Shalya Sigma +

INSTRUCTION & SERVICE MANUAL

 USER GUIDE | Shalya Sigma +

Version: 1.4

This document is a user guide for Shalya Sigma + Electrosurgical unit. Guide is intended to be referred
by qualified & trained physician and surgeon. This instrument is electrically hazardous, user operating
this generator / consulted technician for servicing should read this user manual thoroughly.
Please Note Manufacturer has every right to change specifications and/or functions of this equipment
without any prior notice or announcement.

Words referring to Shalya Sigma ESU in this document are: Generator, ESU, Machine, and Sigma.

Use for: This document is drafted by taking Shalya Sigma + ESU into account only, which is a product
of XcelLance Medical Technologies Pvt. Ltd.

Shalya Sigma
Registered Trademarks:
Shalya®, Turoseal®, Vesseal®

Manufactured By:
XcelLance Medical Technologies Pvt. Ltd.
Shalya Avenue, Plot No. W-237, W-238(A) & W-239,
T.T.C. Industrial Area, M.I.D.C., Rabale– 400701, Navi
Mumbai , Maharashtra, India.

Made in India

Contact us:
Tel: +91-22-7114 2400

For further Information:

Email: [email protected]

Document: XMT/IFU/ESU/16
Version: 1.4
Year & Month: 2023-11
Made & Printed in India

Mars Medical
Landhausstrasse 46,
70190 Stuttgart, GERMANY
Tel: +49 1751938653
[email protected]

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Conventions and Symbols used in this document

Symbol Meaning

General warning sign

Explains the possible damage which may occur to the machine OR minor
injuries to person.

Electrical Hazard
Explains the possible risk associated with personal injury or death.

Prohibition Sign
Explains actions by which the possible damage which may occur to
instruments associated with machine and/or others so, should be prohibited.

Pushing Prohibition

Sitting Prohibition

Stepping Prohibition

General mandatory action to be taken by user

Refer Manual or Booklet

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INDEX
1. Introduction
A. General Features
B. Modes of Electrosurgery
i. Monopolar Electrosurgery
ii. Bipolar Electrosurgery
2. Safety Instructions
3. Controls, Indicators & Output sockets
A. Front Panel
B. Rear Panel
C. Welcome screen
D. System Setting
E. How to select mode & power
F. Program Manager
4. Technical Specifications
A. General specifications
B. Available power settings
C. Output Characteristics
D. Output Frequencies
E. Area Of Application
F. Output Power vs. Load Graphs
5. Before Surgery
A. Preparing the Generator
B. Setting the generator
C. Accessory Connections
6. During Surgery
A. Preparing the Patient Return Electrode.
B. Modes & power settings
C. Helpful hints to avoid hemostat burns
D. Settings for surgeries
E. Alarm conditions
F. Compatibility with other Devices
7. After Surgery
A. Preparing the generator for reuse
B. Cleaning the generator
C. Instrument cleaning
D. Storing the generator
8. Operating Principle
A. General Description
B. Block Diagram & Description
9. Testing Procedures
10. Calibration Procedures
11. Care, Storage and Disposal
12. Troubleshooting
13. Warranty
14. Disclaimer

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CHAPTER 1
Introduction
celLance Medical Technologies Pvt. Ltd.’s Shalya Sigma Electrosurgical Generator provides
X necessary power for different types of surgical needs in Monopolar and Bipolar applications with
multiple options of cut & coagulation effects with following features:

A. GENERAL FEATURES:

➢ Smart ESU: Surgical Monitoring and Automatic & Instant Response Technology ESU for
consistent cutting & coagulation through all types of tissues.

➢ 6SENSE TM Technology: Advance feedback system which senses the change in Voltage,
Current, Power, Tissue Density, Return Electrode Contact quality & leakage RF current.

➢ Smart ENDO-CUT Mode: For Endoscopic Applications.

➢ PREM TM Safety: Patient Return Electrode Monitoring – PREM – is ultimate Safety for
return electrode site burns.

➢ Program Manager: User programmable settings which allows surgeons to set surgical
procedures.

➢ Fully Microprocessor controlled: To achieve high degree of clinical precision.

➢ 5” inch Touch LCD Display: With extensive viewing angle, onscreen modes description
facilitating surgeon to choose the best-suitable mode for the surgical applications.

➢ 4 Monopolar Cut Modes: Low, Pure, Blend & Endo.

➢ 4 Monopolar Coag Modes: Soft, Swift, Fulgurate & Spray.

➢ 2 Bipolar Cut: Macro and BiCut.

➢ 3 Bipolar Coag: Micro, Standard, Force

➢ Auto Bipolar mode (Optional)

➢ ARGON Beam Coagulator upgradable.

➢ Time out function (Optional): Automatic stoppage of HF output on prolonged unintended

activation.

➢ Toggle footswitch: To toggle between monopolar & bipolar mode using dual paddle foot
switch.

➢ BiCoag Alarms: Audio feedback alarm after completion of Bipolar Coagulation reduces
charring & sticking of tissue to forceps & avoids over burning of tissue.

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B. MODES OF ELECTROSURGERY

Monopolar Electrosurgery:
In Monopolar electrosurgery, only one pole, active electrode is in the surgical site. An electric current
from generator is delivered to the surgical site through active electrode & returned back to generator via
patient return electrode. Monopolar electrosurgery is used for most of the general surgical procedures.
Patient return electrode is used in these applications as return path for RF current.

Monopolar Cut Modes: There are four Cut modes-

• Cut -It is used for a cut with no sparking, useful for laparoscopic surgery for precise & clean
cutting for thin tissue.
• Pure - This is the default Monopolar cut mode it may be used for precise cut with no haemostasis.
• Blend - It is used where slower cutting & moderate haemostasis is desired.
• Endo – It is pulsed cutting with appropriate pulse interval.

Monopolar Coag Modes: There are four Coag modes-

• Soft (Desiccate) -Desiccation dehydrates & destroys the tissues with no sparking, as the active
electrode is directly in contact with the tissues, used for coagulation of soft and delicate tissues.
• Swift - Soft coagulation with larger tissue coverage.
• Fulgurate (Low)-This is the default Monopolar Coag mode. This mode is suitable for non-
contact coagulation with moderate sparking in variety of applications.
• Spray (High) – This is designed for distance coagulation for large areas with minimum depth of
tissue damage & necrosis.

Bipolar Electrosurgery:
In Bipolar electrosurgery, both the active & return electrodes are in surgical site. Patient return electrode
is not required as bipolar instrument contains an active electrode & return electrode.
An electric current flows from active electrode to the return electrode through tissue grasped by the
instrument. This technique is mostly used in delicate surgeries, cosmetic surgeries & neurosurgeries.

Bipolar Cut Modes: There are two cut modes

• Macro – Precise bipolar cutting with hemostasis
• BiCut – High voltage for clean bipolar cutting

Bipolar Coag Modes: There are four Coag modes

• Micro (Precise) - The voltage is kept low to avoid sparking. It is selected for delicate bipolar
tissue desiccation.
• Standard - Standard bipolar coagulation for all types of tissue with the moderate hemostasis.
• Force - Bipolar coagulation for thicker and high impedance tissue.

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CHAPTER 2
Safety Instructions

Read all the warnings, cautions provided with this generator before using.

Hazardous Electrical Output: This instrument is to be used only by trained, licensed

physician/surgeon.

If the patient has an internal pacemaker and internal cardiac defibrillator or any kind
of orthopedic implant, consult the pacemaker, defibrillator & orthopedic implant
manufacturer for instructions before performing an electrosurgical procedure.
Maintain adequate distance between these implants and active electrode of the
generator.

Patient plate and patient plate cable connector should be cleaned before and after every use. Not doing so
can cause risk to the patient.

General Warnings and Caution

Warnings-
• This generator should be used by qualified medical person only.
• Do not connect wet accessories to the generator.
• Use generator only if the self-test has been completed.
• Never turn the activation tone down to an inaudible level in any case.
• In any case, patient should not touch any metal parts that are connected to earth/floor/ground.
Take excessive precaution, use antistatic pads.
• Do not lean on the patient, while buzzing the hemostat, accidental and unintended burn injury
may occur.
• To reduce the risk of an inadvertent burn at the electrode site due to monitoring equipment
place the electrode and / or probe as far away as possible from the electrosurgical site.

Cautions:
• Read all the Warnings & Cautions before using this generator.
• Use hand switches, footswitches provided by XcelLance Medical
Technologies Pvt. Ltd. only.
• In case of any doubt or query contact XcelLance Medical Technologies Pvt. Ltd.
• Avoid use of needle like monitoring equipment on patient wherever possible.

Electrode & Instruments:

Warnings-
• Always ensure that instrument & electrode is properly cleaned
and dried before attaching to the generator.
• Keep the cables of electrodes at distant as possible from patient or
other wires.

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• Do not activate the generator, before touching the active electrode to the tissues, electrical arcs
may be created.
• Do not activate the generator in an open circuit condition. Do not short Active electrode with
return electrode.
• Do not activate electrodes while in contact with other instrument, an unintended tissue injury
may occur.
• Do not wrap instrument cables around and/or bring in contact with any metal object as
electromagnetic induction may produce hazardous electric current.
• Never use any instrument above maximum power, voltage ratings as specified by the
manufacturer.
• Never use broken or damaged instruments or cords it may turn out harmful for patient and/ or
surgeon.

Cautions:
• Always use the appropriate instrument for the surgery.
• Always ensure your electrodes are properly cleaned & in good working condition.

Bipolar

Cautions:
• Bipolar accessories must be connected to the bipolar socket only.
• Bipolar mode should be utilized whenever possible.

Warnings:
• During Auto Bipolar mode which is available on request, activation may occur with contact of
any material. When not in use, place electrosurgical instruments in a safety holster or safely
away from patients/user/operator and flammable materials.
• Desired clinical effects may vary depending upon the degree of cleanliness of the electrode tip.
Therefore it is always recommended to maintain a clean electrode tip to eliminate the risk of
detecting wrong tissue impedance.

Electrical Connections & Power:

Warnings-
• Make use of a dry cheesecloth between patient and ground body.
• Inspect electrode connections and contacts frequently.
• Check all the power settings & each and every connection to the generator
before using the device on patient.
• Check if the earthing of power source in surgical room is proper. Make sure equipment chassis
or cabinets are grounded. Never cut off or reverse the ground connection on a plug.
• Please check if power from the main line (AC) is within the specified range as required for
proper functioning of the generator. Inappropriate voltage from the mains plug (AC Line) may
damage the device and/or may turn out to be hazardous to patient and/or surgeon.
• Always use lowest output setting for desired surgical effect. If proper setting is unknown, set
the generator at a very low setting & increase the power continuously until the desired effect is
achieved.

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• Take faults of the circuitry into consideration any time the surgeon continues to request a
higher power. Check all the problematic extents such as: patient electrode, active electrode or
ESU as excessive power may damage and/or burn the tissue.
• Simultaneously activating irrigation & electrosurgical current may result in increased arcing at
electrode tip, burns to unintended tissues, shocks & burns to the surgical site.

Cautions:
• Never use power plug adaptors.
• Avoid the use of “extension cord” for the mains power supply.
• Do not plug in or unplug power cord when mains switch &/or generator’s
switch is in the ON state.
• Never defeat the purpose of a fuse or circuit breaker. Never install a fuse of higher amperage
rating than specified.
• Keep the active electrode clean. Dirty electrode causes the reduction of output power.
• The ESU's electrical cord should be adequate in length & flexibility, to reach the electrical
outlet without stress or the use of an extension cord.
• Replace defective cords and plugs. Inspect cabling for defects such as frayed wiring, loose
connections, or cracked insulation.
• Check all accessories and connections to the electrosurgical generator before using. Improper
connection may result in arcs, sparks.

