elliquence
Surgi-Max and Surgi-Max Plus Instructions for Use Manual Rev I March 2012
Instructions for Use Manual
11 Pages
Preview
Page 1
I. INTRODUCTION The Surgi-Max® and Surgi-Max® Plus enhanced capability Radiosurgery® Devices are a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays which also show the status of self-test and monitoring. This display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered. This device is designed to comply with international safety standards. The atraumatic nature of electrosection provides a noteworthy advantage. The lack of trauma results in tissue healing without fibrous contractile scar tissue, which characterizes the healing of wounds created by manual cutting.
1.1
SYMBOL DEFINITIONS The following symbols are used on the equipment 1.1.1
Classification Class IIb, according to European Council Directive 93/42/EEC concerning medical devices. Classification = Class I, according to the type of protection against electric shock as per IEC 60601-1.
1.1.2
Supply Input Power = 240/220/120/100V ~ 50/60 Hz, Option = 240/230/120/100V ~ 50/60 Hz
1.1.3
Alternating current
1.1.4
Type BF applied part
1.1.5
Caution, consult accompanying documents
1.1.6
Protective earth (ground)
1.1.7
Neutral electrode referenced to ground
1.1.8
Neutral plate
1.1.9
Fingerswitch control
1.1.10 Footswitch 1.1.11 Bipolar 1.1.12 Volume control 1.1.13 Non-ionizing radiation 1.1.14 HF Isolated Patient Circuit 1.1.15 Consult instruction for Use
II. TECHNICAL INFORMATION 2.1
OUTPUT CHARACTERISTICS Mode/Character
Output Waveform
Maximum Output Power
Activation
CUT
4.0 MHz Continuous Wave (CW)
120W @ 500 Ω
via footswitch or via fingerswitch
CUT/COAG
4.0 MHz Full Wave Rectified Sinusoid
90W @ 500 Ω
via footswitch or via fingerswitch
HEMO
4.0 MHz Square Wave Rectified
60W @ 500 Ω
via footswitch or via fingerswitch
BIPOLAR HEMO
1.7 MHz Half Wave Rectified Sinusoid
40W @ 200 Ω
via footswitch
BIPOLAR TURBO
1.7 MHz Continuous Wave (CW)
120W @ 200 Ω
via footswitch
2
2.2
DUTY CYCLE The yellow CUTTING MODE Activation Indicator will be ON when CUTTING MODE circuit is energized. The blue COAGULATION MODE Activation Indicator will be ON when COAGULATION MODE circuit is energized. A continuous tone will alert user of activation. After 55 seconds of continuous applied power (at any power level, in any mode), the tone will change and energy will cease 5 seconds after. The tone continues to alert of footswitch depression even though energy will not be emitted.
2.3
CLASSIFICATION 2.3.1
According to the type of protection against electric shock: the equipment is energized from an external electrical power source and is Class I equipment
2.3.2
According to the type of protection against electric shock: DEFIBRILLATION-PROOF TYPE BF APPLIED PART
2.3.3
Degree of protection against harmful ingress of water: ordinary equipment, or IPX0 according to IEC 60529.
2.3.4
Cleaning and Disinfection of the Unit Before Each Use: Cleaning and disinfection of the unit should only be done with non-flammable and non-explosive agents. Make sure that no moisture or detergents enter the unit. If cleaning or disinfection of the unit with flammable or explosive agents is unavoidable, these must be completely evaporated from the radiosurgical generator before it is switched on.
2.3.5
The mode of operation is continuous operation with intermittent loading, duty cycle 10 seconds ON / 30 seconds OFF.
2.3.6
The permissible operational environment conditions: Ambient temperature range ------ +10°C ~ +40°C Relative humidity range ------ 30% ~ 75%
2.3.7
The following specifications are applicable to the extent called out herein: EN IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. EN IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility. EN IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for safety of high frequency surgical equipment. UL Classified Medical Equipment with respect to electrical shock, fire and mechanical hazards only in accordance with: UL 60601-1, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90 3003
2.4
2.3.8
Over voltage category II: Equipment of OVER VOLTAGE CATEGORY II is energy-consuming equipment to be supplied from the fixed installation.
