Huntleigh OBIX BeCA User Manual
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Huntleigh OBIX BeCA User Manual

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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.

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  • Page 1 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.

  • Page 3: Table Of Contents

    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 February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 4 Sample Trace (OBIX BeCA paper) ........................53 9.7. Turning off 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.
  • Page 5 Appendix 3 Maternal SpO Additional Nellcor Clinical Information ........88 Appendix 4 Wireless Monitoring with OBIX Freedom Telemetry Unit ........93 Appendix 5 Wireless Monitoring with OBIX BeCA Telemetry Unit ........94 February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 6 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 7: Safety Instructions

    Do not use with defibrillators. Ensure OBIX BeCA series monitors are not intended that all the fetal monitor leads and applied for use with patients fitted with cardiac parts are removed from the patient before pacemakers.

  • Page 8: Infection Control

    Do not use if there is any damage to the OBIX BeCA can be isolated from the power device or its accessories. 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 If this product is connected to another item relies for safety on its protective earth.

  • Page 9: Introduction

    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 •...

  • Page 10: Contraindications

    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 •...

  • Page 11: Product Features

    Do not attempt to connect any devices via these sockets other than those supplied by Huntleigh/CCSI. 3.1. Front Panel Features Touchscreen FHR1 US/FECG socket On/Off Button FHR2 US/FECG socket Printer TOCO Transducer socket February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 12: Rear Panel

    AC Power Socket DVI Socket (purchasable option) Equipotential earth/ground point Rating Label Fetal Event Marker Socket USB Ports (2) RS232/CRS Socket Ethernet Port (not enabled - for future use) Wireless Telemetry Socket 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 13: Side Panel

    Maternal SpO Transducer storage * Depending on model/options purchased 3.4. Base Label (on bottom of device) Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 sales@huntleigh-diagnostics.co.uk...

  • Page 14: Product Labeling

    106kPa Temperature Limits of Relative Limits of Atmospheric 40°C Limitations Humidity Pressure -10°C 85kPa Does not contain Not made with natural Use By LATEX rubber latex. USB Port Ethernet Port Warning 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 15: Setup

    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.

  • Page 16: Handling And Mounting

    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.

  • Page 17: Operation

    Control Bar icons located across the bottom of the screen or by touching each application. The following shows a typical application screen and identifies the data displayed. Note that some applications require you to touch and hold on the relevant area. Screen Date/ Patient Data Area Lock/Unlock Time Alarm Battery Status (battery- equipped units only) Control Bar February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 18: Entering Patient Data

    Monitoring screen after entering the details on this screen. 5.3.1. Searching for Patient Names Select Touch to select this patient. The patient name appears in the Patient Data area on the Monitoring screen. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 19: Setting Gestational Age

    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 confirm 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. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 20: Lock / Unlock Screen

    5.4. Lock / Unlock Screen Locking the touchscreen helps prevent unauthorized use of the fetal monitor. to view the Lock Fetal Monitor? screen shown below. To lock the touchscreen, touch Lock Touch 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). 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 21: Set Date / Time

    NST before completion. If this feature is enabled, the Annotation Icon appears in the control bar when printing and recording is active. (See “5.6.5. Annotation – EasiNotes” on page 20.) February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 22: Paper Feed

    Feature)” on page 77 for a list of all available EasiNotes. Note: If the OBIX BeCA is used with the OBIX Perinatal Data System or other central monitoring system, charting should be done in the central monitoring system or electronic health record system rather than using EasiNotes.

  • Page 23: Settings Menu

    Unlock Code Service Code Patient Data Code Settings Management Save new defaults Restore factory settings Import/export options Service only. See page 68. NIBP Protocol Trace Offsets Alarm TOCO MSpO2 NIBP Alarm Volume February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 24 Management Sub Menu” on page 68. Note: If power to the monitor is interrupted for more than 30 seconds and the monitor does not have a backup battery, the monitor reverts to the default settings. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 25: Clinical Sub Menu

    Use arrows to adjust the value. Place a checkmark in the box to turn on automatic fetal movement detection. Touch to confirm and save settings. TOCO/IUP Sets TOCO zero level. Place a checkmark in the box to turn on automatic zeroing of the TOCO. Touch to confirm and save settings. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 26: System Sub Menu

