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1. Faulty modem or faulty Watch the modem lights for activity connection to the modem during dialing If the modem lights show no activity then check the cable connections between the monitor and the modem Check the modem operation Modem not connected to Check the modem connection to the the phone jack to the phone jack File transfers were Disconnect from modem or Check the phone line connections cut off terminated phone line monitor or between the modem and phone jack on before completion remote computer the local and remote computers Poor phone connection Check the phone connection Poor or noisy phone lines will cause the transfer of data to be terminated Insufficient remote Check that the computer running the processor FETALGARD Receiver software meets the minimum system requirements Extension was taken off Check that another extension on the hook same phone line was not used 10 3 FETALGARD Lite View Section 11 FETALGARD Lite View 11 1 Overview FETALGARD Lite View is an application program that is used to view anno tate and store patient data files originating from the FETALGARD Lite moni tor The program runs on a personal computer with either Windows 95 98 or WindowsNT operating systems Patient data files are transferred to the computer using either a serial port hook up between the monitor and computer or via a modem connection The program uses a Windows like user interface with pull
2. 16 34 12 2 14 96 To highlight Recorder Speed Recorder Paper Style or Recorder Paper Vendor To select the highlighted parameter for editing A dialog box will appear with the available options for this parameter To highlight the desired value The list below shows the values that are available for each parameter Recorder speed 1 cm minute 2 cm minute 3 cm minute Recorder paper style U S International Recorder paper vendor Analogic Coro HP To keep the highlighted value and exit the dialog box Repeat the previous steps until Recorder Speed Recorder Paper Style and Recorder Paper Vendor are properly con figured To highlight Return in the Service Menu To exit the Service Menu and return to the main monitoring screen Installation Setup and Operation 3 10 10 Understanding and Setting Alarms The FETALGARD Lite monitor has the capability to alert the caregiver in the event a heart rate goes above or below an alarm limit for a preset time delay The limit values and the delay from onset to alert are configurable An alarm event results in an audible tone and blinking of the heart rate value on the dis play Pressing the speaker key on the monitor s keypad can silence the alarm tone The blinking heart rate will continue as long the alarm condition persists or until alarms are disabled The monitor also has the capability of alerting
3. 24 Hour Date Format MM DD YY DD MM Y Y To select the parameter value for editing To choose new values for the parameter To keep the displayed value for this parameter Repeat the previous steps for each parameter you wish to change To select Return To exit this menu The new time date and format selections are displayed on the main monitor ing screen 3 13 FETALGARD Lite Operator s Manual 3 14 3 10 6 Setting Patient ID This section describes the procedure used to change the patient ID When the monitor is turned on a default patient ID is created by the monitor based upon the present time and date When this default patient ID is changed the new patient ID will be incorporated into the stored patient record within the moni tor and presented on the display If the patient ID 1s changed a second time the monitor assumes a new patient and automatically creates a new patient record Knob Activity Desired Result Rotate To highlight the Patient ID Frame with a heavy border Press To view the Patient ID menu shown below The present patient ID is displayed in parentheses u s 1 Patient ID Menu Q Patient ID 0214961630 150 a 0214961630 Rotate To highlight Patient ID Press To select Patient ID for editing The Set Patient ID sub menu will appear shown below U S1 KW Patient ID Menu C Patient ID 0214961630 1 90 021496163
4. Paper Style Paper Vendor High Speed Print International Analogic Jane Doe 194848 in 16 34 12 2 14 96 Rotate To highlight Modem Initialization Press To select Modem Initialization for editing Rotate To highlight the desired character Press To select this character for editing Rotate To choose a new value for this character Press To keep the new value for this character Repeat the previous four steps until the initialization string has the desired changes Rotate To highlight OK Press To exit the modem initialization dialog box and return to the Communications Menu Repeat the previous steps to set the Modem Number to Dial Rotate To highlight Return Press To exit the Service Menu and return to the main monitoring screen 3 17 FETALGARD Lite Operator s Manual 3 10 9 Setting Recorder Parameters This section describes the procedure used to set the paper speed paper vendor and paper style Knob Activity Rotate Press Rotate Press Rotate Press Rotate Press Desired Result To highlight the Communications Frame with a heavy border To display the communications Menu shown below Communications Menu b Modem Initialization Modem Number To Data Transfer none Recorder Speed 1 cm min none Paper Style International Paper Vendor Analogic High Speed Print oa Jane Doe 194848 li i 3 min
5. Accessories Accessory Description FG Lite Recorder w cable 115V FG Lite Recorder Cable Single U S Trans w belt Single U S Trans w Y amp belt Second U S Trans w belt Tocotonometer w belt Battery Eliminator 115V FG Lite Service Manual Remote Marker FG Lite View Program GCX Adapter FG Lite Carrying Case MedaSonics 9 Part Number FG REC 115 REC UT UTY UTYT TOCO BE 115 FGSM RMO1 FGSP FGGCX FGCC 2 3 Installation Setup and Operation Section 3 Installation Setup and Operation 3 1 Description of the Front Panel LCD Display Screen Speaker Powar On Off 7 Sentral Knob Volume Select Graticule Toco Zero Trend Clinician Event Marker Contrast This figure shows the location of the various parts and controls on the front of the FETALGARD Lite monitor 3 1 FETALGARD Lite Operator s Manual 3 2 Description of the Rear Panel Power Supply RS 232 Connector Patient Marker T ocotonometer Ultrasound This figure shows the location of the various connectors on the rear of the FETALGARD Lite monitor with accessories attached 3 2 Installation Setup and Operation 3 3 Patient Cables The ultrasound transducer and TOCO transducer are attached to the rear of the monitor Each cable has a tab located on the connector housing to insure prop er insertion into the appropriate connector on the monitor The location of the connectors is shown on the label located on the rear of th
6. O A ee ee 3 7 SS EaU e Date retardar 3 8 Sei Or R seria ta De a asa didas 3 8 3 8 FETALGARD Lite Monitor Controls and Indicators 3 8 3 9 FETALGARD Lite Monitor Control Knob 3 9 3 10 Startup 3 9 SOL Bow rson Selena aer ch eee wed eels 3 9 3 10 2 Configuration Settings cloaca ia 3 10 3 10 3 Setting U S Trace Separation 0 0 eee eee 3 11 3104 Setting TOCO Baseline novata 3 12 3 10 5 Setting Time Date and Display Format 3 13 310 0 E Patent MD cpio occ ti Sch aon EE ERE 3 14 3 10 7 Setting the Language Configuration 3 16 Fetalgard Lite Operator s Manual 10 11 3 10 8 Setting Modem Parameters cusco 3 17 3 10 9 Setting Recorder Parameters 0 0 00 eee eee 3 18 3 10 10 Understanding and Setting Alarms 3 19 3 10 11 Adjusting the Display Contrast oo ooooooooo o 3 20 3 10 12 Adjusting Speaker Volume oooooooooom o 3 21 3 11 PETALGARD Lite Recorder ita oe 3 21 3 11 1 Installation and Loading Paper o ooooooooo 3 21 3 119 2 Controls and Indicators suana anasan n ee 3 23 MONITORING FETAL HEART RATE 4 1 MONITORING UTERINE ACTIVITY UA 5 1 REMOTE PATIENT MARKER AND CLINICIAN MARKER 2 20000 cece nnn 6 1 O Elbiician Marker anciano ida Lohse cad 6 1 62 Remote Patient Market srta taa ica 6 1 USING GRATICULES ooooooooooo
7. Starting FETALGARD Lite Receiver The FETALGARD Lite Receiver can be started from the desktop icon or the Start menu 12 4 User Interface 12 2 The user interface allows the user to select which TAPI communication ports will be answered by this program The user interface screen is shown below FE L ALGSHD Lite Fresco Mula Tech Syarma MT SBOE TY 3 op SIS 2 D ais arg CAP pogo E e r win gc FE ALAR Lie View Jiwan sv eetet To enable or disable a port the user must select the port by clicking its description in the list box Then if a port is disabled it can be enabled with the Start button If a port is enabled it can be disabled with the Stop button Enabled ports are indicated by a check mark next to the port description Only one of the Start and Stop buttons will be enabled at any time The quit button closes the Receiver program When the program is closed the FETALGARD Lite Receiver will answer no incoming data calls This leaves the port available for other modem transfers such as Internet access FETALGARD Lite Receiver and Recorder If the user clicks the Statistics button while a port is selected the statistics sum mary will be shown for that port The statistics screen is shown below COM Simistica EJ Le Tran k Hader 1 Enes All T rarata Filer D Hides O 12 5 Installation of the Recorder Adding the FETALGARD Lite Recorder to the printer m
8. from service if an error occurs Determine whether the monitor is powered from the internal battery or the bat tery eliminator If operating on the internal battery check the power status frame on the display to determine whether the battery has sufficient charge to complete the monitoring session Use the battery eliminator if the battery is too low Check the ultrasound transducer to verify proper attachment to the monitor For twins monitoring make sure the second ultrasound transducer is properly connected Adjust heart rate channel one speaker volume to mid level Adjust channel two speaker volume to off if monitoring twins Apply ultrasound gel to the face of the transducer Step 2 Acquiring the Fetal Heart Signal Determine the location of the fetal heart using palpation or a fetoscope Place the transducer on the maternal abdomen and listen for the fetal heart sig nal Reposition the transducer for the loudest fetal heart signal and verify the indicator LED on the transducer is blinking at the fetal heart rate Secure the ultrasound transducer with the elastic belt Make sure the transduc er is still positioned for the loudest fetal heart signal Verify the monitor is displaying fetal heart rate values and that the heart rate indicator on the ultrasound transducer is blinking at the measured heart rate Step 3 Acquiring Twins Heart Rates Follow the steps outlined in step 2 above to acquire the heart rate for the firs
