NeuWave Medical Certus 140 Assembly instructions

2.45 GHz Ablation System
User Reference Manual
Software Version 3.0.X

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User Responsibility
This Product will perform in conformity with the description thereof contained in this User’s
Reference manual and accompanying labels and/or inserts, when assembled, operated,
maintained, and repaired in accordance with the instructions provided. This Product must be
checked periodically. A defective Product should not be used. Parts that are broken, missing,
plainly worn, distorted, or contaminated should be replaced immediately. Should repair or
replacement become necessary, NeuWave Medical recommends that a written request or
request by phone for service advice be made to the nearest NeuWave Medical Customer
Service Center. This Product or any of its parts should not be repaired other than in accordance
with written instructions provided by NeuWave Medical and by NeuWave Medical trained
personnel. The Product must not be altered without the prior written approval of NeuWave
Medical. The user of this Product shall have the sole responsibility for any malfunction which
results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone
other than NeuWave Medical.
Certus 140 Ablation Probes are provided sterile. Follow facility procedures for sterile
device handling.
CAUTION U.S. Federal law restricts this device to sale by or on the order of
a physician. Outside the U.S.A., check local laws for any restrictions
that may apply.
NeuWave Medical products have unit serial numbers with coded logic which indicates a
product group code, the year of manufacture, and a sequential unit number for identication.
Serial Numbers are formatted in the following manner:
SN: NMYYZDDXXXXX
Where: NM is a two-digit code identifying NeuWave Medical as the manufacturer and YY is the
last two digits of the year of manufacture. Z is a one character code identifying the unit as new
(N) or remanufactured (R). DD indicates the product indicator and XXXXX is the sequential unit
number.
Certus 140 is a registered trademark of NeuWave Medical, Inc.
Other brand names or product names used in this manual are trademarks or registered
trademarks of their respective holders.
NeuWave’s systems, devices, software, and uses thereof are covered by one or more issued
patents and pending applications in the United States and foreign jurisdictions. U.S. Pat. No.
9,072,532 and pending applications in the United States and foreign jurisdictions cover energy
and coolant delivery with NeuWave’s Certus®system. U.S. Pat. No. 9,119,649 and pending
applications in the United States and foreign jurisdictions cover NeuWave’s Tissue-LocTM
technology. U.S. Pat. No. 9,192,438 and pending applications in the United States and foreign
jurisdictions cover NeuWave’s Precision Probes. U.S. Pat. No. 7,101,369, licensed exclusively
from the Wisconsin Alumni Research Association (WARF), and pending applications in the
United States and foreign jurisdictions cover NeuWave’s LN, LK and SR Ablation Probes.
Company Contact Information
NeuWave Medical Customer/Technical Service 877-323-WAVE (9283)
NeuWave Medical, Inc.
3529 Anderson Street
Madison, WI 53704 USA
www.neuwave.com - click on “Contact Us”

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Table of Contents
Chapter 1 Introduction ..........................................................................................................1-1
What is a Certus 140™ Ablation System?...............................................................1-1
Indications For Use Statement ................................................................................1-2
Using this manual ...................................................................................................1-2
Symbols used in manual or on equipment...............................................................1-3
Chapter 2 Warnings and Cautions .......................................................................................2-1
Chapter 3 System Overview and Setup...............................................................................3-1
System Display .......................................................................................................3-1
System Cart............................................................................................................ 3-2
USB Port ................................................................................................................3-3
PDM/Cable Assemblies ..........................................................................................3-3
Connecting PDM to the System Cart ...................................................................... 3-4
Connecting PDM to a Rail Mount............................................................................3-6
Installing a NeuWave Medical CT Rail Mount...........................................................3-6
Installing a NeuWave Medical Bed Rail Mount.........................................................3-7
Connecting AC Power ............................................................................................3-9
Cooling System Connections ................................................................................3-10
CO2Cylinder Management Tips............................................................................ 3-16
Connecting the Footswitch ...................................................................................3-17
Positioning the System for Use .............................................................................3-18
Turning System On ...............................................................................................3-19
General User Interface Features ............................................................................3-20
CO2Cooling System Icons.................................................................................... 3-21
Report Tab............................................................................................................3-22
Tools Tab .............................................................................................................. 3-24
Chapter 4 Ablation and Surgical System Use .....................................................................4-1
Tab Selection and Layout........................................................................................4-1
Ablation Probes ......................................................................................................4-4
Using Ablation Mode/Percutaneous Applications .................................................. 4-13
Using Surgical Mode.............................................................................................4-20
Planar Coagulation Technique ............................................................................... 4-25