Accessories Related:

Warnings-
• Inspect ESU unit prior to use. Remove accessories which are
damaged and/or not working properly.
• Do not wrap the accessory leads around the metal objects. This
may induce currents that are dangerous to the patient.
• Do not try to increase or reduce length of cables. Excessive or improper current may
unintentionally damage the tissue or skin.

Cautions:
• Place Foot paddles on flat, dry & clean surfaces.
• Do not reuse or re-sterilize accessories labeled “disposable or single use only”.
• Check all accessories before using, especially if they are endoscopic accessories.

Radio Frequency Burns:

Warnings-
• Keep the monitoring equipment electrode as distant as possible
from electrosurgical site, to reduce the risk of inadvertent
electrosurgical burn.
• Avoid skin-to-skin contact points such as fingers touching leg use dry cloth between contacts.
• Do not activate the electrodes for extended period of time (more than 1 minute) it leads to
excessive heating of the electrode and may burn the tissue.

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Generator Placement & Environment:

Warnings-
• Never place containers of liquid on diathermy unit.
• Never use electrosurgical unit in presence of flammable
anesthetic gases.
• In presence of excessive Oxygen & Nitrogen gases, extra measures must be taken to reduce the
concentration of these gases.

Cautions:
• Do not place the generator on the top of any electrical equipment.
• Always keep as much distance as possible between monitoring
equipment, video equipment and electrosurgical generator.
• Do not disconnect the generator from main line (AC) immediately after turning off keep it
connected to the main line for at least for a minute.
• If generator is relocated from cold to warm room, keep generator ON at least for half an hour
to let generator to acclimate to the room temperature.

Other:

Warnings-
• Check if activation, safety, warning audio & visual alarms are
working properly. If found problematic; restart the generator,
check it again after restarting. If problem still exists do not use the
generator as it may result in erratic functioning which may lead to
hazards. Contact XcelLance Medical Technologies Pvt. Ltd service department.
• Always perform cleaning operation of the generator after surgery; disconnect all the electrical
connections and accessories before cleaning the generator.
• In case if a patient is moved from one place to another recheck all the connections, as the
proper contact of electrode cable with the generator is necessary.
• During procedures in small surgical field, accidental and unintended burn injury may occur.
• Shave off body hairs coming in contact with surgical site whenever necessary.

Cautions:
• Avoid the use of hybrid tracers that include both metal & plastic components.
• Always maintain proper ventilation in the surgical room, as surgical smoke
generated during surgery is harmful to health.

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CHAPTER 3
Controls, Indicators & Output Sockets
A. FRONT PANEL
Bipolar Socket: Accepts
standard 4mm bipolar
interface cables. Active
HF cord in one hole &
return HF cord from lure
Back /Select lock adapter in other hole.
Button PREM Contact/Contact indicator:
It indicates the contact adequacy
using process bars (Green) or gives
audio-visual alarm (flashes Red)
Navigation Keys: Monopolar Footswitch
when contact with the patient is
To Increase/ Socket:
inadequate.
Decrease the power This accepts standard
& To Select modes. single pin foot switching
cable.

Please Note: Function of the keys above changes according to operating screen. Utility function
when different than default; is highlighted in respective windows.

Patient Return
Monopolar Handswitch Electrode Socket:
Power ON/OFF
Socket: Connect a patient plate
switch: To turn the This accepts standard to this receptacle in
generator ON/ OFF.
Three Pin Hand switching Monopolar
cable. electrosurgery.

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Key Symbol Function Of the Key (On the Main Screen)

• On main screen, use Up / Down Key to navigate vertically between modes.

• When in particular ‘Mode’ of surgical procedure; Up and Down key will
increase/ decrease the power of the selected mode.
• Use keys relevant to desired icon.

• On main screen, use right/ left Key to navigate horizontally between modes.
• While selecting ‘Modes’ of surgical procedure use right/left arrow keys to
choose desired mode from different available modes.
• Use keys relevant to desired icon.

• On main screen, use select button to select a particular mode.

• While selecting modes, the same button will act as back button to return in
main screen.

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B. REAR PANEL

Heat Sink:
Power Socket: To supply AC Volume Control: To adjust
Do not place anything
(230V / 50Hz) or (110V/60 Hz) volume of activation tones.
near heat-sink to allow
power to ESU. Please Note: Alarm Volumes
proper cooling of the
are not adjustable
generator

Note: This manual is common for both 110V/230V mains power supply.
For technical specification, refer Chap 4: Technical Specification; Section: Input Power.

Footswitch: 2-paddle
Fuse Socket: Fuse Rating
footswitch for Cut &
(230V, 6A) or (110V, 10A)
Coagulation
Please Note: In case of fuse
malfunction replace fuse
with the same rating

Grounding Lug:
Reduces noise in other
equipments. Connect it
to earthing receptacle.

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C. WELCOME SCREEN
Once the generator is turned ON successfully, Screen1 will be displayed.
Select the check box after reading the instruction manual and press the “Proceed” button, Screen 2
will appear if “Factory Reset” option was selected in “Startup” of Setup option.

SCREEN 1: WELCOME SCREEN

SCREEN 2: MAIN SCREEN

Note: While restarting the unit if user wish to get previously used setting or wants unit in standby mode,
refer “Startup” option from Section D.

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D. SYSTEM SETTING
Press “Setup” option from Main screen to enter
into System setting option. Screen1 will be
displayed.
Select the desired option by selecting relevant
icon present at left hand side on System setting
screen.

SCREEN 1: SYSTEM SETTING

Brightness Adjustment:

For Brightness adjustment, select “System” option

from Screen1 and select “Brightness” option,
Screen2 will be displayed.

Touch buttons to increase and

decrease the brightness.
Note: After setting the desired
brightness press “OK” button to
SCREEN 2: BRIGHTNESS SCREEN save the setting.

Volume Adjustment:

For volume adjustment, select “System” option from Screen1 and select “Volume” option, Screen3 will
be displayed.

System Volume can

be adjusted by turning
volume control knob
on the back panel of
machine.

SCREEN 3: VOLUME SCREEN

Note: After setting the desired brightness press “OK” button to save the setting.

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Calibration

Warning: To be accessed
only by trained professional.
Please contact the
manufacturer to obtain the
Authorization code.

After entering valid Authorization Code, the screen

shown beside with following options will be displayed.
It is used to calibrate machine’s
sensors.
Calibration mode is explained in
later chapters.

Test mode shows the functionality

of input/output interfaces.

To load the default Calibration

Counts.

Function Time Setup(optional)

User can set the time period of HF output and bipolar auto delay using Function Time Setup.

SCREEN 4: FUNCTION TIME SETUP SCREEN

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How to set Time Out Function?

User can ensure that HF output is not activated

unintentionally for longer period of time by using the
Time Out Function. To set Time Out Function follow
steps given below:
Step 1: Select “Function Time Setup” option from
system setting screen.
Step 2: Screen4 will be displayed. Press “Time Out
Function “option.
Step 3: User can set timeout function from 10 to 90
milliseconds as per the requirement. (Refer
SCREEN 5)
Use Up/Down navigation keys to increase/
decrease the delay respectively. SCREEN 5
Note: Press “OK” button to save the desired value.

How to set BIP Auto Time Delay?

Step 1: To select BIP Auto Time Mode, user must select

Autobipolar key & corresponding submodes
from bi-coag mode of main screen (Section F:
How to set Auto Bipolar Mode?)
Step 2: Select “Function Time Setup” option from
system setting screen.
Step 2: Screen4 will be displayed. Press “BIP Auto
Time Delay” option.
Step 3: User can set autobipolar delay from 100 to
900 milliseconds as per the requirement. Use
Up/Down navigation keys to increase/decrease SCREEN 6
the delay respectively. (Refer SCREEN6)
Note: Press “OK” button to save the desired value.

Startup

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Press the “Previous activated” key on display to get the previously used settings every time the unit
starts.

Press the “Standby” option to disable any inputs and outputs from the generator. Generator will not respond
to any sort of activation in standby mode. Generator will show the below screen.
User can exit standby mode anytime by pressing the standby option again.
Entering and exiting the mode will not affect any user settings.

Note: While restarting the unit if user wants unit in standby mode, “Standby” option in the Setup setting
is used. “Standby” option on the main screen is used during the surgery.

Press the “Factory Reset” to restore the device to its original manufacturing settings (refer below screen)
by erasing all the earlier information stored in it.

About screen:

The screen will display the serial number and current software version of the unit.

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E. How to select Power & Mode?

STEP 1: Enter the desired mode just by touching its icon as shown in SCREEN 1 & 2. Select sub-modes
using Touch Selective Icons (SCREEN2).

STEP 2: Once desired sub-mode (procedure) is selected, increase/decrease the power using on-screen or
front panel keypad’s up/down arrow keys to.

STEP 3: Now once power is selected for the desired sub-mode (procedure) press Enter Key (On-screen
or Keypad). Pressing appropriate foot paddle or Handswitch will make power available on relevant port.

SCREEN 1

SCREEN 2

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F. Program manager
Program manager gives facility to edit, load & store custom user programs.

Press the tab from main

screen to enter into
Program Manager.

User can load any program just by selecting

program and pressing “load‟ button.
Use up/down navigation keys to scroll through
programs.

Touching any of the text boxes will open up

user friendly QWERTY on-screen keyboard. SCREEN 1
To add new program follow the steps given
below:
New Program can be added by touching “Add
New” tab on the screen. After pressing, Screen2
will be displayed on the screen.
STEP1:- Enter Program name, surgeon name.
In Program name enter name of surgical
procedure for which setting is to be stored.
STEP2:- Now, enter desired mode & set
appropriate power. User can set power for
multiple surgical modes as shown in the
Screen3.
STEP3:-Once the power and procedures &
modes are selected press “Set ‟ tab (Screen3).
STEP4:-Once done press “Save & Back‟
(Screen2).

SCREEN 2
Note: To understand the process to select power,
refer the section named “How to select power &
Mode?”

SCREEN 3

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CHAPTER 4
Technical Specifications

A. GENERAL SPECIFICATIONS

Output Configuration: Isolated output with cardiac defibrillator protection.

Duty Cycle of Operation: At maximum rated load conditions, pure cut-400 watt setting at 300 Ω.
The system is suitable for activation time of 10 seconds ON, 30 seconds OFF for one hour.
Cooling: Natural by convection: By side and rear panel vents.
Display: 5” touch LCD Screen.

Standards and IEC Classifications

ATTENTION Refer accompanying documents.

SHOCK To reduce the risk of electric shock: Do not remove the cover.
For servicing consult qualified service personnel.

FLOATING The generator output is floating (isolated) with respect to ground.

DANGER Explosion risk if used with flammable anesthetics.

Class I Equipment (IEC 60601-1)

Accessible conductive parts are connected to the protective earth conductor, so they don’t become live in
the event of a basic insulation failure.

Type CF Equipment (IEC 60601-1)

Maximum allowable leakage current limit is as per established standards. Shalya Sigma
provides a high degree of protection against electric shock. Instrument can be used for
cardiac procedures due to type CF isolated (floating) output.

Drip Proof (IEC 60601-2-2)

The Shalya Sigma enclosure is so constructed that liquid spillage in normal use does not wet electrical
insulation or other components which, when wet, are likely to affect adversely to the safety of the
generator.

