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OPERATION MANUAL

Keep this manual for future reference

P/N : 300-ENG-OPM-EUR-R09

BT - 300

BT-300

Fetal Monitor

Summary of Contents for BT-300

Page 1: ...OPERATION MANUAL Keep this manual for future reference P N 300 ENG OPM EUR R09 BT 300 BT 300 Fetal Monitor ...

Page 2: ...Ltd is believed to be accurate and reliable However no responsibility is assumed by Bistos Co Ltd 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 Bistos Co Ltd Revision 09 Mar 2018 Copyright Bistos Co Ltd 2017 All rights reserved 7th FL A Bldg Woolim Lion...

Page 3: ... of the Left Panel 12 3 3 Description of the Right Panel 12 3 4 Descriptoin of the Rear Panel 13 3 5 Power On 13 3 6 Patient Cables 13 3 7 Event Marker Cable 14 4 BT 300 OPERATION 15 4 1 System Startup 15 4 1 1 Configuration Settings 15 4 1 2 Understanding and Setting Alarms 17 4 1 3 Setting PintSpeed FetalMovementPrint AutoPrint Dop2Offset RecordEnlarge 17 4 1 4 Setting Time and Date 18 4 2 BT 30...

Page 4: ... CLEANING AND DISINFECTION 29 9 1 Monitor 29 9 2 Transducers 29 9 3 Belts 30 9 4 Contacting components and characteristics 30 9 5 Description of CidexTM 30 10 SPECIFICATIONS 31 11 TROUBLESHOOTING AND MAINTENANCE 34 11 1 Self Test 34 11 2 Ultrasound Transducer Test 34 11 3 UC TOCO Test 34 11 4 Battery Disposal and Handling 35 11 5 Maintenance 35 11 6 Disposal of the BT 300 35 11 7 Request a service...

Page 5: ...ing The BT 300 is not specified or intended for operation during the use of defibrillators or during defibrillator discharge The BT 300 is not specified or intended for operation in the presence of electrosurgical equipment The BT 300 is not specified or intended for operation in conjunction with any other type of monitoring equipment except the specific devices that have been identified for use i...

Page 6: ...ion performance possible safety hazards and electromagnetic safety problems WARNING Do not contact RS 232C port and patient at the same time WARNING AC DC Adaptor should use appointed product WARNING SHOCK HAZARD Do not attempt to disjoint the power adaptor exterior with no permission It may cause electric shock Also it has low possibility of reaching to death In the case of you have some problems...

Page 7: ...t If the BT 300 have to be connected another medical devices it must be complied with the standards IEC EN 60601 1 and IEC EN 60601 1 2 CAUTION Do not autoclave or gas sterilize the monitor or any accessories Follow cleaning and disinfection instructions in Section 9 of this manual CAUTION Do not immerse BT 300 main body and transducers in liquid When using solutions use sterile wipes to avoid pou...

Page 8: ...s from 10 C to 40 C Operating humidity ranges from 5 to 85 Avoid in the vicinity of Electric heater Avoid placing in an area where there is an excessive humidity rise or ventilation problem Avoid placing in an area where there is an excessive shock or vibration Avoid placing in an area where chemicals are stored or where there is in danger of gas leakage Avoid dust and especially metal material in...

Page 9: ...nd But there is unknown hazardous possibility by ultrasound External Signal IN OUT Port Type BF Equipment IPX8 IPX8 Waterproof 1 meter of water for 40 minutes Operating instructions When disposing of some components ex internal Li ion battery do not dispose as general wastes Adhere to all applicable laws regarding recycling According to IEC 60601 1 6 General requirements for basic safety and essen...

Page 10: ...aphically maternal abdominal contractions and the fetal heart rate by means of display on a non permanent graphical display and 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 hospitals clinics doctor s offices and in the patien...

Page 11: ...ction IPX8 Waterproof Event Marker Used for a Fetal Movement event AST Probe Option Acoustic Stimulation Test Probe Z folded type Paper Z folder type thermal Paper Probe Belt Used for Holding Doppler Probe and or UC Probe Power Cord AC Power cord Power Adaptor Adaptor for transform AC Power 100 240V to DC 18V 2 5A LI ION Battery Type model 18650 Technical data 3 7V 4ea 2600mA Ultrasound Gel Ultras...

Page 12: ... 300 Front Panel Power Indicating LED AC Green Battery Orange DOP 1 Connector DOP 2 Connector AST Connector UC Connector Event Marker Connector FHR UC Value Display Panel Heartbeat Lamp DOP 1 Volume Up Down Button DOP 2 Volume Up Down Button UC Reference Button Printer On Off Button Printer Alarm LED Alarm Sound On Off Button Print Door Open Button ...

