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Fetal2EMR User Manual

1. monitor SHE 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 to print 6 4 Setting Date and Time You can change the date and time on the monitor 1 Select the setup key on the main interface 2 Select Date and Time 3 Set the year month date hour minute and second 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 yyyy mm dd mm dd yyyy default dd mm yyyy 5 Select OK UCAUTION Set date and time information in advance After this information is changed the monitor starts new monitoring with an auto ID Therefore it is advisable to restart the monitor after changing date or time information Do not perform this operation when monitoring is in process 35 WAIACH FETAG 2EMR Chapter 6 Pre Monitoring Preparation 6 5 Adjusting Volume The monitor automatically detects which channel the ultrasound transducer is connected to The corresponding volume adjustment key of this channel displays indicating the fetal heart sound is coming out from this channel while the other one displays for example Press the CHANNEL key to switch the fetal heart sound to the other channel Adjust the
2. NOTE The monitor detects the transducers automatically If no US transducer or DECG cable is connected to the US2 socket the US2 numeric area is not displayed However if they are unplugged midway the monitor gives alarm for the disconnection At this time press the START key to tet the monitor check the transducer connection again 8 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 Medium Level RM ul FAR1 or FHR2 measuring result Check if the alarm limits are suitable xxx gt yyy is higher than the set high Ceci ine alarm limits suitable FHR2 HIGH or alarm limit yyy over the alarm P FHR2 xxx gt yyy delay time LOW OE FHR1 or FHR2 measuring result Check if the alarm limits are suitable FHR1 xxx lt yyy xxx is lower than the set low check the patient s condition FHR2 LOW or alarm limit over the alarm FHR2 lt yyy delay time Technical Alarm Medium Level The battery power is too low to Connect the monitor to AC power Battery Low support further work of the i monitor Suppy WAIACH 2 Chapter 8 Understanding Measurement Results Technical Alarm Low Level US1 UNPLUGGED or US2 UNPLUGGED US transd
3. 4 AUTO ZERO key 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 A J Function Make record of an event Press this key to make an event mark 6 PRINT key Function Start stop printing Press this key to toggle between starting and stopping printing 7 CHANNEL key Function Switch the channels Press this key and the fetal heart sound toggles between US1 channel and US2 channel 8 CONTROL KNOB Function Adjust volume setup and review control The control knob 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 the cursor Operations can be performed in the position on the screen indicated by cursor placement When the cursor is located on a particular function press the control knob to open the 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 1 Rotate the control knob to select an item with the cursor 2 Press the control knob and one of the following will happen WAILACH FETAG 2EMR Chapter 2 Monitor and Acces
4. increases to 180 bpm or higher it is possible for the monitor to mistake the two separate hearbeats for the diastole and systole of a single heartbeat As a result a heart rate trace that is half the actual heart rate is produced This often happens during tachycardia representing an abrupt switch of the trace to half the actual heart rate The clinicians may interpret it as a deceleration 210 180 150 120 90 60 100 80 40 20 However the heart beat sound from the monitor speaker is still reliable even when doubling or halving is occurring 81 WAILACH FETAG 2EMR Appendix 7 Limitations of Ultrasonic Monitoring Auscultation should be applied when sudden changes in baseline are detected If the amniotic membrane rupture and cervical dilatation are sufficient consider using a spiral electrode to obtain precise FHR with direct fetal ECG as the signal source 4 Erratic Traces Drop out When the fetal heart moves partially out of the ultrasound wave path the transducer receives mixed or weak signals and thereby the monitor presents erratic traces When the fetal heart moves fully out of the path inadequate consecutive and periodic signals are received and no trace is represented Erratic traces and transitory episodes of drop out are common especially when the fetus or and mother move s If they exist for an extended period it indicates that the transducer is not aimed at t
5. Accessory Cleansers BURATON LIQUID MIKROZID Teen ETHANOL TU ibd SPORACIDIN CIDEX CAUTION 1 Do not immerse accessories in liquid Only clean the outer surface of the connectors making sure no liquid goes into the connectors 2 Be sure the temperature of cleaning solutions does not exceed 45 C 113 F 3 After cleaning accessories confirm that no remaining cleanser is on the surface WAILACH FETAG 2EMR Chapter 10 Maintenance and Cleaning 2 Cleaning of Belt Wash soiled belts with soap and water The water temperature must not exceed 60 C 140 F 10 3 Disinfecting Clean the equipment before disinfecting The table below lists the allowed disinfectant bases Type Ethylate Acetaldehyde Recommended Ethanol 70 Isopropanol 70 Transducers 4 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 confirm there is no remaining disinfectant on the surface 5 Check that the monitor and accessories are in good condition If any aging or damage is detected e g the belt loses its elasticity replace the damaged part s or contact Wallach Surgical Devices for service before reusing them 10 4 Ster
6. information List start of the monitoring and every ten minutes afterwards 5 FHR1 Mark The trace marked with is the FHR1 trace 6 FHR2 Mark The trace marked with FHR2 is the FHR2 trace z Bac Mar Each recorder paper pack has 150 pages When you notice the page mark comes to the end remember to load new paper WAILACH FETAG 2EMR Chapter 6 Pre Monitoring Preparation Chapter 6 Pre Monitoring Preparation 6 1 Confirming Fetal Life Fetal monitoring with ultrasound cannot differentiate a fetal heart rate signal source from a maternal heart rate source in all situations There are some signal sources that might be mistaken as an FHR signal source as follows High maternal heart rate signal Maternal aorta or other large vessel signals Electrical impulse from the maternal heart transmitted through a recently deceased fetus Movement of the deceased fetus during or following maternal movement Confirm fetal life by other methods before starting to use the fetal monitor 6 2 Switching On A warnincAy e Check that all the metal parts are linked to the protective earth cord and the cord is in good condition before switching on the monitor e If any sign of damage is detected or the monitor displays some error messages do not use it on a patient Contact biomedical engineer in the hospital or the Wallach service engineer immediately Press the POWER switch 2 on the front panel to
7. 4 7 Reviewing Alarms 4 8 Alarm Treatment Measure 4 9 Testing Alarms 4 10 Patient Alarm Defaults Chapter 5 Printing 5 1 Function Description 5 2 Printing Configuration 5 2 1 Switching Auto Start Printing On or Off 5 2 2 Choosing Paper Speed 5 2 3 Changing Print Timer 5 2 4 Switching Print Self Check On or Off 5 3 Understanding Recorder Paper Printout Chapter 6 Pre Monitoring Preparation 6 1 Confirming Fetal Life 6 2 Switching On 6 3 Checking Recorder Paper 6 4 Setting Date and Time 6 5 Adjusting Volume Chapter 7 Fetal Monitoring 7 1 Monitoring Fetal Heart Rate FHR with Ultrasound 7 1 1 Parts Required 7 1 2 FHR Monitoring Procedure 7 1 3 Switching the FHR Alarm On or Off 7 1 4 Changing FHR Alarm Limits 7 1 5 Changing FHR Alarm Delay 7 2 Monitoring Twin FHRs 7 2 1 Monitoring Twins Externally 7 2 2 Signals Overlap Verification SOV 7 2 3 Changing FHR2 DFHR Offset 7 3 Monitoring Uterine Activity Externally 7 3 1 Parts Required 7 3 2 TOCO Monitoring Procedure 7 3 3 Changing UA Baseline 7 4 Monitoring Fetal Movement 7 4 1 Auto Fetal Movement Monitoring AFM 7 42 Enabling or Disabling AFM Trace 7 4 3 Changing AFM Gain 7 4 4 Manual Fetal Movement Monitoring MFM 7 4 5 Changing MFM Volume 7 5 Starting Monitoring 7 6 Inputting Maternal Information Mat Info 7 6 1 Auto ID 7 6 2 Changing
8. A warnincAy Usage Safety Precautions 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 Only qualified service technicians can install this equipment Only service technicians authorized by Wallach Surgical Devices can open the case This device is not intended for use in intensive care units operating rooms or for home use EXPLOSION HAZARD Do not use this device in the presence of flammable anesthetic mixture with air with oxygen or with nitrous oxide SHOCK HAZARD 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 Do not apply this monitor and other ultrasonic equipment simultaneously on a same patient due to the potential of leakage current superposition Do not apply this monitor simultaneously with other PATIENT connected equipment such as a cardiac pacemaker or other electrical stimulators Do not use the monitor with RF surgical equipment Do not switch on device power until all cables have been properly connected and verified Do not touch the signal input or output connector and the patient simultaneously Equipment and devices that connect to the Monitor should form an equipotential body to ensure effective grounding Disconnect power cord before changing fuses Re
9. General symbol for recovery recyclable U S Federal Law restricts this device to sale by or on the order of a physician With respect to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 IEC 60601 2 37 and IEC 60601 2 49 WAIACH FETA ZEMR Chapter 2 Monitor and Accessories Chapter 2 Monitor and Accessories 2 1 Opening and Checking Package Visually examine the package prior to unpacking If any signs of mishandling or damage are detected contact the carrier and file a claim for damage Open the package and take out the monitor and accessories carefully Keep the package for possible future transportation or storage Check the components according to the packing list Check for any mechanical damage Check all cables and accessories Packing List Item Quantity Fetal Monitor 1 FHR Probe Ultrasound Transducer 2 TOCO Transducer Event Marker 1 Belt Pack of 3 Ultrasound Gel Recording Paper Pack of 3 6 Fuse Power Cord Screw Driver User Manual Quick Start Guide Qualification Certificate If there is any problem contact the manufacturer or your local distributor immediately WAILACH FETAG 2EMR Chapter 2 Monitor and Accessories 2 2 Overview 1 Alarm Indicator 2LCD 3 Keys 4 Control Knob 5 Paper Drawer 6 Accessory Ports 7 Indicators 8 Pa
10. v DECG Direct Electrocardiography Not available in this model This symbol indicates that the protection against electric shock of this applied part is Type CF The monitor described in this User Manual is not protected against a The effects of defibrillator shocks b The effects of defibrillator discharge The effects of high frequency currents d The interference of electrosurgery equipment 1 3 Ultrasound Safety Guide Fetal Use The monitor is designed for continuous fetal heart rate monitoring during pregnancy and labor Clinical interpretation of fetal heart rate traces may be helpful in the diagnoses of fetal and or maternal problems and complications Instructions for Use in Minimizing Patient Exposure acoustic output of the Fetal2EMR Monitor is internally controlled and cannot be varied by the operator in the course of the examination The duration of exposure is 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 Exercising clinical judgment in monitoring 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 WAILACH FETAR2EMR Chapter 1 Safety Guide
