OPTIKON 2000 User manual

Cod. 183001EN
2010-03-09 Rev.D
EQUIPMENT CART WITH CYLINDER HOLDER
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13 - 00138 Rome Italy
Phone [phone] - Fax. [phone]
e-mail [email protected] - www.optikon.com

OPTIKON 2000 SpA is an ISO 9001 and ISO 13485 certified
company which manufactures surgical and diagnostic devices
for ophthalmology.
Its products are manufactured to satisfy the requirements of
93/42/EEC Medical Devices Directive.

TABLE OF CONTENTS
1DISCLAIMER....................................................................................1-1
2LIMITED WARRANTY CONDITIONS.............................................2-1
3WARNINGS....................................................................................3-1
4SYMBOLS AND MARKINGS .........................................................4-1
5GENERAL INFORMATION ............................................................5-1
5.1 SYSTEM DESCRIPTION ................................................................................5-1
5.2 CONTROLS AND INDICATORS.....................................................................5-1
5.3 TECHNICAL SPECIFICATIONS.....................................................................5-2
5.4 CIRCUIT DIAGRAMS......................................................................................5-3
6INSTALLATION AND OPERATING PROCEDURE.......................6-1
6.1 INTRODUCTION.............................................................................................6-1
6.2 INITIAL INSPECTION......................................................................................6-1
6.3 INSTALLATION...............................................................................................6-2
6.4 SHUT DOWN PROCEDURE ..........................................................................6-3
6.5 MAINTENANCE AND CARE...........................................................................6-4
7TROUBLE SHOOTING GUIDE ......................................................7-1

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1 DISCLAIMER
OPTIKON 2000 S.p.A. requires the user of this system to carefully read specific
warnings found in this manual. It is responsibility of the user to provide its
personnel with a thorough understanding of the equipment operation before
use. In no event shall OPTIKON 2000 S.p.A. be liable for any injury, incidental
or consequential damages incurred by the purchaser, users or patients as a
result of operation of the product.
Use of this system is a matter of professional medical judgment in all cases.
OPTIKON 2000 S.p.A. is not responsible for any clinical problem resulting from
mishandling this equipment and makes no medical recommendations.
OPTIKON 2000 S.p.A. declares to be liable for safety, reliability and
performance only if:
• upgrades, calibrations, repairs are carried out by OPTIKON 2000 S.P.A.
authorized personnel
• the system is used in accordance with its instructions for use
• the mains electric installation to which the system is connected
complies with the IEC or UL Safety Regulations
IMPORTANT NOTICE
Every effort has been made to have all the illustrations and information
accurately represent the product and its operation as it actually was at the
time this operation manual was printed. Changes in some items may be
made during the life of this manual, so that we may effectively continue to
meet the requirements of users. On occasion, these changes may be made
without notice.
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13
00138 Rome Italy
Teleph. [phone]
Fax. [phone]
e-mail [email protected]
www.optikon.com
NOTICE: Information contained in this manual is proprietary with OPTIKON 2000
S.p.A. reproduction of any part or whole may only be performed with written
permission from OPTIKON 2000 S.p.A.
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2 LIMITED WARRANTY CONDITIONS
All OPTIKON 2000 S.P.A. equipment and accessories sold and installed in the
European Union are guaranteed against defective workmanship and faulty parts
for ONE YEAR, from the date of the invoice. Warranty on consumable materials
is limited to the first use.
Please, inquire with your local Optikon Distributor for warranty conditions in
countries outside the European Union.
All items under warranty will be repaired or replaced free of charge.
Warranty includes the research of causes of the faults, reparation of the defect
and a final inspection of the unit, or part(s).
This warranty does not cover the results of misuse, accident, abuse and
tampering or alteration done by anyone other than personnel authorized by
OPTIKON 2000 S.p.A.
OPTIKON 2000 S.P.A. reserves the right to ascertain, in case of faults, whether
or not the equipment and/or its accessories have been altered, tampered with,
in any way, or have been damaged by improper use.
OPTIKON 2000 S.P.A. also reserves the right to modify the equipment and/or its
accessories whenever operating techniques necessitate modification(s).
No warranty will be recognized if serial number of the equipment and/or
accessories attributed by OPTIKON 2000 S.P.A. is missing, tampered and/or not
clearly readable.
