INSTRUCTIONS FOR USE REUSABLE GUIDES · 2018-04-24 · INSTRUCTIONS FOR USE REUSABLE GUIDES...

2017

EN

KM

AN

-46

03/E

N/5

.0/

2017

.10

.18

INSTRUCTIONS FOR USE

REUSABLE GUIDES

• PERINE® range

• NAIL® range

• CON-LEAD® range

• LIN-LEAD® range

Caution : Federal (USA) Law restricts this device to sale by or on the order of a physician


REUSABLE GUIDES

(PERINE® range, NAIL® range, CON-LEAD® range and LIN-LEAD® range)

KMAN-4603_V5.0_EN

2017.10.18

KOELIS 16 chemin du vieux chêne 38240 Meylan France

Tel.: +33 (0)4 58 17 68 17 - [email protected]

1 / 16

EN

2017

This document provides a set of instructions for use of the reusable guides listed below.

It facilitates routine use of the instrument.

This document is aimed at medical personnel liable to perform or assist in an ultrasound-guided exam.

Name and technical reference of guides

Reference and symbol of the compatible KOELIS probe

Diameter of compatible instruments

Minimum needle length recommended

Compatible nails and reference

Nail 14G and 18G

NAIL.14, NAIL.18

PERINE GRID 18G

KRNG.EL1.18

K3DEL00

Ø = 17 à 20G

20 cm

- PERINE GRID 14G

KRNG.EL1.14 Ø = 14 to 16G

PERINE NAIL

KRNG.EL2

Ø = 14 to 16G or 17 to 20G (depending

on nail size) X

PERINE FULL GRID

KRNG.EL4.18 Ø = 17 to 20G -

PERINE FULL GRID

KRNG.EL4.14 Ø = 14 to 16G -

CON-LEAD

KRNG.AB

K2DAB00

Ø = 14 to 16G or 17

to 20G (depending on nail size)

5 cm X LIN-LEAD

KRNG.LN

K2DLN00

Note: Use appropriate needle length to reach target area.

Warning:

Use the needle size corresponding to the guide (PERINE GRID®) or nail, checking the marking and the color code

below.

NAIL® range

Size of compatible needle

14-16G Nail.14

17-20G Nail.18

Color of nails Green Pink

Nail example

mailto:[email protected]


REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



2 / 16

EN

2017

Table of contents 1. General presentation ...................................................................................................................... 3

1.1 Manufacturer .......................................................................................................................... 3

1.2 Meaning of symbols ................................................................................................................ 3

1.3 Intended use ........................................................................................................................... 3

1.4 Indication for use .................................................................................................................... 3

2. USE OF GUIDES ................................................................................................................................ 4

2.1 PERINE® range ......................................................................................................................... 5

2.1.1 Reusable guide: PERINE FULL GRID® (Ref. KRNG.EL4.14 and KRNG.EL4.18) .................. 5

2.1.2 Reusable guide: PERINE GRID® (Ref. KRNG.EL1.14 and KRNG.EL1.18) ........................... 6

2.1.3 Reusable guide: PERINE NAIL® (Ref. KRNG.EL2) with Nail 14G and Nail 18G (Ref.

Nail.14 and Nail.18) ......................................................................................................................... 7

2.2 Reusable guide: CON-LEAD® range (KRNG.AB) and LIN-LEAD® range (KRNG.LN) with Nail

14G and Nail 18G (Ref. Nail.14 and Nail.18) ....................................................................................... 8

3. Cleaning and Sterilization procedure ............................................................................................ 10

3.1 Pre-soaking/Pre-cleaning ...................................................................................................... 10

3.2 Cleaning ................................................................................................................................. 10

4. Sterilization ................................................................................................................................... 16

5. Service life ..................................................................................................................................... 16

6. Transport, handling and storage ................................................................................................... 16



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



3 / 16

EN

2017

1. General presentation

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

Before using the reusable guide, the operator must have received medical training in needles puncture. 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

Email: [email protected]

1.2 Meaning of symbols

1.3 Intended use The reusable guides ranges (PERINE® range, NAIL® range, CON-LEAD® range and LIN-LEAD® range) are intended

to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the

ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the

prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.

1.4 Indication for use The reusable guides ranges (PERINE® range, NAIL® range, CON-LEAD® range and LIN-LEAD® range) are indicated

for guiding needles during ultrasound-guided interventions for diagnosis and treatment.

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

QTY




REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



4 / 16

EN

2017

2. USE OF GUIDES

Warnings:

▪ Always cover the probe to protect patient and user from any cross-contamination.

▪ Take care not to twist the guide hinge when removing the probe. This could cause the guide to lose its holding

capacity.

