Natus Nicolet Edx Installation Guide
Natus Nicolet Edx Installation Guide
Installation Guide
May 13, 2014
269-640200 Rev 03
© 2012 - 2014 Natus Medical Incorporated or one of its subsidiaries. All rights reserved.
Natus is a registered trademark of Natus Medical Incorporated. All product names appearing on this document are trademarks or registered trademarks owned,
licensed to, promoted or distributed by Natus Medical Incorporated, its subsidiaries or affiliates. All other trademarks are the property of their respective owners.
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Nicolet EDX Table of Contents
General Information
Installation and servicing instructions ..............................................................1-1
Device continuity maintenance and installation test ........................................1-1
Safety Notes..........................................................................................................1-1
Electromagnetic Compatibility ..........................................................................1-1
User guide.............................................................................................................1-1
How do I use this guide? .....................................................................................1-1
Technical support ................................................................................................1-2
European Authorized Representative ...............................................................1-2
Labels and symbols .............................................................................................1-3
Using the Easy Riser tray....................................................................................1-4
Viking EDX control panel...................................................................................1-5
Synergy EDX control panel ................................................................................1-6
AT2 and AT2+6 amplifier functions ..................................................................1-7
HB-6 Headbox functions.....................................................................................1-8
HB-7 Headbox functions.....................................................................................1-8
Nicolet EDX electrical stimulator probes..........................................................1-9
EDX Comfort Probe Plus Stimulator icons ......................................................1-9
SP1/SP2 Stim-Switching Units .........................................................................1-10
Base Unit rear panel icons ................................................................................ 1-11
Base Unit front panel icons ...............................................................................1-12
Base Unit bottom panel label icons ..................................................................1-12
System Verification 1
About this chapter ...............................................................................................5-1
Verifying the Nicolet EDX system operation (Synergy) ..................................5-3
Motor NCS .......................................................................................................5-3
Device continuity maintenance and installation test ........................................5-4
Cart grounding system with Isolation Power Supply .......................................5-4
Cart grounding without an Isolation Power Supply .........................................5-4
Leakage tests ........................................................................................................5-4
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Device continuity During installation, assembly and operation, some protective ground connection
maintenance and points are susceptible to becoming electrically detached or not properly connected. This can
installation test pose a safety hazard to both the user and patient.
It is recommended/required that you perform regular electrical continuity tests from exposed
conductive materials on the medical system to the protective ground on the medical system.
Regular testing will help ensure that proper protective grounding is maintained. This test
should always be performed after installation and maintenance. Additionally, this test
should be performed on a regular maintenance basis.
Safety Notes
Before continuing with any of the procedures in this document, please read the Safety
Notes located in the Additional Information and Safety Notes for Assorted Nicolet Brand Products
Reference (part number 269-594705) on CD.
Electromagnetic Compatibility
Please refer to the Electromagnetic Compatibility Reference Guide (part number 269-
596201) on CD for information concerning your Nicolet EDX system.
User guide
Refer to the Nicolet EDX User guide (part number 269-658300) before using the Nicolet EDX
system.
Procedure Location
Installing an EDX Portable Chapter 2
Technical support
Domestic International
Natus Neurology Incorporated Natus Neurology Incorporated
3150 Pleasant View Road Phone: 0049 (0) 180 501 5544
Middleton, WI USA 53562 Fax: 0049 (0) 89 83942777
1-800-356-0007 service.europe@natus.com
madision.helpdesk@natus.com www.Natus.com
www.Natus.com
Consult Operating Instructions. Failure to follow operating instructions could place the
patient or operator at risk. Image on blue background. (ISO 7010 M002)
Manufacturer.
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
608-829-8500
1 800-356-0007
Fax: 608-829-8589
www.natus.com
Type BF equipment.
Class II device.
RX Only CAUTION: USA Federal law restricts this device to sale or on the order of a licensed
Neurology practitioner.
To lower: Grasp sides of unit as shown. Tip UP front of unit. Move to desired height.
A: Lock wand.
The control panel is active in all Nicolet Viking EDX software modes. However, it is not active in NicVue, the Backup/Restore
mode, the Report Program, the internet, or in any Windows application. In these modes, use the mouse or keyboard.
