Steris gi4000 Operating instructions

gi4000 Electrosurgical Unit
Reference / Reorder No.
G1110001
User and Maintenance Manual

Issue Date: January 2020
Patent U.S. No. 8,083,735B2
An issued or revision date for these instructions is included for the user’s information. STERIS Endoscopy reserves
the right to makes changes to specifications shown herein without notice or obligation.
In the event that two (2) years have elapsed between this date and product use, please contact STERIS Endoscopy
to determine if additional information is available.
Unless otherwise indicated, all marks denoted with ® or ™ are registered with the U.S. Patent and Trademark
Office, or trademarks owned by STERIS Corporation.
US Endoscopy is a wholly owned subsidiary of STERIS Corporation.
Serious incidents that have occurred in relation to this medical device should be reported to the manufacturer and
competent authority in the country where the incident occurred.

TABLE OF CONTENTS
Scope...................................................................................................................................1
Indications for Use ...............................................................................................................1
Contraindications.................................................................................................................1
Definitions ...........................................................................................................................2
Explanation of Symbols ........................................................................................................3
Information for Safety..........................................................................................................8
6.1 Warnings..........................................................................................................................9
6.2 Precautions....................................................................................................................19
6.3 Notes..............................................................................................................................22
7.0 Overview of General Features.............................................................................................23
7.1 gi4000 Electrosurgical Unit............................................................................................23
7.1.1 Front Panel ........................................................................................................24
7.1.2 LED Indicator Lights ..........................................................................................25
7.1.3 Pad Safe System (PSS).......................................................................................26
7.1.4 Touchscreen ......................................................................................................28
7.1.5 Standby Mode ...................................................................................................29
7.1.6 Argon Gas System..............................................................................................30
7.1.7 Footswitch .........................................................................................................31
7.1.8 Back Panel..........................................................................................................32
7.1.9 Bottom Panel.....................................................................................................33
7.2 GoCart Mobile Cart........................................................................................................34
8.0 Technical Specifications......................................................................................................35
8.1 General ..........................................................................................................................35
8.2 Classifications ................................................................................................................35
8.3 Dimensions and Weight.................................................................................................36
8.4 Environmental Operating Parameters...........................................................................36
8.5 Environmental Transport and Storage Parameters.......................................................36
8.6 Audio..............................................................................................................................37
8.7 Input Power ...................................................................................................................37
8.8 Output Power ................................................................................................................38
8.9 Duty Cycle......................................................................................................................39
8.10 Leakage..........................................................................................................................39

8.11 Output Power vs. Resistance Graphs............................................................................ 39
8.11.1 Monopolar Cut Mode........................................................................................ 40
8.11.2 Monopolar Pulse Cut Mode .............................................................................. 41
8.11.3 Monopolar Blend Cut Mode.............................................................................. 42
8.11.4 Monopolar Pulse Blend Cut Mode.................................................................... 43
8.11.5 Monopolar Blend Coag Mode........................................................................... 44
8.11.6 Monopolar Coag Mode ..................................................................................... 45
8.11.7 Monopolar TouchSoft® Mode........................................................................... 46
8.11.8 Monopolar Argon Method................................................................................ 47
8.11.9 Bipolar Method ................................................................................................. 48
8.12 Standards on Electromagnetic Compatibility (EMC)..................................................... 49
9.0 System Installation and Setup.............................................................................................54
9.1 Unpacking the gi4000 ESU ............................................................................................ 54
9.2 Installation - gi4000 ESU .............................................................................................. 54
9.3 Installation - GoCart Mobile Cart .................................................................................. 56
9.4 Setup - Argon Gas System............................................................................................. 57
9.4.1 Argon Gas Bottle Indicator Icons ..................................................................... 57
9.4.2 Installing Argon Gas Bottle................................................................................ 58
9.4.3 Replacing Empty Argon Gas Bottle ................................................................... 59
9.5 Setup - Lavage Pump..................................................................................................... 60
10.0 Using the gi4000 ..............................................................................................................62
10.1 Pre-Procedural Setup.................................................................................................... 62
10.1.1 Power ON Self-Test (POST)............................................................................. 62
10.1.2 Lavage Function.............................................................................................. 64
10.2 Procedural Use.............................................................................................................. 66
10.2.1 Power Settings................................................................................................ 66
10.2.2 Tap-a-Tool™ Software .................................................................................... 67
10.2.3 Warning and Information System .................................................................. 68
10.2.4 Monopolar Method........................................................................................ 68
10.2.5 Bipolar Method............................................................................................... 70
10.2.6 Argon Method ................................................................................................ 71
10.2.7 Using the GoCart Mobile Cart ........................................................................ 72
10.3 Post-Procedural Shut Down.......................................................................................... 73
10.3.1 Disconnecting Accessories.............................................................................. 73