9. it is damp or wet because of condensa tion or spills Avoid using the equipment immediately after moving it from a cold environment to a warm humid location CAUTION Never use sharp or pointed objects to operate the front panel switches CAUTION General purpose personal computers and modems are not designed to meet the electrical safety requirements of medical devices The RS 232 connector on the FETALGARD Lite is electrically isolated to permit safe connections to non medical devices which should be connected with a cable of sufficient length to prevent the non medical equipment from contact ing the patient CAUTION Do not autoclave or gas sterilize the monitor or any accessories Follow cleaning and disinfection instructions in Section 12 of this manual CAUTION Do not immerse transducers in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer Follow clean ing and disinfection instructions in Section 12 of this manual CAUTION When washing the transducer belts the water temperature must not exceed 60 C 140 F 1 3 FETALGARD Lite Operator s Manual Ultrasound Transducer Input Connector 1 4 Definitions and Symbols 7 Toco Transducer Input Connector Remote Marker Input Connector O O RS 232 Connector O Battery Eliminator Connector OOO IPX1 Drip proof Equipment Classification Class If Equipment Symbol double insulation Type BF Applied Part Symbol
10. now change the volume setting for ultrasound channel two A volume indicator icon for channel two located in the heart rate frame for channel two operates the same as described above for channel one Pressing the volume button a third time completes the adjustment process for channel two and saves the desired setting Knob inactivity for more than 10 seconds also completes the adjustment process 3 11 FETALGARD Lite Recorder 3 11 1 Installation and Loading Paper Unpack the recorder and accessories and place the recorder on a solid table surface Connect the communications cable to the connector on the rear of the recorder The other end of the cable connects to its mating connector on the rear of the monitor 3 21 FETALGARD Lite Operator s Manual Attach the AC line cord to the IEC receptacle on the rear of the recorder and to an appropriate AC outlet WARNING The power receptacle must be a three wire grounded outlet Never adapt the three prong plug from the Battery Eliminator or accessory to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate the recorder WARNING Do not connect to an electrical outlet controlled by a wall switch WARNING 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 The paper is loaded by first slid
11. of being printed during a paper advance event will be lost When the button is released printing will resume normally q lt A Printing Enable Disable button A single press and release of LLL his button will to ggle the recorder mode between printing and non printing The indicator LED next to the icon at the left will be on when printing is enabled and off when disabled At power on the unit will default to printing enabled If the recorder is connected to an active monitor the recorder will automatically begin printing as instructed by the monitor D Power on Indicator This indicator will be on whenever the unit is connected to an AC line source and the AC mains switch on the rear of the recorder is on Monitoring Fetal Heart Rate Section 4 Monitoring Fetal Heart Rate Electromagnetic Interference Certain strong electromagnetic fields can interfere with the ultrasound trans ducer and cause a false heart rate reading that does not originate from the patient This interference is rare and usually found in the vicinity of large machinery In order to avoid the possibility of these interfering signals being misinterpreted as fetal heart rates the following procedure should be followed whenever the monitor is to be used in a new location or if it is known that electrical machinery is being operated in the vicinity After connecting the ultrasound transducer s turn on the monitor and observe the heart rate indications
12. on the screen for 30 seconds Intermittent display of random heart rates is acceptable However if there is a constant display of a physiological heart rate lasting more than 5 seconds this is an indication that there is a source of electromagnetic interference in the vicinity The following steps should be taken to determine if it is possible to use the monitor in this environment e Move all line cords and line powered equipment at least 6 feet away from the FETALGARD Lite Check for extension cords running behind or under the bed and equipment in adjacent rooms If the artifact heart rate indication ceases the monitor may be used normally e Remove the line cord from the monitor s power supply If the artifact heart rate indication ceases the monitor may be used normally e Unplug the FETALGARD Lite recorder and move it out of the vicinity If the artifact heart rate indication ceases the monitor may be used normally If these measures do not result in cessation of the heart rate artifact the moni tor cannot be safely used in this environment 4 1 FETALGARD Lite Operator s Manual 4 2 Fetal heart rate is measured by placing an ultrasound transducer on the mater nal abdomen and processing the Doppler echo signal to produce a heart rate and an audio representation of the echo signal Step 1 Preparing the Monitor Turn the monitor on and verify that the normal monitoring screen appears on the display Remove the monitor
13. the second ultrasound channel These function iden tically as described above This channel is labeled U S 2 The trace offset icon will also appear in the heart rate frame if two ultrasound transducers are installed and ultrasound trace offset has been enabled The trace offset icon is a downward pointing arrow 3 7 2 Heart Rate Trend The Heart Rate Trend Frame displays a graphical representation of the fetal heart rate The vertical scale is labeled and corresponds to the selection of recorder paper 30 to 240 BPM for U S style paper 50 to 210 BPM for inter national style paper The graph displays 6 minutes of data if the monitor is set for a print speed of 3 cm per minute 9 minutes of data when set for 2 cm per minute and 18 minutes when set to 1 cm per minute This frame will show two heart rate trends when two ultrasound transducers are installed Two horizontal graticules are included to make it easier for the caregiver to observe heart rate trend or heart rates that exceed limits The position of these two graticules is 120 BPM and 160 BPM This graphical frame is also used to display heart rate data when scrolling through historical patient data 3 7 3 TOCO Numeric This frame contains the numeric value from the TOCO transducer represent ing uterine activity This frame also shows the present TOCO baseline value The TOCO baseline is user adjustable 3 7 4 TOCO Trend The TOCO Trend Frame displays uterine activi
14. time and date when the data values were recorded as they pass the vertical reference lines Rotating the control knob slides the heart rate and TOCO values synchronous ly left and right Clockwise rotation views older data and counterclockwise rotation views more recent data Rotating the knob slowly slides the values through the display at the rate that is convenient for viewing Rotating the knob quickly slides the data through the display at a faster rate This provides a quicker way to move ahead or back Printing Patient Files Section 9 Printing Patient Files This section describes the procedure used to print stored patient files Printing stored files occurs at a faster rate than printing during a monitoring session and is referred to as batch printing or high speed printing Knob Activity Desired Result Rotate To highlight the Communications Frame with a heavy border Press To view the Communications menu shown below Communications Menu Modem Initialization none Modem Number To none Data Transfer Recorder Speed 1 cm min Paper Style International Paper Vendor Analogic High Speed Print Jane Doe 194848 16 34 12 2 14 96 Rotate To highlight High Speed Print Press To select High Speed Print The High Speed Print dia log box will appear U S 1 Modem Initialization none Modem Number To none D a Rd High Speed
15. 0 Cancel Clear 0214961630 16 34 12 2 14 96 Rotate To highlight a character in the patient ID for edit or to high light Clear OK or Cancel Press Rotate Press Rotate Press Rotate Press Installation Setup and Operation To activate the highlighted selection If the knob is pressed when Clear is highlighted charac ters within the Patient ID field will be set to blanks If the knob 19 pressed when a character in the Patient ID is highlighted this character is selected for editing To select new values for this character in the patient ID The characters available are 0 9 A Z and space To keep the displayed value Repeat the previous steps for each character you wish to change To highlight Return OK or Cancel If the knob 19 pressed when OK is highlighted the patient ID will be updated with the displayed characters and the Set Patient ID dialog box will be removed If the patient ID contains all spaces when OK is pressed the monitor will sound the invalid beep tone and not close the dialog box If the knob 19 pressed when Cancel is highlighted the Set Patient ID dialog box will be removed with the original patient ID unchanged To highlight Return To exit the Patient ID menu and return to the main monitor ing screen 3 15 FETALGARD Lite Operator s Manual 3 10 7 Setting th
