Huntleigh OBIX BeCA User manual

For Use with OBIX BeCA Fetal Monitors
Document Number: 777745-5
Date: February 2023
OBIX® and OBIX BeCA® are trademarks of Clinical Computer Systems, Inc.

Table of Contents
February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
1
Table of Contents
1. Safety Instructions................................................................................................................5
1.1. Warnings................................................................................................................................................................. 5
1.2. Infection Control .................................................................................................................................................... 6
1.3. Patient Applied Parts............................................................................................................................................. 6
2. Introduction ........................................................................................................................... 7
2.1. Intended Use and Indications............................................................................................................................... 7
2.2. Contraindications .................................................................................................................................................. 8
2.3. Unpacking / Preliminary Checks .......................................................................................................................... 8
2.3.1. Standard Contents – all models ............................................................................................................ 8
2.3.2. Blood Pressure Option items ................................................................................................................ 8
2.3.3. MSpO2Option Items ............................................................................................................................. 8
2.3.4. Options for Intrapartum models only .................................................................................................... 8
2.4. Operator Positioning ............................................................................................................................................. 8
3. Product Features...................................................................................................................9
3.1. Front Panel Features ............................................................................................................................................. 9
3.2. Rear Panel ............................................................................................................................................................ 10
3.3. Side Panel............................................................................................................................................................. 11
3.4. Base Label (on bottom of device) ...................................................................................................................... 11
3.5. Product Labeling.................................................................................................................................................. 12
4. Setup....................................................................................................................................13
4.1. System Connection ............................................................................................................................................. 13
4.1.1. DVI output (option) .............................................................................................................................. 13
4.2. Probe/Sensor/Cu󰀨Connection........................................................................................................................... 13
4.3. Loading Paper...................................................................................................................................................... 13
4.4. Handling and Mounting....................................................................................................................................... 14
5. Operation .............................................................................................................................15
5.1. Power On .............................................................................................................................................................. 15
5.2. Application Screen .............................................................................................................................................. 15
5.3. Entering Patient Data........................................................................................................................................... 16
5.3.1. Searching for Patient Names .............................................................................................................. 16
5.3.2. Setting Gestational Age....................................................................................................................... 17
5.4. Lock / Unlock Screen........................................................................................................................................... 18
5.5. Set Date / Time ..................................................................................................................................................... 19
5.6. Control Bar ........................................................................................................................................................... 19
5.6.1. Record/Print ........................................................................................................................................ 19
5.6.2. Paper Feed ......................................................................................................................................... 20
5.6.3. Numeric / Trace View .......................................................................................................................... 20
5.6.4. Volume Up/Down ................................................................................................................................ 20
5.6.5. Annotation – EasiNotes....................................................................................................................... 20
5.6.6. Settings Menu ..................................................................................................................................... 21
5.6.6.1. Clinical Sub Menu ............................................................................................................................... 23
5.6.6.2. System Sub Menu............................................................................................................................... 24
5.6.6.3. Secure Settings Sub Menu ................................................................................................................. 26
5.6.6.4. TraceO󰀨setsOptions ......................................................................................................................... 26
5.6.6.5. Alarm Sub Menu ................................................................................................................................. 27
5.6.7. View Menu .......................................................................................................................................... 29
5.6.7.1. Review Trace ...................................................................................................................................... 30
5.6.7.2. Review Mode Sub Menu ..................................................................................................................... 30
5.6.7.3. MECG ............................................................................................................................................... 31
5.6.7.4. FECG .................................................................................................................................................. 31
5.7. Monitoring Parameters ....................................................................................................................................... 32
5.7.1. Numeric Format .................................................................................................................................. 33
5.7.2. Audio ................................................................................................................................................... 33
5.7.3. FetalHeartRateSignalCondence.................................................................................................... 33
5.7.4. FHR Monitoring ................................................................................................................................... 34
5.7.5. TOCO/IUPC ........................................................................................................................................ 34
5.7.6. MSpO2 / MHR / MECG ....................................................................................................................... 34
5.7.7. Maternal NIBP..................................................................................................................................... 34
5.7.8. Trace Format...................................................................................................................................... 35
5.8. Powering OFF....................................................................................................................................................... 36
5.9. Battery Charging ................................................................................................................................................. 36
6. Monitoring Fetal Parameters .............................................................................................37
6.1. Preparation........................................................................................................................................................... 37

