommended by the manufacturer to the device F6 Fetal amp maternal Monitor User Manual 16 Accessory equipment connected to the analog and digital 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 Anybody who connects additional equipment to the
47. interface 2 Select Alarm gt FHR1 or FHR2 gt Alarm 3 Select ON default or OFF 4 Select OK If FHRI or FHR2 alarm is switched off an alarm switched off symbol A appears in the numeric window For example A WARNINGA Do not switch the alarm off for the condition where the patient s safety maybe endangered 8 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 1 Select setup key AA on the main interface 2 Select Alarm gt FHRI or FHR2 3 Select a value from 50 205 for Lower Limit 4 Select a value from 55 210 for Upper Limit 5 Select OK 8 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 setup key AA on the main interface 2 Select Alarm gt FHR1 or FHR2 gt Alarm Delay 3 Select a value from 0 300 4 Select OK 46 F6 Fetal amp maternal Monitor User Manual 8 3 Monitoring FHR with DECG 8 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 The fetal s
48. ions For Use of IUPC prior to insertion The Product has been sterilized by gamma radiation and is sterilized and non pyrogenic unless package is broken or open Do not re sterilize it NOTE Refer to the instruction on the package for more information about using the IUPC 53 F6 Fetal amp maternal Monitor User Manual 8 6 3 IUP Monitoring Procedure 1 Insert IUPC using the procedure described in section 8 6 2 Directions for Use of IUPC Figure 8 7 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 5 Momentarily pressing the re zero button on the IUP cable The green light on the cable will flash for five seconds During this period zero the monitor by pressing the AUTO ZERO key Make sure the display numeric and trace are both 0 6 Ask the mother to cough A spike on the trace in response to the cough indicates proper positioning and function of the IUPC 7 Wash timely during monitoring A spike on the tracing will respond to the washing 8 6 4 Checking Intrauterine Pressure Cable Function To test an IUP cable s function 1 Disconnect the catheter from the cable Insert the cable check plug into the catheter end of the cable See Figure 8 8 Figure 8 8 Test the pressure cable 2 Verify that the green light is continuously lit no fl
49. itor supports some other functions listed below G G G G G G Auto start printing If the function is enabled the recorder starts printing automatically when a new monitoring starts the START key is pressed Otherwise you have to press the PRINT key to start printing Printing timer The printing timer determines the elapsed time for each print This time is adjustable Refer to 5 2 3 Changing the Print Timer o o e o e e Th Remaining time indicating print remaining time appears in the status window unless the timer is set as Infinite or Present ID Fast printing The recorder prints the data saved in the monitor at a high speed up to 25mm s Data Caching When the paper drawer is run out of paper or when it is open the recorder stops printing The data from this time on at most 60 minutes will be temporarily saved in the internal memory When new paper is loaded and or the drawer is closed the saved data will be printed out at a high speed When the saved trace has been printed out the recorder switches back to continue printing the current data at the normal speed automatically NOTE When the monitor is switched off the data in the internal memory will be lost FHR2 offset You can set the offset of the FHR2 trace to separate the two FH traces on the screen and the recorder paper Refer to 8 4 4 Changing FHR2 DFAR Offset Print self check The recorder prints a baseline for self checking w
50. lly monitor one of the FHRs with DECG and uterine activity with an IUPC Contraindications The monitor is not intended for use in intensive care units operating rooms or for home use 1 2 Instruction for Safe Operation G The monitor is designed to comply with the international safety requirements IEC EN 60601 1 for medical electrical equipment It is class I equipment G The monitor operates within specifications at ambient temperatures between 5 C 41 F and 40 C 104 F Ambient temperatures that exceed these limits could affect the accuracy of the instrument and cause damage to the modules and circuits Allow at least 2 inches 5 cm clearance around the instrument for proper air circulation G You must check that the equipment cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before use If damage is evident replacement is recommended before use G The monitor must be serviced only by authorized and qualified personnel The manufacturer 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 G Perform periodic safety testing to ensure proper patient safety This should include leakage F6 Fetal amp maternal Monitor User Manual current measurement and insulation testing The recommended testing interval is once per
51. maternal Monitor User Manual 10 Remove the liner from the adhesive pad and then adhere the pad to the patient s skin Secure the catheter by placing the catheter attachment strap to the adhesive pad See Figure 8 5 Figure 8 5 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 See Figure 8 6 The green light on the cable will flash for five seconds Figure 8 6 Rezeroing the system 2 During this period adjust the monitor to zero by pressing AUTO ZERO key A WARNING 1 2 3 Before insertion placental position should be confirmed amniotic membranes are adequately ruptured and sufficient cervical dilatation is assured Try to insert the catheter opposite the placental site Do not insert the introducer beyond the cervical OS Use it with caution when uterine infection is present If resistance is met at any time during insertion withdraw the catheter slightly and try at a different angle Forced insertion may result in patient s discomfort or injury Y CAUTION 1 oince procedures vary according to hospital needs preferences it is the responsibility of the hospital staff to determine exact policies and procedures for both monitoring and amnioinfusion The safe and effective use of the IUPC depends on the skill of the clinician who applies uses it Read Direct