16. 50 60 Hz 0 2A Power consumption 20 watts maximum at nominal supply voltage Environmental Operating Temperature 10 C to 45 C 50 F to 110 F Storage Temperature 20 C to 60 C 29 F to 175 F Relative Humidity 20 to 90 non condensing Altitude 0 3048m 0 10 000 ft 14 2 Specifications Paper Pack Style Z Fold USA or International Pack Size 152 mm x 90 mm End of Pack Mark along paper edge Loading Front door drop in self aligning Paper Detectors Paper Out Loading Door Open Paper Speeds Normal 1 2 and 3 cm min 1 High Speed 30 cm min Paper Tracking Accuracy 1 exclusive of paper accuracy Troubleshooting and Maintenance Section 15 Troubleshooting and Maintenance 15 1 Self Test The monitor performs a self test each time the unit is turned on 1 Make sure the recorder and monitor are properly interconnected 2 Check the recorder for paper 3 Connect the monitor to the battery eliminator 4 Turn on the monitor and recorder Check that the monitor successfully powered on and is displaying the main monitoring screen If an error occurs the monitor will display the error screen The unit should be removed from service if this occurs Check that the recorder is feeding paper and the power on test pattern printed properly Remove from service if this does not occur 15 2 Ultrasound Transducer Test To test an ultrasound transducer 1 Properly connect the transducer to the rear of t
17. ARD Do not use the FETALGARD Lite in a flammable atmosphere where concentrations of flammable anesthetics or other materials may occur WARNING SHOCK HAZARD The power receptacle must be a three wire grounded outlet Never adapt the three prong plug from the Battery Eliminator or accessory to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempt ing to operate the monitor WARNING Do not connect to an electrical outlet controlled by a wall switch WARNING 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 WARNING Use only patient cables and transducers supplied with the moni tor Use of any other patient cables may result in out of specification perfor mance and possible safety hazards 1 3 Cautions CAUTION United States Law restricts this device to sale by or on the order of a physician CAUTION Keep the operating environment free of dust vibrations corro sive or flammable materials and extremes of temperature and humidity The unit should be kept clean and free of transducer gel and other substances 1 2 Safety CAUTION When installing the unit into a cabinet allow for adequate ventila tion accessibility for servicing and room for adequate visualization and oper ation CAUTION Do not operate the unit if
18. FETALGARD Lite Fetal Monitor MEDASONICs OPERATOR S MANUAL MEDASONICS ANALOGICE for Precision Signal Technology Proprietary Material Information and descriptions contained in this manual are the property of Analogic Corporation and may not be copied reproduced disseminated or distributed without express written permission from Analogic Corporation Information furnished by Analogic Corporation is believed to be accurate and reliable However no responsibility is assumed by Analogic for its use or any infringements of patents or other rights of third parties that may result from its use No license is granted by implication or otherwise under any patent or patent rights of Analogic 16 400823 Revision 3 January 2001 May 2001 June 2001 Copyright Analogic Corporation 2000 All rights reserved MedaSonics a division of CooperSurgical 15 Forest Parkway Shelton CT 06484 Tel 800 243 2974 Printed in U S A Fetalgard Lite Operator s Manual Preface The FETALGARD Lite Operator s Manual contains all of the information the operator needs to operate the FETALGARD Lite monitor system including Monitor Software Revision 1 xx View Software Revision 1 xx Recorder Firmware Revision 1 xx If the software version of your product is not in the range from 1 00 to 1 99 please contact your sales representative to obtain addendum pages or a replace ment manual that describes the operation of your v
19. Monitor Display Screen Main Monitoring Screen Twins Configuration Heart Rate Trend Frame N1 50 en IIA Oe Cr A 40 x TOCO Trend TOCO Numeric Frame Frame al TOCO y y 2 0 5 0 Communications Frame _ Patient ID Frame Jane Doe 194848 16 34 12 2 14 96 lt Power Status Frame Time Date Frame E ow cm min Main Monitoring Screen Single Configuration U S1 KO 240 i 160 a 1 50 120 eM Mi aie TOCO ba 90 l cm min 4 y 3 7 1 Heart Rate Numeric The heart rate numeric frame displays the fetal heart rate a heart icon alarm status icon and a speaker volume icon This channel is labeled U S 1 The heart rate value shows the most recent calculated fetal heart rate The heart rate icon blinks at the measured heart rate interval when a valid rate 1s present 3 5 FETALGARD Lite Operator s Manual 3 6 The volume icon provides an indication of the speaker volume setting for the fetal echo sounds This icon changes when the speaker volume setting is adjust ed The alarm icon is a bell A diagonal line through the bell indicates alarms are disabled A bell missing a diagonal line indicates alarms are enabled When the second ultrasound transducer is installed the heart rate frame will include additionally the fetal heart rate a heart rate icon alarm status icon and a speaker volume icon for
20. Print No printer attached Return Jane Doe 194848 16 34 12 2 14 96 9 1 FETALGARD Lite Operator s Manual 9 2 Rotate Press Rotate Press Rotate Press The most recent patient file is shown at the top of the dialog box as the first choice for printing To highlight Yes No All or Cancel To select Yes No All or Cancel File prints with complete status message Selecting Yes will cause the patient file shown to be printed and the next patient file to be displayed Selecting No will result in not printing of the displayed file and the next patient file to be displayed Selecting All causes all stored patient files to be printed Selecting Cancel closes the dialog box and returns to the Communications menu Repeat the selection process until all desired patient files have been chosen for printing To highlight Cancel To select Cancel and close the dialog box To highlight Return To exit the Communications menu and return to the main monitoring screen High speed printing of the patient files will occur at a rate of approximately 30 cm per minute until all selected files have been printed Transferring Patient Data Section 10 Transferring Patient Data In order to transfer patient data files from the monitor to a remote computer the monitor must be configured w
21. Refer to Accompanying Documents Protective Earth E ib gt e 8 Functional Earth 1 4 2 1 2 2 2 3 2 4 Introduction Section 2 Introduction General This chapter provides a general description of the FETALGARD Lite monitor including e Brief Device Description e Product Features e Model Configurations Brief Device Description The FETALGARD Lite is a family of microprocessor based fetal monitors providing continuous monitoring display and recording of fetal heart rate FHR and uterine activity UA for antepartum testing and monitoring Intended Use The FETALGARD Lite is a Perinatal Monitoring System for non invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non permanent graphical display and optionally on a strip chart recorder This data is intended to aid in assessing the well being of the fetus during the final trimester of pregnancy Non Stress Test This device is for use only by trained medical personnel located in hos pitals clinics doctors offices and in the patient s home Product Features The monitored data can be recorded continuously or intermittently on a strip chart recorder at the operator s discretion The recorded information includes graphic trend data and text information of monitor hardware and software con figuration date and time patient identification changes to operational set tings
22. aximum time between printhead cleaning is one year more frequent clean ing may be required depending on operating environments WARNING Unplug the recorder from the AC power source and detach all accessories before cleaning Do not immerse the unit in water or allow liquids to enter the case FETALGARD Lite Operator s Manual To clean wipe the printhead and roller with a Q tip soaked in isopropyl alco hol while lifting the head or run 6 x 6 cleaning paper pre soaked in iso propyl alcohol through the recorder Pre saturated thermal printer cleaning cards are available in boxes of 25 cards or in bulk They may be ordered directly from Clean Team Company 960 Enchanted Way Building 108 Simi Valley California 93065 Phone 805 581 1000 Fax 805 581 1058 13 3 Transducers Cleaning and Disinfecting the Tocotonometer and Ultrasound Transducer To avoid damage to the transducers clean and disinfect only according to the following instructions Care MUST be taken to preserve both the Tocotonometer label and the Tocotonometer cable label DO NOT remove conceal or deface Tocotonometer labels CAUTION Do not autoclave Do not gas sterilize 1 Wipe the device with a sterile wipe soaked in enzymatic detergent safe for use with metal instruments Wipe the exterior of the device three times Prepare the detergent according to the manufacturer s transducer recom mendations 2 Scrub the transducer with enzymatic deter
23. clinician and patient event marks and recorder model and paper config urations 2 1 FETALGARD Lite Operator s Manual 2 5 Models Options and Accessories There are four standard models in the FETALGARD Lite family e Model FGDO1 Single Fetus Monitoring e Model FGD02 Twins Fetus Monitoring e Model FGDHC Home Care Single Fetus Monitoring e Model FGDT Home Care Twins Fetus Monitoring Table 2 1 defines the factory configurations of each of these models Table 2 1 FETALGARD Lite Configurations Factory Configuration Model Model Monitoring Features and Included Items FGDO1 FGDO2 FGDHC FGDT Fetal Heart Rate FHR Single Fetus monitoring Fetal Heart Rate FHR Twin Fetus monitoring Tocotonometer TOCO with belt Recorder with line cord configured for country of intended use I O cable and 2 packs of paper Factory installed ultrasound cable and transducer U S1 for single monitoring with belt Factory installed ultrasound cable and transducer U S1 with belt and with connector for second transducer cable U S2 for twins monitoring Second ultrasound cable and attached transducer U S2 with belt for twins monitoring One tube of ultrasound gel One Operator s manual One table top Battery Eliminator One line cord for ordered U S or European use Z O Z O 2 2 Introduction Table 2 2 indicates the Accessories that are designed for use with any of the models Table 2 2 FETALGARD Lite