Warranty does not include expenses for return shipment of equipment and
accessories: all expenses for transport, packing etc. are to be borne by the
purchaser.
In case of an expressly requested intervention of our technicians, all travel and
hotel expenses will be debited to the client.
OPTIKON 2000 S.P.A. cannot be held liable for damages caused by
transportation. If this is the case, the customer should apply at once to the
carrier that handled the consignment.
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3 WARNINGS
Care in the handling of surgical equipment and instruments is one of the
first principles in an operating-room, and no amount of warnings can
take place of such care.
NOTE: THIS INFORMATION IS BELIEVED TO BE CURRENT AT THE TIME OF
PUBLICATION, BUT IS PROVIDED WITHOUT WARRANTY OF ANY KIND AND
WE ASSUME NO RESPONSIBILITY WITH RESPECT THERETO.
The following warnings will aid the user to provide adequate safeguards
to assure safe, trouble free performance:
• ALL MEDICAL PERSONNEL SHOULD READ AND UNDERSTAND THE
INSTRUCTIONS IN THIS MANUAL AND THE MANUAL OF THE EQUIPMENT
CONNECTED TO THE CART PRIOR TO THE SYSTEM IS USED. DO NOT
ATTEMPT TO USE THE SYSTEM IF IT FAILS TO PERFORM AS SET OUT IN
THE OPERATION PROCEDURES, IN THESE MANUALS.
• USE OF THE SYSTEM SHOULD BE RESTRICTED TO QUALIFIED MEDICAL
PERSONNEL.
• USE OF THIS SYSTEM IS A MATTER OF PROFESSIONAL MEDICAL
JUDGMENT IN ALL CASES. OPTIKON 2000 S.p.A. IS NOT RESPONSIBLE
FOR ANY CLINICAL PROBLEM RESULTING FROM MISHANDLING THIS
INSTRUMENT AND MAKES NO MEDICAL RECOMMENDATIONS.
• DO NOT USE THE SYSTEM IN THE PRESENCE OF FLAMMABLE
ANAESTHETICS, MIXTURE WITH AIR OR WITH OXYGEN OR NITROUS
OXIDE.
• TO REDUCE THE RISK OF ELECTRIC SHOCK, DO NOT REMOVE COVER
(OR BACK). REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.
• THE OPTIKON EQUIPMENT CART SHOULD BE CONNECTED TO A MAINS
SUPPLY ONLY AS MARKED ON THE REAR PANEL. TO GUARANTEE
SAFETY, A HOSPITAL GRADE POWER CORD AND PLUG MUST BE USED,
THE UNIT MUST BE GROUNDED.
• FOR OPERATING SAFETY DO NOT INSTALL THE SYSTEM IN A LOCATION
WHERE IT WILL BE EXPOSED TO HEATING EQUIPMENT OR RADIATORS.
DIRECT SUNLIGHT AND ANY OTHER SOURCE OF EXTREMELY HIGH
TEMPERATURES.
• BE SURE THAT THE POWER SWITCH ON THE REAR PANEL OF THE CART
IS OFF WHEN PLUGGING IN, OR REMOVING THE POWER CABLE FROM A
WALL OUTLET. TURN OFF THE MAIN POWER SWITCH WHENEVER THE
EQUIPMENT IS NOT IN USE.
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• EXCHANGING FUSES SHOULD BE DONE A FEW MINUTES AFTER THE
MAINS SWITCH HAS BEEN TURNED OFF.
• REPLACE FUSE AS MARKED.
• DO NOT EXCEED THE FOLLOWING MAXIMUM LOAD LIMITS:
Equipment tray 25Kg
OVERLOADING THE CART MAY CAUSE MECHANICAL FAILURES AND
POSSIBLE HARM FOR THE PATIENT AND/OR THE OPERATOR.
• DO NOT TILT THE CART MORE THAN 10° IN ANY DIRECTION.
• TO AVOID RISK OF SMOKE OR FIRE, WHEN PLUGGING HOSTED
EQUIPMENT TO THE CART, DO NOT EXCEED THE SPECIFIED MAXIMUM
ELECTRIC LOAD (SEE TECHNICAL SPECIFICATIONS AND THE LABELING
OF THE CART).
