SUTTER CURIS User Manual

Page 1
®
CURIS
4 MHz Radiofrequency Generator in combination with
RaVoR
TM
bipolar electrodes single-use
4MHz
Radiofrequency
Page 2
CURIS® 4 MHz Radiofrequency Generator One unit – many applications
The CURIS® 4 MHz radiofrequency generator relies on innovative 4 MHz technology: It is gentle to the tissue and effective for coagulation, for submucosal shrinkage, and for cutting. Scienti c studies have shown that tissue trauma may be reduced by using CURIS® 4 MHz radio­frequency technology.*
CURIS® 4 MHz Radiofrequency Technology
The higher the frequency, the less the resistance of biological tissue to electromagnetic  elds – up to the point where cell membranes are capacitively coupled. This effect is created by the CURIS® 4 MHz radiofrequency generator in all monopolar and bipolar modes. When using conventional electrosurgical units the electromagnetic  eld concentrates between the cells and only heats up the outer layer. However, with the CURIS® 4 MHz radiofrequency generator cell membranes are conductive, and energy is absorbed evenly inside the cells. As a result, energy is administered gently and in a highly focused fashion. Precise monopolar cuts are possible while lateral heat damage is kept to a minimum*
*1 Muehlfay G et al., A study on the type of lesions archieved by three electrosurgical methods and their way of healing. Romanian Journal of Morphology & Embryology. 2015; 56(4): 1383 - 1388
2
*
Hoffmann TK et al., Comparative analysis of resection tools suited for transoral robot - assisted surger y. European Archives Oto - Rhino - Laryngology.
2014; 271 (5) : 1207 - 1213
1
2
.
4MHz
Radiofrequency
Permittivity/Frequency
Muscle
Fat tissue
Blood
This diagram shows the permittivity of tissue, which depends on the frequency of the electro­magnetic  eld.
2 | Sutter • CURIS®• 2018
Conventional electrosurgical units CURIS®4 MHz Radiofrequency
Generator
The electromagnetic  eld concentrates between the cells and heats up only the outer layer.
Cell membranes are conductive and the energy is absorbed evenly inside the cells. The results are highly focussed tissue effects.
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Precision thanks to AutoRF ™
AutoRF™ is a smart impedance control function that will tailor the power output of the CURIS® 4 MHz radio­frequency generator to the tissue condition. Whether it is cutting through different types of tissue (such as mucosa, muscle, fat or connective tissue) or altering tissue conditions during coagulation, the AutoRF™ feature will deliver adapted power output as required by the different tissue impedance.
When dissecting different types of tissue in one cut (skin, fat, muscles), the unit has to process and respond to the AutoRF™ data in a  ash. For this reason, the CURIS® 4 MHz radiofrequency generator has two microprocessors for additional safety and speed.
3TM
p
-Technology
3TM
p
, which stands for pulsed power performance, is active in all coagulation modes of the CURIS® 4 MHz radiofrequency generator. Radiofrequency energy is delivered in about 50 small packages per second. Due to the pulsed power output, there are short breaks between the individual packages, giving the tissue enough time to absorb the energy. Highly focused, yet gentle coagulation with minimal thermal damage is possible.
3
p
pulsed power performance
™
®
CURIS
RaVoR
RaVoR™ mode:
The pulsed power output with short intervals between the individual packages gives enough time for the coagulated tissue to absorb the applied energy.
™
®
CURIS
CUT
Monopolar cutting:
Sections 1 to 5 show the different kinds of tissues and cutting speeds to which the unit adjusts its power output automatically. “R“ signi es electric tissue resistance and “P“ the actual power output.
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CURIS®: one device – many applications
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% 50
40
RaVoR™ of the inferior turbinates
RaVoR™ of the soft palate
“Bipolar radiofrequency volumetric tissue reduction, using Sutter technology, appears to have promising results for patients with snoring and mild OSA. One treatment session resulted in signi cant reduction in snoring intensity, improvement in sleep quality and QOL, and reduction in daytime sleepiness.“
Pang KP et al. Sutter bipolar radiofrequency volumetric tissue reduction of palate for snoring and mild obstructive sleep apnoea: is one treatment adequate? The Journal of Laryngology & Otology. 2009; 123(7): 750-754
30
20
10
0
Snoring intensity pre- and postoperatively after treat­ment of nasal turbinates and soft palate
Marinescu, A, Innovative Bipolar Radiofrequency Volumetric Reduction with “ORL - Set” for Treatment of Habitual Snorers. Laryngo-Rhino-Otol, 2014; 83 (9): 610 – 616
1234
0
Pat. preop.
Pat. postop.
NAS Score
RaVoRTM Radiofrequency Volume Reduction
RaVoR™ of the inferior turbinates, soft palate, tongue base, etc. is an interstitial application
for submucosal tissue shrinkage. Precise delivery of energy and smart power adjustment depending on actual tissue impedance aid in creating consistent and repeatable lesions. As soon as the right size of a lesion has been achieved, the CURIS® 4 MHz radiofrequency generator will automa­tically stop the activation (AUTO STOP mode), and give an acoustic signal. The treated tissue is decomposed by the body’s own immune system and transformed into fibrous scar tissue. This process leads to a shrinkage and stiffening of the treated area. Sutter has developed different bipolar electrodes for the treatment of sleep - related breathing disorders based on the anatomical sites of obstruction.
