Codman 901001ESUO Instruction Manual Rev F

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Codman®

Electrosurgical Generator Instruction Manual

SYSTEM OVERVIEW Important Information: Please Read Before Use Codman® Electrosurgical Generator Description The Codman® Electrosurgical Generator (the Generator) is a unit designed for use with monopolar and bipolar instruments to cut and coagulate tissue during surgical procedures. The Generator provides an audible indication of the operating mode each time cutting or coagulation is performed. The Generator can be used with an electrosurgical irrigator, such as the Codman® Electrosurgical Irrigator, and an interconnecting cable, such as the Codman® Electrosurgical Interconnecting Cable, where irrigation is available to the user while performing electrosurgical procedures. Indications The Generator is indicated for use for cutting and coagulation of soft tissue in neurosurgical procedures. Contraindications There are no known contraindications relating to safe application of the Generator. WARNINGS • Read entire instruction manual before attempting to operate the Generator. • Use of monopolar operating modes should be restricted to extracranial cutting/coagulation during neurosurgical procedures (i.e., the opening and closing of neurosurgical cases) and to tissues contained in the extradural compartment. The monopolar operating modes should NOT be used in the cutting/coagulation of tissues in the subdural compartment or the neural parenchyma. • Do not remove the Generator cover. There are no user serviceable components in this system. • Replacement fuses must meet the specifications outlined in this manual. See Technical Specifications. • This Generator must not be modified in any way. Unauthorized modifications could cause the Generator to malfunction or fail and will void the warranty. • The operator of the Generator must be a healthcare professional. The operator must be experienced in the use of electrosurgical devices and generators in surgical procedures. • Failure of the Generator could result in unintentional increase of output power. • The Generator performs a self-test upon initial start-up. An indicator error in any of the self-test sequence indicates a device defect. See the Error Diagnosis/Troubleshooting section to determine if the error can be resolved. If not, discontinue using the device and contact your Integra sales representative. 3

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SYSTEM OVERVIEW Electrical Shock Hazard • To avoid risk of electric shock, the Generator must only be connected to supply mains with protective ground. • Disconnect the power cord to isolate the Generator from the supply mains. Serious shock hazards may be present even with the power switch off. • Do not bypass the grounding prong on the Generator by using an adapter. The Generator must be properly grounded to ensure user and patient safety. Grounding reliability can only be achieved when connected to a receptacle marked “Hospital Only” or “Hospital Grade.” • The output from the Generator must not be applied directly to the heart. • Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (e.g., cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged. • Do not connect multiple portable socket outlets (MPSO) or extension cords to the Generator. • Connect adapters and accessories to the Generator only when the energy is off. Failure to do so may result in an injury or electrical shock to the patient or operating room personnel. • Never simultaneously touch the patient and the external fuse. • Inspect all cords, monopolar and bipolar accessory devices, and Foot Pedal for proper function and intact insulation prior to each use. • Use in typical commercial or hospital environment, except in RF (radiofrequency) shielded room for magnetic resonance imaging, where the intensity of EM (electromagnetic) disturbances is high. • Avoid HF (high-frequency) output settings where maximum output voltage may exceed rated accessory voltage. • Activating the RF current is not permitted while inserting the electrode and during electrode replacement due to risk of burns. • Do not use in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether or alcohol), as explosion may occur. • Do not immerse the Generator in any type of liquid. • Non-flammable agents should be used for cleaning and disinfection whenever possible. • Flammable agents, including disinfectants, cleaning fluids, and solvents, must fully evaporate prior to HF surgical procedures. There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before HF surgical equipment is used. Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the HF surgical equipment. • Unless a compatible monitoring neutral electrode is used with a contact quality monitor, loss of safe contact between the neutral electrode and the patient will not result in an auditory alarm. • Other equipment may be adversely influenced by the interference produced by the operation of HF surgical equipment. Portable and mobile RF communications equipment can affect medical electrical equipment. • Prevent patient contact with metal parts that are grounded or that have an appreciable capacitance to ground; e.g., operating table supports. Use antistatic sheeting. • Prevent patient skin-to-skin contact (e.g., between the arm and the body) when the Generator is in use. Use dry gauze between body parts that might touch during surgery. • When HF surgical equipment and physiological monitoring equipment are used simultaneously on a patient, any monitoring electrodes must be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. If needle electrodes are used, do not place in direct contact with forceps tips. Monitoring systems incorporating high frequency current-limiting devices are recommended. • During surgical procedures where the HF current could flow through parts of the body having a relatively small area, bipolar techniques can prevent unwanted tissue damage. • To prevent injury to the patient and/or user, do not connect the Generator to any item not specified as part of the system or identified as a recommended accessory within this manual. Use of unspecified items with the system could result in excessive leakage current. Refer to individual Instructions for Use for additional information regarding accessories or use with other devices.

