orlvision RSX-USB User manual

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Instructions for use
Video Rhino Laryngoscope
Type RSX-USB / RSX-P
Picture 1:Video Rhino Laryngoscope
1 Integrated LED 4Status LED
2 USB interface 5 Release button
2.1 Tablet PC 6 Probe control
2.2 USB 7 Distal end
3 Power on/off 8 Sensor with precise optics

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Content
1 Risks and hazard warnings .............................................................................................................. 3
2 Intended use ..................................................................................................................................... 5
3 Symbols used ................................................................................................................................... 5
4 Functionality and application ............................................................................................................ 6
4.1 Application ............................................................................................................................... 6
4.2 Image processing .................................................................................................................... 6
4.3 How it works ............................................................................................................................ 6
4.4 Notes on use............................................................................................................................ 6
4.5 Scope of delivery ..................................................................................................................... 6
5 Technical data .................................................................................................................................. 7
6 Manufacturer .................................................................................................................................... 8
7 Use of the Video Rhino Laryngoscope............................................................................................. 9
7.1 Switch on ................................................................................................................................. 9
7.2 Insert, angle and retract the insertion tube. ............................................................................. 9
7.3 Switch off ................................................................................................................................. 9
8 Cleaning, care and disinfection ...................................................................................................... 10
8.1 Manual procedures ................................................................................................................ 10
8.1.1. Cleaning ......................................................................................................................... 10
8.1.2. Disinfection .................................................................................................................... 10
8.1.3. Final rinse ...................................................................................................................... 11
8.2 Machine processes ................................................................................................................ 11
8.3 Leak test ................................................................................................................................ 12
8.4 Care ....................................................................................................................................... 13
9 Maintenance and repairs ................................................................................................................ 13
9.1 Return .................................................................................................................................... 14
10 Disposal ..................................................................................................................................... 14
11 Electromagnetic compatibility .................................................................................................... 14
11.1 Information on the operating environment: ............................................................................ 14
11.2 Information on the performance characteristics .................................................................... 14
11.3 Electrical immunity (immunity) ............................................................................................... 14
11.4 Immunity test ......................................................................................................................... 14
11.5 Electromagnetic emission ...................................................................................................... 15
12 Reporting of serious incidents ................................................................................................... 15

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1 Risks and hazard warnings
1. Please first check the packaging, the Video Rhino Laryngoscope and the accessories for complete-
ness and shipping damage. In case of damage, make a note of the damage and notify your dealer
or the manufacturer.
2. Before each treatment, take a test image of a known object so that you can be sure of the
the correct image quality, the correct image orientation (even if the angulation unit moves) and the
orientation (even if the angulation unit is moved) and that the Video Rhino Laryngoscope is working
laryngoscope. Particular attention should also be paid to colour fidelity.
3. Only use the Video Rhino Laryngoscope for its intended purpose, in accordance with the
of the MPDG or MDR, in accordance with the generally recognised rules of technology, as well as
in accordance with the valid occupational safety and accident prevention regulations.
4. Before using the Video Rhino Laryngoscope, visually inspect it to ensure that it is in good working
order.
to ensure that it is in proper working order and condition. The Video Rhino Laryngoscope is a high-
quality precision mechanical-optical instrument; handle it with care.
Caution:
Do not use the Video Rhino Laryngoscope if it has any defects that could endanger patients,
or third parties, e.g. sharp edges due to damage.
Caution:
Do not use the Video Rhino Laryngoscope if it is leaking. (See chapter 9).
Serious infections may otherwise occur.
Attention:
Only use medically approved devices (PC, tablet, laptop) together with the Video Rhino Laryngo-
scope. Approved according to DIN EN 60601-1 or IEC 60601-1.
The computer must have double insulation (2 MOPP).
Otherwise, the patient or user could be endangered in unfavourable cases. Observe the instructions in
chapter 7.
Caution:
Handle pointed or sharp objects such as scalpels or needles carefully in the vicinity of the
Video Rhino Laryngoscope carefully so that no mechanical damage could be caused to the endo-
scope and especially to the flexible insertion tube.
This also applies in particular to insertion into a disinfection bath.
Caution:
Do not look directly into the light exit at the distal end. The energy of the internal light sources can
cause eye damage. In particular, do not use the laryngoscope for eye examinations contrary to its in-
tended use.
Attention:
Do not look into the connected light guide!

