User Manual
48 Pages
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ENGLISH - User Manual
ENGLISH
CONTENTS 1. Introduction... 1 Upgrade Options... 2 Accessories... 2 2. Recommended Clinical Applications... 3 3. Product Description... 4 4.
Setting Up the BD4000... 5 Mains Connection/Switching On... 5 Paper Loading... 5 System Set-Up Option... 8 Set-up Procedure... 8 Clearing an alarm... 11 Saving Set-up Changes... 12
5. Operation... 13 Antepartum Operation... 13 After Use... 17 Intrapartum Operation... 18 After Use... 21 Twins Monitoring... 21 6. Care of your BD4000... 28 Handling... 28 Maintenance... 28 Ultrasound and ECG Coupling Gel... 28 Cleaning... 28 Disinfection... 29 7. Troubleshooting... 30 8. Warranty and Service... 31 Warranty... 31 Service Returns... 31 9. Technical Data... 32 Addendum 1- IntraUterine Pressure Option... 34 Appendum 2 - FECG Inteface Module (LP2)... 42
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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:
· Connection to electronic viewing and archiving systems. · Connection to Vital Signs monitors for recording maternal data on the CTG print-out
· Connection to fetal Sp02 monitors for recording FSp02 on the CTG print-out.
The standard unit is supplied complete with:
· BD4000 main unit · Ultrasound transducer · External Contractions (toco) transducer · Patient Event Marker · Printer Paper (2 packs) · Gel (1x 250ml bottle) · Latex Free Transducer Belts (x2) · Mains cable · User Manual Fetal Monitor Detector The standard unit includes an automatic fetal movement detection system. This provides an indication of movement, detected from the low frequency components of the Doppler signal.
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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.
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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)
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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:
· Pressure sensor kit and interface module
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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:
· Trolley - optionally available with 2 shelves for twins system
· Wall mounting bracket · Interface cables - refer to ‘Data Interface’ section for details
· Consumables - gel, paper, belts · Carry case
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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, AND
· 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.
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3. Product Description Control Panel
Mains Input Socket + On/Off Switch
Paper Tray
Loudspeaker 2 x RS232 Sockets
Paper Tray Latches Ultrasound/FECG Patient Event Socket Contractions Marker Transducer Socket Figure 1 BD4000 Front View
FHR Display
Pulse Indicator
Contractions Display
Printer On/Off
Text Message Display
Printer On LED Contractions Zero
Menu/Trace Annotation Soft Key Soft Key Soft Key 1 2 3 Volume/Scroll Keys Figure 2 BD4000 Control Panel
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Clinical Event Marker
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.
Paper Loading
Open the paper tray by simultaneously depressing the latches at each end, as shown in Fig. 3. Slide the paper tray forwards. Note that the LCD text display shows ‘PAPER TRAY OPEN’.
Figure 3 Paper Loading Instructions Twins
Special wide paper, supplied with the Twins option pack, provides optimal presentation of the two traces on separate, 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.
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Adjusting Paper Width Ensure that the adjustable paper guide is set to the correct position for the paper.
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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. The paper tray cannot be closed if this is not located correctly.
Inserting Paper
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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.
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
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Pull the top sheet out over the roller. Using both hands, push the paper tray firmly shut.
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Ensure that the latches at both ends are securely locked. (See Fig. 5). If the tray is not properly 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
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System Set-Up Option
Menu/Trace Annotation Soft Key 1
Soft Key 2
Soft Key 3
Volume/ Scroll 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.
· Fetal movement detector · Chart speed - select 1, 2 or 3 cm/min · Time · Date · Grid (beats/cm) - select 20 or 30 bpm/cm · Language · Alarms · 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 the 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:
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Fetal Movement Detector
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Soft key 1 : Soft key 3 : Soft key 2 :
Toggle function off/on. Increment trigger threshold. Decrement trigger threshold.
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). 2 cm/min. 3 cm/min (standard USA setting).
Soft key 2 : Soft key 3 : 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). 30bpm/cm (standard USA setting).