10.3.2 Care, Cleaning and Storage..............................................................................73
11.0 Recommended Accessories...............................................................................................75
11.1 APC Instruments............................................................................................................75
11.2 Neutral Electrodes...........................................................................................................75
11.3 Monopolar and Bipolar Accessories................................................................................75
11.4 Argon Gas Bottle .............................................................................................................76
11.5 Irrigation Tubing..............................................................................................................76
11.6 Footswitch.......................................................................................................................76
12.0 Troubleshooting ................................................................................................................77
12.1 On-Screen Notifications.................................................................................................77
12.2 Troubleshooting ............................................................................................................81
13.0 Maintenance and Repair...................................................................................................83
13.1 Periodic Inspection ........................................................................................................84
13.2 Preventative Maintenance Testing................................................................................84
13.2.1 Device Inspection Procedure ..........................................................................85
13.2.2 Electrical Safety Test Procedure .....................................................................86
13.2.3 RF Output Test Procedure...............................................................................99
13.2.4 Internal Argon Gas Filter Replacement.........................................................104
13.3 Service Menu...............................................................................................................106
13.3.1 Accessing Service Menu................................................................................106
13.3.2 Factory Default Power Settings ....................................................................107
13.4 Pump Head Replacement.............................................................................................108
13.5 Fuse Replacement .......................................................................................................109
13.6 Service Parts ................................................................................................................110
13.7 Equipment Disposal .......................................................................................................110

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00732467 Rev. D Page 1of 110
Scope
This manual describes the installation, use and maintenance of the following equipment and
accessories:
▪gi4000 Electrosurgical Unit
▪ArConnect® argon probe connector
▪gi4000 Argon Gas Bottle
▪GoCart Mobile Cart
Indications for Use
The gi4000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform
cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible
endoscopic applications. The integrated lavage pump is intended to wash tissue or mucosa
within the gut when used in conjunction with washing catheters or bipolar endoscopic probes,
endoscope water jet channels, or endoscope working channels.
The ArConnect® argon probe connector is intended for use with the gi4000 ESU during argon
assisted coagulation.
Contraindications
The gi4000 electrosurgical unit has no known contraindications.

00732467 Rev. D Page 2of 110
Definitions
APC
Argon Plasma Coagulation
CQM
Contact Quality Monitoring
ESA
Electrical Safety Analyzer
ESU
Electrosurgical Unit
IFU
Instructions For Use
LCD
Liquid Crystal Display
LED
Light Emitting Diode
LF
Low Frequency
MR
Magnetic Resonance
POST
Power On Self-Test
PSS
Pad Safe System
RF
Radiofrequency

00732467 Rev. D Page 3of 110
Explanation of Symbols
Table 5-1 contains symbols which may appear on the gi4000 ESU, gi4000 ESU Footswitch,
gi4000 Argon Gas Bottle and GoCart Mobile Cart.
Table 5-1
SDO (if applicable)
Symbol and
Reference Number
Title of Symbol
Meaning of Symbol
ISO 15223-1 Medical
Devices –Symbols to be
used with Medical Device
Labels, Labelling, and
Information to be Supplied
5.1.1
Manufacturer
Indicates the device
manufacturer.
5.1.2
Authorized Representative in the European Community
5.1.3
Date of Manufacture
Indicates the date when the
medical device was
manufactured.
5.1.4
Use By
Indicates the date after which
the medical device is not to
be used.
5.1.5
Batch Code
Indicates the manufacturer’s
batch code.
5.1.6
Catalog Number
Indicates the manufacturer’s
catalogue number.
5.1.7
Serial Number
Indicates the manufacturer’s
serial number.
5.2.7
Non-Sterile
Indicates a medical device
that has not been sterilized.
5.2.8
Do not use if Package is
Damaged
Do not use if the product
sterile barrier system or its
packaging is compromised.
5.3.7
Temperature Limitation
Indicates the temperature
limits to which the device can
be safely exposed.

