en Reprocessing instructions

C-MAC Video Laryngoscope MAC #3

8404AX
01-2022
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 Target group ............................................................................................................................. 4
2 Safety ....................................................................................................................................... 5
2.1 Description of warnings ................................................................................................... 5
2.2 General warnings ............................................................................................................. 5
3 Water quality ............................................................................................................................ 7
3.1 Types of water ................................................................................................................. 7
3.2 Application ....................................................................................................................... 7
3.3 References ....................................................................................................................... 7
4 Overview of processes ............................................................................................................. 9
4.1 Reprocessing cycle for standard products ..................................................................... 9
5 Required materials ................................................................................................................... 11
6 Bedside Pre-Cleaning .............................................................................................................. 12
6.1 Transport to the reprocessing site .................................................................................. 12
7 Pre-Cleaning ............................................................................................................................. 13
7.1 Brushing the surfaces ...................................................................................................... 13
8 Manual cleaning ....................................................................................................................... 14
9 High-Level Disinfection ............................................................................................................ 15
9.1 Manual high-level disinfection ......................................................................................... 15
9.2 Automated high-level disinfection ................................................................................... 15
10 Visual inspection ...................................................................................................................... 16
11 Life span ................................................................................................................................... 17
11.1 Functional check ............................................................................................................. 17
12 Packaging ................................................................................................................................. 18
13 Sterilization ............................................................................................................................... 19
13.1 Hydrogen peroxide (H2O2) – ASP STERRAD .................................................................. 19
13.2 Hydrogen peroxide (H2O2) – STERIS V‑PRO ................................................................. 19
13.3 Peracetic acid – STERIS® system .................................................................................... 19

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 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 • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 4

 Safety

2 Safety
2.1 Description of warnings
WARNING
WARNING
A warning indicates a potential hazard. Failure to observe a warning may result in injury to the
patient, user, or third parties.

CAUTION
CAUTION
A caution indicates that particular measures must be taken to avoid any damage to the
medical devices.

NOTICE
NOTICE
A NOTICE is used to draw attention to general information which does not apply specifically to
a particular product or product group.

2.2 General warnings

WARNING
Incorrect reprocessing! Risk of infection!
Incorrectly reprocessed devices expose patients, users and third parties to a risk of infection
as well as the danger of a device malfunction.
Comply with the documentation enclosed with the device.

WARNING
Non-sterile devices! Risk of infection!
Devices are not sterile when delivered. The use of unsterile devices poses a risk of infection for
patients, users and third parties.
Inspect devices for visible contamination. Visible contamination is an indication that
reprocessing has not been carried out, or has been carried out incorrectly.
Reprocess devices before initial use and before and after every subsequent application
using validated procedures.

WARNING
Creutzfeldt-Jakob disease! Risk of infection!
If Creutzfeldt-Jakob disease (CJD) is suspected or indicated, dispose of the device in
accordance with national regulations and do not use it again.

WARNING
Contaminated devices! Risk of infection!
For work on contaminated devices, the guidelines of the employer's liability insurance
association and equivalent organizations for personnel protection must be observed.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 5

 Safety

CAUTION
Incorrect exposure times and incorrect concentration of chemicals! Risk of infection and
damage to the device!
When preparing and using solutions, follow the chemical manufacturer's instructions
concerning concentration, exposure time and service life.

CAUTION
National laws and regulations must be observed.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 6

 Water quality

3 Water quality
Water quality is important for the reprocessing process to ensure patient safety and to protect
the device from damage.
Therefore, it must be taken into account at every step of the reprocessing process.

3.1 Types of water

Utility water / tap water
Water as it comes out of the tap.
This type of water may require further reprocessing to meet the requirements for minimizing
microbiological contamination and protection against corrosion or residues.

Higher-quality water
Water that is treated or reprocessed to ensure that microorganisms and inorganic and organic
substances are removed (e.g. critical water).
Higher-quality water may include deionized, distilled, sterile, or other types of pure water.

3.2 Application
Precleaning / removal of coarse impurities
Utility water / tap water is suitable for this reprocessing step if it does not contain high
numbers of microbes or if it does not promote the formation of corrosion or residue on the
devices. Higher-quality water is also suitable.

