IntroMedic MiroCam User manual

MiroCamUserManual 1
한글판 버전 1.00
Contents
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

MiroCamUserManual 2
1 SAFETY
1.1Warnings
The MiroCam® has been manufactured to conform to the International Standard for
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/CSAC22.2 NO.601.1.
To guarantee safety and reliability of the equipment, special attention should be paid to all
the precautions directed throughout this manual, such as "WARNING", "
CAUTION", and "NOTE".Also, to prevent incorrect operations and a failure in
maintenance, it is essential that you should be familiar with the functions, operation and
maintenance instructions by thoroughly reading this manual before operating the equipment.
WARNING
"WARNING" is used to alert the user of a potential serious hazard that may lead to death or
serious injury of patients and personnel.
CAUTION
"CAUTION' is used to indicate information the user should know to avoid a hazard that may
lead to device malfunction, device failure, damage to the device, or damage to other property.
NOTE
"NOTE' is used to indicate important information on installation, operation, or maintenance
which you should to know for the safe and effective use of the equipment.
한글판 버전 1.00

MiroCamUserManual 3
1.2Symbols 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
IEC 878-02-03: Indicates that this is classified into Type BF equipment
EN 980: Denotes Date of Manufacture
EN 980: Denotes Date of ManufactureAddress
IEC60601, ANNEX D: Denotes “ON” status of main power switch
IEC60601, ANNEX D: Denotes “OFF” status of main power switch
SN EN 980: Denotes serial number
IEC 417-5031: Denotes DC (Direct Current)
IEC 417-5032: Denotes AC (Alternating Current)
A Denotes Ampere, the unit of current
V Denotes Volt, the unit of Voltage
Hz Denote Herz, the unit of Frequency
IEC 417-5021: Denotes potential equalization terminal
Single Use Only
The Available Period
한글판 버전 1.00

MiroCamUserManual 4
1.3Function Symbols
1.3.1 Apllication Function Symbols
Symbol Description Symbol Description
Functions & Windows for
Receiver Unit
Functions & Windows for Diagnosis
Report
Function & Windows for Patient
Database Listing
Function & Windows for Export
Patient Image Data
Function & Windows for Image
Display and Diagnosis
Function & Windows for Backup
Patient Image Data
Capturing current patient image
to the thumbnail
Landmark current time of patient
image to the thumbnail
Single previous image Single next image
Previous Selected image Next Selected image
Display image continuously Display image continuously reverse
direction
Pause image display Enlarge image display
Single image display mode Dual image display mode
Quad image display mode Display full image
Display selected image Display red image
Grouping image display in
Thumbnail Single image display in
Thumbnail
Minimize application software Close application software
Mark circle in current image Mark arrow in current image
Erase circle and arrow in current
image Select marker color
한글판 버전 1.00

MiroCamUserManual 5
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 Complete backup current patient
Doctor logout Display full patient list
1.3.2 Receiver Function Symbols
Symbol Description
SIG Status of capsule signal receiving
Green : Good
Yellow : Bad
INI Status of initialization of Receiver Unit
Green : Good
Yellow : Bad
BAT
Status of Battery
Green : Full charged
Yellow : Not charged
한글판 버전 1.00

MiroCamUserManual 6
한글판 버전 1.00
1.4Remarks for Safe Use
Follow these safety instructions and the clinically adopted precautions.
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.
The user's manual must ALWAYS be with the equipment. It is the USER’S
RESPONSIBILITY to ensure this!
CAUTION is advised that the foreign substances, ironware or fluids, such as water or
disinfecting fluid, not enter the equipment.
ONLY authorized personnel may perform any type of repair. Never attempt to open the
covers, panels or casings.
DO NOT crease, bend, fold or twist the probe cables and take care to guard them
against mechanical stress (e.g. wheels or heels)!
The probes must not be exposed to mechanical shock (e.g. by dropping). Any damage
caused that way invalidates the warranty.
CAUTION: Damage/injuries to the probe or cable may lead to safety hazard. It is
HIGHLY advised to have them repaired IMMEDIATELY.
DO NOT handle fluids in the vicinity of the system.
When using a cart purchased elsewhere, implement the latch guard method to prevent
the wheels from rolling.
DO NOT USE in moist or damp places.
DO NOT operate the equipment with wet hands.
Avoid using the equipment in extreme temperatures or humid environments.
DO NOT keep the equipment or carry out the procedure in places such as areas
exposed to direct sunlight, vicinity of heaters, vicinity of chemical materials or gases,
areas moist/damp or dusty, or poorly ventilated areas.
DO NOT disassemble or open the equipment without permission. The free repair
warranty will be automatically invalidated.
DO NOT carry out the procedure in areas with high vibrations or in environments where
high electro-magnetic waves are generated.
DO NOT pull out the power cord by grabbing the cable. When disconnecting the power
cord, grab the plug and then pull out. This prevents short-circuits, disconnection, or
cord damage.

