Serim GUARDIAN™ BICARB pH II TEST STRIPS

BICARB pH II TEST STRIPS
Features	Benefits
Provides an independent measurement in addition to conductivity meters	Provides extra confidence that the mix ratio is correct Follows AAMI recommendations not to rely solely on conductivity meter reading to insure proper dialysate ratios
Ready-to-use strips	No preparation or mixing of reagents No calibration, battery replacement of frequent repair of instruments needed No glass vials or sharps needed
Simple to interpret color blocks from 6.5 to 8.5 at 0.5 increments	Color of indicator pad is directly compared to color blocks on bottle label Greater accuracy than pH strips with blocks only at whole pH increments Accurate & consistent results minimizes variation between readers
Immediate results for 32^o-40^oC samples 10 second results for room temp samples	Allows quick initiation of dialysate procedure
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
Two separate color chats provided: • Final dialysate • Concentrated bicarbonate solution	Optimal color charts for each type of solution provide more accurate results
Product performance is not affected by common dialysate & bicarbonate components	Minimize concerns that performance may be affected by variations in brands of dialysate components
Labeled for dialysis use⁵	No Need to qualify an "off-label" test for dialysis use No need to monitor changes in product performance from lot-to-lot
Each bottle clearly labeled with: • Lot number • Expiration date	Traceability of product from manufacturing to final user Leaves no doubt as to the age or integrity of the product

References:
1. AAMI Standards and Recommended Practices, Dialysis, 2008 Edition, RD61-Concentrates for hemodialysis, Association for the Advancement of Medical Instrumentation. Arlington, Virginia. AAMI Standards and Recommended Practice
2. AAMI Standards and Recommended Practices, Dialysis, 2008 Edition, RD52 - Dialysate for hemodialysis, Medical Instrumentation. Arlington, Virginia.
3. Dialysis Therapy, 3rd Edition, pp 71-73, AR Nissenson, RN Fine. Hanley & Belfus, Inc., Philadelphia, PA.
4. Dialysis Therapy, 3 Edition, pg 164, AR Nissenson, RN Fine. Hanley & Belfus, Inc., Philadelphia, PA.

WHAT does this product do?
Serim® GUARDIAN™ Bicarb pH II™ Test Strips are designed to indicate the pH of the bicarbonate concentrates or final dialysate solution (a mixture of acid concentrate, bicarbonate concentrate and water).

WHY should I use this product?
Recognition and application of appropriate concentrates to produce the desired dialysate is the responsibility of the operator. AAMI recognizes that adequate monitoring does not currently exist to assure that mismatched concentrates will not produce a final dialysate of proper total conductivity but improper composition. The user is cautioned not to rely solely on conductivity measurements to ensure safety, but to consider all relevant factors including pH.¹

It is necessary to check the proper composition of the prescribed dialysate after it has been mixed (proportioned) and prior to initiating dialysis. Common pH limits for bicarbonate dialysate are 6.9 to 7.6.² Both the conductivity and pH must be in acceptable ranges before the patient can be dialyzed.³
The instructions for hemodialysis machines with built-in pH monitors require that a manual pH test be run on the dialysate before dialysis is initiated.⁴
Serim GUARDIAN Bicarb pH II Test Strips will provide an estimate of the dialysate pH without the routine calibration and maintenance required by manual pH meters.

WHERE do I use this product?
If powdered bicarbonate is being used, Serim GUARDIAN Bicarb pH II Test Strips can be used to test the bicarbonate concentrate once it has been reconstituted. The pH of the bicarbonate solution can also be checked by drawing a sample from the incoming bicarbonate sample port of the hemodialysis machine. To ensure that the pH of the final mixed dialysate proportioned by the dialysis machine is within the proper range, a sample of dialysate can be drawn from the Hansen connector of the sample port connected to the "To Dialyzer" line prior to initiating dialysis.

WHEN do I use this product?
Use Serim GUARDIAN Bicarb pH II Test Strips to test the pH of the freshly prepared bicarbonate concentrate as well as the bicarbonate/ acid mixture proportioned by the dialysis machine prior to initiating the dialysis.

References:
1. AAMI Standards and Recommended Practices, Dialysis, 2008 Edition, RD61-Concentrates for hemodialysis, Association for the Advancement of Medical Instrumentation. Arlington, Virginia. AAMI Standards and Recommended Practice
2. AAMI Standards and Recommended Practices, Dialysis, 2008 Edition, RD52 - Dialysate for hemodialysis, Medical Instrumentation. Arlington, Virginia.
3. Dialysis Therapy, 3rd Edition, pp 71-73, AR Nissenson, RN Fine. Hanley & Belfus, Inc., Philadelphia, PA.
4. Dialysis Therapy, 3 Edition, pg 164, AR Nissenson, RN Fine. Hanley & Belfus, Inc., Philadelphia, PA.

HOW TO USE GUARDIAN™ BICARB pH II TEST STRIPS
Serim GUARDIAN Bicarb pH II 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 relative to the pH of the solution being tested.

Test Method	Bicarbonate Concentrate	Final Dialysate
Sample*³	Use freshly reconstituted powdered bicarbonate or pre-packaged liquid bicarbonate concentrate	Collect a sample of the proportioned dialysate from the hemodialysis machine
Technique	Immerse the indicator pad into the sample for 1 second.	Immerse the indicator pad into the sample for 1 second.
Results	For samples at room temperature, wait exactly 10 seconds and then compare the color of the indicator pad to the appropriate color chart on the bottle label.	For warmed samples (32°- 40°C), immediately compare the color of the indicator pad to the appropriate color chart on the bottle label.
* Use care in obtaining samples. Agitation of the solution will accelerate the generation of carbon dioxide and cause an increase in pH.
Store bottles Serim GUARDIAN Bicarb pH II 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.

References:
3. Dialysis Therapy, 3rd Edition, pp 71-73, AR Nissenson, RN Fine. Hanley & Belfus, Inc., Philadelphia, PA.

GUARDIAN™ BICARB pH II TEST STRIPS
Product	Description	Packaging
5116A	Bicarb pH II Test Kit	5 Bottles of 100 Strips plus Control Solution / Kit