00732467 Rev. D Page 4of 110
SDO (if applicable)
Symbol and
Reference Number
Title of Symbol
Meaning of Symbol
ISO 15223-1 Medical
Devices –Symbols to be
used with Medical Device
Labels, Labelling, and
Information to be Supplied
(ctd.)
5.3.8
Humidity Limitation
Indicates the range of
humidity to which the device
can be safely exposed.
5.3.9
Atmospheric Pressure
Limitation
Indicates the range of
atmospheric pressure to
which the device can be
safely exposed.
5.4.4
Caution
Consult instructions for use
for cautionary information.
21 CFR 801.109 (b)(1)
N/A
Rx Only (U.S.A)
Caution: Federal law (U.S.A.) restricts this device to sale or
on the order of a physician.
ISO 7000 Graphical
Symbols for Use on
Equipment –Registered
Symbols
1135
General Symbol for
Recovery/Recyclable
Indicates that the marked
item is part of a recovery or
recycling process.
ISO 7010 Graphical
Symbols –Safety Colours
and Safety Signs –
Registered Safety Signs
M002
Follow Instructions for Use
Refer to instruction
manual/booklet.
W012
Warning –Electricity
Use caution to avoid coming
into contact with electricity
when working with high
voltage terminals.
IEC 60417 Graphical
Symbols for Use on
Equipment
5007
Power “ON”
Indicates the position of the
mains switch which connects
the equipment to the mains.
5008
Power “OFF”
Indicates the position of the
mains switch which
disconnects the equipment
from the mains.
5016
Fuse
Indicates the location of the
fuse box and fuse type/rating
for replacement.
5021
Equipotentiality
Indicates the terminals which,
when connected together,
bring various parts of the
equipment/system to the
same potential.
5032
Alternating Current
Indicates that the equipment
is suitable for alternating
current only.

00732467 Rev. D Page 5of 110
SDO (if applicable)
Symbol and
Reference Number
Title of Symbol
Meaning of Symbol
IEC 60417 Graphical
Symbols for Use on
Equipment (ctd.)
5036
Dangerous Voltage
Indicates part(s) of the
equipment which emit
dangerous voltages while
energized.
5114
Footswitch Connection
Indicates the receptacle by
means of which the
footswitch is connected to the
equipment. This receptacle
is ONLY compatible with the
gi4000 ESU footswitch.
5140
Non-Ionizing
Electromagnetic Radiation
Indicates the equipment
intentionally applies RF
electromagnetic energy for
diagnosis or treatment.
5334
Defibrillation-Proof Type
CF Applied Part
Indicates a defibrillation-proof
type CF applied part
complying with
IEC 60601-1. All HF
receptacles and the PSS
receptacle (applied parts)
meet Type CF requirements
and are protected against the
effects of defibrillator
discharge.
IEC 60601-2-2 Medical
Electrical Equipment –Part
2-2: Particular
Requirements for the Basic
Safety and Essential
Performance of High
Frequency Surgical
Equipment and High
Frequency Surgical
Accessories
201.7.2.10
Generator output is floating
(isolated) with respect to
ground.
The patient circuit is isolated
from ground, reducing the
risk of leakage currents to the
patient.
49 CFR § 172.415
N/A
Non-Flammable Gas
29 CFR §
1910.1200.C.4.18
N/A
Gases Under Pressure
European Directive
2012/19/EC Waste
Electrical and Electronic
Equipment
N/A
Waste Electrical and
Electronic Equipment
Do not dispose of electronic
products in the general waste
stream.

00732467 Rev. D Page 6of 110
SDO (if applicable)
Symbol and
Reference Number
Title of Symbol
Meaning of Symbol
N/A
N/A
Unique Device Identifier
Indicates the device unique
device identifier.
N/A
N/A
Medical Device
Indicates the product is a
medical device.
N/A
N/A
Contents
Indicates the number of
devices/kits within the
packaging.
N/A
N/A
Return Electrode
Receptacle
Indicates the receptacle by
means of which the patient
return electrode is connected
to the equipment.
N/A
N/A
ArConnect® Receptacle
Indicates the receptacle by
means of which the
ArConnect® argon probe
connector is connected to the
equipment.
N/A
N/A
Monopolar Receptacle
Indicates the receptacle by
means of which an 8-mm
monopolar active cord is
connected to the equipment.
N/A
N/A
Bipolar Receptacle
Indicates the receptacle by
means of which a bipolar
device with a co-axial style
plug is connected to the
equipment.
N/A
N/A
Decrease Water Flow
Indicates the switch by
means of which the water
flow rate output of the
irrigation pump is decreased.
N/A
N/A
Increase Water Flow
Indicates the switch by
means of which the water
flow rate output of the
irrigation pump is increased.
N/A
N/A
Caution - No Hands Near
Moving Parts
When opening and closing
the pump head, use caution
to avoid coming into contact
with moving parts.
N/A
N/A
Direction of Rotation,
Counter-Clockwise
Indicates the direction in
which the pump head is
rotating.

