TRABECTOME Model 550043-01 High Frequency Generator Operations Manual Rev D

NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

In the event that you need assistance related to this product, please call NeoMedix Corporation at 714-258-8355 or your local authorized distributor. NeoMedix Corporation 15042 Parkway Loop, Suite A Tustin, CA 92780 USA Phone: 714-258-8355 Fax: 714-258-8356 www.neomedix.net

MedNet GmbH Borkstrasse 10 48163 Muenster, GERMANY

© 2008 NeoMedix Corporation 15042 Parkway Loop, Suite A, Tustin, CA 92780 USA Web: www.neomedix.net • E-mail: [email protected]

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

Table of Contents 1.

INTENDED USE ... 4

2.

CAUTIONS... 4

3.

WARNINGS ... 5

4.

CONTRAINDICATIONS ... 5

5.

STORAGE ... 5

6.

SETUP PROCEDURE ... 6

7.

UNIT OPERATION... 9

8.

ACCESSORIES... 9

9.

MAINTENANCE ... 9

10.

TROUBLESHOOTING... 10

11.

TECHNICAL SPECIFICATIONS ... 11

12.

OUTPUT POWER CURVES ... 12

13.

DESCRIPTION OF SYMBOLS ... 13

14.

WARRANTY ... 14

APPENDIX A: ELECTROMAGNETIC IMMUNITY TABLE ... 16 APPENDIX B: ELECTROMAGNETIC EMISSIONS TABLE ... 17

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

1. INTENDED USE: The Trabectome® Generator/LP is for use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.

2. CAUTIONS:  Federal (USA) law restricts the sale of this device to or on the order of a physician.  Read directions prior to use.  Use caution when using the Trabectome® Generator on patients who have a pacemaker or metal implant.  The function of other electromagnetic equipment can be interfered with by use of high frequency current.  When high frequency surgical equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended.  Interference of HF surgical equipment may adversely influence operation of other electronic equipment.  To avoid the possibility of electrosurgical burn to either the patient or the physician, do not allow the patient to come in contact with grounded metal objects during activation. When activating the unit, there should be no direct skin contact between the patient and the physician. It is advisable to remove loose fitting jewelry from the patient prior to activation.  Cables should be positioned in such a way that contact with the patient or other leads is avoided. Unused electrodes should be temporarily stored isolated from the patient.  System is mains voltage regulated with a maximum peak-to-peak voltage of 800V. Actual output is dependent upon the mains voltage. Recalibration is required if input mains voltage is changed.  To reduce the risk of electrical shock, do not remove back plate. Refer servicing to qualified personnel.  This device is a non-sterile product. 4

NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

 Use only NeoMedix Trabectome® accessories.  Contact local authorities for proper disposal of equipment to eliminate or reduce any waste products, residues, etc.

3. WARNINGS:  Do not use the Trabectome® Generator in the presence of flammable anesthetics. Fire could result.  Keep the power setting as low as possible to achieve the desired effect.  For surgical procedures where the high frequency current could flow through parts of the body having a relatively small cross-sectional area, the use of bipolar techniques may be desired to avoid unwanted coagulation.  Apparent low output or failure of the generator to function correctly at the normal operating settings may indicate poor contact in connections to the generator.  Grounding reliability can only be achieved when the generator is connected to an equivalent receptacle marked “Hospital Only” or “Hospital Grade”.  Failure of HF surgical generator could result in unintended increase of output power.  No modification of this equipment is allowed.  Use of flammable anesthetics or oxidizing gases such as oxygen or nitrous oxide should be avoided for thorax or head region.  To avoid electrical shock this equipment must be connected to supply mains with protective earth.  Do not position equipment in such a way as to make it difficult to operate the disconnect device when an appliance coupler or separable plug is used as isolation means.

4. CONTRAINDICATIONS:  Do not use above 1.5 watts with the NeoMedix Trabectome® Handpiece.

5. STORAGE:  Store the generator in a cool, dry place.  Store upright to prevent fluid entry into the enclosure. 5

NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

6. SETUP PROCEDURE: 1. Remove the Trabectome® Generator from its shipping carton. 2. Mount the generator on the optional mobile stand using the two screws in the rear panel (see Figure 1).

