CapsoVision CapsoAccess CDAS3 User manual

INSTRUCTIONS FOR USE
CapsoAccess®
Capsule Data Access System
Catalog Number: CDAS3
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English
INSTRUCTIONS FOR USE
CapsoAccess®
Capsule Data Access System
Catalog Number: CDAS3

IFU-2800 Rev E 11/18
2
1.Warnings and Safety Precautions..................3
2. General ............................................................4
2.1 Device Description ...................................4
2.2 Indications for Use....................................4
2.3 Contraindications.....................................4
2.4 Intended User Prole...............................4
2.5 Adverse Events.........................................4
2.6Warranty...................................................4
2.7 Related Documents..................................5
3. Principle of Operation.....................................5
3.1 CapsoAccess®................................................5
4. Getting Started................................................5
4.1 Unpacking and Inspection ......................5
4.2 Equipment supplied.................................5
5. Installation.......................................................6
6. Operation.........................................................7
7. CapsoAccess® System Indicator Lights..........8
8.Troubleshooting ..............................................9
9. Care, Maintenance and Disposal....................10
10. Specications and Ratings...........................10
11. Federal Communication Commission
(FCC) Compliance................................................11
Table of Contents
Symbol Meaning Symbol Meaning
Manufacturer’s Catalog
Designation or Number Warning: DangerousVoltage
Use Caution Contact/European Representative of
Manufacturer
ProductMeetsEuropean Standards for
Safety and Quality Special Disposal for Electronic Waste Required
Instructions Are Included
and Must Be Followed Manufacturer
Lot Number Temperature Limitation
Atmospheric Pressure Limitation Humidity Limitation
35°C
10°C
1.1atm
0.9 atm
80%
20%

IFU-2800 Rev E 11/18
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1. Warnings and
Safety Precautions
The CapsoAccess® Capsule Data Access System
(CDAS3) has been constructed in accordance with
US (FDA) and international (European MDD)
regulations and standards for operation of
electrical equipment, electromagnetic
compatibility, and stipulated safety requirements.
To prevent accidental damage to the equipment,
and to ensure safe, trouble-free operation, please
read and follow these operating instructions
carefully before using the system. Keep these
instructions in a safe place.
Do not modify this equipment without
authorization of the manufacturer.
Operators should always wear gloves when
handling the capsules and system.
CAUTION! Do not open AC adapter.
Risk of electric shock.
To avoid risk of electric shock, this equipment
must only be connected to grounded electrical
outlets.
Keep liquids out of the system interior. Do not
submerge or autoclave.
Clean exterior surfaces with a cloth and swab
moistened with disinfectant.
Clean, disinfect and completely dry the capsule
prior to inserting it into the system.
Useonlythe supplied medical gradepowersupply.
A medical grade power supply is required for use
in devices intended for medical applications.
This unit only complies to regulatory standards if
used with the supplied medical grade power cord.
Before unplugging the CapsoAccess® system,
make sure the unit is powered OFF.
Symbol Meaning Symbol Meaning
Manufacturer’s Catalog
Designation or Number Warning: DangerousVoltage
Use Caution Contact/European Representative of
Manufacturer
ProductMeetsEuropean Standards for
Safety and Quality Special Disposal for Electronic Waste Required
Instructions Are Included
and Must Be Followed Manufacturer
Lot Number Temperature Limitation
Atmospheric Pressure Limitation Humidity Limitation

