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
INSTRUCTIONS FOR USE
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
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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.
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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2017
2.1.2 Reusable guide: PERINE GRID® (Ref. KRNG.EL1.14 and KRNG.EL1.18)
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, 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 20 holes spaced 3 mm apart, designated as follows:
1
For example, to place a needle at
position G, insert the needle in this
hole.
2
1
3
2
INSTRUCTIONS FOR USE
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]
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2017
2.1.3 Reusable guide: PERINE NAIL® (Ref. KRNG.EL2) with Nail 14G and Nail 18G (Ref. Nail.14
and Nail.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.
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.
Removing the guide: Open the guide hinge and remove the guide from the probe.
2 3
needle
1
1
2
1
3
2
INSTRUCTIONS FOR USE
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]
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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
For example, to place a needle at
position E, insert the nail in this hole
then the needle in the nail.
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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:
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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.
INSTRUCTIONS FOR USE
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]
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
INSTRUCTIONS FOR USE
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]
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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.
INSTRUCTIONS FOR USE
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]
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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.