Single Needle Hemodialysis Caution: Federal Law (USA) restricts this device to sale, by or on the order of a physician. Read Instruction for Use prior to patient application. Trademarks used herein are owned by or licensed to Gambro 2006 Gambro 306050356 Rev B

Objectives Rationale for Single Needle (SN) Dialysis History of SN Dialysis Systems Phoenix SN Stroke Volume & Clearance Efficiency Effects of Changing Pressure Limits & Blood Flow

Why Single Needle? Consistent access to the blood is the weakest link in the hemodialysis process.

History of SN Dialysis Control Systems Pressure – Time Continuous Pump Vital Assists Average Pressure Intermittent Pump COBE Centry® SNC (C2) Pressure – Pressure Centrysystem® 3/3+ Phoenix® Continuous Pump (Double Blood Pump) AK 10 Fresenius + = LOW HIGH AVERAGE LOW HIGH

SN CYCLE All SN systems have two operating Phases Arterial Phase Blood drawn FROM the patient Venous Phase Blood returned TO the patient The combination of the two is referred to as a “CYCLE”

Phoenix® Single Needle Utilizes a Pressure – Pressure control device incorporating the intermittent blood pump and A/V clamping device The operator sets a SN Pressure Max (venous pressure) limit to end the Arterial Phase AND a SN Pressure Min (venous pressure) limit to end the Venous Phase Note: SN Pressure Min/Max = Venous Pressure Min/Max

Arterial Phase Description Blood Pump is ON Arterial Clamp is Open Venous Clamp is Closed When the SN Pressure Max (venous pressure) limit is reached the machine switches to the Venous Phase

Venous Phase Description Blood Pump is OFF Arterial Clamp is Closed Venous Clamp is Open Blood returns to the patient until the SN Pressure Min (venous pressure) limit is reached triggering another Arterial Phase (The blood is returned by the pressure built up in the system)

Stroke Volume & Clearance Efficiency Clearance Efficiency in single needle dialysis is a function of: Stroke Volume Access Recirculation Average Blood Flow Rate Blood Tubing Compliance

Stroke Volume Optimum Stroke Volume = 20 – 30 mls Is the quantity of blood removed from the patient in one Arterial Phase Is relative to how high the SN Pressure Max (venous pressure) limit is set Optimum Stroke Volume = 20 – 30 mls

Stroke Volume (continued) By increasing the volume of blood pumped with one stroke, the percent of that volume being recirculated is Decreased Stroke Volume is optimized on the Phoenix® system using a unique Cartridge Blood Set configuration which includes 1 or 2 pumping chambers and the operator’s ability to manipulate blood side pressure limits

Stroke Volume Calculation The Phoenix® system calculates the Stroke Volume: Arterial Phase Time X Pump Speed 60

Sources of Recirculation Poor blood flow from patient’s access Common space in the Access Device Fistula needle or Single Lumen Catheter Compliance of the blood lines

Recirculation Recirculation is the drawing of dialyzed blood from the Venous Line into the Arterial Line before it circulates through the patient Dialyzed blood has a lower concentration of solutes than the blood in the patient’s circulatory system, therefore Recirculation can adversely affect clearance efficiency

Common Space 1. Is the space from the tip of the needle to the start of the Y where venous and arterial blood mix Use of standard Fistula needle is not recommended due to the common space volume 2. Optimum volume of common space is 0.5 mL

Common Space = Recirculation A/V Fistula needle with a Y adapter attached is not recommended 12” Fistula Needle w/ tubing = 2.6 – 2.9 ml volume Use an Access Device designed for Single Needle

Common Space = Recirculation This chart illustrates Common Space Volume as related to % of Recirculation at a certain Stroke Volume

Access Device designed for Single Needle Pictured below is a fistula needle designed for SN as compared to a standard fistula needle As you can see the common space is vastly different SN ”Y “ Set Fistula Needle Standard Fistula Needle with 12” Tubing

Blood Flow Rate Phoenix® system calculates Blood Flow rate as: Pump Speed x Active Time of Blood Pump Cycle Time

Blood Tubing Compliance Recirculation may be caused by the compliance of the blood tubing set during single needle procedures Pressure differentials as great as 600 mmHg (-200 mmHg arterial, +380 mmHg venous) may occur between venous and arterial phases, causing expansion and contraction of the tubing

Blood Tubing Compliance continued This expansion and contraction causes backflow during the arterial and venous phases Lastly, due to the configuration of the Cartridge Blood Set, blood flow is continuous through the dialyzer

Effects of Adjusting Pressure Limits Increase SN Pressure Max to: Stroke Volume Average Blood Flow Rate Arterial Phase Time Decrease SN Pressure Max to: Stroke Volume Average Blood Flow Rate Arterial Phase Time

Effects of Adjusting Pressure Limits Increase SN Pressure Min to: Stroke Volume Average Blood Flow Rate Venous Phase Time Decrease SN Pressure Min to: Stroke Volume Average Blood Flow Rate Venous Phase Time

Effects of Adjusting Pump Speed Raising or Lowering Pump Speed will: Change blood flow rate speed, arterial phase time Possible change in stroke volume

Gambro® Product Offerings Cartridge Blood Sets: Single Needle Set P/N 003-409-400 Single Needle Set w/prime line attached P/N 003-409-410 Single Needle Conversion Kit P/N 003-429-500 Y Connector P/N S-194C For use with a Single Lumen Catheter