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SYSTEM OVERVIEW • The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it is used. • Refer to the Guidance and Manufacturer’s Declaration section for EMC (Electromagnetic Compatibility) information. • In order for the Generator to be able to fulfill its intended clinical function effectively, a maximum cord and accessory length of 4.5 meters between the Generator and accessories is defined for Bipolar Accessories, 3.2 meters is defined for Monopolar Accessories and 3.0 meters for Neutral Electrodes. • The use of accessories, transducers and/or cords other than those specified, except for those sold by the manufacturer as replacement parts for internal components, could result in increased emissions or decreased immunity of the equipment or system. • The application of a current with high voltage, and in particular of a high voltage monopolar coagulation current, may cause neuromuscular stimulation in the patient. • When vaporizing tissue, do not inhale the combustion fumes that form by design over a longer period in concentrated form. During regular use of the Generator, no pollutants other than these combustion products will be formed. For removal of such combustion products, a fume suction system can be used.

Precautions • The Generator must be separated from other electrosurgical devices and their cords. Close proximity to the Generator and its cords to electrosurgical units that produce excessive RF current radiation could cause the Generator to change output power. Surgical electrode cords must be positioned to avoid contact with the patient or other leads. Temporarily unused active electrodes should be stored in a location that is isolated from the patient. • Do not operate the Generator at temperatures below 50°F (10°C). Allow the Generator to warm up to at least 50°F (10°C) before use. • Visually inspect the power cord, bipolar cord and Foot Pedal for damage prior to each use. Connect Foot Pedal, adjust Generator to desired power setting, and activate Foot Pedal to verify proper function. Replace accessories if necessary. • Non-insulated bipolar forceps are not recommended for use with higher power settings. When higher power settings are employed, insulated bipolar forceps are recommended. • Keep bipolar instrument tips clean. Build-up of eschar may reduce the instrument's effectiveness. Do not activate the instrument while cleaning, as injury to operating personnel may result. • The Generator is designed for use without a neutral electrode while operated in bipolar modes. • The Generator does not generate waste. Disposable products used with the Generator must be disposed of in accordance with hospital procedures and regulations. • Always position Generator so that the power cord can be easily unplugged from the rear panel. • The output power should be set as low as is necessary to achieve the desired effect. • Anyone who connects additional units to the input or output section thereby configures the system and is thus responsible for compliance with section IEC 60601-1:16. • In order to be able to completely separate the unit from the grid in the event of danger, either the power socket of the unit or the outlet into which the mains cable is plugged should remain accessible.

Wiping • Wipe the exterior surfaces of the Generator as necessary with a soft, damp cloth or sponge. Use 70% Isopropyl Alcohol wipes or a mild cleaning solution to remove stains or adhesives that stick to the surface. Subjecting the Generator to excessive moisture can damage the electronic components and nullify the warranty. • Never sterilize the Generator.

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CONTROLS, INDICATORS & CONNECTIONS Front Panel

1

3

2

4

5

7

6

8

Codman® Electrosurgical Generator CUT

COAG

Watt

Watt

max.

MONOCUT

BICUT

max.

