Atmos VideoScope User manual

Operating instructions
ATMOS VideoScope
ATMOS VideoScope PED
English
GA1GB.150000.0
2020-10 Index 01

2
Table of contents
1 Risks and hazard warnings ............................................................... 4
2 Intended use....................................................................................... 6
2.1 Relevance for the following REF................................................................6
3 Symbols used...................................................................................... 7
4 Functionality and application .......................................................... 8
4.1 Application ..................................................................................................8
4.2 Image processing .......................................................................................8
4.3 Functionality................................................................................................8
4.4 Notice on use ..............................................................................................8
4.5 Scope of delivery ........................................................................................9
5 Technical data .................................................................................. 10
6 Manufacturer ................................................................................... 11
7 Using the ATMOS VideoScope (PED) ............................................... 12
7.1 Switching on............................................................................................. 12
7.2 Inserting, bending and removing the insertion hose.......................... 12
7.3 Switchingo............................................................................................. 13
8 Working with the Capture Suite Basic........................................... 14
8.1 Installation of the Capture Suite Basic.................................................. 14
8.2 Switching on............................................................................................. 14
8.3 Settings and operation ........................................................................... 14
9 Cleaning, Care and Disinfection ..................................................... 16
9.1 Cleaning.................................................................................................... 16
9.2 Disinfection .............................................................................................. 16
9.2.1 Carrying out disinfection..................................................................... 16
9.2.2 Final rinsing .......................................................................................... 17
9.2.3 Mechanical process ............................................................................. 17
9.3 Leakage test ............................................................................................. 18
9.4 Care ........................................................................................................... 19
10 Maintenance and repairs................................................................ 20
10.1 Sending in the device.............................................................................. 20
11 Disposal............................................................................................. 21
12 Electromagnetic compatibility ....................................................... 22
12.1 Operating environment information .................................................... 22
12.2 Information on the performance features........................................... 22

3
12.3 Electrical immunity (immunity).............................................................. 22
12.4 Immunity test........................................................................................... 23
12.5 Electromagnetic emission (emission) ................................................... 23

4Risks and hazard warnings
1 Risks and hazard warnings
1. Please check the packaging of the ATMOS VideoScope (PED) and the
accessories for completeness and shipping damage. In the event of any
damage, take a note and inform your dealer or the manufacturer.
2. Before each treatment, convince yourself about the correct image quality,
the correct image orientation (even when moving the bending unit) by taking
a test picture of a familiar object, to see that the ATMOS VideoScope (PED) is
workingproperly.Inparticular,attentionshouldbepaidtothecolordelity.
3. Use the ATMOS VideoScope (PED) only as intended, in accordance with the
regulations of the Medical Devices Act, the generally recognized rules of
technology, as well as the applicable occupational health and safety and
accident prevention regulations.
4. Before using the ATMOS VideoScope (PED), perform a visual inspection to
check the functional safety and proper condition of the device. The ATMOS
VideoScope(PED)isahigh-qualitynemechanical-opticalinstrument,handle
it with care.
ATTENTION:
Do not use the ATMOS VideoScope (PED) if it has any defects which could
endanger patients, users or third parties, e.g. sharp edges due to damage.
ATTENTION:
Do not use the ATMOS VideoScope (PED) if it is leaking. (See chapter 9).
Otherwise serious infections can occur.
ATTENTION:
Only use medically approved devices (PC) with the ATMOS VideoScope (PED).
Otherwise, the patient or user could be put at risk in unfavorable circumstances.
Observe the notes in chapter 7.
ATTENTION:
Be careful when using pointed or sharp objects such as scalpels or needles in the
vicinity of the ATMOS VideoScope (PED) so that no mechanical damage is caused
totheendoscopeandespeciallynottotheexibleinsertionhose.Thisalso
applies in particular to placing them in a disinfectant bath.
ATTENTION:
Avoid looking directly into the light exit at the distal end. The energy from
the internal light sources can cause eye damage. In particular, the ATMOS
VideoScope must not be used for eye examinations which is contrary to its
intended use.