52. mory Refer to section 9 Data Saving for details However when the memory 1s full the anterior data would be cleared There are possibilities that some important data 1s cleared The monitor provides the archive storage to reduce these possibilities Enabling disabling archive storage To enable or disable archive storage 1 Select setup key AA on the main interface 2 Select General Setup gt Archive Storage 3 Select ON or OFF default 4 Select OK To archive the data of a patient locate them using the reviewing keys first When the data 1s displayed on the main interface select the archiving key A The data of this monitoring 1s stored in the monitor as a separate archive NOTE If more than one patient is present on the main interface the data of the patient on the right is archived 39 F6 Fetal amp maternal Monitor User Manual The archives are stored in the long term memory of the monitor The capacity of the archive storage is 3 000 minutes When the storage is full you need to delete some archives before storing new data Loading an archive You can load an archive by selecting the archive opening key on the main interface A list of the archives pops up including the time and duration of the monitoring the patient s name and ID Select the required one and then select Load to load the archive to the main interface The loaded data starts from the left end of the screen You can review the data
53. nction Record an event Press this key to make an event mark 5 PRINT Function Start stop printing Press this key to toggle between starting and stopping printing 6 CHANNEL Function Switch the channels Press this key to toggle the FH sound between USI channel and US2 channel 7 NIBP Function Start or stop a NIBP measurement Reserved 14 F6 Fetal amp maternal Monitor User Manual 8 CONTROL KNOB Rotate Control Knob Press Control Knob He Function Adjust volume setup login 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 Operations can be performed in the position on the screen where the cursor stays When the cursor is located on a certain item you can press the control knob to open its submenu 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 C Amenu pops up on the screen or the menu is replaced by a new one C The cursor pane turns into broken line pane and the background turns into blue the
54. nd you can not change them 4 2 Audible Alarm When an alarm is active the monitor gives out an alarm sound the sound pressure range is 45dB 85dB Middle level alarm a Do tone is repeated three times followed by a pause Low level alarm a Do tone is issued followed by a pause Press the SILENCE key on the front panel to toggle between audible alarm on and off Meanwhile the audible alarm indicator on the main interface will toggle between ay and However the alarm messages will still be displayed and the alarm indicator will still be lighted up when an alarm is active A WARNINGA Do not disable the audible alarm for the condition where the patient s safety may be endangered 4 3 Visual Alarm When an alarm is active Alarm indicator the alarm indicator flashes in orange with a frequency of 0 5Hz if it is a medium level alarm the alarm indicator lights up continuously in orange if it 1s a low level alarm NP F6 Fetal amp maternal Monitor User Manual Alarm message the alarm message appears in the message window of the main interface in yellow with patient alarms on the left and technical alarms in the middle Flashing numeric the numeric of the measurement flashes in grey with a frequency of 2Hz When more than one alarm 1s active the alarm messages appear in the same area in succession The patient alarm messages are displayed either C in text form for example FHR2 LOW
55. ng Trace Advancing Mode Trace advances as time passes by when the monitor receives valid data If no valid data 1s received the screen will either advance with Auto or Valid Auto means the screen keeps advancing as time passes by Valid means the screen advances when valid data is received and it will stop after no valid data has received for 30 seconds It will advance again when valid data 1s received To change the screen advancing mode 1 Select setup key on the main interface 2 Select Fetus gt Trace Advancing 3 Select Auto default or Valid 4 Select OK 7 2 Trace Control Tools Figure 7 3 Trace control tools 1 Searching Key 2 3 Reviewing Keys 4 Archiving Key 5 Archive Loading Key 6 Auto Measuring Key 7 2 1 Searching for a Patient The searching key E mmm under the traces is used to search for a patient s data saved in the monitor i Susan Nancy Select this key to open the patient information list It contains six sets of most recent patient s ID and name Select the required item and the main interface will switch to the most current data of this patient If the patient is not in this list select MORE and input the ID or name to search for the patient 7 2 2 Reviewing The reviewing keys pr Ke pm backward key and we L i forward key under the traces are used to review the traces _ 38 F6 Fetal amp maternal Monitor User Manual Select the backward key to review
