OPTIKON PULSAR2 ESP User manual

Cod. 111007EN
Rev.E
PULSAR2 ESP
ANTERIOR SEGMENT SURGERY SYSTEM
INSTALLATION AND OPERATING MANUAL
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13 - 00138 Rome Italy
Phone [phone] - ax. [phone]
e-mail [email protected] - www.optikon.com

OPTIKON 2000 SpA is an ISO 9001 and ISO 13485 certified company
hich 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
Page
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 TECHNICAL SPECI ICATIONS ......................................................................... 5-2
5.3 CIRCUIT DIAGRAMS .................................................................................... 5-5
5.4 EMC TABLES ............................................................................................. 5-6
5.4.1 ELECTROMAGNETIC EMISSIONS ................................................................... 5-6
5.4.2 ELECTROMAGNETIC IMMUNITY ................................................................... 5-7
5.4.3 RECOMMENDED SEPARATION DISTANCES ....................................................... 5-8
5.5 DIATHERMY POWER CHARACTERISTICS ............................................................. 5-9
6 INSTALLATION .............................................................. 6-1
6.1 INTRODUCTION ......................................................................................... 6-1
6.2 UNPACKING AND INSPECTION ........................................................................ 6-1
6.3 INSTALLATION PROCEDURE .......................................................................... 6-1
6.4 IRRIGATION / ASPIRATION SYSTEM SET-UP ........................................................ 6-3
7 EQUIPMENT DESCRIPTION ................................................ 7-1
7.1 MAIN EATURES ........................................................................................ 7-1
7.2 EQUIPMENT LAYOUT ................................................................................... 7-5
7.3 USER INTER ACE ....................................................................................... 7-9
7.4 VOICE PROMPTING .................................................................................... 7-12
8 EQUIPMENT OPERATION .................................................. 8-1
8.1 BIPOLAR DIATHERMY .................................................................................. 8-1
8.2 I/A (Irrigation/Aspiration) ........................................................................... 8-3
8.3 PHACOEMULSI ICATION ............................................................................... 8-6
8.3.1 PROGRAMMABLE EMISSION MODE (P.E.M.) .................................................... 8-10
8.4 VITRECTOMY ........................................................................................... 8-15
8.5 AUTOMATIC I.V. POLE ................................................................................ 8-17
8.6 OOTSWITCH .......................................................................................... 8-18
8.7 TO RECALL OR STORE A PROGRAM ................................................................. 8-22
8.8 SHUT DOWN PROCEDURE ............................................................................ 8-27
9 CLEANING, STERILIZATION AND MAINTAINANCE ...................... 9-1
9.1 CLEANING ............................................................................................... 9-1
9.1.1 UNIT .................................................................................................. 9-1
9.1.2 ACCESSORIES ........................................................................................ 9-1
9.2 STERILIZATION ......................................................................................... 9-1
9.2.1 UNIT .................................................................................................. 9-1
9.2.2 SINGLE USE ACCESSORIES ......................................................................... 9-2
9.2.3 REUSABLE ACCESSORIES ........................................................................... 9-2
9.3 MAINTENANCE .......................................................................................... 9-2
9.3.1 UNIT .................................................................................................. 9-2
9.3.2 ACCESSORIES ........................................................................................ 9-3
10 TROUBLESHOOTING ................................................... 10-1
10.1 WARNING AND ERROR MESSAGES ................................................................... 10-1
10.2 MISCELLANEOUS PROBLEMS ......................................................................... 10-2
11 INDEX .................................................................... 11-1

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PULSAR
2
ESP Installation and Operating Manual
OPTIKON 2000
Cod. 111007EN Rev.E
1-1
1DISCLAIMER
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 een 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 e made during
the life of this manual, so that we may effectively continue to meet the
requirements of users. On occasion, these changes may e made without
notice.
OPTIKON 2000 S.p.A.
Via del Casale di Settebagni, 13
00138 Rome Italy
Teleph. [phone]
ax. [phone]
e-mail [email protected]
www.optikon.com
NOTICE: Information contained in t is manual is proprietary wit OPTIKON 2000 S.p.A.
reproduction of any part or w ole may only be performed wit written permission from
OPTIKON 2000 S.p.A.