The control panel includes two types of touch-keys, the hardkeys and softkeys. See User Guide for additional details.
Hardkeys
The hardkeys are touch-panel keys with a single function. Each hardkey is labeled with its purpose and are operational only in
relevant modes.
Softkeys
The softkeys are the 12 color-coded touch-panel keys on the control panel. Softkey functions change according to the mode you
are working in and are designated by the corresponding colored buttons in the Display Prompt Area (DPA) displayed in the lower
portion of the screen display.
! B
IMPORTANT:
The Electrical Stimulator outputs are
disabled when the Synergy Control
Panel is connected to an EDX Unit.
The Synergy EDX control panel provides a single control operation for setting essential parameters during a patient examination.
The control panel is active in all Synergy software modes. However, it is not active in NicVue, the Backup/Restore mode, the
Report Program, the internet, or in any Windows application. In these modes, use the mouse or keyboard.
The adjustment dials include the Volume, Sensitivity, Sweep Duration, Stim A (IES-1 amplitude), Stim B (IES-2 amplitude),
and Stim Duration and Stimulus Level dials located on the upper right. See User Guide for additional details.
B B
M
K Nicolet
Nicolet
AT2 amplifier
L L AT2+6 amplifier L
Fz 13
R
K
A1 11 C3 3 Cz 14 C4 4 A2 12
M T5 9
P3
O1
5
7
Pz 15
Oz 16
P4
O2
6
8
T6 10 J
!
19
!
1 2
17 18 19
1 2 C
C C C - + - +
20 21 22
- + - +
D E F GH D E F DE F DE F G H I
A Temperature Probe The temperature probe attaches to this connector for skin temperature measurements. Connecting the
Connector temperature probe displays the temperature on the Exam Record screen.
B - Power Indicator When lit, the amplifier has power.
C Common (Ground) Plug the patient ground electrode into either green jack on the amplifier.
D
- Active (-) Electrode Patient recording electrodes connect to the red (+) and black (-) pin jacks. Negative voltages applied to the
black input jack produce an upward deflection on the Nicolet EDX display. Use the black input jack as the
’active’ electrode.
E - DIN Electrode The DIN electrode connectors accommodate patient electrodes supplied with DIN jacks, such as
Connector concentric needle electrodes. The DIN connectors provide a negative-up convention.
F
+ Reference (+) Electrode Patient recording electrodes connect to the red (+) and black (-) pin jacks. Use the red input jack as the
’inactive’ or ’reference’ electrode for a negative-up convention.
G Run/Standby Switch Turns the EMG amplifier channel inputs ON and OFF.
H - Run/Standby Indicator When lit, the channel is ON and is ready to receive signals from the patient electrodes. When OFF, the
amplifier input jacks are disconnected and grounded internally.
I Headbox Connector For optional HB-6 Headbox.
J L
A1 11 C3 3
Fz 13
Cz 14 C4 4 A2 12
R
1020 Integrated The numbers correspond to the montages defined in the software.
Headbox
P3 5 Pz 15 P4 6
T5 7 T6 10
O1 7 Oz 16 O2 8
K Type BF Equipment.
M Not for use in the presence of electrical cautery device without additional patient protection headbox or other in-line protection device.
N Amplifier
A Common.
T6 10 F
O1 7 Oz 16 O2 8
D Headbox.
17 18 19
20 21 22
E Not for use in the presence of electrical cautery device without additional patient protection
headbox or other in-line protection device.
A 1 2
A
E HB-6
! B
F L
A1 11 C3 3
Fz 13
Cz 14 C4 4 A2 12
R
The HB-6 Headbox consists of 1020 head pattern and 2 ground jacks. It is equipped with a 6 foot
T5 7
P3 5 Pz 15 P4 6
T6 10
signal cable and a clip that allows you to secure the Headbox on or near your patient.
D C
O1 7 Oz 16 O2 8
A Common.
T6 10 F
O1 7 Oz 16 O2 8
D Headbox.
17 18 19
20 21 22
E Designed for use in the presence of electrical cautery.
A 1 2
A
E ! B F The HB-7 Headbox consists of 1020 head pattern and 2 ground jacks. It is equipped with a 6 foot
HB-7
Fz 13
L R
A1 11 C3 3 Cz 14 C4 4 A2 12
signal cable and a clip that allows you to secure the Headbox on or near your patient.
