en Reprocessing instructions

HOPKINS Telescope 30°, 4 mm, 30 cm

26105BA
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

1 Target group ............................................................................................................................. 4

2 General information .................................................................................................................. 5
2.1 Read the reprocessing instructions ................................................................................. 5
2.2 Read the reprocessing instructions for use ..................................................................... 5
2.3 Read the instructions for use for the reprocessing unit .................................................. 5
2.4 National laws and regulations ......................................................................................... 5
2.5 Additional information on the product ............................................................................. 5
2.6 Description of warning messages ................................................................................... 5
3 Safety ....................................................................................................................................... 7
3.1 Unsterile product ............................................................................................................. 7
3.2 Contaminated products ................................................................................................... 7
3.3 Working with process chemicals ..................................................................................... 7
3.4 Creutzfeldt-Jakob disease ............................................................................................... 7
4 Overview of processes ............................................................................................................. 8
4.1 Reprocessing cycle for standard products ..................................................................... 8
5 Requisite materials ................................................................................................................... 9
6 Bedside Pre-Cleaning .............................................................................................................. 10
6.1 Transport to the reprocessing site .................................................................................. 10
7 Cleaning and disinfection ......................................................................................................... 11
7.1 Reprocessing with automated decontamination ............................................................. 11
7.1.1 Pre-cleaning .......................................................................................................... 11
7.1.2 Automated cleaning / thermal disinfection ........................................................... 11
8 Visual inspection ...................................................................................................................... 12
9 Assembly .................................................................................................................................. 13
10 Life span ................................................................................................................................... 14
10.1 Functional check ............................................................................................................. 14
11 Packaging ................................................................................................................................. 15
12 Sterilization ............................................................................................................................... 16
12.1 Steam sterilization ........................................................................................................... 16
12.2 Hydrogen peroxide (H2O2) – ASP STERRAD® ................................................................ 16

NOT APPLICABLE FOR THE US

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 3
 Target group

1 Target group
These reprocessing instructions are intended for personnel with technical knowledge and
expertise in the reprocessing of medical devices.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 4

 General information

2 General information
2.1 Read the reprocessing instructions
If the reprocessing instructions are not followed, patients, users, or third parties may be injured
or the product may be damaged.
Read the reprocessing instructions for the product and its components carefully and follow
all the safety notes and warnings.

2.2 Read the reprocessing instructions for use

If the reprocessing instructions for use are not followed, patients, users, or third parties may be
injured or the product may be damaged.
Read and follow the “Cleaning, disinfection, care, and sterilization of KARL STORZ
instruments” instructions for use (item no. 96216003).
The cleaning, disinfection, and sterilization procedures are explained in detail in the
reprocessing instructions for use.
The reprocessing instructions for use can be downloaded from www.karlstorz.com.

2.3 Read the instructions for use for the reprocessing unit
If the instructions for use are not followed, patients, users, or third parties may be injured or the
product may be damaged.
Read the instructions for use for the reprocessing unit carefully and follow all the safety
notes and warnings.
Carry out reprocessing in accordance with the instructions for use for the reprocessing
unit.

2.4 National laws and regulations

National laws and regulations must be observed in addition to the accompanying
documentation.

2.5 Additional information on the product

Additional general information on the product can be requested and downloaded from
www.karlstorz.com.

2.6 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.

CAUTION
CAUTION
Designates a possible imminent risk. If this is not avoided, it could lead to minor injuries.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 5

 General information

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

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 6

 Safety

3 Safety
3.1 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.

3.2 Contaminated products

During work on contaminated devices, the guidelines for personal safety must be observed.

3.3 Working with process chemicals

Incorrect exposure time, concentration, life span, and range of action of chemicals can lead to
a risk of infection for the patient, user, and third parties, as well as damage to the product.
Note the information provided by the manufacturer of the chemicals and the
microbiological range of action of the chemicals used.

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 Creutzfeld-Jakob disease has been diagnosed or is suspected:
Dispose of the product properly and do not continue to use it.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 7

 Overview of processes

4 Overview of processes
The following reprocessing procedures have been approved for the product:
– Reprocessing with automated decontamination
A detailed description of the processes is provided in the respective chapters in these
instructions.

4.1 Reprocessing cycle for standard products

Use
Storage Purchasing
Transport

Transport
Precleaning

Sterilization,
release Deconta-
mination

Maintenance,
Packaging functional
test

Repair
or
disposal

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 8

 Requisite materials

5 Requisite materials
The reprocessing accessories used must be clean and functional.
The following reprocessing accessories are required:

Application Material
Initial treatment at the site of use Moist compresses, possibly disposable cloth
Preparation before cleaning
Brushing the surfaces Brush, item no. 27652
Cleaning and disinfection
Manual drying and/or after-drying Medical compressed air from compressed air
gun, item no. 27660
Alternatively: syringe 60 cc
Maintenance
Packaging Standardized and approved packaging

Suitable reprocessing accessories are listed in the following catalog:

– HYGIENE – Care, Sterilization, Storage Techniques (item no. 96211004)

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 9

 Bedside Pre-Cleaning

6 Bedside Pre-Cleaning
Reprocessing of the product should start within 2 hours of use to ensure the
effectiveness of the reprocessing processes listed in the reprocessing instructions.

1. Wipe the surfaces of the product with a compress or disposable cloth to remove gross
soiling, corrosive solutions, and drugs.
2. Rinse surfaces with cold water.