PULSAR
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OPTIKON 2000
Cod. 111007EN Rev.E
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PULSAR
2
ESP Installation and Operating Manual
OPTIKON 2000
Cod. 111007EN Rev.E
2-1
2LIMITED WARRANTY CONDITIONS
All OPTIKON 2000 S.P.A. eq ipment and accessories sold and installed in the E ropean
Union are g aranteed against defective workmanship and fa lty parts for ONE YEAR, from
the date of the invoice. Warranty on cons mable materials is limited to the first se.
Please, inq ire with yo r local Optikon Distrib tor for warranty conditions in co ntries
o tside the E ropean Union.
All items nder warranty will be repaired or replaced free of charge.
Warranty incl des the research of ca ses of the fa lts, reparation of the defect and a final
inspection of the nit, or part(s).
This warranty does not cover the res lts of mis se, accident, ab se and tampering or
alteration done by anyone other than personnel a thorized by OPTIKON 2000 S.p.A.
OPTIKON 2000 S.P.A. reserves the right to ascertain, in case of fa lts, whether or not the
eq ipment and/or its accessories have been altered, tampered with, in any way, or have
been damaged by improper se.
OPTIKON 2000 S.P.A. also reserves the right to modify the eq ipment and/or its
accessories whenever operating techniq es necessitate modification(s).
No warranty will be recognized if serial n mber of the eq ipment and/or accessories
attrib ted by OPTIKON 2000 S.P.A. is missing, tampered and/or not clearly readable.
Warranty does not incl de expenses for ret rn shipment of eq ipment and accessories: all
expenses for transport, packing etc. are to be borne by the p rchaser.
In case of an expressly req ested intervention of o r technicians, all travel and hotel
expenses will be debited to the client.
OPTIKON 2000 S.P.A. cannot be held liable for damages ca sed by transportation. If this is
the case, the c stomer sho ld apply at once to the carrier that handled the consignment.

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3 WARNINGS
Care in the handling of PULSAR
2
surgery system is one of the first principles in an
operating-room, and no amount of warnings can take place of such care
The following warnings will aid the user to provide adequate safeguards to assure
safe, trouble free performance
General
•All medical personnel should read and understand the instructions in this
manual prior to the system being used Do not attempt to use the system if it
fails to perform as set out in the operation procedures, in this manual
•Use of the system should be restricted to qualified medical personnel who
fully understand potential risks connected with the use of the equipment and
are trained on the prevention and management of possible clinical
complications
•The presurgical set-up and operation procedures outlined herein should be
performed before each surgical procedure If the system is not operating
properly and the trouble-shooting section does not provide a satisfactory
solution to the problem, do not use the system
•Before using a surgical or non surgical accessory in connection with PULSAR
2
,
verify the compatibility of the same with PULSAR
2
equipment Compatibility
is stated on the accessory accompanying document
•Sound emission capability of the equipment is tested at power-on Verify that
an audible beep is emitted during system boot
•A rotating symbol, placed at the lower side of the user interface screen, shows
that the system is running properly If such symbol stops moving it means that
the system is idle and equipment operation must be stopped
•The computer uplink connection is intended for service procedures only Do
not connect any external device to the rear panel “Computer uplink” socket
during the use of the equipment in surgery
•Plug into the connectors labelled “FOOTSWITCH”, “REMOTE CONTROL”, “I V
POLE” and “EXPANSION UNIT” only the equipment specifically designed for
this purpose

