BioCon 500 User Guide Rev 5.1

II

TM

CUBESCAN BioCon-500 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 [email protected].

•

Non-Mcube Technology product names may be trademarks or registered trademarks of their respective owners.

Manufactured by Mcube Technology Co., Ltd. Room#803 Shinnae-Technotown, 485, Sangbong-Dong, Chungnang-Gu, Seoul, Korea 131-220 Tel: +82-2-3421-7780 Fax: +82-2-3421-7076 E-mail: [email protected]

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IV

Table of Contents

1

DEFINITIONS ... 1

2

GENERAL INFORMATION ... 2

3

4

5

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

INTRODUCTION ... 15 3.1

PRODUCT DESCRIPTION ... 15

3.2

SYSTEM COMPONENTS ... 17

3.3

FUNCTIONS OF EACH PART ... 18

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-500

4.4

CONNECTING THE PROBE TO THE SYSTEM ... 26

4.5

ROLLING CART ASSEMBLY ... 27

TM

... 24

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

V

6

7

5.11

SUMMARY OF EACH SCREEN AND ITS CONTEXT MENUS ... 61

5.12

SUMMARY OF MENUS NOT SHOWN ON CONTEXT MENUS... 65

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

TROUBLESHOOTING ... 82 7.1

8

9

TROUBLESHOOTING ... 82

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

W EEKLY INSPECTION ... 84

8.6

DEVICE REPAIR ... 85

8.7

DISPOSAL ... 85

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 TM

10.1

BIOCON-500

... 96

10.2

BATTERY MODULE ... 97

11 GLOSSARY ... 98 12 REFERENCES ... 99

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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)

1

2

GENERAL INFORMATION

2.1

Indications for Use The BioCon-500TM is a B-mode pulsed-echo ultrasound device. The BioCon500TM 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

Contraindications 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

Prescription Statement Caution:

Federal Law restricts this device to sale by or on the order of a

physician.

2

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

Electrical 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.

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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 connection: 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.

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2.4.2

Battery Safety

BioCon-500TM uses a Lithium-ion battery pack.

To ensure safe use of the

battery, observe the following warnings and cautions. If there are any problems with the battery module, immediately discontinue use of the battery and contact Mcube Technology or your local distributor. WARNING:

The battery module has built in safety mechanisms. Do not disassemble or tamper with the battery pack.

Only use the charger that is supplied with the Unit. Contact Mcube Technology or your local distributor 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 (see chapter 9.4 Specification of adapter ). Charge the batteries only when the ambient temperature is between +10℃ and +40℃ (+50 - +104℉)(in door use).

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.

Only use the manufacturer’s recommended battery.

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 battery pack when something appears abnormal.

Such

as

unusual

smell,

deformation,

discoloration, etc.

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.

If the battery does vent, avoid any contact with the smoke.

Do not expose the battery to water, moisture, or any type of liquid.

Do not use or store the battery in temperatures above 60℃

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or next to any heat source.

Doing so can cause the

battery pack to swell, and explode.

WARNING:

Do not abuse the battery pack.

Doing so can cause

damage to the battery resulting in a potentially unsafe situation. CAUTION:

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. (See chapter 10 “Environmental conditions”)

IMPORTANT:

To lengthen lifetime of the battery module, it is recommended to charge up to 75% and to discharge to 20%.

If the battery pack lasts less than 5 minutes after a full charging, replace the battery with a new one.

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2.4.3

Electromagnetic compatibility

The BioCon-500TM has been tested and found to comply with the electromagnetic compatibility (EMC) limits for medical devices as set forth in IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. CAUTION:

To reduce the performance degradation of this device, use medical devices that comply with IEC 60601-1-2 EMC Standards in the vicinity.

Do not use this device simultaneously with devices having high EMI levels.

Electrostatic discharge (ESD) is a commonly occurring phenomenon

especially

when

the

humidity

is

low.

Electrostatic

discharge

can

cause

damage

to

the

transducer or the system. The following procedures can be useful in reducing the likelihood of ESD: anti-static spray on carpets, anti-static spray on linoleum, and anti-static mats.

2.4.3.1 Manufacturer’s declaration - electromagnetic emissions The BioCon-500 is intended for use in the electromagnetic environment specified below. The customer or the user of the BioCon-500 should assure that it is used in such an environment. Immunity test RF Emissions

Compliance

Electromagnetic environment -guidance

Group 1

The BioCon-500 uses RF energy only for its

CISPR 11

internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

RF Emissions

Class A

CISPR 11

The BioCon-500 is suitable for use in all establishments, other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Harmonic emissions

Class A

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IEC 61000-3-2 Voltage fluctuations/

Complies

Flicker emissions IEC 61000-3-3

2.4.3.2 Manufacturer’s declaration - electromagnetic immunity

The BioCon-500 is intended for use in the electromagnetic environment specified below. The customer or the user of the BioCon-500 should assure that it is used in such an environment. Immunity test

IEC 60601

Compliance level

Electromagnetic environment

Test level Electrostatic

±6kV Contact

±6kV Contact

Floors should be wood,

discharge (ESD)

±8kV air

±8kV air

concrete or ceramic tile. If

IEC 61000-4-2

floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast

±2kV for power

±2kV for power

Mains power quality should

transient/burst

supply lines

supply lines

be that of a typical

IEC 61000-4-4

± 1kV for

± 1kV for

commercial or hospital

input/output lines

input/output lines

environment.

