OPTIKON PULSAR MS User manual

Cod.111001EN
2012-02-16 Rev. J
PULSAR MS
ANTERIOR SEGMENT SURGERY SYSTEM
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
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 SPECIFICATIONS.............................................................................................5-2
5.3 CIRCUIT DIAGRAMS.............................................................................................................. 5-5
5.4 EMC TABLES..........................................................................................................................5-5
5.4.1 ELECTROMAGNETIC EMISSIONS...............................................................................5-5
5.4.2 ELECTROMAGNETIC IMMUNITY.................................................................................5-6
5.4.3 RECOMMENDED SEPARATION DISTANCES ............................................................ 5-7
5.5 DIATHERMY POWER CHARACTERISTICS......................................................................... 5-8
6. INSTALLATION AND MAINTENANCE ....................................... 6-1
6.1 INTRODUCTION.....................................................................................................................6-1
6.2 UNPACKING AND INITIAL INSPECTION.............................................................................. 6-1
6.3 INSTALLATION PROCEDURE...............................................................................................6-1
6.4 IRRIGATION/ASPIRATION SYSTEM SET-UP ...................................................................... 6-2
7. EQUIPMENT OPERATION......................................................... 7-1
7.1 EQUIPMENT DESCRIPTION................................................................................................. 7-1
7.2 EQUIPMENT LAYOUT............................................................................................................ 7-5
7.3 USER INTERFACE.................................................................................................................7-8
7.4 VOICE PROMPTING ............................................................................................................7-10
8. EQUIPMENT OPERATION......................................................... 8-1
8.1 BIPOLAR DIATHERMY........................................................................................................... 8-1
8.2 I/A (IRRIGATION/ASPIRATION).............................................................................................8-3
8.3 PHACOEMULSIFICATION .....................................................................................................8-5
8.4 VITRECTOMY.......................................................................................................................8-10
8.5 AUTOMATIC I.V. POLE........................................................................................................8-12
8.6 FOOTSWITCH......................................................................................................................8-13
8.7 TO RECALL OR STORE A PROGRAM ............................................................................... 8-19
8.8 SHUTDOWN PROCEDURE.................................................................................................8-22
9. CLEANING, STERILIZATION AND MAINTENANCE.................. 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.......................................................................................9-1
9.2.3 REUSABLE ACCESSORIES .........................................................................................9-2
9.3 MAINTENANCE......................................................................................................................9-2
9.3.1 UNIT ...............................................................................................................................9-2
9.3.2 ACCESSORIES.............................................................................................................. 9-2
10. TROUBLESHOOTING GUIDE.................................................. 10-1
10.1 WARNINGS ......................................................................................................................10-1
10.2 MISCELLANEOUS PROBLEMS ...................................................................................... 10-1
11. INDEX........................................................................................ 11-1

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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. 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 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. Warranty on 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 under 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 PULSAR surgical system constitutes one of the basic
operating room principles which should always be adhered to, and no list of
warnings can replace such care.
The warnings below provide the operator with suitable instructions to assure safe,
trouble free performance.
General warnings
•Before using the system, all medical personnel concerned must carefully read
and understand the instructions contained in this user manual. Do not attempt
to use the system if it does not work as defined in the operating procedures
described herein.
•The use of the system must be limited to qualified medical personnel who are
able to fully understand the potential risks connected with the use of the
instrument and are suitably trained on the prevention and management of
possible clinical complications.
•Before each operation, carry out the surgical configuration and operating
procedures described herein. Do not use the system if it does not work
properly and the “Troubleshooting Guide" section does not provide a
satisfactory solution.
•Before using a surgical or non-surgical accessory with the PULSAR unit, verify
its compatibility with the PULSAR apparatus, declared on the documents
attached to the individual accessories.
•Sound emission capability of the equipment is tested at power-on. Verify that
an acoustic signal is emitted during system initialization.
•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

