Mcube BioCon-500 User manual

I
User Guide

II

III
CUBESCAN BioCon-500TM
Bladder Volume Measurement System
User Guide
CAUTION: Federal Law restricts this device to sale by or on the
order of a physician.
• Information in this User Guide may change at any time without notice. Examples of
ultrasound images in this User Guide are fictitious and do not in any way represent real
patient data. For up-to-date user information contact your local distributor or
[e-mail].
• Non-Mcube Technology product names may be trademarks or registered trademarks of
their respective owners.
Manufactured by
M ube Te hnology Co., Ltd.
Room#803 Shinnae-Technotown 485
Sangbong-Dong Chungnang-Gu Seoul
Korea 131-220
Tel: [phone]
Fax: [phone]
E-mail: m[email protected]o.kr

IV

V
Table of Contents
1 DEFINITIONS ............................................................................................. 1
2 GENERAL INFORMATION ......................................................................... 2
2.1 INDICATIONS FOR USE ..................................................................................................... 2
2.2 CONTRAINDICATIONS ....................................................................................................... 2
2.3 PRESCRIPTION STATEMENT ............................................................................................. 2
2.4 SAFETY .......................................................................................................................... 3
2.5 SAFE HANDLING PROCEDURES FOR TRANSPORTER ........................................................ 14
2.6 USER INTERFACE ICON DEFINITIONS .............................................................................. 14
3 INTRODUCTION ....................................................................................... 15
3.1 PRODUCT DESCRIPTION ................................................................................................ 15
3.2 SYSTEM COMPONENTS ................................................................................................. 17
3.3 FUNCTIONS OF EACH PART ............................................................................................ 18
4 SETUP ...................................................................................................... 22
4.1 INSTALLING OR REMOVING THE BATTERY ........................................................................ 22
4.2 CHANGING THE THERMAL PAPER ................................................................................... 23
4.3 CHARGING THE BATTERY MODULE OF THE BIOCON-500TM .............................................. 24
4.4 CONNECTING THE PROBE TO THE SYSTEM ..................................................................... 26
4.5 ROLLING CART ASSEMBLY ............................................................................................. 27
5 HOW TO USE ........................................................................................... 38
5.1 QUICK GUIDE ................................................................................................................ 38
5.2 DEVICE CONTROLS AND CONTEXTUAL MENUS ................................................................ 40
5.3 MEASURING URINE VOLUME .......................................................................................... 43
5.4 CHANGING THE PATIENT ID ............................................................................................ 49
5.5 LOADING THE SAVED DATA ............................................................................................ 50
5.6 SETTING THE CLINIC NAME ............................................................................................ 52
5.7 SETTING THE DATE & TIME ............................................................................................ 54
5.8 CUSTOMIZING OTHER SETUP OPTIONS .......................................................................... 55
5.9 CALIBRATING THE BIOCON-500 USING THE CALIBRATION KIT .......................................... 57
5.10 BUTTONS AND THEIR CONTEXTUAL MENU ABBREVIATIONS............................................... 60

VI
5.11 SUMMARY OF EACH SCREEN AND ITS CONTEXT MENUS .................................................. 61
5.12 SUMMARY OF MENUS NOT SHOWN ON CONTEXT MENUS ................................................. 65
6 THE OPTIONAL SOFTWARE(CUBESCANPC) ....................................... 66
6.1 GENERAL INFORMATION ................................................................................................ 66
6.2 INTENDED USE .............................................................................................................. 67
6.3 INSTALLING CUBESCANPC SOFTWARE .......................................................................... 67
6.4 UNINSTALLING SOFTWARE ............................................................................................. 72
6.5 DEVICE DESCRIPTION.................................................................................................... 74
6.6 GETTING STARTED ........................................................................................................ 74
6.7 USE OF THE SOFTWARE ................................................................................................ 76
6.8 SETTING UP CUBESCANPC ........................................................................................... 81
7 TROUBLESHOOTING .............................................................................. 82
7.1 TROUBLESHOOTING ...................................................................................................... 82
8 MAINTENANCE ........................................................................................ 83
8.1 BATTERY CARE ............................................................................................................. 83
8.2 CHANGING THE BATTERY MODULES ............................................................................... 83
8.3 CHANGING THE THERMAL PAPER ................................................................................... 83
8.4 CLEANING & DISINFECTION ............................................................................................ 83
8.5 WEEKLY INSPECTION ..................................................................................................... 84
8.6 DEVICE REPAIR ............................................................................................................. 85
8.7 DISPOSAL ..................................................................................................................... 85
9 SPECIFICATIONS .................................................................................... 86
9.1 SYMBOL DIRECTORY ..................................................................................................... 86
9.2 ACOUSTIC OUTPUT TABLE ............................................................................................. 87
9.3 DEFINITIONS AND SYMBOLS ........................................................................................... 89
9.4 SPECIFICATION OF COMPONENTS................................................................................... 94
10 ENVIRONMENTAL CONDITIONS ............................................................ 96
10.1 BIOCON-500TM ............................................................................................................. 96
10.2 BATTERY MODULE ........................................................................................................ 97
11 GLOSSARY .............................................................................................. 98
12 REFERENCES .......................................................................................... 99

