Us00-002 860 01 02 02 PDF

Safety Procedure
US
Safety - Electrical Test

System
ACUSON/SONOLINE Electrical Safety Test Proce-
dure
08358686
08267219
08264604
07848547
07848539
07848521
07482826
07482818
07482800
07482479
07478147
07478139
© Siemens AG 2005
The reproduction, transmission or use
of this document or its contents is not
permitted without express written
Siemens Medical
Ultrasound
lne DivisionSolutions
authority. Offenders will be liable for
damages. All rights, including rights
created by patent grant or registration
of a utility model or design, are
reserved.
Print No.: US00-002.860.01.02.02 English

Replaces: US00-002.860.01.01.02 Doc. Gen. Date: 11.05
n.a.
Part No.:
sd
2 Revision / Disclaimer
1Revision / Disclaimer
Copyright
Copyright © 2004 by Siemens Corporation. All rights reserved. No part of this publication
may be reproduced, transmitted, transcribed, stored in retrieval systems, or translated into
any language or computer language, in any form or by any means, electronic, mechanical,
magnetic, optical, chemical, manual, or otherwise, without the prior written permission of
Siemens Corporation. Siemens Corporation reserves the right to change its products and
services at any time. In addition, this manual is subject to change without notice. Siemens
Corporation welcomes customer input on corrections and suggestions for improvements
to this manual.Although Siemens Corporation has attempted to ensure accuracy through-
out this manual, Siemens Corporation assumes no liability for any errors or omissions, nor
for any damages resulting from the application or use of this information.
Trademarks
ACUSON, Sequoia, Cypress, AEGIS, Aspen, 128XP, XP, AcuNav, CV70, SONOLINE,
Adara, Antares, G20, G40, G50, G60S, Omnia and KinetDx are trademarks of Siemens
Corporation registered in the U.S. Patent and Trademark Office. CWS3000, DS3000,
WS3000, and WebPro are trademarks of Siemens Corporation.
Windows XP, 2000 and NT are registered trademarks of Microsoft Corporation. Internet
Explorer is a trademark of Microsoft Corporation. Netscape and Netscape Navigator are
registered trademarks of Netscape Communications Corporation. Java and the JavaScript
name are registered trademarks of Sun Microsystems, Inc. Adobe Acrobat is a registered
trademark of Adobe Systems, Inc.
Other products and brand names are trademarks of their respective owners.
Disclaimer
The service of equipment described herein is to be performed by qualified personnel who
are employed by Siemens or one of its affiliates or who are otherwise authorized by Sie-
mens or one of its affiliates to provide such services.
Assemblers and other persons who are not employed by or otherwise directly affiliated
with or authorized by Siemens or one of its affiliates are directed to contact one of the
local offices of Siemens or one of its affiliates before attempting installation or service pro-
cedures.
License Agreement
All computer programs copyright 1990-2004 by Siemens Corporation or its suppliers. Pro-
grams are licensed under the following agreement:
Siemens or its suppliers retain(s) ownership of and title to any computer program supplied
with the equipment and to the trade secrets embodied in such computer programs. Sub-
ject to the Buyer’s acceptance and fulfillment of the obligations in this paragraph, Siemens
grants the Buyer a personal, non-transferable, perpetual, non-exclusive license to use any
computer program supplied with the Equipment that is necessary to operate the Equip-
ment solely on the medium in which such program is delivered for the purpose of operat-
ing the equipment in accordance with the instructions set forth in the operator’s manuals
supplied with the Equipment and for no other purpose whatsoever. Buyer may not
reverse-assemble, reverse-compile or otherwise reverse-engineer such computer pro-
grams nor may Buyer make a copy of such program or apply any techniques to derive the
trade secrets embodied therein. In the event of a failure by Buyer to comply with the terms
Safety Procedure US00-002.860.01.02.02 Page 2 of 26 Siemens