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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 warnings
•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 (N2O), (O2), should be avoided unless they
are removed by a gas aspiration system.
•To ensure safe operation, do not install the system in a location where it may
be exposed to heating appliances or radiators, direct sunlight or any other
source of heat with extremely high temperatures.
•Install the PULSAR system so that the ventilation openings are not obstructed.
•Dispose waste collection fluids according to the local laws/regulations on
disposal of organic materials.
•Do not dispose of the “PULSAR” unit as unsorted municipal waste. Dispose of
it separately according to local electrical and electronic equipment disposal
laws/regulations.
Electrical warnings
•The unit is already set up for use with a power supply voltage of 220V. Check
that the local voltage is the same as that predetermined on the unit.
Otherwise, prepare the unit for the local power supply voltage. In the
countries where the local voltage is 100 - 120 V, replace the fuses of the unit
with the appropriate fuses supplied. These operations must be carried out
exclusively by appropriately trained personnel.
•To reduce the risk of electric shocks, do not remove the protective cover.
Request the intervention of authorised service personnel.
•Connect the console of the PULSAR unit to a mains having the characteristics
shown on the console’s rear panel. To guarantee safety, a hospital grade
power cord and plug must be used, the unit must be grounded.

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•Before connecting the unit to the mains, or disconnecting it, make sure that
the main switch of the console is off.
•When the PULSAR unit is not in use, keep the main switch turned off.
•To allow time for cooling, the fuses must be replaced after the main switch has
been turned off for a few minutes.
•Replace the fuse with one of the same type, as indicated on the rear panel of
the console.
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 cables.
•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 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.
•Excessive diathermy for the level of power selected could indicate a fault. In
this case, stop using the system at once.
•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 Tubing 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 unit.
•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.
•Check that the BSS bottle is placed at or above the patient’s eye level.

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•Before starting an intervention, ensure that the volume of available irrigation
solution is sufficient and monitor it throughout the intervention.
•Make sure that the quantity of aspirated fluids does not exceed the maximum
capacity of the collection bag, as this may result in an hazardous situation to
the patient or the operators.
•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 according to the following procedure:
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
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.

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•Always use the lowest ultrasonic output power level which is compatible to the
surgical application.
•The phaco handpiece must be connected to the PULSAR irrigation/aspiration
system and must not be used without it.
•Excessive U/S for the level of power selected could indicate a fault. In this
case, stop using the system at once.
Vitrectomy
•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.
•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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4. SYMBOLS
Table shown below reports some I.E.C. approved symbols and their meanings. In
the absence of sufficient space, these symbols are often used on medical
instruments to enable quick and simple communication of information and warnings.
At times two or more symbols are combined together in order to obtain special
meanings.
These are the symbols used on the PULSAR label. Before using the unit, familiarize
yourself with the symbols and definitions provided in the table.
SYMBOLS PUBLISHED BY IEC
SYMBOL DESCRIPTION
MANUFACTURER (AND DATE OF
MANUFACTURE, WHERE APPLICABLE)
ALTERNATING CURRENT
DIRECT CURRENT
EQUIPOTENTIALITY
WARNING
ON (POWER: CONNECTION TO THE
MAINS)
CLOSED (CONNECTED TO MAINS)
TYPE B APPLIED PART
TYPE BF APPLIED PART
SEPARATED WASTE COLLECTION FOR
ELECTRICAL/ELECTRONIC EQUIPMENT
RF EMISSION
SEE OPERATING INSTRUCTIONS

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5. GENERAL INFORMATION
5.1 SYSTEM DESCRIPTION
PULSAR is a unit for anterior segment surgical procedures on the human eye. Reliability and
versatility, combined with sound engineering design, make PULSAR 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 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 a peristaltic pump system. The anticollapse system
eliminates pulsation and increase fluid suction precision. Vacuum is programmable from 5
to 500 mmHg, step 5 mmHg.
Irrigation flow and Intra Ocular Pressure are regulated by the height of the irrigation source.
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 PULSAR” to your specific needs.
Clear audio/visual alerts indicate situations requiring attention, plus ensuring patient
safety.
The PULSAR 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 SPECIFICATIONS
Manufacturer........................ OPTIKON 2000 S.p.A.
via del Casale di Settebagni, 13
00138 Rome - Italy
Model:................................ PULSAR Minimal Stress
Regulatory conformity:............ 93/42/EEC Directive on medical devices
Technical standards:............... EN 60601-1 ; EN 60601-1-1 ; EN 60601-1-2
ENVIRONMENTAL SPECIFICATIONS
Storage............................... temp. range between –10°C and +70°C, humidity 10-100%
(non-condensing)
Operating............................ temp. range between +10°C and +40°C, humidity 30-75%
ELECTRICAL SPECIFICATIONS
Input voltage:....................... selectable at 100/120/220/230 Vac
Frequency ........................... 50/60 Hz
Power consumption: ............... 90 VA (Standard) 125 VA (peak)
Fuses: ................................ 220-240 Volt: 2 A T
........................................ 100-120 Volt: 4 A T
IRRIGATION
Fluid delivery: ...................... Gravity fed – eye pressure determined by the height of irrigation
source
Valving element: ................... solenoid
Control:.............................. System footswitch
ASPIRATION
Aspiration pump types:............ peristaltic
Actuating medium:................. Pressurized air from external source
Default vacuum range: ............ User programmable

