Enraf Nonius Nonius Sonopuls 190 Service Manual

Sonopuls 190

SERVICE MANUAL

Part number: 1416770

Enraf-Nonius B.V.	Sonopuls 190 Service Manual	1416770

Sonopuls 190

SERVICE MANUAL

Copyright:

Enraf-Nonius B.V.

P.O.Box 810

2600 AV Delft

The Netherlands

part number: 1416.770-41

PDF master 23022001

Index

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CONTENTS		Date of issue	page
1	INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 1-1
1.1	INTRODUCTORY REMARKS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 1-1
1.2	GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 1-3
1.3	TECHNICAL DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 1-4
2	DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 2-1
3	TEST EQUIPMENT AND TOOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 3-1
3.1	TEST EQUIPMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 3-1
3.2	TOOLS AND MATERIALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 3-1
4	MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-1
4.1	GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-1
4.2	CHECKLIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-1
4.3	FUNCTIONAL TEST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-1
4.4	TROUBLE SHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-3
4.5	REPLACEMENT PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-4
4.6	ADJUSTMENT PROCEDURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 4-5
5	STORAGE AND TRANSPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 5-1
5.1	STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 5-1
5.2	TRANSPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 5-1
6	SPARE PARTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 6-1
6.1	ORDERING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 6-1
6.2	WARRANTEE CLAIMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 6-1
6.3	REPAIR SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 6-2
6.4	RETURN SHIPMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999	6-2

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CONTENTS (contd.)
APPENDIX A SPARE PARTS LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .			July 1999 A-1
APPENDIX B DRAWINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .			July 1999 B-1
	Fig. 1	Block diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 B-1
	Fig. 2 Sonopuls 190 front view . . . . . . . . . . . . . . . . . . . . . . . . . . . .		July 1999 B-2
	Fig. 3 Sonopuls 190 side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . .		July 1999 B-3
	Fig. 4	Sonopuls 190 front inside incl. PC Board . . . . . . . . . . . . . . .	July 1999 B-4
	Fig. 5	Sonopuls 190 Main PC Board . . . . . . . . . . . . . . . . . . . . . . . .	July 1999 B-5
	Fig. 6	Ultrasound Treatment Head wiring details. . . . . . . . . . . . . . .	July 1999	B-7
APPENDIX C SERVICE INFO'S(Product Change Notes) . . . . . . . . . . . . . . . . .			July 1999	C-1
C.1	GENERAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .		July 1999	C-1
C.2	REVISION HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .		July 1999	C-2

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1 INTRODUCTION

1.1INTRODUCTORY REMARKS

This manual has been written for the technicians involved in the service of the Sonopuls 190. Service can be carried out by the service organization of the supplier or by any other technician authorized by Enraf-Nonius B.V.

The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.

Enraf-Nonius B.V. is further referred to as Enraf-Nonius

1.1.1Safety Aspects

Safe execution of the procedures in this manual requires technical experience and general knowledge of safety precautions.

Warnings, Cautions and Notes have been used throughout the manual to bring special matters to the immediate attention of the reader.

-The Warning concerns danger to the safety of the technician or user;

-The Caution draws attention to an action which may damage the equipment;

-The Note points out a statement deserving more emphasis than the general text, but which does not deserve a Warning or Caution.

The sequence of steps in a procedure may also be important from the point of view of personal safety and prevention of damage, therefore never change the sequence of procedural steps or alter a procedure.

1.1.2Legal Aspects

This manual and the information herein are copyright property of Enraf-Nonius B.V. (Delft, The Netherlands).

Enraf-Nonius B.V. disclaims any responsibility for personal injury and/or damage to equipment caused by:

-Negligence or disregard of a Warning or Caution;

-Deviation from any of the prescribed procedures;

-Execution or activities which are not prescribed;

-Ignorance of the general safety precautions for handling tools and the use of electricity;

-Repairs and/or adjustments made to the equipment with a patient connected.

1.1.3Environmental Aspects

The following materials have been used for construction of the Sonopuls 190:

-	material:	Polyester	Control panel.
-	material:	ABS	Housing of the unit, UTH. housing and UTH. holder.
-	material:	MDF	Supporting plate.

Please dispose off properly in case of replacement according to the local regulations.