MONOCOAG

BICOAG

Monopolar

9

10

Bipolar

11

12

1. Power Button This button controls the primary AC power to the Generator. When the Generator is ON, the Display Screen, Operating Mode Buttons and Power Button illuminate. 2. CUT Output Power Setting Knob Turning the output power setting knob clockwise increases the power setting and turning it counterclockwise decreases the power setting of the Generator. The setting is visible on the CUT Display Screen. 3. CUT Display Screen The screen shows the output power setting for CUT (MONOCUT or BICUT, depending on which Operating Mode Button is activated). 4. CUT Indicator Light The light is illuminated when the user activates the CUT mode, either by finger switch or Foot Pedal. 5. Operating Mode Buttons These buttons control the operating mode of the Generator. The Display Screen will show the output power setting for the selected Operating Mode. Only one (1) CUT and one (1) COAG mode can be selected simultaneously. MONOCUT BICUT MONOCOAG BICOAG 6. COAG Indicator Light The light is illuminated when the user activates the COAG mode, either by finger switch or Foot Pedal.

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CONTROLS, INDICATORS & CONNECTIONS

7. COAG Display Screen The screen shows the output power setting for COAG (MONOCOAG or BICOAG, depending on which Operating Mode Button is activated). 8. COAG Output Power Setting Knob Turning the output power setting knob clockwise increases the power setting and turning it counterclockwise decreases the power setting of the Generator. The setting is visible on the COAG Display Screen. 9. Neutral Electrode Receptacle The neutral electrode receptacle accepts the international rectangular connection. 10. “Neutral Electrode not connected” Indicator Light If the light is illuminated and flashing red, the Neutral Electrode is not properly connected to either the Generator or the patient. 11. Bovie and 3-Pronged Monopolar Receptacle The Monopolar receptacle accepts either a bovie connection or 3-pronged connection cord for use with monopolar instruments. 12. Bipolar Receptacle The Bipolar receptacle accepts a Codman bipolar cord for use with bipolar instruments. (See Recommended Accessories section for product codes.)

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CONTROLS, INDICATORS & CONNECTIONS Rear Panel

13

14

15 16

17

18 19

100-240 V-50/60 Hz T3.15 AH 250V

13. Foot Pedal Connection Receptacle The connection receptacle accepts the four-pin end of the Foot Pedal cord. 14. Irrigator Connection Receptacle The connection receptacle accepts the three-pin end of the Interconnecting Cable. 15. Speaker The speaker produces audible warnings and indications. 16. Volume Control Knob Allows the user to adjust the volume of the speaker. 17. Device Type Plate Provides information to the user about the device. 18. Power Receptacle The power receptacle accepts the three-prong power cord plug. 19. Equipotential Connector Connect a potential equalization conductor to a bus bar in rooms requiring potential equalization. A bus bar is a grounded metal bar in a breaker box to which all neutral and grounding wires are connected.

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CONTROLS, INDICATORS & CONNECTIONS Dual Foot Pedal 901001FPED 20 21

22

23

20. Adjustment Bar When raised, the adjustment bar allows the user to reposition the Foot Pedal with his/her foot mid-procedure. 21. Cord management feature Allows the user to wrap the Foot Pedal cord for storage. 22. CUT pedal (yellow) Depressing this pedal activates cutting power to the instrument. 23. COAG pedal (blue) Depressing this pedal activates coagulation power and irrigation to the instrument. 24

Circular Foot Pedal 901001CPED

24. COAG pedal Depressing this pedal activates coagulation power and irrigation to the instrument.

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INSTRUCTIONS FOR USE Generator Setup

1

Place Generator

Place the Generator on a stand, shelf, or other flat surface capable of securely supporting the device.

Codman® Electrosurgical Generator CUT

COAG

W MONOCUT

BICUT

Monopolar

2

W MONOCOAG

BICOAG

Bipolar

Plug In Generator

a

Plug the power cord into the rear panel of the Generator.

b

Plug the Generator into a grounded electrical outlet of the appropriate voltage rating.

