fetaTRACK 310 - Ultrasound Technologies Ltd.
Contents
1. 19 Focus Icon Indicates active audio channel Fetal Pulse Indicator Transducer Identification Fetal Heart Rate 22 Colour coded to match associated transducer Uterine Activity Reading The layout of the Ultrasound and ECG transducer display will adjust dependant on how many transducers are connected This is to provide the clearest display of all the readings of connected transducers The Uterine Activity readings remain in the same location on the display regardless of which other transducers are connected 5 3 Printer Status Display D cm min Printer Speed Indication Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 6 SOFT KEY FUNCTIONS fn Soft Key Menu Icons Exit soft key menu or return to previous menu Operator event indicator Prints an event mark on the paper Mark appears on top edge of FHR scale Alarm status menu Displays the current alarm status and give access to alarm options Switches the display between trace mode and numeric display mode The target mode will appear as the soft key icon Switches between split trace mode or combined normal mode printing Only available when graticule printing is enabled in system settings Low FHR Alarm This indicates that the Low FHR alarm is enabled Press the associated key on the control panel 4 to disable enable this alarm High FHR Alarm This indicates that the High FHR alarm is enabled2. The FETATRACK 310 must not be used in the presence of flammable anaesthetics or oxygen rich environments WARNING US Federal Law restricts this device for sale on or by order of a physician eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 4 SYMBOL DEFINITIONS The following symbols have been used on the front and rear panels of the FETATRACK 310 and are here defined according to EN60101 1 Alternating Current Associated with Power On Indicator e Type B Equipment R Unit Classification Type BF Equipment Unit Classification Type CF Equipment Unit Classification Ol Off power disconnection from the mains A On power connection to the mains Attention consult accompanying documents Associated with auxiliary connections see operating instructions K This symbol on the product or on its packaging indicates that this product must not be disposed of with your normal waste Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 5 CONTROLS AND INDICATORS 5 1 Identification 8 Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 5 CONTROLS AND INDICATORS rower onna Mmes id Cravate second function yen MI parer status ospy _ Y ser uine Pressure rozer LE Franscucerconecionsdapiay pi Device serialnumber Y 5 2 Transducer Display ON DH BPW DN
3. 9 PREVENTATIVE MAINTENANCE 9 1 Cleaning 10 TROUBLESHOOTING 10 1 Functional Checks 10 2 Operational Checks 11 EQUIPMENT SPECIFICATION 11 1 11 2 11 3 11 31 FETATRACK 310 Device Specification Environmental Requirements Electromagnetic Compatibility Tables Manufacturers declaration and guidance Emissions 11 3 2 Manufacturers declaration and guidance Immunity 11 3 3 Manufacturers declaration and guidance Separation Distances 12 WARRANTY 12 1 Terms and Conditions 12 2 The Ultrasound Technologies CUSTOMER CARE PROMISE 123 Meeting Expectations 13 WEEE and RoHS Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 24 24 25 25 26 26 26 27 27 28 29 29 30 31 32 32 34 34 35 1 ABOUT THIS MANUAL This user manual provides instructions for the operation of the FETATRACK 310 Cardiotocograph hereafter referred to as FETATRACK 310 It is recommended that personnel study this manual before attempting to operate the FETATRACK 310 device The safe and effective use of this equipment requires understanding of and compliance with all warnings cautionary notices and instructions marked on the product and included in this manual Typical users of FETATRACK 310 are trained medical professionals including but not limited to midwives clinicians and other health professionals If you have any queries regarding the operation of the FETATRACK 31
4. Instructions Copyright Ultrasound Technologies Ltd 2012 31 12 WARRANTY 12a Terms and Conditions 1 The Warranty Ultrasound Technologies Ltd warrants the product when new to be free of defects in material and workmanship and to perform in accordance with the manufacturer s specification for a minimum period of three years from the date of purchase from Ultrasound Technologies Ltd 2 Replacement of Product or Components Ultrasound Technologies Ltd will repair or replace any components found to be defective or at variance from manufacturer s specification at no cost during the warranty period 3 Return of a Faulty Product It shall be the purchaser s responsibility to return the product at their cost directly to Ultrasound Technologies Ltd or to an authorized Ultrasound Technologies Ltd distributor agent or service representative 4 Procedure for Return In order to return the product directly to Ultrasound Technologies Ltd the purchaser must first obtain a return authorization from Ultrasound Technologies Ltd s Service Centre 5 Condition of Products for Return All products must be returned in a clean decontaminated condition Ultrasound Technologies Ltd reserves the right to refuse to service equipment returned in a contaminated condition Ultrasound Technologies Ltd will not be responsible for units damaged during return due to poor packing 6 Exclusion from the Warranty This warranty does not include breakage