11. otherwise it might result in harm to the patient or the operator e Always check that the alarm settings are appropriate for your patient before starting monitoring 7 1 Monitoring Fetal Heart Rate FHR with Ultrasound Ultrasound monitoring is a method used to obtain FHR through the maternal abdominal wall which can be used for antepartum monitoring By placing the FHR transducer on the maternal abdomen it will transmit a low energy ultrasound wave to the fetal heart and receive the echo signal WARNINGA Confirm fetal life by other means before using this monitor for FHR monitoring 7 1 1 Parts Required 1 Ultrasound transducer 2 Ultrasound coupling gel 3 7 1 2 Monitoring Procedure 1 Placing Transducer Belt Place the transducer belts across the bed ensuring that the belts will reach around the patient s abdomen and be able to be fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange the belt around the abdomen 2 Determining the Transducer Position To acquire the FH signal search for the location of the fetal heart using a handheld doppler fetoscope The best fetal heart signal can be obtained through the fetal back 37 WAIACH FETAR2EMR Chapter 7 Fetal Monitoring Fetal Heart Pregnancy Early Parturition Late Parturition Figure 7 1 Positioning Ultrasound Transducer single fetus During partur
12. should be avoided 3 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 the monitoring prolonged lying in the supine position should be avoided due to the possibility of supine hypotension Sitting up or lateral positions are preferable and may be more comfortable 38 WAILACH FETAR2EMR Chapter 7 Fetal Monitoring 4 During long time monitoring the gel may dry out as the transducer moves around Add more gel if necessary 5 Itis not possible to examine FHR unless an audible fetal heart signal is present 7 1 3 Switching the FHR Alarm On or Off Always check if the alarm settings are appropriate for your patient before starting to monitor If the fetal heart alarm is switched off the monitor will no longer give any audible or visual warning for this monitoring item Select the setup key B on the main interface Select Alarm gt FHR gt Alarm Select ON default or OFF Select OK se 50 Rom If FHR alarm is switched off an alarm switched off symbol will appear in the alarm message area on the main interface For example A warnincA Do not switch the alarm off for any condition where the patient s safety may be endangered 7 1 4 Changing FHR Alarm Limits The alarm limits set determine the parameters that trigger the alarm Select the setup key E on the main interface Select Alarm gt F
13. 49 EN 60601 2 37 Anti electric Shock Type Class I equipment with internal power supply Ingress of Water for the Transducers FHR1 FHR2 Anti electric Shock Degree DECG Degree of Protection against Harmful IPX 8 Degree of Safety in Presence of Flammable Gases Equipment not suitable for use in presence of flammable gases Disinfection Sterilizing Method Refer to this user manual for details EMC Group I Class A E WAIACH 2 Appendix 1 Product Specifications Working System Continuous running equipment Earth Leakage C t Limit Ma SPE arth Leakage Current Limi 8 300HA 300nA TJ N C S EC Enclosure Leakage Current Limit 100HA 300 NC SEC Patient Leakage Current Limit d c 10pA 50uA ac 10HA 50nA NC SEC Patient Auxiliary Current Limit dc 100 50pA ac l0pA 50 LCD Size 5 6 Active Area Display 112 9 mm W x 84 7 mm H Resolution 640 RGB x 480 Display Mode Normally White Transmissive Signal Interface DB9 RJ45 network interface Ultrasound Transducer Weight 190g Cable Length 2 5m Dimension 88mmx35mm TOCO Transducer Weight 180g Cable Length 2 5m Dimension 88mmx35mm Remote Event Marker Length 2 5m Weight 56g A1 3 Performance Specifications Tech
14. Maternal Information 7 6 3 Switching Mat Info Inputting On or Off Chapter 8 Understanding Measurement Results 8 1 Changing Screen Display Mode 8 2 Traces 8 2 1 Changing Time Scale 8 2 2 Searching for a Patient s Record 8 2 3 File Management Optional 8 2 4 Reviewing 8 3 Number Values 8 4 Alarm Messages Chapter 9 After Monitoring 9 1 Saving Data 9 2 Completing the Monitoring 9 3 Switching Off Chapter 10 Maintenance and Cleanin 10 1 Maintenance 10 1 1 Maintaining Inspection 10 1 2 Maintenance of Monitor 10 1 3 Maintenance of Transducers 10 1 4 Storage of Recorder Paper 10 1 5 Maintenance of Recorder 10 2 Cleaning 10 2 1 Cleaning of the Monitor 10 2 2 Cleaning of Accessories 10 3 Disinfecting 10 4 Sterilizing Chapter 11 Warranty and Service Poli Appendix 1 Product Specifications Environmental Specification A1 2 Physical Specifications 1 3 Performance Specification AL Recorder Specifications ALS Rechargeable Lithium ion Battery Specification A1 6 Low Output Summary Table Appendix 2 Signal Input Output Connector Appendix 3 Troubleshooting 3 Recorder Error A3 4 Trouble with Ultrasound FHR Monitoring A3 5 Troubles with Contractions Monitoring External A3 6 Blown Fuses A3 7 Paper Jam Appendix 4 Abbreviation Appendix 5 Ordering Information Appendix 6 EMC Information Guidance and Manufact
15. Printing On or Off Switch auto start printing on or off as follows Select the setup key 8 the main interface Select Start Monitoring gt PRINT Select ON or OFF default Select OK fhe eC 5 2 2 Choosing Paper Speed Paper speed choices are 1 cm min 2cm min or 3cm min Select the setup key B on tne main interface 1 2 Select Recorder gt Print Speed 3 Select 1 em min 2 cm min or 3 cm min default 4 Select OK NOTE Different paper speed setting causes different FHR trace appearances on the record paper To avoid misinterpretation we recommend you to set all monitors in use to the same paper speed 5 2 3 Changing Print Timer Different time lengths can be chosen for the print timer 1 Select the setup key B on the main interface 2 Select Recorder gt Timer 3 Set timer to 10 90 minutes the increment is 5 Present ID or Infinite For a fixed time the recorder stops when the time is up For Present ID and Infinite the recorder will only print the traces of the patient with the present ID and stops automatically when her traces come to an end If there is no ID on the current reviewing screen the recorder with Present ID setting starts printing from the beginning of this ID and with a fixed timing or Infinite setting it starts printing from the left border of the screen Whatever the setting is the recorder stops when the PRINT key is pressed in midway 4 Select OK n WAILAC
16. Reviewing Alarms alarm reviewing menu records a list of up to 50 of the most recent patient and technical alarm f 4 1 LOW 11 i FIR LO 118 lt 120 messages with date and time information LOW 1105120 FIRI LOW 115 lt 120 gnals Overlap FHR1 FHR2 Select the alarm reviewing key in the message window to open this menu Each page displays 10 alarm records The page mark 1 5 informs you that there are 5 pages and the present one is page 1 To review more records select the alarm list and then rotate the control knob When a new monitoring starts or after the monitor is switched off the alarm mes cleared 4 8 Alarm Treatment Measures During monitoring make sure there is at least one physician in the area where the alarm sound can be heard or the alarm messages can be seen so necessary measures can be taken when an emergency occurs When the monitor gives out an alarm and catches your attention you should Check the patient s condition Identify the cause of the alarm Silence the alarm if necessary Check if the alarm is terminated when the alarm condition is solved When the monitored parameter s come s back within the adjusted limits or if the abnormal technical condition does not exist any longer the monitor stops giving out the alarm WAILACH FETAR2EMR Chapter 4 Alarms 4 9 Testing Alarms To test the functions of visible and audible a
17. and the battery label faces down 18 WAIACH 2 Chapter 3 Installation Guide Battery Connector Anode amp Cathode of Battery Output A warnincA Do not touch the anode and cathode of the battery output with fingers or metal materials to avoid hazards caused by the short circuit 4 Arrange the battery flat in the compartment and push the strip at the end of the battery into the gap 5 Shut the battery compartment cover and replace the screws 2 Battery Removal Remove the battery in reverse order You can pull the strip at the end to take the battery out from the compartment NOTE 1 Ifa rechargeable battery is outfitted charge it fully each time after using the device to ensure the electric power is adequate 19 WAILACH FETAG 2EMR Chapter 3 Installation Guide 2 When the battery configuration is provided after the device is transported or stored the battery must be charged Connecting the Fetal2EMR to a power supply will charge the battery even if the monitor is not turned on 3 2 Installing Monitor The monitor should be placed on a flat surface Alternatively it can be installed on an optional cart Consult the sales representative for more information UCAUTION Installation must be carried out by qualified personnel authorized by the manufacturer 3 3 Loading Recorder Paper CAUTION Use only the recorder paper provided by the
18. by pulling the cable directly 3 7 Placing Accessories in the Holder In order to protect the accessories place the not in use accessories in the holder The accessory holder is on the left of the front panel The first hole from the top is for the remote event marker and the other three are for the transducers To place a transducer into the holder hold the transducer on the edge and then place the buckle 24 WAILACH FETAG 2EMR Chapter 3 Installation Guide all the way into one of the holes on the holder Make sure that the transducer cable is on the bottom To place the remote event marker put the small end of the marker into the hole as far as it can go Placing the transducer Placing the marker NOTE In the process of monitoring the transducer that is placed in the holder may be affected and thereby produce interfering signals Therefore when monitoring a patient it is recommended to remove or disconnect the transducer that is not in use 3 8 Connecting Power Cable Make sure the AC power supply of the monitor complies with the following specifications 100V 240V 50Hz 60Hz Connect the power cable provided with the monitor to the monitor s power socket Connect the other end to a hospital grade grounded 3 wire AC outlet A warninc If the protective grounding protective earth system is in question the monitor must be powered only by the battery NOTE 1 Make sure the monitor and
19. failure and possible health hazards 10 1 2 Maintenance of Monitor Keep the exterior surface of the monitor clean and free of dust and dirt The appearance of moisture on the screen may occur with abrupt temperature or humidity changes A stable environment is recommended Avoid scratching and damaging the screen WAILACH FETAR2EMR Chapter 10 Maintenance and Cleaning 10 1 3 Maintenance of Transducers Keep the transducers in a dry environment where the temperature should be lower than 45 C 113 F Gel must be wiped from the US transducer after use These precautions will prolong the life of the transducer Avoid contacting the transducers with hard or sharp objects Although transducers are designed for durability they should be handled with care Rough handling could damage the cover piezoelectric crystals and mechanical movement Do not excessively flex the cables 10 1 4 Storage of Recorder Paper The thermosensitive recorder paper is not intended to be used as a long term storage medium We recommend you save the monitoring data to another medium 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 affect the accuracy o
