™

vPad-353
Electrical Safety Analyzer
for IEC 62353

Operating Manual
 vPad-353™
Electrical Safety Analyzer
Operating Manual

© 2013-2014 Datrend Systems Inc.

Unit 130 - 4020 Viking Way
Richmond, BC • CANADA • V6V 2L4
Tel: 800.667.6557 (North America Only) or
604.291.7747 • Fax 604.294.2355
e-mail: [email protected]
To order this manual, use Part Number 6100-041
Revision History
Revision Description Date

B Update figures for PiPO tablet 2013-June-13

C AC Fault, address 2013-Dec-12

D Clarified Tablet RAM limits 2014-Aug-21

Copyright
Datrend Systems Inc. (“DSI”) agrees to a limited copyright release that allows you to reproduce manuals and other
printed materials for use in service training programs and other technical publications. If you would like other
reproductions or distributions, submit a written request to Datrend Systems Inc.

Unpacking and Inspection

Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage
is found, stop unpacking the instrument. Notify the freight carrier and ask for an agent to be present while the instrument
is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking
it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.

Claims
Our routine method of shipment is via common carrier. Upon delivery, if physical damage is found, retain all packing
materials in their original condition and contact the carrier immediately to file a claim.
If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any
other problems not caused by shipping damage, please contact your local sales representative or DSI immediately.

Standard Terms and Conditions

Refunds & Credits

Please note only serialized products (products labelled with a distinct serial number) and accessories are eligible for
partial refund and/or credit. Non-serialized parts and accessory items (cables, carrying cases, auxiliary modules, etc.)
are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been damaged,
and must be returned complete (meaning all manuals, cables, accessories, etc.) within 90 days of original purchase and
in “as new” and resalable condition. The Return Procedure must be followed.

Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number,
obtained from Datrend Customer Service. All items being returned must be sent prepaid (freight, duty, brokerage, and
taxes ) to our factory location.

Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15%. Products returned
in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20%. Additional
charges for damage and/or missing parts and accessories will be applied to all returns. Products which are not in “as
new” and resalable condition, are not eligible for credit return and will be returned to the customer at their expense.

Certification
This instrument was thoroughly tested and inspected and found to meet DSI’s manufacturing specifications when it was
shipped from the factory. Calibration measurements are traceable to the National Research Council of Canada (NRC)
and/or the National Institute of Standards and Technology (NIST). Devices for which there are no NRC/NIST calibration
standards are measured against in-house performance standards using accepted test procedures.

Page i
Warranty

Warranty and Product Support

Datrend Systems Inc. ("DSI") warrants the Analyzer Base Unit of vPad-353 (the "Datrend product") to be free from
defects in materials and workmanship under normal use and service for one (1) year from the date of original purchase.
This warranty will be automatically extended to two (2) years from the date of original purchase, provided that calibration
is performed on an annual basis by a Datrend Authorized Service Center*. During the warranty period DSI will, at our
option, either repair or replace defects in materials and workmanship at no charge; provided the Datrend product is
returned (shipping, duty, brokerage and taxes prepaid) to DSI. Any and all transportation charges incurred are the
responsibility of the purchaser and are not included within this warranty. This warranty extends only to the original
purchaser and does not cover damage from abuse, neglect, accident or misuse or as the result of service or modification
by other than DSI. IN NO EVENT SHALL DATREND SYSTEMS INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES.

This warranty is subject to the following limitations:

! Tablet PC: per tablet manufacturer's original warranty
! Standard Accessories: 90 day limited warranty
! Damage due to activation of devices under test which are connected to the “applied parts” inputs is not covered under
the warranty
! Re-calibration of the instrument, which has a recommended annual calibration frequency, is not covered under the
warranty.

No warranty shall apply when damage is caused by any of the following:

! Power failure, surges, or spikes,
! Damage in transit or when moving the instrument,
! Improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or misuse of the instrument,
! Fire, water damage, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.

Only serialized products (those items bearing a distinct serial number tag) and their accessory items are covered under
this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE
WARRANTY. Items such as cables and non-serialized modules are not covered under this warranty.

This warranty gives you specific legal rights and you may have other rights, which vary from province to province, state
to state, or country to country. This warranty is limited to repairing the instrument to DSI's specifications.

When you return an instrument to DSI for service, repair or calibration, we recommend shipment using the original
shipping foam and container. If the original packing materials are not available, we recommend the following guide for
repackaging:
! Use a double-walled carton of sufficient strength for the weight being shipped.
! Use heavy paper or cardboard to protect all instrument surfaces. Use non-abrasive material around all projecting parts.
! Use at least four inches of tightly packed, industrial-approved, shock-absorbent material all around the instrument.

DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper packaging
or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and taxes). No
returns will be accepted without a Return Materials Authorization ("RMA”) number. Please contact Datrend (refer to
Chapter 5 of this manual) to obtain an RMA number and receive help with shipping/customs documentation.

* Subject to some exclusions, based on sales territory. Contact Datrend for details.

Page ii
Warranty Disclaimer
Should you elect to have your instrument serviced and/or calibrated by someone other than Datrend Systems or an
Authorized Service Centre, please be advised that the original warranty covering your product becomes void when the
tamper-resistant Quality Seal is removed or broken without proper factory authorization. We strongly recommend,
therefore, that you send your instrument to Datrend Systems or an Authorized Service Centre for service and calibration,
especially during the original warranty period.

In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as this seal is the key to your
original instrument warranty. In the event that the seal must be broken to gain internal access to the instrument (e.g.,
in the case of a customer-installed firmware upgrade), you must first contact Datrend Systems at 1-604-291-7747. You
will be required to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality
Seal. You should break this seal only after you have received factory authorization. Do not break the Quality Seal before
you have contacted us! Following these steps will help ensure that you will retain the original warranty on your instrument
without interruption.

WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards
or improper operation. Datrend Systems will not be responsible for any injuries sustained due to unauthorized equipment
modifications.

DSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.

UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID
THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES.

Note: Calibration of Datrend products typically involves adjustment of parameters stored in firmware by proprietary
software. Parties other than Datrend and its Authorized Service Centers are limited to verification of the status of the
accuracy of the instrument. Do not confuse verification with calibration.

vPad™, vPad-XPORT™, vPad-ES™, vPad-353™, vPad-AS™, vPad-A3™,vPad-Record Manager™, vPad-RM™ ,

vPad-EQM™, vPad-Check™, vPad-Cal™, and Datrend Docs™ and CMX™ are trademarks of Datrend Systems Inc.

Android™ is trademark of Google Inc.

Page iii
Page iv
vPad-353 OPERATORS MANUAL

Table of Contents
ABBREVIATIONS AND DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VII

SYMBOL DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX

1 SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Electrical Safety Testing Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 Safety Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.3 Instrument Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.1 Voltage Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.2 Load Current Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.3 Power Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.4 Earth Resistance Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.3.5 Insulation Resistance Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.6 Equipment and Applied Part Leakage Tests (vPad-353) . . . . . . . . . . . . . . 3
1.3.7 Chassis and Lead Leakage Tests (vPad-ES) . . . . . . . . . . . . . . . . . . . . . . 3
1.3.8 Leakage Current Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3.9 ECG Simulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Measurement Terminals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.1 Test Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.2 Current Source Terminals (SRC+/-) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.3 Meter Input Terminals (EXT+/-) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.4 ECG Terminals (APx) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.6 Electrical Ratings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.7 Externally-Accessible Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.8 Environment for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.9 Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.10 Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.11 Standard Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.12 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
1.13 Compliance With Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.1 Analyzer Base Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1.2 Test Receptacle Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.3 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.2 Test Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.3 Safety Test Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3 SETUP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

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vPad-353 OPERATORS MANUAL

4 OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.1 HOME Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2 Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.3 Test Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.4 Receptacle Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.5 Voltage Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.5.1 Mains Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.5.2 External Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.5.3 External Micropotential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.6 Equipment Load Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.6.1 Load Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.6.2 Power Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.7 Earth Resistance Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.7.1 Protective Earth Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.7.2 External Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.7.3 Measurement Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.7.4 Test Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
4.8 Insulation Resistance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.8.1 Insulation Test: L1+L2 to PE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.8.2 Insulation Test: AP to PE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
4.8.3 Test Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.9 Leakage Current Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
4.9.1 Equipment Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.9.2 Applied Part Leakage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
4.9.3 Test Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4.10 Leakage Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
4.11 ECG Simulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
4.11.1 ECG Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
4.11.2 Common-Mode Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
4.12 Equipment Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.12.1 Inspection Tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
4.12.2 Performing an Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
4.13 Data Recording . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.13.1 Using the Android Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
4.13.2 Recording Measurements and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . 68
4.13.3 Viewing Measurements and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
4.13.4 Recording Equipment Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.13.5 Creating a Test Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.14 Record Manager App . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

5 CALIBRATION AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

APPENDIX A. SAMPLE TEST RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

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vPad-353 OPERATORS MANUAL

Abbreviations and Definitions

The following abbreviations, terms and acronyms are used throughout this manual:

µA Micro-ampere
A Ampere
AAMI American Association of Medical Instrumentation
AP Applied Parts (patient leads)
App Software application for a mobile device
Cct. Abbreviation for circuit (ie. electrical circuit in a power distribution
system)
Earth See GND
EUT Equipment Under Test. The electrical device being tested.
GND or Ground The line (conductor) connected to a place that is maintained at
“Ground” or “Earth” voltage. Same as Protective Earth.
Hz Hertz
IEC International Electrotechnical Commission
IME Android input method (e.g. keyboard)
kHz kilohertz
L1, Line 1 or Hot Line 1 of the AC supply voltage, or "mains". In North America, the “Hot”
or “Live” line (conductor) of the AC supply.
L2, Line 2 or Neutral Line 2 of the AC supply voltage, or "mains". In North America, the
“Neutral” line (conductor) of the AC supply.
LA left arm ECG lead
LL left leg ECG lead
MAINS The voltage provided by the building installation, nominally 120 VAC or
230 VAC depending on the country
M.A.P. / MAP Mains on applied part(s)
Measurement Category I Intended for measurements on circuits with no direct connection to
Terminal MAINS (CAT I)
Measurement Category II Intended for measurements on circuits which may have a direct
Terminal connection to MAINS (CAT II)

MHz Megahertz

Definitions # Page vii

vPad-353 OPERATORS MANUAL

NC Normal Condition of AC supply to EUT: ground and neutral are both

connected
PE Protective Earth. The line (conductor) connected to a place that is
maintained at “Ground” or “Earth” voltage.
RA right arm ECG lead
RL right leg ECG lead
RMS Root-Mean-Square measurement of a parameter (eg. Vrms, Arms....)
Safety Standard Standards established by various national and international regulatory
agencies. The most recognized Standards Organizations include:
AAMI - Association for Advancement of Medical Instrumentation
IEC - International Electrotechnical Commission
SFC Single-fault condition of AC supply to EUT: either ground or neutral is
disconnected, but not both
Type B (Body) IEC protection class referring to patient-applied parts (leads) which are
not isolated from ground
Type BF (Body Floating) IEC protection class referring to patient-applied parts (leads) which are
isolated from ground
Type CF (Cardiac Floating) IEC protection class referring to patient-applied parts (leads) which are
isolated from ground and also intended for direct cardiac application
V Volt
V1-V6 Precordial (chest) ECG leads
Vrms Volts rms

Definitions # Page viii

vPad-353 OPERATORS MANUAL

Symbol Definitions
The following symbols may be found on vPad-353:

CONSULT MANUAL FOR PROPER OPERATION

The operating manual provides valuable information on the proper use of vPad-353. It is highly recommended
the operator read the instructions thoroughly before operating the device. It is possible to damage the Equipment
Under Test (EUT) and/or cause harm to the operator if vPad-353 is used incorrectly.