5. P is the maximum output power rating of the transmitter in watts W according to te transmitter manufacturer and d is the recommended separations distance in meters m Field strengths from fixed RF transmitters as determined by an electomagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked te with the following symbol A 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 or people a 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 Fetatrack310 device is used exceeds the applicable RF compliance level above the Fetatrack310 device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Fetatrack
6. Press the associated key on the control panel 5 to disable enable this alarm Bradycardia Alarm This indicates that the Bradycardia alarm is enabled Press the associated key on the control panel 6 to disable enable this alarm Tachycardia Alarm This indicates that the Tachycardia alarm is enabled Press the associated key on the control panel 7 to disable enable this alarm This line is drawn across an alarm symbol to indicate that the alarm is disabled Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 6 SOFT KEY FUNCTIONS fn 6 2 Operating the Soft Key Menu The soft key menu will appear when the fn key 2 is pressed during normal operating mode The menu will appear at the bottom of the display and will disappear again after 10 seconds if no further keys are pressed When the soft key menu is visible the control panel keys do not carry out the functions marked on them Instead the keys will activate the functions shown on the display directly above the keys The table above gives a brief description of the functions of the soft keys which may appear Not all the controls will appear on the FETATRACK 310 Basic and these soft keys will have no effect 6 3 Alarm Status Menu The Alarm Status menu displays the current state of the alarm system Only alarms that are enabled in the System Settings menu will appear in this menu Alarms can be enabled or disabled by pre
7. 0 or understanding the information provided in this manual please contact Ultrasound Technologies Ltd Lodge Way Portskewett Caldicot NP26 5PS South Wales United Kingdom Tel 44 0 1291 425425 Fax 44 0 1291 427093 EMAIL service doppler co uk Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 2 ABOUT THE FETATRACK 310 The FETATRACK 310 Cardiotocograph is a fetal monitor designed to provide cost effective care throughout pregnancy The FETATRACK 310 can be configured as an Antepartum or Intrapartum monitor for use in maternity wards antenatal clinics or doctor s surgeries The FETATRACK 310 can monitor fetal heart rates using low power ultrasound or fetal ECG external uterine pressure using an external tocodynamometer and intrauterine pressure Measurements are displayed on a large graphic LCD while the data is recorded on a high resolution thermal printer Fetal heart rates are monitored using Doppler ultrasound transducers Up to three ultrasound transducers can be connected to a single FETATRACK 310 Elite only to track the heart rates of twins or triplets The FETATRACK 310 has bradycardia and tachycardia alarm functionality memory backup and an output socket for remote display of screen information on a compatible system The FETATRACK 310 is supplied with the following accessories for each version Pf asic sr te Wie Angle Utrasound Transducer usi 1 Opti
8. 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 11 EQUIPMENT SPECIFICATION 11 33 Manufacturers declaration and guidance Separation Distances The Fetatrack310 is intended for use in an electromagnetic environment in which RF disturbances are controlled The user of the Fetatrack310 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Fetatrack310 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter m pee Hae 150KHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz ro d 1 2VP d 1 2VP d 2 3VP 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 applicatble to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHZ the 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 or people This equipment complies with the essential requirements of the European Council Directive 93 42 EEC 2007 47 EC relating to Medical Devices Fetatrack 310 Operating
9. ELECTRODE APPLICATION Note If both the heart rate and uterine activity are to be monitored using internal techniques it is generally recommended to insert the uterine catheter before the ECG electrode is attached if possible 8 6 1 Contra indications Do not use a fetal ECG electrode if you cannot identify the fetal presenting part to which the electrode is to be attached Do not attach the electrode to the fetal face fontanelles or genitalia Do not use the electrode if uterine infection or placenta previa is present 8 6 2 Leg Lead Preparation Prepare an area high on the patient s thigh or on the lower abdomen by cleaning with an alcohol swab Allow to dry Apply the leg electrode to the prepared area and fix in place with Safelink Attachment Pad Details on LifeTrace Safelink Instructions 8 6 3 Leg Lead Connection Plug the Fetal ECG module cable connector into an available socket on the front panel of the FETATRACK 310 making sure that it is pushed firmly in eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 23 8 OPERATING THE FETATRACK 310 8 6 4 Fetal ECG Electrode Application Explain the procedure to the patient Because there are several alternative designs of Fetal ECG Electrodes application techniques are considered to be beyond the scope of this manual Consult the instructions included with the manufacturer s package for proper technique 8 6 5 Elec