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Chapter 5 After a Procedure.................................................................................................5-1
End Procedure........................................................................................................ 5-1
Turning the System Off............................................................................................5-1
Probe Disposal .......................................................................................................5-1
AC Power Cord.......................................................................................................5-1
Positioning System Display for Transport/Storage ...................................................5-1
Disconnecting CO2Cylinders ..................................................................................5-2
PDM Disconnection and Storage ............................................................................ 5-4
Footswitch ..............................................................................................................5-4
Chapter 6 Cleaning and Maintenance .................................................................................6-1
Cart Cleaning.......................................................................................................... 6-1
User Maintenance................................................................................................... 6-1
Servicing................................................................................................................. 6-1
System Disposal .....................................................................................................6-2
Monitor Arm Adjustment ......................................................................................... 6-2
Chapter 7 Alarms and Troubleshooting...............................................................................7-1
System Messages...................................................................................................7-1
Chapter 8 Theory of Operations...........................................................................................8-1
System Overview ....................................................................................................8-1
Cooling System Overview .......................................................................................8-1
Triaxial Probe Design............................................................................................... 8-2
Chapter 9 Specications.......................................................................................................9-1
System Dimensions ................................................................................................9-1
Environmental Specications................................................................................... 9-1
Measurement Accuracy .......................................................................................... 9-1
Electrical Specications...........................................................................................9-2
Power Output Specications...................................................................................9-9
IEC 60601-1 Classications ....................................................................................9-9
IEC 60601-1-2 Specications ...............................................................................9-10
EMC Emissions Guidance.....................................................................................9-11
Electrical Diagram .................................................................................................9-14
Windows License.........................................................................................Windows License-1
Warranty Statement .............................................................................................................. W-1

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What is a Certus 140TM 2.45 GHz Ablation System?
Microwave energy refers to a specic subset of the radio frequency
(RF) spectrum operating between 300 MHz to 300 GHz. The
Certus 140 is a fully featured soft tissue ablation system that uses
small diameter ablation/surgical accessories, a single microwave
source with three (3) 140W microwave power ampliers operating
at 2.45 GHz, a CO2based cooling system and Power Distribution
Module or PDM. Microwave energy is applied to the target tissue,
heating the tissue to the point of necrosis.
One, easy to use, touch-screen user interface controls the system.
The User Interface can be set for either Ablation Mode or Surgical
Mode. An optional footswitch can be connected to the system to
control power delivery in Surgical Mode.
Microwave energy is delivered through three distinct channels. A
single system is capable of powering up to three energy delivery
accessories at one time. The cooling system helps limit the
temperature of the handle and cable.
The PDM is designed to minimize user set-up time, improve operator
and patient safety, and improve power delivery efciency. The
PDM interface utilizes connections that allow the user to connect
the power, electrical signals, and cooling lines of the Certus 140
energy delivery accessories in one simple step. In percutaneous
applications, the PDM can mount directly to the CT table and therefore can move with the CT table
during imaging. This allows the probe and probe cables to move with the patient, greatly reducing
the potential for patient injury due to accidental probe or probe cable movement. In open surgical
applications, the PDM can mount directly to the Certus 140 or to the surgical table. The PDM also
uses a larger, more efcient cable from the PDM to the power amplier. This increased efciency of
the larger cable enables more energy to be sent to the energy delivery accessory.
A variety of energy delivery accessories are available for use with the Certus 140. All are comprised
of a sharp trocar on the end of a cannula, a handle, a cable and a connector assembly.
Ablation probes include Models CertusLN, CertusLK, CertusSR and CertusPR.
Models CertusLK and CertusPR are available in 15 gauge and 17 gauge cannulas and in 15 cm and
20 cm lengths. These probes have a cable length of 1.4m.
Model CertusLN has a 17 gauge cannula and is available in 15 cm and 20 cm lengths. These probes
have a cable length of 1.4m.
1
Introduction