24. d The Data C Transfer dialog box will show the record number being transferred the total number of files to be transferred and percent complete The Communications frame will display a two phone icon with both dark shown below This means files are being transferred When all files have successfully transferred the Data Transfer dialog box will display a message confirming completion Transferring Patient Data Press To exit the Data Transfer dialog box and display the Communications menu Rotate To highlight Return Press To exit the Communications menu and return to the main monitoring screen 10 1 Troubleshooting Here are some comments that may help when the process doesn t go smoothly Behavior Possible Remedy The monitor dialed Remote Modem did not Check that the remote modem is a number but did answer connected and turned on make a connection to the remote computer Dialed number was busy Check the number by calling using the phone Wait for current call to complete Remote Modem connected Check that the FETALGARD View but Data Transfer timed Receiver is running and that the modem out before any data was is selected to receive data on the transferred remote computer No dial tone or dialing The modem may be set to Examine the modem documentation was heard when the disable the speaker and initialization strings to enable the monitor dialed the the modem speaker during dialing remote computer
25. d at the time an event occurs This marker time is record ed in the patient record in the monitor The nurse marker icon is a downward pointing arrow The monitor will dis play this downward pointing arrow in the information frame of the display A strip chart printout of the patient record will also show this mark accompanied by the time and date 6 2 Remote Patient Marker The patient marker arrow is provided so that the patient can record the time of important events The patient merely presses the marker button located on the end of the marker cable at the time an event occurs This marker time is recorded in the patient record in the monitor The patient marker icon is an upward pointing arrow The monitor will display this upward pointing arrow in the information frame of the display A strip chart printout of the patient record will also show this mark Using Graticules Section 7 Using Graticules Graticules are reference lines on a chart that are used to aid in interpreting the plotted data The FETALGARD Lite has two horizontal graticule lines in the ultrasound trend frame located at 120 BPM and 160 BPM These graticule lines provide a reference for estimating heart rate The TOCO trend frame also has a graticule reference line It is located at the TOCO baseline value This graticule line is relocated when the baseline value is changed to one of the other values When the operator presses the graticule button on the keypad
26. dence of damage that may affect patient safety or monitoring performance The recommended inspection interval is once per week or less Do not use the monitor if there is any visible sign of damage e Only the Battery Eliminator supplied with the device is approved for use in supplying external power for operation and recharging the internal batteries e Only the AC line cord supplied with the FETALGARD Lite Recorder or its equivalent is approved for use with the Recorder e Do not attempt to service the FETALGARD Lite monitor or recorder Only qualified service personnel should attempt any needed internal servicing e The FETALGARD Lite is not specified or intended for operation during the use of defibrillators or during defibrillator discharge e The FETALGARD Lite is not specified or intended for operation in the pres ence of electrosurgical equipment e The FETALGARD Lite is not specified or intended for operation in conjunc tion with any other type of monitoring equipment except the specific devices that have been identified for use in this Operator s Manual e Perform periodic safety testing to insure proper patient safety This should include leakage current measurement and insulation testing The recom mended testing interval is once per year e Do not operate the FETALGARD Lite monitor if it fails to pass the power on self test procedure 1 1 FETALGARD Lite Operator s Manual 1 2 Warnings WARNING EXPLOSION HAZ
27. dialog will list all patients in the currently selected database Entries will be sorted alphabetically by user ID The user would initiate the file delete by selecting a patient name and clicking the DELETE button If the user tries to delete patient records which have not been backed up then the application will inform the user of this and allow the operation to be cancelled File Backup Starts the dialog used for storing patient records to other media This menu entry provides a mechanism for copying all records corresponding to one or more patients to backup media such as a zip drive The File Backup dialog will list all patients in the currently selected database Entries will be sorted alphabetically by user ID FETALGARD Lite Operator s Manual The user must select a destination file If the destination file already exists then the user will be prompted to overwrite the file The user would initiate the file archive by selecting one or more patient IDs and clicking the BACKUP button File Page Setup The page setup dialog enables the user to specify the display format The user can select from Analogic HP or Corometrics style paper U S or International format and print speed 1 2 or 3 cm min To change the display format the user must select one of the six paper types or one of the print speeds from the pull down menu File Print This will bring up the standard Windows print dialog for
28. dio buttons that can be used to set the type of data being searched Annotation Patient Marker and Clinician Marker The dialog box has a PREVIOUS button a NEXT button and a CLOSE button Edit Find Next Finds the next object in the record The type of object 1s the same as the last Find Edit Find Previous Finds the previous object in the record The type of object 1s the same as the last Find Edit Go To Starts the Go To dialog box for re centering the data to specific times The dialog has an edit control for entering the time This edit control is initialized to the time of the current cursor position and will display time in either 12 24 hour format The user can enter the desired time and click the Go button The program will find the specified time and redraw the display centered on that data Edit Patient ID This dialog box provides a way to edit the patient ID to handle the case where it was incorrectly entered when the test was originally performed If the patient ID has been modified from what was originally in the record it will be displayed followed by an asterisk and an annotation will be displayed indicat ing a change was made Configure Language This item opens a language selection dialog box to allow the user to select the language of all menus and dialogs from a list of supported languages The dia log box displays a list of the available languages with the curr
29. down menus and mouse operation 11 2 Installation System Requirements e IBM compatible personal computer e Standard VGA graphics e CD ROM drive e 2 megabytes minimum available hard drive free space e Windows 95 98 or NT operating system Procedure e Insert View CD in the CD ROM drive e Follow the on screen instructions e The View program will be installed in the default directory or in one selected by the operator during the installation process e The Help Files are supplied in Adobe Acrobat pdf format To access these files the system needs Adobe Acrobat Reader which is available at www adobe com This 1s free of charge FETALGARD Lite Operator s Manual 11 3 11 4 e In order to install FETALGARD Lite View administrative rights to the sys tem are needed If an error message is displayed during the installation process contact the system administrator Starting FETALGARD Lite View Running the View program is accomplished by clicking on the Viewer con tained in the Program selection of the Start menu Display Screen The picture below shows the FETALGARD Lite View program with a patient record open The Main menu selections are shown at the top of the screen SITAR lee ee erie 19 15 G N MOL ey Chi De ie Lehi n Le ros Hap S P raii ee o Each patient file is identified at the top of the window by its file name and location The patient data is displayed in a format similar to the strip chart printo
30. e Language Configuration This section describes the procedure used to change Language displayed on the display Knob Activity Desired Result Rotate To highlight the Power Status Frame with a heavy border Press To view the Service menu shown below The present lan guage setting 1s displayed in parenthesis us 1 K E Set Language English 1 System On Time 21 hours Demo Mode Disable View Error Log View A D Values TOCO 3 Jane Doe 194848 Z cm min ggg 16 34 12 2 14 96 Rotate To highlight Language Press To select a new language setting Rotate To highlight the desired language Available options are English German French Russian Spanish Portuguese and Italian Press To select the highlighted language Rotate To highlight Return Press To exit the Service menu and return to the main monitoring screen Caution Selecting an unfamiliar language may make it difficult to resume normal operations Installation Setup and Operation 3 10 8 Setting Modem Parameters This section describes the procedure used to establish the correct modem set tings for proper operation These settings control the operation of the external modem Knob Activity Desired Result Rotate To highlight the Communications Frame with a heavy border Press To view the Communications menu shown below Modem Initialization Modem Number To Data Transfer Recorder Speed 1 cm min
