Huntleigh BD4000 Fetal Monitor
Contents
1. 3 Product Description Control Panel Mains Input Socket _ On Off Switch Loudspeaker 2 x RS232 Sockets Paper Tray Paper Tray Latches Ultrasound FECG Patient Event Socket Marker Contractions Transducer Socket Figure 1 BD4000 Front View FHR Contractions Printer Display Pulse Display N Indicator On Off Text Printer Message E BPM ES UA j Display 135 1 Gall On LED Contractions Zero ur D a enu Trace Annotation Q JE 304000 Clinical Event Soft Key Soft Key Soft Key Marker 1 2 Volume Scroll Keys Figure 2 BD4000 Control Panel 4 Setting Up the BD4000 Mains Connection Connect the unit to a suitable mains power Switching On Paper Loading source using the cable supplied The BD4000 will operate at any a c mains voltage in the range 100 to 250V at 50 or 50Hz No adjustment is necessary Switch the unit on Open the paper tray by simultaneously depressing the latches at each end as shown in Fig 3 Slide the paper tray forwards Note PA the LCD text display shows PAPER TRAY PEN Twins Figure 3 Paper Loading Instructions Special wide paper supplied with the Twins option pack provides optimal presentation of the two traces on separa2. Connect the scalp clip wires to the two terminals by depressing the spring loaded plunger inserting the bared end of the wire into the opened side entry slot and then releasing the plunger Repeat for the second wire connecting it to the other terminal Check that the wires are securely held Note that the wires can be connected either way round Allow the scalp clip fetal connection to stabilise this may take several minutes and check for signal A regular audio bleep at the fetal heart rate should be heard adjust volume as required and fetal heart rate should be displayed on the FHR display Also the fetal pulse indicator should flash with each detected pulse If signal quality is poor check the scalp clip connections and the system wiring Check that the transducer is firmly held in contact with the maternal thigh and if necessary re apply the Clip Leads off Detector If at any time contact is lost after a short delay the text display will show CHECK LEADS Check all leg plate connections maternal contact and scalp clip attachment If necessary re apply or replace clip Printing Ensure sufficient paper is available in the paper tray Initiate printing as for antepartum monitoring Trace Interpretation This is beyond the scope of this document It is assumed that the user is clinically qualified and experienced both in the use of similar fetal monitoring equipment the application of the clip and in int
3. OX ZN Patient Event Marker Printing ES DO Clinical Event Marker Trace Annotation Ey OL Attach the contractions transducer in the same way as the ultrasound transducer Do NOT use gel Position over the fundus for best performance Tighten the belt to ensure good contact Press the contractions zero button This removes the pre load due to the belt tension and sets the contractions trace to the baseline on the print out and UA display set to 20 on standard units Uterine activity UA is displayed adjacent to the FHR display Note that these are relative units displayed as percentage of full scale If the trace drops below O the display width shows L Check belt tension too loose and re zero Similarly H will be displayed if the trace rises above the top of the scale Check belt tension too tight and re zero This should be held by the patient Instruct the patient to press the button whenever any fetal movement is felt To initiate printing press and release the printer On Off button The Printer On indicator will illuminate while printing is in progress If printing does not start check that paper is installed and that the paper tray is properly latched shut To stop printing press and release the printer On Off button After a short fast feed of the paper the printer will stop See Fig 8 While printing the clinical event marker button can be pressed to ma
4. Trace g With Mode selected use Softkey 3 to select the make of equipment to be connected or to disable this function select Off o With Trace selected use Softkey 3 to turn trace mode On or Off When any change to the set up is made the change must be saved to initiate the new set up Press the Menu button The display will show Save changes Yes or No Using the soft keys select Yes or No as required The unit will return to normal operation and initiate any saved changes gt Note that during set up if no key presses are detected for a period of 30 seconds the unit will return to normal operation and will restore the last saved set up 12 5 Operation Before each monitoring session check that system set up is correct date time chart speed etc and that there is sufficient paper Check that the unit is not damaged in any way and ensure that cleaning procedures have been followed Antepartum Operation Connecting the Transducers Ultrasound Transducer Plug the ultrasound transducer marked US1 colour coded red into the Ultrasound FECG socket on the front panel of the main unit This socket is also colour coded red Align the red dot on the metal connector with the red dot at the top of the socket and press the connector in firmly Do not use excessive force Similarly plug the contractions transducer marked TOCO
5. the module can be wiped with a soft cloth dampened witha sodium hypochlorite 1000ppm solution and wiped dry Interface cables Isopropyl based alcohol swabs are recommended to assist in disinfecting the interface cables Caution Phenolic detergent based disinfectants containing cationic surfactants ammonia based compounds or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system as permanent damage will result WARNING The IUP module interface cables and external pressure sensors are not designed to be sterilised 40 Technical Data Performance Range Resolution Accuracy Sensor Interface Excitation Voltage Nominal sensor impedance Sensitivity Input sensitivity IEC 601 1 Classification Degree of shock protection Protection against water ingress Degree of safety in presence of flammable anaesthetics Mode of operation Environmental Operating temperature module Storage temperature Display 9 to 99mmHg or 1 to 13kPa System 50 to 300mmHg or 6 7 to 40 kPa Display 1mmHg or kPa Printer 1mmHg or 0 13 kPa 1 of FSD 5 V d c 1KQ 25 uV mmHg Type BF Ordinary equipment Not suitable for use in presence of flammable anaesthetics Continuous 10 C to 30 C 40 C 10 C 10 C to 40 C 41 Appendum 2 FECG Inteface Module LP2 Upgrade Options The following additional options may h
