INSTRUCTION FOR USE VALVULOTOMES

Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: [email protected] Read instruction for use

Non sterile

Medical product class I and shortcut for Notified Body TÜV SÜD Product Service GmbH, Munich, Germany 0123

Medical Device

Batch code

Catalogue number

Keep dry

Do not expose to sunlight

Prescription – U.S. federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner Read the instructions for use regarding warnings and precautions

Thank you for purchasing. Please read carefully the instruction for use.

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 2 to 7

Page 2 of 7

First use of new Surgical Instruments Every instrument must be cleaned and sterilized before it is used. Caution The instruments may only be used for their intended purpose in the surgical specialties by educated and qualified personal. The surgeon shall be responsible for the propper selection of the instruments for each application, for obtaining the appropriate training, knowledge and experience, and for their operative use. Geister Medizintechnik GmbH as manufacturer and seller cannot accept any liability for immediate or consequential damages caused by inappropriate application and use or by inappropriate sterilisation and maintenance of the instruments. If instruments are repaired by any companies or persons not authorized by Geister Medizintechnik GmbH to do so, all warranties are becoming null and void. Carefully examine each surgical instrument for breaks, cracks, deformations and malfunctions before use. It is especially essential to check areas such as blades, points, ends, stops and snaps as well as movable parts. Instruments that are worn out, corroded, deformed, porous or damaged in any other way must be sorted out. Indication The instruments are used for a surgical procedure and are reusable. Valvulotome are used to remove tissue. Contraindication The instruments are not specially intended for use on the central nervous and circulatory system. Infection risk  Prepare before use  Prepare instrument before returning to manufacturer Risk of injury  Use only original accessories or compatible third party accessories  Do not use or repair damaged instruments  Carefully remove from the packaging  Do not touch sharp edges User The attending medical practitioner or instructed persons are exclusively responsible for the use of the product. Patient target group The user is responsible for the intended patient target group. Storage Instruments should be stored in a clean, dry, moisture free area. Instruments should be stored individually in their shipping carton or in a protective tray with partitions. Protect tips, edges, etc. with tubing, protecting caps, gauze or fabric. Make sure that no chemicals are close to or in the storage area.

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 3 to 7

Page 3 of 7

Disposal Please ensure safe disposal of the product, its accessories and any consumables used. Note The user is obliged to report an incident to the manufacturer immediately! Used materials Stainless steel

EN ISO 7153-1

Steel instruments The stainless steels used for instrument manufacture form specific passive layers as protective layers due to their allow. These steels are only partially resistant to the attack of chloride ions and aggressive waters! Hints The steel materials used can cause allergic and hypersensitive reactions in patients. However, the risk of allergic and hypersensitive reactions is low because only approved materials are used to manufacture the surgical instruments. In addition to the endeavours undertaken by the manufacturer with regards to the selection of the proper materials and its careful processing, the user has to ensure continuous and proper care of the surgical instruments as well as proper preparation, cleaning and sterilisation. We recommend the following procedures for the reprocessing of our reusable surgical instruments: For this purpose, please follow the reprocessing instructions from the “Instructions for use Surgical Instruments”. Note: Please check the instruments for visual, functional and corrosion damage before and after each reprocessing and do not use the instruments if any of these damages occur or if you are unsure. Reprocessing procedures have only limited implications to a surgical instrument. The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device. In case of damage the device should be reprocessed before sending back to the manufacturer for repair. At the end of the product's service life, dispose of the surgical instruments properly or recycle them. Reprocessing validation study information: The following testing test devices, materials & machines have been used in this validation study: General:

Description:

Detergent:

Neodisher® MediClean forte; Dr. Weigert, Hamburg (alcaline)

Neutralizer:

Neodisher® Z; Dr. Weigert, Hamburg

Washer / Disinfector:

Miele G 7835 CD

Key hole surgery rack:

MIC Wagen E 450

Details:

Cleaning

Report No. 1807.1185

Sterilization

Report No. 1807.1919

Additional instructions:

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 4 to 7

Page 4 of 7

If the above-described chemicals and machines are not available, the user must validate his own process. The user must ensure that the biocompatibility of the devices could be assured through the selection of appropriate cleaning chemicals and re-processing procedures. The user is responsible for the removal of the cleaning chemicals after the used cleaning process. The complete removal of the cleaning chemicals for the used process must be specified and made valid. When using autoclaves for sterilization of surgical instruments, it has to be strictly ensured that the steam used is absolutely free of foreign substances such as corrosive particles or dirt to avoid subsequent corrosion or dirt (scum) deposit. Please observe strictly the instructions for use given by the manufacturers of autoclaves. Do not use any damaged instruments. It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly. Hints for the sterilization of the instruments with sterilization container systems



Do not wrap the sterilization container on the outside with paper or textile filters during the sterilization cycle. This would cover the holes, press the filter inside and does not allow for the steam to move in and out properly. Also drying is not possible in proper manner.



