Storz VITOM II Bedienungsanleitung
Instructions for use
VITOM II telescopes 0°/ 90°
en
Copyright ©
All product illustrations, product descriptions, and texts are the intellectual property of
KARLSTORZSE&Co.KG.
Their use and reproduction by third parties require the express approval of
KARLSTORZSE&Co.KG.
All rights reserved.
02-2021
Table of contents
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 3
Table of contents
1 General information.......................................................................................................................................4
1.1 Read the instructions for use.................................................................................................................... 4
1.2 Read the instructions for use of combinable products............................................................................. 4
1.3 Scope........................................................................................................................................................4
1.4 Description of warning messages.............................................................................................................4
2 Normal use....................................................................................................................................................5
2.1 Intended use .............................................................................................................................................5
2.2 Indications.................................................................................................................................................5
2.3 Contraindications......................................................................................................................................5
2.4 Target user populations ............................................................................................................................ 5
2.5 Patient population.....................................................................................................................................5
3 Safety ............................................................................................................................................................6
3.1 Serious incidents ......................................................................................................................................6
3.2 Unsterile product ......................................................................................................................................6
3.3 Correct handling .......................................................................................................................................6
3.4 Damaged products ...................................................................................................................................6
3.5 Working in the field of vision.....................................................................................................................6
3.6 Hot components .......................................................................................................................................7
3.7 High light intensity ....................................................................................................................................7
3.8 Patient leakage current ............................................................................................................................. 7
4 Product description ......................................................................................................................................8
4.1 Product overview ......................................................................................................................................8
4.2 Technical data...........................................................................................................................................9
4.3 Ambient conditions .................................................................................................................................10
4.4 Symbols on the packaging ..................................................................................................................... 10
5 Application ..................................................................................................................................................12
5.1 Using the product ...................................................................................................................................12
6 Disassembly................................................................................................................................................13
6.1 Disassembling the product ..................................................................................................................... 13
7 Maintenance, servicing, repairs, and disposal............................................................................................14
7.1 Repairing the product .............................................................................................................................14
7.2 Disposing of the product ........................................................................................................................14
8 Accessories and spare parts ......................................................................................................................15
8.1 Accessories.............................................................................................................................................15
8.2 Spare parts .............................................................................................................................................15
9 Subsidiaries.................................................................................................................................................16
General information
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 4
1 General information
1.1 Read the instructions for use
If the instructions for use are not followed, patients, users, and third parties may be injured or
the product may be damaged.
Read the instructions for use carefully and follow all the safety notes and warnings.
Keep the instructions for use clearly visible next to the product.
1.2 Read the instructions for use of combinable products
If the instructions for use of combinable products are not followed, patients, users, and third
parties may be injured or the product may be damaged.
Read the instructions for use of the combinable products carefully and follow all the safety
notes and warnings.
1.3 Scope
These instructions for use are valid for the following products:
Art. no. Description
20916025AA VITOM II telescope
20916025AGA VITOM NIR/ICG telescope
20916025AIA VITOM PDD telescope
20916025DA VITOM 90° telescope
26013VDA VITOM 90° telescope with green filter
1.4 Description of warning messages
To prevent any injury to persons or damage to property, the warnings and safety notes in the
instructions for use must be observed. The warning messages describe the following levels of
danger.
WARNING
WARNING
Designates a possible imminent risk. If this is not avoided, it could lead to death or serious
injuries.
CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.
ATTENTION
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.
Normal use
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
Exoscopes are used to visualize the surgical field during microsurgical, open and endoscopic
procedures. Exoscopes do not come into contact with the body.
2.2 Indications
Extracorporeal visualization of the operating field during microsurgical, open, and endoscopic
procedures. The VITOM / VITOM 3D system is only used for visualization; it does not change
the surgical method. Use of the VITOM / VITOM 3D system is indicated if visualization or
documentation of the surgical procedure makes sense in the opinion of the responsible
physician.
2.3 Contraindications
VITOM / VITOM 3D systems are not used in contact with the patient's body, they are intended
solely for imaging. Beyond that, there are no contraindications for the use of the VITOM /
VITOM 3D systems directly associated with the product. As KARL STORZ light sources are not
intended for use in ophthalmology, the use of the VITOM / VITOM 3D system is also
contraindicated in this field.
2.4 Target user populations
The medical device may only be used by doctors and medical assistants with a relevant
specialist qualification.
2.5 Patient population
There are no restrictions in terms of patient groups for this product.