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•Use of accessories and cables other than those provided with the unit may
result in an increase of the emissions or in decreased immunity of the system
Portable and mobile communications equipment can affect the performance
of the unit
•Carefully follow the instructions when installing and using the unit , in order
to prevent harmful interferences with other devices in the vicinity If the
unit causes harmful interferences to other devices (determined by turning
the unit off and on), the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the other devices
• Increase the distance between the equipment
• Connect the unit into an outlet on a circuit different from that to which the
other devices are connected
• Consult your local distributor or OPTIKON 2000 technical assistance
Environmental
•The system should never be used in the presence of flammable anaesthetics,
disinfecting agents, cleaning agents, etc , due to possible fires or explosion
•The use of flammable anaesthetics (N
2
0), (0
2
), should be avoided unless they
are removed by a gas aspiration system
•For operating safety do not install the system in a location where it will be
exposed to heating equipment or radiators, direct sunlight, or any other
source of extremely high temperatures
•Do not install the PULSAR
2
system in such a way that the ventilating openings
are blocked
•Dispose waste collection fluids according to the local laws/regulations on
disposal of organic materials
•Do not dispose of PULSAR
2
as unsorted municipal waste Collect it separately
according to the local laws/regulations on disposal of waste electrical and
electronic equipment
Electrical
•To reduce the risk of electric shock, do not remove cover Refer servicing to
qualified service personnel

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Cod. 111007EN Rev.E
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•The PULSAR
2
control console 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
•Be sure that the power switch on the control console is off when plugging in,
or removing the power cable from a wall outlet
•Turn off the main power switch whenever the PULSAR
2
unit is not in use
•Exchanging fuses should be done a few minutes after the mains switch has been
turned off in order to allow time for cooling
•Replace fuse as marked
Diathermy
•Risk of burns or fire; do not use diathermy near conductive materials such as
metal bed parts, inner-spring mattresses, and the like Renew electrode
cables upon evidence of deterioration
•Use only original OPTIKON 2000 S P A diathermy cable
•Severe RF burns can result if the diathermy output current is diverted to the
operator by careless handling
•When the bipolar diathermy handpiece and a monitoring system are used at
the same time, all the electrodes of the monitoring system that are not
protected by resistors or high frequency inductors should be placed as far
away as possible from the diathermy electrodes
•The cable of the bipolar diathermy handpiece should not touch the patient or
other cables
•Always use the lowest output diathermy power level which is compatible to
the surgical application
•An evident low output level or a faulty operation of the bipolar diathermy
handpiece, even though the equipment has been set for a normal use, may
indicate a bad contact in the electrodes connection
•During bipolar diathermy handpiece operation, do not use flammable
anaesthetics, nitrogen monoxide, oxygen, unless they are vented by a suitable
aspiration system

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•Flammable materials such as disinfecting agents and cleaning agents should be
evaporated before using the bipolar diathermy handpiece Some materials
such as cotton wool or gauze, if soaked with oxygen, can catch fire because of
the sparks caused by the equipment in its normal use
•There is a possible risk for patients carrying cardiac stimulator or stimulating
electrodes because of RF interference caused by diathermy generator The
stimulator itself can fail Should any doubt arise, apply to the cardiology
division for advice
•Caution: possible interference with other medical equipment when the bipolar
diathermy handpiece is in use
Handpieces
•Do not allow the tip of the vitrectomy probe, diathermy, or I/A handpiece to
touch metallic objects
•Do not attempt to alter the shape of any part of a handpiece
•Do not attempt to separate the plug from the cable
•Do not store or use a handpiece if wet or moist
I/A
•Carefully observe the indications of "Irrigation/Aspiration Tu ing Set-up"
paragraph in this manual The failure to follow these indications could have
serious consequences
•Correct set-up of irrigation and aspiration lines is critical to ensure proper
operation of the PULSAR
2
unit
•Switching from peristaltic mode to Venturi mode may cause anterior chamber
collapse if a low impedance tip is used (i e U/S tip) and if the vacuum is set
at an high level To ensure patient safety, always check that vacuum setting is
proper for the desired type of pump before restarting aspiration after a pump
type switch
•Use only original OPTIKON 2000 S P A tubing sets
•Do not prime or tune the handpiece while the tip is in the eye of the patient;
this could result in patient injury