5
Risks and hazard warnings
ATTENTION:
The ATMOS VideoScope (PED) may only be used by people who, based on their
training or their knowledge and practical experience, can guarantee the proper
handling of the device.
ATTENTION:
The distal end can heat up to 10 °C above room temperature when the ATMOS
VideoScope is used for a long period of time.
&Notice: The supplied ATMOS image display program was tested on the
optionallyavailablePanelPC.Ifyouloaddierentsoftwareversionsorother
programs onto this PC it can cause malfunction in the image display. ATMOS
does not accept liability for such malfunction. We recommend not to modify
the Panel PC. Make sure that a saved image is not being viewed if current
examinations are to be carried out.
5. Additional software for evaluating the images is optionally available.
6. Avoiddirectsunlight,X-radiation,suddenstrongtemperatureuctuationsor
warming above 60 °C as well as mechanical stress such as hard knocks and
kinks of the insertion hose.
7. The operational safety and readiness for use of the medical product depends
not only on your capabilities, but also on the care and maintenance given to
the device. Regular cleaning and maintenance work is therefore necessary
(see chapter Cleaning, maintenance and disinfection).
8. By applying only original spare parts you will have the guarantee that
operational safety, readiness for work and the value of your medical product
is preserved.
9. Intheeventofprolongedorimproperuse(sharpkinkingoftheexible
insertionhose),damagetothebreopticlightcable(breakage)canreduce
illumination in the observation area. The ability to illuminate should
therefore be checked from time to time outside of examinations (Illuminate a
whitesheetofpaper,donotlookintothebreopticlightcable!).

6Intended use
2 Intended use
&The ATMOS VideoScope (PED) is used for endoscopic examinations in the
humanear,noseandthroatmedicine.WiththeexibleATMOSVideoScope
(PED) the nose, the pharynx, and the larynx, the nasal cavities and the
nasopharynx can be examined. The examination regions can be displayed on
a (panel) PC on high-resolution displays.
&The ATMOS VideoScope (PED) is not intended for examining the paranasal
sinuses and the lower larynx area.
&It is used exclusively in medical practices and clinics by personnel who are
specially trained in handling endoscopes.
ATTENTION:
The ATMOS VideoScope (PED) may only be used on people who have a
sucientlylargeoricefortheinsertionoftheinsertionhose.Thisisparticularly
important when performing nasal examinations on children.
2.1 Relevance for the following REF
REF Name
950.0360.0 ATMOS VideoScope PED
950.0361.0 ATMOS VideoScope PED - single item
950.0362.0 Leakage tester
950.0363.0 VideoScope camera cable USB
950.0364.0 Cover cap cable connection
950.0365.0 Carryingcaseex.Endoscope
950.0366.0 ATMOS VideoScope
950.0367.0 ATMOS VideoScope PED - single item
950.0362.0 Leakage tester
950.0363.0 VideoScope camera cable USB
950.0364.0 Cover cap cable connection
950.0365.0 Carryingcaseex.Endoscope

7
Symbols used
3 Symbols used
On the type plate: Attention, observe the operating instructions
Symbol for the separate collection of electrical and electronic
equipment
Applied part type BF
In the operating instructions: Attention, general potential dangers
IP 68 The device is dustproof protected against permanent immersion

