Trocars with multifunctional and flap valve Instructions For Use

10-2021 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 ... 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 ...

4 4 4 4 6

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

8 8 8 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 Single-use product ... 9 3.5 Creutzfeldt-Jakob disease ... 10 3.6 Disposal of pointed and sharp products ... 10 4 Product description ... 11 4.1 Product overview ... 11 4.2 Possible combinations ... 11 4.3 Symbols on the packaging ... 15 4.4 Ambient conditions ... 15 5 Preparation ... 16 5.1 Unpacking the product ... 16 5.2 Assembling the product ... 16 6 Disassembly ... 19 6.1 Disassembling the product ... 19 7 Maintenance, servicing, repairs, and disposal ... 21 7.1 Repairing the product ... 21 7.2 Disposing of the product ... 21 8 Accessories and spare parts ... 22 8.1 Accessories ... 22 8.2 Spare parts list ... 22 9 Subsidiaries ... 23

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_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. 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 name

Item number

Automatic Valve, size 7 mm

30101A1

Trocar Mandrel

30101C

Trocar Sleeve, without valve, 7 mm

30101H2

Multifunctional Valve, size 7 mm

30101M1

Trocar Mandrel

30101P

Trocar Mandrel

30102A

Automatic Valve, size 9 mm

30102A1

Trocar Sleeve, without valve, size 9 mm

30102H2

Trocar Mandrel

30103A

Automatic Valve, 11 mm

30103A1

Trocar Mandrel, size 11 mm

30103C

Trocar Mandrel

30103EC

Trocar Mandrel

30103EP

Trocar Sleeve, without valve, 11 mm

30103H1

Trocar Sleeve, without valve, 11 mm

30103H2

Trocar Sleeve, without valve, 11 mm

30103H5

Trocar Sleeve, without valve, 11 mm

30103H6

Trocar Sleeve, without valve, size 11 mm

30103H8

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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General information

Product name

Item number

Multifunctional Valve, size 11 mm

30103M1

Multifunctional Valve, size 11 mm

30103M2

Trocar Mandrel

30103MO

Trocar Mandrel

30103O

Trocar Mandrel, with pyramidal tip

30103P

Trocar Mandrel

30103SB

Trocar Mandrel

30103X

Trocar Mandrel

30103Y

Trocar Mandrel

30103Z

Flap valve

30105K1

Flap valve

30106K1

Trocar Mandrel

30107A

Automatic Valve, size 13 mm

30107A1

Trocar Mandrel

30107C

Trocar Sleeve, without valve, 13 mm

30107H2

Trocar Sleeve, without valve, 13 mm

30107H5

Multifunctional Valve, size 13 mm

30107M1

Trocar Mandrel, with pyramidal tip

30107P

Trocar Mandrel with blunt tip

30108A

Trocar Mandrel, with conical tip

30108C

Trocar Sleeve, without valve, 13.5 mm

30108H2

Multifunctional Valve, size 13.5 mm

30108M1

Trocar Mandrel, with pyramidal tip

30108P

Automatic Valve, size 3.8 mm

30114A1

Trocar Sleeve, without valve, size 3.5 mm

30114H1

Trocar Mandrel, with pyramidal tip

30114Y

Automatic Valve, size 3.9 mm

30117A1

Trocar Sleeve, without valve, 3.9 mm

30117H2

Trocar Sleeve, without valve, 3.9 mm

30117T2

Trocar Mandrel

30160A

Automatic Valve, 6 mm

30160A1

Trocar Mandrel

30160B

Trocar Mandrel, with conical tip

30160C

Trocar Mandrel

30160CL

Trocar Sleeve, without valve

30160H1

Trocar Sleeve, without valve, 6 mm

30160H2

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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General information