2.3.9
Flammability Material Classification according to UL 94-V0.
2.3.10
Pollution Degree Classification II: Normally only non-conductive pollution occurs. Temporary conductivity caused by condensation is to be expected.
2.3.11
Normal operating conditions for the generator is within an Altitude range of up to 2000 meters.
PREVENTIVE INSPECTION AND MAINTENANCE 2.4.1
By Customer; Regular preventative inspection should be carried out to avoid reduced performance of the unit due to aging, wear, deterioration, etc. Cables, electrodes, and other products must be checked before each use. The recommended preventative inspections are: L =B?42C8>=5>A0=H30<064C>C74D=8C0=38CB0224BB>A84B L =B?42C8>=>5?A>?4A5D=2C8>=>5C74D=8C
2.4.2
By elliquence; Technical safety inspections should only be carried out by elliquence. elliquence assumes no responsibility for improper
3
changes or repairs carried out on the unit or its accessories by unauthorized persons. Improper changes or repairs carried out by unauthorized personnel voids the warranty. The recommended technical safety inspections are: L =B?42C8>=>54;42CA820;B054CH8=2><?;80=24F8C7 L =B?42C8>=>578675A4@D4=2H>DC?DC?>F4A8=C74E0A84CH>5<>34B
2.5
ENVIRONMENTAL PROTECTION Disposal of the equipment and accessories must follow or comply with local disposal rules.
III. CAUTIONS, WARNINGS AND SAFETY INSTRUCTIONS 3.1
CAUTIONS: 3.1.1
Do not use the Surgi-Max® or Surgi-Max® Plus in the presence of flammable anesthetics or other flammable gases, liquids, or objects For transportation and storage: Ambient temperature range ------ -10°C ~ +50°C Relative humidity range ------ 10% ~ 95% Atmospheric pressure range ------ 500 hPa ~ 1060 hPa
3.1.2
Electrical shock hazard. Do not remove cover. Refer to authorized personnel for service.
3.1.3
May present a hazard to patients with all active electrical implants. Consult qualified medical personnel.
3.1.4
elliquence strongly recommends the use of Corneal Shields for any procedure involving Radiofrequency around the eyelid and the immediate surrounding areas.
3.1.5
This equipment complies with IEC 60601-1-2:2007 EMC standard for medical devices. This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical and non-medical devices and radio communications. To provide reasonable protection against such interference, this product complies the radiated emission as per CISPR11 Group1 Class A standard limits. However, there is no guarantee that inter ference will not occur in a particular installation. If this equipment is found to cause interference (which may be deter mined by turning the equipment on and off), the user (or qualified service personnel) should attempt to correct the problem by one or more of the following measure(s): L(4>A84=C>AA4;>20C4C7405542C4334E824B L =2A40B4C74B4?0A0C8>=14CF44=C744@D8?<4=C0=3C7405542C4334E824 L&>F4AC744@D8?<4=C5A><0B>DA2438554A4=C5A><C70C>5C7405542C4334E824 L>=BD;CC74?>8=C>5?DA270B4>AB4AE824A4?A4B4=C0C8E45>A5DAC74ABD664BC8>=B The manufacturer is not responsible for any interference caused by using other than recommended interconnect cables or by unauthorized changes or modifications to this equipment. Unauthorized changes or modifications could void the users' authority to operate the equipment. All interconnect cables to peripheral devices must be shielded and properly grounded, except when technologically prohibited. Use of cables not properly shielded and grounded may result in the equipment causing radio frequency interference.”
3.1.6
When being used in Monopolar Cut and Cut/Coag, never increase the power setting without first checking the proper connections of both the active electrode and the neutral plate. Important: Please read Sections 5.1, 5.2 and 5.3 before operating the device.
3.1.7
When multiple monopolar energy sources are to be used in a procedure, elliquence recommends activating only one (1) energy source at a time.
