Important Safety Information

Caution:

Federal (US) law restricts these devices to sale by or on the order of a physician.

Indications for Use

The Tablo® Hemodialysis System and TabloCart™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician’s prescription and observed by a trained individual who is considered competent in the use of the device. The Tablo Hemodialysis System is also indicated for use in the home. Treatment types available include Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), Prolonged Intermittent Renal Replacement Therapy (PIRRT), and Isolated Ultrafiltration.

Warning and Precautions:

1. The Tablo Hemodialysis System is a prescribed device for use by adults.
2. Failure to install, operate, and maintain this equipment according to the manufacturer’s instructions may cause patient injury or death.
3. The machine must be plugged directly into the electrical outlet; extension cords and power strips are prohibited.
4. To avoid damaging the equipment or personal injury, internal adjustments to the blood pressure module should only be made by a qualified technician.
5. This dialysis machine may be susceptible to electromagnetic interference (EMI) causing a false alarm and/or shutdown of the Hemodialysis delivery machine or components. Devices emitting strong electromagnetic radiation such as portable phones, radio equipment (walkie-talkies, etc.), radio transmitters, and like equipment, should not be used in the vicinity of this equipment. The use of digital cell phones can be conditionally allowed. Discontinue use of any device if any interference is noted, such as false pressure indications that disappear when external signal is removed.
6. Never perform maintenance when a patient is connected to the machine as this could result in serious injury to the patient. 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 before returning the machine to clinical use.
7. Unidentified malfunctions or alarm failures 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. These must be maintained within safe physiological limits as specified by the prescribing physician.
8. Possible Explosion Hazard if used in the presence of flammable anesthetics.
9. Check all bloodlines for leaks after the treatment has started. Keep access sites uncovered and monitored. Improper bloodline connections or needle dislodgements can result in excessive blood loss, serious injury, and death. Machine alarms may not occur in every blood loss situation.
10. The dialysate path is a closed fluidics system. Discontinue use immediately if a fluid leak is detected. Do not attempt to administer or continue dialysis treatment with a machine which has a fluid leak, this could result in excessive fluid removal from the patient leading to serious injury or death. System leaks may also pose a slip-and-fall hazard. Clean up spills immediately.
11. Ensure to test your incoming water per Federal and State Regulations.
12. HIGH PRIORITY and SYSTEM Errors ( Color coded RED) require an immediate user response. For detailed descriptions and instructions regarding remedial actions, refer to “Alarms and Alerts”. Failure to respond immediately to High Priority alarms could result in patient harm.
13. Do not use any external fluid delivery devices. Using these devices may cause blood loss, undesired fluid delivery, inaccurate flows, leaks, and other failure of the fluid deliver device to perform its intended function.
14. The low venous pressure alarm may not occur with every disconnection or needle dislodgement. Check all blood lines for leaks after the treatment has started. Keep access sites uncovered and monitored. Improper blood line connections or needle dislodgements can result in excessive blood loss, serious injury, and death. System alarms may not occur in every blood loss situation. Always immediately contact your center in the event of a blood loss event.

Cautions:

1. Read all warnings, cautions, and instructions provided with this Hemodialysis System before using.
2. The Tablo system disposables are for single use only. Do not reuse or resterilize. Materials used to make the disposables may not withstand reprocessing or reuse or both. Reuse or re-sterilization of the disposables may result in, but is not limited to, the following problems:
   • Risk of cross contamination
   • Material degradation
   • Biocompatibility issues
   • Endotoxin reactions
   • Failure of the disposable to perform as intended