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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
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6.2. Ultrasound Monitoring ........................................................................................................................................ 37
6.2.1. Hints on Monitoring ............................................................................................................................. 38
6.3. Preventing False Recording of FHR................................................................................................................... 39
6.4. Twins Ultrasound Monitoring ............................................................................................................................. 39
6.5. Fetal ECG using a scalp electrode (intrapartum models only)........................................................................ 40
6.5.1. Connecting FECG Transducer to OBIX BeCA.................................................................................... 40
6.5.2. Monitoring procedure using Safelinc™ / Qwik Connect™/Philips electrodes ..................................... 40
7. Monitoring Maternal Parameters .......................................................................................41
7.1. Contractions (using TOCO transducer)............................................................................................................. 41
7.2. Contractions (using Intrauterine Pressure Catheter (IUPC), Intrapartum models only)............................... 41
7.3. Fetal Movement Event Marker ............................................................................................................................ 42
7.3.1. Automatic Fetal Movement Event Marker ........................................................................................... 42
7.3.2. Manual Fetal Movement Event Marker ............................................................................................... 42
7.4. Maternal ECG ....................................................................................................................................................... 43
7.5. Maternal Blood Pressure..................................................................................................................................... 44
7.5.1. AttachingtheCu󰀨................................................................................................................................ 44
7.5.1.1. Cu󰀨size .............................................................................................................................................. 44
7.5.1.2. Cu󰀨positioning ................................................................................................................................... 44
7.5.1.3. Other considerations ........................................................................................................................... 44
7.5.2. Taking BP Measurements ................................................................................................................... 45
7.5.3. Reviewing BP Results ........................................................................................................................ 47
7.6. Maternal Oximetry................................................................................................................................................ 47
8. Alarms ................................................................................................................................ 49
8.1. What is Meant by an Alarm ................................................................................................................................. 49
8.2. Alarm Indications................................................................................................................................................. 49
8.2.1. Printed Indicators ................................................................................................................................ 50
8.3. Responding to Alarms......................................................................................................................................... 50
8.4. Controlling Alarms............................................................................................................................................... 50
9. Printing ...............................................................................................................................51
9.1. Paper Options ...................................................................................................................................................... 51
9.2. Paper Care and Handling .................................................................................................................................... 51
9.3. Print Speed and Duration.................................................................................................................................... 51
9.4. Changing Paper Packs........................................................................................................................................ 52
9.5. Using Non-OBIX BeCA Paper ............................................................................................................................. 53
9.6. Sample Trace (OBIX BeCA paper) ...................................................................................................................... 53
9.7. Turningo󰀨thePrinter ......................................................................................................................................... 54
9.7.1. Stopping the printer while print timer running...................................................................................... 54
10. Using OBIX BeCA with a Central Perinatal Monitoring System.........................................55
11. Troubleshooting...................................................................................................................56
11.1. Essential Performance ........................................................................................................................................ 56
11.2. FHR........................................................................................................................................................................ 56
11.3. Oximetry ............................................................................................................................................................... 56
11.4. Fetal Event Marker............................................................................................................................................... 56
11.5. Maternal blood pressure ..................................................................................................................................... 57
11.6. Printing ................................................................................................................................................................. 57
11.7. General.................................................................................................................................................................. 57
12. Care and Cleaning ............................................................................................................... 58
12.1. General Care......................................................................................................................................................... 58
12.2. General Cleaning and Disinfecting ................................................................................................................... 58
12.3. Cleaning and Disinfecting Patient Applied Parts.............................................................................................. 58
12.4. CleaningNIBPCu󰀨andMaternalOximetrySensor ......................................................................................... 59
12.5. Washing Transducer Belts.................................................................................................................................. 59
13. Maintenance ........................................................................................................................60
13.1. User Maintenance ................................................................................................................................................ 60
13.1.1. Mechanical inspection......................................................................................................................... 60
13.1.2. Clean the print head on the printer...................................................................................................... 60
13.1.3. CheckNIBPcu󰀨sandhose ................................................................................................................ 60
13.1.4. Check oximetry sensor........................................................................................................................ 60
13.2. Technical Maintenance........................................................................................................................................ 60
13.3. Corrective Maintenance ...................................................................................................................................... 60
13.4. Servicing............................................................................................................................................................... 60
13.5. Secure Settings Menu ......................................................................................................................................... 61

