Kong 911 SHELL User manual

EN
Regulation (EU)
2017/745
911 SHELL
880.03

2 Original Italian version of 10/01/2022
Download the digital version - Scarica la versione digitale

880.03 911 SHELLwww.kong.it 3 Original Italian version of 10/01/2022
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 Optional components 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 Medical Device label 18
9.2 Symbols 18
10 - DOCUMENTS 19
10.1 Inspections and servicing register 19
10.2 Maintenance and repair register 20
10.3 EU Declaration of conformity 21
11 - LIST OF STANDARDS AND REFERENCE STANDARDS APPLIED 22
11.1 Standards applied 22
11.2 Standards used as a reference 23

4 Original Italian version of 10/01/2022
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.
It identifies that the Medical Device is manufactured, designed and produ-
ced 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
SYMBOLOGY
AND ASSISTANCE
For information, contact the Kong Customer Service Department by:
telephone [phone]
- fax [phone]
- email: [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 10/01/2022
Warning: not suitable for
use in an ATEX environment
(Directive 94/9/CE)
Theinformationprovidedbythemanufacturer
(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

6 Original Italian version of 10/01/2022
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 10/01/2022
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 table below defines the capacities of the “911 SHELL” stretcher, based on the method of
use deemed most appropriate by the rescue operator, the outcome of the laboratory tests and
recommended safety coefficients.
How to use Tensile
strength
Safety
coefficient Capacity
Transport with the handles (fig. 2) > 450 kg 1:3 150 kg
Lifting and lowering with rescue
devices (fig. 3)
with 880.02 PHOENIX suspensions
(optional components)
> 1500 kg 1:10 150 kg
Lifting and lowering using helicopters (fig. 3)
with 880.02 PHOENIX suspensions
(optional components)
> 1500 kg 1:14 100 kg
Before any recovery operation, make sure that the weight does not exceed
the capacity defined above!
Fig.2
F
F

8 Original Italian version of 10/01/2022
Fig.4
3.4 OPTIONAL COMPONENTS AND SPARE PARTS
3.4.1 Optional components
The methods of connection and use of the optional components are defined in the relative
user instructions.
880.02 PHOENIX
Suspension with coloured ends (red, head side - blue, feet side) and connectors with screw-
equipped ring nut, suitable for lifting and lowering using rescue devices and helicopters.
C – Mattresses,
G – Padding for handles.
3.4.2 Spare parts
Fig.3
H
H
G
C

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INFORMATION
SPECIFICATIONS
4.1 INTENDED USE
4.2 ASSEMBLY
The “911 SHELL” stretcher is a MD specially designed for the recovery and transport of
patients, even if immobilized on “X-TRIM” spinal boards or on the “VACUUM” 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. 5),
b) Lift and rotate the two locking arms (fig. 6),
CHAPTER 4
Fig.5 Fig.6

10 Original Italian version of 10/01/2022
c) Connect the two parts of the structure using the pins on the frame (fig. 7),
d) Reposition the two locking arms in their respective brackets (fig. 8),
e) Reposition the two safety arms (fig.9) and check the tightness of the coupling,
f) Fully tighten the two ring nuts (Fig. 10).
Fig.7
Fig.8
Fig.9
Fig.10

880.03 911 SHELLwww.kong.it 11 Original Italian version of 10/01/2022
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. 11),
b) Lay the patient in the stretcher, hook on the buckles and tension the straps until they secure
the patient (Fig. 12).
This procedure must also be used for patients immobilized on the “X-TRIM” spinal board or on
the “VACUUM” vacuum mat.
Avoid prolonged contact of the patient’s skin with the fabrics of the device
Fig.11
Fig.12

12 Original Italian version of 10/01/2022
4.4.1 Connecting the handles
a) Connect the handles to the frame of the stretcher (fig.13), making sure to observe the
coupling numbering,
b) Lock the connection by inserting the shaped plug into the corresponding hole (Fig. 14).
Fig.13
Fig.14
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 10/01/2022
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 (red, head side - blue, feet side) (Fig. 15),
b) Screw the ring nuts of the connectors fully tight.
Fig.15

14 Original Italian version of 10/01/2022
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, when deemed necessary or after prolonged inactivity (more than 21 days),
preceded by cleaning: wipe with a clean cloth , soaked in a water solution of sodium
hypochlorite (bleach) witha 0,1% concentration (1000 ppm). When blood or other
bodily fluids are present, the recommended concentration of sodium hypochlorite is
0,5%(5000ppm).
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

16 Original Italian version of 10/01/2022
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 10/01/2022
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

18 Original Italian version of 10/01/2022
LABELLING
AND SYMBOLS
9.1 MEDICAL DEVICE LABEL
9.2 SYMBOLS
CHAPTER 9
Manufacurer's identification
Product identification code
Unique serial number
Country, year and month of production.
Unique Device Identifier
Medical Device
Consult the user manual
Compliant with Regulation (EU) 2017/745
UDI
MD
ITALY
YYYY / MM
Manufacurer's identification
Product identification code
Unique serial number
Country, year and month of production.
Unique Device Identifier
Medical Device
Consult the user manual
Compliant with Regulation (EU) 2017/745
UDI
MD
ITALY
YYYY / MM
Identification and traceability
Information and safety
Any changes to the positioning of the symbols does not change the content thereof.
UDI
MD
ITALY
2022 / 01
880.03 - MOD. 911 SHELL
(01)08023577046082(21)1234561234
KONG S.p.A.
Via XXV Aprile, 4
I - 23804 MONTE MARENZO (LC) - ITALY
Tel. [phone]
123456 1234
Data matrix UDI
Readable with the Apps:
iGepir - BarValid - Barcode Scanner

880.03 911 SHELLwww.kong.it 19 Original Italian version of 10/01/2022
DOCUMENTS
STRETCHER- Class I MD
REF. 880.03 MOD. 911 SHELL
UDI-DI 08023577046082 SN
Date of first use
CHAPTER
10
10.1 INSPECTIONS AND SERVICING REGISTER
INSPECTIONS AND SERVICING
DATE I / R Description Outcome Responsible

20 Original Italian version of 10/01/2022
STRETCHER - Class I MD
REF. 880.03 MOD. 911 SHELL
UDI-DI 08023577046082 SN
Date of first use
10.2 MAINTENANCE AND REPAIR REGISTER
MAINTENANCE AND REPAIRS
DATE M/R Description Outcome Supervisor