Fresenius Medical Care 2008T Quick Start Manual

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Quick Start Guide
Indications for Use: 2008T Hemodialysis Machine: The 2008T hemodialysis
machine is indicated for acute and chronic dialysis therapy.
bibag® System (Optional): The bibag system is used with three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician’s prescription.
Crit-Line® Clip Monitor (CLiC™) (Optional): The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which uid is removed from the blood) in order to remove the maximum amount of uid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
This 2008T Hemodialysis Machine Quick Start Guide is intended to be a supplement to the 2008T Operator’s Manual (P/N 490122) for single-use. Operators must read and understand the Operator’s Manual supplied with the equipment. Attention must be given to all “Warning” and “Caution” statements in the Operator’s Manual
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Caution: Federal (US) law restricts this device to sale by
or on the order of a physician.
Note: Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling available at www.fmcna.com.
Notes
WARNING!
Failure to operate and maintain the machine according to the manufacturer’s instructions may cause operator or patient injury or death.
WARNING! To maintain sterility of the blood pathway, do not allow the ends of the bloodlines to come in contact with non-sterile solutions or surfaces which may contaminate the blood pathway.
Note: To conrm a changed parameter, do any of
the following:
• Double-click the touchpad.
• Press the Conrm key.
• Press either of the Enter keys on the keyboard.
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Set Up Concentrate
1. Press the Powe r key on the control panel. The Select Program screen will then appear on the monitor.
2. Flip down the touchpad and/or the keyboard.
3. Plug the acid (red) concentrate connector into the acid source.
4. Select the Dialysis button, the Dialysate screen will appear on the monitor.
5. Conrm the concentrate. If the concentrate must be changed, select the CONC button, enter the concentrate type using the Up or Down Keys on the keyboard, then press Conrm.
6. Select the Base Na+ and Bicarbonate buttons, enter the prescribed value using the data entry keys, and then press Conrm.
7. Select the Home button. The Home screen will appear on the monitor (Air Detector alarm will be displayed in the Status Box).
8. Plug the biocarbonate (blue) concentrate connector into the bicarbonate source.
Note: If the bibag disposable is the bicarbonate source, do not pull the blue bicarbonate connector from the machine’s rinse port. Do the following to prepare the bibag disposable:
1. Remove the plastic seal from underneath the water and
bicarbonate nozzles of the bibag disposable.
2. Open the bibag door on the machine by lifting up on
the dark gray handle.
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3. With the white bibag handle facing out (the blue
labeling should be facing you), hang the bag on the bibag connector nozzles.
4. Close the door, making sure it latches rmly in place.
You will hear an audible click indicating the door is closed.
5. When the machine is ready, (water is at the minimum
temperature and no air in the hydraulics), the bag will ll with heated water to be used as a bicarbonate concentrate for dialysate production.
Note:
1. Dialysate ow must be on in order to ll the bag.
2. The bibag disposable contains a xed amount of
bicarbonate powder. Refer to the bibag Estimated Run Time Reference Card (P/N 101746-01 or P/N 102768-01) to verify that enough run time is available to complete a treatment.
3. Do not remove the blue bicarbonate connector from
the machine’s bicarbonate port while using the bibag system for treatment. Doing so will stop the ow to and from the bibag disposable.
4. The bibag disposable must hang freely below the bibag
connector. Make certain that there are no jugs or other objects obstructing or touching the bibag disposable.
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Setup Concentrate (continued)
WARNING!
Acid concentrate products are used as one component in mixing dialysate bath. These acid products contain chemical compounds that, after mixing, yield acetate (and citrate in certain products) in the dialysate. (Please refer to the acid concentrate product labeling for specic acetate/ citrate amounts.) After diffusion across the dialyzer membrane, acetate (and citrate when present) is metabolized by the liver to serum bicarbonate and adds to the serum bicarbonate that separately results from the diffusion of dialysate bicarbonate across the dialyzer membrane. During dialysis, the dynamic of diffusion and concentration gradients prevent serum bicarbonate concentration from exceeding the dialysate bicarbonate concentration. The bicarbonate concentration of the dialysate is the “bicarbonate” setting on the dialysis machine, and is the bicarbonate dose prescribed by the physician. On the 2008® series hemodialysis machines, the bicarbonate dose may be set in a range between 20 and 40 milliequivalents per liter, but may be set in different range in the other machines.
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