A drying cycle time of 20 minutes after autoclave cycles must be observed by all means! It’s not allowed to skip this dry time, because it’s crucial! After this the sterilization container and the goods should be quite dry inside. This should be tested. Remaining humidity in sterilization container and subsequent storage in this way can cause brownish discoloration or rust on instruments. IMPORTANT! Loading weight of 1/1 sterilization containers shall be not more than 10 kgs! The loading weight of the smaler sterilization containers shall be appropriate less than the 1/1 sterilization containers.

 

For Crutchfield-Jacob contaminationed instruments sometimes the holding time at the sterilization cycle will be increase to a higher time of 30 min. This is known to cause problems on many instruments. It’s better to use a proper disinfectant before and use common holding time for instruments.

Equipment and methods used for cleaning, desinfection and sterilization have to be in accordance with the following standards and recommendations: EN ISO 17664

Sterilization of medical devices – Information to be provided by the manufacturer for thr processing of resterilizable devices

EN ISO 17665-1

Sterilization of health care products - Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

EN ISO 14937

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process

EN 285

Sterilization – Steam-sterilizers – Large Sterilizers

EN 13060

Small steam sterilizers

ISO 15883

Washer-disinfectors

EN 556-1

Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices

EN ISO 11607-1

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 5 to 7

Page 5 of 7

EN 868

Packaging materials for terminally sterilized medical devices

EN ISO 11737-1

Sterilization of medical devices - Microbiological methods – Part 1: Determination of a population of microorganisms on products

EN ISO 11737-2

Sterilization of medical devices - Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process

DIN 58946-7

Sterilisation; Dampf-Sterilisatoren; Bauliche Anforderungen bei GroßSterilisatoren

Proper maintenance of instruments, working group instrument preparation http://www.a-k-i.org/ Maintenance of instruments Maintenance of surgical instruments means lubrication with physiologically inert instrument oil (acc. to DAB 8 or Ph.Eur. or Usp) particularly of the joints. The used lubrication with physiologically inert instrument oil must be eligible for the using with surgical instruments. Make it a basic rule to thoroughly lubricate surgical instruments prior to checking for function. All movable parts (joints) and cutting blades of scissors have to be lubricated. This avoids metal abrasion when checking for function. Lubricants used must guarantee, that even after frequently repeated use the “sticking” of joints through a multiplying effect is avoided. Information If you require further information or product demonstration / product training, please contact the responsible GEISTER® Product Specialist.

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 6 to 7

Page 6 of 7

Article No.

Description

03-7495

Valvulotome 40cm, blade 3mm, w/ball

03-7496

Valvulotome 40cm, blade 4mm, w/ball

03-7499

Valvulotome, Antegrade, with Ball

30cm edge 2mm

03-7500

Valvulotome, Retrograde, with Ball

30cm edge 2mm

03-7500.50

Valvulotome 50cm, blade 2mm, w/ball

03-7504

Valvulotome, Antegrade, with Ball

25cm edge 2mm

03-7505

Valvulotome, Retrograde, with Ball

25cm edge 2mm

03-7505.01

Valvulotome, Retrograde,without ball

25cm edge 2mm

03-7509

Valvulotome, Antegrade, with Ball

23cm edge 2mm

03-7510

Valvulotome, Retrograde, with Ball

23cm edge 2mm

03-7520

Valvulotome, Antegrade, with Ball

16cm edge 2mm

03-7521

Valvulotome, Retrograde, with Ball

16cm edge 2mm

03-7530

Valvulotome

100cm Ø 2mm

03-7531

Valvulotome

100cm Ø 2.5mm

03-7532

Valvulotome

100cm Ø 3mm

03-7533

Valvulotome

100cm Ø 3.5mm

03-7534

Valvulotome

100cm Ø 4mm

Filename with change level: IFU_Valvulotom_A_EN

IFU-0070_Geister_Valvulotomes

created/changed at: 28.06.2021

edited by: fbec

checked by: cgro

released by: cgro

Page 7 to 7

Page 7 of 7