IFU-2800 Rev E 11/18
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Power cord is used as a disconnection device.
To de-energize equipment, disconnect the
power cord.
Per manufacturer’s declaration all USB ports are
for exclusive connection to IEC 60601-1 certied
equipment when it is placed within a patient
environment.
It should not be used with life-support systems.
2. General
2.1 Device Description
The CapsoAccess® Capsule Data Access System
enables trained medical personnel to extract
in-vivo datafromthe CapsoCamPlus® capsule.The
system transfers the data to a computer running
the CapsoView® software.
The system is not intended for use by patients or
on patients and is not intended to interact with
any part of the body or any type of body tissue.
2.2 Indications for Use
This CapsoAccess® Capsule Data Access System
is intended for accessing data from the
CapsoCam Plus® capsule endoscopes.The
system may be used in hospitals, outpatient
clinics, and physician oces.
2.3 Contraindications
The CapsoAccess® Capsule Data Access System
has no known contraindications.
2.4 Intended User Prole
The CapsoAccess® Capsule Data Access System is
intended for use by trained medical personnel.
2.5 Adverse Events
The CapsoAccess® Capsule Data Access System
has no adverse events.
2.6 Warranty
CapsoVision warrants that the system is free from
defects in both materials and workmanship.
Suitability for use of the system for any procedure
shall be determined by the user. CapsoVision shall
not be liable for incidental or consequential

IFU-2800 Rev E 11/18
5
damages of any kind.The above warranties are in
lieu of all other warranties either expressed or
implied including any warranty of any
merchantability or tness for use.
2.7 Related Documents
CapsoView® Software Instructions for Use (IFU)
CapsoCam Plus® Instructions for Use(IFU)
3. Principle of Operation
3.1CapsoAccess®CapsuleDataAccessSystem
The CapsoAccess® Capsule Data Access System
provides power inductively to the capsule. It can
be used either with capsules that have depleted
batteries or ones with still-active batteries and
ashing LEDs.The magnet on the lid of the system
opens the switch inside the capsule, disconnecting
the batteries from the inductive power.
The system and capsule communicate via a
bidirectional optical link, and the capsule
transfers the clinical data to the system.
4. Getting Started
4.1 Unpacking and Inspection
Upon receipt of the system, carefully remove the
contents from the box and check for visible
damage to components. If you see damage,
contact your local CapsoVision representative.
Save the shipping box and packaging until you
have successfully installed and veried correct
operation of the system.The original packaging
provides the best protection for return shipment,
if necessary.
4.2 Equipment supplied
The equipment supplied includes the
components listed below:
1. CapsoAccess® Capsule Data Access System
2. AC adapter
3. Power cable
4. USB cable
5. Instructions for Use

IFU-2800 Rev E 11/18
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5. Installation
Connect the power cable (3) to the supplied
AC adapter (2).
Connect the AC adapter (2) to the 12V DC input of
the CapsoAccess® Capsule Data Access System (1).
Connect the power cable(3)to an outlet rated for
a voltage between 110 and 240V AC.
Attach the USB cable(4) to the USB input of the
CapsoAccess® Capsule Data Access System (1).
Connect the other end of the USB cable (4)to the
computer with the CapsoView® software and
the required USB driver installed.

IFU-2800 Rev E 11/18
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6. Operation
Verify that the capsule has been cleaned and
disinfected and is completely dry.
Inspect the inside of the CapsoAccess® Capsule
Data Access System receptacle and remove
any obstructions.
USB POWER ON/OFF
POWER SWITCH
Turn ON the system power switch.
The light on the front of the system should
illuminate.

IFU-2800 Rev E 11/18
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Place the capsule into the system receptacle
battery-end up and close the lid of the system.
The download operation will fail with an
incorrectly oriented capsule.
Start the CapsoView® software. Refer to the
CapsoView® Instructions for Use.
To begin the download process, click Download
on the CapsoView® menu bar.
Select the destination where you would like to
save the le and click Next. A window should
appear where procedure-specic information
must be entered before beginning the download.
Click Next after the information has been entered.
Review the information in the window and click
Yes to begin the download of data from the
capsule.
After all capsule downloads are completed,
the system may be turned OFF.
7. CapsoAccess® System
Indicator Lights
Light Status
SolidYellow Unit is idle and lid is open
Solid Green Ready for download or download is complete
Flashing Green Data transfer in progress
FlashingYellow Error status
No light Power is o
Batteries