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•Check that the BSS bottle and the pressurized bag for forced irrigation are
placed at or above the patient’s eye level
•Before starting an intervention, ensure that the volume of available irrigation
solution is sufficient and monitor it throughout the intervention
•During the operation constantly monitor the saline solution level in the
irrigation bottle If the amount of saline solution is deemed insufficient for
completing the operation, immediately inform the surgeon and proceed to
replace the irrigation bottle and the pressurized bag for forced irrigation
according to the following procedure:
GRAVITY INFUSION
1 Interrupt the surgical procedure and remove the handpiece’s tip from the
incision
2 Close the clamp on the infusion set’s line
3 Unhook the bottle from the I V pole when the bottle is almost empty
4 Remove the infusion set’s spike from the bottle, being careful not to touch it
with your hands and not to allow it to come into contact with any non-sterile
material
5 Insert the infusion set’s spike in the cap of the new bottle and hook it to the
I V pole
6 If the drip chamber becomes completely empty, squeeze it to fill it with
saline solution until it is approximately 50% full
7 Reopen the irrigation clamp
Note: If air bubbles are observed in the infusion set’s line or in the irrigation
line, ask the surgeon to activate just irrigation until the bubbles have been
expelled, before reinserting the surgical instrument’s tip in the patient’s eye
FORCED INFUSION
1 Interrupt the surgical procedure and remove the handpiece’s tip from the
incision
2 Close the clamp on the infusion set’s line
3 Disconnect the air tube from the “AIR” outlet located on the instrument
4 Unhook the almost empty bag from its support
5 Remove the infusion set’s spike from the bag, being careful not to touch it
with your hands and not to allow it to come into contact with any non-sterile
material
6 Insert the infusion set’s spike in the cap of the new bag and hook it to the
support

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7 Connect the air tube to the “AIR” outlet located on the instrument
8 Reopen the irrigation clamp
•Note: If air bubbles are observed in the infusion set’s line or in the irrigation
line, ask the surgeon to activate just irrigation until the bubbles have been
expelled, before reinserting the surgical instrument’s tip in the patient’s eye
U/S
•Do not activate the phaco U/S handpiece with the phaco tip in air The
ultrasonic power should be applied to the phaco handpiece with the phaco tip
immersed in a test chamber filled with infusion fluid or in a beaker of sterile
fluid at ambient temperature Otherwise handpiece damage may result
•Do not check vibration by placing hand or finger against handpiece tip
Prolonged exposure to or direct contact with the vibrating tip may cause
damage to healthy tissue
•Always use the lowest ultrasonic output power level which is compatible to
the surgical application
•The phaco handpiece must be connected to the PULSAR
2
irrigation/aspiration
system and must not be used without it
Vit
•Do not activate the vitrectomy handpiece with the tip in air The tip should
always be test run in a beaker of sterile solution Testing in air will cause
irreparable damage to the tip
Footswitch
•Never lift or move footswitch by the cable Damage may result
•The footswitch is not autoclaveable
Sterilization
•The re-use of materials labelled as “For single use” may be cause of
malfunctions and/or infections which could severely affect patient’s safety

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•All reusable accessories are supplied non sterile They must be first cleaned,
then sterilized in autoclave as indicated on the relevant instructions for use
They could be damaged by the use of other sterilization methods, like hot air
or "chemclave" sterilization
•All disposable accessories are provided in a sterile condition and labelled as
such Do not sterilize them after use

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4SYMBOLS
Table shown below reports some symbols approved by I E C and their meaning
When there is not enough room, they are frequently used on medical equipment to
enable an easy and fast communication of information and warnings Sometimes
two or more symbols may be assembled to obtain a special meaning
These symbols are used in the PULSAR
2
label Before starting to use the unit, you
should familiarize yourself with them and their definitions shown in the table
SYMBOLS PUBLISHED BY THE IEC
SYMBOL DESCRIPTION
ALTERNATING CURRENT
DIRECT CURRENT
PROTECTIVE EARTH (GROUND)
ATTENTION, CONSULT
ACCOMPAINING DOCUMENTS
OFF (POWER: DISCONNECTION
FROM THE MAINS)
ON (POWER: CONNECTION TO
THE MAINS)
TYPE B
PART APPLIED TO THE PATIENT
(BODY)
TYPE BF
FLOATING PART APPLIED TO THE
PATIENT (BODY-FLOATING)
SEPARATE COLLECTION OF
WASTE ELECTRICAL/ELECTRONIC
EQUIPMENT
A
RF EMISSION