20. for recycling or proper disposal WAILACH FETAG 2EMR Chapter 1 Safety Guide 1 5 Definitions and Symbols UST TOCO IUP m A Mod ROS Socket for ultrasound transducer 1 Type BF applied part Socket for ultrasound transducer 2 Type BF applied part Socket for DECG cable Type CF applied part Socket for TOCO transducer or IUP cable Type BF applied part Socket for Remote Event Marker BF applied part Reserved BF applied part CF applied part Charge Indicator AC Alternating Current Indicator Power Indicator ON OFF switch for the device Start Alarm silence Auto zero Event marker Print WAILACH FETAG 2EMR Chapter 1 Safety Guide p lt BE i lolol aa C 0123 x REF SN amp Rx Only U S SSIF sake 3 9 Channel selection Equipotential Grounding System Fuse Attention See Instructions for use Antenna USB Universal Serial Bus Connection Serial interface Network port 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 Reorder Number Serial Number Date of Manufacture Manufacturer
21. in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ux for 5 sec Mains power quality should be that of typical commercial or hospital environment If the user of the Fetal Monitor requires continued operation during power mains interruptions it is recommended that the Fetal Monitor be powered from an uninterruptible power supply a battery NOTE U is the a c mains voltage prior to application of the test level T6 WAIACH FETA 2EMR Appendix 6 EMC Information A6 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The Fetal Monitor is intended for use in the electromagnetic environment specified below The user of the Fetal Monitor should assure that it is used in such an environment Compli Elect tic envi t Immunity test IEC 60601 test level P tance E A level guidance Portable and mobile RF communications equipment including cables should be used no closer to any part of the Fetal Monitor than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 80 MHz to 800 MHz Conducted RF
22. 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 79 WAILACH FETAR2EMR Appendix 7 Limitations of Ultrasonic Monitoring Appendix 7 Limitations of Ultrasonic Monitoring A7 1 How Does Ultrasound Work When the ultrasound waves strike an object they bounce back and create an echo If the object moves toward the sound source the frequency of the echo increases If the object moves away from the sound source the frequency of the echo decreases This is called Doppler Effect In the 1960 s the ultrasonic technique was first applied to medical diagnostic imaging The ultrasound process involves placing a small device called a transducer against the skin of the patient near the region of interest The ultrasound transducer combines functions of emitting and receiving ultrasounds in one device This transducer produces a stream of inaudible high frequency sound waves which penetrate into the body and bounce off the organs inside It detects sound waves as they bounce off or echo back from the internal structures and contours of the organs The movement of the organs produces the Doppler Effect and this movement can be measured and described by measuring the echo In fetal monitoring the ultrasound transduce
23. 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 switch the start up music on or off Select the setup key B on the main interface 1 2 Select General gt Start up Music 3 Select ON default or OFF 4 Select OK NOTE Check all the functions to make sure that the monitor is in good condition If the monitor has a large 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 A message Load failed indicates that the data has been damaged and therefore cannot be loaded 3 WAILACH FETAG 2EMR Chapter 6 Pre Monitoring Preparation 6 3 Checking Recorder Paper The monitor provides the print self check function to check if the recorder paper is loaded correctly and set The recorder prints a baseline after start up if Print Self Check in the menu is ON Observe the borders of the printed baselines illustrated with the arrow The borders should be printed exactly on the margins of the pane if the recorder paper is correctly loaded and set If they do not comply with the margins reload paper or ask the service technician to change the paper setup of the
24. 1 No Display Error Condition Possible Cause Corrective Action Power indicator is off Power cable is loose Tighten the power cable The fuse is blown Change the fuse The battery runs out of power Connect to AC power supply A3 2 Noise Error Condition Possible Cause Corrective Action Noise Volume set too high Turn down the volume Interference from mobile phone or other source Turn or remove the interference source Move the monitor to a place with less interference A3 3 Recorder Error Error Condition Possible Cause Corrective Action Paper jam Paper is loaded paper is damp incorrectly or Load paper correctly and keep paper away from moisture Wrong paper is being used Use the paper that is provided by the manufacturer or contact the manufacturer for service Recorder does not work The recorder is not turned on Press the PRINT key Out of paper Load paper The paper drawer is not locked Close ihe drawer cover and press it until both latches are locked in position Wrong paper is being used Use the paper that is provided by the manufacturer or contact the manufacturer for service 67 WAIACH 2 Appendix 3 Troubleshooting Faint trace or no trace Wrong paper is being used Use paper recommended by manufacturer The monit
25. 3 V IEC 61000 4 6 150 kHz 80 MHz Vms d 800 MHz to 2 5 GHz Where P is the maximum output power Radiated RF 3 V m 3V m rating of the transmitter in watts W IEC 61000 4 3 80 MHz to 2 5 GHz 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 71 WAIACH FETA ZEMR Appendix 6 EMC Information NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 2 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones 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 Fetal Monitor s used exceeds the applicable RF compliance level above the Fetal Monitor should be observed to verify normal operation If abnormal performanc
26. EMR Software 902320 Rechargeable Lithium ion Battery 4200mAh 902350 JU CAUTION Only accessories supplied or recommended by Wallach Surgical Devices may be connected to the monitor m WAIACH FETA 2EMR Appendix 6 EMC Information Appendix 6 EMC Information Guidance Manufacturer s Declaration A6 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic emission The Fetal Monitor is intended for use in the electromagnetic environment specified below The user of the Fetal Monitor should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance The Fetal Monitor uses RF energy only for its internal function Therefore its RF emissions are CISPR 11 Group very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 1 uen The Fetal Monitor is suitable for use in all Harmonie missions establishments other than domestic and those IEC 61000 3 2 Glass A directly connected to the public low voltage Volge power supply network that supplies buildings Mike eee ders coiiiles used for domestic purposes IEC 61000 3 3 74 WAIACH FETAG2EMR Appendix 6 EMC Information A6 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declarat
27. H FETAG 2EMR Chapter 5 Printing 5 2 4 Switching Print Self Check On or Off To switch print self check on or off Select the setup key on the main interface Select Recorder gt Print Self Check Select ON or OFF default Select OK m 5 3 Understanding Recorder Paper Printout A warnincA 1 If there is any difference between the display and the printout the printout should prevail 2 If the data is ambiguous clinicians should make diagnoses based on the clinical assessment Figure 5 1 is an example of the recorder paper with traces Comparing it with the monitor screen you can find this extra information on the printed recording D 015 TS P w25R 75114 016 u 7 i Figure 5 1 Example of recorder paper with traces 2 WAIACH 2 Chapter 5 Printing Item Information Description pem The patient s ID and name Information Selt check Trace 179 monitor prints a self check trace after being switched on It is used to check if the recorder paper is properly loaded The FHR pane range 30 bpm 240 bpm indicates the paper style is Paper Style American Standard The FHR pane range 50 bpm 210 bpm indicates the paper style is International Standard Trace A list of current date time print speed and FHR2 offset is printed at the
28. HR Select a value from 60 205 for lower alarm limit Select a value from 65 210 for higher alarm limit Select OK 7 1 5 Changing FHR Alarm Delay vee The alarm delay indicates how long the measured result continues exceeding its limit before the alarm is triggered Select the setup key B on the main interface Select Alarm gt FHR gt Alarm Delay Select a value from 0 300 seconds Select OK Pe odie al WAILACH FETAG2EMR Chapter 7 Fetal Monitoring WARNINGA The FHR alarm delay is adjustable between 0 and 300 seconds If there is a condition to which attention should be directed the alarm delay should be set properly 7 2 Monitoring Twin FHRs 7 2 1 Monitoring Twins Externally To monitor twin FHRs externally you need to connect a US transducer to the US1 socket and the second US transducer to US2 socket of the monitor Follow the instructions described in Section 7 1 Monitoring FHR with Ultrasound to acquire FHR signals for both channels Press CHANNEL button to switch the fetal heart sound from one channel to the other When the two US transducers are in place make sure fetal heart sounds from both channels are clear Two FHR traces and two FHR values are displayed on the screen NOTE To ensure that both transducers stay at the optimal location each transducer should be fixed with a separate belt 7 2 2 Signals Overlap Verification SOV When monitoring twins there are possibiliti
29. WAIACH FETAKZEMR User Manual Fetal Monitor REF 902300 37474 Rev B 2 12 Statement The manufacturer makes no warranty of any kind with regard to this material including but not limited to the implied warranties of merchantability and fitness for a particular purpose Wallach Surgical Devices hereinafter called Wallach assumes no responsibility for any error that may appear in this document or for incidental or consequential damage in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without prior written consent of Wallach All information contained this publication is believed to be correct Wallach shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance use of this material The information contained in this document is subject to change without notice Responsibility Wallach is responsible for any effect on safety reliability and performance of the equipment if Assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by Wallach The electrical installation of the relevant room complies with national standards and The instrument is used in accordance with the instructions for use NOTE This device is not intended for home use Intensive Care Unit s o
30. allachsurgical com Ce 0123 Edan Instruments Inc Nanshan Medical Equipments Park Nanhai Rd 10194 Shekou Nanshan Shenzhen 518067 P R China EC REPRESENTATIVE Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 D 20537 Hamburg Germany Tel 49 40 2513175 Fax 49 40 255726 37474 Rev B 2 12
31. default monitoring volume The fetal heart volume returns to the default level after the START key default level is adjustable To change this level J is pressed This Select the setup key 6 main interface Select Start Monitoring gt Volume Select the volume from 1 10 in increments of 1 The default level is 3 Select OK ee S 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 1 Select the volume adjustment key on the main interface 2 Rotate the control knob clockwise one step and the volume increases by one level There are ten levels The volume level indicator increases by one bar for every two steps rotate the knob counterclockwise to decrease the volume 3 Press the knob again to confirm the selection Adjust the key volume volume of the sound emitted when pressing keys and rotating pressing the control knob is also adjustable Select the setup key TD on the main interface Select General gt Key Volume Select Low default High or OFF Select OK mw WAILACH FETAG 2EMR Chapter 7 Fetal Monitoring Chapter 7 Fetal Monitoring A WARNINGA The monitor is not intended for use in intensive care units ICU operating rooms or for home use e The monitor is not protected against defibrillation Do not apply it during electro surgery or MRI