8Functionality and application
4 Functionality and application
4.1 Application
TheexibleATMOSVideoScope(PED)isahighqualitymedicalproduct.The
ATMOS VideoScope (PED) is used for endoscopic examinations in the human
ear, nose and throat medicine. The nasopharynx can be examined with the
exibleATMOSVideoScope(PED).Theimageoftheareatobeexaminedcanbe
displayed on a PC with a high resolution display via the USB interface.
The ATMOS VideoScope (PED) is intended for use in clinics and medical practices
and may only be used by personnel who are specially trained in the handling of
endoscopes!
For cleaning and disinfection, proceed as described in these operating
instructions.
4.2 Image processing
An image processing software is required to display and evaluate the images. The
Software Capture Basic Suite is included in the scope of delivery. This is suitable
for displaying the images on the optionally available panel PC.
4.3 Functionality
Theexitofthebreopticlightcablewhichilluminatestheobservationregion
can be found at the distal end of the ATMOS VideoScope (PED). An attached lens
allows imaging at a 90 ° angle of vision. The image is recorded by a video camera,
converted into an electrical signal and made available to a PC via a USB interface.
The light for illuminating the observation region is obtained from an LED
integrated in the handpiece. The distal end of the insertion hose can be angled in
the range of ± 120 ° by pressing the adjustment lever.
Power is supplied to the PC via the USB interface.
Images or videos can be displayed and saved using the optional software.
4.4 Notice on use
The operating instructions explain how the medical device can be operated
safely,properlyandeectively.Priortorstuse,pleaseperusetheoperating
instructions and start with the chapter on risks and hazard warnings. These
operating instructions must always be kept available near the device. Always
complywiththeambientconditionsspeciedinthetechnicaldata.
These operating instructions does not replace the appropriate medical and
technical knowledge. If necessary, the user must acquire such knowledge in
specialist training courses.

9
Functionality and application
ATMOSassumesnoliabilityfordiagnosesandinterpretationsofndingsthat
have been made with the aid of medical products acquired from ATMOS. The
acquisition of medical expertise and its diagnostic and therapeutic consequences
are the sole responsibility of the user of the medical device.
Before each use, test the direction of movement of the bending unit by operating
the adjustment lever in order to avoid a wrong bending direction.
We recommend using a lubricating gel on the shaft before inserting it into the
nasal cavity to be examined.
4.5 Scope of delivery
ThescopeofdeliveryfortheexibleATMOSVideoScope(PED)includes:
• The ATMOS VideoScope (PED) handpiece with insertion hose, the connector
for the USB connection, the connection for the leak tester and the ATMOS
VideoScope connection cable USB.
• A hand air pump (leakage tester) to carry out the leakage test.
• The Capture Suite Basic.
• Operating instructions

10 Technical data
5 Technical data
Parameter VideoScope VideoScope PED
Focus area 10 - 55 mm 10 - 55 mm
Viewing angle 90° 90°
Ø Distal end 3.9 mm 2.9 mm
Ø Insertion hose 3.9 mm 2.9 mm
Distal bending up/down 120°/120° 120°/120°
Working length 310 mm 310 mm
Overall length 540 mm 540 mm
Resolution in pixels 400x400 400x400
White balance Is factory set Is factory set
Lighting: Internal LED berlightguide berlightguide
Electric power supply 5V DC/0.3 A via USB 5V DC/0.3 A via USB
Performance max. 2.2 W max. 2.2 W
Interface USB 2.0 "A" USB 2.0 "A"
Weight in g approx. 320 g Handpiece approx. 320 g Handpiece
Risk class according to
Medical Devices Act
1 1
Transport and storage
temperature in ° C
-10°C to +60°C -10°C to +60°C
Operation temperature
in °C
0°C to 40°C 0°C to 40°C
Relative humidity 0 to 100% 0 to 100%
Air pressure 950 to 1050 hPa 950 to 1050 hPa
Protection class
against environmental
inuences
IP 68 IP 68
Operation mode Continuous operation Continuous operation

11
Manufacturer
6 Manufacturer
The manufacturer of the ATMOS VideoScope (PED) is:
orlvision GmbH
Gewerbestraße 17
35633 Lahnau
Germany
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
Web: www.orlvision.de

