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.
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: Active leg plate transducer Leg Plate belt (2 off) ECG gel Twins upgrade Comprising: Interface cable (incorporating interface electronics) Wide Twins paper (2 packs) The twins option requires two BD4000 main units.
2. Recommended 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: Ultrasound is unable to provide reliable continuous traces,...
4. Setting Up the BD4000 Mains Connection/ Connect the unit to a suitable mains power source using the cable supplied. The BD4000 Switching On 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.
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Adjusting Paper Width Ensure that the adjustable paper guide is set to the correct position for the paper. Note that this can only be adjusted, by sliding left/right, when the paper tray is fully open. Ensure that it is located in the appropriate position indent.
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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.
System Set-Up Option Menu/Trace Annotation Volume/ Scroll Soft Key Soft Key Soft Key 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.
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Fetal Movement Soft key 1 : Toggle function off/on. Soft key 3 : Increment trigger threshold. Detector Soft key 2 : Decrement trigger threshold. Notes: Default setting is 40% (Recommended setting for normal use. This function is intended for antenatal use only and should be disabled during labour monitoring.
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Set-up: 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 & 3: Increment/decrement value When mode selected: Soft key 3 : Selects Off/Silent/Audio Tachycardia alarm Detects when fetal heart rate (FHR) has remained above a user selectable threshold, for...
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 & 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, press softkey 2.
External Data 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 Vital Signs Maternal heart rate can be presented either as numeric data printed at regular intervals or as a monitoring.
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...
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Monitoring 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.
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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.
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Contractions Transducer 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’...
FHR Trace Operating Mode Fetal Movement Detection (FMD) Markers UA Trace ‘zeroed’ at +20% Figure 8 Single Channel Printout Trace Interpretation The print-out is presented in internationally 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.
Intrapartum Operation For external ultrasound monitoring refer to the “Antepartum Operation” section. Connecting the Transducers Leg Plate Plug the leg plate (marked ‘LP1’, connector colour coded red) into the ‘US/FECG’ socket, Transducer also colour coded red on the main unit, in place of the ultrasound transducer.
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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 towards the feet and secure the transducer in position, engaging the two ends of the belt over the button as per...
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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.
After Use The system should be carefully cleaned and decontaminated. Refer to Care of Your Baby Dopplex cleaning instructions for details. Twins Monitoring Equipment Set-up 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.
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Transducers/Operating Modes 2 Channel Fetal The user can optionally use: Heart Rate Ultrasound transducers on both local and remote units 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.
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Clinical Event Marker + Trace Annotation Channel/Mode Label Cross-Channel Warning Marker (FHR1 = FHR2?) Date/Time/Chart Speed Fetal Movement Patient Event Detector Channels Marker FMD Markers 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.
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Trace Labels (L= Local, R = Remote) FHR mode for Cross-Channel each channel Warning Marker (FHR1 = FHR2?) Figure 11 Twins Printout on Standard Paper Printing 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.
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External Data Input/Output Electronic Viewing & The BD4000 can be connected to the Dopplex® Centrale electronic viewing and Archiving systems 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 commissioning of the Dopplex®...
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MHR Trace VSM Alarm VSM Alarm Cancelled Maternal Maternal BP Vital Signs data Figure 12 Vital Signs Monitoring sample printout Fetal Sp0 monitoring The BD4000 can be connected to a Fetal Sp0 monitor for including FSp0 data on the CTG print-out.
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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 data will be printed as configured.
Ultrasound and The use of water based gels supplied by 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.
Ultrasound These should be cleaned by immersing in warm (50°C max.), mild detergent solution, using a Transducer and bottle brush if necessary. Do not soak, or run FECG Leg Plate under a tap. Rinse with clean water and dry thoroughly before use. WARNING Do NOT immerse connectors Contractions...
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 Reposition transducer. incorrectly positioned. Insufficient gel. Apply gel. Poor signal (FECG) Poor scalp clip attachment.
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.
9. Technical Data General Baby DOPPLEX ® 4000 Product Name: Model No.: BD4000 Physical Size - Control Unit: 93mm x 380mm x 250mm (HxWxD) Weight : 4.5Kg Environmental Operating Temperature: +10°C to +30°C +40°C Storage Temperature : -10°C to +40°C -10°C Electrical Power Supply:...
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Performance FHR Range: - 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.
Addendum 1- IntraUterine Pressure Option Introduction 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). This addendum should be read in conjunction with the BD4000 user manual.
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Figure 1 - IUP system installed with Sensortip™ probe connected IUP Interface This interface module provides an electronic interface between the sensor and the BD4000 Module 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 to connect the sensor directly to the main unit, or in any way to bypass this module.
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Figure 2 - IUP module installed on trolley Alternatively, adhesive pads are provided to allow the IUP mounting bracket to mounted directly onto the BD4000 case (see Figs. 1 & 3). Figure 3 - Mounting IUP module on BD4000, External Sensor + Pressure Dome...
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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.
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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.
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Plug the cable from the IUP module into the contractions socket (‘Toco’ - colour coded blue) on the monitor. Sensor Set-up: External Sensor: 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...
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Handling & There are no special maintenance requirements for the reusable parts of the IUP system, Maintenance 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.
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Technical Data Performance Range Display -9 to +99mmHg or -1 to +13kPa System -50 to +300mmHg, or - 6.7 to +40 kPa Resolution Display 1mmHg or kPa Printer 1mmHg or 0.13 kPa Accuracy 1% of FSD Sensor Interface Excitation Voltage 5 V d.c. Nominal sensor impedance Sensitivity...
Appendum 2 - FECG Inteface Module (LP2) Upgrade Options The following additional options may have been supplied with your unit or can be ordered separately to upgrade your unit: Intrapartum upgrade Contains: FECG Interface Module (LP2) Leg plate interface cable. Intrapartum Operation For external ultrasound monitoring refer to the “Antepartum Operation”...
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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.
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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.
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Ultrasound and The use of water based gels supplied by 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.
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