32. dical electrical equipment It is class I equipment The Fetal2EMR 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 5 cm 2 inches clearance around the instrument for proper air circulation 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 The Fetal2EMR Monitor must be serviced only by authorized and qualified personnel Wallach Surgical Devices 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 Perform periodic safety testing to ensure proper patient safety This should include leakage current measurement and insulation testing The recommended testing interval is once per year The protective categories against electric shock of the patient connections are WAILACH FETAR2EMR Chapter 1 Safety Guide Al 1 Ultrasound 2 2 External 3 Intrauterine Pressure IUP 4 Fetal Movement Mark FM This symbol indicates that the electric shock defend grade of this applied part is Type BF
33. e is observed additional measures may be necessary such as reorienting or relocating the Fetal Monitor s Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 78 WAIACH FETAG2EMR Appendix 6 EMC Information A6 4 Recommended Separation Distance Recommended separation distance between portable and mobile RF communications equipment and the Fetal Monitor The Fetal Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the Fetal Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Fetal Monitor as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz t itte A ransmitter 4 35 4 85 a lye w V E E 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 73 1 12 12 23 10 37 37 73 100 12 12 23 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
34. els and these settings cannot be changed 4 2 Audible Alarm If the audible alarm is not disabled the alarm indicator displays IR when an alarm is active the monitor gives out an alarm sound The sound range is 45dB 85dB Medium level alarm a Do tone is repeated three times and then pauses for 4 seconds Low level alarm a Do tone is issued and then pauses for 20 seconds Press the SILENCE key and off Settings can be changed to make this temporary or indefinite on the front panel and the audible alarm toggles between on If the current audible alarm is temporarily disabled the alarm indicator displays with a remaining time on the right When the time is out or when other alarms present the monitor enables the audible alarm automatically If the current audible alarm is disabled the alarm indicator displays flashing The audible alarm is enabled again when the SILENCE key is pressed or when other alarms present During the silence period the alarm messages are displayed and the alarm indicator lights up as usual You can press the SILENCE key again to enable the audio alarm 26 WAILACH FETAG 2EMR Chapter 4 Alarms 4 3 Visual Alarm When an alarm is active the following 3 visuals occur Alarm indicator the alarm indicator lights up Alarm Category Indicator Color Flashing Frequency Cycle Medium level alarm Flashing orange 0 4Hz to 0 8Hz 20 to 60 on Low l
35. emselves All the service should be performed by Wallach technical personnel Limit of Warranty The warranty is void in the case of Assembly extensions readjustments of any parts Modification and repair by unauthorized persons e Subsequent damage caused by improper use or maintenance If you have any question about maintenance technical specifications or malfunctions of devices contact Wallach at 800 243 2463 or 866 928 3211 An email may also be sent to wallach wallachsurgical com 60 WAIACH 2 Appendix 1 Product Specifications Appendix 1 Product Specifications A1 1 Environmental Specifications Temperature 5 C 40 C 41 F 104 F Working Relative Humidity 25 80 non condensing Atmospheric Pressure 860hPa 1060hPa Temperature 20 C 55 C 4 F 131 F Transport and Storage Relative Humidity 25 93 non condensing Atmospheric Pressure 700hPa 1060hPa A1 2 Physical Specifications Monitor Dimensions and Weight Size depth x width x height 350mm x 300mm x 104mm 13 78 x 11 81 x 4 09 Power Supply Weight Approx 3 5 kg 6 6 lbs Operating Voltage 100V 240V Operating Frequency 50Hz 60Hz Input Power 70VA Battery 14 8V 4200mAh UL IE Standards Compliance EN 60601 1 IEC EN 61157 IEC EN 60601 1 2 IEC 60601 2
36. en the monitor is switched on again the saved data will be loaded You can review the data or print it at a high speed AUTION Turn off the monitor as described in section 9 3 Switching Off Interrupted power off may cause data loss and failure in data reloading 9 2 Completing the Monitoring After monitoring is completed l 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 NOTE 1 The remaining coupling gel on the ultrasound transducer may cause the monitor to create noise Therefore the gel should be wiped off the transducer after monitoring 2 After the fetus is delivered the monitor may pick up signals of the umbilical cord and display a trace numerie value To avoid misinterpretation it is recommended the transducers be removed from the patient and the monitor switched off immediately after the fetus is delivered 9 3 Switching Off l Press and hold the POWER switch for at least 1 second to switch off the monitor 2 Unplug the power cord CAUTION After the monitor is switched off please wait for at least 10 seconds before switching it on again WAILACH FETAG 2EMR Chapter 10 Maintenance and Cleaning Chapter 10 Maintenance and Cleaning 10 1 Maintenance 10 1 1 Maintaining Inspection 1 Visual Inspection Pri
37. es that one twin s FHR signal is mistaken for the other one s signal The monitor provides a signal 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 appear on the screen to warn you It may be necessary to check the patient and reposition the transducers 7 2 3 Changing FHR2 DFHR Offset In order to distinguish FHR1 trace from FHR2 DFHR trace FHR2 DFHR offset is provided to help you separate the two traces by an offset of 20 bpm or 420 bpm To change the FHR2 DECG offset Select the setup key on the main interface Select Recorder FHR2 Offset Select 20 bpm default 0 bpm or 20bpm Select OK e dq T This preset FHR2 DFHR offset will be printed on the recorder paper every 10 minutes 40 WAIACH FETAG 2EMR Chapter 7 Fetal Monitoring 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 7 3 Monitoring Uterine Activity Externally 7 3 1 Parts Required 1 TOCO transducer 2 Belt 7 3 2 TOCO Monitoring Procedure 1 Placing Transducer Belt Place the transducer belts across the bed ensuring that the belt will be around the patient s abdomen when it is fastened Lay the patient on the bed Alternatively the patient can take a sitting position Arrange t
38. evel alarm orange Constant on 100 Alarm message the alarm message appears in the alarm message area of the main interface in yellow Flashing numeric the numerical value of the measurement flashes in grey with a frequency of 2Hz When more than one alarm is active the alarm messages appear in the same area in succession The patient alarm messages are displayed either in text form for example FHR2 LOW or in numeric form for example FHR2 115 lt 120 indicates this is a medium level alarm event the first number is the current measurement result the second number is the preset alarm limit The technical alarm messages are displayed in text form for example Fetus EQUIP MALF 4 4 Choosing Alarm Silence Duration To choose the alarm silence duration 1 Select the setup key E on ine main interface 2 Select Alarm gt Silence Duration 3 Select Infinite default 1 min 2 min or 3 min 4 Select OK 4 5 Choosing Alarm Display Form To change the patient alarm display form 1 Select the setup key 8 the main interface 2 Select Alarm gt Message Form 3 Select Text default or Numeric 4 Select OK N WAIACH 2 Chapter 4 Alarms 4 6 Changing Alarm Volume To change the alarm volume 1 Select the setup key on the main interface 2 Select Alarm gt Alarm Volume 3 Select Low default Medium or High 4 Select OK 4 7
39. f grid lines or make the trace unreadable 10 1 5 Maintenance of Recorder WARNINGA Switch off the monitor and remove the power cord prior to recorder cleaning Check to see if the paper sensor is covered with dust If it is dirty gently wipe it clean with a dry cloth or a cotton swab 56 WAILACH FETAG 2EMR Chapter 10 Maintenance and Cleaning The recorder plate thermal print head and paper sensing mechanism must be cleaned at least once a year or when needed when trace becomes faint The following procedure may be used 1 Switch off the monitor and open the paper drawer 2 Wipe the printhead with a cotton swab or a soft cloth moistened with isopropyl alcohol 3 Air dry the printhead surface and then close the drawer UCAUTION Use only paper provided by Wallach Surgical Devices or damage to the recorder may occur This type of damage is not covered by warranty 10 2 Cleaning In order to avoid contamination clean and disinfect the monitor and accessories after each use 10 2 1 Cleaning of the Monitor WARNINGA 1 Unplug the monitor from the AC power source remove the battery and detach all accessories before cleaning 2 Do not immerse the unit in water or allow liquids to enter the case If liquid is splashed on or into the main unit inadvertently or enters the conduit stop using the monitor and contact the manufacturer for service immediately Regular cleaning
40. g File managing key Recorder status speed indicator 14 3 No printing in progress Printing in progress 8 stands for the printing speed 3 cm min Alarm sound status indicator Alarm sound on Alarm sound is disabled Alarm sound pause and the remaining time Battery status indicator 16 Battery not installed Battery installed the vertical strips indicate the electric charge 17 Patient ID identification WAIACH 2 Chapter 2 Monitor and Accessories 2 4 2 Setup Interface The setup menu is provided to change the monitor configurations and monitoring settings Press the Setup key B on the main interface to open this menu Main Menu start Monitoring Fetus is General Date And Time Alarm System Recorder 19 Figure 2 12 Setup Menu Item Screen element 18 Setup Items 19 Function Description In the setup main menu you have access to all the items other than System You can select EXIT to exit from this menu The items in this main menu all have submenu s To confirm the setting changes in the lect submenus you need to select OK to exit If you don t want to store the new setting Cancel or press the START key to return to the main interface If no operation is performed within 30 seconds the menu will return to the upper level directory The change will not be stored Once you select OK to confirm the setting changes the new se
41. he belt around her abdomen 2 Fixing the Transducer Wipe away any gel remaining on abdomen around this area Place the TOCO transducer on the patient s abdomen on the uterine fundus Wrap the abdomen with the belt over the transducer Fix the transducer by pushing its buckle through the overlapping section of the belt Make sure the belt fits the patient snugly and comfortably 3 Adjusting the Numeric Value to Zero Press the AUTO ZERO button to adjust the numeric value 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 needs adjustment NOTE 1 Do not apply aquasonic coupling gel on a 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 7 3 3 Changing UA Baseline The UA baseline can be changed 41 WAIACH FETAR2EMR Chapter 7 Fetal Monitoring Select the setup key TD on the main interface Select Fetus gt UA Baseline Select 5 10 default 15 or 20 Select OK 59 85 7 4 Monitoring Fetal Movement 7 4 1 Auto Fetal Movement Monitoring AFM During fetal heart monitoring with ultrasound 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 freq