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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
3
13.5.1. Service Sub Menu............................................................................................................................... 61
13.5.1.1. Licensing ............................................................................................................................................ 61
13.5.1.2. NIBP Calibration.................................................................................................................................. 61
13.5.1.3. Recordings Manager........................................................................................................................... 62
13.5.1.4. Manometer .......................................................................................................................................... 62
13.5.1.5. Contacts .............................................................................................................................................. 62
13.5.1.6. Archive Manager ................................................................................................................................. 62
13.5.2. Set Language...................................................................................................................................... 63
13.5.3. Hospital Name..................................................................................................................................... 63
13.5.4. Demonstration..................................................................................................................................... 63
13.5.5. Version Information ............................................................................................................................. 64
13.5.6. Regional Settings ................................................................................................................................ 64
13.5.7. Clinical Settings................................................................................................................................... 64
13.5.8. Patient Data ........................................................................................................................................ 65
13.5.9. Trace & Printer Settings ...................................................................................................................... 65
13.5.9.1. Trace Speed & Scale ......................................................................................................................... 66
13.5.9.2. Printer Paper ....................................................................................................................................... 66
13.5.10. Lock Codes ......................................................................................................................................... 66
13.5.10.1. Secure Settings Code ......................................................................................................................... 67
13.5.10.2. Unlock Code ....................................................................................................................................... 67
13.5.10.3. Service Code....................................................................................................................................... 67
13.5.10.4. Patient Data Code............................................................................................................................... 68
13.5.11. Settings Management Sub Menu........................................................................................................ 68
13.5.12. NIBP Protocol .................................................................................................................................... 68
14.Specications.....................................................................................................................69
14.1. EquipmentClassication................................................................................................................................... 69
14.2. General ................................................................................................................................................................. 69
14.3. Environmental...................................................................................................................................................... 69
14.4. Transducers ......................................................................................................................................................... 70
14.4.1. Ultrasound........................................................................................................................................... 70
14.4.2. FECG .................................................................................................................................................. 70
14.4.3. Uterine activity (external TOCO) ......................................................................................................... 71
14.4.4. Uterine activity (internal IUPC)............................................................................................................ 71
14.4.5. Maternal heart rate and MECG ........................................................................................................... 71
14.5. Alarm characteristics .......................................................................................................................................... 71
14.6. Maternal Blood Pressure..................................................................................................................................... 72
14.7. Maternal Oximetry................................................................................................................................................ 73
14.8. Printer .................................................................................................................................................................. 73
14.9. Connections ......................................................................................................................................................... 74
14.9.1. Front Panel.......................................................................................................................................... 74
14.9.2. Side Panel........................................................................................................................................... 74
14.9.3. Rear Panel .......................................................................................................................................... 74
14.9.4. Interfaces ............................................................................................................................................ 74
14.9.5. Display ............................................................................................................................................... 74
14.9.6. Data Display........................................................................................................................................ 75
14.10. Default Settings.................................................................................................................................................... 75
14.10.1. Alarms ................................................................................................................................................ 75
14.10.2. Audio Volume ...................................................................................................................................... 75
14.10.3. NIBP ................................................................................................................................................... 75
14.10.4. Printer ................................................................................................................................................. 76
14.10.5. Test Timer .......................................................................................................................................... 76
14.10.6. View ................................................................................................................................................... 76
14.10.7. Uterine Activity ................................................................................................................................... 76
14.10.8. Miscellaneous .................................................................................................................................... 76
14.11. EasiNotes (Optional Feature).............................................................................................................................. 77
14.12. General Standards............................................................................................................................................... 78
15. Accessories and Consumables...........................................................................................79
16. Warranty and Service.......................................................................................................... 80
16.1. Warranty Statement to End User........................................................................................................................ 80
16.2. Service .................................................................................................................................................................. 81
Appendix 1 Electromagnetic Compatibility ............................................................................ 82
Appendix 2 Ultrasound Safety Considerations ....................................................................... 86
Appendix 3 Maternal SpO2Additional Nellcor Clinical Information....................................... 88
Appendix 4 Wireless Monitoring with OBIX Freedom Telemetry Unit ................................... 93
Appendix 5 Wireless Monitoring with OBIX BeCA Telemetry Unit ........................................94