IP Class Specification
IP Class of this equipment is rated at IP21 as per IEC Standard 60529.

Caution - Do not stack any equipment upon Shalya Sigma or place the generator on top of
other electrical equipment. This configuration does not allow proper cooling of the
generator.
Caution - Do not place any chemical or solution in operating room, may spoil safety of
electronic circuit by liquid spillage.

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Voltage Transients (Emergency Generator Mains Transfer)

The Shalya Sigma operates in a safe manner when the transfer is made between line AC and an
emergency generator voltage source.

Defibrillator Proof
The Shalya Sigma meets specifications for “Defibrillator proof” design.

Dimensions and Weight

Length: 38.0 cm
Width: 31.5 cm
Height: 12.0 cm
Weight: < 5.0 kg

Transport and Storage

Temperature range: -40°C to 70°C
Relative humidity: 10% to 100%, condensing.

Operating Parameters
Temperature range: 10°C to 40°C
Relative humidity: 30% to 75%, noncondensing.

Warm-up time
Allow one hour for the generator to reach room temperature before use, if transported or stored
at temperature outside the operating temperature range.

Internal Memory
Non-volatile

Audio Volume
Activation Tone: Volume (adjustable): 40 to 65 dB
Frequency: Bip Cut: 340Hz 
Bip Coag: 455Hz 
Mono Cut: 580Hz 
Mono Coag: 865Hz 

Alarm Tone: Volume (not adjustable): 65 dB

Frequency: 865Hz 
Pulse: Two 800msec.coag tone separated by 800msec.of silence

PREM Contact Quality Monitor

Measurement frequency: 80 kHz 10 kHz
Measurement current: <10A
Acceptable Resistance Range upto 40%(not available in dre manual)
Dual Area PREM return electrode: 5 to 135 Ω
Single Area Patient return electrode: 0 to 10 Ω

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Low Frequency (50 - 60 Hz) Leakage Current:

Source current, patient leads, all outputs:
Normal polarity, intact ground: <10A
Normal polarity, ground open: <50 
Reverse polarity, ground open: <50
Enclosure source current, ground open: <300A

igh Frequency (RF) Leakage Current

Monopolar (RF) leakage current: < 150 mA rms
Bipolar RF leakage current: < 60 mA rms

Input Power 2 table

Mains nominal voltage: 230 V 110 V

Input mains voltage, full regulation range: 210-264 Vac 104-132 Vac
Input mains voltage, operating range: 180-264 Vac 85-132Vac
Idle: 0.2 A Idle: 0.4 A
Cut: 2.7 A Cut: 5.4 A
Mains current (maximum):
Bipolar: 1.5 A Bipolar :3 A
Coag: 2 A Coag: 4 A
Idle: 52VA Idle: 52VA
Cut:712 VA Cut:712 VA
Maximum VA at nominal line voltage:
Bipolar: 396 VA Bipolar: 396 VA
Coag: 528 VA Coag: 528 VA
Mains line frequency range (nominal): 50 to 60 Hz 50 to 60 Hz
Fusing: 6A 10A

B. AVAILABLE POWER SETINGS (In Watts)

1. Monopolar Cut:
Low: 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 300 by step of 10.
Pure & Endo: 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 400 by step of 10.
Blend: 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 250 by step of 10.

2. Monopolar Coag:
Soft : 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 150 by step of 10.
Swift, Fulgar and Spray: 1 to 40 by step of 1, 40 to 100 by step of 5, 100 to 120 by step of 10.

3. Bipolar Cut
Macro and Bicut:1 to 40 by step of 1, 40 to 100 by step of 5

4. Bipolar Coag
Micro, Standard and Force :1 to 40 by step of 1, 40 to 100 by step of 5

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C. OUTPUT CHARACTERISTICS
Maximum Output for Bipolar and Monopolar Modes
Power readouts agree with actual power into rated load to within 20% or 10watts, whichever is greater.

Mode Open Circuit Rated Load Power(max) Crest Factor

P-P Voltage (in Ωs) (in Watts)
(in Volts)
Monopolar Cut
Low 1200 300 300 1.5
Pure 1600 300 400 1.5
Blend 2200 300 250 2.5
Endo 1600 300 400 1.5
Monopolar Coag
Soft 2500 500 150 4.0
Swift 4500 500 120 6.2
Fulgurate 4900 500 120 7.0
Spray 5200 500 120 8.0
Bipolar Cut
Macro 880 100 100 1.5
BiCut 880 100 100 1.5
Bipolar Coag
Micro 360 100 100 1.5
Standard 550 100 100 1.5
Force 880 100 100 1.5

*Crest factor measured at half power condition.

*Crest factor is an indication of a waveform’s ability to coagulate bleeders without a cutting effect.

D. OUTPUT FREQUENCIES

6SENSE Technology, an automatic adjustment, is applied to all bipolar modes and all cut modes. It is not
applied to the Coag modes because of their non-contact capabilities.

Bipolar Cut
Macro 390 kHz sinusoidal
Bi cut 390 kHz sinusoidal

Bipolar Coag
Micro 390 kHz sinusoidal
Standard 390 kHz sinusoidal
Force 390 kHz sinusoidal

Monopolar Cut
Low 390 kHz sinusoidal. Maximum voltage is limited to a lower value.
Pure 390 kHz sinusoidal
Blend 390 kHz bursts of sinusoid, recurring at 29 kHz intervals. 55% duty cycle envelope

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Endo 390 kHz sinusoid with moderate pulse interval

Monopolar Coag
Soft 460 kHz damped sinusoid repeated at 84 kHz. 20% duty cycle
Swift 460 kHz damped sinusoidal repeating at 42 kHz
Fulgurate 460 kHz damped sinusoidal bursts repeated at 34 kHz.
Spray 460 kHz damped sinusoid repeated at randomized frequencies 34 kHz < f <50 kHz.

E. AREA OF APPLICATION

❑ Applications of ESU / Diathermy Section:

✓ Gynecology
✓ Urology (Resection)
✓ Laparoscopic Surgeries.
✓ Endoscopy (ERCP)
✓ Oncosurgery
✓ Heart & Chest surgery, CABG
✓ Neurosurgery, Spine
✓ Arthroscopy
✓ All other general surgical procedures.

F. OUTPUT POWER VS. LOAD GRAPHS

Monopolar Low Cut Mode

325
300
275
250
Output Power ( watts )

225
200
175
150
125
100
75
50
25
0
0

200

400

600

800

1000

1200

1400

1600

1800

2000

Load Resistance ( ohms )

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Monopolar Cut - Pure/Endo

425

400

375
350

325
300

275
250

225 200W
Output Power (W)

200 400W
175

150
125

100
75

50

25

0
0

100

200

300

400

500

600

700

800

900

1000

1100

1200

1300

1400

1500

1600

1700

1800

1900

2000
Load Resistance ( ohms )

Monopolar BlendCut Mode

300

250
Output Power ( watts )

200

125W
150
250W

100

50

0
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
1600
1700
1800
1900
2000

Load Resistance ( ohms )

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Monopolar Coag - Soft

160

140
Output Power ( watts )

120

100
75W
80 150W

60

40

20

0
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
1600
1700
1800
1900
2000
Load Resistance ( ohms )

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Monopolar Fulgurate Mode

140

120
Output Power ( watts )

100

80
60W
120W
60

40

20

0
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
1600
1700
1800
1900
2000
Load Resistance ( ohms )

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Bipolar mode - Bicut/Macro

100

80
Output Power ( watts )

60 50 watt
100 watt

40

20

0
0

100

200

300

400

500

600

700

800

900

1000
Load Resistance ( ohms )

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CHAPTER 5
Before Surgery
Electric Shock Hazard:
Warning - Never remove the cover of the instrument.

Before Surgery:
Caution - Read all the Warnings, Cautions provided with this generator before using.
Active accessories:
Electric Shock Hazard:
Warning - Avoid the connection of wet accessories to the generator.
Caution - Do not reuse or desterilize accessories labeled “disposable” or “single use
only”.
Patient Return Electrode:
Warning - Do not cut patient return electrode to reduce its size, due to this, pad site
burns may occur.

A. PREPARING THE GENERATOR

• If using a footswitch, connect it to the appropriate instrument socket on the rear panel.
• Connect the instrument to the appropriate instrument socket on the front panel.
• Apply patient return electrode to the patient for monopolar surgery only; connect it to the Patient
Return Electrode socket on the front panel.
• Verify or change the mode & power setting.
• Optional-Press the Program key on the front panel to display pre-programmed settings. Change
the mode or settings if required as surgical conditions & patient placement may require change in
settings. This also varies as per individual skills.

B. SETTING THE GENERATOR

• Verify the generator is off by pressing the power switch OFF (0).
• Place the generator on a stable flat surface, such as table, provide at least 4-6 inches of space from
the sides & top of the generator for cooling. Generally the top, sides & rear panel are warm when
the generator is used continuously for extended periods of time.
• Plug the generator power cable into rear panel socket.
• Plug the generator power cable into a grounded socket.
• Turn on the generator by pressing the power switch ON (1). Verify the following:
▪ All visual indicators & displays on the front panel illuminate.
▪ Activation tones sound to verify that the speaker is working properly.
• If self-test is successful, a tone sounds. Verify the following:
▪ Each display shows a power setting of 1 watt.
▪ The PREM Alarm indicator illuminates red. If the self-test is successful, connect the
accessories & set the generator controls.

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C. ACCESSORY CONNECTIONS

Program Mode Settings for Surgeries:

For Bipolar surgery, insert bipolar instrument in Bipolar front panel socket and Footswitch in
footswitch socket on the rear panel. Use of Neutral Electrode (Patient Return Electrode) in Bipolar
surgery is not recommended.

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For Monopolar surgery, insert Foot switching or Hand switching accessory in socket on front panel
and connect Foot switch in footswitch socket on the rear panel. Also connect patient return
electrode in front panel socket.

Connection with patient (Monopolar Mode)

Please Note: Patient Return Electrode is necessary for Monopolar electrosurgical modes only.

Handswitching Pencil

Cut Switch Coag Switch

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During normal Monopolar operation, Handswitching electrode (Pencil) can be used for Monopolar Cut
and Monopolar Coagulation operations. Pressing yellow button will activate Monopolar Cut output and
pressing blue button will activate Monopolar Coagulation output.

Steps to use pencil as a remote control

Please Note 1:- Power can be adjusted for recently activated mode.
Please Note 2:- For Enter operation: Press cut & coag keys simultaneously.

Step-I Increase
To activate remote control press cut & coag button simultaneously.

Step-II
Activate the desired mode using the corresponding input i.e. to enter in Decrease
the cut mode, press cut key (yellow).
Similarly to enter coag mode, press coag key (blue).

Step-III
Press cut & coag switches simultaneously to enter the recently activated mode for which power has to be
set.

Step-IV
Use cut and coag buttons to increase and decrease the power respectively. And press Enter (Ref. Note2).

Step-V
Choose keys to switch between modes.

Step-VI
Once the desired mode and power is selected press enter (Ref. Note2) & activate corresponding input.

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CHAPTER 6
During Surgery
Electric Shock Hazard:
Warning - Never remove the cover of instrument.

Generator Power Settings

Warning - Use lowest power setting for desired surgical effect.
Warning - Do not increase the power settings without first checking both active electrode & patient
return electrode & their connections.

Contact with metal objects

Warning - Patient should not touch any metal parts that are connected to earth.
Warning - Contact of active electrode with any metal will increase the current flow & can result in
catastrophic burn injury.