10. HE FETATRACK 310 8 5 2 2 Catheter Insertion Because there are several alternative designs of uterine catheterisation kits insertion techniques are considered to be beyond the scope of this manual Consult instructions included with the manufacturer s package for proper insertion technique WARNING MEMBRANES MUST BE RUPTURED PRIOR TO CATHETER INSERTION DO NOT USE THE INTRAUTERINE CATHETER IF THERE IS BLEEDING FROM THE UTERINE CAVITY OR IF UTERINE INFECTION OR PLACENTA PREVIA IS PRESENT 8 5 2 3 Preparation of IUP Transducer Plug the IUP module connector into an available socket on the front panel of the FETATRACK 310 Because there are several alternative designs of IUP transducer which may be used with the FETATRACK 310 it is necessary to consult the specific instructions supplied with the transducer If using an external transducer with fluid filled coupling the system must be flushed and primed to remove air bubbles prior to use The relative UA zero may be set by pressing the front panel UAO key 7 on the control panel Note The zero setting may drift slightly until the entire system is at room temperature 8 5 2 4 Proceed with Monitoring Turn the printer on and check whether the UA recording is adequate Between the contractions the UA channel will not return to zero This is the measure of the uterine resting tone If during monitoring the UA channel does not appear to be accurately plotting contractions or the trac
11. a domestic establishment under the jurisdiction of a Healthcare professional The FETATRACK 310 is designed to comply with EN60601 1 Medical Electrical Requirements for Safety and is a Class 1 device 11 3 1 Manufacturers declaration and guidance Emissions Care has been taken through the design and manufacturing process to minimize the electromagnetic EM emissions which may be produced by this equipment However in the unlikely event that the unit causes an EM disturbance to adjacent equipment we suggest that the procedure is performed out of range of the affected equipment Electromagnetic Emission The Fetatrack310 is intended for use in the electromagnetic environment specified below The user of the Fetatrack310 should assure that it is used in such an environment RF Emissions CISPR II Group 2 The Fetatrack310 must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF Emissions CISPR II The Fetatrack310 is suitable for use in all Harmonie missions Class establishments other than domestic and may be IEC 61000 3 4 used in domestic establishments and those directly connected to the public low voltage power supply Voltage Fluctuations Complies network that supplies buildings used for domestic flicker emissions purposes providing the following warning is IEC61000 3 3 heeded WARNING This equipment system is intended for use by healthcare professional
12. agent 10 1 Functional Checks Make sure the AC line cable is connected Make sure the power switch is on Check that the power on indicator is illuminated Make sure the recorder is correctly loaded and the door closed Turn the recorder on and confirm that the printer speed is displayed Check that the chart paper is moving 10 2 Operational Checks Make sure all connectors are firmly plugged in that the transducers are correctly positioned and the audio volume set to the desired level Observe that the appropriate fetal pulse lamp flashes with each heart beat Ifthe problems still persist replace the suspect transducer with a spare if available Note If the monitor does not perform as described above call your service agent Be ready to provide the model and serial numbers 18 and the nature of the problem There are no user serviceable parts inside the monitor A fully comprehensive Service Manual is available to qualified personnel 26 Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 11 EQUIPMENT SPECIFICATION 11 1 FETATRACK 310 Device Specification Continuous Doppler Multi element wide angle 1 5MHz 2 or 1 6MHz 2 or 1 7MHz 2 5mW cm max SATA Response 300 to 1KHz 30 to 250 bpm High resolution multi point digital autocorrelator Differential external pressure transducer 0 to 5 Hz 0 110 relative contractions strength 90 120BPM adjusta
13. al of Waste Equipment This symbol on the product or on its packaging indicates that this product must not be disposed of with your general waste EE For users of Ultrasound Technologies equipment Ultrasound Technologies will provide free recycling of equivalent medical electronic equipment once a customer has returned the equipment to Ultrasound Technologies with all transport and importation costs paid and where a replacement product is being supplied by Ultrasound Technologies Where a replacement product is not being supplied recycling services may be provided on request at additional cost RoHS The RoHS Restriction of Hazardous Substances directive 2002 95 EC compliments the WEEE Directive by banning the presence of specific hazardous substances in the products at the point of manufacture Ultrasound Technologies take our responsibilities to the environment very seriously and 100 of our entire manufacturing process and parts meet the RoHS directive and are fully compliant Dee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 35 Ultrasound Technologies Ltd Lodge Way Portskewett Caldicot NP26 5PS South Wales United Kingdom Tel 44 0 1291 425425 Fax 44 0 1291 427093 Email service doppler co uk Printed in United Kingdom Ultrasound Technologies Ltd reserves the right to modify this product specification without prior notice Note that some options and functionalitie