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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023

Safety Instructions
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
1. Safety Instructions
We recommend that exposure to ultrasound be kept As Low As Reasonably Achievable
(ALARA guidelines).
The fetal monitor provides 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 taking appropriate action. If there is any doubt concerning the accuracy of any
measurement, an alternative method should be used.
Symbols
General Warning
Attention, consult this manual. Refer to safety section.
Rx
Only
Caution: Federal law restricts this device to sale by, or on the order of a licensed healthcare
practitioner.
Refer to Instructions for Use Attention, consult accompanying documents
/ Instructions for Use
1.1. Warnings
Do not use in the presence of flammable
gases or in oxygen rich environments.
Do not sterilize the fetal monitor or its
accessories. The product will be damaged,
and there is a risk of patient and user harm.
Keep fetal monitor dry. Do not immerse the
fetal monitor in liquid. Wired ultrasound
and TOCO transducers are IPX7 rated. For
water births, you must use the optional
OBIX®®wireless telemetry unit and wireless
transducers with the OBIX BeCA®®fetal
monitor.
This equipment contains sensitive
electronics, therefore, strong radio
frequency fields could possibly interfere with
it. This will be indicated by unusual sounds
from the loudspeaker. We recommend that
the source of interference is identified and
eliminated.
Do not use in the sterile field unless
additional barrier precautions are taken.
Use only recommended accessories listed in
this manual.
Do not dispose of batteries in fire as this
can cause them to explode.
The optional lithium battery pack is a
service replaceable item. Replacement by
inadequately trained personnel could result
in a hazard.
Do not use with defibrillators. Ensure
that all the fetal monitor leads and applied
parts are removed from the patient before
applying defibrillation.
OBIX BeCA series monitors are not intended
for use with patients fitted with cardiac
pacemakers.

Safety Instructions
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
Do not use if there is any damage to the
device or its accessories.
OBIX BeCA can be isolated from the power
outlet by unplugging the power cord. Ensure
the power cord plug is fully accessible at all
times.
The fetal monitor is a Class 1 product that
relies for safety on its protective earth.
Ensure it is connected to a grounded,
hospital-grade AC power outlet.
If this product is connected to another item
of electrical equipment, ensure that the
system is fully compliant with IEC 60601-
1:2005.
Do not use in the home environment. Do not use in vehicles or in aircraft.
Do not use with electrosurgical devices. Do not expose to excessive heat, including
prolonged exposure to sunlight.
Do not modify the device or its
accessories.
This equipment is for use only by suitably
qualified healthcare practitioners.
When setting up the fetal monitor, consider
and minimize the risk of persons tripping
over cables.
Do not use during magnetic resonance
imaging (MRI) scanning.
The OBIX Freedom will not operate when
OBIX BeCA is running on battery power.
Do not use the fetal monitor on more than
one patient at a time.
Cover the fetal monitor if there is a risk of
fluid ingress when moving or storing OBIX
BeCA.
The risk of cyber attack on the fetal monitor
is negligible. No special means are required
to secure the device or its updates.
The emissions characteristics of this equipment make it suitable for use in individual areas and
hospitals (CISPR 11 Class A). If it is used in a residential environment, (for which CISPR 11 Class
B is normally required), this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as re-locating or
re-orienting the equipment.
1.2. Infection Control
Single use transducer belts are for single patient use only and must not be re-used. For other single use
accessories refer to the user instructions supplied with them.
1.3. Patient Applied Parts
AsdenedinIEC60601-1:2005,thepatientappliedpartsoftheOBIXBeCAFetalMonitorarethe:
• TOCO Transducer • MSpO2Sensor • NIBPCu󰀨
• Ultrasound Transducer • MECG Electrodes • FECG Scalp Electrodes
• Patient Event Marker