Cleaning
Utility water / tap water is suitable for this reprocessing step if the specifications correspond to
the recommendations made by the cleaning agent manufacturer. Higher-quality water is also
suitable.

Final rinse after cleaning:

For devices, water of at least drinking water quality is required for the final rinsing step of the
cleaning process.

Final rinse after high-level disinfection

Higher-quality water is recommended for rinsing after disinfection. Utility water / tap water may
be suitable for the final rinse after disinfection if it meets the necessary microbiological
requirements to prevent re-contamination of the device.
If the microbiological requirements for water quality cannot be guaranteed and thus pose a risk
to patient safety, the highest water quality is recommended (e.g. sterile or sterile filtered water).

Steam generation in autoclaves for sterilization

Higher-quality water is required for steam generation to avoid residues and ensure saturated
steam quality.

3.3 References
– AAMI TIR 34: Water for the reprocessing of medical devices
– ISO 17665: Sterilization of health care products – Moist heat

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 7

 Water quality

– WHO: Decontamination and Reprocessing of Medical Devices for Health-care Facilities

2016

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 8

 Overview of processes

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

4.1 Reprocessing cycle for standard products

Reprocessing cycle with high-level disinfection

Use
Storage Purchasing
Transport

Transport
Precleaning

Packaging Cleaning
High-
Maintenance,
level
functional disinfection
test

Repair
or
disposal

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 9

 Overview of processes

Reprocessing cycle with sterilization

Use
Storage Purchasing
Transport

Transport
Precleaning

Sterilization,
release Cleaning

Mainte-
Sterilization nance,
packaging functional
test
Repair
or
disposal

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 10

 Required materials

5 Required materials
The following reprocessing materials are needed:
NOTICE
The accessories used here must be clean and fit for purpose.

Application Material
Initial treatment at the site of use Moist compresses, possibly disposable cloth
Pre-Cleaning
Brushing the surfaces Brush, item no. 27652
Cleaning and disinfection
Manual cleaning Cleaning solution ENZOL Enzymatic Deter-
gent ASP (Advanced Sterilization Products)
Manual disinfection Disinfection solution CIDEX Activated Dialde-
hyde Solution (Advanced Sterilization Prod-
ucts), drinking water quality or higher
Manual disinfection Disinfection solution CIDEX OPA Solution
(Advanced Sterilization Products), drinking
water quality or higher
Manual disinfection Disinfection solution Revital-Ox RESERT High
Level Disinfectant (STERIS), drinking water
quality or higher
Manual drying and/or after-drying Compressed air for medical purposes from
compressed-air gun (item no. 27660)
Maintenance
Packaging Standardized and approved packaging

NOTICE
A detailed description of the reprocessing processes can be found in the respective
subchapters of these instructions.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 11

 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 product in a suitable dry transport container.
2. Transport the securely positioned product to the site of reprocessing.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 12

 Pre-Cleaning

7 Pre-Cleaning
The product is not suitable for ultrasonic treatment.

Attaching the protection cap

Place the protection cap on the connector to protect the contacts of the connector during
cleaning and disinfection.

7.1 Brushing the surfaces

Required materials:
– Brush, item no. 27652
1. Clean the surfaces of the product under cold running water with the brush.
2. Brush the surfaces at least 3 times or until all visible residue has been removed.
3. Rinse the surfaces with cold running water (temperature < 68°F).

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 13

 Manual cleaning

8 Manual cleaning
Required materials:
– Cleaner: ENZOL Enzymatic Detergent ASP (Advanced Sterilization Products)
– Brush, item no. 27652
1. Immerse the product completely in the cleaning solution.
2. Allow to take effect in accordance with the specifications of the chemicals manufacturer.
3. For neutralization, flush the product with cold running water (temperature < 68°F).