42. he fetus Repositioning of the transducer is needed A7 3 Audio Output and Screen Reading In most instances the audio output from the monitor speaker corresponds to the readings presented on the monitor screen But occasionally the fetal heart sound may differ from the trace and numeric When the fetal heart moves partially out of the ultrasound wave path the transducer receives weaker FHR signal and other stronger signals usually maternal heart pulse rate After the signals are transmitted to the monitor the audio system and the video system of the monitor process the signals separately On one hand the audio circuit filters the low frequency signals and gives audio output of the high frequency signals so fetal heart sound is heard On the other hand the autocorrelation algorithm computes the stronger signal source and thereby the maternal heart pulse rate is displayed As a result the audio output differs from the screen reading If this situation occurs it can be corrected by repositioning the transducer In summary the abnormalities listed above artifacts sound and reading differences are caused by the limitations of ultrasonic monitoring technique Fortunately they rarely occur But a good understanding of how to detect them and what countermeasures should be taken will help obtain better fetal monitoring effect 8 Manufactured for WALLACH SURGICAL DEVICES 95 Corporate Drive Trumbull CT 06611 USA 800 243 2463 wallach w
43. hould export and save the files in a timely manner 4 When there are more than 100 files it may take an extended period of time for the monitor to load them WAIACH FETAR2EMR Chapter 8 Understanding Measurement Results 8 2 4 Reviewing The reviewing keys FARA backward key BM forward key under the traces are used to review the traces Select the backward key to review 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 counterclockwise 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 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 counterclockwise 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 button LII is pressed at this moment the recorder prints the traces of the patient on the current screen ata high speed according to the settings X indicates the proportion of current traces positioned in the entire reviewable traces Move the cursor to any item o
44. ight or too loose Adjust the belt 68 WAILACH FETAG 2EMR Appendix 3 Troubleshooting fluctuant TOCO baseline E The belt has no elasticity Replace the belt Request that the patient reduce Maternal movement movement Frequent fetal movements Delay the monitoring Confirm good contact to patient skin with transducer Change the position of TOCO transducer if necessary Too high The body pressure from uterus to sensitivity higher than TOCO transducer is far higher 100 unit than the average numeric A3 6 Blown Fuses WARNINGA Switch off the monitor and remove the power cord before changing the fuse Replace the blown fuse when needed The two fuses of the monitor are located on the rear panel Their specifications are Size 5mm 20mm Model T2AH250V To replace a fuse 1 Place the monitor on a flat surface and remove the power cord 2 Pull the fuse container out as far as it can go 3 Use a screw driver or a pair of pliers to push the fuse up from the bottom of the container 69 WAILACH FETAG 2EMR Appendix 3 Troubleshooting 4 Take the fuse out and replace it with a new one that is supplied by the manufacturer or of the same specifications 5 Push the fuse container all the way back in position A3 7 Paper Jam When the recorder does not function properly open the drawer to check for a paper ja
45. ilizing Do not sterilize the monitor or the accessories unless this is necessary according to your hospital regulation WAILACH FETAR2EMR Chapter 11 After Sales Service Chapter 11 Warranty and Service Policy Warranty Wallach s obligation under this warranty is limited to repairing at Wallach s option any part which upon Wallach s examination proves defective If the product doesn t function as warranted during the 1 year warranty period we will repair or replace it without charge Material and Manufacture Wallach warrants that there is no defect in material and manufacture During the 1 year warranty period Wallach will repair or replace the defective part free if the defect has been confirmed as material or manufacture defect Software or Firmware Wallach software and firmware products which are designated by Wallach for use with a hardware product when properly installed on that hardware product are warranted not to fail to execute their programming instructions due to defects in materials and workmanship If Wallach receives notice of such defects during the warranty period that begins on the date of shipment Wallach shall repair or replace software media or firmware which does not execute their programming instructions due to such defects However Wallach does not warrant that operating of the hardware software or firmware shall be uninterrupted or free from error This unit has no parts can be repaired by users th
46. imum index values exceeding 1 0 System Fetal Monitor Ipa 3 Mlmax Transducer Model Wit TE Type TI Value MI Wem TIS 0 055 PW 1 0 MHz 2 77 0 029 0 01 TIB 0 629 WAILACH FETAG 2EMR Appendix 2 Signal Input Output Connector Appendix 2 Signal Input Output Connector Accessory equipment connected to these interfaces must be certified according to the respective IEC EN standards e g IEC EN 60950 for data processing equipment and IEC EN 60601 1 for medical equipment Furthermore all configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 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 Pin Signal Input Output 1 5V Output 2 Rx Input 3 Tx Output 4 485EN Input 5 OV Ref 6 TA Output 7 TB Output 8 RA Input 9 RB Input RJ45 Interface Pin Signal Input Output Hl 1 TD Output Hm 2 TD Output 3 RD Input 4 Reserved 5 Reserved 6 RD Input 7 Reserved 8 Reserved 66 WAIACH 2 Appendix 3 Troubleshooting Appendix 3 Troubleshooting A3
47. ing 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 Fast printing The recorder prints the data saved in the monitor at a high speed up to 15mm s Data Caching When the paper drawer runs 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 After the saved trace has been printed out the recorder switches back to 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 set the offset of the FHR2 trace to separate the two fetal heart traces on the screen and the recorder paper Refer to 7 3 4 Changing FHR2 DFHR Offset Print self check The recorder prints a baseline for self checking when the monitor is switched on Paper advance When printing stops the paper advances to the next perforation making it easy to be torn off Refer to 5 2 5 Switching Paper Advance On or Off 5 2 Printing Configuration NOTE All the parameters should be configured correctly before printing starts You cannot change the configuration in the process of printing WAILACH FETAG 2EMR Chapter 5 Printing 5 2 1 Switching Auto Start
48. into the USB socket on rear panel of the monitor figure 2 4 A message Ready to use USB disk in the message area indicates the proper insertion of the connection 3 Select the file managing key on the main interface to open the File Management interface which records a list of up to 50 most recent monitoring records patients ID name and date and a few operation items File Management Name Date Jone Julia 1101201148 Elva 1101201117 Hebe 1101201045 Lili 1101201014 Linda Next xport All Delete All Remove Disk EXIT Figure 8 6 File Management 4 If the required record is not on the current page select Next to view more records 5 Move the cursor to select the required item and then select Export in the pop up item and the monitor exports this record through the USB connection Or you can select Export All to export all the records through the USB connection NOTE 1 When the monitor is in the process of printing or is connected to the network the files cannot be exported 2 The manufacturer advises against plugging in the USB connection and exporting the data during the process of monitoring 3 A USB thumb drive is not an appropriate tool for long term data storage Save the 49 WAILACH FETAG 2EMR Chapter 8 Understanding Measurement Results exported files on a PC 4 The monitor only supports those USB disks with FAT or FAT32 recommended format and with capacity no
49. ion electromagnetic immunity The Fetal Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Fetal Monitor should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floor discharge ESD mo is covered with synthetic IEC 61000 4 2 GRUB CENA 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 Surge 1kVlinetoline 1 kV line to line ak ae IEC 61000 4 5 42 kV line to ground 2 kV line to ground P hospital environment Power frequency 50Hz 60Hz magnetic field 1 61000 4 8 Power frequency magnetic fields should be at levels characteristic of typical location in a typical commercial or hospital environment WAIACH FETAG2EMR Appendix 6 EMC Information Voltage dips short interruptions voltage variations on power supply input lines IEC 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip
50. iscretion of the provider Alarms may be set up based on different situations Audio should be activated when monitor is in use Battery Safety Precautions Before using the rechargeable lithium ion battery hereinafter called battery be sure to read the user manual and safety precautions thoroughly 2 Do not connect the battery cable connector or battery socket with metal objects which can result in short circuit Do not unplug the battery when monitoring 4 Do not heat or throw the battery into a fire 5 Do not use or leave battery close to fire or other places where the temperature may be above 60 C 140 F 6 Do not allow the battery to get wet 7 Do not destroy the battery Do not pierce battery with a sharp object such as a needle do not hit with a hammer step on or throw or drop to cause strong shock Do not disassemble or modify the battery 8 the battery only in this Monitor Do not connect battery directly to an electrical outlet or cigarette lighter charger 9 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 10 Do not solder the leading wire and the battery terminal directly 11 If the liquid leaks from the battery and spills onto your skin or clothes wash well with fresh water immediately 12 Keep battery away from flames If leakage or foul odor is detected discontinue use 13 Stop using the battery if abno
51. ition the fetal heart moves downward as the labor progresses It is recommended to move the transducer along with the fetus 3 Acquiring Fetal Heart Signal Apply acoustic gel on the transducer and move it slowly around the abdomen Find at least 2 or 3 sites and choose the one where the clearest most sonorous and steady fetal heart sound is heard 4 Fixing the Transducer To secure the transducer wrap the abdomen with the belt over the transducer Secure the transducer by pushing its buckle through the overlapping section of the belt Make sure the belt fits the patient snugly but comfortably When the fetal heart beat sound is detected the FHR trace and numeric value are displayed on the screen 5 Confirming that the Fetus is the Signal Source Ultrasound Doppler technology is utilized to observe the fetal heart rate externally There are possibilities that the maternal heart rate signal can be mistaken for the FHR signal It is highly recommended to confirm that the fetus is the signal source continuously for example checking the maternal pulse If the maternal heart signal is misidentified as the fetal heart signal repositioning of the transducer is needed NOTE 1 Do not mistake the high maternal heart rate for fetal heart rate 2 The best quality records will only be obtained if the transducer is placed in the optimum position Positions with strong placental sounds swishing or fetal cord pulse indistinct pulse at fetal rate