00732467 Rev. D Page 7of 110
SDO (if applicable)
Symbol and
Reference Number
Title of Symbol
Meaning of Symbol
N/A
N/A
Tubing Inner Diameter
Indicates inner diameter
measurement (in mm).
N/A
N/A
Tubing Wall Thickness
Indicates wall thickness
measurement (in mm).
N/A
N/A
Standby
Indicates the switch(es) by
means of which the
monopolar and bipolar
equipment outputs are
brought into a stand-by
(inactive) condition.
N/A
N/A
Power ON/OFF Pedal
Indicates the pedal by means
of which the monopolar and
bipolar outputs are activated.
N/A
N/A
Irrigation Pedal
Indicates the pedal by means
of which the irrigation pump
output is activated.
N/A
N/A
Note
Indicates an operating tip or
general information useful for
operating or servicing the
equipment.
N/A
N/A
Standards Compliance
This certification symbol on
the gi4000 ESU indicates it is
listed by Intertek Testing
Services as meeting the
requirements of AAMI/ES/IEC
60601-1, IEC 60601-1-2, IEC
60601-1-6, IEC 60601-2-2,
CAN/CSA C22.2 No.
60601-1.
ASTM F2503 Standard
Practice for Marking
Medical Devices and Other
Items for Safety in the
Magnetic Resonance
Environment
N/A
MR Unsafe
Indicates this device has not
been tested for MR
compatibility and should not
be introduced into the MR
scanner room.

00732467 Rev. D Page 8of 110
Information for Safety
The following Warnings and Precautions must be observed when installing, operating or
performing maintenance on the gi4000 Electrosurgical Unit and Accessories.
For emphasis, certain warnings and precautions are repeated throughout this manual. It is
important to review ALL warnings and precautions before operating or servicing this
equipment. Strictly following these warnings and precautions enhances your ability to safely
and effectively use the equipment and helps to avoid improper maintenance methods which
may damage the equipment or render it unsafe. It is important to understand that these
warnings and precautions are not exhaustive; customers are encouragedto develop their own
safety policies and procedures to enhance and complement these warnings and precautions.
DANGER
Indicates an imminently hazardous situation which, if not
avoided, could result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury.
NOTE
Indicates an operating tip or general information useful for
operating or servicing the equipment.

00732467 Rev. D Page 9of 110
6.1 Warnings
WARNING: Personal Injury and/or Equipment Damage Hazard. The instructions
provided in this manual MUST be followed, otherwise, compromised safety, equipment
malfunction, injury to the user and/or patient, or costly damage to the unit and/or other
equipment may occur.
WARNING: Hazardous Electrical Output. Electrosurgical units are generators of high
frequency (radiofrequency) electric energy potentially involving high current intensity and
high voltage for their intended use. To prevent hazards for the patients, users, and third
persons, be sure to use this method properly and with great care, strictly following the
operating and safety instructions provided. All safety instructions apply as well to the
use of all accessories in combination with the gi4000 ESU.
WARNING: Endoscopic procedures should only be performed by persons having
adequate training and familiarity with endoscopic techniques.
WARNING: Consult the medical literature relative to complications, hazards, and
techniques of endoscopy and electrosurgery prior to the performance of any endoscopic
procedure.
WARNING: A thorough understanding of the technical principles of endoscopic
electrosurgery is necessary before using these devices.
WARNING: Hazardous Electrical Output. DO NOT use electrosurgical equipment
unless trained to use it properly in accordance with this Manual. Use of this equipment
without such training can result in serious patient injury or death or damage to equipment
or property.
→Read ALL sections of this manual carefully BEFORE using the gi4000 ESU,
such that safety requirements and unit operation are understood. If you
should have any questions, please contact STERIS Customer Service at
1-800-769-8226 or your local STERIS Endoscopy Electrosurgery
Specialist.
WARNING: Tipping Hazard. Move cart slowly and apply moving force on narrow
dimension. Never apply force at top; always push near middle utilizing the cart handles.
Push do not pull. Disengage brakes prior to moving the cart. Cart can tip over, resulting
in risk of operator injury and/or equipment damage.
WARNING: Tipping Hazard. The total loading capacity of the GoCart Mobile Cart is
132 lb. (60 kg). Never overload the cart. Position heavier items toward the bottom of the
cart for optimum stability. Overloading may cause shelf damage or instability resulting
in user injury and/or equipment damage.