6. and use the Volume Scroll keys to scroll through the menu to select Tach alarm Soft key 1 Selects time rate mode When time rate selected Soft keys 2 amp 3 Increment decrement value When mode selected Soft key 3 Selects Off Silent Audio Detects when FHR has remained below a user selectable threshold for a user selectable time The alarm can be disabled or can operate in silent or audio modes o FHR threshold range 50 120 bpm default setting 100bpm o Time range 0 20 mins default setting 10 minutes o Modes Off alarm function is disabled default mode Silent alarm condition indicated on LCD display and print out Audio ISO and print out as per Silent mode accompanied by bleeping audio tone 10 Set up Enter set up mode and use the Volume Scroll keys to scroll through the menu to select Brad alarm Soft key 1 Selects time rate mode When time rate selected Soft keys 2 amp 3 Increment decrement value When mode selected Soft key 3 Selects Off Silent Audio Clearing an alarm To reset the alarm following an alarm condition ee NO press softkey 2 The alarm remains enabled and will detect any subsequent alarm conditions as per the selected time threshold settings A marker will be printed on the print out to log when the alarm is reset TES The volume of the alarm bleep when enabled is set independently to a factory
7. as configured Alarm events triggered by the connected device will be reflected on the CTG print out See example print out Figure 12 below note that printout details will vary depending on make model of connected device 25 60 mat HR De or re HAE EE ON ir us N VSM Alarm Cancelled 12 00 14 Jan 2003 1 cm min 12 10 100 E 100 OC O ee FUI ne A earl ae aS e Re OS ED ini 60 CS 60 ine bt NBP 10008 PORC te oaie E NEP 1070000 Maternal 40 mat HR_86 min a nece ateste MN NL eS OI i mat Sp J Vital Signs O aat rem 36270 ii MatemalBP data oa e ER A ea Da So o 2 x Q9 Huntleigh Healthcare BD4000 amp Hun Figure 12 Vital Signs Monitoring sample printout Fetal Sp02 monitoring The BD4000 can be connected to a Fetal SpO gt Set up monitor for including FSpO gt data on the CTG print out Currently the Nellcor N400 is the only supported device However it is anticipated that other similar devices may be added in future software upgrades As this is subject to change this section will explain the operation of this feature in outline only Technical data sheets are available from your supplier giving detailed information on specific makes models of Fetal SpO2 monitors Interface cables are specific to each make model of external device Ensure that you have the correct cable for your external device Simply plug the female en
8. colour coded blue into the TOCO socket on the front panel This is also colour coded blue Patient Event Plug the patient event marker into the left hand Marker socket 3 5mm jack socket Ensure plug is fully inserted The unit is now ready for use 13 Monitoring Ultrasound Transducer Gel Locate Fetus Check Signal Volume Position the patient as required typically in the semi supine position and pass the elastic belts around the patient s abdomen Typically the contractions transducer is positioned at the level of the fundus of the uterus while the ultrasound transducer is positioned lower on the abdomen at the level of the fetal heart To locate the best position for the ultrasound transducer note the gestational age with increasing gestational age the heart will be higher up the abdomen and palpate Best results will be achieved with the transducer placed over the fetus s upper back over the left scapula Apply sufficient gel to the abdomen or to the face of the transducer to ensure good contact over the full face of the transducer Apply the transducer by hand with firm pressure to maintain contact Adjust the position for the best signal For best result position the transducer to detect fetal heart sounds not umbilical sounds Note that umbilical sounds will be at the fetal heart rate but do not contain the characteristic slapping valve sounds heard from the heart i
9. default level ensuring that alarms will be heard even when the user adjustable volume level is turned down When the alarm is reset the volume level is restored to the user set level Under no circumstances must these alarm features be relied on for monitoring the patient Normal clinical practice with regular visual checking of the CTG trace must be maintained In twins mode alarms can be independently set on each unit disconnect twins cable from remote unit to change remote settings Alarm conditions on either unit will be displayed and printed out on the local unit alarm identified as FHR1 local or FHR2 remote Alarms in either unit are cleared by pressing soft key 2on the local unit 11 External Data Maternal Vital Signs monitoring Applicable from Serial Number 614AX0201600 02 software issue 71441 BD4000 can be configured to receive data from a range of external monitoring devices Received data is printed on the CTG print out Maternal heart rate can be presented either as numeric data printed at regular intervals or as a continuous trace superimposed on the FHR scale This option is not available on all makes models of vital signs monitors Fetal Oxygenation monitoring Saving Set up Changes FSpO gt can be presented either as numeric data printed at regular intervals or as a continuous trace superimposed on the contractions UA scale g Use Softkey 1 to toggle between Mode and
10. 9 60 Remo te ls PF toca is 15 23 2916197 Lenin 100 E Cross Channel lt Warning Marker FHR1 FHR2 FMD It FMO L wi HUNTLE1GH DIAGNOSTICS Printing Cross channel Warning Audio Figure 11 Twins Printout on Standard Paper The twins system is now ready for recording twins To commence monitoring switch the local unit printer on by pressing and releasing the printer On Off button Check that different rate patterns are shown on the two traces The system continuously checks for this also and will indicate FHR1 FHR2 if it detects the same data on both channels In this event simply reposition one of the ultrasound transducers to ensure that both twins are being separately monitored A marker or E on standard width paper will also be printed on the paper When using ultrasound separate audio sounds will be heard from each main unit Adjust volume on each unit as required Note that if one of the units is operating in FECG scalp clip mode electronic bleeps will replace the Doppler heart sound in that unit 24 External Data Input Output Electronic Viewing amp Archiving systems The BD4000 can be connected to the Dopplex Centrale electronic viewing and archiving system for real time remote viewing and archiving of CTG data Connection into this system is via an RS232 interface cable which would be included as part of the installation and commissio
11. IENUEM 4A9SN HSTIONZ ENGLISH CONTENTS Ta INN OOUCEIOI e cca ma ccs eek we ess a ADA da i Rei RIA ee eG 1 Upgrade ODUGNS cnet area ae ara bb baked rit A e oe ed 2 ACCESSOMOS i668 ieee deeb ee are A ae dees 2 2 Recommended Clinical Applications 3 3 Product Description sais cetera cee et eed wee ee ee 4 4 Setting Up the BD4000 5 Mains Connection Switching On 5 Paper Loading vasos prada eco eee 5 System Set Up Option 4 84 bas sue mea a n aaa 6 ea ema 8 Set up Procedure naaa hed ace AA 8 Clearing an alan amp ss 00 000 RA AAA 11 Saving Set up Changes 12 5 Operations i cian we eke sara AAA 13 Antepartum Operation 13 After USE co rec paia sa doe soni e BORE aan aa 17 Intrapartum Operation 18 After USE es ar seiu ct coda ca De casca vi d ot di wth ata ti il a a 21 TWINS ICE ee e e i de Re See i ca i Sw ws we Bu Sari ae 21 6 Care of your BD4000 28 Handing RER Sete a ce 28 Maintenance m se 22564629 Gack de E Ge ee See dress 28 Ultrasound and ECG Coupling Gel 28 CleaniNg taire care ae ia iata de rai a eee de 28 DISIMGCIION i ie ase e Sarea AAA 29 7 Troubleshooting se i sue ama eue mue aaa ui 30 8 Warranty and Service 31 IST e n ana arse Su aide ew bee eee cc Gb Se ew o e g
