Gambro

U8000S (S Ultrafilter – Ultra Pure Dialysis Fluid)

The U 8000 S ultrafilter is indicated for the purification of the incoming water for the dialysis fluid and for the purification of the dialysis fluid to obtain microbiologically high-quality dialysis fluid. Thus, the risk of exposure to bacteria and endotoxins can be minimized. The U 8000 S ultrafilter is intended for use with a water purification system. The U 8000 S ultrafilter should be routinely replaced every month or after a maximum of 2 months of use, based on results from microbiological checks of ultrapure dialysis fluid.

U9000 (Ultrafilter – Ultra Pure Dialysis Fluid)

The U9000 ultrafilter is indicated for the purification of the incoming water for the dialysis fluid and for the purification of the dialysis fluid to obtain microbiologically high-quality dialysis fluid. The U9000 ultrafilter is intended for use with a water purification system. For AK98 V2, V3, and Artis dialysis systems: The U9000 ultrafilter should be replaced after 3 months of use or 150 disinfection cycles, whichever happens first. For AK 96 and AK 98 V1 dialysis systems: The U9000 ultrafilter should be replaced after 2 months of use or 100 disinfection cycles, whichever happens first. During the lifetime of the U9000, it is possible to have a maximum of 12 disinfections with sodium hypochlorite and a maximum of 8 disinfections with sodium carbonate. The U9000 ultrafilter is disinfected by the dialysis machine. It is also compatible with heat disinfection.

PRISMAFLEX System-Hemofilter Sets

M100-M150 should be restricted to patients with a body weight greater than 30 kg. With the AN 69 Dialyzer Membrane, set configurations are created and can be used to perform all CRRT treatments (SCUF, CVVH, CVVHD, and CVVHDF). The PRISMAFLEX Set is indicated for use only with the PRISMAFLEX Control Unit to provide continuous fluid management and renal replacement therapies. The system is designed for patients with acute renal failure, fluid overload, or both. This set is intended for use in the following vein-venous treatments: SCUF, CVVH, CVVHD, CVVHDF. All treatments administered through the PRISMAFLEX Set must be prescribed by a doctor. The patient’s size, weight, uremia status, cardiac status, and general physical condition should be carefully evaluated by the prescribing doctor prior to each treatment. The PRISMAFLEX M100 and M150 Sets should be restricted to patients with a body weight greater than 30 kg.

REVACLEAR 300 – REVACLEAR 400

Dialyzers produced with REVACLEAR Dialyzer Technology have a three-layer membrane. REVACLEAR is designed to remove critical uremic toxins such as urea while preserving important proteins such as Albumin and other similar-sized molecules. In addition to small molecular weight molecules, REVACLEAR Dialyzer’s membrane removes most of the medium molecules with a size similar to that of Beta-2 Microglobulin. REVACLEAR Dialyzer uses steam sterilization and is never sterilized with E-beam or EtO. REVACLEAR is considered Baxter’s most successful dialyzer to date. 

POLYFLUX 14L

The Polyflux L dialyzer series is specialized for low flux. While hemodialysis treatments, featuring a distinctive membrane that acts as an effective barrier to potential fluid contaminants, still deliver high performance, Polyflux L dialyzers are a good choice for proven biocompatible yet effective low-flux treatments designed with safety in mind. In addition, they are designed to promote biocompatibility. Polyflux L dialyzers are low-flux hemodialysis treatments designed to deliver high quality. More than 300 million Polyflux dialyzers have been used globally since 1988. Polyflux L dialyzers are designed to prevent endotoxins from crossing the dialyzer membrane. Polyflux L dialyzers are steam sterilized from the inside out to increase biocompatibility and avoid exposure to chemicals such as ethylene oxide and manufacturing residues. Polyflux L dialyzers have a special 3-layer membrane structure designed to support a stable high performance over time.