Introduction
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
2. Introduction
The OBIX BeCA series of fetal/maternal monitors are intended for antepartum (AM models) and intrapartum
use (IM models).
Thefollowingfeaturesarestandardonallmodels:
• Dual channel ultrasound fetal heart rate detection with audio
• External monitoring of maternal contractions
• Maternally sensed fetal movements
• Automatic detection of fetal movement
• Color 8.4” touchscreen display
• Connection to perinatal monitoring system via serial port
• Connection to optional OBIX wireless transducer system
• USBport–forupgradingandconguration
Thefollowingoptionsareavailableforallmodels:
• Integral rechargeable battery
• DVI video output
• Paper tray insert for pre-printed paper
• Maternal Non-Invasive Blood Pressure
• Maternal pulse oximetry (MSpO2)
Intrapartummodelsalsohavethefollowingstandardfeatures:
• Fetal ECG *
• Maternal ECG (MECG) **
• Intra-uterine pressure catheter compatibility**
* Electrodes/sensors supplied separately
** Interface cables and electrodes/sensors supplied separately
2.1. Intended Use and Indications
The OBIX BeCA fetal monitors are indicated for use by trained healthcare professionals in non-invasive and
invasivemonitoringofphysiologicalparametersinpregnantwomenandfetuses,duringtheantepartumand
intrapartum periods of pregnancy. The OBIX BeCA fetal monitors are intended for pregnant women from the
28thweekofgestation,throughtotermanddelivery.Thedevicesareintendedforuseinclinicalandhospital-
type facilities.
OBIX BeCA Antepartum is suitable for use when there is a need to monitor the following physiological
applications:
• Single or twin fetal heart rates by means of ultrasound
• Uterine activity - externally sensed
• Fetal movement - maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure

Introduction
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
OBIX BeCA Intrapartum is suitable for use when there is a need to monitor the following physiological
applications:
• Single or twin fetal heart rates by means of ultrasound and/or FECG
• Maternal heart rate via ECG electrodes
• Uterine activity - externally or internally sensed
• Fetal movement - maternally sensed and externally via ultrasound
• Maternal heart rate and oxygen saturation via pulse oximetry
• Maternal non-invasive blood pressure
2.2. Contraindications
Thisdeviceiscontraindicatedforpatientsttedwithpacemakers.
2.3. Unpacking / Preliminary Checks
Performathoroughvisualinspectionwhenthemonitorisreceived.Ifdeviceisdamagedorpartsaremissing,
notify Clinical Computer Systems Inc. at once.
2.3.1. Standard Contents – all models
1 OBIX BeCA device 1 Ultrasound transducer
(2 transducers if Twins model purchased)
1 TOCO transducer
1 Event marker 1 pack of standard paper (unless Philips or GE
paper tray option was ordered)
1 250ml Ultrasound gel
1 Power cord 2 Transducer belts 1 Monitor mounting plate
1 Quick Start Guide 1 User manual
2.3.2. Blood Pressure Option items
1Mediumcu󰀨 1Largecu󰀨 1 Connecting hose
2.3.3. MSpO2Option Items
1 Interface cable 1 Finger sensor
2.3.4. Options for Intrapartum models only
1 FECG cable (type depends on option selected with order)
1 IUPC cable (type depends on option selected with order)
2.4. Operator Positioning
The fetal monitor can be comfortably operated from a standing or seated position in front of the device.

