Intromedic INTROMEDIC2 Capsule Endoscope & Receiver User Manual
Intromedic Co., Ltd. Capsule Endoscope & Receiver
Contents
- 1. User Manual 1
- 2. User Manual 2
User Manual 1
Copyright© 2007 IntroMedic Co., Ltd. MM1000-0809
Version 1.24 Date : 2008-09-20
User Manual
Warranty
Page 3
Trademarks
MiroCam®, MiroView™, IntroMedic, and the associated logos are the
registered trademarks ® or trademarks ™ of IntroMedic Co., Ltd. © IntroMedic
Co., Ltd. July 2007.
Except as required by applicable copyright laws; any use of the IntroMedic
trademarks, or any reprinting, reproduction, modification, referencing and
translations of the User Manual, without the prior written approval of
IntroMedic Co., Ltd. is strictly prohibited.
Warranty
Every effort has been made to ensure the information contained in this User
Manual is accurate, and is believed to be correct at time of printing.
IntroMedic reserves the right to change any content contained with this User
Manual without prior notice.
IntroMedic Co., Ltd. warrants the product against defects in material and
workmanship for a period of twelve (12) months from the date of sale, unless
different local regulations apply. IntroMedic Co., Ltd. will repair or replace
products that are ascertained by IntroMedic to have defects during the
warranty period. IntroMedic Co., Ltd. is not liable for the defects occurred by
misuse, careless handling, unauthorized modifications or erroneous use, or
any use that is non-compliant with instructions detailed within this User
Manual. This includes use of the product in non-appropriate locations or
conditions. Any other warranties are neither represented here nor recognized
by implication.
To validate the warranty, please complete product registration with the local
authorized IntroMedic distributor.
Warranty
Page 4
Exclusive warranty service
The warranty service provided hereby is applicable exclusively to the
purchaser of the product. IntroMedic will only warranty the product for
purposes and usage as defined in this User Manual. Any usage not heeding
the warnings, cautions and recommended usages as defined in this manual
will nullify the warranty.
Support
For warranty or repair service please contact the local authorized IntroMedic
distributor.
For customer service or support please contact your point of purchase or
IntroMedic Co., Ltd. Service agreements are only applicable to products of
IntroMedic Co., Ltd.
IntroMedic Customer Service
TEL: 82-2-801-9300
FAX: 82-2-801-9330
http://www.intromedic.com
E-mail: helpdesk@intromedic.com
Safety
Non-compliance with the user’s manual, unauthorized modifications of the
product or replacement of parts, and/or opening of the product casing is
prohibited and may be hazardous.
Contents
Page 5
CONTENTS
1. SAFETY INFORMATION 3
1.1 Warnings 3
1.2 Symbols for Safety 4
1.3 Function Symbols 5
1.4 Notes for Safe Use 8
2. SYSTEM OVERVIEW 3
2.1 Intended Purpose 3
2.2 Observable Diseases 4
3. PERFORMING CAPSULE ENDOSCOPY 3
3.1 General Comments 3
3.2 Safety Warnings 3
3.3 Examination Preparation 4
3.4 Patient Preparation 6
3.5 Sensor Placement & Capsule Ingestion 7
3.6 Uploading Images 15
3.7 Receiver Management – Post Procedure 16
4. USING MIROVIEW™ 3
4.1 Before Using MiroView™ 3
4.2 Administering and Initializing Patients 12
4.3 Viewing Setting 18
4.4 Creating a Report 27
4.5 Atlas 33
4.6 Backing up Patient Data 35
Contents
Page 6
5. USING MIROVIEW™ RTV 3
5.1 Overview 3
5.2 Using MiroView™ RTV 5
1
Safety Information
Safety Information Chapter 1
1- 2
Chapter 1 Safety Information
1-3
1. SAFETY INFORMATION
1.1 Warnings
MiroCam® has been manufactured to conform with 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.
MiroCam® has been manufactured to conform to the electric shock, fire
and mechanical hazard standards as defined in CAN/CSA C22.2
NO.601.1.
Based on request of the buyer, IntroMedic will provide the labeling, such
as ID labels, and the User Manual in the national language(s) of
European countries. Translated documents will be evaluated by a local
language expert, and will be confirmed by a native speaker of the
respective national language.
Safety Symbols: The User Manual incorporates various safety symbols
to ensure safe and correct use of the product and to prevent any personal
injury or property damage. These symbols are defined in the following
table:
WARNING
WARNING indicates a potential hazard that, if not avoided, could
result in serious personal injury or damage to the product.
CAUTION
CAUTION indicates a potential hazard that, if not avoided, could
result in minor personal injury or damage to the product.
NOTE
NOTE does not indicate potential hazards as in Caution or
Warning, but contains important information regarding the
installation, operation or maintenance of the product.
Safety Information Chapter 1
1- 4
1.2 Symbols for Safety
This section describes a set of symbols that the IEC (International
Electrotechnical Commission) has established for medical electronic
equipment to classify connections and warnings 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 Address of Manufacture
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 Hertz, the unit of Frequency
IEC 417-5021: Denotes potential equalization terminal
Single Use Only
Use by date
Chapter 1 Safety Information
1-5
1.3 Function Symbols
1.3.1 MiroView™ Function Symbols
The following table describes symbols or icons used in the
MiroView™ software.
Symbol Description Symbol Description
Connect to the receiver
and open receiver control
screen.
Open the report screen to
create a patient capsule
endoscopy report.
Open the patient data
screen.
Open screen to export
(save externally) selected
image data for a specific
patient.
Open screen to review for
a specific patient
Open screen to backup
image data for a specific
patient.
Select and save an image
being reviewed.
Place a landmark in an
image being reviewed.
Move to the previous
image. Move to the next image.
Move to the previous
captured image.
Move to the next captured
image.
Play images in sequential
order.
Play images in reverse
order.
Stop playback of images. Show images in full screen
Show images in a single
screen.
Show images in the dual
screen.
Safety Information Chapter 1
1- 6
Symbol Description Symbol Description
Show images in the quad
screen. Play all images.
Play the selected images
only. View images via
Quick Mode function.
SGIB - Play the images
captured via Suspected GI
Bleeding function.
Show images in the
Capture Box by group.
Show all images in the
Capture Box.
When editing the captured
image in the report mode,
add a circle on the
captured image.
When editing the captured
image in the report mode,
add an arrow on the
captured image.
Erase the circle or arrow
displayed in an image
when a report is created.
Select a color to use in an
image when a report is
created.
Cancel the last action
applied to an image when
a report is created.
Re-apply the cancelled
changes when a report is
created.
Indicate that a report for
the selected patient is
being created.
Indicate that a report for the
selected patient has been
created.
Indicate that image data for
the selected patient has
been exported.
Indicate that image data for
the selected patient has
been backed up.