IFU-2800 Rev E 11/18
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8. Troubleshooting
In case of any issues with the system, refer to this guide for possible solutions. If the problem persists,
contact CapsoVision or your local distributor of CapsoVision devices.
Symptom Possible Solutions
CapsoView® menu item
“Download gDownload
Images” is not enabled (it is in
gray font and not black)
1.Verify that the USB cable is connected between the system and the computer, that the system power is ON and
that system indicator light is illuminated.
2.Verify that the computer has been congured for downloading capsule data and conrm that the system USB
driver is installed.
3.Turn system OFF, wait a few seconds, and turn it back ON.
4. Disconnect and reattach the USB cable.
5. Close and restart the CapsoView® software application.
6. Reboot the computer.
After selecting“Download Images”
a system data transfer error
message appears
1.Turn the system OFF, wait a few seconds, and turn it back ON to reset the USB connection. Try downloading again.
2.Try docking a known, good capsule, such as a capsule with data previously downloaded. If the error message
reappears, the system may be malfunctioning. On the other hand, if this known-good capsule docks successfully (the
Procedure Information window appears), the original capsule may be damaged or malfunctioning. In this case, click
“Cancel”in the Procedure Information window.
After selecting“Download Images”
an error message appears indicating
that no capsule is detected
1.Verify that the capsule is in the receptacle and in the correct orientation with the battery-end facing upwards.
2. Ensure that the capsule dimple and system receptacle are clean.
3. Rotate the capsule approximately 180° and retry.
The CapsoAccess® system indicator
light is not illuminated
1.Verify that the power switch is turned to ON.
2.Verify that the power cable is fully inserted into the outlet and plugged into the power supply
and that the light on the power supply is illuminated.
3.Verify that the power supply is plugged into the system.

IFU-2800 Rev E 11/18
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9. Care, Maintenance and
Disposal
The CapsoAccess® Capsule Data Access System
is typically used in an oce environment with
clean, disinfected, dry capsules.The system
should be cleaned only as needed. More
extensive cleaning may be required if the
system is accidentally soiled or contaminated.
Follow the recommendations herein.
Cleaning: Disconnect the power and USB cables
prior to cleaning.The system chassis contains
electronics. Keep liquids from entering the chassis.
Avoid submerging the system in liquid or sterilizing
it in an autoclave. All exposed surfaces may be
wiped with a swab or cloth moistened in isopropyl
alcohol or other disinfectant. Clean the receptacle
with a swab including the underside of the rubber
gasket that comes in contact with the capsule.
Disposal: After its useful life or after sustaining
unrepairable damage, the CapsoAccess® Capsule
Data Access System and its power supply should
be disposed of in an environmentally sound
manner. Please consult and obey national, state,
and local laws and ordinances governing the safe
disposal of electronic equipment.
General: Contact your local distributor or
CapsoVision representative if capsule docking
becomes unreliable.
10. Specications and Ratings
Class I medical (Grounded) device
The CapsoAccess® Capsule Data Access System is
classied as NO APPLIED PARTS EQUIPMENT.
TheCapsoAccess® Capsule Data Access Systemshall
beclassied asORDINARYEQUIPMENT,notintended
orevaluatedfor useinthe presenceof ammable
anestheticmixturewith air, oxygen, or nitrousoxide.
The CapsoAccess® system needs special
precautions regarding EMC and needs to be
installed and put into service according to the
EMC information provided in this manual.
Portable and mobile RF communications
equipment can aect the CapsoAccess® system.
The use of accessories, transducers and cables
other than those specied by CapsoVision, Inc.