    To enable, touch the black check box to add a checkmark, then use up/down arrows to select the desired time for testing, in 5-minute increments. Touch at the top of the screen to confirm and save the new setting. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...
  • Page 27 Use up/down arrows to select desired values, then touch to confirm and save the setting. The fetal monitor displays and prints time using 24-hour format. Printer Illumination The printer area is illuminated when the box is checked. To enable, place a checkmark by touching the black check box, then touch to confirm and save the setting. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 28: Secure Settings Sub Menu

    20 bpm to make viewing clearer. Touch the checkmark at the top of the screen to accept the settings. Note: Print Twin Grids is not accessible when printing or recording. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 29: Alarm Sub Menu

    Select the check box to enable / disable the alarm. If selected a appears in the box. Touch to set the threshold. Touch the checkmark at the top of the screen to save the setting. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 30 Select the check boxes to enable / disable the NIBP alarms. If selected a appears in the box. Touch to set the thresholds. Touch the checkmark at the top of the screen to accept the settings. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 31: View Menu

    Note: MECG and FECG buttons are only available on Intrapartum models, and only when an FECG or MECG lead is connected. Touch each category to access the sub menu options available. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 32: Review Trace

    Starts a new monitoring session with a new patient. Note: Discharging the patient deletes the blood pressure results viewable from the View menu: Review Trace option. New Trace Starts a new monitoring session with the selected patient. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 33: Mecg

    5.6.7.4. FECG MECG FECG buttons display a trace from any ECG probe (fetal or maternal) that is plugged in. Touch Capture to freeze the screen to view the trace. Touch to restart the trace. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 34: Monitoring Parameters

    5.7. Monitoring Parameters You can configure the screen to display a white or black background. Refer to ‘“5.6.6. Settings Menu” on page 21. Touch to toggle between displaying the data in numeric or trace format. Trace format Numeric format 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 35: Numeric Format

    A speaker symbol is displayed on the channel if audio is enabled. To turn the audio off, touch the region displaying the speaker symbol. The speaker symbol is removed. 5.7.3. Fetal Heart Rate Signal Confidence The heart rate (HR) is shown by a flashing heart symbol on the bottom right corner of each region. The color of this heart denotes the HR confidence, it is not an indicator of signal strength. Red - High Amber - Moderate Yellow - Low If the heart symbol is displayed in outline only and no FHR is displayed, the OBIX BeCA cannot detect the fetal heartbeat. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 36: Fhr Monitoring

    The NIBP region shows the most recent blood pressure measurement. Touch and hold the NIBP region to access the NIBP menu. Refer to '”7.5. Maternal Blood Pressure” on page 44' for instructions on performing maternal blood pressure readings. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 37: Trace Format

    Touch the white triangle to expand a measurement. NIBP is shown expanded in the example shown above. Annotations and Clinical Events are printed vertically in the TOCO / MSpO region of the on-screen trace and the paper, if printing. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 38: Powering Off

    90% capacity from discharged is 3 hours. Note: When running on the battery and monitoring a single ultrasound channel at 25% volume and no printing, the fetal monitor can operate for a minimum of 4 hours. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 39: Monitoring Fetal Parameters

    6. Connect the fetal event marker to the socket on the rear panel. Explain to the mother how and when to use it. Note that a timeout between presses prevents markers being generated continuously. 7. Adjust the sound level with the volume controls on the touchscreen. 8. To start printing/recording, touch and hold the print/record on/off button on the touchscreen. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 40: Hints On Monitoring

    • It is not possible to monitor the fetal heart rate unless an audible fetal heart signal is present. It is important to distinguish the fetal pulse from the maternal pulse. To do this, feel the mother’s pulse during the examination, or monitor Maternal HR with MECG or MSpO 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 41: Preventing False Recording Of Fhr

    8. See “5.6.6. Settings Menu” on page 21 to select printer offsets for the traces. Note: During twin FHR monitoring, when switching to FECG for the presenting twin, disconnect the US transducer from the green FHR socket on the front of the OBIX BeCA and replace with the FECG transducer.