56. ng its buckle through the overlapping section of the belt Make sure the belt fits the patient snugly but comfortably Meanwhile fetus heart beat sound is heard the FHR trace and numeric are displayed on the screen NOTES 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 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 If the fetus is in the cephalic position and the mother is supine the clearest heart sound will normally be found on the midline below the umbilicus During monitoring the pregnant woman s prolonged lying in the supine position should be avoided owing to the possibility of supine hypotension Sitting up or lateral positions are preferable and may be more comfortable It is impossible to examine FHR unless an audible fetal heart signal is detected _ 45 F6 Fetal amp maternal Monitor User Manual 8 2 3 Switching FHR Alarm On or Off Always check if the alarm settings are appropriate for your patient before starting a monitoring You can choose to switch the FHR alarm on or off If the fetal heart alarm is switched off the monitor will no longer give any audible or visual warning for this monitoring item 1 Select setup key AA on the main
57. not remain any cleaning solution on the surface of the monitor NOTES 1 2 The monitor surface can be cleaned with hospital grade ethanol and dried in air or with crisp and clean cloth The manufacturer has no responsibility for the effectiveness of controlling infectious disease using these chemical agents Please contact infectious disease experts in your hospital for details l F6 Fetal amp maternal Monitor User Manual 10 2 2 Cleaning of Accessories 1 Cleaning of Transducers Follow these steps to clean the US transducer TOCO transducer and IUP cable 1 Wipe them with a soft cloth dampened in cleaning solution 2 Clean them with a soft cloth dampened in water 3 Air dry them or wipe the remaining moisture with a soft dry cloth The recommended cleansers for accessories are listed below Accessory Cleansers Ultrasound Transducer BURATON LIQUID TOCO Transducer MIKROZID ETHANOL 70 SPORACIDIN CIDEX DECG Leads Mild alcohol free soap water IUP Cable Mild alcohol free soap water Y CAUTION 1 Be sure the temperature of cleaning solutions does not exceed 45 C 113 F 2 Do notimmerse them in any liquid 3 Only clean the outer surface of the connectors make sure no liquid goes into the connector 4 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 C 140 F
58. nt CISPR 11 The F6 Fetal amp maternal Monitor is suitable for Harmonic emissions use in all establishments other than domestic IEC 61000 3 2 and those directly connected to the public low voltage power supply network that supplies Voltage fluctuations buildi EEE t flicker emissions Complies DL La E IEC 61000 3 3 s 6s F6 Fetal amp maternal Monitor User Manual A5 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic immunity The F6 Fetal amp maternal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of F6 Fetal amp maternal Monitor should assure that it is used in such an environment IEC 60601 test Electromagnetic environment Compliance level Immunity test y level guidance Floors should be wood Electrostatic concrete or ceramic tile If floor 6 kV contact 6 KV contact l discharge ESD MN OE are covered with synthetic IEC 61000 4 2 7 Ee m qe material the relative humidity should be at least 30 Electrical fast 2 kV for power 2kV for power Mains power quality should be transient burst supply lines supply lines that of a typical commercial or IEC 61000 4 4 hospital environment 1 kV line to line Mains power quality should be d 2 kV line to Lac that of a typical commercial or IEC 61000 4 5 2 kV line to ground d ground hospital environment Power frequency ma
59. on or throw or drop to cause strong shock Do not disassemble or modify the battery 28 Use the battery only in the F6 Monitor Do not connect battery directly to an electric outlet or cigarette lighter charger 29 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 30 Do not solder the leading wire and the battery terminal directly F6 Fetal amp maternal Monitor User Manual 31 If the liquid leak from the battery spills onto your skin or clothes wash well with fresh water immediately 32 Keep away from fire immediately when leakage or foul odor is detected 33 Stop using the battery if abnormal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor 34 Do not use a battery with serious scar or deformation L CAUTION 1 Federal U S law restricts this device to sale by or on the order of a physician 2 Refer servicing to qualified personnel 3 The device is designed for continuous operation and is ordinary i e not drip or splash proof 4 Keep the environment clean Avoid vibration Keep it far from corrosive medicine dust area high temperature and humid environment 5 When installing the unit into a cabinet allow for adequate ventilation accessibility for servicing and room for adequate visualization and operation 6 Do not operate the uni
60. or Follow the instructions described in Section 8 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 8 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 USI socket connect DECG cable to DECG socket Monitor one twin with a US transducer using the procedures described in Section 8 2 Monitoring FAR with Ultrasound Monitor the second twin with a DECG cable using the procedures described in Section 8 3 Monitoring FHR with DECG CAUTION The US transducer must be connected to US1 socket If the US transducer connects to US2 socket while DECG cable is connected to DECG socket the FHR trace and numeric from US2 will not be displayed 49 F6 Fetal amp maternal Monitor User Manual 8 4 3 Signals Overlap Verification SOV When monitoring twins there are possibilities that one twin s FHR signal is mistaken for the other one s signal The monitor provides signals overlap verification SOV function to reduce these possibilities In the process of monitoring if the SOV detects signals overlapping an alarm message Signals Overlap FHR1 FHR2 DFHR will
