arkmeds Tesla User manual

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ELECTRICAL SAFETY ANALYZER
User Guide.

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Table of Contents
INTRODUCTION ---------------------------------------------------- 4
SAFETY INFORMATION ------------------------------------------ 4
ACRONYMS AND DEFINITIONS -------------------------------- 6
IEC 60601 SYMBOLOGY ----------------------------------------- 7
CONCEPTS ---------------------------------------------------------- 7
PACKAGE CONTENT ---------------------------------------------- 9
UNDERSTANDING THE DEVICE ------------------------------ 10
TURNING ON THE DEVICE ------------------------------------- 13
BLUETOOTH ------------------------------------------------------------- 14
WIFI -------------------------------------------------------------------------- 15
SHUTDOWN BUTTON ------------------------------------------------ 16
TEST MODULES -------------------------------------------------- 16
GROUND RESISTANCE TEST ----------------- 17
INSULATION RESISTANCE TEST ------------ 19
LEAKAGE CURRENT TEST ------------------- 21
FUNCTIONAL CURRENT TEST --------------- 27
SOFTWARE AND APPLICATION ------------------------------ 28
PROBLEMS AND SOLUTIONS -------------------------------- 29
MAINTENANCE ---------------------------------------------------- 30
TECHNICAL SPECIFICATIONS ------------------------------- 30
FAQ ------------------------------------------------------------------ 32

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INTRODUCTION
SAFETY INFORMATION
TESLA Electrical Safety Analyzer is practical, compact, portable, and
easy to handle. It is used in electrical safety test procedures of hospital
medical devices under IEC 60601-1 and IEC 62353 standard procedures.
For better conservation of your device and to prolong its useful life,
please consider the following:
Tesla allows the simulation of:
Ground
Resistance
Current
Leakage Current
( Ground and
Applied Parts)
Mains
Voltage
Insulation
Resistance
Power

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If you notice any irregularity with the device, do not put it into operation.
Depending on the problem, the device may suffer irreversible damage,
which will lead to costly maintenance or discontinuity. Whenever the
device fails, set it aside and contact the Arkmeds Support Team
through the channel:
https://www.arkmeds.us/support
Do not expose
the device to
high humidity
Insert the connectors
only into the spots
intended for operation.
Replace accessories
if any damage is
identied.
Replace the power
cord if any damage is
identied.
Always examine
the device before
and after each use.
Do not expose
the device to
temperatures
above 50ºC.
Do not connect this
device to the patient.
Do not open the device
without the expertise
and the manufacturer’s
qualication.

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ACRONYMS AND DEFINITIONS
DUT: Device Under Test.
Applied Part: part of the device designed for physical contact with the patient.
F-Type Applied Part: applied part electrically isolated from the ground and
other medical device parts.
B-Type Applied Part: part applied in compliance with specied requirements
for protection against electric shock. B-Type applied parts are parts generally
referenced to ground. They are not suitable for direct cardiac application use.
BF-Type applied part: F-Type applied part with a higher degree of protection
against electric shock than B-Type applied parts. BF-Type applied parts are
not suitable for direct cardiac application.
CF-Type Applied Part: CF-Type are parts suitable for cardiac application.
Class I: Protection of the device against electrical shock by additional
protection (grounded) for basic insulation through connection to the exposed
conductive parts to the ground protector in the xed wiring of the installation.
Class II: Also known as double insulation. It is a protection of the device
against electric shock. It is achieved by additional protection for the basic
insulation, through supplementary means of insulation, with no provision for
the exposed metal connection of the device to a protective conductor.
Protective Ground: dedicated circuit intended to carry fault and leakage
current in class I device and is connected to the protective ground terminal.
Functional Ground: Dedicated circuit intended to provide an electrical shield
and be connected to a functional ground terminal.

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IEC 60601 SYMBOLOGY
In their approval processes, manufacturers of medical and hospital devices
carry out extensive tests to verify the device’s performance at the end of
the production line. In these processes, it is recommended to carry out
checks that ensure no risk of harm to the patient and operator as soon as
the device is approved for use.
The timeline of a medical-hospital device observes the following points:
1. Design
2. Product Tests
3. Approval for Use
4. Operator Training
5. Preventive Maintenance
6. Calibration
7. Repair
8. Discontinuity
CONCEPTS

