orlvision FS2 User manual

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Instructions for use
Rhino Laryngoscope
Type FS2
1. Connection for light guide 3. focusing
2. Connection for pressure tester 4. angling lever

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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 Functionality...................................................................................................................................6
4.3 Notes on use..................................................................................................................................6
4.4 Scope of delivery ...........................................................................................................................7
5 Technical data, manufacturer and accessories .....................................................................................8
5.1 Technical data Rhino Laryngoscope FS2 .....................................................................................8
6 Manufacturer ..........................................................................................................................................9
7 Swiss Representative .............................................................................................................................9
8 UK Authorised Representative ...............................................................................................................9
9 Recommended accessories ................................................................................................................ 10
10 Using the Rhino Laryngoscope ...................................................................................................... 11
10.1 Inserting, angling and withdrawing the insertion tube. ............................................................... 11
10.2 Ending the examination .............................................................................................................. 11
11 Cleaning, care and disinfection ...................................................................................................... 12
11.1 Manual procedures ..................................................................................................................... 12
11.1.1. Cleaning .............................................................................................................................. 12
11.1.2. Disinfection ......................................................................................................................... 12
11.1.3. Final rinse ........................................................................................................................... 12
11.2 Machine processes ..................................................................................................................... 13
11.2.1. Cleaning .............................................................................................................................. 13
11.3 Leak test ..................................................................................................................................... 14
11.4 Maintenance ............................................................................................................................... 15
12 Maintenance and repairs ................................................................................................................ 15
12.1 Maintenance ............................................................................................................................... 15
12.2 Return ......................................................................................................................................... 15
13 Reporting of serious incidents ........................................................................................................ 15

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1 Risks and hazard warnings
1. Please first check the packaging, the Rhino Laryngoscope and the accessories for completeness and
shipping damage. In case of damage, make a note of the damage and notify your dealer or the manu-
facturer.
2. Use the Rhino Laryngoscope only for its intended purpose, in accordance with the regulations of the
MDR or MPDG, in accordance with the generally recognised rules of technology, and in accordance
with the valid occupational safety and accident prevention regulations.
3. In particular, only use medically approved light sources for connection to the Rhino Laryngoscope.
4. Before using the Rhino Laryngoscope, visually inspect it to ensure that it is in good working order and
condition. The Rhino Laryngoscope is a high-quality precision-mechanical-optical instrument; handle it
with care.
Caution:
Do not use the Rhino Laryngoscope if it has any defects that could endanger patients, users or third par-
ties, e.g. sharp edges or burrs caused by damage.
Caution:
Do not use the Rhino Laryngoscope if it is leaking. (See chapter
Cleaning, care and disinfection). Serious infections may otherwise occur.
Caution:
Handle pointed or sharp objects such as scalpels or needles with care in the vicinity of the Rhino Laryn-
goscope so that no mechanical damage could be caused to the endoscope or the insertion tube.
This 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 connected light sources can cause
eye damage. In particular, the laryngoscope must not be used for eye examinations contrary to its in-
tended use.
Attention:
Likewise, do not look into the light emission of a suitable light source, the radiation is even higher.
Caution:
The Rhino Laryngoscope may only be used by persons who, on the basis of their training or knowledge
and practical experience, can guarantee proper handling.
Attention:
In case of prolonged or improper use (sharp bending of the flexible insertion tube), damage to the light
guides and image guides (breakage) can lead to a reduction in illumination and a reduction in the trans-
mitted pixels in the observation room.

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Caution: Avoid direct sunlight, sudden strong temperature fluctuations or
mechanical stress such as hard impacts and kinking of the insertion tube.
Attention:
The operational safety and usability of the medical device depend not only on your skills, but also on the
care of the device. Regular cleaning and care are therefore necessary (see chapter Cleaning, care and
disinfection).
Attention:
Qualified service and the use of original spare parts guarantee that the operational safety, usability and
value of your medical device are maintained.
Attention:
Before using the laryngoscope, make sure that it is working properly, especially that the images are trans-
mitted correctly without too many missing parts.

