Accessories for Operating Laryngoscopes Instructions For Use

03-2022 Copyright © All product illustrations, product descriptions, and texts are the intellectual property of KARL STORZ SE & Co. KG. Their use and reproduction by third parties require the express approval of KARL STORZ SE & Co. KG. All rights reserved.

Table of contents

Table of contents 1 General information ... 1.1 Read the instructions for use ... 1.2 Read the instructions for use of compatible products ... 1.3 Scope ... 1.4 General signs and symbols ... 1.5 Description of warning messages ...

4 4 4 4 5 6

2 Normal use ... 2.1 Intended use ... 2.2 Indications ... 2.3 Contraindications ... 2.4 Target user populations ... 2.5 Patient groups ...

7 7 7 8 8 8

3 Safety and warning ... 9 3.1 Serious incidents ... 9 3.2 Correct handling and product testing ... 9 3.3 Unsterile product ... 9 3.4 Creutzfeldt-Jakob disease ... 9 3.5 Hot components ... 10 3.6 High light intensity ... 10 3.7 Patient leakage current ... 10 3.8 Appropriate combination of endoscope and fiber optic light cable ... 10 4 Product description ... 11 4.1 Product overview ... 11 4.2 Possible combinations ... 12 4.3 Symbols on the packaging ... 18 4.4 Ambient conditions ... 18 5 Preparation ... 19 5.1 Unpacking the product ... 19 6 Maintenance, servicing, repairs, and disposal ... 20 6.1 Repairs to the product ... 20 6.2 Disposing of the product ... 20 7 Accessories and spare parts ... 21 7.1 Spare parts ... 21 8 Subsidiaries ... 22

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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General information

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. Read the reprocessing instructions carefully and follow all the safety notes and warnings. The reprocessing instructions can be downloaded from www.karlstorz.com/ifu by entering the item number. Keep the instructions for use and reprocessing instructions in a safe place.

1.2 Read the instructions for use of compatible products If the instructions for use of compatible 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 compatible products carefully and follow all the safety notes and warnings. Read the reprocessing instructions of the compatible products carefully and follow all the safety notes and warnings.

1.3 Scope This instruction manual is valid for: Product

Item number

Clip for Illumination, for proximal illumination

497AC

Illumination Clip for 8588L/N/12067C

497AD

HAVAS Light Carrier

497HC

Telescope Protective Sheath for 497HC

497HCS

Short Light Carrier for 8574DD/F/N

8574FD

Injection Cannula, diameter 2 mm

8574GY

Injection Cannula, diameter 3 mm

8574GZ

Fiber Optic Light Carrier, 12 cm

8574JH

Suction Tube to Remove Vapor

8574JK

Fiber Optic Light Carrier, 16 cm

8574LF

Fiber Optic Light Carrier for 8590KL, 8890A

8574LG

Suction Tube to Remove Vapor, 16 cm

8574LM

Suction Tube to Remove Vapor for 8590KL, 8890A

8574LN

Fiber Optic Light Carrier for 8575C

8575CF

Fiber Optic Light Carrier for 8580B

8580BL

Fiber Optic Light Carrier for 8582B

8582BL

Fiber Optic Light Carrier for 8583A

8583AL

Fiber Optic Light Carrier for 8583B

8583BL

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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General information

Product

Item number

Fiber Optic Light Carrier, 7.5 cm

8587GF

Injection Cannula, 8.5 cm

8587K

Suction Tube to Remove Vapor, 8.5 cm

8587M

Suction Tube to Remove Vapor

8587MK

Fiber Optic Light Carrier, 6.5 cm

8587PF

Suction Tube to Remove Vapor

8587PM

Fiber Optic Light Carrier

8588GF

Fiber Optic Light Carrier

8588GP

Injection Cannula

8588K

Fiber Optic Light Carrier for 8588L/N

8588LF

Suction Tube to Remove Vapor for 8588L, long

8588LM

Suction Tube to Remove Vapor for 8588L, short

8588LN

Suction Tube to Remove Vapor for 8588L

8588LP

Suction Tube to Remove Vapor

8588M

Suction Tube to Remove Vapor for 8588C

8588MP

Fiber Optic Light Carrier, 14 cm

8590GF

Fiber Optic Light Carrier, 18 cm

8590GL

Fiber Optic Light Carrier, 7.5 cm

8590HF

Injection Cannula, 8.5 cm

8590KC

Suction Tube to Remove Vapor, 12.5 cm

8590M

Suction Tube to Remove Vapor

8590ML

Suction Tube to Remove Vapor, 9 cm

8590N

Suction Tube to Remove Vapor

8590VC

Suction Tube to Remove Vapor, 3 mm, 16 cm 8661M Suction Tube to Remove Vapor, 3 mm, 20 cm 8661N Adaptor for Suction Tubes 8661M/N

8661P

Suction Tube to Remove Vapor, curved, 11 cm

8668M

Prismatic Light Deflector

10101JA

Prismatic Light Deflector, autoclavable

10101JUA

The products listed here may not yet be available in all countries due to differences in approval requirements.