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Caution:
The Video Rhino Laryngoscope may only be used by persons who, on the basis of their training or
knowledge and practical experience, can guarantee proper handling.
The Video Rhino Laryngoscope may only be used by persons who, on the basis of their training or
knowledge and practical experience, can guarantee proper handling.
Caution:
The distal end may heat up to 10°C above room temperature during prolonged use of the laryngo-
scope.
above room temperature.
Note: The supplied image display programme Orlview has been tested on the optionally available
panel PC, which is available as an option. The installation of different software versions or other pro-
grammes on this PC may cause faults in the image display. Orlvision does not accept any guarantee
for such faults. We recommend that you do not modify the Panel PC.
Make sure that no stored image is being viewed when current examinations are to be carried out.
are to be performed.
5. Avoid direct sunlight, X-rays, sudden sharp temperature changes or heating above 60°C and me-
chanical stresses such as hard impacts and kinking of the insertion tube.
6. The operational safety and usability of the medical device depend not only on your skills but also
on the care of the device.
but also on the care of the device. Regular cleaning and care are therefore necessary (see chapter
Cleaning, care and disinfection).
7. Qualified service and the use of original spare parts give you the guarantee that the operational
safety, the operational capability and the value of your medical device are maintained.
8. Prolonged or improper use (sharp kinking of the flexible insertion tube) may result in reduced illumi-
nation in the observation room due to damage to light guides (breakage). The ability to illuminate
should therefore be checked from time to time outside examinations ( Illumination of a white sheet
of paper ).

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2 Intended use
 The Video Rhino Laryngoscope RSX-USB / RSX-P is used for endoscopic examinations in
human ear, nose and throat medicine. The flexible Video Rhino Laryngoscopes can be used
to examine the nose, pharynx and larynx, nasal cavities and nasopharynx. The examination
regions can be displayed on high-resolution screens via a (panel) PC.
 The Video Rhino Laryngoscope is not intended for examination of the paranasal sinuses and
lower larynx.
 It is used exclusively in medical practices and clinics by staff specially trained in handling en-
doscopes.
Attention:
The Video Rhino Laryngoscope RSX-USB / RSX-P may only be used on persons who have a suffi-
ciently large body opening for the insertion of the insertion tube. This is especially important for nasal
examinations in children.
3 Symbols used
On the type plate: Attention, follow instructions for use
Symbol for separate collection of electrical and electronic equipment
Applied part type BF
In the instructions for use: Caution, general danger area
IP 68 Unit is dust-tight and protected against permanent submersion
Device is a medical device

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4 Functionality and application
4.1 Application
The flexible Video Rhino Laryngoscopes RSX-USB / RSX-P from orlvision GmbH (hereinafter re-
ferred to as orlvision) are high-quality medical products. They are used for endoscopic examinations in
human ear, nose and throat medicine. The flexible Video Rhino Laryngoscopes can be used to exam-
ine the nasopharynx. The image of the examination region can be displayed on a PC equipped with a
high-resolution screen via the USB interface.
The RSX-USB laryngoscope is intended for use in clinics and doctors' surgeries and may only be used
by personnel specially trained in handling endoscopes!
Proceed with cleaning and disinfection as described in these instructions for use.
4.2 Image processing
Image processing software is required to display and evaluate the images. The OrlView software is
included in the scope of delivery. This is suitable for displaying the images on the optionally available
panel PC.
4.3 How it works
At the distal end of the Video Rhino Laryngoscope is the exit of a light guide that illuminates the obser-
vation region. The lens allows imaging at a 90° angle of view. The image thus captured 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 tube can be angled in a range of +/- 120° by operating the angulation
lever.
Power is supplied via the PC through the USB interface.
Using the optional software, pictures or videos can be displayed and also saved.
4.4 Notes on use
The instructions for use explain how to operate the medical device safely, properly and effectively.
Please read the instructions for use before putting the device into operation, starting with the chapter
on risks and hazard warnings. Keep the instructions close to the device. Observe the ambient condi-
tions specified in the technical data.
The instructions for use do not replace the corresponding basic medical and technical knowledge. The
user may have to acquire such knowledge in special advanced training courses.
orlvision accepts no liability for diagnoses and interpretations of findings made with the aid of medical
products acquired from orlvision. The acquisition of medical expertise and its diagnostic and thera-
peutic consequences are solely the responsibility of the user of the medical product.
Before each use, test the direction of movement of the angulation unit by operating the adjustment
lever to avoid an incorrect angulation direction.
We recommend the use of a lubricant on the shaft before inserting the shaft into the nasal cavity to be
examined.
4.5 Scope of delivery
The scope of delivery for the flexible Video Rhino Laryngoscope is as follows:

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 the Video Rhino Laryngoscope handpiece with insertion tube and
the connector for the USB connection and the
 Connection Cable RSX-USB / RSX-P (Article no. M-820-02001-0046)
 A hand air pump (Leak Tester; item no. M-860-00003-0057).
for carrying out the leak test.
 The OrlView software
 These instructions for use or a note on downloading from the homepage
 Cover cap " Plug Cap Naso " for 9-pole plug connection
 Cover cap for connection pressure test, article no. M-860-0003-0086-P
5 Technical data
Parameter Data RSX-USB Data RSX-P
Focus area 10 - 55 mm 10 - 55 mm
Angle of view 90° 90°
Diameter distal end 3.9 mm 2.9 mm
Diameter insertion tube 3.9 mm 2.9 mm
Distal angulation up / down 120° / 120° 120° / 120°
Working length 310 mm 310 mm
Total length 540 mm 540 mm
Resolution in pixels 400x400 400x400
White balance Factory set Factory set
Lighting: LED internal Fibre optic cable Fibre optic cable
Power supply 5V DC / 0.3 A via USB 5V DC / 0.3 A via USB
Power max. 2.2 W max. 2.2 W
Interface USB 2.0 "A USB 2.0 "A
Weight in g approx. 320g handpiece approx. 320g handpiece
Risk class according to MDR 1 1
Transport and storage temperature in ° Cel-
sius
- 10°C to + 60°C - 10°C to + 60°C
Operating temperature in ° Celsius
The distal end can warm up to 9°C above
room temperature.
0° to + 40° 0° to + 40°
Relative humidity 0 to 100% 0 to 100%
Air pressure 950 to 1050 hPa 950 to 1050 hPa
Protection class against environmental influ-
ences
IP 68 IP 68
Operating mode Continuous operation Continuous operation
Table1

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6 Manufacturer
The manufacturer of the Video Rhino Laryngoscope RSX-USB/RSX-P is
orlvision GmbH
Industrial Road 17
D-35633 Lahnau
Tel.: [phone] - 0
Fax.: [phone]
[email protected]e
www.orlvision.de

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7 Use of the Video Rhino Laryngoscope
7.1 Switch on
The Video Rhino Laryngoscope is switched on and off using the on/off switch (see Fig. 2).
Figure 2: Operating elements on the handpiece
1 Save button
2 On-off switch
3 Status LED
4 Connector plug, attention: only plug in, do not turn
The save button can be used to save an image. For more details on saving images, see the descrip-
tion of the image processing software.
7.2 Insert, angle and retract the insertion tube.
Carefully insert the insertion tube into the corresponding regions to be examined (nasal and pharyn-
geal cavities). If necessary, the distal end can be adjusted +/- 120° with the adjustment lever (see fig-
ure 3). The plane of the angulation should be checked in a free trial. The examining doctor holds the
laryngoscope in his hand to check the adjustment of the distal end and observes the image on the
screen.
Figure 3: Adjustment lever
After the examination, return the adjustment lever to the rest position and carefully withdraw the inser-
tion tube.
7.3 Switch off
After use, the laryngoscope must be switched off (see Fig. 2) and then the necessary cleaning and
disinfection work must be carried out. See chapter 8.