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Model CertusSR has a 13 gauge cannula and is available in a 25 cm length only. These probes have
a cable length of 1.4m.
The CertuSurgGT is a hand-held surgical tool and has a 6 cm, 17 gauge cannula and is designed
specically for surgical coagulation (including Planar Coagulation) in open surgical settings. The
CertuSurgGT has a nger-activated power delivery mechanism and a cable length of 2.9 m.
Each energy delivery accessory contains temperature measurement sensors that help monitor
performance and ensure patient and operator safety.
Additionally, the different percutaneous ablation probes have been designed to optimize the energy
transfer efciency from the probe into different types of tissue based on known electrical properties
of each tissue.
The CertuSurgGT is designed to produce focal, rapid coagulation of soft tissue in open surgical
applications, including planar coagulation performed prior to tissue resection.
The Certus 140 Ablation System also uses the CO2cooling system to control the cable and handle
temperatures and also to enable Tissu-Loc™. The Tissu-Loc feature is available on all Certus
ablation probes. It is not available with the CertuSurgGT. The Tissu-Loc feature produces a “stick”
function that lowers the temperature near the tip of the probe to temporarily adhere the probe to
tissue. This feature helps prevent the probe from moving once it has been placed in the desired
location.
The Certus 140 Ablation System can be used in either Ablation Mode or Surgical Mode. These
two modes deliver power the same way, but the user interface and workow in the two modes are
different and optimized for different applications.
• Ablation Mode is used for Target Ablation. Target ablation involves placing a probe into a
substantial target and then ablating for up to several minutes until the target tissue is necrotic.
This is done either percutaneously, via a laparoscopic port or in open surgical settings.
• Surgical Mode is used for Surgical Coagulation. Surgical Coagulation involves using an
energy delivery accessory to ablate/coagulate for shorter periods of time, while moving the
energy delivery accessory frequently. This is often done using the technique called “Planar
Coagulation” to create a plane of coagulated tissue in an organ prior to resection. Surgical
Mode can incorporate the use of a footswitch, which connects to the USB port next to the
System ON/OFF switch.
The Certus 140 Ablation System has several safety features which monitor system performance.
The Certus 140 Ablation System will automatically stop delivering energy to the patient in response
to system performance issues.
Indications For Use:
The NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories are indicated for
the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with
laparoscopic surgical settings.
The Certus 140 2.45 GHz Ablation System is not indicated for use in cardiac procedures. The
system is designed for facility use and should only be used under the orders of a physician.

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Using this manual
This manual uses text formatting to identify different aspects of the product and its use.
NOTE: This user manual covers the use of the Certus 140 with both ablation probes and surgical
tools. To reduce potential confusion, the term “Probe” is used throughout the manual to refer to
both ablation probes and surgical tools.
Warnings and Cautions tell about the dangerous conditions that can occur if the instructions in the
manual are not followed. Read and follow all warnings and cautions.
Warnings Warnings tell about a condition that can cause injury to the operator or the patient.
In the manual, the word WARNING is in all caps and bold text with additional
text indented. If more than one warning is listed in a row, the word warning is only
printed once.
Caution Cautions tell about a condition that can cause damage to the equipment. In the
manual, the word CAUTION is presented in italics and in all caps. If more than one
caution is listed in a row, the word caution is only printed once.
Important Important statements provide tips on device operation or settings. In the manual,
the word Important is presented in italic text.
Device Device commands are written in bold typeface, for example Ablate All.
Commands
Menu Menu Tabs on the system display are presented in bold, italic text. For example,
Tabs Procedure.
Messages Messages that appear on the system display are presented in single quotation
marks, for example, ‘Check Probe 1 connection at the PDM’.
Sections and When referring to different sections or headings in this manual, the text is presented
Headings in the color green, for example, System Controls and Menus.

