Mcube CUBEscan BioCon-900S Operator'S Manual Download Page 57 | Manualshive

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Mcube CUBEscan BioCon-900S Operator'S Manual Download Page 57

CUBEScan

TM

BioCon-900S Operator’s Manual

Page 57

Relative humidity

+20% - +80% non-condensing

Atmospheric pressure range

+600hPa - +1060hPa

9.6

European Union Declaration of Conformity

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.

Products

CUBEScan Charger / Charger-001

Bladder Volume Measurement System / BioCon-900S

Product Description

WPT System

EU Directives

2014/53/EU – Radio Equipment Directive (RED)

Reference standards used for presumption of conformity:

Article Number

Requirement

External use

3.1a

Medical electrical equipment

IEC 60601-1 : 2005 + CORR. 1

(2006) + corr. 2 (2007)

EN 60601-1 : 2006 + A1 : 2013

RF Exposure

EN 62311:2008

3.1b

ElectroMagnetic Compatibility (EMC)
standard for radio equipment and services

EN 301 489-1 V2.1.1
EN 301 489-3 V2.1.1

3.2

Wireless power transmission systems,
using technologies other than radio
frequency beam, in the 19 - 21 kHz, 59 - 61
kHz, 79 - 90 kHz, 100 - 300 kHz, 6 765 - 6
795 kHz ranges

EN 303 417 V1.1.1

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Summary of Contents for CUBEscan BioCon-900S

Page 1: ...BioCon 900S OPERATOR S MANUAL...

Page 2: ...CUBEScanTM BioCon 900S Operator s Manual Page 2 This page left blank intentionally...

Page 3: ...rm or by any means electronic or mechanical for any purpose without the express written permission of Mcube Technology Examples or images in this document are fictitious and do not in any way represen...

Page 4: ...CON DIRECTORY 15 4 SETUP 18 4 1 ACCURACY OF MEASUREMENT 18 4 2 CHARGE THE BATTERY 18 4 3 SCAN TYPE 19 5 HOW TO USE 20 5 1 CHECKUP BEFORE USE 20 5 2 TURN SYSTEM ON OFF 20 5 3 SELECT PATIENT TYPE 21 5 4...

Page 5: ...ALOG BOXES FOR MAINTENANCE 43 8 3 CLEANING DISINFECTION 44 8 4 BATTERY MAINTENANCE 46 8 5 WEEKLY INSPECTION 46 8 6 DISPOSAL 46 8 7 DEVICE REPAIR 46 8 8 SELF TEST 47 8 9 CALIBRATION 48 9 SPECIFICATIONS...

Page 6: ...the BioCon 900S are fetal use and use on pregnant patients 1 3 PATIENT USER CHARACTERISTICS 1 3 1 PATIENT POPULATION 1 Male All other patients 2 Female patient A female who has not had a hysterectomy...

Page 7: ...CUBEScanTM BioCon 900S Operator s Manual Page 7 If you encounter difficulty with the system please contact local distributers or Mcube Technology at mcube mcubetech co kr...

Page 8: ...y Data on acoustic output levels is listed in section 9 Specifications 2 4 ELECTRICAL SAFETY This system meets IEC 60601 1 Class I Type BF isolated patient applied parts safety requirements This syste...

Page 9: ...ic shock is a discharge of electrical energy from a charged body to a lesser or non charged body The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound syst...

Page 10: ...mmunications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense This devic...

Page 11: ...d 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...

Page 12: ...ovides scan results in a short time Easy to use staff can easily learn how to scan patients in a short time Battery operated wireless charging Figure 1 CUBEScanTM BioCon 900S 3 2 SYSTEM COMPONENTS No...

Page 13: ...nology Only use the ultrasonic gel approved by FDA CE 3 3 OUTER APPEARANCE PROBE Figure 2 Probe Appearance No Part Function 1 Touchscreen Display Displays bladder volume and other information 2 Power...

Page 14: ...NOTE The appearance of these labels No 8 9 depends on wheter the barcode option is selected or not Figure 3 Charger Front View Figure 4 Charger Bottom View No Item Function 1 Battery indicator Indicat...

Page 15: ...CTORY Patient Type Home screen Information screen Pre scan screen No Description 1 Status Current time the number of saved data and battery status 2 Main Display controls the user interface Icon Descr...

Page 16: ...lume P1 Plane No The 1st plane of 12 planes of the result PX The ordinal number of 12 planes Scan Re scan the bladder Home Return to the Home screen Save Save the scan result Icon Description Delete O...

