OPTIKON I.V. User manual

Code 181004EN
2007-10-09 Rev. 0
EQUIPMENT CART
WITH ELECTRIC I.V. POLE
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13 - 00138 Rome – Italy
Tel. [phone] – Fax [phone]
e-mail: [email protected]
www.optikon.com

OPTIKON 2000 S.p.A. is an ISO 9001 and ISO 13485 certified company that
manufactures surgical and diagnostic devices for ophthalmology.
All OPTIKON 2000 products are manufactured in compliance with the
requirements of Directive 93/42/EEC on medical devices.

TABLE OF CONTENTS
1. DISCLAIMER ........................................................................................................... 1-1
2. LIMITED WARRANTY CONDITIONS...................................................................... 2-1
3. WARNINGS.............................................................................................................. 3-1
4. SYMBOLS................................................................................................................ 4-1
5. GENERAL INFORMATION...................................................................................... 5-1
5.1 SYSTEM DESCRIPTION..................................................................................................................5-1
5.2 CONTROLS AND INDICATORS.......................................................................................................5-1
5.3 TECHNICAL SPECIFICATIONS.......................................................................................................5-3
5.4 CIRCUIT DIAGRAMS........................................................................................................................5-4
6. INSTALLATION AND OPERATING PROCEDURE................................................. 6-1
6.1 INTRODUCTION...............................................................................................................................6-1
6.2 INITIAL INSPECTION .......................................................................................................................6-1
6.3 INSTALLATION.................................................................................................................................6-2
6.4 SHUTDOWN PROCEDURE .............................................................................................................6-3
6.5 MAINTENANCE.................................................................................................................................6-3
7. TROUBLESHOOTING 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 the 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. 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 responsible for the safety, reliability and
performance only if:
• updates, calibrations and repairs are carried out by personnel which has been
authorised by OPTIKON 2000 S.p.A.;
• the system is used in compliance with the user instructions;
• the mains electric installation to which the system is connected complies with the
IEC Safety Regulations.
IMPORTANT NOTICE:
Every effort has been made so that all the illustrations and information precisely
represent the product and its operation as they were at the time this manual was
printed. It is possible, however, that during the existence of this manual
modifications have been made in order to continue to effectively satisfy the needs
of the users. At times, such modifications are made without advance notice.
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13
00138 Roma
Tel. [phone]
Fax. [phone]
e-mail: [email protected]
www.optikon.com
NOTE
The information contained in this manual is the exclusive property of OPTIKON 2000
S.p.A. Partial or total reproduction of this manual is permitted only upon written
authorisation by OPTIKON 2000 S.p.A.

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2. LIMITED WARRANTY CONDITIONS
All the OPTIKON 2000 S.p.A. instruments and accessories sold and installed in the
European Union are guaranteed against manufacturing and material defects for ONE
YEAR from the invoicing date. The guarantee on the consumable material is limited
to the first use of the apparatus.
For the warranty conditions outside the European Union, contact your authorised
OPTIKON 2000 S.p.A. distributor.
All items covered by warranty will be repaired or replaced free of charge.
The warranty includes the research for the defect’s cause, repair of the failure and
final inspection of the unit or components
This warranty does not cover any problems which are the result of improper use,
accidents, incorrect use and tampering or modifications made by persons who are
not part of the authorised OPTIKON S.p.A. technical service.
OPTIKON 2000 S.p.A. reserves the right to verify, in case of failures, if the instrument
and/or its accessories have been modified or tampered with in any way, or if they
have been damaged by improper use.
OPTIKON 2000 S.p.A. also reserves the right to modify the instrument and/or its
accessories in the event operating techniques require such modifications.
The warranty is not valid if the serial number of the instrument and/or accessories
attributed by OPTIKON 2000 S.p.A. is missing, tampered with and/or unreadable.
The warranty does not include the expenses for returning the instrument and
accessories: all charges for shipping, packaging etc. shall be borne by the buyer.
In the event of an explicit request for work by OPTIKON technicians, all travelling and
lodging expenses shall be charged to the customer.
OPTIKON 2000 S.p.A. is not liable for damages caused during transport. If this
occurs, the customer must immediately notify the carrier that handled the delivery.