▪ Check the condition of the needle before insertion into the guide.

▪ Stop using the guide immediately if there is any mechanical slack when it is fixed onto the probe, if it is

deformed or if there are any splits or cracks.

▪ Avoid moving the probe when the needle inserted into the body. This causes a risk of needle deformation and

deviation outside the ultrasound plane.

▪ If the needle is not visible in the ultrasound image, stop the procedure immediately and check that the guide

is correctly fitted to the probe. Also check that its channel is not deformed and that there is no excessive slack.

If the problem persists, stop using the guide. It should be noted that the problem can also be caused by a

defective probe.

Recommendations:

▪ Only use water-soluble gels. Petroleum or mineral oil-based substances can damage the probe cover. The

absence of gel can cause a poor-quality image.

▪ To avoid any creases or air bubbles that could adversely affect the image quality or even cause perforation of

the cover, it is recommended that a probe cover with a diameter of 35 mm be used for the K3DEL00 probe.

Information: The acceptance criterion for validating the positioning accuracy of the guides is +/- 5mm.

Probe protection 1) Apply a suitable amount of gel to the probe and inside the probe cover.

2) Insert the probe into the probe cover, taking care to follow good hygiene procedures.

3) Gently unroll the probe cover along the length of the probe, taking care not to pierce it. 4) Adjust the probe cover to eliminate any creases or air bubbles.



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



5 / 16

EN

2017

2.1 PERINE® range

Intended use: The guides from the PERINE® range are intended to guide a needle during ultrasound-guided interventions.

Indication for use: The guides from the PERINE® range are indicated for guiding needles during percutaneous ultrasound-guided

interventions for diagnosis and treatment on adult males.

2.1.1 Reusable guide: PERINE FULL GRID® (Ref. KRNG.EL4.14 and KRNG.EL4.18)

Fixing the guide in place: 1) Open the guide hinge and position the guide on the probe (Fig.1).

2) Close the hinge and fix the guide in place (Fig.2).

3) Check that the guide is stable.

4) Insert the needle in the required position, to cover the whole prostate, if necessary rotate the probe

with the guide fixed on it and place the guide in front of the target before insertion of the needle.

Removing the guide: Open the guide hinge and remove the guide from the probe.

Graduation: This guide has 169 holes spaced 5 mm each other, designated as follows:

1

For example, to place a needle at

position E6, insert the needle in this

hole.

1

2

3

2



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



6 / 16

EN

2017

2.1.2 Reusable guide: PERINE GRID® (Ref. KRNG.EL1.14 and KRNG.EL1.18)




4) Insert the needle in the required position, to cover the whole prostate, rotate the probe with the guide

fixed on it and place the guide in front of the target before insertion of the needle.


Graduation: This guide has 20 holes spaced 3 mm apart, designated as follows:

1


position G, insert the needle in this

hole.

2

1

3

2



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



7 / 16

EN

2017

2.1.3 Reusable guide: PERINE NAIL® (Ref. KRNG.EL2) with Nail 14G and Nail 18G (Ref. Nail.14

and Nail.18)




Using the nails: The nails are used to position and release needle.

1) Place the nail(s) in the notches provided at the desired puncture level (Fig.1). To cover the whole

prostate, rotate the probe with the guide fixed on it and place the guide in front of the target before

insertion of the needle.

2) Position the open part of the nail on the guide side to form a closed channel (Fig.2). Insert the needle.

3) To release the needle, turn the nail through 180 degrees (Fig.3) or slip it along the needle.


2 3

needle

1

1

2

1

3

2



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



8 / 16

EN

2017

Graduation: This guide has 13 holes spaced 5 mm apart, designated as follows:

2.2 Reusable guide: CON-LEAD® range (KRNG.AB) and LIN-LEAD® range

(KRNG.LN) with Nail 14G and Nail 18G (Ref. Nail.14 and Nail.18)

Intended use: The guides from CON-LEAD® range and LIN-LEAD® range are intended to guide a needle during ultrasound-

guided interventions.

Indication for use: The guides from CON-LEAD® range and LIN-LEAD® range are indicated for guiding needles during percutaneous

ultrasound-guided interventions for diagnosis and treatment.

Fixing the guide in place: 1) Position the guide on the side of the probe where the keyed connection is located (Fig.1).

2) Rotate the guide to fix the other side to the probe (Fig.2).

1

2


position E, insert the nail in this hole

then the needle in the nail.



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



9 / 16

EN

2017

Using the nails: The nails are used to position and release needle.

1) Place the nail in the notch (Fig.1).

2) Position the open part of the nail on the guide side to form a closed channel. Insert the needle (Fig.2).

