Olympus CelonLab ENT User manual

W7098046 (2014-08)
Celon
Lab
ENT
EN Instructions for Use 3
DE Ge rauchsanweisung 13
FR Mode d'emploi 23
IT Istruzioni d’uso 35
ES Instrucciones de uso 47
PT Manual de instruções 59
NL Ge ruiksaanwijzing 71
SV Bruksanvisning 83
FI Käyttöohje 93
DA Brugsanvisning 103
NO Bruksveiledning 113
EL Οδηγίες χρήσης 123

W7098046 3
Instructions for Use (English)
CelonLab ENT
RFITT po er control unit
REF: WB991007 (100 ... 120 V~)
REF: WB991001 (200 ... 240 V~)
1. Safety and Warnings
2. Description
2.1 Indications for Use
2.2 Contraindications
2.3 Features of the Unit
2.4 Description of the Controls
3. Installation Instructions
3.1 Po er Supply Connection
3.2 Equipotential Bonding
3.3 Moisture Protection
3.4 Commissioning
4. Instructions for Use
5. Cleaning and Disinfection
6. Maintenance and Repair
6.1 Changing the Po er Fuses
6.2 Repairs
6.3 Safety Checks
6.4 Disposal of the Unit
7. Technical Data
8. Legal Information
9. Sym ols
10. Manufacturer

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1. Safety and Warnings
Warning: The safety and effectiveness of electrosurgical
interventions depend not only on the design of the equipment used,
ut also to a major extent on factors which are under the control of
the user. It is therefore extremely important to read, understand and
follow the instructions supplied with the coagulation electrodes, the
power control unit and the accessories in order to ensure safety and
effectiveness.
Caution: The safety of electrosurgery ill be greatly enhanced by a thorough
kno ledge of the medical literature on the subject. Study of specific
information on the hazards and complications of the procedure in question is
especially recommended.
Caution: The CelonLab ENT po er control unit may only be used ith
compatible coagulation electrodes and accessories. The electrodes must be
designed for the maximum peak output voltage. (see Technical Data).
Caution: Before use, the electrosurgical unit and accessories must be
examined for damage. Cables and accessories ith damaged insulation or
connections must not be used.
Caution: Wherever possible, the patient should not be able to come into
contact ith electrically conductive components that are earthed. Route all
connecting cables, in particular the cables to the coagulation electrodes, so
that they are not in direct contact ith the patient or other cables.
Warning: The high frequency equipment, when applied to a patient
with a cardiac pacemaker, an implanted cardioverter defi rillator
(ICD) or other implanted electronic devices (IED), may cause
malfunctioning or failure of the implanted electronic device and may
seriously affect the patient. Always confirm that it is safe to proceed
with a cardiologist or the manufacturer of the implanted electronic
device efore proceeding. If monopolar modes of the electrosurgical
generator are used, position the neutral electrode so that the current
pathway does not pass through or near the implanted electronic
device and its lead system. The risk of malfunction or failure of an
implanted electronic device is reduced y the use of a ipolar mode.
A risk does exist, however, if the application is in close proximity to
the implanted electronic device.
Warning: The risk of flamma le gases or other materials eing
ignited exists with any surgical application of electrical energy.
Precautionary measures must e taken to keep flamma le materials
and su stances away from the site of intervention (do not use
flamma le anaesthetics, nitrous oxide or oxygen). Flamma le agents
used for cleaning and disinfection must e allowed to evaporate
efore the electrosurgical unit is used.
Caution: Electrodes and probes of monitoring, stimulation and imaging
devices can conduct radiofrequency currents. Electrodes and probes (e.g. ECG
and EEG) must be kept as far a ay as possible from the site of the
electrosurgical intervention. Needle monitoring electrodes should not be used,
as they may cause patient burns. Physiological monitoring equipment
incorporating high frequency current limiting devices is recommended.

Instructions for Use EN CelonLab ENT
W7098046 5
Caution: The CelonLab ENT po er control unit complies ith the EMC
(electromagnetic compatibility) standard. Nevertheless, hen the po er
control unit is active it may disturb neighbouring electronic equipment. Please
follo the instructions in the technical documentation regarding
electromagnetic ambient conditions (“EMC Guidelines”).
Caution: Mobile communication equipment (e.g. mobile phones) may disturb
the functioning of the po er control unit and other electrical medical
equipment.
Caution: Contact ith the tip of the coagulation electrodes may cause burns
hen the po er control unit is active.
Caution: In the event of a defect or malfunction in the unit, an undesirably
high output po er may be emitted.
Caution: When the housing is opened there is a danger of electric shock. The
unit must only be serviced by authorised technicians.
Caution: Federal La of the USA restricts this device to use by or on the
order of a physician.
2. Description
2.1 Indications for Use
The system, comprising the CelonLab ENT and compatible coagulation
electrodes, is indicated for ablation and coagulation of soft tissue in
otorhinolaryngology (ENT) surgery. This method of treatment is also referred to
as bipolar radiofrequency induced thermotherapy (RFITT).
2.2 Contraindications
Electrosurgical interventions are contraindicated if, in the judgment of the
physician, tissue coagulation could have a negative effect on the state of the
patient. Radiofrequency induced coagulation may be contraindicated for patients
ith a eakened immune system.
2.3 Features of the Unit
The CelonLab ENT po er control unit supplies the compatible bipolar
coagulation electrodes via its bipolar output. A neutral electrode (return
electrode) is not necessary.
The po er control unit features clearly laid out controls. After s itching on the
unit, the user only has to select the po er level and activate the po er output
using the foots itch.
The po er control unit provides an acoustic output of the coagulation status.
With CelonLab ENT, the “generator active” signal, hich usually has a fixed
frequency ith conventional radiofrequency generators, is designed so that its
frequency is proportional to the tissue resistance at any particular moment. This
permits acoustic monitoring of the coagulation status, since the latter is directly
connected ith the tissue resistance. If the resistance increases beyond a
specific limit value, hich means that the coagulation process has ended, this is
indicated by the tone being pulsed.

