Table of Contents
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MiroCam User Manual
1
SAFETY.............................................................................................................................2
1.1
Warnings ................................................................ 2
1.2
Symbols for Safety ...................................................... 3
1.3
Function Symbols ........................................................ 4
1.4
Remarks for Safe Use .................................................... 6
2
Overview ..........................................................................................................................12
2.1
Description of MiroCam Capsule Endoscope System ........................ 12
2.2
System Overview ........................................................ 13
2.3
Feature of MiroCam Capsule Endoscope System ............................ 14
2.4
Function Explanation ................................................... 15
2.5
Intened Pupose and Side Effect ......................................... 18
3
Product.............................................................................................................................19
3.1
Pictures ............................................................... 19
3.2
Supply Items ........................................................... 21
4
Installation.......................................................................................................................22
4.1
Installation ........................................................... 22
5
Technical Data.................................................................................................................24
5.1
Overview ............................................................... 24
5.2
Hardware ............................................................... 24
5.3
Software ............................................................... 25
5.4
COMPLIANCE/APPROVALS ................................................... 25
6
Environment condition for storage and transport. ........................................................27
6.1
Safety environment condition for storage ............................... 27
6.2
Environment condition for transport .................................... 27
7
Troubleshooting...............................................................................................................28
7.1
Introduction ........................................................... 28
7.2
Who should perform repairs ............................................. 28
7.3
Obtain replacement parts ............................................... 28
7.4
Troubleshooting guide .................................................. 28
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Contents
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Summary of Contents for IntroMedic MiroCam
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Page 1: Table Of Contents
Symbols for Safety ............3 Function Symbols ............4 Remarks for Safe Use ............ 6 Overview ..........................12 Description of MiroCam Capsule Endoscope System ......12 System Overview ............13 Feature of MiroCam Capsule Endoscope System ......14 Function Explanation ........... 15 Intened Pupose and Side Effect ......... -
Page 2: Safety
Medical Electrical Equipment: General Requirements for Safety IEC 60601-1, together with the Collateral Standard for Electromagnetic Compatibility Requirement and Tests IEC 60601-1-2. The MiroCam® has been manufactured to conform Medical Equipment with respect to electric shock fire and mechanical hazard only CAN/CSA C22.2 NO.601.1. -
Page 3: Symbols For Safety
MiroCam User Manual 1.2 Symbols for Safety This section describes a set of symbols that IEC (The International Electrotechnical Commission) has established for medical electronic equipment to classify a connection or warning of any potential hazards. IEC 348: Notice for the user to pay special attention to the following details... -
Page 4: Function Symbols
MiroCam User Manual 1.3 Function Symbols 1.3.1 Apllication Function Symbols Symbol Description Symbol Description Functions & Windows Functions & Windows for Diagnosis Receiver Unit Report Function & Windows for Patient Function & Windows Export Database Listing Patient Image Data Function & Windows for Image Function &... - Page 5 MiroCam User Manual Symbol Description Symbol Description Undo mark in current image Redo mark in current image Doctor login Cancel login Patient’s diagnosis history Delete current patient information Progress reporting current patient Complete reporting current patient Complete Export current patient...
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Page 6: Remarks For Safe Use
The manufacturer is not liable for harm or damage caused by improper, unauthorized, unprofessional or inexpert use of the device IntroMedic.Co.Ltd., is NOT responsible for physical harm or equipment problems caused by the user’s careless operation or mismanagement. The user MUST have read and understood the user's manual. ONLY trained and qualified persons may operate the system. - Page 7 MiroCam User Manual CAUTION: Verify that the power voltage supplied from the power receptacle, matches with the voltage the system requires. Check Voltage and Frequency on the AC/DC adaptor. CAUTION: Verify that all connection terminals are securely connected to the system.
- Page 8 MiroCam User Manual 1.4.1 Environmental Conditions for Operation : -10 ℃ - +70 ℃ (Operating : +10 ℃ - +40℃) Temperature Relative humidity : 10% - 80% (Operating : 45% - 75%) Atmospheric pressure : 700hPa to 1060hPa WARNING DO NOT operate the equipment in the vicinity of generators, power stations, X-ray devices, and broadcasting stations where high levels of electro- magnetic waves are generated.
- Page 9 MiroCam User Manual 1.4.2 Safety Precautions Make sure the environment is without interference from electromagnetic CAUTION fields. Make sure the environment is without noise and vibration. DO NOT carry out the procedure while using other equipments, devices or products. The instruction for use of the probes MUST be observed.
- Page 10 During upload of the data recorded in the receiver to the PC, avoid disconnecting the USB(It may damage the patient’s data). Always confirm that the USB is connected by checking on the screen of the MiroCam application program. 한글판 버전 1.00...
- Page 11 MiroCam User Manual 1.4.3 Cleaning and maintenance 1.4.3.1 System and accessories Other units and accessories should be cleanly maintained. For cleaning, rub them lightly with a soft cloth wet with warm water at least once a week. Do not use organic solvents such as lacquer, thinner, ethylene and oxide because they can damage the equipment.