14. ble in steps of 5BPM Bradycardia algorithm or level sense 160 190BPM adjustable in steps of 5BPM Tachycardia algorithm or level sense Last paper sheet taken 128 mm thermal array printhead 8 dots mm 1 2 3 cm min Better than 1 145mm wide x 100mm page x 15M long z fold pack FHR 20 or 30 b cm UA 0 100 Pre printed or plain black thermal Full colour LED backlit graphic LCD 115 x 86mm FHR UA Print Speed FHR UA 30 240BPM 1BPM 0 110 units Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 27 11 EQUIPMENT SPECIFICATION 100 130 VAC or 200 260 VAC 46 64 Hz 30 VA High Breaking Capacity TO 25A 230V or TO 50A 115V Complies with EN60101 1 Class 1 Type B PC ABS AKg 290 x 260 x 220mm User operated pendant switch User operated soft key Ultrasound Transducer detected RS232 9600 baud 8 bits no parity 1 stop bit 142 Environmental Requirements Ambient 10 C to 40 C Temperature Relative Humidity 30 70 non condensing Ambient 40 C to 70 C Temperature Relative Humidity 10 to 100 including condensation ee eee 28 Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 11 EQUIPMENT SPECIFICATION 11 3 Electromagnetic Compatibility Tables As detailed in the Specifications this product is classified as a Class A Group 1 type of product according to EN55011 This product is allowed in
15. d on the midline below the umbilicus In the lateral position clearer sounds may be found with the transducer displaced from the center line to the upper surface of the abdomen The clearest signals in breach presentation may be located higher and to one side Transducer position which results in sounds with a strong placental or cord signal should be avoided as these frequently render traces with artifacts It is important that a distinct fetal heart sound is present during monitoring for correct function of the FETATRACK 310 Any doubt about fetal viability should be checked by listening to the audible signal or by an alternative diagnostic technique A simple check of the ultrasonic system can be made by holding the transducer against the palm of the hand and stroking the back of the hand at a fixed rate say twice per second A clear audible signal should be heard and the digital display should show a rate after approximately five seconds With the printer running this rate will be recorded on the chart 8 4 5 Alarms The FETATRACK 310 can detect both high and low fetal heart rates providing an alarm signal if required If an alarm condition arises the FETATRACK 310 emits an intermittent beep The chart recording indicates an alarm state with a down arrow marked with an A on the top edge of the chart Pressing either volume button resets the alarm The current settings for the alarms can be accessed through the soft key
16. domen locating it approximately in the position determined by the Doppler detector Secure the transducer in place using the elastic belt as described above Ensure that the belt tension is sufficient to hold the transducer in good contact with the abdomen The heart rate processor will start to calculate heart rate within a few seconds and the heart rate can be observed on the digital display Correct operation can be verified by observing that the heart shaped fetal pulse indicator is flashing at the audible heart rate Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 8 OPERATING THE FETATRACK 310 8 4 2 Signal Quality The fetal pulse heart is also used as a signal quality indicator When positioning the transducer observe the fetal pulse heart which should flash solid under best signal conditions If the flashing heart is hollow this is an indication that the signal quality is not at its optimum Improved recordings can be obtained by repositioning the transducer so that the heart flashes solid No Signal Poor Signal Good Signal When the fetal pulse heart changes to hollow a black dot or line is marked on the recording for the time that signal quality remains low No mark is made in the absence of signal or when signal quality is adequate for correct positioning Low signal quality is marked on the lower edge of the fetal heart rate scale 8 4 3 Audio Signal When monitoring more t
17. e remaining end over rear of the transducer the button on the transducer to secure the belt a Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 18 8 OPERATING THE FETATRACK 310 8 4 Fetal Heart Rate Monitoring 8 4 1 Ultrasound The FETATRACK 310 Ultrasound Transducers are used to detect the fetal heart beat The transducers are colour coded for ease of identification ete Us 2 Any combination of transducers can be used to track up to 3 fetal heart rates however only one of each colour transducer may be used at a time To monitor the first heart rate push the transducer plug any of the 3 transducers may be chosen firmly into the front panel socket of your choice and turn the FETATRACK 310 on A second heart rate channel may be used simultaneously to monitor twins externally by connecting a second ultrasound transducer to any other socket This transducer must be a different colour to the transducer used to track the first fetal heart rate Single FHR Twins FHR Triplets FHR US1 US1 amp US2 US3 US1 amp US2 amp US3 Locate a clear fetal heart sound using a Doppler Fetal Heart Detector FETATRACK 120 or similar Place an elastic belt around the patient see Transducer Belts above Apply a liberal amount of coupling gel to the transducer face and place the transducer on the ab
