
Chapter 1. Information and safety
1.3 Warnings
ER3-14A 13mm foam earplugs (50 pcs)
40116
3M
ER3-14B foam earplugs 10mm (50 pcs)
40117
3M
1.3
Warnings
In this manual the warnings and information given have the following meaning:
The
warning
label indicates conditions or procedures that may put the patient and/or user at
risk.
The
warning
label indicates conditions or procedures that could cause the equipment to mal-
function.
The
information
label refers to notices or information that are not related to accident hazards
or device malfunction.
CAUTION
: The device must be handled by a qualified operator (hospital staff, doctor, etc.).
The patient must not come into contact with the device other than through the accessories.
CAUTION
: The device must be connected to a computer with a certified medical power
supply (double insulation according to ISO 60601-1)
CAUTION
: No changes to the device are permitted. It is strictly forbidden to open the de-
vice case.
CAUTION
: The device complies with applicable electromagnetic compatibility standards. If
you experience interference or other problems with another device, contact Électronique du
Mazet or the distributor for advice on how to avoid or minimize the problem.
CAUTION
: Operation in close proximity (e.g., 1 m) to shortwave or microwave therapy EM
DEVICES may cause instabilities in the output power of the STIMULATOR
CAUTION
: The device must be used with the accessories determined by the manufacturer
to be compatible with the device (see 1.2.7).
CAUTION
: The device must not be accessible to the patient.
It should not be placed in contact with the patient.
CAUTION
: the computer must never be located in a space accessible to the patient
CAUTION
: Be sure to follow the maintenance instructions listed in the 6.Maintenance and
CAUTION
: The battery can only be replaced by Électronique du Mazet technicians or their
distributors.
The device collects data. It is the responsibility of the user to apply and comply with the Eu-
ropean Parliament's General Data Protection Regulation 2016/679. When returning to the af-
ter-sales service, the user must delete the data so that it is not disclosed.