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.

Huntleigh OBIX BeCA Specifications

General

Brand	Huntleigh
Model	OBIX BeCA
Category	Medical Equipment
Language	English

Summary

1. Safety Instructions

1.1. Warnings

Covers various safety warnings and precautions for device usage.

1.2. Infection Control

Guidelines for preventing infection during device use and cleaning.

1.3. Patient Applied Parts

Identifies parts of the device that come into contact with the patient.

2. Introduction

2.1. Intended Use and Indications

Specifies the intended use and medical indications for the fetal monitor.

2.2. Contraindications

Details conditions or situations where the device should not be used.

2.3. Unpacking / Preliminary Checks

Instructions for unpacking and initial inspection of the device and its contents.

2.4. Operator Positioning

Guidance on the recommended position for operating the fetal monitor.

3. Product Features

3.1. Front Panel Features

Description of the components and controls located on the front panel of the device.

3.2. Rear Panel

Details the connectors and ports available on the rear panel of the fetal monitor.

3.3. Side Panel

Identifies the connectors and storage features on the side panel.

3.4. Base Label (on bottom of device)

Information provided on the label located on the bottom of the device.

3.5. Product Labeling

Explanation of the various symbols and labels found on the product.

4. Setup

4.1. System Connection

Instructions for connecting the fetal monitor to other electrical equipment and grounding.

4.2. Probe/Sensor/Cuff Connection

Guidance on correctly connecting the various probes, sensors, and cuffs to the device.

4.3. Loading Paper

Instructions for loading paper into the printer.

4.4. Handling and Mounting

Procedures and precautions for safely handling and mounting the fetal monitor.

5. Operation

5.1. Power On

Steps for turning the fetal monitor on and initial start-up sequence.

5.2. Application Screen

Overview of the main operating screen, its layout, and access to functions.

5.3. Entering Patient Data

Procedure for inputting patient identification and gestational age information.

5.4. Lock / Unlock Screen

How to lock and unlock the touchscreen to prevent unauthorized use.

5.5. Set Date / Time

Instructions for setting the current date and time on the monitor.

5.6. Control Bar

Description of the control bar icons and their functions at the bottom of the screen.

5.3.1. Searching for Patient Names

Method for searching and selecting previously monitored patients.

5.3.2. Setting Gestational Age

Options for entering gestational age using LMP, current age, or estimated due date.

5.6.1. Record/Print

Functionality for recording and printing fetal heart rate traces.

5.6.2. Paper Feed

How to manually feed paper through the printer.

5.6.3. Numeric / Trace View

Switching between numerical and graphical display formats.

5.6.4. Volume Up/Down

Adjusting the volume for audible heart tones.

5.6.5. Annotation – EasiNotes

Optional feature to add notes to the printout or recorded file.

5.6.6. Settings Menu

Accessing and navigating the various configuration settings for the monitor.

5.6.6.1. Clinical Sub Menu

Settings related to fetal movement detection and TOCO zero level adjustments.

5.6.6.2. System Sub Menu

Configuration options for sound, non-stress test timing, and printer illumination.

5.6.6.3. Secure Settings Sub Menu

Accessing secure settings which require a passcode for protection.

5.6.6.4. Trace Offsets Options

Option to offset twin traces for clearer viewing.

5.6.6.5. Alarm Sub Menu

Configuration of alarm limits and thresholds for various parameters.

5.6.7. View Menu

Accessing options to review traces, MECG, and FECG data.

5.6.7.1. Review Trace

Procedure for selecting and viewing previously stored cardiotocography traces.

5.6.7.2. Review Mode Sub Menu

Options within review mode, including discharging patients or starting new traces.

5.6.7.3. MECG

Displaying and capturing maternal ECG (MECG) waveforms.

5.6.7.4. FECG

Displaying and capturing fetal ECG (FECG) waveforms.

5.7. Monitoring Parameters

Overview of how to configure screen display for monitoring parameters.

5.7.1. Numeric Format

Displaying only numerical data for parameters, increasing readability.

5.7.2. Audio

Enabling or disabling audible signals for fetal and maternal heart rates.

5.7.3. Fetal Heart Rate Signal Confidence

Interpreting the color-coded heart symbol indicating FHR signal confidence.

5.7.4. FHR Monitoring

Display of Fetal Heart Rate for singleton and twin monitoring.

5.7.5. TOCO/IUPC

Measurement and zeroing of contractions (TOCO) or IUPC.

5.7.6. MSpO2 / MHR / MECG

Display of maternal oxygen saturation, heart rate, and ECG data.