P3 5 Pz 15 P4 6
T5 7 T6 10
D C
O1 7 Oz 16 O2 8
S1
S2
S3
!
+_
C D E F GHI
A Stimulation On/Off.
B Press wheel to start / stop stimulation. Rotate wheel to increase / decrease stimulus intensity.
LL
12
12
6
6
11
11
5
5
10
10
4
4
С С С С
3
9
2
8
1
7
SP-1 SP-2 SP-1 SP-2
A A
C Stimulator Outputs
A B C D E F G H I JKL
VA Output Power 70
Output
V UT S RG Q P O N W M
L Loudspeaker. W Fuse.
C LOT C 1 0 0 9 2 7 0 0 1
D 50
0086
E F G
A Manufacturing Reference Number. E 50 years of life before leakage of contaminates into land
fill.
B Manufacture (xxxx = year of manufacture). F Special Recycling Required. Do not dispose in landfill.
D CE Mark.
Tools needed
You may need a small flat-blade screwdriver to secure some of the system connectors.
A Philips head screwdriver is needed for attaching the Grounding Strap between the Base Unit and
Cart (when using a Laptop on a cart without an Isolation Power Supply).
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Voltage requirements
This section lists the voltage requirements for the main system components.
Laptop computer The laptop computer used for the portable systems accepts AC voltage ranges of 100V - 240V,
±10%, 50-60 Hz.
Make sure your power cord plug is correct for the power outlet into which it
will be plugged. That is, plug in a 120V power cord into a 120V outlet only.
Base unit The electrically isolated Base Unit is designed to accept AC voltages of 100V, 120V, 230V, ±10%,
50-60 Hz.
Printer The voltage ranges accepted by printers vary according to the printer model. Check the printer
power supply for the voltage requirements.
1. Connect the USB cable between the Base Unit connector and one of the
Laptop USB ports.
2. Connect the Amplifier cable between the Base Unit and Amplifier.
3. Connect the remaining components and options as shown below.
NOTE: If you have the photic strobe option, follow the instructions included with that stimulator to
connect it to the system.
Base Unit
Laptop Footswitch
Blue Red
Trigger In from
External Device
AEP Option Only
Patient's VEP Option Only AT2 AT2+6
Headphones LED Goggles
or Other Auditory NIC-105A
RIGHT
NIC-105A
LEFT
OR
Transducers Nicolet
AT2 amplifier
Nicolet
AT2+6 amplifier L
A1 11 C3
P3
3
5
Fz 13
Cz 14
Pz 15
C4
P4
4
6
R
A2 12
T5 7 T6 10
O1 7 Oz 16 O2 8
!
19
!
1 2 1 2
17 18
- + - + - + - +
20 21 22
2 Channel 8 Channel
Amplifier Amplifier
For proper isolation while the patient is connected to the system, only connect
a battery powered or independently isolated printer to the system. Do not charge the
printer’s battery or operate the printer from a wall outlet when the system is connected to the
patient.
NOTE: Do not load the printer drivers that are supplied with the printer.
If using the printer with a patient connected to the system, connect the other end of the adapter
cable to the Isolation Power Supply and then connect the Isolation Power Supply input Power cable
between the Isolation Power Supply and a Medical Grade Wall Outlet.
If using the printer without a patient connected to the system, connect the other end of the adapter
cable to a Medical Grade Wall Outlet. The isolation power supply is not required.
See your printer user guide for additional information as necessary:
Your Laptop may require a power cable adapter to plug into the computer's
power connector properly. If so, locate the adapter and connect it between the computer's
AC Adapter and the Base Unit. Contact your local Natus Neurology Incorporated
representative for more information.
Wall Outlet On
Off
Laptop (Model may vary)
Base Unit
To Laptop
Power Input
Laptop Power Supply
To switch off the system, switch the components off in the following order:
1. Laptop Computer.
2. Base Unit. Press the "O" on the power switch to turn off the Base Unit.
Turning the Printer on Press the printer Power button to turn power on. Because the printer power is controlled by the
and off isolation power supply, you can leave this power switch on.
