Richard Wolf 2271 User manual

GA--A 181 /en/ Index: 09--05--5.0 / ÄM: KG 04--252
Ultrasound Generator
2271
Instruction Manual

0GA--A 181
Important general instructions for use
Ensurethatthisproductisonlyusedasintendedanddescribed intheinstructionmanual,byade-
quately trained and qualified personnel, and that maintenance and repair is only carried out by
authorized specialized technicians.
Operate this product only in the combinations and with the accessories and spare parts listed in
the instruction manual. Use other combinations, accessories and wearing parts only if they are
expressly intended for this use and if the performance and safety requirements are met.
Reprocesstheproducts beforeeveryapplicationand before returningthemfor repairasrequired
by the instruction manual in order to protect the patient, user or third parties.
Subject to technical changes!
Due to continuous development of our products, illustrations and technical data may deviate
slightly from the data in this manual.
CAUTION -- USA only:
Federallawrestrictsthisunittobeusedorsold, exceptunderthesupervision ofamedicaldoctor.
Safety instructions and levels of danger
Symbol Level of danger
WARNING!
Failure to observe can result in death or severe injury.
CAUTION!
Failure to observe can result in slight injury or damage to the product.
.IMPORTANT!
Failure to observe can result in damage to the product or surrounding.
.NOTE!
Tips for optimum use and other useful information.
GERMANY
RICHARD WOLF GmbH
D--75438 Knittlingen
Pforzheimerstr. 32
Tel.:(..49)--(0)7043--35--0
Fax:(..49)--(0)7043--35300
MANUFACTURER
E--mail: [e-mail]
Internet: www.richard--wolf.com
USA
RICHARD WOLF
Medical Instruments Corp.
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Tel.: [phone]
Fax:[phone]
E--mail: sales&[email protected]
Internet: www.richardwolfusa.com
UK
RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW 17 0HB
Tel.: [phone]
Fax:[phone]
E--mail: [email protected]
Internet: www.richardwolf.uk.com
BELGIUM
N.V. Endoscopie
RICHARD WOLF Belgium S.A.
Industriezone Drongen
Landegemstraat 6
B--9031 Gent --Drongen
Tel.: [phone]
Fax:[phone]
E--mail: [e-mail]
FRANCE
RICHARD WOLF France S.A.R.L.
Rue Daniel Berger
Z.A.C. La Neuvillette
F--51100 Reims
Tel.: [phone]
Fax:[phone]
E--mail: [email protected]
AUSTRIA
RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A--1160 Wien
Tel.: +43 1-- 405 51 51
Fax:+43 1-- 405 51 51--45
E--mail: [e-mail]
Internet: www.richard--wolf.at

Contents
I
GA--A 181
1 General information 1.......................................................
1.1 Symbols 1..................................................................
1.2 Intended use 2..............................................................
1.2.1 Contraindications 2...........................................................
1.3 Combinations 2..............................................................
1.3.1 Device combinations 2........................................................
1.3.2 General requirements on products/components of a combination 3.................
1.3.3 Specific requirements on the products/components of a combination 4..............
1.4 Electromagnetic compatibility (EMC) 4..........................................
2 Illustration 6................................................................
2.1 Front panel 6................................................................
2.1.1 Legend 6...................................................................
2.2 Rear panel 7................................................................
2.2.1 Legend 7...................................................................
3Setup 8....................................................................
3.1 Preparation when using Suction Pump 2207 9...................................
3.1.1 Ultrasound Generator with “Suction Pump 2207” 9................................
3.1.2 Legend 9...................................................................
3.1.3 Rear panel connectors 10......................................................
3.1.4 Front panel connectors 10......................................................
4 Checks 11...................................................................
4.1 Visual check 11...............................................................
4.2 Functional checks 11..........................................................
4.2.1 Ultrasound generator and transducer 11..........................................
4.2.2 Ultrasound Generator and Suction Pump 12......................................
5Use 13......................................................................
5.1 Operating principle of Ultrasound Generator 13...................................
5.2 Operating principle of ultrasound lithotripsy 13....................................
5.3 Operation of Ultrasound Generator 14...........................................
5.3.1 Controls and indicators of Ultrasound Generator 2271 (US--LITHO) 15...............
5.3.2 Ultrasound Generator ON/OFF 15...............................................
5.3.3 “Intensity” preselection (power stage) 16.........................................
5.3.4 Activation of transducer 16.....................................................
5.3.5 ”Transducer malfunction” warning lamp 16........................................
5.3.6 ”Generator malfunction” alarm lamp 16...........................................
5.4 Changing the sonotrode 17.....................................................
5.4.1 Checking the sonotrodes 17....................................................
5.4.2 Changing the sonotrodes 18....................................................
6 Operation in the RIWO NET SYSTEM 19.......................................
6.1 Combination with RIWO NET SYSTEM 19.......................................
6.2 Operation 19.................................................................
6.3 Connection to the RIWO NET SYSTEM 20.......................................
6.4 Controlling the devices using the RIWO--NET menu 21.............................
6.4.1 Controlling the devices via the different input media 21.............................
6.4.2 Illustration of menu 21.........................................................

