Mcube CUBEscan BioCon-900S Operator's Manual
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Mcube CUBEscan BioCon-900S Operator's Manual

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BioCon -900S
OPERATOR'S MANUAL

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Alexandra Parting
May 7, 2025

We have a Cubescan 900. It seems to be stuck on the first screen saying Cubescan or a scrambled version of that and won't move from there. We have been charging it thinking it's flat but still doesn't work.

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Summary of Contents for Mcube CUBEscan BioCon-900S

  • Page 1 BioCon -900S OPERATOR’S MANUAL...
  • Page 2 CUBEScan BioCon-900S Operator’s Manual This page left blank intentionally. Page 2...
  • Page 3 Mcube Technology. Examples or images in this document are fictitious and do not in any way represent real patient data.

  • Page 4: Table Of Contents

    CUBEScan BioCon-900S Operator’s Manual TABLE OF CONTENTS GENERAL INFORMATION ..................6 PRODUCT DESCRIPTION ......................6 INTENDED USE / INDICATIONS FOR USE ................... 6 PATIENT/USER CHARACTERISTICS ..................6 PRESCRIPTION STATEMENT....................... 6 SERVICE ............................6 SAFETY INFORMATION ................... 8 NOTICE TO ALL USERS........................ 8 CONTRAINDICATIONS .........................
  • Page 5 CUBEScan BioCon-900S Operator’s Manual TIME SETTINGS ........................... 39 SLEEP MODE SETTINGS ......................40 DISPLAY BRIGHTNESS SETTINGS ................... 40 PRE-SCAN SETTINGS ........................ 41 DELETE ALL MEASUREMENTS ....................41 MAINTENANCE ....................... 43 TROUBLESHOOTING ......................... 43 DIALOG BOXES FOR MAINTENANCE..................43 CLEANING & DISINFECTION ..................... 44 BATTERY MAINTENANCE ......................

  • Page 6: General Information

    CUBEScan BioCon-900S Operator’s Manual GENERAL INFORMATION PRODUCT DESCRIPTION CUBEScan BioCon-900S is a safe and easy, non-invasive system to measure the bladder volume. The device consists of a probe, CUBEScan Charger, and various components. The probe is a B-mode instrument, hand-held, wireless and battery-operated. A 3D-mechanical sector transducer provides cross– sectional images of the bladder from up to 12 scan planes and bladder volume is calculated based upon those images and displays 12 scan planes on a screen.
  • Page 7 CUBEScan BioCon-900S Operator’s Manual If you encounter difficulty with the system, please contact local distributers or Mcube Technology at mcube@mcubetech.co.kr Page 7...

  • Page 8: Safety Information

    CUBEScan BioCon-900S Operator’s Manual SAFETY INFORMATION NOTICE TO ALL USERS This guide covers components, function, maintenance, storage, and precautions needed to use this system. All users must read and thoroughly understand this entire guide prior to using the BioCon-900S. This section has information on safe use of the BioCon-900S (Biological Safety, Electrical Safety, Device Safety and Safe handling procedures for transporter).

  • Page 9: Device Safety

    The user might need to take mitigation measures, such as relocating or re-orienting the device.  Do not use the system if an error message appears on the display: note the error code; call Mcube technology or your local distributor, shut down the system DEVICE SAFETY To protect your BioCon-900S, and components, follow these warnings and cautions.
  • Page 10 Use the system indoors only.  Do not use the system if it exhibits erratic or inconsistent behavior. Shut down the system and contact Mcube Technology or your local distributor.  Do not spill liquid on the system. COMPLIANCE STATEMENTS...

  • Page 11: Safe Handling Procedures For Transporter

    CUBEScan BioCon-900S Operator’s Manual SAFE HANDLING PROCEDURES FOR TRANSPORTER Quarantine: Packages that are crushed, punctured or torn open to reveal contents should not be placed into deployment. Such packages should be isolated until the shipper has been contacted, provides disposition instructions and, if appropriate, arranges to have the product inspected and repacked. Spoiled Product: In the event that damage to packaging results in damage to the battery causing released electrolyte, the spill should be contained and the shipper should be contacted for instructions.

  • Page 12: Introduction

    CUBEScan BioCon-900S Operator’s Manual INTRODUCTION PRODUCT FEATURES The main components of CUBEScan BioCon-900S are a Probe and the Charger. BioCon-900S Probe & Charger  Hand-held, portable and lightweight  Touchscreen interface  Measures bladder volume with ultrasound  Provides a live image of bladder during Pre-scan ...