Patient Leads: Hazardous Voltage: 264 VAC or 500 VDC max

This warning appears on the label for the patient lead connections, located at the rear of vPad-353. During testing
of the isolation of the EUT patient applied parts leads with respect to either ground, or to the power input leads,
a voltage of either 100% of the AC line voltage or 500 VDC may be present on the (CAT I) lead connectors. This
voltage may reach a maximum of ~264 VAC or 500 VDC and, while current limited, represents a serious shock
hazard to the operator. Proper precautions should be taken when performing a test which includes the application
of this voltage to the EUT patient leads. The display of vPad-353 will indicate when a hazardous voltage is present
at the patient lead connectors.

CAUTION: Electrical Shock Hazard, Refer Servicing to Qualified Personnel

CAUTION: Consult Accompanying Documents

These warnings appear on the serial number label of vPad-353. vPad-353 contains hazardous electrical voltages
internally which WILL BE present when the covers are removed. The operator should read the Operating Manual
to determine what actions to take in the event of failure of vPad-353. Refer to the Troubleshooting and
Maintenance Section of the Operating Manual.

Kelvin Cable

The Kelvin Cable (CAT I) is used to measure the Line Cord Grounding Resistance, using a pulsed 1 amp current
(200 mA RMS). The voltage present at these terminals is below 6 volts. Consult the Operating Manual for the
proper operation of the Grounding Resistance test.

DO NOT EXCEED THE FOLLOWING CURRENT LOAD ON THE EUT

RECEPTACLE:

15AMPS @ 100 - 120 VAC, 60 Hz (in 20A circuit)

11AMPS @ 100 - 120 VAC, 60 Hz (in 15A circuit)
12AMPS @ 230 VAC, 50 Hz (in 16A circuit)

Definitions # Page ix
vPad-353 OPERATORS MANUAL

The regulatory requirements for loading a circuit (cct.) in a power distribution system sets a current limit on any
individual receptacle to 80% of the value of the circuit breaker on that circuit. For instance, in a circuit with a 15A
circuit breaker (or fuse), the maximum current allowed to be drawn from any individual receptacle is 12A.
Allowing 1A for the vPad-353 circuitry, the load current for the Equipment Under Test (EUT) should not exceed
11A. These limits are set by the Electrical Code in most jurisdictions in an attempt to avoid unexpected circuit
overloads and subsequent circuit failure. If the EUT load is expected to approach the maximum value on a
routine basis, it is recommended that a circuit with only a single receptacle be provided for use with vPad-353.

WARNING: OPENING THE vPad-353 MAY COMPROMISE USER SAFETY.

REFER SERVICING TO DATREND AUTHORIZED AGENT.

vPad-353 is a complex instrument which contains internally distributed line voltages and other high voltages for
specific measurement purposes. Failure to observe appropriate measures when the instrument has been
opened, or failure to reassemble correctly may compromise the safety of the user.

WARNING: GROUNDING CIRCUIT CONTINUITY IS VITAL FOR SAFE

OPERATION. NEVER OPERATE THE vPad-353 WITH GROUNDING
CONDUCTOR DISCONNECTED.

Proper grounding is essential to ensure operator safety. Do not bypass the grounding provisions inherent in the
design of vPad-353, otherwise, the operator may be subjected to an electrical shock risk.

WARNING: HAZARDOUS VOLTAGES OR CONDITIONS MAY EXIST DURING

TESTS. CONSULT THE ACCOMPANYING DOCUMENTS FOR APPROPRIATE
PRECAUTIONS.

During the execution of an electrical safety test on the EUT, vPad-353 may apply a high voltage (up to 264 VAC)
to the EUT. While this voltage is current limited, it does represent a shock hazard to the operator if precautions
are not followed. Consult the instructions in this manual regarding Isolation Leakage Current tests (MAP test)
for further information.

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1 Specifications

Equipment Performance Specifications

1.1 Electrical Safety Testing Standards

- IEC62353
- IEC60601 (via vPad-ES application, included)
- AAMI-ES1 (via vPad-ES application, included)

1.2 Safety Tests

- Mains Voltage
- External (point-to-point) Voltage
- External (point-to-point) Micropotential
- Equipment Load Current
- Equipment Power Consumption
- Protective Earth Resistance
- External (point-to-point) Resistance
- Equipment Leakage Current
- Applied Part Leakage
- Insulation Resistance

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1.3 Instrument Specifications

1.3.1 Voltage Measurement

Mains voltage
Range....................................... 90 to 264 V rms
Accuracy ................................. ±(2 % of reading + 0.2 V)
External (point-to-point) voltage
Range...................................... 0 to 300 V rms
Accuracy ................................ ±(1 % FS + 0.2 V)
External (point-to-point) micropotential
Ranges..................................... 0 to 199.9 mV rms
200 to 1,999 mV rms
2,000 to 19,999 mV rms
Accuracy ................................ ±(1 % of reading + 1 mV)

1.3.2 Load Current Measurement

Ranges .................................................. 0 to 1.999 A ac rms

2.00 to 19.99 A ac rms
Accuracy .............................................. ±(2 % reading + 0.2A)
Duty cycle ............................................ 0 A to 10 A, continuous
10 A to 15 A, 7 min. on/3 min. off
15A to 20 A, 5 min. on/5 min. off

1.3.3 Power Measurement

Range ................................................... 0 to 2400 watts

Accuracy .............................................. ±(5 % reading + 5W)

1.3.4 Earth Resistance Measurement

Modes .................................................. Four-terminal, fully isolated

Test Current ....................................... 1A pulsed, 0.2A rms
Range .................................................. 0.000 to 2.000 Ω
Accuracy ............................................. ±(1 % of reading + 0.02 Ω)

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1.3.5 Insulation Resistance Measurement

Ranges................................................... 0.5 to 5 MΩ
5 to 50 MΩ
50 to 999.9 MΩ
Range Selection.................................... Automatic
Accuracy
5 MΩ Range ............................ ±(1 % of reading + 0.1 MΩ)
50 MΩ Range .......................... ±(2 % of reading + 0.2 MΩ)
50 to 100 MΩ........................... ±(5 % of reading + 0.2 MΩ)
Test Voltage
Selections.................................. 500V or 250V
Accuracy................................... ±5 % for 0 to 1 mA load
Maximum load capacitance.... 1 µF

1.3.6 Equipment and Applied Part Leakage Tests (vPad-353)

Measurement........................................ True RMS

Method.................................................. Direct method
Patient Load......................................... Per IEC62353
Functional Group Selections............. AP1; AP1 and AP2; AP3 and AP4; AP1 to AP3;
AP1 to AP4; AP5 to AP10; AP1 to AP10

1.3.7 Chassis and Lead Leakage Tests (vPad-ES)

Measurement........................................ AC+DC (True RMS)

AC only
DC only
Patient Load Selections....................... IEC60601
AAMI-ES1

1.3.8 Leakage Current Measurement

Crest Factor.......................................... <= 3

Ranges................................................... 0.0 to 199.9 µA
200 to 1,999 µA
2,000 to 19,999 µA
Accuracy
DC to 1 kHz............................ ±(1 % of reading + 1 µA)
1 to 100 kHz ........................... ±(2 % of reading + 1 µA)
100 kHz to 1 MHz.................. ±(5 % of reading + 1 µA)
Isolation test voltage........................... 100 % ±5 % of AC supply

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1.3.9 ECG Simulator

Output
Amplitude.............................. 1 mV QRS into Lead II
Impedance............................. 500 ohms
Accuracy
Frequency............................... ±1 %
Amplitude................................ ±2 %
Waveforms
ECG Complex....................... 30, 60, 120, 180, 240 and 300 BPM
Square wave............................ 0.125 Hz, 2 Hz and 1 kHz
Pulse wave.............................. 63 msec, 30PPM and 60PPM
Triangle wave......................... 2 Hz
Sine wave................................ 0.5, 10, 40, 50, 60 and 100 Hz
CMRR tests............................. SQR 2Hz & 1 kHz, PUL 4 sec, SIN 0.5, 50 & 60Hz
Arryhthmias............................ VFIB, AFIB, SVT, VTACH, PVC and ASYS

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1.4 Measurement Terminals

1.4.1 Test Receptacle

Category............................................... CAT II
Maximum Voltage
North America....................... 132 VAC
Europe/Asia........................... 264 VAC
Maximum Current
North America....................... 15A AC
Europe/Asia........................... 13A AC

1.4.2 Current Source Terminals (SRC+/-)

Category............................................ CAT I
Maximum Voltage........................... 6V
Maximum Current........................... 200 mA RMS

1.4.3 Meter Input Terminals (EXT+/-)

Category............................................. CAT I
Maximum Voltage
External µA/mV mode....... 20V
External voltage mode......... 300V
Maximum Current............................. 0.2 mA @ 300V

1.4.4 ECG Terminals (APx)

Category.............................................. CAT I
Maximum Voltage................................ 264 VAC (Isolation Test )
Maximum Current............................... 14mA AC @ 264 VAC

Connect measurement terminals ONLY as instructed in this manual.

See Chapter 4, Operation

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1.5 User Interface

Display............................................................ 10.1" colour LCD (1280 x 800)

User Controls................................................. Capacitive touchscreen

Wired Connectivity........................................ Micro USB 2.0 Type B (shareable with base unit)
USB 2.0 Type A (premium tablet only)
XBUS Interface (RJ11-6)

Wireless Connectivity................................... 802.11 b/g/n

Bluetooth 2.1+ EDR

Memory Internal............................................ 16GB Maximum †

Memory Expansion....................................... 16GB to 32GB Micro SD Card (optional)

Modes of Operation....................................... Manual (standard)

Automatic (accessory option)

†
16 GB is the maximum amount of internal memory installed in the tablet. The internal memory is
formatted similar to a hard disk to facilitate storage and access to data including the Operating System,
Programs, and Data. The formatting process reduces that amount of storage available for use by the tablet.
Additionally, the Operating System can consume up to 4 GB of storage. The nominal internal storage
available for users is approximately 12 GB as shipped from Datrend.

If additional storage is required, an SD card can be installed in the tablet. Upon initial installation of an SD
card, check for proper operation and that the correct size is reported. It may be necessary to format your
SD card. If so, ensure that the card is formatted for the FAT32 file system, and that the long format mode is
used (do NOT use “quick format”).

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Equipment Technical Specifications

1.6 Electrical Ratings

Country Specific: 120 VAC ± 10%, 60 Hz, 16A in 20A circuit

120 VAC ± 10%, 60 Hz, 12A in 15A circuit
230 VAC ± 10%, 50 Hz, 13A
Notes:
- This instrument has been designed to test equipment that meets local power distribution
standards, which limit devices to draw no more than 80% of the specified current capacity
of a circuit. For instance, a single device should draw no more than 16A from a single
receptacle on a 20A circuit.
- Transient overvoltages typically present on the mains supply are expected to be impulse
withstand (overvoltage) category II of IEC 60364-4-443

1.7 Externally-Accessible Fuses

20A / 250V AGC

1.8 Environment for Use

15 to 40 EC
10% to 90% RH
Altitude: 2000m max.
Indoor use only
Pollution Degree 2

1.9 Dimensions

Base unit....................................... 11.8 x 8.9 x 3.3 in. (30 x 23 x 8.4 cm)

Tablet PC (detachable).................... 10.5 x 6.7 x 0.5 in. (27 x 17 x 1.3 cm)

1.10 Weight

5.5 lb (2.5kg)

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1.11 Standard Accessories

vPad Kelvin Cable......................................... P/N 3140-475

vPad Tablet USB Cable................................ P/N 3140-478
vPad Tablet DC Cable.................................. P/N 3140-476 (12V) or -477 (5V), depending on
tablet model
Power Cord (country specific)
North America 15A............................ P/N 3000-009
North America 20A............................ P/N 3000-010
Continental Europe............................ P/N 3000-011
United Kingdom................................. P/N 3000-012
Australia............................................... P/N 3000-018

1.12 Optional Accessories

For a complete list of available accessories, visit www.datrend.com or contact Datrend Customer
Service (see Chapter 5 for contact details)

1.13 Compliance With Standards

vPad-353 has been certified to meet the following safety standards:

CAN/CSA-C22.2 No. 61010-1-(2nd Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use, Part 1: General Requirements

UL Std. No. 61010-1 (2nd Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1: General Requirements

Following manufacture, all units are subjected to, and have passed the requirements of the
‘Routine Tests’ defined in Annex F of the above Standard(s).