1.4 General signs and symbols The signs and symbols used in this document have the following meaning:

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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General information

Practical tip This sign refers to useful and important information. Actions to be performed Action to be carried out by several steps: ü

Prerequisite that must be met before carrying out an action.

1.

Step 1 ð Interim result of an action

2.

Step 2

ð Result of a completed action Actions in safety notes or in the case of a single step: Step 1 Lists 1.

Numbered list

–

Unnumbered list, 1st level – Unnumbered list, 2nd level

1.5 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 warnings use 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 NOTICE Designates a possibly harmful situation. If this is not avoided, the products could be damaged.

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Normal use

2 Normal use 2.1 Intended use Suction tube to remove vapor Suction tubes to remove vapor are used to evacuate vapor during laser treatments in combination with a laryngoscope. Suction tubes to remove vapor are designed for short-term use in surgically invasive procedures. Light carrier Light carriers are used for distal or proximal illumination of the laryngoscope. Light carriers are designed for short-term use in surgically invasive procedures. Injection cannula Injection cannulas are used for surgery in the laryngeal area, particularly for use with laryngoscopes for positive pressure assisted ventilation. Injection cannulas are designed for short-term use in surgically invasive procedures. Adaptor for suction tube to remove vapor Adaptors for suction tubes to remove vapor are used for fixing suction tubes to remove vapor on surgical laryngoscopes. Adaptors for suction tubes to remove vapor are non-invasive and are designed for short-term use. Prismatic light deflector Prismatic light deflectors are used for proximal illumination of the inner lumen of the laryngoscope or tracheoscope. Prismatic light deflectors are attached to a separate connector at the proximal end of the laryngoscope/tracheoscope. Prismatic light deflectors are designed for non-invasive use. Telescope protective sheath Telescope protective sheaths are used to protect telescopes during use with light carriers in laryngoscopy. Telescope protective sheaths are designed for short-term use in surgically invasive procedures.

2.2 Indications The use of the telescopes and instrument set for laryngoscopy is indicated if diagnostic and/or therapeutic treatment of the larynx is indicated in the opinion of the attending physician. The following indications apply, among others: –

Breathing difficulties

–

Swallowing disorders

–

Voice disorders

–

Foreign bodies

–

Injuries to the larynx

–

Vocal fold augmentation

–

Changes to the larynx and vocal folds (tumors, deformities, paralysis of the vocal folds, polyps, cysts, etc.)

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Normal use

2.3 Contraindications The use of telescopes and the instrument set for laryngoscopy is contraindicated if, in the opinion of the attending physician, the surgical method is contraindicated or the patient is not able to undergo surgery or anesthesia due to his or her general condition. The telescopes and instrument set must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system.

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 groups There are no restrictions in terms of patient groups for this product.

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Safety and warning

3 Safety and warning WARNING Danger due to non-observance of warnings and safety notes This chapter contains warnings and safety notes structured according to hazards and risks. 1. Carefully read and observe all warnings and safety notes. 2. Follow the instructions.

3.1 Serious incidents A ‘serious incident’ includes incidents which, directly or indirectly, had, could have had or could have any of the following consequences: –

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 Correct handling and product testing 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 properties, for example, before and after every use: –

Functionality

–

Damage

–

Changes to the surface

–

In the case of several components: completeness and correct assembly Do not continue to use damaged products. Dispose of the product properly. 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.

3.3 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.

3.4 Creutzfeldt-Jakob disease Products that come into contact with the central nervous system can become contaminated by organic residue containing prions. Prions lead to infection with Creutzfeldt-Jakob disease. If Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product.

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Safety and warning

Dispose of the product properly.

3.5 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 output of the adjustable light sources to a level that is just high enough to ensure optimal illumination of the operating area. Prevent the distal end, light connections, and adjacent components from coming into contact with tissue and operating room accessories.

