Cleaning Adaptor RSJ779 Reprocessing Instructions

03-2023 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 6 6

2 Normal use ... 2.1 Intended use ... 2.2 Indications ... 2.3 Contraindications ... 2.4 Clinical benefits ... 2.5 Residual risks ... 2.6 Target user populations ... 2.7 Patient population ...

8 8 8 8 8 8 8 8

3 Safety and warning ... 3.1 Serious incidents ... 3.2 Correct handling and product testing ... 3.3 Unsterile product ... 3.4 Creutzfeldt-Jakob disease ...

9 9 9 9 9

4 Product description ... 11 4.1 Product overview ... 11 4.2 Possible combinations ... 15 4.3 Symbols on the packaging ... 23 4.4 Ambient conditions ... 23 5 Preparation ... 24 5.1 Unpacking the product ... 24 5.2 Reprocessing the product ... 24 6 Maintenance, servicing, repairs, and disposal ... 25 6.1 Repairing the product ... 25 6.2 Disposing of the product ... 25 7 Accessories and spare parts ... 26 7.1 Accessories ... 26 7.2 Spare parts ... 26 8 Subsidiaries ... 27

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

3

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 The products listed here may not yet be available in all countries due to differences in approval requirements. This instruction manual is valid for: Cleaning Adaptor Product name

Item number

Cleaning Adaptor for Working Channel

11014RA

Irrigation Adaptor

11301CD

Irrigation Adaptor

11301CD1

Irrigation Tube for Cleaning

11900RA

Irrigation Adaptor

11910CD

Albarran Channel Cleaning Adaptor

13991AKRA

Double Valve Channel Splitter

13991CD

Leakage Tester Adaptor

13991CL

Air/Water Port Adaptor

13991CR

Suction Port Adaptor

13991CS

Double Channel Irrigation Adaptor

13991DKSA

Supplementary Adaptor for ETD

13991ETDA

Irrigation Adaptor

13991JASA

Irrigation Tube, reusable

13991SS

Irrigation Tube for Albarran Channel

13991SSA

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

4

General information

Product name

Item number

Cleaning Adaptor for Water-jet Channel

13991SWJ

Y-irrigation Tube, reusable

13991YS

Cleaning Adaptor

26153DR

Cleaning Adaptor for 26168D

26168DR

Cleaning Adaptor

26168SCD

Cleaning Adaptor for 26168z

26168ZL

Cleaning Adaptor

27001RA

Cleaning Adaptor for LASER Hand Instrument

27840LR

Cleaning Adaptor MIP L

27840RA

Irrigation Adaptor

28163FIA

Cleaning Adaptor

28164BRA

Irrigation Adaptor

28164LAR

Cleaning Adaptor

28166LL

Cleaning Adaptor

28179R1

Cleaning Adaptor

28179R2

Cleaning Adaptor

28184RA

Cleaning Adaptor

28200RA1

Cleaning Adaptor

28200RA2

Cleaning Adaptor

28200RA3

Cleaning Adaptor

39040RA

Cleaning Adaptor

39042RA

Multiport Bridge, 6 ports

39100VA

Cleaning Adaptor

39103RA

Cleaning Adaptor

39104RA

Irrigation Adaptor for Suction and Coagulation Cannula

39105C

Cleaning Adaptor for Forceps Tips

39107A

Cleaning Adaptor for LUER Stopcock, small

39107ALK

Cleaning Adaptor

39107Z

Valve Seat Adaptor for B.I.O.H.

39501XCA

Cleaning Adaptor for Inner Blades

41200RA1

Cleaning Adaptor for Outer Blades

41200RA2

Cleaning Adaptor for DrillCut-X

41250RA

Cleaning Adaptor for 459015, 459035

459015LL

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

5

General information

Product name

Item number

Cleaning Tube for Sheaths 723527A, 723527B, 723527F

723527L

Cleaning Tube for 723540A, 723540B, 723540C, 723540F

723540L

Cleaning Adaptor

8295391

Wire trays Product name

Item number

Multiport Bridge for Wire Tray 39501X, 39501XK

39501XRV

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 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.

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

6

General information

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

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

7

Normal use

2 Normal use 2.1 Intended use Cleaning adaptors Cleaning adaptors are used to connect the existing interfaces of a medical device during the reprocessing process. Cleaning adaptors do not have body contact. Wire trays Wire trays are used to store, protect and transport the medical devices in them, also during reprocessing (cleaning, disinfection and sterilization). Wire trays do not have body contact.

2.2 Indications Not applicable, as there is no direct or indirect contact with the patient and the products in question are not designed for clinical use.

