Sutter CURIS 36 0 00-01 User manual

INSTRUCTIONS FOR USE
CURIS®
4 MHz Radiofrequency Generator
REF 36 0 00 –01
These instructions for use apply for all devices according to chapter 5.1.

CURIS®Instructions for Use
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Table of contents
1EXPLANATION OF SYMBOLS AND ABBREVIATIONS ...................................................................... 1
2MODE OF ACTION AND INTENDED USE ......................................................................................... 2
2.1 General information about the mode of action of electrosurgery ....................................... 2
2.2 Intended use of the CURIS®................................................................................................... 4
3TRANSPORTATION AND PACKAGING ............................................................................................. 5
3.1 Receiving inspection............................................................................................................... 5
3.1.1 Transport damage .......................................................................................................... 5
3.1.2 Claims for compensation ............................................................................................... 5
3.2 Returns .................................................................................................................................... 5
4FUNCTION AND MEANING OF THE DISPLAY AND CONTROL ELEMENTS..................................... 6
5COMMISSIONING ............................................................................................................................ 9
5.1 Validity of these instructions for use ..................................................................................... 9
5.2 Potential equalization connection ......................................................................................... 9
5.3 Mains supply ........................................................................................................................... 9
5.4 Turning the device on and off ................................................................................................ 9
5.5 Self-test..................................................................................................................................10
5.6 Connecting accessories........................................................................................................10
5.6.1 Connecting the neutral electrode................................................................................10
5.6.2 Connecting monopolar handles for cutting and coagulation.....................................10
5.6.3 Connecting bipolar accessories...................................................................................11
5.6.4 Bipolar accessories with automatic instrument detection ........................................11
5.6.5 Operating mode selection............................................................................................12
5.6.6 Setting the output power .............................................................................................12
6OPERATION....................................................................................................................................14
6.1 Special functions...................................................................................................................14
6.2 Program memory...................................................................................................................16
6.3 Function test .........................................................................................................................16
7SAFETY MEASURES.......................................................................................................................18
7.1 General information..............................................................................................................18
7.2 Patient positioning ................................................................................................................18
7.3 Application of the neutral electrode and high-frequency current ......................................18
7.4 Pacemaker, implants............................................................................................................19
7.5 Setting down RF instruments...............................................................................................20
7.6 Risks due to electromagnetic interference .........................................................................20
7.7 Accessories............................................................................................................................21
7.8 Operation with bipolar cutting forms ...................................................................................21
7.9 Risks due to high electric voltage ........................................................................................22

CURIS®Instructions for Use
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8CARE INSTRUCTIONS ....................................................................................................................23
8.1 Cleaning and disinfection.....................................................................................................23
8.2 Sterilization of accessories ..................................................................................................23
8.3 Accessories that cannot be sterilized..................................................................................23
9TECHNICAL INFORMATION............................................................................................................24
9.1 Technical data, standards, certification ..............................................................................24
9.2 Recurring safety-related inspections...................................................................................25
9.3 Diagrams ...............................................................................................................................26
9.3.1 RF output ......................................................................................................................26
9.3.2 RF voltage .....................................................................................................................28
9.3.3 Control characteristic curve.........................................................................................30
9.4 Guidelines and manufacturer declaration for electromagnetic compatibility ..................31
10 ENVIRONMENTAL NOTICES ..........................................................................................................35
10.1 Packaging ..............................................................................................................................35
10.2 Environmentally friendly device operation ..........................................................................35
10.3 Device disposal .....................................................................................................................35
11 ERROR DIAGNOSIS........................................................................................................................36
12 FOOT SWITCH (ACCESSORY) ........................................................................................................38
13 EQUIPMENT CART (OPTIONAL) .....................................................................................................39

CURIS®Instructions for Use
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1Explanation of symbols and abbreviations
Non-ionizing radiation
Observe the instructions for use, notice, warning
Disposal instructions