User logs out from
MiroView™.
Show the complete list of
patients
Chapter 1 Safety Information
1-7
1.3.2 Receiver Function Symbols
Symbol Description
SIG
Indicates status of signal from capsule
Green : Signal is being received from capsule
Yellow : Signal is not being received from capsule
INI
Initialization status of Receiver Unit
Green : Receiver is initialized
Yellow : Receiver is not initialized
BAT
Battery Status
Green : Fully charged
Yellow : Not charged
Safety Information Chapter 1
1- 8
1.4 Notes for Safe Use
Follow the safety instructions included in this User Manual and clinical
precautions advised by the medical professional.
The manufacturer is not liable for harm or damage caused by improper,
unauthorized, unprofessional or inexpert use of the device and/or
product.
IntroMedic Co., Ltd. is NOT responsible for physical harm or
equipment problems caused by the user’s careless operation or
mismanagement of the device and/or product.
Users MUST have read and understood the User Manual. ONLY
trained and qualified medical professionals or authorized
representatives of IntroMedic Co., Ltd. may operate the system.
User Manual must ALWAYS be with the equipment. This is the USER’S
RESPONSIBILITY.
CAUTION: foreign substances including water, cleaning fluids,
disinfecting cleanser and such substances may harm the equipment,
and should not enter the equipment.
ONLY authorized personnel may perform repairs. Never attempt to
open covers, panels or casings.
DO NOT crease, bend, fold or twist the data cables. Take care to guard
them against mechanical stress (e.g. wheels or heels)!
The sensor pads, receiver, data cables, and capsules must not be
exposed to mechanical shock (e.g. by dropping). Any damage caused
that way will void the product warranty.
CAUTION: Damage/injuries to the sensor pad or data cable may cause
a safety hazard. Damaged items MUST be repaired IMMEDIATELY.
DO NOT handle fluids in the vicinity of the system.
When using a cart purchased elsewhere, ensure the brake or latch
guard is in use to prevent the wheels from rolling.
DO NOT USE in moist or damp places.
Chapter 1 Safety Information
1-9
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. This
will invalidate the warranty.
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, grasp the plug, and pull out. This
prevents short-circuits, disconnection, or cord damage.
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 sensor pad.
DO NOT discard sensor pads, cables and connectors with general
waste. Discard separately as industrial 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 use for purposes other than medical treatment.
DO NOT connect the USB cable to the receiver while the receiver’s
data cable and sensor pads are still connected
Safety Information Chapter 1
1- 10
DO NOT charge the receiver while the receiver’s data cable and
sensor pads 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 (i.e computers with the
MiroView™ software).
The capsule is disposable and should not be reused.
The capsule and sensor pads are medical waste, and should be
disposed of according to local regulations or WEEE directive on waste
disposal.
Only use the capsule, receiver, data cables and sensor pads in the
medical environment condition.
All products connected with the MiroCam® Endoscope system must be
compliant with requirements of IEC60950-1 or UL certifications.
Chapter 1 Safety Information
1-11
1.4.1 Environmental Conditions for Operation
Temperature : +10 ℃ - +40℃
Relative humidity : 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 MiroCam® alongside or together with medical
devices or procedures involving electrical currents.
Do not use MiroCam® 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.
Safety Information Chapter 1
1- 12
1.4.2 Safety Precaution
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 sensor pads MUST be
observed.
- DO NOT use on patients with pacemakers or
defibrillators.
CAUTION DO NOT use the capsule if the package is unsealed.
DO NOT reuse a used capsule.
To prevent unexpected accidents like fire or explosion, do not use any
product near or in the presence of inflammable or ignitable substances.
DO NOT disassemble the equipment case nor open the cover. In case
service is required, please contact IntroMedic customer support or
local point of sale immediately.
Only the accessories authorized and designed by IntroMedic Co., Ltd.
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
other products.
Follow your doctor’s instructions and abide by the guidelines in the
User Manual.
DO NOT try to upload the data while the data cables are still
connected to the receiver.
DO NOT charge the rechargeable battery in the receiver while the data
cable and sensor pads are still connected to the receiver.
Chapter 1 Safety Information
1-13
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.)
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 data cable.
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 be informed via a medical professional regarding
appropriate medication & dosage.
For more accurate data and better analysis, patients can have solid
food for lunch, but must have liquid food for dinner on the day prior to
the procedure. The patient must fast for 11 hours prior to ingesting the
capsule.
If recommended by the physician, the patient may take a laxative prior
to the procedure.
DO NOT smoke for at least 12 hours prior to the capsule endoscope
procedure.
DO NOT apply body lotion before the procedure.
DO NOT bite the capsule.
Avoid excessive physical activity during the capsule endoscope
procedure.
2 hours after ingesting the capsule, patients may drink water, and after
4 hours, patients may have liquid food.
Safety Information Chapter 1
1- 14
When undergoing the capsule endoscope procedure, DO NOT make
physical contact with another person undergoing the same procedure.
During operation of the receiver, DO NOT touch the receiver, or get the
receiver wet.
Only use the provided batteries, and never remove the battery from the
receiver during the procedure.
During upload of the data recorded in the receiver to the PC, avoid
disconnecting the USB. This may damage the patient’s data.
Always confirm that the USB is connected by checking the Receiver
screen on the MiroView™ software.
Always check the AC Power range before use the workstation.
DO NOT touch AC Power code with wet hands.
DO NOT open the receiver bag or touch receiver outside of the
hospital.
This device is intended for patient over the age of 18.
WARNING The Capsule takes a picture for 11 hours and gets naturally
excreted in about 24 hours under normal conditions. If the
capsule has not been excreted from the patient within 72
hours, patient should contact the physician. After
examining, the physician may need to perform a surgical
operation or treatment to remove the capsule.
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 the hardware is fully
installed, secure and stable.
Chapter 1 Safety Information
1-15
1.4.3 Cleaning and Maintenance
System and accessories
- All products 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.
- ALWAYS operate the equipment under sanitary environmental
conditions. DO NOT use heat or gas for disinfection of the capsule.
Service Document
If required, or upon request, the local IntroMedic Distributor (authorized
IntroMedic Representative) may provide block diagrams, lists 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
IntroMedic Co., Ltd. .
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 discovered after moving, immediately
contact IntroMedic or local Distributor.
Safety Information Chapter 1
1- 16
2
Overview & Intended Usage
Overview & Intended Usage Chapter 2
2- 2
Chapter 2 Overview & Intended Usage
2-3
2. SYSTEM OVERVIEW
MiroCam® is an orally ingested capsule endoscope designed to capture
and wirelessly transmit images of the lining of the small intestine.
Captured images are viewed via the MiroView™ software for diagnosis of
diseases related to the small intestine.