Product Features
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
3. Product Features
WARNING
Safety and performance are only assured when used in conjunction with the correct types of
transducer. Do not attempt to connect any devices via these sockets other than those supplied by
Huntleigh/CCSI.
3.1. Front Panel Features
1Touchscreen 4FHR1 US/FECG socket
2On/O󰀨Button 5FHR2 US/FECG socket
3Printer 6TOCO Transducer socket
1 2
465 3

Product Features
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
3.2. Rear Panel
1AC Power Socket 6DVI Socket (purchasable option)
2Equipotential earth/ground point 7Rating Label
3Fetal Event Marker Socket 8USB Ports (2)
4RS232/CRS Socket 9Ethernet Port (not enabled - for future use)
5Wireless Telemetry Socket
65321 487 9

Product Features
11
February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
3.3. Side Panel
1Maternal ECG* 3Maternal Non-Invasive Blood Pressure (NIBP) *
2Maternal SpO2* 4Transducer storage
* Depending on model/options purchased
3.4. Base Label (on bottom of device)
4
321
777801-1
Medical
Electrical
Equipment
25EA
UL60601-1,
CAN/CSA
C22.2 No 601.1
Distributed By:
Clinical Computer Systems, Inc.
2895 Greenspoint Parkway
Suite No. 500
Hoffman Estates, Illinois 60169
Tel: [phone]
www.obix.com
1001049-1
Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of;
Huntleigh Healthcare Ltd.
35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom
T: [phone] [e-mail]
www.huntleigh-diagnostics.com
ArjoHuntleigh AB
Hans Michelsensgatan 10
211 20 Malmö, Sweden

Product Features
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
3.5. Product Labeling
Note: Product labeling should be read from a distance no greater than 0.5 m, as dened by IEC60601-1.
Applied parts
(Ultrasound Probes /
TOCO/ FECG/MECG)
are type CF
Applied parts
(Maternal NIBP/MSpO2/
fetal event marker) are
type BF
IP30
Protected against ingress
of solid foreign objects
>2.5mm diameter. Not
protected against ingress
of water.
Thissymbolsigniesthatthisproduct,includingitsaccessoriesandconsumablesissubjectto
the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of
responsibly in accordance with local procedures.
ThissymbolsigniesthatthisproductcomplieswiththeessentialrequirementsoftheMedical
Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745)
YYYY
-MM
Legal Manufacturer in association with the CE mark in Europe
ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden
Manufactured By:
Huntleigh Healthcare Ltd.
35PortmanmoorRoad,Cardi󰀨,CF245HN,UnitedKingdom
T: [phone] [email protected]
www.huntleigh-diagnostics.com
MEDICAL — PATIENT-MONITORING EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI ES60601-1:2005 + A1:2012, CAN/CSA C22.2 No. 60601-1:14, IEC 60601-1-
6:2010 (ed.3) + A1:2013, IEC 60601-1- 8:2006 (ed.2) + Am.1:2012, IEC 80601-2-30:2009 (ed.1) + A1:2013 , IEC
60601-2-37 (ed.2), Am1, IEC 60601-2-49 (ed.2):2011, ISO 80601-2-61:2011 (ed.1)
Rx Only Caution: Federal law restricts this device to sale by, or
on the order of a licensed healthcare practitioner. This side up
RoHS Compliant (RoHS -
Restriction of Hazardous
Substances)
Attention, consult accompanying documents
/ Instructions for Use
~Alternating current
(AC) On/Standby Fetal Event Marker
Equipotential Earth Protective Earth DI DeviceIdentier
SN Serial Number
REF
Reference Number MD Medical Device
Max stack x 4
identical boxes
YYYY
-MM
Date of Manufacture
Cardboard packaging
can be recycled.
Keep Dry Do Not Reuse Fragile
40°C
-10°C
Temperature
Limitations
93%
Limits of Relative
Humidity
106kPa
85kPa
Limits of Atmospheric
Pressure
PVC
Does not contain
PVC
LATEX
Not made with natural
rubber latex.
YYYY-MM
Use By
USB Port Ethernet Port Warning