Ohm
A
Ampere
AC
Alternating current
CF
Cardiac floating
dB
Decibel
DC
Direct current
Display
Indicator panel on the generator
Err
Error
F
Floating
hPa
Hectopascal
Hz
Hertz
kHz
Kilohertz
mA
Milliampere
MDD 93/42 (EEC)
EU Medical Device Directive
MHz
Megahertz
MPG
Medical Devices Act (Germany)
LF
Low frequency
P
Power
PE
Potential equalization
Peak
Peak
R
Resistance
RaVoR™
Radio frequency volume reduction
RF
Radio frequency
V
Volt
VA
Volt-ampere
Rx only
Sale restricted to attending physicians (USA)
(also see chapter 4)

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2Mode of action and intended use
2.1 General information about the mode of action of electrosurgery
Electrosurgery is a surgical method that uses electric current to achieve surgical effects. To prevent
this current from causing nerve stimulation (electric shocks), alternate current with a sufficiently
high frequency (approximately 4 MHz with this device) is used so that nerve stimulation no longer
occurs (Nernst equation). Since the frequency is in the range of radio waves, one also speaks of
“radio frequency surgery” (RF surgery).
If the current is supplied to the surgical area by an electrode and conducted away from the body
again outside the surgical area using a large-scale electrode with no electrosurgical effect, one
speaks of monopolar application. The electrode in the surgical area is called the active electrode,
the current return electrode is called the neutral electrode. If on the other hand the current is
conducted away from the body and back to the device by an electrode directly within the surgical
area –which is usually symmetrical to the supply electrode –then one speaks of bipolar
application.
When RF surgery and monitoring screens are used simultaneously on a patient, only
monitoring electrodes with supply cables that contain protective resistors or RF inductors
may be used. Needle electrodes for monitoring may not be used. Do not use the active
surgery electrode in the vicinity of the ECG electrodes (minimum distance 15 cm)!
Compliance with the following general rules is required for RF surgery applications:
Always work with the lowest RF output setting for the desired surgical effect. On the other
hand, note that setting the output too low can also constitute a risk, for instance because
a first cut is not made due to excessively low output so that local coagulation results
where it is not desirable or even dangerous.
NOTE
An inadequate effect with the usual setting may for instance be due to poor application
of the neutral electrode, poor contact in plug connections, cables broken underneath
the insulation, or encrusted electrodes. This needs to be checked and defective
components must be replaced.
After repositioning the patient, the electrodes and cables must be checked to verify they
are correctly applied.
In case of procedures on body parts with a small cross-section in proportion to their
dimensions (filamentary structures and skin flaps), using bipolar technology or forgoing
the use of RF surgery may be necessary to prevent unwanted coagulation in other areas.
The use of ignitable anesthetics, nitrous oxide (N2O), and oxygen should be avoided. The
use of RF devices may generate sparks on the active electrode. Combustible substances
used as cleaning agents, disinfectants, or solvents must evaporate before the
application of RF surgery. There is a risk that combustible liquids may accumulate under

CURIS®Instructions for Use
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the patient or in body recesses such as the navel or body cavities such as the vagina.
Wipe up liquid that has accumulated in these areas before using the RF device. There is
a risk that endogenous gases may ignite. Materials saturated with oxygen such as cotton
wool and gauze may be ignited by the sparks that form during the intended use of the
RF device.
Combinations with other devices may only be realized by the manufacturer or with the
manufacturer’s consent.
The operation of the RF device may interfere with other electromedical devices.
In principle, one differentiates between two electrosurgical effects:
Electrosurgical cutting
Electrosurgical coagulation
Electrosurgical cutting
With electrosurgical cutting, a high current concentration occurs at the transition between the
electrode and tissue, leading to very rapid heating at that point. This causes water vapor to escape
from the tissue. The release of vapor separates the tissue from the electrode, creating an insulating
layer. This layer needs to be electrically penetrated by ionizing the steam so the current can
continue to flow. Now physical effects occur in this water vapor layer, which has become electrically
conductive, leading to tissue separation. If the tissue contains only little or no water, then this
cutting process only works moderately or not at all. This method is used to sever or resect tissue
using blade or needle-shaped electrodes, or wire or tape loops.
Electrosurgical coagulation
Two active principles are generally differentiated for electrosurgical coagulation. When the current
from the electrode enters the tissue, the tissue at that point is heated by electrothermal energy
conversion (resistive heating). This is used to denature (coagulate) tissue for surgical purposes or
to stop major bleeding (hemostasis). This type of electrosurgical coagulation is called contact
coagulation, and is carried out using a ball or plate-shaped electrode or the flat side of a blade-
shaped electrode.
Another possible application is the targeted destruction of tissue using piercing electrodes, which
in this case can postoperatively lead to a desired volume reduction in the tissue (radio frequency
volume reduction: RaVoR™).
In the bipolar application, the electrode pair is frequently carried out as tweezers or forceps, often
designed for special preparations.
A different coagulation effect occurs when the voltage on the active electrode is so high that sparks
can form from the electrode to the tissue. Low ends form at the ends of these sparks. Within them,
the temperature is extremely high, but the temperature gradient from the inside to the outside is
also extreme so that coagulation only takes place in a thin layer on the surface. This allows large-
scale hemostasis with only minor depth damage to the tissue to be achieved. This type of

