BioCon 700 User Guide Rev1.1 Feb 2010

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BioCon-700 Bladder Volume Measurement System

User Guide CAUTION: Federal Law restricts this device to sale by or on the order of a physician. Copyright ⓒ 2009-2010 Mcube Technology Co., Ltd. All rights reserved. •

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].

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Non-Mcube Technology product names are the property of their respective owners.

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Manufactured by:

Distributor:

Mcube Technology Co., Ltd. Room #803 Shinnae-Technotown, 485, Sangbong-Dong, Chungnang-Gu, Seoul, 131-220, Korea Tel. Fax. E-mail Web site

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

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Contents 1

DEFINITIONS ... 17

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GENERAL INFORMATION ... 18 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8

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INDICATIONS FOR USE ... 18 CONTRAINDICATIONS ... 18 PRESCRIPTION STATEMENT ... 18 SERVICING ... 19 SAFETY ... 19 SAFE HANDLING PROCEDURES FOR TRANSPORTER ... 33 ALARA ... 33 USER INTERFACE ICON DEFINITIONS ... 34

INTRODUCTION... 35 3.1 PRODUCT DESCRIPTION ... 35 3.2 SYSTEM COMPONENTS ... 37 CONSOLE ... 39 3.3 ULTRASONIC PROBE ... 46

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SETUP ... 48 4.1 4.2

INSTALLING OR REMOVING THE BATTERY ... 48 CHANGING THE THERMAL PAPER ... 51

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4.3 4.4 4.5

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HOW TO USE ... 59 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8

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QUICK GUIDE ... 59 DEVICE CONTROLS ... 61 MEASURING URINE VOLUME ... 62 REVIEW THE SAVED DATA ... 76 SETTING THE SYSTEM DATA ... 82 USING THE KEYPAD ... 97 CALIBRATION ... 99 SUMMARY OF EACH SCREEN AND ITS CONTEXT MENUS ...103

TROUBLESHOOTING ...114 6.1 6.2

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CHARGING THE BATTERY MODULE OF THE BIOCON-700 ... 53 CONNECTING THE PROBE TO THE SYSTEM ... 57 ASSEMBLING THE ROLLING CART ... 58

TROUBLESHOOTING ... 114 MESSAGE FOR ALERT ... 116

MAINTENANCE...117 7.1 7.2 7.3 7.4 7.5 7.6

BATTERY CARE ... 117 CHANGING THE BATTERY MODULES ... 117 CHANGING THE THERMAL PAPER ... 117 CLEANING & DISINFECTION ... 117 WEEKLY INSPECTION ...120 DEVICE REPAIR ...120

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7.7

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SPECIFICATIONS ... 122 8.1 8.2 8.3 8.4 8.5

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DISPOSAL ...120

SYMBOL DIRECTORY ...122 ACOUSTIC OUTPUT TABLE ...124 DEFINITIONS AND SYMBOLS ...126 EXCESSIVE TEMPERATURE TEST RESULT ...133 SPECIFICATION OF COMPONENTS ...134

ENVIRONMENTAL CONDITIONS ... 137 9.1 9.2

BIOCON-700 ...137 BATTERY MODULE ...139

10 GLOSSARY ... 140 11 REFERENCES... 141

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Be sure to read this user guide before use. Important Safety Notices Read Instructions: Pay Attention Warnings: Follow Instructions:

All the safety and operating instructions should be read before use. to All warnings and cautions on the device and in the operating instructions should be paid attention to. All operating and use instructions should be followed.

Power Source and Adapter WARNING:

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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. This device should be operated only from the type of power source indicated on this user guide. 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

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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. 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. 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. Do not use with other devices. Do not disassemble. Do not expose to high heat and humidity. Do not subject to strong physical shocks. If the AC adapter causes radio interference, reorient or relocate the receiving antenna.

Enclosures WARNING:

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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

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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 WARNING:

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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 either 100120V AC or at 200-240V AC without the need for user adjustment. 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

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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.

Water and Moisture WARNING:

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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.

Use WARNING:

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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. Do not touch signal input, signal output or other connectors, and patient simultaneously. Transmission of data: When transmitting data to or from a computer, make sure that the BioCon-700, any accessories, and the computer are at least 2

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meters or 6.5 feet away from the patient. When a memory card is removed, the card could come out of the slot too quickly. Use your finger to hold it and gently release the card. Inspect the transducer and cable prior to using the device. Do not use if the transducer or cable is damaged. To ensure that data are recorded correctly, do not subject the device to impact or physical shocks while data are being recorded to the SD card. Do not release the SD card during data recording, this can damage to the SD card and/or to the device. To prevent fire or shock hazard, do not expose the unit to rain or moisture. 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. ESD (Electrostatic discharge) is a commonly occurring phenomenon especially in low humidity conditions. The static discharge can cause damage to a transducer or a system. To reduce ESD, following procedures can be useful: anti-static spray on carpets, anti-static spray on linoleum, and antistatic mats. 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.

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Do not immerse the system or the transducer beyond the level in specified in this user guide. 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. 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 the Setup Screen. When measuring the urine volume of a patient, ensure that the probe’s SCAN button is on the right side of the patient. 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 this level of the probe. Only use the transducer which shipped with your unit The probes are not interchangeable between units. They are calibrated to a specific machine. If changing the probe associated with a machine, it is necessary to calibrate the two prior to deployment Be sure to insert the paper in the correct orientation. To avoid damaging the system: - Only use thermal paper recommended by Mcube Technology. - Only print when the thermal paper is correctly loaded.

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LCD WARNING:

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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 WARNING:

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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 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.

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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.

Service WARNING:

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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.

Storage WARNING:

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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 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.

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Battery WARNING:

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Do not use the battery pack not specified by Mcube Technology. 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).

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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 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.

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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. 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. Battery capacity decreases at low temperatures; a depleted battery may not

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function at when cold. Keep a fully charged spare battery in a warm place and exchange as necessary, or keep the battery in your pocket or other warm place and insert it in the device only when using. Do not place the battery in direct contact with hand warmers or other heating devices. 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. 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. Keep the terminals clean. 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.

Memory Card WARNING:

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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 small children. If a child swallows a memory card, seek medical attention or call an emergency number.

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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

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GENERAL INFORMATION

2.1

Indications for Use The BioCon-700 is a B-mode pulsed-echo ultrasound device. The BioCon-700 is intended as a portable battery-operated device. The BioCon-700 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-700 is intended to be used only by qualified medical professionals. Contraindications for the BioCon-700 are fetal use and use on pregnant patients.

2.2

Contraindications Do not use the BioCon-700 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.

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