For proper isolation while the patient is connected to the system, only connect
a battery powered or independently isolated printer to the system. Do not charge the
printer’s battery or operate the printer from a wall outlet when the system is connected to the
patient.
Where do I go next?
If you do not see the Nicolet EDX icon on the Desktop screen display, please go to Chapter 4 and
load the software.
If you see the Nicolet EDX icon, please go to Chapter 5 and verify the system is functional.
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Tools Needed
You may need a small flat blade screwdriver to secure some of the connectors.
Blank page.
Voltage requirements
This section lists the voltage requirements for the main system components, including:
• Base Unit
• Printer
• Isolation Power Supply
Base Unit The electrically isolated base unit is designed to accept AC voltages of 100V, 120V, 230V, ±10%,
50-60 Hz.
Make sure your power cord plug is the correct voltage for the power outlet
into which it will be plugged.
Because the Base Unit is electrically isolated, be sure that the Base Unit is
connected to the Isolation Power Supply outlet labelled "Base Unit only." Do not connect any
other device to this outlet or current leakage limits may be exceeded.
Printer The voltage ranges accepted by printers vary according to the printer model. Check the printer
power supply for the voltage requirements. Make sure it matches the line voltage for your country.
Plug the printer power supply into the Isolation Power Supply only. If it is
not connected to the Isolation Power Supply, current leakage limits may be exceeded.
Isolation Power Supply The cart-based system uses an external, stand-alone Isolation Power Supply to provide electrically
isolated power to all system devices, except the Base Unit. Two types of Isolation Power Supplys
are available:
• One accepts AC voltage ranges of 100V-120V, ±10%, 50-60 Hz.
• One accepts AC voltage of 220V-240V, ±10%, 50-60 Hz.
Verify that your Isolation Power Supply is appropriate for your power
source. For example, if your power source is 120 VAC, make sure you have the 100V - 120V
Isolation Power Supply.
YES
Power
Computer Monitor
Data Power
Data Isolation Wall
Patient Base Unit Power Outlet
(Isolated) Transformer
(Iso Box) Power
Data
Printer
Power
NO
Power
Computer Monitor
Data Power
Power
Printer
NO
Power
Computer Monitor
Data
Power
Data Wall
Patient Power Outlet
Base Unit
(Not Isolated)
Power
Data Wall
Power Outlet
Printer
Knob
Cable Hanger
Knob
Photic Cable
Clearance Hole for Knob
Post Chain
To Photic
Power Supply
Base
Optional Location
Needle Holder Bracket Needle Holder Bracket
Optional Location
Needle Holder Bracket Needle Holder Bracket
Mounting the amplifier 1. Insert the Amplifier mounting posts into the two key holes on the Amplifier Plate (Figure 1).
to the amplifier holder 2. Slide the Amplifier downward until it is locked to the Amplifier Plate.
Amplifier
mounting holes
Front View
Side View
Mounting the needle 1. If mounting the needle holder to the amplifier bracket, determine on which side you want to
holder to the amplifier mount the bracket (Figure 1).
bracket 2. Clean the mounting surface areas before attaching the tape.
3. Mount the needle holder bracket to the amplifier bracket using the tape provided.
4. Attach the needle holder to the needle holder bracket using the factory attached tape on the
holder.
5. Allow the tape's glue to dry for at least 1 hour.
Amplifier
1 Tape
Needle Holder Bracket
Rear View Top View
Optional needle holder If you wish, you can choose a different location (e.g., cart, wall, etc.) to mount the needle holder
mounting instead of mounting it on the amplifier bracket. You can choose to use or not use the needle holder
bracket.
1. Clean the mounting surface areas before attaching the tape.
2. If using the needle holder bracket, mount the bracket to the desired mounting surface using the
tape provided (Figure 2). If not using the bracket, skip this step.
3. If using the needle holder bracket, attach the needle holder to the bracket using the factory
attached tape on the holder. If not using the bracket, attach the needle holder directly to the
desired mounting surface.
4. Allow the tape's glue to dry for at least 1 hour.
Needle Holder
3
Tape
Needle Holder Bracket
2
Tape
1
Mounting surface
Top View
Figure 2: Mounting the Needle Holder Bracket and Needle Holder to an optional surface.
