KLS Martin group marSafe Gebrauchsanweisung Seite 14

Legend relating to illustrations on fold-out page
No. Description
1 Container cover
2 Holding unit
®
3 microStop disk
4 Cover Seal
5 Filter holder
6 Button
7 Container tank
8 Grip plate
9 Carry Handle
10 Coding label
11 Seal Carrier
12 Color field
13 Attachment field for protocol labels
14 Locking plate
1 Product Liability and Warranty
1.1 General
Thank you for choosing a KLS Martin product. This product has the CE mark, which means that it
is compliant with the essential safety and performance requirements for medical devices pursuant
to applicable European regulations.
We are the manufacturer of this product:
Gebrüder Martin GmbH & Co. KG
A company of the KLS Martin Group
KLS Martin Platz 1 · D-78532 Tuttlingen · Germany
www.klsmartin.com
Hotline
If you have questions about how to use this device or product or questions about clinical
applications, please contact the product management team:
Tel: +49 7461 706-234
Fax: +49 7461 706-312
All packaging, and in some cases also the product itself, is marked with a batch number (LOT)
and an item number (REF). When making a product complaint, please include the LOT and REF.
1.2 Adverse incident reporting requirement
All serious incidents occurring in connection with the product shall be reported immediately to
Gebrüder Martin and to the competent authority.
1.3 Safety warnings used in this document
Could result in the death of or serious injury to the patient, user or a third party if these
instructions are not followed
Read and observe the Instructions for Use completely. In particular, please observe all warnings
and precautions.
This text refers to male, female and non-binary individuals equally, but not all pronouns have been
used, solely for reasons of readability.
The electronic version of these Instructions for Use can be requested at www.klsmartin.com.
14
marSafe
1.4 Abbreviations and Terms
Abbreviation Description
Standard for the elimination of microorganisms in moist heat
A0
processes, ISO 15883
MDRU Medical device reprocessing unit
EtO Ethylene oxide
OR operating room
W/D Washer-disinfector
CSSD Central Sterile Services Department
1.5 Validity of this document
This document applies to all products in the marSafe
all required accessories.
This covers the following UDI/DI groups:
40576055AB
40576057AF
2 Product Overview
The product is illustrated on the fold-out page (cover page) of these Instructions for Use.
For a description of the various features, see opposite page.
2.1 Inspection of the delivery for completeness and correctness
Immediately after receiving the delivery, check that it is complete and in good condition.
Report any damage that occurs during transit promptly.
After delivery of the product, check the original packaging and the packaging seal for intactness.
3 Intended use
3.1 Purpose
Sterilization containers are used to pack, sterilize, transport and store sterile products and for
sterile staging of sterile products.
3.2 Target patient population
No direct patient contact
3.3 Users
Professional users in a CSSD/MDRU/OR
3.4 Environmental conditions during use
The container is used during the medical device reprocessing cycle (in clinical and outpatient
facilities).
The locations of its use thus include all sites in this cycle which utilize sterile products:
• Operating rooms in clinics/hospitals (non-sterile zone)
• Outpatient surgical clinics (non-sterile zone)
• Physicians in private practice
• Outside when needed in emergency settings
• In field hospitals
3.5 Restrictions on use
Sterilization using H2O2, EtO and formaldehyde may destroy this product. For further restrictions,
see sections 5 and 8.
The container is not suitable for sterilizing medicines or biological products.
4 Operation/Use/Application
• Before use, check device for functionality and proper condition.
• Ensure that sterilization containers are only used by properly-trained staff capable of
recognizing the risks and preventing potential hazards based on their training and
experience.
• Keep Instructions for Use accessible to personnel.
• Observe general guidelines concerning contaminated and sterilized goods as well as goods
to be sterilized.
Instructions for Use
and marSafe + Sterilization container system
® ®
® and marSafe ® plus product lines including
Revision 04