Surge

±1kV differential

±1kV differential

Mains power quality should

IEC 61000-4-5

mode

mode

be that of a typical

±2kV common

±2kV common

commercial or hospital

mode

mode

environment.

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Voltage dips,

<5% Uт

<5% Uт

Mains power quality should

short

(>95% dip in Uт)

(>95% dip in Uт)

be that of a typical

interruptions and

for 0.5cycle

for 0.5cycle

commercial or hospital

voltage

40% Uт

40% Uт

environment. If the user of

variations

(60% dip in Uт )

(60% dip in Uт )

the BioCon-500 requires

on power supply

for 5 cycle

for 5 cycle

continued operation during

input lines

70% Uт

70% Uт

power mains interruptions,

IEC 61000-4-11

(30% dip in Uт)

(30% dip in Uт)

it is recommended that the

for 25 cycle

for 25 cycle

BioCon-500 ultrasound

<5% Uт

<5% Uт

system be powered from an

(<95% dip in Uт )

(<95% dip in Uт )

uninterruptible power supply

for 5 s

for 5 s

or a battery.

3 A/m

3 A/m

Power frequency magnetic

Power frequency (50/60Hz)

fields should be at levels

magnetic field

characteristic of a typical

IEC 61000-4-8

location in a typical commercial or hospital environment.

NOTE Uт is the a.c. mains voltage prior to application of the test level.

2.4.3.3 Manufacturer’s declaration - electromagnetic immunity The BioCon-500 is intended for use in the electromagnetic environment specified below. Users of the BioCon-500 should ensure that use occurs in such an environment Immunity test

IEC 60601

Compliance

test level

level

Electromagnetic environment

Conducted

3 Vrms

3 Vrms

Portable and mobile RF communications

RF

150 kHz to

150 kHz to

equipment should be used no closer to any

IEC 61000-4-

80MHz

80MHz

part of the BioCon-500, including cables,

6

than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

9

Radiated RF

3 V/m

3 V/m

IEC 61000-4-

80 MHz to

80MHz to

3

2.5GHz

2.5GHz

Recommended separation distance

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

a

should be less than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with the following symbol :

NOTE 1) At 80MHz and 800MHz, the higher frequency range applies. NOTE 2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects 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 cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be

10

considered. If the measured field strength in the location in which the BioCon-500 is used exceeds the applicable RF compliance level above, the BioCon-500should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the BioCon-500. b

Over the frequency range 150kHz to 80MHz, field strengths should be less than [V1] V/m.

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2.4.4

Equipment Safety

To prevent damage to the system and/or accessories, observe the following cautions. CAUTION:

A dirty transducer can degrade the accuracy of the system. Clean the transducer with a soft cloth dampened in a mild soap or detergent.

Dropping a transducer or impact on a transducer can cause the system to malfunction or be inaccurate.

Do not drop

or shock the transducer.

To avoid damaging the cable or transducer connector, handle them with care.

Do not immerse the system or the transducer beyond the level in specified in 8.4 “Cleaning & Disinfection”

If the system is not likely to be used for more than a week, charge the battery up to about a 75% charge level, remove the battery module from the device and store it according to storage conditions of the battery.

This step will help

maximize the lifetime of the battery.

(See chapter 10

“Environmental conditions”)

The device has a setting to power down automatically if not used during a specified time period. This setting may be adjusted by selecting the ‘Auto Power’ option in ‘Setup Menu’.

The device will not power on without a battery installed.

When measuring the urine volume of a patient, ensure that the probe’s SCAN button is on the right side of the patient.

When using the system on a medical cart, ensure that the cart is placed on a flat and level surface.

The safe level of immersion for the probe is marked by the border between the cap of the probe and the body of the probe. Do not immerse beyond the ‘B’ portion of the probe illustrated in the figure to the left.

Only use the transducer which shipped with your unit

The transducers are not interchangeable between units, They are calibrated to a specific machine. If changing the

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probe associated with a machine, it is necessary to calibrate the two prior to deployment

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2.5

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.

2.6

User Interface Icon Definitions Symbol

Meaning Indicates a male patient

Indicates a female patient

Indicates a battery more than 75% charged Indicates a battery 50~75% charged Indicates a battery 25~50% charged Indicates a battery 5~25% charged Indicates the battery is near depletion or depleted

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