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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.
• THE SYSTEM SHOULD NEVER BE USED IN THE PRESENCE OF
FLAMMABLE ANAESTHETICS, DISINFECTING AGENTS, CLEANING
AGENTS, ETC., DUE TO POSSIBLE FIRES OR EXPLOSION.
• 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. USE EXCLUSIVELY
THE MAINS POWER CABLE PROVIDED OR A CABLE THAT IS IN
COMPLIANCE WITH SAFETY REGULATIONS.
• 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 LEFT SIDE 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.
• NEVER LIFT OR MOVE FOOTSWITCH BY THE CABLE. DAMAGE MAY
RESULT.
• DO NOT EXCEED THE FOLLOWING MAXIMUM LOAD LIMITS:
MAYO TRAY: 2KG
EQUIPMENT TRAY 30KG
BOTTLE HOOK 1KG
OVERLOADING THE CART MAY CAUSE MECHANICAL FAILURES AND
POSSIBLE HARM FOR THE PATIENT AND/OR THE OPERATOR.
• THE POLE EXTENDS UP TO A MAXIMUM OF APPROX. 235cm OF
HEIGHT: DO NOT PLACE THE CART UNDER LOW CEILING.
• 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
STRENGTH, PLUG TO THE CART COMPATIBLE OPTIKON EQUIPMENT
ONLY (SEE COMPATIBILITY CHART IN THE TECHNICAL
SPECIFICATIONS).
• 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
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
ALTERNATING CURRENT
DIRECT CURRENT
PROTECTIVE EARTH
ATTENTION, CONSULT
ACCOMPANYING
DOCUMENTS
OFF (POWER:
DISCONNECTION FROM THE
MAINS)
ON (POWER: CONNECTION
TO THE MAINS)
TYPE B APPLIED PART
TYPE BF APPLIED PART
SEPARATED WASTE
COLLECTION FOR
ELECTRICAL/ELECTRONIC
EQUIPMENT
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5. GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
The Optikon equipment cart 181004 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 mayo tray mounted on a swing arm for sustaining the surgical instruments
connected to the console during the setup and the surgical procedure. An electric I.V. pole
holds the BSS bottle to be used as irrigation source. The bottle position (height) can be
adjusted by the means of a rocker footswitch and/or it can be controlled by the connected
console.
The I.V. pole controller is interfaced to the hosted console that can read and memorize the
bottle position set by the user in the various surgical functions. It can read and store the
position of the bottle set by the surgeon. This position can be stored and recalled in a user
program in the console along with all the other operating parameters.
5.2 CONTROLS AND INDICATORS
.
Fig. 1
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POWER (ON/OFF MAINS SWITCH/PILOT LAMP)
This illuminated switch is located on the left side of the cart and controls both the internal
electric I.V. pole and the power outlets for the control panels on 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.
PROTECTION COVER
This protection cover, located at the rear of the cart, was designed to prevent the use of
the cart's power outlets to connect any device other than approved Optikon instruments.
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. The following are
located under the protection cover (Fig. 1):
1. MAINS POWER CONNECTION FOR HOSTED CONSOLES.
Three mains sockets allow connecting the mains power for the hosted surgical
consoles.
2. INTERFACE CONNECTOR
It allows the position control of the integral electric I.V. pole by the hosted
console. The console connects here by the means of the signal cable supplied
with the cart.
3. FOOTSWITCH CONNECTOR
The bottle Up/Down rocker footswitch connects here.
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. VOLTAGE SETTING CONNECTOR
By turning the voltage setting connector to the proper position, it is possible to set
the mains voltage (220 or 110 V).
TAG (MARKINGS)
Provides serial number, electrical rating and other information as required by EN 60601-1