  • Page 13: Outer Appearance - Probe

    Users can replace only gel  The other parts are not allowed for the users to disassemble or replace except the gel. Please contact your local distributor or Mcube Technology.  Only use the ultrasonic gel approved by FDA, CE.

  • Page 14: Outer Appearance - Charger

    CUBEScan BioCon-900S Operator’s Manual Indicates charging status. Battery indicator Orange solid - Battery is being charged. Off – Battery is fully charged. Reads printed a barcode Barcode Module Laser Safety Label Explanatory label – Class 1 laser product Label Put on this label when there is no optional barcode module NOTE : Labels are subject to change without prior notice Back Label NOTE: The appearance of these labels(No.8 - 9) depends on wheter the barcode option is selected or...

  • Page 15: Display And Icons

    CUBEScan BioCon-900S Operator’s Manual DISPLAY AND ICONS A touch-screen display allows you to perform scans, manage results and setup. The Home screen appears when the probe is turned on. It services as a starting point for all the main functions of the device. You can select the desired icons by tapping them directly on the touch-screen.
  • Page 16 CUBEScan BioCon-900S Operator’s Manual Icon Description Barcode - Record a barcode (Optional) Home – Return to the Home screen. Scan – Perform the Normal scan or Pre-scan. Exit –Return to the Information screen. Scan Result screen Icon Description Aiming Information – Rotate 15° clockwise, indicating the aiming point of the bladder. Urine Volume –...
  • Page 17 CUBEScan BioCon-900S Operator’s Manual Sleep mode (2min, 3min, 5min) Display brightness (0 to 100%, default= 50%)) Pre-scan On ( ) / Off ( Delete all saved results. Calibration Reminder On ( ) / Off ( Self-test (YY/MM/DD) Phantom Calibration (YY/MM/DD) CalKit Calibration (YY/MM/DD) On the self-test or calibration screen, perform self-test or calibration Cease –...

  • Page 18: Setup

     Immediately discontinue use of the battery, if the battery emits an unusual smell, feels hot, changes color or shape, or appears abnormal in any other way. Contact Mcube Technology or your local distributors. The probe is powered by a internal lithium ion battery. The battery is charged by Charger and the Battery...

  • Page 19: Scan Type

    CUBEScan BioCon-900S Operator’s Manual Status icon ( ) is always displayed in the Status at the top of the screen, indicating the current capacity. Before using the probe for the first time, you must fully charge the battery. When you don’t use your probe, we recommend that you mount and store it on the Charger to ensure that the probe is sufficiently charged.

  • Page 20: How To Use

    CUBEScan BioCon-900S Operator’s Manual 5 HOW TO USE CHECKUP BEFORE USE Before using BioCon-900S, ensure you are familiar with the device and its parts. If you use it for the first time, we strongly recommend you to try your first bladder volume measurement on a patient with moderately full bladder using Pre-scan.

  • Page 21: Select Patient Type

    CUBEScan BioCon-900S Operator’s Manual 1) Press the Power Button ( ) shortly to wake the probe from sleep mode. 2) Only Loading screen (2) appears on the display. 3) Home screen appears when the system is fully loaded at start up. Turn System off 1) Press the Power Button ( ) shortly twice to go into sleep mode.

  • Page 22: Record Information For A Patient

    CUBEScan BioCon-900S Operator’s Manual Figure 14 Patient Type Figure 15 Female Patient Type RECORD INFORMATION FOR A PATIENT INPUT INFORMATION – VIRTUAL KEYBOARD 5.4.1 The Information screen appears when you tap one of the Patient icon on the Home screen. You can tap the text box and update information for a patient by typping the virtual keyboard.
  • Page 23 CUBEScan BioCon-900S Operator’s Manual First Name Tap First Name text box, and then enter the patient’s first name by typping the virtual keyboard Sur Name Tap Sur Name text box, and then enter the patient’s sur name by typping the virtual keyboard If you would like to the change the virtual keyboard type, tap Keyboard icon ( ) in the left corner of the virtual keyboard.