Soft key 3 : Language
Soft key 3 :
Alarms
Applicable from Serial Number: 614-98-B-0407
Loss of Contact (LOC) alarm
Selects the desired language.
Detects when loss of contact (drop-out) occurs 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. r Time range :
0 to 20 minutes (default setting -
10 minutes) r %LOC range : 0 to 99 (default setting – 50%) r Modes t Off – alarm function is disabled (default mode) t Silent – alarm condition indicated on LCD display
and print-out
t Audio – display and print-out as per Silent mode
accompanied by bleeping audio tone
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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 a user selectable time. The alarm can be disabled or can operate in silent or audio modes. r FHR threshold range:
150 – 200 bpm (default setting – 180bpm) r Time range: 0–20 mins (default setting –10 minutes) r Modes t Off – alarm function is disabled (default mode) t Silent – alarm condition indicated on LCD display and print-out t Audio – display and print-out as per Silent mode accompanied by bleeping audio tone Set-up
Enter set-up mode 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 & 3: Increment/decrement value When mode selected: Soft key 3 : Selects Off/Silent/Audio
Bradycardia alarm
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. r FHR threshold range :
50 - 120 bpm (default setting – 100bpm) r Time range: 0–20 mins (default setting –10 minutes) r Modes t Off – alarm function is disabled (default mode) t Silent – alarm condition indicated on LCD display
and print-out
t Audio – display and print-out as per Silent mode
accompanied by bleeping audio tone.
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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. 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.
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NOTES: 1. The volume of the alarm bleep (when enabled) is set independently to a factory 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. 2. 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. 3. 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.
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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 monitoring.
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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.
FSp02 can be presented either as numeric data printed at regular intervals or as a continuous trace superimposed on the contractions (UA) scale. r Use Softkey 1 to toggle between ‘Mode’ and
‘Trace’. r With ‘Mode’ selected, use Softkey 3 to select the make of equipment to be connected or to disable this function select ‘Off’. r With ‘Trace’ selected, use Softkey 3 to turn trace mode ‘On’ or ‘Off’. Saving Set-up Changes
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.
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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.
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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
1 US
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.
Contractions Transducer O C TO
Patient Event Marker
Similarly, plug the contractions transducer (marked ‘TOCO’, colour coded blue) into the ‘TOCO’ socket on the front panel. This is also colour coded blue.
Plug the patient event marker into the left hand socket (3.5mm jack socket). Ensure plug is fully inserted.
The unit is now ready for use.
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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.
Ultrasound Transducer
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.
Gel
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.
Locate Fetus
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 itself.
Check Signal
Confirm the signal is fetal by comparing the rate with the maternal rate. The fetal heart rate is typically about double the maternal rate.
Volume
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.
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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. Avoid over-tightening as this will cause unnecessary discomfort to the patient.
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. Ultrasound Signal Quality indicator
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.
Rate Display
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 ‘- - -’.
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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’ 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 ‘0’ 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.
Patient Event Marker Printing
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).
Clinical Event Marker
While printing, the clinical event marker button can be pressed to mark clinical actions. This prints a different style event mark at the top of the FHR channel to distinguish it from normal patient event marks.
Trace Annotation
While printing, the ‘Menu’ button can be used to scroll through a selection of trace annotation messages.
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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.
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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. It is important to 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.
After Use
The system should be carefully cleaned. Refer to “Cleaning Instructions” for details.
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Intrapartum Operation For external ultrasound monitoring refer to the “Antepartum Operation” section. Connecting the Transducers Leg Plate Transducer
Plug the leg plate (marked ‘LP1’, 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.
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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 (IUP) Monitoring Option
For use in intrapartum monitoring instead of the external contractions transducer. For set-up and operation, refer to the instructions supplied with the IUP option pack.
Patient Event Marker
If required, connect as for antepartum operation - refer to Antepartum Operation section.
Fetal Movement Detector
This is intended for antenatal use and should be disabled during labour monitoring (refer to “System Configuration” section). It is automatically disabled in FECG mode. The unit is now ready for use.
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