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5-1
5GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
PULSAR
2
is an unit for anterior and posterior segment surgical procedures on the
human eye Reliability and versatility, combined with sound engineering design,
make the PULSAR
2
unique among similar devices currently available on the world
market It is designed to perform irrigation, irrigation/aspiration,
phacoemulsification, anterior vitrectomy and bipolar diathermy coagulation
procedures
PULSAR
2
operates with time saving simplicity and is easy to use thanks to the LCD
(liquid Crystal Display) touch-screen user interface
It can be operated with factory set parameters, or user defined setup parameters
(user programs) All functions and operational parameters are independently set up
by pressing the appropriate “soft” keys on the touch-screen Once the selected
function has been set up, it may be executed in real-time by simply depressing the
footswitch
The aspiration is equipped with an unique dual pump system in a single tubing set:
the surgeon can switch between Venturi and peristaltic pump during surgery The
anticollapse system eliminates pulsation and increase fluid suction precision
Vacuum is programmable from 5 to 500 mmHg, step 5 mmHg
The irrigation flow rate and the intraocular pressure (IOP) are adjusted through the
height of the irrigation source or by means of the forced irrigation bag, if the
optional vit module is available
Gravity fed reflux from BSS irrigation source provides reverse flow in a perfectly
sterile environment
Versatility is assured by the wide range of available accessories, which provide the
surgeon with the facility to undertake most ophthalmic procedures All
microsurgical handpieces are ergonomically designed for comfort in use and
maximum manual dexterity Custom option and variety of accessories allow
tailoring "OPTIKON 2000 PULSAR
2
" to your specific needs Clear audio/visual alerts
indicate situations requiring attention, thus ensuring patient safety
The PULSAR
2
unit is optimally safeguarded and built according to the latest
INTERNATIONAL SECURITY STANDARDS All possible safeguards are built-in so that
the equipment will not react on inappropriate manipulations

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5.2 TECHNICAL SPECIFICATIONS
PARAMETER SPECIFICATION
Man fact rer:....................... OPTIKON 2000 S.p.a.
via del Casale di Settebagni, 13
00138 Rome - Italy
Model: ................................ PULSAR
2
Reg latory compliance: .......... 93/42/EEC Medical Devices Directive (MDD)
Technical standards: .............. EN 60601-1 ; EN 60601-1-1 ; EN 60601-1-2 ; EN
60601-2-2
ENVIRONMENTAL SPECS
Storage: .............................. temp range –10°C to +70°C, h midity 10-100%
(non condensing)
Operation: ........................... temp range +10°C to +40°C, h midity 30-75%.
ELECTRICAL SPECS
Inp t voltage: ....................... 100/120/220/230-240 V A.C. select.
Freq ency: .......................... 50/60 Hz
Power cons mption: ............... 150 W
Line f ses: ........................... 220/240 Volt: 2,5 A T
100/120 Volt: 5 A T
COMPRESSED AIR SPECS
Inp t air press re: ................. from 500 to 800 KPa (72 to 116 PSI)
Air cons mption: ................... 30 normal litre/min te
IRRIGATION
Fl id delivery: ...................... gravity fed - eye press re determined by the height of
irrigation so rce
Valving element: ................... solenoid driven pinch valve
Control: .............................. system footswitch
ASPIRATION
Aspiration p mp types: ............ Vent ri and peristaltic
Act ating medi m: ................. press rized air from external so rce
press re: 500÷800 KPa (72÷116 PSI)