Acuson x-300 Safety PDF

Safety Procedure
US
Safety Information
System
Field Electrical Safety Test Procedure
This document is valid for:

© Siemens, 2011
ACUSON: Antares family, Aspen, CV70, Cypress family;

Sequoia, XP, X300,X300 PE, X150 and X500; ACUSON
S2000, Sonovista FX systems; ACUSON SC2000 Sys-
tems
© Siemens, 2011
All documents may only be used for rendering
services on Siemens Healthcare Products. Any
document in electronic form may be printed
BJ
Siemens
once. Copy and distribution of electronic docu-
ments and hardcopies is prohibited. Offenders
will be liable for damages. All other rights are re-
served.
Print No.: US00-002.860.01.07.02 English

Replaces: US00-002.860.01.06.02 Doc. Gen. Date: 08.11
n.a.
Part No.: 2011
Ultrasound
2
SONOLINE: Adara, Antares family, Elegra, G20, G40 family, G50, G60 S family, Omnia, Premier,
Prima, Sienna, Versa Plus, and Versa Pro systems
SONOVISTA: G40, X500, X300, systems
10433816
10428841
10041461
10036666
10034261
10021500
08648375
08358686
08267219
08264604
07848547
07848539
07848521
07482826
07482818
07482800
07482479
07478147
07478139
Safety Procedure US00-002.860.01.07.02 Page 2 of 54 © Siemens, 2011

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Copyright / Version / Disclaimer 3
1Copyright / Version / Disclaimer
Copyright
“© Siemens, 2011“ refers to the copyright of a Siemens entity such as Siemens Aktienge-
sellschaft - Germany, Siemens Shenzhen Magnetic Resonance Ltd. - China, Siemens
Shanghai Medical Equipment Ltd. - China, Siemens Medical Solutions USA Inc. - USA
and/or Siemens Healthcare Diagnostics Inc. - USA.
Document Version
Siemens reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents corre-
spond to the version at the time of system delivery and/or printout. Versions to hardcopy
documentation are not automatically distributed. Please contact your local Siemens office
to order current version or refer to our website http://www.healthcare.siemens.com.
Disclaimer
Siemens provides this documentation “as is“ without the assumption of any liability under
any theory of law.
The installation and service of equipment described herein requires superior understand-
ing of our equipment and may only be performed by qualified personnel who are specially
trained for such installation and/or service.
© Siemens, 2011 US00-002.860.01.07.02 Page 3 of 54 Safety Procedure

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4 Table of Contents
0Table of Contents
1 _______ Field Electrical Safety Test Procedure _______________________________ 6
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Purpose of this Document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
General Testing Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Procedure Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Setup Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2 _______ Prerequisites __________________________________________________ 11
Use of the Electrical Safety Analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Operating the Electrical Safety Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Test Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3 _______ Visual Inspection _______________________________________________ 18
Part 1: Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4 _______ Leakage Test: Protective Ground __________________________________ 19
Part 2: Protective Ground Continuity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Perform the Protective Ground Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5 _______ Leakage Test: Ground Leakage Current ____________________________ 27
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Perform the Ground Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
6 _______ Leakage Test: Chassis Current ___________________________________ 31
Part 4: Chassis Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Perform the Chassis Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
7 _______ Leakage Test: ECG Leakage Current _______________________________ 35
Part 5: ECG Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Perform the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
8 _______ Leakage Test: Transducer________________________________________ 40
Part 6: Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Transducer Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
System Transducer Connector Assembly Inspection . . . . . . . . . . . . . . . . . . . . . . . . 41

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Table of Contents 5
Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Perform the Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
9________ Leakage Test: Speciality Transducers ______________________________ 51
Part 7: Specialty Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
10_______ Completion and Verification ______________________________________ 52
Completion and Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
11_______ Changes to Previous Version _____________________________________ 53
Changes to Previous Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

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6 Field Electrical Safety Test Procedure
1-
Overview
1Field Electrical Safety Test Procedure
Purpose of this Document 0
This document provides procedural steps and information concerning electrical safety test-
ing when required for preventative maintenance procedures. Electrical safety testing is also
required when a primary electrical component has been replaced. Primary electrical com-
ponents are found in the AC subsystem of the ultrasound system. This document provides
the minimal requirements for the electrical safety testing.
This procedure uses a Dale 601 (15A/120V) and 601 E (10A/240V) safety analyzer to per-
form the electrical safety tests. For ACUSON XP and SONOLINE Elegra use the Fluke 505
Pro (20 A) safety analyzer.
NOTE In areas where local regulations require additional tests or

stricter limits than those specified herein, perform whatever
tests are required to adhere to the local regulations and
notify Siemens Medical Solutions, Ultrasound Division of the
additional requirements.
NOTE 100 V systems use the same test limits as 115 V systems;
test limits for 230 V systems vary greatly from the 115 V sys-
tems. Test limits are provided in a separate, product-specific
document titled “Electrical Safety Limits/Test Report.”
General Safety Information 0
Only trained personnel may install or maintain medical products and systems.
Only persons who can provide evidence of appropriate training, e.g. relevant technical
training courses, self study or equivalent training, may be regarded as technically qualified
to install and repair our products. Completion of occupational training alone, e.g. as a jour-
neyman, master craftsman, technician or engineer is not sufficient without product-specific
training.The employee shall be provided with all required knowledge regarding safety reg-