Performing the visual inspection

4. Check products for the following points:
‒ Visible soiling
‒ Damage and corrosion
‒ Completeness
‒ Dryness
5. Subject any products displaying visible soiling to another complete cleaning process.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 14

 High-Level Disinfection

9 High-Level Disinfection
The following procedures are validated and approved for high-level disinfection of the medical
device:
– Manual High-Level Disinfection
– Automated high-level disinfection

9.1 Manual high-level disinfection

Required materials:
– Disinfection solution CIDEX Activated Dialdehyde Solution (Advanced Sterilization
Products)
– Disinfection solution CIDEX OPA Solution (Advanced Sterilization Products)
– Disinfection solution: Revital-Ox RESERT High Level Disinfectant (STERIS)
– Water of at least drinking water quality according to country-specific regulations
– Water-pressure and compressed-air gun (item no. 27660)
1. Immerse the product completely in the disinfectant solution.
2. Allow to take effect in accordance with the specifications of the chemicals manufacturer.
3. Rinse the product using a water gun and rinsing attachment.
4. Dry all surfaces, joints, openings, channels, and lumens completely using compressed air
or an air-filled syringe.
NOTICE
This product has been validated according to the parameters specified as effective.
For further information, please contact the manufacturer of the original chemical.
WARNING
Insufficient drying! Risk of infection!
In case of insufficient drying, the effectiveness of the validated processes is not
guaranteed.
Allow the devices to dry completely.

9.2 Automated high-level disinfection

Required materials:
– Suitable slide-in trolley and, if necessary, suitable instrument holder.
The selection must be made in consultation with the manufacturer of the AER.
Place the device in the slide-in trolley and, if necessary, in the instrument holder.
The product has been validated and approved for use in the following WD-E:
– Reliance EPS
– Medivators AER, SSD series
Check if the product is dry and dry it by hand if necessary, see chapter Visual inspection
[p. 16].
WARNING
Insufficient drying! Risk of infection!
In case of insufficient drying, the effectiveness of the validated processes is not
guaranteed.
Allow the devices to dry completely.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 15

 Visual inspection

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

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 16

 Life span

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

11.1 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 correct positioning of the assembled components and, if necessary, also
check the cleaning connector.
5. Check if the image is transmitted.
6. Check whether light is transmitted and whether the surface of the light input and light
output is dirty or damaged.
7. Check the fastening element for damage.
8. Check whether the fastening element is suitable for the anticipated load to which it will
be exposed by the intended application.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 17

 Packaging

12 Packaging
The packaging material must always be matched to the sterilization process being used.
Required materials:
– Standardized packaging materials and packaging systems, and packaging materials and
packaging systems that are approved for the device (EN 868 Parts 2–10, EN ISO 11607
Parts 1 + 2, DIN 58953)
Either pack the device in an FDA-certified tray, and the tray or container in an FDA-certified
sterilization wrap, or pack the device in an FDA-certified sterilization pouch.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 18

 Sterilization

13 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.

13.1 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 material was used:

– H400 HALYARD ONE-STEP sterilization wrap
The following STERRAD procedures have been validated and approved by KARL STORZ for
the product:
– STERRAD 100S Long Cycle without Booster
– STERRAD 100S Short Cycle without Booster
– STERRAD NX Standard Cycle
– STERRAD 100NX Standard Cycle

13.2 Hydrogen peroxide (H2O2) – STERIS V‑PRO

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 material was used:

– KIMBERLY-CLARK KC600 KIMGUARD STERILIZATION WRAP
The following STERIS V-PRO procedures have been validated and approved by KARL STORZ
for the product:
– STERIS V-PRO 1
– STERIS V-PRO 1 Plus lumen cycle
– STERIS V-PRO 1 Plus non-lumen cycle
– STERIS V-PRO maX lumen cycle
– STERIS V-PRO maX non-lumen cycle
– STERIS V-PRO 60 lumen cycle
– STERIS V-PRO 60 non-lumen cycle

13.3 Peracetic acid – STERIS® system

1. Place the product in the tray.
2. Start the process.

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 19

 Sterilization

The following STERIS® System procedures have been validated and approved by KARL
STORZ for the product:
– STERIS® SYSTEM 1E® with S40 sterilization concentrate
The parameters of the STERIS® System sterilization process validated by KARL STORZ are
specified in the document entitled “Cleaning, disinfection, care, and sterilization of
KARL STORZ instruments” (item. no. 96216003).

Reprocessing instructions • C-MAC Video Laryngoscope MAC #3 • 8404AX _EN_V7.1_01-2022_RI_FDA 20

 KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
8404AX • EN • V7.1 • 01-2022 • RI • FDA

78532 Tuttlingen
Postfach 230
78503 Tuttlingen
Germany

Phone: +49 7461 708-0

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