  • Page 24: Measure Bladder Volume

    CUBEScan BioCon-900S Operator’s Manual WARNING  “LASER RADIATION – AVOID DIRECT EXPOSURE TO BEAM”  Do not capture human being with the barcode module.  Hold the probe with both hands tightly, when you read barcodes with patient information.  Recording barcodes is not available, after the scan result is saved. Figure 22 Information Screen Figure 23 Barcode Scan Screen How to read a barcode...
  • Page 25 CUBEScan BioCon-900S Operator’s Manual Figure 24 Positioning Bladder Figure 25 Probe Direction 1) Tap the Scan icon( ) on the Information screen or press the probe Scan Button . The scanning process begins. 2) The progress bar on the screen appears. It takes 3 seconds to complete the normal scan. Hold the probe steady while scanning.

  • Page 26: Display A Scan Results

    CUBEScan BioCon-900S Operator’s Manual Figure 27 Positioning Bladder Figure 28 Probe Direction 5) Tap the Scan icon( ) on the Information screen or press the probe Scan Button to start Pre- scan. A Pre-scan image such as 2D ultrasonic image appears on the probe screen. Description Center Line Bladder point: It helps to...
  • Page 27 CUBEScan BioCon-900S Operator’s Manual Figure 31 Scan Result Screen BLADDER VOLUME 5.6.1 View the bladder volume displayed in milliliters (ml). The Urine Volume icon( ) shows the measured urine volume. (1) shows the most recent volume and (2) shows the maximum volume from multiple results for one patient. PATIENT INFORMATION AND SCAN DATE &...

  • Page 28: Re-Aim Bladder

    CUBEScan BioCon-900S Operator’s Manual RE-AIM BLADDER If the bladder is not centerd in the target or too small, you can re-aim and re-scan the bladder before saving the scan result. We strongly recommend that you re-aim and re-scan more than one time for accuracy.

  • Page 29: Fetch A Missing Data

    CUBEScan BioCon-900S Operator’s Manual FETCH A MISSING DATA If you did not save a scan result and return to the Home screen, the Missing Data icon ( ) appears on the Home screen. Tap the Missing Data icon ( ) to fetch the unsaved scan result. The Scan Result screen on the missing data appears.
  • Page 30 CUBEScan BioCon-900S Operator’s Manual Figure 36 Home Screen Figure 37 Review Screen DELETE A SAVED SCAN RESULT 5.11.2 1) The Review screen is displayed when you tap the Review icon ( ) on the Home screen. 2) Select the scan result you want to delete by tapping Previous & Next icon ( 3) Tap the Deletion icon ( ) and a Delete Confirm dialog box ( ) appears.
  • Page 31 CUBEScan BioCon-900S Operator’s Manual Figure 40 Delete Last Scan Result Figure 41 Empty Folder Dialog Box Page 31...

  • Page 32: Screens

    CUBEScan BioCon-900S Operator’s Manual 6 SCREENS HOME SCREEN Turn the probe on and the Home screen appears. It shows the main functions of the probe. The icons below on the screen allow you to select patient type, go to the Review screen or go to the Setup screen. Description Time Number of Saved Data / Internal Storage (50)

  • Page 33: Barcode Screen (Optional)

    CUBEScan BioCon-900S Operator’s Manual BARCODE SCREEN (OPTIONAL) The Barcode screen is used to record data by scanning barcode with patient information. See the section “5.4.2 INPUT INFORMATION – OPTIONAL BARCODE” for more information if you want. Figure 46 Information Screen Figure 47 Barcode Screen (Optional Barcode) VIRTUAL KEYBOARD SCREEN...

  • Page 34: Normal Scan Screen

    CUBEScan BioCon-900S Operator’s Manual Add a space. Exit the screen after recovering previous characters. NORMAL SCAN SCREEN Normal scan - Get 12-plane ultrasound images and calculate the residual urine in the bladder (3D scanning). It takes 3 sec to complete the Normal scan. As bladder volume is calculated, the progress bar increases until the scan is completed.

  • Page 35: Scan Result Screen

    CUBEScan BioCon-900S Operator’s Manual SCAN RESULT SCREEN The Scan Result screen appears automatically when a normal 3D measurement is complete. The aiming information (crosshair) helps you verify the Scan result. The icons below on the display allow you to review other planes of the same measurement, return to the Home screen, and save the measurement.

  • Page 36: Setup Screen

    CUBEScan BioCon-900S Operator’s Manual Figure 57 Review Screen Description Time Number of Saved Data / Internal Storage (50) Battery Status Aiming /information(Crosshair) Measured Date & Time Patient Tag The first plane of 12 planes Delete Icon Previous & Next Patient Icon Exit Icon Chronological Order of Saved Results / Total Order of Saved Results...