  • Page 42: Fetal Ecg Using A Scalp Electrode (Intrapartum Models Only)

    An FECG transducer can be connected to the green FHR1 or FHR2 sockets on the front of the monitor. Note: During twin FHR monitoring, when switching to FECG for the presenting twin, disconnect the US transducer from the green FHR socket on the front of the OBIX BeCA and replace with the FECG transducer.

  • Page 43: Monitoring Maternal Parameters

    7.1. Contractions (using TOCO transducer) WARNING Use only TOCO transducers supplied with the OBIX BeCA or listed in “16. Accessories and Consumables” on page 79. 1. Ensure that the TOCO transducer and belt are clean and ready for use. In particular, check the transducer for cracks or signs of damage. See “13.3. Cleaning and Disinfecting Patient Applied Parts” on page 58.

  • Page 44: Fetal Movement Event Marker

    Manual Fetal Movement Event Marker The manual fetal movement marker supplied with OBIX BeCA is a pushbutton with a cable and connector. It is plugged into the jack on the rear of the unit. The mother can record maternally sensed fetal movements by pressing the pushbutton.

  • Page 45: Maternal Ecg

    WARNING Ensure that any loose conductive parts of electrodes and associated connectors for applied parts including the neutral electrode do not contact any other conductive parts including earth/ground. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 46: Maternal Blood Pressure

    – it should not be held in position by the patient. • The patient should not move or speak during the test. • The cuff must be of the correct size and correctly positioned as detailed above – do NOT rely on the hose as the artery position marker. A conventional sphygmomanometer uses a fundamentally different method of measuring BP based on auscultation. This is generally recognized as the gold standard in non-invasive BP measurement and it is recommended that local protocols are in place for this method to be used for diagnosing/confirming hypertension. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 47: Taking Bp Measurements

    1 to 5 minutes. WARNING Always use the correct size of cuff. Use of an incorrectly sized cuff may result in blood pressure measurement errors. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 48 Extremes of temperature, humidity and altitude outside limits specified for OBIX BeCA can affect results. Note: Use of non-OBIX blood pressure cuffs with OBIX BeCA: If using any cuff not supplied by CCSI, the customer acknowledges that neither CCSI nor Huntleigh make any representation as to the accuracy of the measurement of NIBP.

  • Page 49: Reviewing Bp Results

    Intravascular dyes or externally applied coloring such as nail polish, dye, or pigmented cream • Artificial fingernails WARNING Do not use any maternal oximetry sensor cables with OBIX BeCA other than Nellcor compatible sensor cables. Use of incompatible sensors may result in inaccurate readings. WARNING Use only Nellcor compatible DOC 10 connecting cables. WARNING Remove any nail coloring or artificial fingernails before use as they are likely to affect the readings.
  • Page 50 Note: Use of non-Nellcor SPO sensors/cables with OBIX BeCA: If using any SPO sensor or connecting cable other than Nellcor, the customer acknowledges that neither CCSI nor Huntleigh make any representation as to the accuracy of the measurement of SPO 777745-5...

  • Page 51: Alarms

    An alarm acknowledgment indicator will be printed on the trace screen identifying the time of the alarm acknowledge . Alarm(s) Acknowledged will be printed on the TOCO region of the screen. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 52: Printed Indicators

    • Adjust the volume of the audio alarm. Note: The speaker is tested each time the OBIX BeCA is powered on. To confirm that the speaker is working, confirm that it beeps loudly when the fetal monitor is powered on.

  • Page 53: Printing

    Printing OBIX BeCA has a thermal printer for use with continuous fan-fold thermal paper. 9.1. Paper Options The printer is optimized for use with plain thermal print paper, although alternative paper trays are available as accessories to allow the use of Philips or GE/Corometrics paper with preprinted grids. Print options available with alternative paper types may be restricted due to difference in size compared to the plain paper. Standard thermal print paper fades over a period of time, typically up to 5 years depending on storage conditions. If it is necessary to guarantee a longer storage time for paper traces, the use of Architrace paper is recommended. This has a 25-year rated lifetime. A central monitoring system that stores traces electronically is another option.