00732467 Rev. D Page 10 of 110
WARNING: Tipping Hazard. The GoCart Mobile Cart is designed for use with the
gi4000 ESU ONLY. Use with non-compatible equipment may cause instability resulting
in user injury and/or equipment damage.
WARNING: Tripping Hazard. Route the power cord to the receptacle to minimize
tripping hazards for personnel in the area of use.
WARNING: Reciprocal Interference Hazard. Care must be taken when operating
this equipment around other equipment to avoid reciprocal interference. Potential
electromagnetic or other interference could occur to this or to the other equipment.
The gi4000 ESU intentionally uses RF energy for treatment during activation. The
user should observe other equipment being used in the vicinity of the gi4000 ESU
for adverse electromagnetic effects.
WARNING: Interference Hazard. The gi4000 ESU has been designed to comply with
electromagnetic safety standards. This equipment generates, uses, and can radiate
radio frequency energy and, if not installed and used in accordance with the instructions
listed in this manual, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular installation.
Harmful interference to other devices can be determined by turning this equipment ON
and OFF. When doing so, observe the equipment in the installation area for abnormal
behavior. Try to correct the interference using one or more of the following:
→Reorient or relocate the receiving device.
→Increase the separation between the gi4000 ESU and other electrical
equipment.
→Connect the gi4000 ESU to a receptacle on a different circuit from that to
which the other device(s) are connected.
WARNING: Personal Injury and/or Equipment Damage Hazard. Check the
equipment and accessories each time before using them. Use of damaged equipment
and / or accessories or use of modified equipment and / or accessories may result in
serious burns or injury to the patient and / or user or equipment damage or malfunction.
→Replace damaged or defective accessories immediately.
→If your equipment or accessories are damaged, please contact STERIS
Customer Service at 1-800-769-8226 or your local STERIS
Endoscopy Electrosurgery Specialist for a repair or replacement.
WARNING: Electric Shock Hazard. Risk of electrical shock and other injuries to the
patient and user may occur because of improper electrical input parameters and / or the
use of a non-compatible power cord. Reference section 8.0 Technical Specifications.
for manufacturer specified input parameter requirements.
→The mains power supply voltage and frequency MUST match the input
voltage and frequency specified on the rear panel of the equipment.

00732467 Rev. D Page 11 of 110
WARNING: Personal Injury or Equipment Damage Hazard. The power cord is used
as a means of disconnection. The power cord MUST remain accessible in case it
becomes necessary to remove mains power from the gi4000 ESU in an emergency
situation. To safely remove mains power from the device, disconnect the power cord
from the wall mains power supply receptacle.
→If using the optional mobile cart, DO NOT position the GoCart Mobile Cart
so that access to the power cord is obstructed.
WARNING: Personal Injury Hazard. Any attempt to operate the gi4000 ESU with any
gas source other than the gi4000 Argon Gas Bottle, or to attach argon probe accessories
to the gi4000 ESU in any way other than by the use of the ArConnect®argon probe
connector may pose a serious hazard to patients and users.
WARNING: Pinch Point Hazard. When installing the gi4000 ESU on the GoCart Mobile
Cart, pinch points are created underneath the gi4000 ESU. Watch hands and fingers
when placing the gi4000 ESU on the mobile cart plate.
WARNING: Personal Injury and/or Equipment Malfunction. DO NOT wrap accessory
cords or cables or patient electrode cables around metal GoCart Mobile Cart handles.
This may induce currents that could lead to shock, fire, or injury to the patient or user.
WARNING: Electric Shock Hazard. To avoid the risk of electrical shock and damage to
property, the gi4000 ESU power cord must ONLY be connected to a properly grounded
power supply mains receptacle with a protective earth.
→Use ONLY the STERIS Endoscopy power cord with the gi4000 ESU.
STERIS Endoscopy recommends connecting the power plug of the
power cord directly to a hospital grade grounded wall outlet (green dot)
or to a multiple power socket outlet equipped with an isolation transformer
of medical grade, conforming to IEC 60601-1. In this case, observe the
maximum permitted current or power loading of the multiple power socket
outlet and the isolation transformer. Failure to do so could render the
device inoperable or electromagnetic or other interference may occur
between the gi4000 and other electronic devices.
→DO NOT use power plug adaptors. Use of power plug adaptors may
result in electric shock for the user.
→DO NOT use an extension cord. Use of an extension cord may result in
an electrical fire.
DANGER: Explosion Hazard. DO NOT use electrosurgery in the presence of
flammable anesthetics or in the gut in the presence of explosive mixtures of endogenous
gases. Use under these conditions may result in serious patient or user injury or death
or damage to equipment or property. In electrosurgery, electric sparks and arcs may
occur during the use of electrosurgical accessories. Flammable gases, vapors and
liquids can catch fire or explode.
→Avoid the accumulation of naturally occurring flammable gases in body
cavities that may be ignited by sparks produced during normal use of the
gi4000 ESU.

