Kong Lecco 2.0 Tactical Manuale utente

EN

Regulation (EU) 2017/745

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LECCO 2.0

870.04

QR

EN

2

original version in Italian dated 10/01/2022

Download the digital version - Scarica la versione digitale

870.04 LECCO 2.0www.kong.it

3

original version in Italian dated 10/01/2022

TABLE OF CONTENTS

1 - SYMBOLS AND SUPPORT 4

1.1 Symbols 4

1.2 Support 4

2 - GENERAL INFORMATION 5

3 - TECHNICAL FEATURES 6

3.1 Terminology and materials of the parts 6

3.2 Technical data 8

3.3 Optional components and spare parts 9

4 - SPECIFIC INFORMATION 16

4.1 Intended use 16

4.2 Preparing the scoop stretcher 17

4.3 Positioning and immobilising the patient 20

4.4 Transporting the patient 22

4.5 Disassembling the scoop stretcher 25

4.6 Removing the sheet from the metal structure 26

4.7 Fixing the sheet into the metal structure 26

5 - MAINTENANCE AND REPAIR 30

5.1 General 30

5.2 Maintenance 30

5.3 Repair 30

6 - STORAGE 31

7 - CHECKS, INSPECTIONS AND SERVICING 32

7.1 Checks 32

7.2 Inspections 32

7.3 Servicing 32

8 - DURATION AND WARRANTY 33

8.1 Duration 33

8.2 Disposal 33

8.3 Warranty 33

8.4 Law obligations 33

9 - LABELLING AND SYMBOLS 34

9.1 Medical Device Label 34

9.2 Separable components label 34

9.2 Symbols 34

10 - DOCUMENTS 35

10.1 Recording inspections and servicing 35

10.2 Maintenance and repair register 36

10.3 EU declaration of conformity (facsimile) 37

11 - LIST OF APPLIED AND REFERENCE STANDARDS 38

11.1 Applied standards 38

11.2 Standards used as reference 39

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original version in Italian dated 10/01/2022

CHAPTER

For the sake of comfort and clarity while reading this manual, below are the symbols used

for handling important warnings for a proper and safe use of the device.

1.1

SYMBOLS

REQUIREMENT FOR PROPER USE

It identiﬁes the presence of information for proper use of the device.

INFORMATION REQUIREMENT

It identiﬁes the presence of useful and general information which guides

the reader towards a conscious use of the device and/or performance of

actions.

It identiﬁes that the Medical Device is manufactured, designed and pro-

duced in compliance with the provisions of the General Safety and Perfor-

mance Requirements of Regulation (EU) 2017/745 (Class I medical device,

in compliance with classiﬁcation rule 1 as indicated in the attachment VIII).

1

SYMBOLS

AND SUPPORT

For information please contact Kong Customer Support Service by:

- telephone +39 0341 630506

- fax +39 0341 641550

- email: [email protected]

or write to KONG S.p.A. – Via XXV Aprile, 4 – 23804 Monte Marenzo LC - ITALY.

To facilitate support operations, please always communicate or state the serial number (SN)

indicated on the label ﬁxed to the Medical Device.

1.2

SUPPORT

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Warning: not suitable for

use in an ATEX environment

(Directive 94/9/CE)

The information provided by the manufacturer

(hereinafter referred to as information)

must be read and clearly understood by

the user prior to using the Medical Device

(MD hereafter). The information regards the

description of the features, performance,

assembly, disassembly, maintenance,

preservation, disinfection, etc. of the device.

Even though the information offers tips on

use, this information shall not be considered

as a user manual under actual conditions of

use.

WARNINGS AND

LIMITATIONS OF USE:

- this device shall be strictly used by people

who are physically ﬁt, trained (instructed

and taught) to use the device and with

speciﬁc experience regarding moving

the patient or, during training activities,

by people under direct supervision of the

trainers/ supervisors who guarantee the

safety thereof,

- do not use the device before fully reading

and understanding this user manual,

- strictly follow the manufacturer’s

information, improper use of the device is

hazardous,

- modifying and/or repairing the device is

strictly forbidden,

- all checks described in chapter 7

must be carried out prior to and

after using the device. In case of any

doubt on the efficiency of the device,

the user must replace it immediately,

- non-compliant use, deformations, falls,

wear, chemical contamination, exposing

textile/plastic components/devices

to temperature below -30°C or above

2

GENERAL INFORMATION

+50°C and metal components/devices to

temperatures exceeding 100°C are some

examples of causes that can reduce, limit

and end the life of the device,

- Prior to any rescue operation, be keen

not to exceed the capacity indicated in

paragraph 3.3,

- in order to reduce risks of exposure to /

transmission of infectious diseases, clean

and disinfect the device as indicated in

chapter 5,

- improper use of the patient immobilisation

systems can jeopardise the safety of the

patient,

- always check the compatibility of the

devices used alongside the device by

consulting the relative manufacturer’s

information,

- use of spare parts or optional components

different from the ones indicated in

paragraph 3.4 can be hazardous,

- do not expose the device to sources of heat

and at contact with chemical substances.

Reduce exposure to direct sunlight as

much as possible. At low temperatures

and in the presence of humidity, formation

of ice could reduce ﬂexibility and increase

cutting and abrasion-related risks on

textile and synthetic devices,

- Report to the manufacturer and the

competent authority of the member

state where the user and / or patient is

established any serious incident occurring

in relation to the MD.

All our devices are tested/ checked piece

by piece in compliance with the procedures

laid down by the Quality System certiﬁed

in accordance with the UNI EN ISO

9001 standard. Laboratory tests, testing,

information and standards do not always

reproduce the practical result. Thus, the

results obtained under the actual conditions

of use of the device in the natural environment

may differ, even considerably at times.

The best information lies in the continuous

practical use under the supervision of skilled/

expert/qualiﬁed people.

CHAPTER 2

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original version in Italian dated 10/01/2022

A – Aluminium alloy heads,

B – Aluminium alloy longitudinal beams,

C1 and C2 – Aluminium alloy handles,

D – Foam elastomer handle padding covered in polyester.

The scoop stretcher is provided, and can be kept away in the user’s bag, with the sheet

connected to the framework so as to facilitate preparation to use.

The parts, illustrated in paragraph 3.1, can still be separated from each other.

TECHNICAL

FEATURES

3.1 TERMINOLOGY AND MATERIALS OF THE PARTS

Fig. 1

CHAPTER 3

C2

B

DD

D

B

A

C1

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original version in Italian dated 10/01/2022

E – Polyamide sheet,

F – Polypropylene external belts,

G – Polypropylene internal belts,

H – Belts for connecting to the polypropylene framework,

I – Belts for connecting to the polypropylene hanging kit ,

L – Polyamide headrest cushion,

M – Polyamide bag.

Fig. 1

M

F

E

G

L

H

I

H

HH

F

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original version in Italian dated 10/01/2022

3.2 TECHNICAL DATA

Length: 198 cm (without handles) 310 cm (with handles)

Width: 46.5 cm

Overall weight: 16.9 kg (excluding backpack) 19.2 kg (including backpack)

Capacity 300 kg*

3.3 OPTIONAL COMPONENTS AND SPARE PARTS

3.3.1 Optional components

871.13 ORION 2.0

Hanging kit with coloured ends (red, head side - blue, feet side) and connectors with twist

lock sleeve, suitable for lifting and lowering using rescue devices and helicopters.

The methods of connection and use of the optional components are deﬁned in the relative

user instructions.

*For helicopter hoisting and lowering operations, given the 1:14 safety factor, the capacity

is reduced to 150 kg.

Fig. 2

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original version in Italian dated 10/01/2022

Fig. 3

871.04 EVOLUTION

Two-piece hanging kit with coloured ends (red, head side - blue, feet side) and connectors

with twist lock sleeve, suitable for lifting and lowering using rescue devices and helicopters.

871.01 GEMINI

Hanging kit with coloured ends (red, head side - blue, feet side) and connectors with twist

lock sleeve, suitable for transporting the scoop stretcher on ropeway conveyor and

overhead lines.

Fig. 4

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original version in Italian dated 10/01/2022

871.02 VIRGO

High-load-capacity belt, to be connected to the rope, for fastening when lowering and

rescuing on areas with steep inclinations and in the space.

Fig. 5

871.03 AQUARIUS

Kit for ﬁxing the scoop stretcher to the deck of the helicopters. Consisting of 4 length-wise

adjustable webbings with oval links and quick-release stainless steel connectors.

