Machine - Fresenius Medical Care 2008T Operator's Manual

General Warnings
Warning! The machine must be labeled to indicate the type of concentrate for which it is
configured. Check the composition (i.e., Na, Cl, K, Ca, Mg, HCO ) and pH of the dialysate
3
solution after the machine is installed or after the machine is modified for different
concentrate types. Check the conductivity and approximate pH of the dialysate solution
with an independent device before initiating dialysis. Improper conductivity or pH could
result in patient injury or death.

Machine

Warning! Failure to install, operate, and maintain this equipment according to the
manufacturer's instructions may cause patient injury or death.
Warning! Proper functioning of the machine must be verified prior to initiating treatment.
Unidentified malfunctions or alarm failure could potentially expose a patient to a serious
health risk. Alarm limits for the arterial pressure monitor, venous pressure monitor, and
transmembrane pressure (TMP) monitor are automatically set and delayed for pressure
stabilization. Alarm limits for temperature and conductivity are calculated for the dialysate
composition and may be somewhat adjusted by the operator. These must be maintained
within safe physiological limits as specified by the prescribing physician.
Warning! Never perform maintenance when a patient is connected to the machine. If
possible, remove the machine from the treatment area when it is being serviced. Label the
machine to ensure it is not accidentally returned to clinical use before the service work is
completed. Disinfect the machine and test the dialysate for acceptable conductivity and pH
values before returning the machine to clinical use. Always test the machine when
maintenance is completed.
Warning! The electrical source must be single phase, three-conductor type provided with a
hospital grade receptacle and a ground fault interrupter at 120 volts, 60 Hz. The proper
polarity and ground integrity must be initially checked and maintained. Failure to do so may
result in electrical shock or burn to the operator or patient. The machine must be plugged
directly into the electrical outlet; extension cords and power strips are prohibited.
Warning! Shock hazard. Do not remove covers. Refer servicing to qualified personnel.
Replace fuses only with the same type and rating.
Warning! Do not install the 9-Volt battery backwards in the machine, as it will damage the
"No Power" alarm.
Warning! Do not use devices emitting strong electromagnetic radiation such as portable
phones, radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment near
your machine. Improper operation may result.
Cellular phones and WiFi connected devices may be conditionally allowed. However, if any
interference is noted, such as false pressure readings that disappear when the external signal
is removed, it is recommended to move the cellular phone at least ten feet away from the
2008T hemodialysis machine when making or receiving phone calls. If a WiFi-connected
device (e.g. laptop computers, tablet devices, smartphones) is found to cause interference, it
is recommended to use that device at least four feet away from the 2008T hemodialysis
machine.
For exact separation distance recommendation, please refer to the Manufacturer's EMC
Declaration statement on page 271.
2008T Machine Operator's Manual P/N 490122 Rev N 15