3.1.8
When multiple neutral plates are applied to a patient for multiple energy sources, elliquence recommends applying our disposable neutral plate on a separate side of the patient, with no wires being crossed.
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3.2
3.3
3.1.9
The elliquence RF generator requires special precautions regarding EMC. Install and use the elliquence RF generator according to the guidelines of the EMC declaration tables. (REFER TO: TABLES 1-4)
3.1.10
Portable and RF communications equipment may affect the elliquence RF generator. Always observe the recommended separation distances as defined in the EMC declaration tables. (REFER TO: TABLES 1-4)
WARNINGS: 3.2.1
Hazardous electrical output. This equipment is for use only by qualified personnel.
3.2.2
Never increase the power setting without first checking the proper connections of both the active electrode and the neutral plate.
3.2.3
Only elliquence supplied and/or approved accessories should be used to ensure proper operation. The elliquence generator and its accessories are identified with the manufacturer information and reference identification number for proper traceability.
3.2.4
Failure of the RF SURGICAL EQUIPMENT could result in an unintended increase of output power.
3.2.5
Read the instruction manual in detail before use.
3.2.6
The Surgi-Max® and Surgi-Max® Plus will retain the latest power output settings. When using Monopolar and Bipolar techniques, always start at the lowest setting.
3.2.7
Keep the electrode tips clean at all times. Prevent eschar build-up, which increases resistance and contributes to arcing. Eschar can ignite and cause a fire.
3.2.8
Use of accessories or cables other than elliquence specified, as replacement parts for internal components, may result in increased emissions or decreased immunity of the elliquence RF generator.
3.2.9
The use of external cables and leads that exceed 3.5 meters, may result in increased emissions or decreased immunity of the elliquence RF generator.
SAFETY INSTRUCTION Please review the below cautionary instructions to reduce the incidence of accidental burns. 3.3.1
It is recommended to place the Neutral Plate as close to the surgical site as possible (usually in opposition to the surgical site). If you are operating on the chest area, place the plate on the back. The Neutral Plate's entire area must be in contact with the patient’s skin. Proper contact of the Neutral Plate to the patient should be monitored, during a procedure. If the neutral place is not place correctly and it is not in contact with the patient skin an alarm will sound.
3.3.2
The patient should not come into contact with metal parts which are earthed or which have appreciable capacitance to earth.
3.3.3
Skin to skin contact (for example, between the arms and the body of the patient) should be avoided, for example by insertion of dry gauze.
3.3.4
When the Surgi-Max® or Surgi-Max® Plus is used simultaneously with physiological monitoring equipment on the same patient, the monitoring electrodes should be placed as far as possible from the surgical electrodes and the Neutral Plate. Needle monitoring electrodes are not recommended. In all cases, monitoring systems incorporating high-frequency current-limiting devices are recommended
3.3.5
The cables to the surgical electrodes should be positioned in such a way that contact with the patient or other leads is avoided. Temporarily unused active electrodes should be stored segregated from the patient.
3.3.6
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 desirable to avoid unwanted coagulation.
3.3.7
The output power selected should be as low as possible for the intended purpose.
5
3.3.8
Apparent low output or failure of the surgical equipment to function correctly at the normal operating settings may indicate faulty application of the Neutral Plate or poor contact in its connection. In this case, the application of the Neutral Plate and its connections should be checked before selecting a higher output power
3.3.9
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before application of the Surgi-Max® or Surgi-Max® Plus.
3.3.10
Any flammable fluid pooled in the body depressions and/or body cavities or under the patient should be mopped up prior to using the Surgi-Max® or Surgi-Max® Plus. Attention should be called to the danger of ignition of endogenous gases.
3.3.11
Some materials, such as cotton, wool, and gauze when saturated with oxygen may be ignited by sparks produced in normal use of the High Frequency surgical equipment
3.3.12
Before each use, inspect the accessories, electrode cables and probes for possible physical damage.
