prismaflex user manual

. . . . . . ferrite or equivalent to fulfill EMC requirements. . . Carefully read this Prismaflex Operator’s Manual and the Prismaflex disposable. . . . . . . . Use at least. . . . . . . . . . . . . . . . . carried out by an authorized service technician. Figure 2:5 on page 2:12 shows miscellaneous components. . . . Refer to “Guidance and Manufacturer’s Declaration — Electromagnetic. Apenas para Rx. . . . . . . Alarm screens (instructions when an alarm situation occurs). Blood Purif. . . Use aseptic technique when handling the blood and fluid lines in the disposable, Do not use the Prismaflex disposable set if the package is damaged, if the. . . . . . . . . . . . . . . chemical composition for correct disposal. . . . . PRISMAFLEX. . . . . On the disposable set the symbol is a relief. . . . . . . . . . Para obtener más información sobre los dispositivos mencionados aquí, consulte el Manual del Operador correspondiente. . . . . . . . . . . . . . Patient Data Management Systems and Remote Alarms, If a Patient Data Management System (PDMS) is to be used with the, Prismaflex system, the Responsible Organization is obliged to verify, compatibility between the two systems. . There are no known contraindications to Therapeutic Plasma Exchange. . . . . . . • Display gráfico. . . . . . . . . . . . segment from the air bubble detector to the patient is free of air. configuration. (See “Prismaflex® Disposable Sets”, The CSA (C-US) mark indicates that the Prismaflex control unit conforms to the, requirements related to safety of medical devices for the US and Canada. . . . . . . . . . . . . Honoré PM, Joannes-Boyau O, Collin V, Boer W, Jennes S. Continuous hemofiltration in 2009: what is new for clinicians regarding pathophysiology, preferred technique and recommended dose? . . . . . . . . . . . . . . . . . . . . accuracy, can exceed a level that can be tolerated by low-weight patients. . . . Interior Components . . . Instructions and warnings . . . . priming has started. • Instrucciones para el uso de los sets Prismaflex. . . . . . . . . . . . . . The Prismaflex system has been tested and validated for use with these accessories and, disposables. . . . . . . . recommended by the manufacturer, can result in patient injury or death. . . . . . . . When hanging a fluid bag, evenly distribute its weight among the three hooks of, the scale carrying bar. Upper and lower limits are expressed with numeric values, Temperature limitation. . . . . . . . Devices connected to the RS232 serial communication port or the Ethernet port, must comply with IEC 60950. . . . . Electrical Safety . . . Destroy the Prismaflex disposable set after a single use, using appropriate. The background color is yellow. . When a set is loaded, the bar code reader automatically scans the . . . . . . . . Always inspect the blood flowpath for signs of clotting before returning the blood, in the disposable set to the patient. . . . . . package insert for environmental requirements, including storage conditions. . . . Pay careful attention to the possible medical hazards associated with, Blood return from a blood primed extracorporeal circuit can result in. . . Delivers anticoagulant solution into the blood flowpath. . . Blood or fluid leakage from a pod diaphragm or wetting of the fluid barrier, at the distal end of the monitor line will impair pressure monitoring in the, Prismaflex system and requires immediate troubleshooting. . . The Prismaflex system consists of the Prismaflex control unit, a Prismaflex disposable, set, disposable solutions and optional accessories. . . . Connected cables must have a Kitagawa RFC-10. This may require the use of, a new bag of priming solution and a new (empty) collection bag. . Consult physician's prescription. . . HP Cartridge Holder . . . . . . . Incorrect use of the access, port or other restrictions to fluid flow might lead to incorrect patient weight loss, and may result in machine alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . www.multiorgansupport.ch. connected to the Prismaflex control unit. . . . may contain toxic substances which, if released into the. . . . . . . . . . . . . . . that delivers the following: • from 100 (–10%) Vac to 240 (+10%) Vac; from 45 Hz to 65 Hz. Pay particular attention to the extracorporeal blood volume. . . unit foot, before