31. e monitor The cables are inserted or removed by squeezing the narrow ends of the con nector housing This releases the connector locking mechanism A second ultrasound transducer and cable are supplied with the version of the FETALGARD Lite capable of monitoring two fetuses This second transducer comes with a shorter cable that inserts into a connector located on the primary ultrasound transducer cable To install the second transducer remove the pro tective cover from the connector on the primary cable and insert the second transducer cable WARNING Use only patient cables and transducers supplied with the moni tor Use of any other patient cables may result in out of specifications perfor mance and possible safety hazards 3 4 Remote Marker Cable The remote marker cable is inserted into a connector on the rear The rear label shows the location of the connector The cable connector is inserted into the connector firmly until it is fully engaged 3 5 Battery Eliminator The battery eliminator is used to charge the monitor s internal battery The battery can be charged either during normal fetal monitoring or when off The battery eliminator consists of a tabletop box with a permanently attached cable and a separate AC line cord The attached cable is inserted into its mating con nector located on the rear of the monitor The label on the rear of the monitor shows the location of this mating connector Insert the cable into th
32. eline 3 Jane Doe 194848 16 34 12 2 14 96 To highlight TOCO Baseline To select this parameter for change To highlight the desired baseline value 5 10 15 or 20 To keep this selection cm min To select Return To exit this submenu and return to the main monitoring screen The new baseline value is displayed in parentheses in the TOCO numeric frame Installation Setup and Operation 3 10 5 Setting Time Date and Display Format This section describes the procedure used to change the time and date settings of the monitor Knob Activity Rotate Press U S 1 E Rotate Press Rotate Press Rotate Press Rotate Press Desired Result To highlight the Time and Date Frame with a heavy border To view the Time Date menu shown below Next to each parameter 1s the present setting in parentheses Time Date Menu n Set Time Set Date Set Time Format 24 Hour Set Date Format MM DD YY Jane Doe 194848 cm min 16 34 12 2 14 96 To highlight the item you want to change Set Time Set Time Format Set Date or Set Date Format To select this item for editing To highlight the parameter value for editing The options for each parameter in the submenu are Time hours minutes seconds Date month day year Time Format 12 Hour
33. elp About This menu entry will display a dialog containing revision and copyright information FETALGARD Lite Receiver and Recorder Section 12 FETALGARD Lite Receiver and Recorder 12 1 Overview The FETALGARD Lite Receiver is a Windows application that is used to transfer data from the FETALGARD Lite monitor to a database on a PC The Receiver runs as an application on Windows 95 98 or Windows NT An icon representing the FETALGARD Lite Receiver will appear in the System Tray This program must be installed on the computer which has the patient data base files This can be the same computer that has the FETALGARD Lite View program or a separate computer The FETALGARD Lite Recorder program is a Windows application for adding the FETALGARD Lite Recorder to the printer menu This enables the FETALGARD Lite Viewer user to print to the FETALGARD Lite Recorder 12 2 Installation System Requirements e IBM compatible personal computer 200 MHz Pentium or equivalent e Standard VGA graphics e CD ROM drive e 2 megabytes minimum available hard drive free space e Windows 93 98 or NT operating systems Procedure e All applications will be installed when FETALGARD Lite Viewer is installed s The Receiver program will be installed in the default directory or in one selected by the operator during the installation process s The Recorder program will be installed in the system folder FETALGARD Lite Operator s Manual 12 3
34. ensure the display contrast is centered and the display is reasonably viewable The knob is rotated clockwise to lighten the contrast or counterclockwise to darken the contrast Installation Setup and Operation Pressing the contrast button a second time completes the adjustment process The new contrast setting is saved until the next time it is changed Knob inac tivity for more than 10 seconds will also complete the adjustment process as if the button were pressed a second time md 3 10 12 Adjusting Speaker Volume Speaker volume can be increased or decreased by pressing the speaker volume button followed by clockwise or counterclockwise rotation of the knob This volume adjustment affects only the amplitude of the ultrasound heart sounds A volume icon located in the ultrasound heart rate frame of the display changes with knob rotations to provide visual feedback of the volume setting Pressing the volume button a second time completes the adjustment process The new volume setting 1s saved until the next time it is changed Knob inac tivity for more than 10 seconds also completes the adjustment process The adjustment process varies slightly for a monitor with two ultrasound channels The first press of the volume button followed by knob rotation adjusts the volume for ultrasound channel one The second press of the vol ume button completes the adjustment for channel one and enables the adjust ment of channel two Knob rotation will
35. ently selected language checked Language selection is the fourth pull down menu and the first option FETALGARD Lite Operator s Manual Configure Add Patient Records to When new patient records are transferred from a monitor to the PC they will be added to the database file specified in this dialog box If the file does not exist FETALGARD Lite Viewer will create it Once specified the name of this database will appear in the lower right corner of the FETALGARD Lite Viewer screen Configure Time Format This menu entry allows the user to set the time and date formats for the appli cation Choices for time format are 12 hour or 24 hour Choices for date for mat are MM DD YY or DD MM YY Utility Database Compact Compacts the database This command 1s used to remove deleted files from the database and compact the database to the smallest size possible Utility Database Repair Repairs a corrupted database Window Tile Splits the data window so that two or more records can be viewed simultaneously Window Cascade Cascade the windows so that one patient record dominates the window and the top window mostly obstructs other open patient records Window Patient ID Allows the user to switch between opened patient files by selecting the Patient ID of interest Help FETALGARD Lite Viewer Help Starts the help subsystem Help Contact Info Phone number and email address for tech support H
36. enu is accomplished by running the FETALGARD Lite Recorder program Select the FETALGARD Lite Recorder icon in the Control Panel The Control Panel is found by using the start button and the settings menu The Recorder Properties box will appear and click on Add Hscardar Propraj FETALGARD Lite Operator s Manual The Install New Recorder box will appear Type the name of the Recorder Then select the port to which the Recorder is connected and click on OK Inctall Hew Maconies Then select close in the Recorder Properties box 12 4 Cleaning Section 13 Cleaning This chapter contains instructions for the care and cleaning of the FETAL GARD Lite unit and its accessories The FETALGARD Lite requires proper care and preventive maintenance This ensures consistent operation and maintains the high level of performance necessary in monitoring procedures 13 1 Monitor Keep the external surface clean and free of dust dirt and residual liquids Clean with a damp cloth using mild soap and water or hospital approved non abrasive disinfectants WARNING Unplug the monitor from the AC power source and detach all accessories before cleaning Do not immerse the unit in water or allow liquids to enter the case CAUTION Take extra care when cleaning the display surfaces which are sensitive to rough handling Rub the lens that covers them with a soft dry cloth 13 2 Recorder M
37. ersion of the product The FETALGARD Lite Operator s Manual is intended for trained medical personnel including midwives nurses and physicians who are familiar with obstetric procedures Keep this operator s manual with the unit for use by the operator Table of Contents SAFETY aida came emacs 1 1 1 1 Instructions for the Safe Operation and Use of the FETALGARD Lite Famil Ob MONOS srta aaa oh ofan 1 1 I is A n ee O E E T HE rand 1 2 ES e lt sre TTT 1 2 LA JDennitions OF Symbol ida rated 1 4 INTRODUCTION lt lt x s s s ee 2 1 2M sl AAA acta ees ne es dae ah eh Rene Canine A 2 1 22 Bier Device R e eT 515 diia 2 1 Dey AMlendEC USES duras a Fn csc ah a aiii 2 1 24 Product Beatures as arado bet eons 2 1 2 5 Models Options and Accessories 00 0 cee eee teens 2 2 INSTALLATION SETUP AND OPERATION 3 1 3 1 Description of the FrontPanel o oooooooooomooooo 3 1 3 2 Description of the Rear Panel nanana 3 2 So Patient Cables ira sida 3 3 34 Remote Marker Cable cuncrssionvsridrroerrcida deudas 3 3 30 Baller ERMINIO lr a roca cda 3 3 0 GCA Mounin Plate i erea a da oie ado 3 4 3 7 FETALGARD Lite Monitor Display Screen o oooooooo oo 3 5 3TA etal deat Numero 22d usina cita sida dio 3 5 II Teat Rie Tend AA A ohare 3 6 Ss TOCO NUNE tai oem O 3 6 IRE TOCO Tien 20 ra 3 6 SITI POWER StAWUS oda Se ne aaa oes adhd edd tans dla OS 3 7 Or COMMUNICANONS talado 3 7 O A