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2.4 Description of the Controls
Fig. 2.1: Front panel of the RFITT po er control unit CelonLab ENT
Fig. 2.2: Back of the RFITT po er control unit CelonLab ENT

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W7098046 7
1Power switch: The po er s itch is for s itching the unit on and off.
When the po er control unit is s itched on the po er s itch glo s green.
For safety reasons the unit is only ready for use after approx. 10 seconds.
The po er setting is al ays at its minimal value of 1 after s itching on.
2Connection sockets for RFITT coagulation electrodes: All compatible
bipolar coagulation electrodes can be connected to this socket.
3Connection socket for the foot switch: The CelonFoot S itch can be
connected to this socket. When the foots itch is pressed, po er output is
activated. The generator cannot be operated ithout a foots itch
connected.
4Signal lamp: “Power output”: If the control unit is activated by pressing
the foots itch, and if po er can be emitted at the output, this is indicated
by this blue lamp.
5Signal lamp: “resistance too low”: This red lamp illuminates, in
combination ith an acoustic signal (intermittent tone), to indicate that the
resistance is lo er than 30 ohms. Possible cause: short circuit in the
electrode or cable. For safety reasons the po er output is automatically
s itched off.
6Power display: This t o-digit LED display indicates the chosen po er
setting (values bet een 1 and 25). The indicated value does not necessarily
correspond to the emitted po er in atts because the po er depends on
the tissue resistance.
7Button for increasing the power setting: Pressing this button increases
the po er level by 1.
8Button for reducing the power setting: Pressing this button decreases
the po er level by 1.
9Sym ol: “Unit is defi rillator-safe”: The use of a defibrillator ill not
cause any damage to the unit, provided that the po er control unit is not
active, i.e. the foots itch is not pressed.
10 Sym ol: “Caution! Read the Instructions for Use”: If a unit carries
this symbol, it is necessary to read the Instructions for Use before using it
for the first time.
11 Connection for equipotential onding: See Chap. 3.2 (Installation
Instructions)
12 Power connection: This socket is used for connecting the unit to the
po er supply system. (see Chap. 3.1)
13 Holder for power fuses: The po er control unit is protected by t o
external fuses (see Chap. 6.1). If these fuses blo , an authorised technician
should check the unit for possible defects before ne fuses are fitted and
the unit is operated again.
14 Rating plate: Details of the manufacturer, supply voltage, maximum
po er input, moisture protection class (IP), serial number and relevant
output data.
15 Volume switch: This s itch is used for setting the volume of the acoustic
signal to loud or quiet. In the standard setting (s itch not pressed) the
signal is loud. The sound can be decreased by pressing the s itch.
16 Sym ol: “Non-ionising radiation”: Units hich carry this symbol emit
radiofrequency energy for diagnostic or therapeutic purposes.

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3. Installation Instructions
The unit must be properly installed and commissioned by Olympus Winter & Ibe
GmbH or by a person or firm (distributor) commissioned and authorised by
Olympus Winter & Ibe GmbH.
3.1 Power Supply Connection
The unit must only be connected to the po er supply system ith the cable
supplied or a cable of the same quality (see Chapter 7 Technical Data ). The
po er socket must be correctly installed and must have an earthing contact.
Before connecting up to the po er supply, check that the supply voltage agrees
ith the electrical data on the po er supply unit’s rating plate.
3.2 Equipotential Bonding
To increase electrical safety, the unit can be connected to the equipotential
bonding system of the treatment room. (The housings of all equipment that
comes into contact ith the patient are electrically connected in order to prevent
lo -frequency electrical currents endangering the patient in the event of a
defect in the conventional protective conductor system.)
3.3 Moisture Protection
The unit’s housing is drip-proof (IP 21). Nevertheless, no containers containing
liquid should be placed on the unit.
The CelonFoot S itch is atertight (IP 68). If it comes into contact ith liquid
there is no risk of short circuit.
3.4 Commissioning
Before any unit is used for the first time, the follo ing functional test must be
carried out:
1. Connect to the po er supply and equipotential bonding (see above).
2. Connect the foots itch to the socket (3).
3. S itch on the control unit at the po er s itch (1); the green pilot lamp
must glo .
4. Set the maximum coagulation po er ith buttons (7) and (8) up to the
maximal value of 25. Check that the po er display (6) sho s all values
bet een 1 and 25 correctly.
5. Press the foots itch: The blue signal lamp (4) must no glo , an acoustic
signal (intermittent tone) must be audible.
6. Release the foots itch.
7. End of commissioning.

