BioCon-700 Service Manual Rev 1.9 May 2018

DongBangAcuprime 1 Forrest Units, Hennock Road East, Marsh Barton, Exeter EX2 8RU, U.K : +44 1392 829500 : +44 1392 823232 Distributor:

U.S. Distributor:

Manufacturer Mcube Technology Co., Ltd. #803, 123, Bonghwasan-ro, Jungnang-gu, Seoul, Korea Tel. Fax. E-mail Web site

: +82-2-3421-7780 : +82-2-3421-7076 : [email protected] : www.mcubetech.co.kr

Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060 USA 1-800-MEDLINE

www.medline.com

Bladder Volume Measurement System Service Manual Any service work performed by persons who are not authorized by Mcube Technology Co.,Ltd. may void your warranty. The Information contained in this service manual is proprietary to the Mcube Technology Co., Ltd. It is only used for convenience of our customers. The information in this document is subject to change at any time without notice. No part of this document may be reproduced or transmitted in any form 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 represent real patient data.

For

up-to-date

user

information,

contact

your

local

distributor

or

[email protected] it becomes necessary for the device to undergo servicing, please contact local distributor or [email protected] for more information. Non-Mcube Technology product names are the property of their respective owners. Copyright ⓒ2009-2012Mcube Technology Co., Ltd. All rights reserved.

i

SAFETY SIGNS Safety sign

Reference

Title

Description

ISO 7010-M002

Refer to instruction manual/booklet

-

ISO 7010-M001

General mandatory action sign

Filled circles with an exclamation mark indicate an action that must be performed

ISO 7010-P001 and ISO 3864-1, Figure 1

General prohibition sign

Circular icons with a diagonal bar tell you that the action indicated is prohibited

ISO 7010-W001

General warning sign

This icon indicates that personal injury or material damage can result if the information is ignored

ii

Power Source and Adapter 

     

Do not use the device if the power cord is damaged. Do not heat or unduly twist or pull the cord and do not place heavy objects on the cord. These actions could damage the cord and cause a fire or electric shock. If the cord is damaged, contact your local distributor or Mcube Technology. Do not move the device while the AC power adapter is still connected. Do not pull on the connection cord to disconnect the AC power adapter. This can damage the power cord or cables and cause a fire or electric shock. Do not use with other devices. Do not disassemble. Do not expose to high heat and humidity. Do not subject to strong physical shocks. In order for the device to be disconnected safely in the event of an emergency, the plug should be located suitable place where the socket outlet is readily accessible, by removal of the plug from the socket outlet. (When an separable plug is used as isolation means)

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 

     

This device should be operated only from the type of power source indicated on this Operator Manual. If you are not sure, consult your local distributor or Mcube Technology. Power supply cords should be routed so that they are not likely to be walked on or pinched by items placed upon or against them, paying particular attention to cords at plugs, convenience receptacles, and the point where they exit from the device. The AC adapter is for indoor use only. Be sure the DC plug is securely connected to the device. Turn the device off before disconnecting the adapter. Disconnect the adapter by the plug, not the cable. If the AC adapter causes radio interference, reorient or relocate the receiving antenna. Pay attention to the direction of the DC power jack. Check the direction of the DC power jack. The “This Side Up” indication of the DC power jack has to be shown upright. Only use the AC/DC Adapters recommended by Mcube Technology.

Water and Moisture  Do not use this device near water or in a wet environment.  Do not use the device in the bathroom or shower. This can cause a fire or electric shock.  Do not use if the transducer that has been immersed beyond the specified cleaning or disinfection level. iv

Enclosures 



Do not attempt to disassemble the device. Do not open the device’s enclosures except the battery cover. All servicing, except battery and printer paper replacement, must be made by a qualified technician. Do not use the device when it has been dropped or the enclosure is damaged. This can cause a fire or electric shock. Contact your local distributor or Mcube Technology. Never push objects of any kind into this device through openings as they may touch dangerous voltage points or short out parts that could result in a fire or electric shock. Never spill liquid of any kind on the device.

Components and Accessories    

Risk of explosion: To avoid the risk of injury, do not operate the device in the presence of flammable gasses or anesthetics. The hazard of potential explosion exists. Do not use the device with any defibrillator at the same time. Do not use the device with any HF surgical equipment at the same time. Power Cord: Make sure the power cord is the correct type for your area. The equipment has a universal power adapter that allows operation at v