11.05 sd Medical Solutions USA, Inc.
Revision / Disclaimer 3
of this license, the license granted by this paragraph shall terminate. Further, because
unauthorized use of such computer programs will leave Siemens without an adequate
remedy at law, Buyer agrees that injunctive or other equitable relief will be appropriate to
restrain such use, threatened or actual. Buyer further agrees that (i) any of Siemens"s
suppliers of software is a direct and intended beneficiary of this end-user sublicense and
may enforce it directly against Buyer with respect to software supplied by such supplier,
and (ii) No supplier of Siemens shall be liable to buyer for any general, special, direct, indi-
rect, consequential, incidental or other damages arising out of the sublicense of the com-
puter programs supplied with the equipment.
Siemens US00-002.860.01.02.02 Page 3 of 26 Safety Procedure

Medical Solutions USA, Inc. 11.05 sd
4 Table of Contents
1- 0Table of Contents
1 _______ Field Electrical Safety Test Procedure_______________________________ 5
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Purpose of this Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Setup Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Electrical Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Completion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Field Electrical Safety Test Procedure 5
2-
Overview
1Field Electrical Safety Test Procedure
The Field Electronic Safety Test procedure is divided into the following major sections:
• Overview
• Instructions
• Completion
Since different electrical safety analyzers may be used for this procedure, safety analyzer
setup and modes of operation are referenced only in general terms. Follow the electrical
safety analyzer manufacturer’s operating instructions when setting up the safety analyzer
for each test.
NOTE This procedure presents basic specifications for required safety

tests.
Siemens representatives: for additional information on electrical
safety testing of medical equipment from Siemens, refer to docu-
ment ARTD-002.731.17.01.02 “Safety Regulations for Installation
and Maintenance.”
Important Note: Be aware that the test method presented in the
document ARTD-002.731.17.01.02 “Safety Regulations for Installa-
tion and Maintenance” is an alternative and simplified method for
testing electrical safety. This method assumes that reference mea-
surements from an earlier test are available, using the same Equiv-
alent Leakage Current Test method. The resulting measurements
will differ from the test limits described in this procedure. Use one
of the two tests and do not combine both methods when perform-
ing the electrical safety test.
NOTE In areas where local regulations require additional tests or stricter

limits than those specified herein, perform whatever tests are re-
quired to adhere to the local regulations and notify Siemens Med-
ical Solutions, Ultrasound Division of the additional requirements.
NOTE 100 V systems use the same test limits as 115 V systems; test lim-
its for 230 V systems vary greatly from the 115 V systems. Test lim-
its are provided in a separate, product-specific document titled
“Electrical Safety Test Limits.”

6 Field Electrical Safety Test Procedure
NOTE The test limits provided in the document titled “Electrical Safety
Test Limits.” are reference values. Use them only if no initial facto-
ry values are available for the particular system. Initial factory val-
ues are initial measurements and repeat measurements.
Perform this electrical safety test and the complete (US00-001.860.01 / ACUSON/SONO-
LINE Electrical Safety Test Report). Completing the test report includes the following:
• Fill out the report while performing the steps in the Electrical Safety Test procedure.
• Note any ECG and transducer leakage current measurements in the test report if appli-
cable. If the electrical safety analyzer has a print capability, print the measured values
and attach them to the test report.
• Supply a copy of the test report to the customer to keep with the system records.
• Return a copy of the test report to the Uptime Service center that maintains the equip-
ment records for the region.
• Follow any additional regional record keeping requirements.
• Siemens recommends that the CSE keeps a copy of the test report.
Purpose of this Document 0
This document provides the minimal requirements for the electrical safety test, which must
be performed on ACUSON and SONOLINE systems under the following conditions:
• During a planned maintenance.
• After servicing when electrical safety may have been affected.
• When a safety check is specified in a service procedure.
CAUTION Improper use of the electrical safety analyzer can affect the validity
of the test or cause the safety analyzer fuse to open.
¹ Review the operating instructions carefully before using
the electrical safety analyzer.
Warning alerts notify the user and service personnel of potential hazards to the user, the
patient, or to service personnel and are presented in the following format:

