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.