Product name

Item number

Trocar Sleeve, without valve, size 6 mm

30160H6

Multifunctional Valve, size 6 mm

30160M1

MOTSON Trocar Mandrel only

30160MO

Trocar Mandrel, with pyramidal tip

30160P

Trocar Mandrel

30160X

Trocar Mandrel

30160Y

Trocar Mandrel

30160YK

Trocar Mandrel

30160Z

Trocar Mandrel

30160ZK

Trocar Mandrel

31103A

Trocar Mandrel

31103C

Trocar Sleeve, without valve, size 11 mm

31103H1

Trocar Mandrel

31103P

Trocar Sleeve, size 13.5 mm, length 15 cm

31108H1

Trocar Mandrel, size 13.5 mm, length 15 cm

31108P

Trocar Mandrel

31160A

Trocar Mandrel

31160C

Trocar Sleeve, without valve, size 6 mm

31160H1

Trocar Mandrel

31160P

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: 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

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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General information

Lists 1.

Numbered list

–

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

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Normal use

2 Normal use 2.1 Intended use Trocar sleeve Trocar sleeves are used to create access for the insertion of telescopes and instruments in minimally invasive and endoscopic surgery. Trocar sleeves are surgically invasive and designed for short-term use. Trocar mandrel Trocar mandrels are used to position a trocar and to create access in minimally invasive and endoscopic surgery. Trocar mandrels are surgically invasive and designed for transient use. Trocar valve Trocar valves are used to seal the trocar against gas loss in minimally invasive and endoscopic surgery. Trocar valves are surgically invasive and are designed for short-term use.

2.2 Indications Trocars and port systems are tool-like instruments that are used in laparoscopic and endoscopic diagnosis and surgery if their use is indicated in the medical opinion of the attending physician.

2.3 Contraindications Trocars and port systems must not be used for procedures in direct contact with the central nervous system (CNS) and central cardiovascular system. Beyond that, there are no contraindications for use of the medical devices that are associated with the medical devices.

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 • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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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 Single-use product The product must only be used once. Using the product more than once exposes patients, users, and third parties to a risk of infection and injury. Dispose of the product properly after using it once. Do not continue to use it.

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Safety and warning

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 Creutzfeldt-Jakob disease has been diagnosed or is suspected: Do not continue to use the product. Dispose of the product properly.

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 • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Product description

4 Product description 4.1 Product overview 2

1

3

7

11 12

10

1

Spring cap

7

Flap valve

2

Cock plug

8

Thumb plate

3

Bayonet mount

9

Pusher

4

Valve head

10

Pusher

5

Seal

11

Sealing cap

6

Trocar mandrel

12

Cannula

6

4 5

8 9

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. The following components can be combined: Trocar size Trocar sleeve