3.2.13
The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used
IV. DESCRIPTION OF CONTROL ELEMENTS 4.1
SPECIAL FEATURES The elliquence Surgi-Max® and Surgi-Max® Plus comprise unique accessories, including a waterproof Triple Action or Dual Footswitch for both Monopolar and Bipolar applications. (REFER TO: FIGURE 4A and FIGURE 4B) 4.1.1
Mode and Power Output Level memory
4.1.1.1 Mode and Power Output levels are stored in a non-volatile memory and recalled upon turning the device on. 4.1.1.2 The memory is set to default values of zero (0) upon shipment. To reset to the default values, press and hold both the Cutting Mode and Coagulation Mode Selector buttons simultaneously while turning on the device and continue to hold the buttons until “Clr” is seen in the display. 4.1.2
Triple Action Footswitch or Dual Footswitch
4.1.2.1 Triple Action Footswitch: A heavy duty waterproof Triple Action Footswitch for Cutting and Coagulation Modes of both Monopolar and Bipolar applications. The specific selection of each mode (CUT, CUT/COAG, HEMO, BIPOLAR HEMO and BIPOLAR TURBO) is manually selected by pressing the mode selector button. The control function of the Triple Action Footswitch is described below. Each specific footpedal can only activate the corresponding setting on the display. a) The left, yellow footpedal controls whatever mode is displayed on the Cutting Mode (CUT or CUT/COAG) b) The right, blue footpedal controls whatever mode is displayed on the Coagulation Mode (HEMO, BIPOLAR HEMO or BIPOLAR TURBO) c) The center, black button footswitch ONLY controls BIPOLAR TURBO 4.1.2.2 Dual Footswitch: A heavy duty waterproof Dual Footswitch for Coagulation Modes of both Monopolar and Bipolar applications. The specific selection of each mode (HEMO, BIPOLAR and BIPOLAR TURBO) is manually selected by pressing the mode selector button. The control function of the Dual Footswitch is described below. Each specific footpedal can only activate the corresponding setting on the display. a) The left, blue footpedal controls whatever mode is displayed on the Coagulation Mode (HEMO, BIPOLAR HEMO or BIPOLAR TURBO) b) The right, black footpedal ONLY controls BIPOLAR TURBO
6
FIGURE 4A: REAR PANEL CONTROL ELEMENTS 6c
5
6a
4
6b 3
Power Plug
1
Power Socket
2
Line Fuses
3
Audio Volume Control
4
Footswitch Receptacle
5
Cutting Mode Activation Pedal 6a Coagulation Mode Activation Pedal 6b BIPOLAR TURBO Activation Pedal 6c
1
2
FIGURE 4B: FRONT PANEL CONTROL ELEMENTS
7
12
20
10
11
21
ON/OFF Power Switch 1
17
FAULT Indicator 2 NEUTRAL Receptacle 3
8
NEUTRAL Indicator 4 BIPOLAR Receptacle 5 2
9
MONOPOLAR Receptacle 6 Cutting Mode Selector 7 CUT Mode Indicator 8
14 15
4
CUT/COAG Mode Indicator 9 Cutting Mode Output Power Indicator 10 Cutting Mode Power Increase Selector 11
16
Cutting Mode Power Decrease Selector 12 Coagulation Mode Selector 13 6
13
19
5
18
1
3
HEMO Mode Indicator 14 BIPOLAR HEMO Mode Indicator 15 BIPOLAR TURBO Mode Indicator 16 Coagulation Mode Output Power Indicator 17 Coagulation Mode Power Increase Selector 18 Coagulation Mode Power Decrease Selector 19 Cutting Mode ACTIVATED Indicator 20 Coagulation Mode ACTIVATED Indicator 21
7
V. OPERATING THE DEVICE 5.1
5.2
5.3
5.4
GENERAL INFORMATION 5.1.1
The device will retain the latest power output settings. When using Monopolar and Bipolar techniques, always start at the lowest setting and increase in 1-2 point increments to reach desired tissue effect.