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2 Overview
vPad-353™ is a manually-operated electrical safety analyzer providing basic electrical safety testing of
medical devices with patient leads. This chapter provides an overview of vPad-353 features and test modes.
A summary of testing requirements specified by the IEC 62353 safety standard (Medical Electrical
Equipment - Recurrent test and test after repair of medical electrical equipment) is included at the end of
this chapter.

2.1 Features

2.1.1 Analyzer Base Unit

The vPad-353 safety analyzer is comprised of an Android™-powered tablet which provides the user
interface, and a Base Unit which provides the analyzer instrumentation. Referring to Figure 1 , controls,
interfaces and features of the Analyzer Base Unit are:

Item Description/Function
1. AC supply input Connect to AC power supply using line cord provided with vPad-353
2. Line fuse Main supply fuse; replace with AGC 20A / 250V
3. AUX test jack Use when testing applied part leakage current of Class II medical equipment
4. Test receptacle Connect to AC power input of Equipment Under Test (EUT)
5. Receptacle Active Lights when power is applied to/available at test receptacle (4)
indicator
6. Tablet tray Supports tablet when safety analyzer in use
7. TABLET DC Connect to DC power input of tablet, using cable provided (either 12V (P/N
3140-476) or 5V (P/N 3140-477), according to tablet model)
8. TABLET USB Connect to USB port of tablet, using cable provided (P/N 3140-478)
9. Cable storage bay Store tablet USB and Power cables here when transporting or storing vPad-353

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Figure 1 - vPad-353 Analyzer Base Unit.

Overview/Chapter 2 # Page 10
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Item Description/Function
10. Binding posts Connect to EUT patient leads or applied parts, for example, ECG leads
11. Meter input, EXT+/- Input to voltmeter or leakage measuring device
12. Current source, SRC+/- Current source output for four-wire resistance measurement
13. Test resistor, 1.0 Ω Use to verify function of ohmmeter
14. Test current, 100µA Use to verify function of leakage measuring device
15. AC supply indicator Lights when AC supply is connected to Base Unit
16. Reset button Press to reset Base Unit
17. Normal/remote switch Set to "normal" for operation by Android tablet; set to "remote" for
operation via remote control from PC running Microsoft Windows®
(Android tablet is bypassed)
18. PC IN USB Type B (Device) - connect to PC for remote control operation
19. XBUS Port Connect to Vision-Pad Technology™ accessory devices

2.1.2 Test Receptacle Configuration

vPad-353 may be equipped with one of these test receptacles, but other receptacles may be substituted to
satisfy customer requirements. For additional configurations, please contact Datrend Customer Service (see
Chapter 5 for contact details).

North America Western Europe United Kingdom Australia/China

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2.1.3 User Interface

The user interface of vPad-353 is based on an Android™-powered tablet computer. Android provides
numerous features which make vPad-353 unique as a biomedical test instrument:

• High Definition (HD) colour display with capacitive touchscreen

• 4 to 16GB of internal memory (depending on tablet model), expandable via accessory SD Card

• WiFi for wireless connectivity to printers, PC's and the Internet

• Bluetooth for wireless connectivity to PC's and hardware add-ons (keyboard; barcode scanner; etc.)

• USB Host Port on premium Vision-Pad tablets supports hardwired accessories such as flash drive,
keyboard, barcode scanner, etc.

• Still-image camera and audio/video recorder (tablet dependent)

• Full-size (8½ x 11") document printing

• Pre-installed software applications ("apps"): file manager; Internet browser; PDF and e-book reader; e-
mail; calendar; notepad; plus many others

• More Android apps easily installable via direct download from Google Play, GetJar, and other sources

The vPad-353 app for Android drives the Analyzer Base Unit. In addition to large, easy-to-read indicators and
pushbutton controls necessary for analyzer operation, Datrend's vPad apps provide data recording and other
features which are unprecedented in a safety analyzer in this price range:

• Save tens of thousands of Test Records on the safety analyzer, with each Record storing a practically
unlimited number of measurement values in combination with in-line notations

• Save equipment information to Test Records, including control number, description, make, model, serial
number and more

• Perform and record equipment inspections following the General Devices Acceptance Procedure published by
the ECRI Institute (USA)

• Manage vPad Test Records: copy; delete; convert to PDF; and print to full-size (8½ x 11") pages - on an
individual basis or on multiple selected Records at once

More information on the many features of the user interface and apps may be found in Chapter 4 of this
manual.

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2.2 Test Modes

vPad-353 provides a variety of test modes which are useful for performing electrical safety measurements
on medical equipment.

Mains Voltage Use this mode to test the AC supply which powers vPad-353. Measure voltages
from AC mains Line 1 (L1) to Line 2 (L2); from L1 to Protective Earth (PE); and
from L2 to PE.

External Voltage Use this mode to check larger voltages between two arbitrary points, up to 300V
RMS maximum.

External Use this mode to observe small voltages in the millivolt range between two
Micropotential arbitrary points. In this mode, the voltmeter has a low input resistance (1 kohm).
vPad-353 auto-ranges to suit the potential being measured (200, 2000 or 20000
mV RMS full scale).

Load Current Use this mode to measure current drawn from the AC mains supply by the
equipment under test (EUT). vPad-353 auto-ranges to suit the current being
measured (2A or 20A AC full scale).

Power Use this mode to measure the power consumption of the EUT. Power is
calculated from the product of the line voltage and load current. This test mode is
useful for monitoring power consumption of loads over 50W.

Protective Use this mode to test the resistance of the EUT's power supply cord, up to a
Earth maximum of 2 Ω. In this test mode, vPad-353 uses an isolated, four-wire
Resistance ohmmeter with a pulsed 1 amp current source.

External Use this mode to measure resistance between two arbitrary points, up to 2 Ω. A
Resistance four-wire ohmmeter is used.

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Equipment Use this mode to check for leakage current that may flow from the chassis or
Leakage enclosure of the EUT to ground of the AC supply when the PE connection is
open.

The leakage measuring device (MD) is configured for true-rms measurement, per
the standard. The test receptacle may be set to normal or reverse polarity. As
required, vPad-353 auto-ranges to suit the leakage being measured (200, 2000 or
20000 µA full scale).

Applied Part Use this mode to check for leakage current from EUT "Applied Parts" or patient
Leakage leads to Earth of the AC mains supply, when an isolated voltage equal to the
mains is connected to one or more leads.

Applied Parts (AP) may be tested in various combinations or groups, according to

their medical function.

Insulation Use this mode to measure the insulation resistance between the Mains Part and the
Resistance PE of the EUT; and, the insulation resistance between the EUT AP and PE.

ECG Simulator Use this mode to produce calibrated test signals such as pulse, square, sine and
physiological waveforms which are useful in testing patient monitoring systems.

In addition to measurements required by the IEC 62353 standard, the vPad-353 analyzer can be used to
perform electrical safety testing in accordance with IEC 60601 and AAMI-ES1 standards.

IEC 60601 and AAMI-ES1 safety tests are implemented in the vPad-ES software "app", which is installed
on the Android tablet of the vPad-353 analyzer. Refer to MN-074 vPad-ES Operator's Manual, included
with vPad-353, for instructions on using the analyzer to perform IEC 60601 and AAMI-ES1 tests.

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2.3 Safety Test Standards

vPad-353 may be used to perform electrical safety tests of medical devices with patient leads, following the
IEC62353 standard. TABLE 2.3-1 defines terms which pertain in general to electrical safety testing of
medical equipment.

TABLE 2.3-1: Safety Test Terminology

Term Definition
EUT Equipment Under Test

NC Normal operating condition. AC supply to EUT has PE (ground) and L2 (neutral) both normal (closed).

SFC Single-Fault Condition. AC supply to EUT has ground disconnected (open).

AP Applied Part(s). IEC term referring to patient / ECG leads of EUT

Type B IEC applied part protection class, type "Body" (non-isolated)

Type BF IEC applied part protection class, type "Body-Floating" (isolated)

Type CF IEC applied part protection class, type "Cardiac-Floating" (isolated, rated for direct cardiac application)

Leakage current testing is performed by connecting a measuring device, or "MD", to the EUT chassis
and/or patient leads. vPad-353 incorporates the measuring device specified by the IEC62353 standard,
which is shown in Figure 2. The MD incorporates a low-pass filter between the 1k test resistance and
millivoltmeter to compensate for an allowable increase in leakage limits with increasing frequency.

Overview/Chapter 2 # Page 15
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Figure 2 - Measuring device (MD) for IEC 62353 standard.

In addition to specifying the measuring device circuit, the IEC 62353 standard also specifies test conditions
under which leakage current must be measured. The requirements of the standard and the practical
interpretation of these requirements are summarized in TABLE 2.3-2. vPad-353 meets these requirements
by providing the necessary test settings that enable you to follow the IEC 62353 standard.

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TABLE 2.3-2: Leakage Test Requirements of IEC 62353

Test Requirement Practical Interpretation

Test by the direct method at mains voltage and in Measure leakage with normal AC mains polarity, and with
either position of the mains plug, if applicable. reversed mains polarity.

Test leakage with equipment in all intended functional Unless a specific functional condition is known a priori to
conditions (i.e. switch positions) that influence the produce the highest leakage, test with EUT power switch set
leakage current. The highest value and the related to "OFF" position, and with EUT power switch set to "ON"
condition, if relevant, shall be documented. position. Testing with equipment set to additional functional
states may be necessary to find the highest leakage.

Test applied part leakage with all patient connections When patient connections of a common medical function are
of a single function of the Applied Part connected shorted together, the shorted leads will then form a single
together. When testing equipment with multiple "Applied Part" per the definition of IEC62353.
Applied Parts, test each Applied Part in turn. Applied
Parts which are not part of a measurement shall be For example, in testing leakage current of a portable patient
left floating. monitor which provides three ECG leads and two invasive
blood pressure (IBP) channels, the IEC62353 standard
requires that the ECG leads must be shorted together and
measured, while leaving the two IBP connections floating.
Then, the two IBP connections are shorted together and
measured, while leaving the three ECG leads floating.

Leakage current is measured and recorded for each medical

function separately. According to additional requirements
above, test with normal/reverse mains polarity and with EUT
on/off.

All leakage values must be less than the maximum limit

specified in IEC62353 (see TABLE 2.3-3 following).

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Acceptance limits according to IEC 62353 are shown in TABLE 2.3-3. These limits are applied by vPad-353
to determine the pass/fail result of a measurement. Note the following with respect to TABLE 2.3-3:

• EUT ON or OFF and supply polarity reversed are normal operating conditions and have no bearing on
limits specified.

• Equipment Class affects the limit for Equipment Leakage. Cord-connected equipment without
protective earth connection, designated as Class II, must have lower leakage than Class I equipment,
which has a three-wire power cord.

• Applied Part Type affects the limit for Applied Part Leakage. Applied Parts intended for direct cardiac
application, designated as Type CF, must have lower leakage than Type BF Applied Parts, which are
sufficiently isolated for body application but are not for application near or on the heart.