REAR PANEL

Foot Pedal & Electrosurgical Irrigator Setup

1

Plug In Foot Pedal

When you are using a Foot Pedal with the Generator:

a

Insert the plug of the Dual Foot Pedal or Circular Foot Pedal into the Foot Pedal Receptacle on the rear of the Generator. Place the Foot Pedal in an area accessible to the user.

b

Twist the cable collar 1/4 turn to lock the Foot Pedal cable in place.

CIRCULAR FOOT PEDAL

Note: Verify activation of the Foot Pedal before each use. REAR PANEL

2

DUAL FOOT PEDAL

Codman Electrosurgical Irrigator Setup (Optional)

IRRIGATOR: REAR PANEL

If you are using the Electrosurgical Irrigator with the Generator:

GENERATOR: REAR PANEL

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a

Follow the Instructions for Use provided with the Irrigator.

b

Using the Electrosurgical Interconnecting Cable, connect one end of the cable to the Generator receptacle on the rear of the Irrigator. This cable allows you to control irrigation while coagulating when using the Foot Pedal to activate the system.

c

Connect other end of the cable to the receptacle on the rear of the generator.

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INSTRUCTIONS FOR USE Power On Power on the Generator by pushing the power button. The power button will illuminate blue. An error in the start-up indicates a device defect. Refer to the Error Diagnosis/Troubleshooting section of this IFU.

Self-Test The Generator performs a self-test after it is powered on. All display elements on the front panel are turned on during this process. The following light up briefly in the order they are listed: The MONOCUT and BICUT mode buttons, then MONOCOAG and BICOAG mode buttons, followed by the red indicator light above the neutral electrode receptacle. The two Output Power displays light up with “88” and the white CUT and COAG Indicator lights illuminate sequentially; the respective activation tone must sound simultaneously. The default start-up of the device is BICUT and BICOAG with both displays lit up with “00”. An error in the self-test sequence indicates a device defect. Refer to the Error Diagnosis/Troubleshooting section of this IFU.

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INSTRUCTIONS FOR USE: CONNECTING ACCESSORIES Connecting the Neutral Electrode

1 Connect the Neutral Electrode to the receptacle on the front of the device. NOTE: • If the neutral electrode is NOT connected during monopolar mode, the “Neutral electrode not connected” indicator above the receptacle will light up red and flash. • If the finger switch or Foot Pedal is activated while in monopolar mode without the neutral electrode connected, an audible warning sounds. RF current cannot be activated. This has no influence on the bipolar current. • When using a multi-surface electrode, the “Neutral electrode not connected” indicator will turn off after the safe application state is reached. • The entire area of the neutral electrode should be reliably attached to a suitably prepared and appropriate area of the patient’s body as defined by the manufacturer.

Connecting Monopolar Accessories

1 Connect a 3-pronged connection monopolar cord or bovie connection monopolar cord to the appropriate location in the monopolar receptacle. Ensure the 3-pronged connection is in the correct orientation (see illustration below).

2 Connect the desired Monopolar Instruments to this cord. NOTE:

a1 Connect a Monopolar device with a finger switch for CUT and COAG activation. OR Monopolar

a Monopolar device without a finger switch, in combination with the Foot Pedal for CUT and a2 ConnectBipolar COAG activation.

Connecting Bipolar Accessories

1 Connect a Codman Bipolar cord to the receptacle. See Recommended Accessories section. 2 Connect the desired bipolar instrument to the cord. The Foot Pedal is used for CUT and COAG activation. NOTE: • The neutral electrode is NOT required for bipolar applications.

Bipolar

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RECOMMENDED ACCESSORIES AND ORDERING INFORMATION Description

Catalog No.