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Field Electrical Safety Test Procedure 7
ulations through product training, Technical Service documentation, general and workplace
specific safety instructions and radiation protection briefings (applies also to third-party ser-
vice companies contracted by us to perform pre-installation work).
The manager (Technical, Service, or Installation Manager) decides whether the employee
has due regard for safety and is reliable enough to meet all safety requirements.
In addition to the safety information and various technical documentation, adhere to all
laws, regulations, and guidelines regarding occupational safety and accident prevention
when performing installation, start-up, and maintenance activities.
Obtain and use all protective equipment required for the work being performed.
Use only the measurement devices, tools, and auxiliary equipment (ladders, scaffolding,
lifting devices, ropes, etc.) specified for the work to be performed. The equipment must be
kept in good condition and should be inspected for safety-related damage prior to use.
Damaged equipment may not be used under any circumstances. Equipment should be
inspected and calibrated at regular intervals in accordance with country-specific regula-
tions.
Working on Components Under Voltage

With the exception of measurement and test activities, work may not be performed on com-
ponents under a voltage of more than 25 V / > 60 V (DIN VDE 0100-710 : 2002-11).
• Be particularly careful when performing troubleshooting measurements and tests
(when using testing and adjustment devices). Life-threatening high voltages may be
present in addition to low voltages.
• Measurement and adjustment points must be accessible without endangering the
employee. Otherwise, the system should be switched off to safely connect the mea-
surement device.
• Always switch off the system prior to connecting measurement devices when measur-
ing voltages over 1000V. Always use fully insulated measurement devices with the
appropriate test leads and terminals
WARNING Electrical Shock Hazard May Result

¹ After switching off the system, any residual charge in
high voltage circuits must be discharged to ground.
Adhere to the product documentation.
¹ Connect the measurement device to the protective
conductor as specified.
¹ The ground connection for the measurement device
should be connected first and disconnected last.
• To the extent applicable to our measurement and auxiliary circuits, adhere to the five
rules of safety when dealing with high currents:
a) Switch off the system

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b) Secure against accidental switch on

c) Ensure there is no residual voltage
d) Ground and bypass
e) Cover nearby components under voltage to protect against their being touched
accidentally
• When working with systems or devices under voltage, ensure that third parties do not
access the devices (even if systems are in different rooms) by installing warning signs,
etc.
• Regardless of these regulations, adhere to all product-specific safety instructions.
• A second person is required when performing measurement and test activities under
difficult conditions (e.g., humid or wet areas). In this case, the second person must at
least be instructed by the trained expert on how the product (system) can be switched
off and which additional technical and first-aid measures must be initiated in the event
of danger or accident.
• Definition: An instructed person is defined as anyone who has received instruction
and, if necessary, been trained on the job regarding his duties, the possible dangers
resulting from improper action, and the required protective equipment and measures.

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Field Electrical Safety Test Procedure 9
General Testing Requirements 0
Reference Measurement Value

The reference measurement and repeated measurements are performed at this point. The
purpose of recurrent measurements is to detect deviations from the initial measurement
value as early as possible. The specified maximum values may not be exceeded when
measuring the reference value. The system may not be put into operation if maximum per-
mitted values are exceeded.
The "reference measurement value" is used as a comparative value for subsequent mea-
surements and must be documented.
Testing Prior to Start-Up
For new products, measure and document the “reference measurement value” prior to
start-up. On-site measurement may be omitted if reference measurement values are avail-
able from the factory. Document the values accordingly to ensure that they are available for
repeated measurements.
In the case of products already in use for which there are no reference measurement val-
ues, perform the measurement and document the values during the first maintenance
event or repeated test.
Recurrent Tests
The values obtained from these tests must be documented and evaluated in conjunction
with the measurement procedure. The measurement values may not exceed threshold val-
ues. Use previously measured values for evaluation. If the comparison of the measurement
values shows a steep rise, or if previous measurements are not available, recurrent testing
may have to be performed at shorter intervals.
Systems must be visually inspected to determine whether individual units need to be
replaced, added, or eliminated compared to the configuration when testing for the recurrent
measurement values. The changes must be documented.
When changes are made to the system, measured values must be documented as “refer-
ence measurement values”.
Values close to threshold indicate the system is unsafe; initiate actions to reduce risks.
Procedure Summary 0
Perform this electrical safety test and complete the applicable product-specific Field Elec-
trical Safety Limits/Test Report. Completing the test report includes the following:
• Fill out the report while performing the steps in the Electrical Safety Test procedure.
• Note ECG and transducer leakage current measurements in the limits/test report when
applicable.
• Distribute a copy of the test report to the following locations:
- to the customer
- to the regional Uptime Service Center
- to the CSE records

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• Follow any additional regional record keeping requirements.
Setup Requirements 0
Tools and Materials

The following tools are required to perform this procedure:
• Electrical safety analyzer1 (Dale 601 or Dale 601E or Fluke 505 Pro)
• Ground resistance meter2
• Small, non-conductive tank
• Metal conductor3
• Conductive solution (typically tap water). Do not use distilled water.
• For TEE specialty transducers, please see User Manual for required tools.
CAUTION All instruments, including the electrical safety analyzer and

the ground resistance meter must be calibrated according to
the standards defined by the local authorities.
¹ Measurements taken using instruments that are not
calibrated are not considered accurate measurements.
Reference Documentation
• Field Electrical Safety Test Limits (product specific)
• Field Electrical Safety Test Limits/Report
Time Required
At least 60 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.
• Whether a system has ECG leads.
• Time to access conductive parts of the machine.
1. If alternate tester is used, the electrical safety analyzer must comply with the UL 60601-1 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 electrical safety analyzer has the capability to measure
ground resistance. Refer to the electrical safety analyzer manufacturer’s documentation.
3. A metal conductor is not necessary if the electrical safety analyzer probe can be immersed directly into
water. Refer to the manufacturer’s documentation.