The MiroCam® capsule endoscope system consists of the MiroCam®
capsule, MiroCam® receiver, MiroView™ software, and accessories.
2.1 Intended Purpose
MiroCam® is intended for visualization of the small bowel mucosa as an
adjunctive tool in the detection of abnormalities of the small bowel. The
device captures images of the small bowel with a wireless camera
contained in a capsule. This device includes an ingestible capsule
(containing a light source, camera, transmitter, and battery), an electrode
array, a receiving/recording unit, a data storage device, computer
software to process the images (MiroView™), and accessories.
Overview & Intended Usage Chapter 2
2- 4
2.1.1 Contraindications
Not intended for patients with known or suspected gastrointestinal
tract obstructions, perforations, strictures or fistular.
Not intended for patients who have difficulty ingesting food or pills
(dysphagia).
Not intended for patients who have difficulty communicating.
Not intended for patients with indigestion, or slow gastric emptying.
Not intended for patients who may be affected by electromagnetic
radiation, such as pregnant women, infants, and patients with heart
disease or epilepsy.
Not intended for patients with diverticulosis in the Small Bowel.
Not intended for patients who are recommended against having the
procedure by a Physician.
Not intended for patients with pacemakers and/or defibrillators.
This device is intended for patient over the age of 18.
2.2 Observable Diseases
2.2.1 Obscure gastrointestinal bleeding (OGIB)
Angioectasia
Meckel diverticulum
NSAIDs
2.2.2 Crohn’s Disease
Chapter 2 Overview & Intended Usage
2-5
2.2.3 Small Bowel Tumors
Polyps
Peutz-Jeghers Syndrome
Familial adenomatous polyposis
Lymphoma
Carcinoid
Gastro-Intestinal Stromal Tumor (GIST)
Lipoma
Hemangioma
2.2.4 Inflammation
Intestinal Tuberculosis
Typhoid Fever
Angeitis
Amyloidosis
Eosinophilic enteritis
2.2.5 Celiac Disease
2.2.6 Behcet’s Disease
2.2.7 Cowden Disease
2.2.8 Cronkhite-Canada Syndrom
Overview & Intended Usage Chapter 2
2- 6
3
Performing Capsule Endoscopy
Chapter 3 Performing Capsule Endoscopy
3- 2
Performing Capsule Endoscopy Chapter 3
3-3
3. PERFORMING CAPSULE ENDOSCOPY
3.1 General Comments
This chapter describes how to operate and control MiroCam®
capsule endoscope system.
Installation and initial operation must be done by an Authorized
IntroMedic Service Technician.
3.2 Safety Warnings
WARNING Before turning on the system, check the environment
condition for MiroCam® capsule endoscope system.
CAUTION In case the system has been brought from cold
environment (stock room or airfreight) into a warm room,
you should first switch on it after some hours for
temperature balance and removing of condensation
humidity (Risk of leakage current).
CAUTION For the electrical safety, make sure that peripheral
equipments (external PC, Monitor, printer etc) should be
connected to wall socket of independent power supply with
a perfect ground. Particularly make sure whether or not
those peripheral equipments should be authorized for
medical usage.
CAUTION DO NOT touch the dome of the capsule.
CAUTION if SIG indicator of the Receiver turns yellow after ingesting
the capsule, immediately contact the physician.
CAUTION If SIG indictor of the Receiver does not turn green when the
patient holds the capsule by the gold bands, immediately
stop the procedure.
NOTE If images of the small bowel are not captured during the
procedure, ensure the capsule has been excreted by the
patient and perform procedure again.
Chapter 3 Performing Capsule Endoscopy
3- 4
3.3 Examination Preparation
The following steps (3.3.1 to 3.3.4) explain the process to initialize the
receiver and register patient data for the capsule endoscopy procedure.
For more information see section 4.2.
3.3.1 Start System
Turn on power of MiroCam® workstation.
Click icon to start the MiroView™ software program.
Insert the ID and password and click icon.
WARNING Before starting the system, check the power rating for the
workstation.
3.3.2 Initialize the Receiver
Connect the smaller connector of USB Cable to Receiver unit.
Connect normal connector of USB cable to workstation.
Turn on the power of the Receiver unit.
Click icon in MiroView™.
Click icon in the top right of MiroView™ screen.
After end of formatting of MiroCam® Receiver unit, complete
patient information and click button.
Performing Capsule Endoscopy Chapter 3
3-5
Note Before clicking the icon in MiroView™, connect USB
cable to MiroCam® Receiver unit.
WARNING If MiroCam® receiver unit is initialized, any patient data
stored on the device will be deleted permanently.
3.3.3 Receiver Preparation
Connect battery to the receiver unit.
- Insert pins on back side of the receiver unit in the slots on the
battery.
- Press battery to receiver until clasp locks battery in place.
Turn on power switch of receiver unit.
Check battery indicator (BAT) of upper side of receiver unit. If
battery is fully charged, light will be green. If light is not green,
charge the battery.
Check initialization indicator (INI) of upper side of receiver unit.
Prior to beginning a procedure, this light must be green.
Connect data cable to receiver unit.
Indicator Description
SIG Indicates status of signal from capsule
Green : Signal is being received from capsule
Yellow : Signal is not being received from capsule
INI Initialization status of Receiver Unit
Green : Receiver is initialized
Yellow : Receiver is not initialized
BAT
Battery Status
Green : Fully charged
Yellow : Not charged
WARNING DO NOT do begin procedure when receiver unit’s battery
indicator is not green. This indicates battery is not fully
charge or out of order, and patient data may be lost.
Chapter 3 Performing Capsule Endoscopy
3- 6
3.4 Patient Preparation
Provide the patient with the following instructions to prepare for the
capsule endoscope procedure.
3.4.1 Patient Preparation
One day prior to the capsule endoscope procedure
- Lunch: Patient can have a normal mean around noon, followed
by a liquid diet as instructed by the physician.
- The patient should fast for at least 12 hours prior to the
procedure. Patient may only drink water (no food or other
beverages such as milk or coffee).
- The patient should not take any medications two hours before
ingesting the capsule endoscope.
- Male patients may need to shave area, as advised by
physician or nurse.
- Patient should stop taking iron supplements 1 week before the
capsule endoscope procedure, and should not ingest any
medicine at least 2 hours prior to the procedure.
- Diabetic patients need to follow any changes to insulin dosage
as prescribed by the physician.
- Physician is recommended to prescribe patient a laxative such
as PEG or Sodium Phosphate. Patient should ingest laxative
12 hours prior to procedure.
- Physician is recommended to prescribe patient an anti-foaming
agent (such as simethicone), to reduce bubbles in the GI tract.
This should be ingested after the laxative.
- The patient should abstain from smoking 12 hours before the
procedure.
- On the day of the capsule endoscope test, the patient should
wear comfortable and loose cloths. One-piece clothing should
not be worn.