Codman Integrated Bipolar Cord and Tubing Set, Rotary Pump, Fixed Leads

9190001RP

Codman Bipolar Cord Sets, Reusable, Unitized Leads

801186

Codman Bipolar Cord Sets, Disposable, Unitized Leads

801188

Codman Electrosurgical Interconnecting Cable

901001CBL1

Codman Electrosurgical Foot Pedal

901001FPED

Codman Electrosurgical Irrigator

901001IRRO

Codman VersaTru [Standard/Slim] Disposable Non-Stick Bipolar Forceps

9007050ST, 9007100ST, 9007150ST, 9008050ST, 9008100ST, 9008150ST, 9009050ST, 9009100ST, 9009150ST, 9008050SL, 9008100SL, 9008150SL, 9009050SL, 9009100SL, 9009150SL

Codman Electrosurgical Circular Foot Pedal

901001CPED

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ERROR DIAGNOSIS/TROUBLESHOOTING The Generator conducts extensive functional tests during the power-on self-test. All safety-related functions are also checked continuously during operation. In case of errors, the RF energy output is stopped and the error is indicated by an error message. Table 1 below describes an example of an error diagnosis, possible cause, and solutions. The messages where resolution by the user is possible are listed in the Possible Solutions column. Note: After an error message is displayed, the device can only be reset by turning it off and back on again. Note: Contact your Integra sales representative if a displayed message is not described below. Table 1 - Error Diagnosis Error Messages

Possible Causes

Solutions

Apparent low output or failure of the HF surgical equipment to function correctly at the normal operating settings.

Faulty application of the neutral electrode or poor contact in its connections.

Application of the neutral electrode and its connections should be checked before selecting a higher output power.

Power cord not plugged into the outlet.

Plug power cord into the outlet.

Power cord is not fully connected to Generator.

Assure that the power cord is completely plugged into both the device and the outlet.

Device is not turned ON.

Switch ON the device.

Defective fuse.

Device defect; service required.

Defective internal power supply.

Device defect; service required.

Visual elements on the front work normally; no RF output power.

Defective accessory.

Replace the accessory.

Defective device.

Turn the device OFF and ON again. If any error message is displayed, contact your Integra sales representative.

Err 41, Err 42

Monopolar hand piece switch activated before the self-test was complete.

Release the finger switch.

Defective instrument or connection cord.

Disconnect the hand piece and turn the device OFF and ON.

Defective device.

Contact your Integra sales representative.

Defective instrument or connection cord.

Disconnect the hand piece and turn the device OFF and ON.

Defective device.

Contact your Integra sales representative.

Activation of the Foot Pedal before the self-test was complete.

Release the Foot Pedal.

Short circuit in the Foot Pedal or its connection cable.

Disconnect the Foot Pedal and turn the device OFF and ON.

Defective device.

Contact your Integra sales representative.

Operator panel button was activated before the self-test was completed.

Turn the device OFF and ON again. If any error message is displayed, contact your Integra sales representative.

Defective device.

Contact your Integra sales representative.

Visual elements on the front are dark; device does not function.

CUT

COAG

Err 45, Err 46 CUT

COAG

Err 47, Err 48 CUT

COAG

Err 51 CUT

COAG

Err 89 CUT

COAG

Overheating caused by continuous RF activation Turn OFF the Generator and let it cool down for for an extended time outside the specification. a few minutes before turning it ON again. If the error is still displayed, contact your Integra sales representative. 14

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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS Current Mode MONOPOLAR BIPOLAR

Current Type

RF Output Power

RF Output Current

RF Output Voltage

Nominal

Modulation

MONOCUT (Cutting) max. 80 W ±20 % on 600 Ω

0.51 A on 600 Ω max 800 Vp

4.00 MHz

33 kHz

MONOCOAG (Coag.) max. 80 W ±20 % on 400 Ω

0.51 A on 400 Ω max 560 Vp

4.00 MHz

33 kHz

BICUT (cutting)

max. 80 W ±20 % on 300 Ω

0.6 A on 300 Ω

max 400 Vp

4.00 MHz

33 kHz

BICOAG (coag.)

max. 60 W ±20 % on 50 Ω

1.2 A on 50 Ω

max 440 Vp

4.00 MHz

33 kHz

Classification Mains Supply

100-240 VAC ; 50/60 Hz

Power Consumption

Without HF output: approximately 50 VA At maximum output power: approximately 500 VA

