Kong 911 SHELL Manuale utente
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
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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 0039 0341 630506
- Fax 0039 0341 641550
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
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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
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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
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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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Original Italian version of 04/07/2018
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
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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
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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
Altri manuali per 911 SHELL
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