61. or other protecting pad 5 With a flat head screw driver push the fuse in for about 1 mm and then unscrew it anticlockwise 6 Remove the old fuse and replace it with a new fuse that is supplied by the manufacturer or of the same specifications 7 Push the new fuse into the socket for about 1 mm and then screw it clockwise back in position 74 F6 Fetal amp 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 Cardiotocography ve Do bwmOmm woo mmy Oo o ds F6 Fetal amp maternal Monitor User Manual Appendix 5 EMC Information Guidance and Manufacture s Declaration A5 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacture s declaration electromagnetic emission The F6 Fetal amp maternal Monitor is intended for use in the electromagnetic environment specified below The customer of the user of the F6 Fetal amp maternal Monitor should assure that it is used in such and environment Emissiontest Compliance Electromagnetic environment guidance The F6 Fetal 8 maternal Monitor uses RF o energy only for its internal function Therefore dd Group 1 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipme
62. or should assure that it is used in such an environment Compliance Electromagnetic environment Immunity test IEC 60601 test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the F6 Fetal amp maternal Monitor including cables than the recommended Conducted RF 3 Vine separation rado calculated from the IEC 61000 4 6 150 kHz to 80 MHz equation applicable to the frequency of the transmitter Recommended separation distance Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz J ELT Vi 3 5 aa 80 MHz to 800 MHz 1 TP 800 MHz to 2 5 GHz 1 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co 79 F6 Fetal amp maternal Monitor User Manual 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 a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones
63. piral electrode should not be applied to the fetal face fontanels or genitalia Do not apply the fetal spiral electrode when placenta previa is present when the mother has visible genital herpes lesions or reports symptoms of prodromal lesions when the mother is HIV sero positive when mother is a confirmed carrier of hemophilia and the fetus 1s affected or of unknown status or when it is not possible to identify fetal presenting part where application is being considered This method is not recommended when fetus is extremely premature or in the presence of a maternal infection such as Hepatitis B Group B hemolytic strep syphilis or gonorrhea unless a clear benefit to the fetus or mother can be established 8 3 2 Parts Required 1 DECG cable 2 Fetal spiral electrode 3 Disposable maternal attachment pad electrode 8 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 Do not use ether or pure alcohol which will increase skin impedance 3 Rub the skin briskly to increase capillary blood flow in the tissues 4 Remove skin scurf and grease 8 3 4 Directions for Using Fetal Spiral Electrode With the patient in the dorsal lithotomy position perform a vaginal examination and
64. ree of dust A WARNINGA Only use the recorder paper provided by the manufacturer or it may damage the recorder This kind of damage is not covered by warranty 60 F6 Fetal amp maternal Monitor User Manual 10 2 Cleaning In order to avoid infection clean and disinfect the monitor and accessories after each use 10 2 1 Cleaning of Monitor Regular cleaning of the monitor enclosure and the screen 1s strongly recommended The solutions recommended for monitor cleaning are soft soap water Tensides Ethylate and Acetaldehyde AN WARNING Unplug the monitor from the AC power source and detach all accessories before cleaning Do not immerse the unit in water or allow liquids to enter the case Clean the monitor enclosure with soft cloth and diluent non caustic detergents recommended above Clean the screen with a dry soft cloth Y CAUTION 1 Although the monitor is chemically resistant to most common hospital cleaners and non caustic detergents different cleaners are not recommended and may stain the monitor Many cleansers must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor Do not use strong solvent for example acetone Never use an abrasive such as steel wool or metal polish Do not allow any liquid to enter the product and do not immerse any part of the monitor into any liquid Avoid pouring liquids on the monitor while cleaning Do
65. requency of transmitter m Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for 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 81 75 EDAN i s EDAN INSTRUMENTS INC 3 F B Nanshan Medical Equipments Park Nanhai Rd 10192 Shekou Nanshan Shenzhen 518067 P R CHINA TEL 86 755 26882220 FAX 86 755 26882223 EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany TEL 49 40 2513175 FAX 49 40 255726 E mail antonjin yahoo com cn
66. ry Table for systems with no transducers having global maximum index values exceeding 1 0 System F6 Fetal amp maternal Monitor od Ipa 39M Ima Transducer Model TI Type TI Value EIE W cm 0 055 Eu mm na TIB 0 629 68 F6 Fetal amp maternal Monitor User Manual A1 3 Transducers and Cables Weight 190g Ultrasound Transducer Cable Length 2 5m Dimension 88mm x 35mm Weight 1809 TOCO Transducer Cable Length 2 5m Dimension 88mm x 35mm Remote Event Marker A1 4 Rechargeable Lithium ion Battery Rechargeable Lithium ion Battery Continual Working Time 2h 4h depending on the configuration Charge Current SCA Standard 0 2C5A 800mA Charge Voltage 16 8 40 1 V Maximum Continuous s000mA Charge Current Short Term within 1 month 20 C 60 C 4 F 140 F Medium Term within 3 months 20 C 45 C 4 F 113 F Long Term within 1 year 20 C 20 C 4 F 68 F During storage recharge the battery at least every six months Storage Temperature 69 F6 Fetal amp maternal Monitor User Manual Appendix 2 Signal Input Output Connector Accessory equipment connected to these interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1