Protection Class

I

LF and RF Leakage Currents

According to IEC 60601-2-2

Application Type

CF; defibrillator safe

Operating Mode

Intermittent 10 seconds ON /30 seconds OFF

Mains Fuse

2 x T 3.15 AH 250 V 5x20 mm

Signal Level

RF indicator: 40-65 dB(A) adjustable. Alarm: 65 dB(A)

Weight

Approximately 5.0 kg

Dimensions

Width 403 mm Height 170 mm Depth 313 mm

Standards

IEC 60601-1:2005 + A1:2012, Ed. 3.1 CAN/CSA-C22.2 No. 60601-1:14 ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 IEC 60601-1-2:2007, Ed. 3.0 IEC 60601-1-2:2014, Ed. 4.0 IEC 60601-2-2:2017, Ed. 6.0

Environmental

Operational

Transport

Storage

Temperature

10° to 40°C / 50° to 104°F

-40° to 60°C / -40° to 140°F

-40° to 60°C / -40° to 140°F

Relative Humidity (non-condensing)

30% to 75%

15% to 85%

15% to 85%

Atmospheric Pressure

700 hPa to 1050 hPa

500 hPa to 1050 hPa

500 hPa to 1050 hPa

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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS Service and Repair The manufacturer will provide schematics, parts list, and other technical information to authorized service centers. For service, repair or replacements, contact your local Integra representative. Equipment under warranty should be returned to Integra LifeSciences Corporation. It will be repaired or replaced without charge to the purchaser.

End of Useful Life The Generator contains electrical components. Consider recycling at the end of service life. The product can be returned to Integra for recycling. Dispose of the equipment in accordance with local ordinances.

Warranty Period lntegra LifeSciences Corporation warrants that this medical device is free from defects in both materials and workmanship for two full years from date of purchase. Only accessories approved by Integra (including the accessories listed in the recommended accessories section) are covered under this warranty. Use of any other accessories nullifies this warranty. Any other express or implied warranties, including warranties of merchantability or fitness for a particular purpose, are hereby disclaimed. Suitability for use of this medical device for any surgical procedure should be determined by the user in conformance with the manufacturer's instructions for use. There are no warranties that extend beyond the description on the face hereof. PRODUCT INFORMATION DISCLOSURE INTEGRA LIFESCIENCES CORPORATION (“INTEGRA”) HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA WARRANTS THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR APPLICABLE PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE, AND INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS. INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN CONNECTION WITH THESE PRODUCTS.

Field Maintenance and Repair Equipment under warranty should be returned to Integra LifeSciences Corporation. It will be repaired or replaced without charge to the purchaser. Annual safety and functional checks are recommended. Proprietary testing equipment is required for this 4 MHz generator. Using any other testing equipment may not yield expected measured outputs. For more information regarding testing set up please contact your local Service and Repair department or Integra sales representative.

Guidance and Manufacturer’s Declaration Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the tables below. NOTE: Portable and mobile RF communications equipment can affect medical electrical equipment.

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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS Table 2 -Guidance and Manufacturer’s Declaration-Emissions All ME Equipment and ME Systems Guidance and Manufacturer’s Declaration-Emissions The Generator is intended for use in the electromagnetic environment specified below. The customer or user of the Generator should ensure that it is used in such an environment. Emissions Test

IEC 60601-1-2, 3rd edition Compliance Level

IEC 60601-1-2, 4th edition Compliance Level

Electromagnetic Environment-Guidance

Radiated RF Emissions CISPR 11

Group 2

Group 2

The Generator must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected.