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Design: In the first stage, the device is designed pursuant to IEC
60601 (if applicable).
Product Testing: During the production stage, the hardware and software
of the device are assembled and verified pursuant to IEC 60601.
Approval for Use: the device has passed the tests and is ready for use.
Operator training: an extremely important step that guarantees the
good use of the device and provides the operator with the best usage
practices and their functionalities.
Preventive Maintenance: the device is subjected to periodic checks
to prevent potential problems. In this step, IEC 62353 is applied.
Calibration: comparison with a known standard to validate the
measurements and parameterization of the device in question. Step
carried out with standard calibration device, calibrated, and with
Inmetro traceability.
Repair: the device undergoes intervention to correct a problem, with the
replacement of parts and components. In this step, IEC 62353 is applied.
Discontinuity: the device reaches the end of its useful life and is
replaced by new technology.
In summary, the application of IEC 60601 is present in the stages
related to the device’s production. IEC 62353 is adopted in the stages
of maintenance and repair of devices in operation.
The purpose of IEC 62353 is to provide a standard that ensures safe
practices, reducing the complexity of IEC 60601 and the stress of the
device under test.

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CONTEÚDO DA EMBALAGEM
TESLA Electrical Safety Analyzer comes with the following items:
1 x Tesla (PN 42000002)
1 x User Manual (PN 12000038)
1 x Calibration Certificate
Accessories
1 x Alligator Clip (PN 11000081)
1 x Chassis Cable (PN 31000016)
1 x Banana/Banana Connector (PN 31000015)
1 x Carrying Bag (PN 12000040)
1 x Power Cord*
Brazil (PN 11000015)
USA (PN 11000236)
Europe (PN 11000237)
* The customer chooses the power cord standard.

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UNDERSTANDING THE DEVICE
Next, the device will be demonstrated with the identification of its
connectors and controls.
FRONT VIEW
1Connectors Applied Part.
Touch Screen.
On/Off Button.
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3

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UPPER VIEW
1Power cord with fuse
holder..
DUT Connector.
500V connector.
Insulation
resistance test.
Air circulation.
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3
3
LEFT SIDE VIEW
1Chassi’s cable XLR connector.

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RIGHT SIDE VIEW
BACK VIEW
1
1
Active air circulation.
Serial number identi cation tag.
1

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TURNING ON THE DEVICE
Press the “on/off” button to turn the device on.
The device will perform internal communication tests and will then
display the screen with the test options.

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BLUETOOTH
The Bluetooth option is displayed in the upper right corner, indicating
whether it is enabled or disabled. If it is disabled, an “X” will be
displayed next to the symbol, and to enable it, just click on the
Bluetooth icon.

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WIFI
In the upper right corner, the Wi-Fi option is presented. Click on the
Wi-Fi icon to access this function. A screen with available networks and
a field for filling in the SSID and password of the desired network will
be displayed. Simply click on the Available Networks list to select a
network, enter the password, and click on Connect.
To return to the home screen, click on the arrow in the upper right corner.

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We show in this section each of the features of the Electrical Safety
Analyzer, TESLA.
TEST MODULES
SHUTDOWN BUTTON
In the upper right corner, the option to turn o󰀨 the device is displayed.
Clicking on this option will display a message asking if you want to turn o󰀨
the analyzer. By selecting “yes,” the device will turn o󰀨, and by selecting
“no,” it will return to the home screen.

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The “Ground Resistance” Test is a procedure that aims to verify
the resistance level of the grounding system of the device under test.
This test is carried out directly and reversely and is performed only
on Class I devices.
GROUND RESISTANCE TEST
Connect as instructed:
1. Connect TESLA to the power grid.
2. Connect the power cord of the device under test to the DUT.
3. Connect the Chassis cable to the ground pin of the device
under test.
With all connections made, start the test.
Ground Resistance Connection

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In the “Ground Resistance” option we will have access to the test.
Click Start to begin resistance measurement.
Note: the Chassis cable leaves the factory with its resistance
compensation. If you want to check if the cable is showing resistance
and interfering with the measurement, follow these steps:
1. Disconnect the device from the DUT port
2. With the Chassis cable connected to Tesla, connect the banana
pin to the ground pin of the DUT.
3. Start the measurement. If a resistance reading appears, repair
or replace the Chassis cable.
Settings

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The “Insulation Resistance” test applies a voltage of 500V to the device
case to validate the case insulation..
INSULATION RESISTANCE TEST
Connect as instructed:
1. Connect TESLA to the power grid.
2. Connect the power cord of the device under test to the DUT.
3. Connect the banana/banana connector to the 500V output of
Tesla and the other end to the case of the device under test.
With all connections made, start the test.
Insulation Resistance Connection

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In the “Insulation Test” option, we will have access to the Insulation
Resistance measurement test. Click Start to begin measurement..
Warning
When TESLA is activated, the test will release 500 VDC in the device
under test. Avoid contact with connecting parts of the device.
This test is performed if:
Does the National or Local Security Code require the test? Does
the Manufacturer require the test?
Settings