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Symbols used in manual or on equipment
Symbols replace words on the equipment, on the display, or in NeuWave Medical manuals and
Instructions for Use. The following symbols appear on the Certus 140 system and accessories.
Manufacturer
Sterilized via H2O2Gas Plasma using
STERRAD equipment.
Sterilized using Ethylene Oxide Gas
The expiration date of the product.
A single-use product that should not
be reused.
Authorized representative in the
European Community.
System ON/OFF Switch
USB Port Connection
Type BF Equipment protection
against electric shock.
The serial number of the unit which
also identies the year in which the
product was manufactured. When
used, serial numbers are unique to a
specic unit.
The lot number of the item, unique
to a specic number of units
manufactured under identical
conditions.
Is the reference or part number of a
given item. REFs are identical for all
items of a given type.
Set caster brake before changing
CO2tanks.
Caution: Hot Surface
Device contains an RF Emitting
Source.
Refer to user manual.
Caution: Federal law in the US
restricts this device to sale by or on
the order of a physician.
Indicates that the waste of electrical
and electronic equipment must
not be disposed as unsorted
municipal waste and must be
collected separately. Please contact
an authorized representative
of NeuWave Medical for
decommissioning of equipment.
Device complies with the European
Medical Device Directive (MDD).
Device contains no natural rubber.
Reset settings to default power and
time settings.
A footswitch is connected to the
system and is active (system is in
Surgical Mode).
A footswitch is connected to the
system and is not active (system is in
Ablation Mode).
Indicates a reected power error has
occurred.
Press this icon to return to the
Tissue Selection screen. This icon
is not active when the system is
delivering power.
Use these buttons to increase or
decrease settings.
Denotes a procedure performed only
in Ablation Mode.
Denotes a procedure performed only
in Surgical Mode.
Denotes a procedure performed
using both Ablation and Surgical
Mode.
Press this icon to adjust the system
audio settings. This icon is not active
when the system is delivering power.

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Users should be familiar with all warnings and cautions prior to using the Certus 140 Ablation System.
The warnings and cautions listed in this chapter also appear in the relevant sections of the manual.
WARNINGS • NeuWave recommends against the use of the Certus 140 2.45 GHz
Ablation System in the following situations:
- Pregnant patients – potential risks to patient and/or fetus have not
been established.
- Patients with implantable pacemakers or other electronic implants.
Implanted electronic devices may be adversely affected by microwave
power.
- Use on the central nervous system.
• The Certus 140 Ablation System should only be used by physicians and
staff properly trained in the use of this technology and its associated
warning and cautions. Physicians should avail themselves of preclinical
training, a review of pertinent literature, and other appropriate education
before attempting to use the Certus 140 Ablation System.
• Use only one Certus 140 Ablation System at a time and never use
additional ablation systems in combination with the Certus 140 Ablation
System. Doing so may result in excess energy delivery to the patient.
• Do not operate the Certus 140 Ablation System near life-support
equipment that is sensitive to 2.45 GHz microwave energy.
• Electrosurgical/electrocautery devices may interfere with the Certus 140
and cause system errors. Ensure that all Certus 140 probes are removed
from the patient prior to using electrosurgical/electrocautery devices.
• Use only Certus 140 Ablation Probes from NeuWave Medical with the
Certus 140 Ablation System. Probes from other manufacturers may cause
patient injury or fail to function properly.
• Do not perform microwave procedures on patients with cardiac
pacemakers or other implanted electronic devices.
• Remove hearing aids and all metal jewelry from the patient prior to a
procedure. Ensure there are no metallic buttons, snaps, or other metallic
items in direct contact with the patient.
2
Warnings and Cautions