52. larms do the following Switch on the monitor Enable the alarm Set the alarm limits to a narrow range Pepe Simulate a signal that is higher than the upper alarm limit or lower than the lower alarm limit Or disconnect one of the plugs 5 Verify if the visible and audible alarms are working properly 4 10 Patient Alarm Defaults Alarm Setting Options Default FHR1 FHR2 Alarm On Off On FHR1 FHR2 Low alarm limit 60 bpm 205 bpm in increments of 5 120 bpm FHR1 FHR2 High alarm limit 65 bpm 210 bpm in increments of 5 160 bpm FHR1 FHR2 Alarm Delay 0 300 second s in increments of 5 10 seconds FHR1 FHR2 Alarm Level Medium not adjustable Medium NOTE The upper alarm limit must be higher than the lower limit When setting the upper alarm limit you do not have access to the options that are lower than the preset lower limit and vice versa 29 WAILACH FETAG 2EMR Chapter 5 Printing Chapter 5 Printing 5 1 Function Description The built in thermal recorder applied in the monitor supports both the American and international standard width recorder paper It prints continuous traces synchronously along with marks The monitor supports some other functions listed below Auto start printing If the function is enabled the recorder starts printing automatically when a new monitoring starts the START key is pressed Otherwise you have to press the PRINT key to start print
53. le for the exact time 8 2 2 Searching for a Patient s Record The auto saved data of every monitoring is stored as a separate file in the monitor With the searching key you are able to find a patient s monitoring record easily 1 Select the search key on the main interface to open the Patient Searching interface which records a list of up to 50 most recent patients ID and name When the USB feature is disabled the interface is shown as follows Patient Searchi 1D R Jone Julia 1148 Elva 1101201117 Hebe Lili Linda Next EXIT Figure 8 5 Patient Searching 2 Ifthe required record is not on the current page select Next to view more records 3 Move the cursor to select the required item if the USB feature is enabled you should select Load in the pop up item and the monitor loads the traces of this record to the main interface for review 48 WAILACH FETAG 2EMR Chapter 8 Understanding Measurement Results 8 2 3 File Management Optional wed files into a USB disk and then you can save the files in a PC or open them in a data managing system The USB feature of the monitor allows you to export the auto s Once the monitor is configured with the relevant hardware the USB feature can be enabled or disable by the service personnel of the manufacturer 8 2 3 1 Exporting Files 1 Make sure the USB feature is enabled Stop printing and disconnect the network 2 Plug the USB connection
54. m Remove the paper jam as follows 1 Cut the recorder paper from the paper drawer edge 2 Pull up the plastic strip in the drawer to lift the remaining paper Remove the paper 70 WAIACH FETAR2EMR Appendix 3 Troubleshooting Plastic Strip ti 3 Reload paper and then close the drawer WAIACH FETA ZEMR Appendix 4 Abbreviation 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 DC Direct Current DFHR Direct FHR ECG Electrocardiogram FHR Fetal Heart Rate FM Fetal Movement ICU Intensive Care Unit ID Identity LCD Liquid Crystal Display MFM Manual Fetal Movement Detection NST Non Stress Test sov Signals Overlap Verification TOCO Tocotonometer UA Uterine Activity TOCO IUP us Ultrasound Transducer n WAILACH FETAG 2EMR Appendix 5 Ordering Information Appendix 5 Ordering Information The following accessories can be used with the monitor The accessories all carry the CE mark Accessory Spare Part Part Number FHR Probe Ultrasound Transducer 902302 TOCO Transducer 902303 Remote Event Marker 902307 Belt pack of 3 902308 Rolling cart with tray 902340 Thermosensitive Paper GE American 902304 Fetal2
55. manufacturer otherwise the printer 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 drawer latch on the front panel to flick open the paper drawer cover 720 WAILACH FETAG 2EMR Chapter 3 Installation Guide 2 Take out the thermosensitive paper remove the wrapper 3 Guide the pack into the drawer underneath the retaining rod abutting it against the right edge Make sure the blank side of the paper faces you and the FHR trace area is on the left 4 Unfold a sheet from the top of the pack and pull its end out of the drawer make sure the pack in the drawer remains flat 2 WAIACH FETAG 2EMR Chapter 3 Installation Guide CAUTION Be careful when inserting paper Do not touch the thermosensitive print head or the paper sensor by hand as damage may be caused by static electricity 2 Make sure the paper pack in the drawer remains flat when the top sheets are pulled out of the drawer If paper deflection is detected after the drawer cover is closed reload paper to prevent paper jam Use only paper provided by Wallach Surgical Devices to avoid printing problems 3 Keep the drawer closed except when loading paper or servicing 4 careful not to trap fingers when closing the paper drawer cover WAIACH FETAR2EMR Chapter 3 Installation Guide 3 4 Tearing Off Recorder pape
56. ng the belts the water temperature must not exceed 60 C 140 F Electromagnetic Interference Ensure that the environment in which the monitor is installed is not subject to any source of strong electromagnetic interference such as CT radio transmitters mobile phone base stations etc Do not use mobile phones near monitoring While the battery is charged used or stored keep it away from objects or materials with static electric charges If the terminals of the battery become dirty wipe with a dry cloth before using the battery The recommended charge temperature range is from 0 C 32 F to 40 C 104 F Do not exceed this range Batteries have life cycles If the time that the monitor runs on the battery becomes 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 Wallach Surgical Devices 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 Remove a battery whose life cycle has expired from the monitor immediately For information on installing and removing the battery from the monitor thoroughly read the user manual device and accessories are to be disposed of in accordance with all applicable Federal State and local medical hazardous waste practices at the end of their useful lives Alternatively they can be returned to the manufacturer
57. nique Ultrasound Pulse Doppler with autocorrelation Pulse Repetition Rate Ultrasound 2 KHz Pulse Duration 92 us g WAIACH 2 Appendix 1 Product Specifications Ultrasound Ultrasound Frequency 1 0 10 MHz p 1 MPa Ia lt 10 mW em lt 100 mW em FHR Measurement Range 50 bpm 240 bpm Resolution 1 bpm Accuracy 2 bpm Dielectric Strength gt 4000Vrms ISATA the transducer face 1 865 mW cm Entrance beam 6 08 cm Measurement uncertainties for ISATA 26 6 Measurement uncertainties for ultrasonic power 26 6 TOCO Range 0 100 Non linear Error 10 Resolution 1 Zero Mode Automatic Manual Dielectric Strength gt 4000Vrms Technique Pulsed Doppler ultrasound AFM Range 0 100 Resolution 1 Marking Manual fetal movement mark A1 4 Recorder Specifications Paper Z fold thermosensitive Paper width 152mm GE Effective printing width 110mtn American Standard 120mm International Standard R 70mm American Standard printout width 80mm International Standard 30bpm cm American Standard FHR scaling 20bpm cm International Standard 2695 WAIACH FETA ZEMR Appendix 1 Product Specifications TOCO printout width 40mm TOCO scaling 25 Printing speed Standard S
58. of the monitor enclosure and the screen is strongly recommended The solutions recommended for monitor cleaning are mild soapy water Tensides Ethylate and Acetaldehyde 51 WAILACH FETAG 2EMR Chapter 10 Maintenance and Cleaning Clean the screen with a dry soft cloth If necessary the screen may be cleaned with a neutral detergent or isopropyl alcohol Do not use chemical solvents acidic or alkali solutions AUTION 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 2 Many cleansers must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the monitor 3 Do not use strong solvent for example acetone 4 Never use an abrasive such as steel wool or metal polish 5 Do not allow any liquid to enter the product and do not immerse any part of the monitor into liquid 6 Avoid pouring liquids on the monitor while cleaning 7 Do not leave any cleaning solution on the surface of the monitor 10 2 2 Cleaning of Accessories 1 Cleaning of Transducers To clean the US transducer and TOCO transducer Wipe them with a soft cloth dampened in cleaning solution them with a soft cloth dampened in water Air dry them or wipe the remaining moisture with a soft dry cloth The recommended cleansers for accessories are listed below
59. onitor is powered off Table 2 1 Indicator description 13 WAILACH FETAG 2EMR Chapter 2 Monitor and Accessories 2 3 Accessories 2 3 1 Ultrasound US Transducer A 1 US Transducer Pink Labeled 2 Transducer Cable 3 Transducer Connector Figure 2 7 US Transducer 2 3 2 TOCO Transducer 1 TOCOS Transducer Blue Labeled 2 Transducer Cable 3 Transducer Connector Figure 2 8 TOCO Transducer 2 3 3 Belt Figure 2 9 Belt WAIACH 2 Chapter 2 Monitor and Accessories 2 3 4 Remote Event Marker 1 Marker Plug 2 Press Key 2 1 Figure 2 10 Remote Event Marker 2 4 Screen 2 4 1 Main Interface 1 2 3 4 5 6 1003301512 R 7 1716 15 14 13 12 11 10 9 8 Figure 2 11 Main Interface Item Screen element Description 1 Alarm messages displaying area 2 Alarm reviewing key WAIACH 2 Chapter 2 Monitor and Accessories 3 LP Display mode switch 4 6 Setup key Fetal heart sound volume adjust indicator 5 BRA the current fetal heart sound comes from this channel fetal neart sound of this channel is mute Fetal heart signal quality indicator E E acceptable optimum 7 10 Trace review keys 8 FM count 9 System time Monitoring timer the number the right indicates the duration of the current monitoring 12 Patient searchin
60. or gives check paper warning when there is paper in the drawer The paper sensor is dirty Clean the paper sensor gently with dry cloth A3 4 Trouble with Ultrasound FHR Monitoring Error Condi Possible Cause Corrective Action Inconstant trace I display The pregnant woman is too Monitor FHR with DECG if obese applicable Adjust the posiion of the Improper ultrasound transducer transducer until a better signal position is received Loose belt Tighten the belt Excess ultrasound coupling gel Wipe off excess ultrasound coupling gel Frequent fetal movements Delay the monitoring Maternal movement Request the patient to reduce movements Inadequate ultrasound coupling gel Add coupling gel ultrasound aquasonic Questionable FHR Recording maternal heart rate inadvertently Change the position of the ultrasound transducer The transducer is not securely placed in position and the mixed noise has been recorded Adjust the position of the transducer The channel from the unused transducer displays numeric values left connected inadvertently unused transducer monitoring while Unplug the unused transducer A3 5 Trouble with Contractions Monitoring External Error Condition Possible Cause Corrective Action Bad trace quality or The belt is too t
61. or to using the monitor perform the following inspections 1 Check the monitor and accessories to if there is any visible evidence of damage that may affect patient safety Pay special attention to the seams on the transducers and cables before immersing them into conductive fluid 2 Check all the outer cables power socket and power cables 3 Check if the monitor functions properly If any damage is detected stop using the monitor Replace the damage part s or contact Wallach Surgical Devices 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 live parts 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