Figure 1. Rear panel view of High Frequency Generator/LP.

3. Do not operate the generator in the horizontal position as liquids may spill into the unit.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

4. Plug the female end of the power cord into the receptacle on the bottom of the unit (see Figure 2, letter A).

Figure 2. Front panel view of High Frequency Generator/LP. 5. Plug the male end of the power cord into a grounded wall receptacle marked “Hospital Only” or “Hospital Grade”. 6. Plug the electrosurgical probe or handpiece into the bipolar (see Figure 2, letter B) output receptacles on the lower front panel of the unit.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

7. Connect the plug end of the optional footswitch cable or other activation cable into the receptacle on the lower front panel marked “Footswitch” (see Figure 2, letter C). 8. Adjustment of the audible tone is achieved by a switch located on the rear panel of the unit (see Figure 3). Two tone choices are available; high and low.

Figure 3. Audible tone adjustment.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

7. UNIT OPERATION: 1. Turn the generator on utilizing the power switch on the right side of the unit (see Figure 2, letter D). 2. Set the power by using the dial on the front panel of the unit (see Figure 2, letter E). Power output is displayed in “.1” watt increments in the display window. NOTICE: The output settings can not be adjusted while the generator is being activated. 3. A footswitch or other switch closure device is required to activate the generator. 4. Activate the generator as desired for the procedure being performed. When the unit is activated, an audible tone is sounded and the blue active light will illuminate (see Figure 2, letter F). 5. When the procedure is completed, turn the generator off utilizing the power switch on the right side of the unit (see Figure 2, letter D).

8. ACCESSORIES: Accessories for the Trabectome® High Frequency Generator are supplied only by NeoMedix. Accessory instruments used with this device must comply with applicable portions of ANSI/AAMI HF-18 for high frequency leakage current and ISO 10993 requirements for the applicable use conditions. Sterile accessories should have a Sterility Assurance Level (SAL) of 10-6.

9. MAINTENANCE: The NeoMedix Trabectome® Generator requires periodic cleaning depending upon frequency of use. When the unit case requires cleaning, simply utilize a soap and water solution and wipe clean. Be careful that no water enters the unit through various openings. Dry the unit with a clean lint-free cloth.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

10. TROUBLESHOOTING: The NeoMedix Trabectome® Generator has been designed and manufactured with the utmost safety in mind. The unit is equipped to automatically detect a malfunction. The following table lists error codes, their meaning and recommended actions to be taken to resolve the error. Error Code

Description of Error

Recommended Action

E1

Activation upon power up

E2

DC Supply Over Voltage Detection

E3

Pulse Width

 Check footswitch for activation; once the activation is halted the unit will resolve the error. If the error persists, the footswitch could be malfunctioning and may need to be replaced.  Check activation cable for shorts and replace if necessary  Switch unit off and on again.  Make sure unit is connected to the correct power source for the unit  Switch unit off and on again.

E4

Delta Error

 Switch unit off and on again.

E5

Multiple errors

 Switch unit off and on again.

E6

Temperature error

 Switch unit off. Allow unit to cool. Switch on again.

If problems persist, the unit should be taken out of service and NeoMedix customer service contacted.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

11. TECHNICAL SPECIFICATIONS Mains Connection Mains Voltage:

240V ± 10%

Mains Frequency:

50 – 60 Hz

Mains Current:

800 mA Max.

Power Consumption:

20 Watts

Duty Cycle:

10 sec on / 30 sec off

Mains Fuses:

2 x 800mA(slow blow)

HF Nominal Output Characteristics Bipolar Output Power:

3.5Watts / 1000 ohms, 6 Watts / 200 ohms

Output Frequency:

~550 kHz

Peak Open Circuit Voltage:

~800 V

Safety Basic Construction:

In accordance with IEC 60601

Mode of Operation:

Intermittent operation

Protection Class:

CLASS I EQUIPMENT

Output Type:

TYPE BF

Dimensions and Weight Length x Depth x Height: Weight: Operating Parameters Ambient Temperature range:

9” x 4.5” x 6.3” [23cm x 11.5cm x 16cm] 5 lbs [2.27 kg] 10° C to 40° C (50°F to 104° F)