12. Pressure For use in intrapartum monitoring instead of the IUP external contractions transducer For set up and Monitoring operation refer to the instructions supplied with Option the IUP option pack Patient Event If required connect as for antepartum operation Marker refer to Antepartum Operation section Fetal Movement This is intended for antenal use and should be Detector disabled during labour monitoring refer to System Configuration section It is automatically disabled in FECG mode The unit is now ready for use Monitoring Leg Plate Secure the leg plate on the thigh using an attachment pad with the cable leading down towards the feet as shown below in Figure 2 Figure 2 Leg Plate Positioning 43 Scalp Electrode Leads off Detector Printing The BD4000 is designed for use with the Corometrics Qwik Connect Plus spiral electrode These and the legplate attachment pads are supplied separately individually sterile wrapped for single use only Before opening inspect sterile pack carefully If there is any breach of the sterile packing the electrode must be discarded Using sterile technique apply the scalp electrode in accordance with the manufacturer s instructions Plug the scalp electrode connector into the leg plate socket See Fig 2 Allow the scalp electrode fetal connection to stabilize this may take several minutes and check for signal A regular audio b
13. are 31 Service Returns e ee ka aa de ate sees adi a n n aid 31 9 Technical Data ss se ea AAA AR 32 Addendum 1 IntraUterine Pressure Option 34 Appendum 2 FECG Inteface Module LP2 42 i 1 Introduction The Baby DOPPLEX 4000 fetal monitor BD4000 provides a unique combination of options Incorporating all the standard functions of conventional cardiotocographs CTGs it provides the most cost effective and flexible approach to fetal monitoring The BD4000 model is available in standard form for antepartum monitoring Additionally plug in options are available to provide intrapartum and twins capability These options are available separately and can be added retrospectively simply by plugging them in when required Interface cables are available to connect the BD4000 to external equipment for data exchange Options include e Connection to electronic viewing and archiving systems e Connection to Vital Signs monitors for recording maternal data on the CTG print out e Connection to fetal Sp02 monitors for recording FSp02 on the CTG print out The standard unit is supplied complete with e BD4000 main unit e Ultrasound transducer e External Contractions toco transducer e Patient Event Marker e Printer Paper 2 packs e Gel 1x 250ml bottle e Latex Free Transducer Belts x2 e Mains cable e User Manual Fetal Monitor Detector The standard unit includes an automatic fetal move
14. ave been supplied with your unit or can be ordered separately to upgrade your unit Intrapartum upgrade Contains e FECG Interface Module LP2 e Leg plate interface cable Intrapartum Operation For external ultrasound monitoring refer to the Antepartum Operation section Connecting the Transducers Leg Plate Plug the FECG interface module marked LP2 Interface Cable connector colour coded red into the US FECG socket also colour coded red on the main unit in place of the ultrasound transducer This automatically reconfigures the system for intrapartum operation The display will show FECG in the top right corner Insert the Leg plate interface cable plug colour coded green into the green socket on the FECG interface module LP2 refer to Figure 1 Leg Plate Interface BD4000 Cable Insert into US FECG Socket Scalp Clip Figure 1 LP2 amp Scalp Clip Connection cE The signal quality indicator is disabled in FECG mode However a Leads Off indicator will detect loss of FECG signal 42 Contractions Transducer Connect as for antepartum operation refer to Antepartum Operation section WARNING The FECG interface module contains sensitive electronics and provides the additional electrical isolation type BF required for safe connection to the fetus Inspect carefully before use for any damage as this may affect electrical isolation Intra Uterine
15. ck Refer to Paper Loading instructions The two FHR traces will then be printed separately on two separate full size FHR scales A single contractions channel slightly reduced in size is printed below the two FHR channels The patient event marks will appear at the bottom of the lower FHR grid while the clinical event marker and trace annotation text will appear above the top FHR grid See Fig 10 The two scales are labelled Local and Remote 22 OXYGEN Clinical Event Marker m Trace Annotation 180 160 140 120 Bl Channel Mode 4 Label 200 BPM Date Time Chart Speed gt gt 11 31 251513 E E Loca T Us Patient Event Marker Finta 20 a MIR AR 5 HUNTLEIGH DIAGNOSTICS 200 14 55 2516197 1 cm m 100 e Y eo O io ME Detector Channels HUNTL e A A E Cross Channel SS a Warning Marker FHR1 FHR2 Local US Fetal Movement FMD Markers EIGH DIAGNOSTICS Figure 10 Twins Printout on Wide Paper Alternatively the standard paper can be used The unit will automatically detect which paper width is installed and adjust the print out accordingly With standard paper both traces will be Superimposed on the standard FHR scale The two traces will be labelled L and R at regular intervals to avoid confusion See Fig 11 23 FHR mode for each channel 8
16. d of the serial cable labelled BD4000 into the serial port 1 on the rear panel of the BD4000 and the other end into the external device Note that only one external device can be connected at a time The second serial port on the BD4000 cannot be used for this application This is reserved for out going communication with electronic viewing and archiving system 26 Ensure that the BD4000 is set up to work with the connected external device refer to Section 4 for system set up details Operate the external device in accordance with the manufacturer s operating instructions Start the printer on the BD4000 and the Fetal Sp0 gt data will be printed as configured Alarm events triggered by the connected device will be reflected on the CTG print out See example print out Figure 13 below note that printout details will vary depending on make model of connected device NA een Se re a a PAI Cems ore eth OA Shem Ter ae 200 Paps Sacer ere ee Re ae a ata bei sabi E Aa ae aru Alarm Sensor loss of contact Bet a aR on Oe Wam Canela ES fee iad Aes Espoz 88 Le A aaa a a ga M00 Alam Aud Muted 1 60 Fsp0 Trace Mae ic Example shows W400 Alarm Audio Enabled A test data only 20 20 amp Huntleigh Healthcare BD4000 S H Figure 13 Fetal Sp02 sample printout 27 6 Care of your BD4000 Handling Although the BD4000 is robust and designed to withstand no
