Wolf 2271 User manual

Instruction Manual

Ultrasound Generator

GA--A 181 /en/ Index: 09--05--5.0 / ÄM: KG 04--252

2271

Important general instructions for use

Ensurethatthisproduct isonlyusedas intendedanddescribedin theinstructionmanual,by ade­quately trained and qualified personnel, and that maintenance and repair is only carried out by
authorized specialized technicians.

Operate this product onlyinthe combinations and with the accessoriesandspare parts listed in
the instruction manual. Use othercombinations, accessories and wearing parts only if theyare
expressly intended for this use and if the performance and safety requirements are met.

Reprocesstheproductsbefore every applicationandbeforereturning them forrepairasrequired
by the instruction manual inorder 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 inthis manual.

CAUTION -- USA only:
Federallawrestrictsthis unittobeused orsold,exceptunder the supervisionofamedical doctor.

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

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]

0

USA

RICHARD WOLF
Medical Instruments Corp.
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Tel.: [phone]
Fax:[phone]

E--mail: sales&[e-mail]
Internet: www.richardwolfusa.com

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: [e-mail]

UK

RICHARD WOLF UK Ltd.
Waterside Way
Wimbledon
SW 17 0HB
Tel.: [phone]
Fax:[phone]

E--mail: [e-mail]
Internet: www.richardwolf.uk.com

AUSTRIA

RICHARD WOLF Austria
Ges.m.b.H.
Wilhelminenstraße 93 a
A--1160 Wien
Tel.: +431-- 405 51 51
Fax:+431-- 405 51 51--45

E--mail: [e-mail]
Internet: www.richard--wolf.at

GA--A 181

Contents

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 1 1..........................................................

4.2.1 Ultrasound generator and transducer 1 1..........................................

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.........................................................

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I

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.................................................................

II

GA--A 181

1 General information

1.1 Symbols

Symbols

µ

Meaning

Attention,consultACCOMPANYING DOCUMENTS

Off(disconnection from mains/power)
On (connection to mains/power)

Equipotentality

Fuse
Alternating current(AC)

TYPE BF APPLIED PART

Intensity preselection, stage III

Intensity preselection, stage II

Intensity preselection, stage I

Fault indicator“Generator malfunction” warning lamp

REF

Fault indicator”Transducer malfunction” warning lamp

Standby indicator, “Device output active” lamp (foot switch actuated)

Socket for foot switch

Interfacesymbol/device output(e.g.RIWONET SYSTEM)

Interfacesymbol/device input(e.g.RIWO NET SYSTEM)

Socket, 4--pole, control output (Suction Pump)
Order number

A Registered Trademark of ETL, a Recognized Testing Laboratory, listing compliance as
Medical Electrical Equipment tostandard 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 andabove, as well as
sterile products or products with measuring function of category I, are additionally marked with the
code number of thenotified body (0124).

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1

1.2 Intended use

1.2.1 Contraindications

The ultrasound generator (US--LITHO) 2271 with transducer and sono­trode is used in intracorporeal ultrasound lithotripsy exclusively for desin­tegrating 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.

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

.

1.3.1 Device 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.

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.

2

GA--A 181

1.3.2 General requirements on products/components of a combination

The general requirements depend on whethertheproducts/components arein­side or outside the patient environment.

Medically used room

Inside the patient environment

MP

µ

MP

µ

MP NMP

µ

MP

NMP

MP

µ

NMP

µ

**

Patient environment

Acc. to UL 60601--1: R = 1.83 m (6 feet) ; h = 2.29 m (71/2feet)

outside the patient

environment

--

--

R=1.5m

Non--medically

used room

--

--

Patient environment

h=2.5m

Requirements / measures

Leakage currents to clause 19

IEC/EN 60601--1--1

*

--

a) additional protective earth connection

(to be clarified with manufacturer),

or

b) with additional isolating transformer

**

µ

MP

µ

MP

µ

additional isolating transformer
according to IEC/ EN 60601--1--1 **

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 µA for systems in acc.withUL 60601--1).

** e.g. Richard Wolf Video Trolley with ”isolating transformer”.

NMP

µ

additional separating device
according to IEC/ EN 60601--1--1

--

MP or

NMP

µ

--

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 inthe case of a
potential difference)

Functional
connection

µ power supply grid

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3

1.3.3 Specific requirements on the products/components of a combination

establishmentsandthosedirectlyconnectedtothepubliclow--voltage

IMPORTANT!

.

Persons combining products to form a system areresponsible fornot impairing thesystem’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 ofinterference occurring between this product and other products
can cause failures or malfunctions.
When selecting the system components ensure thatthey meet the requirements for the medical environment
they are used in,inparticular IEC/ EN60601--1--1. In caseof doubt contact the manufacturer(s)of the system
components.
Do not touch connecting devicesfor electrical connections betweenthe different components (such as signal
input and output connections for video signals, data exchange,controlcircuits, etc.) and thepatientatthe
same time.