Relative Humidity:

30% to 75% non-condensing

Atmospheric Pressure:

700 to 1060 hPa (700 to 1060 millibar)

Transport and Storage Ambient Temperature range:

-34° C to 65° C (-29°F to 149° F)

Relative Humidity:

0% to 75% non-condensing

Atmospheric Pressure:

500hPa to 1060hPa (500 to 1060 millibar) 11

NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

12. OUTPUT POWER CURVES The curves that follow depict the typical changes for each mode at specific power settings

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

13. DESCRIPTION OF SYMBOLS

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

14. WARRANTY NeoMedix has exercised care in the manufacturing of the Trabectome® High Frequency Generator/LP. The warranty period for the unit is one (1) year from the date of purchase and covers parts and labor. Shipping costs are the responsibility of the customer unless otherwise previously arranged with NeoMedix or its authorized agents. The warranty is limited to the repair or replacement of the unit at the discretion of NeoMedix and may not apply if the unit has been subject to abuse on the part of the user. Prior to contacting NeoMedix or the local authorized distributor, thoroughly review Section 10. Troubleshooting of this manual to verify that the problem cannot be resolved using the recommended actions. Please keep in mind that there are no userserviceable parts inside the console and its accessory equipment options. Customer attempts to access internal components by removing the fasteners securing outer covers and panels may void any applicable warranties. After confirming that the problem(s) cannot be resolved by using the troubleshooting actions, some basic information should be collected by the customer prior to contacting NeoMedix or the local authorized distributor.    

Name of institution - or- customer Full name of individual to contact at customer site Phone number of individual customer contact Serial Number of Trabectome® High Frequency Generator/LP (found on the lower left side rear panel product label) -or- Model # and Serial Number of accessory (found on accessory product label)  Description of problem(s) encountered  Presence of any visible damage to enclosure or components  Urgency of repair time

When the above informational items have been collected, contact NeoMedix Corporation (1-714-258-8355) or your local authorized distributor and request a Return Goods Authorization (RGA) Number. Record the RGA Number for future reference, as it will be required to track the status of the repair order. Include the RGA in all correspondence and prominently mark the outside of the packaging containing the item(s) to be repaired with the RGA Number. 14

NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

Items for repair (warranty and non-warranty) should be sent with all original packaging and instructions included. Please use proper packaging to prevent damage during shipment. It is recommended that all shipments be insured with the shipping carrier for loss or damage. Include a copy of the original invoice with the return and state the reason for the return (i.e., a specific description of the problem(s) encountered). Shipping charges for warranty and non-warranty repairs are the responsibility of the customer unless otherwise previously arranged with NeoMedix or its authorized agents.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

APPENDIX A: ELECTROMAGNETIC IMMUNITY TABLE Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Model 600026 Electrosurgical Equipment is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 600026 Electrosurgical Equipment should assure that it is used in such an environment. IMUNITY Test

IEC 60601 Level

Compliance Level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 6 kV contact ± 8 kV air

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

± 2 kV for power supply lines ± 1 kV for input/output lines

± 2 kV for power supply lines ± 1 kV for input/output lines

Mains power quality should be that of a typical hospital environment.

Surge IEC 61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

± 1 kV differential mode ± 2 kV common mode

Mains power quality should be that of a typical hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s

<5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s

Mains power quality should be that of a typical hospital environment. If the user of the Model 600026 Electrosurgical Equipment requires continued operation during power mains interruptions, it is recommended that the Model 600026 Electrosurgical Equipment be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

0, 3 A/m

If the handpiece is not operating properly, it may be necessary to position the Model 600026 Electrosurgical Equipment further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.

NOTE UT is the a.c. mains voltage prior to application of the test level.

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NeoMedix – TRABECTOME® High Frequency Generator/LP (230V) Operations Manual

APPENDIX B: ELECTROMAGNETIC EMMISSIONS TABLE

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Model 600026 is intended for use in the electromagnetic environment specified below. The customer or the user of the Model 600026 should assure that it is used in such an environment. Emissions Test

Electromagnetic Environment – Guidance

Compliance

RF emissions CISPR 11

Group 1

The Model 600026 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The Model 600026 is suitable for use in all establishments, other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

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