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1.1.4Data registration

1.1.4.1Equipment and customer registration/Service file

From the point of view of safety and product liability the following data must be registered for each unit:

-	Equipment data:	Type (part) and serial number
-	Customer data:	Date of delivery of the equipment to the customer, name and full
		address of the customer
-	Configuration file:	The actual configuration data of the equipment.
-	Service file:	Data of all service activities

The distributor as well as their dealer and/or service organization if any, is responsible for these records. They must be able to provide these data when requested.

1.1.4.2Configuration file

A configuration file gives the serial numbers and/or batch numbers of main sub-assemblies and/or important parts per unit. The parts listed in a configuration file are defined as registered parts. Such are for example parts as transformers, PC Boards, key-boards and software. The registered parts of the Sonopuls 190 are marked with a "Y" for "Yes" in the spare parts list in appendix A (column C).

Enraf-Nonius has the original configuration file of each unit. Any possible changes in the original configuration of the supplied units must be filed and the distributor must be able to provide this data. These changes can simply be stored in the service file of the specific unit. Part, serial or batch number(s) of the new parts have to be mentioned.

In case of a claim we expect the distributor to report the claim and the actual configuration data of the equipment in question.

1.1.5Product documentation

The documentation set for the Sonopuls 190 also incudes an Instruction manual and a therapy book. The instruction manual is a recommended item for all service engineers.

Ordering data:

-1416.750 Instruction manual

-1416.770 Service manual

-1482.762 Therapy book "Ultrasound Therapy"

1.1.6Installation

(For installation of the Sonopuls 190 see the Operating Instruction manual.)

-It is not allowed to use this unit in so-called "wet rooms" (hydrotherapy rooms).

-The mains supply connections must comply with the national requirements regarding medical used rooms.

-Before connection of this apparatus to the mains supply, check that the mains voltage and frequency stated on the type plate of the power supply adapter corresponds to that of

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the mains supply. The mains supply adapter which is used for the Sonopuls 190 unit (ENB-1530) can be used for mains voltages between 100 to 240 VAC 50 - 60 Hz.

1.1.7Modifications

This publication could include technical inaccuracies or typographical errors. Changes are periodically made to the information herein; these changes will be published as Service Info's in appendix C of this Service Manual.

1.1.8Product evaluation

In order to continuously improve the quality of our products, Enraf-Nonius requests her service organizations to report any structural problem which may be discovered. When the same problem regularly occurs or when safety problems occur, we would like you to send us a product complaint report. The report must contain the name, the type of the product, a detailed description of the problem, the number of the same problems, quantity of sold equipment and your solution to the problem (if any). The product complaint report can be found as an enclosure in the Service Reference book.

1.1.9Additional Information

Please do not hesitate to contact your National sales organisation or distributor. For additional information:

Enraf-Nonius B.V. P.O. Box 810 2600 AV Delft The Netherlands

Tel: +31 (0)15 - 2698400 Telefax: +31 (0)15 - 2624317 Telex: 38083 nl

1.2GENERAL

The Sonopuls 190 is a single channel Ultra Sound (US.) unit which operates with a frequency of 1Mhz. The compact design, the simple operation and the bright LED displays makes the Sonopuls 190 very useful as a stand-alone US. unit.

The Ultra sound Treatment Head (UTH) has a fixed connection to the unit and can not be connected to other units without unit calibration.

The Sonopuls 190 has been designed and manufactured to ensure the highest level of safety; the unit itself fully complies with the IEC 601-1 and IEC 601-1-2 standards. The power supply complies with the IEC 950 standards.

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1.3TECHNICAL DATA

1.3.1	General
	Power supply unit:
	Mains supply adapter	: ENB-1530
	Mains supply voltage	: 100 - 240VAC.
	Mains frequency	: 50-60 Hz
	Supply adapter output voltage	: 15 VDC.
	Supply adapter output current	: min. 2 A.
	Sonopuls 190 unit:
	Current consumption	: max. 1.8 A
	Patient leakage current	: typical 1 A	(IEC requirement 100 A)
	Ditto, single fault condition	: typical 1 A	(IEC requirement 500 A)
	Safety class	: II 1) type, BF 2)
	Safety approval	: CE-MDD (TÜV Rheinland) 3)
	Radio interference compliance	: EN60601-1-2 : 1993
	Dimensions	: 22 x 19.5 x 20 cm
	Weight	: 1.7 kg
	Colour specification	: EN. Custom colours

1)II: The equipment has a double insulation.