6.1 Transport to the reprocessing site

1. Right after using it, place the dry product in a suitable transport container.
2. Transport the securely positioned product to the site of reprocessing.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 10

 Cleaning and disinfection

7 Cleaning and disinfection

The following procedures are validated and approved for cleaning and disinfection of the
product:
– Automated cleaning: thermal disinfection

7.1 Reprocessing with automated decontamination

7.1.1 Pre-cleaning
The product is not suitable for ultrasonic treatment.

7.1.1.1 Brushing surfaces

Required materials:
– Brush, item no. 27652
1. Clean the surfaces of the product under cold running water with a brush.
2. Brush the surfaces until no residue can be seen any more.
3. Irrigate the surfaces with cold running water.

7.1.2 Automated cleaning / thermal disinfection

A washer-disinfector for thermostable devices must be used for the device. The washer-
disinfector must meet the requirements of standard ISO 15883.
The A0 value of the disinfection process must be observed.
Required materials:
– Suitable slide-in trolley and, if necessary, suitable instrument holder.
The selection must be made in consultation with the manufacturer of the WD.
1. Place the device in the slide-in trolley and, if necessary, in the instrument holder.
2. The parameters of the automated cleaning and disinfection process validated by
KARL STORZ are specified in the document “Cleaning, Disinfection, Care, and
Sterilization of KARL STORZ Instruments” (item no. 96216003).

Steps
1. Pre-irrigation
2. Cleaning
3. Intermediate irrigation
4. Thermal disinfection
5. Drying

WARNING
Risk of infection due to residual liquid!
If devices are not adequately dried following disinfection, the effectiveness of the validated
reprocessing processes is not guaranteed.
Use compressed air or a syringe filled with air to dry devices fully following
disinfection.
Check if the product is dry and dry it by hand if necessary, see chapter Visual inspection
[p. 12].

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 11

 Visual inspection

8 Visual inspection
1. Check products for the following points:
‒ Visible contamination
‒ Damage and corrosion
‒ Completeness
‒ Dryness
2. Subject any products displaying visible soiling to another complete cleaning and
disinfection process.
3. Discard damaged and corroded medical devices.
4. Discard incomplete medical devices or replace missing parts.
5. Dry the product by hand if necessary.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 12

 Assembly

9 Assembly
WARNING
Risk of infection due to inadequate sterilization!
Assembled products cannot be adequately sterilized using a low-temperature process.
Disassemble the product before sterilizing it using a low-temperature process.

Assemble the product in reverse order, see chap. Disassembly.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 13

 Life span

10 Life span
The end of the product life is largely determined by wear, reprocessing processes, the
chemicals used and any damage resulting from use.

10.1 Functional check

If the device does not fulfill one of the points listed below or if damage can be identified, see
chapter ‘Maintenance, repair, servicing and disposal’ in the instructions for use.
The following tests must be carried out to detect functional limitations:
1. Check the surface of the product for mechanical integrity and changes.
2. Check the labeling for legibility.
3. Check the product for mechanical integrity.
4. Check the mobility of all mobile components, if necessary once the components have
been assembled in the case of products that can be dismantled.
5. Check whether the end positions of the application part are reached.
6. Check if the image is transmitted.
7. Check the structure of the gripping surfaces for mechanical integrity.
8. Check whether light is transmitted and whether the surface of the light input and light
output is dirty or damaged.

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 14

 Packaging

11 Packaging
The packaging material must always be matched to the sterilization process being used.
Required materials:
– Standardized packaging materials and packaging systems that are approved for the
product (EN 868 Parts 2–10, EN ISO 11607 Parts 1 + 2, DIN 58953)

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 15

 Sterilization

12 Sterilization
The sterilization processes described below have been validated and approved for this medical
device by KARL STORZ.
Select the suitable procedure, taking into consideration the country-specific regulations
and in consultation with the device manufacturer.

12.1 Steam sterilization

When carrying out sterilization using saturated steam, the steam sterilizer with fractionated
pre-vacuum and the sterilization process must meet the requirements of the following
standards:
– EN 285 Large steam sterilizers (from 1 StU upward) – requirements and test procedures
– DIN EN 13060 small steam sterilizers
– DIN EN ISO 17665 for routine monitoring
Within the scope of validation, the following packaging material was used:
– KLS Martin Group marSafe® container
The product must be sterilized using a fractionated prevacuum procedure
(DIN EN ISO 17665) with the following parameters:
134°C–137°C with a minimum contact time of 3 minutes and maximum of 18 minutes

12.2 Hydrogen peroxide (H2O2) – ASP STERRAD®

WARNING
Risk of infection due to inadequate sterilization!
Greased or oiled products cannot be adequately sterilized using a low-temperature process.
Only products that are not greased or oiled may be sterilized using a low-temperature
process.

Within the scope of validation, the following packaging material was used:
– H600 HALYARDTM ONE-STEPTM sterilization wrap
– KIMBERLY-CLARKTM KC400 KIMGUARDTM STERILIZATION WRAP
– KIMBERLY-CLARKTM KC600 KIMGUARDTM STERILIZATION WRAP
The following STERRAD® procedures have been validated and approved by KARL STORZ for
the device:
– STERRAD® 100S Short Cycle without Booster
– STERRAD® NX® Advanced Cycle
– STERRAD® NX® Standard Cycle
– STERRAD® 100NX® Standard Cycle

Reprocessing instructions • HOPKINS Telescope 30°, 4 mm, 30 cm • 26105BA_EN_V3.1_10-2021_RI_CE 16

 KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
26105BA • EN • V3.1 • 10-2021 • RI • CE

78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany

Phone: +49 7461 708-0

Fax: +49 7461 708-105
E-mail: [email protected]
www.karlstorz.com