3) Turn the nail through 180 degrees to release the needle (Fig.3) or slip it along the needle.

Removing the guide: Remove one side of the guide then the other.

Warning: do not press the ultrasound lens when fixing and removing the guide.

1

Ultrasound lens

Ref: K2DAB00 Ref: K2DLN00

needle

3

2



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



10 / 16

EN

2017

3. Cleaning and Sterilization procedure Using an inappropriate cleaning agent may damage the product. Before the first use and after each

use, the reusable guides and nails must be pre-soaked/pre-cleaned and cleaned.

Warnings :

Always use protective eyewear and gloves when cleaning the product. Always comply with the instructions provided with the cleaning agent. Reusable guides and nails are packaged non-sterile. They are reusable. Pre-soaking/pre-

cleaning and cleaning are mandatory before any sterilization and after each use. Remove the guide from the probe along the same axis as fixed. Remove the nail from the

PERINE NAIL® and from the guides of the CON-LEAD® and LIN-LEAD® ranges.

3.1 Pre-soaking/Pre-cleaning

- Prepare a bath with an enzymatic detergent (e.g. : ENZOL® Enzymatic Detergent

(Johnson & Johnson), or ANIOSYME DD1 (Laboratoires ANIOS)), at air temperature (20 ±

5°C/68 ± 9°F).

- Immerse the guide and its associated nails (if applicable) for 10 minutes.

- Rinse the guide and its associated nails (if applicable) with cold water from hospital

network before proceeding to cleaning phase for 1 minute.

Warnings:

▪ The guide and its associated nails (if applicable) must be cleaned immediately and within 20

minutes after use to reduce the possibility of drying before cleaning.

▪ Extending immersion for several hours is not recommended as the contact with certain products

may cause instruments deterioration.

▪ Some substances are incompatible with the constituent materials of the instruments: strong

mineral acids (sulfuric acid, nitric acid, hydrochloric acid, etc.), strong Lewis acids (zinc chloride,

sodium hypochlorite, caustic soda etc.), ethylene dichloride solvents, phenolic solution and aniline.

Recommendation:

▪ During the pre-soaking/pre-cleaning phase, the conditions of use of the pre-soaking/pre-cleaning

agents must be strictly observed. Adequate personal protection measures must be taken.

3.2 Cleaning Care must be taken not to shock or damage the instruments.

Before starting the cleaning, the guide and its associated nails (if applicable) must be inspected in

order to highlight any damage in the devices.

Several types of brushes can be used for opened cavities or closed cavities:



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



11 / 16

EN

2017

Opened cavities

CON-LEAD® and LIN-LEAD® ranges (nail holes): Single use tube brush: Total length 325 mm Tube Ø 1.00 mm Length: 300 mm Brush: Ø 4 mm Length 25 mm

PERINE NAIL® (nail holes): Single use tube brush: Total length 325 mm Tube Ø 1.00 mm Length: 300 mm Brush: Ø 4 mm Length 25 mm

Port-a-cath hole: Brush: Total length 180 mm Brush 2: Length 10 mm Width 2 mm

Nail 14 G: Single use tube brush: Total length 175 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 3 mm Length 25 mm

Nail 18 G: Single use tube brush: Total length 165 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 2 mm Length 15 mm

Closed cavities

PERINE GRID® 14 G (holes): Single use tube brush: Total length 175 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 3 mm Length 25 mm

PERINE GRID® 18 G (holes): Single use tube brush: Total length 165 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 2 mm Length 15 mm

PERINE FULL GRID® 14 G (holes): Single use tube brush: Total length 175 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 3 mm Length 25 mm

PERINE FULL GRID® 18 G (holes): Single use tube brush: Total length 165 mm Tube: Ø 1.03 mm Length 150 mm Brush: Ø 2 mm Length 15 mm

Other parts of the guides and nails



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



12 / 16

EN

2017

Brush: Total length 180 mm Brush 1 : Length 35 mm Width 10 mm

The cleaning procedure is composed of several cleaning steps:

1. Brush the guide and its associated nails (if applicable) for 2 minutes in order to remove visible soils with legally marketed and appropriate brushes detailed above.

As a recommendation, Koelis provides a detailed procedure for each guide:

For the PERINE® guides:

Perine guides

PERINE NAIL® (with nail) PERINE GRID® 14 G and 18 G (without nail)

PERINE FULL GRID ® 14 G and 18 G (without nail)

Brush the

holes with a

single tube

brush

Critical zones to brush

with the brush 2

Brush the holes in

which the nail will

fit with a single

tube brush

Critical zones to brush

with the brush 2

Brush the

holes with a

single tube

brush

Critical zones

to brush with

the brush 2



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



13 / 16

EN

2017

Brush the opened cavities (nail holes) with a single tube brush and the closed cavities (holes) with the

appropriate single use tube brush according to diameter (14 G and 18 G).