Page 17: ...n YY MM DD CalKit Calibration YY MM DD On the self test or calibration screen perform self test or calibration Cease On the self test or calibration screen cease self test or calibration Exit Return f...

Page 18: ...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 inter...

Page 19: ...onnect the AC DC adapter to the Charger 3 Plug the AC DC adapter into an electric outlet 4 The battery indicator 3 on the Charger lights on in steady green Power on 5 Mount the probe on the Charger Ma...

Page 20: ...n depends on the power mode and it shows during start up Figure 9 Loading Screen 1 Figure 10 Loading Screen 2 Figure 11 Home Screen 5 2 1 SLEEP MODE To preserve battery power the probe goes into sleep...

Page 21: ...pears on the display and Loading screen 2 follows shortly 3 Home screen appears when the system is fully loaded at start up Turn System off 1 Press the Power Button for 3 4 seconds 2 A Shutdown dialog...

Page 22: ...the function of the virtual keyboard You can scan a bladder volume without entering patient information If you do not enter a patient information the patinet tag content 2 is empty on the Scan Result...

Page 23: ...select an numeric uppercase or lowercase virtual keyboard Figure 18 Numeric Key Figure 19 Letter Key Lowcase Figure 20 Letter Key Uppercase Date of Birth Tap Date of Birth text box and then enter the...

Page 24: ...od barcode scan 6 You have a good barcode with a short beep The barcode numbers is displayed on Patient Tag of the Information screen good bad 5 5 MEASURE BLADDER VOLUME 5 5 1 NORMAL SCAN The normal s...

Page 25: ...uted only when Pre scan setup is ON on the Setup screen When Pre scan is Off a normal scan is executed See the section 7 7 PRE SCAN SETTING 1 The patient should be lying in a supine position and lift...

Page 26: ...image is the largest and most centered is the optimal place to start the normal scan process Locate the bladder along the centerline 1 on the Pre scan screen It helps detect the optimal position durin...

Page 27: ...the current scan 4 shows the patient tag entered on the Information screen 5 6 3 BLADDER PLANES Tap the bladder plane repeatedly with your finger to check other 12 planes of bladder on the Scan Resul...

Page 28: ...ow that the user has to move or tilt the probe for a more accurate scan If the bladder appears in the center of the crosshair press the Scan Button or tap the Pre scan part of the screen Figure 34 How...

Page 29: ...unt it for charging internal battery in the Charger 5 11 MANAGE SAVED SCAN RESULTS 1 The scan results are saved to the internal memory of BioCon 900S Probe If you scan the patient several times using...

Page 30: ...cancel Figure 38 Review Screen Figure 39 Delete Scan Result 6 If you delete the last scan result Empty Foder dialog box appears and BioCon 900S returns to the Home screen 7 If you tap the Review icon...

Page 31: ...CUBEScanTM BioCon 900S Operator s Manual Page 31 Figure 40 Delete Last Scan Result Figure 41 Empty Folder Dialog Box...

Page 32: ...creen No Description 1 Time 2 Number of Saved Data Internal Storage 50 3 Battery Status 4 Model Name 5 Patient Type Icons 6 Review Icon 7 Setup Icon Figure 42 Home Screen 6 2 INFORMATION SCREEN The In...

Page 33: ...arcode Figure 47 Barcode Screen 6 4 VIRTUAL KEYBOARD SCREEN BioCon 900S has three different virtual keyboard types Numeric Letter Uppercase Lowcase and Date Figure 48 Numeric Keyboard Figure 49 Letter...

Page 34: ...operator locate bladder position and predict the range of residual urine And also the centerline is provided during Pre scan Locate the bladder along the centerline on the screen It helps detect the o...

Page 35: ...5 Measured Date Time 6 Patient Tag 7 The first plane of 12 planes 8 Save 9 Home 10 Re Scan 11 Current Volume from Multiple Results 12 Maximum Volume from Multiple Results 13 Patient Types 14 Bladder O...

Page 36: ...hronological Order of Saved Results Total Order of Saved Results 12 Bladder volume 13 Patient Types 14 Bladder Outline 15 Centerline helps detect the optimal position 16 First Name Sur Name 17 Date of...

Page 37: ...x Needs to be recharged To conserve battery power the probe goes into sleep mode by turning off the screen when not in use for a specified time You can adjust the time to go into sleep mode in the set...

Page 38: ...nt to go into shutdown mode Alert Message The message prompts you when calibration is needs Alert Message The battery is nearly depleted and needs to be recharged Alert Message The battery needs to be...

Page 39: ...rmat 3 A format of date values immediately updates depending on the date format Figure 63 Date Format YY MM DD MM DD YY DD MM YY 7 2 DATE SETTINGS 1 Tap the Setup icon on the Home screen Tap the Home...