Page 13: ... EUR R09 Bistos Co Ltd 2018 03 3 2 Description of the Left Panel Fig 3 2 BT 300 Left Panel DOP 1 Probe Holder DOP 2 Probe Holder AST Probe Holder 3 3 Description of the Right Panel Fig 3 3 BT 300 Right Panel UC Probe Holder Event Marker Holder ...

Page 14: ...ont panel Each transducer has a label DOP or UC to insure proper connection to the exact connector on the monitor Also each connector in the front panel has a label DOP I DOP II AST or UC to insure proper cable connection The cables are connected or removed by putting into the connector tightly or pulling out of the connector There is no connector locking mechanism Another ultrasound transducer is...

Page 15: ...m WARNING Do not connect to an electrical outlet controlled by a wall switch WARNING SHOCK HAZARD Power receptacle must be a three slot grounded outlet If the outlet has only two slots make sure that it is replaced with a three slot grounded outlet before attempting to operate the monitor WARNING Do not connect to an electrical outlet controlled by a wall switch WARNING SHOCK HAZARD Do not attempt...

Page 16: ...complete list of these parameters is shown below Configuration parameter Mode Key Factory Default Fetal Heart Rate Upper Alarm Limit Alarm 190 BPM Fetal Heart Rate Lower Alarm Limit 130 BPM Record Paper Speed UC Reference 30 mm min Fm Prn Fetal Movement Graph Print OFF Auto Print 0 Dop2 Offset 0 Prn EnL Zoom Function OFF Item Mode Key Setup Menu Details Alarm Date Alarm hi Heart Rate Upper Alarm L...

Page 17: ...es do not change If you press the DOP1 volume down button enter the next menu year month date hour minute second sequentially And you can change the value by pressing the DOP2 volume button If you press the UC Reference pushbutton for more than two seconds you can set the print values In print setting menu you can change the record speed to one of the three choices 10 20 30mm minute The Fm Prn fun...

Page 18: ...wer Limit 10 235 BPM 1 BPM increments Heart Rate Lower Limit 35 Heart Rate Upper Limit 5 BPM 1 BPM increments Button Press To save and exit setup menu 4 1 3 Setting Print Speed Fetal Movement Print Auto Print Dop2 Offset Record Enlarge This section describes the procedure used to set the paper speed and auto stop time When ultrasound trace separation is enabled the trend data for ultrasound channe...

Page 19: ...4 2 BT 300 Monitor Display Screen Fig 4 3 FHR UC value display panel Symbol Name Description Heart Rhythm Icon Blinking according to heart rate Alarm Sound Icon Indicating of Alarm sound enable disable Print Icon Indicating of a printing status 4 2 1 FHR I II Frame Fetal Heart Rate Numeric Frame FHR I II frames display the fetal heart rate and heart icon And in this frame the volume buttons are pr...

Page 20: ...is opened while BT 300 is printing Paper is not loaded while BT 300 is printing Battery s charging level is low while BT 300 is monitoring 4 3 BT 300 Monitor Controls and Indicators There are seven buttons located on the front panel The buttons are activated by pushed with the finger until an audible click is heard The operation of the buttons is summarized below Symbol Name Description Dop1 Volum...

Page 21: ... paper should drape forward over the shaft of the recorder The orientation of the paper is with the printed grid facing up unfolding from the top of the pack and the UC grid area right side The recorder is now ready for use Fig 5 1 Loading Paper 5 2 Operation Print On Off button A single press and release of button will toggle the recorder mode between printing and nonprinting CAUTION When loading...

Page 22: ...ased The recorder will resume its original activity when the button is released This function is ignored during recording When the record is finished the paper feeding function is performed automatically during short time The below is shown the printing parameters Symbol Description Source of mark Possible events Event Mark Press Event marker by pregnant woman When pregnant woman feels fetus movem...

Page 23: ...icinity The following steps should be taken to determine if it is possible to use the monitor in this environment Move all line cords and line powered equipment at least 6 feet away from the BT 300 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 Remove the line cord from the moni...

Page 24: ...etal heart signal Verify the monitor is displaying fetal heart rate values and that the heart shape icon on the display 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 first fetus Adjust the ultrasound audio volume for channel one down and channel two up so that the second heart sounds can be hear...