12 Using the ATMOS VideoScope (PED)
7 Using the ATMOS VideoScope (PED)
7.1 Switching on
&TheATMOSVideoScope(PED)isswitchedonandowiththeon/oswitch
(see picture).
&An image can be saved with the save button. For further details on image
storage, see the instructions for the image processing software.
7.2 Inserting, bending and removing the insertion
hose
1. The insertion hose must be carefully inserted into the regions to be
examined (nose and throat). If necessary, the distal end can be adjusted by ±
120 ° with the adjustment lever. The level of adjustment should be checked
in a free trial. The examining doctor holds the ATMOS VideoScope in his hand
enabling him to control the adjustment of the distal end and observe the
image on the display.
Save button
connector
status LED
on/o switch

13
Using the ATMOS VideoScope (PED)
&After the examination, the adjustment lever must be returned to the rest
position and the insertion hose carefully withdrawn.
7.3 Switching o
Afteruse,theATMOSVideoScopemustbeswitchedoandshutdownandthe
necessary cleaning and disinfection work performed. See chapter 9.

14 Working with the Capture Suite Basic
8 Working with the Capture Suite Basic
8.1 Installation of the Capture Suite Basic
1. UsethesuppliedUSBashdrivewithamedicalPC.SelecttheCaptureSuite
Basicsetup.exeleandfollowtheinstallationinstructionsonthedisplay.
8.2 Switching on
1. After successful installation, you can connect the ATMOS VideoScope to the
medical PC via a USB interface.
2. Open the image display program "Capture Suite Basic". The live image
appears. If necessary the correct camera must still be selected (see options
8.3).
3. The pictures and videos that have already been recorded and saved can be
seen on the left hand side.
8.3 Settings and operation
The setting options in live mode are shown in the following image:
Live image
Video recording
Start/Stop
Photograph
saved image /
video sequences
zoom in or out
Options
Close
Camera settings

15
Working with the Capture Suite Basic
The language, storage paths and camera sources can be set using the
"Options button" in the software.

16 Cleaning, Care and Disinfection
9 Cleaning, Care and Disinfection
9.1 Cleaning
&The ATMOS VideoScope must be carefully cleaned after each use. In order to
do this, wipe all accessible outer parts with a clean, disposable cloth soaked
in a suitable disinfectant.
&We recommend: 2% Sekusept® active (manufacturer Ecolab). Exposure time
5 minutes. Make sure that the surfaces remain moist. Then wipe with a dry
disposable cloth. Alternatively, we recommend Triamin disinfectant wipes
from Wet Wipe for cleaning. Exposure time depending on the possible
organisms 5-15 minutes, see separate data sheet, available at www.wetwipe.
eu.
ATTENTION:
Pleasedonotexertanymechanicalforcesontheexibleendoftheendoscope
whenwipingit,asthebreopticlightcableinsidecouldbedamaged(break).
9.2 Disinfection
Disinfectionmayonlybecarriedoutbytrainedstaandbasedonthe
requirements of the Robert Koch Institute.
9.2.1 Carrying out disinfection
ATTENTION:
To protect the 9-pin plug connection, we recommend using the optionally
available cover cap.

17
Cleaning, Care and Disinfection
ATTENTION:
Permanent immersion of the laryngoscope in concentrated alcohol leads to
irreversible damage. If necessary, perform a wipe disinfection. However, make
absolutely sure that the alcohol can evaporate immediately after the wipe
disinfection.
ATTENTION:
Under no circumstances should the USB cable be placed in the immersion
disinfection. The cable may only be cleaned and disinfected by wipe disinfection /
surface disinfection.
9.2.2 Final rinsing
1. Remove the ATMOS VideoScope and accessories from the disinfectant
solution with a clean pair of disposable gloves.
2. Place the disinfected ATMOS VideoScope in a basin / tub with
microbiologically safe water (drinking water quality).
&Use fresh water for each device. Thoroughly rinse the outer surfaces of the
ATMOS VideoScope with microbiologically safe water.
9.2.3 Mechanical process
&We recommend the following procedures with the BHT INNOVA® E3 CMS DC
cleaning and disinfection device:
Cleaning
Pre-cleaning: Use the pre-soaked wipes with 0.5% Dr. Weigert Neodisher
Mediclean forte® until the device is optically clean.
ATTENTION:
Pleasedonotexertanymechanicalforcesontheexibleendoftheendoscope
whenwipingit,asthebreopticlightcableinsidecouldbedamaged.(break)
Cleaning
Cleaning agent: 0.5% Dr. Weigert neodisher Mediclean forte®. Automatic cleaning
process with program No. 24 with the following settings:
• Step pre-cleaning for four minutes
• Step emptying
• Step cleaning 0.5% at 37°C for six minutes
• Step cleaning 0.5% at 43°C for 6 minutes
• Step emptying
• Step intermediate rinse for two minutes