2)BF: The equipment has a floating patient circuit. The Sonopuls 190 meets the requirements of IEC 601 safety standards.

3)Copies of certificates or certificates of conformity (COC) are available on request.

1.3.2European union:

Marking

: CE 4)

4)This equipment complies with all requirements of the EMC for the Medical Device Directive (93/42/EEG).

1.3.3Ultrasound therapy

Ultrasound frequencies	: 1 MHz ± 0,2 %
Output mode	: continuous
Pulse frequency/ duty cycle	: 100 Hz / 100%
Intensity	: 0	- 2	W/cm2 continuous
Output mode	: pulsed
Pulse frequency/ duty cycle	: 100 Hz / 5, 10, 20, 50, 100%
Intensity	: 0	- 3	W/cm2, duty cycle 5, 10, 20, 50%
	: 0	- 2	W/cm2, duty cycle 80%
Contact control threshold level	: 65 % of initial value
	(min. output power 0.3W/cm² = 1.5 W)
Display modes	: intensity in W/cm2 and output power in W (SATP 4))
Indication accuracy	: ± 20 % (for any level above 10 % of maximum)

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Timer	: 0 - 30 minutes, coupled to contact control, 0 - 10
	minutes in 0.5 minute steps, 10 - 30 minutes in 1
	minute steps

4)SATP: Spatial Average Temporal Peak (mean pulse power)

1.3.4Ultrasound Treatment Heads

Treatment head, large, 1 MHz:

Geometrical surface	: 6.2 cm²
ERA 5)	: 5.0 cm²
BNR 6)	: Max. 6.0
Type	: Collimating
Side wall radiation	: Max.10 mW/cm²

5)The Effective Radiating Area (ERA) is defined as the geometrical area of a plane (in square centimetres), parallel to, and at a distance of 5 mm from the front of the treatment head, where the ultrasound intensity is more than 5 % of the maximum intensity in that plane.

6)The Beam Non-uniformity Ratio (BNR) is defined as the ratio of the maximum peak intensity somewhere in the ultrasound beam and the effective intensity of that ultrasound beam.

ERA and BNR are measured according to the FDA definitions

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2DESCRIPTION

Because of the modular construction of the Sonopuls 190 the description is on block diagram level.

2.1BLOCK DIAGRAM (see appendix B fig. 1)

The electronic circuit of the Sonopuls 190 is located on 2 modules:

-Application / display module (also referred to as main PC Board).

-User interface module (also referred to as keyboard)

The Ultrasound Treatment Head (UTH) is connected to the unit without using an connector which makes it unable to disconnect the UTH by the user. The electronic circuit of the treatment head (feedback circuit) is found on the main PC Board. The treatment heads used with other series are equipped with a feedback and an head id. circuit inside the UTH which makes the heads interchangeable with other units. Other units are able to provide two output frequencies 1 and 3 Mhz, the Sonopuls 190 unit is a single frequency unit. Because the UTH which is used with the Sonopuls 190 unit does not have this circuits inside, the UTH must be calibrated to the unit in question. One advantage is that the treatment cable is available as a spare part because it is a part of the electronic circuit. The calibration routine covers the complete unit including cable and treatment head assembly.

2.1.1Application module (main PC Board)

The function of the application module is to supply the Ultra Sound (US.) drive current for the Ultrasound Treatment Head (UTH) connected to the Sonopuls 190 unit.

The Ultra Sound drive current is an alternating current at a frequency of 1MHz and can be either continuous or pulsed mode.

The application module comprises the following circuits:

-US. micro controller circuit

-US. measuring circuits

-US. driver and output stages

-Timer circuits

-LED display

The ultrasound treatment head connected to the Sonopuls 190 unit is specially designed and it has a permanent connection to the unit. The UTH. does not have a connector and therefore it is not possible to disconnect it from the unit.

2.1.2User interface module (keyboard)

The keyboard is found at the front of the Sonopuls 190 unit. The switch-matrix is decoded at the main PC Board. The LED displays ( which are a part of the main PC Board) will give a clear view of the treatment parameters and treatment timer.

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