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WARNINGS • The Certus 140 Ablation System and accessories are NOT MRI compatible.
• Any part of the patient’s body containing metal implants should not be
treated with microwave energy unless specialized medical advice is
obtained.
• Do not direct the Certus 140 Ablation Probes toward the eyes or testes.
• When performing target ablation procedures, always use the lowest
power setting and shortest time that will achieve the intended results.
Refer to the Certus 140 Ablation Probe Instructions for Use for example
ablation sizes based on power and time settings.
• Use medical imaging devices to verify proper probe placement prior to
starting an ablation.
• Do not reuse or re-sterilize any product labeled “SINGLE USE”. Doing so
may result in cross-contamination, injury to the patient or medical staff, or
equipment malfunction.
• Connect only medical grade CO2cylinders to the Certus 140 Ablation
System. Connecting a different gas to the Certus 140 Ablation System
will result in system malfunction and may lead to patient and/or user
injury.
 • Nomodicationofthisequipmentbytheuserisauthorizedby
NeuWave Medical.
• Do not connect ablation probes directly to the back of the cart as
potential injury to the patient or user is possible.
• Use caution when adjusting the moveable display arm to avoid pinching
handsorngers.
• Do not attach any device to the USB port while delivering therapy.
The USB port is for the connection of approved accessories only,
including the footswitch. USB memory sticks may be connected to the
USB port when the system is not delivering power for the purposes of
removing/saving system information (i.e. procedure logs). Do not attach
any unapproved devices to the USB port as this may cause a device
malfunction.
• During initial set-up, inspect the system for any damage that may have
been caused during shipping and transportation. If damaged, do not use
or attempt to repair. Call NeuWave Medical for service assistance.
• Inspect the system before each use. If there is evidence of damage, do
not use the system. Call NeuWave Medical for service assistance.
• The Certus 140 Ablation System has no parts that can be serviced by the
user. To avoid electric shock, do not remove system covers or attempt
repairs.
• Electromagnetic interference (EMI) produced by the Certus 140 Ablation
System may adversely affect performance of other equipment during
normal operation. Precautions should be taken to ensure that the well
being of the patient is maintained in the event of such interference.
Increase the distance between the Certus 140 Ablation System and other
electronic equipment. Plug devices into separate branch circuit outlets.
Call NeuWave Medical for assistance.

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WARNINGS • When the Certus 140 Ablation System and physiological monitoring
equipment are used simultaneously on a patient, any monitoring
electrodes should be placed as far away as possible from the
ablation area.
• Heating associated with microwave power can provide an ignition
source.Observereprecautionsatalltimes.Avoidtheaccumulationof
ammablegasesthatmaycollectinbodycavitiessuchasthebowel.
Some materials, for example cotton, wool and gauze, when saturated
with oxygen may be ignited by sparks. When using microwave power
in the same room as any of these substances or gases, prevent their
accumulation under surgical drapes, or within the area where microwave
procedures are performed.
• Fire/Explosion Hazard: Verify that all oxygen circuit connections are
leak free before and during the use of microwave power. Verify that
endotracheal tubes are leak free and that the cuff is properly seated to
prevent oxygen leaks. Enriched oxygen atmosphere or the presence of
anyammable/oxidizinggasesandliquidsmayresultinresandburns
to the patient or medical team.
• A non-functioning system may cause an interruption in a procedure. A
back-up system should be available for use.
• Do not stack other equipment on the Certus 140 Ablation System.
 • KeepuidsawayfromtheCertus140AblationSystemandprevent
liquids from dripping or spilling onto the system during use and storage.
• Do not use two- or three-prong adapters with the system power cord.
The power cord assembly should be checked periodically for damaged
insulation or connectors. Do not use damaged cords.
• Reliable grounding can only be achieved when the equipment is plugged
into a receptacle marked “Hospital Grade.” Any interruption of the
Protective Earth conductor will result in a potential shock hazard, which
could cause injury to patient or operator.
• Do not use extension cords.
 • Certus140AblationSystemcomponents(microwavepowerampliers,
PDM, probes and other accessories) are designed to be used as a single
unit. Failure to understand and follow instructions provided may result in
improper functioning of the system and cause injury to the patient or user.
• Intraprocedure and/or post ablation imaging are recommended to assess
the extent of tissue coagulation.
• Always inspect probes and cables for chips, cracks, or other damage
before each use. Do not use damaged probes.
• Donotdebrillateapatientwithaprobeinserted.Completelyremovethe
probefromthepatientbeforedebrillation.
• Do not obstruct the system display or speakers providing activation
tones. These are important safety features that must be visible and
audible at all times.

