KLS Martin independant Fix Bridge User manual

ront Cover
English
independant
Fix Bridge
independant
Fix Ceiling
independant
Fix Wall
Instructions for Use
0051
90-577-52-10
Revision 01
Date of Release: 2020-11
www.klsmartin.com

2 Revision 01
Symbol Explanation
The following symbols are either part of this instruction for use and / or of the product labeling.
Safety alert symbol
CAUTION Indicates a situation which, if not avoided,
could result in minor or moderate injury.
WARNING Indicates a situation which, if not avoided,
could result in death or serious injury.
DANGER Indicates a situation which, if not avoided,
will result in death or serious injury.
Instructions for Use
Serial number
Date of manufacture
Manufacturer
Distributor
0051 CE marking of conformity
Type B applied part
Protective earth (ground)
Do not dispose this product into the ordinary municipal waste.
Supply voltage
110-120 220-230 V
50/60 Hz
Type of power supply and frequency
xxxVA (each electrical
outlet) Power consumption of each electrical socket

Revision 01 3
N
L
Neutral
Line
F1, F2, F3, … Fuse identification as per electrical diagram (where applicable)
SOCKET 1, SOCKET 2, … Socket identification as per electrical diagram (where applicable)
xxxVA (lighting) Power consumption of each light
Correct Configuration
Key required
Inlay shape diameter
Click
Drag towards arrow direction
Tighten screw/nut
Maximum Load Capacity
Rotate to Lock/Unlock

independant Fix
Instructions for Use
4Revision 01
Table of Contents
1 General Information....................................................................................................................................5
1.1 Manufacturer .....................................................................................................................................5
1.2 Hotline................................................................................................................................................5
1.3 Terms & Acronyms.............................................................................................................................5
2 General Safety Warnings.............................................................................................................................6
3 Intended Use ...............................................................................................................................................8
4 Configuration...............................................................................................................................................9
5 Screw Torques ...........................................................................................................................................10
6 Functioning................................................................................................................................................11
7 General and Technical Features................................................................................................................16
7.1 General Features..............................................................................................................................16
7.2 Technical Specification.....................................................................................................................16
8 Cleaning and Maintenance........................................................................................................................18
8.1 Required Maintenance.....................................................................................................................18
8.2 Recommended Maintenance...........................................................................................................18
8.3 Cleaning............................................................................................................................................18
9 Carriage, Storage and Disposal..................................................................................................................19
10 FAQ & Troubleshooting.............................................................................................................................20
10.1 FAQ...................................................................................................................................................20
10.2 Troubleshooting...............................................................................................................................20
11 Electromagnetic Interference Tables ........................................................................................................21
12 Maintenance Log Book..............................................................................................................................23

independant Fix
Instructions for Use
Revision 01 5
1General Information
1.1 Manufacturer
We thank you for buying one of our products.
This product bears the CE mark. This means that it meets the basic requirements on the safety and the
performance of medical devices set forth by the respective applicable European regulations.
We are the manufacturer of this product:
LM Medical Division s.r.l.
Via Brigate Alpine 9
25036 Palazzolo sull’Oglio
Brescia – Italy
Phone [phone]
1.2 Hotline
Should you have any questions on how to handle the device or product or use it for clinical applications,
please do not hesitate to contact the Product Management:
Phone: [phone]
Fax: [phone]
In case of technical questions and questions regarding maintenance contracts and training, please contact
our Martin Service Center:
Phone: [phone]
Fax: [phone]
E-mail: [email protected]
To answer your technical questions as efficiently as possible, our service technicians require the serial
number of the product. Therefore, please have this number at hand when contacting our hotline. The
serial number is indicated on the rating plate
.
1.3 Terms & Acronyms
Designation Description
UDA Medical Supply Units
MD Medical Device
EMC Electromagnetic Compatibility

independant Fix
Instructions for Use
6Revision 01
2General Safety Warnings
The following warnings concern the medical device general functioning.
MD use must be done only after having read all sections of the current operating instructions.
•Please follow all warnings in these instructions for use and in the enclosed MD's.
Risk of injury due to explosion!
•
Don’t use UDA in areas where flammable gases, combustible materials or explosives can be found.
Risk of injury due to unqualified installation!
UDA installation must be done following indication listed on manufacturer installation manual. Electrical
connection must be done following the manufacturer electrical scheme.
Gas outlet distribuiton must be done by qualified personeel according to EN
7396-1 and EN 7396-2
regulations. Distribuiton medical gas system must be tested
and prewired before delivery.
UDA is not sterilizable.
Risk of injury due to spare parts
not authorized by the manufacturer!
•
Please make sure to replace damaged parts with original parts only.
•
Please replace damaged screws with new ones with the same specification.
Risk of injury due to electrical shock
!
UDA may contain electrical
current.
•
Please don’t open system housing.