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2 Intended use
The Rhino Laryngoscope FS2 is used for human oto-rhino laryngology.
The flexible Rhino Laryngoscopes can be used to examine the nose, pharynx and larynx, nasal cavities
and nasopharynx.
The Rhino Laryngoscope is not intended for examination of the paranasal sinuses and the lower larynx.
larynx area.
It is used exclusively in medical practices and clinics by staff specially trained in handling endoscopes.
trained in handling endoscopes.
Caution:
The Rhino Laryngoscope FS2 may only be used on persons who have a sufficiently large body opening
for the insertion of the insertion tube. This is especially important for nasal examinations in children.
The optical quality of the endoscope is only guaranteed in the image plane area. If you focus out-
side the sharp image plane area, it is possible to detect foreign particles within the optical system.
This is not a quality defect, but a design-related optical effect.
3 Symbols used
The symbols used have the following meaning
On the type plate: Attention, follow instructions for use
Symbol for separate collection of electrical and electronic equipment
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 Rhino Laryngoscopes FS2 of orlvision GmbH (hereinafter referred to as orlvision) are high-
quality medical products. They are used for endoscopic examination in human ear, nose and throat medi-
cine. The flexible Rhino Laryngoscopes can be used to examine the nasopharynx.
4.2 How it works
The Rhino Laryngoscope is a fibre-optic endoscope and has an optical focusing and imaging unit as well
as an image guide. The image is captured at the distal end, guided via the image guide into the optical
unit (multiple lens system) and can be viewed through the eyepiece. The image is focused at the focal
point. At the distal end of the Rhino Laryngoscope is the exit of a light guide that illuminates the observa-
tion region.
The light for illuminating the observation region is supplied by a light guide via the light guide plug from an
external light source. The distal end of the insertion tube can be angled within a range of 130° by operat-
ing the angulation lever.
4.3 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 conditions 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 therapeutic
consequences are the sole responsibility of the user of the medical product.
Before each use, test the direction of movement of the bailing unit by operating the bailing lever to avoid
an incorrect bailing direction.
We recommend the use of a lubricant on the shaft before inserting the shaft into the nasal cavity to be
examined.

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4.4 Scope of delivery
The scope of delivery for the flexible Rhino Laryngoscope is as follows:
 The Rhino Laryngoscope: Handpiece with insertion tube and the connection sockets for the light guide
to the cold light source and for connection to the pressure tester.
 A hand air pump (pressure tester; item no. M-860-00003-0057) for carrying out the leak test.
 These instructions for use or a note on downloading from the homepage

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5 Technical data, manufacturer and accessories
5.1 Technical data Rhino Laryngoscope FS2
Parameter
Data
Focus area 3 mm ± 1 to 50mm -5 / +10
Field of view (FOV) 90° ± 5
Diameter distal end 2.9 mm + 0 / -0.1
Diameter insertion tube 2.9 mm ± 0.1
Distal angulation up / down 130° ± 5
Working length 300 mm ± 5
Total length 540 mm
Weight in g 310g ± 10
Risk class according to MDR 1
Transport and storage temperature in ° Celsius - 10°C to + 60°C
Operating temperature in ° Celsius
The distal end can warm up to 9°C above room temperature.
0° to + 35°
Relative humidity 0 to 100 %
Air pressure 950 to 1050 hPa
Protection class against environmental influences IP 68
Operating mode Continuous operation

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6 Manufacturer
The manufacturer of the Rhino laryngoscope FS2 is:
orlvision GmbH
Industrial Road 17
D-35633 Lahnau
Tel: [phone] - 0
Fax: [phone]
[email protected]e
www.orlvision.de
7 Swiss Representative
Pfenniger Medical Technology GmbH
Parkstrasse 25, CH-6410 Goldau
Tel.: [phone]
[e-mail]
8 UK Authorised Representative
UK REP
UK Responsible Person
Jeremy Taylor, LiteOptics Ltd,
The Nucleus, Chesterford Research Park,
Little Chesterford, Essex CB10 1XL
Tel [phone]
[e-mail]

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9 Recommended accessories
Only use a medically approved cold light source.
Attention:
The light source must meet the requirements of the DIN EN ISO 60601-1 standard!
The connection on the Rhino laryngoscope is compatible for light guides with ACMI / Storz /
Wolf endoscope connection.
Possibilities:
 Lighthandle Firefly ES201, 5W LED
 Light source orlLED 180, ILO
Caution:
If a high-power cold light source is used and there is dirt at the outlet of the light guide or the light inlet
plug on the laryngoscope, strong heat may be generated due to light absorption. There is a risk of burns.
On request, we are also happy to offer you a wide range of adaptation options to light sources and
endoscopes of other makes and also to LED hand-held light sources.

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10 Use of the Rhino Laryngoscope
10.1 Insert, angle and retract the insertion tube.
Carefully insert the insertion tube into the regions to be examined (nasal and pharyngeal cavities). If nec-
essary, the distal end can be adjusted by 130° with the angling lever (see illustration) . The level of ad-
justment should be tested in a free trial. The examining doctor holds the laryngoscope in his hand to
check the adjustment of the distal end.
After the examination, return the angling lever to the rest position and carefully withdraw the insertion
tube.
10.2 Finishing the examination
After use, the laryngoscope must be cleaned and disinfected, see chapter 11.

