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CUBEScan

TM

 BioCon-900S Operator’s Manual 

 

 

Page 44 

8.3 

CLEANING & DISINFECTION 

 

 

 

  CAUTION 

 

This  product  may  only  be  cleaned  and  disinfected  by  using  the  approved  processes  provided  in  this 
manual. Cleaning and disinfection methods listed  are recommended by Mcube  Technology based on 
compatibility with component materials.   

 

Ensure that  you follow the manufacturer’s instructions for handling and disposing of the cleaning and 
disinfection solutions provided in this manual. 

 

BioCon-900S  probe  is  intended  to  contact  the  abdominal  skin  to  measure  the  bladder  volume.  For  this 
reason, cleaning and  disinfecting the  probe  and  Charger  is an  important  procedure  in using  the system. 
The following table shows the risk assessment for the probe including the Spauling’s/CDC classification for 
the minimum required disinfection level. 
 

Component 

Packaged 

Use 

Spaulding’s/CDC 

classification 

Clean 

Disinfection level 

Low 

High 

Probe Head 

Nonsterile 

Reusable 

Noncritical 

√ 

√

 

 

Probe Except head 

Nonsterile 

Reusable 

Noncritical 

√ 

 

 

Charger 

Nonsterile 

Reusable 

Noncritical 

√ 

 

 

 

8.3.1 

Compatibility 

 

The  following  solutions  have  demonstrated  cleaning  or  disinfection  efficiency  and  material  compatibility 
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 gel, soils and dirt completely off the Charger or 

  WARNING 

 

 

Cleaning is a necessary step to perform before disinfecting the device. If the device is not cleaned 
properly,  even  after  the  disinfection  procedure  is  completed,  there  may  be  contamination  of  the 
device.   

 

Incorrect cleaning or disinfecting of any part of the system can cause permanent damage.   

 

Do not use solvents such as thinner or benzene, or abrasive cleaner on any part of the system. 

 

Do not subject the system to any method of sterilization. 

 

Do not immerse the probe except the probe head in cleaning or disinfectant solution.   

 

Do not immerse the Charger in cleaning or disinfectant solution.   

 

Do not use metal or abrasive brushes. These may scratch the instrument causing permanent device 
damage. 

 

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.   

 

Do not spray the disinfectant spray solution directly on the surface, recessed areas, crack,    etc. of 
the probe and the Charger. 

Содержание CUBEscan BioCon-900S

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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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