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User Manual

Sring ARCO Handpieces


53-027, 53-029, 53-030, 53-047, 53-049

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ARCO Handpiece

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Table of Contents

Table of Contents

1 Introduction ............................................................................................... 5
1.1 About This Manual ................................................................................................5
1.2 Display Conventions.............................................................................................5
1.2.1 Safety Information and Warnings....................................................................5
1.2.2 Additional Information ........................................................................................6
1.3 General Conditions ...............................................................................................7

2 Safety.......................................................................................................... 8
2.1 Intended Use ...........................................................................................................8
2.2 General Safety Information ................................................................................9

3 Overview .................................................................................................. 12
3.1 Overview of Instruments.................................................................................. 12
3.2 Scope of Delivery ................................................................................................ 16
3.3 Accessories and Spare Parts............................................................................ 16
3.4 System Overview ................................................................................................ 16

4 Storage ..................................................................................................... 17

5 Assembly and Connection ...................................................................... 18

6 Operation ................................................................................................. 21

7 Disconnection and Disassembly ............................................................ 24

8 Reprocessing............................................................................................ 25
8.1 Disassembling the Instrument....................................................................... 26
8.2 Cleaning and Disinfecting Individual Parts by Machine....................... 28
8.3 Sterilising the Instrument ................................................................................ 30

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Table of Contents

9 Maintenance.............................................................................................31
9.1 Regular Checks .................................................................................................... 31
9.2 Faults....................................................................................................................... 31
9.3 Repairs .................................................................................................................... 32

10 Disposal ....................................................................................................33

11 Technical Data..........................................................................................34

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Introduction

1 Introduction
1.1 About This Manual
This user manual provides instructions and tips for the proper use of
ARCO handpieces. The assembly and disassembly of the ARCO
handpieces and the reprocessing after use are described in detail.
The medical application is not described.
This user manual is included with each ARCO handpiece. Please
read the user manual completely before using an ARCO handpiece.
Please keep this manual for future reference.
The ARCO handpieces are intended for use with an high-frequency
surgical unit from Sring. Please also heed the instructions given in
the user manual for the high-frequency surgical unit.
If you have further questions on the content of this user manual or
use of the ARCO handpieces please contact Sring GmbH (contact
data on back page) or an authorised dealer.

1.2 Display Conventions


1.2.1 Safety Information and Warnings
In this user manual safety information and warnings are marked by
symbols and signal words. Hazards are categorised into four levels.

Names the source of the hazard


Describes the results of the hazard. This will result in death or severe
personal injury.
Specifies the steps that must be taken to eliminate the hazard.

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Introduction

Names the source of the hazard


Describes the results of the hazard. This could result in death or se-
vere personal injury.
Specifies the steps that must be taken to eliminate the hazard.

Names the source of the hazard


Describes the results of the hazard. This could result in minor per-
sonal injury.
Specifies the steps that must be taken to eliminate the hazard.

Names the source of the hazard


Describes the results of the hazard. This could result in material
damage.
Specifies the steps that must be taken to eliminate the hazard.

1.2.2 Additional Information


In this user manual special information is marked by the following
symbol.

Gives further information about the instrument.

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Introduction

1.3 General Conditions


Ensure that the following conditions are met when working with an
ARCO handpiece:
The user manual must be read before an ARCO handpiece can
be used.
Any recurring faults or problems must be reported to Sring
GmbH or an authorised dealer.
Sring GmbH does not accept liability for any damage or personal
injury arising from:
alteration of the instrument,
improper use,
use of accessories other than the recommended ones,
improper handling or
non-compliance with this user manual.