• TO AVOID POSSIBLE ELECTRIC SHOCK TO THE PATIENT DUE TO
EXCESSIVE LEAKAGE CURRENT OR INSUFFICIENT DIELECTRIC
STRENGHT, PLUG TO THE CART COMPATIBLE OPTIKON EQUIPMENT
ONLY (SEE COMPATIBILITY CHART IN THE TECHNICAL
SPECIFICATIONS).
• CAUTION: ELECTRIC SHOCK HAZARD. AVOID DRIPPING WATER ON
THE ELECTRIC RECEPTACLE OF THE CART. IF THE ELECTRIC
RECEPTACLE GETS WET, DISCONNECT THE CART FROM MAINS AT THE
WALL OUTLET END BEFORE TRYING TO REMOVE THE WATER.
• DO NOT DISPOSE OF THE TROLLEY AS UNSORTED MUNICIPAL WASTE.
COLLECT IT SEPARATELY ACCORDING TO THE LOCAL
LAWS/REGULATIONS ON DISPOSAL OF WASTE ELECTRICAL AND
ELECTRONIC EQUIPMENT.
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4 SYMBOLS AND MARKINGS
The following symbols are often used on medical equipment, with the
function of delivering information and warnings in a limited space.
The user should become acquainted to these symbols before using the
equipment.
SYMBOL DESCRIPTION
ALTERNATE CURRENT
DIRECT CURRENT
PROTECTIVE EARTH
ATTENTION CONSULT ACCOMPANYING
DOCUMENTATION
OPEN (POWER DISCONNECTED FROM
THE MAINS)
CLOSED (POWER CONNECTION FROM
MAINS)
TYPE B APPLIED TO THE PATIENT
(BODY)
TYPE BF FLOATING PART APPLIED TO
THE PATIENT (BODY-FLOATING)
SEPARATE COLLECTION OF WASTE
ELECTRICAL/ELECTRONIC EQUIPMENT
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5 GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
The Optikon equipment trolley with cylinder holder 183001 has been designed to
host the Optikon surgical systems console and to move them conveniently in the
Operating Room area.
It is also provided with a housing for CO2 or N2O gas cylinders, and relevant
cylinder holders (spring).
The base of the cart is provided with antistatic wheels, with locking system.
5.2 CONTROLS AND INDICATORS
All controls and indicators are located on the rear of the cart.
1. POWER (ON/OFF MAINS SWITCH/PILOT LAMP)
This illuminated rocker switch controls the sockets to power the consoles
hosted by the cart. Provided that the mains switches of the single consoles are
left to the on position, this switch will energize or de-energize all the surgical
system.
2. MAINS POWER CONNECTION FOR HOSTED CONSOLES.
Three mains sockets allow connecting the mains power for the hosted surgical
consoles.
3. PROTECTION COVER
This transparent lid has been designed to prevent the use of the mains sockets
to connect any device other than an approved Optikon console. The lid must be
removed by a qualified technician when the console is first installed. The lid
must be restored in place once the equipment has been installed.
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4. MAINS INLET AND FUSE HOLDER
The power cord to energize the cart must be connected to this inlet. Use only
the supplied cord or a Medical grade power cord. The socket also hosts two
fuses that interrupt the mains power in case of fault in the cart or in the hosted
consoles.
5. TAG (MARKINGS)
Provides serial number, electrical rating and other information as required by
EN 60601-1
5.3 TECHNICAL SPECIFICATIONS
PARAMETER SPECIFICATION
Manufacturer:................... OPTIKON 2000 S.p.a.
via del Casale di Settebagni, 13
00138 Rome - Italy
Model:............................ 183001 equipment cart
Regulatory compliance: ...... 93/42/EEC Medical Devices Directive (MDD)
Technical standards: .......... EN 60601-1
ELECTRICAL SPECS
Input voltage:................... 220-230/240 Volt 50 Hz
100/120 Volt 50/60 Hz
Line fuses:....................... 220/240 Volt: 6.3 A T
100/120 Volt: 16 A T
Max output power.............. 1kW
MECHANICAL SPECS
MAXIMUM LOAD:
Equipment tray ................. 25 Kg
Degree of protection against
harmful ingress of water...... IPX0
Level of safety of its use in the presence
of an inflammable anaesthetic mixture
containing air or oxygen or nitrous oxide NOT SUITABLE
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DIMENSIONS
HEIGHT: .............................. 106 cm
WIDTH: ............................... 57.5 cm
DEPTH: ............................... 54 cm
WEIGHT:.............................. 24 Kg
5.4 CIRCUIT DIAGRAMS
OPTIKON 2000 S.p.A. will make available on request circuit diagrams, component
part lists, descriptions, calibration instructions, or other information which will
assist the user's appropriately qualified technical personnel to repair those parts of
equipment which are repairable.