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Gambro AK 96 can be defined as a dialysis machine that has been designed for use in one single patient for the application of hemodialysis treatment as prescribed by the doctor in patients who have renal failure or fluid overload issues. Teaching of patient consultancy and treatment techniques directly under the inspection and discretion of the doctor. The AK 96 dialysis machine has been designed to be used in a selfcare environment such as home, provided that it is applied by a competent and specialized person as prescribed by the doctor in a dialysis center environment.

Also, selfcare such as a home environment should only be allowed when the patient and observer receive the necessary training on preparing the machine, safely stopping the treatment and disinfecting and cleaning the machine between treatments. The doctor is responsible for regularly checking whether the patient and/or observer have the qualifications to fulfill these procedures. The trainings and/or conformity checks must be recorded by the doctor in charge.

It is known that the AK 96 dialysis machine has been designed to be used with a BiCart cartridge and that their combined use is approved in cases where the AK 96 dialysis machine is used for dialysate production created at solid concentrations and containing bicarbonates. Gambro refuses responsibility in the event that other solid concentrate containers are used.

Safety Philosophy

The AK 96 dialysis machine is designed in conformance with the IEC 60601-2-16 standard which is accepted as the standard for the hemodialysis equipment. And that means safety is guaranteed with the system called Single-Event Error. In practice, this means that treatment parameters such as controllable conductivity, temperature and ultrafiltration are controlled by a control system and that they are monitored by the protective system, a completely separate system that uses its own sensors, electrical currents and microprocessors. The functionality of the protective system is checked by the AK 96 dialysis machine before each treatment. When an error is found during the tests done before treatment, the treatment cannot start.

In order to confirm that the relevant control systems and protective systems are working with the right entry values, the user should compare the values that they read on these systems with each other before hooking the patient up to the machine. It should be checked whether the calculated conductivity values displayed in the conductivity menu (C/P) are consistent. When this comparison is not sufficient, an authorized technician should be called.

When a parameter that is measured by the protective system is out of the alarm limits, the protective system makes the AK 96 dialysis machine safe for the patient. In other words, the protective system can stop the blood pump, shut off the venous clamp, stop the dialysate from reaching the dialyzer, and warn the user using sound and light.

There is a risk of the patient’s blood becoming contaminated with bacteria and endotoxins because of unwanted substances being carried from the dialysate section into the blood section of the dialyzer. This risk can be mitigated by using sturdy dialyzers, high quality input water, high quality concentrates and ultrafilters for the dialysate (option).

Ultrafiltration in Gambro Disposable Dialysis

Transmembrane pressure (TMP) is used as a protective system for the ultrafiltration control system. The TMP alarm limits concerning the dialyzer UF coefficient and the expected UF rate should be adjusted to be close to the real TMP value when starting the treatment. The TMP alarm limits are equivalent to a UF deviation limit which is explained with the TMPAlarm limit x UFcoefficient. The default value of the alarm window is set as ±100 mmHg. The alarm window should be ensured to be as close to the working TMP value as possible. It is recommended that the blood pressure is regularly checked as an additional precaution.

A venous pressure monitoring system is included to the AK 96 dialysis machine with the purpose of protecting the patient against a possibly dangerous blood loss. This system is activated when there is a change in the venous pressure, for example, when the pressure value drops below the lower alarm limit. It should be noted that a blood loss cannot cause the venous pressure to drop below the lower alarm limit under certain pressure/flow conditions. It is extremely important to make sure that all of the connections in the extracorporeal current are tight and sturdy, the fistula needle is correctly positioned and fixed and the lower alarm limit is set to a value that is as close to as possible to the operating venous pressure in order to prevent blood loss.

The venous pressure measuring system assumes the role of protecting against blood loss. This measuring system is automatically controlled before each treatment the treatment cannot start if a failure is found.

The monitoring of the blood bump stopping duration can be defined as the protection system that is used in case the patient loses blood due to coagulation during treatment. The user is notified with an alarm about the expiration of the duration of stopping the blood pump.

The blood leak detector system where an optic sensor is used is automatically tested to determine before each treatment that it is transparent (no blood found) or not transparent (blood found).

An ultrasonic sound detection system is used in the air detector and the transmitter is operated by a microprocessor in the protective system; and the receiver by both microprocessors.