5.1.2
CAUTION: Power level must be adjusted in response to tissue effects. If there is tissue dragging, power should be raised and if there is sparking, power should be lowered.
MONOPOLAR CUT AND CUT/COAG 5.2.1
SETTING POWER LEVEL: Press the yellow Cutting Mode Select Button until the matching mode indicator illuminates. Use Cutting Mode Power Increase Selector button or Cutting Mode Power Decrease Selector button to set the desired power level.
5.2.2
ENERGY ACTIVATION: For energy emission, press the CUT or BLEND button on the 3-Button Handpiece or the yellow footswitch (if available).
MONOPOLAR HEMO, BIPOLAR HEMO and BIPOLAR TURBO 5.3.1
SETTING POWER LEVEL: Press the blue Coagulation Mode Select button until the matching mode indicator illuminates. Use Coagulation Mode Power Increase Selector button or Coagulation Mode Power Decrease Selector button to set the desired power level.
5.3.2
CAUTION: Prior to energy activation, BIPOLAR HEMO must always be selected.
5.3.3
ENERGY ACTIVATION: For BIPOLAR HEMO or TURBO, use the corresponding footswitch. MONOPOLAR HEMO is activated using the HEMO button on the handpiece.
5.3.4
ATTENTION: To turn off MONOPOLAR safety alarm when using only the (2) BIPOLAR modes, all (3) MONOPOLAR modes (CUT, CUT/COAG and HEMO) must be set at 0 (zero).
ERROR CODES TABLE / SINGLE FAULT CONDITION
DESCRIPTION
ERROR CODE
Interface to LEDS failed
1 2
Interface to keypad failed
3
Processor had a warm reset
4
A/D converter error
7
Interface to displays failed
Foot/Fingerswitch interface failed
8
Bond sensor interface failed
9
Keypad pressed during power up protection failed Foot or Fingerswitch pressed during power up protection failed Temperature out of limits
10 11 12
Output power test failed
13 15
Linearization Table in Error EEPROM Read
16
EEPROM Write
17
Oscillator Control Monopolar / Bipolar Enable
18
8
TABLE 1
TABLE 2
9
TABLE 3
TABLE 4
10
WARRANTY STATEMENT elliquence warrants the elliquence RF generator against defects in materials and workmanship for a period of two (2) years from the date of purchase. During the warranty period, elliquence will replace, at its discretion, any defective elliquence RF generator, subject to the conditions and exclusions stated herein. This warranty applies only to new devices. In the event that an elliquence RF generator is replaced, the warranty period will not be extended. This warranty is valid only if the elliquence RF generator is used in accordance with the manufacturer’s instructions. This warranty will not apply: L 530<064A4BD;CB5A><270=64B>A<>385820C8>=B<034C>C744;;8@D4=24( 64=4A0C>A1HC74DB4A>AC78A3?4AB>=B05C4AC7430C4>5 manufacture. L 530<064A4BD;CB5A><B4AE824>AA4?08AB?4A5>A<431H0=H?4AB>=>A4=C8CH>C74AC70=C74<0=D502CDA4A>A0??A>E43C427=820;B4AE8241H elliquence. L 530<064A4BD;CB5A><0 >A24#094DA4>A>C74A4E4=C14H>=3C742>=CA>;>5C74<0=D502CDA4A L 530<064A4BD;CB5A><=46;864=24>A8<?A>?4ADB48=2;D38=61DC=>C;8<8C43C>8<?A>?4ABC>A06434;814A0C4BD1<4AB8>=8=F0C4A physical abuse, such as dropping or otherwise. This warranty shall be personal to the original user. Any sale, rental or other transfer or use of the product covered by this warranty to or by a user other than the original user shall cause this warranty to immediately terminate. The remedies provided for in this warranty are the exclusive remedies available for any breach hereof. Neither elliquence nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. Any statutory rights granted to consumers under any applicable legislation are reserved. All other warranties, express or implied, except any applicable mandatory statutory warranties, are excluded, including the warranties of merchantability and fitness for a particular purpose.
20120329
IN 0010 I