Trocar Mandrel

Multifunc- Automatic tional valve valve

Reducer

Cone

3–3.5 mm

30114H1

30114Y

-

30114A1

-

-

3.9 mm

30117H2

30117A

-

30117A1

-

30117C1

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Product description

Trocar size Trocar sleeve

Trocar Mandrel

Multifunc- Automatic tional valve valve

Reducer

Cone

30160M1

30141AA

30160C1

30140KA

30160C3

30117P 6 mm

30160H1

30160Y

30160A1

30160Z 30160X 30160DD 30160X 30160H2

30160C

30160M1

30160P 30160A 30160B 30160LD 301260MO 30160H6

30160CL

30160M1

31160H1

31160C

30160M1

31160P 31160A 31160D 7 mm

30101H2

30101C

30101M1

30101A1

-

30101C

30101P 9 mm

30102H2

30102A

-

30102A1

-

-

11 mm

30103H1

30103Y

30103M1

30103A1

30141DB

30103C1

30103Z

30140DA

30103C2

30103X

30140DB

30103C3

30103DD

30140DD

30103CM1

30103H2

30103C

30103M1

30103P 30103A 30103MO 30103SB 30103LD 30103H6

30103O

30103M1

30103H5

30103C

30103M1

-

30103P 30103A 30103MO 30103SB 30103LD

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Product description

Trocar size Trocar sleeve 30103H8

31103H1

Trocar Mandrel

Multifunc- Automatic tional valve valve

30103EC

30103M2

Reducer

-

Cone 30103C1

30103EP

30103C2

30103ED

30103C3

31103C

30103M1

30103A1

30107A1

30103CM1

31103P 31103A 31103D 13 mm

30107H2

30107A

30107M1

30107H5

30107P

30107M1

30107C

30141HB

30107C1

30141HE

30107C3

30142HB 30140HB 30140HE

13.5 mm

30108H2

31108H1

30108C

30108M1

-

30141HB

30108P

30141HE

30108A

30142HB

30108D

30140HB

31108P

30108M1

30108C1

30140HE

-

31108D Trocar size

Trocar sleeve

Trocar mandrel

Seal

Reducer

15 mm

30105H2

30105A

30105K1

30140FB

30105P 22 mm

30106H2

30140FE

30106A

30106K1

30140GB

30106P

30140GE

Trocar sleeve

Thread Sleeve

Spacer

30160S

30103S

30107S

30108S

30160D

30103D

30114H1

-

-

-

-

-

-

30117H2

-

-

-

-

-

-

30160H1

x

-

-

-

x

-

30160H2

x

-

-

-

x

-

30160H6

x

-

-

-

x

-

31160H1

x

-

-

-

x

-

30101H2

-

-

-

-

-

-

30102H2

-

x

-

-

-

-

30103H1

-

x

-

-

-

x

30103H2

-

x

-

-

-

x

30103H6

-

-

-

-

-

x

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Product description

Trocar sleeve

Thread Sleeve

Spacer

30160S

30103S

30107S

30108S

30160D

30103D

30103H5

-

x

-

-

-

-

30103H8

-

-

-

-

-

x

31103H1

-

-

-

-

-

-

30107H2

-

-

x

-

-

-

30107H5

-

-

x

-

-

-

30108H2

-

-

-

x

-

-

31108H1

-

-

-

x

-

-

Combination via LUER-Lock connector Items 30103H5 and 30103H8 can be combined via the HiCap connector for insufflation tubes. All other items can be combined via the LUER-Slip connector for insufflation tubes. Combination with other instruments Trocar size

Reducer size

Instrument size

3.5 mm

-

3–3.3 mm

3.9 mm

-

3.9 mm

6 mm

-

5–5.5 mm

3.5 mm

3–3.5 mm

7 mm

-

6 mm

9 mm

-

8 mm

11 mm

-

10–10.5 mm

5 mm

5–5.5 mm

-

13–13.5 mm

5 mm

5–5.5 mm

10 mm

10–10.5 mm

-

14 mm

5 mm

5 mm

10 mm

10 mm

-

20 mm

5 mm

5 mm

10 mm

10 mm

13.5 mm

15 mm

22 mm

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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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

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.

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_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 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.

5.2 Assembling the product 1.

Attach the small sealing cap.

2.

Check whether the flap valve is correctly seated when closed.

3.

With the thumb plate pressed down, insert the tappet from the rear.

4.

Relieve the pressure on the thumb plate until the slide can be pushed over the ball-end holder.

5.

With 6 mm and 7 mm trocars, unscrew the rear head section with seal. It is easier to unscrew the rear head section if the sealing cap is in place.

6.

Carry out function test.

7.

Insert the valve head into the trocar sleeve.

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Preparation

8.

Close the bayonet mount.

9.

Attach the sealing cap.

10. Press on the thumb plate and insert the trocar mandrel. 11. Attach the trocar protective cap. 12. Oil the joint of the flap valves and the lateral attachment of the thumb plate.

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Preparation

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Disassembly

6 Disassembly 6.1 Disassembling the product KARL STORZ recommends replacing the seals after every use. 1.

Remove the trocar mandrel.

2.

Release the bayonet mount on the trocar sleeve.

3.

Remove the valve head. ð The valve head of the multifunction valve can be further dismantled in order to replace the small sealing cap and tappet.

4.

With 6 mm and 7 mm trocars, unscrew the rear head section with seal. It is easier to unscrew the rear head section if the sealing cap is in place.

5.

Pull the slide on the thumb plate of the valve head outwards.

Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR

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Disassembly

6.

Hold the thumb plate down and remove tappet by taking it out towards the rear.

7.

Remove the sealing cap and check for damage.

8.

Replace the sealing cap if necessary.

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