  • Page 54: Changing Paper Packs

    Ensure that at least one paper pack is available to replace the old one when it comes to an end. Paper packs have a pre-printed marker to alert the user that the paper pack is running out. The OBIX BeCA paper marker is a red line near the top edge of the paper that starts approximately 1 meter before the end of the pack, giving 30-100 minutes notice of paper end.

  • Page 55: Using Non-Obix Beca Paper

    Note: The use of pre-printed graticuled paper disables ‘twins side-by-side’ trace printout. 9.6. Sample Trace (OBIX BeCA paper) The illustration below shows an actual tracing and identifies where the patient information is shown. Header Legend FHR trace from ULT1 MHR from MSPO MSPO Oxygen Saturation from TOCO Trace Maternal NIBP End of Trace Marker February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 56: Turning Off The Printer

    If the print timer is available this will show as an overlay on the print button When the printer is active this will show as follows If you attempt to stop the printer before the print timer expires, the following screen will be displayed. Touch Stop Printing to stop the recording or to cancel. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 57: Using Obix Beca With A Central Perinatal Monitoring System

    To connect the fetal monitor to the central system: 1. Connect the central monitoring system's data cable to the RS232 connector on the rear of the OBIX BeCA monitor. 2. Connect the other end of the data cable as described in the instructions supplied with your OBIX system or other perinatal data system.

  • Page 58: Troubleshooting

    Check event marker is connected. when the mother presses the event • Check enough time has elapsed since button last pressed. marker. OBIX BeCA does not beep when the • Check event marker is connected. mother presses the event marker. •...

  • Page 59: Maternal Blood Pressure

    Paper runs out • Replace paper pack. OBIX BeCA paper from Huntleigh paper has a colored stripe that appears when the paper pack nears its end. The printer icon on the control bar indicates when paper runs out. Information will be stored in memory for up to 100 hours to allow the paper pack to be changed.

  • Page 60: Care And Cleaning

    Always wipe off disinfectant using a cloth dampened with clean water. 12.2. General Cleaning and Disinfecting Always keep external surfaces clean and free of dirt and fluids using a clean dry cloth. 1. Wipe any fluids from the surface of the product using a clean dry cloth. 2. Wipe with a cloth dampened in 70% Isopropyl Alcohol. 3. Completely dry with a clean, dry lint-free cloth. 4. If the product has been contaminated, use the methods described for patient applied parts. 12.3. Cleaning and Disinfecting Patient Applied Parts Before examining patient: clean the applied parts using the low-risk cleaning method below. Following patient examination, clean and/or disinfect the applied parts by the appropriate method based upon the level of cross contamination risk, as defined in the following table: 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 61: Cleaning Nibp Cuff And Maternal Oximetry Sensor

    12.4. Cleaning NIBP Cuff and Maternal Oximetry Sensor For cleaning and disinfection, refer to instructions supplied by the manufacturer. 12.5. Washing Transducer Belts Reusable belts can be hand-washed at 40°C (104°F) maximum using a washing powder or mild detergent solution following the detergent manufacturer’s guidance. Rinse with clean water and dry without using heat. Single use disposable belts are designed for single patient use only and should not be washed. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 62: Maintenance

    Refer to your Service department for details of technical maintenance and support. 13.3. Corrective Maintenance All corrective maintenance must be performed by qualified engineers approved by Huntleigh Healthcare Ltd. The OBIX BeCA Service Manual (part number 777755) is an aid to engineers in maintenance and service of repairable parts. 13.4. Servicing Servicing should be performed only by Huntleigh Healthcare Ltd or their appointed service agent. Contact the distributor, Clinical Computer Systems Inc., at 1-888-871-0963. Press 2 for support.

  • Page 63: Secure Settings Menu

    (default code 5 5 5 5 5) to view the Service Menu. 13.5.1.1. Licensing For service use only. Allows additional features to be enabled with a valid license key. 13.5.1.2. NIBP Calibration For service use only. Allows qualified biomedical engineers to calibrate the fetal monitor’s NIBP system. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 64: Recordings Manager

    USB drive back to the fetal monitor for viewing. Also allows patient traces recorded and stored in the OBIX BeCA fetal monitor to be exported to a USB drive for archival. Archived traces are no longer available for viewing on the fetal monitor.