TABLE 2.3-3: Maximum Limits

Test IEC62353 (Ed. 1)

Protective Earth Resistance 0.3 Ω

Equipment Leakage Class I: 500 µA

Class II: 100 µA

Applied Part Leakage Type BF Leads: 5000 µA

Type CF Leads: 50 µA

Insulation Resistance No limits specified

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3 Setup

After placing the Analyzer Base Unit on a stable,

flat surface, pull out the tablet tray on the front
of the unit.

Figure 3

At the back of the Base Unit above the binding

posts, grab the tablet and carefully lift it away
from the unit.

Figure 4
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Place the bottom of the tablet on the tray and

rest the rear of the tablet on the front of the base
unit.

The tablet may also be held in place without the

tray, using the inherent ‘sticky’ characteristics of
the labels on the back of the tablet and the front
of the base unit.

Figure 5

Connect the power cable from the TABLET DC jack of the Base Unit to the DC IN jack of the tablet. The
cable provided with vPad-353 will depend on tablet model: 12V (P/N 3140-476) or 5V (P/N 3140-477).

Figure 6 Figure 7

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Connect the USB cable provided with vPad-353 (P/N 3140-478) from the TABLET USB jack of the Base
Unit to the USB port of the tablet.

Figure 8

Figure 9

Setup/Chapter 3 # Page 21
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Connect the power cord provided with vPad-353 to the right side panel of the unit, then plug the cord into
a power outlet (Figure 10 ). If the AC outlet has power, the indicator lamp on the left panel of the Analyzer
Base Unit should now be lit (Figure 11 ).

Figure 10

Figure 11

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With the Base Unit now powered up, switch the tablet ON by pressing and holding the power button on
the top of the tablet until the tablet is felt to vibrate (approx. 5 - 10 sec). Approximately 60 seconds after
switching ON, the Android HOME screen should appear on the tablet.

Figure 12

The foregoing instructions are for the standard tablet model. Alternative tablet models may have DC and
USB connections and the Power button in different locations; one example is shown in Figure 13. If
necessary, refer to the tablet operator manual provided with vPad-353 for further guidance.

Figure 13

Setup/Chapter 3 # Page 23
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Switch the tablet OFF when vPad-353 is not in use. Press and hold the ON/OFF switch until a
confirmation message appears on the tablet screen. Select the appropriate response to complete the Power
Off sequence.

Note: Pressing and releasing the Power ON/OFF button momentarily will put the tablet in a ‘sleep’ mode.
Press the ON/OFF button momentarily again to ‘wake’ the tablet. This is NOT the same as OFF. This
mode is useful when moving the vPad-353 between locations, and avoids the delay in starting from the
Power OFF state.

To store or transport vPad-353, reverse the setup procedure by starting at Figure 10 and proceeding to
Figure 3 above.

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4 Operation
This chapter explains how to use vPad-353 to perform electrical safety tests and inspections of medical
equipment. Test Record management is also covered in this chapter.

4.1 HOME Screen

The Android HOME screen (Figure 15 ) is displayed approximately 60 seconds after switching the tablet
ON.

Figure 15 - HOME screen.

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Initiate actions on the tablet by pressing the corresponding icon or button. For example:

Press to launch the vPad-353 software application, or "app". Use this app to perform
electrical safety testing according to the IEC 62353 standard.

Press to launch the vPad-ES app. Use this app to perform electrical safety testing according
to the IEC 60601 standard, or AAMI-ES1 standard. For full details on vPad-ES, refer to
MN-074 vPad-ES Operator Manual , provided on the Android tablet.

Press to launch the vPad Record Manager app. Use this app to copy, print, convert or delete
Test Records saved by vPad-353.

Press to access Settings. Use this menu to configure sound, display, touchscreen, and
wireless setup.

By default, vPad-353 is supplied with both WiFi and Bluetooth connectivity disabled.
Use the Settings menu to enable wireless connectivity, in accordance with policies of
your institution or organization.

At top right on the screen, press the Apps button to access more apps which are installed
on the tablet.

At bottom left on the screen, press the Home button to return from an app to the Home
screen.

At bottom left, press the Back button to navigate back one step, from the app or screen
currently being displayed, to a previous one. For some apps, this button's function may be
disabled.

At bottom left, press the Recents button to jump from the current app to a different app
that was started earlier, but is currently on pause.

For more information on how to use the Android tablet, refer to the tablet operator manual supplied with
vPad-353.

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4.2 Startup

Press the vPad-353 icon on the Android Home screen to start the app. A splash screen will display the
product name and the software version.

Figure 16 - vPad-353 startup screen.

As the splash screen is displayed, the app will "connect" to the Analyzer Base Unit and cause it to perform a
number of internal self-tests. The AC supply which powers vPad-353 is also tested. Normally, all tests will
complete successfully and the main activity of the app will then be displayed.

Faults in the Base Unit or the AC supply may be detected during the self-test, in which case an alarm
message is displayed below the software version number. In the event of a Base Unit fault, the app will
automatically exit to the Home screen. In the event of an AC supply fault, in addition to the alarm message
the app will display an Alert Dialog, which you must then acknowledge by pressing “Continue”, “Exit”or
“OK” (see Figure 17 ). Refer to TABLE 4.2-1 for recommended actions in the event of a startup alarm
message.

Figure 17 - Alert Dialog: AC supply fault.

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TABLE 4.2-1: Startup Alarms and Corrective Actions

Alarm Message Cause Actions

ERROR: App is unable to send • Check Base Unit has power
cannot communicate with messages to one or more (check power indicator, left panel - see Figure 1 on
Base Unit instrument systems inside page 10)
the Base Unit
• Check Base-to-tablet USB connection
(see Figure 9 on page 21)

• If AC power and USB cables are OK, press and hold RESET
button of Figure 1 for 3 seconds, then try restarting app

• If error persists, contact Datrend Customer Service (see

Chapter 5 for contact information)

AC SUPPLY FAULT AC outlet incorrectly wired • Do not use vPad-353 with incorrect or unsafe AC supply
(polarity reversed)
• Connect Base Unit to a different outlet

AC SUPPLY FAULT AC outlet incorrectly wired • Do not use vPad-353 with incorrect or unsafe AC supply
(ground disconnected)
• Connect Base Unit to a different outlet

AC SUPPLY FAULT Isolated power system • Do not perform leakage testing as results will be invalid
(ground disconnected)
• Optionally, vPad-353 may be used to perform tests other than
leakage (e.g., voltage, resistance or ECG simulator tests)

• If possible, change to grounded power outlet

RMS zero calibration Unable to zero voltmeter • Press RESET button of Figure 1 for 3 seconds, then try
failure restarting app

• If problem persists, contact Datrend Customer Service (see

Chapter 5 for contact information)

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4.3 Test Navigation

After startup, the main menu of vPad-353 is displayed. Tabs the top of the screen navigate test modes
provided by vPad-353. By default, vPad-353 selects the Voltage tab after startup. To select a different test
mode, press the corresponding tab.

Figure 18 - Test Tabs.

4.4 Receptacle Control

This section contains important information which relates to operator

safety. Read and follow all instructions.

Voltage, Resistance and Simulator test modes provide a button which you may press to switch the test
receptacle ON or OFF as required. The Equipment Inspection menu also provides this control.

Figure 19 - Test receptacle power button.

For convenience, vPad-353 automatically switches the receptacle ON when you select the Equipment
Load or Leakage Current mode.

By default, vPad-353 automatically switches the receptacle OFF if you change test mode to Voltage,
Resistance, Insulation or ECG Simulator. If desired, this default behaviour can be overridden for the ECG
Simulator mode via the vPad-353 Settings menu; refer to Section 4.10 for details.

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Android navigation buttons override the app display but do not necessarily stop what an app may be doing.
If the test receptacle is ON, and you navigate away from vPad-353 by pressing:

Home , or

Recent

the test receptacle will remain ON. A characteristic of Android is that once an app such as vPad-353 is
launched, the app may keep running, even if the app's display is partly or completely obscured by another app
or the Android Home screen.

While viewing Voltage, Leakage and other test displays of vPad-353, the Android "Back" button
may be pressed to completely close the application. Since unsaved measurement data will be lost if vPad-353
is closed, a warning dialog is displayed which will allow you to exit or otherwise keep the application
running. When vPad-353 is closed, the test receptacle is switched OFF automatically. Note the Android
"Back" button is enabled on the test displays, but is disabled when viewing smaller pop-up menus such as
Save Data, which typically have a dedicated "Cancel" button for exiting the pop-up.

For safest operation of vPad-353, follow these instructions:

• Before connecting or disconnecting equipment, observe the Receptacle

Active lamp (Figure 1 , page 10). Use caution when the Receptacle Active
lamp is lit.

• Switch the test receptacle OFF when not in use

• Do not disable the Receptacle Auto-OFF setting unless the EUT or test
requires that the AC supply must be continuously ON

• Before launching a new application, press the Android "Back" button

and respond "YES" to the displayed message. This will close vPad-353 and
switch the test receptacle OFF.

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4.5 Voltage Tests

Following application startup, vPad-353 defaults to measurement of the AC supply or "Mains Voltage",
from Line 1 (L1) to Line (L2).

Figure 20 - Voltage test mode.

This test mode enables measurement of three different voltages associated with the AC supply, and two
external or point-to-point voltages. As selected by the upper row of buttons, the voltage currently under test
is indicated immediately above the numeric readout. Voltage is continuously measured and displayed until a
different test mode is selected. The bottom row of buttons provides these functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the voltage measurement currently being displayed. Refer to Section
4.13 for instructions on data recording.
View Data Press to review measurement data recorded during testing.
Receptacle Press to switch the test receptacle ON or OFF as desired. Refer to Section 4.4 for
ON/OFF important information and instructions concerning operation of the test
receptacle.

Sections 4.5.1 to 4.5.3 provide instructions for the Voltage test mode.

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4.5.1 Mains Voltage

Press the corresponding Mains Voltage button to measure the desired potential per Figure 21 to Figure
23. No external test leads are necessary. Voltages are measured over a range of 90-264 VAC.

With respect to the illustrations, note the following:

Line 1 (L1) = AC supply Hot (H)
Line 2 (L2) = AC supply Neutral (N)
Earth (E) = AC supply Ground (G)

Figure 21: Line voltage test, L1-L2 (hot-neutral). Figure 22: Line voltage test, L1-PE (hot-ground)

Figure 23: Line voltage test, L2-PE (neutral-ground)

If the AC supply which powers vPad-353 is correctly wired and is not connected to an isolated power
distribution, potentials L1-L2 and L1-PE should be approximately equal, and potential L2-PE should be
substantially smaller than L1-L2.

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4.5.2 External Voltage

Press the External Voltage button to measure large voltages, typically greater than 20 Volts, between two
arbitrary points, up to a maximum of 300V.

Connect test leads to the voltmeter at EXT+ and EXT- jacks on the left panel of the Analyzer Base Unit.
You may use standard multimeter (DMM) probes, or alternatively two vPad Kelvin Cables as respectively
shown in Figure 24 and Figure 25 following.

Figure 24: External voltage with two DMM probes

Figure 25: External voltage with two Kelvin Cables

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4.5.3 External Micropotential

Press the External mV button to measure small potentials in the millivolt range between two arbitrary
points, up to a maximum of 20V.

When you select this test, an Alert Dialog is displayed to remind you of vPad-353 maximum ratings. Press
"OK" to clear the Alert Dialog and begin testing, or "Cancel" to abort and return to the previous test
mode.

Figure 26 - Alert Dialog - maximum input 20V.

Exceeding specified maximum ratings may result in damage to vPad-353

and is not covered by warranty.