II GA--A 181
6.4.3 Main menu 22................................................................
6.4.4 Ultrasound output function 22...................................................
6.5 System messages 22..........................................................
6.5.1 Operating instructions 22.......................................................
6.5.2 Warnings 22..................................................................
6.5.3 Error messages 22............................................................
7 Reprocessing and maintenance 23............................................
7.1 Reprocessing of device 23.....................................................
7.2 Reprocessing of accessories 24.................................................
7.2.1 Wet preparation at the point of use 24...........................................
7.2.2 Disassembly before cleaning 24.................................................
7.2.3 Manual cleaning 25............................................................
7.2.4 Machine cleaning 25...........................................................
7.2.5 Disinfection 26................................................................
7.2.6 Steam sterilization 26..........................................................
7.2.7 Assembly 26.................................................................
7.2.8 Reprocessing of foot switch 26..................................................
7.3 Maintenance of device and accessories 27.......................................
7.4 Maintenance 27...............................................................
7.4.1 Maintenance intervals 27.......................................................
7.5 Quarterly check 27............................................................
7.5.1 Measuring devices and auxiliary means for checking 27............................
7.5.2 Visual check 28...............................................................
7.5.3 Functional checks 28..........................................................
7.6 Technical safety check 29......................................................
8 Technical description 30.....................................................
8.1 Trouble shooting 30...........................................................
8.1.1 Device faults 30...............................................................
8.2 Technical data 31.............................................................
8.2.1 Electrical connection 31........................................................
8.2.2 Technical data of ultrasound generator 31........................................
8.2.3 Interfaces of ultrasound generator 31............................................
8.2.4 Technical data of transducer (2271.501) 32.......................................
8.2.5 Technical data of footswitch (2030.12) 32.........................................
8.3 Operating, storage, transport and shipping conditions 32...........................
8.4 Spare parts and accessories 33.................................................
8.5 Replacing parts 34............................................................
8.5.1 Device fuses 34...............................................................
8.5.2 Disposal of the product, packing material and accessories 34.......................
9 Literature 35.................................................................

1
GA--A 181
1 General information
1.1 Symbols
Symbols Meaning
Attention, consult ACCOMPANYING DOCUMENTS
Off (disconnection from mains/power)
On (connection to mains/power)
Equipotentality
Fuse
µAlternating current (AC)
TYPE BF APPLIED PART
Intensity preselection, stage III
Intensity preselection, stage II
Intensity preselection, stage I
Fault indicator “Generator malfunction” warning lamp
Fault indicator ”Transducer malfunction” warning lamp
Standby indicator, “Device output active” lamp (foot switch actuated)
Socket for foot switch
Interface symbol/device output (e.g. RIWO NET SYSTEM)
Interface symbol/device input (e.g. RIWO NET SYSTEM)
Socket, 4--pole, control output (Suction Pump)
REF Order number
A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as
Medical Electrical Equipment to standard CAN/CSA C 22.2 No. 601.1 (c) and UL 60601--1 (us)
Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product
and/or packagingis marked with this symbol. Products of category IIa and above, as well as
sterile products or products with measuring function of category I, are additionally marked with the
code number of the notified body (0124).