Safety
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 6
3 Safety
3.1 Serious incidents
According to the Medical Device Regulation (MDR), a “serious incident” includes incidents that
directly or indirectly had, could have had, or could have any of the following consequences
(MDR, Art.2, No.65[1]):
– Death of a patient, user, or another person
– Temporary or permanent serious deterioration in the medical condition of a patient, user,
or another person
– A serious threat to public health
The manufacturer and appropriate authority must be notified of all serious incidents.
3.2 Unsterile product
The product is not sterile when delivered. The use of non-sterile products poses a risk of
infection for patients, users, and third parties.
Reprocess the product in line with the reprocessing instructions before initial use and
every subsequent use.
3.3 Correct handling
If the product is not handled correctly, patients, users, and third parties may be injured.
Only persons with the necessary medical qualification and who are acquainted with the
application of the product may work with it.
Check that the product is suitable for the procedure prior to use.
Check the product for the following points before and after every use:
– Completeness
– Good working order
– Rough surfaces left inadvertently
– Sharp corners
– Burred edges
– Correct assembly of the components
– Functionality
Do not leave broken-off components inside the patient.
Do not overload the product with mechanical stress.
Do not bend bent products back to their original position.
3.4 Damaged products
Damaged products can result in injury to patients, users, or third parties.
Before each use, check all components of the product for damage.
Do not use damaged products.
3.5 Working in the field of vision
Using the product outside the field of vision can cause injury to tissue or can damage the
product.
Only use the product in the field of vision.
Safety
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 7
3.6 Hot components
The high level of light intensity produced by the light source may cause the distal end, the light
connections, and adjacent components to heat up. This can cause burns to patients, users,
and third parties.
Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.
Avoid contact with the distal end and light connections.
3.7 High light intensity
The high level of light intensity produced by the light source may lead to permanent eye
damage or blindness, and may cause tissue and items facing the light output to heat up.
Do not look into the light output.
Set the light source output to a level that is just high enough to ensure optimal illumination
of the operating area.
Make sure the light output is sufficiently far away from tissue and operating accessories.
3.8 Patient leakage current
Patient leakage currents from products may add up if powered products and powered
endotherapy devices are used simultaneously. Excessively high leakage current levels may
result in the patient becoming injured.
Only use products of the same type together, particularly in the case of CF products.
Product description
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 8
4 Product description
4.1 Product overview
13
10
2
VITOM II telescope 90° (20916025DA)
1 Direction of view
2 Screw base, for KARLSTORZ fiber optic light cable, Olympus/Winter and Ibe
OR
Plug-in base, 9mm diameter, for Wolf fiber optic light cable
OR
Light inlet socket, without adapter
3 Eyecup
VITOM II telescope 0° (20916025AA)
VITOM II ICG telescope 0° (20916025AGA)
Product description
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 9
VITOM II PDD telescope 0° (20916025AIA)
4.2 Technical data
Description 20916025AA 20916025AG
A
20916025AIA 20916025DA 26013VDA
Dimensions
(L x H x W)
183.26 x
48.38 x
31.75mm
183.26 x
48.38 x
31.75mm
183.26 x
48.38 x
31.75mm
187.26 x
48.38 x
31.75mm
188.56 x
47.07 x 31.75
Weight 168.79 g 172.04 g 172.04 g 172.01 g
Working
length
(AR length to
the irrigation
bottle)
104.8mm 104.8mm 104.8mm 115.8mm 115.8mm
Angle of im-
age field
12° 12° 12° 12° 12°
Direction of
view
0° 0° 0° 90° 90°
Fluorescence
diagnostics
- ICG PDD - Green filter
Light cable
coding
III III III III III
Color code Green Green Green Blue Green
Dismantling No No No No Yes
Light trans-
mission
medium
Fiber optic
light cable
Fiber optic
light cable
Fiber optic
light cable
Fiber optic
light cable
Fiber optic
light cable
Working dis-
tance
White light applications: 20-75cm
Fluorescence application: 20-30cm
Product description
Instructions for use • VITOM II telescopes 0°/ 90° • TLQ518_EN_V1.0_02-2021_IFU_CE-MDR 10
4.3 Ambient conditions
Storage/transport conditions
Temperature -20°C...+60°C
Relative humidity
(non-condensing)
10–95%
Air pressure 700–1,060hPa
Operating conditions
Temperature 10°C...40°C
Relative humidity
(non-condensing)
30–75%
Air pressure 700–1,060hPa
4.4 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Medical device
Article no.
Serial number
Number of products in the product packaging
Unique Device Identifier
Unsterile
Fragile, handle with care
Inhaltsverzeichnis
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