MiroCamUserManual 7
한글판 버전 1.00
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.
CAUTION: Turn off the power switch before connecting the probe.
DO NOT discard probes, cables and connectors with general waste. Separately discard
as industrial waste or medical waste.
CAUTION: Discard the battery according to the regulations of industrial waste. DO
NOT discard with general waste.
DO NOT carry out the procedure simultaneously with other procedures using medical
products or equipment.
DO NOT carry out the procedure on patients with pacemakers and/or defibrillators.
DO NOT use for purposes other than medical treatment.
DO NOT connect the USB cable to the receiver while the receiver’s patch probes are still
connected
DO NOT charge the receiver while the receiver’s patch probes are still connected.
Connect USB cable to receiver only after mounting it on charger.
DO NOT install any other programs onto the workstation utilized for review and diagnosis
of patient image data.
DO NOT carry out the procedure on patients with known or suspected gastrointestinal
tract obstruction, perforation, stricture or fistular.
DO NOT carry out the procedure on patients who have difficulty swallowing food or
pills(dysphagia).
DO NOT carry out the procedure on patient who have difficulty communicating.
DO NOT carry out the procedure on patient with indigestion or delay in gastric emptying.
DO NOT carry out the procedure on patient who may be affected by electromagnetic
radiation, such as pregnant women, infants, and patients with heart disease or epileptics.
DO NOT carry out the procedure on patients with diverticulosis in the Small Bowel.
DO NOT carry out the procedure on patients who are recommended against having the
procedure by a Physician.
The capsule is disposable and should not be reused.

MiroCamUserManual 8
1.4.1 Environmental Conditions for Operation
Temperature : -10 ℃- +70 ℃(Operating : +10 ℃- +40℃)
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. The electro-magnetic waves can cause
equipment malfunctions.
CAUTION If the equipment has been brought in from a cold environment (stock room,
airfreight) into a warm room, initial activation should take place after a few
hours, to allow for temperature adjustment and balance and evaporation of
condensed humidity.
WARNING DO NOT operate the equipment in the vicinity of heat sources, strong
electric or magnetic fields (close to a transformer), or near instruments
generating high-frequency signals.
WARNING - Do not use this device when the output contains d.c. components.
- Do not use the unit with h.f. surgical equipment. It may result in burns at the site
of the electrodes and possible damage to the capsule and receiver.
- Do not use the unit in close radius (within 1 m) of short wave or microwave
therapy equipment. It may produce instability in the captured image.
WARNING This device is a Class B device according to EN60601-1-2 standards. This
equipment can cause radio interference in residential areas. In this case, the
owner (or operator) can be held responsible to take appropriate measures or
take proper measures for compensation.
한글판 버전 1.00

MiroCamUserManual 9
1.4.2 Safety Precautions
CAUTION - Make sure the environment is without interference from electromagnetic
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.
- DO NOT use on patients with pacemakers or defibrillators.
NOTE This device has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of U.S. FCC Rules.
CAUTION EQUIPOTENTIAL BONDING:
In hospital, doctors and patients are subjected to dangerous, uncontrollable
compensating currents. These currents are due to the potential differences
between connected equipment and touchable conducting parts as found in
medical rooms. The safest solution to the problem is consistent equipotential
bonding. Medical equipment is connected with connecting leads made up
with angle sockets to the equipotential bonding network in medical rooms.
CAUTION DO NOT use the capsule if the package is unsealed. If capsule package is
unsealed, it can be infected.
DO NOT reuse a used capsule.
To prevent unexpected accidents like fire or explosion, do not use it near or in the
presence of inflammable or ignitable substances.
DO NOT disassemble the equipment case nor open the cover. In case of problems in
equipment or need for other service, please contact our head office or a customer
support staff immediately.
Only the accessories authorized and designed by our company should be used with this
equipment. Faults resulting from the usage of unapproved or inappropriate accessories
are not guaranteed against.
This equipment may have an effect on other products or be effected by them.
Follow your doctor’s instructions and abide by the guidelines in the user manual.
DO NOT try to upload the data while the patch probes are still connected to the receiver.
DO NOT charge the rechargeable battery in the receiver while the patch probes are still
connected to the receiver.
Stay away from high frequency radiation sites (such as high voltage, radar, installation
power plants, MRI, CT or electric blankets etc.) during your capsule endoscope
procedure. (It may result in serious side effects requiring an emergency operation.)
한글판 버전 1.00

MiroCamUserManual 10
한글판 버전 1.00
In case of any symptoms of abdominal pain, vomiting, fever, heart trouble, dizziness or
seizure during or after the capsule endoscope procedure, please notify your doctor.
Always check the connection between the receiver and the patch probes.
Always check that the battery in the receiver is fully charged before use.
DO NOT use the capsule if the package is unsealed.
After ingesting the capsule, always check whether the capsule has been excreted.
Prior to undergoing the capsule endoscopy procedure, patients with diabetes must
control their insulin doses.
For more accurate data and better analysis, patients can have solid food for lunch, but
must have liquid food as dinner on the day before the procedure and need to fast for 12
hours before the procedure.
12 hours before the procedure, take a laxative such as Sodium phosphate or PEG
solution.
DO NOT smoke for 12 hours prior to the capsule endoscope procedure.
DO NOT apply body lotion to your body before the procedure.
DO NOT bite the capsule before swallowing.
Avoid excessive physical activity during the capsule endoscope procedure.
2 hours after swallowing the capsule, patients may drink water, and after 4 hours,
patients may have liquid food.
When undergoing the capsule endoscope procedure, DO NOT makes physical contact
with another person undergoing this same procedure.
During operation of the receiver, DO NOT touches it or gets it wet.
Use the provided batteries only and never take it out of the receiver body during the
procedure.
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.