 



either 100-120V AC or at 200-240V AC without the need for user adjustment. (※ Only use the Power cord supplied by Mcube Technology.) Adapter: The device complies to the above standards only when used with the power adapter included. Only use adapters supplied by Mcube Technology. Accessories: Do not use accessories not recommended by the manufacturer because they may cause hazards. Do not place this device on an unstable cart, stand, or table. The device may fall, causing serious injury to a user or a patient, and serious damage to the device. Use only with a cart, stand, or table recommended by Mcube Technology. Any mounting of the device should follow the manufacturer’s instructions, and should use a mounting accessory recommended by the manufacturer. A device and cart combination should be moved with care. Quick stops, excessive force, and uneven surfaces may cause the device and cart combination to overturn. Computer connection: When connecting the BioCon-700 to a computer, the computer must be certified to EN/IEC/CSA/UL 60950 or 60101-1 standard to maintain the device’s compliance to EN/IEC/CSA/UL 60601-1-1 standard.

vi

LCD    

In the event that LCD is damaged, care should be taken to avoid contact with liquid crystal. Take the urgent action indicated should any of the following situations arise: If liquid crystal comes in contact with your skin, clean the area with a cloth and then wash thoroughly with soap and running water. If liquid crystal enters your eyes, flush the affected eye with clean water for at least 15 minutes and then seek medical assistance. If liquid crystal is swallowed, rinse your mouth thoroughly with water. Drink large quantities of water and induce vomiting, then seek medical assistance.

Maintenance   



Do not immerse the console or the probe, when the cleaning and disinfecting Do not use harsh, corrosive chemicals when cleaning the outer case and probe. Do not use Cidex Plus or MetricidePlus 30 to disinfect the device. Cidex Plus or MetricidePlus 30 will attack and damage the plastic enclosure, when the disinfecting. This will be considered as abuse and will void the warranty. Cleaning: Unplug the adapter from the wall outlet and turn off the device before cleaning. Do not use liquid cleaners or aerosol cleaners. Use a damp

vii

    

cloth for cleaning. In the event that LCD is damaged, care should be taken to avoid contact with liquid crystal. Take the urgent action indicated should any of the following situations arise: If liquid crystal comes in contact with your skin, clean the area with a cloth and then wash thoroughly with soap and running water. If liquid crystal enters your eyes, flush the affected eye with clean water for at least 15 minutes and then seek medical assistance. If liquid crystal is swallowed, rinse your mouth thoroughly with water. Drink large quantities of water and induce vomiting, then seek medical assistance. To avoid electric shock disconnect the system from the AC mains and the battery, when cleaning the outer case and probe, when the cleaning and disinfecting

Service 

Service: Do not attempt to service this device yourself as opening or removing covers may expose you to dangerous voltage or other hazards. Request all servicing to qualified service personnel only.



Parts: When replacement parts are required, be sure to use replacement parts specified by the manufacturer. Unauthorized substitutions may result in fire, electric shock or other hazards.

viii

Storage  

Do not leave this device in places subject to extremely high temperatures. Do not leave the device in locations such as a sealed vehicle or in direct sunlight. This can cause a fire. Do not place heavy objects on the device. This can cause the heavy object to turn over or fall and cause injury.



For added protection for this device during a lightning storm, or when it is left unattended and unused for long periods of time, unplug it from the wall outlet.

 

Do not use the battery pack not specified by Mcube Technology. Do not short-circuit the battery. Short circuiting the battery may cause rapid heating resulting is possible explosion. To avoid short-circuiting, do not let the battery come in contact with metal objects at any time, especially when transporting. Do not connect the battery in reverse polarity. Do not charge the battery in reverse polarity as it may cause the battery to rapidly heat, swell or even explode. Do not use a pack when something appears abnormal. Such as unusual

Battery

 

ix

   

     



smell, deformation, discoloration, etc. Do not expose the battery to water, moisture, or any type of liquid. Do not use or store the battery in temperatures above 60℃ or next to any heat source. Doing so can cause the battery pack to swell, and explode. Do not abuse the battery pack. Doing so can cause damage to the battery resulting in a potentially unsafe situation. Do not heat, change or take apart the battery. Do not drop or subject the battery to impacts. Do not store the battery with metallic products. Any of these actions can cause the battery to burst or leak and cause fire or injury as a result. Do not transport or store with metal objects such as necklaces or hairpins. Do not expose to flame or heat. Do not disassemble or modify. Dispose of used batteries promptly. Do not drop or subject to strong physical shocks. The battery module has built in safety mechanisms. Do not disassemble or tamper with the battery pack. Only use the adapter that is supplied with the Unit. Contact a local distributer or Mcube Technology for replacements. Do not charge the battery outside of the recommended conditions, as it may damage the battery resulting in possible leakage of the electrolyte or explosion. Charge the batteries only when the ambient temperature is between +10℃ and +40℃ (+50 - +104℉) (in door use). If electrolyte leakage occurs, do not touch the liquid. If it should come into contact with the skin or eyes, immediately seek help from a doctor. x

    

