Kong 911 SHELL User manual

EN
Direttiva 93/42/CEE
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ZZV009EN Rev. 0
911 SHELL
880.03
Directive 93/42/CEE

Laden Sie die Übersetzung in Ihrer Sprache herunter
- Download the translation in your language - Bájate
la traducción en tu idioma - Télécharger la traduction
dans vostre langue - Scarica la traduzione nella tua
lingua

880.03 911 SHELLwww.kong.it 3 Original Italian version of 04/07/2018
INDEX
1 - SYMBOLS AND ASSISTANCE 4
1.1 Symbols 4
1.2 Assistance 4
2 - GENERAL INFORMATION 5
3 - TECHNICAL CHARACTERISTICS 6
3.1 Terminology and materials of components 6
3.2 Dimensions 7
3.3 Flow rate 7
3.4 Accessories and spare parts 8
4 - SPECIFIC INFORMATION 9
4.1 Intended use 9
4.2 Assembly 9
4.3 Positioning and physically securing patient 11
4.4 Transport of patient 12
5 - MAINTENANCE AND REPAIR 14
5.1 General 14
5.2 Maintenance 14
5.3 Repair 14
6 - STORAGE 15
7 - CHECKS, INSPECTIONS AND OVERHAULS 16
7.1 Checks 16
7.2 Inspections 16
7.3 Overhauls 16
8 - DURATION AND WARRANTY 17
8.1 Product Lifetime 17
8.2 Disposal 17
8.3 Warranty 17
8.4 Legal obligations 17
9 - LABELING AND SYMBOLS 18
9.1 Labelling 18
9.2 Symbols 18
10 - DOCUMENTS 19
10.1 Inspection and revision register 19
10.2 Declaration of conformity (facsimile) 20
11 - LIST OF STANDARDS AND REFERENCE STANDARDS APPLIED 21
11.1 Standards applied 21
11.2 Standards used as a reference 21

4 Original Italian version of 04/07/2018
CHAPTER
To make the manual easy and clear to read, the following symbols are used for important
warnings for correct, safe use of the device.
1.1 SYMBOLS
REQUIREMENT FOR CORRECT USE
Identifies the presence of information for correct use of the device.
INFORMATION REQUIREMENT
Identifies the presence of useful, general information, the reading of which
guides the user towards using the device with care and / or performing
specific actions.
Identifies that the product has been manufactured, designed and produ-
ced in compliance with the safety requirements (RES) of the Medical Devi-
ces Directive 93/42 / EEC (Class I medical device, in compliance with the
classification 1 rule as indicated by Annex IX).
1
SYMBOLOGY
AND ASSISTANCE
For information, contact the Kong Customer Service Department by:
- Telephone [phone]
- Fax [phone]
- E-mail: [email protected]
To facilitate the assistance we can give you, always communicate or indicate the serial
number (SN) shown on the label affixed to the Medical Device.
1.2 ASSISTANCE

880.03 911 SHELLwww.kong.it 5 Original Italian version of 04/07/2018
Warning: not suitable for
use in ATEX environments
(Directive 94/9 / EC)
The information provided by the
manufacturer (hereafter the information)
must be read and understood by the
user before using the device. The
information comprises a description of the
characteristics, performance, assembly,
disassembly, maintenance, storage,
disinfection, etc. of the device, even if there
are also some suggested uses that do not
necessarily need to be considered in a user
manual designed for real situations.
WARNINGS AND
LIMITATIONS OF USE:
- This device may only be used by
persons who are physically fit, trained
(informed and trained) in its use and who
have specific experience regarding the
movement of patients or else, in training
activities, by persons who are under the
direct supervision of trainers / supervisors
ensuring their safety;
- Do not use the device until you have read
and understood this user manual in its
entirety;
- Comply scrupulously with the
manufacturer’s information: incorrect use
of the device is dangerous;
- It is absolutely forbidden to modify and /
or repair the device;
- Both before and after use, all the
checks described in chapter 7 must
be performed If the user has the
slightest doubt about the efficiency
of the device, he must replace it
immediately;
- Non-compliant use, warping, accidental
dropping, wear, chemical contamination,
2 GENERAL INFORMATION
exposure to temperatures below -30 °
C or higher than + 50 ° C in the case of
textile / plastic components / devices, and
+ 100 ° C in the case of metal components
/ devices, are just some examples of
causes that can reduce, limit and even
end the life of the device;
- Before any patient recovery operation,
make sure that the weight to be carried
does not exceed the capacity stated in
paragraph 3.3;
- To reduce the risk of exposure /
transmission of infectious diseases,
perform cleaning and disinfection of the
device as described in chapter 5;
- Incorrect use of the systems designed
to physically secure the patient could
compromise the patient’s safety;
- Always check the compatibility of any
devices used in combination with each
other against the relevant information
provided by the manufacturer;
- The use of spare parts or accessories
other than those listed in paragraph 3.4
can be dangerous;
- Avoid exposing the device to sources of
heat or contact with chemicals. Reduce
direct exposure to the sun, as necessary.
At low temperatures and in the presence
of moisture, ice formation may reduce
materials’ flexibility and increase the risk
of cutting and abrasion posed by textile
and synthetic devices.
All of our devices are tested / checked piece
by piece in accordance with the Quality
System procedures certified under the UNI
EN ISO 9001 standard. Laboratory tests,
inspections, information and standards are
not always able to reproduce actual practice,
so that the results obtained when the
device is used under real conditions in the
natural environment may differ, sometimes
significantly. The best information is always
obtained from continued practice with
using the device under the supervision of
competent / expert / qualified persons.
CHAPTER 2

