PERFORMANCE TRAINER
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OPERATION MANUAL
19
REGULATORY AND COMPLIANCE NOTICES
SAFETY NOTIFICATIONS
TYPE/DEGREE OF PROTECTION
CLASSIFICATION/IDENTIFICATION/WARNINGS
SYMBOL
The degree of protection against
electric shock
Device is powered by two D cell alkaline batteries.
Electrical safety evaluation conducted by TÜV SÜD per
IEC/EN 60601-1 requirement.
The degree of protection against the
ingress of liquids
Not protected
N/A
The degree of safety in the presence
of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide
Not suitable
N/A
The mode of operation
Continuous
N/A
Information regarding potential
electromagnetic or other interference
and advice regarding avoidance
The Keiser Performance Trainers use electromagnetic and
RF energy only for its internal function. Therefore, its EMC
and RF emissions are very low and are not likely to cause
any interference in nearby electronic equipment.
N/A
EMC Notices, Statement of Compliance See Electromagnetic Compatibility (EMC) section, page 20.
N/A
ID of specified optional external power
supplies or battery chargers
The Keiser Performance Trainer does not require an
external power supply.
N/A
ID of any risks associated with the
disposal of waste products, residues,
including disposal of the equipment
itself at the end of its useful life.
The Keiser Performance Trainer contains electronic circuit
assemblies, 2 alkaline D cell batteries, and a sealed lithium
coin cell battery that may require compliance with specific
local disposal or recycling procedures.
The specification of the environmental
conditions for operation
Use indoor in climate-controlled environment only.
Keep away from areas of extreme humidity.
NOTICE: Equipment is not tested at extreme high/low
temperatures.
N/A
Standards
ISO/EN 20957-1 Accuracy Class A (High accuracy) and Usage Class S (Studio, commercial use)
IEC/EN 60601-1 and IEC/EN 60601-1-2
Marks
Displayed watts testing parameters:
“Current Power,” “Peak Power,” and “Percent of Peak Power” are not suitable for
use in applications where the health and safety of the patient may be dependent on the accuracy of those parameters.
Clinical Settings Note:
In clinical settings, patients may operate this equipment in accordance with this user manual
and the instructions and guidance provided by the healthcare personnel responsible for supervising their treatment
and care. However, patients shall not perform preventive maintenance, repairs or replace batteries on equipment
installed in clinical facilities.