Setup
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
4. Setup
4.1. System Connection
WARNING
These requirements must be met when connecting the OBIX BeCA to any other electrical equipment,
such as a PC.
1. Non-medical equipment must comply with the relevant IEC or ISO safety standard. For Information
Technologyequipment,thisstandardisIEC950/EN60950.
2. Anyone who connects additional equipment to signal input or signal output parts of the system is
conguringamedicalsystem,andisthereforeresponsibleforensuringthatthesystemcomplieswiththe
requirementsofIEC60601-1:2005;clause16.Ifthereisanydoubtastowhetheryoursystemcomplies,
consult the CCSI technical support.
3. If non-medical equipment (such as a PC or printer) with enclosure leakage currents greater than those
allowedbyIEC60601-1istobeusedinthepatientenvironment(within1.5mofthepatient),theenclosure
leakagecurrentsmustbebroughtwithinthelimitsspeciedbyIEC60601-1.Thismaybeachievedbyusing
amedicalgradeisolatingtransformer.ContactClinicalComputerSystems,Inc.formoreinformation.
4. An Equipotential earth/ground point is provided on the rear of the monitor for connection to a recommended
earth/ground point at the installation. The earth/ground wire should be run separately from any other AC
power cord or current carrying cables and should be kept as short as possible. Connection is achieved
using a DIN 42801 type female terminal terminated onto 4mm2256/28AWG yellow and green earth/ground
wire,connectedtotheEquipotentialEarthpoint/groundattheinstallation.Atnopointshouldapatient
be connected directly to earth/ground. All external earth/ground connections should be visually inspected
to ensure that all cables and connections are of good condition. Earth/ground bonding checks should be
carried out with a suitable portable appliance tester. The impedance between the protective earth/ground
andEquipotentialearth/groundattheinstallationshallnotexceed0.1Ω.
4.1.1. DVI output (option)
The DVI output allows an external display monitor (must support 800x600 resolution) to be connected to OBIX
BeCAusingastandardDVIcable.Iftheexternaldisplayisatouchscreen,asecondcablefromthedisplay
can be plugged into one of the USB ports. This allows OBIX BeCA to be controlled from the external display
monitor. The integral screen re active in this mode as a display but the touch function is disabled.
Theexternaldisplaymonitormusteitherbemedicalgrade,oradditionalelectricalisolationmeasuresmustbe
taken to ensure that the system complies with the relevant electrical / safety standards.
4.2. Probe/Sensor/Cu󰀨Connection
Ensure all cable connectors are fully inserted into the appropriate socket.
WARNING
Never remove cables by pulling on the wires; use the plug or connector instead.
4.3. Loading Paper
See “9.4. Changing Paper Packs” on page 52.

Setup
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
4.4. Handling and Mounting
Using a Cart
Ifthefetalmonitorwillbemovedregularly,itisrecommendedthatitbemountedonamobilecart.Contact
CCSI for available options. Follow the instructions provided with the cart regarding assembly and proper
mounting of the fetal monitor.
WARNING
Ensure cart's wheels are locked except when the cart is being moved.
WARNING
The fetal monitor must be equipped with the backup battery option in order to use it while transporting
a patient within the hospital.
WARNING
Ensure that cables do not present trip hazards that could lead to the equipment falling. Always store
unused transducers correctly.
WARNING
Do not attempt to move the cart, or use the OBIX BeCA without ensuring that the fetal monitor and all
transducers and cables are secured.
WARNING
Keep hands clear of the cart wheels while the cart is in motion. Do not attempt to free trapped cables
without stopping the cart and locking the wheels.
WARNING
When storing the fetal monitor, store it in its original shipping carton or cover it to help keep the device
clean.
Mounting Options
ContactClinicalComputerSystems,Inc.forinformationonbedsidecartsandothermountingoptionsforthe
fetal monitor and the optional OBIX wireless telemetry unit.
WARNING
Bedside carts and mounting hardware must be assembled and installed by trained personnel in
accordance with the manufacturer’s instructions. Perform load tests before use.
WARNING
If installing the fetal monitor on a mobile cart, ensure that it is securely attached to the support arm
using the correct base plate and hardware as described in the instructions supplied with the cart.

