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
6 Operation ................................................................................................. 21
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
9 Maintenance.............................................................................................31
9.1 Regular Checks .................................................................................................... 31
9.2 Faults....................................................................................................................... 31
9.3 Repairs .................................................................................................................... 32
10 Disposal ....................................................................................................33
11 Technical Data..........................................................................................34
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.
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.
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.
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.
Contaminated instruments
Use of contaminated instruments may result in life-threatening in-
fections in patients.
Sterilise the instrument prior to each use.
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
2
4
5
Fig. 3.3 Components of the ARCO Handpieces 53-029 and 53-049
3
1
2
5
6
Fig. 3.4 Components of the ARCO Handpiece 53-030
3
4
1
2
6
7
Fig. 3.5 Components of the ARCO Handpiece 53-047
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.
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.
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.
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.
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.
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.
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.
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.
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).
Requirements
The instrument has been disconnected from the high-fre-
quency surgical unit.
Procedure
1. Unscrew the ceramic nozzle from the handpiece body.
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.
Requirements
The instrument is disconnected from the high-frequency surgi-
cal unit.
Procedure
1. Unscrew the multifunction probe from the handpiece body.
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
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.
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
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).
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.
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)