18 Cleaning, Care and Disinfection
Disinfection
ATTENTION:
A leakage test must be carried out prior to each disinfection/immersion (chapter
„9.3 Leakage test“ on page 18). In the event of a leak, the ATMOS VideoScope
must be discarded immediately and sent to the manufacturer for repair. If there
isaleak,thedisinfectionwillbeineective.
• Pre-cleaning: Use the pre-soaked wipes with 0.5% Dr. Weigert Neodisher
Mediclean forte® until the instrument is optically clean.
• Cleaning: 0.5% Dr. Weigert neodisher Mediclean forte®.
• Disinfection: 1.0% Dr. Weigert neodisher endo SEPT PAC.
Automatic cleaning and disinfection process with program No. 22 NORMAL-PAA
with the following settings:
• Step pre-cleaning for four minutes
• Step emptying
• Step cleaning 0.5% at 37°C for six minutes
• Step cleaning 0.5% at 43°C for six minutes
• Step emptying
• Step intermediate rinse for two minutes
• Step chemical disinfection with 1% disinfectant at 25 ° C for ten minutes
• Step emptying
• Stepnalcleaningat20°Cforfourminutes.
9.3 Leakage test
ATTENTION:
Theleakagetestmustbecarriedoutbeforeeachimmersionprocess!
ATTENTION:
The connection hose of the leakage tester and the tester connection on the
ATMOSVideoScopemustbedry!

19
Cleaning, Care and Disinfection
1. Placethetesterconnectioncaprmlyonthetesterconnectionandturnita
quarterofaturninaclockwisedirection.Thetesterisnowrmlyattachedto
the ATMOS VideoScope and can no longer be removed.
2. Close the valve on the leakage tester.
3. Generate the maximum permissible test pressure of 160 mm Hg by pumping
on the leakage tester.
ATTENTION:
If the vacuum gauge reading falls by more than 10 mm Hg within one minute, the
ATMOS VideoScope must not be immersed in liquid.
1. In this case, wipe the outer sheath with instrument disinfectant or
isopropanol 70%, wrap the ATMOS VideoScope in a protective foil cover,
pack it in the original packaging and mark it with the comment "leaky, not
disinfected". Then pass it on to the service or the manufacturer.
ATTENTION:
Never connect or disconnect the tester under water, otherwise moisture could
penetrate the device and repairs may be necessary.
1. After completing the leakage test, open the valve on the leakage tester to
release the excess pressure. Then turn the tester connector cap to the left,
and remove it.
9.4 Care
The ATMOS VideoScope (PED) is low-maintenance. In addition to thorough
cleaning and regular checks for damage, no special care is required. The ATMOS
VideoScope must be stored in a dry area and protected against dust.

20 Maintenance and repairs
10 Maintenance and repairs
The components of the ATMOS VideoScope (PED) are maintenance-free for their
users. Repairs and maintenance work may only be carried out by ATMOS or by
specialist companies authorized by them. ATMOS will provide all the necessary
product documents to the authorized companies.
ATTENTION:
Unauthorized opening, repairs and changes to the ATMOS VideoScope release
ATMOS from any liability for operational safety. Thus all warranty claims will be
void during the guarantee period.
10.1 Sending in the device
In the event of sending back the device, please use the original shipping
packaging, this will help to avoid damage during transport and shipping.
For shipping and transport, always connect the pressure tester to the light
connectionleavingthevalveopen!