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4. Instructions for Use
Caution: The po er control unit is intended for use by qualified medical
personnel trained in the use of electrosurgical equipment and targeted
puncture of areas of organs. Please also observe Section 1 (Safety and
Warnings) and also the Instructions for Use for the coagulation electrodes and
accessories.
1. Connect the foot s itch to the socket (3).
2. S itch on the control unit at the po er s itch (1). The unit is ready for
operation after approx. 10 seconds.
3. Connect an RFITT coagulation electrode to the socket (2).
4. Set the necessary coagulation po er ith buttons (7) and (8) in the range
bet een 1 and 25. The po er depends on the type of treatment in
question. Suggestions for suitable settings are to be found in the
Instructions for Use of the compatible coagulation electrodes.
5. Insert the coagulation electrode into the tissue area to be treated.
6. Activate the po er output by pressing the foots itch (the foots itch must
be held do n throughout the entire treatment).
7. End the application by releasing the foots itch hen the end of treatment
(dehydration of the tissue) is indicated by a pulsed acoustic signal or at
any time during the treatment.
8. Repeat steps 4 to 7 if required by the therapy.
9. S itch off the unit at the po er s itch (1).
10. Clean the components follo ing the instructions in Section 5.
Caution: When using bipolar radiofrequency induced thermotherapy (RFITT),
a lo er po er level may lead to longer application times and therefore a larger
coagulation volume.
5. Cleaning and Disinfection
All surfaces of the unit’s housing can be cleaned and disinfected ith the
cleaning agents and surface disinfectants normally used for medical equipment
(mild cleaning solution, e.g. 70 % isopropyl alcohol). No liquid must enter the
connector or the unit during cleaning.
The CelonFoot S itch can be spray or ipe disinfected ith the products
mentioned above.
6. Maintenance and Repair
6.1 Changing the Power Fuses
The unit is protected by t o po er fuses accessible from the outside. If these
fuses blo , an authorised technician should check the unit for possible defects
before ne fuses are fitted and the unit is operated again, as overloading of the
fuses is usually the result of a defect.
Caution: Disconnect the po er plug before changing the fuses! The fuses
inside the housing must only be changed by an authorised technician.

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6.2 Repairs
If a defect occurs, Olympus Winter & Ibe GmbH or a contact appointed by
Olympus Winter & Ibe GmbH (e.g. distributor) must be informed. The repair
must only be carried out by Olympus Winter & Ibe GmbH or a firm authorised by
Olympus Winter & Ibe GmbH (ask the Olympus Winter & Ibe GmbH distributor
responsible for your area). Service documents such as circuit diagrams, parts
lists, equipment descriptions and setting instructions are available from the
manufacturer for technicians ho are authorised to carry out maintenance and
repair.
Caution: When the housing is opened there is a danger of electric shock. The
unit must only be opened by authorised technicians.
6.3 Safety Checks
The unit must undergo a safety check at yearly intervals in accordance ith the
national statutory regulations. For this purpose, Olympus Winter & Ibe GmbH or
a firm authorised by Olympus Winter & Ibe GmbH must be commissioned by the
operator.
6.4 Disposal of the Unit
When disposing of the product, or any of its components, follo all applicable
national and local la s and guidelines.
Waste Electrical and Electronic Equipment
In accordance ith European Directive 2002/96/EC on Waste Electrical
and Electronic Equipment, this symbol indicates that the product must
not be disposed of as unsorted municipal aste, but should be
collected separately.
Refer to your local Olympus distributor for return and/or collection systems
available in your country.
7. Technical Data
Unit designation CelonLab ENT po er control unit
REF: WB991007 (100 ... 120 V~)
REF: WB991001 (200 ... 240 V~)
Outputs bipolar
Applied part Type BF, defibrillation-safe
Rated output po er 25 W at 100 Ohm
Po er selection From 1 to 25 W in 1 W steps
Impedance dependency of the po er See information accompanying the unit
Rated output frequency 470 kHz
Max. peak output voltage < 150 V
peak
Max. peak output voltage as a function
of the po er level
See information accompanying the unit
Audio-frequency of “generator active”
signal 300 Hz – 2.5 kHz (for impedance range 25 – 400 ohms)
Audio-frequency if impedance too lo 300 Hz, pulsed ith approx. 1 Hz