18. etter A is printed next to the arrow to indicate automatic detection Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 9 PREVENTATIVE MAINTENANCE To ensure continued accuracy and reliability from your monitor you should regularly perform the following routine maintenance tasks EA Cleaning Maintain a clean environment for the monitor Switch the monitor off and disconnect the AC line supply cable and transducers Wipe the case with a cloth dampened with an aqueous disinfectant Remove all coupling gel blood saline etc as soon as possible after use Wipe dry with a clean cloth NEVER Autoclave the transducers The transducers should be cleaned with a sterile non abrasive cloth dampened with an aqueous disinfectant If in extreme cases it is considered necessary to sterilize the transducer this should be done using gas sterilization methods at pressure and at elevated temperature in accordance with hospital practice Note that out gassing periods should be adhered to NEVER clean transducers with alcohol based cleaners or wipes The print head may be cleaned by GENTLY wiping with a soft cloth moistened with alcohol until ink deposits have been removed Dee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 25 10 TROUBLESHOOTING If you suspect a problem with your monitor complete the following checks before calling your service
19. fetaTRAcK 3 10 fetal monitoring system Operating Manual Issue 1 02 CONTENTS 1 ABOUT THIS MANUAL 2 ABOUT THE FETATRACK 310 3 SAFETY 4 SYMBOL DEFINITIONS 5 CONTROLS AND INDICATORS 5 1 Identification 5 2 Transducer Display 5 3 Printer Status Display 6 SOFT KEY FUNCTIONS fn 6 1 Soft Key Menu Icons 6 2 Operating the Soft Key Menu 6 3 Alarm Status Menu 7 SETTING UP THE FETATRACK 310 7 1 Electrical Connection 7 2 System Settings Menu 7 3 System Settings Descriptions 7 4 Navigation 7 5 Exiting System Settings mode 8 OPERATING THE FETATRACK 310 8 1 The Printer 8 2 Paper Out 8 3 Transducer Belts 8 4 Fetal Heart Rate Monitoring 8 4 1 Ultrasound 8 4 2 Signal Quality 8 4 3 Audio Signal 8 4 4 General Guidance 8 4 5 Alarms 8 5 Uterine Activity Monitoring 8 5 1 External Uterine Pressure 8 5 2 Intrauterine Pressure 8 5 2 1 Contra indications 8 5 2 2 Catheter Insertion 8 5 2 3 Preparation of IUP Transducer 8 5 2 4 Proceed with Monitoring 8 6 Direct Fetal ECG FECG 8 6 1 Contra indications 8 6 2 Leg Lead Preparation 8 6 3 Leg Lead Connection 8 6 4 Fetal ECG Electrode Application Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 ooo NWA uN A Xe 10 11 11 12 12 13 13 14 14 15 15 16 17 18 18 19 19 19 20 21 21 21 21 22 22 22 23 23 23 23 24 8 6 5 8 7 Electrode to Leg Lead Connections Fetal Activity Monitoring
20. han one fetus it is possible to listen to each of the ultrasound channels by pressing the Audio Selector Switch 5 The display will indicate the selected channel with the focus icon 19 The audio volume of the selected ultrasound channel can be adjusted by pressing the volume increase 4 and volume decrease 5 control buttons Once a clear fetal heart signal has been located turn the printer on and observe that the digital display of fetal heart rate FHR and chart record are in agreement taking into account that the recording is a few seconds behind the display 8 4 4 General Guidance Transducer position should be checked at least half hourly during labour monitoring or prolonged NST When repositioning the transducer further coupling gel may be required When repositioning the transducers always ensure that the fetal pulse icon flashes solid to ensure good quality recordings and heart rate tracking Results will vary from one patient to another but in all cases good transducer positioning is essential and this may be aided by the use of a liberal amount of coupling gel It is also important that the belts are correctly tensioned to maintain good contact with the abdomen eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 19 8 OPERATING THE FETATRACK 310 With the fetus in the vertex presentation and the mother sitting or supine the clearest sound will normally be foun
21. icator 1 is illuminated when the unit is switched on The FETATRACK 310 is now operational and the display will indicate the operating mode w FETATRACK 310 Elite displaying trace mode operating screen Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 7 SETTING UP THE FETATRACK 310 7 2 System Settings Menu Hold down the fn button 2 whilst turning on the FETATRACK 310 to enter the System Settings mode ad 1 2 20 Eas Sn IL 2 73 System Settings Descriptions TE Jo DE some ruemmes DEnfrocowamems ozo Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 7 SETTING UP THE FETATRACK 310 74 Navigation To navigate the SETUP screen use the control panel keys below the desired soft key icon The soft keys provide the following controls em Navigate Left Navigate Up Increase Value l Select Confirm 5 Navigate Down Decrease Value l Navigate Right To select a setup option for editing navigate to the desired setting using the four navigation keys Once the required option is highlighted press the Select Corfirm key 5 the setting can now be adjusted using the Increase Decrease Value keys 4 6 If more than one value can be adjusted in a setting such as Time amp Date use the Navigate Left Right keys 3 7 to switch between values eg Hour