Brush with insistence and with the brush 2 the hinge and the port-a-cath hole. It is important to pay

particular attention to these critical zones.

Brush the other areas (surface) with a brush with minimum dimensions detailed above.



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



14 / 16

EN

2017

For the guides from the CON-LEAD® and LIN-LEAD® ranges :

CON-LEAD® range (with nail) LIN-LEAD® range (with nail)

Brush the hole for the nail with the appropriate single use tube brush.

Brush with insistence and with the brush 2 the recesses. It is important to pay particular attention to

these critical zones.

Brush the other areas (surface) with a brush with minimum dimensions detailed above.

For the nails:

Nails (14 G and 18 G)

Brush the hole for the nail with the appropriate single use tube brush according to the diameter of

the nail (14G and 18G).

Brush the surface of the nail with a brush with minimum dimensions detailed above.

2. Prepare the cleaning bath with a protease enzyme based-detergents (in order to remove protein-based soils). We recommend pH-neutral detergents in order to preserve the integrity of the device (e.g. : ENZOL® Enzymatic Detergent (Johnson & Johnson) or ANIOSYME DD1 (Laboratoires ANIOS)) at air temperature (20 ± 5°C/68 ± 9°F).

3. Immerse the guide and its associated nails (if applicable) in the cleaning bath during 5 minutes

Brush the

nail hole with

a single tube

brush

Brush the

nail hole

with a

single tube

brush

Critical zone to brush

with the brush 2 Critical zone to brush

with the brush 2

Brush the nail hole with

a single tube brush

Brush the nail surface



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



15 / 16

EN

2017

4. During immersion, perform manual brushing for 2 minutes with the use of a brush for outer parts and a tube brush for inner parts (see table above).

5. Rinse with purified water (at ambient temperature) from the hospital network for 1 minute until full elimination of the detergent on the surface of the guides and the associated nails.

6. In case soil is still visible, repeat steps 3, 4 and 5 of the procedure. 7. Dry the guide and its associated nails (if applicable) carefully with a clean absorbent cloth.

Hollow parts can be dried with forced air at a pressure below 3 bars and at ambient temperature until full elimination of water.

8. After drying, the guide and its associated nails (if applicable) are visually inspected in order to validate effectiveness of cleaning and to detect damages or mechanical deteriorations. Check that all parts are still present.

Warnings:

▪ Automatic cleaning is not validated for the reusable guides and nails.

▪ Highly acidic or alkaline detergents must not be used.

▪ Do not (re-)use the reusable guides and nails in case of mechanical deterioration.

Recommendations:

▪ Follow the instructions for use from the detergent manufacturers for the preparation of the

detergent and the personnel protection.

▪ Regardless of the cleaning method used, the instrument must be stored quickly in order to avoid

recontamination.



REUSABLE GUIDES


KMAN-4603_V5.0_EN

2017.10.18



16 / 16

EN

2017

4. Sterilization The recommended method for the guide and its associated nails (if applicable) sterilization is pre-

vacuum steam autoclaving at 134°C (-0°C/+3°C) / 273.2°F (-0°F/+5.4°F) for a 3 to 18-minutes cycle or

at 132°C/270°F for a 4 minutes cycle followed by 20 minutes of dry time on product packaged on

legally marketed double peel pouches.

Obtaining and maintaining devices sterility is the responsibility of the healthcare institution,

according to the current local directives (for instance, in France, circular n°97-672 du 20/10/1997)

relative to the sterilization of medical devices in healthcare institutions.

Recommendation:

▪ All the parts of the guide, including all the nails (if applicable) must be individually cleaned,

sterilized and packaged in double peel pouches.

5. Service life The maximum number of cleaning and sterilization cycles validated by Koelis is 50.

6. Transport, handling and storage Recommendation:

It is important to take care of the guide and its associated nails (if applicable) during transport,

handling and storage, in order to prevent any deterioration (torsion, breakage, etc.). It is

recommended to use rigid and padded containers for guide transportation, and to store them in

maximal hygiene conditions at ambient temperature.


INSTRUCTIONS FOR USE REUSABLE GUIDES · 2018-04-24 · INSTRUCTIONS FOR USE REUSABLE GUIDES...

Documents

Transcript of INSTRUCTIONS FOR USE REUSABLE GUIDES · 2018-04-24 · INSTRUCTIONS FOR USE REUSABLE GUIDES...