2GA--A 181
1.2 Intended use
The ultrasound generator (US--LITHO) 2271 with transducer and sono-
trode is used in intracorporeal ultrasound lithotripsy exclusively for desin-
tegrating kidney stones, urinary bladder stones and ureter stones under
direct endoscopic view. The use of this device for purposes other than
the above is not admissible.
CAUTION!
In therapeutic use an adequate backup unit must be available for
the unlikely event that the device fails.
1.2.1 Contraindications Contraindications directly related to the product are presently unknown.
On the basis of the patient’s general condition the doctor in charge must
decide whether the planned use is possible or not. For further information
please refer to the current medical literature.
.NOTE!
Before the first use we recommend reading the relevant literature (see
chapter 9 literature“).
1.3 Combinations
WARNING!
Danger of life-threatening embolism.
If used in combination with a peristaltic suction pump (e.g. Suction
Pump 2207) no air or liquid must be discharged from the tip of the
sonotrode. The sonotrode must be used exclusively for evacuating.
Strictly follow the instruction manual of the roller suction pump.
.IMPORTANT
In addition to this instruction manual follow the manuals of the products
used in combination with this product.
1.3.1 Device combinations The Ultrasound Lithotriptor consisting of Ultrasound Generator 2271 with
transducer and sonotrode may only be used in conjunction with a suitable
suction device, e.g. a suction pump. The R.Wolf “Suction Pump 2207” is
specially designed for use with the ultrasound generator and provides
ideal conditions for the use of this device.
If a different suction pump or suction device (different manufacturer) is
used, the operator/user must check whether the suction device features
a controllable, adjustable vacuum, which meets the requirements.
To ensure sufficient cooling of the transducer and the sonotrode, make
sure that the suction device can provide an adjustable vacuum of up to
--0.6 bar on a continuous basis.

3
GA--A 181
1.3.2 General requirements on products/components of a combination
The general requirements depend on whether the products/components are in-
side or outside the patient environment.
Patient environment
R=1.5m Patient environment
h=2.5m
Acc. to UL 60601--1: R = 1.83 m (6 feet) ; h = 2.29 m (71/2feet)
Inside the patient environment Non--medically
used room
Medically used room
outside the patient
environment
Requirements / measures
Leakage currents to clause 19
IEC/EN 60601--1--1 *
MP MP
MP NMP
MP NMP
MP NMP
MP MP or
NMP
µ
a) additional protective earth connection
(to be clarified with manufacturer),
or
b) with additional isolating transformer **
a) common protective earth connection, or
b) additional protective earth connection
(to be clarified with manufacturer), or
c) additional separating device (to avoid
earth/ground loops in the case of a
potential difference)
MP NMP
-- --
-- --
-- --
**
--
additional separating device
according to IEC/ EN 60601--1--1
additional isolating transformer
according to IEC/ EN 60601--1--1 ** µpower supply grid
Functional
connection
µ
µµ
µ
µ
µµ
µ
µ
MP =medical electrical device according to IEC/ EN 60601--1, UL 60601--1, CSA C22.2 No. 601
NMP =non--medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards
*If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 µA
(300 µAfor systems in acc.with UL 60601--1).
** e.g. Richard Wolf Video Trolley with ”isolating transformer”.

4GA--A 181
1.3.3 Specific requirements on the products/components of a combination
.IMPORTANT!
Persons combining products to form a system are responsible for not impairing the system’s compliance with
the performance and safety requirements, and that the technical data and the intended use are adequately
fulfilled.
Electromagnetic interference or other types of interference occurring between this product and other products
can cause failures or malfunctions.
When selecting the system components ensure that they meet the requirements for the medical environment
they are used in, in particular IEC/ EN 60601--1--1. In case of doubt contact the manufacturer(s) of the system
components.
Do not touch connecting devices for electrical connections between the different components (such as signal
input and output connections for video signals, data exchange, control circuits, etc.) and the patient at the
same time.
1.4 Electromagnetic compatibility (EMC)
NOTE: The device or system in the following called product always relates to the ultrasound generator 2271
Guidance and manufacturer’s declaration -- electromagnetic emissions
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Emissions measurement/test Compliance Electromagnetic environment -- Guidance
HF emissions to CICPR 11 Group 1 The product uses HF energy for its internal function.
The HF emission level is extremely low and it is not likely to cause any
interference in nearby electronic equipment.
HF emissions to CISPR 11 Class B
Harmonic emissions to IEC 61000--3--2 Class A The product is suitable for use in all establishments, including domestic
e
s
t
a
b
l
i
s
h
m
e
n
t
s
a
n
d
t
h
o
s
e
d
i
r
e
c
t
l
y
c
o
n
n
e
c
t
e
d
t
o
t
h
e
p
u
b
l
i
c
l
o
w
--
v
o
l
t
a
g
e
In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker
emissions”
e
s
t
a
b
l
i
s
h
m
e
n
t
s
a
n
d
t
h
o
s
e
d
i
r
e
c
t
l
y
c
o
n
n
e
c
t
e
d
t
o
t
h
e
p
u
b
l
i
c
l
o
w
--
v
o
l
t
a
g
e
power supply network that supplies buildings used for domestic purposes.
Guidance and manufacturer’s declaration -- electromagnetic immunity
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Immunity tests IEC 60601 test level Compliance Electromagnetic environment -- guidance
Electrostatic Discharge (ESD)
to IEC 61000--4--2 ±6 KV contact
±8KVair Yes Floors should wood, concrete or ceramic tile.
If the floors are covered with synthetic material, the
releative humidity should be at least 30%.
Electrical fast transients, bursts
to IEC 61000--4--4 ±2 KV for power supply lines
±1 KV for input/output lines Yes Mains/line power quality should be that of a typical
commercial or hospital environment.
Surge voltage (surges)
to IEC 61000--4--5 ±1 KV differential mode
±2KVcommonmode Yes Mains/line power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short interruptions and
voltage variations on power supply
input lines
to IEC 61000--4--11
Voltage dip for 0.5 cycle
> 95% UT*
Voltage dip for 5 cycles
> 60% UT*
Voltage dip for 25 cycles
> 30% UT*
Voltage dip for 5 sec
> 95% UT*
Yes
Mains/line power quality should be that of a typical
commercial or hospital environment. If the user of
the product requires continued operation during
power mains/line interruptions it is recommended
that the product be powered from an uninterruptible
power supply or battery.
Power frequency (50/60 Hz) magnetic
field,
to IEC 61000--4--8 3A/m Yes Power frequency magnetic fields should be at
levels characteristic of a typical location in a
commercial or hospital environment.
*NOTE: UTis the line/mains voltage prior to application of the test level.