Active Accessories
Warning - Fire Hazard-Keep the active accessories away from flammable
materials.
Warning - Place the active accessories in dry, clean & nonconductive area when not
in use.

Using two generators simultaneously

Caution - Do not stack equipment on top the generator. Ensure that the two patient return Electrodes do
not touch.

A. PREPARING THE PATIENT RETURN ELECTRODE

Warning - Do not wrap cloth over return electrode as it increases the tissue
resistance, more power will require for surgery.
Warning - Avoid bony prominences, scar tissue and skin over an implanted metal
prosthesis, hairy surfaces, pressure points, and adipose tissue.
Caution - Inspect the return electrode before each use for wire breakage or
fraying.
Caution - Choose a return electrode of an appropriate size for the patient.
Caution - Do not warm return electrode prior to application.
Caution - Place the return electrode after positioning the patient.
Caution - Apply the return electrode to a clean, dry skin surface, over well-vascularized, large
muscle mass, and on a convex area in close proximity to the procedure site.
Caution - If necessary, shave, clean, and dry the return electrode application site.
Caution - Avoid pooling of solutions: Prep, Irrigation & Patient fluids etc.

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B. MODES AND POWER SETTINGS

(i) Changing the Mode:
Operator should verify the selected mode with the surgeon. You cannot change mode while the
generator is active. To change the mode, press the mode key. The indicator for selected mode will
illuminate green. You can activate only one mode at a time. When you change the modes within a
function the power setting remains the same unless it exceeds maximum for the new mode. In that
case, it reverts to the maximum for new mode.

(ii) Changing the Power Setting:

Operator should verify the power setting for the selected mode with the surgeon. One cannot be
change the power setting when generator is activated. To increase the power, press the up arrow
key for the selected mode. To decrease the power, press the down arrow key for the selected
mode.
To reach maximum or minimum power setting for selected mode, press up & down key. Release
the key when the desired setting is displayed.

(iii) Technique for keeping Power Setting Low:

1. Using a small active electrode to deliver current less power is required to produce the
same surgical effect.
2. Coagulate tissues by using fulguration rather than desiccation because fulguration sparks to
a wider area of tissue, surface coagulation can be achieved with lower power setting using
Fulgurate rather than Desiccate.
3. Hold active electrode just above the tissue & keep in motion as sparking produces
continuous sparks that cut cleanly and quickly. Placing the active electrode in contact with
the tissue produces desiccation that increases tissue resistance. A higher power setting may
be required to overcome the increased resistance.
4. Using Bipolar Surgery - Bipolar surgery requires lower power because the amount of tissue
included in electrosurgical circuit limits the tissue that is held in the bipolar instrument.

C. HELPFUL HINTS TO AVOID HEMOSTAT BURNS

Warning: Hold hemostat with full grip.
Caution - Use lowest power setting possible of generator.
Caution - Activate low voltage (Sp Cut/ Desiccate) waveform.
Caution - Avoid touching the patient by other hand.
Caution - Do not activate in open circuit, touch the electrode to object & then activate the generator.
Caution - Avoid metal to metal arcing.

D. SETTINGS FOR SURGERIES:

a) Pediatric –
Cut Low: 15 to 25, Coag Soft: 15 to 20, Bipolar BiCut: 20 to 25, Bipolar Standard: 10 to 15

b) Onco /Fatty Tissues Surgery –

Cut Pure: 55, Coag Spray: 50, Bipolar BiCut: 20 to 30, Bipolar Standard: 15 to 20

c) TURP/ TCRE/Hysteroscopy –
Cut Pure: 110, Coag Fulgurate: 50

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d) Plastic/ Neuro/ ENT/ Spine/Ophthal Surgery-

Cut Pure: 30, Coag Soft: 25, Bipolar BiCut: 1 to 10, Bipolar Micro: 1 to 10

e) Laparo/Gynac/Hernia-
Cut Pure: 40, Coag Fulgur: 35, Bipolar BiCut: 45 to 60, Bipolar Standard: 25 to 35

a) Ortho/Open/General Surgery-
Cut Pure: 45, Coag Fulgur: 35, Bipolar BiCut: 1 to 10, Bipolar Standard: 15 to 20

b) GI/Papillotomy/Polypectomy/ERCP—
Cut Endo: 40 to 60, Coag Soft: 35 to 45

E. ALARM CONDITIONS
The following conditions can generate a PREM alarm:
1. The patient return electrode is not connected to the generator when the generator is activated
for Monopolar surgery.
2. The return electrode does not have adequate contact with the patient.
3. The contact area is reduced due to movement, loss of adhesion, fluid pooling or dry contact
gel.
4. The return electrode cord is damaged, causing excessive resistance.

Non - PREM Patient Return Electrode Alarm:

When a non - PREM patient return electrode is connected and generator detects a cord fault condition,
the PREM Alarm indicator illuminates red. When you activate in alarm condition, the indicator blinks.

System Alarm:
When the generator senses a system alarm condition, an alarm tone sounds and the generator is
deactivated. An alarm number flashes on the display.
1. Turn off the generator.
2. Turn on the generator & verify that the self – test is completed successfully.
If you are unable to correct the system alarm condition use standby generator to complete the surgical
procedure.

F. COMPATIBILITY WITH OTHER DEVICES

1. Argon Plasma Coagulator: Unit can be combined with Argon gas delivery system to get the
combined effect of argon plasma coagulation system, containing necessary hardware and software
protocol for working as an APC unit.
2. Ultrasonic surgical aspirator: Unit can be attached with ultrasonic surgical aspirator such as
CUSA, by connecting necessary interfacing cable. Unit works in low cut mode and soft
coagulation mode during this interface other cut and coagulation modes are not available.
3. Smoke evacuator system: Surgical smoke suction system can be interface with electrosurgical
unit. The necessary hardware and software protocol is already inbuilt with this electrosurgical
unit. This works only in Monopolar surgical mode. It is recommended to go through the
instruction manual of smoke evacuator system provided by the manufacturer thoroughly, prior to
using for surgery.

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CHAPTER 7
After Surgery
Electric Shock Hazard:
Warning - Never remove the cover of instrument.

After Surgery:
Electric Shock Hazard
Warning - Always turn off & unplug the generator before cleaning.
Cleaning
Caution - Do not clean the generator with abrasive cleaning that could damage the
generator.

A. PREPARING THE GENERATOR FOR REUSE

Disconnect the Accessories:
1. Turn off the generator.
2. Remove the patient return electrode from the patient if used. Disconnect all other accessories
from the front panel.
• If disposable accessory, dispose of it according to the procedures.
• If the accessory is reusable, clean & resterilize it according to the manufacture’s
instruction.
3. Disconnect & store footswitch if used.

B. CLEANING THE GENERATOR

1. Unplug the power cord from the wall outlet.
2. Thoroughly wipe all surfaces of the generator & power cord with a mild cleaning solution or
disinfectant & damp cloth. Strictly follow the procedures for cleaning as mentioned in the
manual. Do not allow fluids to enter the chassis. The generator cannot be sterilized.

C. INSTRUMENT CLEANING
• Cleaning is required for all instruments with lumens and hollow spaces.
• Abrasive materials should not be used on the any parts because they will damage the instrument’s
outer surface. Instead, use soft-brushes & cottons clothes.
• Use distilled de-mineralized water for the final rinse.
• Hard water (high mineral contains) should not be used, it may impact the performance of the
instrument.
• Use Neutral PH enzymatic detergent for cleaning whenever possible. Alkaline detergents, if used,
must be completely rinsed from the devices. Do not use corrosive fluids.
• Do not exceed 130°C during the washing and sterilization process. Cold soak sterilization is not
typically recommended and, as is always necessary for all instrumentation.
• After disassembly, the following manual cleaning steps are important:
1. All components should be soaked in a blood-dissolving enzymatic solution for at least five minutes
with gentle agitation.
Note: It is advisable to soak longer if protein containing material is present.
2. Soak instruments vertically which cleans instrument thoroughly.
3. Rinse it thoroughly with tap water for 5 minutes.
4. Clean all surfaces of instrument using detergent solution.

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5. Brush the surfaces using soft brush. Handle cord connectors, fittings and joints with care.
6. Use the soft brushes in up and down motion to clean completely through the lumen.
7. Compressed air can be used for flushing if a precise nozzle is available and if the pressure can be
controlled. Ultrasonic irrigators are also a useful way to flush instruments with lumens to remove debris
from hard-to-reach areas, and they can do so in a less time than a manual cleaning process. The cycle
time should be five minutes or less, and water temperature should not exceed 50°C.
8. Rinse thoroughly under running distilled water for at least five minutes.

D. STORING THE GENERATOR

If the generator is stored at a temperature outside its normal operating range of 50 to 104 0F (10 to
40 oC) allow it to sit at room temperature for one hour prior to use. The generator can be stored
indefinitely. You must perform specific checkout procedure before use if you see it longer than one year.

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CHAPTER 8
Operating Principle
Operating Principle:
This section will emphasize on the working principle of the system.
• General description
• Block diagram
• Detailed description

A. GENERAL DESCRIPTION

6SENSE Technology:
This is a recent innovation in field of advance feedback controlled Electrosurgical technology System
maintains the set power by sensing- voltage, current, power, tissue density, patient return electrode
monitoring and leakage RF current- at 4000 times per second.
• Minimizes dragging of electrodes in different tissues.
• No need to change the power setting as the tissue changes.
• Less thermal damage by 50% than standard ESU’s hence improves the patient recovery time.
• Reduces the risk of collateral tissue damage.
• Reduces noise in other OT equipment.
• Reduces the risk of neuro-muscular stimulation.
• Less charring and sparking hence precise & clean cutting.

Smart ENDO Cut:

For polypectomy & papillotomy cutting is intelligently divided in cut & pause in such a way that
coagulation occurs in each pause. The system is smart to change the pause interval as tissue density
changes. Hence, produces fine cutting with coagulation effect.
Smart Endo Cut: Change in cut & pause as tissue demands. d1, d2, d3 are dependent on the tissue
impedance.

Randomized spray coag: In conventional spray coag, beam tends to follow the same path left by
previous spark. Hence, no homogeneous coagulation over larger area occurs. By randomizing spray
frequency & amplitude, spark takes multiple paths.
• Starts sparking more distance from tissue.
• Uniform & homogeneous coagulation over large surface area at lower power settings.
• Less tissue necrosis & carbonization.
• Increases the speed. Reduces the output voltages.
• Drastically improves the performance when combined with Argon enhanced ESUs.

PREM – Ultimate safety from burns: Patient Return Electrode Monitoring – PREM is the care &
safety against the return electrode site burns. This ensures burn free electrosurgery using DUAL AREA
Return electrode by continuously monitoring the contact quality with the patient. PREM system gives an
audio-visual alarm and stops the RF output before critical situation arises.

BiCoag Alarm: The system is delivering an alarm after completion of coagulation in endoscopic & open
surgery. This feature is very effective in endoscopic surgeries where surgeon do not have direct contact with

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tissue being coagulated. BiCoag Alarm avoids over coagulation of tissue, hence reduces tissue sticking to
instruments and reduces smoke, charring, necrosis & carbonization of tissue.

B. BLOCK DIAGRAM & DESCRIPTION

System is divided in three basic parts:

• Processor and control circuit.
• Variable voltage power supply
• Radio frequency output amplifier.

