Huntleigh Healthcare BD4000 User Manual

ENGLISH

l a u n a

M r

e s

I L

G N

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 Sp0

CTG print-out.

The standard unit is supplied complete with:

monitors for recording FSp02 on the

· 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.

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:

· 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. 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

Note that details on the Intrauterine Pressure option, are covered

Accessories A wide range of accessories is available for use

separately in the instructions supplied with the option kit.

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. 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. Product Description

Mains Input Socket + On/Off Switch

Loudspeaker

2 x RS232 Sockets

Control Panel

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

Volume/Scroll

Keys

Printer

On LED

Clinical Event Marker

Figure 1 BD4000 Front View

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.

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

Inserting Paper Remove the paper pack outer film, discard the

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.

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

Pull the top sheet out over the roller.

Using both hands, push the paper tray firmly shut.

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

System Set-Up Option

Menu/Trace Annotation

Soft Key1Soft Key2Soft Key

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:

Fetal Movement Detector

Notes:

Chart Speed Soft key 1 : 1 cm/min (standard European

Time Soft key 1 : Select hours/minutes.

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.

Soft key 1 : Toggle function off/on. Soft key 3 : Increment trigger threshold. Soft key 2 : Decrement trigger threshold.

setting). Soft key 2 : 2 cm/min. Soft key 3 : 3 cm/min (standard USA

setting).

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: 614-98-B-0407

Loss of Contact (LOC) alarm

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

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.

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.

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.

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.

This option is not available on all makes/models of vital signs monitors.

Fetal Oxygenation monitoring.

Saving Set-up Changes

Maternal heart rate can be presented either as numeric data printed at regular intervals or as a continuous trace superimposed on the FHR scale.

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’.

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.

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.

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.

Contractions Transducer Similarly, plug the contractions transducer

(marked ‘TOCO’, colour coded blue) into the ‘TOCO’ socket on the front panel.

This is also colour coded blue.

Patient Event Marker

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.

+ 33 hidden pages