WARNING Check the outer surfaces of endocavity and intraoperative trans-

ducers for rough surfaces, sharp edges, or protrusions.
¹ Failure to do so may present a safety hazard to the
patient.
Notes contain helpful suggestions or references to material not covered in the document:
NOTE In this procedure, the ultrasound system, or other type of equip-

ment being tested, will be referred to as the system. The electrical
safety analyzer will be referred to as the safety analyzer.
Setup Requirements 0
Tools and Materials
CAUTION All instruments, including the electrical safety analyzer and the
ground resistance meter must be calibrated according to the stan-
dards defined by the local authorities.
¹ Measurements taken using uncalibrated instruments are
not considered accurate measurements.
• Electrical safety analyzer1

• Ground resistance meter2
• Small, non-conductive tank
• Metal conductor3
• Conductive solution (typically tap water)
Reference Documentation
• Field Electrical Safety Test Report (US00-001.860.01 / ACUSON/SONOLINE Electri-
cal Safety Test Report).
1. The electrical safety analyzer must comply with the UL 2601-1 standard for NTSC/EIA systems or with
the IEC 60601-1 standard for PAL/CCIR systems.
2. A ground resistance meter is not necessary if the safety analyzer has the capability to measure ground
resistance. Refer to the safety analyzer manufacturer’s documentation.
3. A metal conductor is not necessary if the safety analyzer probe can be immersed directly into water.
Refer to the manufacturer’s documentation.

• Electrical Safety Test Limits

Use the Electrical Safety Test Limits procedure that corresponds to the system being
tested:
- ACUSON: Antares, Antares pe, Aspen, CV70, Sequoia, and XP systems
- SONOLINE: Adara, Antares, Elegra, G20, G40, G50, G60S, Omnia, Prima, Sienna,
Versa Plus, and Versa Pro systems
Time Required
At least 30 minutes are required to perform this procedure. Additional time may be
required, depending on the occurrences of the following events:
• The number of transducers tested with the system.
• The number of times to fully boot and power down the system for each test setting.

Instructions 0
The following sections contain the safety test procedures. Perform these procedures in
the order presented.
• Visual Inspection
• Protective Ground Continuity Test
• Ground Leakage Current Test
• Chassis Leakage Current Test
• ECG Leakage Current Test
• Transducer Leakage Current Test
• Equivalent Leakage Current Test
• Leakage Current Test for Specialty Transducers
The Equivalent Leakage Current Test should only be performed if other leakage current
tests cannot be performed.
Print the (US00-001.860.01 / ACUSON/SONOLINE Electrical Safety Test Report) and
enter the customer and system information. Record the test conditions required by the
report.
NOTE In this procedure, the ultrasound system, or other type of equip-

ment being tested, will be referred to as the system. The electrical
safety analyzer will be referred to as the safety analyzer.
Preparation 0
This portion of the document is divided into the following sections:

• Operating the Safety Analyzer
• Test Conditions
• Visual Inspection
Operating the Safety Analyzer

Read the operating instructions before using any safety analyzer.
CAUTION Improper use of the safety analyzer can affect the validity of the
test or cause the safety analyzer fuse to open.
¹ Review the operating instructions carefully before using
the electrical safety analyzer.

