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Telephone: [phone]

FAX: [phone]

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Human Subjects Research Review Office

ITC – Alpha 2205

Binghamton, NY 13902-6000

Human Subjects Mechanical Electronic Equipment Approval Form/Safety Checklist

Devices that connect to or touch the subject

This form must be completed when human subjects will be in contact with any mechanical, electronic, electrical or other equipment, which may cause accidental injury or harm. This includes custom as well as commercial devices.

Title of Research Protocol:      
Name of Researcher:      
Department:       Office Phone:       Emergency Phone:      
Faculty Supervisor:      
Name of Device:      
Device Storage Location:       Bldg.       Room:      
Device Use Location:       Bldg.:       Room:      

This experiment involves the use of the following electronic devices: (if a custom device, who built it)

DEVICE	Description	IDE*	Model#	Manufacturer
1.
2.
3.
4.

Physiological measures: (describe each measure by device number above, electrodes used and method of attachment)

     

How will the subject interact with the equipment (describe potential risks and measures taken to reduce the risk)

     

Authorized individuals: (list those trained to run the experiment)

Name	Faculty	Graduate	Undergrad	Other	Phone

I certify that I have read the appropriate guidelines and equipment manuals for the devices described above and certify that the authorized individuals are trained in the operation and safety issues. I understand the potential risks (listed above) and will inspect the equipment for safe operation as required by the manuals.* This device conforms to the FDA IDE regulations [21 CFR part 812] as a (NSR) non-significant risk device and I have read the appropriate guidelines.
_____________________________________________ ___________________________

Name Date

Human Subjects Mechanical Electronic Equipment Approval Form/Safety Checklist
Title of Research Protocol:      

Name of Researcher:      
The mechanical and electrical inspection is designed to provide general guidelines for the safety of the subject. This inspection does not look into the physiological or medical issues that may be part of the experiment or interaction with the subject. These issues must be approved by an appropriate person as suggested by the Human Subjects guidelines.
Safety Inspection items Comments OK

Grounded plugs
Grounded fault outlets
Metal in contact with subject
Wires / Connectors in good condition
Ability to easily touch other electrical device
Electrical devices UL approved
If not UL approved, list other approval
Standard manufactured devices
Safety inspections or current updates of equipment
Obvious physical danger to subjects, (sharps, disinfection, etc,)
Overrides and easy to disconnect if necessary
Across chest electrode or contact points
Potential difference (voltage test) at electrodes within limits
Equipment battery operated (not plugged in to charge when running)
Heat related issues - covering vents
Other:
Other:
Other:

Additional Comments:      


Inspection: The equipment described above has been examined and appears to be in good working order for use in the research protocol listed above. It must be maintained by the authorized individuals and checked by them for safety on a regular basis.
Inspected by: Wayne Kashinsky _____________________________ Date: _______________________