Processor & Control circuitry:

This is the main control system that calculates all the system parameters as per the selected mode and
monitors the overall activity of the system.
Variable voltage power supply: As per the selected mode and the set power settings, power supply
devices the necessary power as an input for the RF stage.
RF output amplifier: This converts the controlled dc voltage in Radio frequency as demanded for
surgical applications.

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Circuit Board Description:

CPU and Display Board:

Processor and control board consists of –

1. Main microcontroller: IC U02 is main microcontroller and brain of the system, which controls
overall function of a system using inbuilt I/O ports. U02 has inbuilt program memory to store the
system program. All activation requests go to the system and it works accordingly by giving I/O
signals to process tasks.

2. Digital to Analog converter: Two analog control signals, Power control signal & voltage control
signal are derived from ICs U03. During activation of power delivery both control signals change
with change in tissue impedance.

3. Output waveform Coupler: RF output waveform as per selected mode is delivered by main
microcontroller U02. Signal conditioning is done by U07 & Q01.

4. Analog to Digital converter: Micro-controllers in-built ADC converts all analog sense voltage in
digital form to process them for monitoring the calculation in a close loop. Sensed voltage is
continuously monitored by the processor for checking the contact quality of patient with return
electrode.

5. Display Circuit: 5 inch LCD Display is interface by Display communication IC U01.

6. Keyboard Circuit: Front panel keyboard is directly connected to the CPU. CPU continually
scans for the pressed key.

7. LED driver Circuit: Front panel socket LEDs are driven by IC U05 & U06.

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Power Supply and RF Main Board:

This board can be divided in two parts, mains power supply and output RF stage. This board circuitry
also supports for RF power delivery, handswitching logic, PREM and all other sense circuit.
• Variable HV power supply: Supply voltage is converted in dc voltage by CR01 & C02,C05 and
again converted in Isolated DC voltage by using bridge converter. MOSFET Q01 to Q04 works in
bridge configuration along with Transformer T02 and MOSFETs are driven by T01 pulse
transformer. IC’s U01 & U02 controls the pulse width of ON Time depending on Error voltage
between output dc voltage & set value in particular operating mode. This voltage is continuously
changing during activation hence reflecting the change in pulse width. The output of Transformer
T02 is fed to HF bridge rectifier formed of CR02 to CR05 and filtered by L01 & C08, C09 which
produces pure dc voltage to drive RF stage.
• O/P RF amplifier stage: This stage is driven by pure controlled dc voltage from HV power supply
and control signal from waveform generator circuit on CPU board. Depending on the selected mode,
the o/p transformer T05 configuration is selected by primary relay k01. O/P stage is driven by
switching devices Q09 to Q12 at various levels. CR27 is also used to protect the device from reverse
current.
• O/P Resonator and filter: RF o/p of amplifier stage is supplied to patient via resonator stage which
is resonating at particular load conditions. This stage has two functions of resonator & filter for RF
frequencies. Inductor L02 & L03 and capacitor C74 to C78 forms the resonator that can filter circuit,
which is also used to deliver the o/p in different modes of monopolar & bipolar applications.
• Configuration & mode selection circuit: This circuit is used to obtain the RF o/p at required
channel. Relays k03 to k07 are used to select different o/p channel & load conditions. When power is
delivered in monopolar(any of the channels), no leakage power in bipolar or other monopolar
channels is present unless and until it is not operating in 2Si coag mode. In bipolar mode, return
electrode circuit & both monopolar channel are isolated from RF by this circuit.
• Monopolar & Bipolar Handswitch Decode: Handswitch decode circuitry works on floating
principle. IC U16, U17 is used for detecting the activation request if any. This circuitry is powered by
isolated power supply separated for each channel. All activation requests pass on to activate request
generator.
• Activation Request Generator: This circuit keeps watch on activation request from foot or hand
controlled accessories. This generates the necessary signals for CPU to start the process for RF
delivery depending on the selected mode & the channel.
• PREM Circuit: Patient Return Electrode Monitoring circuit consists of IC’s U05 to U07 and series
transformer T04. Contact quality resistance is reflected in the form of voltage, which is sensed by
CPU. Sensing frequency is around 80 KHz & tuning can be done by adjusting preset Rp01.
• Leakage sense circuit: Current flows from active electrode and return electrode is measured if
difference crosses the safety limit circuit gives error voltage. The CPU as IF- sense senses this. CPU
takes corrective action to reduce the current in safe limit.
• RF current sense: Actual RF o/p current is sensed by current sense T07 and IC U07 .U08 converts
the current in average value, which is sensed by CPU as I- sense.
• RF voltage sense: O/P voltage is sensed by voltage sense T06 and processed by true rms converter in
dc voltage by IC’s U09 & U10, which is sensed by CPU as V- sense. Also it gives the signal to spark
controller.
• High voltage sense circuit: This circuit continuously monitors that RFHV is not crossing the limit.
This senses the voltages in primary side of RF and converts in dc by True RMS detector of
U11&U12. Signal is sensed by CPU as HV sense.

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• Footswitch decode logic: This circuit checks the footswitch activation input gives the input signal to
CPU Board for activation of RF output.
• Audio circuit: Circuit generates different audio tones for cut, coag and bipolar activation. It gives
two pulse outputs for ERROR conditions. Audio oscillator & driver stage comprises of U18 to U20.
Signals are fed to speaker SPK 01 & audio volume can be controlled by control knob kP01.

Detailed circuit diagrams & components list relevant to the purchased product will be
made available to a valid customer upon request.

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CHAPTER 9
Testing Procedures
Warning- Electric Shock Hazard - the generator power cord must be connected only with a properly
grounded socket. Do not use power plug adaptors.
Warning- Fire Hazard - Do not use extension cords.
Caution - Do not stack equipment on top of the Shalya Sigma or do not place the
generator on top of other electrical equipment. These configurations do not
allow for adequate cooling.
Caution - Place the generator on any stable or flat surface, such as a table or
platform.
Carts with conductive wheels are recommended. Refer to the procedures for your
institution or to local codes for details.
Provide at least four to six inches of space from the sides and top of the generator for
cooling. Normally, the top, sides and rear panel are warm when the generator is used
continuously for extended period of time.
Caution - According to the procedures, connect an equipotential grounding cable to the grounding
plug on the rear panel of the generator. Then, connect the cable to earth ground.
Caution - If required connect the generator to the hospital equalization connector
with an equipotential cable.
Caution - Connect the power cord to a wall socket having the correct voltage.
Otherwise, product damage may result.
Caution - Plug the generator power cord into a grounded socket. Grasp the plug, not
the Power cord. Do not pull the cord itself.
Warning- Keep test leads to the minimum length usable; lead inductance and stray capacitance can
adversely affect readings. Carefully select suitable ground points to avoid ground loop
error in measurements. The accuracy of most RF instruments is approximately 1-5% of
full scale. Do not use uncompensated scope probe, causes large errors when measuring
high voltage RF waveforms.

Periodic Safety Check:

Perform the following safety check every two years to verify that the Shalya Sigma
Generator is functioning properly. Record the test results for reference in future tests. If
the generator fails to meet any of the checks, refer to Chapter 10, troubleshooting.

Warning - Electric Shock Hazard - While taking measurements or troubleshooting the

generator, take appropriate precautions, such as using isolated tools and
equipment, using the “one hand rule,” etc.
Warning - Electric Shock Hazard- do not touch any exposed wiring or conductive
surfaces while the generator is disassembled and energized.
Warning - Electric Shock Hazard- Never wear a grounding strap when working on
an energized generator.
Caution - The generator contains electrostatic- sensitive components. When
repairing the generator, work at a static control workstation. Wear a
grounding strap when handling electrostatic- sensitive components, except when working
on an energized generator.

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Handle circuit boards by their nonconductive edges. Use an antistatic container for
transport of electrostatic-sensitive components and circuit boards.

The summary of safety checks:

Inspect the generator and accessories.
Inspect the internal components.
Test the generator.
Verify PREM Function.
Confirm outputs.
Check leakage current and ground resistance.

Recommended Test Equipment:

Digital voltmeter
True RMS voltmeter
Oscilloscope
Leakage current tester
Leakage table – per IEC 60601-2-2,
100, 200, 300, 500 ohm, all 250 watt, 1% tolerance, non-inductive

Inspecting the Generator and Accessories:

Equipment list
Dual paddle toggle (Bipolar/Monopolar) footswitch
Bipolar instrument cords (footswitching)
Monopolar instrument cords (handswitching and footswitching)

Steps for a rear-panel inspection:

Turn OFF (0) the generator by pressing the front panel power switch.
Disconnect the power cord from the wall socket.

Rear Panel Inspection

1. Check the rear panel footswitch sockets for obstructions or damage.

2. Check for a secure fit by inserting the Dual paddle toggle (Bipolar/Monopolar) footswitch
connector into respective socket.
3. Remove the fuse and verify correct voltage and current rating.

Front Panel
1. Check the bipolar instrument socket for any obstructions or damage. Insert the bipolar
instrument connector (footswitching) into the appropriate socket to verify a secure fit. If the
connection is loose, replace the front panel assembly.
2. Check the monopolar instrument sockets for obstructions or damage. Insert the monopolar
instrument connector (footswitching and handswitching) into the appropriate socket to verify
a secure fit. If any of the connections are loose, replace the front panel assembly.
3. Check the patient return electrode socket for a broken pin or an obstruction. If the socket is
damaged or obstructed, replace the front panel assembly.

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Footswitches and its connector

1. Remove the footswitch from the generator.
2. Disassemble the footswitches connector. Inspect the connector for damage or corrosion.
3. In case of damage or corroded footswitch connector, replace the footswitch connector.
If found appropriate, reassemble the footswitches connector.
4. Inspect the footswitches for damage.
5. In case of damage footswitch, replace the footswitch.
If found appropriate, reconnect the footswitches to the generator.

Power cord:
1. Remove the power cord from the unit and ensure that it is unplugged from the wall socket.
2. Visually inspect the power cord for damage.
3. Reconnect the power cord to the generator and wall socket.

Inspecting the Internal Components:

This section is only required when the system is open for troubleshooting, repair, or spare
Replacement..

Equipment list
-Phillips screwdriver

o Turn OFF (0) the generator by pressing the front panel power switch.
o Loosen the chassis screws. Lift the cover off the chassis. Set the cover aside for reinstallation.
o Verify that all connectors are firmly seated.
o Inspect each board for damaged components, wires, cracks, and corrosion.
o If you find evidence of damage on the Controller board, Relay Board or Front panel, replace the
board.
o If you find evidence of damage on the Power Supply /RF Board, replace the board only if the
damage is severe. Reinstall the cover on the generator. Tighten the screws that fit the cover to the
chassis.

Configuration Outputs:
Use these procedures to ensure the accuracy of the generator. Always confirm the output at these times.
o After calibrating the generator
o Every Year

Equipment
o Two small test cables (less than 24 inches long) with banana plugs
o Current transformer
o True RMS voltmeter
o 100,300, and 500 Ω 1% non-inductive power resistors
o Dual paddle toggle (Bipolar/monopolar footswitch)

Checking the Bipolar Output

1. Verify if the generator successfully completes the self-test.
2. Connect the test equipment for bipolar output.
3. Connect the two test cables to the bipolar socket.
4. Pass one test cable through the current transformer and connect the current transformer to the
voltmeter.