38. escribes the procedure used at the monitor to complete a transfer of all patient records in the monitor to a remote computer Make sure the remote PC is properly configured and running the FETALGARD Lite View application program before starting When connecting the monitor directly to a computer use a null modem PC cable no longer than 3 meters in length having a female DB9 connector at both ends The conductor shield must be tied to the metal shells of the DB connectors 10 1 FETALGARD Lite Operator s Manual 10 2 Knob Activity Rotate Press Rotate Press U S 1 Desired Result To highlight the Communications frame with a heavy border To view the Communications menu shown below To highlight Transfer Data a Modem Initialization none Modem Number To none Data Transfer Recorder Speed 1 cm min Paper Style International Paper Vendor Analogic High Speed Print Jane Doe 194848 min 16 34 12 2 14 96 To select Data Transfer The dialog box will show the dialing number and com mence dialing You will hear the dial tone and dialing process from the modem speaker The Communications frame will display a two phone icon with one dark and one light shown below This icon means the monitor 1s attempting to connect to the remote computer Transferring patient data files occurs automatically when the monitor and remote computer are connecte
39. g made to connect to another device This icon appears when the attached modem is transferring patient L data files This icon appears when the monitor 19 connected directly to an external computer and they are able to communicate with each other This icon appears when the monitor is connected to the FETAL GARD Lite Recorder This icon is accompanied by the present set ting for print speed 3 7 7 Patient ID This section displays the patient identification The monitor uses a time and date encoded identification scheme that insures no duplication of names The user may also enter a different name if desired 3 7 FETALGARD Lite Operator s Manual 3 7 8 Time and Date This frame shows the current time and date for the monitor These settings can be changed as needed The format for time and date is also user configurable 3 7 9 Error Display Error 0x1003456 Refer to Service Manual The error screen will be displayed when the monitor is unable to operate prop erly If this screen appears discontinue use of monitor Refer to the service manual for appropriate action 3 8 FETALGARD Lite Monitor Controls and Indicators There are seven buttons located on the front panel The buttons are activated by pushing with the finger until an audible click is heard CAUTION Never use sharp or pointed objects to operate the front panel switches The operation of the buttons is summarized below Icon Descr
40. gent using soft bristled brush for five 5 minutes DO NOT IMMERSE THE TRANSDUCER CAUTION Do not immerse in liquid When using solutions use sterile wipes to avoid pouring fluids directly on the transducer 3 Wipe the transducer three 3 times with sterile water to remove soap residue 4 Wipe the transducer with a sterile wipe soaked in Cidex Wipe all exteri or surfaces of the transducer three 3 times 13 2 Cleaning 5 Wipe the transducer three 3 times with sterile water to remove Cidex residue 6 Dry the device thoroughly with a sterile soft towel or gauze surgical sponge 7 Wrap the dry device in a fresh sterile soft towel or transparent sterile wrap for storage until next use 13 4 Belts Wash soiled belts with soap and water CAUTION The water temperature must not exceed 60 C 140 F Specifications Section 14 Specifications FETALGARD Lite Monitor Specifications Physical Characteristics Dimensions 18 cm H x 24 2 cm W x 13 cm D Weight approx 1 9 kg Safety Complies with EN60601 1 EN60601 1 1 En60601 2 Class II Equipment double insulated Continuous Operation Type BF applied parts Power Internal External Power Dissipation Battery powered AC powered Environmental Operating Temperature Storage Temperature Relative Humidity Altitude Lead acid rechargeable 2 hours operation fully charged at 10 C 14 hours to full recharge during monitori
41. he internal battery check the power status frame on the display to determine whether the battery has sufficient charge to complete the monitoring session Use the battery eliminator if the battery is too low Check the TOCO transducer to verify proper attachment to the monitor Check for the proper setting for TOCO baseline Adjust as needed Step 2 Acquiring Uterine Activity Data Place the face button side of the Tocotonometer on the fundus of the uterus when contractions are not occurring No gel is required Secure the Tocotonometer with the belt The uterine activity reading at this point should be greater than 30 and less than 90 units If the readings fall out side this range the belt may be too tight or too loose If the belt is over tight ened the contraction peaks may have a flat top at less than 100 on the TOCO scale If the belt is under tightened the position of the transducer may wander and cause unusable readings Readjust the belt pressure as needed Step 3 Monitor Adjustments Press the TOCO Zero button on the front panel to adjust the values to the baseline This must be done during non contraction intervals 5 1 Remote Patient Marker and Clinician Marker Section 6 Remote Patient Marker and Clinician Marker 6 1 Clinician Marker Y The nurse s marker arrow is provided so that the nurse can record the time of important events The clinician merely presses the marker button located on the front panel keypa
42. he monitor 2 Turn on the monitor and recorder 3 Adjust the speaker volume to an audible level 4 Hold the transducer on one hand and tap on the transducer face with the other hand The tapping should be heard from the monitor The transducer is operating properly if you can hear noise from the speaker Remove from service if no noise is heard or until the proper cause is identified and repaired FETALGARD Lite Operator s Manual 15 3 TOCO Test To test the TOCO transducer 1 Properly connect the transducer to the rear of the monitor 2 Turn on the monitor and recorder 3 Gently apply pressure to the button centered on the face of the transducer The display and printout should show a change in pressure if the transducer 1s operating properly Remove from service if this does not occur 15 4 Battery Disposal and Handling Caution when disposing of internal lead acid battery Adhere to all applicable laws regarding recycling Avoid storing battery above 140 F If clothing or skin comes in contact with material from inside the battery immediately wash with plenty of clean water 15 5 Maintenance The FETALGARD Lite monitor recorder and accessories require no periodic calibration or adjustment The recommended interval for performing hipot and leakage testing is once per year 15 2 MedaSonics a division of CooperSurgical 15 Forest Parkway Shelton CT 06484 Tel 800 243 2974 Fax 800 262 0105 www coopersu
43. ing the paper drawer forward as shown below A spacer is required in the paper tray when HP paper is used This spacer is sup plied with the monitor and is installed into the left side of the paper tray This spacer must be installed to properly align the paper to the print head Make sure this spacer 1s installed properly prior to proceeding with loading paper Unwrap a pack of paper and slide it into the paper tray as shown below 3 22 Installation Setup and Operation Several pages from the top of the pack of paper should drape forward over the top of the paper drawer The orientation of the paper is with the printed grid facing up unfolding from the top of the pack and the TOCO grid area closest to the recorder keypad Slide the paper drawer into the recorder The recorder is now ready for use Turn the recorder on using the AC mains switch on the rear of the recorder An indicator LED on the front of the recorder will confirm the unit is attached to an AC source and the unit is powered on 3 11 2 Controls and Indicators This section describes the fixed function buttons and indicator lights on the recorder Icon Description Paper Advance button This button is used to fast forward the recorder paper A press and hold of this button will advance the recorder paper at high speed until the button is released The recorder will resume its original activity when the button is released Any text and graphics in the process
44. iption ae Power On Off button turns monitor power on and off U S Volume Select button selects an ultrasound channel in order md to adjust its audio volume The control knob is then used to increase or decrease volume settings This button 1s also used to silence the audible warning indicator that accompanies a heart rate alarm con dition TOCO Zero button resets the TOCO baseline Clinician Event Marker button inserts a nurse event mark on the display and strip chart paper when pressed Contrast Adjust button changes the operation of the control knob for adjusting the display contrast 3 8 Installation Setup and Operation lt Trend Scroll button this button puts the monitor into trend scroll mode The trend frames shows historical patient data and the con trol knob provides navigation capability Graticule button displays a pair of horizontal level lines 15 BPM apart on the FHR trend frame Rotating the control knob moves these lines up or down on the display The keypad has two LED indicators The indicator next to the battery symbol is on whenever the monitor is powered from the internal battery The indicator next to the power cord connector symbol is on whenever the monitor is pow ered from AC mains via the external battery eliminator 3 9 FETALGARD Lite Monitor Control Knob The Control Knob is the primary method of adjusting parameters and navigat ing through the menu