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Prerequisites 11
2-
Use of the Electrical Safety Analyzers
2Prerequisites
This section describes the proper use of electrical safety analyzers, what to do in case an
electrical safety analyzer fuse opens, and the proper testing conditions in which to perform
the electrical safety test. Make sure that you are familiar with this information before pro-
ceeding.
• Operating the Electrical Safety Analyzer
• Test Conditions

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12 Prerequisites
Operating the Electrical Safety Analyzer 2.1
Read the Safety Analyzer operating manual before using any electrical safety analyzer.
CAUTION Improper use of the electrical safety analyzer can affect the
validity of the test or cause the electrical 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
the analyzer, located in the Safety Analyzer operating manual. The power fuse of many
electrical safety analyzers will open, if an energized system is unplugged from the electrical
safety analyzer. The fuse in these electrical safety analyzers is a precision device and can
be difficult to replace. Most electrical safety analyzers will require the following sequence
of actions (or similar operations) before disconnecting an energized system:
• Power down the system and wait for the system to complete the power off cycle. The
shutdown of the internal computer can require a span of time.
The operational switches on the electrical safety analyzer used for these tests are Neutral,
Polarity, and Ground. The following table shows the three switches and how they are
labeled on the Dale 601 analyzer and on the schematics.
Tab. 1 Analyzer Switch Configurations
Switch Dale 601 Schematic

Neutral L2 S1
Polarity Outlet S2
Ground M.A.P. S3

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Prerequisites 13
Fig. 1: DALE 601 Safety Analyzer
Pos. 1 Dale 601 power cord

Pos. 2 System power (connect the system power cord)
Pos. 3 L2 / S1 / Neutral switch
Pos. 4 Outlet / S2 / Polarity switch
Pos. 5 Map / S3 / Earth switch
Pos. 6 Function knob
Pos. 7 ECG lead selection knob
Pos. 8 Display
Pos. 9 ECG lead connectors / S4
NOTE There is a switch on the back of the Dale 601 tester that
switches between two types of test loads. Siemens uses the
AAMI ES1-1993 test load.
During the testing performed with the electrical safety analyzer, the Neutral, Polarity, and
Ground switches are operated to produce the different test conditions. The opening of the
Neutral switch disconnects the system from the voltage source until the Neutral switch is
again closed. The operation of the Polarity switch 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 five
to ten seconds to re-initialize before a valid test can be performed.

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14 Prerequisites
WARNING Switching between Neutral, Polarity, or Ground while the sys-

tem 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.
Fig. 2: Fluke 505 Pro Safety Analyzer
1. Universal ECG Jacks: Receptacles for the ECG snap or banana jack.
2. Receptacle Status Indicators: The LED indicators illuminate to indicate test recepta-
cle configuration and mode of operation.
3. Polarity Key: The polarity key reverses the polarity of the test receptacle.
4. Ground Key: The ground key opens the ground wire to the test receptacle.

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Prerequisites 15
5. Neutral Key: The neutral key opens the neutral line to the test receptacle.
6. Single/Dual Key: The lead key allows for selection of single- or dual-lead testing.
7. Green/Red/Black Input Jacks: The signal to be measured is applied between the red
and black input jacks during dual-lead measurements. Use the red jack for single-lead
measurements.
8. Test Receptacle: The 115V (15/20A) test receptacle provides power to the device
being tested during single-lead testing. It is enabled when the 505 Pro is powered at line
voltages less than 140 VAC.
9. Auto Sequence Status Indicatiors: (valid with 505 Pro RS).
10. Start/Stop Key: Initiates or terminates operation of automatic mode (valid with 505 Pro
RS).
11. Heading Key: Enables printing of instrumentation headings to be filled in by the opera-
tor (valid with 505 Pro RS).
12. Print Key: Enables printing capability (valid with 505 Pro RS).
13. Program Key: Allows the user to enter program mode and modify automatic test
sequences (valid with 505 Pro RS).
14. UP/DOWN Arrow Keys: Upward and downward arrow keys move the cursor to select
ECG leakage combinations or ECG performance options.
15. LED Cursor Display: LED indicates the status (On/Off) of ECG leakage combinations
or ECG performance options.
16. ECG Leak Key: Allows selection of ECG leads to test for leakage.
17. ECG Performance Key: Allows selection of ECG performance waveforms to be output
to ECG jacks.
18. Test Mode Keys: Test mode keys are used to select resistance, chassis leakage,
ground wire leakage, current, voltage, DC-only, isolation and calibration tests to be per-
formed. Additionally, the chassis leakage and ground leakage keys can toggle the test
load between the AAMI and IEC loads.
19. Units of Measure: The LED indicators display units of measurement and illuminate to
indicate ohms, micro-amps, amps, and volts.
20. Digital Display: Four LED digits indicate the magnitude of the measurements.
21. System indicators: LED will illuminate to indicate the selection in operation.
WARNING Switching between Neutral, Polarity, or Ground while the sys-

tem 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.