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Safety

2 Safety
2.1 Intended Use
ARCO handpieces are intended exclusively for argon-assisted mo-
nopolar cutting and coagulation on humans. ARCO handpieces are
suitable for use in open, minimally invasive and endoscopic surgery
as well as otolaryngology.
ARCO handpieces may only be used in medical operating rooms.
Only surgeons may operate on patients with the ARCO handpieces.
The ARCO handpieces may only be used by qualified specialists in-
cluding OP staff, physicians, sterilisation department staff, medical
technicians and medical technical assistants.
The ARCO handpieces are intended for use with an high-frequency
surgical unit from Sring.
Any other use is considered to be improper use.
The local health and safety at work, hygiene and safety regulations
and the specifications in this user manual and the user manual for
the high-frequency surgical unit used must be complied with.

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Safety

2.2 General Safety Information

Insufficient qualification
Improper instrument handling may lead to severe personal injury,
irreversible physical injury or death.
Only deploy qualified specialists.
Do not grant access to unauthorised individuals.
Contact the manufacturer if necessary for repairs and mainte-
nance work.

Magnetic fields
Magnetic fields can affect the instrument function and severely in-
jure patients.
Do not use the instrument in the region of influence of a mag-
netic field.
Ensure electromagnetic compatibility.

Damaged connection cable


Damaged insulation on the connection cable may cause electric
shock and result in severe personal injury or death.
Check the connection cable for damage.
If the connection cable is damaged, immediately switch off the
power supply and the gas supply (or do not switch them on).
Only use the instrument if the connection cable is in perfect
condition.

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Safety

Sparking from plasma beam


The sparks and arcs formed during operation may cause fire or ex-
plosions. Explosions and fire may cause severe personal injury or
death as well as considerable material damage.
Avoid endogenous gases. Adapt the patient's diet accordingly
prior to the operation.
Never point the plasma beam at explosive or flammable materi-
als.
Do not use any explosive or flammable materials. Use of the fol-
lowing is strictly prohibited: oxygen-saturated cotton wool or
cotton gauze, alcohol-soaked gauze, flammable anaesthetics,
flammable skin cleansers, flammable degreasers, flammable dis-
infectants, laughing gas (nitrous oxide) or oxygen.
Instruments and probes not in use should not be stored near
the patient.

High-frequency current
The high-frequency current directed at the tissue by the plasma
beam may cause cuts or burns.
The instrument should be used with care and for its intended
purpose only.
The plasma beam may only be directed at the tissue to be
treated.

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Safety

Contaminated instruments
Use of contaminated instruments may result in life-threatening in-
fections in patients.
Sterilise the instrument prior to each use.

Incorrectly connected probe


An incorrectly connected probe may lead to malfunctioning and se-
verely injure patients.
Prior to each use of the instrument ensure that the probe is
properly connected.
Only use disposable probes once.

Incorrect accessories and spare parts


Use of accessories other than those recommended or of incorrect
spare parts may lead to malfunctioning and severely injure patients.
Only use recommended accessories and original spare parts.

Use with other medical devices


Use of the instrument in combination with medical devices from
other manufacturers can have incalculable consequences.
Only use the instrument in combination with suitable medical
devices. The user bears the responsibility for use with any other
medical devices.

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Overview

3 Overview
3.1 Overview of Instruments
ARCO Handpiece 53-027

4
1 5
2
3

7
8
Fig. 3.1 Components of the ARCO Handpiece 53-027

1 ceramic nozzle with O-ring 5 button for selecting coagulation


2 multifunction needle (not 6 handpiece body
included) 7 connection cable
3 sliding sleeve 8 connector
4 button for selecting cutting

Fig. 3.2 Cutting Mode (Left) and Coagulation Mode (Right)

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Overview

ARCO Handpieces 53-029 and 53-049

1
2

4
5
Fig. 3.3 Components of the ARCO Handpieces 53-029 and 53-049

1 probe (not included) 4 connection cable


2 twist sleeve on probe 5 connector
3 handpiece body

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Overview

ARCO Handpiece 53-030

3
1
2

5
6
Fig. 3.4 Components of the ARCO Handpiece 53-030

1 probe (not included) 4 handpiece body


2 twist sleeve on probe 5 connection cable
3 button for selecting coagulation 6 connector

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Overview

ARCO Handpiece 53-047

3
4
1
2

6
7
Fig. 3.5 Components of the ARCO Handpiece 53-047

1 multifunction probe (not 5 handpiece body


included) 6 connection cable
2 sliding sleeve 7 connector
3 button for selecting cutting
4 button for selecting coagulation

Fig. 3.6 Cutting Mode (Left) and Coagulation Mode (Right)

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Overview

3.2 Scope of Delivery


The ARCO handpieces are supplied without accessories.
Recommended accessories are listed in the ARCO catalogue.