2.3 Contraindications The medical devices are not used in body contact with the patient.

2.4 Clinical benefits The products have no specific clinical indication and are generally used in the context of medical device reprocessing. The products allow the reprocessing and cleaning of medical devices.

2.5 Residual risks None.

2.6 Target user populations The medical device may only be used by doctors and medical assistants or staff of a central sterile services department (CSSD) with a relevant specialist qualification.

2.7 Patient population There are no restrictions in terms of patient groups for this product. The product does not come into direct contact with the patient.

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

8

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 • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

9

Safety and warning

Dispose of the product properly; see Disposing of the product.

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

10

Product description

4 Product description 4.1 Product overview

Irrigation Adaptor (e.g., 11301CD1)

Cleaning Adaptor Type MIELE-ETD (11301GG2)

Irrigation Adaptor (e.g., 11910CD)

Double Valve Channel Splitter (13991CD)

Leakage Tester Adaptor (13991CL)

Air/Water Port Adaptor (13991CR)

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

11

Product description

Suction Port Adaptor (13991CS)

Double Channel Irrigation Adaptor (13991DKSA)

Supplementary Adaptor for ETD (13991ETDA)

Irrigation Adaptor (e.g., 13991JASA)

Irrigation Tube, Reusable (13991SS)

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

12

Product description

Irrigation Tube for Albarran Channel (13991SSA)

Cleaning Adaptor for Water-Jet Channel (13991SWJ)

Y-Irrigation Tube, Reusable (13991YS)

Cleaning Adaptor (e.g., 26153DR)

Cleaning Adaptor (e.g., 26168DR)

Cleaning Adaptor (e.g., 26168ZL)

MIPL Cleaning Adaptor (27840RA)

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

13

Product description

Irrigation Adaptor (e.g., 28163FIA)

Valve Seat Adaptor for B.I.O.H. (39501XCA)

Multiport Bridge for Wire Tray (39501XRV)

Cleaning Adaptor for Inner Blades (e.g., 41200RA1)

Cleaning Adaptor for DrillCut-X (41250RA)

Cleaning Adaptor (e.g., 459015LL)

Cleaning Tube (e.g., 723540L)

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

14

Product description

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 described products in this medium may not be available in all countries due to different regulatory requirements. The product can be combined with the following components: Combination of irrigation adaptor with endoscope Endoscope

Irrigation Adaptor (11301CD1)

11272VH

x

11272VHU

x

11301BNX

x

11302BDX

x

11303BNX

x

11304BCX

x

Combination of irrigation adaptor with video bronchoscope Video Bronchoscope

Irrigation Adaptor (11910CD)

11910T

x

11910D

x

11910P

x

11910S

x

Combination of cleaning adaptor with video cystoscope Video Cystoscope

Cleaning Adaptor (11014RA)

11272VH

x

11272VHK

x

11272VHU

x

11272VHUK

x

Combination of cleaning adaptor with flexible videoendoscope Flexible Videoendoscope