  • Page 37: Battery Status

    CUBEScan BioCon-900S Operator’s Manual Tap a Setup Value of the desired setup item. Tap repeatedly a setup value untile desired setup value. You can move to other Setup screen (1, 2, 3) by tapping the Previous or Next icon ( Tap the Home icon ( ) to finish adjusting the setup.

  • Page 38: Dialog Boxes

    CUBEScan BioCon-900S Operator’s Manual DIALOG BOXES 6.11 Windows Description Confirm Message: “Are you sure you want to delete this saved scan result?” Confirm Message: “Are you sure you want to delete all saved measurements?” Confirm Message: shutdown mode – To prevent the probe from discharging. “Are you sure you want to go into shutdown mode?”...

  • Page 39: Settings

    CUBEScan BioCon-900S Operator’s Manual 7 SETTINGS DATE FORMAT SETTINGS Tap the Setup icon ( ) on the Home screen. Tap the Home icon ( ) to return to the Home screen, if you want. Locate the Date Format option( ), and then tap the Date Format Items ( ) repeatedly to adjust the desired date format.

  • Page 40: Sleep Mode Settings

    CUBEScan BioCon-900S Operator’s Manual A 24-hour clock provided only. Tap the Setup icon ( ) on the Home screen. Tap the Home icon ( ) to return to the Home screen, if you want. Locate the Time option( ) and tap Time Item (eg. ) to adjust the time, use the virtual keyboard to enter a time.

  • Page 41: Pre-Scan Settings

    CUBEScan BioCon-900S Operator’s Manual Tap the Setup icon ( ) on the Home screen. Tap the Home icon ( ) to return to the Home screen, if you want. Use the Next icon ( ) on the Setup screen, and look for Brightness option( Tap the Brightness Item (eg.50%, 60%, 70%) repeatedly to adjust display brightness (0%-100%).
  • Page 42 CUBEScan BioCon-900S Operator’s Manual Tap the Setup icon ( ) on the Home screen to open the Setup screen. Tap the Home icon ( to return to the Home screen, if you want. Use the Next icon ( ) on the Setup screen, and look for the Delete option( Tap the Ok Item( ) to delete all saved results.

  • Page 43: Maintenance

    BioCon-900S Operator’s Manual 8 MAINTENANCE TROUBLESHOOTING Error message Description Actions FPGA Configuration Contact your local distributor or Mcube Technology. Error System Information Contact your local distributor or Mcube Technology. Error Angle Motor Error Contact your local distributor or Mcube Technology.

  • Page 44: Cleaning & Disinfection

    Wear protective gloves when cleaning the device.  Availability of cleaning and disinfection products varies by country, and Mcube Technology is not able to test the products in every market. Please contact your local service provider or Mcube technology if you need more information. ...
  • Page 45 CUBEScan BioCon-900S Operator’s Manual and probe. 1) Cleaning outer case (housing) of the Charger. a) Put on new gloves. b) Spray a soft-bristled brush(M16 recommended and validated) with Metrex CaviCide spray until thoroughly wet. Using the brush, scrub mated surfaces, recessed areas, cracks, crevices and other hard to reach areas until no visible contaminant is left on the Charger.

  • Page 46: Battery Maintenance

    The device and components may contain environmentally hazardous materials (mineral oil, lead, battery pack, etc.). When they have reached the end of its useful service life, return them to the Mcube Technology, or follow your local regulations for hazardous waste disposal.

  • Page 47: Self Test

    CUBEScan BioCon-900S Operator’s Manual SELF TEST Self-test 1) Put the probe on the Charger 2) Turn the probe on and tap the Setup icon ( ) on the bottom right side of the Home screen. 3) Tap the Next icon ( ) on the Setup screen and select the Self-test icon ( 4) Tap the Scan icon ( ) to start the calibration.

  • Page 48: Calibration

    CUBEScan BioCon-900S Operator’s Manual CALIBRATION BioCon-900S must be calibrated every 12 months to ensure accurate results. Calibration ensures accurate alignment of BioCon-900S’s internal system. You can take scan, even if calibration is not performed by the designated date. But result can be compromised. There are following methods for the calibration. CAUTION ...
  • Page 49 CUBEScan BioCon-900S Operator’s Manual 8.9.2 CALKIT CALIBRATION Calkit Calibration 1) Open the cover of the calibration kit and pour the 2) There is a mark on the inside of the Calkit saline solution. showing the Water Level. The Water Level is about 1cm below the top edge.
  • Page 50 CUBEScan BioCon-900S Operator’s Manual Dialog box disappears. When you finish the calibration, the last calibration date is updated and the Calibration Reminder icon ( ) disappears. Figure 76 Calibration Reminder Icon on Home Screen Page 50...