Review the startup and shutdown procedures for the electrical safety analyzer before
using it. The power fuse of many analyzers will open, if an energized system (also known
as unit-under-test or UUT) is unplugged from the analyzer. The fuse in these analyzers is
a precision device and can be difficult to replace. Most analyzers will require the following
sequence of actions (or similar operations) before disconnecting an energized system:
1. Power down the system and wait for it to power off. The shutdown of the internal com-
puter can require a span of time.
2. Verify that the system is powered down and only then perform the shut-down proce-
dure dictated for the electrical safety analyzer.
3. Verify that the electrical safety analyzer is de-energized and only then unplug the sys-
tem.
During the testing performed with the electrical safety analyzer, switches S1 (neutral), S2
(polarity), and S3 (ground) are operated to produce the test conditions. The opening of the
neutral switch (S1) disconnects the system from the voltage source until the S1 switch is
again closed; the operation of the polarity switch (S2) disconnects the system from the
voltage source for a short period of time during its travel from one polarity to the other.
When the voltage source is interrupted and then restored as described, the system may
require 5-10 seconds to re-initialize before a valid test can be performed.
WARNING Switching between S1, S2, or S3 while the system is energized may
cause the system to power down abruptly.
Verify the system is fully de-energized prior to changing the switch
settings on the safety analyzer.
¹ Failure to do so may result in software corruption.
CAUTION When performing safety tests with the electrical safety analyzer,
always verify that the system has had sufficient time to re-initial-
ize, after a change of the test mode, before performing the next
test.
¹ Failure to do so may result in an inaccurate measure-
ment.
Test Conditions
Perform the electrical safety test under the following conditions:
• Disconnect remote or off-board peripherals (printers, VCRs, etc. that are not mounted
on the system) from the system signal connectors.
• Verify that no remote or off-board devices are connected to the system power outlets.

• Verify the on-board peripherals (OEM devices) are connected to the ultrasound sys-
tem. Power on the on-board peripherals and leave them on during this testing; the cur-
rent leakage and grounding of these devices is tested by these procedures.
NOTE During these tests, AC power is applied, removed, or placed in

standby according to the test requirements and the mode of oper-
ation of the safety analyzer. Always return the system and OEMs
to the energized state at the beginning of each sequence of tests.
Verify that all power switches are on, even when the system is not
energized.
Part 1 - Visual Inspection

Before starting work on the ultrasound system, perform the following visual inspection.
1. Unplug and disconnect (where applicable) the power cord and inspect it for signs of
wear or abuse. Replace a power cord that is frayed, split, or shows signs of wear.
2. Inspect the system for any internal and external electrical faults. Pay particular atten-
tion to protective ground wires and their connections.
3. Visually inspect all transducers. Do not use a transducer that has a cracked, punc-
tured, or discolored casing; or a frayed cable.
WARNING Check the outer surfaces of endocavity and intraoperative trans-

ducers for rough surfaces, sharp edges, or protrusions.
¹ Failure to do so may present a safety hazard to the
patient.
NOTE Cidex OPA and Gigasept FF may discolor specific transducer

housings without degrading performance or reliability. Consult
the disinfectant compatibility matrix in the Operating Instructions
to determine compatibility.
4. Repair all detected faults before continuing.
NOTE If the visual inspection identifies failures and the failures can not
be corrected, do not continue with this procedure. Note in the test
report that the system has failed the electrical safety test. Discuss
with the customer further steps necessary to resolve the identified
failures before repeating the electrical safety test.

Electrical Tests 0
This portion of the document is divided into the following sections:

• Protective Ground Continuity Test (earth resistance)
• Ground Leakage Current Test
• Chassis Leakage Current Test
• ECG Leakage Current Test
• Transducer Leakage Current Test
• Equivalent Leakage Current Test
• Leakage Current Test for Specialty Transducers
Part - 2 Protective Ground Continuity Test

The Protective Ground Continuity Test verifies the resistance of the protective ground cir-
cuit through the power cord and into the system. Perform the measurements, step 1
through step 6, between the ground contact areas listed below:
• From the power cord ground pin to the equipotential connection that is typically located
near where the power cord enters the chassis, or from the power cord ground pin to an-
other metal component of the main chassis.
• From the power cord ground pin to an exposed metal component of the monitor, or to
the mounting hardware of the system monitor.
• From the power cord ground pin to an exposed metal component of the control panel, or
to the mounting hardware of the control panel.
• From the power cord ground pin to a metal component of an on-board OEM chassis.
For the Productive Ground Continuity setup, refer to the following figures:
• For systems with 20A service (for example: ACUSON XP and SONOLINE Elegra) use
the (Fig. 1 / p. 13).