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5. Connect the 100 Ω power resistor across the output jacks at the end of the test cables.
6. Connect the Dual paddle toggle footswitch to Footswitch socket on the rear panel.
7. Set the footswitch in bipolar mode by pressing toggle switch provided on the top side of
footswitch or by enabling the footswitch icon in the mode & power setting window.
(Visible indication provided for footswitch selection on LCD display)
8. Select the Macro mode in Bipolar cut and set the bipolar power to 10.
9. Press the footswitch cut pedal and, while activating the generator, note the output on the
voltmeter.
10. Test the output current for the selected bipolar mode.
11. Select other sub modes from the Bipolar cut & Bipolar coag and repeat step 4.
12. Verify that the generator output for each mode is 316 ± 16mA rms.

If the output is outside the specified range, calibrate the bipolar output as described in calibration step
then repeat this procedure. If the output for one or more modes remains outside the specified range,
contact XcelLance Medical Technologies Pvt. Ltd. Service Center.

Checking the Monopolar Cut Output

1. Check the output for the cut modes.
2. Verify that the generator successfully completes the self-test.
3. Connect the test equipment for monopolar2 output.
4. Connect one test cable in the Monopolar2 socket. Pass the test cable through the current
transformer and connect the current transformer to the voltmeter.
5. Use a test cable to short the two pins on the Patient (return electrode) socket.
6. Connect the second test cable from the voltmeter to both pins of the Patient (return electrode)
socket.
7. Connect the 300 Ω resistor across the output jacks at the end of the test cables.
8. Connect the Dual paddle toggle footswitch to Footswitch socket on the rear panel.
9. Set the footswitch in monopolar mode by pressing toggle switch provided on the top side of
footswitch or by enabling the footswitch icon in the mode & power setting window.
(Visible indication provided for footswitch selection on LCD display)
10. Select the Pure mode.
11. Press the cut up/down keys to set the cut power to 80 watts.
12. Test the monopolar2 cut output.
13. Press the footswitch cut pedal and while activating the generator, note the output on the voltmeter.
14. Release the footswitch pedal.
15. Based on the voltmeter setting and the current transformer used at the customer end, calculate and
record the output current.
16. Select the Low cut mode and repeat step 11.
17. Select the Blend mode and repeat step 11.
18. Verify that the generator output for each mode is 516 ± 26mA rms.
19. If the output is outside the specified range, calibrate the monopolar output as described in
calibration steps4. 2. Then repeat this procedure. If the output for one or more cut modes remains
outside the specified range, call the XcelLance Medical Technologies Pvt. Ltd. Service Center.

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Checking the Monopolar Coag Output

1. Check the output for the coag modes.
2. Disconnect the 300 Ω resistor and replace it with the 500 Ω resistor.
3. Select the Soft mode.
4. Press the coag Up/Down keys to set the coag power to 80 watts.
5. Test the monopolar2 coag outputs.
6. Press the footswitch coag pedal and note the output on the voltmeter while activating the
generator.
7. Release the footswitch pedal.
8. Based on the voltmeter setting and the current transformer you are using, calculate and record the
output current.
9. Select Press the Fulgurate mode and repeat step 4.
10. Select Press the Spray mode and repeat step 4.
11. Verify that the generator output for each mode is 400 ± 20 mA rms. If the output is outside the
specified range, calibrate the monopolar output as described in calibration steps 5.Then repeat this
procedure. If the output for one or more coag modes remains outside the specified range, call the
XcelLance Medical Technologies Pvt. Ltd. Service Center.

Verifying PREM Function

Equipment list
• PREM plug
• Resistance decade box, 1 Ω resolution, 1% tolerance, 1/8 W or greater, or 50 Ω and 100 Ω 1%
tolerance, non-inductive resistance loads.

1. Remove the test cable from the Patient (return electrode) socket. Confirm the REM LED indicator
light illuminates red.
2. Set the resistance decade box to 100 Ω or select a 100 Ω load. Connect the resistance box to the REM
receptacle, and verify that the PREM level bar is within Level 1 to Level 3. Confirm that the REM LED
indicator light illuminates green.
3. Decrease the resistance to 50 Ω or select a 50 Ω load and verify that the PREM level bar is within
Level 4 to Level 6.
4. Decrease the resistance to 0 Ω or short the REM pins together and confirm the
REM LED indicator light illuminates red with no level bar.

Checking Low Frequency Leakage Current and Ground Resistance

Check the frequency leakage current and ground resistance before returning the Shalya Sigma generator
to clinical use.
Equipment
o DVM
o Leakage current tester

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Output Socket and PREM Source Current

1. Set the DVM to AC volts (200 mV) and connect the leakage current test circuit.
2. Turn on the generator.
3. Measure between all the output sockets (including the PREM Patient Return Electrode socket)
and earth ground. Record the largest reading.
4. Determine the leakage current using the conventional 1 microamp per 1 millivolt.
5. Verify under normal conditions (ground closed, normal polarity) the leakage current is less than
10 microamps. If the leakage current is greater than 10 microamps, call the XcelLance Medical
Technologies Pvt. Ltd. Service Centre.
6. Verify single fault conditions (ground open) the leakage current is less than or equal to 50
microamps. If the leakage current is greater than 50 microamps, call the XcelLance Technologies
Service center.

Chassis or Earth Leakage

1. Set the DVM to AC volts (200 mV) and connect the leakage current test circuit.
2. Turn on the generator.
3. Measure between the chassis and earth ground.
4. Determine the leakage current using the conventional 1 microamp per 1 millivolt.
5. Verify under normal conditions (ground closed, normal polarity) the leakage current is less than
300 microamps. If the leakage current is greater than 300 microamps, call the XcelLance Medical
Technologies Pvt. Ltd. Service center.
6. Verify single fault conditions (ground Open) the leakage current is less than or equal to 1000
microamps. If the leakage current is greater than 1000 microamps, call the XcelLance Medical
Technologies Pvt. Ltd. Service Centre.

Output Socket and PREM Sink Current

1. Set the DVM to AC volts (200 mV) and connect the leakage current test circuit.
2. Turn on the generator (110 or 220 VAC) and connect the end of the leakage current test circuit to
mains voltage through a 120k Ω resistor.
3. Connect the other side of the IEC leakage load to all the output sockets (including the PREM
Patient Return Electrode socket).
4. Determine the leakage current using the conventional 1 microamp per 1 mill volt.
5. Verify the leakage current is less than or equal to 50 microamps. If the leakage current is greater
than 50 microamps, call the XcelLance Medical Technologies Pvt. Ltd. Service Center.

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Ground Continuity Testing

1. Connect the system to a ground continuity tester or a digital multimeter (DMM).
2. Test between the equipotential ground lug on the rear of the system and the supplied
power cord, or directly to the middle ground pin of the inlet receptacle.
3. Initiate the test according to IEC standards.
4. Maximum permissible values are 0.3 ohms using a supplied power cord or
0.2 ohm connected directly to the middle pin of the inlet receptacle. If then specifications are not
met, contact XcelLance Medical Technologies Pvt. Ltd. Service Center.

Checking High Frequency Leakage Current

Check the high frequency leakage current and ground resistance before returning the Shalya Sigma
generator to clinical use. Check the leakage current at these times.
• After calibrating the generator.
• Annually.

Equipment
o 200 Ω, 250 watt, noninductive resistor
o Current transformer
o True RMS voltmeter (Fluke 8920 or equivalent)
o Dual paddle toggle (Bipolar/monopolar) footswitches and handswitching accessories
o Leakage setup per IEC 60601-2-2 clause 19.101 or 19.102

Checking Monopolar High Frequency Leakage Current

1. Connect the 200 Ω load from the monopolar active accessory through the current transformer to
the equipotential ground plug on the rear of the generator.
2. Connect the current transformer to a true RMS voltmeter.
3. Connect a Dual paddle footswitch to the footswitch socket at the rear panel of the generator.
4. Set the footswitch in monopolar mode
5. Activate the footswitch in each monopolar mode at the maximum control setting. Record the
leakage current. It should not exceed 150 mA for any mode.
6. If the high frequency leakage exceeds 150 mA, call the XcelLance Medical Technologies Pvt.
Ltd. Service Center for further instructions.

Checking Patient Return High-Frequency Leakage Current

1. Connect the 200 Ω load from the PREM cable through the current transformer to the equipotential
ground plug on the rear of the generator.
2. Connect the current transformer to a true RMS voltmeter.
3. Connect a Dual paddle footswitch to the footswitch socket at the rear panel of the generator.
4. Set the footswitch in monopolar mode
5. Activate the footswitch in each monopolar mode at the maximum control setting. Record the
leakage current. It should not exceed 150 mA for any mode.
6. If the high frequency leakage exceeds 150 mA, call the XcelLance Medical Technologies Pvt.
Ltd. Service Center for further instructions.

Checking Bipolar High Frequency Leakage Current

• Remove the monopolar accessories, and connect the 200 Ω load from one side of the bipolar
output through the current transformer to the equipotential ground lug on the rear panel of the
generator.

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• Connect the current transformer to the true RMS voltmeter.

• Connect a dual paddle footswitch to footswitch socket at the rear panel of the generator.
• Set the footswitch in bipolar mode
• Activate the footswitch in each mode at maximum control setting. Record the leakage current. It
should not exceed 60 mA for any mode.
• If the high frequency leakage exceeds 60 mA, call the XcelLance Medical Technologies Pvt. Ltd.
Service Center for further instructions.

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CHAPTER 10
Calibration Procedures
Calibrating the Shalya Sigma
For normal running Shalya Sigma, program requires data constants, which are dependent on the
hardware. All this data is stored in NV Ram after calibration process is completed. Calibration is
recommended after:
• Changing CPU or RF main board.
• Every six months.
Steps and description:
Step 1 - PREM Calibration
Step 2 -Energy Calibration
A - Close loop current Calibration
B - Close loop voltage Calibration
C - Close loop power Calibration
D - Open loop power Calibration
E - Open loop voltage Calibration

Preparing for Calibration:

Equipments:
• Dual paddle toggle footswitch.
• Small test cables with banana plugs.
• PREM plug modified.
• Resistor substitution box.
• Oscilloscope.
• True RMS current meter.

Entering Calibration Mode:

To enter in calibration mode, switch ON Shalya Sigma and Follow following sequence:
Setup Key >> Calibration (Enter Unlock key)>> Again Calibration.

Exiting Calibration Mode:

One can exit calibration procedure at any time by pressing back keys on the screen.
Or just restart the generator by turning it off and on.
(For Calibration follow the guide given below on the next page).

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(Calibration Mode Screen)

Calibration Step1 - PREM Calibration

Equipment:
• PREM plug (modified)
• Resistor substitution box

Procedure:
1) Select mode ‘1:1 REM min’.
2) Connect PREM plug in the PREM socket and connect appropriate substitution resistor as
indicated by ‘Load R’, across the PREM socket.
3) Press the Coag pedal switch provided to get Fire count reading. Press ‘Write counts’ to store the
acquired count.
4) Once the memory write operation is successful press Back key
5) Follow the same Steps(1 to 4) for ‘1:3 REM Max’

Please Note: Load R is different for both modes.

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Calibration Step 2 - Energy Calibration

XcelLance Medical Technologies recommends that only qualified personnel calibrate the Shalya Sigma +
unit. XcelLance Medical Technologies defines qualified personnel as someone with experience in
electrosurgical equipment repair, such as biomedical personnel, or individuals who have taken official
training courses.
During calibration, the user verifies system-specific information and adjusts the information if necessary.
A - Close Loop Current Calibration
Sub step-1(BIP mode)
Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs
b) True RMS current meter
c) 50 Ω non-inductive power resistor.