62. peed Real Time Traces 1 cm min 2 cm min 3 cm min Fast Print Speed Stored Traces Up to 15mm sec Accuracy of data 590 X axis Accuracy of data 1 Y axis Resolution 8 dots mm Record Information FHRI trace mark FHR2 trace mark TOCO trace AFM trace fetal movement mark event mark AUTO zero symbol date time printing speed ID name FHR2 Offset etc A1 5 Rechargeable Lithium ion Battery Specifications Part Number 902350 Nominal Capacity 4200mAh Charge Current Standard 0 2CsA 1200mA Continual Working Time 7 hours Nominal Voltage 14 8V Charge Voltage Standard 16 840 1 V Cycle Life 2300 times Charge Temperature 0 C 50 C 32 F 122 F Operating Temperature 20 C 60 C 4 F 140 F Relative Humidity 45 75 Charge Mode Constant current constant voltage 64 WAIACH 2 Appendix 1 Product Specifications Storage Short Term within 1 month Long Term within 1 year 20 C 60 C 4 F 140 F Middle Term within 3 months 20 C 45 C 4 F 113 F 20 C 20 C 4 F 68 F During storage recharge the battery at least every six months Charge State When Leaving Factory 20 50 A1 6 Low Output Summary Table Low Output Summary Table for systems with no transducers having global max
63. per Drawer Latch Figure 2 1 Front View 9 Accessory Holder Figure 2 2 Left Panel WAIACH 2 Chapter 2 Monitor and Accessories 10 11 12 13 14 15 Figure 2 3 Front Panel Figure 2 4 Rear Panel 10 10 DECG Socket 11 TOCO IUP Socket 12 FHR1 Socket 13 FHR2 Socket 14 MARK Socket 15 EXT 1 Socket 16 Power Socket 17 Equipotential Grounding Terminal 18 DB9 Socket 19 RJ45Socket 20 USB Socket WAIACH FETAG 2EMR Chapter 2 Monitor and Accessories 21 Handle 22 Battery Compartment Figure 2 5 Bottom Panel 2 2 1 Keys and Control Knob Figure 2 6 Keys and Control Knob The Fetal2EMR monitor is a user friendly device with operation controlled by a few keys on the front panel and the control knob Their functions are as follows 1 POWER switch oo Function Switch on or off the monitor 2 START key Function Start monitoring or return to the main interface Press this key to start monitoring the monitor automatically stops printing data of the last monitoring checks transducer connection clears the MFM count and the monitoring timer zeroes the pressure When inputting maternal information or when changing the monitor settings press this key to return to the main interface STA WAIACH FETAG 2EMR Chapter 2 Monitor and Accessories 3 SILENCE key ES Function Switch on off the alarm sound Press this key to switch on off the alarm sound 205
64. place the fuses with those of the same specifications only 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 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 The monitor is not protected against defibrillation Do not apply it during electrosurgery or MRI as it might result in harm to the patient or the operator Only connect accessories supplied or recommended by Wallach Surgical Devices to the device 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 All configurations shall comply with the valid version of the system standard IEC EN 60601 1 1 Anyone who connects additional equipment to the signal input connector or signal output connector configures a medical system and therefore is responsible 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 2e WAIACH FETAG 2EMR Chapter 1 Safety Guide technical service department or your local distributor Proper Monitoring Safety Precautions Clinical decision making based on the output of the device is left to the d
65. r Perform the following procedure to tear off the recorder paper 1 Press the PRINT key on the front panel if the recorder is running 2 Pull up the end of the paper fold the paper if it is very long and use moderate force to tear paper off in an upward motion along the paper cutting edge CAUTION Always tear off the paper along the paper cutting edge or the perforation Pulling the paper fiercely may damage the printhead or cause misalignment of the paper in the drawer 3 5 Adjusting Screen Angle The Fetal2EMR screen can lie completely flat or tilt to an appropriate angle To tilt or to fold the screen 1 Push the tab on top of the screen right to spring it open 2 Hold the centre part of the screen on the top edge and push it forward or backward to the required angle 5 WAILACH FETAG 2EMR Chapter 3 Installation Guide 3 6 Connecting Transducers Check for visible damage to the transducers every time before connecting them to the monitor Pay special attention to possible cracks on the transducers and cables before immersing them into conductive fluid If damage is found replace them When plugging transducers into the monitor make sure the arrow symbol of the connector facing up Connecting the transducer Disconnecting the transducer When disconnecting a transducer pinch the body of the transducer plug and pull it out gently NOTE Never try to disconnect the transducer
66. r Operating Rooms ZAWARNING This device is not intended for treatment Using This Label Guide This guide is designed to give key concepts on safety precautions AxwarnincA A WARNING label advises against certain actions or situations that could result in personal injury or death A CAUTION label advises against data or invalidate a procedure tions or situations that could damage equipment produce inaccurate NOTE A NOTE provides useful information regarding a function or a procedure Table of Contents Chapter 1 Safety Guide 1 1 Intended Use 1 2 Instruction for Safe Operation 1 3 Ultrasound Safety Guid 14 Safety Precautions 1 5 Definitions and Symbol Chapter 2 Monitor and Accessorie 2 1 Opening and Checking Package 2 2 Overview 2 2 1 Keys and Control Knob 2 3 1 Ultras 2 3 2 TOCO Transducei 2 3 3 Belt 2 3 4 Remote Event Marker 2 4 Screen 2 4 1 Main Interface 2 42 Setup Interface Chapter 3 Installation Guid 3 1 Installing Battery 3 2 Installing Monitor 3 3 Loading Recorder paper 3 4 Tearing Off Recorder paper 3 5 Adjusting Screen Angle 3 6 Connecting Transducers 3 7 Placing Accessories in the Holder 3 8 Connecting Power Cable Chapter 4 Alarms 4 1 Alarms Classification 4 2 Audible Alarm 4 3 Visual Alarm 4 4 Choosing Alarm Silence Duration 4 5 Choosing Alarm Display Form 4 6 Changing Alarm Volume
67. r produces a stream of sound waves which penetrate into the maternal abdomen and bounce off the fetal heart Then the transducer receives the echoes and transfers them to the monitor which turns the signal into fetal heart beating sound and fetal heart rate trace Therefore placement of the transducer is critical to ultrasound fetal heart monitoring A7 2 Artifacts in Fetal Heart Monitoring 1 How does artifact happen The transducer detects sound waves as they bounce off or echo back from the fetal heart However the sound waves bouncing off from maternal blood vessels may be detected by the transducer and then be processed by the monitor as well As a result artifacts may be produced The artifacts if not correctly interpreted may cause the physicians to perform unnecessary interventions or to fail to detect the fetal distress and the need for interventions The most common artifacts are doubling and halving 2 Doubling When the FHR drops to 120 bpm or lower the diastole and systole become far apart thereby the monitor may mistake these two movements of a single heartbeat for two separate heartbeats As a result a heart rate trace that is double the actual heart rate is produced This often happens during severe decelerations and bradycardia representing an abrupt switch of the trace to double the actual heart rate 80 WAILACH FETAR2EMR Appendix 7 Limitations of Ultrasonic Monitoring 3 Halving When the
68. rate pane vary with the alarm limits with the lowest at 100 and highest at 180 You can easily tell if the fetal heart rate is too low or too high 3 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 4 TOCO trace The y axis indicates the numeric of TOCO The range is 0 100 Other elements This symbol indicates the new monitoring starts 1 This symbol indicates a manual fetal movement and it appears after the patient presses the FM marker when she feels a fetal movement This symbol indicates the MARK key is pressed to record an event such as the patient turning around This symbol indicates the monitor is zeroed by pressing AUTO ZERO key 41 WAIACH FETAG 2EMR Chapter 8 Understanding Measurement Results 8 2 1 Changing Time Scale The fetal monitoring traces share the same time scale which displays the time every two minutes This scale is either in real time format or relative time format Real time is the time of the monitor Relative time records the elapsed time for the current monitoring To change this time format Select the setup key the main interface 1 2 Select Date And Time gt Time Scale 3 Select Real Time default or Relative Time 4 Select The real time contains only the hour and minute but not seconds Do not mistake the time sca
69. rmal heat odor discoloration deformation or abnormal condition is detected during use charge or storage Keep it away from the monitor 14 Do not use a battery that is visually damaged 15 2 Proper disposal is required Follow your Local Regulations for disposal UCAUTION 1 U S Federal law restricts this device to sale by or on the order of a physician 2 Only qualified personnel shall service the unit 3 The device is designed for continuous operation 282 WAILACH FETAG 2EMR Chapter 1 Safety Guide 12 13 14 17 18 Keep the working environment clean Avoid vibration Keep it far from corrosive medicine dust areas high temperature and humid environments When installing the unit into a cabinet allow for adequate ventilation accessibility for servicing and room for adequate visualization and operation Do not operate the unit if it is damp or wet because of condensation or spills Avoid using the equipment immediately after moving it from cold environment to a warm humid location Do not sterilize the monitor or any accessory with autoclave or gas Turn off the monitor and unplug it 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 70 ethanol or isopropranol When washi
70. s movements in 5 seconds are considered to be one movement and the patient should be instructed to press the key only once 7 4 5 Changing MFM Volume The monitor gives a sound when the remote marker key is pressed and the volume is adjustable To change the MFM volume 1 Select the setup key E on the main interface Select Fetus gt MFM Volume Select Low or High default Select OK 7 5 Starting Monitoring After the START key C is pressed the monitor automatically zeroes the pressure checks transducer connections clears the MFM count and the monitoring timer A start symbol is presented on the screen If the Auto start printing function is disabled press the PRINT button to start printing NOTE Pressing the START key indicates a new patient is being monitored Therefore please remember to press the START key when monitoring a new patient 7 6 Inputting Maternal Information Mat Info 7 6 1 Auto ID After you press START button the system creates auto ID for the present patient if Mat Info inputting function is switched off The auto ID consists of the date and time when the monitoring starts NOTE Do not press the START button continuously in a short period of time as the system will not accept the command to indicate a new patient each time 43 WAILACH FETAR2EMR Chapter 7 Fetal Monitoring 7 6 2 Changing Maternal Information You can change the c
71. sories A menu pops up on the screen or the menu is replaced by another one b A submenu with several options appears If this item has more than 6 options they will be displayed on more than one page Select Prev to switch to the previous page or select Next to switch to the next page c The function operates immediately NOTE 1 The word select hereinafter stands for rotating the control knob cursor to an item and then pressing the knob 2 If the key sound is enabled the monitor gives a normal key sound when the operation is valid and gives a sharp Di sound when the operation is invalid CAUTION This monitor is a medical device Please avoid violent operation such as continuously pressing the keys or control knob 2 2 2 Indicators There are four groups of indicator lights 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 2 1 lists their meanings Indicator Status of Indicator Meaning Alarm Indicator Flash or light in orange An alarm is active Off No alarm is active Charge Indicator On The battery is being charged es Off No battery is loaded or the battery is fully charged AC Indicator On The monitor is connected to AC power supply T Off The monitor is not connected to AC power supply Power Indicator On The monitor is powered on 0 Off The m