17. e next option moving either up key or down key through the options When the desired option is displayed in the text display use the 3 keys below the display to adjust the option as required These operate as soft keys where their function is defined by labels in the text display as described below Fetal Movement Soft key 1 Toggle function off on Detector Soft key 3 Increment trigger threshold Soft key 2 Decrement trigger threshold LE Notes 1 Default setting is 40 Recommended setting for normal use 2 This function is intended for antenatal use only and should be disabled during labour monitoring 3 For reliable operation the ultrasound transducer should be correctly fitted with the supplied belt Do not hand hold as movement of the transducer may falsely trigger the detector 4 Function not available in FECG mode Chart Speed Soft key 1 1 cm min standard European setting Soft key 2 2 cm min Soft key 3 3 cm min standard USA setting Time Soft key 1 Select hours minutes Soft key 2 and 3 Increment decrement the selected value as required Date Soft key 1 Selects Day Month Year Soft key 2 and 3 Increment decrement the selected value as required Grid beats cm Soft key 1 20bpm cm standard European setting Soft key 3 30bpm cm standard USA setting Language Soft key 3 Selects the desired language Alarms Applicable from Serial Number 61 4 98 B 0407 Loss o
18. e procedure and must only be performed by suitably qualified practicing clinicians e IUP monitoring should be discontinued when 2nd stage labour commences as the data will no longer be accurate due to maternal bearing down IntraUterine Pressure monitoring provides a more accurate method of monitoring maternal contractions or uterine activity than conventional external tocography External tocography provides a relative indirect indication of uterine activity IntraUterine pressure monitoring provides a more direct absolute measure of contractions by monitoring the amniotic fluid pressure inside the uterus The output is calibrated in user selectable options of millimetres of Mercury mmHg or kiloPascals kPa The IUP option kit comprises e IUP interface module e IUP module trolley bracket kit e Sensor connecting lead e Sensor system In certain markets only these are usually centrally sourced by hospitals from their preferred supplier This kit is used in conjunction with the BD4000 to provide a full IUP monitoring capability 34 IUP Interface Module Figure 1 IUP system installed with Sensortio probe connected This interface module provides an electronic interface between the sensor and the BD4000 main unit WARNING This module provides the necessary additional electrical isolation required for this invasive application type before Under no circumstances must any attempt be made t
19. eep at the fetal heart rate should be heard adjust volume as required and fetal heart rate should be displayed on the FHR display Also the fetal pulse indicator should flash with each detected pulse If signal quality is poor check the scalp electrode connections and the system wiring Check that the transducer is firmly held in contact with the maternal thigh and if necessary re apply the electrode If at any time contact is lost after a short delay the text display will show CHECK LEADS Check all leg plate connections maternal contact and scalp electrode attachment If necessary re apply or replace electrode Ensure sufficient paper is available in the paper tray Initiate printing as for antepartum monitoring Trace Interpretation This is beyond the scope of this document It is assumed that the user is clinically qualified and experienced both in the use of similar fetal monitoring equipment the application of the electrode and in interpreting the data provided As with antepartum monitoring it must be recognized that FHR is just one indicator of fetal condition which should be interpreted within an holistic approach to labour management As with any similar device in poor difficult signal conditions false data may be displayed printed Additional educational material and support is available from Huntleigh Healthcare 44 Handling Although the BD4000 is robust and designed to withstand normal clinica
20. erpreting the data provided As with antepartum monitoring it must be recognised that FHR is just one indicator of fetal condition which should be interpreted within an holistic approach to labour management As with any similar device in poor difficult signal conditions false data may be displayed printed Additional educational material and support is available from Huntleigh Healthcare contact your supplier for details 20 After Use Twins Monitoring Equipment Set up 1 20 1 Renote FER bpm 2 Twi ns Renote Uni t The system should be carefully cleaned and decontaminated Refer to Care of Your Baby Dopplex cleaning instructions for details This requires two BD4000 main units connected together to provide twins capability Please consult this User Manual Identify the 2x RS232 sockets on the rear panel marked as shown Using the interface cable provided with the twins option pack plug the femal plug marked 1 into socket number 1 on one of the units ensuring fixing screws are tightened securely This unit will automatically be configured as the local unit The text display will show Remote FHR in the top line of the text display with the remote unit s FHR data displayed immediately below shown as bpm with no signal Connect the other end a male plug marked 2 to socket number 2 on the second unit This unit will automatically be configured as
21. f Contact Detects when loss of contact drop out occurs LOC alarm for a percentage LOC of a preset time period Both the percentage threshold and time are user selectable The alarm can be disabled or can operate in silent or audio modes g Time range 0 to 20 minutes default setting 10 minutes o LOC range 0 to 99 default setting 50 o Modes Off alarm function is disabled default mode Silent alarm condition indicated on LCD display and print out Audio display and print out as per Silent mode accompanied by bleeping audio tone Set up Tachycardia alarm Set up Bradycardia alarm Enter set up mode and use the Volume Scroll keys to scroll through the menu to select LOC alarm Soft key 1 Selects time mode When time selected Soft keys 2 amp 3 Increment decrement value When mode selected Soft key 3 Selects Off Silent Audio Detects when fetal heart rate FHR has remained above a user selectable threshold for a user selectable time The alarm can be disabled or can operate in silent or audio modes o FHR threshold range 150 200 bpm default setting 180bpm o Time range 0 20 mins default setting 10 minutes o Modes Off alarm function is disabled default mode Silent alarm condition indicated on LCD display and print out Audio display and print out as per Silent mode accompanied by bleeping audio tone Enter set up mode