MiroCamUserManual 11
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.
Be careful that foreign substances do not enter the main system when cleaning. Please
maintain the probe according to the disinfection instructions.
The vaginal manometry probe must not be cleaned with a wet towel before usage. Use
the vaginal probe ONLY after putting a disposable latex condom on it, and then discard
only the condom after use.
The patch probe for abdominal attachment must not be rubbed or wiped.
ALWAYS operate the equipment under sanitary environmental conditions. DO NOT use
heat or gas for the disinfection of the probes and cables.
CLEAN vaginal probes, anal probes, patch probes and vaginal manometry probe should
ALWAYS be used.
1.4.3.2 Service documents
If required, or upon request, the supplier may provide block diagrams, list of spare parts,
descriptions, adjustment instructions or other related information which may help qualified
technical personnel in repairing specified parts of the equipment which have been defined
repairable by the manufacturer.
1.4.3.3 Moving the Equipment
CAUTION when moving equipment.
WARNING: Excessive impact/shock causes internal damage.
If wiring is connected/disconnected when moving, check the exact wiring status after
moving.
If damage to the equipment is found out after moving, immediately contact the company
or dealer.
WARNING Before moving the system, always make sure to disconnect the monitor from the
main system, and then safely move the main system and monitor separately.
Connect the main system and monitor only after moving is finished and the systems
structure is settled and stabilized.
한글판 버전 1.00

MiroCamUserManual 12
2 Overview
2.1Description 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 2
한글판 버전 1.00

MiroCamUserManual 13
2.2System Overview
MiroCam Capsule Endoscope Systems consist of Capsule Receiver and Image
Processing Workstation (Software).
Image Sensor
Data
Transmittion Analog Amplifier Analog Filter
FPGA
DSP Data
Communication
Image
Processing
Image Display
Capsule Receiver Software
MiroCam System Block Diagram
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.
2.2.3 IPW
MiroCam Capsule Endoscope System’s Software is running on the Microsoft
Windows XP using the IBM compatible PC platform and provide easy-to-use icon
menu. It consist of Image reconstruction part and Image display part.
한글판 버전 1.00

MiroCamUserManual 14
한글판 버전 1.00
2.3Feature 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
-Small, light and easy to carry around
IPW
-User Friendly software feature
-Red Color Detection
-Color of images are virtually natural
-Dual and quad image views
System
-Over Intel P4 3.0GHz
-Over 1G Byte Memory
-Over 100GByte Hard Disk

MiroCamUserManual 15
2.4Function Explanation
2.4.1 Display flow
Report View
Image Review
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.
Press button for playing image data.
한글판 버전 1.00

MiroCamUserManual 16
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 Sequence of Operation
Initialize Receiver Unit
①Connect USB Cable between Receiver unit with Workstation Æ②Click button
Æ③Click button ④Click Input Patient Info button Æ⑤Input
Patient information Æ⑥Click Save button
Upload Image Data
①Connect USB Cable between Receiver unit with Workstation Æ②Click button
Æ③Click button
Display Image Data and Diagnosis
①Select Patient in Patient List for data review Æ②Click button Æ③Click
button
Print Diagnosis Data
①Select Patient in Patient List for data review Æ②Click button Æ③Input
diagnosis result Æ④Insert diagnosis point in patient image data
한글판 버전 1.00

MiroCamUserManual 17
한글판 버전 1.00
2.4.4 Connection and Disconnection
Part Where When Method
Patch
Probe
Connector of
upper side of
receiver unit
Before
process
capsule
endoscope
Connection : Hold the connector on the end of
the receiver’s patch probe and put it into the
socket of the top of the patch.
Disconnection : Hold the connector on the end
of the receiver’s patch probe and pull it out by
hands..
USB
Cable
USB
Connector of
left side of
receiver unit
After process
capsule
endoscope
Connection : Hold the USB cable connector
and push it into the USB connector on the side
of the receiver.
Disconnection : Hold the connector on the tip
of the USB cable and pull it out by hands.
Cradle Lower side of
receiver unit
After process
capsule
endoscope
Connection : Place down the receiver into the
Cradle as its slot. .
Disconnection : Pull out the receiver from the
Cradle vertically.
Adaptor Rear side of
cradle
System
Installiation
Connection : Put the DC cable of the charger
into the DC jack of the Cradle..
Disconnection : Pull out the connector of the
DC cable of the charger by hands.

MiroCamUserManual 18
한글판 버전 1.00
2.5Intened 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.

MiroCamUserManual 19
3 Product
3.1Pictures
3.1.1 Main Device
Capsule
Receiver
한글판 버전 1.00

MiroCamUserManual 20
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
한글판 버전 1.00