5.7.7. Maternal NIBP

Display and access to maternal non-invasive blood pressure readings.

5.7.8. Trace Format

Graphical display of parameters with numerical data on the right side.

5.8. Powering OFF

Procedure for turning the fetal monitor off.

5.9. Battery Charging

Information on how the backup battery is charged and its operating time.

6. Monitoring Fetal Parameters

6.1. Preparation

Steps to ensure the monitor and transducers are ready for fetal monitoring.

6.2. Ultrasound Monitoring

Procedure for connecting and using the ultrasound transducer for FHR monitoring.

6.2.1. Hints on Monitoring

Tips and best practices for optimizing ultrasound monitoring placement and signal quality.

6.3. Preventing False Recording of FHR

Methods to avoid artifacts and ensure accurate FHR readings, such as double-rating.

6.4. Twins Ultrasound Monitoring

Procedure for monitoring two fetuses simultaneously using multiple transducers.

6.5. Fetal ECG using a scalp electrode (intrapartum models only)

Guidance on using fetal ECG scalp electrodes for intrapartum monitoring.

6.5.1. Connecting FECG Transducer to OBIX BECA

Steps for connecting the FECG transducer to the OBIX BECA monitor.

6.5.2. Monitoring procedure using Safelinc™™ / Qwik Connect™™/Philips electrodes

Procedure for monitoring fetal ECG using specific electrode types.

7. Monitoring Maternal Parameters

7.1. Contractions (using TOCO transducer)

Procedure for monitoring uterine contractions using a TOCO transducer.

7.2. Contractions (using Intrauterine Pressure Catheter (IUPC), Intrapartum models only)

Monitoring uterine contractions using an IUPC for intrapartum models.

7.3. Fetal Movement Event Marker

Methods for capturing and marking fetal movement events.

7.4. Maternal ECG

Procedure for monitoring maternal ECG to differentiate from fetal heart rate.

7.5. Maternal Blood Pressure

Process for measuring maternal systolic, diastolic, and mean arterial pressure.

7.5.1. Attaching the Cuff

Guidance on correctly attaching the NIBP cuff for accurate readings.

7.5.1.1. Cuff size

Matching the correct NIBP cuff size to the patient's arm circumference.

7.5.1.2. Cuff positioning

Correctly positioning the NIBP cuff on the patient's upper arm for measurement.

7.5.1.3. Other considerations

Factors affecting BP measurement accuracy and best practices.

7.5.2. Taking BP Measurements

Steps for performing manual or automatic blood pressure measurements.

7.5.3. Reviewing BP Results

How to view and print previously recorded maternal blood pressure measurements.

7.6. Maternal Oximetry

Procedure for measuring maternal oxygen saturation and pulse rate.

8. Alarms

8.1. What is Meant by an Alarm

Explanation of the purpose and limitations of the monitor's alarm system.

8.2. Alarm Indications

How alarms are indicated visually and audibly on the monitor.

8.2.1. Printed Indicators

Explanation of visual indicators and printed symbols for various alarm conditions.

8.3. Responding to Alarms

Recommended user actions to take when specific alarms are triggered.

8.4. Controlling Alarms

Methods for acknowledging, silencing, or adjusting alarm settings.

9. Printing

9.1. Paper Options

Information on available paper types and trays for the printer.

9.2. Paper Care and Handling

Guidelines for storing and handling thermal print paper to maintain quality.

9.3. Print Speed and Duration

Details on selectable print speeds and their impact on paper usage.

9.4. Changing Paper Packs

Step-by-step instructions for replacing the printer paper roll.

9.5. Using Non-OBIX BeCA Paper

Advantages and limitations of using non-OBIX paper, especially pre-printed types.

9.6. Sample Trace (OBIX BeCA paper)

An example tracing showing patient information and parameter display.

9.7. Turning off the Printer

Procedure for safely turning off the printer and handling paper run-out scenarios.

10. Using OBIX BECA with a Central Perinatal Monitoring System

11. Troubleshooting

11.1. Essential Performance

What to do if essential performance criteria are not met.

11.2. FHR

Common FHR signal issues, causes, and remedies.

11.4. Fetal Event Marker

Troubleshooting issues with the fetal event marker not appearing or beeping.

11.7. General

General troubleshooting for issues like the monitor not turning off.

11.3. Oximetry

Common issues with the oximetry sensor signal and potential causes.

11.5. Maternal blood pressure

Troubleshooting NIBP readings and printer issues.

11.6. Printing

Common printing problems like paper out, poor quality, or printer stopping.

12. Care and Cleaning

12.1. General Care

General precautions and warnings for handling and cleaning the device.