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16 Prerequisites
CAUTION When performing safety tests with the electrical safety ana-
lyzer, always verify that the system has had sufficient time to
re-initialize, after a change of the test mode, before perform-
ing the next test.
¹ Failure to do so may result in an inaccurate measure-
ment.

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Prerequisites 17
Test Conditions 2.2
Perform the electrical safety test under the following conditions:

• Disconnect remote or off-board peripherals (printers, VCRs, external monitors, 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.
• Disconnect the ethernet cable.
NOTE During these tests, AC power is applied, removed, or placed

in standby according to the test requirements and the mode
of operation 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.

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18 Visual Inspection
3-
Part 1: Visual Inspection
3Visual Inspection
Before performing the electrical safety check, make sure that you perform visual inspection.
Use the following instructions to perform an 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 and
tear.
2. Inspect the system for internal and external electrical faults. Pay particular attention to
protective ground wires and their connections.
3. Repair all detected faults before continuing.
¹ If the visual inspection identifies failures that cannot be corrected, do not con-
tinue 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 fail-
ures before repeating the electrical safety test.

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Leakage Test: Protective Ground 19
4-
Part 2: Protective Ground Continuity Test
4Leakage Test: Protective Ground
This test verifies the resistance of the protective ground circuit through the power cord and
into exposed grounded conductive parts of the system. The following figures show the test
setup for the Fluke 505 Pro and the Dale 601.
Fig. 3: Protective Ground Continuity Test Setup - 505 Pro
Fig. 4: Protective Ground Continuity Test Setup - Dale 601

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20 Leakage Test: Protective Ground
Preparation 4.1
Test Setup:
1. Remove power from the system and verify all off-board equipment (VCRs, DVR, Print-
ers, and Monitors) are disconnected from the system. If testing the ACUSON S2000
ABVS, disconnect the cables (transducer, USB and video) from the ACUSON S2000
system.
2. Verify the on-board peripherals (VCRs, DVRs, Printers) are connected to the ultra-
sound system and powered on. (Not applicable for ABVS)
3. Plug the Safety Analyzer power cord into the wall socket.
4. Plug the system’s AC power cord into the safety analyzer.
NOTE If the safety analyzer cannot perform this test, use the
ground resistance meter.
5. [For Dale 601] Connect the coiled Black lead to the Chassis connector, or [For Fluke
505] Red lead to the Test Leads connector.
6. Energize the Dale 601 or Fluke 505 analyzer.
7. [For Fluke 505 analyzer] Set the analyzer to:
a) Load Select to Resistance
b) Single/Dual Lead to Single Lead
Fig. 5: Fluke 505 Functions

[For Dale 601analyzer] Set the analyzer to:
a) Function Switch to Earth Resistance.

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b) Neutral (S1) to Closed

c) Polarity (S2) to Normal
d) Ground (S3) to Off
Fig. 6: Dale 601 Functions

8. Connect Safety Analyzer cable to system ground connection:
- [For Fluke 505] Red cable to system ground pin (typically located near where the
power cord enters the chassis)
Fig. 7: Fluke 505 Properly Connected

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- [For Dale 601] Black coiled cable to system ground pin (typically located near where
the power cord enters the chassis)
Fig. 8: Dale 601 Properly Connected
NOTE The Dale 601 and Fluke 505 Safety Analyzers display the
measurement in ohms. The example below displays 0.17 and
0.053 respectively. The Dale 601 displays 0.17 which equals
to 170 milliohms, while the Fluke 505 displays 53 milliohms.
Fig. 9: Dale 601 and Fluke 505 Electrical Safety Analyzers

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Perform the Protective Ground Test 4.2
This Protective Ground Test preforms ground tests on the system Power Cord, Monitor or
Display, Peripherals, and Control Panel.
1. Measure the ground resistance between the Power Cord ground pin and the potential
connection (typically located near where the power cord enters the chassis). Take the
measurement for at least five seconds per measurement while flexing the cord.
Fig. 10: Power Cord Ground with Dale 601 Shown
CAUTION Fluctuations in the ground conductor resistance value,

caused by the flexing of the cord, indicate that the wire or the
terminal is conducting only intermittently. Verify that the
variation in the resistance is not due to the poor contact of
the test circuit, but by the failure of the ground conductor or
the terminal.
¹ If flexing the cord causes a fluctuation in the resis-
tance value that can be attributed to the conductor or
terminal and not to the test connections, replace the
cord.

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2. Move the Safety Analyzer cable to an exposed metal component or the ground wire on
the system Monitor or Display. (For ABVS, connect the cable to the hinge on the moni-
tor arm).
Fig. 11: Monitor Grounding with Dale 601 Shown
NOTE This normally requires partial removal of the assembly cov-

ers.
3. Using the Pass or Fail limits provided in the product-specific electrical safety test limits
as a standard to determine the worst-case measurements for each test performed
above. ACUON S2000 ABVS Pass or Fail limits are provided in the S2000 electrical
safety test limits document. Refer to (US15-101.860.01 / S2000 Field Electrical Safety
Limits/Test Report).
4. Record the worst-case measurements for each test in the report and specify the test
result in the applicable section.
NOTE The following steps 5 through 10 do NOT apply to ACUSON