3.3 Accessories and Spare Parts


Recommended accessories and original spare parts are listed in the
ARCO catalogue.
Probes are available in various models with various lengths and di-
ameters for easy access to all operating regions.
Only use recommended accessories and original spare parts.

3.4 System Overview


Probe ARCO handpiece High-frequency
600KXXXX 53-0XX surgical unit
600SXXXX ARCO-1000
605KXXXX ARCO-2000
605SXXXX ARCO-3000
630SXXXX
650KXXXX
650SXXXX
The possible combinations of probes and ARCO handpieces are
given in the ARCO catalogue.

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Storage

4 Storage
Always store the sterilised instrument in sterile packaging conform-
ing to ISO 11607. The storage environment must be dry, clean and
dust-free.
Storage temperature: between -20C and 50C.
Relative humidity: max. 85%.
The instrument can also be stored in the product packaging.
Probes belonging to the instrument must be shaped into rings for
storage to prevent kinking or damage.

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Assembly and Connection

5 Assembly and Connection


Assembling and Connecting the ARCO Handpiece 53-027

Requirements
The instrument has been sterilised.
The multifunction needle (or multifunction knife) and the ce-
ramic nozzle have been sterilised.
The high-frequency surgical unit is ready for operation.

Procedure
1. Slide the multifunction needle into the handpiece body until it
reaches the stop.

2. Screw the ceramic nozzle on to the handpiece body and


tighten.

3. Check whether the multifunction needle can be extended and


retracted.
To do this, move the sliding sleeve to and fro.

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Assembly and Connection

4. Insert the connector at the end of the cable into the connector
socket on the high-frequency surgical unit.
The connector engages in the socket.
The instrument is connected to the high-frequency surgical
unit.
The high-frequency surgical unit recognises the connected
instrument.
The instrument is purged with argon gas.

Assembling and Connecting the ARCO Handpieces 53-029, 53-030 and


53-049

Requirements
The instrument has been sterilised.
The probe has been sterilised.
The high-frequency surgical unit is ready for operation.

Procedure
1. Screw the probe on to the handpiece body and tighten.
While doing so, be sure to grip the probe by the twist sleeve
only.

2. Insert the connector at the end of the cable into the connector
socket on the high-frequency surgical unit.
The connector engages in the socket.
The instrument is connected to the high-frequency surgical
unit.
The high-frequency surgical unit recognises the connected
instrument.
The instrument is purged with argon gas.

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Assembly and Connection

Assembling and Connecting the ARCO Handpiece 53-047

Requirements
The instrument has been sterilised.
The multifunction probe has been sterilised.
The high-frequency surgical unit is ready for operation.

Procedure
1. Screw the multifunction probe on to the handpiece body and
tighten.

2. Check whether the multifunction probe can be extended and


retracted.
To do this, move the sliding sleeve to and fro.

3. Insert the connector at the end of the cable into the connector
socket on the high-frequency surgical unit.
The connector engages in the socket.
The instrument is connected to the high-frequency surgical
unit.
The high-frequency surgical unit recognises the connected
instrument.
The instrument is purged with argon gas.

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Operation

6 Operation
Use of the ARCO handpieces and the treatment may only be carried
out by qualified specialists.
The treating physician is responsible for weighing the risks of treat-
ment against the benefits.
Please read the user manual supplied with the high-frequency sur-
gical unit.

Contaminated instruments
Use of contaminated instruments and accessories may result in
life-threatening infections in patients.
Sterilise the instruments and accessories prior to each use.
Only use sterilised instruments and accessories.
Only use disposable accessories once.