tilting the Prismaflex control unit into horizontal position. . . . . . . The Prismaflex control unit is intended for: Continuous Renal Replacement Therapy for patients with acute renal failure and/or, Therapeutic Plasma Exchange Therapy for patients with diseases where removal of, Hemoperfusion for patients with conditions where immediate removal of substances, All treatments administered via the Prismaflex control unit must be prescribed by a. . . On the disposable set the symbol is. . . . . . The manufacturer will not be responsible for patient safety if the procedures to, operate, maintain, and calibrate the Prismaflex system are other than those, specified in this manual, the Service Manual, the Instructions for Use of the. . . . . . . . By following this directive we are helping man and. . . . . . . . The color is black on a yellow background. . . . . . Contraindications . A higher minimum patient weight limit may apply for the disposable set, selected for the therapy. . . . . Intended Use . . . as its package and sterilization caps are removed. . . . . . Use aseptic technique whenever inserting needles into sample sites. . The operator sets the prescribed values, in accordance with the prescribed treatment, responds to alarms, troubleshoots the, Prismaflex control unit, handles the bags, etc. Gambro, Prismaflex, Adsorba, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX, diaMARS, X-MARS. . . . . . . . . . . . . Control Unit Functions . . . Refer to the Instructions For Use of the disposable set. . . . . However, if using, multiple portable socket-outlets, they must comply with IEC 60601-1-1 and must, not be placed on the floor. . The dilution effect of infusions must be, considered according to the flow settings and sample sites, for example PBP, infusion rate on an access site blood sample. . . . . . . special attention in case a warmer sleeve is in use. . . O sistema PRISMAFLEX destina-se a: Terapias contínuas – CVVHDF, CVVHD, CVVH, SCUF Terapias plasmáticas – TPT. . . the part is below the SJ/T 11363-2006 limit (Chinese regulation). . environment, pose a risk to the health of living organisms and the environment itself. . . . . . Nearby high-voltage conductors could be hazardous if contacted. . . . . Date of manufacture with year as four digits. . . . . System Components . 27. . . . . . . blood warmer, or when treating low body weight patients. Para os dispositivos aqui mencionados, consulte o manual do operador adequado. . . . Up to date Spare Parts and Service tool listings and Online ordering. . . . Ignoring and/or indiscriminately pressing the CONTINUE softkey as a response, to Caution: Flow Problem alarms may lead to incorrect patient weight loss or, gain. . . . . During priming and operation, observe the system closely for leakage at joints. . Calibration weights are to be removed before tilting the Prismaflex control. . . . . . . is inadvertently entered, restart the control unit to return to Operating mode. Syringe pump control panel UP and DOWN buttons on the machine allow you to install or remove a syringe. . . . . . . Prismaflex disposable sets, disposable. . observe fluid bags and connectors during treatment. . . . . . . The use of incorrect solution/fluid can result in, The Prismaflex system is unable to detect all situations in which a fluid bag has, been attached to the wrong line or has been hung on an incorrect scale. . . . . . . . . . Disposal of Waste Batteries and Accumulators, According to Directive 2006/66/EC and RAEE Directive concerning batteries the, manufacturer shall provide instructions how to replace/remove batteries in a safely and, environmentally friendly manner. . . . . . . Control Unit . . . . . . . . . . . . . . . . . Prismaflex System User Manual waverunner service manual, the angels of the battlefields the florence nightingales of the us civil war, the rules of success 20 proven laws for a successful life, chincoteague island, study guide the call of the wild, factory jcb jz140 tier 3 service manual … Do not, connect additional devices between the return line and the blood access, device. . Gambro does not accept any responsibility or liability for use of accessories, or disposables other than those specified in this manual or if any specified accessory, or disposable is not used in accordance with this manual, online