45. is connec tor firmly until it is fully engaged Insert the AC line cord into the three pronged IEC receptacle on the battery eliminator The other end of the AC line cord is then inserted into an appropri ate wall outlet 3 3 FETALGARD Lite Operator s Manual WARNING SHOCK HAZARD The power receptacle must be a three wire grounded outlet Never adapt the three prong plug from the Battery Eliminator or accessory to fit a two slot outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempt ing to operate the monitor WARNING Do not connect to an electrical outlet controlled by a wall switch WARNING 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 3 6 GCX Mounting Plate The GCX mounting plate attaches to the bottom of the monitor by sliding the narrow piece of the mounting plate into the slot on the bottom of the monitor The spring loaded plunger will snap into place when the GCX mounting plate is fully engaged To remove the mounting plate simply pull on the spring loaded plunger until the plate is free to slide out The monitor and GCX plate is attached to a standard GCX roll stand GCX part number ANA 0001064 3 4 3 7 Heart rate Numeric Frame U S 1 OQ 240 Twins configuration Installation Setup and Operation FETALGARD Lite
46. ith the correct modem setup string and dial ing phone number see the chapter entitled Installation Setup and Operation for details Additionally the remote computer must have a modem installed and be running the FETALGARD Lite View applications program Installation and operation of FETALGARD Lite View is discussed in another chapter within this operator s manual The user must purchase an approved modem in order for file transfers to work properly Please contact the factory for the list of approved modem vendors and model numbers Follow the installation procedure supplied by the modem vendor prior to connecting to the FETALGARD Lite monitor The communications port on the rear of the monitor is connected to a tabletop modem using an RS 232 cable with a female DB9 connector and a male DB25 connector The cable supplied with the FETALGARD Lite Recorder will work CAUTION General purpose personal computers and modems are not designed to meet the electrical safety requirements of medical devices The RS 232 con nector on the FETALGARD Lite is electrically isolated to permit safe connec tions to non medical devices which should be connected with a cable of suffi cient length to prevent the non medical equipment from contacting the patient Make sure the cable is attached properly and the connectors are fully engaged The monitor will display the telephone icon shown below when properly attached to a modem The following section d
47. ng 8 hours to full recharge when monitor is off AC powered Battery Eliminator two models P N 21 615116 100 120V 50 60 Hz 0 15A P N 21 615115 220 240V 50 60 Hz 0 08A 6 watts maximum 10 watts maximum 10 C to 45 C 50 F to 110 F 20 C to 60 C 4 F to 140 F 20 to 90 non condensing 0 3048m O 10 000 ft 14 1 FETALGARD Lite Operator s Manual Doppler Ultrasound FHR Monitoring Parameter Value I SATA at the transducer face 0 766 mW cm 27 8 23 6 Entrance beam dimensions 19 95 cm circular Ultrasonic frequency 1024 MHz 0 5 Pulse duration 97 65625 microseconds Pulse repetition frequency 3 2 kHz Ultrasonic power 15 28 mW 27 8 23 6 BPM Range USA Paper 50 240 BPM International Paper 50 210 BPM Accuracy 1 1 BPM Leakage lt 10 uA O 264 VAC applied to transducer Isolation gt 4 kV RMS Type BF applied part Tocotonometer Uterine Activity TOCO Monitoring Parameter Value TOCO Range 0 100 relative units Resolution 1 Count Accuracy 1 1 relative unit Leakage lt 10 uA O 264 VAC applied to transducer Isolation gt 4 kV RMS Type BF applied part FETALGARD Lite Recorder Specifications Physical Characteristics Dimensions 11 5 cm H x 24 2 cm W x 20 4 cm D Weight approx 3 4 kg Safety Complies with EN60601 1 EN60601 1 1 En60601 2 Class I Equipment requires 3 prong outlet with protective earth Continuous Operation Power 100 120V 50 60 Hz 0 4A 220 240V
48. ooo o 7 1 USING TREND SCROLL lt lt lt lt lt eee 8 1 PRINTING PATIENT FILES 00 0c cece nnn lt lt 9 1 TRANSFERRING PATIENT DATA 10 1 LOAY Troubleshootnd 2 alitas 10 3 FETALGARD LITE VIEW lt lt lt lt x 11 1 UA MOVCIMICW eva RD he tthe bed ee oh awe ee 11 1 11 2 Tastallacon ewe es tote ee dia eras 11 1 11 3 Starting FETALGARD Lite View 0 0 cee eee eee 11 2 UE Display Seres ras 11 2 MUS Mem Syse as a ee Ree A Ai 11 3 FETALGARD LITE RECEIVER 12 1 Ez ION CE VIC A a ret ke Ce acetil Ao 12 1 122 Installation sacarina tds Snes ew baled aterm ek 12 1 12 3 Starting FETALGARD Lite Receiver nunne 12 2 124 User Interact os area 12 2 12 5 Installation of the Recorder 12 3 CLEANING siii aa 13 1 DAMONO dor bade nt iaa a dees 13 1 F RCT tas a iu eed 13 1 SITAS MES A A Didi 132 ISN usara a tia 13 3 SPECIFICATIONS 230 5 az o Se aS 14 1 TROUBLESHOOTING AND MAINTENANCE 15 1 SS SA O ee ee eer ee ee are men ae 15 1 15 2 Ultrasound Transducer Test 15 1 Bo TOTES add ea a dedos 15 2 15 4 Battery Handling and Disposal nanana 15 2 15 5 Maintenance s sist id dd a 15 2 Safety Section 1 Safety 1 1 Instructions for the Safe Operation and Use of the FETALGARD Lite Family of Monitors e Examine the monitor and any accessories periodically to ensure that the cables line cords transducers and instruments do not have visible evi
49. or tone will continue until the power is turned off If this occurs remove the monitor from service until appropriate action is taken 3 10 2 Configuration Settings The monitor has several configuration settings that the user can change Some of these settings are reset to the default value each time the monitor is powered down Other parameter settings are saved in the monitor until the next time they are changed These parameters are unaffected when the monitor is pow ered down A complete list of these parameters is shown below Configuration Parameter Saved Until Changed U S Trace Separation No TOCO Baseline Set Point Yes Time Format Yes Date Format Yes Patient Id No Language Yes Modem Initialization String Modem Phone Number P Yes Recorder Paper Speed Yes Recorder Paper Vendor Yes Recorder Paper Style Yes Alarms Yes U S Heart Rate Upper Alarm Limit 120 BPM Yes U S Heart Rate Lower Alarm Limit 60 BPM Yes Heart Rate Alarm Delay Yes Loss of Heart Rate Alarm Delay 120 seconds Yes Display Contrast Speaker Volume Ss Yes Installation Setup and Operation 3 10 3 Setting U S Trace Separation When ultrasound trace separation is enabled the trend data for ultrasound channel 2 is shifted down by 20 BPM This feature is provided to clearly see separate heart rate trends when both heart rates are similar The heart rate value shown in the numeric frame is not affected Follow the steps below to change the heart
50. rate separation setting Knob Activity Desired Result Rotate To highlight the heart rate frame Press To view the ultrasound menu shown below Ultrasound Menu E Trace Separation 0 bpm FHR Upper Limit 120 bpm FHR Lower Limit 60 bpm FHR Alarm Delay 15 seconds Loss of FHR Delay 120 seconds Alarm Status Disable 20 5 3 Jane Doe 194848 Z cm min 16 34 12 2 14 96 Rotate To select Trace Separation Press To select this parameter for change Rotate To select O BPM or 20 BPM Press To keep this selection Rotate To select Return Press To exit this submenu and return to the main monitoring screen When trace separation is activated it 1s indicated on the monitoring display by an arrow pointing downward next to the U S 2 numeric value This indicator will flash at a 1 Hz rate 3 11 FETALGARD Lite Operator s Manual TOCO U S 1 240 lt 1 50 D 160 K 20 5 0o lo So ee 1 E elie Jane Doe 194848 120 Mat 1 16 34 12 2 14 96 O 3 10 4 Setting TOCO Baseline This section describes the procedure for setting the TOCO baseline Knob Activity Desired Result Rotate Press U S 1 150 A TOCO 20 IS Rotate Press Rotate Press Rotate Press To highlight the TOCO numeric frame To view the TOCO menu shown below TOCO Menu E TOCO Bas
51. rgical com 16 400823 REV 3 MEDASONICS ANALOGIC E for Precision Sianal Technoloav
52. selecting the printer By default the printed output will be the entire trend data set The user can choose to print just the highlighted portion by clicking on Selection in the Print Menu If a FETALGARD Lite Recorder has been installed it will appear as an option Note Original chart paper numbers will not coincide with FETALGARD Lite Viewer numbers File Purge FGLite Recorder This will cancel the current printing job Note The Recorder will finish with a few pages of blank paper File Exit Ends the program Edit Annotate Starts the Enter Annotation dialog The Edit Menu provides tools for annotat ing the patient record and for searching within the patient record The user can add annotations search for markers and annotations jump to specific times during the test and change the patient ID to fix data entry errors When Annotate is selected an annotation marker a circled number will be superimposed on the patient data to show the location of the annotation It will show who made the annotation and when it was made To enter the annota tion the user must type their annotation text and click OK Annotations are stored immediately and cannot be deleted or modified FETALGARD Lite View Edit Find Starts the Find dialog box for finding markers and annotations The Find dia log allows the user to re center the display around markers and annotations in the patient data This dialog box has three ra
53. system Rotating the knob while in the main monitoring screen moves a Selection frame to each of the frames in the display When the knob is pressed a menu appears that contains monitor settings that are rele vant to the display frame that was selected If the knob is rotated while in a menu the cursor moves throughout the items within the menu This process is used to select a menu item for modification The knob is then pressed to select this item for editing Once a menu item has been selected for editing the knob is rotated to scan through the available choices for this parameter Pressing the knob stores the new value Pressing the knob when Return is selected will exit the present menu In some cases this action will return the monitor to the main monitoring screen In other cases the monitor will display the previous menu Specific Control Knob procedures are included in the chapters describing setup monitoring recording and viewing patient data 3 10 Startup El 3 10 1 Power on Self test The monitor performs a self test each time it is turned on This process allows the monitor to check various systems for proper operation The monitor dis plays the startup screen during the power on self test When the test is suc cessfully completed the FETALGARD Lite displays the monitoring screen 3 9 FETALGARD Lite Operator s Manual If a malfunction is detected an error screen appears and an error tone is sound ed The err