Operation
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
5. Operation
5.1. Power On
Note: If the DVI option is installed and an external touchscreen is connected, the fetal monitor’s touchscreen is
disabled, and all instructions that refer to the touchscreen apply to the external touchscreen.
When using an external touchscreen, you must power it on before plugging in or powering on the fetal
monitor in order for the external touchscreen to work.
Plugthemonitorpowercordintothebackofthefetalmonitorandthenintoahospital-grade,earth-grounded
3-prong AC power outlet. The monitor will automatically power up.
Ifthemonitorisalreadypluggedinbutisino󰀨/standbymode,pressandhold for approximately
2 seconds to turn on. A short tone will be heard.
Themonitorbrieydisplaysasplashscreen,thendisplaystheApplicationScreen.
5.2. Application Screen
Theapplicationscreenisconguredaccordingtothefetalmonitor’soptionsandmodules.Thescreenis
arrangedintoaseriesofwaveformsandnumericalindicators.Allfunctionsareaccessedviathetouchscreen,
either through the Control Bar icons located across the bottom of the screen or by touching each application.
Thefollowingshowsatypicalapplicationscreenandidentiesthedatadisplayed.Notethatsomeapplications
require you to touch and hold on the relevant area.
Patient Data Area
Screen
Lock/Unlock
Date/
Time
Battery
Status
(battery-
equipped
units only)
Alarm
Monitoring Parameters
Control Bar

Operation
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
5.3. Entering Patient Data
Note: If you are using the OBIX Perinatal Data System or another central monitoring system, do not enter
patient data in this screen. Use the central monitoring system instead. Patient data entered into the fetal
monitor is not transferred to the central monitoring system.
Touch and hold the Patient Data area in the top left corner of the screen to view the Patient Data screen
(shownbelow).Thisscreenallowsentryofpatient’sname,IDnumber,navigationtotheSet Gestational Age
screen,orsearchforpreviouspatients.
Enter Patient Name and Patient ID using the on-screen keyboard. Touch toconrmandenterthedata.
Touch Clear to clear all data from the screen if necessary.
Touch Search to view the Select Patient screen (below) that allows selection of patient data for a mother
who has been previously monitored.
Note: To search for patient records stored in the fetal monitor, enter passcode 9 8 7 6 5 after touching Search.
Touch the Gestation box to view the Set Gestational Age screen.
Touch to return to the Monitoring screen after entering the details on this screen.
5.3.1. Searching for Patient Names
Touch Select to select this patient. The patient name appears in the Patient Data area on the Monitoring
screen.

Operation
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February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5
5.3.2. Setting Gestational Age
The Set Gestational Age screenallowsentryofgestationalageusinganyofthefollowingthreemethods:
• Last menstrual period date
• Gestational age
• Estimated due date
The initial dates displayed assume a due date of the current date. Changing any one of the three parameters
automatically updates the other two.
Touch any up or down arrow icon to change the values. The maximum value for gestational age is 44 weeks.
Aftersettinggestationalage,touch toconrmandenteryourselectedsettingandreturntothePatient
Datascreen.Toexitthescreenwithoutsavingtheinformation,touch .
Touch Clear to clear the gestational age values and return to the Patient Data screen.

Operation
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777745-5 OBIX BeCA Fetal Monitor User Manual February 2023
5.4. Lock / Unlock Screen
Lockingthetouchscreenhelpspreventunauthorizeduseofthefetalmonitor.
Tolockthetouchscreen,touch to view the Lock Fetal Monitor? screen shown below.
Touch Lock to lock screen or to exit without locking.
Tounlockthescreen,touch ,thenentera5-digitcodeviathetouchscreen(defaultcode00123).