- Prior to the procedure, do not apply any lotions or perfumes.
On the day of capsule endoscope procedure
- After arriving in a hospital at the appointed time, the patient
should submit an examination permission form and check in.
After ingesting capsule endoscope
- The patient should refrain from taking any food or drink two
hours after ingesting the MiroCam® capsule endoscope. Water
is permitted after two hours.
Performing Capsule Endoscopy Chapter 3
3-7
- The patient can start with light food after 4 hours. When the
examination is complete, the patient can start having normal
meals.
- In case of any abdominal pain, nausea or vomiting after
ingesting the MiroCam® capsule, the patient should contact
physician or nurse immediately.
3.5 Sensor Placement & Capsule Ingestion
Following is the detailed procedure required to correctly administer the
capsule endoscope procedure.
Chapter 3 Performing Capsule Endoscopy
3- 8
3.5.1 Connecting Sensor Pads
After attaching sensor pads to the data cables, attach the sensor pad
correctly to each area as shown below.
14
6 7
8
Xiphoid process Line
Pelvic Line 5
R
23
Performing Capsule Endoscopy Chapter 3
3-9
3.5.2
Attach sensor pads according to the number on the data cable.
-
Locate the center between the umbilical and the xiphoid process.
From this center point, attach the sensor to the distal point on
the right flank of the patient’s body.
-
Place the sensor pad on the xiphoid process line, directly below
the right clavicle.
-
Place the sensor pad on the xiphoid process line, directly below
the left clavicle.
-
Locate the center between the umbilical and the xiphoid process.
From this center point, attach the sensor to the distal point on
the left flank of the patient’s body.
-
Place the sensor pad on the right pelvic line, 2 cm behind
sensor #1.
-
Place the sensor on the right inguinal line, 2 cm to the outside of
sensor #2.
-
Place the sensor on the right inguinal line, 2 cm to the outside of
sensor #3.
5 8Pelvic
Line
Xiphoid
p
rocess Line
1 4
Chapter 3 Performing Capsule Endoscopy
3- 10
- Place the sensor pad on the right pelvic line, 2 cm behind
sensor #4.
- Place the sensor directly below the right clavicle.
CAUTION The numbering of the data cables and sensor pad must
match the specified area. Please follow the numbering
sequence appropriately.
CAUTION To prevent entanglement of the data cables during
procedure, organize cables and place appropriately in cable
bag.
WARNING Correct image signal may not be obtained if a sensor pad is
not in direct, immediate contact with the skin. Ensure the
sensor pads are in direct contact with the skin. Shaving
may be required for male patients.
The pictures below show the sensor pads attached in the correct locations.
Performing Capsule Endoscopy Chapter 3
3-11
3.5.3 Removing Capsule from Packaging
While holding the MiroCam® upside down, peel off the sterilized
packaging cover.
3.5.4 Removing the Case
Turn the package over, the MiroCam® case will slip out of the
packaging. While holding the MiroCam® case, open the lid.
3.5.5 Removing the Capsule
Grip capsule with right hand, and remove from cast. Do not touch the
dome of the capsule.
Chapter 3 Performing Capsule Endoscopy
3- 12
Make sure that the capsule packaging is not damaged in any way.
When removed capsule from case, the capsule should be flashing.
CAUTION Do not use a capsule endoscope when the packaging or
the capsule is damaged.
Check if the front of the capsule is flashing when it is removed
from the case
After washing hands, patients should grip the gold section of the
capsule between the thumb and the forefinger of the both hands.
3.5.6 Checking Operation of the Receiver and Signal Reception
After the patient holds the capsule as detailed above, the signal
indicator on the receiver is green and signal indication melody is
generated.. If signal indicator is yellow, there is no signal being
received from the capsule.
Switch on the receiver.
Check if the battery indicator (BAT) at the top of the receiver shows
that the battery is fully charged. The battery indicator on the
Performing Capsule Endoscopy Chapter 3
3-13
receiver should be green.
Check if the initialize indicator (INI) at the top of the receiver shows
that initialization is complete. The INI indicator on the receiver
should be green.
Connect the data cable to the MiroCam® receiver.
After patient grasps capsule by opposing gold bands (as detailed
in picture above, check the SIG indicator on the receiver is green
and signal indication melody is generate.
CAUTION If the battery indicator on the receiver shows that the
battery is not fully charged, do not start the endoscopy
procedure. The battery may be depleted during the
procedure and images may not be saved properly.
3.5.7 Ingesting the Capsule
After checking if the signal indicator on the receiver is green, ingest
the capsule with water.
CAUTION Do NOT bite the capsule while ingesting.
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3.5.8 Checking and Wearing the Receiver
After ingesting the capsule, make sure that the SIG indicator is
green.
Place the receiver in the bag.
Organize the contents of the bag so that the cables are not
entangled.
Adjust cables, and place excess in cable bag.
Adjust the bag strap as needed.
Capsule endoscopy procedure will be complete after 11 hours.
CAUTION Patient should not touch receiver during the procedure. This
may lead to loss of image data.
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3.6 Uploading Images
Once the capsule endoscopy procedure is complete, upload image data
from the receiver to the workstation and start diagnosis of the data using
MiroView™.
3.6.1 Transferring and Checking image data
Switch on the workstation.
Click the icon on the desktop to launch MiroView™.
When the login window appears, enter the user ID and password,
and then click the button.
Connect the smaller end of the USB cable to the receiver.
Connect the other end of the USB cable to the workstation.
Click the button in MiroView™.
Click the button in the upper right corner of MiroView™.
When the image data in the MiroCam® receiver is successfully
uploaded, click the button in the upper left corner of
MiroView™.
Select the patient image data and click the icon to review
patient images.
WARNING For more information on using MiroView™, please refer to
Chapter 4, Using MiroView™.
Chapter 3 Performing Capsule Endoscopy
3- 16
3.7 Receiver Management – Post Procedure
3.7.1 Cleaning
Remove data cable from receiver unit.
Capsule and sensor pads should not be reused.
To clean the MiroCam® Receiver unit and Workstation, dampen a
soft cloth with warm water or with a commercial, nonabrasive
cleaner (or a mild soap or detergent solution) and wipe the exterior
surface lightly. Do not allow any liquids to come in contact with the
power connector, cable connector or switches. Do not allow any
liquids to penetrate connectors or openings in the system cover.
Cleaning of the system and accessories should be conducted at
least once a week.
CAUTION Do not immerse the MiroCam® capsule endoscope system
or its accessories in liquid or clean with caustic or abrasive
cleaners. Do not spray or pour any liquid on the system or
its accessories. Do not use the organic solvents such as a
lacquer, thinner, ethylene and oxide because they can
damage the equipment. When cleaning the data cables, do
not use the cleaning tools such as brush and sandpaper.