Page 40: ...Tap the OK icon to finish adjusting the time Figure 66 Time Setup Figure 67 Enter Time Values hour minute 7 4 SLEEP MODE SETTINGS A time setting to go into sleep mode 2min 3min 5min 1 Tap the Setup i...

Page 41: ...ness 0 100 NOTE The display brightness setting affects battery life To conserve battery life adjust brightness to a lower setting Figure 69 Brightness Setup 7 6 PRE SCAN SETTINGS 1 Tap the Setup icon...

Page 42: ...t 2 Use the Next icon on the Setup screen and look for the Delete option 3 Tap the Ok Item to delete all saved results 4 And a dialog box to confirm appears before deletion 5 Tap the Ok icon to delete...

Page 43: ...Contact your local distributor or Mcube Technology Low Temperature Error Contact your local distributor or Mcube Technology Data Deletion Error Contact your local distributor or Mcube Technology 8 2 D...

Page 44: ...atibility with system components Metrex CaviWipes Metrex CaviCide Spray 8 3 2 Cleaning Ensure the power cord is not plugged into wall outlet Using a dry paper towel or soft cloth wipe any ultrasound g...

Page 45: ...e ensure that the electric inlet of Charger is not exposed to any solution during the cleaning procedure If the inlet is exposed to the solution such as water isopropyl alchol or ethyl dry the Charger...

Page 46: ...tery cannot be removed by the user If you do not plan to use BioCon 900S for a long period of time you should switch the probe to shutdown mode to prevent its battery from fully discharging The BioCon...

Page 47: ...icon to start the calibration You can cease the Self test by tapping the Cease icon Tap the Exit icon to return to Setup screen if you want 5 Self test progress bar appears when the calibration is st...

Page 48: ...the phantom cover on the top of the CubeScan phantom Check if the cover is in a stable and flat position 4 Put the probe head into the probe holder firmly 5 Turn the probe on and Tap the Setup icon on...

Page 49: ...he Next icon on the Setup screen and select the CalKit Calibration icon 7 Tap the Scan icon to start the calibration You can cease the calkit calibration by tapping the Cease icon Tap the Exit icon to...

Page 50: ...900S Operator s Manual Page 50 Dialog box disappears When you finish the calibration the last calibration date is updated and the Calibration Reminder icon disappears Figure 76 Calibration Reminder Ic...

Page 51: ...C COMPATIBILITY 9 2 1 Electromagnetic emissions Guidance Manufacturer s declaration electromagnetic emissions The BioCon 900S is intended for use in the electromagnetic environment specified below The...

Page 52: ...etic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV 100 kHz repetition frequency In compliance Mains power quality should be that of a typical...

Page 53: ...and people a 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 canno...

Page 54: ...absorption and reflection from structures objects and people 9 2 5 Components conformance to standards To maintain electromagnetic interference EMI within certified limits the device must be used with...

Page 55: ...According to the scanning instruction and scanning on a Mcube Technology tissue equivalent bladder phantom Scan time Less than 3 sec Power MC BA 01 Lithium ion rechargeable battery Nominal Voltage 3...

Page 56: ...mmediate use of the probe which has been stored under 10 without warming may damage the probe So take it into a room where the temperature is over 10 and let BioCon 900S warm up for a while And then w...

Page 57: ...Scan Charger Charger 001 Bladder Volume Measurement System BioCon 900S Product Description WPT System EU Directives 2014 53 EU Radio Equipment Directive RED Reference standards used for presumption of...

Page 58: ...asound transducer B mode A kind of ultrasound imaging mode Displays the brightness information corresponding to the amplitude of the signal Pre scan General 2D real time ultrasound scanning 2D ultraso...

Page 59: ...protection against harmful ingress of water as detailed in the IEC 60529 IPX3 Protected against spraying water Manufactured date Manufacturer EC REP Authorized representative in the European community...

Page 60: ...CUBEScanTM BioCon 900S Operator s Manual Page 60 Use no hook Atmospheric pressure limitation Keep dry Do not use blades to open...

Page 61: ...rical Equipment Part 1 General Requirements for Basic Safety and Essential Performance Canadian Standards Association 2012 IEC 60601 2 37 Medical electrical equipment Part 2 37 Particular requirements...

Page 62: ...ongBang Acuprime 1 Forrest Units Hennock Road East Marsh Barton Exeter EX2 8RU U K Tel 44 1392 829500 Fax 44 1392 823232 Local Distributor Manufacturer Mcube Technology Co Ltd 803 123 Bonghwasan ro Ju...

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