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WARNINGS • Ensure the radiating section of the probe is always fully inserted into
tissuetopreventelongatedwaveformeldsthatcancauseunintended
thermal energy delivery to the user or patient. The characteristics of
microwaveeldsdifferbasedonthepermittivityofthelocalenvironment
around the radiating section of the probe.
• Energy delivery will automatically cease if a serious error is detected by
the system. If this occurs, follow instructions on the display.
• The CO2cooling system does exhaust CO2into the procedure room.
Ensure that the procedure room has adequate ventilation/room air
exchanges.
• Prior to moving patient into a CT imager, ensure the placed probes have
sufcientclearancefromtheCTbore.Patientinjurycanresultiftheprobe
handles contact the CT bore while moving the patient in and out of the CT
scanner.
• Do not place probes so that the probe cables are draped on or near the
patient’s head or neck.
 • Priortostartingtheablation,useimagingtoconrmproperprobe
placement and that the probe is not bent or broken.
• In the event of a display failure, use the System ON/OFF switch to turn
the system OFF. Discontinue use of the system until repair services are
obtained.
• Do not attempt to remove an ablation probe from the PDM while the
probe is active.
• Failure of the Certus 140 Ablation System may lead to an unintended
increase in output power.
• Do not use damaged probes, probes whose sterile barrier is suspect or
probes beyond the expiration date noted on the packaging.
• Examine each probe prior to use. Do not use probes with obvious visual
damage. Injury to the user or patient may occur.
• Do not attempt to bend or reshape probes as they may malfunction when
attached to the Certus 140 Ablation System.
• Probes are provided sterilized. Follow your facility sterile handling
guidelines.
• Probe tips are sharp. Handle with care.
• Do not use any probes that fail to pass the system test or show evidence
of a CO2leak. Use of a faulty probe could lead to user or patient injury.
• Never press the Test button when the probe tip is in air. Testing in air does
not allow for the check of a CO2leak. Use of a faulty probe could lead to
user or patient injury.
• The probe cable can heat and reach 58.4° C during energy delivery.
When placing the probe, verify that the probe cable does not rest on the
patient’s skin. Use the included clips to secure the probe cable away from
the patient’s skin as needed.
• Any undue handling or touching of the probe shaft during or following use
could result in a thermal injury to the patient or user.

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WARNINGS • Certus 140 Ablation Probes can be used with needle introducers. If a
needle introducer is used, it must be retracted so that it doesn’t interfere
with the planned ablation zone prior to delivering energy. Failure to retract
theneedleintroducerasufcientdistancemayimpactenergydelivery.
Introducers used with 17 gauge probes must be 14 gauge introducers or
larger to help minimize the risk of probe damage.
• The Certus 140 Ablation System is not a cryogenic ablation device.
The CO2suppliedprovidessufcientcoolanttoenabletheTissu-Loc™
function and to cool an active probe. The CO2suppliedisnotsufcientto
ablate tissue.
 • NeverremoveaprobefromthepatientwhileTissu-Loc™modeis
enabled or the displayed temperature is below 0° C. Serious internal
injuries may result.
 • DonotactivatetheTissu-Loc™functionwhentheprobeisnotplaced
in tissue.
• Never begin delivering energy to a probe when the probe tip is in the air. The
systemwilldetecta“reectedpower”errorandstopdeliveringenergy.
• Cylinders contain high pressure. Make sure the cylinders are closed prior
to removing the yokes.
• Repairs should only be attempted by trained NeuWave Medical Inc.
personnel or by persons having completed NeuWave Medical Inc.
approved service training.
• The Certus 140 Ablation System requires special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in this user manual.
• Portable and mobile RF communications equipment can affect the Certus
140 Ablation System. Refer to the EMC information provided in this user
manual.
• The Certus 140 Ablation System should not be used adjacent to or
stackedwithequipmentotherthanspeciedinthisusermanual.If
adjacent or stacked use is necessary, the Certus 140 Ablation System
shouldbeobservedtoverifynormaloperationinthecongurationin
which it will be used.
• The Certus 140 Ablation System intentionally applies RF/Microwave
energy for ablation during activation. Observe other electronic medical
equipment in the vicinity during Certus 140 Ablation System activation for
any possible adverse electromagnetic effects. Ensure adequate separation
of electronic medical equipment based on observed reactions.
• The Certus 140 Ablation System was tested using Certus 140 Ablation
Probes. The use of accessories other than those listed in this user manual
may result in increased emissions or decreased immunity of the Certus
140 Ablation System.
• Probes removed from the body may be hot. Handle with care to avoid
user and/or patient injury.
• Do not handle probes that appear excessively cold.
• Do not apply a clamp or hemostat to the probe shaft or cable as this may
damage the probe and cause a malfunction.