67. s 16 If the terminals of the battery become dirty wipe with a dry cloth before using the battery 17 The recommended charge temperature range is from 0 C 32 F to 40 C 104 F Do not exceed this range 18 Batteries have life cycles If the time that the monitor uses the battery becomes much shorter than usual the battery life is at an end Replace the battery with a new one the same as the one provided or recommended by the manufacturer 19 When not using battery for an extended period remove it from the monitor and store it in a place with low humidity and low temperature 20 Remove a battery whose life cycle has expired from the monitor immediately 21 For information on installing and removing the battery from the monitor thoroughly read the user manual 22 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 23 The useful life of the monitor is 5 years dating from the manufacturing date marked on the bottom panel label 24 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 batterie
68. s over to the applicable collection points for the recycling of waste batteries For more detailed information about recycling of this product or battery please contact your local Civic Office or the shop where you purchased the product 1 5 Definitions and Symbols Socket for ultrasound transducer Type B applied part Socket for ultrasound transducer 2 Type B applied part C C A x v A b AN L 123 F6 Fetal amp maternal Monitor User Manual Socket for DECG cable Type CF applied part Socket for TOCO transducer Type B applied part or IUP cable Type BF applied part Socket for Remote Event Marker Type B applied part Socket for Fetal Stimulator Type B applied part DB9 Interface RJ45 Interface Equipotential Grounding System Charge Indicator Alternating Current a c Stand by Attention Consult Accompanying Documents Type B Applied Part Symbol Type BF Applied Part Symbol Type CF Applied Part Symbol The symbol indicates that the device complies with the European Council Directive 93 42 EEC concerning medical devices The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life The symbol indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life and that this unit was put on the market af
69. s recommended Scratching and damaging the screen should be avoided 10 1 3 Maintenance of Transducers Keep the transducers in a dry environment where the temperature had better be lower than 45 C Gel must be wiped from the US transducer after use These precautions will prolong the life of the transducer Although transducers are designed for durability they should be handled with care Rough handling could damage the cover piezoelectric crystals and mechanical movement Contacting the transducers with hard or sharp objects should be avoided Do not excessively flex the cables 10 1 4 Storage of Recorder Paper When storing recorder paper including used paper with traces Do not store in plastic envelopes Do not leave exposed to direct sunlight or ultraviolet light Do not exceed a storage temperature of 40 C 104 F Do not exceed a relative humidity of 80 Storage conditions outside these limits may distort the paper and adversely atfect the accuracy of grid lines or make the trace unreadable 10 1 5 Cleaning of Recorder The recorder platen thermal print head and paper sensing mechanism must be cleaned at least once a year or when needed when traces become faint To do this 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 f
70. se Doppler with autocorrelation Mode PW Doppler Mode Pulse Repetition Rate 2 KHz Pulse Duration 92 us Ultrasound Frequency 1 0 10 MHz p 1 MPa lp lt 10 mW cm Ispta lt 100 mW cm FHR Measurement Range 50 bpm 240 bpm Resolution 1 bpm Accuracy 2 bpm Earth Leakage Current lt 10 UA 264 VAC applied to transducer Dielectric Strength gt 4000Vrms ISATA the transducer face 1 865 mW cm Entrance beam dimensions 6 08 cm Measurement uncertainties for ISATA 26 6 Measurement uncertainties for ultrasonic power 26 6 Global Maximum Value MI 0 029 Ispta 3 2 77 mW cm Isppa 3 10 mW cm 467 s F6 Fetal amp maternal Monitor User Manual Technique Peak peak detection technique DFHR Measurement Range 30bpm 240bpm Resolution 1bpm Accuracy 1bpm Input Impedance gt 10M Differential DC50 60Hz Input Impedance gt 20M Common Mode CMRR gt 110dB Noise lt 4uVp Skin Voltage Tolerance 500mV Fetal Input Voltage Current 20uVp 3mVp TOCO Range 0 100 Sensitivity 3 7u V V g Non linear Error 1096 Resolution 196 Zero Mode Automatic Manual Dielectric Strength gt 4000Vrms Pressure Range 0 100mmHg Sensitivity 5uV V mmHg Non linear Error 3mmHg Resolution 1 Zero Mode Automatic Manual Technique Pulsed Doppler ultrasound Range 0 100 Resolution 196 Manual fetal movement mark A1 2 Low Output Summary Table Low Output Summa