5
GA--A 181
Guidance and manufacturer’s declaration -- electromagnetic immunity for products that are not life--supporting
The product is intended for use in the environment specified below. The user should assure that the product is used in such an environment.
Immunity test IEC 60601 test levels Compliance
level Electromagnetic environment -- guidance
Conducted HF interference
to IEC 61000--4--6
Radiated HF interference
to IEC 61000--4--3
3V
rms
150kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
Yes
Portable and mobile RF communications equipment should be
used no closer to any part of the product, including cables,
than the recommended separation distance calculated from
equation applicable to the frequency of the transmitter.
Recommended separation distance:
d=1.2pP
d=1.2pP for 80 MHz to 800 MHz
d=2.3pP for 800 MHz to 2.5 GHz
P = Nominal power output rating of the transmitter in watts (W)
(according to the transmitter manufacturer)
d = recommended separation distance in meters (m)
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey1, should be less than the
compliance level in each frequency range2.
Interference may occur in the vicinity of devices with the
following symbol:
REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.
These guidelines may no apply in all situations, as the propagation of electromagnetic waves is affected by absorption and
reflexion from buildings, objects and people.
1= The field strength of fixed transmitters (e.g. base stations for radio telephones, land mobile radios, amateur radio, radio broadcast and
TV broadcast, ...), cannot be predicted theoretically with accuracy. To assess the EMC environment due to fixed transmitters an
electromagnetic site survey should be conducted. If the measured field strength in the location in which the product is used exceeds
the applicable compliance level above, the product should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be required, such as reorienting or relocating the product.
2= Over the frequency range between 150 kHz and 80 MHz the field strength should be below 3 V/m.
The recommended separation distances between portable and mobile HF telecommunication devices and
devices which are not life--supporting
The product is intended for use in an electromagnetic environment with HF disturbances are controlled.
The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
HF telecommunications equipment and the product.
R
a
t
e
d
n
o
m
i
n
a
l
o
u
t
p
u
t
p
o
w
e
r
o
f
t
h
e
Separation distance as a function of transmitter frequency (m)
Rated nominal output power of the
transmitter (Watts) 150 kHz to 80 MHz
d=1.2pP80 MHz to 800 MHz d=1.2pP800 MHz to 2.5 GHz d=2.3pP
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a nominal output power not listed in the table above, the recommended separation distance (d) in meters (m) can
be determined using the applicable equation (observe frequency). P = nominal power of the transmitter in Watts (W).
REMARKS: At 80 MHz and 800 MHz the higher frequency range applies.
These guidelines may no apply in all situations. Electromagnetic propagation is affected by absorption and reflexion
from buildings, objects and people.

6GA--A 181
2Illustration
2.1 Front panel
3
45
2
67
1
2.1.1 Legend
1Power switch with green LED 5“Foot switch actuated” indicator lamp
2Socket for foot switch 6“Transducer malfunction” warning lamp
3Connection bar for transducer 7“Generator malfunction” alarm lamp
4Intensity button for power stage preselection