72. t larger than 8G You are advised to use the USB disk provided by the manufacturer In the FetusData folder of the USB disk a sub folder named after the export date and time created when the export is performed The exported records are saved in this sub folder as tre files named after the monitor started date time and ID e g 20100120 124936 12345 trc 8 2 3 2 Removing USB Disk After the export finishes select Remove Disk on the File Management interface Do not unplug the USB disk until a message The USB can now be safely removed is prompted If the message Failure is prompted you should perform the above procedures again NOTE 1 Make sure you perform the Remove Disk procedure otherwise data lose or USB disk damage may be caused 2 You should unplug the USB disk after performing the Remove Disk procedure otherwise the monitor cannot identify the USB disk 8 2 3 3 Deleting Files After the files are saved you can delete them l Select the file managing key on the main interface to open the File Management interface 2 Select Delete All gt Yes All the files in the monitor are deleted 3 Select Exit NOTE 1 When the monitor is in the process of printing the files cannot be deleted 2 File deleting should be performed with caution since the deleted files cannot be restored 3 The monitor automatically erases the earliest files when the memory is full the maximum capacity is 12 hour data You s
73. the power outlet are placed where it is easy to connect and disconnect the power cord 2 When the power is interrupted the device switches to inner power and operates normally if a battery is installed If a battery is not installed the monitor shuts down and resumes the previous settings at the subsequent operation 3 After the AC power supply is connected please wait for at least 2 seconds before pressing the POWER switch to turn on the monitor 25 WAILACH FETAG 2EMR Chapter 4 Alarms Chapter 4 Alarms 4 1 Alarms Classification The monitor has two types of alarm patient alarm and technical alarm Patient alarms indicate that the vital signs are 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 cannot measure and therefore cannot reliably detect critical patient conditions When a patient alarm is switched off its related technical alarms will be disabled as well According to the degree of severity the alarms are divided into two levels medium and low A medium level alarm is a serious warning labeled with the symbol is a low level alarm is a general warning The medium level alarms have higher priority than the low level alarms If both types of alarms are active at the same time the monitor sounds an audible indicator for the medium level alarms The system sets all patient alarm lev
74. ther than the reviewing and searching keys to return to the real time main interface When reviewing the traces the monitor does not stop The fetal heart sound and number values are all real time information of the current patient A warnincA The reviewing printout is provided for reference only Please take the real time printout as criterion when making diagnoses CAUTION 1 You must pause before starting to print Attempting to print while in the playback mode might result in missing data on the paper 2 After the reviewed data has been printed out the recorder does not switch back to real time printing automatically 8 3 Number Values The fetal monitoring number values in the numeric window include FHR1 FHR2 DECG TOCO IUP and MFM FHR1 measurement numeric display area If the US1 socket is not connected with a US transducer nothing displays here If the transducer is connected but no valid signal is received it displays WAIACH FETAG 2EMR Chapter 8 Understanding Measurement Results TOCO or IUP measurement numeric display area If the TOCO socket is not connected with a transducer catheter nothing displays here If the socket is connected with transducer catheter it displays the value FHR2 or DFHR measurement numeric display area If the transducer cable is connected but no monitoring is going on it displays MFM count display area
75. ttings 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 Start Monitoring in the illustration above Correspondingly its function Set new monitoring items is shown in the blue frame pane WAILACH FETAG 2EMR Chapter 3 Installation Guide Chapter 3 Installation Guide Note Installation must be carried out by qualified personnel authorized by Wallach Surgical Devices In order to ensure the operator and patient safety read through this chapter before using this monitor 3 1 Installing Battery A warnincA Switch off the monitor and unplug it before installing or removing the battery If the monitor is purchased with the optional rechargeable lithium ion battery follow these steps to install the battery 1 Battery Installation 1 Fold the LCD flat and then place the monitor upside down on a flat surface covered with cloth or other type of protective pad 2 Remove the screws of the battery compartment using a Philips head screwdriver Remove the battery compartment cover 3 Take the battery out from package and put it into the compartment Make sure the battery connector is on the left
76. ucer 1 or US transducer 2 is not well connected Check the connection of the transducer US1 SIGNAL LOSS or US2 SIGNAL LOSS FHR1 or FHR2 signal is too weak for the system to analyze Check if the US transducer is aimed at the fetal heart check if the alarm limits are suitable check the patient s condition TOCO UNPLUGGED TOCO transducer is not well connected Check the connection of the transducer Fetus EQUIP MALF The monitor board cannot communicate with the system successfully Restart the monitor and try again contact the manufacturer if the connection still fails Check Paper There is no paper in the paper drawer or the drawer is open Load paper and or close the drawer Signals Overlap FHR1 FHR2 US transducer 1 and US transducer 2 are positioned at the same fetal heart the signals overlap Adjust one of the US transducers until another fetal heart signal is detected Signals Overlap FHR1 DFHR US transducer 1 is aimed at the fetus that the spiral electrode is attached to the signals overlap Adjust the US transducer until another fetal heart signal is detected WAIACH FETAG 2EMR Chapter 9 After Monitoring Chapter 9 After Monitoring 9 1 Saving Data The monitor automatically saves the data every five minutes and prior to shutdown including fetal monitoring traces and maternal information The maximum capacity is 12 hour data Wh
77. uency The larger extent is due to the bigger scope of moving areas e g the fetal arms or legs lower frequency is due to the lower velocity of the fetal movements compared with those of the fetal heart Only the USI channel can monitor AFM 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 monitoring can be switched off and is gain adjustable 7 4 2 Enabling or Disabling AFM Trace The AFM trace on the screen can be enabled or disabled Select the setup key E on the main interface Select Fetus gt AFM Select ON or OFF default Select OK ee eS 7 4 3 Changing AFM Gain The AFM gain affects overall numeric values and scope of the AFM trace Select the setup key El on the main interface Select Fetus gt AFM Gain Select 1 2 3 default or 4 Select OK ed acm 42 WAILACH FETAG 2EMR Chapter 7 Fetal Monitoring 7 4 4 Manual Fetal Movement Monitoring MFM The MFM monitoring result comes from the patient s feeling of fetal movement The count will be displayed on the screen in MFM numeric window area 1 Insert the remote event marker connector into the MARK socket on the monitor 2 Let the patient hold the remote event marker in hand ask her to press the key when a fetal movement is felt Continuou
78. urer s Declaration A6 1 Electromagnetic Emissions for all EQUIPMENT and SYSTEMS A6 2 Electromagnetic Immunity for all EQUIPMENT and SYSTEMS A6 3 Electromagnetic Immunity for EQUIPMENT and SYSTEM that are not LIFE SUPPORTING A6 4 Recommended Separation Distanc Appendix 7 Limitations of Ultrasonic Monitoring A7 1 How Does Ultrasound Work 7 2 Artifacts in Fetal Heart Monitoring A7 3 Audio Output and Screen Reading av WAILACH FETAG 2EMR Chapter 1 Safety Guide Chapter 1 Safety Guide NOTE For Operator and Patient safety please read through this instruction manual before using the Wallach Fetal2EMR Fetal Monitor 1 1 Intended Use Wallach Fetal2EMR Model Fetal Monitor hereinafter called Fetal2EMR is intended for non invasive monitoring of a single or twin fetuses 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 Fetal2EMR provides fetal monitoring It can externally monitor the Fetal Heart Rates FHRs using ultrasound and uterine activity via transducer Contraindications Fetal2EMR Monitor is not intended for use in intensive care units operating rooms or for home use 1 2 Instruction for Safe Operation The FetaDEMR Monitor is designed to comply with the international safety requirements IEC EN 60601 1 for me
79. urrent patient s information after the monitoring starts 1 Select the patient ID area next to the Mat Info key on the main interface Select ID Select the required number for patient s ID on the soft keyboard Select OK Select Name Enter the required letters for patient s name the soft keyboard Select OK Select OK e om Enter patient informa 1004231026 Amada Figure 7 2 Mat Info inputting menu Figure 7 3 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 CAUTION 1 The monitor only saves the most recent inputted maternal information 2 If the maternal information is changed in the printing process the monitor prints the new ID and name immediately 7 6 3 Switching Mat Info Inputting On or Off If the Mat Info entering function is switched on the menu will pop up for you to input the ID and name for the patient after the START key is pressed The monitoring starts immediately after exiting from the menu To switch the Mat Info Inputting function on or off Select the setup key Bl on the main interface Select Start Monitoring gt Mat Info Select ON or OFF default Select OK Be m pom 44 WAILACH FETAEZEMR Chapter 8 Understanding Measurement Results Chapter 8 Understanding Measurement Results 8 1 Changing Screen Displa
80. y Mode The monitor has three display modes trace numeric mode trace mode and numeric mode If you want to observe the traces FHR TOCO and AFM and numerics simultaneously choose the trace numeric mode figure 8 1 If you want to observe traces only on the screen choose the trace mode figure 8 2 If you want to observe the numerics in large typeface choose the numeric mode figure 8 3 To change the display mode select the display mode switch on the main interface The display mode will switch among the three modes pb 16 37 30 T0 Figure 8 1 Trace Numeric Mode WAIACH 2 Chapter 8 Understanding Measurement Results ee or 44 16 47 08 10 Figure 8 2 Trace Mode 525 TOCO us2 47 138 7 146 16 46 17 To Figure 8 3 Numeric Mode 46 WAIACH FETAG2EMR Chapter 8 Understanding Measurement Results 8 2 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 The printout should prevail when making diagnoses 1 FHR1 Trace 2 FHR2 Trace 3 AFM Trace 4 Trace 1003301521 Q Figure 8 4 Traces Main traces 12 The y axis of the trace indicates the numerics of FHR The range is 30 bpm 240 bpm American standard or 50 bpm 210 bmp International standard FHR1 FHR2 trace anes The positions of the two broken lines in between the fetal heart

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