22. in warm Transducer and 50 C max mild detergent solution using a FECG Leg Plate bottle brush if necessary Do not soak or run under a tap Rinse with clean water and dry thoroughly before use WARNING Do NOT immerse connectors Contractions Wipe with a soft cloth dampened with a mild Transducer TOCO detergent solution avoiding the connector Do not allow any fluid to seep into the transducer Dry thoroughly before use Transducer Belts These should be hand washed at 40 C max using a mild detergent solution Rinse with clean water and dry thoroughly without using heat before use Disinfection Transducers and Leg Plate LP1 Only To assist with disinfection wipe the transducers and leg plate with a soft cloth dampened with a sodium hypochlorite 1000ppm solution and wipe dry Please be sure to check your local infection control policies or equipment cleaning procedures CAUTION Phenolic detergent based disinfectants containing cationic surfactants ammonia based compounds or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system as permanent damage will result 29 7 Troubleshooting If you encounter difficulties in operating your BD4000 fetal monitor the following table lists some possible causes and solutions Problem Cause Solution Poor signal U S Fetus moved or transducer incorrectly positioned Reposition transduce
23. l contractions transducer For set up and Monitoring operation refer to the instructions supplied with Option the IUP option pack Patient Event If required connect as for antepartum operation Marker refer to Antepartum Operation section Fetal Movement This is intended for antenatal use and should be Detector disabled during labour monitoring refer to System Configuration section It is automatically disabled in FECG mode The unit is now ready for use 18 Monitoring Leg Plate Apply ECG gel to the metal contact plate on the underside of the leg plate module Pass the short belt supplied with the Intrapartum option pack around the maternal upper thigh Position the leg plate transducer on the thigh with the cable leading down towaras the feet and secure the transducer in position engaging the two ends of the belt over the button as per the other transducers refer to antepartum section Use only sufficient tension in the belt to ensure reliable contact is maintained Figure 9 Leg Plate Positioning 19 Scalp Clip The BD4000 is compatible with all known makes of Fetal Scalp Electrodes These are supplied separately individually sterile wrapped for single use only Before opening inspect sterile pack carefully If there is any breach of the sterile packing the clip must be discarded Using sterile technique apply the scalp clip in accordance with the manufacturer s instructions
24. l use the unit does contain delicate components and should be treated with care This applies especially to the transducers and the FECG interface module which contain sensitive electronics and should not be dropped or knocked Maintenance Other than careful cleaning the BD4000 does not require routine maintenance If any parts of the system appear damaged in any way the system should be returned to your local service centre for repair Ultrasound and The use of water based gels supplied by ECG Coupling Gel Huntleigh Healthcare is strongly recommended Oil based gels can damage the transducer and must not be used The use of oil based gels will invalidate your warranty The gels supplied are carefully designed for optimum performance in their intended uses It is important to use the correct gels for each application to ensure best performance CAUTION Switch the unit off and disconnect from the electrical outlet before cleaning WARNING The BD4000 and its range of options and accessories are not designed to be sterilised FECG scalp electrodes are normally supplied sterile for single use only Cleaning Main Unit If required this can be wiped with a soft cloth dampened with a mild detergent solution avoiding the connectors Do not allow any fluid to seep into the unit Ensure the unit is completely dry before reconnecting to the electrical outlet Ultrasound This should be cleaned by immersing in warm Transduce
25. ment detection system This provides an indication of movement detected from the low frequency components of the Doppler signal CE It should be noted that this system will be triggered by any low velocity movement above a set threshold user adjustable and may arise from other movements such as transducer or maternal movement Upgrade Options The following additional options may have been supplied with your unit or can be ordered separately to upgrade your unit Intrapartum upgrade Comprising e Active leg plate transducer e Leg Plate belt 2 off e ECG gel Twins upgrade Comprising e Interface cable incorporating interface electronics e Wide Twins paper 2 packs CE The twins option requires two BD4000 main units When interconnected one is automatically configured as the local unit the second as the remote unit See the twins set up and operation section for more details Intrauterine Pressure Option Comprises e Pressure sensor kit and interface module LS Note that details on the Intrauterine Pressure option are covered separately in the instructions supplied with the option kit Accessories A wide range of accessories is available for use with the BD4000 fetal monitor including e Trolley optionally available with 2 shelves for twins system e Wall mounting bracket e Interface cables refer to Data Interface section for details e Consumables gel paper belts e Carry case 2 Rec
26. ning of the Dopplex Centrale system For further details contact your supplier The BD4000 can also be configured via an extended set up menu to interface with other makes of electronic viewing and archiving systems Maternal Vital Signs monitoring Set up The BD4000 can be connected to compatible Vital Signs Monitors VSM for including maternal data on the CTG print out A range of VSMs are supported As this is subject to change this section will explain the operation of this feature in outline only Technical data sheets are available from your supplier giving detailed information on specific makes models of VSM Interface cables are specific to each make model of external device Ensure that your have the correct cable for your external device Simply plug the female end of the serial cable labelled BD4000 into the serial port 1 on the rear panel of the BD4000 and the other end into the external device E Note that only one external device can be connected at a time The second serial port on ihe BD4000 cannot be used for this application This is reserved for out going communication with electronic viewing and archiving system Ensure that the BD4000 is set up to work with the connected external device refer to Section 4 for system set up details Operate the external device in accordance with the manufacturer s operating instructions Start the printer on the BD4000 and the VSM data will be printed
27. note that 1 FHR is just one single indicator of fetal condition and that it must only be considered within an holistic approach to obstetric management 2 In poor difficult signal conditions false data may be displayed printed Rate can be confirmed by listening to the audio signal The system should be carefully cleaned Refer to Cleaning Instructions for details 17 Intrapartum Operation For external ultrasound monitoring refer to the Antepartum Operation section Connecting the Transducers Leg Plate Plug the leg plate marked LP1 connector Transducer colour coded red into the US FECG socket also colour coded red on the main unit in place of the ultrasound transducer This automatically reconfigures the system for intrapartum operation The display will show FECG in the top right corner LS The signal quality indicator is disabled in FECG mode However a Leads Off indicator will detect loss of FECG signal WARNING The leg plate contains sensitive electronics and provides the additional electrical isolation type BF required for safe connection to the fetus Inspect carefully before use for any damage as this may affect electrical isolation If any damage is found do not proceed Contractions Transducer Connect as for antepartum operation refer to Antepartum Operation section Intra Uterine Pressure For use in intrapartum monitoring instead of the IUP externa