S2000 ABVS systems. For ABVS systems continue to step 11
and continue.
5. Move the Safety Analyzer cable to an exposed metal component or the ground pin on
the installed Peripherals. (Not applicable to ABVS systems)

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NOTE This normally requires partial removal of the assembly cov-

ers.
Fig. 12: System Peripheral Shown

above.
8. Move the Safety Analyzer cable to an exposed metal component on the Control Panel.
(Not applicable to ABVS systems)

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NOTE Normally the lower assembly screws fasten to the control

panel metal housing.
Fig. 13: Control Panel with Fluke 505 Attached to Ground

above.
The following steps 11 through 13 apply to the ABVS systems only..
11. Move the Safety Analyzer Cable to an exposed metal component on the transducer
inside the pod assembly.
12. Use the Pass or Fail limits provided in the product-specific electrical safety test limits
(US15-101.860.01 / S2000 Field Electrical Safety Limits/Test Report)as a standard to
determine the worst-case measurements for each test performed above.
result in the applicable section

08.11 Ultrasound
Leakage Test: Ground Leakage Current 27
5-
Preparation
5Leakage Test: Ground Leakage Current
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. 14: Ground Leakage Current Test Setup - Dale 601 and 505 Pro
Tab. 2 Ground Leakage Current Test Settings
Switch Action
Dale 601 /Schematic Name
L2/S1 Neutral Open or Closed
Outlet/S2 Polarity Neutral or Reverse
Map/S3 Earth Open by default

08.11 Ultrasound
28 Leakage Test: Ground Leakage Current
1. Select the Safety Analyzer function controls (Testing requires changing the polarity and
ground settings). Refer to figures below.
Fig. 15: Dale 601 Function Control Settings

• Function Switch: Earth Leakage
• Neutral (S1): Open or Closed
• Polarity (S2): Normal or Reversed
• Ground (S3): Off or Lift GND (Open)
Fig. 16: Fluke 505 Function Control Settings

• Load Select: Gnd Leak
• SIngle/Dual Lead: Single Lead
• Neutral: Closed
• Polarity: Normal or Reverse
• Ground: Off or Open GND

08.11 Ultrasound
Leakage Test: Ground Leakage Current 29
Perform the Ground Leakage Current Test 5.1
With the Safety Analyzer function controls properly set perform the following.
3. Ensure that the Polarity (S2) and Ground (S3) swtiches are set in accordance with the
test limits chart listed in the Field Electrical Safety Test Limits document for the system.
NOTE Remember to properly shutdown and re-energize the system

before changing the Polarity (S2) and Ground (S3) switches.
4. Turn on the Main Power Switch at the power cord input, but do NOT energize the sys-
tem. If testing the ACUSON S2000 ABVS , it is OK to energize the system.
5. Without energizing the system, (unless performing this test on the ABVS system), per-
form the measurement for each test configuration listed in the product-specific docu-
ment title “Field Electrical Safety Test Limits”.
6. Record the ground leakage current for all test configuration on the test report and spec-
ify the pass or fail result in the appropriate section.
NOTE If initial reference test data exists, compare the present test
values to the reference data rather than using the limits sup-
plied in the “Field Electrical Safety Test Limits”. Present test
values must not exceed initial reference values by 10µA, or
by 1.5 times the initial reference value, whichever is greater.
NOTE The Fluke 505 analyzer always has an open ground when this
test is performed by nature of the test. The Dale 601 ana-
lyzer’s ground switch is operable but has not effect on the
test results.
NOTE The Fluke 505 analyzer during this test produces invalid data.
There is no need to check any configurations other than
Polarity, Normal and Reversed when using the Fluke 505.
7. If the test fails under any test conditions repeat the test, and then do the following:

08.11 Ultrasound
30 Leakage Test: Ground Leakage Current
- 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, user another wall outlet to perform the test.
Function: Measures the current flowing in the system’s PE. The test is performed with nor-
mal and reverse polarity using S2, and single fault condition by opening L2 using S1. The
open ground switch is non-functional since the ground is internally opened during this test.

08.11 Ultrasound
Leakage Test: Chassis Current 31
6-
Part 4: Chassis Leakage Current Test
6Leakage Test: Chassis Current
This test verifies the isolation of the power cord from the system chassis, and measures
the current flowing from the Chassis Terminal on the Dale 601 and the Red Test Terminal
on the Fluke 505 Pro to the MAIN PE. The test is performed with the normal and reverse
MAIN supply polarity using Outlet/S2, single fault condition open L2/S1, and open earth
using Map/S3.
Tab. 3 Chassis Current Leakage Test Settings
Switch Action
Dale 601 /Schematic Name
Map/S3 Earth Open or Closed
Fig. 17: Chassis Leakage Current Test Setup - 505 Pro and Dale 601

08.11 Ultrasound
32 Leakage Test: Chassis Current
Preparation 6.1
Test Setup:
1. Select the Safety Analyzer function controls (Testing requires changing the polarity,
neutral, and ground settings). Refer to figures below.