1.4 Electromagnetic compatibility (EMC)

NOTE: The device orsystem 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

HF emissions to CISPR 11 Class B
Harmonic emissions to IEC 61000--3--2 Class A
In conformity with IEC 61000--3--3 “Voltage fluctuations / flicker

emissions”

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.

The product is suitable for use in all establishments, including domestic

--

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

Electrical fast transients, bursts
to IEC 61000--4--4

Surge voltage (surges)
to IEC 61000--4--5

Voltage dips, short interruptions and
voltage variations on power supply
input lines
to IEC 61000--4--11

Power frequency (50/60 Hz) magnetic
field,
to IEC 61000--4--8

* NOTE: UTis the line/mains voltage prior to application of the test level.

± 6 KV contact
± 8KVair

± 2 KV for power supply lines
± 1 KV for input/output lines

± 1 KV differential mode
± 2KVcommonmode

Voltage dip for 0.5cycle
> 95% U

Voltage dip for 5cycles
> 60% U

Voltage dip for 25cycles
> 30% U

Voltage dip for 5 sec
> 95% U

3A/m Yes

*

T

*

T

*

T

*

T

Yes

Yes

Yes

Yes

Floors should wood, concrete or ceramic tile.
If the floors are covered with synthetic material, the
releative humidity should be at least 30%.

Mains/line power quality should be that of a typical
commercial or hospital environment.

Mains/line power quality should be that of a typical
commercial or hospital environment.

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 orbattery.

Power frequency magnetic fields should be at
levels characteristic of a typical location in a
commercial or hospital environment.

4

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

Conducted HF interference
to IEC 61000--4--6

Radiated HF interference
to IEC 61000--4--3

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.

3V

rms

150kHz to 80 MHz

3V/m
80 MHz to 2.5 GHz

Compliance

level

Yes

Electromagnetic environment -- guidance

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=1.2p P
d=1.2p P for 80 MHz to 800 MHz
d=2.3p P 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 survey
compliance level in each frequency range

Interference may occur in the vicinity of devices with the
following symbol:

1

, should beless than the

2

.

The recommended separation distances between portable and mobile HF telecommunication devices and
devices which are notlife-- 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.

Rated nominaloutput power of the

transmitter(Watts)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 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.

150 kHz to 80 MHz

d=1.2p P

Separation distance as a function of transmitter frequency (m)

80 MHz to 800 MHz

d=1.2p P

800 MHz to 2.5 GHz

d=2.3p P

GA--A 181

5

2Illustration

2.1 Front panel

1

3

4

2.1.1 Legend

1 Power switch with green LED 5 “Foot switch actuated” indicatorlamp
2 Socket for foot switch 6 “Transducermalfunction” warning lamp
3 Connection bar for transducer 7 “Generator malfunction”alarmlamp
4 Intensity buttonforpower stage preselection

5

2

6

7

6

GA--A 181

2.2 Rear panel

8

2.2.1 Legend

8 Power input connector with fuse holder 12.1 CAN --BUS inputconnector(option)
9 Fuse holder with device fuses 12.2 CAN --BUS outputconnector(option)
10 Control output for suction pump (4--pole socket) 13 Equipotentialconnector
11 Identification plate

9

12.1 12.2

10 1113

GA--A 181

7

3Setup

WARNING!
This device is not protected against explosions.
Explosion hazard.
Do not operate this device in areas where there is a danger of
explosions.

CAUTION!
Danger of faults and malfunctions.
To guarantee the safety of the user, the patient and others use only
accessories and spare parts specified by the manufacturer of this
product.
Other accessories or spare parts can cause the emission of
increased electromagnetic radiation or reduced immunity against
interference.

IMPORTANT!

.

Medical devices are subject to special precautions with regard to electro­magnetic compatibility (EMC).

Make sure you observe the notes on EMC for installation and operation.
Medical electrical devices can be influenced by mobile HF communica­tion devices.

If it is necessary to stack the devices or place them next to each other
and HF interference is observed, make sure you observe the intended
use of the devices.

CAUTION!
Danger of infection from unsterile accessories.
Sterilize reprocessed parts and accessory items before use.
Follow the sterilization instructions for the product in question!

IMPORTANT!

.

Make sure that the mains/grid voltage and the voltage indicated on the
identification plate are the same. Connect the device only through the
supplied power cord or a power cord meeting the same specifications.

NOTE!

.

During operation place the device on an even, level, non--slippery
surface.

8

GA--A 181