28. o connect the sensor directly to the main unit or in any way to bypass this module IUP Module Trolley Bracket Kit The attached connecting lead plugs into the BD4000 main unit in place of the external contractions transducer see Fig 1 The sensor or sensor interface lead depending on sensor type used plugs into the integral socket on the end panel of the IUP module see Fig 1 It is recommended that the BD4000 monitor is mounted on its trolley A bracket kit is provided with the IUP kit to enable the IUP module to be mounted alongside the monitor on the trolley see Fig 2 Refer to Fig 4 for assembly instructions 35 P module installed on trolley Figure 2 IU Alternatively adhesive pads are provided to allow the IUP mounting bracket to mounted directly onto the BD4000 case see Figs 1 amp 3 Figure 3 Mounting IUP module on BD4000 External Sensor Pressure Dome 36 Figure 4 Mounting Bracket Assembly Sensor System There are two types in general use external see Fig 3 and internal see Fig 1 External External sensor systems use an external physiological pressure transducer connected to a fluid filled catheter system via a pressure dome The catheter is inserted into the uterus intrauterine fluid pressure being measured remotely i e external to the patient through the fluid column in the catheter To eliminate hydrosta
29. ommended Clinical Applications The BD4000 is intended for use in all conventional fetal monitoring applications DO use BD4000 for Antenatal monitoring in the hospital health clinic home or community Hospital admission CTG s Labour monitoring use of external ultrasound is recommended in all monitoring applications except where e Ultrasound is unable to provide reliable continuous traces AND e Clinical risk factors indications justify the use of invasive scalp clips for FECG monitoring DO NOT use BD4000 for Underwater monitoring in waterbirth management a range of Aqua Dopplex Dopplers are available for this Monitoring in any environment where the patient user or unit is likely to come into contact with water Guidelines on the use of BD4000 Fetal monitors provide just one indicator of fetal condition This should be assessed as part of an holistic approach to obstetric care together with other factors A complete assessment must be made before appropriate action is taken Scalp clips are invasive and their use carries a degree of risk including increased risk of cross infection They should only be used under the conditions outlined above The decision to use them remains the responsibility of the clinician Ultrasound monitoring should be performed in accordance with current guidelines The ALARA guideline AIUM recommends that ultrasound exposure should be kept As Low As Reasonably Achievable
30. r Poor connections Insufficient gel Apply gel Poor signal FECG Poor scalp clip attachment Re apply or replace scalp clip Poor leg plate maternal Adjust belt contact belt loose or insufficient ECG gel Apply ECG gel Check connections UA display shows L or H Toco transducer too loose Lor tight H Check and adjust belt Re zero using control panel zero button Paper feeds but no printing Paper installed upside down Re install paper pack with sensitive side up Paper not feeding Paper tray not fully shut Out of paper Paper jammed Push firmly in at both ends of tray ensure both latches are locked in Check paper Check correct pack installed Ensure top and bottom packing cards are removed Print quality poor Paper tray not latched shut at one end or both ends Push firmly in at both ends of tray ensure both latches are locked in If trouble persists consult your service centre CAUTION This product contains sensitive electronics therefore strong radiated radio frequency signals could possibly interfere with it This will be indicated by unusual sounds from the loudspeaker This should not affect the CTG However we recommend that the source of interference is identified and eliminated 30 8 Warranty and Service Warranty Huntleigh Healthcare s standard terms and conditions apply to all
31. r 50 C max mild detergent solution using a bottle brush if necessary Do not soak or run under a tap Rinse with clean water and dry thoroughly before use WARNING Do NOT immerse connectors 45 FECG interface module Wipe with a soft cloth dampened with a mild legplate interface cable detergent solution avoiding the connector Do and Contractions not allow any fluid to seep into the transducer Transducer TOCO Dry thoroughly before use Transducer Belts These should be hand washed at 40 C max using a mild detergent solution Rinse with clean water and dry thoroughly without using heat before use Disinfection Transducers and Leg Plate interface cable To assist with disinfection wipe the transducers and leg plate with a soft cloth dampened with a sodium hypochlorite 1000ppm solution 20z bleach per each gallon of water and wipe dry Please be sure to check your local infection control policies or equipment cleaning procedures CAUTION Phenolic detergent based disinfectants containing cationic surfactants ammonia based compounds or antiseptic solutions such as Steriscol or Hibiscrub should never be used on any part of the system as permanent damage will result CE 0088 Medical Devices Directive 93 42 EEC Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Rd Cardiff UK Tel 44 0 29 20485885 Fax 44 0 29 20492520 Corometrics amp Qwik Connect Plus a
32. r damage Do not proceed if any damage is suspected 1 Prepare the BD4000 for use in accordance with the user manual instructions 2 Inthe user set up menu select the preferred IUP units options mmHg or kPa selected by pressing softkey 1or 3 The printed uterine activity UA scale and the UA display will be calibrated in the selected units TWINS For twins monitoring the IUP module must be connected to the local unit NOT the remote unit refer to BD4000 user manual for details 3 Mount the IUP module in its bracket 38 Sensor Set up Plug the cable from the IUP module into the contractions socket Toco colour coded blue on the monitor 5 External Sensor a b c d f 9 Plug the lead attached to the physiological pressure sensor into the socket on the IUP module colour coded yellow Using sterile technique connect the pressure dome to the sensor in accordance with the manufacturer s instructions Connect the catheter to the pressure dome in accordance with the manufacturer s instructions Through the pressure dome ports fill the catheter with fluid e g Saline and purge the system of air Zero the system to atmospheric pressure by holding the catheter tip level with the sensor and pressing the contractions zero button on the monitor Insert the catheter in accordance with the manufacturer s instructions The system is now ready for monito