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coagulation is called spray coagulation and can be carried out with a needle electrode or the
pointed end of a blade electrode.
2.2 Intended use of the CURIS®
The CURIS®radio frequency device with its output power of max. 100 watts is suitable for
monopolar and bipolar electrosurgical procedures in neurosurgery, ear, nose, and throat medicine,
plastic/cosmetic surgery, oral and maxillofacial surgery, dermatology, and by registered surgeons.
Meaningful applications may exist in other specialist fields.
The CURIS®is suitable for electrosurgical cutting and coagulating.
Exclusions are application immersed in liquids and applications that require a higher RF output
than the maximum output specified in the technical data for the respective current type.
The CURIS®may only be used by persons that have been trained in the proper and safe use of the
device. The instructions for use must be observed for training and application.
The safe application of electrosurgery requires the user to be familiar with the technology and forms
of application.
Any change to the product or deviation from these instructions for use waives the liability
of Sutter Medizintechnik.

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3Transportation and packaging
3.1 Receiving inspection
3.1.1 Transport damage
The device and accessories must be inspected for possible transport damage and defects on
receipt.
Scope of delivery: CURIS®, mains cable, instructions for use
3.1.2 Claims for compensation
Claims for compensation can only be asserted if the seller or shipper is notified promptly. A record
of damages must be prepared immediately. The record of damages has to be submitted to the
nearest Sutter representative or directly to Sutter so that claims for compensation can be reported
to the insurer.
3.2 Returns
If possible, the original packaging must be used to return a device to Sutter or a Sutter service
center. If this is not available, packaging that properly protects the device being returned is
mandatory. In case of improper packaging, liability rests exclusively with the sender. The following
accompanying documents must be included:
Name and address of the sender/return recipient
Model and device number
Description of the defect
The version of these instructions for use
The most recent inspection record for the safety-related inspection
NOTE
The packaging of the generator is not intended for transportation together with the foot
switch! The foot switch must be packaged separately. Shipping them together may
result in transportation damage and Sutter assumes no liability for this.
When returning or shipping an RF generator, please ensure that the membrane packaging is
correctly inserted.
The packaging can be reordered under the following article number: 98 91 19

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4Function and meaning of the display and control elements
Front of the device
1
Mains switch
2
“Auto-RF control active” indicator
3
Program memory P1 …P4 (to store device settings)
4
CONTACT selection button for monopolar contact coagulation
5
CUT 1 selection button for monopolar cutting
6
SOFTSPRAY selection button for contactless monopolar coagulation (spray coagulation)
7
CUT 2 selection button for monopolar cutting with coagulation
8
The indicator lamp lights up during RF output in the MONOPOLAR operating mode.
9
MACRO selection button for bipolar coagulation
10
BICUT 1 selection button for bipolar cutting
11
PRECISE selection button for bipolar coagulation with fine instruments
12
BICUT 2 selection button for bipolar cutting with coagulation
13
RaVoR™ selection button for bipolar RF volume reduction, for instance in snore therapy
14
EXCISE selection button for bipolar cutting with ring forceps
15
The indicator lamp lights up during RF output in the BIPOLAR operating mode.
16
Display of the RF cutting output setting
(operating modes CUT1, CUT2, BICUT1, BICUT2, EXCISE)
17
Rotary knob to select the RF cutting output
(operating modes CUT1, CUT2, BICUT1, BICUT2, EXCISE)
18
Display of the RF coagulation output setting