- Function Switch: Enclosure Leakage
- Neutral (S1): Open or Closed
- Polarity (S2): Normal or Reversed
- Ground (S3): Off or Lift Gnd (open)

08.11 Ultrasound
Leakage Test: Chassis Current 33
- Load Select: Chassis Leak

- Single/Dual Lead: Single Lead
- Polarity: Normal or Reverse
- Neutral: Closed
- Ground: Off or Open Ground

08.11 Ultrasound
34 Leakage Test: Chassis Current
Perform the Chassis Current Test 6.2
With the Safety Analyzer function controls properly set perform the following.
3. Connect Safety Analyzer cable to the system ground connection.
- [For Fluke 505]: Red cable to system chassis
- [For Dale 601]: Black coiled cable to system chassis
4. Turn the Main Power Switch at the power cord input, but do NOT energize the system.
NOTE If testing the ACUSON S2000 ABVS, it is Ok to energize the

ACUSON S2000 system for steps 4 and 5.
5. Without energizing the system, (unless testing the ABVS system) perform the measure-
ment for each test configuration listed in the product-specific document titled “Field
Electrical Safety Test Limits”.
6. Record the chassis 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 conditions 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, user another wall outlet to perform the test.
NOTE Opening neutral on the Fluke 505 analyzer during this test
produces invalid data. There is no need to check any config-
urations other than polarity, normal/reversed, and ground
open/closed when using the Fluke 505

08.11 Ultrasound
Leakage Test: ECG Leakage Current 35
7-
Part 5: ECG Leakage Current Test
7Leakage Test: ECG Leakage Current
This test measures the current flow between a selected applied part, or all applied parts
and the MAIN PE. The following test configurations are available; normal and reverse MAIN
supply polarity using Outlet/S2 and single fault conditions open using L2/S1, and open
earth using Map/S3.
The ECG Leakage Current Test measures the current that would flow from any of the ECG
leads through a patient to ground.
Fig. 20: ECG Leakage Current Test Setup - 505 Pro and Dale 601
Switch Action
Diagram Reference Name
Map/S3 Earth Open or Closed
S4 Lead Select Variable

08.11 Ultrasound
36 Leakage Test: ECG Leakage Current
Preparation 7.1
Test Setup:
1. Energize the system.
2. Connect the ECG Cable plug into the system ECG connector.
Fig. 21: ECG Cable Shown Plugged into System ECG Connector
3. Connect the ECG leads to the Patient Lead connections on the Safety Analyzer.
Fig. 22: ECG Patient Lead Connections Shown on Safety Analyzers

08.11 Ultrasound
4. Select the Safety Analyzer function controls. Testing requires changing the Polarity
(S2), Ground (S3) and Lead Select settings. Refer to figures below.

- Function Switch: Patient Lead Leakage
- Neutral (S1): Closed
- Polarity (S2): Normal or Reversed
- Ground (S3): Open or Closed
- Leads: to Corresponding Lead

08.11 Ultrasound
38 Leakage Test: ECG Leakage Current
- Load Select: ECG Leak

- Single/Dual Lead: Single
- Polarity: Normal or Reverse
- Neutral: Closed
- Ground: Off or Open Ground

08.11 Ultrasound
Perform the Test 7.2
1. Change the Polarity (S2) and Ground (S3) switches as per the Test limit Chart listed in
the Field Electrical Safety Test Limits document.
2. Turn on the system. Remember to properly shutdown and re-energize the system
before you change the Polarity (S2) and Gound (S3) switches.
3. Activate ECG.
4. Measure the leakage current for the test configuration for each ECG lead connected to
the Safety Analyzer.
Fig. 25: Fluke 505 Leakage Current Test Example
Fig. 26: Dale 601 Leakage Current Test Example

5. Record the ECG leakage current for all test configurations on the test report and spec-
ify the pass or fail result in the appropriate section.
6. If the test fails under any test condition, repeat the test.
7. After a test failure has been remedied, re-test.
8. Record the net ECG leakage current for all test configurations in the report and specify
the pass or fail result in the appropriate section.

08.11 Ultrasound
40 Leakage Test: Transducer
8-
Part 6: Transducer Leakage Current Test
8Leakage Test: Transducer
Transducer Visual Inspection 0
1. Visually inspect all transducers. Do not use a transducer that has a frayed cable or that
has a cracked, punctured, or discolored casing.
WARNING Check the outer surfaces of endocavity and intraoperative

transducers 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 trans-

ducer housings without degrading performance or reliabil-
ity. Consult the disinfectant compatibility matrix in the
Operating Instructions to determine compatibility.
2. Inspect the transducer heads for physical damage such as cracks, splits, or anything
that may effect image performance or safety.
Fig. 27: Transducer Head Shown

08.11 Ultrasound
Leakage Test: Transducer 41
3. Inspect the cable and the connections at the strain relief points on both ends.
Fig. 28: Transducer Cabling with Strain Relief Points Shown

4. Check the transducer connector POD for any physical damage and the locking assem-
bly for proper operation. Also inspect the connector contacts for damage and cleanli-
ness. If necessary, clean the contacts with contact cleaner or a mild isopropyl alcohol
solution.
Fig. 29: Transducer POD Shown
System Transducer Connector Assembly Inspection 0
Following the transducer inspection, inspect the system Transducer Connector Assembly,
including the CW Transducer Connector if installed.

08.11 Ultrasound
Fig. 30: Transducer Connector Assembly Shown
1. Inspect the transducer door assembly for proper movement (if equipped).
2. Inspect the individual connector pins for damage and cleanliness. Clean the connector
assembly using an ESD vacuum cleaner. If the connector pins need a more extensive
cleaning, use a medium bristle brush with contact cleaner or isopropyl alcohol.
Fig. 31: Connector Pins and Vacuuming the Connector Assembly

08.11 Ultrasound
Transducer Leakage Current Test 8.1
This test is designed to measure the current that flows from the active transducer, through
a patient, to ground.
Fig. 32: Transducer Leakage Current Test Setup
Switch Action
Diagram Reference Name
S1 Neutral Closed
S2 Polarity Reverse
S3 Earth Open
Perform the Test 0
The following is a step by step procedure using the Dale 601 and Fluke 505 Safety Ana-
lyzer.
2. Plug the ultrasound system power cord into the Safety Analyzer.