3.7.2 Charging Battery
Battery must be recharged after every procedure.
Battery can be individually recharged or with receiver unit.
Battery must be recharged in battery charger.
If two batteries are inserted in charger, the batteries will
automatically consecutively charge (not simultaneous).
Performing Capsule Endoscopy Chapter 3
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Connect adapter DC cable to battery charger.
Connect AC power code to adaptor.
Connect AC power code to AC consent or multi-tap.
Battery charger indicator lights:
Battery is charging when green light is blinking
Battery is fully charged when light is solid blue
Battery is not-charging if light is yellow
Note: second battery in charger will automatically begin
charging once first battery is fully charged.
WARNING If the indicator on the battery charger is blinking yellow
there is a bad connection. Please disconnect the battery
from the battery charger and try again.
WARNING Only use batteries provided by IntroMedic. Usage of
inappropriate batteries can cause serious damage to the
receiver.
WARNING Recharge the MiroCam® receiver batteries with the
adaptor and the battery charger only from IntroMedic.
Improper adaptors and battery chargers cause serious
damage.
Chapter 3 Performing Capsule Endoscopy
3- 18
WARNING Try not to contact the metallic terminal board of batteries
with conductive objects or human body. It can cause an
electric shock or damage and/or breakage of the
batteries.
WARNING Do not use the batteries with visible surface damage on.
Usage of damaged batteries can result in leakage of
contents of the batteries.
WARNING To avoid the risk of explosion, keep batteries away from
fire.
WARNING Treat the batteries carefully from serious impact or shock.
This can cause serious damage to the batteries.
WARNING Do not expose the batteries to liquids. This can cause
serious damage.
4
Using MiroView™
Chapter 4 Using MiroView™
4- 2
Using MiroView™ Chapter 4
4-3
4. USING MIROVIEW™
MiroView™ is a computer software program that aids in diagnosis of
disease of the small bowel via displaying images obtained from the
MiroCam® capsule.
4.1 Before Using MiroView™
MiroView™ will be pre-installed on workstations. Click the corresponding
icon on the desktop to launch MiroView™.
4.1.1 Starting MiroView™
Switch on the workstation.
Click the icon on the desktop to launch MiroView™.
When the login screen appears, enter your user ID and password
and press the button to access MiroView™.
CAUTION Before starting the system, check the power rating for the
workstation.
NOTE If you have forgotten your password, contact your system
administrator or local IntroMedic representative.
Chapter 4 Using MiroView™
4- 4
4.1.2 MiroView™ Icons
Symbol Description Symbol Description
Connect to the receiver
and open receiver control
screen.
Open the report screen to
create a patient capsule
endoscopy report.
Open the patient data
screen of the MiroCam®
system.
Open screen to export
(save externally) selected
image data for a specific
patient.
Open screen to review for
a specific patient
Open screen to backup
image data for a specific
patient.
Select and save an image
being reviewed.
Place a landmark in an
image being reviewed.
Move to the previous
image. Move to the next image.
Move to the previous
captured image.
Move to the next captured
image.
Play images in sequential
order.
Play images in reverse
order.
Stop playback of images. Show images in full screen
Show images in a single
screen.
Show images in the dual
screen.
Show images in the quad
screen. Play all images.
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4-5
Symbol Description Symbol Description
View images via Quick
Mode function.
SGIB - Play the images
captured via Suspected GI
Bleeding function.
Show images in the
Capture Box by group.
Show all images in the
Capture Box.
When editing the captured
image in the report mode,
add a circle on the
captured image.
When editing the captured
image in the report mode,
add an arrow on the
captured image.
Erase the circle or arrow
displayed in an image
when a report is created.
Select a color to use in an
image when a report is
created.
Cancel the last action
applied to an image when
a report is created.
Re-apply the cancelled
changes when a report is
created.
Indicate that a report for
the selected patient is
being created.
Indicate that a report for the
selected patient has been
created.
Indicate that image data for
the selected patient has
been exported.
Indicate that image data for
the selected patient has
been backed up.
User logs out from
MiroView™.
Show the complete list of
patients
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4.1.3 MiroView™ Menus
File Menu
Save Save changes (captured images,
comments etc.) to Database
Backup… Backup patient information and image
data file (complete file)
Restore… Restore patient information and image
data file into MiroView (from backup file)
Export Save captured images, videos and/or
patient report to a designated storage
space (USB etc.)
Export for MiroView Express… Export patient information and image data
file for MiroView Express
Import for MiroView Express… Import patient information and image
data file from MiroView Express
Preview… Preview of printing image
Print Report Print current patient report
Save as PDF File Convert the report to a PDF file
Print check list Print system and/or patient check list
Printer options Printer settings
Close Close MiroView™ Software
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Tools Menu
Settings… Setting MiroView™ Software
View history of changes… View history of changes
View personal info… Display patient information
Delete Delete the selected file from the
list
Reload Refresh the list of patient files
Play mode Change the play mode
Show compare window Show comparison window
Show position window Show positioning window
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4.1.4 MiroView™ Keyboard shortcuts
List Screen
<<F5>> Refresh List
or Mouse Wheel Move the cursor up / down the list
<<Enter>> Select a file from the list to review
<<Home>> Go to first page of patient files
<<END>> Go to last page of patient files
<< PGUP>> Move 1 page in direction of older files
<<PGDN>> Move 1 page in direction of newer files
<<CTRL>> + << PGUP>> Move 10 pages in direction of older files
<<CTRL>> + <<PGDN>> Move 10 pages in direction of newer files
Review Screen
<<Space>>
(While Playing)
Start / Pause video while in play mode
Increase Frame-rate
Decrease Frame-rate
Mouse Wheel Move forward / backward frame by frame
<<CTRL>> +
<<PGUP/PGDN>>
Skip forward / backward to next ten
captured images.
<<CTRL>> +
<<direction arrows>> or
<<CTRL>>+ mouse wheel
Move to previous / next captured image
<<LShift>> + /
(LShift+ wheel up/dn)
Move to the previous/next sub-captured
image
<<CTRL>>+<<+>> Expand to display all sub-captured
images.
<<CTRL>>+<<->> Hide all sub-captured images.
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Drawing Tool
(Used in Comparison Window & Report Mode)
<<Delete>>
(After selecting a or
more diagram)
Delete a selected arrow or circle
<<CTRL>> + <<Delete>> Delete all arrows / circles
<<CTRL>> + <<z>> Undo
<<CTRL>> + <<LSHIFT>>
+<<z>>
Redo
Chapter 4 Using MiroView™
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4.1.5 Basic Screen Layout
c Receiver Connect to the receiver and switch to the control
screen.
d List Switch to the patient data screen of the
MiroCam® system.
e Review Switch to the screen where images for the
selected patient can be reviewed.
f Report Switch to the screen where a report for the
selected patient can be created.
g Export Switch to the screen where image data for the
selected patient can be exported.
h Backup Switch to the screen where image data for the
selected patient can be backed up.
i Whole List Show the complete list of patients contained on
the workstation.
j Active Item In the complete list of patients, the patients in
yellow are the ones being diagnosed and the
items in grey are the ones deleted.