6 Original Italian version of 04/07/2018
A – Aluminum alloy frame, removable in two symmetrical parts,
B – VTR protective shells,
C – Polyurethane foam mats,
D – Polyester webbing for physically securing patient,
E – Polyester tapes for fixing the mats,
F – Aluminum alloy handles,
G – Polyurethane padding for handles.
TECHNICAL
FEATURES
3.1 PARTS TERMINOLOGY AND MATERIALS
A
F
G
B
E
E
E
E
B
D
D
C
Fig.1
CHAPTER 3

880.03 911 SHELLwww.kong.it 7 Original Italian version of 04/07/2018
H
3.2 DIMENSIONS
Length without handles: 220 cm
Width with handles: 350 cm
Width: 60 cm
Total weight of parts (fig.1): 18 kg
3.3 CAPACITY
The “911 SHELL” stretcher is tested to support the following loads, evenly distributed:
- 1500 kg with lifting / lowering carried out using the suspension assembly (H),
- 450 kg with lifting performed by the handles (F).
Depending on the methods of lifting and transport that the rescuer considers appropriate, we
recommend applying at least the following safety factors:
- 1:3 = usable load: 150 kg for lifting and manual transport using the handles (F) -
(fig. 2),
- 1:10 = usable load: 150 kg for lifting with rescue devices using the suspension assembly
((H) - (Fig. 3).
- 1:14 = usable load: 100 kg for lifting / lowering and transport by helicopter using the
suspension assembly (H) - (Fig. 3).
Before any recovery operation takes place, make sure that the weight does not
exceed the predefined capacity of the device!
F
F
Fig.3
Fig.2

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Fig.5
3.4 ACCESSORIES AND SPARE PARTS
3.4.1 Accessories
H - Suspension assembly for lifting and lowering the stretcher (item 880020100KK)
G
C
H
C – Mattresses,
G – Padding for handles.
3.4.2 Spare parts
Fig.4

880.03 911 SHELLwww.kong.it 9 Original Italian version of 04/07/2018
INFORMATION
SPECIFICATIONS
4.1 INTENDED USE
4.2 ASSEMBLY
The “911 SHELL” stretcher is a medical device specially designed for the recovery and
transport of patients, even if immobilized on “X-TRIM” spinal boards or on the “VACUUM 3”
vacuum mat.
All decisions regarding movement and immobilization of the patient, as well as the duration of
these operations, the methods to be adopted and use in conjunction with other devices, must
be taken and implemented by expert, trained personnel only.
The suspension assembly (H), not supplied, makes the “911 SHELL” stretcher capable of
being lifted by helicopter.
Assemble the two parts of the structure in the following steps:
a) Rotate the two safety arms (fig. 6),
b) Lift and rotate the two locking arms (fig. 7),
CHAPTER 4
Fig.6 Fig.7