08.11 Ultrasound
NOTE If testing the ACUSON S2000 ABVS transducer, plug the

S2000 power cord into the safety analyzer and power the
ABVS separately as normal. Power on both systems.
Fig. 33: Fluke 505 - Ultrasound Power Cord Inserted
Fig. 34: Dale 601 - Ultrasound Power Cord inserted

3. Power on the Safety Analyzer and the ultrasound system to be measured.
NOTE Allow the system to fully boot before performing each test,
otherwise the measurements may be incorrect.
4. Connect the cables to the Safety Analyzer as follows:

08.11 Ultrasound
- [For the Fluke 505] connect the Red cable to the Red Test Leads connection of the
Analyzer.
Fig. 35: Fluke 505 Safety Analyzer - Test Leads Shown

- [For the Dale 601] connect the Black coiled cable to the Chassis connection of the
Analyzer.
Fig. 36: Dale 601 Safety Analyzer - Test Leads Shown

5. [For the Fluke 505 Safety Analyzer], select function controls as follows;

08.11 Ultrasound
- Set Load Select to Chassis Leak.

- Set Single/Dual Lead to Single Lead.
- Set Ground to Open Ground.

6. [For the Dale 601 Safety Analyzer], place the function switch to Enclosure Leakage.
Fig. 38: Dale 601 Function Switch Shown
Measure the Transducer Offset Leakage Current

Measure the offset leakage current for the transducer and record the offset leakage current
value: This is the leakage current of the test setup, with Ground open and no Transducer
in the water.
1. Fill a non-conductive container with tap water.
NOTE Do NOT use distilled, purified or de-ionized water.
NOTE If testing the ABVS transducer, a water bath wide enough to

fit the ABVS POD will be needed to perform this procedure.
2. Place the Safety Analyzer Test Cable into the non-conductive container.

08.11 Ultrasound
NOTE If testing the ABVS, clip the test cable to a metal plate before
setting it into the water bath.
Fig. 39: Fluke 505 Safety Analyzer Test Cable in Water
Fig. 40: Dale 601 Safety Analyzer Test Cable in Water

3. [For the Dale 601], press the Lift GND (S3).
Fig. 41: Dale 601 Safety Analyzer - Lift GRN (S3) Setting Shown
4. [For the Fluke 505], no action is required.
5. Observe the measurement and write it down. This is the Offset Value (A). measure-
ment in microamperes.

08.11 Ultrasound
Measure the ABVS Transducer Measured and Calculated Leakage Current
1. Remove the lower plastic ring around the pod as shown in the figure below.
Fig. 42: S2000 ABVS System POD Shown

2. Clip the safety tester lead to a metal plate and set it in the water bath.
3. Lower the ABVS POD into the water bath until the water reaches slightly above the
clear plastic edges of the POD.
4. [For the Dale 601], press the Lift GND (S3).
5. [For the Fluke 505], no action is required.
6. Observe the measurement and write it down. This is the Measured Value (B), mea-
surement in microamperes.

08.11 Ultrasound
Measure the Measured and Calculated Values for non-specialty / non-ABVS trans-
ducers
1. Place the transducer head into the non-conductive container with the test cable as
shown.
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.
Fig. 43: Fluke 505 Safety Analyzer - Transducer in Water
Fig. 44: Dale 601 Safety Analyzer - Transducer in Water

2. Observe the measurement and write it down. This is the Measured Value (B) in micro-
amps.
3. Obtain the Calculated Value (C) by subtracting the Offset Value (A) from the Mea-
sured Value (B). [(C) = (B) - (A)].

08.11 Ultrasound
NOTE The Dale 601 and Fluke 505 Safety Analyzers display the
measurement in microamperes. The example below displays
the leakage reading of a failed transducer using both Safety
Analyzers.
Fig. 45: Dale 601 Reading Fluke 505 Reading
NOTE When using the Dale 601, the Calculated Value may have lit-
tle or no change from the Offset Value when testing good
transducers. However, this test does work and will effec-
tively detect any significant transducer current leakage.
4. Activate the next transducer to test.
Speciality Transducer leakage Current Test
1. Perform the Leakage Current test on any Speciality Transducer using the Speciality
Transducer Leakage Tester. For example, the V5Ms Transesophageal (TEE) Trans-
ducer is sold with a companion Leakage Tester.

08.11 Ultrasound
Leakage Test: Speciality Transducers 51
9-
Part 7: Specialty Transducer Leakage Current Test
9Leakage Test: Speciality 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).

08.11 Ultrasound
52 Completion and Verification
10-
Completion and Verification
10Completion and Verification
After completing the electrical safety test, perform the following steps:
1. Visually inspect all electrical connections, transducers, and other parts of the system
affected by the test to ensure proper connection and operation. Resolve any issues that
are identified.
2. Complete the product-specific Field Electrical Safety Limits/Test Report.
3. Supply the customer with a copy and make additional copies as necessary to fulfill
regional record-keeping requirements; keep a copy of the Field Electrical Safety Lim-
its/Test Report.
4. Supply a copy of the test report to the responsible party who maintains the equipment
records for the region.
5. Keep a copy to be used for reference values for the next visit.