Fig. 6

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original version in Italian dated 10/01/2022

871.20 WILLY

Height-wise adjustable wheel with low-pressure tyre to be applied to the stretcher in a

barycentric position. It allows the transportation of the patient on ﬂat grounds or on mule

tracks.

Fig. 8

871150000KK LECCO X-TENSION

Kit consisting of 4 polyamide straps necessary to connect the stretcher, with the X-TRIM

spinal board inserted, to the hanging kit.

Fig. 7

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original version in Italian dated 10/01/2022

871.31 VISI

Lexan® face protection visor.

Fig. 10

871.22 TWIN WILLY

Height-wise adjustable twinned wheel with low-pressure tyres to be applied to the stretcher

in a barycentric position. It allows the transportation of the patient on ﬂat grounds or on

mule tracks. Can be combined with the 871.20 WILLY single wheel.

Fig. 9

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original version in Italian dated 10/01/2022

871.51 GRIPS

Quick coupling grippers for moving the scoop stretcher in narrow spaces.

871.50 HANDLES

Quick-coupling handles for transporting the stretcher using the 871.20 WILLY and 871.22

TWIN WILLY wheels. Also suitable for shoulder-transportation carried by four rescue

operators.

Fig. 12

Fig. 11

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original version in Italian dated 10/01/2022

871.41 WRAP

Backbone protection for transportation and sliding on snowy slopes.

Fig. 13

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original version in Italian dated 10/01/2022

3.3.2 Spare parts

C1 and C2 – Handles,

D– Paddings for handles,

E – Sheet,

H – Headrest cushion,

M – Bag.

Fig. 14

D

H

M

E

C1

C2

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original version in Italian dated 10/01/2022

SPECIFIC

INFORMATION

4.1 INTENDED USE

The “LECCO 2.0” stretcher is a medical device, particularly suitable for mountain rescue

operations, for rescuing and transporting a patient, even immobilised on “X-TRIM” spinal

boards or on “VACUUM” mattresses.

Decisions concerning moving and immobilising the patient, as well as the duration, method

to be used and combination with other devices, shall be taken and executed by expert and

trained personnel only.

The 871.13 ORION 2.0 and 871.04 EVOLUTION hanging kits, not part of standard supply,

make the stretcher utilisable with winch.

CHAPTER 4

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original version in Italian dated 10/01/2022

4.2 PREPARING THE STRETCHER

a) Take the pre-assembled stretcher from the bag and spread it with the sheet facing

towards the ground,

b) connect the central longitudinal beams (A1) to the longitudinal beams of the head element

(A2) and subsequently to the longitudinal beams of the other head element.

To connect the longitudinal beams:

- keep the pin (N) pressed,

- insert the central longitudinal beam into the longitudinal beam of the head element,

- check whether the pin (N) is automatically inserted into the hole of the longitudinal

beam of the head element.

The resistance of the stretcher is guaranteed by the correct assembly and

stretching of the sheet belts. The pins (N) are provided solely for facilitating

assembly.

Fig. 15

N

A2A2

A1 A1

A2A2

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original version in Italian dated 10/01/2022

c) Slightly tighten the transversal belts,

d) slightly tighten the longitudinal belts being keen not to misalign the transversal belts,

Fig. 17

Fig. 16

870.04 LECCO 2.0www.kong.it

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original version in Italian dated 10/01/2022

e) tighten the transversal belts deﬁnitely, insert the surplus part into the through element

and position it between the sheet and the stretched belt,

f) stretch the longitudinal belts deﬁnitely, insert the surplus part into the through element

and position it between the sheet and the stretched belt.

Fig. 19

Fig. 18

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original version in Italian dated 10/01/2022

4.3 POSITIONING AND IMMOBILISING THE PATIENT

With the stretcher positioned on a ﬂat and stable surface:

a) open the sheet zip fully and release the buckles of the internal belts,

b) lay the patient on the stretcher, couple the buckles and stretch the belts until the patient is

immobilised.

Avoid prolonged contact of the patient’s skin with the fabrics of the device

Fig. 20

Fig. 21

This procedure shall be applied even when patients are immobilised in “X-TRIM”

spinal boards (except for the groin belt) or with “VACUUM” mattresses.

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