  • Page 51: Specifications

    CUBEScan BioCon-900S Operator’s Manual 9 SPECIFICATIONS ACOUSTIC OUTPUT TABLE WARNING ALARA principle (As Low As Reasonably Achievable) should be employed for all medical ultrasound exposure. Users can not adjust the acoustic output energy of the BioCon-900S. The output level is below than the levels which were referred in AIUM remarks in 1992 and there were no reported biological effects under the level.
  • Page 52 CUBEScan BioCon-900S Operator’s Manual internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class A The BioCon-900S is suitable for use in all establishments, other than domestic and those Harmonic Current Emissions Class A directly connected to the public low-voltage...
  • Page 53 CUBEScan BioCon-900S Operator’s Manual Conducted RF Portable mobile communications 0.15-80 MHz 0.15-80 MHz IEC 61000-4-6 equipment should be used no closer to any part of the BioCon-900S, including cables, than the 6 V in ISM 6 V in ISM recommended separation distance calculated bands bands from the equation applicable to the frequency of...

  • Page 54: Excessive Temperature Test Result

    To maintain electromagnetic interference (EMI) within certified limits, the device must be used with the cables, components specified or supplied by Mcube Technology. The use of cables or compoments other than those specified or supplied may result in increased emissions or decreased immunity of the system.
  • Page 55 Item Features Bladder Volume Range 0 - 999ml 0-99ml±10ml, 100-999ml±10% Accuracy (According to the scanning instruction, and scanning on a Mcube Technology tissue-equivalent bladder phantom.) Scan time Less than 3 sec MC-BA-01 (Lithium-ion rechargeable battery) - Nominal Voltage: 3.6v - Nominal capacity:5200mAh...

  • Page 56: Environmental Conditions

    If you are not using BioCon-900S more than 3 months, remove the battery to prevent it from discharging and store it in accordance with the recommended conditions, and charge the battery every 6 months.  Contact your local distributor or Mcube Technology, when you need to remove or replace the battery. Enviromental Specifications Operating conditions Indoor Ambient temperature range +10 - +40℃...
  • Page 57 This device complies with the essential requirements of the Radio Equipment directive: 2014 / 53 / EU. The following test methods have been applied to prove presumption of conformity with the essential requirements of the Radio Equipment directive: 2014/53/EU: Manufacturer Mcube Technology Co.,Ltd. CUBEScan Charger / Charger-001 Products Bladder Volume Measurement System / BioCon-900S...

  • Page 58: Glossary

    CUBEScan BioCon-900S Operator’s Manual 10 GLOSSARY Probe The main device with the LCD display. Charger CUBEScan Charger; Charge a lithium-ion battery with a probe. Device that transforms one form of energy into another form of energy. Transducer Ultrasound transducer transforms electric energy into acoustic energy and vice versa.

  • Page 59: Symbol Directory

    CUBEScan BioCon-900S Operator’s Manual 11 SYMBOL DIRECTORY Symbol Description Symbol Description Failure to observe the warning could result in personal injury Serial number or serious damage to the Warning system Failure observe recommendations Catalog(Part) number precautions result Caution system damage or failure Provide information to help you Type BF applied part your...
  • Page 60 CUBEScan BioCon-900S Operator’s Manual Atmospheric pressure Use no hook limitation Keep dry Do not use blades to open Page 60...

  • Page 61: References

    CUBEScan BioCon-900S Operator’s Manual 12 REFERENCES AIUM: Medical Ultrasound Safety, American Institute of Ultrasound in Medicine, Laurel, MD, 1994. AIUM: Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufactures Should Specify Acoustic Output Data, Revision 1, American Institute of Ultrasound in Medicine, Laurel, MD, 2008.
  • Page 62 CUBEScan BioCon-900S Operator’s Manual U.S. Distributor Medline Industries, Inc. One Medline Place Manufacturer Mundelein, Illinois, 60060 USA Mcube Technology Co., Ltd. Tel: 1-800-MEDLINE #803, 123, Bonghwasan-ro, Website: www.medline.com Jungnang-gu, Seoul, Korea Tel.: +82-2-3421-7780 DongBang Acuprime Fax.: +82-2-3421-7076 1 Forrest Units, Hennock Road East, E-mail: mcube@mcubetech.co.kr...

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