Mounting the 1. Determine on which side you want to mount the stimulator probe bracket (Figure 1).
stimulator probe 2. Clean the mounting surface area before attaching the tape.
holder to the amplifier
3. Mount the stimulator probe bracket on the amplifier bracket.
bracket
4. Attach the probe holder to the bracket using the factory attached tape on the holder.
5. Allow the tape's glue to dry for at least 1 hour.
NOTE: Once mounted, do not remove the Holder from the bracket.
Optional Location
Stimulator Probe Bracket
Tape
Amplifier Mounting Bracket 2 1 Amplifier Mounting Bracket
Figure 1: Mounting the Stimulator Probe Holder to the Amplifier Mounting Bracket.
Optional stimulator If you wish, you can choose a different location (e.g., cart, wall, etc.) to mount the stimulator probe
probe holder mounting holder instead of mounting it on the amplifier bracket.
1. Clean the mounting surface areas before attaching the tape.
2. Attach the stimulator probe holder using the factory attached tape on the holder to the desired
mounting surface (Figure 2).
3. Allow the tape's glue to dry for at least 1 hour.
Tape
1
Mounting surface
Top View
Figure 2: Mounting the Stimulator Probe Holder to an optional surface.
Mount the AT2+6 1. Determine on which side you want to mount the headbox bracket (Figure 1).
Headbox Bracket 2. Secure the AT2+6 headbox bracket to the amplifier bracket.
Figure 1: Mounting the AT2+6 Headbox Bracket to the Amplifier Mounting Bracket.
NOTE: Make sure the securing clamps are tight against the monitor base and parallel with the
cart top (not tilted).
Ensure that both tapes are snug to guard against the computer from
excessive shaking or falling off of the cart.
Cart Shelf
Ground
NOTE: The Printer is optional. Printer models may vary. Please refer to the manufacturer's Printer
guide to locate the connection(s).
Do NOT connect the Power Cable between the Isolation Power Supply and
Wall Outlet until the end of this procedure.
See Note 1
Note 1: For additional/advance audo configuration options and “Producer” audio details, please
contact Customer Support.
Note 2: Computer Port locations may differ from those shown.
IES-1 IES-2
!
- + - +
Future Future
Use Use
Optional Second
To (Touch-proof) Electrodes Electrical Stimulator Probe
1S
3S
2S
!
+_
Electrical Stimulator Probe
To (Touch-proof) Electrodes
S1
S2
S3
!
+_
Connect the base unit power cable
On
Off
Base Unit
1 2 !
!
L R 1 2
Connecting an external speaker to the EDX set to Digital (PC) generated audio
NOTE: The External Speaker is not provided. Speaker models may vary. This reference is provided
for users that prefer to add external speaker rather than use the speaker embedded in the EDX Base
Unit.
NOTE: In Synergy software, go to Audio Setup and select ‘Mute EDX Speaker.’
Do NOT connect the Power Cable between the Isolation Power Supply and
Wall Outlet until the end of this procedure.
NOTE: The External Speaker is not provided. Speaker models may vary. This reference is provided
for users that prefer to add external speaker rather than use the speaker embedded in the EDX Base
Unit.
NOTE: In the EMG software, go to Audio Setup and select ‘Mute EDX Speaker.’
Do NOT connect the Power Cable between the Isolation Power Supply and
Wall Outlet until the end of this procedure.
Base Unit
Printer precautions
Regardless of the printer type used with your system, all printers must be connected
into the Isolation Power Supply. If it is not connected to the Isolation Power Supply, current leakage
limits may be exceeded.
Where do I go next?
If you do not see the Nicolet EDX icon on the Desktop screen display, please go to Chapter 4 and
load the software.
If you see the Nicolet EDX icon, please go to Chapter 5 and verify the system is functional.
Overview
Your Nicolet EDX was shipped with the NicVue (if ordered), Windows OS and the Nicolet EDX
application software you purchased already installed on the hard drive. As part of your system
package, you received the Nicolet EDX Master Software CD. These items contain the Nicolet
EDX software programs that you purchased.
You will not need to install any Nicolet EDX software you purchased with your initial order.
