SERIM GUARDIAN BLOOD LEAK TEST STRIPS
Features	Benefits
Ready-to-use strips	No preparation or mixing of reagents No accessories, calibration or instruments needed No glass vials or sharps needed
Labeled specifically for dialysis use3	No need to qualify an "off-label" test for dialysis use No need to monitor changes in product performance from lot-to-lot
Simple to interpret color blocks	Accurate and consistent results minimize variation between readers Color of indicator pad is directly compared to color blocks on bottle label Simple to interpret color change
Convenient packaging	No waste of strips even for units with a low frequency blood leak alarms Larger package size for units with higher alarm frequency or for those units who routinely check for blood leaks
Sensitivity for positive color block set at 1.5 mg/dL vs. machine alarm sensitivity of 5.5 mg/dL	Confirms any significant blood leak, even if slightly lower than machine alarm threshold Detects the level considered critical for blood leaks
Stable product performance	Performance is not affected by common constituents of dialysate
Each bottle clearly labeled with: • Lot number • Expiration date	Traceability of product from manufacturing to final use Leaves no doubt as to the age or integrity of the product
Simple procedure	Eliminates reliance on inaccurate visual examination of dialysate for blood
Quick, qualitative results in 60 seconds	Decision as to whether to stop or continue dialysis procedure can be made quickly
Test strip can be immersed into sample or held in sample stream	Maximum convenience for user, no matter where a proper sample is most easily obtained

References:
2. NANT Dialysis Technology – A Manual for Dialysis Technicians, 2 Edition (2000), pg 76. National Association of Nephrology Technicians/Technologists, Dayton, OH.
3. Proper mechanisms for assuring disinfectant concentrations for use in hemodialysis. Nephrol News Issues. 1999 Jun.;13(6):18, 23, 27. Arduino MJ.

WHAT does this product do?
Serim® GUARDIAN™ Blood Leak Test Strips give a qualitative indication of the presence of blood in dialysate to assist in differentiating an actual blood leak from a false alarm.

WHY should I use this product?
The blood leak alarm may be triggered by air in the dialysate flow path, a dirty light source or photoelectric cell or by a malfunctioning detector system as well as an actual blood leak in the dialyzer membrane. Serim GUARDIAN Blood Leak Test Strips confirm that the alarm was due to an actual blood leak and avoids unnecessary interruption of the hemodialysis procedure.
AAMI recommends that dialysis machine blood leak detectors on the dialysis machine activate an alarm if blood escapes through the membrane at a rate of 0.35 mL/minute or more.¹ This leak rate calculates to a level of 5.5 mg/dL of hemoglobin in the dialysate (assuming a hematocrit of 25% and a dialysate flow of 0.5 L/minute). Serim GUARDIAN Blood Leak Test Strips are more sensitive than the AAMI- recommended setting for blood leak detectors; the test strips yield positive readings at 1.5 mg/dL hemoglobin. This increased sensitivity provides a safety margin, thereby protecting the patient against blood loss.

WHERE do I use this product?
Test the dialysate that exits from the dialyzer or test dialysate waste fluid collected from the dialysate drain line.

WHEN do I use this product?
Whenever the blood leak detector alarms, use Serim GUARDIAN Blood Leak Test Strips to verify the presence of blood in the dialysate.²

References:
1. AAMI Standards and Recommended Practices, Dialysis, 2008 Edition, RD5 – Hemodialysis systems, Association for the Advancement of Medical Instrumentation. Arlington, Virginia.
2. NANT Dialysis Technology – A Manual for Dialysis Technicians, 2 Edition (2000), pg 76. National Association of Nephrology Technicians/Technologists, Dayton, OH.
3. Proper mechanisms for assuring disinfectant concentrations for use in hemodialysis. Nephrol News Issues. 1999 Jun.;13(6):18, 23, 27. Arduino MJ.

HOW TO USE GUARDIAN™ BLOOD LEAK TEST STRIPS
Serim GUARDIAN Blood Leak Test Strips are supplied in ready-to-use form. When placed in contact with the sample according to the directions for use (see below), the indicator pad changes color in the presence of blood.

Test Method	Immersion	Stream
Dialysate sample	Using a clean container, collect a dialysate sample from the dialysate drain line	Remove the line where the dialysate exits and allow it to run out in a slow stream
Test Strip Technique	Immerse indicator pad into dialysate sample and remove immediately	Wet the indicator pad of the test strip by placing the pad into the stream of dialysate for 1 second or less
Results	After 60 seconds, compare the color of the indicator pad to the color blocks on the bottle label
Store bottles of Serim GUARDIAN Blood Leak Test Strips at temperatures between 15°- 30°C (59°- 86°F). The lot number and expiration date are printed on the bottom of each bottle.