Connect test leads to the voltmeter at EXT+ and EXT- jacks on the left panel of the Analyzer Base Unit.
You may connect to external points using two standard multimeter (DMM) probes, or two vPad Kelvin
Cables as shown in Figure 27. If points are less than 1" (2 cm) apart, a single Kelvin Cable may optionally
be used, as shown in Figure 28.

Figure 27: External micropotential with 2 x Kelvin Cable

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Figure 28: External micropotential test with one Kelvin Cable

According to the above schematics, external micropotential is measured with an IEC measuring device.
Range is automatically selected by vPad-353 to suit the voltage being measured (200, 2000 or 20000 mV full
scale).

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4.6 Equipment Load Tests

Select the Equipment Load test mode by pressing the corresponding tab at the top of the screen. When
this mode is selected, the test receptacle is switched ON automatically. Refer to Section 4.4 for important
information and instructions concerning operation of the test receptacle.

Figure 29 - Load test mode.

This test mode enables you to measure the AC supply current of the equipment under test (EUT), and the
power consumption. The upper two buttons select the test, which is indicated immediately above the
numeric readout. AC current or power is continuously measured and displayed until a different test mode is
selected. The bottom row of buttons provides these functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the measurement value currently being displayed. Refer to Section
4.13 for instructions on data recording.
View Data Press to review measurement data recorded during testing.

Sections 4.6.1 and 4.6.2 provide instructions for the Equipment Load test mode.

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4.6.1 Load Current

Connect the EUT to the test receptacle and press the Load Current button to place an AC ammeter in
series with the EUT (Figure 30 ). No external test leads are necessary. AC current is measured up to 2A or
20A, with the range being automatically selected by vPad-353 as required.

Figure 30: Load current test

4.6.2 Power Consumption

With the EUT connected to the test receptacle, press the Equipment Power button to measure EUT
power consumption (Figure 31 ). No external test leads are necessary. vPad-353 derives power by
measuring the load current, then the line voltage L1-L2, and multiplying the results: power = voltage x
current.

Figure 31: Power consumption test

Considering specified tolerances of voltage and current measurements, this test mode is most useful when
measuring loads which draw 50W of power or higher. Examples would include lamps, heaters, ovens, fans
and other equipment incorporating larger induction motors or pumps.

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4.7 Earth Resistance Tests

Select the Earth Resistance test mode by pressing the corresponding tab at the top of the screen.

Figure 32 - Resistance test mode.

This mode enables measurement of the resistance of the line cord which conveys AC power to the
equipment under test (EUT). Point-to-point (External) resistance may also be measured. The upper two
buttons select the resistance test mode, which is then indicated immediately above the numeric readout.
Resistance is continuously measured and displayed until a different test mode is selected. The bottom row of
buttons provides these functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the resistance value currently being displayed. Refer to Section 4.13
for instructions on data recording.
View Data Press to review measurement data recorded during testing.
Receptacle Press to switch the test receptacle ON or OFF as desired. Refer to Section 4.4 for
ON/OFF important information and instructions concerning operation of the test
receptacle. For safety, this button is disabled when measuring resistance of the
EUT power cord.

Sections 4.7.1 and 4.7.2 provide instructions for the Resistance test mode.

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4.7.1 Protective Earth Resistance

Press the Protective Earth Resistance button to measure the resistance of the line cord, from the EUT
chassis to the ground pin on the plug of the EUT's line cord. This test is the default on entry to the Earth
Resistance mode.

An Alert Dialog is displayed if the test receptacle is ON when this test is selected. Press "OK" when you are
ready to power down the EUT and proceed with the resistance test.

Figure 33 - Alert Dialog - EUT will be powered OFF for test.

Connect the EUT line cord to the test receptacle. Plug the vPad Kelvin Cable into SRC+ and EXT+ jacks
on the left panel of the Analyzer Base Unit, then connect the Kelvin Cable to a protectively earthed terminal
or conductive point on the EUT chassis (Figure 34 ).

Figure 34: Protective earth resistance test

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Resistance is measured up to 2 Ω. If vPad-353 indicates X.XX, the resistance exceeds 2 Ω and may be
open-circuit. When the display shows X.XX, a poor connection to the EUT chassis may be the problem;
inspect the attachment of the Kelvin Cable or move the cable to a different point on the chassis.

Note: all exposed metal is not necessarily connected to protective earth.

Avoid connecting the Kelvin Cable to "functional earth" (FE) terminals on the EUT. FE terminals are zero-
reference points for EUT input/output signals, and are not intended to provide protective grounding of
medical equipment. Examples of FE include the grounded shell or frame of connectors used for computer
interface (e.g. RS-232 Port; USB Port; etc.)

4.7.2 External Resistance

Press the External Resistance button to measure resistance between two arbitrary points. In this mode,
the receptacle ON/OFF button is enabled so that the EUT may be powered up, if desired.

Figure 35 - External Resistance test

This test requires two vPad Kelvin Cables, connected as shown in Figure 36. Resistance up to 2 Ω may be
measured. As with the line cord test, high resistance or open-circuit conditions are represented by X.XX on
the display; inspect the attachment of the Kelvin Cables in this case.

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Figure 36: External (point-to-point) resistance test

4.7.3 Measurement Method

Referring to Figure 34 and Figure 36, vPad-353 uses a "four-wire method" when measuring line cord or
point-to-point resistance. Not apparent from the schematics are two separate insulated conductors in the
Kelvin Cable, one conductor conveying a current (I) to the resistance under test (R), and the other
conductor conveying voltage (V), caused by the current (I), to a voltmeter. For a known or measured
current (I) and a measured voltage (V), resistance can then be calculated as R = V/I. The four-wire method
is preferred for measurement of small resistance values, since error caused by internal resistance of the test
leads is eliminated.

The four-wire ohmmeter of vPad-353 uses a pulsed 1A (200 mA rms) current source. Both the current
source and the voltmeter of vPad-353 are "floating", that is, isolated from the ground of the AC supply.
This permits vPad-353 to be used for measuring resistance between any two points, grounded or otherwise.

4.7.4 Test Application

If medical equipment is not double-insulated (IEC Class II), resistance of the line cord should be tested to at
least one point of contact, or preferably to several different points, on the equipment chassis. Additionally, it
may be necessary to test continuity from one conductive part of the equipment to another, for example,
across the articulation points of a hospital bed.

The maximum protective earth resistance permitted by the IEC 62353 standard appears in TABLE 2.3-3 of
Section 2.3, and is represented on the test display as "Limit: 0.300 Ω". Resistance measurements which
exceed this limit will cause a "FAIL" indication to be displayed to the right of the measurement. Indications
of "X.XX" are assumed to be open-circuit and so are also assigned a "FAIL". Otherwise, the measurement
is assigned a "PASS" as shown in the example figures above.

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4.8 Insulation Resistance Test

Select the Insulation Resistance test mode by pressing the corresponding tab at the top of the screen.
When this mode is selected, the test receptacle is switched OFF automatically. Refer to Section 4.4 for
important information and instructions concerning operation of the test receptacle.

Note: Set the power switch of the EUT to the "ON" position when performing insulation tests. A
reminder will be displayed on the screen when this test mode is initially selected.

Figure 37 - Insulation test mode.

This test mode enables measurement of the insulation resistance between EUT Line 1 and Line 2 to Earth
(L1+L2 to PE), or alternatively all Applied Parts (AP) to PE. The test may be performed at 500 VDC or
250 VDC, as selected by the radio buttons on the display, just above the test buttons. The measurement is
performed when the Run Insulation Test button is pressed. The bottom row of buttons provides these
functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the resistance value currently being displayed. Refer to Section 4.13
for instructions on data recording.
View Data Press to review measurement data recorded during testing.

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4.8.1 Insulation Test: L1+L2 to PE

Press the Insulation Test: L1+L2 to PE button to measure insulation resistance between the Mains Part
of the EUT (L1+L2) and the EUT's protective earth terminal (PE). A test voltage of either 500V or 250V
may be used, with 500V being the default upon selection of the Insulation Test mode.

To prepare for the test, simply connect the EUT to the test receptacle. No external test leads are necessary.

Figure 38 - Insulation Resistance test - Mains Parts to Protective Earth

With the EUT connected to vPad-353, press the Run Insulation Test button to make the measurement.
During the measurement, the screen of Figure 39 will be displayed, indicating the High Voltage (250 or 500
VDC) has been applied.

Figure 39 - Insulation Resistance test - RUN

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After 2 to 3 seconds, the measured result will be displayed on the screen, as in Figure 40.

Figure 40 - Insulation Resistance test result

4.8.2 Insulation Test: AP to PE

Referring to the display screen shown in Figure 37, the Insulation Test: AP to PE button may be used to
enable measurement of resistance between the EUT's Applied Parts (AP) and its protective earth terminal
(PE). This is represented in the schematic of Figure 41.

Figure 41 - Insulation Resistance test - Applied Parts to Protective Earth

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To prepare for the test, connect the EUT power cord to the test receptacle and connect all Applied Parts of
the EUT to the corresponding binding posts of vPad-353 (refer to Section 4.9.2 for details on connecting
EUT patient leads to the binding posts). When the Run Insulation Test button is pressed, vPad-353 will
apply the high voltage to the Applied Parts and measure the resistance to PE of the EUT, as described
earlier for the L1+L2 to PE measurement.

4.8.3 Test Application

Before IEC standards were published, some countries had standards for testing the insulation of medical
equipment. At the time, it was not possible to measure leakage current with acceptable accuracy, and so
resistance of the equipment insulation was measured instead of current through the insulation.

The IEC 62353 standard does not specify an acceptance limit for insulation resistance, although some other
standards do. Insulation resistance measurement is included in IEC 62353 since the test may be helpful in
addition or instead of leakage current measurement for certain components or equipment, such as heating
elements which may show changes in insulation characteristics with temperature.

The IEC 62353 standard recommends that insulation resistance should be checked periodically. Over time,
a significant decrease in the resistance would then provide a rationale for further investigation of the
equipment or a reduction in test interval.

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4.9 Leakage Current Tests

Select the Leakage Current test mode by pressing the corresponding tab at the top of the screen. When
this mode is selected, the test receptacle is switched ON automatically, in the NORMAL condition. Refer to
Section 4.4 for important information and instructions concerning operation of the test receptacle.

Figure 42 - Leakage test mode.

Note that prior use of the External Voltage test function (Section 4.5.2) will cause a warning to be displayed
when Leakage test mode is initially selected. This warning prompts to user to confirm that a source of high
voltage, which could have been under test by the External Voltage function and which could damage the
safety analyzer if still active, has been disconnected from the EXT(+) input jack. The leakage meter of
vPad-353 is not activated until the user acknowledges this warning with the "Continue" button.

Figure 43 - Warning - check EXT(+) input.

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The Leakage test mode enables measurement of Equipment and Applied Part Leakage currents. As selected
by the upper row of buttons, the leakage under test is indicated immediately above the numeric readout.
The selected leakage current is continuously measured and displayed until a different test mode is selected.
The bottom row of buttons provide these functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the leakage value currently being displayed. Refer to Section 4.13 for
instructions on data recording.
View Data Press to review measurement data recorded during testing.
Polarity Press to toggle the polarity of the test receptacle between "Normal" and "Reverse"
conditions.

Sections 4.9.1 and 4.9.2 provide instructions for the Leakage Current test mode.

4.9.1 Equipment Leakage

Press the Equipment Leakage button to measure leakage current from the enclosure and the applied parts
of the EUT to earth of the AC mains supply. Equipment Leakage is the default upon selection of the
Leakage test mode.

