12
Adherus AutoSpray ET Dural Sealant Disposal
When the final spray application is complete, turn off the device, open the battery door to break the internal seal
and remove the batteries for appropriate disposal. The following table relays important information regarding
disposal of the Adherus AutoSpray ET Dural Sealant components.
Device
Disposal Instructions
Adherus AutoSpray ET
Dural Sealant
Adherus AutoSpray ET Dural Sealant consists of a plastic
enclosure and electrical components. This device must be taken
to separate collection at the product end of life. Do not dispose
of this product as unsorted municipal waste.
Troubleshooting Adherus AutoSpray ET Dural Sealant
The following potential failure modes for Adherus AutoSpray ET Dural Sealant have been identified. Each of the
failure modes includes a safeguard (as listed below) to control for the results of such malfunctions.
Potential Failure Modes
Safeguard
1. Air-pump not activated
1. On/Off switch not depressed
2. Spray nozzle blocked
2. Do not remove vial adapter hubs prior to turning
on air pump, wipe off nozzle after use.
To avoid complications, follow exactly the Adherus AutoSpray ET Dural Sealant Troubleshooting Flow Chart in
the above table. During a procedure, the user
’
s efforts to troubleshoot Adherus AutoSpray ET Dural Sealant
should be strictly limited to the steps described above. If troubleshooting is not successful, discontinue use of the
current Adherus AutoSpray ET Dural Sealant unit
immediately
and open a new Adherus AutoSpray ET Dural
Sealant unit.
Adherus AutoSpray ET Dural Sealant Electrical Specifications
The Adherus AutoSpray ET Dural Sealant meets the following standards:
x
IEC 60601-1 3
rd
edition
Electrical safety standard requirements
x
IEC 60601-1-2 3
rd
edition
Immunity requirements
Guidance & Manufacturer
’
s Declaration
–
Electromagnetic Emissions
Adherus AutoSpray ET Dural Sealant is intended for use in the electromagnetic environment specified below. The
customer or user of Adherus AutoSpray ET Dural Sealant should assure that it is only used in such an
environment.
Emissions Test
Compliance
Electromagnetic Environment Guidance
RF emissions CISPR 11
Group 1
Adherus AutoSpray ET Dural Sealant uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are
not likely to cause interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Adherus AutoSpray ET Dural Sealant is suitable for use in all
establishments, including domestic establishments and those
directly connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2
Not applicable
Voltage fluctuations /Flicker
emissions IEC 61000-3-3
Not applicable