• For systems with 15A service use the (Fig. 2 / p. 14).
Fig. 1: Protective Ground Continuity Test Setup - 505 Pro
Switch Action
Diagram Reference Name
S1 Neutral N/A
S2 Polarity N/A
S3 Earth N/A
Test Setup:
1. Remove power from the system and disconnect any external equipment from the sys-
tem (for example, external printer or monitor).
2. Verify the OEM cables are connected to the ultrasound system.
3. Plug the ultrasound system into the 505 Pro tester.
4. Energize the 505 Pro tester.
5. Connect the red lead of the tester to the system chassis.
6. Select the Ω (ohm) switch on the tester.
7. Measure the monitor, control panel, and OEM chassis ground resistance values using
the method described in step 4.
8. Record the worst-case measurements for each test in the report and specify the test re-
sult in the appropriate section. Use the pass or fail limits provided in the product-specif-
ic document titled “Electrical Safety Test Limits.”

Function: Measures the impedance between the outlet PE terminal of the ESA505 Pro
and exposed conductive parts of the system (also known as device under test or DUT)
that are connected to the system’s protective earth.
Proceed to the (Part - 3 Ground Leakage Current Test / p. 15).
Fig. 2: Protective Ground Continuity Test Setup - Dale 601
Switch Action
S1 Neutral N/A
S2 Polarity N/A
S3 Earth N/A
Test Setup:
1. Remove power from the system and disconnect any external equipment from the sys-
tem (for example, external printer or monitor).
2. Verify the OEM cables are connected to the ultrasound system.
3. Plug the system’s AC power cord into the safety analyzer.
NOTE If the safety analyzer cannot perform this test, use the ground re-
sistance meter.

4. Connect the black lead of the tester between “chassis“ on the 601 tester and to the sys-
tem chassis.
5. Energize the Dale 601 tester.
6. Measure the ground resistance between the power cord ground pin and the equipoten-
tial connection that is typically located near where the power cord enters the chassis.
Take the measurement for at least five seconds per measurement while flexing the
cord.
CAUTION Fluctuations in the ground conductor resistance value, caused by

the flexing of the cord, indicate that the wire or the terminal is con-
ducting only intermittently. Verify that the variation in the resis-
tance is not due to the poor contact of the test circuit, but by the
failure of the ground conductor or the terminal.
¹ If the flexing of the cord causes a fluctuation in the resis-
tance value that can be attributed to the conductor or ter-
minal and not to the test connections, replace the cord.
7. Measure the monitor, control panel, and OEM chassis ground resistance values using
the method described in step 4.
8. Record the worst-case measurements for each test in the report and specify the test re-
sult in the appropriate section. Use the pass or fail limits provided in the product-specif-
ic document titled “Electrical Safety Test Limits.”
Function: Measures the impedance between the outlet PE terminal of the Dale 601 E
and exposed conductive parts of the system that are connected to the system’s protective
earth.
Part - 3 Ground Leakage Current Test

The Ground Leakage Current Test verifies the isolation of the system power supply from
ground.
For the Ground Leakage Current setup, refer to the following figure: (Fig. 3 / p. 16).

Fig. 3: Protective Leakage Continuity Test Setup - 505 Pro and Dale 601
Switch Action
S1 Neutral Open or Closed
S2 Polarity Normal or Reversed
S3 Earth Open
Test Setup:
1. With the system plugged into the safety analyzer, set up the safety analyzer to perform
the test.
2. Connect the black lead of the tester between “chassis“ on the 601 tester and to the sys-
tem chassis.
3. Apply power and measure the leakage current to the system ground.
4. Perform the measurement for each test configuration listed in the product-specific doc-
ument titled “Electrical Safety Test Limits.”