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Battery capacity decreases at low temperatures; a depleted battery may not function at when cold. Do not place the battery in direct contact with hand warmers or other heating devices. Never use excessive force to install the battery. If the battery does vent, avoid any contact with the smoke. If the battery leaks and fluid gets in contact with your eyes, skin or clothing, flush the affected area with clean water and seek medical attention or call an emergency number right away. When carrying the battery, install it in a device or keep it in the hard case. When storing the battery, keep it in the hard case. When discarding, cover the battery terminals with insulation tape. Contact with other metallic objects or batteries could cause the battery to ignite or burst. After full charging, unplug the adapter from the power socket. Leaving the adapter plugged into the power socket can cause a fire. The battery is not charged at shipment. Charge the battery before use. Keep the battery in hard case when not in use. The battery gradually loses its charge when not in use. Charge the battery one or two days before use. Battery life can be extended by turning the device off when not in use. At normal temperatures, the battery can be recharged about 300 times. A noticeable decrease in the length of operation time indicates that it has reached the end of its service life and should be replaced. Keep the terminals clean. xi

       

When connecting the battery module to a console, be careful about polarity. Be sure to securely fasten the battery cover. Long term storage: If the system is not likely to be used for more than a week, remove the battery module from the device and store it according to the recommended storage conditions. The battery pack life is over if the device can’t run normal scanning continuously at least for 10 min after full charging battery. Please replace it with a new a battery pack. Fully charged battery is able to take up approximately 2,400 times of normal scan It takes approximately 6 hours of full charging for a completely discharged battery To avoid the risk of explosion, only use the battery recommended by Mcube Technology. When removing the battery cover, be careful not to bend the cover. If the time in the device shows 00:00 or it stops, the coin battery in the device was depleted. Please contact Mcube Technology or distributor for replacing new battery.

xii

Memory Card 

 

Keep memory cards out of the reach of small children. Because memory cards are small, they can be swallowed by children. Be sure to store memory cards out of the reach of children. If a child swallows a memory card, seek medical attention or call an emergency number. Only use the SD card supplied by Mcube Technology. Use after formatting the SD card as FAT32 in the PC.

Rolling Cart When the lock-handle is released, the spring-loaded or shock absorber column may expand rapidly and could cause injury. Carefully hold the upper column during the unscrewing of lock-handle. Keep your head away from the assembly Rolling cart edges may cause injury. Keep your head and other body parts away from the rolling cart edges. Watch your step while moving the rolling cart in order to avoid any collision. The lock handle has to be in the same direction of the back of console plate. Do not load the wire basket over 5kg.

xiii

DEFINITIONS These definitions are used in this Service Manual. SCAN , PWR UP ,

Tactile switch. These are not the icons on the LCD screen. The functions are activated when the tactile switches are physically pressed.

DN

Pre-scan

General 2D real-time ultrasound scanning. 2D ultrasound images are displayed continuously in real time basis. This helps a operator locate bladder position and predicting the range of residual urine.

Normal scan

Get 12-plane ultrasound images and calculate the residual urine in the bladder (3D scanning).

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Table of Contents SAFETY SIGNS ... II DEFINITIONS ... XIV 1

2

3

INTRODUCTION ... 1 1.1

PRODUCT DESCRIPTION... 1

1.2

SERVICE PARTS LIST... 2

1.3

PRODUCT CONFIGURATION ... 21

1.4

SYSTEM STRUCTURE ... 31

1.5

SIGNAL INTERFACE DIAGRAM ... 34

ASSEMBLY OF THE BIOCON-700 ... 37 2.1

ASSEMBLY OF THE CONSOLE... 37

2.2

ASSEMBLY OF THE PROBE (3B702 01012)... 58

2.3

ASSEMBLY OF THE PROBE (37S02 01022) ... 70

CIRCUIT DIAGRAM ... 86

3.1

CONTROL BOARD CPU... 98

3.2

CONTROL BOARD POWER IN/CHARGER ... 99

3.3

CONTROL BOARD PROBE IF / PRINTER / KEY... 100

3.4

PROBE ASP BOARD ... 101

3.5

PROBE MOT_PUL BOARD ... 102

3.6

PROBE ADT BOARD ... 103

4

CALIBRATION ... 104

5

TROUBLESHOOTING... 111

6

5.1.

THE SYSTEM IS NOT CHARGED. ... 111

5.2.

THE CONSOLE IS ABNORMAL. ... 112

5.3.

IF THE MEASURED VALUE IS NOT ACCURATE OR THE PROBE OPERATING IS ABNORMAL ... 113

5.4.

WARNING MESSAGE ... 114

5.5.

ERROR MESSAGE ... 117

5.6.

CALIBRATION ERROR MESSAGE ... 120

MAINTENANCE ... 127 6.1

BATTERY CARE ... 127

7

6.2

CLEANING & DISINFECTION ... 127

6.3

WEEKLY INSPECTION ... 127

6.4

DEVICE REPAIR ... 127

6.5

DISPOSAL ... 128

GLOSSARY ... 129

1