10 Original Italian version of 04/07/2018
c) Connect the two parts of the structure using the pins on the frame (fig. 8),
d) Reposition the two locking arms in their respective brackets (fig. 9),
e) Reposition the two safety arms (fig.10) and check the tightness of the coupling,
f) Fully tighten the two ring nuts (Fig. 11).
Fig.8
Fig.9
Fig.10
Fig.11

880.03 911 SHELLwww.kong.it 11 Original Italian version of 04/07/2018
4.3 POSITIONING AND SECURING THE PATIENT
With the stretcher positioned on a flat, stable surface:
a) Unhook the buckles and open the securing straps (Fig. 12),
b) Lay the patient in the stretcher, hook on the buckles and tension the straps until they secure
the patient (Fig. 13).
This procedure must also be used for patients immobilized on the “X-TRIM” spinal board or on
the “VACUUM” vacuum mat.
Fig.12
Fig.13

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4.4.1 Connecting the handles
a) Connect the handles to the frame of the stretcher (fig.14), making sure to observe the
coupling numbering,
b) Lock the connection by inserting the shaped plug into the corresponding hole (Fig. 15).
Fig.14
Fig.15
4.4 PATIENT TRANSPORT
The stretcher enables the patient to be lifted and transported by:
a) the side slots in the frame
b) the handles,
c) the suspension assembly.

880.03 911 SHELLwww.kong.it 13 Original Italian version of 04/07/2018
4.4.2 Connection to the suspension assembly
a) Connect the suspension assembly to the corresponding side holes on the stretcher,
using the eight connectors (Fig. 16),
b) Screw the ring nuts of the connectors fully tight.
Fig.16

14 Original Italian version of 04/07/2018
The maintenance procedures that must be performed by the user are:
a) Cleaning: wash after each use with lukewarm drinking water (max 40 ° C), possibly with
the addition of a neutral detergent (e.g. Marseille soap). Rinse and leave to dry in the
shade, away from direct heat,
b) Disinfection, whenever necessary: immerse the product for one hour in lukewarm water
diluted with 1% bleach (sodium hypochlorite), then rinse thoroughly with drinkable water
and allow to dry in the shade, far away from any direct sources of heat.
Repairs may only be carried out by the manufacturer.
The user is permitted to replace with new, original parts only those parts
mentioned in paragraph 3.4.2.
The “SHELL” stretcher is made from materials with high resistance to wear and to external
agents. Despite this, practical conditions of use will require some maintenance to be carried
out and, in certain special cases, even some repairs.
MAINTENANCE
AND REPAIR
5.1 GENERAL
5.2 MAINTENANCE
5.3 REPAIR
CHAPTER 5
Maintenance and repairs must be recorded in an appropriate log, an example
of which is given in chapter 10.

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After cleaning, disinfection and drying, store the device and its accessories in a dry (relative
humidity 40-90%), cool (temperature 5-40 ° C), dark (avoid UV radiation), chemically neutral
(absolutely avoid saline and / or acidic environments) place, away from sharp edges,
sources of heat, humidity, corrosive substances or other possible damaging conditions.
Do not store this device wet!
6STORAGE
CHAPTER 6
STORAGE

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Before and after each use, it is necessary to check the device and to make sure that:
- it is suitable for the use for which it is designed,
- it has not undergone any mechanical deformations and shows no cracks or signs of wear,
- the textile parts do not show cuts, burns, residues of chemical products, excessive hair,
wear; in particular, check the areas in contact with the metal components,
- all markings, including the labels, are legible.
The device must be inspected at least once a year, starting from the date of first use, by
competent personnel trained and authorized by KONG SpA.
The date of first use and the results of the inspections must be recorded in the Inspection
and Overhauls Log, an example of which is given in chapter 10.
All overhauls of the device must be performed by KONG SpA, or by competent personnel
trained and authorized by the same, if:
- any malfunctions are detected,
- the outcome of pre and post-use checks or inspections is negative.
The results of the overhauls must be recorded in the Inspections and Overhauls Log, an
example of which is given in chapter 10.
The overhauled device is guaranteed for one year from the date of the overhaul
CHECKS
INSPECTIONS
AND OVERHAULS
7.1 CONTROLS
7.2 INSPECTIONS
7.3 OVERHAULS
CHAPTER 7