NOTE In the complete list of patients screen, use the review, report
or backup function by clicking the right mouse button.
c defgh
i
j
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c d
c Review View d Report View
Chapter 4 Using MiroView™
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4.1.6 Basic Procedure
In the patient list, select a desired patient and press the button
to review data for the selected patient.
Press the button to play the images.
Press the button to stop playback of the images.
Press the button to save the current image in the Capture Box.
Press the button to create and print a report for the patient
being diagnosed.
Press the button to upload the data from the receiver or to
initialize the receiver.
4.2 Administering and Initializing Patients
Before performing capsule endoscopy, run MiroView™ to check in
(administer) and initialize the receiver for a patient.
4.2.1 Sequence of Operation
Initialize the receiver unit
- Press the button.
- Connect the receiver’s USB cable to the receiver.
Using MiroView™ Chapter 4
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- Press the button to continue.
- The initialization screen will appear.
- Click the Yes button to initialize.
- When the progress bar is full and the ‘complete’ message
appears, the initialization is complete.
- Click the button and enter basic information for
the patient.
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- Complete all fields and click button. Receiver is
ready for use.
Upload image data for patient
- Press the button.
- Connect the receiver’s USB cable to the receiver.
- Press the button, and wait until the following screen
appears.
Using MiroView™ Chapter 4
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- When the progress bar is full and the ‘complete’ message
appears, the upload is complete.
Play and diagnose image data for a patient
- Select the desired patient from the patient list.
- Press the button.
- Press the button to play and diagnose image data.
Printing Patient Report
- Press the button.
- Create a report.
- Print the report
CAUTION The installation and initial operation of the system should be
performed by authorized service personnel from IntroMedic.
Follow the steps in the Service Manual.
CAUTION Before starting the procedure, ensure the environmental
conditions are suitable, as described in the User Manual. ,
Chapter 4 Using MiroView™
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4.2.2 MiroView™ Setting
Settings Menu is selected from Tools Menu
- Name of hospital: Input the hospital name
- DB server: IP address for using a DB (PostGreSql server).
Consult with IT staff to properly use this option.
- Language: Select preferred language.
- Measurement units: Choose preferred measurement units.
User Option Tab within Settings Menu
- User Name: Change the name of doctor which appears in the
top right of the MiroView program.
- Number of sub-capture images: Select the number of sub-
captured images (from 0 to 9).
- Export option: Select type of report files to be exported: avi +
Using MiroView™ Chapter 4
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jpeg, avi only, jpeg only, avi + jpeg. Selecting ‘All’ includes all
files (both included and not-included in report).
- View Style: Select preferred viewing style.
Miscellaneous Tab within Setting Menu
- New User: Create a new ID. Only the master user can use this
function.
- Current User: Change the password of the current user.
- Select Image: Save a logo image to insert into the report.
Appropriate image file size should be used.
- Delete Image: Delete logo image.
NOTE To apply the changes from the Settings menu, the user must
close and re-start the MiroView program.
Chapter 4 Using MiroView™
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4.3 Viewing Setting
Single view
- Click the icon in the upper right corner of MiroView™.
- The Single View screen will appear, allowing viewing of a
single image.
Dual view
- Click the icon in the upper right corner of MiroView™.
- The Dual View screen will appear, allowing viewing of two
images at a time.
- In this screen, images are displayed alternately in each pane.
Using MiroView™ Chapter 4
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Quad view
- Click the icon in the upper right corner of MiroView™.
- The Quad View screen will appear, allowing viewing of four
images at a time.
- In this screen, images are displayed alternately in each pane.
CAUTION Because the playback speed varies depending on the view
type, use the view that is most comfortable and appropriate
for diagnosis.
Do not be confused due to odd image on the center. The
S/W distorts center of an image to fill out.
Zoom
- Click the icon in the upper right corner of MiroView™.
- The Zoom screen will appear, allowing viewing of zooming
image at a time
Chapter 4 Using MiroView™
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4.3.1 Viewing Mode Setting
Click the icon in the upper right corner of MiroView™ to view
images in normal playback mode, in which all images are
displayed.
Click the icon in the upper right corner of MiroView™ to view
images in brief playback mode, in which the selected images are
displayed based on their similarities. This mode will skip images
which are the same.
CAUTION Quick View mode does not display all images, so it is not
intended for diagnosis. Use normal playback mode for
diagnosis.
Click the icon in the upper right corner of MiroView™ to use
the SGIB (Suspected GI Bleeding) function to view images
containing suspected bleeding.
CAUTION Because SGIB mode only display images selected by
software, it is possible that there are some images or areas
of GI bleeding not detected by the software.
Use the image playback speed bar in the center of the MiroView™
screen to adjust the playback speed for images. The playback
speed is measured in the number of images displayed per second.
Use the control icon in the center of the MiroView™ screen to
specify how images are displayed.
Image displayed by following capsule progress.
Image displayed by reverse capsule progress.
Stop image display.
Display next frame image
Display previous frame image
Display next captured image
Display previous captured image
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4.3.2 Setting and Using Capture Box
Save data in capture box
Clicking the button in the upper right corner of MiroView™
displays the area corresponding to the current image in the time
bar and saves the image group for the area in the Capture Box.
Use the capture ( ) button to save images. Images will be
displayed in the Capture Box.
Chapter 4 Using MiroView™
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Save data in capture box
Click the icon in the center of the MiroView™ screen to
specify the start point of each area of the GI tract. Images for each
area of the GI tract are displayed in the time bar and are saved in
the Capture Box.
Specify playback position
Drag and drop the position control bar in the time bar to place an
image to display in the center of the screen.
Using MiroView™ Chapter 4
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View saved images
The captured images group and landmarked images can be
viewed in the Capture Box. Captured images cannot be viewed in
the Quad View screen.
Use the left or right arrow to view the saved images from start to
finish.
NOTE Using the Mouse Wheel
When paused, move the mouse wheel down to view the
'next image’ and move it up to view the ‘previous image.’
During playback, you can display the previous or next
images by using the mouse wheel.
Click the + icon to display the all captured images in the group. A
group consists of between 2 to 9 neighboring images before and
after a captured image.
Use the SGIB (Suspected GI Bleeding) detection bar at the top of
the time bar to retrieve images with suspected bleeding.
Previous Next Image
Chapter 4 Using MiroView™
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4.3.3 Setting and Using Tracking Function
Click the button in the lower center of the
screen.