71. ssscccccccccssssscssccccssssssssssees 30 6L Loadine Recorder paper 30 SS Oa a n T HH 32 6 3 Checking Recorder Paper esras aeter e a E 32 0d Adjustung Sereno le nola S 33 6 9 Setting Date and TME 2259 9 ete lia 34 0 0 Connecting TransSdUCefS midi iia 34 O LNGTUSUTEP V ODUTIIG v siasi ale etat ail doccia 34 Chapter 7 Understanding Measurement Results eee e ecce eee eee e eee eee eese Se 36 TAMOS e nu MEM IM MU MM MM I M 36 Fh FENMEN Winnie ale aria 37 72 Chansme Trace Adyancime MOS nad io 38 A ei 38 T2 1 Scarce TORA Paie A aida 38 T2 ARENI OWIE TH URN 38 AZ AAA T T T UT T TT 39 Ja PUTO M A A 40 T NUG r DNE M RR 41 TAAA MESSE Saia eee 42 Chapter 9 Fetal Monmitorine co m M M 44 SCONE MS Peal 44 8 2 Monitoring FHR with Ultrasound cur dee eae A aca 44 5 2 1 Parts Required licei 44 3 22 FHR Montorne Procedure 44 9 2 9 Switchine FHR Alar On Or OTT ra aa 46 8 2 4 Chansmg PAR Alarm Limits uri aaa 46 5 2 5 Chane me PAR Alarm Delay aiii 46 5 5 Monitorme PAR With DEC GL acini eee e OU cad 47 5 9 I CONMAINGICALIONS anse 47 00 2 Parts REQUIRE init riali 47 8 3 3 Preparing Patient s Skin Prior to Placing Electrodes 47 8 3 4 Directions for Using Fetal Spiral Electrode 47 9 9 DECO Montorine PrOCGQUEO aaa idas 48 5 5 6 Detaching Fetal Spiral Blectrode sie their eins
72. t Monitor FHR with DECG Adjust the position transducer till the better ilios IS received Improper ultrasound transducer position Loose belt 0 belt Tighten the belt the belt Inconstant trace osa aquasonic coupling Vici NN off superfluous aquasonic display coupling gel x fetal movements Delay the monitoring Request the patient to calm down Maternal movement and stay still aan aquasonic coupling Use recommended aquasonic coupling gel quantity Record maternal heart rate Change the position of the wrongly ultrasound transducer Doubtful FHR The transducer is not well placed in position and the mixed noise has been recorded Adjust the position of the transducer Use paper recommended Improper paper ub dc ae by manufacturer Slide the paper drawer in until Feint trace or no trace The paper drawer is not locked both latches are locked in position Adjusting nuts of the print head Contact the manufacturer for are unbalanced service e F6 Fetal amp maternal Monitor User Manual A3 5 Troubles with DECG FHR Monitoring No ECG signal Use a new spiral electrode Inconstant trend Inconstant display Bad contact of reference electrode Use a new spiral electrode and patient concisa The DECG cable has not been Fix an attachment pad at the fixed firmly DECG cable A3 6 Troubles with Contractions Monitoring External The belt is too tight or too loose Adjust the belt
73. t if it is damp or wet because of condensation or spills Avoid using the equipment immediately after moving it from a cold environment to a warm humid location 7 Sterility can not be guaranteed if package of the fetal spiral electrode is broken or opened 8 The fetal spiral electrode has been sterilized by gamma radiation Do not re sterilize 9 Do not sterilize the monitor or any accessory with autoclave or gas 10 Switch off the system power before cleaning Cleaning consists of removing all dust from the exterior surface of the equipment with a soft brush or cloth Use a brush to dislodge any dirt on or around the connectors and panel edges Remove dirt with a soft cloth slightly dampened with a mild detergent solution or 7096 ethanol or isopropranol 11 When washing the belts the water temperature must not exceed 60 C 140 F 12 Electromagnetic Interference Ensure that the environment in which the F6 monitor is installed is not subject to any source of strong electromagnetic interference such as CT radio transmitters mobile phone base stations etc 13 Do not use mobile phones nearby in the process of monitoring 14 The device and reusable accessories could be sent back to the manufacturer for recycling or proper disposal after their useful lives Nm F6 Fetal amp maternal Monitor User Manual 15 While the battery is charged used or stored keep it away from objects or materials with static electric charge
74. ter 13 August 2005 7 F6 Fetal amp maternal Monitor User Manual P N Part Number Serial Number Date Of Manufacture val Manufacturer Authorized Representative in the European Community ES Recycle Federal U S Law restricts this device to sale by or on the order of a Rx only U S physician F6 Fetal amp maternal Monitor User Manual Chapter 2 Installation Guidance NOTE Installation must be carried out by qualified personnel authorized by the manufacturer 2 1 Opening and Checking Package Open the package take out the monitor and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list C Check for any mechanical damage G Check all the cables and accessories If there is any problem contact us or your local distributor immediately 2 2 Installing Battery A WARNINGA Switch off the monitor and unplug the power cord before installing or removing the battery If your monitor has configured the rechargeable lithium ion battery follow these steps to install the battery 1 Battery Installation 1 Carefully place the monitor upside down on a flat surface covered with cloth or other type of protecting pad 2 Remove the screws of the battery compartment using a cross head screw driver Remove the battery compartment cover us d 3 Take the battery out from package Place the battery into the compartment with the
75. the back of the electrode and place the electrode on maternal thigh press it firmly in place Connect the fetal spiral electrode to the DECG cable Insert connector of DECG cable into the DECG socket of the monitor A WARNING Do not plug the fetal spiral electrode wire into the power socket Y CAUTION Do not mistake the higher maternal heart rate for DECG 48 F6 Fetal amp maternal Monitor User Manual NOTES 1 If there is any doubt as to the presence of a fetal heart signal with ECG check with the US transducer on the patients abdomen or with a separate diagnostic instrument The presence of an audible Doppler heart sound at a rate distinct from that of the maternal pulse is unequivocal evidence of the fetal life 2 After the electrode is well attached allow a few minutes for the electrode and fetal tissue to become stabilized It is essential that the ECG signal electrode is in good contact with the fetal presenting part 8 3 6 Detaching Fetal Spiral Electrode To detach the fetal spiral electrode rotate it counterclockwise until it is free from the fetal presenting part Do not pull the electrode from the fetal skin forcefully Dispose of the used fetal spiral electrode in a proper way Do not use it again 8 4 Monitoring Twin FHRs 8 4 1 Monitoring Twins Externally To monitor twin FHRs externally you need to connect a US transducer to US socket and the second US transducer to US2 socket of the monit