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PARAMETER SPECIFICATIONS
Available vacuum range:.......... 5 to 500 mmHg
Default flow rate:.................. User programmable
Available flow rate range: ........ 2 to 50cc/min
Available aspiration rise time: ... 2 to 50cc/min
Surgeon mode (linear aspiration): Linear aspiration (vacuum and/or flow rate) from 0 to preset
linearity controlled via system footswitch
Safety device:....................... Vacuum sensor; monitors the vacuum in the aspiration line
Control:.............................. System footswitch
VIT (VITRECTOMY)
Handpiece type:.................... Pneumatically powered guillotine cutter (VIT)
Cutting mode:....................... Reciprocating motion
Default cut rate: ................... User programmable
Available cutting rate: ............ From 60 to 700 cuts per minute
Single cut:........................... Single cut mode available
Port size: ............................ Adjustable from 0,2 to 0,7mm (reusable cutters only)
Actuating medium:................. Pressurized air from internal source
Operating pressure:................ 190 KPa (27,5 +0/-1.5 PSI)
Surgeon mode (linear cut): ....... Linear cut rate from 0 to preset controlled via system
footswitch
Control:.............................. System footswitch
DIATH (DIATHERMY)
Type: ................................. Bipolar generator – generator stops when RF power is not
needed
Operating frequency:.............. 2 MHz
Nominal power:..................... 7W (450 Ohm LOAD)
No load max. voltage: ............. 100 V
Default bipolar power: ............ User programmable
Available bipolar power:.......... 5 to 100%. SURGEON MODE (linear power): Allows linear control
of the DIATHERMY power via system footswitch depression
Handpiece type:.................... Bipolar microforceps, slim stat pencil eraser, intraocular
diathermy handpieces
Diathermy cable:................... Two poles, 26 gauges, 75 ohm, steam autoclavable. Use only
original OPTIKON 2000 SpA diathermy cable
Control:.............................. System footswitch

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PARAMETER SPECIFICATIONS
PHACOEMULSIFIER
Handpiece type:.................... piezoelectric
Frequency ........................... Approx 40 KHz
Tip stroke:........................... From 0 to 100 µm
Power: ............................... Panel or linear control of the U/S power via system footswitch
depression
U/S Mode: ........................... Linear or Panel; Continuous, Short Pulse
(1,2,3,4,5,6,8,10,13,16,20,25,32,40Hz), Single Burst, Multi-
Burst, Continuous Burst
U/S Timer:........................... From 0.00 minutes to 59.59 minutes
Timer EPT: .......................... From 0.00 minutes to 59.59 minutes – equivalent Phaco Time
display
CLASSIFICATION OF THE INSTRUMENT ACCORDING TO IEC 60601-1
Type of protection against
electric shocks...................... Class 1
Degree of protection against electric shocks:
Diathermy ........................... Type BF, floating both at high and low frequencies
U/S.................................... Type B
Degree of protection against harmful
ingress of water .................... IPX1
Degree of protection against harmful
ingress of water (footswitch):.... IPX8
Degree of safety of application
in the presence of a flammable
anaesthetic mixture: .............. Not suitable
DIMENSIONS
Height........................................ 16 cm
Width......................................... 37 cm
Depth......................................... 40 cm
Weight........................................ 14 Kg
NOTES
1) The weight and dimensions indicated are approximate
2) Specifications subject to variations without advance notice.