IFU-2800 Rev E 11/18
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Table 1 — Guidance and manufacturer’s declaration – electromagnetic emissions
The CapsoAccess® system is intended for use in the electromagnetic environment specied below.
The customer or the user of the CapsoAccess® system should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11 Group 1 The CapsoAccess® system uses RF energy only for its internal function.Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11 Class B
The CapsoAccess® system is suitable for use in all establishments, including domestic establishments and those
directly connected to the public low voltage power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage uctuations/
icker emissions
IEC 61000-3-3
Complies
may result in increased EMISSIONS or decreased
IMMUNITY of the CapsoAccess® system.
This CapsoAccess® system should not be used
adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary,
the CapsoAccess® system should be observed
to verify normal operation in the conguration
in which it will be used.
Essential Performance: Data integrity during video
download is considered to be the essential
performance of the CapsoAccess® system. If the
essential performance is lost or degraded due to EM
disturbances, the video data may be incomplete or
corrupted which will require redownload.
11. Federal Communication
Commission (FCC) Compliance
The CapsoAccess® system (CDAS3) complies with
Part 15 of the United States FCC rules and with
international standards for electromagnetic
compatibility regarding its use.

IFU-2800 Rev E 11/18
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Table 2 — Guidance and manufacturer’s declaration – electromagnetic immunity
The CapsoAccess® system is intended for use in the electromagnetic environment specied below.
The customer or the user of the CapsoAccess® system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment –
guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Floors should be wood, concrete or ceramic
tile. If oors are covered with synthetic
material, the relative humidity should be at
least 30%.
Electrical fast transient/
burst IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Voltage dips:
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% UT; 1 cycle and 70% UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0% UT; 250/300 cycles
Voltage dips:
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270°
and 315°
0% UT; 1 cycle and 70% UT; 25/30 cycles
Single phase: at 0°
Voltage interruptions:
0% UT; 250/300 cycles
Mains power quality should be that of a
typical commercial or hospital
environment. lf the user of the
CapsoAccess® system requires continued
operation during power mains
interruptions, it is recommended that the
CapsoAccess® system be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic elds should be
at levels characteristic of a typical location
in a typical domestic, commercial or
hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.

IFU-2800 Rev E 11/18
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Table 3 — Guidance and manufacturer’s declaration – electromagnetic immunity
The CapsoAccess® system is intended for use in the electromagnetic environment specied below.
The customer or the user of the CapsoAccess® system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
IEC 61000-4-6
Conducted RF
Radiated RF
IEC 61000-4-3
3Vrms
150 KHz to 80 MHz
6Vrms in ISM bands
between 150 KHz and
80MHz
3V/m
80 MHz to 2.7 GHz
3Vrms
6Vrms in ISM bands
3V/m
Portable and mobile RF communications equipment should be used no closer
to any part of the EQUIPMENT, including cables, than the recommended
separation distance calculated from the equation applicable to the frequency of
the transmitter. Recommended distance
d = 1.2√P 150 KHz to 80 MHz
d = 1.2√P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from xed RF transmitters, as determined by an electromagnetic
site surveya, should be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
aField strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast andTV broadcast cannot be predicted theoretically with accuracy.To assess the electromagnetic environment due to xed RF transmitters, an
electromagnetic site survey should be considered. If the measured eld strength in the location in which the CapsoAccess® system is used exceeds the applicable RF
compliance level above, the CapsoAccess® system should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the CapsoAccess® system.
bOver the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

IFU-2800 Rev E 11/18
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Table 4 — Recommended separation distances between portable and mobile RF communications
equipment and the CapsoAccess® system (CDAS3)
The CapsoAccess® system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The
customer or the user of the CapsoAccess® system can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the CapsoAccess® system as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d = 1.2√P
80 MHz to 800 MHz
d = 1.2√P
800 MHz to 2.7 GHz
d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.