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 output of the adjustable light sources 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 Patient leakage current If several products supplied with energy are used simultaneously, the patient leakage currents of the product can accumulate. Excessively high leakage current levels may result in the patient becoming injured. Only use products of the same type together, particularly if CF products are required. If the product is connected to a type BF generator, the product will also correspond to type BF.

3.8 Appropriate combination of endoscope and fiber optic light cable If the fiber bundle diameter of the fiber optic light cable is too large, the endoscope light connection will heat up. This may cause damage to the endoscope. If the fiber bundle 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 bundle diameter, see chapter Possible combinations.

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview

Suction Tube to Remove Vapor (e.g., 8587M)

Injection Cannula (e.g., 8587K)

Fiber Optic Light Carrier (e.g., 8587GF)

Telescope Protective Sheath (e.g., 497HCS)

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Product description

Clip for Illumination (e.g., 497AC)

Prismatic Light Deflector (e.g., 10101JA)

4.2 Possible combinations It is recommended that the suitability of the products for the intended procedure be checked prior to use. Please note that the products listed here may not yet be available in all countries due to differences in approval requirements. Accessories for operating laryngoscopes are combined as follows: Combination of operating laryngoscopes with prismatic light deflectors Operating Laryngoscope

Prismatic Light Deflector 10101FA 10101JA 10101JUA

8574B

x

8574C

x

8574D

x

8574E

x

8574G

x

8576C

x

8576CC

x

8576D

x

8576E

x

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

Combination of operating laryngoscopes with fiber optic light carrier and clip for illumination Operating Laryngoscope

Fiber Optic Light Carrier

Clip for Illumination 497AC

497AD

8574F

8574FD

-

-

8574J

8574JH

x

-

8574JB

8574JH

x

-

8574JP

8574JH

x

-

8574N

8574FD

-

-

8574SL

-

x

-

8574SLS

-

x

-

8574SSL

-

x

-

8575C

8575CF

-

-

8576A

-

x

-

8576AA

-

x

-

8576B

-

x

-

8580B

8580BL

-

-

8582B

8582BL

-

-

8583A

8583AL

-

-

8583B

8583BL

-

-

8587A

8587GF

-

-

8587AA

8587GF

-

-

8587KK

8587GF

-

-

8587N

8587PF

-

-

8587P

8587PF

-

-

8588A

8588GF

-

-

8588B

8588GF

-

-

8588BV

8590GF

-

-

8588C

8588GP

-

-

8588L

8588LF

-

x

8588N

8588LF

-

x

8589B

8574LF

x

-

8589C

8574LF

x

-

8590A

8590GF

x

-

8590AL

8574LF

-

-

8590B

8590GF

x

-

8590BL

8574LF

-

-

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

Operating Laryngoscope

Fiber Optic Light Carrier

Clip for Illumination 497AC

497AD

8590C

8590GF

x

-

8590CL

8574LF

-

-

8590DL

8574LF

-

-

8590JA

8574LF

-

-

8590JL

8590GF

x

-

x

-

8590GL 8590K

8590GF 8590HF

8590KL

8574LG

-

-

8590L

8590GF

x

-

8590HF 8590LL

8574JH

-

-

8590DN

8590GF

x

-

8590J

8590GF

x

-

8661AN

-

x

-

8661CN

-

x

-

8661DN

-

x

-

8661EN

-

x

-

8666A

8587GF

x

-

8666AN

-

x

-

8666DN

-

x

-

8890A

8574LG

-

-

Combination of esophageal specula with fiber optic light carrier and clip for illumination Esophageal Speculum

Fiber Optic Light Carrier

Clip for Illumination

8590GF

497AC

12064A

x

x

12064B

x

x

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

Combination of diverticuloscopes with fiber optic light carrier and clip for illumination Diverticuloscope

Fiber Optic Light Carrier

Clip for Illumination

8590GF

497AC

12067A

x

-

12067B

x

-

12068A

x

x

12068B

x

x

Combination of operating laryngoscopes with injection cannula and suction tube to remove vapor Operating Laryngoscope

