User's Manual

-15-
Medical Requirement
(Medical applied model only)
Classifications:
In accordance with UL 2601-1/IEC 60601-1, the product is classified as Continuous duty Class I
equipment, which is not protected against ingress of liquids. The product is not suitable for use in the
presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide.
- Type of protection against electrical shock : Class l
- Degree of protection against electrical shock (Patient connection) : Not applicable
- Degree of protection against harmful ingress of water : Ordinary equipment
- Methods of sterilization or disinfection : Not applicable
- Degree of safety of application in the presence of a flammable anesthetic material with air or with
oxygen or nutrous oxide : Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
- Mode of operation : Continuos operation.
EMC
This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001.
These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance
with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices,
which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference
by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the other device (s) are connected.
• Consult the manufacturer or field service technician for help.
Video In / RS 232 / Video Out
Accessories equipment connected to the analog and digital interfaces must be certified to the respective IEC standards
(i.e. IEC 60950-1 for data processing equipment and IEC 60601-1 for medical equipment.) Furthermore all configurations
shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal output part configures a medical system,
and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1.
If in doubt, consult the technical services department or your local representative.
Transport and Storage Limitations:
Temperature Range of -40°C to +70°C
Relative Humidity of 10 -95%, non-condensing
Barometric pressure : 700hPa to 1060 hPa
Symbols
The below is provided for your identiification of important symbols located in labels.
This symbol indicated that high voltage is present inside. It is dangerous to make any kind of contact with
any internal part of this product.
This symbol alerts you that important literature concerning operation and maintenance has been included
with this product.
Manufacturer's declaration of product compliance with applicable EEC directive(s)
Protective Earth Ground
AC (alternating current) voltage source
DC (direct current) voltage source
* Bio-accumulative is defined as substances which accumulate within living organisms.
** Lead, Cadmium and Mercury are heavy metals which are Bio-accumulative.