76. the previous traces The traces start to retreat The amount of the progress symbol lt on top of the traces indicates the retreating speed Rotate the control knob anticlockwise to increase the speed until it reaches the maximum Rotate the knob clockwise to decrease the speed until it reaches the minimum Press the knob to pause Select the forward key to review the next traces The traces start to advance The amount of the progress symbol gt on top of the traces indicates the advancing speed Rotate the control knob clockwise to increase the speed until it reaches the maximum Rotate the knob anticlockwise to decrease the speed until it reaches the minimum Press the knob to pause When the reviewing is paused the progress symbol turns to lt X gt If the PRINT key is pressed at this moment the recorder will print the traces starting from the left edge of the screen at a high speed X indicates the proportion of current traces positioned in the whole reviewable traces Move the cursor away from the trace control tools to return to the real time main interface When reviewing the traces the monitor does not stop The FH sound and numerics are all real time information of the current patient A CAUTION You must pause before start printing Printing in the process of playback might result in failed information on the paper 7 2 3 Archive Managing By default the monitor saves the most recent 24 hour data in its me
77. turn Material Authorization RMA form that includes the appropriate return address and instructions An RMA form must be obtained prior to any return Freight policy Under warranty the service claimer is responsible for freight amp insurance charges when a return is shipped to EDAN for service including custom charges EDAN is responsible for freight insurance amp custom charges from EDAN to service claimer Out of warranty the service claimer is responsible for any freight insurance amp custom charges for product Contact information If you have any question about maintenance technical specifications or malfunctions of devices contact your local distributor Alternatively you can send an email to EDAN service department at support edan com cn 64 F6 Fetal amp maternal Monitor User Manual Appendix 1 Product Specifications A1 1 Monitor Physical Dimensions 347mm x 330mm x 126mm Characteristics Weight Approx 6 kg Safety Comply with IEC 60601 1 1988 A1 A2 EN 60601 1 1990 A1 A2 IEC EN 61157 IEC EN 60601 2 37 IEC EN 60601 1 2 2001 A1 Anti electric Shock Type Class equipment with internal power supply Anti electric Shock Degree FHR1 FHR2 TOCO FM FS B IUP BF DECG CF Degree of Protection against Harmful Ingress of Water Ordinary equipment sealed equipment without liquid proof Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flamma
78. ty period The warranty period begins on the date the products are shipped to distributors The warranty is void in cases of a damage caused by handling during shipping b subsequent damage caused by improper use or maintenance c damage caused by alteration or repair by anyone not authorized by EDAN d damage caused by accidents e replacement or removal of serial number label and manufacture label If a product covered by this warranty 1s determined to be defective because of defective materials components or workmanship and the warranty claim is made within the warranty period EDAN will at its discretion repair or replace the defective part s free of charge EDAN will not provide a substitute product for use when the defective product is being repaired 11 2 Service Policy All repairs on products must be performed or approved by EDAN Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall be exclusively be performed by EDAN certified service personnel If the product fails to function properly or if you need assistance service or spare parts contact EDAN s service center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone or Email avoiding potential unnecessary returns In case a return can not be avoided the representative will record all necessary information and will provide a Re
79. uscritas 11 Chapter 3 Monitor and Accessories ssssccccccccsssssssssccccccccssssscsscccccssccsssssssssccsssssssssscsecs 12 DUC OPnDEOUTACLODS aec ierctav meats us odo C ria voee Ut oa bcati ao eceiee 12 SAU RU EN EN IRE 12 Sd I Keys and Control KO iuit uot cierto edt ento d b mew sut gero veo den Odd mud 14 E O us Tr Re 15 9 2 INC COSSOMMES ean A busdam asl ues ducat Fave bug adi ea et Etre ont ba ase dup aea med Lud 16 32d EAN SAUCES oasis eate mes ai 16 2 2 2 Remote EventMorkerae braccia 17 325 Fetal Spira l Electtode o iii aiar 17 32A Fetal SOU lO nadaa pide 177 PIP 18 EEE als 18 A T S 20 oct Ordermb Information iaia 21 Chapter 4 AIAEHIS iia 23 AA Alarms Classic peine rd ete axel pega e Pe Draco tuts 23 o coe ee EEUU gx lvethauet vasca ia tw ce alta utu ie na EDU tie ees 29 DONA 23 d Choosme Mari Display POLI Js ouo eei odi pa Me A PEE 24 4 5 Changing Alarm Volere 24 A OR VL WINS Alnar 24 ao Alar reatment Measures Sins 25 RM A O O a A 25 7 9 Patient Alarm Dera utes snai 25 Chapter PEDINS aiii 26 2 1 FUNCTION DESCAPion urina 26 3 2 PADUNE COM Te UPdtEOD elle 26 5 2 1 Switching Auto Start Printing On or Off i 26 LEAD SIMA Papers Dee Otte damascene nan ese dado aloe ZI IAS Chane me Print Timer araldico 27 5 2 4 switching Print Self C heck On ot OF uiii E EE en ero lia 27 23 9 Understanding Recorder Paper Pri a 21 Chapter 6 Pre Monitoring Preparation cccsssssssscccccssssssss