NOTE:
1) Weight and dimensions shown are approximate.
2) Specifications are subject to change without notice.
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6 INSTALLATION AND OPERATING PROCEDURE
6.1 INTRODUCTION
This section details a recommended installation and operational checkout
procedure for the Optikon Equipment Cart 183001. The operational checks,
however, which are performed after the system installation to verify instrument
operation, must be performed exactly as indicated and should not be regarded as
recommended practice or as encouragement for surgical operating room
procedures.
To bring your system in operation, a series of mechanical assembly operation for
the cart and a series of cable and tubing connections for the control console and
the accessories must be made.
Follow the installation and operating instructions carefully in a step by step manner
and, within a short time, you will have gained all the knowledge needed for
successful operation of your surgery system.
6.2 INITIAL INSPECTION
This instrument was carefully inspected, mechanically and electrically, prior to
shipment.
Before unpacking the OPTIKON Equipment Cart, inspect the carton for damage. If it
is damaged, be especially careful when inspecting the contents for any mechanical
damage which may have occurred during shipment, and test the electrical
performance.
If physical damage is found, you should apply at once to the carrier that handled
the consignment (mail, railways or forwarding agents) and have an appropriate
certificate established. Without documentary evidence, claim cannot be filed.
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6.3 INSTALLATION
Unpack the cart and then refer to the following figure for the assembly
instructions.
a. Assemble the cart column (1) on the base with wheels (2) using the
screws (3) and the washers (4) and the supplied Allen wrench.
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b. Assemble the equipment tray (5) at the desidered height using the
supplied screws and washers and Allen wrench.
c. Assemble the cylinder holder (6) in the suitable holes, according with
cylinder’s height.
d. Place the Optikon Console on the equipment tray.
e. Remove the protection cover covering the electric sockects (7) and
plug in the power cord for the equipment console. Re-install the
protection cover.
f. Plug the supplied mains power cord to the 183001 receptacle (8) and
into the wall mains outlet.
g. Switch on the equipment and the cart (9), then proceed according to
the hosted equipment user manual.
6.4 SHUT DOWN PROCEDURE
If the Optikon cart is not being used for an extended period, the following
procedure should be observed:
1. Depress the “Power” switch on the rear of the cart column to power down the
console and the cart.
2. Unplug power cord from wall outlet and roll it around the mushroom style
supports on the side of the column. Be sure to pull the plug, not the cord.
3. Place the system footswitch on the base of the cart, rolling the cable on the
supports at the side of the column.
4. Cover the hosted equipment and the cart with a drape to protect from dust.
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6.5 MAINTENANCE AND CARE
The 183001 Optikon Equipment Cart with cylinde holder requires very few
attentions to provide you with a long lasting satisfactory service.
The medical personnel must take the responsibility to keep existing instruments
and equipment functioning properly. The following simple steps serve as practical
guidelines in establishing your care and maintenance program:
1. The Optikon Equipment Cart and the hosted console(s) should be stored in a
clean and dry environment at room temperature.
2. In order to remove salt solution deposits or other residuals, periodically
clean the cart and the control console with soft dusting cloth dampened with
distilled water. If necessary use only neutral detergent.
3. Do not move the cart or equipment footswitch by pulling on their respective
cables.
4. Do not overload the equipment tray.
NOTE:
OPTIKON 2000 S.p.A. reserves the right to change design and specifications without notice because
of its policy of continuous product research and development.
CAUTION:
- DO NOT USE SYNTHETIC DETERGENTS OR OIL-BASED SOAPS.
- DO NOT USE ALCOHOL, SOLVENTS, OR ABRASIVES ON THE CART
OR THE CONTROL CONSOLE.
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