Huntleigh Baby DOPPLEX 4000 User manual

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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
(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:
·Connection to electronic viewing and archiving systems.
·Connection to Vital Signs monitors for recording maternal data
on the CTG print-out
·Connection to fetal Sp02monitors for recording FSp02on 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.
FIt 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.
1

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)
FThe 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
FNote 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
2

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.
3

3. Product Description
Figure 1 BD4000 Front View
4
Mains Input Socket
+ On/Off Switch
Loudspeaker
2 x RS232
Sockets
Control Panel
Paper Tray
Paper Tray
Latches
Patient Event
Marker Contractions
Transducer
Socket
Ultrasound/FECG
Socket
Contractions
Display
Pulse
Indicator
FHR
Display
Contractions
Zero
Printer
On/Off
Text
Message
Display
Menu/Trace
Annotation
Soft Key
1
Soft Key
2
Soft Key
3
Volume/Scroll
Keys
Printer
On LED
Clinical
Event
Marker
Figure 2 BD4000 Control Panel

4. Setting Up the BD4000
Mains Connection/
Switching On
Connect the unit to a suitable mains power
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.
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.
5

Adjusting Paper Width
Ensure that the adjustable paper guide is set to
the correct position for the paper.
FNote 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 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.
FNote 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
6

Pull the top sheet out over the roller.
Using both hands, push the paper tray firmly
shut.
FEnsure 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.
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.
7
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
Figure 5 Paper Tray Firmly Shut

System Set-Up Option
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:
8
Menu/Trace
Annotation
Soft Key
1
Soft Key
2
Soft Key
3
Volume/
Scroll
Keys
Figure 6 User Selectable Options