NOTE If factory test data exists, compare the present test values to the
factory data rather than using the limits supplied in the “Electrical
Safety Test Limits.” Present test values must not exceed initial fac-
tory values by 10 µA, or by 1.5 times the factory value, whichever
is greater.
5. Place the system in standby mode or power off the system (whichever is applicable),
and repeat the test.
6. Record the ground leakage current for all test configurations on the test report and
specify the pass or fail result in the appropriate section.
7. If the test fails under any test condition repeat the test, and then do the following:
- Check the ground on the power cord and power plug for continuity. Replace the cord
if it is defective.
- Tighten all grounds.
- Inspect the wiring for crimps, poor connections, or damage.
- Test the wall outlet to ensure that it is properly grounded. Notify the customer if any
faults are found. If faults are found, use another wall outlet to perform this test.
Function: Measures the current flowing in the system’s PE. The test is performed with
normal and reverse polarity using S2, and single fault condition open L2 using S1. The
open ground switch is non-functional during this test since the ground is internally opened
during this test.
Part - 4 Chassis Leakage Current Test

The Chassis Leakage Current Test verifies the isolation of the power cord from the system
chassis.
For the Chassis Leakage Current setup, refer to the following figures:
• For systems with 20A service (for example: ACUSON XP and SONOLINE Elegra) use
the (Fig. 4 / p. 18).
• For systems with 15A service use the (Fig. 5 / p. 19).

Fig. 4: Chassis Leakage Current Test Setup - 505 Pro
Switch Action
S2 Polarity Neutral or Reverse
S3 Earth Open or Closed
Test Setup:
1. Plug the system into the related receptacle on the 505 Pro.
2. Plug the red lead into the red input jack of the tester front panel and connect the other
end of the cable to the system “chassis”.
3. Press the Chassis Leak key on the tester. The µA LED illuminates.
4. Press the single/dual key on the tester. The LED switches off.

if it is defective.
- Test the wall outlet to ensure that it is properly grounded. If faults are found, notify the
customer and use another wall outlet to perform this test.
Function: Measures the current flowing from the Red Terminal of the 505 Pro to the
MAINS PE. The test is performed with the normal and reverse MAINS supply polarity
using S2, single fault condition open L2 using S1, and open earth using S3.
Fig. 5: Chassis Leakage Current Test Setup - Dale 601
Switch Action
Test Setup:
the test as shown in the illustration.

2. Apply power and measure the leakage current to the system chassis.
is greater.
5. Record the chassis leakage current for all test configurations on the test report and
specify the pass or fail result in the appropriate section.
if it is defective.
- Test the wall outlet to ensure that it is properly grounded. If faults are found, notify the
customer and use another wall outlet to perform this test.
Function: Measures the current flowing from the Chassis Terminal of the Dale 601 to
the MAINS PE. The test is performed with the normal and reverse MAINS supply polarity
using S2, single fault condition open L2 using S1, and open earth using S3.
Part - 5 ECG Leakage Current Test

The ECG Leakage Current Test measures the current that would flow from any of the
ECG leads through a patient to ground.
For the ECG Leakage Current setup, refer to the following figure: (Fig. 6 / p. 21).

Fig. 6: ECG Chassis Leakage Current Test Setup - 505 PRo and Dale 601
Switch Action
S4 Lead Select Variable
Test Setup:
the test as shown in the illustration above.
2. Connect the ECG cable leads to the system and to the ECG test connectors on the
tester. Measure the leakage current for the test configuration.