Conducted RF Emissions CISPR 11

Class A

Class A

Harmonics IEC 61000-3-2

Class A

Class A

Emissions of voltage fluctuations/flicker IEC 61000-3-3

Complies

Complies

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

NOTE: The Generator must be installed and operated according to the EMC regulations laid out in this document. NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 class B is normally required), this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Table 3 -Guidance and Manufacturer’s Declaration-Immunity All ME Equipment and ME Systems Guidance and Manufacturer’s Declaration-Immunity The Generator is intended for use in the electromagnetic environment specified below. The customer or user of the Generator should ensure that it is used in such an environment. Immunity Test

IEC 60601-1-2, 3rd edition Compliance Level

IEC 60601-1-2, 4th Electromagnetic Environment-Guidance edition Compliance Level

ESD IEC 61000-4-2

±6 kV Contact ±8 kV Air

±8 kV Contact ±15 kV Air

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

EFT IEC 61000-4-4

±2 kV Mains ±1 kV I/Os

±2 kV Mains ±1 kV I/Os

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

Surge IEC 61000-4-5

±1 kV Differential ±2 kV Common

±1 kV Differential ±2 kV Common

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

Voltage Dips/ Dropout IEC 61000-4-11

<5% UT for 0.5 Cycle

0% UT for 0.5 Cycle

40% UT for 5 Cycles

0% UT for 1 Cycle

70% UT for 25 Cycles

70% UT for 25/30 Cycles

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

<5% UT for 5 Seconds

0% UT for 250/300 Cycles

Power Frequency 3 A/m, 50/60 Hz Magnetic Field IEC 61000-4-8

30 A/m, 50/60 Hz 17

Power frequency magnetic fields should be that of a typical commercial or hospital environment.

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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS Table 4-Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Reference Table 204 IEC 60601-1-2 3rd and 4th edition Guidance and Manufacturer’s Declaration-Immunity The Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Generator should ensure that it is used in such an environment. Immunity Test

IEC 60601 test level

Compliance level

Electromagnetic Environment – Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Generator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF 3 Vrms 3 Vrms d = 1.2 √ P (Mains and I/Os) 150 kHz to 80 MHz 150 kHz to 80 MHz IEC 61000-4-6 6 Vrmsa in ISM frequency bands 150 MHz to 80 MHz Radiated RF IEC 61000-4-3

6 Vrmsa in ISM frequency bands 150 MHz to 80 MHz

3 V/m 3 V/m 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz

d = 1.2 √ P 80 MHz to 800 MHz d = 2.3 √ P 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a

The ISM bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz, 13.553 MHz to 13.567 MHz, 26.957 MHz to 27.283 MHz, and 40.66 MHz to

40.70 MHz. b

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM

and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Generator is used exceeds the applicable RF compliance level above, the Generator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Generator. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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TECHNICAL SPECIFICATIONS AND ENVIRONMENTAL REQUIREMENTS Table 5-Recommended Separation Distances for the Generator, per IEC 60601-1-2, 3rd edition The Generator is intended for use in the electromagnetic environment specified below. The customer or user of the Generator should ensure that it is used in such an environment. Maximum Output Separation (m) Power (Watts) 150 kHz to 80 MHz

Separation (m) 80 to 800 MHz

Separation (m) 800 MHz to 2.5 GHz

d = 1.2√P

d = 1.2√P

d = 2.3√P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

Recommended separation distances between portable and mobile RF telecommunications equipment and the Generator Requirements for high-frequency wireless communication equipment Frequency band (MHz)

Test frequency (MHz)

Modulation

Compliance level (V/m)

380-390

385

Pulsea –18 Hz

27

430-470

450

FM ±5 kHz Hub or Pulsea –18 Hz

28

704-787

710, 745, 780

Pulsea –217 Hz

9

800-960

810, 870, 930

Pulsea –18 Hz

28

1,700-1,990

1,720, 1,845, 1,970

Pulsea –217 Hz

28

2,400-2,570

2,450

Pulsea –217 Hz

28

5,100-5,800

5,240, 5,500, 5,785

Pulsea –217 Hz

9

A minimum safety distance of 30 cm (12") between portable HF communication equipment emitting in the Note

respective frequency band and the Generator should be observed. This includes e.g. cell phones and WIFI, RFID and Bluetooth devices. Non-observance may result in reduction of the performance features of the device.

a

Pulse modulation is defined as a square wave signal with 50% duty cycle.

