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KOELIS KPHA.00 Скачать руководство пользователя страница 4

EN

User manual

Steady Pro® range

KMAN-5001_V6.1_EN
2019.04.30

KOELIS 16 chemin du vieux chêne 38240 Meylan France

Tél. : +33 (0)4 58 17 68 17 -

[email protected]

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13

Year of CE marking : 2017

1

General presentation

Warning: the present manual does not provide any training in clinical practices.

Before using the Steady Pro® range, the operator must have received medical training. The operator
must be aware that the success of the procedure to be performed partly depends on his/her
knowledge of the system and experience. It is for this reason that operators must familiarize
themselves with the technical and regulatory aspects concerning the device before carrying out the
procedure.
KOELIS cannot be held liable if the device is used incorrectly.

1.1

Manufacturer

KOELIS

16 chemin du Vieux Chêne
38240 MEYLAN - FRANCE

Tel: +33 (0)4 58 17 68 10

Service: +33 (0)4 58 17 68 17

Fax: +33 (0)4 58 17 68 24

Mail:

[email protected]

1.2

Meaning of symbols

Product reference

Manufacturer

Product lot

Warning: consult the instructions
for use

European conformity

Quantity contained in the package

Year of manufacture

Product supplied non-sterile

Consult the instructions before use

1.3

Intended use

The Steady Pro® range is intended to reliably maintain the position of a transrectal ultrasound probe
during ultrasound-guided interventions. Typical applications are biopsy or cancer treatment.

1.4

Indications for use

The Steady Pro® range provides physician a tool for performing ultrasound-guided interventions with
the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and
cancer treatment.

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Содержание KPHA.00

Страница 1: ... range STEADY PRO Probe Holding Arm Steady Pro Support for 3D End Fire Endocavitary probe Steady Pro Support for 3D Side Fire Endocavitary probe KMAN 5001 EN 6 1 2019 04 30 Caution USA Federal Law restricts this device to sale by or on the order of a physician ...

Страница 2: ... 5 K3DEL00 KPHA EL 2 Steady Pro supports for side fire probe 5 5 Transrectal KPHA 01 EC Steady Pro Probe Holding Arm with I and U extension Steady Pro supports for end fire probe 5 5 K3DEC00 K3DEC00 2 KPHA 00 EC Steady Pro Probe Holding Arm with I and U extension Steady Pro supports for end fire probe 5 2 KPHA EC 2 Steady Pro supports for end fire probe 5 5 KPHA EC Steady Pro supports for end fire...

Страница 3: ...acturer 4 1 2 Meaning of symbols 4 1 3 Intended use 4 1 4 Indications for use 4 2 Steady Pro Probe holding arm KPHA 00 5 3 Steady Pro Support s assembly 5 4 Cleaning procedure 7 4 1 Manual Cleaning 8 4 1 1 Pre soaking Pre cleaning directly after use 8 4 1 2 Cleaning 8 4 2 Automatic Cleaning 10 4 2 1 Pre soaking Pre cleaning directly after use 10 4 2 2 Cleaning 11 5 Sterilization 13 6 Service life ...

Страница 4: ...le if the device is used incorrectly 1 1 Manufacturer KOELIS 16 chemin du Vieux Chêne 38240 MEYLAN FRANCE Tel 33 0 4 58 17 68 10 Service 33 0 4 58 17 68 17 Fax 33 0 4 58 17 68 24 Mail service koelis com 1 2 Meaning of symbols Product reference Manufacturer Product lot Warning consult the instructions for use European conformity Quantity contained in the package Year of manufacture Product supplied...

Страница 5: ... holding arm Ref GM402 Extension s change 1 Fix the clamping base on a rail firmly Tighten the handle A firmly Position the provided 13 wrench at B and unscrew the I or U extension Fig 1 2 Unscrew the handle A and remove the extension from the clamping base Fig 2 3 Screw the new extension U or I using the 13 wrench at B insert the extension into the clamping base and tighten the handle A Fig 3 3 S...

Страница 6: ...e in the direction illustrated by the diagram outside of the internal part Fig 5 a 2 Assemble both internal components around the end fire probe Fig 5 a 3 Loosen the screw of the external component and insert the internal components into the external part Fig 5 b 4 Tighten the screw of the external component to secure the internal components Fig 5 c KPHA EL 2 1 Unscrew the inferior screw of the in...

Страница 7: ...ng the product Always comply with the instructions provided with the cleaning agent Steady Pro supports are packaged non sterile and are reusable Before the first use and after each use the Steady Pro supports must be pre soaked pre cleaned cleaned and sterilized according to the recommendations in force Remove the probe from the Steady Pro support and unplug the Steady Pro probe holding arm Do no...

Страница 8: ...etergent Johnson Johnson or ANIOSYME DD1 Laboratoires ANIOS or equivalent at air temperature 20 5 C 68 9 F Realize the dilution according to the concentration specified by the detergent manufacturer Immerse all the parts of the support for the time specified by the detergent manufacturer Rinse the Steady Pro supports for 1 minute with cold water from hospital network before proceeding to cleaning ...

Страница 9: ...mm Ø diameter L Length Brush with insistence and with the brush 2 the recesses It is important to pay particular attention to these zones The screws are brushed with the brush 1 for the surfaces and the tube brush for the hollow parts 2 Prepare the cleaning bath with a protease enzyme based detergent We recommend pH neutral detergents in order to preserve the integrity of the device e g ENZOL Enzy...

Страница 10: ... directly after use a Immersion and surface brushing 1 Prepare a bath with an enzymatic detergent at air temperature 20 5 C 68 9 F Suitable solutions can include but are not limited to ENZOL Enzymatic Detergent Johnson Johnson ANIOSYME DD1 or ANIOSYME X3 Laboratoires ANIOS Neodisher MediClean Forte Dr Weigert Realize the dilution according to the concentration specified by the detergent manufactur...

Страница 11: ...CE marking 2017 External parts Internal parts 4 2 2 Cleaning Put the devices in a cleaning basket of proper size Koelis recommends to use the cleaning basket of dimension 241x251x92mm e g JG114R BRAUN for the Steady Pro supports Equivalent references can be used The cleaning procedure is composed of several steps all included in the washer disinfector program 1 JG114R ...

Страница 12: ...itable solutions can include but are not limited to Aniosyme DLM Maxi Laboratoire Anios Neodisher MediClean Forte Dr Weigert or ENZOL Enzymatic Detergent Follow the recommendations of concentration provided by the detergent manufacturer For instance for the Neodisher MediClean Forte Dr Weigert the concentration is ranging from 0 2 to 1 3 Rinse Purified water for 5 minutes at ambient temperature 20...

Страница 13: ... medical devices in healthcare institutions Recommendation For the sterilization all the parts of the disassembled Steady Pro supports shall be individually packaged in legally marketed double peel pouches The temperature shall not exceed 137 C 278 6 F to avoid deterioration of the devices 6 Service life Steady Pro supports can be used 50 times without functional degradation number of cleaning and...

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