880.03 911 SHELLwww.kong.it 17 Original Italian version of 04/07/2018
PRODUCT LIFETIME
AND WARRANTY
Carefully read the section “Warnings and Limitations of Use” in chapter 2.
The lifetime of this device is determined by the results of inspections, carried out at least once
a year, (paragraph 7.2) and of any overhauls.
The suspension assembly, even if never used, has a maximum lifetime of 10 years from the
date of manufacture shown on the label.
8.1 PRODUCT LIFETIME
For correct disposal, you must comply with the regulations in force in the country of use or
the waste disposal procedures used by the reference hospital.
8.2 DISPOSAL
The manufacturer guarantees the conformity of the device with the standards in force
at the time of production. The warranty for defects is limited to defects in raw materials
and manufacturing, does not include normal wear and tear, oxidation, damage caused by
non-compliant use and / or competitions, incorrect maintenance, transport, preservation
or storage, etc. The warranty will become void immediately if any changes to the device
are made or if it is tampered with. Its validity corresponds to the legal warranty for the
country in which the device was sold, from the date of sale by the manufacturer. Once this
period has expired, no claim can be made against the manufacturer. Any request for repair
or replacement under warranty must be accompanied by proof of purchase. If the defect
is acknowledged, the manufacturer undertakes to repair or, at its discretion, replace the
device or else refund the purchase price. In no case shall the manufacturer’s liability extend
to an amount higher than the purchase price of the device.
8.3 WARRANTY
Important: remove and make devices unusable that have not passed the
pre-use, post-use or periodic inspections.
CHAPTER 8
Professional and leisure activities are often regulated by specific national laws that may
impose limits on and / or obligations regarding the use of these devices. It is the user’s duty
to know and to apply such laws, as these may provide for restrictions different from those
stated in this information notice.
8.4 LEGAL OBLIGATIONS

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LABELLING
AND SYMBOLS
9.1 LABELLING
9.2 SYMBOLS
Manufacturer identification
Product identification code
Unique serial number
Consult the user manual
Warning: For safety information, refer to user manual
Complies with Council Directive 93/42 / EEC and smi, DM Class I
Any variations in the presentation of symbols do not change their meaning.
CHAPTER 9
LLLLLL : Production batch
YY : Production year
XXXX : Serial number
Example of labelling.

880.03 911 SHELLwww.kong.it 19 Original Italian version of 04/07/2018
DOCUMENTS
STRETCHER- Class I Medical Device
REF. 880.03 MOD. 911 SHELL
SN Registration number DM 1448767
Date of first use
CHAPTER
10
10.1 INSPECTIONS AND OVERHAULS LOG
ISPEZIONI E REVISIONI
DATE I / R Description Outcome Responsible

20 Original Italian version of 04/07/2018
10.2 DECLARATION OF CONFORMITY (FACSIMILE)
DECLARATION OF CONFORMITY
The manufacturer:
Business name : KONG S.p.A.
Registered office: Via XXV Aprile, 4 - 23804 Monte Marenzo (LC)
Operating office: Via XXV Aprile, 4 - 23804 Monte Marenzo (LC)
VAT number: IT 00703180166
declares that the:
Medical Device: 911 SHELL
Class: The second annex IX rule 1
REF: 880.03
SN (serial number): _________________
Date of production: _________________
registered in the database of the Ministry of Health under number 1448767,
complies with the essential requirements of Legislative Decree 46/97 and subse-
quent amendments, which transposes Medical Devices Directive 93/42/EEC and
subsequent amendments
Production of the Medical Device took place in accordance with our own quali-
ty management system, which meets the requirements of Annex VII of Directive
93/42/EEC and subsequent amendments.
Monte Marenzo, ________________ KONG S.p.A.
The legal representative
Dr. Marco Bonaiti
Module in revision 0 of 01/08/2016
Company Capital . € 2.000.000,00 CCIAA Lecco REA 165758 Reg. Companies of Lecco 00703180166 P.IVA (VAT): IT 00703180166
ThisdeviceissoldwiththerespectiveCEDeclarationofConformitydrawnupandsignedinthe
original. If it has been lost or the packaging was missing, you can request a replacement from:
[email protected] communicating the univocal serial number [SN] shown on the device
label.
KONG S.p.A.
Via XXV Aprile, 4 - (zona industriale)
I - 23804 MONTE MARENZO (LC) - ITALY
Tel [phone] - Fax [phone]
www.kong.it certified UNI EN ISO 9001