  • Page 65: Set Language

    To enter demonstration mode, touch one of the demo traces, then place a checkmark in the Start in Demonstration Mode check box. Touch ; the monitor prompts to power off. Touch Power Off . The next time the fetal monitor is powered on, the demonstration trace will run. To exit demo mode, power the fetal monitor off and then on again. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 66: Version Information

    The screen also allows use of the OBIX BeCA oximeter when the OBIX wireless transducers and telemetry unit are used. Touch after selecting the desired settings to save your selections. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 67: Patient Data

    Touch to save your selections. 13.5.9. Trace & Printer Settings This button is not available while printing is in progress. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 68: Trace Speed & Scale

    13.5.9.2. Printer Paper Printer Paper Touch to change the paper type used with the OBIX BeCA. OBIX BeCA (plain) paper is the default setting. Touch to save your selection. Note: The corresponding paper tray option must be installed in order to use paper with a preprinted grid.

  • Page 69: Secure Settings Code

    Note: Forgotten or lost codes cannot be reset. Touch to save your selection. 13.5.10.3. Service Code Allows editing of the code needed for accessing the monitor’s service features. Note: Forgotten or lost codes cannot be reset. Touch to save your selection. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 70: Patient Data Code

    OBIX BeCA factory default settings. Import Export buttons allow data transfer from one OBIX BeCA to another via USB Flash Drive. Note: The Import and Export buttons shown are only visible if a USB flash drive is plugged into the rear of the fetal monitor.

  • Page 71: Specifications

    5.7 Kg (with Printer) 7 years Service Life This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. 14.3. Environmental Operating Conditions Storage Conditions Temperature: +10°C to +40°C (50°F to 104°F) Temperature: -10°C to +40°C (14°F to 104°F) Relative Humidity: 10% to 90% (non condensing) Relative Humidity: 93% maximum Pressure: 86 kPa to 106 kPa Pressure: 86 kPa to 106 kPa (645 mmHg to 795 mmHg) (645 mmHg to 795 mmHg) February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 72: Transducers

    Input impedance 30µV to 500µV peak to peak Input range DC offset ±2V common mode ±300mV differential ±20V @ frequency Common mode range Noise <10µV peak-to-peak referred to input Type CF protection Safety 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 73: Uterine Activity (External Toco)

    Maximum 92db(A) 3 pulses: Alarm tone Pulse frequency = 311Hz Pulse duration = 170ms Rise time = 17ms Fall time = 28ms Inter pulse gap = 160ms Pulse amplitudes within 10% of each other Inter burst interval between 2.5s and 30s February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 74: Maternal Blood Pressure

    Mean arterial pressure Systolic High: 100-180mmHg Alarms Systolic Low: 50-150mmHg Diastolic High: 70-130mmHg Diastolic Low: 40-120mmHg Safety Type B protection Hardware and software controls to limit: • Inflation (max. 300 mmHg) • Measurement time (max. 90 s) EN 1060-3 Standards EN 1060-4 EN ISO 81060-2 EN 80601-2-30 ANSI/AAMI SP-10 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 75: Maternal Oximetry

    128mm thick film 8 dots per mm Resolution 1, 2, or 3 cm per minute (user selectable) Printer speeds 10 cm per minute fast forward Plain thermal paper, z-fold, 45m length Paper 30–240 bpm or 50–210 bpm (user selectable) FHR scales • Hospital name, time, date, paper speed, monitoring modes, signal loss Annotation • Mother’s name and ID number (optional) February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 76: Connections

    14.9.4. Interfaces Telemetry OBIX Wireless Telemetry OBIX Perinatal Data System System Contact Clinical Computer Systems Inc. for information on interfacing OBIX BeCA to other central monitoring systems. * Intrapartum models only 14.9.5. Display TFT Liquid Crystal Display (LCD) Technology 8.4" diagonal...