00732467 Rev. D Page 12 of 110
WARNING: Dispersive Electrode. Safe electrosurgery requires the proper placement
of the patient dispersive electrode. Consult the dispersive electrode manufacturer’s
Instructions for Use for information regarding proper use of the patient dispersive
electrode. Failure to place the patient dispersive electrode correctly may result in
electrosurgical burns at the patient dispersive electrode site.
→DO NOT cut a patient dispersive electrode to reduce its size as this may
result in patient burns due to high current density in the smaller patient
dispersive electrode.
→Place dispersive electrodes in the most suitable position that is closest to
the operating site.
→Choose a site that is muscular and well vascularized.
→NEVER attach the dispersive electrode over implants, metal, bony
protuberances, broken skin or scar tissue. Circumstances may require the
skin to be cleaned and / or shaved to get even contact.
→Use ONLY fresh disposable dispersive electrodes as conductive gels may
dry out over time impacting function which may result in the dispersive
electrode disconnecting from the patient during use.
→If reusable dispersive electrode cables are used, be sure they are properly
attached. Be sure that the attachment clip covers the gel free connecting
lugs or tabs so that they do not contact the patient’s skin.
→Ensure the patient dispersive electrode makes complete contact with the
patient’s skin. The user should continuously check the patient dispersive
electrode throughout the procedure and during the procedure if the patient
is repositioned, is in a deep anesthetic sleep, or during procedures involving
long periods of electrosurgery activation.
WARNING: Radiofrequency (RF) Current Leakage. RF leakage current can be
discharged unintentionally through points of contact with grounded metal objects such
as the patient operating table or bed rails which may result in patient alternate site burns.
When using the gi4000 ESU, ensure the active accessories and patient/user are not
contacting grounded metal objects. If necessary, place dry gauze between the patient
and the grounded metal object and continually monitor potential contact points.
WARNING: RF Current Leakage. RF leakage current can be discharged unintentionally
through points of contact between patient’s skin and patient cardiac monitoring resulting
in a patient alternate site burn.
→DO NOT use needle electrodes during electrosurgery.
→Patient cardiac monitoring electrodes should be placed as far away from the
location the active accessory is being used as possible.