independant Fix
Instructions for Use
Revision 01 7
Risk of injury due to electrical shock!
Before connecting UDA to the main power supply, pay attention to tension and frequency displayed on
label.
•
Uda must be protected by circuit braker differential switch.
Risk of injury due to electrical shock!
To avoid electric shock danger, UDA must be wired with grounded connection.
Risk of injury due to electrical shock!
About UDA’s connection, regardless any kind or combinations of devices, please don’t
exceed the
electrical power UDA was made for, which can be found on the labels applied on the plate. Please don’t
connect adapters between the device’s electrical sockets and plugs.
Risk of injury due to system parts falling down!
•
Please don’t overload UDA’s max load, listed on the related label.
Risk of injury due to unauthorized use!
UDA must not be tempered with or used differently from the intended use.
Risk of injury due to unauthorized maintenance work!
The user is not allowed to
replace UDA’s components. This operation must be done by authorized
personnel only.
•
In order to replace worn-out parts, please follow the maintenance instructions carefully.
Damaged UDA removal must be don
e by authorized personnel only.
•
Before removing the UDA, remove the power supply using the protection switch on the general panel
and ask qualified personnel to replace the UDA.

independant Fix
Instructions for Use
8Revision 01
Risk of injury due to unauthorized use of outlets!
Connecting an electrical appliance to multiple outlets to create an RM
system which may result in a
reduced level of safety. The UDA should not be used near other equipment.
3Intended Use
The pendant models Indepedant Fix are manufactured for medical use areas only, in order to allow:
•Electrical current flow;
•Data (nurse calling system, phone, PC network)
•Medical gas outlet, AIR, VAC
•Anaesthetic gas
And supporting
•Diagnostic devices
•Therapy devices
•Surgery devices
These medical devices are built in order to obtain an all in one pendant device which can provide all
functions and needs of intensive care, recovery rooms.

independant Fix
Instructions for Use
Revision 01 9
4Configuration
independant Fix Bridge
independant Fix Wall independant Fix Ceiling

independant Fix
Instructions for Use
10 Revision 01
5Screw Torques
Dimension Torques
M5 7 Nm
M6 12 Nm
M8 30 Nm

independant Fix
Instructions for Use
Revision 01 11
6Functioning

independant Fix
Instructions for Use
12 Revision 01

independant Fix
Instructions for Use
Revision 01 13

independant Fix
Instructions for Use
14 Revision 01

independant Fix
Instructions for Use
Revision 01 15

independant Fix
Instructions for Use
16 Revision 01
7General and Technical Features
7.1 General Features
The independant Fix integrate, electrical distribution, diagnostic alerts, signals, nurse call system and
medical gas distribution in one device; a series of accessories make it suitable to support other medical
equipment. All bed head units are made from extruded aluminium profiles of a suitable thickness, anodized
or painted with epoxy RAL colours chosen by the customer. The different types are derived from the
combination of multiples profiles, meet the different needs of the hospital.
7.2 Technical Specification
Regulation The equipment should be considered class IIb
Electrical hazards protection raiting
classification
Class I device. Electrical shock protection is guaranteed by ground protection metal
parts
Direct and indirect contact safety raiting
classification The device is not equipped with applied parts
Fluid penetration and external agents
protection raiting classification IP20
Use and condition classification Seamless operation device
Noise level Less than 35 dB
Single unit production test
For each unit the following tests are performed:
•Ground impedance protection conform to standard 8.6 laid down by
IEC EN 60601-1
•Standard leakage current and dielectric strength measure conform to
standards 8.7, 8.8, 16.6 laid down by EN 60601-1
•Medical gas and vacuum distribution test conform to standards 12.3, 12.4,
12.5, 12.6 laid down by EN ISO 7396-1
•Testing facilities on evacuation of anesthetic gases conform to standards 12.2,
12.3, 12.4 laid down by EN ISO 7396-2
All tests performed on end-of-line produtcs are a core part of the current manual
Electromagnetic interferences
The operation of other devices placed nearby this medical device (such as portable
equipment or furnitures) may cause electromagnetic interferences or other
interferences. Please always check with qualified personnel
Supply voltage 110–120 V and 220–230 V, 50/60 Hz
Auxiliary voltage 24 VDC or 24 VAC (usually)
Power consumption
Lighting
Electrical socket
Max 150 W
Max 2,000 W for each socket
Components replaceable by technical
support staff All the electrical components listed in the “Parts list”
External power circuit protection Circuit breakers or power related sized fuse guarantee a top notch protection
Standards reference ISO 11197, IEC EN 60601-1, EN ISO 14971, EN ISO 15223-1, EN 1041,
EN ISO 7396-1, EN ISO 7396-2, EN ISO 5359