54. t fetus Adjust the ultrasound audio volume for channel one down and channel two up so that the second heart sounds can be heard Determine the location of the second fetal signal using palpation or fetoscope Monitoring Fetal Heart Rate Apply gel to the second ultrasound transducer and place it on the maternal abdomen where the second fetal signal was located Adjust the position of the transducer to find the fetal signal and to maximize its loudness Secure the ultrasound transducer with the elastic belt Make sure the transduc er is still positioned for the loudest fetal heart signal Also verify the position of transducer one has not changed Verify the monitor is displaying fetal heart rate values for both fetuses and that the heart rate indicators in both ultrasound transducers are blinking at the mea sured heart rate Step 4 Monitor Adjustments Readjust the volume settings for the desired loudness 4 3 Monitoring Uterine Activity UA Section 5 Monitoring Uterine Activity UA Uterine activity is measured externally by placing a pressure sensitive device Tocotonometer on the maternal abdomen and recording relative pressure changes Step I Preparing the Monitor Turn the monitor on and verify that the normal monitoring screen appears on the display Remove the monitor from service if an error occurs Determine whether the monitor is powered from the internal battery or the bat tery eliminator If operating on t
55. t Rate Alarm Delay or Loss of Heart Rate Delay To select the highlighted parameter for editing A dialog box will appear with the available options for this parameter To highlight the desired value The list below shows the values that are available for each parameter Heart Rate Upper Limit 120 220 BPM 5 BPM increments Heart Rate Lower Limit 60 120 BPM 5 BPM increments Heart Rate Alarm Delay 15 120 sec 15 sec increments Loss of Heart Rate Delay 30 120 sec 30 sec increments To keep the highlighted value and exit the dialog box Repeat the previous steps until Heart Rate Upper Limit Heart Rate Lower Limit Heart Rate Alarm Delay or Loss of Heart Rate Delay are properly configured To highlight Alarm Status To select Alarm Status for a new setting To highlight Enabled or Disabled Enabled activates the alarm system Disable deactivates the alarm system To keep the highlighted selection To highlight Return To exit the Ultrasound Menu and return to the main monitor ing screen 3 10 11 Adjusting the Display Contrast Display contrast is set to a default value at the factory This setting is adjustable to optimize the display for best viewing The contrast button and the control knob are used for this adjustment Pressing the contrast button initiates the process and resets the contrast to the factory default This is done to
56. the clinician if a loss of heart rate detection occurs This alert occurs if a valid heart rate is followed by no measurable heart rate for a preset time delay The heart rate frame will display blinking dashes and the audible warning tone will sound if this condition hap pens The audible warning tone can be silenced by pressing the speaker button on the monitor s keypad The display of blinking dashes will continue as long as the alarm condition persists or until alarms are disabled The loss of heart rate alarm delay time is adjustable by the user Alarms are enabled or disabled by accessing the selection in the Ultrasound menu If alarms are disabled then all alarms are off If alarms are enabled then all alarms are on The following section describes the procedure used to set alarm parameters for ultrasound heart rates Knob Activity Desired Result Rotate To highlight the Ultrasound Frame with a heavy border Press To view the Ultrasound menu shown below U S 1 KO Ultrasound Menu Trace Separation FHR Upper Limit Cr FHR Lower Limit FHR Alarm Delay Loss of FHR Delay 120 seconds Alarm Status Disable TOCO 20 6 Jane Doe 194848 A cm min 16 34 12 2 14 96 3 19 FETALGARD Lite Operator s Manual 3 20 Rotate Press Rotate Press Rotate Press Rotate Press Rotate Press To highlight Heart Rate Upper Limit Heart Rate Lower Limit Hear
57. the two refer ence graticule lines in the ultrasound trend frame are replaced with two new graticule lines These lines are 15 BPM apart and can be moved up and down by rotating the control knob This pair of moveable graticule lines will stay on the screen until there is 20 seconds of knob inactivity at which point they will change back to the fixed lines at 120 BPM and 160 BPM The purpose for these moveable graticule lines is to aid in establishing heart rate variability particularly when performing a non stress test NST For example the lower line can be placed on a reference heart rate baseline and the other line used to locate the reference point where the heart rate change equaled 15 BPM Timing marks are spaced 1 minute apart to provide a simple time scale 7 1 Using Trend Scroll Section 8 Using Trend Scroll lt lt gt The FETALGARD Lite can store up to 12 hours of patient data Only the most recent 6 12 or 18 minutes of this data is observable on the display at any point in time depending on the print speed setting Scrolling capability is a feature that enables viewing stored data from the present session or historical data from previous monitoring sessions Pressing the scroll mode button on the keypad enters scroll mode This button is labeled with an image of two opposing arrows Two opposing arrows will be displayed above the ultrasound trend frame indicating the monitor is in scroll mode A second press of this but
58. ton or knob inactivity for 30 seconds will exit scroll mode US 1 9 510 150 d 1 50 AY O TOCO 30 T Jane Doe 194848 16 30 12 2 14 96 The monitor will display a vertical reference line centered in the ultrasound trend frame and a vertical reference line centered in the TOCO trend frame TOCO and heart rate values pass the vertical reference line as the data is scrolled through the display The heart rate values at the reference line are dis played above the vertical reference line in the ultrasound trend frame and the TOCO values at the reference line are displayed below the vertical reference line in the TOCO trend frame FETALGARD Lite Operator s Manual 8 2 The heart rate numeric frames TOCO numeric frame power status frame and the communications frame are unaffected when in scroll mode and continue displaying the most current data and status information pertinent to the present monitoring session The patient ID frame displays the appropriate ID for the stored data The ID will be for the current patient when scrolling through the data from the current monitoring session When scrolling further back into previous records the dis played ID will reflect the record being viewed The Patient ID will change after the present record has scrolled fully off the display and the next record begins to scroll onto the display The time and date frame will display the
59. ty trend data The scale is from zero to 100 in relative units The graph displays 6 minutes of data if the monitor is set for a print speed of 3 cm per minute 9 minutes of data when set for 2 cm per minute and 18 minutes when set to 1 cm per minute This graphical frame also displays uterine activity data when scrolling through patient data Installation Setup and Operation 3 7 5 Power Status This frame contains either a battery icon or an AC power connector icon If the unit is operating on AC power then an AC power connector icon is dis played If the monitor is operating on internal battery power then a battery icon 19 displayed The battery icon also includes a scale indicating battery charge status The battery icon will flash when the battery is low less than 30 minutes of remaining time The battery eliminator should be connected to the monitor to charge the battery The monitor will operate normally while the battery elimi nator is charging the battery The battery will be fully recharged in 8 hours if the monitor is not in use or in 14 hours while in normal use 3 7 6 Communications This frame shows the status of devices connected to the monitor s serial inter face port Icon Description A This phone icon appears if the monitor is connected to an external modem and no call is in process This icon appears when the connected modem is making a call to another modem The call is in process and an attempt is bein
60. ut from the recorder All graphical data and text information 1s included Annotations made within the View program are displayed in the bottom sec tion of the window Elevator controls are used to scroll left and right or up and down to view the desired section of the patient record FETALGARD Lite View 11 5 Menu System The main menu system contains the following selections File Open Starts the dialog box used for opening patient records This dialog shows a multi column list box containing all of the records in the currently selected FETALGARD Lite Viewer database Patient ID start time duration and monitor serial number are shown for each file The records can be sorted ascending or descending by any of the headings by clicking on the heading The user can select one or more records in the list box by left clicking on it select a group of records with Shift Left click or select de select a record with Control Left click The button allows the user to select another database via a Windows File dialog box The user can select a file and then click Open File Close Closes the window containing the currently active patient data File Delete Starts the dialog used for deleting patient records This menu entry provides a mechanism for removing all records corresponding to a specific patient from the currently selected database Deletes are final There will be no way to undelete The File Delete

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