00732467 Rev. D Page 13 of 110
WARNING: RF Current Leakage. RF current can be discharged unintentionally through
points of contact between patient’s skin, such as their abdomen and arm. This may
result in a patient alternate site burn.
→Patient skin to skin contact points should be kept dry and/or separated
with dry gauze or dry toweling.
WARNING: Malfunction of Cardiac Pacemaker and Other Active Implants.
Interference produced by the use of electrosurgical devices can cause a pacemaker or
other active implant to enter an asynchronous mode or can block or interfere with the
implant’s effect. Prior to use of the gi4000 ESU on patients with cardiac pacemakers,
consult the pacemaker manufacturer or a cardiac specialist for further information.
WARNING: Leakage Current via Other Medical Electrical Equipment. If the gi4000
ESU and physiological monitoring equipment are to be simultaneously used on a patient,
ONLY monitoring systems that incorporate high frequency current-limiting devices (i.e.
ECG monitors whose connecting cables incorporate protective resistors or RF chokes)
are recommended to reduce interference with the monitoring devices.
→Monitoring electrodes should be placed as far as possible from the surgical
electrodes.
→Needle monitoring electrodes are NOT recommended.
WARNING: Burn Hazard. Position the patient monitoring leads in such a way that
contact with the patient or other leads is avoided because the capacitance between the
electrode cable and the patient may result in some local high current densities causing
thermal burns to the patient.
→Needle monitoring electrodes are not recommended as their small surfaces
allow for high current density.
→Keep the active electrode at least 15 cm (6 inches) away from any
monitoring electrode.
→DO NOT place the active cord or other equipment cables on the patient.
→DO NOT allow the monopolar active cord or the cord to the patient
dispersive electrode to lie alongside, or be entwined with, the cables to the
monitoring electrodes.
WARNING: Interference Hazard. DO NOT place dispersive electrode cables, active
cords or other electrosurgical accessory cables near cables leading to or from cardiac
or other patient monitoring equipment. DO NOT bundle cables or cords with cables or
cords from other electrical equipment as it may result in interference.
WARNING: Capacitive Coupling Hazard. Wrapping electrosurgical instrument cords
around metal objects can generate currents (capacitive coupling) which may lead to
electrical shock to the patient or user or fire. Route these cords so they are free from
contact with metal objects.
WARNING: Electrical Shock Hazard. Follow the instructions for use provided with the
electrosurgical accessories for proper connection to the electrosurgical generator. Prior
to use, ensure all accessories are properly connected to their receptacles and that no
metal components of the accessories are exposed as this may result in injury to the
patient or user.

00732467 Rev. D Page 14 of 110
WARNING: Incompatible Accessory Hazard. The output receptacles of the gi4000
ESU are designed to accept a single type of electrosurgical instrument at a time.
Reference the Instructions for Use provided by the instrument manufacturer for proper
connection and use of the instrument with the electrosurgical system.
WARNING: Personal Injury or Equipment Damage Hazard. Use the gi4000 ESU
ONLY if the Power ON Self-Test (POST) has been successful, otherwise inaccurate
power outputs may result in serious patient or user injury or damage to equipment.
→If the display fails, the gi4000 ESU can no longer be operated safely. If the
touchscreen is non-responsive or no longer visible, immediately stop using
the equipment and contact STERIS Customer Service at 1-800-769-8226
or your local STERIS Endoscopy Electrosurgery Specialist for a repair or
replacement.
WARNING: Electrical Shock Hazard. Electrosurgical accessories should only be
connected to the gi4000 ESU when output energy is OFF. Failure to turn energy off may
result in electrical shock the patient and / or user. When connecting accessories, it is
recommended the system be placed in STANDBY MODE.
WARNING: Alternate Site Burn and / or Shock Hazard. DO NOT place active portions
of accessories in contact with grounded patients as a burn may result if the unit is
inadvertently activated when not in Standby Mode.
→DO NOT activate the gi4000 ESU in open circuit conditions.
→Activate ONLY when the active accessory is in view and near or touching
target tissue.
→DO NOT use worn or ill-fitting active cords, dispersive electrode cables or
connector adapters as shock or burn can occur.
→DO NOT leave the active accessory in the patient when not in use.
WARNING: Burn Hazard. The user should assess the condition of the patient and use
clinical judgement to set the appropriate electrosurgical settings to avoid patient injury.
Use the lowest output setting necessary to achieve desired clinical effect.
→The higher the electrical output power that is applied, the greater the
hazards posed by electrosurgery. Always use the lowest power setting that
achieves the desired surgical effect.
→Certain devices or accessories may present an unacceptable risk at low
power settings. For example, when using argon beam coagulation, the risk
of gas embolism rises if there is insufficient RF power to produce a rapid,
impermeable eschar on the target tissue.
→The temperature at the patient dispersive electrode application site may
increase during long, continuous activations. Ensure there is sufficient
cooling phases between activations to prevent temperature build-up at the
dispersive electrode.
WARNING: Neuromuscular Stimulation Hazard. The use of modes that produce an
electrical arc between the active accessory and patient tissue may result in
neuromuscular stimulation. Use the lowest output setting necessary to achieve desired
clinical effect.