The route taken by a capsule will be displayed in 2D based on
actual human anatomy.
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4.3.4 Setting and Using Comparison Window
The current image can be compared with existing images of other
patients in the Compare window to readily identify disease
pathologies or abmormalities.
Click the button in the right side of the screen.
Click the button in the Compare window.
Image data that will be displayed in the Compare window can be
selected and sorted.
Chapter 4 Using MiroView™
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The function can be used in the Compare window.
In the Compare window, circle or arrow marks can be placed or
removed to highlight a specific area.
Using MiroView™ Chapter 4
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4.4 Creating a Report
After reviewing images, a diagnostic report can be created for the patient.
Access via the icon.
4.4.1 Editing Report
Click icon in the upper left corner of MiroView™.
Enter patient information, and procedure findings in the
appropriate text boxes; choose a desired text box from the tab.
The tab is editable. Click the icon to add and name a text box
onto the tab.
A specific image can be selected, and related comments entered
in the text box. Double-click the left mouse button to select desired
image.
If needed, place a mark on disease pathology in the captured
image.
Add circle mark
Add arrow mark
Delete added mark
Change marker color
Undo last action
Redo last undo action
Chapter 4 Using MiroView™
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Check the Final Approval option in the lower right corner.
Press the button to save the created report.
Press the button to print a report for the selected patient.
CAUTION If Final Approval is not checked, a report cannot be used as
a medical examination certificate. However, if it is checked,
the report becomes a finalized medical examination
certificate that is not editable.
Using MiroView™ Chapter 4
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4.4.2 Settings
Press the button to change settings.
Press the right-mouse button to see the pop-up menu.
Chapter 4 Using MiroView™
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Press the right-mouse button on the desired text line to edit.
Pop-up menu will appear and select ‘Edit Caption’ to change text.
Add images or logos to report:
o Click ‘Add Image’ on the pop-up menu.
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o Rectangular area appears.
o Click the right-mouse button on the rectangular area.
Click ‘Select Image’.
Chapter 4 Using MiroView™
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o Select the desired image or logo to insert.
o Image box can be resized and moved to the desired
location.
Using MiroView™ Chapter 4
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4.5 Atlas
For reference, the MiroCam® Image Atlas provides an extensive image
library of disease pathology and normal anatomy. Users can access the
Atlas DB via ‘Atlas’ function on the Help menu.
4.5.1 Accessing Atlas
Execute ‘Atlas’ from the Help menu
Select image from categories in the bottom left.
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Click on an image from the Image Atlas to add to the Comparison
Window in Review Mode
CAUTION My Atlas DB is not available in MiroView™ Express but only
in MiroView™.
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4.6 Backing up Patient Data
4.6.1 Backing up Image Data
The entire image data for the selected patient can be backed up
onto a DVD, an external HDD or a USB flash memory.
Select a patient to back up from the patient list in MiroView™ and
click the icon.
Click the icon and then move and save image data onto a
DVD. If needed, insert an additional DVD and continue to save the
data.
CAUTION The number of DVDs required for backup is displayed.
Check the number of DVDs available and click the
icon.
NOTE A 4.7G DVD is recommended for optimal backup results.
Chapter 4 Using MiroView™
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4.6.2 Exporting Image Data
Selected images and report files for a patient can be exported to a
CD/DVD, an external HDD or a USB flash memory.
Select a patient to back up from the patient list in MiroView™ and
click the icon.
Click the Burn icon and then move and save the image data onto a
DVD.
If needed, insert an additional DVD or CD and continue to save the
data.
CAUTION The number of DVDs or CDs required for exporting is
displayed. Check the number of DVDs or CDs available and
click the icon.
CAUTION The same type of CD or DVD should be used for a backup.
If backup fails, it should be started again from the
beginning.
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4.6.3 Exporting Image Data for MiroView™ Express
MiroView™ Express Overview
MiroView™ Express software is a ‘light’ version of the MiroView™
software, which can be installed on laptops or a PC (at home or
the office), and is designed to enable Physicians to more readily
review patient files. To view a patient file with MiroView™ Express,
it is necessary to export the desired patient file from the
MiroView™ workstation (via the Export for Express function). The
file can be exported to external storage devices, including USB
flash memory or USB external hard drive.
Before using the ‘Export to MiroView Express…’ function, insert or
connect the external storage device (external hard disk or USB flash
memory). The storage device must have a minimum of 4GB free space to
export a file for MiroView™ Express (exact requirement will vary).
Select ‘Export for MiroView Express…’ from the File tab in
MiroView™.
Chapter 4 Using MiroView™
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Select the location of the storage device and complete the ‘File
name’ field.
A progress bar will appear.
When complete, the following message “Exporting has been
completed.” will appear.
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4.6.4 Importing Image Data for MiroView™ Express
After reviewing the patient file with MiroView Express, the changed
data (i.e. saved images, comments, reports etc.) can be synchronized
with the patient file in the MiroView workstation via the ‘Import from
MiroView Express’ function.
Select ‘Import from MiroView Express’ from the File tab in
MiroView™.
Select the patient file to import (from the external storage device
with the patient file).
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Confirm file by click Button.
A progress bar will appear.
When import is complete, following message “Import from
MiroView Express is complete.” will appear.
CAUTION For further information about MiroView™ Express, please
refer to the MiroView™ Express User Guide included with
the installation CD, and/or contact your local IntroMedic
Representative for assistance.
5
Using MiroView™ RTV
Chapter 5 Using MiroView™ RTV
5- 2
Using MiroView™ RTV Chapter 5
5-3
5. USING MIROVIEW™ RTV
MiroView™ RTV, the application software for the MiroCam® System Real-
time Viewer, consist of a data transmission module that directly receives
the image data from the receiver and an output module for image display.
5.1 Overview
MiroView™ RTV will be pre-installed on UMPC(Ultra-Mobile PC) that
provided by IntroMedic. Click the corresponding icon on the desktop to
launch the MiroView™ RTV.
5.1.1 Basic Screen Layout
c Patient
Information
Display patient name, ID, gender and age
d Operation
Button
Change MiroView™ RTV operation status
between start, pause and resume.
e Main Display Display captured image.
f Time Display Indicates the MiroCam® capsule endoscope
procedure time.
d Start / Pause / Resume
e Main Display
c Name / ID / Gender / Age
f Time Display
Chapter 5 Using MiroView™ RTV
5- 4
5.1.2 Basic UMPC Layout
c USB Port USB Port for connect with MiroCam® Receiver
d DC-Jack Connector for UMPC Charger
e Power Switch UMPC Power on switch.
WARNING Only use UMPC provided by IntroMedic. Usage of
inappropriate UMPC can cause serious harm to the patient.
WARNING Only recharge the UMPC batteries with the adaptor from
IntroMedic. Use of the improper adaptor can cause serious
damage to patient and UMPC.