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5.3 TECHNICAL SPECIFICATIONS
PARAMETER SPECIFICATIONS
Manufacturer:............................... OPTIKON 2000 S.p.A.
Via del Casale di Settebagni 13
00138 Roma - Italia
Model........................................... I.V. Pole cart
Regulatory conformity:................. 93/42/EEC Directive on medical devices
Technical standards..................... EN 60601-1
Classification................................ Class I
ELECTRICAL SPECIFICATIONS
Input voltage: ............................... 220 V 50 Hz
110 V 50/60 Hz
Fuses:.......................................... 220 V 6.3 A T
110 V
16 A T
IV Pole power consumption......... 40 VA
Maximum connectable power...... 1 KVA
I.V. POLE
Maximum Height:......................... 235cm approx
Maximum travel:........................... 70cm approx
Control ......................................... UP/DOWN ROCKER FOOTSWITCH.
Height can be memorized in a user program by the connected
equipment.. See the equipment user manual for details.
Compatibility: ............................... The electric I.V. pole interface is compatible with the following
Optikon equipment.
Pulsar Minimal Stress, Pulsar2,Antares 2000

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PARAMETER SPECIFICATIONS
MECHANICAL SPECIFICATIONS
Maximum Load:
Mayo tray: ................................ 2 kg
Equipment tray........................ 30 kg
I.V.Pole................................... 1 kg
Degree of protection against
harmful ingress of water:.......... : IPX1
Degree of safety for use in the presence
Of a flammable anaesthetic mixture unsuitable
DIMENSIONS
Height ..................................... 235 cm (Pole extended)
Width ....................................... 52 cm
Depth....................................... 64 cm
Weight..................................... 52 Kg
IMPORTANT NOTICE:
- The footswitch is not autoclaveable.
- The switches located inside the footswitch are immersion-proof (protection
class: IPX8). Therefore this accessory is suitable for use in operating room
environment .
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) The weight and dimensions indicated 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 181004.
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 cable and tubing connections between cart
and control console, footswitch, handpieces and I/A system 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.
If damage of a mechanical nature is discovered or if the instrument does not match the
specifications, immediately inform the shipping company and the nearest OPTIKON
service center, which will repair or replace the instrument.

I.V. Pole cart Installation and operating manual
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6.3 INSTALLATION
Remove the cart from its packing and follow the installation instructions.
Fig. 2
a. Pick up the I.V. pole extension and manually screw it on the end of the I.V.
pole. Insert the arm with the hook for holding the bottle on the end of the
extension so that the hook is on the same side as the instrument's suction
pump. Lock the arm into place by manually tightening the knob at the top of
the extension.
b. Place the Optikon Console on the equipment tray.
c. Remove the protection cover from the electric sockets by unscrewing the 4
socket-head screws. Removing the protection cover will give you access to
the mains sockets (Fig. 2). Connect the control panel's power cable to one of
the appropriate sockets (Fig. 1, no. 1) and pass it through the interspace on
the right formed by the plastic support and the metal side of the cart.
Connect the cable for controlling the electric I.V. pole to the interface
connector for the I.V. POLE (Fig. 1, no. 2) and pass it through the interspace
on the left formed by the plastic support and the metal side of the cart.
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d. Pass the connector of the control panel's main footswitch through the large
hole (from inside) located on the lower right side of the cart (Fig. 2). Then
connect the I.V. pole's Up/Down footswitch to the "footswitch" connector (Fig.
1, no. 3) by passing it through the large hole (from inside) located on the
lower right side of the cart (Fig. 2).
e. Connect the power cable provided with the cart 181004 to the appropriate
mains inlet (Fig. 1, no. 4) and lock it in place using the strain-relief safety
system, make sure that the voltage setter (Fig. 1, no. 5) is set on the proper
level of voltage for the mains power, and then remount the protection cover.
Lastly, connect the power cable to the power outlet in the operating room.
f. Switch on the equipment and the cart, then proceed according to the hosted
equipment user manual.
6.4 SHUTDOWN PROCEDURE
If the Optikon cart is not being used for an extended period, the following procedure should
be observed:
1. Set the pole to the minimum height.
2. Depress the “Power” switch on the rear of the cart column to power
down the console and the cart.
3. Disconnect the cart's cable from the power outlet and wrap it around
the column. Be sure to pull the plug not the cord.
4. Place the cart footswitch and the system footswitch inside the cart's
main drawer.
5. Cover the hosted equipment and the cart with a drape to protect from
dust.
6.5 MAINTENANCE
The 181004 Optikon Equipment Cart 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 mayo tray and/or the equipment tray.

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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.