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Instructions for use Cleaning Adaptor
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
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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 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
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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
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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.
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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
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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.
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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.
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Safety and warning
Dispose of the product properly; see Disposing of the product.
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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)
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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)
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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)
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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)
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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
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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
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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
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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
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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
–
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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
–
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