Incorrect use of the instrument


Keeping the probe tip in one position for a prolonged period of
time may cause damage to tissues, nerves, vessels and the skin as a
result of coagulation.
Do not hold the probe tip in one place for a long time.
Only activate the instrument for a maximum of 10 seconds at a
time.

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Operation

Contact with grounded objects


Contact with grounded objects will result in grounding of the pa-
tient. When this occurs the high-frequency current cannot flow
through the intended path; a leakage current arises. This may result
in severe burns.
Do not touch the patient with a grounded object.
Do not use passive instruments during the treatment.

Contact with fluids


Contact with fluids may result in grounding of the patient. When
this occurs the high-frequency current cannot flow through the in-
tended path; a leakage current arises. This may result in severe
burns.
Place the patient on a dry surface.
Keep the surface dry.
Immediately vacuum up any fluids.

Insufficient visual monitoring of the neutral electrode


If the neutral electrode has not been positioned properly on the pa-
tient, a very high contact resistance may result and the patient may
sustain severe burns. The performance of the instrument will also
drop.
Make sure the neutral electrode is flat against the skin.
Check the position of the neutral electrode during the treat-
ment.

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Operation

Freely hanging connection cable


If the connection cable is hanging freely it can hinder the staff and
cause tripping, increasing the danger to the patient. The treatment
may have to be interrupted as a result.
Lay the instrument cable such that it cannot get in anyone's
way.

Prior to each use the instrument must be cleaned, disinfected and


sterilised (see chapter 8 Reprocessing on page 25). This also applies
to the initial use as the instrument is delivered in an unsterilised
condition.
Prior to each use the instrument function must be tested.
After use the instrument must be disassembled and reprocessed
(see chapters 7 Disconnection and Disassembly on page 24 and 8 Re-
processing on page 25).

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Disconnection and Disassembly

7 Disconnection and Disassembly


After use the instrument must be disconnected from the high-fre-
quency surgical unit. Then the instrument must be disassembled for
reprocessing (see section 8.1 Disassembling the Instrument on
page 26).

Requirements
The high-frequency surgical unit has been deactivated.

Procedure
1. Disconnect the connection cable from the connector socket on
the high-frequency surgical unit.
Pull on the gripper sleeve on the connector to do this.
The instrument is now disconnected from the high-fre-
quency surgical unit.

If the instrument cannot be disassembled and reprocessed immedi-


ately place it into a closed container. The container protects the in-
strument during transport and prevents contamination by the
environment.

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Reprocessing

8 Reprocessing
After each use the ARCO handpieces and used probes must be re-
processed.
The instrument undergoes natural wear due to thermal, chemical
and mechanical loading. Reprocessing of the instrument has a mini-
mal effect on its service life.
Reprocessing comprises three main steps:
cleaning,
disinfection and
sterilisation.
Only use disinfectants recommended by the Robert Koch Institute
(see DGHM-List).

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Reprocessing

8.1 Disassembling the Instrument


Disassembling the ARCO Handpiece 53-027

Requirements
The instrument has been disconnected from the high-fre-
quency surgical unit.

Procedure
1. Unscrew the ceramic nozzle from the handpiece body.

2. Pull the multifunction needle out of the handpiece body.

The instrument is now disassembled.

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Reprocessing

Disassembling the ARCO Handpieces 53-029, 53-030 and 53-049

Requirements
The instrument is disconnected from the high-frequency surgi-
cal unit.

Procedure
1. Unscrew the probe from the handpiece body.
While doing so, be sure to grip the probe by the twist sleeve
only.

The instrument is now disassembled.

Disassembling the ARCO Handpiece 53-047

Requirements
The instrument is disconnected from the high-frequency surgi-
cal unit.

Procedure
1. Unscrew the multifunction probe from the handpiece body.

The instrument is now disassembled.