IFU-2800 Rev E 11/18
15
Manufactured For
CapsoVision, Inc.
18805 Cox Avenue, Suite 250
Saratoga, CA 95070, U.S.A.
Telephone: [phone]
Email: [email protected]
European Authorized
Representative
Dr. Hans-Joachim Lau
Airport Center (Building C)
Flughafenstraße 52a
22335 Hamburg, Germany
Fax: [phone]
Conformity Assessment
Body
TÜV Rheinland LGA
Products GmbH
Tillystrasse 2,
90431 Nuremburg
Germany
Contact Information
Protection against harmful ingress of water:
INGRESS PROTECTION (IP21)
Environmental conditions
Operating .................................... 10°C to 30°C
Storage /Transportation............. 10°C to 35°C
Humidity (non-condensing)
Operating..................................... 20% to 80%
Storage /Transportation............. 10% to 90%
Altitude
Operating..................................... 0 to 3000m
Storage /Transportation............. 0 to 12,000m
The CapsoAccess® Capsule Data Access System
(CDAS3) is intended for general use in hospital
environment for data collection for reference.
Electrical Ratings:
Adapter: HiTronElectronicsCorp./ HEMG24-S120200-7
Adapter InputVoltage: 100-240V AC, 60/50 Hz,
0.46-0.25A
Adapter OutputVoltage: 12V DC, 2A, max 24W
CapsoAccess® InputVoltage: 12V DC
CapsoAccess® Input Current: 2 A

Nederlands
GEBRUIKSAANWIJZING
CapsoAccess®
Capsule-datatoegangssysteem
Catalogusnummer: CDAS3

IFU-2800 Rev E 11/18
2
1.Waarschuwingen en
veiligheidsmaatregelen.............................. 3
2. Algemeen.................................................... 4
2.1 Beschrijving van het apparaat.............. 4
2.2 Indicaties voor gebruik ......................... 4
2.3 Contra-indicaties................................... 4
2.4 Proel van de beoogde gebruiker........ 4
2.5 Ongewenste voorvallen........................ 4
2.6 Garantie................................................. 4
2.7 Gerelateerde documenten.................... 5
3.Werkingsprincipe........................................ 5
3.1 CapsoAccess®............................................ 5
4. Om te beginnen.......................................... 5
4.1 Uitpakken en inspecteren..................... 5
4.2 Meegeleverde apparatuur.................... 5
5. Installatie .................................................... 6
6. Bediening.................................................... 7
7. Indicatielampjes van het
CapsoAccess®-systeem............................... 8
8. Probleemoplossing..................................... 9
9.Verzorging, onderhoud en afvoer............... 10
10. Specicaties en nominale waarden......... 10
11. Naleving van de voorschriften van de Federal
Communication Commission (FCC)...............11
Inhoudsopgave
Symbool Betekenis Symbool Betekenis
Aanduiding of catalogusnummer van
de fabrikant Waarschuwing: gevaarlijke spanning
Voorzichtigheid is geboden Contactpersoon/Europese
vertegenwoordiger van de fabrikant
Het product voldoet aan de Europese
normen voor veiligheid en kwaliteit Speciale afvoer van elektronisch afvalvereist
Gebruiksaanwijzing is bijgesloten en moet
worden opgevolgd Fabrikant
Chargenummer Temperatuurlimiet
Luchtdruklimiet Vochtigheidslimiet
35°C
10°C
1,1atm
0,9atm
80%
20%