1
1 DEFINITIONS
These definitions are used in this user guide.
WARNING: Describes precautions necessary to prevent injury or loss of life.
CAUTION: Describes precautions necessary to protect the products.
IMPORTANT:
Describes information that a user should know for safe and
effective use of this system.
SCAN : Tactile switch
SCAN : Context menu based on system state (Screen)

2
2 GENERAL INFORMATION
2.1 Indi ations for Use
The BioCon-500TM is a B-mode pulsed-echo ultrasound device. The BioCon-
500TM is intended as a portable battery-operated device. The BioCon-500TM
projects ultrasonic energy through the abdomen of the patient obtaining images
of the bladder in order to calculate the urine volume non-invasively. The
BioCon-500TM is intended to be used only by qualified medical professionals.
Contraindications for the BioCon-500TM are fetal use and use on pregnant
patients.
2.2 Contraindi ations
Do not use the BioCon-500TM on following cases:
a) Fetal use or pregnant patients.
b) Patients with ascites.
c) Patients with open or damaged skin.
d) Wounds in the suprapubic region.
2.3 Pres ription Statement
Caution: Federal Law restricts this device to sale by or on the order of a
physician.

3
2.4 Safety
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-500TM. This section has information on safe
use of the BioCon-500TM (Electrical Safety Battery Safety EMC (Electromagnetic
Compatibility) Equipment Safety).
WARNING:  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.
2.4.1 Ele tri al Safety
This device meets IEC 60601-1 ClassⅠ Type BF isolated patient-applied parts
safety requirements. This device complies with the applicable medical equipment
requirements published in the Canadian Standards Association (CSA) European
Harmonized Standards and Underwriters Laboratories(UL) safety standards.
Please review and follow the following safety warnings.
WARNING:
 The power supply should be properly grounded. The power
supply must be connected to an AC socket that is medical
grade or equivalent. The grounding pin must not be
removed or tampered with.
 Do not use the device if the power cord is damaged.
 Do not open the device’s enclosures. All servicing except
battery and printer paper replacement must be made by a
qualified technician.
 Inspect the transducer and cable prior to using the device.
Do not use if the transducer or cable is damaged.
 Use the device within operating conditions specified in
chapter 10 “Environmental conditions.”
 Do not use the device with any defibrillator at the same
time.
 Use accessories only recommended by Mcube Technology.
 Do not use if the transducer that has been immersed
beyond the specified cleaning or disinfection level.

4
WARNING:  The device should be used with ultrasonic gel either applied
on the probe or patient’s abdomen. Thus users should
avoid using this device on patients with skin disease or
injury.
 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 either 100-120V AC or at 200-240V AC without
the need for user adjustment.
Always use a hospital grade power cord with the correct
plug type. The cord must be rated for 125VAC at 15A and
be of type SJT or better.
 Adapter:
The device complies to the above standards only when
used with the power cord included.. Only use adapters
supplied by Mcube Technology. (see chapter 9.4
Specification of adapter ).
 Computer onne tion:
When connecting the BioCon-500TM 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.
 Transmission of data:
When transmitting data to or from a computer make sure
that the BioCon-500TM any accessories and the computer
are at least 2 meters or 6.5 feet away from the patient.