However, under unusual circumstances, you may be instructed by a qualified Natus Neurology
Incorporated service representative to reinstall one or more software programs. Should this
reinstallation be necessary, your Natus Neurology Incorporated service representative will provide
you with detailed instructions on the Nicolet EDX software installation procedure.
If you are instructed to reinstall only NicVue or the Nicolet EDX software, please follow the
instructions in the NicVue Install Guide (269-639100) on the NicVue Application DVD and the
Reinstalling the Nicolet EDX Software section later in this chapter.
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12. From the NicVue dialog, choose whether you want NicVue as the Patient Administrative
System, click Yes or leave blank, click Next.
13. From the Start Installation dialog, click Next.
14. On a Windows 7 system, the following message may appear. Click Install this driver
software anyway.
15. Several dialogs will appear and disappear, followed by a Progress dialog. When the
installation is completed, click Finish.
16. A pop-up will appear explaining the application will need to be restarted for the license
changes to take effect. Click Yes if you are ready to restart the application. The application
will shut down and can be reopened by double-clicking the Synergy software icon on the
Windows desktop.
• If the pop-up does not appear, you will need to restart the application by closing it and
reopening it as stated above for the updated license to take effect.
17. Your new feature(s) have been activated.
NOTE: The Synergy License Number will change if additional software features are added or the
PC is replaced. The Synergy System ID Number will change if the PC is replaced.
NOTE: If open, the application will require to be restarted after the license is updated.
1. If it is not already, power up the PC and log in to Windows. The Synergy software should
initialize after Windows boots.
• If this is a first time Synergy software load, proceed to Step A.
• If this is a Synergy software features upgrade, proceed to Step B.
Step A: Activating a When the Synergy software opens, the ‘Initialize License’ window (Figure 1) appears.
new Synergy software
load
Figure 1.
1. If you have not already, contact Technical Support to obtain your Synergy License Number.
Ensure to have the following information ready.
• System Serial Number:
• Synergy System ID Number: This number is found between the 2 hyphens on the ‘Initial
License’ pop-up.
If you are unsure on where this information is, Technical Support will be able to assist you in
locating this information.
• U.S.: 1-800-356-0007
• International: 608-829-8500
2. Enter the Synergy License Number that you received from our Customer Support.
3. Click OK.
4. Click OK to the notification. Your software has been activated.
Step B: Activating a 1. With the Synergy software open, from the Main Menu bar, click System > Machine
new Synergy feature Configuration… (Figure 2).
Figure 2.
2. The ‘Machine Configuration’ window (Figure 3) appears, click the Software License…
button.
Figure 3.
3. The ‘Software License’ window appears (Figure 4). Enter the Synergy License Number that
you received from our Customer Support.
Figure 4.
4. Click OK to accept the new Synergy License Number.
5. Click OK to the notification.
6. Click OK to close the ‘Machine Configuration’ window.
7. A pop-up will appear explaining the application will need to be restarted for the license
changes to take effect. Click Yes if you are ready to restart the application. The application
will shut down and can be reopened by double-clicking the Synergy software icon on the
Windows desktop.
• If the pop-up does not appear, you will need to re-start the application by closing it and
reopening it as stated above for the updated license to take effect.
8. Your new feature(s) have been activated.
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Motor NCS Follow this procedure if the Motor NCS package is installed as part of the system software. This
test verifies the electrical stimulator and the amplifiers as well as the PC, Base Unit and software.
1. From the Function keys or the Test Menu, select the test you want.
2. Use the mouse to select the nerve and click to select a side. Press Enter or click on OK to
accept the selection. If you do not find the desired protocol, select General Nerve.
3. Attach surface electrodes for a Median Nerve study to a subject according to your conventions.
4. Press Acquire On for recurrent stimulation. Increase the stimulus intensity and duration to get
the Compound Muscle Action Potential (CMAP). Stop recurrent stimulation by pushing
Acquire On.
5. Type in the distance (in cm). It is displayed in the yellow highlighted box in the result table.
Press Enter to complete the entry. Velocity is not computed at the distal site.
8. When finished, press <F2> or click on Test Menu to return to the Main Screen.
Cart Shelf
Ground
Cart grounding
without an Isolation
Power Supply
Leakage tests
Perform leakage tests annually or as required by your place of employment.