Enraf Nonius Sonopuls 190 User manual

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Sonopuls 190
EN109-1631750-48 IFU
July 9, 2020
Instructions for use

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Table of contents
1Introduction ......................................................................................................................................................3
2Symbols ..............................................................................................................................................................4
3Device components .......................................................................................................................................6
4Package contents............................................................................................................................................7
5Installation .........................................................................................................................................................8
6Intended use and intended user...............................................................................................................9
7Indications ...................................................................................................................................................... 10
8Contraindications......................................................................................................................................... 11
9Precautionary instructions........................................................................................................................ 12
10 Operation........................................................................................................................................................ 14
11 Application information............................................................................................................................. 23
12 Maintenance and troubleshooting........................................................................................................ 25
13 Specifications................................................................................................................................................. 27
14 Contact............................................................................................................................................................. 32
15 Product liability............................................................................................................................................. 33

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1Introduction
Foreword
This manual has been written for the owners and operators of the Sonopuls 190. It contains general
instructions on operation, precautionary practices, maintenance and parts information. In order to
maximize the use, efficiency and lifespan of your unit, please read this manual thoroughly and become
familiar with the controls as well as the accessories before operating the unit.
For detailed explanation on installation and operation of the Sonopuls 190 with StatUS™ Pack 100 (for
static ultrasound), we refer you to the operating instructions StatUS™ Pack 100 (art.nr. 1629.750). This
guide (CD-ROM) can be found in the packaging of the StatUS™ Pack 100.
Specifications put forth in this manual were in effect at the time of publication. However, owing to
Enraf-Nonius BV’s policy of continual improvement, changes to these specifications may be made at
any time without obligation on the part of Enraf-Nonius BV.
It is important to read the following instructions carefully before using this device
properly and safely. The manufacturer cannot be held responsible for the results of using
this device for any purposes other than described in these operating instructions.
Device Description
The Sonopuls 190 is a multi-frequency ultrasound unit. The multi-frequency ultrasound applicators for
the 100-serie provide both 1 and 3 MHz operation. The applicators can be used with both, large and
small treatment surfaces and are suitable for subaqual treatments.
Contact control suspends the application of ultrasonic energy when acoustical contact with the
treatment area becomes insufficient.
The user can connect two ultrasound applicators. These can be activated from the ultrasound menu.

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2Symbols
Symbol used
Description
Follow the instructions in the Instructions for Use.
It is important that you read, understand and observe the precautionary and
operating instructions
General Prohibition Sign.
Prohibition is used to mean “You MUST NOT”
Warning or Caution:
Indicates a hazardous situation which, if not avoided, could result in:
a. Death or serious injury to the patient (or)
b. Minor to moderate injury to the patient (or)
c. Damage to the equipment
Type B applied part complying with the specified requirements to provide
protection against electric shock, particularly regarding allowable patient
leakage current and patient auxiliary current.
Temperature Range.
Indicates acceptable temperature range
Humidity Limits.
Indicates acceptable relative humidity
Atmospheric Pressure.
Indicates the range of atmospheric pressure to which the medical device can
be safely exposed.
Waste electrical items that can be recycled.
Indicates the electrical and electronic components of the device can be
recycled and has to be disposed separately.
Keep the device dry
Manufacturer name, address and date of manufacture.
Reference Number or Part Number
Serial Number
Indicates the serial number so that a specific medical device can be
identified.
CE Mark along with number indicates conformity with European Council of
directive concerning Medical Devices and this device is under the direct
supervision of the Notified Body.

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Pulse frequency
Continuous
Duty cycle
Pulse duration
Ultrasound frequency
Alternating current
“ON” (power)
“OFF” (power)