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8 Cleaning, care and disinfection
In accordance with KRINKO/BfArM recommendations, the machine method is always the preferred
method for reprocessing.
8.1 Manual procedures
8.1.1. Cleaning
After each use, the Video Rhino Laryngoscope must be carefully cleaned. To do this, wipe it with a
clean disposable cloth soaked in an appropriate disinfectant on all accessible external parts.
We recommend for cleaning: 2% Sekusept® active (manufacturer Ecolab). Leave on for 5 minutes.
Make sure that the surfaces remain moist. Wipe with a dry disposable cloth afterwards.
Alternatively, we recommend using Triamin disinfectant wipes from Wet Wipe (available from
Orlvision). Contact time depending on possible organisms 5-15 minutes, see separate data sheet,
available at www.wetwipe.eu .
Attention:
Please do not exert any great mechanical forces on the flexible end of the endoscope when wiping it.
endoscope, the light guides inside could be damaged (breakage).
8.1.2. Disinfection
Disinfection may only be carried out by trained personnel and in accordance with the specifications of
the Robert Koch Institute.
Attention:
Before each disinfection / insertion, a leak test (see chapter 8.3) must be carried out. In case of
the Rhino Laryngoscope must be discarded immediately and sent to the manufacturer for repair.
manufacturer for repair. In case of leaks, the immersion disinfection becomes ineffective!
We recommend the following disinfection: Immersion disinfection with 2% Sekusept® active.
(manufacturer Ecolab). Immersion time 30 minutes.
Attention:
To protect the 9-pole plug connection, we recommend using the enclosed "Plug Cap Naso".
cover cap "Plug Cap Naso".
Fig. 4: Cover cap Plug Cap Naso

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Caution:
Permanent immersion of the laryngoscope in concentrated alcohol will cause irreversible damage. If
necessary, perform a short 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 immersed in the disinfectant. The cable may only
be cleaned and disinfected by wipe disinfection / surface disinfection.
8.1.3. Final rinse
Remove the Rhino Laryngoscope and accessories from the disinfectant solution with fresh disposable
gloves. Place the disinfected laryngoscope in a basin / tub with microbiologically safe water (drinking
water quality). Use fresh water for each instrument. Rinse the Rhino laryngoscope outer surfaces thor-
oughly with microbiologically safe water.
8.2 Machine processes
We recommend the following procedures using the BHT INNOVA® E3 CMS DC washer-disinfector
from CANTEL GmbH or an equivalent machine with the settings given below.
Cleaning
Cleaning agent: 0.5 % Dr. Weigert neodisher Mediclean forte®
Automatic cleaning process with programme no. 24 with the following settings:
 Step Pre-cleaning for 4 minutes
 Step Emptying
 Step Cleaning 0.5% at 37°C for 6 minutes
 Step Cleaning 0.5% at 43°C for 6 minutes
 Step Emptying
 Step Intermediate rinse for 2 minutes
Attention:
Before each cleaning or disinfection / insertion, a leak test (see chapter 8.3) must be carried out. In
case of leakage, the Rhino Laryngoscope must be discarded immediately and sent to the manufac-
turer for repair. In case of leakage, the disinfection will be ineffective!
Pre-cleaning:
Pre-cleaning with pre-soaked cloths with 0.5 % Dr. Weigert neodisher Mediclean forte® until the in-
strument is visually clean.
Attention:
Please do not exert large mechanical forces on the flexible end of the endoscope when wiping it, the
light guides inside could be damaged (breakage).
CleaningCleaning agent: 0.5 % Dr. Weigert neodisher Mediclean forte®.
DisinfectionDisinfectant: 1.0 % Dr. Weigert neodisher endo SEPT PAC

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Automatic cleaning and disinfection process with programme no. 22 NORMAL-PAA with the following
settings:
 Step Pre-cleaning for 4 minutes
 Step Emptying
 Step Cleaning 0.5% at 37°C for 6 minutes
 Step Cleaning 0.5% at 43°C for 6 minutes
 Step Emptying
 Step Intermediate rinse for 2 minutes
 Step chemical disinfection with 1% disinfectant at 25°C for 10 minutes.
 Step Emptying
 Step Final cleaning at 20°C for 4 minutes
Attention:
Usually the laryngoscope is connected to the automatic pressure monitoring during machine cleaning.
If this is not done, we recommend using the optionally available cover cap M-860-0003-0086-P to pro-
tect the valve connection.
It is also recommended to use this cover cap for manual cleaning.
Fig. 5, Cover cap Article number M-860-0003-0086-P
Figure 6: Valve cover cap fitted
8.3 Leak test
Attention:
The leak test must be carried out before each reprocessing!
Caution: The connection tube of the leak tester and the tester connection on the laryngoscope must
be dry!