22. ing of the contractions looks sluggish you should suspect the catheter tip has either collected debris from the amniotic fluid or contains air bubbles depending on the type in use Follow the manufacturer s instructions to clear any obstruction and continue recording To check that the system is operational it is often helpful to ask the patient to cough which should produce an artifact on the strip chart record Note Since the pressure should never read below zero this would be considered a fault condition and an error will be displayed The error is reported in the Transducer Connection eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 8 OPERATING THE FETATRACK 310 Display 9 highlighting the IUP Symbol in Red If such a condition develops check the catheter connections and repeat the UA zero procedures replace the IUP transducer if necessary 8 6 Direct Fetal ECG FECG The Fetal ECG internal method of obtaining FHR is generally considered to be the most accurate and reliable method available To apply the fetal ECG electrode the membranes must be ruptured and there must be at least 2 cm cervical dilation WARNING BECAUSE THE TIP OF THE FETAL ELECTRODE IS DESIGNED TO PENETRATE THE FETAL SKIN IT MAY PRESENT THE POSSIBILITY OF TRAUMA HAEMORRHAGE OR INFECTION THEREFORE THESE ELECTRODES SHOULD ONLY BE USED UNDER ASEPTIC CONDITIONS MEMBRANES MUST BE RUPTURED PRIOR TO
23. menu by selecting the Alarm status menu Active alarms may be de activated by selecting them with the control panel key below the icon The alarm settings can be adjusted in the SETUP screen see section SETTING UP THE FETATRACK 310 Alarm settings are printed between the chart scales on every page of the recording A low heart rate alarm may be set between 90 and 120 BPM in steps of 5 BPM The alarm can be set to trigger based on a low heart rate value by Bradycardia detection or can be switched off A high heart rate alarm may be set between 160 and 190 BPM in steps of 5 BPM The alarm can be set to trigger based on a high heart rate value by Tachycardia detection or can be switched off Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 8 OPERATING THE FETATRACK 310 8 5 Uterine Activity Monitoring 8 5 1 External Uterine Pressure et The FETATRACK 310 External Uterine Pressure tocodynamometer gt TRACKs _ transducer is used to monitor external uterine activity The transducer is colour coded yellow for ease of identification To monitor uterine activity LS plug the transducer into the input socket of your choice The FETATRACK 310 TOCO transducer is sealed to prevent the ingress of fluids nevertheless no coupling gel or other fluid should come into contact with the transducer face Place the transducer on the center line over the fundus in a position where the u
24. ndicate Paper Out and the unit will emit an audible beep Load a new paper pack as described above and close the recorder door During the time taken to change the paper pack the unit will store the trace data in its internal memory This stored data will be printed at high speed once a new paper pack is loaded In this way a complete recording may be obtained without any loss of information whilst the printer is reloaded To recommence recording press the printer on off switch 2 momentarily Once the memory printout is complete the printer will continue to record at the selected speed The printer may also be turned off while the paper pack is changed if the printer on off switch 2 is pressed and held before opening the printer door In this case there is no automatic printout of data at the recommencement of recording Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 8 OPERATING THE FETATRACK 310 8 3 Transducer Belts Both the ultrasound and contractions transducers are held in position with elastic belting which maintains the active elements in contact with the abdomen The belt should first be placed around the patient before securing in place at the correct tension over the plastic button on the rear of the transducer Place the belt around the patient Place the transducer on the abdomen Place one end of the belt over the button on the Tension the belt and place th
25. omptly to any call made with regard to service If required we will provide you with written estimates of the work to be carried out and the costs before commencing work A comprehensive service manual for this equipment including circuit diagrams parts lists and test procedures is available and may be purchased from your supplier or directly from Ultrasound Technologies Ltd For any service related query contact Ultrasound Technologies Ltd Lodge Way Portskewett Caldicot NP26 5PS South Wales United Kingdom Tel 44 0 1291 425425 Fax 44 0 1291 427093 EMAIL service doppler co uk Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 13 WEEE and RoHS Waste Electrical and Electronic Equipment WEEE Directive 2002 96 EC There is an increasing interest in the proper disposal of used electronic equipment The European Union EU has developed the WEEE Waste Electrical and Electronic Equipment Directive to ensure that systems for collection treatment and recycling of electronic waste will be in place throughout the European Union Ultrasound Technologies Position with Regard to the WEEE Directive Product recycling is nothing new and Ultrasound Technologies have implemented processes in each member state where the Company has a presence Ultrasound Technologies will comply with the provisions of the WEEE Directive and national implementing legislation Instructions for Dispos
