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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]

 

3

/

13 

 

 

Year of CE marking : 2017 

Table of contents 

 

1 

General presentation ...................................................................................................................... 4 

1.1 

Manufacturer .......................................................................................................................... 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 ..................................................................................................................................... 13 

7 

Transport, handling and storage ................................................................................................... 13 

 

 

 

Summary of Contents for KPHA.00

Page 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 ...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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...

Page 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 ...

Page 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...

Page 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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