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11 Cleaning, care and disinfection
11.1 Manual procedures
In accordance with KRINKO/BfArM recommendations, the machine method is always the preferred
method for reprocessing.
11.1.1. Cleaning
The laryngoscope must be carefully cleaned after each use. 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® aktiv (manufacturer Ecolab). Leave on for 5 minutes. Make
sure that the surfaces remain moist. Wipe with a dry disposable cloth afterwards.
Attention:
Please do not exert large mechanical forces on the flexible end of the endoscope when wiping it, the light
and image guides inside could be damaged (breakage).
11.1.2. 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 11.3) must be carried out. In case of leakage,
the laryngoscope must be discarded immediately and sent to the manufacturer for repair. In case of leak-
age, the immersion disinfection becomes ineffective!
We recommend the following disinfection: Immersion disinfection with 2% Sekusept® active.
(manufacturer Ecolab). Immersion time 30 minutes.
Caution:
Permanent immersion of the laryngoscope in concentrated alcohol will cause irreversible damage. If nec-
essary, perform a short wipe disinfection. However, make absolutely sure that the alcohol can evaporate
immediately after the wipe disinfection.
11.1.3. Final rinse
Remove the 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 qual-
ity). Use fresh water for each instrument. Thoroughly rinse the outer surfaces of the laryngoscope with
microbiologically safe water.

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11.2 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.
11.2.1. Cleaning
Cleaning agent: 0.5 % Dr. Weigert neodisher Mediclean forte®
Automatic cleaning process with programme no. 24 with the following settings:
o Step Pre-cleaning for 4 minutes
o Step Emptying
o Step Cleaning 0.5% at 37°C for 6 minutes
o Step Cleaning 0.5% at 43°C for 6 minutes
o Step Emptying
o Step Intermediate rinse for 2 minutes
Attention:
Before each cleaning or disinfection / insertion, a leak test (see chapter 11.3) must be carried out. In case
of leakage, the Rhino laryngoscope must be discarded immediately and sent to the manufacturer for re-
pair. In case of leakage, the disinfection will be ineffective!
 Pre-cleaning:
Pre-cleaning with pre-soaked wipes with 0.5 % Dr. Weigert neodisher Mediclean forte® until the
instrument 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).
 Cleaning
Detergent: 0.5 % Dr. Weigert neodisher Mediclean forte®
 Disinfection
Disinfectant: 1.0 % Dr. Weigert neodisher endo SEPT PAC
Automatic cleaning and disinfection process with programme no. 22 NORMAL-PAA with the fol-
lowing settings:
o Step Pre-cleaning for 4 minutes
o Step Emptying
o Step Cleaning 0.5% at 37°C for 6 minutes
o Step Cleaning 0.5% at 43°C for 6 minutes
o Step Emptying
o Step Intermediate rinse for 2 minutes
o Step chemical disinfection with 1% disinfectant at 25°C for 10 minutes.
o Step Emptying
o Step Final cleaning at 20°C for 4 minutes
Attention:
Usually the laryngoscope is connected to the automatic pressure monitoring system during machine
cleaning. If this is not done, we recommend using the optionally available cover cap M-860-0003-0086-P
to protect the valve connection.
It is also recommended to use this cover cap for manual cleaning.

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Cover cap Article number M-860-00003-0086-P
Valve cover cap fitted
11.3 Leak test
Attention:
The leak test must be carried out before each reprocessing! The light guide may be removed for the leak
test.
Connection Leak Tester
Attention:
The connection tube of the pressure tester and the connection of the pressure tester to the laryngoscope
must be dry!
Place the valve adapter firmly on the connection of the pressure tester and turn them a quarter turn clock-
wise. The pressure tester is now firmly connected to the laryngoscope and cannot be pulled off.
Close the drain plug on the pressure tester. 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 immerse the laryngo-
scope in liquid. In this case, wipe the outer sheath with the recommended disinfectant or isopropanol 70
%, wrap the laryngoscope 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.

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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 off the tester connection.
11.4 Care
The Rhino Laryngoscope is easy to care for. Apart from thorough cleaning and regular checking for dam-
age, no special care is required. The Rhino Laryngoscope should be stored in a dry place, safe from dust.
12 Maintenance and repairs
12.1 Maintenance
The components of the Rhino Laryngoscope are maintenance-free for their users. Repairs and mainte-
nance work may only be carried out by orlvision or by specialist companies authorised by orlvision. 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 liability
for operational safety. This will void any warranty claims during the warranty period.
12.2 Return
In order to avoid damage due to transport and shipping in the event of a return, please use only the origi-
nal shipping packaging.
13 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 via the ma-
nufacturer
For this purpose, please send to the manufacturer at:
Orlvision GmbH, Gewerbestraße 17, D-35633 Lahnau.
Disposal in household waste is prohibited.
14 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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Notes
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orlvision GmbH
Gewerbestrasse 17
D-35633 Lahnau
Tel. [phone]
Fax [phone]
[e-mail]
www.orlvision.com
Rev. 17, 01.12.2022
Document is translated electronically