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WARNINGS • Probe movement during ablation is possible. Probe movement can be
caused by patient movements from breathing, coughing, etc. and also by
pressure applied to the probe when target tissue contracts in response to
the ablation. To help prevent probe movement, hold the probe handle in
place during the initial period of the ablation (at least 45 seconds). Monitor
the probe for movement throughout the procedure and hold the probe
in place as needed. If repositioning of a probe is required, stop energy
delivery prior to repositioning the probe.
• Charred tissue may accumulate on the probe tip during planar
coagulation. As needed, use a sterile soft cloth or soft pad to remove any
tissue build up on the probe tip. Probe tip may be hot. Never use a rough
surface or scratch pad to clean the probe tip as this may damage the
probe and result in errors or malfunction.
• When using the CertuSurgGT, keep metal objects, including other medical
instruments away from the shaft when delivering energy. Energy from the
CertuSurgGT may radiate to the metal objects causing them to heat.
• System or probe malfunction can result in a delay of surgical procedures.
Always ensure that an alternative coagulation method and additional
Certus probes are available.
• When using a probe in or near rigid structures such as bones and
cartilage, use care not to apply excessive lateral force or excessively bend
the probe. Near the probe tip, the probe shaft is made of ceramic, which
may break if excessive force is applied. This may result in the probe tip
being detached from the probe and possibly remaining in the patient.
• There are temperature sensors on the outside of the probe shaft. If the
temperature sensors are damaged during placement or use of the probe,
the Certus 140 will generate an error and disable the probe. To minimize
the risk of damaging the temperature sensors during placement, avoid
penetrating rigid structures such as bones and cartilage without the use
of an introducer. Sharp instruments and hemostats/clamps should never
be used along the probe shaft. Ultrasound guides and needle introducers
should be used with caution.
• The Dual Probe Clip is designed for use only with 17 gauge probes. To
avoid damage to the probe clip and/or the probes, do not use 13 gauge
(SR) or 15 gauge (LK or PR) probes with the Dual Probe Clip.
• Use only NeuWave approved accessories listed in this manual. Use of
other accessories may impact system performance.
• Never bend or apply excessive force to the probe. Probe malfunction may
occur, possibly causing user and/or patient injury.
• Cauterizing track sizes are dependent on probe temperature and probe
removal rate. Cauterizing with probes at higher temperatures and/or with
slower rates of removal may result in larger cautery tracks.

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Certus 140™
2-7
CAUTIONS • Lock caster brakes during procedures.
• The PDM mount uses a spring loaded lever which could cause a pinch
point. Use caution when attaching the PDM to the CT table mounting
bracket or system cart storage location.
• When turning off the system, the LEDs in the ON/OFF switch will
blink while the internal system safely shuts down. Wait for the LEDs
to extinguish completely (should take less than 30 seconds) before
disconnecting the power cord. A system error could result if power is
disconnected while the system is shutting down.
• Do not use abrasives, sharp tools, or any methods that may damage
the surface of the parts.
• Flexible connection covers (3) protect the PDM from dirt, debris and
liquids. Ensure the covers remain in place when the system is not
in use.
• Lock caster brakes before installing or changing CO2cylinders.
• Removing the probe too slowly while cauterizing may result in a probe
temperature error.