33. re registered trademarks of GE Marquette Medical Systems Company Nellcor is a registered trademark of Nellcor Puritan Bennett Inc Huntleigh Healthcare Ltd Diagnostic Products Division A Huntleigh Technology PLC Company Dopplex Huntleigh and H logo are registered trademarks of Huntleigh Technology PLC Huntleigh Healthcare Ltd 2004 614320 4 21 10 2004 46
34. ring 6 Internal Sensor a b c d Plug the correct interface lead depending on sensor make into the socket on the IUP module colour coded yellow Using sterile technique connect the sensor to the interface cable connector Zero the system in accordance with the manufacturer s instructions in conjunction with the contraction zero push button on the BD4000 Insert the catheter in accordance with the manufacturer s instructions The system is now ready for monitoring 7 Proceed with monitoring as required 8 After each use dispose of the sensor catheter single use items and clean the system as described under Cleaning If any doubt exists at any time during the trial uterine activity should be confirmed by palpation or other means 39 Handling amp There are no special maintenance requirements Maintenance for the reusable parts of the IUP system beyond inspection for damage and cleaning after each use Cleaning Between each use the system must be cleaned in accordance with local infection control procedures IUP Module If required this can be wiped with a soft cloth dampened with a mild detergent solution avoiding the connectors Do not allow any fluid to seep into the unit Ensure it is completely dry before reconnecting Interface cables Isopropyl based alcohol swabs are recommended for cleaning the interface cables Disinfection IUP Module To assist with disinfection
35. rk clinical actions This prints a different style event mark at the top of the FHR channel to distinguish it from normal patient event marks While printing the Menu button can be used to scroll through a selection of trace annotation messages Select the message required on the display using the Menu button and then press the clinical event marker button The selected message will be printed above the FHR channel immediately after the clinical event mark This allows clinical actions to be immediately and reliably recorded with accurate indication of timing The unit is supplied with a standard set of messages programmed in including Pethidine Oxygen Epidural Vaginal examination etc However these can be customised to suit your requirements Refer to your service department or supplier for further information 16 Bo Operating Mode no E ae 60 PE Fetal Movement Detection 15 45 25 6 97 1 cm m FMD Markers 100 pone a FM 4 tot 14 i UA Trace zeroed at 20 HUNTLEIGH DIAGNOSTICS Figure 8 Single Channel Printout Trace Interpretation The print out is presented in internationally After Use standardised formats depending on set up options selected see Set Up section to ensure consistent presentation Interpretation of this information is beyond the scope of this document and should only be undertaken by experienced qualified clinicians It is important to
36. rmal clinical use the unit does contain delicate components and should be treated with care This applies especially to the transducers and the active leg plate which contain sensitive electronics and should not be dropped or knocked Maintenance Other than careful cleaning the BD4000 does not require routine maintenance If any parts of the system particularly the leg plate appear damaged in any way the system should be returned to your local service centre for repair Ultrasound and The use of water based gels supplied by i Huntleigh Healthcare is strongly recommended ECG Coupling Gel Oil based gels can damage the transducer and must not be used The use of oil based gels will invalidate your warranty The gels supplied are carefully designed for optimum performance in their intended uses It is important to use the correct gels for each application to ensure best performance CAUTION Switch the unit off and disconnect from the mains before cleaning WARNING The BD4000 and its range of options and accessories are not designed to be sterilised FECG scalp clips are normally supplied sterile for single use only Cleaning Main Unit If required this can be wiped with a soft cloth dampened with a mild detergent solution avoiding the connectors Do not allow any fluid to seep into the unit Ensure the unit is completely dry before reconnecting to the mains 28 Ultrasound These should be cleaned by immersing
37. s laid down in IEC1157 1992 the peak negative acoustic pressure does not exceed 1MPa The output beam intensity does not exceed 20mW cm and the spatial peak temporal average intensity does not exceed 100mW cm2 Contractions Transducer Range O to 100 relative units Max Load 300g Regulatory Compliance Standards Complies with BS5724 Part 1 1989 IEC601 1 1988 EN60601 1 1990 EN60601 1 Classification Type of shock protection Type B except Leg Plate LP1 Type BF Degree of Protection Against Water Ingress Ordinary equipment except Leg plate LP1 amp LP2 IP67 Degree of Safety in Presence of Flammable Gases Not suitable for use in the presence of flammable gases Mode of Operation Continuous 32 Performance FHR Range U S 50 to 210 bpm FECG 30 to 240 bpm FHR Accuracy 1bpm over full range FHR Scale Options 50 to 210 bpm at 20 bpm cm 30 to 240 bpm at 30 bpm cm 33 Addendum 1 IntraUterine Pressure Option Introduction Description This addendum details the procedure for IntraUterine Pressure IUP monitoring using the optional IUP interface module and suitable sensor system in conjunction with the Baby Dopplex 4000 BD4000 e This addendum should be read in conjunction with the BD4000 user manual e It is assumed that the user is familiar with the use of the BD4000 and experienced in normal fetal monitoring practice e IUP is an invasiv
38. sales A copy is available on request These contain full details of warranty terms and do not limit the statutory rights of the customer Service Returns For service maintenance and any questions regarding this or any other Huntleigh Healthcare Dopplex product please contact Huntleigh Healthcare Ltd Diagnostic Products Division 35 Portmanmoor Rd Cardiff CF24 5HN United Kingdom Tel 44 0 29 20496793 Service 24hr answer machine email service huntleigh diagnostics co uk Tel 44 0 29 20485885 Customer Care Fax 44 0 29 20492520 or your local supplier CAUTION In the unlikely event that you need to return this product please adopt local decontamination procedures and provide documentation outlining the product s status Please ensure that this documentation is accessible without having to open the package Huntleigh Healthcare Ltd reserves the right to return unopened any shipment not complying with this requirement 31 9 Technical Data General Product Name Baby DOPPLEX 4000 Model No BD4000 Physical Size Control Unit 93mm x 380mm x 250mm HxWxD Weight 4 5Kg Environmental Operating Temperature 10 C to 30 C Storage Temperature 10 C to 40 C we Electrical Power Supply 100 to 250Va c 50 60Hz Fuse Type T2A 250V Audio Power 1 Watt max Ultrasound Transducer Transmitter Frequency US1 1 5MHz 1 Acoustic Output Under the requirement
