Respironics bilichek, User Instruction Manual

Page: 9 / 25

ENGLISH
6.0 WARNINGS AND CAUTIONS
CAUTION: US federal law restricts this device to sale by or on the order of a physician.
WARNINGS
• The Bili Chek® Hand-Held Unit is to be operated only in conjunction with Respironics approved charger base, battery
packs, power supply, and Bili Cal TM Individual Calibration Tips.
• Do not point at eyes while taking a measurement.
• Do not use on areas of the skin with visible bruising.
• If you suspect Bili Chek is interfering with other electronic devices or vice versa, try the following measures to
correct it:
• Relocate the device until the interference stops.
• Move the Bili
Chek farther away from the device.
• Plug the Bili Chek Power Supply into a different power outlet so that the Bili Chek Power Supply and the
device are on different breaker or fuse circuits.
• Not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Do not puncture or incinerate the battery pack or dispose of in a landfill. Batteries should be disposed of properly
according to local guidelines.
• Do not use outdoors or place in direct sunlight.
• The charger base unit (battery charger) should be plugged into a properly grounded outlet. Do not operate with
damaged plug or cord.
CAUTIONS
• The Bili Cal Individual Calibration Tip should not be exposed to light for extended periods of time. Keep the
Bili Cal in its package prior to use.
• If the product is dropped and frequent error messages occur, it should be inspected for proper operation by an
authorized service representative.
• Do not immerse in water or other liquid.
• Do not let power cord hang over edge of counter or table as this may pose a tripping hazard.
CONTRAINDICATIONS
• The Bili Chek should not be used on patients who have undergone an exchange transfusion.
• Avoid using measurement sites with the following conditions since they can produce erroneous results:
• Brusing
• Birthmarks
• Hematomas
• Excessive Hairiness
NOTES
Certain medical conditions and medications are known to disrupt bilirubin-albumin carrying capacity and binding.
These factors may alter the transcutaneous bilirubin measurement by increasing or decreasing the bilirubin deposition
in the skin especially at high total serum bilirubin concentrations (>15 mg/dL or 255 µmol/L). Therefore, additional
caution should be used in interpreting the Bili
Chek measurement in patients with serious illnesses or complications
such as septicemia, PDA, IVH, and RDS. In these patients, a separate serum bilirubin measurement should be
considered if the Bili
Chek indicates elevated bilirubin levels.
There is limited data on use of the Bili Chek on patients under intensive phototherapy (>30 µW/cm 2 /nm or 1.5 m
Wcm 2 ), double-sided phototherapy, or after exchange transfusions. Caution should be used in interpreting Bili Chek
results under these conditions.
7