WARNING For safe use of UMPC, please refer to UMPC User Manual.
c
e
d
Using MiroView™ RTV Chapter 5
5-5
5.2 Using MiroView™ RTV with MiroCam® Receiver MR1000
5.2.1 Before Using MiroView™ RTV
The MiroView™ RTV software is pre-install on UMPC provided by
IntroMedic.
WARNING Do not use MiroView™ RTV software and UMPC before
upgrading the MiroCam® receiver.
WARNING Do not upgrade MiroCam® receiver during the MiroCam®
capsule endoscopy procedure, it may result in loss if image
data .
Connect the data cable for the Real-time Viewer to the MiroCam®
receiver.
NOTE The data cable for MiroView™ RTV has no cover for the
USB port on the receiver.
Fallow the MiroCam® capsule endoscopy procedure.
NOTE For more information on the MiroCam® capsule endoscope
procedure, please refer to Chapter 3, Performing Capsule
Endoscopy.
Chapter 5 Using MiroView™ RTV
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5.2.2 Starting MiroView™ RTV
Switch on the UMPC.
Click the icon on the desktop to launch MiroView™ RTV.
Connect the small side of the USB cable to the receiver.
Connect the large side of the USB cable to the UMPC.
Click the button to start image display
Click the button to stop image display
Click the button to restart image display
Click the button on the top-right to close the MiroView™ RTV.
NOTE Start, Pause, and Resume use the same button. The
function (Start, Pause or Resume) changes based upon the
status of MiroView™ RTV software.
CAUTION MiroView™ RTV is not software for to be used for
diagnostic purposes. Use the MiroView™ software for
viewing the patient images for diagnostic purposes.
CAUTION Do not disconnect the receiver while the RTV is in use. If
the receiver is disconnected during use, the software may
need to be restarted.
NOTE If an error message appears while using MiroView™ RTV,
reconnect the USB cable between MiroCam® receiver and
UMPC
Using MiroView™ RTV Chapter 5
5-7
5.2.3 After Using MiroView™ RTV
Disconnect USB cable from MiroCam® Receiver and UMPC.
Charge the UMPC by using the adaptor provided by IntroMedic.
Continue MiroCam® capsule endoscope procedure.
5.3 Using MiroView™ RTV with MiroCam® Receiver MR2000
5.3.1 Before Using MiroView™ RTV
The MiroView™ RTV software is pre-install on UMPC provided by
IntroMedic.
Fallow the MiroCam® capsule endoscopy procedure.
NOTE For more information on the MiroCam® capsule endoscope
procedure, please refer to Chapter 3, Performing Capsule
Endoscopy.
Chapter 5 Using MiroView™ RTV
5- 8
5.3.2 Starting MiroView™ RTV
Switch on the UMPC.
Click the icon on the desktop to launch MiroView™ RTV.
Connect the small side of the USB cable to the receiver.
Connect the large side of the USB cable to the UMPC.
Click the button to start image display
Click the button to stop image display
Click the button to restart image display
Click the button on the top-right to close the MiroView™ RTV.
NOTE Start, Pause, and Resume use the same button. The
function (Start, Pause or Resume) changes based upon the
status of MiroView™ RTV software.
CAUTION MiroView™ RTV is not software for to be used for
diagnostic purposes. Use the MiroView™ software for
viewing the patient images for diagnostic purposes.
CAUTION Do not disconnect the receiver while the RTV is in use. If
the receiver is disconnected during use, the software may
need to be restarted.
NOTE If an error message appears while using MiroView™ RTV,
reconnect the USB cable between MiroCam® receiver and
UMPC
Using MiroView™ RTV Chapter 5
5-9
5.3.3 After Using MiroView™ RTV
Disconnect USB cable from MiroCam® Receiver and UMPC.
Charge the UMPC by using the adaptor provided by IntroMedic.
Continue MiroCam® capsule endoscope procedure.
Chapter 5 Using MiroView™ RTV
5- 10
A
Appendix
Case Form Report
A- 2
Case Form Report
A-3
Trial ID : Version No. : 1.0 : 30/07/2007
CASE REPORT FORM
Subject No.: Subject Initials : Center No.:
Principal
Investigator :
Center Name :
Address :
Telephone No. :
Fax No. :
E-mail :
CONFIDENTIAL
Case Form Report
A- 4
Trial ID : Version No. : 1.0 :
30/07/2007
Screening
Subject No.: Subject Initials : Center No.:
Date of Informed consent signed
DMMYYYY
Inclusion Criteria
Yes No N/A
1. Informed consent form voluntarily signed
2. Male / Female subject of age 19 years~70 years.
If there is one or more mark of ‘No’, you shall be contradicted for this clinical test.
CONFIDENTIAL
Case Form Report
A-5
Trial ID : Version No. : 1.0 : 30/07/2007
Screening
Subject No.: Subject Initials : Center No.:
Date of visit :
D MMYYYY
Exclusion Criteria
Yes No N/A
1. Do you have a gastrointestinal disorder (suspected
malignantlesions or gastrointestinal obstructive disorders,
perforation, stenosis or fistula)?
2. Do you have a cardiovascular disorder (dysrhythemia, trouble
with cardiac conduction system, hypertension(high blood
pressure) or ischemic heart disease)?
3. Have you been diagnosed of cardiac insufficiency, angina
pectoris or cardiac arrest (heart attack) in recent 6 months?
4. Are you with (or implanted) medical devices such as cardiac
pacemaker or defibrillator?
5. Do you have a swallowing disorder?
6. Do you have delayed gastric emptying or serious gastric
disorder?
7. Are you a pregnant or nursing woman, or a woman of child
bearing potential?
8. Are you an infant or epileptic? Are you easily affected by
electronic waves?
9. Do you have several small bowel diverticulums ?
10. Did you fail to obtain a voluntary agreement?
11. Are you judged unqualified for this test by doctors or nurses?
If there is one or more mark of ‘Yes’, you shall be contradicted for this clinical test.
CONFIDENTIAL
Case Form Report
A- 6
EC Representative
NanoMedical
Largo do Sequeira 7 G3 P.E.
1100-587 Lisboa Portugal
Key Contact: Nuno Nicola Covacich
Office: +351-21-884-3140
Mobile: +351964468482 or +351961300259
Email: nuno.nicola@nano-medical.org
IntroMedic Co.,Ltd.
Suite 1104, E&C Venture Dream Tower 6-Cha
197-28 Guro-Dong, Guro-Gu, Seoul, KOREA 152-719
Tel : +82-2-801-9300
Fax : +82-2-801-9330
http://www.intromedic.com
e-mail : help@intromedic.com 0843
Disposal of Old
Electrical &
Electronic
Equipment
Applicable in the
European Union
and other
European
countries with
separate collection
systems