39. te full range FHR scales together with contractions movement and event marker data Alternatively using standard paper the two traces are superimposed on the standard FHR scale Adjusting Paper Width Ensure that the adjustable paper guide is set to the correct position for the paper ES Note that this can only be adjusted by sliding left right when the paper tray is fully open Inserting Paper Ensure that it is located in the appropriate position indent The paper tray cannot be closed if this is not located correctly Remove the paper pack outer film discard the top and bottom card inserts and insert pack into the tray Ensure that the sensitive side is facing up To confirm this ensure that the pre printed sheet numbers are visible on the right hand side of the pack see Fig 4 Refer to the paper loading guide in the paper tray This guide should be left in place for future reference CS Note that the small hole in this guide must be positioned towards the front right hand side to ensure end of paper detection A marker strip on the last few sheets of paper will indicate when the paper is about to run out When no paper is left in the tray the display will indicate END OF PAPER Figure 4 paper Loading Guide Pull the top sheet out over the roller Using both hanas push the paper tray firmly shut Ensure that the latches at both ends are securely locked See Fig 5 If the tray is not properl
40. the remote unit All controls on the remote unit will be disabled except for the volume control The remote unit display will read Twins Remote Unit The system is now automatically configured for twins operation CAUTION If RS232 outputs 1 and 2 are used simultaneously the system should comply with EN60601 1 1 Any equipment connected to outputs 1 or 2 should comply with EN60601 1 EN60950 EN60065 EN60335 or EN61010 21 Transducers Operating Modes 2 Channel Fetal Heart Rate Ee Contractions Patient Event Marker Paper The user can optionally use e Ultrasound transducers on both local and remote units e Ultrasound on one either unit and FECG scalp clip on the other unit Connect the ultrasound transducers leg plate as required and set up on patient as normal The ultrasound signal quality indicator is not available in twins modes When using the leg plate on either unit a leads off or poor contact condition will be indicated on the local unit display as Check Leads Connect the contractions transducer to the local unit and set up on the patient as normal Note that the remote unit contractions function is disabled in twins mode Connect to the local unit Note that the remote unit event marker function is disabled in twins mode In the local unit optionally replace the standard paper pack with the special wide paper pack supplied with the Twins pa
41. tic errors the external sensor must be positioned at the same height as the tip of the catheter The system must be zeroed before insertion Caution The sensor which plugs directly into the IUP module is reusable but the catheter and pressure dome are single use components 37 Internal Internal sensors have the sensing element integrated into the tip of the catheter This is much simpler to set up and use and there is no hydrostatic effect The external end of the catheter includes a zero port to allow calibration after insertion and an electrical connector to connect toa reuseable interface lead Caution This type of sensor is intended for single patient use only Caution These pressure sensors are precision instruments they must be handled with care at all times in accordance with the manufacturer s instructions Huntleigh Healthcare do not manufacture IUP sensor systems The BD4000 IUP system is compatible with a range of both external and internal sensor systems currently available from independent sensor suppliers Existing users will already have an established preferred sensor type sourced centrally by the hospital For more information on sensor suppliers contact your dealer Interface leads to suita range of sensor systems are available either from the sensor supplier or directly from Huntleigh Healthcare System Set up Before use inspect the monitor IUP module and other components fo
42. tself Confirm the signal is fetal by comparing the rate with the maternal rate The fetal heart rate is typically about double the maternal rate Adjust the audio volume using the keys as required While either key is pressed the display will show volume level setting in the form of a bar graph 14 Belt Attachment Attach one end of the belt to the transducer by engaging one of the holes in the belt over the button on the top of the transducer Keeping the transducer in position tension the other end of the belt and engage the belt over the button ensuring sufficient tension to keep the transducer in firm contact with the abdomen Avoid over tightening as this will cause unnecessary discomfort to the patient Ultrasound Signal Quality indicator OOO Rate Display Figure 7 Transducer Belt Positioning Re adjust the transducer position to get the best possible signal If the fetus moves it may be necessary to adjust the transducer to restore signal A signal quality indicator in the form of a 4 level bar graph is provided in the top right hand corner of the text display For best performance all four elements should be showing In the absence of signal no elements will be seen The FHR display on the control panel shows fetal heart rate in real time When no signal or poor quality signal is present the display will show 15 Contractions Transducer
43. y latched shut at both ends the unit may not print or poor print quality may be observed Figure 5 Paper Tray Firmly Shut Use only the correct paper packs supplied by Huntleigh Healthcare Paper quality varies widely Use of inferior quality paper may result in poor trace quality may damage the unit and invalidate the warranty CAUTION Do not use pre printed paper designed for use in other fetal monitors the registration of the trace to the pre printed scale will not be accurate System Set Up Option 11 Feb 97 OOOO Menu Trace Annotation Volume Soft Key Soft Key Soft Key Scroll 1 2 3 Keys Figure 6 User Selectable Options The following user selectable options can be selected using the keys on the control panel refer to Fig 6 These settings should be set as required when the unit is first installed The saved settings will be retained when the unit is switched off e Fetal movement detector e Chart speed select 1 2 or 3 cm min e Time e Date e Grid beats cm select 20 or 30 bpm cm e Language e Alarms e External Data Set up Procedure Ensure the unit is not printing the Printer On LED must not be lit Press the Menu button The display will show User Setup with flashing arrows pointing to the Volume Scroll keys Use either key to scroll through the options listed above Each key press will move on to th
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