Verify:
a) The display shows calibration mode 2:1.
b) Resistor substitution box must of 50Ω.
Procedure:
1) Connect
a) One test cable from Bipolar socket in series with RMS current meter to 50 Ω resistor.
b) One test cable from Bipolar socket to 50 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the I-max for bipolar output.
a) Press the coag pedal & check if current reading is equivalent to 1000 mA ± 20 mA RMS.
b) Stop activation. If the output current is high decrease Fire count by pressing down key. If
low, increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.

3) Disconnect the test cables from bipolar output.

Sub step- 2 (Cut Mode)

Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 50 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 2:2.
b) Resistor substitution box must of 50Ω.

Procedure:
1) Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 50 Ω resistor.
b) Another test cable from PREM socket to 50 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the I-max for Monopolar Cut output.

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a) Press the cut footswitch pedal & check if current reading is equivalent to 1414 mA ± 20
mA RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If
low increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
e) I-max for Pure Endo & Low modes are adjusted automatically.
3) Disconnect the test cables from Monopolar output.

Sub step- 3 (Blend Mode)

Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 50 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 2:3.
b) Resistor substitution box must of 50Ω.
Procedure:
1) Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 50 Ω resistor.
b) Another test cable from PREM socket to 50 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the I-max for Monopolar Blend output.
a) Press the Cut footswitch pedal & check if current reading is equivalent to 1048 mA ± 20
mA RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If
low increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
3) Disconnect the test cables from Monopolar output.

B - Close Loop Voltage Calibration

Sub step-1(BIP mode)
Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs
b) True RMS current meter
c) 1000 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 3:1.
b) Resistor substitution box must of 1000Ω.

Procedure:
• Connect:
a) One test cable from Bipolar socket in series with RMS current meter to 1000 Ω resistor.

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b) One test cable from Bipolar socket to 1000 Ω resistor.

c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
• Check and adjust the V-max for bipolar output.

• Press the coag footswitch pedal & check if current reading is equivalent to 158 mA ± 5
mA RMS.
• Stop activation. If the output current is high decrease fire Counts by pressing down key. If
low increase it by pressing up key.
• Repeat step (b) until the meter reading is not in the stated range.
• When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.

• Disconnect the test cables from bipolar output.

Sub step- 2 (Cut Mode)

Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 3000 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 3:2.
b) Resistor substitution box must of 3000Ω.
Procedure:
1. Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 3000 Ω resistor.
b) Another test cable from PREM socket to 3000 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2. Check and adjust the V-max for Monopolar Cut output.
a) Press the cut footswitch pedal & check if current reading is equivalent to 103 mA ± 5 mA
RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If low
increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
e) V-max for Pure Endo & Low modes is adjusted automatically.
3. Disconnect the test cables from Monopolar output.

Sub step- 3 (Blend Mode)

Equipment
• Monopolar footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 3000 Ω non-inductive power resistor.

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Verify:
a) The display shows calibration mode 3:3.
b) Resistor substitution box must of 3000Ω.
Procedure:
1) Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 3000 Ω resistor.
b) Another test cable from PREM socket to 3000 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the V-max for Monopolar Blend output.
a) Press the Cut footswitch pedal & check if current reading is equivalent to 85 mA ± 5 mA
RMS.
b) Stop activation. If the output current is high, decrease fire Counts by pressing down key. If
low increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
3) Disconnect the test cables from Monopolar output.

C - Close Loop Power Calibration

Sub step-1 (BIP mode)
Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs
b) True RMS current meter
c) 100 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 4:1.
b) Resistor substitution box must of 100Ω.
Procedure:
1) Connect:
a) One test cable from Bipolar socket in series with RMS current meter to 100 Ω resistor.
b) One test cable from Bipolar socket to 100 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the P-max for bipolar output.
a) Press the coag footswitch pedal & check if current reading is equivalent to 547 mA ± 10 mA
RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If low
increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.

3) Disconnect the test cables from bipolar output.

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Sub step- 2 (Cut Mode)

Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 300 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 4:2.
b) Resistor substitution box must of 300Ω.

Procedure:
1) Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 300 Ω resistor.
b) Another test cable from PREM socket to 300 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.
2) Check and adjust the P-max for Monopolar Cut output.
a) Press the cut footswitch pedal & check if current reading is equivalent to 365 mA ± 10 mA
RMS.
a) Stop activation. If the output current is high decrease fire Counts by pressing down key. If low
increase it by pressing up key.
b) Repeat step (b) until the meter reading is not in the stated range.
c) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
d) P-max for Pure Endo & Low modes is adjusted automatically.
3) Disconnect the test cables from Monopolar output.

Sub step- 3 (Blend Mode)

Equipment
• Dual paddle toggle footswitch.
a) Small test cables with banana plugs & PREM plug.
b) True RMS current meter
c) 300 Ω non-inductive power resistor.
Verify:
a) The display shows calibration mode 4:3.
b) Resistor substitution box must of 300Ω.
Procedure:
1) Connect:
a) One test cable from Monopolar socket in series with RMS current meter to 300 Ω resistor.
b) Another test cable from PREM socket to 500 Ω resistor.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.

2) Check and adjust the P-max for Monopolar Blend output.

a) Press the Cut footswitch pedal & check if current reading is equivalent to 365 mA ± 10 mA
RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If
low increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count
reading in the system memory.
3) Disconnect the test cables from Monopolar output.

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D - Open Loop Power Calibration (Econ)

(Soft/Swift/Fulgar/Spray)
Equipment:
• Dual paddle toggle footswitch.
• Small test cables with banana plugs
• True RMS current meter
• 500 Ω non-inductive power resistor.
• PREM plug modified.

Verify:
1) Mode displayed on the screen is 5:‘x’ ( x may be 1,2,3,4 as per chosen mode)
2) Resistance of connected resistance substitution box 500Ω

Procedure:
1. Connect:
a) One test cable from socket PREM plug to 500 Ω.
b) Another test cable from Monopolar socket passes through true RMS current meter to 500Ω.
c) Dual paddle toggle footswitch to the footswitch socket on the rear panel.

2. Check and adjust the Econ for Monopolar Soft output.

a) Press the coag footswitch pedal and check the current equivalent to 282 mA ± 10 mA RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If low
increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count reading
in the system memory
.
3. Disconnect the test cables from Monopolar output.

Use same equipments & repeat the same procedure for calibrating ‘Vpk’ of different modes
(Swift/Fulgar/Spray) by choosing corresponding calibration modes.

Calibration Step 6 - Open Loop Voltage Calibration

(Soft/Swift/Fulgar/Spray)
Equipment:
• Dual paddle toggle footswitch.
• Small test cables with banana plugs
• True RMS current meter
• 5000 Ω non-inductive power resistor.
• PREM plug modified.
Verify:
a) Mode displayed on the screen is 6:‘x’ ( x may be 1,2,3,4 as per chosen mode)
b) Resistance of connected resistance substitution box 5000Ω

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Procedure:
Connect:

a) One test cable from socket PREM plug to 5000 Ω.

b) Another test cable from Monopolar socket passes through true RMS current meter to 5000Ω.
c) Monopolar footswitch to the Monopolar footswitch socket on the rear panel.
Check and adjust the Vpk for Monopolar Soft output.
a) Press the coag footswitch pedal and check the current equivalent to 56 mA ± 5mA RMS.
b) Stop activation. If the output current is high decrease fire Counts by pressing down key. If low
increase it by pressing up key.
c) Repeat step (b) until the meter reading is not in the stated range.
d) When reading is in stated range, press ‘Write Counts’ for storing corresponding fire count reading
in the system memory.
Disconnect the test cables from Monopolar output.

Use same equipments & repeat the same procedure for calibrating ‘Vpk’ of different modes
(Swift/Fulgar/Spray – Measuring current(69 mA ± 5mA RMS) by choosing corresponding
calibration modes.

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CHAPTER 11
Care, Storage and Disposal
After each use, perform the following cleaning procedures immediately. If cleaning is delayed, debris
encrustation may become a source of infection. Encrustation may also result in electrosurgical unit
malfunction.

11.1 CARE OF THE UNIT

WARNING
After cleaning the electrosurgical unit, dry it thoroughly before using it again. If it is used when wet,
there is the risk of an electric shock.
Usage of Dust Cover on the unit is mandatory.

CAUTION
Never immerse the electrosurgical unit in water, clean or disinfect by immersion, gas sterilization or
autoclaving. It may cause equipment damage.
Do not wipe the external surface with hard or abrasive wiping material. The surface will be scratched.
Before sending the accessories for servicing, ensure the sterilization by Autoclaving from the User end.

11.2 STORAGE OF THE UNIT

1. Turn the electrosurgical unit OFF and disconnect the power cord from the receptacle (wall mains
outlet)
2. If the equipment is soiled with blood or other potentially infectious materials, first wipe off all the
debris using neutral detergent, then wipe its surface with a lint-free cloth moistened with a surface
disinfectant.
3. To remove dust, dirt and non-patient debris, wipe the electrosurgical unit and foot switch using a soft,
lint-free cloth moistened with 70% ethyl or isopropyl alcohol.
4. Make sure that the electrosurgical unit and foot switch are completely dry before storage.

WARNING
Do not store these devices in humid and unventilated environment as it may encourage the growth of
micro-organisms and pose an infection control risk.

CAUTION
Do not store the electrosurgical unit in a location exposed to direct sunlight, x-ray, radioactivity, liquids
or strong electromagnetic radiation (e.g. near microwave medical treatment equipment, short wave
medical treatment equipment, MRI equipment, radio or mobile phones). Damage to the electrosurgical
unit may result.

Do not apply excessive bending, straining or squeezing force to any cords during storage. It may cause
malfunction.

1. Disconnect the power cord

2. Store the equipment at room temperature in the horizontal position in a clean, dry and stable
location.

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11.3 CARE OF MAINS CABLE

CAUTION
The cable should not be sterilized by EtO gas or autoclaving. These methods will cause deformation and
damage that will render the cable useless.

Ensure that foreign matter does not enter the mains cord end connection as this will result in poor
connection.
1. After each procedure, wipe with a soft, clean, lint-free cloth. If dirt persists, moisten the cloth
with 70% ethyl or isopropyl alcohol and wipe again.
2. Dry thoroughly after wiping. A cable that is not completely dry may cause an electric shock.

11.4 STORAGE OF MAINS CABLE

WARNING
Never store the cable in shipping box as this may pose an infection control risk.
1. Store under the conditions away from direct sunlight and source of liquids.
2. Store the cable with the clamping screw attached.

11.5 DISPOSAL

When disposing this electrosurgical unit, accessories or any of its components (such as fuses), follow all
applicable national and local laws and guidelines.

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CHAPTER 12
Trouble Shooting
Trouble shooting
If the generator is not functioning properly, use the information in this section to perform the following
tasks:
Identify and correct the malfunction.
If a system alarm number is displayed, take the appropriate action to correct the alarm conditions.

Inspecting the Generator

If the Shalya Sigma generator malfunctions, check for obvious conditions that may have caused the
problem:
Check the generator for visible signs of physical damage.
Verify that all accessory cords are properly connected.
Check the power cord. Replace the power cord if you find exposed wires, cracks, frayed insulation, or
a damaged connector.
Open the fuse drawer and inspect the fuse housing and fuses for damage and corrosion. Verify that
the fuses are firmly seated.
An internal component malfunction in the generator can damage the fuses. You may need to replace the
fuses if the generator fails the self-test or stops functioning.

A. CORRECTING MALFUNCTIONS
If a solution is not readily apparent, use the table below to help identify and correct specific malfunctions.
After you correct malfunction, verify that the generator completes the self-test.

