GE TONOPORT VI Operator's Manual page 9

1.3 Safety Information
Danger
Risk to Persons—
– The equipment is not designed for use in areas
where an explosion hazard may occur. Explosion
hazards may result from the use of flammable
anesthetic mixtures with air or with oxygen,
nitrous oxide (N O), skin cleansing agents, or
2
disinfectants.
2001589-312 Revision B
Application, Safety Information
Risk to Persons—
– Equipment may be connected to other equipment
or to parts of systems only when it has been made
certain that there is no danger to the patient, the
operators, or the environment as a result. In those
instances where there is any element of doubt
concerning the safety of connected equipment, the
user must contact the manufacturers concerned or
other informed experts as to whether there is any
possible danger to the patient, the operator, or the
environment as a result of the proposed
combination of equipment. Compliance with the
standard IEC 60601-1 or IEC 60950-1 must
always be ensured.
– Connection of this device to an IT-network that
includes other equipment could result in
previously unidentified risks to patients, operators
or third parties. The responsible organization
should identify, analyze, evaluate and control
these risks.
– Changes to the IT-network could introduce new
risks that require additional analysis.
Changes to the IT-network include:
• changes in network configuration
• connection of additional items (e.g. connecting
another TONOPORT device to another port of
the PC can lead to interference during data
transfer)
• disconnection of items
• update or upgrade of equipment
– TONOPORT VI may be connected to CASE or to
a PC with the CardioSoft program. While
connected to any of these devices, TONOPORT VI
must be disconnected from the patient.
– Chemicals required, for example, for the
maintenance of the equipment must under all
circumstances be prepared, stored, and kept at
hand in their specific containers. Failure to
observe this instruction may have severe
consequences.
– The equipment has no protection against the
ingress of liquids. Liquids must not enter the
equipment. Equipment into which liquids have
entered must be inspected by a service technician
before use.
TONOPORT VI
Warning
9