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Reprocessing

8.2 Cleaning and Disinfecting Individual Parts by Machine


A cleaning and disinfecting machine must be used for cleaning and
disinfection of the individual parts.
Please read the user manual supplied with the cleaning and disin-
fecting machine.

Requirements
The instrument has been disassembled into its individual parts
(see section 8.1 Disassembling the Instrument on page 26).

Procedure
1. Lay the accessories without lumens (e.g. multifunction needles
or knives) in a suitable sieve insert.
2. Place the disassembled instrument and the connection cable in
a storage rack.
3. Load the storage rack and the sieve insert into the cleaning and
disinfecting machine.
Connect all individual parts and instruments with lumens (e.g.
probes or extension pieces) to flushing devices.
Make sure all lumens can be sufficiently flushed through.
4. Clean all individual parts in the cleaning and disinfecting ma-
chine.
Follow the guidelines of the Robert Koch Institute in the proc-
ess.
Water type: mains water
Process chemical: alkaline with pH > 10
Temperature: 55C
Duration: 10 minutes
5. Carry out an intermediate neutralisation rinsing step on all indi-
vidual parts.
Water type: mains water

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Reprocessing

6. Disinfect all individual parts in the cleaning and disinfecting ma-


chine.
Water type: mains water
Temperature: 93C
Duration: 5 minutes
7. Allow all individual parts to dry in the cleaning and disinfecting
machine.
Make sure all lumens are dried.
Temperature: 90C
Duration: 40 minutes
All individual parts have now been cleaned and disinfected.

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Reprocessing

8.3 Sterilising the Instrument


An autoclave and special packaging conforming to ISO 11607 must
be used for instrument sterilisation.
Please observe the instructions for use supplied with the autoclave.

Requirements
All individual parts have been cleaned and disinfected (see sec-
tion 8.2 Cleaning and Disinfecting Individual Parts by Machine on
page 28).

Procedure
1. Place the instrument in the packaging.
2. Sterilise the packaged instrument in the autoclave with a frac-
tionated pre-vacuum.
Pressure: 3 bar
Temperature: 134C
Duration: 5 minutes
3. Allow the instrument to dry in the packaging.
Duration: 5 minutes
The instrument has now been sterilised and can be used for
treatment.

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Maintenance

9 Maintenance
9.1 Regular Checks
Prior to each use ensure that:
the instrument is in perfect condition,
the instrument has been sterilised and
the connection cable is undamaged.
A safety inspection must be carried out on the instrument once a
year. The safety inspection may only be carried out by competent
individuals using suitable measuring and testing devices. The proce-
dure and the results of this safety inspection must be reported.

9.2 Faults

Use despite the presence of a fault


Use of the instrument when a fault condition exists may lead to mal-
functions and result in life-threatening injury to patients.
Immediately eliminate the cause of the fault.
Report any recurring faults to the manufacturer.

Fault Possible cause Remedy


No current applied to The probe has not Install the probe cor-
tissue. been installed cor- rectly.
rectly. Replace the instru-
The instrument is de- ment.
fective.
Error message show- Gas flow blockage or Check the instructions
ing on high-frequency gas deficiency. given in the user man-
surgical unit. ual for the high-fre-
quency surgical unit.

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Maintenance

9.3 Repairs

Unauthorised repairs
Improper repairs may lead to malfunctions and result in life-threat-
ening injury to patients.
Repairs may only be carried out by the manufacturer or individ-
uals authorised by the manufacturer.
Only original spare parts may be used.

You can replace spare parts yourself. Only use original spare parts
(see the ARCO catalogue).
Defective instruments may be sent to the manufacturer for repair.
Only send cleaned, disinfected and sterilised instruments.
Please send irreparable instruments to the manufacturer or a dis-
posal company for proper disposal (see chapter 10 Disposal on
page 33).

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Disposal

10 Disposal
If the instrument has reached its end of life it must be properly dis-
posed of.
Send the instrument to a disposal company or deliver it to the man-
ufacturer.
Only cleaned, disinfected and sterilised instruments can be sent for
disposal or returned to the manufacturer.