Injection Cannula 8574GY

8574GZ

8587K

8588K

8590KC

Suction Tube to Remove Vapor

8574J

-

-

-

-

-

8574JK

8574JB

-

-

-

-

-

8587PM

8574JP

-

-

-

-

-

8574JK

8574SL

x

x

-

-

-

-

8574SLS

x

x

-

-

-

-

8574SSL

x

x

-

-

-

-

8587A

-

-

x

-

-

8587M

8587AA

-

-

x

-

-

8587M

8587KK

-

-

x

-

-

8587MK

8587N

-

-

-

-

-

8587PM

8587P

-

-

-

-

-

8587PM

8588A

-

-

-

x

-

8588M

8588B

-

-

-

x

-

8588M

8588C

-

-

-

x

-

8588MP

8588BV

-

-

-

x

-

-

8588L

-

-

-

x

-

8588LM 8588LN for lateral channel 8588LP for central channel

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

Operating Laryngoscope 8588N

Injection Cannula 8574GY

8574GZ

8587K

8588K

8590KC

-

-

-

x

-

Suction Tube to Remove Vapor 8588LM 8588LN for lateral channel 8588LP for central channel

8589B

-

-

-

-

-

8574LM

8589C

-

-

-

-

-

8574LM

8590A

-

-

-

-

x

8590M

8590AL

-

-

-

-

-

8574LM

8590B

-

-

-

-

x

8590M

8590BL

-

-

-

-

-

8574LM

8590C

-

-

-

-

x

8590M

8590CL

-

-

-

-

-

8574LM

8590DL

-

-

-

-

-

8574LM

8590DN

-

-

-

-

x

8590M

8590J

-

-

-

-

x

8590M

8590JA

-

-

-

-

-

8574LM

8590JL

-

-

-

-

x

8590M

8590JV

8590M 8590VC

8590K

-

-

-

-

x

8590N

8590KL

-

-

-

-

-

8574LN

8590L

-

-

-

-

x

8590N

8590LL

-

-

-

-

-

8574JK

8661CN

-

-

-

-

-

8661M 8661N with 8661P

8661DN

-

-

-

-

-

8661M 8661N with 8661P

8661EN

-

-

-

-

-

8661M 8661N with 8661P

8666A

-

-

-

-

-

8668M

8890A

-

-

-

-

-

8574LN

Instructions for use • Accessories for Operating Laryngoscopes • MMG183_EN_V1.0_03-2022_IFU_CE-MDR

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Product description

Combination of esophageal specula with injection cannula and suction tube to remove vapor Esophageal Speculum

Suction Tube to Remove Vapor

12064A

8590ML

12064B

8590ML

Combination of diverticuloscopes with injection cannula and suction tube to remove vapor Diverticuloscope

Suction Tube to Remove Vapor

12067A

8590ML for laser treatment 12067M

12067B

8590ML for laser treatment

12068A

8590ML

12068B

8590ML

Combination of video laryngoscopes Video Laryngoscope

Telescope

Fiber Optic Light Carrier

Clip for Illumination

Suction Tube to Remove Vapor

8590JV

8575AV

8590GF

497AC

8590M

8590TV

-

Combination of HAVAS video laryngoscopes HAVAS Video Laryngoscope

Telescope Protective Sheath

8790A

497HCS

8790B

Telescope

Light Carrier with Integrated Telescope Guide

7230AA

497HC

7230BA 7230CA 7230DA 7230EA 7230FA

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Product description

4.3 Symbols on the packaging Symbol

Meaning Manufacturer

Date of manufacture

Medical device

Article no.

Batch code

Number of products in the product packaging

Unique Device Identifier

Consult the printed or electronic instructions for use

Unsterile

Fragile, handle with care

Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this marking, the manufacturer declares the conformity of the product with the applicable EU directives. A code number after the CE mark indicates the responsible notified body. The EU directives relevant to the product can be found in the EU Declaration of Conformity, which can be requested from KARL STORZ.

4.4 Ambient conditions There are no special transport and storage conditions for this product.

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Preparation

5 Preparation 5.1 Unpacking the product 1.

Carefully remove the product and accessories from the packaging.

2.

Check the delivery for missing items and any possible damage.

3.

In the case of damage, hidden defects, and short deliveries, document their nature and extent and contact the manufacturer or supplier immediately.

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Maintenance, servicing, repairs, and disposal

6 Maintenance, servicing, repairs, and disposal 6.1 Repairs to the product Repair work may only be performed by KARL STORZ or by a company authorized by KARL STORZ. Please contact your local KARL STORZ subsidiary or authorized dealer (see the list of subsidiaries). Contaminated devices may not be shipped. To prevent contact infections and airborne infections, products must first be decontaminated. KARL STORZ reserves the right to send back contaminated products.

6.2 Disposing of the product For disposal, the following measures are necessary: 1.

Decontaminate the products prior to disposal.

2.

Country-specific national laws and regulations must be observed.

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