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Figure 7: Leak tester connection
1. Place the tester connection cap firmly on the tester connection and turn it clockwise a quarter
turn. The tester is now firmly connected to the laryngoscope and cannot be removed.
2. Close the valve on the leak tester.
3. Create a test pressure of 160 (±10) mmHg by pumping the leak tester.
Caution:
If the manometer reading drops by more than 10 mmHg within one minute, do not place the laryngo-
scope in liquid.
In this case, wipe the outer sheath with instrument disinfectant or isopropanol 70 %, wrap the laryngo-
scope in a protective foil cover, pack it in the original packaging and label it "leaking, not disinfected".
Then hand it over to the service workshop or the manufacturer.
Attention:
Never connect or disconnect the tester under water, otherwise moisture may enter the unit and repair
may be necessary.
After completing the leak test, open the valve on the leak tester to release the excess pressure. Then
turn the tester connection cap to the left and pull it off.
8.4 Care
The Video Rhino Laryngoscope is easy to care for. Apart from thorough cleaning and regular inspec-
tion for damage, no special care is required. The laryngoscope should be stored in a dry place, safe
from dust.
9 Maintenance and repairs
The components of the Video Rhino Laryngoscope are maintenance-free for their users. Repairs and
maintenance work may only be carried out by the company orlvision or by specialist companies au-
thorised by it. The company orlvision provides the authorised companies with all necessary product
documentation.
Attention:
Unauthorised opening, repairs and modifications to the laryngoscope release orlvision from any liabil-
ity for operational safety. This will void any warranty claims during the warranty period.

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9.1 Return
In order to avoid damage due to transport and shipping in the event of a return, please use only the
original shipping packaging.
For shipping and transport, always connect the pressure tester to the tester connection with the valve
open!
10 Disposal
Environmentally friendly disposal according to EU Directive 2012/19/EU. The appliance
contains electronic components. To prevent environmental risks or hazards due to im-
proper disposal, the product, including accessories, must be disposed of in accordance
with the applicable EU directives 2012/19/EU. Disposal can be carried out by the manu-
facturer.
For this purpose, please send to the manufacturer at:
Orlvision GmbH, Gewerbestraße 17, D-35633 Lahnau.
Disposal in household waste is prohibited.
11 Electromagnetic compatibility
11.1 Information on the operating environment:
The Video Rhino Laryngoscope is intended for low-interference RF environments such as doctors' of-
fices. No shielded location is required.
11.2 Information on the performance characteristics
 Key features of the Video Rhino Laryngoscope are: Display of images of the examination re-
gion (the nose, pharynx and larynx, nasal cavities and nasopharynx). If there is strong electro-
magnetic interference, the image quality may be impaired.
 Warning: Use of this unit immediately adjacent to other units or with other units stacked to-
gether should be avoided as this may cause interference.
 Cables, transformers and accessories that can be replaced without affecting the EMC: None
 Warning: The use of other accessories (especially PC) may lead to incorrect operation
 Warning: Portable communication (radio) equipment operating in close proximity may result in
incorrect operation
11.3 Electrical immunity (immunity)
Parameter Data RSX-USB Data RSX-P
Static electricity discharge (ESD)
according to EN 61000-4-2, level
according to EN 60601-1-2
+/- 8 kV Contact discharge
+/- 15 kV Air discharge
11.4 Immunity test
Parameter Data RSX-USB Data RSX-P
Immunity to electromagnetic radiation
according to EN 61000-4-3, level ac-
cording to EN 60601-1-2
f = 80 MHz to 2.7 GHz
10V/M; 3 V/m
According to EN 60601-1-2 chapter
8.10; / PM, 18 Hz or 217 Hz
380 MHz - 5.8 GHz
9 - 28 V/m

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Parameter Data RSX-USB Data RSX-P
Conducted RF according to EN 61000-
4-6, levels according to EN 60601-1-2,
150 kHz - 80 MHz
3 V/m
ISM frequencies 6 V/m
11.5 Electromagnetic emission
HF interference emission (Radiated Emission) according to CISPR 11;
(level according to EN 55011; 30 MHz to 1 GHz)
Class B
Conducted emission according to CISPR 11
(level according to EN 55011 with 150 kHz - 30 MHz)
Class B
12 Reporting of serious incidents
All serious incidents related to this product shall be reported to the manufacturer and to the competent
authority of the Member State in which the user and/or the patient is established.

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Notes
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orlvision GmbH
Gewerbestrasse 17
D-35633 Lahnau
Tel. [phone]
Fax [phone]
[e-mail]
www.orlvision.com
Rev. 21 from 01.06.2022