Cleaning Adaptor 13991CD

13991CL

13991CR

13991CS

13991DKSA

13821NKS

x

x

x

x

–

13821PKS

x

x

x

x

–

13923NKS

x

x

x

x

–

13823PKS

x

x

x

x

–

13826NKS

x

x

x

x

x

13826PKS

x

x

x

x

x

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

15

Product description

Flexible Videoendoscope

Cleaning Adaptor 13991CD

13991CL

13991CR

13991CS

13991DKSA

13885NKS

x

x

x

x

–

13885PKS

x

x

x

x

–

13912NKS

x

x

x

x

–

13912PKS

x

x

x

x

–

13920NKS

x

x

x

x

–

13920PKS

x

x

x

x

–

13924NKS

x

x

x

x

–

13924PKS

x

x

x

x

–

13925NKS

x

x

x

x

–

13925PKS

x

x

x

x

–

13926NKS

x

x

x

x

–

13926PKS

x

x

x

x

–

13927NKS

x

x

x

x

–

13927PKS

x

x

x

x

–

Flexible Videoendoscope

Cleaning Adaptor 13991ETDA

13991JASA

13991SS

13991SSA

13991SWJ

13821NKS

x

–

x

–

–

13821PKS

x

–

x

–

–

13923NKS

x

–

x

–

–

13823PKS

x

x

x

–

–

13826NKS

x

x

x

–

–

13826PKS

x

x

x

–

–

13885NKS

x

–

x

x

–

13885PKS

x

–

x

x

–

13912NKS

x

–

x

–

–

13912PKS

x

–

x

–

–

13920NKS

x

–

x

–

x

13920PKS

x

–

x

–

x

13924NKS

x

–

x

–

–

13924PKS

x

–

x

–

–

13925NKS

x

–

x

–

x

13925PKS

x

–

x

–

x

13926NKS

x

–

x

–

x

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

16

Product description

Flexible Videoendoscope

Cleaning Adaptor 13991ETDA

13991JASA

13991SS

13991SSA

13991SWJ

13926PKS

x

–

x

–

x

13927NKS

x

–

x

–

x

13927PKS

x

–

x

–

x

Combination of cleaning adaptor with TROPHYSCOPE sheath TROPHYSCOPE Sheath

Cleaning Adaptor (26153DR)

26152DA

x

26152DB

x

26153DB

x

26153DC

x

Combination of cleaning adaptor with uterine manipulator Uterine Manipulator

Cleaning Adaptor 26168DR

26168SCD

26168ZL

26168DA

x

–

–

26168SCA

–

x

–

26168ZF

–

–

x

26168ZG

–

–

x

26168ZH

–

–

x

26168ZM

–

–

x

26168ZN

–

–

x

26168ZO

–

–

x

26168ZP

–

–

x

26168ZR

–

–

x

Combination of cleaning adaptor with instrument ports and seal Instrument Port

Seal (27500N)

Cleaning Adaptor 27001RA

27840RA

27001G

x

x

–

27001GF

x

x

–

27001GG

x

x

–

27001GH

x

x

–

27001GP

x

x

–

27840GP

–

–

x

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

17

Product description

Combination of cleaning adaptor with handpiece Handpiece

Cleaning Adaptor (41250RA)

26702050

x

27702050

x

Combination of cleaning adaptor with LASER hand instrument LASER Hand Instrument 27840LI

Cleaning Adaptor (27840LR) x

Combination of cleaning adaptor with ARTHROFORCE TAKE-APART instruments ARTHROFORCE TAKE-APART Instruments

Cleaning Adaptor (28166LL)

28166A

x

28166B

x

28166BL

x

28166BR

x

28166MB

x

28166ML

x

28166MO

x

28166MR

x

28166RL

x

28166RR

x

28166SA

x

28166SL

x

28166SR

x

28167A

x

28167B

x

28167BL

x

28167BR

x

28167MB

x

28167MO

x

28168B

x

28168BL

x

28168BR

x

28168P

x

28168PL

x

28168PR

x

28169A

x

28169G

x

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

18

Product description

ARTHROFORCE TAKE-APART Instruments

Cleaning Adaptor (28166LL)

28169GS

x

28169L

x

28169LS

x

28183A

x

28183B

x

28183G

x

28183GS

x

28183L

x

28183LS

x

28183MB

x

28183ML

x

28183MR

x

28183P

x

28183S

x

28183SL

x

28183SR

x

Combination of irrigation adaptor with operating telescope Operating Telescope

Irrigation Adaptor (28163FIA)

28163BTA

x

28163BFA

x

28163FFA

x

Combination of cleaning adaptor with handle Handle

Cleaning Adaptor (28179R2)

28179HG

x

Combination of cleaning adaptor with suture attachments Suture Attachment

Cleaning Adaptor 28184RA

28179R1

28184ML

x

–

28184MR

x

–

28184NA

x

–

28184NG

x

–

28184NGL

x

–

28184NL

x

–

28184NR

x

–

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

19

Product description

Suture Attachment

Cleaning Adaptor 28184RA

28179R1

28179PA

–

x

28179PB

–

x

28179PC

–

x

28179PD

–

x

28179PE

–

x

28179PF

–

x

28179PG

–

x

28179PH

–

x

28728NA

–

x

28728NB

–

x

28728NC

–

x

28728ND

–

x

28728NE

–

x

28728NF

–

x

28728NG

–

x

Combination of cleaning adaptor with MULTIDRIVE-X ARTHRO components MULTIDRIVE-X ARTHRO

Cleaning Adaptor 28200RA1

28200RA2

28200RA3

28200MX

x

–

–

28200QB

–

x

–

28200QS

–

x

–

28200JB

–

–

x

Combination of cleaning adaptor with working element Working Element

Cleaning Adaptor 39040RA

39042RA

27042LV

–

x

27040EB

x

–

27040DB

x

–

27040EO

x

–

27040DO

x

–

27054EB

x

–

27040E

x

–

27040D

x

–

Instructions for use • Cleaning Adaptor • RSJ779_EN_V3.0_03-2023_IFU_CE-MDR

20