26. onal Optional ET 1 No 1 No No 1 3 2 1 1 2 3 4 Mes Em No No Event Marker o ae ee ee Enter Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 3 SAFETY The FETATRACK 310 is designed to comply with EN60601 1 Class 1 with protective earth via the AC line cord The FETATRACK 310 must be used with an appropriately rated and approved cord set in accordance with the regulations of the country it is used in When positioning the unit ensure that access is available to the mains On Off switch and power cable located on the rear of the unit Should the electrical safety fuses have to be replaced use only fuses of the type and rating defined on the rear label of the unit and in the Device Specification If in doubt about the correct operation of the FETATRACK 310 fetal condition must be checked immediately by an alternative method Fluids should not be allowed to enter the device as this may result in damage to the system We would recommend that to maintain the standard of performance of the FETATRACK 310 whenever possible the monitor is included in a scheduled maintenance scheme Only qualified personnel should service the device and the unit cabinet should not be opened except by these personnel due to the risk of hazardous electrical shock All service requirements should be referred to an Ultrasound Technologies Ltd authorised representative WARNING
27. or failure due to tampering misuse neglect accident or shipping nor the effects of normal wear and tear 7 Negating the Warranty This warranty is also void if the product is not used or serviced in accordance with the manufacturer s instructions or has been repaired by any person other than a Ultrasound Technologies Ltd authorized agent Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 12 WARRANTY 8 Commencement of Warranty Period The purchase date determines the period of the warranty 9 Limitation of Warranty No other express or implied warranty is given Ultrasound Technologies Ltd will under no circumstances be liable for loss from any indirect or consequential damage Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 33 12 WARRANTY 122 The Ultrasound Technologies CUSTOMER CARE PROMISE When you bought this quality product you also bought a commitment from Ultrasound Technologies Ltd to support the product throughout its lifetime and the supply of spare parts where possible for up to 10 years 123 Meeting Expectations The Ultrasound Technologies Ltd Service Centre is only a phone call away whether the product is under warranty covered by a service agreement or the repair is to be paid for This applies whether the product was bought directly from Ultrasound Technologies Ltd or through an authorized distributor We will Respond pr
28. s and Minutes Once the setting has been adjusted press the Select Confirm key 5 again to store the udpated value and return to the setting navigation 75 Exiting System Settings mode To exit the system setting mode and save any changes made press the Save and Exit key 2 The system will restart and any changes made to the setup will become active To exit the system setting mode without saving switch the FETATRACK 310 off without pressing the Save and Exit key to store the changes The system will then start up with the previous settings when switched back on eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 8 OPERATING THE FETATRACK 310 8 1 The Printer The FETATRACK 310 prints on thermo sensitive z fold paper using a high resolution thermal matrix printer The data is presented to the thermal printer digitally and therefore no calibration is necessary Heart rate uterine activity and fetal movement are recorded together with event marks alarm indication date time recorder speed operating mode and alarm status To load the paper pack in the printer open the printer door by pulling the door open i giving easy access for paper loading ii Open two pages of paper from the beginning of the paper pack with the thermal sensitive side uppermost and then place the pack in the bottom of the printer tray iii Make sure that the paper is properly posi
29. s might not be available on product release Please confirm availability with our representative 2012 Ultrasound Technologies Ltd Document Date 01 11 2012 36 Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 37
30. s only This equipment system may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigating measures such as re orienting or relocating the Fetatrack310 or shielding the location Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 29 30 11 EQUIPMENT SPECIFICATION 11 3 2 Manufacturers declaration and guidance Immunity If the user has any doubt regarding the unit s EM immunity during routine operation we suggest that the source of EM disturbance is identified and its emissions reduced Electromagnetic Immunity The Fetatrack310 is intended for use in the electromagnetic environment specified below The user of the Fetatrack310 should assure that it is used in such and environment Immunity Test IEC60601 test Electromagnetic Environment guidance level level Electrostatic 6KV contact 6KV contact Floors should be wood concrete or ceramic Discharge ESD 8KV air 8KV air tile f the floor is covered in synthetic material IEC61000 4 2 the relative humidity should be at least 30 Portable and mobile RF communications equipment should be used no closer to any part of the Fetatrack310 including cables than te recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF IEC 3V m 80MHz 3V m d 1 2VP 80MHz to 800MHz 61000 4 3 to 2 5GHz d 2 3VP 800MHz to 2 5GHz Where