To prepare for the test, connect the power cord of the EUT to the test receptacle, and use the vPad Kelvin
Cable to connect a conductive, protectively earthed point on the EUT chassis to the EXT+ jack on the left
of the Base Unit (see Figure 44 ). If the EUT has applied parts or patient leads, connect them to the
corresponding binding posts of vPad-353 as shown in the figure (refer to Section 4.9.2 for details on
connecting EUT patient leads to the binding posts). If the EUT has unearthed conductive parts, use a test
jumper lead to connect such unearthed parts to the point where the Kelvin Cable is attached to the EUT, or
alternatively to AP10 or other unused applied part binding post on the vPad-353 (for more information, see
Section 4.9.3). During the test, leakage current is measured over three ranges (200, 2000 or 20000 µA full
scale), with range being automatically selected by vPad-353 as required.

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Figure 44 - Equipment leakage test.

During measurement of Equipment Leakage, the MAP Voltage button is disabled, as this test setting is
applicable only to the Applied Part Leakage test. Equipment Leakage may be measured with the test
receptacle in Normal condition and in Reverse Polarity condition. When Polarity is changed, the test
receptacle is switched OFF for a period of time, after which the receptacle is then re-activated at the new
polarity (see Figure 45 ). During the delay, the Polarity control is disabled. This time delay is necessary to
prevent surges in supply current which could potentially damage the EUT and/or the vPad-353. When
Polarity is changed, a user-selectable delay applies which may be set, using the Settings function, over a
range of 2 to 8 seconds; refer to Section 4.10 for details.

Figure 45 - Polarity change in progress.

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4.9.2 Applied Part Leakage

Referring to the display screen shown in Figure 46, the Applied Part Leakage button may be used to
enable testing of EUT patient leads or "Applied Parts" in various combinations or groups, according to the
medical functions provided by the EUT. In this test, leakage is produced by applying an isolated AC voltage
to the selected patient leads, where the voltage is equal to the mains supply.

Figure 46 - Applied Part leakage display.

The test setup is represented in the schematic of Figure 47, in which switches S1 through S5 correspond to
the Applied Part (AP) radio buttons on the menu of Figure 46. Pressing the Settings button of Figure 46
allows you to choose the Type of Applied Parts (BF or CF), which then affects the leakage limit that is
indicated below the Applied Part radio buttons.

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Figure 47 - Applied Part leakage test (AP1 to AP3).

To prepare for the test, connect the power cord of the EUT to the test receptacle, and connect the EUT
patient leads to the corresponding binding posts of vPad-353 as shown in Figure 47. If the EUT is Class II
(two-wire power cord), use a jumper lead to connect the green "AUX" test jack on the right side of the Base
Unit to the EUT enclosure. If the EUT is Class I (three-wire power cord), and the EUT has unearthed
conductive parts, use a jumper lead to connect the "AUX" jack to these unearthed parts. See Section 4.9.3
for more information.

Binding posts of vPad-353 operate according to Figure 48 : for patient leads terminated in a 3 mm or 4 mm
banana plug, press the spring-loaded collar of the binding post down to expose the receptacle inside, insert
the plug, then release to secure the plug in place (Figure 48 -(b)). If testing ECG snap on leads, press the
collar of the binding post down then rotate clockwise to lock in place, exposing the male button (Figure 48-
(c)). ECG snap connectors may then be attached to the buttons. Follow the markings on the vPad-353 label
when connecting ECG leads (LA; RA; LL; RL and V1-V6).

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Figure 48 - Operation of binding post.

Press the MAP Voltage button on the display of Figure 46 to initiate a leakage test of the selected Applied
Parts. Leakage current is measured over three ranges (200, 2000 or 20000 µA full scale) while the test
voltage is being applied, with the range being automatically selected by vPad-353 as required. This test may
be performed with the mains polarity in either Normal condition or Reverse condition.

For the user's safety, the AC test voltage will be applied for a maximum of 20 seconds, after which the
voltage will then be switched off. To continue testing, simply press the MAP Voltage button after the 20
second timeout. Different Applied Part groups may be selected while the test voltage is active. While the
Leakage Current is displayed, it may be saved using the Save Data button.

Figure 49 - Applied Part leakage - MAP voltage ON.

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4.9.3 Test Application

At a minimum, equipment leakage of medical equipment should be tested with the equipment ON and the
AC mains in normal polarity and in reverse polarity. In this case, the number of measurements performed
will be two. Test leakage with equipment in all intended functional conditions (i.e. switch positions) that
influence the leakage current. If the functional condition that produces the highest leakage is not known,
test with the EUT power switch set to OFF position, in addition to the equipment-ON tests. For non-
conductive equipment enclosures, apply tin foil onto the enclosure an attach the Kelvin Cable to the foil.

If the equipment has conductive parts which are not earthed, but which could contact a person, such parts
should be included in the equipment leakage test. To do so, use a test jumper lead to connect such
conductive parts to the same point on the equipment enclosure where the Kelvin Cable is attached.
Alternatively, it may be more convenient to connect unearthed conductive parts to an unused applied part
binding post of the vPad-353 (e.g., AP10). Referring to Figure 44 , leakage from unearthed parts is then
combined with chassis and applied part leakages to produce the total equipment leakage.

Applied Parts leakage tests will depend on the EUT, and the number and type of applied parts it has. Per
IEC 62353, each medical function provided by the EUT is to be tested separately, with all patient leads or
connections of the medical function tested as a group.

For example, a portable patient monitor may provide three ECG leads (LA; RA; and LL) and two invasive
blood pressure channels (IBP-1 and IBP-2). To test this patient monitor, LA, RA and LL are respectively
connected to binding posts AP1, 2 and 3 of vPad-353, and IBP-1 and -2 are respectively connected to AP4
and 5. ECG leakage is measured by pressing the AP1-3 radio button on the display of Figure 49 , and IBP
leakage is measured by pressing the AP4-10 radio button. Per IEC 62353, each group of applied parts
should be tested with AC mains in normal polarity and in reverse polarity, with equipment power switch set
to ON position and to OFF position.

If the equipment is Class II (two-wire power cord), a test jumper lead must be used to connect the enclosure
of the equipment to the "AUX" jack of the vPad-353, as shown in Figure 47. If the "AUX" connection is
omitted when testing applied parts of Class II equipment, then no leakage current will be measured.

If the equipment is Class I (three-wire power cord), and the equipment has unearthed conductive parts
which may contact a person, then such parts should be connected to the earth when measuring leakage of
the applied parts. A convenient way to accomplish this is to use a test jumper lead to connect such
unearthed parts to the "AUX" jack of the vPad-353, according to Figure 47.

The limits for leakage current tests are defined in the IEC 62353 standard, per TABLE 2.3-3 of Section 2.3.
The measured values will be assessed according to those limits, and a PASS or FAIL assessment will be
recorded with the measurements.

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4.10 Leakage Settings

Press the Settings button on the Leakage Test mode screen to enter the Leakage Settings menu, shown
below.

Figure 50 - Leakage settings menu.

At the bottom of the menu, the Receptacle Auto-OFF setting determines behaviour of the test receptacle
when changing test modes. For convenience, vPad-353 automatically switches the test receptacle ON when
Equipment Load, Leakage or Patient Lead test mode is selected. When changing to Voltage, Resistance or
Simulator mode, the test receptacle will be automatically switched OFF if Auto-OFF is checked, as shown
in Figure 50. If Auto-OFF is not checked, when changing modes the test receptacle will be switched OFF
only if the receptacle is in reverse polarity condition, otherwise the receptacle will remain ON as modes are
changed.

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The default is Auto-OFF enabled; disable Auto-OFF only for special situations where repeated application
and removal of power to the EUT must be avoided.

To view or change a setting other than Auto-OFF, press the corresponding row on the menu (ME Class;
Applied Parts; or Polarity Delay).

The ME Class setting (Figure 51 ) allows you to choose the Class (I or II) of the EUT. This will affect the
pass/fail limit which is applied to Equipment Leakage measurements. Press the radio button corresponding
to the desired Class, or Cancel to exit without changing the setting. Note the selected Class is indicated
above the Settings button on the Leakage display.

Figure 51 - Set medical equipment class.

The Applied Parts setting (Figure 52 ) allows you to select a part Type (BF or CF). This will affect the
pass/fail limit which is applied to Applied Part leakage measurements. Press the radio button to select the
applicable part Type, or Cancel to exit without changing the setting. Note the selected part Type is
indicated above the Settings button on the Leakage display.

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Figure 52 - Set applied part type.

When test receptacle polarity is changed during a test, the receptacle is switched OFF for a period of time,
after which the receptacle is then re-activated at the new polarity. This time delay is necessary to prevent
surges in supply current which could potentially damage the EUT and/or vPad-353. When polarity is
changed, a user-selectable delay then applies which may be set over a range of 2 to 8 seconds (see Figure
53).

The default delay is 2 seconds. Delays of 2 or 3 seconds may be used with low-powered equipment which
will not suffer ill effects from cycling of the AC power. Longer delays of up to 8 seconds should be used for
higher-powered equipment, particularly if the equipment presents a reactive load such as an induction
motor.

Press the radio button to select the desired delay time, or Cancel to exit without changing the setting.

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Figure 53 - Set polarity switching delay.

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4.11 ECG Simulator

Select ECG Simulator mode by pressing the corresponding tab at the top of the screen. vPad-353 will
default to outputting a 2 Hz square wave to the ECG binding posts.

Figure 54 - ECG simulator mode.

Test signals and physiological simulations are organized in five general categories such as Performance
Waves or Sinus Rhythm. Under each category, six waveforms may be selected via radio buttons. Upon
selecting a waveform, a simplified illustration of the signal is displayed on-screen above the radio buttons.
The bottom row of buttons provides these functions:

Equipment Press to launch the equipment inspection procedure. See Section 4.12 for
Inspection instructions.
Save Data Press to save the name of the ECG waveform in use. In addition to the waveform,
test notations may be saved. Refer to Section 4.13 for instructions on data
recording.
View Data Press to review measurement data recorded during testing.
Receptacle Press to switch the test receptacle ON or OFF as desired. Refer to Section 4.4 for
ON/OFF important information and instructions concerning operation of the test
receptacle.

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TABLE 4.11-1 describes the waveforms which may be selected via the menu. Amplitudes are specified for
ECG Lead II connection at the patient monitor.