independant Fix
Instructions for Use
Revision 01 17
Regulation The equipment should be considered class IIb
Documentation available on user request
The manufacturer agrees to provide circuit diagrams, component parts lists,
calibration instructions or any other useful information that technical assistance
may requires in order to repair component’s replaceable parts.
Manufacturer registered office and
production site address Via Brigate Alpine n° 9 San Pancrazio – 25036 Palazzolo Sull’Oglio (BS) – Italy
Disposal In compliance with provisions No. 151/05 laid down by Legislative Decree
Unit of Measures [mm]

independant Fix
Instructions for Use
18 Revision 01
8Cleaning and Maintenance
8.1 Required Maintenance
If inside the power unit are installed flexible prepping, you can find inspection points on the pendant and
the suspension structure, in order to guarantee a proper inspection.
We recommend a regular inspection every 6 months. Flexible prepping replacement every 8 years is
required. The new flexible prepping must be conform to standards laid down by EN ISO 5359.
After installation, tests must be perform in order to match standards laid down by EN ISO 7396-1 and
EN ISO 7396-2.
8.2 Recommended Maintenance
We recommend to check the following list every 6 months.
•Correct operation of the brake system (LEDs, movement and braking correct)
•Possible motorized movement (silent/check the lubrication of the worm screw, check the operation of
the limit switch)
•Correct operation of the swivel joint (silent, vibration free)
•Case matching (without opening)
•Operation of electrical sockets, fuses, gas sockets, accessories
8.3 Cleaning
The painting or anodic oxidation guarantee the durability of the external surfaces of the headboards.
Cleaning must be done using a soft cloth slightly moistened with non-alcoholic disinfectants but non-
abrasive detergent. Do not use active solvents to clean the plastic parts.

independant Fix
Instructions for Use
Revision 01 19
9Carriage, Storage and Disposal
In the following environmental conditions, carriage and storage conformity is needed
•Temperature: -10 °C to +40 °C (14 °F to +104 °F)
•Humidity: 30 – 75%
•Atmospheric pressure: 700 – 1,060 hPa
Do not overlap more than 5 devices and do not place them vertically. In case of irreparable damages or
end-of-life equipment, the device must be disposed following the existing rules. If the user does not follow
the rules above, he assumes full responsibility for creating potential effects to the environment and to
human health.
Below are shown the environment conditions’ use
•Temperature: -5°C to +35°C (23 °F to +95 °F)
•Humidity: 30 – 75%
•Atmospheric pressure: 700 – 1,060 hPa

independant Fix
Instructions for Use
20 Revision 01
10 FAQ & Troubleshooting
10.1 FAQ
Question Answer
Which are the materials Independent Fix is made
of?
Fixing structure (where provided) and screws – galvanized steel
Internal parts of swiveling joint – galvanized steel and nitride steel
Frame, arms, pendant – epoxy painted aluminum
Accessories – refer to the drawings (ABS, AVONITE, STEEL, STAINLESS
STEEL, CDF, etc.)
Is Independent Fix easy to install? Independent Fix is easy to install. Please follow the instruction manual
alongside a qualified staff.
Does Independent Fix ship to destination as
separated elements?
Independent Fix is shipped in a single pallet packing, while the arms system
is packed separately.
Is Independent Fix easy to clean? Yes, Independent Fix is easy to clean due to smooth surfaces
Is Independent Fix easy to maintain? No maintenance is needed except for gas implants (please refer to this
manual)
Does Independent Fl Fix ex include the fixing
structure? As standard we supply also fixing structure (except where specified)
How many parts Independent Fix brake system
does it have?
The swiveling joint between console and console tube has a mechanical
friction brake for stiffer movement
Which is swiveling joints minimum internal
diameter? 114 mm
What does “declared carrying capacity” mean? The declared carrying capacity is to be intended as maximum payload as
shown in drawnings in the Functioning chapter of this manual
10.2 Troubleshooting
Issue Cause Solution
Manual movement (rotation) doesn’t work Swiveling joint blocked Please contact after-sales service
Electrical outlet power failure No power supply Check if power supply has been plugged correctly