80. when you exit from the reviewing status 7 3 Numerics The numeric window includes FHR1 FHR2 DECG TOCO IUP and MEM FHR1 FHR2 TOCO MFM _ 41 F6 Fetal amp maternal Monitor User Manual The fetal monitoring values in the numeric window include FHRI value FHR2 value TOCO value and MFM count Y FH refreshing rate S FH sound volume adjusting key BH YT FH sound volume indicator 137 FHR1 measurement numeric If the US1 socket is not connected with a US transducer nothing displays here if the transducer is connected but no monitoring is going on it displays FHR2 DECG 136 FHR2 DFHR measurement numeric If the US2 DECG socket is not connected with a US transducer DECG cable when switching on it displays OFF but no numeric here if the transducer cable is connected but no monitoring is going on it displays TOCO IUP 10 UA baseline 11 current 1t eurent umi measurement numeric m m 7 4 Alarm Messages This table lists the alarm information that might appear during fetal monitoring their respective causes and countermeasures Alarm Message Cause Countermeasure Patient Alarm FHR1 HIGH or FHR1 or FHR2 measuring result FHR1 xxx yyy xxx is higher than the set upper FHR2 HIGH or limit yyy over the alarm delay FHR2 xxx yyy me Check if the alarm limits are suitable check the woman s condition FHR1 LOW or FHR1 or FHR2 measuring result FHR1 xx
81. wired direction on the outside 4 Insert the cable connector into the socket F6 Fetal amp maternal Monitor User Manual 2 Battery Removal Fold the LCD display completely flat before turning the monitor upside down Remove the battery in reverse order NOTES 1 If a rechargeable battery is outfitted charge it fully each time after using the device to ensure the electric power is enough 10 F6 Fetal amp maternal Monitor User Manual 2 When the battery configuration is provided after the device is transported or stored the battery must be charged Connecting to power supply will charge the battery no matter if the monitor is powered on 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 G Make sure the AC power supply of the monitor complies with the following specification 100V 240V 50Hz 60 Hz G Apply the power cable provided with the monitor Plug one end of the power cable to the power socket of the monitor Connect the other end to a grounded 3 phase power output special for hospital usage AN WARNING If the protective grounding protective earth system is doubtful the power of the monitor must be supplied by inner power only La F6 Fetal amp maternal Monitor User Manual Chapter 3 Monitor and Accessories 3 1 Configuration The standard confi
82. x yyy xxx is lower than the set lower EHR2 LOW or limit yyy over the alarm delay FHR2 xxx yyy time Check if the alarm limits are suitable check the woman s condition 42 F6 Fetal amp maternal Monitor User Manual Technical Alarm US1 UNPLUGGED or US2 UNPLUGGED USI Or US2 SIGNAL LOSS SIGNAL LOSS TOCO UNPLUGGED Fetus EQUIP MALF Battery Low Check Paper Signals FHR1 FHR2 Overlap Signals FHR1 DFHR Overlap DECG LEADS OFF DECG UNPLUGGED DECG SIGNAL LOSS US well US transducer 1 or transducer 2 is not connected FHR1 or FHR2 signal is too weak for the system to analyze TOCO transducer connected is not well The fetus board can not communicate with the system successfully The battery power is too low to support further work of the monitor There is no paper in the paper drawer or the drawer is open US transducer 1 and US transducer 2 are aimed at the same fetal heart the signals overlap US transducer 1 is aimed at the fetus that the spiral electrode is attached to the signals overlap The spiral electrode is not well connected The DECG lead is not well connected to the monitor DECG signal is too weak for the system to analyze af Check the transducer connection of the Check if the US transducer is aimed at the fetal heart check if the alarm limits are suitable check the woman s condition Check the transduc
83. y to observe 1f the FHR exceeds this range So you can easily tell 1f the fetal heart rate 1s too low or too high 3 Numeric Window The fetal monitoring numerics are displayed here 4 Status Window 2009 04 13 15 33 18 e Power indicator AC power supplied 19 h J k 1 F6 Fetal amp maternal Monitor User Manual no AC power supplied Battery indicator MW battery is loaded the green pane indicates the charge of the battery no battery is loaded Network connection indicator and device no the monitor 1s online the monitor is offline NOTE The network connection indicator is not available if the net version is Insight or Philips Audio alarm indicator A the audible alarm is switched on HA the audible alarm 1s switched off Recorder status indicator the recorder is in the process of printing EA no printing is going on Print speed Print remaining time The date and time of the monitor 3 4 2 Setup Interface The setup menu is provided to change the monitor configurations and monitoring settings Press the Setup key AA on the main interface to open this menu to Main Menu A Start Monitoring Al General ol Alarm rr Recorder Set sustem items of the monitor A IE 0h G 0n Fetus Date And Time 1 Setup Items 2 Function Description 3 Software Version V

Manual - Cardiac Direct

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