TABLE 4.11-1: ECG Simulator Waveforms

Simulator Menu Simulator Waveform Description vPad-353 Name

Performance Square wave, 2 Hz, 1 mV p-p (-0.5 to +0.5 mV) SQR 2Hz

Performance Triangle wave, 2 Hz, 1 mV p-p (-0.5 to +0.5 mV) TRI 2Hz

Performance 'DC' Pulse, +1 mV for 4 seconds, 0 mV for 4 seconds PUL 4sec

Performance Pulse, +1 mV for 63 msec, rate = 30 pulses/minute PUL 30ppm

Performance Pulse, +1 mV for 63 msec, rate = 60 pulses/minute PUL 60ppm

Performance Square wave, 1 kHz, 1 mV p-p (-0.5 to +0.5 mV) SQR 1KHz

Sine wave Sine wave, 0.5 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 0.5Hz

Sine wave Sine wave, 10 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 10Hz

Sine wave Sine wave, 40 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 40Hz

Sine wave Sine wave, 50 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 50Hz

Sine wave Sine wave, 60 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 60Hz

Sine wave Sine wave, 100 Hz, 1 mV p-p (-0.5 to +0.5 mV) SIN 100Hz

CMRR test Square wave, 2 Hz, 10 mV common-mode SQR 2Hz

CMRR test DC Pulse, 10 mV common-mode PUL 4sec

CMRR test Sine wave, 0.5 Hz, 10 mV common-mode SIN 0.5Hz

CMRR test Sine wave, 50 Hz, 10 mV common-mode SIN 50Hz

CMRR test Sine wave, 60 Hz, 10 mV common-mode SIN 60Hz

CMRR test Square wave, 1 kHz, 10 mV common-mode SQR 1KHz

NSR ECG normal sinus rhythm, 30 beats/minute, 1 mV QRS 30 BPM

NSR ECG normal sinus rhythm, 60 beats/minute, 1 mV QRS 60 BPM

NSR ECG normal sinus rhythm, 120 beats/minute, 1 mV QRS 120 BPM

NSR ECG normal sinus rhythm, 180 beats/minute, 1 mV QRS 180 BPM

NSR ECG normal sinus rhythm, 240 beats/minute, 1 mV QRS 240 BPM

NSR ECG normal sinus rhythm, 300 beats/minute, 1 mV QRS 300 BPM

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Simulator Menu Simulator Waveform Description vPad-353 Name

Arrhythmia Arrhythmia, ventricular fibrillation, coarse VFIB

Arrhythmia Arrhythmia, atrial fibrillation, coarse AFIB

Arrhythmia Arrhythmia, supraventricular tachycardia at 200BPM SVT

Arrhythmia Arrhythmia, monomorphic ventricular tachycardia VTACH

at 190 BPM

Arrhythmia Arrhythmia, unifocal preventricular contraction following PVC

5 normal ECG beats

Arrhythmia Arrhythmia, asystole, random baseline ASYS

4.11.1 ECG Test

To test a patient monitor, connect ECG leads to the binding posts of vPad-353 as shown in Figure 55.
Specific instructions for connecting patient leads to binding posts are given in Section 4.9.2. Optionally, the
EUT may be connected to the test receptacle and powered from there. According to Figure 55, the ECG
simulator outputs three independent signals for the limbs (LA, RA, LL) and a fourth signal which is
common to all chest leads (V1-V6). RL provides the zero reference for the circuit which, as indicated, is
isolated with respect to ground of the AC supply.

Figure 55 - Connection to ECG simulator.

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4.11.2 Common-Mode Test

When a Common-Mode Rejection Ratio (CMRR) test is selected, the ECG simulator is internally
configured as shown in Figure 56. Limb and chest leads are connected together and driven with a common
10 mV signal with respect to RL.

Figure 56 - Common-mode rejection test.

Provided differential amplifiers in the patient monitor are operating correctly, the common-mode signal
should be cancelled and there should be no indication on the monitor display for Lead I, II or III. Different
waveforms are provided for the CMRR test, allowing common-mode performance to be verified for a range
of frequencies and waveshapes.

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4.12 Equipment Inspection

4.12.1 Inspection Tasks

All test modes provide an Equipment Inspection button. Pressing this button displays a dialog for
performing and recording an inspection.

Figure 57 - Equipment Inspection dialog.

The Equipment Inspection is based on a list of checkpoints or tasks, which are explained in the General
Devices Acceptance Procedure (no. 438-20081015-01), published by the ECRI Institute (USA). This guidance
document is in the public domain and may be downloaded from this URL:

https://www.ecri.org/Documents/General_Devices_USA_Acceptance.pdf

The IEC version of the procedure may be obtained from this URL:

https://www.ecri.org/Documents/General_Devices_IEC_Acceptance.pdf

The General Devices Acceptance Procedure was developed by ECRI to be generically applicable to medical
equipment undergoing incoming inspection, installation or repair service. The procedure includes a number
of qualitative checks and maintenance steps which are routinely performed on a wide range of medical
devices. Specific electrical safety tests are also described in the ECRI document.

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This inspection is provided to meet the requirements of the IEC62353 standard with respect to ‘Reporting
of Results’. The Standard only indicates that results of visual INSPECTIONS be recorded, but does not
suggest any specific inspection details.

The Next Task button on the dialog of Figure 57 increments the displayed "Task" through a list of items
to be inspected or serviced, following the ECRI procedure as summarized in TABLE 4.12-1.

TABLE 4.12-1: Equipment Inspection Tasks

Inspection Activity
(perform as
Task applicable) Summary
1 Chassis/housing Check for shipping damage; cleanliness; general physical condition.
2 Mounting/fasteners Check stability (unit won't tip); check security of wall-mount
equipment.
3 Casters/brakes Check casters are correct size; check casters roll freely; check
brakes. Repair/replace as necessary.
4 Plug/receptacle(s) Check plug for damage; ensure blades and/or blade screws are not
loose. Replace if necessary.
5 Power cord Ensure power cord is long enough; for detachable cord, check for
capture device/cleat; check for wear; replace if necessary.
6 Strain reliefs Verify strain reliefs hold power cord securely and are not damaged;
check both ends.
7 Circuit breaker/fuses Check correct fuses are installed, per equipment labelling or
instructions.
8 Tubes and hoses Check condition; repair/replace as necessary.
9 Cables Check condition; check continuity while twisting; repair/replace as
necessary.
10 Fittings/connectors Check fittings are correct type; check labelling is correct; check for
leaks; check for wear/damage; repair/replace as necesary.
11 Electrodes/transducers Check required electrodes/transducers are with the equipment;
check condition of reusable transducers.
12 Filters Check condition; clean or replace as required.

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Inspection Activity
(perform as
Task applicable) Summary
13 Controls and switches Verify software setup parameters accessible through hidden or
service menus are correctly set; check physical condition, secure
mounting and range of motion for mechanical controls/switches.
14 Heater Examine for damage; verify heater controls function correctly.
15 Motor/pump/fan Check shaft alignment; check wear; lubricate as required.
16 Fluid levels Check and fill as required.
17 Battery/charger Replace battery if necessary or per schedule; check rechargeable
battery can hold sufficient charge; check battery charger function.
18 Indicators/displays During inspection activities, check operation of all lights, indicators,
meters, gauges, waveform displays and numeric display segments.
Repair/replace as required.
19 Cal/self-test function Check calibration due label; check self-calibration function; activate
self-test or service-mode functions for basic performance
verifications.
20 Time/date settings Check settings are correct.
21 Network setup/security Document device, operating system, version, IP address; verify
passwords and virus protection; verify data backup processes.
22 Alarms and interlocks Verify alarm settings; induce alarm condition(s) and verify alarm
function.
23 Audible signals During inspection activities, check audio tones/alarms; check
volume control function.
24 Labelling Check required placards, labels, charts and instruction cards are
present, legible and easy to understand.
25 Accessories Verify required accessories are with the equipment.

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4.12.2 Performing an Inspection

To use the Equipment Inspection dialog of Figure 57:

a.) Select the task to be performed, using the Next / Previous Task buttons. Per the ECRI
document, tasks can be performed in any order; some tasks may not be applicable to the
equipment and would therefore be skipped.

b.) Perform the inspection task, following the specific instructions of the ECRI document. If
necessary, connect the EUT to the test receptacle and apply AC power via the Receptacle
ON / OFF button on the dialog.

c.) On completion of the task, press the Inspected checkbox. Checking this box adds the
inspected item to the Test Record, combining it with safety test measurement data which
may be recorded either before or after the inspection (refer to Section 4.13 for full details on
saving test results and vPad-353 Test Records). Inspection Tasks which do not have the
Inspected box checked will not appear in the Test Record.

d.) If the inspected item meets requirements, press the OK checkbox. This assigns a "PASS" to
the inspected item in the Test Record.

e.) If an inspected item is not acceptable, and you are not able to correct the problem, do not
press the OK checkbox. In this case, a "FAIL" will be assigned to the inspected item in the
Test Record.

f.) While inspecting, you may wish to record comments about what you find, and any repairs or
modifications you may have made to the EUT. To do so, press the Comments on... text
field, located below the buttons. This will display the Android onscreen keyboard (Figure
58). Although the text field is displayed as a single line, you may enter as many characters or
sentences as you wish. Comment data entry is reformatted as paragraphs later, when the Test
Record is saved.

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Figure 58 - Inspection comment entry.

g.) Other inspection items may be selected via Next / Previous Task buttons while the
Android keyboard is being displayed. Alternatively, once a comment has been input the
keyboard can be dismissed, by pressing the ENTER button , or alternatively the

"dismiss keyboard" button at bottom left on the screen. More information on using
the Android keyboard is given in Section 4.13.1.

h.) Once all pertinent items have been inspected, press Save & Exit to return to the previous
test mode. The Equipment Inspection dialog can be re-opened anytime prior to saving of
the Test Record, allowing you to view, modify or add inspection results as needed.

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4.13 Data Recording

Each test mode of vPad-353 provides means for recording and viewing measurement data during the course
of a test. Once sufficient data has been collected and information about the equipment under test (EUT)
has been entered, results may then be saved as a file in a designated folder on the "internal SD card"
(internal non-volatile memory) of the Android tablet.

This section provides instructions for recording measurements and notes during a test, and creating Test
Records.

4.13.1 Using the Android Keyboard

When you press a text field, the Android keyboard is displayed at the bottom of the screen.

Figure 59 - Android onscreen keyboard (default IME).

Android permits use of various input methods, called "IME". The onscreen keyboard is the default IME. If
you have connected an alternative input device to the tablet (e.g. Bluetooth/USB keyboard or barcode
scanner), then the Android keyboard will not appear when a text field is pressed and data entry will then be
from the external input device. To switch back to the default IME, disconnect the external input device.

The text field which is currently accepting data from the Android keyboard or other IME will be
highlighted:

Figure 60 - Single-line text field.

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Android text fields may be either single- or multi-line. A practically unlimited amount of text may be typed
for either single- or multi-line fields.

Pressing ENTER for a single-line text field causes data entry to jump to the next text field on
the screen.

Pressing ENTER on a multi-line text field inserts a new line. To move from a multi-line field to
a different text field on the screen, tap on the desired field.

Press to navigate forward through multiple text fields on a screen. Press to

navigate backward. You can also jump to a particular field on a screen simply by tapping the field.

Switch the Android keyboard from alpha to numeric modes by pressing .

In alpha mode, to activate Caps Lock press and hold until the indicator lights up:

Once activated, press to switch Caps Lock off.

To correct a mistake in typing, tap the text field to the right of the error. This will activate the Android edit
cursor. Erase with backspace/correct then retype.

Figure 61 - Error correction with edit cursor.

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As an alternative to typing with the keyboard, voice recognition may be used. Note that this will require an
active internet connection. To enable, press . Android voice recognition technology has good

performance, particularly when entering numbers.

When done entering text, the Android keyboard may be removed from the screen by pressing at
bottom left.

4.13.2 Recording Measurements and Notes

While safety testing, press the Save Data button to capture the reading currently being displayed on the
screen. The captured reading is combined with a description of the measurement and is forwarded to the
Save Data menu, which appears as pop-up over the test activity. The measurement, with optional notes,
may then be saved to a temporary holding buffer located in (volatile) memory.

Figure 62 - Save Data pop-up menu.

Tap on the Additional notes text field to enter notations or comments, which will then be attached to the
measurement being saved. Tapping the text field causes the Android keyboard to be displayed (Figure 63 ).
If an external keyboard or barcode scanner is connected to the tablet, the Android keyboard is not displayed
and data entry is then accepted from the external input device. Refer to Section 4.13.1 for detailed
instructions on using the Android keyboard.

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Figure 63 - Enter additional notes or comments.

By default, notes are inserted into the test data before the measurement value. Alternatively, to place
notations after the measurement value, press the Insert note... After data radio button (see Figure 62 ).

To save notations only, without any measurement data, uncheck the Save this checkbox near the top of
Figure 62.

Other buttons on the menu of Figure 63 provide these functions:

Save Data Press to add the measurement data and notations (if any) to the holding
buffer, then return to the test activity. This button can be pressed anytime
to save and exit the menu, even while the keyboard is being displayed.
Cancel Press to return to the test activity without saving.
Clear Notes Press to erase the Additional notes test field.
Enter Equipment Info Press to display the equipment information editor (see Section 4.13.4 for
instructions on using the editor).