  • Page 77: Data Display

    14.10.2. Audio Volume 6 (out of 20) 6 (out of 20) Touch 10 (out of 20) Alarms 10 (out of 20) Fetal Movement 14.10.3. NIBP Auto Enable 15 minutes Repeat Interval February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 78: Printer

    1 minute MSpO Alarm Timeout 10 minutes NIBP Valid Period Show Mean Arterial Pressure 12345 Secure Settings Code Keyboard Language en-US 40% OFF Automatic Fetal Movement Detect HP50 over RS232 Communications protocol 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 79: Easinotes (Optional Feature)

    Up to Bathroom Pitocin Off Semi-Fowlers Up to Chair Epidural Infusion Off On Bedpan Up to Shower Oxygen On Sitting Cervical Exam Peanut Ball Altered Breathing Lithotomy Altered Pushing Trendelenburg Called for Assistance Physician Notified Resident Notified Midwife Notified February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 80: General Standards

    Induction of Labor Labor Other Custom Users can enter custom notes of up to 70 characters, including spaces and punctuation. Mark Places a mark on the maternal tracing when selected. 14.12. General Standards IEC 60601-1: 2005 + A1:2012 ISO 15223-1:2012 ANSI/AAMI ES60601-1:2005 IEC 60601-2-49:2011 CAN/CSA C22.2 No 601.1-M90 (R2005) IEC 62304 JIS T 0601-1:2012 IEC 60601-1-2: 2007 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 81: Accessories And Consumables

    ACC-OBS-079 Patient Event Marker SP 7775-6901 OBIX BeCA 1.0MHz Ultrasound Transducer (green) - 2 meters ACC-OBIX-001 OBIX BeCA 1.0MHz Ultrasound Transducer (green) - 3 meters ACC-OBIX-001L OBIX BeCA Toco Transducer (Pink) - 2 meters ACC-OBIX-002 OBIX BeCA Toco Transducer (Pink) - 3 meters ACC-OBIX-002L Nellcor DS-100A Adult Oxygen Reusable Finger Sensor ACC-NEL-DS-100A Nellcor SpO Connection Cable...

  • Page 82: Warranty And Service

    16. Warranty and Service 16.1. Warranty Statement to End User This Warranty Statement is provided by Huntleigh Healthcare (“Manufacturer”) to end users who purchase or lease Huntleigh products from Clinical Computer Systems, Inc, Huntleigh’s U.S. Distributor. All Huntleigh Healthcare products supplied are new and not reconditioned and are warranted by Manufacturer against defects, in ordinary use, in materials and workmanship for the following periods from date of shipment by...

  • Page 83: Service

    35 Portmanmoor Road, Cardiff CF24 5HN U.K Tel: +44 (0)29 20485885 Fax: +44 (0)29 20492520 This Warranty statement is governed by the laws of the United States and the State of Illinois without reference to conflicts of law principles. The application of the United Nations Convention on Contracts for the International Sale of Goods is expressly excluded. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 84: Appendix 1 Electromagnetic Compatibility

    WARNING Portable RF communications equipment (with the exception of antenna mounting kit ACC-OBS-084) should be used no closer than 30 cm (12 inches) to any part of the OBIX BeCA. Otherwise, degradation of the performance of this equipment could result.
  • Page 85 Interference may occur in the vicinity of the equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 4070 MHz. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the fetal monitor observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the fetal monitor. Over the frequency range 150 kHz to 80 kHz, field strengths should be less than 3V/m. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 86 IEC 61000-4-8 NOTE U is the AC voltage prior to the application of the test level. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...
  • Page 87 Unexpected or erratic pulse rate patterns would prompt the user seeking voltage in tolerance. alternative confirmation. Input impedance maintained. Unexpected or erratic pulse rate patterns would prompt the user seeking alternative confirmation. Input noise maintained. Common mode rejection maintained February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 88: Appendix 2 Ultrasound Safety Considerations

    The calculated de-rated intensity values for the OBIX BeCA fetal monitors compare very favorably with previously reported acoustic safety data for Doppler ultrasound instruments and are appropriate for all clinical applications recommended in this manual. At present, there is a clear consensus that the benefits to patients of prudent use of diagnostic ultrasound outweigh the risks that may be present. See:...
  • Page 89 The reported uncertainties are based on standard uncertainties multiplied by a coverage factor k = 2 providing a level of confidence of approximately 95%. Acoustic Parameter Uncertainty Power ±28% Pressure ±10% Intensity ±20% Center Frequency ±10% Thermal and mechanical indices are below 1 under all circumstances. Measurements were made by the National Physical Laboratory, Teddington, Middlesex, UK in accordance with NEMA UD-2 (2004). February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...