Page 25: ...sducer cable into the connector labeled DOP I or DOP II AST Apply a small amount of ultrasonic coupling gel to the face of the transducer Place the transducer face down on the maternal abdomen over the area determined to be the fetal back Secure the transducer comfortably in the place by inserting the transducer button through the buttonholes on each end of the belt Volume Up Down button may be us...

Page 26: ... N 300 ENG OPM EUR R09 Bistos Co Ltd 2018 03 If the printer is not already activated press the button located on the front panel of the monitor The recorder plots the FHR on the paper strip chart Figure 6 2 Positioning of UC Probe ...

Page 27: ...n side of the UC probe on the fundus of the uterus when contractions are not occurring No gel is required Secure the UC probe with the belt The uterine contraction reading at this point should be greater than 30 and less than 90 units If the readings fall outside this range the belt may be too tight or too loose If the belt is over tightened the contraction peaks may have a flat top at less than 1...

Page 28: ... at 10 Position tocotransducer on the maternal abdomen over the uterine fundus or where there is the least maternal tissue and the contractions are strongly palpated Connect each end of the belt to the transducer by inserting the transducer button through a buttonhole on the strap Select a buttonhole that ensure a comfortable fit and holds the transducer securely in the place Between contractions ...

Page 29: ...r 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 The event marker icon by patient s press is an upward pointing arrow A strip chart printout of the patient record will also show this mark ...

Page 30: ...meter labels 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 recommendations 2 Scrub the transducer with enzymatic detergent using soft bristled brush for five 5 minutes 3 Wipe the transducer three 3 times with sterile water to remove ...

Page 31: ...M 1 CidexTM is FDA cleared for use in the United States Therefore we suggest that the disinfection effect using CidexTM is valid 2 FDA Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices March 2009 www fda gov MedicalDevices DeviceRegulationandGuidance Reprocessi ngofSingle UseDevices UCM133514 Manufacturer Active Ingredient Steril...

Page 32: ...rnal Li ion rechargeable battery Power Dissipation AC powered 80 W maximum Battery powered 80 W maximum 1 hour battery operation when fully charged at 25 Environmental Operating Temperature 10 C to 40 C 50 F to 104 F Operating Humidity 5 to 85 non condensing Storage Temperature 20 C to 60 C 4 F to 140 F Storage Humidity 0 to 95 non condensing Altitude Pressure 0 2000m 0 6 561 68 ft 70kPa 106kPa Do...

Page 33: ...o transducer Isolation 4 kV RMS Type BF applied part Paper Pack Style Z Fold Pack Size 130 mm x 120 mm x 20 mm End of Pack Mark along paper edge Loading Front door slide in Paper Detectors Paper Out Loading Door Open Paper Speeds Normal 1 2 and 3 cm min 1 High Speed 50 cm min Paper Tracking Accuracy 1 exclusive of paper accuracy ...

Page 34: ...cm 1 1 Operating Control Conditions Control 1 Default Mode Default Mode Default Mode Control 2 Control 3 Control 4 Control n Measured values were multiplied by nine to account for nine elements in the transducer Ultrasonic Power 16 7 mW Ultrasonic element diameter 1 1cm Duty Factor DF Pulse Duration x Pulse Repetition Frequency 128 x 10 6 x 3 472 0 444416 Area corresponding to entrance beam dimens...

Page 35: ...rs Check that the recorder is feeding paper and the power on test pattern printed properly Remove from service if this does not occur 11 2 Ultrasound Transducer Test To test an ultrasound transducer 1 Properly connect the transducer to the front panel 2 Turn on the monitor 3 Adjust the speaker volume to an audible level 4 Hold the transducer on one hand and tap on the transducer face with the othe...

Page 36: ...ry s capacity This situation can cause not intended stop of measuring and monitoring function 11 5 Maintenance The BT 300 monitor and accessories require no periodic calibration or adjustment The recommended interval for performing hipot and leakage testing is once per year 11 6 Disposal of the BT 300 When disposing of the BT 300 adhere to all applicable laws regarding recycling If you are not abl...

Page 37: ...ntact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC...

Page 38: ...on distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation ...

Page 39: ...nce in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic pro...

Page 40: ...oduct is manufactured and passed through strict quality control and inspection Compensation standard concerning repair replacement refund of the product complies with Consumer s protection law noticed by Economic Planning Dept Service Telephone and Fax Numbers Telephone 82 31 750 0340 Fax 82 31 750 0344 Bistos Co Ltd 7th FL A Bldg Woolim Lions Valley 5 cha 302 Galmachi ro Jungwon gu Seongnam si Gy...

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