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NeuWave Medical®
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PL-000353 Rev D
Certus 140™
3-1
Read this entire manual and any accessory documents prior to use.
Several minor aspects of the System Cart design will depend on the age of the cart. Where these
differences are signicant, they will be shown in this manual.
System Display
The system display is a touch screen, and
is the user interface for the Certus 140
Ablation System. Use the system display
to access all controls and settings.
The system display is mounted on a
moveable arm that allows the display to
be easily positioned and repositioned as
needed.
Instructions on using the user interface
are provided throughout this manual.
Figure 3-1: System Display
WARNING Use caution when adjusting the moveable display arm to avoid pinching
handsorngers.
3
System Overview
and Setup

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NeuWave Medical®
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System Cart
The Certus 140 Ablation System cart contains the
microwave power ampliers and cooling system.
The system ON/OFF switch is located on the cart just
below the system display arm.
The cart holds 2 CO2 cylinders.
A cylinder wrench for opening and closing the CO2
cylinders is provided in the drawer.
The PDM mounting bracket allows the PDM to be easily
stored on the cart for transport and storage.
Follow facility procedures for storing the CO2tanks. Local
regulations may prohibit storing the CO2 tanks with the
Certus 140 Ablation System when not in use.
All four casters can lock.
The cart includes:
1. System ON/OFF Switch
2. Writing Surface
3. Drawer
4. Casters/Caster Locks
5. PDM/Cable Assembly Mount/Cable Wrap
6. Probe/Surgical Tool PDM Connection
7. AC Power Cable Wrap
8. AC Power Inlet
9. Footswitch (Optional Accessory)
Figure 3-2: System Cart - Original Design
4
3
2
1
6
5
7
8
9
System Cart - Current Design
9

PL-000353 Rev D
Certus 140™
3-3
USB Ports
A USB port (next to the ON/OFF switch) is available to
download system data. It can also be used to connect
the “Standard USB Footswitch”.
There are two “Locking USB” connectors on current
version system carts for connecting “Locking USB
Footswitch”. The data port is not currently functional.
Figure 3-3: Certus 140 Ablation System USB Port and Footswitch Connection.
PDM/Cable Assemblies
Figure 3-4: PDM and PDM Connection to Cart
The PDM provides a single connection point for up to three ablation probes while minimizing
cabling to the cart. The PDM Connections are identied as channels 1, 2 and 3.
CAUTION Flexible connection covers (3) protect the PDM from dirt, debris and
liquids. Ensure the covers remain in place when the system is not
in use.
The PDM cable connects to the cart. The three PDM connectors and the three channels are
numbered to ensure proper connection. The connectors attach to the corresponding cart channel.
The PDM and cable assembly enable energy delivery, CO2cooling and temperature monitoring
while minimizing cable clutter and cable management issues.
The PDM mounts directly to the rail on the CT scanner table or to the Certus 140 CT table bracket.
NeuWave Medical recommends leaving the PDM connections connected to the cart between
uses. This will reduce wear and extend the life of the PDM and cable assembly.
Data Port
(not enabled)
Locking USB

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Connecting PDM to the System Cart
The PDM Connections are identied as channels 1, 2, and 3. The PDM cable connects to the cart.
The three PDM connectors and the three channels are numbered to ensure proper connection.
Attach the connector to the corresponding cart channel.
Thumbscrews
PDM Cable
Guide Plate Grate
1. Loosen the thumbscrews on the PDM
cable guide plate (2) and grate (4), and
remove the cable guide plate and grate.
2. Position a PDM connector to the
corresponding channel port, making sure
the rounded end of the connector aligns
with the rounded end of the port.
3. Press and hold the connector release tabs.
4. Insert the PDM connector fully into the port.
5. Release the connector release tabs and
listen for an audible click.
6. Verify the integrity of the connection by
gently attempting to remove the connector.
7. Repeat steps 2-6 with the remaining
PDM cables.
8. Reinstall the grate on the cart and secure in
place with the thumbscrews (4).
9. Place the PDM cable guide plate such that
each cable rests in one of the three guides.
10. Press the plate against the cart and secure
with thumbscrews (2).
Figure 3-5: Connecting PDM Cables to the Cart