instructions and the. . Prismatherm II extension line . . Please refer to the Operators Manual for further information. . . . . . Handle the control unit carefully. . . . . . . . . . . . . . . . . . . Figure 2:2 on page 2:6 shows the pressure components. . . . Disposables, and any accessories specified for use with the Prismaflex control unit are marked, with CE conformity marks in their own right. Help screens (additional information about an operating or alarm screen). . . . . . inspected by an authorized service technician. . To avoid the risk of electric shock, this equipment must only be connected to a, Do not use the Prismaflex control unit near flammable gas or a flammable. . . . . . . . WRO 300 H 1.3.3 Reminders Reoccurring notifications can be preset to remind the user to take certain actions, for example exchange cartridge in the pre- filter. . . . . Calcium Infusion Line . . . . The use of additional devices, such as three-way valves, stopcocks, or, extension lines, may impair return pressure monitoring. . . . . . . On the disposable set the symbol is a relief. . . . . . There are no known contraindications to Hemoperfusion. . . . As the blood, passes through the filter, the desired treatment processes take place. . . . . . . Do not resterilize. . . . . . . . TPE on the PRISMAFLEX System. . . . . . . . . . . . . . . . . . . . Keywords Used in this Manual . Safety Definitions . . . . The CE-conformity mark indicates that the Prismaflex control unit conforms to the, requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning, medical devices. . . . . . . shape in the plastic cover indicating the PBP pump. . . . . . . . . . . . . . . . . . . . . Note: Check your local regulations for any restrictions on therapies, disposables. . . . . . . . Pumps blood through the blood flowpath of the Prismaflex disposable set. . . . . . . . . . . . . . . . . In this manual, Responsible Organization means a function or a person who can identify, analyze, and control potential risks that could occur, for example, when connecting the, Prismaflex control unit to other equipment or when making changes to the equipment. . . . . The Prismaflex control unit displays different screens during operation. . . . in boluses (See Prismaflex Operator Manual for specification). . The Prismaflex system is intended for: Continuous therapies – CVVHDF, CVVHD, CVVH, SCUF Plasma therapies – TPE. . . . . . . . . . . , Deliver a complete range o . . . . . . . . Disposal of Waste Batteries and Accumulators . . . . . and Table “Sets and patient weight limits” on page 2:17. The maximum stacking load permitted on the transport package is 100 kg. . . . . If only one hook is needed, use the center hook. . . . market-leading Prismaflex platform, helping to increase user confidence in delivering CRRT through improved ease of use and user efficiency. . The PRISMAFLEX System is the only device that delivers multiple modes of therapy without additional equipment. . . The PRISMAFLEX TPE 2000 Set is indicated for use only with the PRISMAFLEX Control Unit, after having selected TPE therapy (therapeutic plasma exchange). . . . . . . . . . . . resulting from the operation or performance of any device, or any injury caused thereby, after repair has been performed by any person other than an authorized service technician, Under no circumstances will Gambro be liable for any indirect, incidental, special or, consequential damages of any kind, its liability being hereby limited solely to repair. . . . . . . . . . . al sistema Prismaflex® per l’anticoagulazione con citrato e la gestione integrata del calcio. . . Before first use. . . . . . The, CRRT – Continuous Renal Replacement Therapies, CVVH – Continuous Veno-venous Hemofiltration, CVVHD – Continuous Veno-venous Hemodialysis, CVVHDF – Continuous Veno-venous Hemodiafiltration, CRRT septeX – Continuous Renal Replacement Therapies with high cut-off, CVVHD+post – Continuous Veno-venous Hemodialysis + post infusion, CRRT MARS®– Continuous Renal Replacement Theapies supporting Molecular, Note: All therapies beside CRRT require a service configuration. information to enable authorized service technicians to repair those Prismaflex Service Manual sw ver 7.1x PDF download . . . . . . . . . . . . . . Upper and lower limits are expressed with, Humidity limitation. . . . . . . . Transportation