IFU-2800 Rev E 11/18
3
1. Waarschuwingen en
veiligheidsmaatregelen
Het CapsoAccess®-capsule-datatoegangssysteem
(CDAS3) is vervaardigd conform Amerikaanse en
internationale voorschriften en normen (van de
Amerikaanse FDA en de Europese Richtlijn medische
hulpmiddelen) voor het gebruik van elektrische
apparatuur, elektromagnetische compatibiliteit en de
gestelde veiligheidsvoorschriften.
Om onvoorziene beschadiging van de apparatuur te
voorkomen en een veilige, probleemloze werking te
garanderen, dient u vóór gebruik van het systeem deze
gebruiksaanwijzing aandachtig te lezen en dient u
deze in acht te nemen. Deze gebruiksaanwijzing moet
op een veilige plaats worden bewaard.
Zonder toestemming van de fabrikant mogen geen
modicaties aan deze apparatuur worden
aangebracht.
Bij het hanteren van de capsules en het systeem
moeten gebruikers altijd handschoenen dragen.
OPGELET! De netspannings-
adapter niet openen. Risico van
elektrische schokken.
Om het risico van elektrische schokken te voorkomen,
mag deze apparatuur uitsluitend worden aangesloten
op geaarde stopcontacten.
Er mogen geen vloeistoen in het systeem
terechtkomen. Niet onderdompelen of in een
autoclaaf steriliseren.
De buitenkant moet worden gereinigd met een met
desinfecteermiddel bevochtigde doek en wattenstokje.
De capsule moet gereinigd, gedesinfecteerd en
volledig gedroogd worden voordat deze in het systeem
wordt ingebracht.
Alleen de meegeleverde, voor medisch gebruik
bestemde stroomvoorziening mag worden gebruikt. Er is
een voor medisch gebruik bestemde stroomvoorziening
vereist voor gebruik bij hulpmiddelen die voor medische
toepassingen bestemd zijn.
Deze unit voldoet alleen aan de regelgevende normen
als hij met het meegeleverde, voor medisch gebruik
bestemde netsnoer wordt gebruikt.
Symbool Betekenis Symbool Betekenis
Aanduiding of catalogusnummer van
de fabrikant Waarschuwing: gevaarlijke spanning
Voorzichtigheid is geboden Contactpersoon/Europese
vertegenwoordiger van de fabrikant
Het product voldoet aan de Europese
normen voor veiligheid en kwaliteit Speciale afvoer van elektronisch afvalvereist
Gebruiksaanwijzing is bijgesloten en moet
worden opgevolgd Fabrikant
Chargenummer Temperatuurlimiet
Luchtdruklimiet Vochtigheidslimiet

IFU-2800 Rev E 11/18
4
Voordat het netsnoer van het CapsoAccess®-systeem
wordt losgekoppeld, moet worden gecontroleerd of de
unit UIT staat.
Het netsnoer wordt als ontkoppelingsmechanisme
gebruikt. Om de apparatuur buiten werking te stellen,
moet het netsnoer worden losgekoppeld.
Volgens de verklaring van de fabrikant dienen alle
USB-poorten uitsluitend voor aansluiting op conform
IEC 60601-1 gecerticeerde apparatuur wanneer deze
in een patiëntenomgeving wordt geplaatst.
Niet met levensondersteunende systemen gebruiken.
2. Algemeen
2.1 Beschrijving van het apparaat
Het CapsoAccess®-capsule-datatoegangssysteem stelt
getrainde medische medewerkers in staat om invivo -
gegevens van de CapsoCam Plus®-capsule te
verkrijgen. Het systeem brengt de gegevens over naar
een computer met CapsoView®-software.
Het systeem dient niet voor gebruik door of bij
patiënten en dient niet voor gebruik in combinatie met
enig lichaamsdeel of type lichaamsweefsel.
2.2 Indicaties voor gebruik
Dit CapsoAccess®-capsule-datatoegangssysteem dient
voor het geven van toegang tot gegevens van de
CapsoCam Plus®-capsule-endoscopen. Het systeem
kan in ziekenhuizen, poliklinieken en artsenpraktijken
worden gebruikt.
2.3 Contra-indicaties
Er zijn voor zover bekend geen contra-indicaties voor
het CapsoAccess®-capsule-datatoegangssysteem.
2.4 Proel van de beoogde gebruiker
Het CapsoAccess®-capsule-datatoegangssysteem dient
voor gebruik door getrainde medische medewerkers.
2.5 Ongewenste voorvallen
Er zijn geen ongewenste voorvallen in verband met
het CapsoAccess®-capsule-datatoegangssysteem.
2.6 Garantie
CapsoVision garandeert dat het systeem geen
gebreken in materialen en vakmanschap vertoont.
Degeschiktheid van het systeem voor gebruik bij een
procedure wordt door de gebruiker bepaald.
CapsoVision is niet aansprakelijk voor incidentele of
gevolgschade van welke aard dan ook.