KARL STORZ ENDOSKOPE
Automatic Valve, 11 mm
Trocars with multifunctional and flap valve Instructions For Use
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Instructions for use Trocars with multifunctional and flap valve
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.
Instructions for use • Trocars with multifunctional and flap valve • XWF530_EN_V2.0_10-2021_IFU_CE-MDR
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