31. ssing the associated soft key when the menu is visible A line will be drawn through an alarm that is disabled and the line removed for an alarm that is enabled Further alarm settings are accessed through the System Settings see SETTING UP THE FETATRACK 310 Dee eee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 11 7 SETTING UP THE FETATRACK 310 7 1 Electrical Connection The FETATRACK 310 will operate with a mains input voltage between 100 and 260 volts AC 50 or 60 Hz Ensure that the correct voltage is selected before connecting the unit to the mains supply The FETATRACK 310 is fitted with a dual range mains power supply which can be changed externally to suit the local AC line voltage The currently selected voltage is displayed in the window of the fuse drawer 15 located on the rear of the unit To select a different voltage ensure the unit is switched off and the AC power cord is not connected Open the fuse door 15 using a small flat blade screwdriver and remove the fuse tray using the screwdriver Turn over the fuse tray 180 and re insert in the fuse drawer The new voltage should now be visible through the window of the fuse door once it has been closed Connect the AC supply cord and switch on the FETATRACK 310 The AC input on off switch 16 is located on the rear of the unit adjacent to the AC line input socket 17 Observe that the front panel power on ind
32. terus is firm and secure in place with stretch belting As with the ultrasound transducer the belt should first be secured in position and then the transducer slid onto it Once the transducer is in position push the UAO button 7 on the front panel to zero the recording The position of the zero baseline can be set to suit individual preference see the section SETTING UP THE FETATRACK 310 8 5 2 Intrauterine Pressure Actual intrauterine pressure IUP including contraction intensity and uterine tone pressure between contractions is measured using an intrauterine catheter and pressure module To use an intrauterine catheter and pressure transducer the membranes must be ruptured and the cervix dilated at least 2 cm Note If both the heart rate and uterine activity are to be monitored using internal tech niques it is generally recommended to insert the uterine catheter before the ECG electrode is attached if possible Note The intrauterine pressure module is not supplied as standard with the FETATRACK 310 For advice on connection of an IUP module contact Ultrasound Technologies Ltd or your supplier 8 5 2 1 Contra indications Do not insert catheter unless membranes are ruptured Do not use catheter if there is bleeding from the uterine cavity Do not use catheter if there is uterine infection or placenta previa Dee Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 21 8 OPERATING T
33. tioned pull the free end of the pack over the roller and close the door with the paper coming out over the top edge of the printer door iv The chart pack will self align once the recorder is running To operate the printer press the Printer On Off switch 2 on the front panel The printer will start to run and the chart speed will be shown in the display To turn the printer off press and hold the printer on off switch 2 until the printer stops A few centimetres of paper will be fed out at high speed The FETATRACK 310 printer will record at 1 2 or 3 cm min To change the speed during recording simply press the printer on off switch 2 momentarily Fetatrack 310 Operating Instructions Copyright Ultrasound Technologies Ltd 2012 15 8 OPERATING THE FETATRACK 310 The FETATRACK 310 is pre set to run at a default speed and will always start at this speed every time the printer is turned on For details of how to change the default speed see the section entitled SETTING UP THE FETATRACK 310 A data block can be printed on the paper at the start of recording this contains Patient Name Gestational Age Patient Number Hospital Doctor and Bed Number For details of how to change the printed language and data entry see the section entitled SETTING UP THE FETATRACK 310 8 2 Paper Out In the event that the paper pack is exhausted during recording the printer will automatically turn off The display will i
34. trode to Leg Lead Connections The FETATRACK 310 uses the Life Trace Safelink fetal scalp system the fetal scalp electrode plugs into the end of the leg plate Details on LifeTrace Safelink Instructions Turn the FETATRACK 310 on and check that for every heartbeat as indicated by the flashing fetal pulse heart an audible beep may be heard Adjust the audio volume as described in the Ultrasound Audio Signal section 8 4 3 Turn the printer on and observe that the digital display of FHR and the chart record are in agreement 8 7 Fetal Activity Monitoring Fetal activity may be recorded with the assistance of the patient A hand held Event Marker switch is provided for this purpose and this is plugged into any socket on the front of the FETATRACK 310 If the patient feels fetal movement she may press the switch and this will mark the paper with an arrow at the bottom edge of the FHR scale The midwife may also use the Event Marker to indicate any changes made during the procedure such as repositioning of the transducers or movement of the patient Events can also be marked using the control panel on the FETATRACK 310 as explained in the Soft Key Functions section of this manual The FETATRACK 310 also has ultrasound detected automatic movement identification When set to active the low frequency movements of the fetus are detected a movement event is printed on the paper using an arrow at the bottom edge of the FHR scale A l
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