Contaminated instruments
Improperly disposed of contaminated instruments can lead to
life-threatening infections in people and/or damage to the environ-
ment.
Only send cleaned, disinfected and sterilised instruments for
disposal.

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Technical Data

11 Technical Data
ARCO Handpiece 53-027
Material: high-performance thermoplastic
(PEEK)
Power output: max. 120 W
Compatibility: ARCO-3000, ARCO-2000,
ARCO-1000
Power connection: integrated connection cable
Gas connection: integrated connection cable
Temperature: operation: 10C to 40C
transport and storage: -20C to
50C
Relative humidity: operation: max. 80%
transport and storage: max. 85%
Activation: button for selecting cutting,
button for selecting coagulation
Maximum activation time: 10 s
Reprocessing: machine-washable
Classification: protection class I (in accordance
with EN 60601-1),
type BF (in accordance with EN
60601-1),
class IIb (in accordance with
93/42/EWG)

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Technical Data

ARCO Handpiece 53-029


Material: high-performance thermoplastic
(PEEK)
Power output: max. 120 W
Compatibility: ARCO-3000, ARCO-2000,
ARCO-1000
Power connection: integrated connection cable
Gas connection: integrated connection cable
Temperature: operation: 10C to 40C
transport and storage: -20C to
50C
Relative humidity: operation: max. 80%
transport and storage: max. 85%
Activation: foot switch
Maximum activation duration: 10 s
Reprocessing: machine-washable
Classification: protection class I (in accordance
with EN 60601-1),
type BF (in accordance with EN
60601-1),
class IIb (in accordance with
93/42/EWG)

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Technical Data

ARCO Handpiece 53-030


Material: high-performance thermoplastic
(PEEK)
Power output: max. 120 W
Compatibility: ARCO-3000, ARCO-2000,
ARCO-1000
Power connection: integrated connection cable
Gas connection: integrated connection cable
Temperature: operation: 10C to 40C
transport and storage: -20C to
50C
Relative humidity: operation: max. 80%
transport and storage: max. 85%
Activation: button for selecting coagulation
Maximum activation time: 10 s
Reprocessing: machine-washable
Classification: protection class I (in accordance
with EN 60601-1),
type BF (in accordance with EN
60601-1),
class IIb (in accordance with
93/42/EWG)

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Technical Data

ARCO Handpiece 53-047


Material: high-performance thermoplastic
(PEEK)
Power output: max. 90 W
Compatibility: ARCO-3000, ARCO-2000,
ARCO-1000
Power connection: integrated connection cable
Gas connection: integrated connection cable
Temperature: operation: 10C to 40C
transport and storage: -20C to
50C
Relative humidity: operation: max. 80%
transport and storage: max. 85%
Activation: button for selecting cutting,
button for selecting coagulation
Maximum activation time: 10 s
Reprocessing: machine-washable
Classification: protection class I (in accordance
with EN 60601-1),
type BF (in accordance with EN
60601-1),
class IIb (in accordance with
93/42/EWG)

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Technical Data

ARCO Handpiece 53-049


Material: high-performance thermoplastic
(PEEK)
Power output: max. 90 W
Compatibility: ARCO-3000, ARCO-2000,
ARCO-1000,
software version 3.20 and higher
Power connection: integrated connection cable
Gas connection: integrated connection cable
Temperature: operation: 10C to 40C
transport and storage: -20C to
50C
Relative humidity: operation: max. 80%
transport and storage: max. 85%
Activation: foot switch
Maximum activation duration: 10 s
Reprocessing: machine-washable
Classification: protection class I (in accordance
with EN 60601-1),
type BF (in accordance with EN
60601-1),
class IIb (in accordance with
93/42/EWG)

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Sring GmbH
Justus-von-Liebig-Ring 2
D-25451 Quickborn
Tel.: +49 (0)4106-6100-0
Fax: +49 (0)4106-6100-10 Redaction
E-Mail: info@soering.com ZINDEL AG
Internet: www.soering.com www.zindel.de

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