12.2. General Cleaning and Disinfecting

Procedures for cleaning and disinfecting the external surfaces of the monitor.

12.3. Cleaning and Disinfecting Patient Applied Parts

Methods for cleaning and disinfecting transducers and other patient-applied parts.

12.4. Cleaning NIBP Cuff and Maternal Oximetry Sensor

Specific instructions for cleaning NIBP cuffs and oximetry sensors.

12.5. Washing Transducer Belts

Guidelines for hand-washing reusable transducer belts.

13. Maintenance

13.1. User Maintenance

Routine checks and cleaning tasks that can be performed by the user.

13.2. Technical Maintenance

Information regarding technical maintenance procedures.

13.3. Corrective Maintenance

Requirements for performing corrective maintenance by qualified engineers.

13.4. Servicing

Information on how to arrange for servicing of the fetal monitor.

13.5. Secure Settings Menu

Accessing and managing secure settings, including service and security codes.

13.5.1. Service Sub Menu

Options available within the service menu for trained biomedical staff.

13.5.1.3. Recordings Manager

Features for searching, archiving, or exporting patient recordings.

13.5.1.4. Manometer

Service-only function for tests related to NIBP measurement.

13.5.1.5. Contacts

Contact information for the fetal monitor distributor.

13.5.1.6. Archive Manager

Functionality for restoring or exporting archived patient traces.

13.5.2. Set Language

Option to change the user interface language of the monitor.

13.5.3. Hospital Name

Setting and displaying the hospital name on printouts.

13.5.4. Demonstration

Entering demonstration mode to play recorded traces.

13.5.5. Version Information

Display of monitor software and hardware version details.

13.5.6. Regional Settings

Configuration of time zone and on-screen keyboard settings.

13.5.7. Clinical Settings

Adjusting clinical parameters like alarm icons, MAP display, and SpO2 timeout.

13.5.8. Patient Data

Enabling or disabling patient data entry, EasiNotes, and recordings.

13.5.9. Trace & Printer Settings

Accessing settings for trace speed, scale, and printer paper type.

13.5.9.1. Trace Speed & Scale

Changing trace printing/scrolling speed and grid parameters.

13.5.9.2. Printer Paper

Selecting the type of paper used with the printer.

13.5.10. Lock Codes

Managing security codes for accessing different settings.

13.5.10.1. Secure Settings Code

Changing the passcode for accessing secure settings.

13.5.10.2. Unlock Code

Setting or disabling the code required to unlock the screen.

13.5.10.3. Service Code

Changing the passcode for accessing the monitor's service features.

13.5.10.4. Patient Data Code

Changing the passcode for editing patient data files.

13.5.11.Settings Management Sub Menu

Options for saving defaults, restoring factory settings, and data transfer.

13.5.12. NIBP Protocol

Configuring automatic blood pressure measurement protocols.

14. Specifications

14.1. Equipment Classification

Classification of the device regarding protection against electric shock.

14.3. Environmental

Operating and storage conditions for temperature, humidity, and pressure.

14.2. General

General specifications including voltage, size, weight, and service life.

14.4. Transducers

Technical specifications for Ultrasound and FECG transducers.

14.5. Alarm characteristics

Details on alarm sound pressure levels and alarm tone characteristics.

14.6. Maternal Blood Pressure

Technical specifications for the maternal blood pressure measurement function.

14.7. Maternal Oximetry

Technical specifications for maternal oxygen saturation and pulse rate monitoring.

14.8. Printer

Specifications for the printer, including print head, resolution, and paper type.

14.9. Connections

Overview of all available connectors on the front, side, and rear panels.

14.10. Default Settings

Default values for alarms, audio, NIBP, printer, and other system parameters.

14.11. EasiNotes (Optional Feature)

List of available EasiNotes categories for annotating traces.

14.12. General Standards

List of general standards to which the product complies.

15. Accessories and Consumables

16. Warranty and Service

16.1. Warranty Statement to End User

Terms and conditions of the manufacturer's warranty for the product.

16.2. Service

Procedures for returning the device for service, repair, or decontamination.

Appendix 1 Electromagnetic Compatibility

Manufacturer's Performance Criteria Specification

Expected performance levels and user expectations if essential performance is lost.

Appendix 2 Ultrasound Safety Considerations

Appendix 3 Maternal SpO2 Additional Nellcor Clinical Information

Appendix 4 Wireless Monitoring with OBIX Freedom Telemetry Unit

Appendix 5 Wireless Monitoring with OBIX BeCA Telemetry Unit