Storz 094053 Bedienungsanleitung
Instructions for use
Headlight
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 • Headlight • TOR361_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 Appropriate combination of endoscope and fiber optic light cable .........................................................6
3.6 High light intensity ....................................................................................................................................7
3.7 Hot components .......................................................................................................................................7
3.8 Failure of products.................................................................................................................................... 7
4 Product description ......................................................................................................................................8
4.1 Product overview, model 094051 .............................................................................................................8
4.2 Product overview, model 095501 .............................................................................................................9
4.3 Possible combinations..............................................................................................................................9
4.4 Ambient conditions ...................................................................................................................................9
4.5 Symbols on the packaging ..................................................................................................................... 10
5 Preparation..................................................................................................................................................11
5.1 Unpacking the product ...........................................................................................................................11
5.2 Inspecting the product............................................................................................................................11
5.3 Assembling headlight 094051.................................................................................................................11
5.4 Assembling headlight 095501.................................................................................................................13
6 Disassembly................................................................................................................................................16
6.1 Disassembling headlight 094051............................................................................................................ 16
6.2 Disassembling headlight 095501............................................................................................................ 17
7 Maintenance, servicing, repairs, and disposal............................................................................................19
7.1 Repairing the product .............................................................................................................................19
7.2 Disposing of the product ........................................................................................................................19
8 Accessories and spare parts ......................................................................................................................20
8.1 Spare parts list........................................................................................................................................ 20
9 Subsidiaries.................................................................................................................................................21
General information
Instructions for use • Headlight • TOR361_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 in a safe place.
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:
Headlight Headband Light cable Neoprene fore-
head cushion
Clip with band
094053
095502
078730 495NAS
095503
078511
078513
310073
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.
NOTICE
ATTENTION
Designates a possibly harmful situation. If this is not avoided, the products could be damaged.
Normal use
Instructions for use • Headlight • TOR361_EN_V1.0_02-2021_IFU_CE-MDR 5
2 Normal use
2.1 Intended use
Intended use – headlight
The headlight is used for illuminating body surfaces, cavities, and body or surgical orifices. The
headlight is non-invasive and is designed for short-term use in non-surgically invasive
procedures and surgical procedures.
Intended use – headband
The headband is used for holding the individual components of the headlight, making it
possible to carry the headlight on the head. The headband is non-invasive and is designed for
short-term use in non-surgically invasive procedures and surgical procedures.
2.2 Indications
The use of the headlight is indicated if it is indicated in the opinion of the responsible
physician. This includes, amongst other things:
– Otorhinolaryngology
– Urology
– Heart, vascular, and thoracic surgery
2.3 Contraindications
The use of headlights is contraindicated if, in the opinion of the responsible physician, the
surgical method is contraindicated.
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 • Headlight • TOR361_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 Appropriate combination of endoscope and fiber optic
light cable
If the fiber diameter of the fiber optic light cable is too large, the endoscope light connection
will heat up. This may cause damage to the endoscope.
Safety
Instructions for use • Headlight • TOR361_EN_V1.0_02-2021_IFU_CE-MDR 7
If the fiber diameter of the fiber optic light cable is too small, not enough light will enter the
endoscope. This may mean that the operating area is not sufficiently illuminated.
Use the endoscope with a fiber optic light cable that has an appropriate fiber diameter.
3.6 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.
3.7 Hot components
The high level of light intensity may cause the distal end of the endoscope to heat up. This can
cause burns to patients, users, or 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 of the endoscope.
3.8 Failure of products
The product may fail during use.
Have a replacement product ready for each application or plan for an alternative surgical
technique.
Product description
Instructions for use • Headlight • TOR361_EN_V1.0_02-2021_IFU_CE-MDR 8
4 Product description
4.1 Product overview, model 094051
4
1
2
3
5
6
7
8
9
11 12
13
10
1 Light 094053 2 Ball joint
3 Rotary knob for size adjustment 4 Knurled cap and brake cylinder
5 Connector for light source 6 Forehead cushion
7 Light cable 8 Clip with band
9 Headband 10 Suspension
11 Clip with clamp spring 12 Focus handle
13 Light cable with straight connector
495NAS
Product description
Instructions for use • Headlight • TOR361_EN_V1.0_02-2021_IFU_CE-MDR 9
4.2 Product overview, model 095501
4
1
2
3
5
6
7
8
9
10
11
12
1 Light with mirror 2 Ball joint
3 Rotary knob for size adjustment 4 Knurled cap and brake cylinder
5 Forehead cushion 6 Light cable
7 Clip with band 8 Headband
9 Mirror 10 Aperture socket
11 Suspension 12 Headlight with integral light cable
and straight plug for headlight
4.3 Possible combinations
Headlight Light cable, detach-
able
Integral light cable Light source
094051 495NAS Cold light sources with
standard light cable con-
nection
095501 095502
095506
4.4 Ambient conditions
There are no special transport and storage conditions for this product.
Product description
Instructions for use • Headlight • TOR361_EN_V1.0_02-2021_IFU_CE-MDR 10
4.5 Symbols on the packaging
Symbol Meaning
Manufacturer
Date of manufacture
Article no.
Number of products in the product packaging
Batch code
Medical device
Unique Device Identifier
Fragile, handle with care
Keep dry
Unsterile
Federal (USA) law restricts this device to sale by or on the order of a
physician.
CE conformity mark
With this mark, the manufacturer declares the compliance of the prod-
ucts with the applicable regulation (EU) 2017/745. A code number after
the CE mark indicates the responsible notified body.
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