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Page 12: Overview
MiroCam User Manual 2 Overview 2.1 Description of MiroCam Capsule Endoscope System MiroCam is Capsule Endoscope Systems and accessories to be used to diagnosis of patients. It consists of the capsule and receiver. 2.1.1 Photos 2.1.1.1 Capsule 2.1.1.2 Receiver .1.1.3 Accessory... -
Page 13: System Overview
Analog Filter Transmittion Image Display 2.2.1 Capsule MiroCam Capsule Endoscope System’ Capsule Unit consists of optical dome, white LED, image sensor, lens and gold courted cage. 2.2.2 Receiver MiroCam Capsule Endoscope System’s Receiver unit consist of 8 channel connector, differential amplifier, filter, data demodulator, data storage memory and USB communication channel. -
Page 14: Feature Of Mirocam Capsule Endoscope System
MiroCam User Manual 2.3 Feature of MiroCam Capsule Endoscope System 2.3.1 Main Feature Capsule High Resolution Image (320 X 320) Widest Field of view (150 degrees) Smallest Capsule size (11 X 24mm) Longest operation time Receiver Built-in circuit protection functions... -
Page 15: Function Explanation
MiroCam User Manual 2.4 Function Explanation 2.4.1 Display flow Image Review Report View 2.4.2 Function of Control and Display of Signal All operations start after completing or selecting the patient registration on the default screen. If select Patient in Patient List for data review and press button, Review window is displayed. - Page 16 MiroCam User Manual Press button for stop playing image data. Press button for save current image to thumbnail. Press button for recording diagnosis data and printing paper. Press button for operation for receiver unit initialization and image data upload. 2.4.3...
- Page 17 MiroCam User Manual 2.4.4 Connection and Disconnection Part Where When Method Patch Connector of Before Connection : Hold the connector on the end of Probe upper side of process the receiver’s patch probe and put it into the receiver unit capsule socket of the top of the patch.
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Page 18: Intened Pupose And Side Effect
MiroCam User Manual 2.5 Intened Pupose and Side Effect 2.5.1 Intended Purpose MiroCam is intended for the detection of pathologies as an adjunctive tool in the diagnosis of small bowel gastrointestinal disorders and diseases. 한글판 버전 1.00... -
Page 19: Product
MiroCam User Manual 3 Product 3.1 Pictures 3.1.1 Main Device Capsule Receiver 한글판 버전 1.00... - Page 20 MiroCam User Manual 3.1.2 Accessories Patch Cable Model : 21-1-19-1, 10P Manufacturer : Mednis USB Cable Model : AV22201-06 Manufacturer : BELKIN Cradle Model : MR1000-C Manufacturer : JEC Korea Adaptor Model : JMW128KAXXXXNXX(Compliance with requirements of IEC601-1) Manufacturer : JEC Korea...
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Page 21: Supply Items
MiroCam User Manual 3.2 Supply Items 3.2.1 Basic Supply Item Model MiroCam Quantity Description Replace Product Code Period Capsule MC1000-C 1 ea Receiver MR1000-R 1 ea Cradle MR1000-C 1 ea Adaptor MR1000-A 1 ea Power Code MR1000-P 1 ea Patch Probe... -
Page 22: Installation
MiroCam Capsule Endoscope System Box MiroCam MADE IN KOREA BARCODE LABEL 190.00 480.00 Pulp MAT'L Q'TY. REMARK MODEL ITEM MiroCam Capsule Endoscope Receiver Set Box MiroCam MADE IN KOREA BARCODE LABEL 100.00 210.00 Pulp MAT'L Q'TY. REMARK MODEL Receiver Box ITEM 한글판... - Page 23 MiroCam User Manual MiroCam Capsule Endoscope Battery Charger Box MiroCam MADE IN KOREA BARCODE LABEL 150.00 350.00 Pulp MAT'L Q'TY. REMARK MODEL ITEM Charger Box MiroCam Capsule Endoscope Accessory Box MiroCam 140.00 BARCODE LABEL MADE IN KOREA 640.00 Pulp MAT'L Q'TY.
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Page 24: Technical Data
MiroCam User Manual 5 Technical Data 5.1 Overview Product Name : MiroCam Capsule Endoscope System Model Name : MiroCam Serial Number : Refer to the label which is attaching in the reverse side of the product. 5.2 Hardware 5.2.1 Capsule Size : 10.8 X 24mm... -
Page 25: Software
Color status Display User Friendly software feature Automated detection of GI tract bleeding Color of images are virtually natural 5.4 COMPLIANCE/APPROVALS The MiroCam capsule endoscope system and accessories complies with the Medical Device Directive 93/42/EEC (CE 0843 한글판 버전 1.00... - Page 26 MiroCam User Manual In addition, the product complies with IEC 60601-1:1988 + A1:1991 + A2:1995 (EN 60601-1:1990 + A1:1992 + A2:1995) EN 60601-1-2 EN 10993-1 EN 10993-10 The possibility of hazards arising from software errors was minimized in compliance with EN1441 and EN60601-1-4.
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Page 27: Environment Condition For Storage And Transport
MiroCam User Manual 6 Environment condition for storage and transport. 6.1 Safety environment condition for storage 6.1.1 Receiver unit Environment condition for storage Temperature : -10℃ - +70℃ Relative humidity : 10% - 80% Atmospheric pressure : 700hPa to 1060hPa Keep in the place which is not contacted with water. -
Page 28: Troubleshooting
MiroCam User Manual 7 Troubleshooting 7.1 Introduction This section explains how to troubleshoot the MiroCam capsule endoscope system if problems arise. Tables are supplied that list of possible difficulties, probable cause, and recommended actions to correct the difficulties. 7.2 Who should perform repairs Only qualified service personnel should open the HMT2100 housing, remove and replace components, or make adjustments.
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