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4.13.3 Viewing Measurements and Notes

Via the Save Data menu of Section 4.13.2, measurements and notes may be saved to a holding buffer while
testing is in progress. To view contents of the buffer, press the View Data button. If the amount of data
exceeds the length of the window, scroll it into view by means of a press-and-drag gesture on the window.

Figure 64 - View Data menu.

Buttons on the View Data menu provide these functions:

Enter Equipment Press to display the equipment information editor (see Section 4.13.4 for
Info instructions on using the editor).
Clear Last Press to erase the last line of text saved to the holding buffer.
Clear All Press to erase all data currently stored in the holding buffer. An Alert Dialog will
be displayed which will prompt you to confirm the erasure.
Create Record Press to save recorded measurement values, notes, equipment information and
inspection results as a Test Record file on the Android tablet. This button
remains disabled until an Equipment Control Number has been input. See
Sections 4.13.4 and 4.13.5 for instructions.
Exit Press to close the View Data menu and return to the test activity.

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4.13.4 Recording Equipment Information

Press Enter Equipment Info on the Save Data or View Data menu to pop-up the equipment information
editor.

Figure 65 - Equipment information editor.

Tap on a text field to display the Android keyboard. If an external keyboard or barcode scanner is
connected to the tablet, the Android keyboard is not displayed and data entry is then accepted from the
external input device. Refer to Section 4.13.1 for detailed instructions on using the Android keyboard.

Figure 66 Figure 67

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Pressing ENTER on the keyboard advances data input to the next text field on the screen.

Alternatively, use to navigate the text fields, or simply tap a field to jump immediately there.

At minimum, you must enter an equipment control number or other ID in the Control Number field in
order to save a Test Record.

"Facility" and "Technician ID" fields are backed up in permanent storage on the Android tablet. These
information fields are maintained after power to vPad-353 is switched off, and are restored on subsequent
use of the app, but may be changed as necessary.

When done entering information, press to dismiss the keyboard and expose these buttons at the
bottom of the menu:

Clear Control+Serial No. Press to erase Control Number and Serial Number fields.
Clear All Press to erase all text fields on the menu.
Cancel Press to return to Save or View Data menu without saving changes.
Save Info Press to save information as displayed, and then return to Save or View
Data menu.

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4.13.5 Creating a Test Record

Press the Create Record button on the View Data menu to save recorded measurement values, notes,
equipment information and inspection results as a Test Record file. You must save at least one measurement
and an equipment control number/ID before the View Data menu will permit you to create a Test Record
(see Sections 4.13.2 through 4.13.4 respectively).

Figure 68 - Create Record menu.

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The filename and path of the Test Record are shown at the top of the Create Record menu (Figure 68 ).
The filename is derived automatically by vPad-353, in the following format:

<control_number>_<date_code>_<timestamp>_<result>.txt

where:

control_number is the Control Number field from the Equipment Information menu (see
Section 4.13.4).

date_code represents the date of the Record, format YYYYmmDD (year-month-day)

timestamp represents the time of the Record, format hhMMss (hours-minutes-seconds)

result represents the overall result of the test: pass (P) or fail (F)

Test Record files are saved in TXT format, with character encoding that is compatible with both Android
(Linux) and Microsoft Windows® operating systems.

Test Records are saved to this location in the Android file system:

/mnt/sdcard/Datrend/vPad-353/Records

Note: sdcard refers to internal memory of the Android tablet.

sdcard is NOT a removable "SD Card" memory device, which may

be optionally plugged into the external card slot of the tablet.

Any accessory SD Card which may be plugged into the tablet's card slot
is referred to as extsd in the Android file system.

The Overall test result shown in Figure 68 will be set to PASS, unless a failing result was recorded during
an Equipment Inspection (see Section 4.12) or as a result of a test measurement. The Pass/Fail indication
that has been automatically applied may be over ridden by selecting either the PASS or FAIL radio button
to reflect the result you wish to store in the Test Record file.

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Optionally, time spent working on the EUT may be entered after tapping on the Technican labor time
field. This causes the Android numeric keypad to be displayed. Enter the labor time in hours.

Figure 69 - Optionally, enter technician labor time (hours).

Test Record files include a Title at the beginning of the file. This may be modified from default “vPad
Safety Analyzer” after tapping the Test report title field. Optionally, enter name of your institution or
business, address, phone number and so on. Up to 16 lines may be entered into this text field, of which the
first three lines will be shown when the menu is initially displayed (to view or edit additional lines, scroll the
window using a press-and-drag gesture). The Test report title is backed up in permanent storage on the
Android tablet; the title is maintained after power to vPad-353 is switched off, and is then restored on
subsequent use of the app.

Figure 70 - Optionally, enter report title.

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Optionally, concluding comments about the EUT or test results may be entered after tapping the Final
comments field. Information entered in this text field will appear at the end of the Test Record file. Any
number of lines may be entered into the text field.

Figure 71 - Optionally, enter final comments about EUT or test.

Press the Create Record button at any time to save the Test Record file, whether or not the Android
keyboard is active. Alternatively, press Cancel to exit the menu without saving a file. On cancelling,
measurements and other data stored in the temporary holding buffer are retained.

When Create Record is pressed:

• The Test Record file is saved to /mnt/sdcard/Datrend/vPad-353/Records in the tablet;

• The temporary holding buffer is erased, clearing all recorded measurement values, notes, and
equipment inspection results;

• Control Number and Serial Number fields of the Equipment Information are erased;

• Other fields of the Equipment Information (Description, Manufacturer, Model and so on) are not
erased. This is intended as a time-saving feature when performing acceptance tests and inspections
on multiple EUT of the same type.

An example of a Test Record file saved by vPad-353 is given in APPENDIX A.

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4.14 Record Manager App

vPad Record Manager is an app which is installed on the Android tablet and which may be run
independently of, or simultaneously with, the vPad-353 app.

Record Manager may be used to copy, print, and/or delete Test Record files saved by vPad-353. Record
Manager can also be used to convert Test Records to Adobe PDF documents. Note that PDF is a format
which enables vPad Record compatibility with other Android apps, for example, e-book readers and
document printing apps.

Press on the Android HOME screen to launch the Record Manager app.

Figure 72 - File browser of vPad Record Manager.

Refer to MN-087 6100-081 vPad-RM Operators Manual for further information on use of the Record
Manager.

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5 Calibration and Maintenance

Calibration of vPad-353 by a Datrend Authorized Service facility is recommended on an annual basis, and is
required to extend the product warranty. The basic one (1) year warranty on the Analyzer Base Unit can be
extended to a maximum of two (2) years provided that annual calibration is performed by a Datrend
Authorized Service Center on an annual basis. Refer to the Calibration Decal applied to the rear panel of
the unit to determine calibration status of your vPad-353.

vPad-353 contains no user serviceable parts, other than a 20 Amp/250V AGC fuse located on the right side
panel of the Analyzer Base Unit. Any other failure will require return of vPad-353 to an authorized service
facility for repair. Opening the case of vPad-ES for any reason will void the warranty and may
compromise user safety.

Service must be performed by a factory trained, authorized service agent.

This unit contains hazardous voltages which may cause injury if correct
service procedures are not followed.

For calibration or service assistance, contact Datrend for a Return Materials Authorization (RMA) number
and the location of the nearest Service Facility.

Datrend Systems Inc.

Unit 130 - 4020 Viking Way
Richmond, BC • CANADA • V6V 2L4
Tel 604.291.7747 or 800.667.6557 • Fax 604.294.2355
e-mail [email protected]
www.datrend.com

vPad-353 may be cleaned with a soft, lint free, damp cloth using a mild detergent. Use of other cleaning
agents on the touchscreen may result in scratching, discolouration, streaking or even failure.

Electrical safety protection of the operator may be compromised if the

instructions in this manual are not followed, or if vPad-353 is used for a
purpose not specified in this manual.

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APPENDIX A. Sample Test Record

This appendix provides an example of a vPad-353 Test Record, illustrating the data representation for
voltage, current, resistance and leakage measurements, as well as ECG waveform data. Inspection data and
example notes have been recorded for some measurements to show how these typically appear in a record.
This is an example of a file where most available measurements and inspections have been recorded.

Biomedical Engineering Dept.

St. Joseph's Hospital
1234 Main Street
MyTown MyState 98765
Phone: 123-456-7890 Ext. 123

File: CN123456_20120618_173835.txt
Date: 2012 Jun 18
Time: 17:38:35
vPad-353: VPES12010001

Equipment Information...
Control Number: CN123456
Description: Diagnostic ECG
Manufacturer: Marquette
Model: MAC VIEW
Serial Number: 4459-712-50-DE
Location: CCU
Facility: St Josephs Hosp

Technician ID: MEM

Tech Time (hrs): 0.5

Overall Result: PASS

Signature:______________________________ Date:__________

Equipment Inspection...
Chassis/housing: PASS
Small dent at the rear of the unit.
Acceptable.
Mounting/fasteners: PASS
Casters/brakes: PASS

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vPad-353 OPERATORS MANUAL

Plug/receptacle(s): PASS
Power cord: PASS
Line cord insulation was split. Replaced
the cord.
Strain reliefs: PASS
Circuit breaker/fuses: PASS
Wrong fuse was installed. Replaced with
correct fuse.
Tubes and hoses: PASS
Cables: PASS
Fittings/connectors: PASS
Electrodes/transducers: PASS
Filters: PASS
Controls and switches: PASS
Heater: PASS
Motor/pump/fan: PASS
Fluid levels: PASS
Battery/charger: PASS
Replaced the clock backup battery.
Indicators/displays: PASS
Cal/self-test function: PASS
Time/date settings: PASS
Network setup/security: PASS
Alarms and interlocks: PASS
Audible signals: PASS
Labelling: PASS
Accessories: PASS

Detailed Test Data...

Elec. Safety Standard: IEC62353

Earth Resistance Limit: Maximum 0.300 ohm
Equipment Leakage Limit: Maximum 500.0 µA (Class I)
Applied Part Lkg Limit: Maximum 50 µA (Type CF)

This test begins with some voltage measurements

although any test data may come first in a file.
This paragraph is an example of "additional notes".
By default, notes are inserted BEFORE the data.
Mains Voltage L1-L2: 120.2 V
Mains Voltage L1-PE: 121.3 V
Mains Voltage L2-PE: 2.2 V
External Voltage: 3.2 V

The notes text box can also be used to insert a

blank line, as immediately above this note.
Load Current: 10.49 A
Equipment Power: 1256 W

Here are the IEC62353 safety test measurements...

Prot. Earth Resistance: 0.093 ohm - PASS
Insulation Resistance, L1+L2 to PE: 74.4 Megohm
Insulation Resistance, AP to PE: 672.7 Megohm
Equipment Leakage (NP): 174.4 µA - PASS
Equipment Leakage (RP): 178.7 µA - PASS
Applied Part Lkg ALL AP (NP): 44.4 µA - PASS
Applied Part Lkg ALL AP (RP): 48.4 µA - PASS
Applied Part Lkg AP1-3 (NP): 32.4 µA - PASS
Applied Part Lkg AP1-3 (RP): 33.4 µA - PASS

Additional AP combinations can also be measured here....

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Now run a quick check on the ECG monitor with some

standard waveforms...
ECG Test: SQR 2Hz
ECG Test: TRI 2Hz
ECG Test: PUL 4sec
ECG Test: 30 BPM
ECG Test: 60 BPM
ECG Test: 120 BPM
ECG Test: 240 BPM
All BPM within 1 count .... ok.
Finish off by entering some final comments here...
PM tag affixed.
Parts inventory updated.

END OF RECORD

Appendix A # Page 83