WARNING: Per IEC 60601-1-2, 4th edition, portable RF communications should be used no closer than 30 cm (12 inches) to any part of the Generator, including cords specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

19

EN - ENGLISH

POWER CURVES RF Output The below power charts show typical output characteristics of the Generator for all available modes. For each mode, the power output at the maximum (1) and half (2) power level as a function of the resistive load is depicted. Actual measurements of the output power may vary depending on the chosen test accessory and the measurement setup. According to IEC 60601-2-2:2017 paragraph 201.12.1.101, the power output shall not deviate by more than ±20 %.

Monopolar Curve 1: Output setting “maximum output” Curve 2: Output setting “half output”

Curve 1: Output setting “maximum output” Curve 2: Output setting “half output”

MONOCOAG MONOCOAG 90

90

80

80

80

80

60

90

MONOCUT MONOCUT

70

1

60

90

50

80 70

50 40

60 50

20

10

10

40

0 0

30

0

20

20

10

10

0 400

200600

400800

6001000

8001200

1000 1400

1200 1600

1400 1800

1600 2000 1800

BICUT BICUT 800 1200 1000 1400 1200 1600 1400 1800 1600 2000 1800 Curve 1: Output setting “maximum output” 90 90 Resistance (Ω) Curve 2: Output Resistance setting “half output” (Ω) 200

Output Power (Was) Output Power (Was)

80 70 60

90 80 70 60 50

50 40 30 20 10

40

0

0 400

30 20

400800

600 1000

70

10

BICUT

0 0

20

20

10

10

BICUT

20

1

10

40

0

100 30

0200

100300

200 400

300 500

400 600

500 700

600 800

700 900

800 1000

1000

60

50

40

50

20

40

10

30

0

0 400

1000 1400

12001600

14001800

100 300

200 400

300 500

400 600

500 700

600 800

700 900

800 1000

900

800

700

700

500

900

400 300

700

200 100

800

600

600

MONOCUT MONOCUT

600 1000

60

BICOAG BICOAG

50

30 100

0 0200

100 300

200 400

300 500

400 600

500 700

600 800

700 900

Resistance Resistance (Ω) (Ω)

10

500

500

400

500

300 200 100

20

400

600

300

300

500

200

400 100

800 1000

900

1000

1 2

0 100

600

400

2000

40 10

600

600

500

( Vp)

600

2000

50 20

0

1000

Voltage ( Vp)

800

Voltage ( Vp)

900

1600 2000 1800

60 30

Voltage ( Vp)

0200

900

Vp)

Voltage ( Vp) Vp)

600

400800

20

( Vp)

100

MONOCUT MONOCUT Resistance Resistance (Ω) (Ω)

700

200600

0

0 0

800

8001200

10

0

900

6001000

70 40

10 10

400800

Resistance Resistance (Ω) (Ω)

0

20

2

Resistance Resistance (Ω) (Ω)

20

900

200600

0

60 30

30

50

0 400

BICOAG BICOAG 800 1200 1000 1400 1200 1600 1400 1800 1600 2000 1800 Curve 1: Output setting “maximum output” 70 70 Resistance Resistance (Ω) (Ω) Curve 2: Output setting “half output”

40

60

0

200

70

70

10

200 30

0

50

80

2

20

40

0

2000

60

90

0

200600

80

Output Power (Was) Output Power (Was)

0

30

50

30

Resistance Resistance (Ω) (Ω)

Bipolar 0

0

2000

1

40

60

20

40

200 30

50

70

30

Output Power (Was) Output Power (Was)

40

40

50

50

60

80

60

60

20

50

70

2

30

MONOCOAG MONOCOAG

70

90

80

70

30

60

90

80

40

70

Output Power (Was) Output Power (Was)

70

Output Power (Was) Output Power (Was)

90

Output Power (Was) Output Power (Was)

90

Output Power (Was) Output Power (Was)

Output Power (Was) Output Power (Was)

MONOCUT MONOCUT

200

400 100

0200

100 300

200 400

300 500

400 600

500 700

600 800

700 900

MONOCOAG MONOCOAG Resistance Resistance (Ω) (Ω)

MONOCOAG MONOCOAG

800 1000

900

1000