3. Record the ECG leakage current for all test configurations on the test report and speci-
fy the pass or fail result in the appropriate section.
is greater.
4. If the test fails under any test condition, repeat the test. Then complete the following
steps:
- Check the ground terminal of the power cord and power plug for continuity. Replace
the cord if it is defective.
- Inspect and tighten all grounds.
- Inspect the wiring for crimped and damaged conductors, poor connections, or other
damage.
- Test the wall outlet to ensure that it is properly grounded; if an improperly grounded
outlet is discovered, use another wall outlet to perform the test. Advise the customer
of the condition of the outlet.
5. After a test failure has been remedied, re-test all configurations.
6. Record the net ECG leakage current for all test configurations in the report and specify
the pass or fail result in the appropriate section.
Function: Measures the current flow between a selected applied part, or all applied parts
and the MAINS PE. The following test configurations are available; normal and reverse
MAINS supply polarity using S2 and single fault conditions open L2 using S1, and open
earth using S3.
The “V” leads in the 505 Pro are all shorted together. This lead selection (V1 - V6) is
depicted by one single connection in (Fig. 6 / p. 21).
Part - 6 Transducer Leakage Current Test

The Transducer Leakage Current Test measures the current that flows from a transducer
through a patient to ground.
For the Transducer Leakage Current setup, refer to the following figure: (Fig. 7 / p. 23).

Fig. 7: Transducer Leakage Current Test Setup
NOTE If the safety analyzer cannot perform this test, use the transducer
leakage tester.
Test Setup:
the test as shown in the illustration above.
2. Fill a non-conductive tank with a conductive solution: tap water or saline. Do not use pu-
rified or de-ionized water.
3. If the specifications of the safety analyzer probe allows immersion of the probe, place it
in the water. If the probe is not immersible, connect it to a metal conductor and place
one end of the conductor in the water.
4. Connect the transducer to an appropriate system connector.
5. Place the transducer on a non-conductive surface adjacent to the water tank.
6. Measure the offset leakage current for the transducer and record the offset leakage cur-
rent value: This is the leakage current of the test setup.
7. Immerse the patient applied part of the transducer in the water tank.
CAUTION Do not immerse the transducer to a depth that allows water to seep
inside the transducer housing.
¹ Doing so may damage the transducer.
8. Measure the leakage current of the transducer and subtract the offset leakage current
value recorded in step 6.The result of this calculation produces the real value for the
leakage current.

9. After subtracting the offset leakage current value recorded in step 6, record the
worst-case measurement for the tested transducer on the test report and specify the
pass or fail result in the appropriate section.
Part - 7 Equivalent Leakage Current Test

Equivalent leakage current measurements enable the detection of deviations from an ini-
tially measured value. For this test, a voltage source is applied between different combina-
tions of the short-circuited mains-plug contact, the system chassis, and the isolated or
insulated portions of patient applied parts.
NOTE Perform this test only if the other leakage current tests included in
this document cannot be performed.
NOTE For regions using the IEC 60601-1 standard, equivalent leakage
current measurements involve comparing the measured value to
an initial measurement value taken previously. The value of the
current measurement must not exceed the value of the initial mea-
surement by 1.5 times, or by a total of 10 µA above the initial value,
whichever limit is higher.
Part - 8 Leakage Current Test for Specialty Transducers

Specialty transducers, including intra-cardiac and intra-luminal (catheter) transducers,
require leakage current testing according to compliance standards.
For the transesophageal (TEE) transducer leakage test, refer to the Transesophageal
Transducer chapter of the Transducer Reference (in the system operating instructions).

Completion 0
After completing the electrical safety test, perform the following steps:
Test Setup:
1. Visually inspect all electrical connections, transducers, and other parts of the system af-
fected by the test to ensure proper connection and operation. Resolve any issues that
are identified.
2. Complete the Electrical Safety Test Report.
3. Supply the customer with a copy and make additional copies as necessary to fulfill re-
gional record-keeping requirements; keep a copy of the Electrical Safety Test Report.
4. Supply a copy of the test report to the UPTIME Service center that maintains the equip-
ment records for the region.



