IFU High pressure syringe Instructions For Use

02-2021 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... 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... 6 2.1 Intended use ... 6 2.2 Indications... 6 2.3 Contraindications... 6 2.4 Target user populations ... 6 2.5 Patient groups... 6 3 Safety ... 7 3.1 Serious incidents ... 7 3.2 Damaged products ... 7 3.3 Correct handling ... 7 3.4 Unsterile product ... 7 3.5 Creutzfeldt-Jakob disease ... 7 3.6 Disposal of pointed and sharp products ... 8 4 Product description ... 9 4.1 Product overview ... 9 4.2 Possible combinations... 9 4.3 Symbols on the packaging ... 10 4.4 Ambient conditions ... 11 5 Preparation... 12 5.1 Unpacking the product ... 12 5.2 Testing the product... 12 5.3 Assembling the high pressure syringe (771400) ... 12 5.4 Assembling the PERETTI high pressure syringe (771410)... 14 6 Disassembly... 18 6.1 Disassembling the high pressure syringe (771400) ... 18 6.2 Disassembling the PERETTI high pressure syringe (771410) ... 19 7 Maintenance, servicing, repairs, and disposal... 22 7.1 Repairing the product ... 22 7.2 Disposing of the product ... 22 8 Accessories and spare parts ... 23 8.1 Spare parts ... 23 9 Subsidiaries... 24

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_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. 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 This instruction manual is valid for: High pressure syringe, for viscous fluid injection (771400) Product name

Item number

High pressure handle

27200

Adaptor, 3 piece

27200B

Syringe holder, 3 piece

27201Q

Injection cannula, 3 piece

27200S

PERETTI high pressure syringe (771410) Product name

Item number

High pressure handle

27200

Syringe holder for plastic syringe

771412

Pusher

771413

Injection cannula, 20 cm, 3 piece

771420

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.

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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General information

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.

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Normal use

2 Normal use 2.1 Intended use High pressure syringes High pressure syringes are used to administer (inject) synthetic or autologous material in the larynx area. They consist of the handle, syringe holder, plastic syringe, and, where necessary, the pusher. High pressure syringes are used with injection cannulas. High pressure syringes are non-invasive and are designed for transient use in surgically invasive procedures. Injection cannulas for high pressure syringe The injection cannula is a surgical instrument that can be used together with a high pressure syringe for injection of viscous fluid or for fat injection into the vocal cords for the reconstruction of the vocal folds. The injection cannula is designed for transient 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 responsible 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.)

2.3 Contraindications The use of telescopes and the instrument set for laryngoscopy is contraindicated if, in the opinion of the responsible 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.

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Safety

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 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.

3.3 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 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.

3.5 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 Creutzfeld-Jakob disease has been diagnosed or is suspected:

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Safety

Dispose of the product properly and do not continue to use it.

3.6 Disposal of pointed and sharp products If pointed and sharp products are not disposed of in suitable waste containers, there is a risk of injury and infection. Dispose of pointed and sharp products only in suitable waste containers.

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview 3 1

2

4

5

High pressure syringe, for viscous fluid injection 1

Injection cannula

4

High pressure handle

2

Adaptor

5

Plastic syringe

3

Syringe holder for plastic syringe

2

1

4

3

PERETTI high pressure syringe 1

Injection cannula

3

High pressure handle

2

Plastic syringe

4

Syringe holder for plastic syringe

4.2 Possible combinations The following possible combinations are available:

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

PERETTI high pressure syringe (771410) High pressure handle

High pressure syringe (771400)

27200

Syringe holder for plastic syringe

771412

27201Q

Pusher

771413

–

Plastic syringe

771415

27200P

Injection cannula

771420

27200S

Adaptor

–

27200B

Additional possible combinations for the high pressure syringe (771400) High pressure syringe

Cannulas

771400

27200SK 27200SL 27200SM 27200T

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

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Product description

Symbol

Meaning Unsterile

Federal (USA) law restricts this device to sale by or on the order of a physician. CE marking With this mark, the manufacturer declares the compliance of the devices with the applicable standards and directives The device must not be modified in any way

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

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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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 evidence of shipping damage.

3.

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

4.

Keep packaging for further transport.

5.2 Testing the product 1.

Inspect the product for visible contamination. Do not use if contaminated.

2.

Inspect the product for the following characteristics:

–

Good working order

–

Functionality

–

Correct assembly of the components

–

Completeness

5.3 Assembling the high pressure syringe (771400) 1.

Press the button on the handle (27200) to move the rod.

2.

Push the rod in the proximal direction as far as it will go.

3.

Remove the piston of the syringe (27200P) for filling.

4.

The adaptor (27200B) can be used to help fill the syringe (27200P).

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Preparation

5.

Push the full syringe (27200P) into the syringe holder (27201Q).

6.

Screw the syringe holder (27201Q) onto the handle (27200).

7.

Connect the injection cannula (27200S) to the syringe (27200P).

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

5.4 Assembling the PERETTI high pressure syringe (771410) 1.

Connect the pusher (771413) to the handle (27200).

2.

Press the button on the handle (27200) to move the rod.

3.

Push the rod in the proximal direction as far as it will go.

4.

Remove the screw cap attached to the distal end of the syringe holder (771412).

5.

Move the ring in the distal direction.

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

6.

Screw the syringe holder (771412) onto the handle (27200).

7.

Move the syringe holder (771412) into the desired position and fix in place using the threaded ring.

8.

Place the syringe (771415) in the syringe holder (771412).

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

9.

Push the ring up to the grip plate of the syringe.

10. Screw the screw cap into the syringe holder (771412).

11. Connect the injection cannula (771420) to the syringe (771415).

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Preparation

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Disassembly

6 Disassembly 6.1 Disassembling the high pressure syringe (771400) 1.

Remove the injection cannula (27200S) from the syringe (27200P).

2.

Unscrew the syringe holder (27201Q) from the handle (27200).

3.

Pull the syringe (27200P) out of the syringe holder (27201Q).

4.

Press the button on the handle (27200) and push the rod in the distal direction.

Instructions for use • High pressure syringe • FKN486_EN_V1.0_02-2021_IFU_CE-MDR

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Disassembly

6.2 Disassembling the PERETTI high pressure syringe (771410) 1.

Remove the injection cannula (771420) from the syringe (771415).

2.

Unscrew the screw cap from the syringe holder (771412).

3.

Push the ring away from the syringe grip plate.

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Disassembly

4.

Take the syringe (771415) off the syringe holder (771412).

5.

Loosen the threaded ring.

6.

Unscrew the syringe holder (771412) from the handle (27200).

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