08.11 Ultrasound
Changes to Previous Version 53
11-
Changes to Previous Version
11Changes to Previous Version
Change(s) Description
Revision 07 Added testing for ACUSON S2000 ABVS system
(Measure the ABVS Transducer Measured and
Calculated Leakage Current / p. 48), and
reviewed for document improvement project.
Revision 06 Revised transducer section and added new “Gen-
eral Safety” section.Also added new images to
procedures.
Revision 05 Updated General Requirements
Updated document format
Added references to Fluke 505 and Dale 601 ana-
lyzers
Revision 04 Removed comment from Prerequisite Section
Updated list of applicable sys- Added SONOVISTA FX and ACUSON SC2000
tems systems
Updated the list of applicable ACUSON X300, X500 and SONOVISTA X500
systems: systems
Updated the list of references: Added links to the reference procedures.

08.11 Ultrasound
54 Changes to Previous Version

08.11 Ultrasound

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Safety Procedure

This document is valid for:

ACUSON: Antares family, Aspen, CV70, Cypress family;

Print No.: US00-002.860.01.07.02 English

Part No.: 2011

Safety Procedure US00-002.860.01.07.02 Page 2 of 54 © Siemens, 2011

© Siemens, 2011 US00-002.860.01.07.02 Page 3 of 54 Safety Procedure

1 _______ Field Electrical Safety Test Procedure _______________________________ 6

2 _______ Prerequisites __________________________________________________ 11

Use of the Electrical Safety Analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3 _______ Visual Inspection _______________________________________________ 18

Part 1: Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

4 _______ Leakage Test: Protective Ground __________________________________ 19

Part 2: Protective Ground Continuity Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5 _______ Leakage Test: Ground Leakage Current ____________________________ 27

6 _______ Leakage Test: Chassis Current ___________________________________ 31

Part 4: Chassis Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

7 _______ Leakage Test: ECG Leakage Current _______________________________ 35

Part 5: ECG Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

8 _______ Leakage Test: Transducer________________________________________ 40

Part 6: Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Safety Procedure US00-002.860.01.07.02 Page 4 of 54 © Siemens, 2011

Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

9________ Leakage Test: Speciality Transducers ______________________________ 51

Part 7: Specialty Transducer Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

10_______ Completion and Verification ______________________________________ 52

Completion and Verification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

11_______ Changes to Previous Version _____________________________________ 53

Changes to Previous Version . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

© Siemens, 2011 US00-002.860.01.07.02 Page 5 of 54 Safety Procedure

Purpose of this Document 0

NOTE In areas where local regulations require additional tests or

General Safety Information 0

Safety Procedure US00-002.860.01.07.02 Page 6 of 54 © Siemens, 2011

Working on Components Under Voltage

WARNING Electrical Shock Hazard May Result

© Siemens, 2011 US00-002.860.01.07.02 Page 7 of 54 Safety Procedure

b) Secure against accidental switch on

Safety Procedure US00-002.860.01.07.02 Page 8 of 54 © Siemens, 2011

General Testing Requirements 0

Reference Measurement Value

© Siemens, 2011 US00-002.860.01.07.02 Page 9 of 54 Safety Procedure

• Follow any additional regional record keeping requirements.

Tools and Materials

CAUTION All instruments, including the electrical safety analyzer and

Safety Procedure US00-002.860.01.07.02 Page 10 of 54 © Siemens, 2011

© Siemens, 2011 US00-002.860.01.07.02 Page 11 of 54 Safety Procedure

Operating the Electrical Safety Analyzer 2.1

Tab. 1 Analyzer Switch Configurations

Switch Dale 601 Schematic

Safety Procedure US00-002.860.01.07.02 Page 12 of 54 © Siemens, 2011

Fig. 1: DALE 601 Safety Analyzer

Pos. 1 Dale 601 power cord

© Siemens, 2011 US00-002.860.01.07.02 Page 13 of 54 Safety Procedure

WARNING Switching between Neutral, Polarity, or Ground while the sys-

Fig. 2: Fluke 505 Pro Safety Analyzer

Safety Procedure US00-002.860.01.07.02 Page 14 of 54 © Siemens, 2011

WARNING Switching between Neutral, Polarity, or Ground while the sys-

© Siemens, 2011 US00-002.860.01.07.02 Page 15 of 54 Safety Procedure

Safety Procedure US00-002.860.01.07.02 Page 16 of 54 © Siemens, 2011

Test Conditions 2.2

Perform the electrical safety test under the following conditions:

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

1 _ Field Electrical Safety Test Procedure _________________________ 6

2 _ Prerequisites ____________________________________________ 11

3 _ Visual Inspection _________________________________________ 18

4 _ Leakage Test: Protective Ground ____________________________ 19

5 _ Leakage Test: Ground Leakage Current ______________________ 27

6 _ Leakage Test: Chassis Current _____________________________ 31

7 _ Leakage Test: ECG Leakage Current _________________________ 35

8 _ Leakage Test: Transducer__________________________________ 40

9 Leakage Test: Speciality Transducers ______________________ 51

10_ Completion and Verification ________________________________ 52

11_ Changes to Previous Version _______________________________ 53