Us00-002 860 01 02 02 PDF

Caricato da

Informazioni sul documento

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

Us00-002 860 01 02 02 PDF

Caricato da

Copyright:

Formati disponibili

Safety Procedure

Safety - Electrical Test

Print No.: US00-002.860.01.02.02 English

Safety Procedure US00-002.860.01.02.02 Page 2 of 26 Siemens

Siemens US00-002.860.01.02.02 Page 3 of 26 Safety Procedure

1 _______ Field Electrical Safety Test Procedure_______________________________ 5

Safety Procedure US00-002.860.01.02.02 Page 4 of 26 Siemens

NOTE This procedure presents basic specifications for required safety

NOTE In areas where local regulations require additional tests or stricter

Siemens US00-002.860.01.02.02 Page 5 of 26 Safety Procedure

Purpose of this Document 0

Safety Procedure US00-002.860.01.02.02 Page 6 of 26 Siemens

WARNING Check the outer surfaces of endocavity and intraoperative trans-

NOTE In this procedure, the ultrasound system, or other type of equip-

Tools and Materials

• Electrical safety analyzer1

Siemens US00-002.860.01.02.02 Page 7 of 26 Safety Procedure

• Electrical Safety Test Limits

Safety Procedure US00-002.860.01.02.02 Page 8 of 26 Siemens

NOTE In this procedure, the ultrasound system, or other type of equip-

This portion of the document is divided into the following sections:

Operating the Safety Analyzer

Siemens US00-002.860.01.02.02 Page 9 of 26 Safety Procedure

Safety Procedure US00-002.860.01.02.02 Page 10 of 26 Siemens

NOTE During these tests, AC power is applied, removed, or placed in

Part 1 - Visual Inspection

WARNING Check the outer surfaces of endocavity and intraoperative trans-

NOTE Cidex OPA and Gigasept FF may discolor specific transducer

4. Repair all detected faults before continuing.

Siemens US00-002.860.01.02.02 Page 11 of 26 Safety Procedure

This portion of the document is divided into the following sections:

Part - 2 Protective Ground Continuity Test

Safety Procedure US00-002.860.01.02.02 Page 12 of 26 Siemens

• For systems with 15A service use the (Fig. 2 / p. 14).

Fig. 1: Protective Ground Continuity Test Setup - 505 Pro

Siemens US00-002.860.01.02.02 Page 13 of 26 Safety Procedure

Fig. 2: Protective Ground Continuity Test Setup - Dale 601

Safety Procedure US00-002.860.01.02.02 Page 14 of 26 Siemens

CAUTION Fluctuations in the ground conductor resistance value, caused by

Part - 3 Ground Leakage Current Test

Siemens US00-002.860.01.02.02 Page 15 of 26 Safety Procedure

Safety Procedure US00-002.860.01.02.02 Page 16 of 26 Siemens

Part - 4 Chassis Leakage Current Test

Siemens US00-002.860.01.02.02 Page 17 of 26 Safety Procedure

Fig. 4: Chassis Leakage Current Test Setup - 505 Pro

Safety Procedure US00-002.860.01.02.02 Page 18 of 26 Siemens

Fig. 5: Chassis Leakage Current Test Setup - Dale 601

Siemens US00-002.860.01.02.02 Page 19 of 26 Safety Procedure

Part - 5 ECG Leakage Current Test

Safety Procedure US00-002.860.01.02.02 Page 20 of 26 Siemens

Siemens US00-002.860.01.02.02 Page 21 of 26 Safety Procedure

Part - 6 Transducer Leakage Current Test

Safety Procedure US00-002.860.01.02.02 Page 22 of 26 Siemens

Fig. 7: Transducer Leakage Current Test Setup

Siemens US00-002.860.01.02.02 Page 23 of 26 Safety Procedure

Part - 7 Equivalent Leakage Current Test

Part - 8 Leakage Current Test for Specialty Transducers

Safety Procedure US00-002.860.01.02.02 Page 24 of 26 Siemens

Siemens US00-002.860.01.02.02 Page 25 of 26 Safety Procedure

Safety Procedure US00-002.860.01.02.02 Page 26 of 26 Siemens

Potrebbero piacerti anche

1 _ Field Electrical Safety Test Procedure_________________________ 5