Situation Possible Cause Recommended Action

ESU does not Disconnected power cord, Check power cord connections with wall socket and
respond when faulty wall socket, or faulty ESU. Connect the power cord to a functional wall
Turned on. power cord. socket. If necessary, replace the power cord.
Fuse drawer is open or fuses Close the fuse drawer. If necessary, replace the fuse. If
are blown. a problem persists, use a backup generator.
Loose or disconnected internal Check all internal connections. Press the connectors and
cables Boards if required.
Faulty input power filter or Check input power filter and its cable connections.
connections
Faulty low voltage power Check the low voltage power supply.
supply
Damaged CPU board Remove the CPU board and inspect the connectors to
connectors and/or the Power Supply & RF board and to the Display board
malfunctioning CPU board for damage. Replace the CPU board if required.
Shorts or disconnects on Check the Power Supply & RF board for shorts or
Power Supply & RF board disconnects.
Faulty mains ON-OFF switch Replace the switch.
` Replace the front panel assembly.

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Situation Possible Cause Recommended Action

Generator is An alarm condition exists Check the display for an alarm number. Note the
on, but did not number and refer to Responding to System Alarms in
complete the this section.
self-test Software malfunction Turn off and then turn on the generator.
Loose or disconnected internal Check and correct all internal connections. Press the
cables and/or boards. connectors and boards if required.
Faulty low voltage power Check the low voltage power supply. If not working
supply properly, replace it.
Damaged CPU board Remove the CPU board and inspect the connectors to
connectors and/or the Power Supply & RF board and to the Display board
malfunctioning CPU board for damage. Replace the CPU board if required.
Shorts or disconnects on Check the Power Supply & RF board for shorts or
Power Supply & RF board disconnects.
Faulty mains ON-OFF switch Replace the switch.
Malfunctioning front panel Replace the front panel assembly.
components
Situation Possible Cause Recommended Action
Activation Faulty connections or speaker Replace the speaker
and/or alarm on main Rf board
tones do not Audio signal malfunction on Replace the control board.
sound, Control board
speaker is
malfunctioning

LCD display Faulty ribbon cable between Check/connect ribbon cable that connects the LCD
Not turning CPU and LCD Display Display to the CPU board.
ON or Incorrect data communicated Replace the CPU board.
Malfunctioning through the CPU board
. LCD Display malfunction Replace the LCD Display .

Front Panel Faulty ribbon cable between Check/connect ribbon cable that the keypad to the
keys do not CPU board and Keypad Control board.
function Incorrect data communicated Replace the CPU board.
correctly when through the CPU board
pressed

Generator is on Malfunctioning footswitch or Turn off the generator. Check and connect all accessory
and accessory handswitching instrument connections. Turn on the generator. Replace
is activated, the accessory if it continues to malfunction.
but generator Connect the footswitch & the footswitching instrument
does not to the same instrumentation socket.
deliver o/p Power set too low Increase the power setting.
Blown fuse on Main RF board Check the high voltage power supply fuse (F02) and
Replace if necessary.

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CPU board malfunction If the indicator bar does not illuminate and the tone
does not sound, replace the CPU board.
High voltage power supply If high voltage is not present on the Main RF board,
malfunction (high voltage is troubleshoot the high voltage power supply
not present during activation) Check all MOSFET Q01 to Q04, replace with same part
no. if require.
Generator is on Check Diodes CR02 to CR05 replace with same part
and accessory no. if require.
is activated, RF output stage malfunction Troubleshoot the RF output stage as described below on
but generator (high voltage is present during the Power Supply /RF board :
does not activation) verify T_ON pulses at R77, If pulses are present,
deliver output. Check all MOSFET Q09 to Q12, replace with same
part no. if require.
Check Diodes CR27 replace with same part no.
If T_ON pulses are not present,
verify T_ON pulses at TP 16, If pulses are not
present ,replace the CPU
Check IC U14, replace with same part no. if require.

Situation Possible Cause Recommended Action

Footswitch will Malfunctioning or damaged Replace the Footswitch board.
not activate footswitch socket
output Footswitch activation signal Replace the Power Supply & RF board.
lost on Power Supply & RF
board
Footswitch activation signal Replace the CPU board.
lost on CPU board

Malfunctioning monitor Replace the monitor.

Interference Metal-to-metal sparking Check all connections to the generator, patient return
with other electrode, and accessories.
devices only High settings used for Use lower power settings for fulguration or select the
when fulguration Desiccate mode.
generator is Loose contact in ground wiring Verify that all ground wires are as short as possible and
activated in the operating room go to the same grounded metal.
If interference continuous Check with the manufacturer of the monitor.
when the generator is Some manufacturers offer RF choke filters for use in
activated, the monitor is monitor leads. The filters reduce interference then the
responding to radiated generator is activated and minimizes the potential for an
frequencies. electrosurgical burn at the site of the monitor electrode.

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Situation Possible Cause Recommended Action

Intermittent connections or Check all connections to the generator.
Pacemaker metal-to-metal sparking It may be necessary to reprogram the pacemaker.
interference Current traveling from active Use bipolar instruments, if possible. If you must use a
to return electrode during monopolar instrument, place the patient return electrode
monopolar electrosurgery is as close as possible to the surgical site. Make sure the
passing too close to current path from the surgical site to the patient return
pacemaker. electrode does not pass through the vicinity of the heart
or the site where the pacemaker is implemented.
Always monitor patients with pacemakers during
surgery and keep a defibrillator available.
Consult the pacemaker manufacturer or hospital
Cardiology Department for further information when
use of Electrosurgery is planned on patients with
cardiac pacemakers.
Check all connections to the generator, patient return
electrode, and active electrode.

Metal-to-metal sparking

Can occur during coag Use a lower power setting for the Fulgurate and spray
modes or select the Desiccate mode.
Abnormal
neuromuscular
stimulation Abnormal 50-60 Hz leakage Inside the generator, carefully inspect for the damage
(stop surgery currents that may cause shorting between the AC line voltage
immediately) and connected patient components.

B. RESPONDING TO ERROR CODES

When system alarm condition exists, an alarm tone sounds and display indicates error code number.
System will not work till error condition is cleared. Alarm conditions require some action to correct it.
Following screen shows the error window.

Note down the error code and type of error and take necessary measures to eliminate as described in the
following table.

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Error Code Description Recommended Action

No.
501 Up Key may be Stuck • Turn OFF and again turn ON the generator.
Do not press any Key during self-test.
502 Down Key may be Stuck • If the alarm repeats, disconnect all
accessories. Check/connect the ribbon cable
503 Enter Key may be Stuck that connects the Display board to the front
panel. Turn OFF and again turn ON the
504 Left key may be Stuck generator.
• If the alarm repeats, replace front keypad.

If the problem still persist, Call XcelLance

505 Right Key may be Stuck Medical Technologies Pvt. Ltd. Service
cell.

Handswitch1/FootSwitch1 Cut • Turn OFF and again turn ON the generator.

601
pedal may be stuck Do not press any activation during self-test.
602
Handswitch1/FootSwitch1 • If the alarm repeats, disconnect all
Coagulation pedal may be stuck accessories. Turn OFF and again turn ON
Foot Switch 2 Cut pedal may be the generator.
603
stuck. • If the alarm repeats, check the activation
Foot Switch 2 Coagulation pedal request generator circuit.
604
may be stuck
If the problem still persist, Call XcelLance
606 Toggle switch may be stuck Medical Technologies Pvt. Ltd. Service
cell.

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Warranty

XcelLance Medical Technologies Pvt. Ltd. warrants each product manufactured by it to be free from
defects in material and workmanship under normal use and service for the period.

XcelLance Medical Technologies Pvt. Ltd. obligation under this warranty is limited to the repair or
replacement, at its sole option, of any product, or part thereof, which has been returned to it or its
Distributor within the applicable time period shown below after delivery of the product to the original
purchaser, and which examination discloses, to company’s satisfaction, that the product is defective.

This warranty does not apply to any product, or part thereof, which has been repaired or altered outside
XcelLance Medical Technologies Pvt. Ltd. factory in a way so as, in company’s judgment, to affect its
stability or reliability, or which has been subjected to misuse, neglect, or accident.

The warranty periods for XcelLance Medical Technologies Pvt. Ltd. products are as follows:

Electrosurgical Generators: One year from date of shipment

Trolley: One year from date of shipment
Footswitches: One year from date of shipment
Sterile disposables: Shelf life only as stated on packaging
Non-Sterile Electrodes & Cables: Warranty on manufacturing defects only
Single use patient return electrodes: Shelf life only as stated on packaging

Please Note: Warranty on accessories is subject to manufacturing defect before usage only.

Please Note: XcelLance Medical Technologies Pvt. Ltd. will not be liable to pay/fund any sort of
penalty/due other than the aggregate purchase price of goods sold by XcelLance
Medical Technologies Pvt.Ltd., in case of any damage/injury occurs to patient/ surgeon
and/or any entity.

XcelLance Medical Technologies Pvt. Ltd. neither assumes nor authorizes any other person to assume
for it any other liability in connection with the sale or use of any of XcelLance Medical Technologies
Pvt. Ltd. products.

This warranty and the rights and obligations hereunder shall be construed under the governed by the
laws of the Maharashtra State, India. The sole forum for resolving disputes arising under or relating in
any way to this warranty is the Court of Mumbai, Maharashtra State, India.

XcelLance Medical Technologies Pvt. Ltd. its dealers and representatives reserve the right to make
changes in equipment built and/or sold by them at any time without incurring any obligation to make the
same or similar changes on equipment previously built and /or sold by them.

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Disclaimer

3) Electro Surgery is proven in surgical applications over more than 60 yrs. If safety instructions are
not followed/ implemented, usage of this equipment in operation theatre can be hazardous. Risk
associated with the product/procedure cannot be denied, if not used as per ‘user & safety
instructions’ provided in ‘User/ Instruction Manual’.

4) The equipment has to be strictly used only by qualified, trained & licensed surgeon/physician.

5) Optimized & safe usage of equipment is warranted only if manufacturer’s approved accessories
are used along with the equipment during surgery. Company will not be responsible for any
damage/injuries/complications caused to user or patient due to the use of unsafe, non-approved
electrosurgical accessories.

6) Company is not responsible for any damage/ complications to patient or user due to use any
equipment which has not been maintained & calibrated periodically as described in
user/instruction manual.

7) The equipment maintenance has to be done by a Company trained & qualified

technician/engineer. Company is not responsible for any kind of losses to equipment/ patient/ user
caused due to the incorrect operation/ maintenance of the equipment by an unauthorized/
untrained person.

8) Consumables/ accessories have to be used as per the instructions given in the accompanying
documents. Use of expired or re-used accessories beyond the lifecycle may lead to
injury/damage/complication to patient or user. Company will not be responsible for such
injury/damage/complications.

9) The equipment’s warranty is in lieu of all other warranties, expressed or implied, including
without limitations, the warranties of merchantability and fitness for a particular purpose, and of
all other obligations or liabilities on the part of the Company. Company neither assumes nor
authorizes any other person to assume for any other liability in connection with the sale or use of
any of the Company products.

10) Notwithstanding any other provision herein or in any other document or communication,
Company’s liability of products sold hereunder shall be limited to the aggregate purchase price
for the goods sold by Company to the customer. There are no warranties which extend beyond the
terms hereof. Company disclaims any liability hereunder or elsewhere in connection with the sale
of this product, for indirect or consequential damages.

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