Audio Feedback
If desired, an acoustic feedback function (AUDIO FEEDBACK) can be activated. While a lesion is created in RaVoR™ mode, the change in tissue condition is signaled by a changing pitch: The further the lesion progresses, the higher the activation sound. This mode may also be used to potentially increase the patient’s comfort. The patient will be able to listen and follow what happens inside the tissue.
4 | Sutter • CURIS®• 2018
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Page 5
RaVoR™ bipolar electrodes single-use
Plug and operate
• Convenient handling for surgeon and staff
• Perfect match with the
CURIS® 4MHz radiofrequency generator
• Auto recognition of the instrument and
instant selection of the RaVoR
• CURIS®– Precision thanks to AutoRF
™
program
™
“The RaVoR™ bipolar electrodes single - use
for the reduction of the inferior turbinates are a convenient solution for my private practice. My staff and I enjoy the ease of use due to
the new plug and operate feature.”
S. Grupp, MD, Freiburg (Germany)
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Page 6
RaVoR™ of the inferior turbinates
70 44 62 RaVoRTM bipolar electrode
for the inferior turbinates, single-use working length: 103 mm
“RaVoR™ is a modern surgical technique showing good and
long-lasting treatment results when used to reduce the volume of hypertrophic turbinates. At the same time it preserves the mucosa and its function.”
R. Romeo, MD, Israelitic Hospital
Rome (Italy)
Schematic view of the puncture sites for the application of radiofrequency energy of the hypertrophic turbinates.
Inferior turbinate – Preoperative condition and six months postope­ratively with signi cantly enlarged nasal passage.
RaVoR™ of the soft palate
70 44 95 RaVoRTM bipolar electrodes
for the soft palate, single-use working length: 110 mm
“The radiofrequency assisted soft
palate procedure is a minimally invasive, safe and quick procedure. It is well tolerated by patients. We have not observed any bleeding that needed special attention.”
D. Brehmer, MD
Göttingen (Germany)
Puncture sites for the application of radiofrequency energy in the soft palate
Dissection of surplus uvula tissue and incision lines for the triangular excision of the posterior palatal pillars.
(With ARROWtip™ monopolar micro­dissection electrode, REF: 36 03 42)
6 | Sutter • CURIS®• 2018
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Page 7
CURIS® Basic set/Accessories
CURIS® Basic set
87 00 10 – CURIS® basic set with single-use patient plates
Anzahl REF Beschreibung
1
1 36 01 10 Foot switch two pedals for CURIS® (cut & coag),
1 37 01 54L
1 36 07 04 Monopolar handpiece (pencil) cut & coag,
1 36 02 38 Cable for single-use patient plates, length: 3 m
1 (x50)
36 01 00-01
36 02 22
CURIS® 4 MHz radiofrequency generator (incl. mains cord, user‘s manual and test protocol)
cable length: 4 m
Bipolar cable for CURIS®, length: 3 m
shaft 2.4 mm, cable length: 3 m
Safety patient plates, single-use, packing 5 x 10 pcs. (not shown)
36 09 00
Fuego trolley
Fuego Trolley
99 01 10
CURIS® trolley case
Trolley Case for CURIS® 4 MHz radiofrequency generator
The trolley has a solid design and guarantees that the CURIS® 4 MHz radiofrequency generator will not shift. It also comes with a hook to mount the foot switch.
Two storage baskets for accessories and documentation.
Disclaimer:
The information presented herein has been carefully researched and compiled with the help of specialist physicians. They are not meant to serve as a detailed treatment guide. They do not replace the user instructions for the medical devices used. Sutter accepts no liability for the treatment results beyond the mandatory legal regulations.
Products shown in this catalog are available in the EU. Availability in other markets may vary.
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The CURIS® trolley case is ideally suited to preserve your radiofrequency generator from damage.
| 7Sutter • CURIS® • 2018
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CURIS
RF output max. performance operating frequency
monopolar
CUT 1 (unmodulated) CUT 2 (modulated) 80 W ± 20 % 600 Ω 4.0 MHz CONTACT (Coag) 80 W ± 20 % 400 Ω 4.0 MHz SOFTSPRAY (Coag) 60 W ± 20 % 600 Ω 4.0 MHz
bipolar
BICUT 1 80 W ± 20 % 300 Ω 4.0 MHz BICUT 2 80 W ± 20 % 300 Ω 4.0 MHz EXCISE (Cut) 80 W ± 20 % 300 Ω 4.0 MHz MACRO (Coag) 80 W ± 20 % 50 Ω 4.0 MHz PRECISE (Coag) 50 W ± 20 % 50 Ω 4.0 MHz RaVoR™ 40 W ± 20 % 50 Ω 4.0 MHz
®
– Technical data
monopolar
100 W ± 20 % 600 Ω 4.0 MHz
Modulation frequency 33 kHz Mains supply 100-240 V; 50/60 Hz Measurements W x H x D 320 mm x 170 mm x 385 mm Weight approx. 5.0 kg Mode of operation Intermittent INT 10 s / 30 s equals 25 % ED Standards DIN EN 60601-1; DIN EN 60601-2-2 Safety class I EMC (Interference suppr.) EN 60601-1-2 Type CF (cardiac  oating), de brillator-proof German MPG class. II b Quality assurance EN ISO 13485
© Sutter Medizintechnik · Subject to change · REF 1259 A – R09 · printed on acid free paper
SUTTER MEDIZINTECHNIK GMBH
A
LFRED-WALZ-STR. 22 · 79312 EMMENDINGEN/GERMANY · TEL. +49(0)7641-96256-0 · FAX +49(0)7641-96256-30
WWW.SUTTER-MED.COM · [email protected]
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