  • Page 90: Appendix 3 Maternal Spo Additional Nellcor Clinical Information

    These capabilities are beyond the scope of known bench top testers. SpO measurement accuracy can only be evaluated in vivo by comparing monitoring system readings with values traceable to SaO measurements obtained from simultaneously sampled arterial blood using a laboratory CO-oximeter. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...
  • Page 91 When calculating saturation from a blood gas partial pressure of oxygen (PO ), the calculated value may differ from the SpO measurement of a monitoring system. This usually occurs when saturation calculations exclude corrections for the effects of variables such as pH, temperature, the partial pressure of carbon dioxide (PCO and 2,3-DPG, that shift the relationship between PO and SpO February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 92 Optical Power Output Nellcor DS-100A 660 and 900nm nom. <15mW • Displayed ranges: MSpO and pulse ranges are shown in ”15. Specifications” on page 69. • Data update period: 1 second • Heart rate averaging: 6-7 seconds • Alarm latency: < 1 second • Alarm limits: See ”15. Specifications” on page 69. • Compatible probe type: Nellcor Durasensor DS-100A • Recommended maximum application time: 4 hours • Probe temperatures >41°C (105.8°F)– Specific instructions: Not applicable 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...
  • Page 93 Table 1. Demographic Data Type Class Total Gender Male Female Race Caucasian Hispanic African American Asian 19-48 Weight 108-250 Skin pigment Very light Olive Dark olive/Medium black Extremely dark/Blue black Study Results Accuracy was calculated using the root mean square difference (RMSD). February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 94 Trendline of MAX-FAST sensor ____  Adverse Events or Deviations The study was conducted as expected with no adverse events and no deviations from the protocol. Conclusion The pooled results indicate that for a saturation range of 60-80% for SpO , the acceptance criterion was met for the monitoring system when tested with MAX-A, MAX-N and MAX-FAST sensors. The pooled results indicate that for a saturation range of 70-100% for SpO , the acceptance criterion was met. 777745-5 OBIX BeCA Fetal Monitor User Manual February 2023...

  • Page 95: Appendix 4 Wireless Monitoring With Obix Freedom Telemetry Unit

    Using the OBIX Freedom Telemetry Unit Note: While using OBIX BeCA with the OBIX Freedom in wireless mode, the NIBP is enabled, the maternal pulse with oximetry is optional, and the MECG is disabled. To allow use of the oximeter in wireless mode, see “14.5.7.

  • Page 96: Appendix 5 Wireless Monitoring With Obix Beca Telemetry Unit

    Appendix 5 Wireless Monitoring with OBIX BeCA Telemetry Unit Please refer to the IFU supplied with the OBIX BeCA Wireless Transducer System for detailed instructions on the use, care and maintenance before connecting and using the equipment. Connecting the Telemetry Unit OBIX BeCA Wireless Transducer System should be placed on a flat surface. Alternatively, it can be...
  • Page 97 MECG cable be kept straight to avoid damage to the TOCO-E transducer’s interface caused by twisted cable. To disable wireless operation and return to wired transducer monitoring, dock the wireless transducers back into the docking slots in the base station. Ending Monitoring Once monitoring is complete and the wireless transducers and base station have been cleaned, dock the wireless transducers into the docking slots in the base station, so they are easily located when you want to use the system again, and so the transducer batteries can be charged. February 2023 OBIX BeCA Fetal Monitor User Manual 777745-5...
  • Page 98 In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; Distributed By: ArjoHuntleigh AB Clinical Computer Systems, Inc.

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