10 |
safEty inforMation
Safety Information
Shock Hazard
When disconnecting the device from the power line, remove the plug from the wall
outlet first, before disconnecting the cable from the device.
Do not use multiple portable socket outlets (MPSO) to connect devices to the power
line.
If a printer is operated in the patient environment, the printer must comply with
IEC 60601 requirements or it must be a modified printer with additional protective
earth conductor (potential equalization).
All devices of a system must be connected to the same electric circuit. Devices that
are not connected to the same circuit must be electrically isolated when operated,
e.g., by means of an isolated RS232 interface (not required in the USA).
Devices may be connected to other devices or to parts of systems only when it has
been made certain that there is no danger to the patient, the operators, or the en-
vironment 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 oth-
er 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.
Standard IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.
All bicycle ergometers and treadmills connected to the system must meet
IEC60601-1 requirements.
Liquids must not be allowed to enter the devices. If liquids have entered the devices,
the ERS 2 system must be checked by a service technician before being used again
Do not open any of the devices. There are no user-replaceable components inside
the devices.
Do not insert objects of any kind into the device. They may touch live components
and you might suffer an electric shock, cause fire, or damage the device.
Warning
Patient Hazard — For stress-test examinations, a defibrillator and a pacemaker,
regularly checked for proper functioning, must be readily accessible at all times.
Patient Hazard, Interpretation Hazard — A qualified physician must overread all
computer-generated records.
Patient Hazard — The operator must be trained in the use of the device.
Patient Hazard, Equipment Damage — Do not modify the ERS 2 system in any way.
| 11
safEty inforMation
Safety Information
Warning
Risk of Poisoning — Observe all information provided by the manufacturers of
chemical products required for the use and care of the devices. Always keep these
chemical products in their original containers to avoid any confusion which may
have severe consequences.
RF Interference — Known RF sources, such as cell phones, radio or TV stations, and
two-way radios, may cause unexpected or adverse operation of the ERS 2 system.
Check the performance before each use.
Caution
Equipment Damage — Before connecting the device to the power line, check that
the voltage and frequency ratings of your power line match the values indicated on
the device nameplate.
Equipment Damage — Make sure that viruses, malware, etc. do not infect your PC
(check USB sticks for viruses before connecting them).
Equipment Damage — Do not set up the PC or the ergometers in the direct vicinity of
a window. Rain, humidity, and sunlight may damage the equipment.
Loss of Data — Back up the program directory and the database directory (as deter-
mined during installation) every day to avoid loss of data.
Equipment Damage — Set up the device in a location which affords sufficient ven-
tilation. The ventilation openings must not be obstructed. The ambient conditions
stated in the user manual must be ensured at all times.
Equipment Configuration — The PC should not be used adjacent to, or stacked with,
other equipment. If adjacent or stacked use is necessary, the equipment or system
should be tested to verify normal operation in the configuration in which it is being
used.
systEM rEquirEMEnts
Processor x86 or x64 processor with 2 gigahertz (GHz) minimum
RAM 1 gigabyte (GB) RAM (32 bit), 2 gigabyte (GB) RAM (64 bit)
Hard drive recommended: minimum storage capacity of 250GB
Graphics card with 1 or 2 monitor outputs, depending on configuration
Monitor(s) 1920 x 1080 pixels
Input devices keyboard, mouse
Interfaces 1 USB interface for connection of the hardware key,
1 USB interface for connection of a printer,
1 to 16 serial interfaces for connection of the ergometers
Printer ink jet or laser printer with USB connector
Operating system Windows XP, Windows Vista, Windows 7