and storage . . . . . . . . . . . . . . . . During the setup procedure, the operator selects the therapy desired. . . . . The PRISMAFLEX system should be restricted to patients with a body weight greater than 20 kg (44 lb). . . . . . . . . . . General Information . . . . . . . . Solutions . Information on devices serviced by Baxter. Since Gambro has no control over service work which is not performed by authorized, service technicians, Gambro will in no way be responsible or liable for any damages. Disposal of Discarded Equipment . . . . . Prismaflex system, see chapter 2: “Description of the Prismaflex® System” on page 2:1. . . . . . . . . . . It is essential that the power socket is properly grounded and in good. . . . . . . . This operator's manual is the primary training material for staff who is to operate the, This manual provides operating, maintenance, and troubleshooting instructions, as, well as general information. . . . . . . . . . . . . . . . . . . . . . A single system for all CRRT therapies, including SCUF, CVVH, CVVHD, and CVVHDF. The overall patient fluid balance is subject to fluid losses or gains outside the, control of the Prismaflex treatment system. . . . . . . . . . . . . . . . . . Chapter 3: “General Prismaflex® Functions” describes the principles of operation of, the system, notably about fluid and pressure management. . . . Prismaflex control unit and call for service. . . . . . . . . . . . . Observe the effluent bag for pink or red tinge as an indicator of hemolysis. . . . . . . Pay attention to the fact that some components of the Prismaflex control unit (display, batteries, circuit boards, etc.) . . . . . . . Responsibility and Disclaimer . . . . . . . . . . solutions and accessories are purchased separately. . . . . . . . . . . . . . . Monitors the system and alerts the operator to abnormal situations through alarms. . . . . other permanently affixed labels of this device. . . . . Online Instructions . Rx Only. . . . material of the part is above the SJ/T 11363-2006 limit (Chinese regulation). . . . . . . . Anticoagulation Methods . . Each Prismaflex control unit is pre-attached to a column and a base with casters. disposables. . . . . . . . . . Be, sure that the test is conducted using a container of water to substitute for the, The Prismaflex control unit weighs approximately 78 kg (172 lb). . . . The PRISMAFLEX system is intended for: Continuous therapies – CVVHDF, CVVHD, CVVH, SCUF Plasma therapies – TPE. The instructions are available online, through the interactive display. . . . . . . . service manual which contains all necessary circuit diagrams, calibration instructions, and service information to enable authorized service technicians to repair those parts of this equipment which Gambro considers to be repairable. . Gambro will provide, on request, a service manual which contains all necessary circuit, diagrams, calibration instructions, and service information to enable authorized service, technicians to repair those parts of this equipment which Gambro considers to be, This manual contains references to accessories and disposables for use with the. . . . . . Ensure that the patient's blood return, connection is firmly secured. . . Minimum Patient Weight . . . . . . . . For installation information, see the Prismaflex Service Manual. Consult the. . . . . Misinterpretation of ECG readings due to artefacts may, Carefully observe the Prismaflex treatment system, including the disposable, Monitor patient blood chemistry to ensure electrolyte balance and, Monitor patient temperature to avoid hypo- or hyperthermia. . . . . . Certification Marks . Prismaflex user manual - Free ebook download as PDF File (.pdf), Text File (.txt) or read book online for free. If Service mode. . . . . . . Do not use cellular phones or other radiofrequency emitting equipment within, a short distance from the Prismaflex control unit since disturbance may, occur. . . NEW PATIENT or CHANGE BAG. It, is the responsibility of the physician to verify all data before prescribing any. . . . . . The overall fluid balance must. . . . Follow the, instructions in section “Leakage in pressure pods or blood reaching fluid barrier”, Always connect the return line directly to the blood access device. . . . . . . Stand-alone Fluid Barrier . Low and High Flow Sets . . . . . . . . . . Rx Only. Depending on the, therapy in use, these processes can include fluid removal and/or solute clearance. . . originating cause may result in patient injury or death. . For technical assistance, contact your local Gambro representative. . . . Even if a remote alarm is used, the. . Baxter - Gambro Prismaflex System Flexibility that meets the strict demands of multiple blood purification therapies. . . . . . . . . . Leakage can cause blood loss or air embolism. . . . Refer to the Prismaflex disposable set Instructions for Use and the solution/fluid. . . . . . Do not use the Prismaflex control unit after blood leakage from a pod diaphragm, or after blood having passed the fluid barrier at the distal end of the monitor, line. . . . Box 10101, Magistratsvägen 16, SE-220 10 Lund, Sweden, Tel: +46-46-16 90 00, Fax: +46-46-16 96 96. . . Operator’s Manual . . . . The Prismaflex control unit operates from an electrical power source. . . . . If found, refer to the manual. . . . Front Panel Components . . . . . . . Square sign; placed as colored symbol on dialysate scale and in the graphical user, interface in screens related to dialysate. . . . . . Hazardous Substances . . . . . View online or free download from eBooks-go.com The Prismaflex System - Gambro The Prismaflex System. Prismaflex International se ha convertido en uno de los líderes de la fabricación industrial de paneles publicitarios y de la impresión digital de gran formato, ya que la empresa siempre ha sabido movilizarse para anticipar las expectativas de sus clientes. Para os dispositivos aqui mencionados, consulte o Manual de Utilizador adequado. . . O Sistema PRISMAFLEX destina-se a: Terapias contínuas – CVVHDF, CVVHD, CVVH, SCUF Terapias com plasma – TPE. . . . . . . . . . . Chapter 2: “Description of the Prismaflex® System”. . . . . . . . . Installation, Service and Transport . Always check local regulations for correct environmental, The table below describes where the batteries are located, the type of battery, and. . Therapies . . . . . . . . Note: Deviation in the classification of a warning and a caution between the manual. complies with the Type B applied part classification per IEC 60601-1 standard. . . . . . . . . . operator works within one meter from the front of the Prismaflex control unit. prismaflex CRRT machine version 6.xx user manual, American Sniper: The Autobiography of the Most Lethal Sniper in U.s. Military History, Rich Dad's Cashflow Quadrant: Guide to Financial Freedom, Secrets of the Millionaire Mind: Mastering the Inner Game of Wealth, The Life-Changing Magic of Tidying Up: The Japanese Art of Decluttering and Organizing, Braiding Sweetgrass: Indigenous Wisdom, Scientific Knowledge and the Teachings of Plants, Unfu*k Yourself: Get out of your head and into your life, The New Jim Crow: Mass Incarceration in the Age of Colorblindness, How to Destroy America in Three Easy Steps, 75% found this document useful, Mark this document as useful, 25% found this document not useful, Mark this document as not useful. . . . . . . . . . 0086) has approved the Quality Management System. . . . . . . manual, it is written in capital italic letters, e.g. ensure that all of the scales are firmly closed. . . . . . . . . . . . Effluent Bag . . . . If clotting is suspected, do not return the, The Prismaflex control unit is intended to be used on patients weighing 8 kg or, more. . . . . . Prior to using the Prismaflex control unit, let the unit rest at ambient operating, The Prismaflex control unit shipping carton, foam packing, and other packaging material. . . . . . . . . . . . . . . . . . . . . . . Contact your local representative for additional information. Solo con prescripción médica. . . The year of manufacture may be included in the symbol expressed, – since the equipment contains dangerous substances, it must be recycled rather. . . . . . . Prismaflex disposable set and solutions, and the online instructions. O sistema PRISMAFLEX só deve ser usado em pacientes com peso corporal superior a 20 kg (44 lb). . Controls the patient fluid removal or plasma loss, according to the therapy in use. Prismaflex® Control Unit . Cautions . Whenever a screen, is referred to in this manual, it is identified by its title, e.g. • CVVHDF: Continuous veno-venous hemodiafiltration ... • Eliminates the need for manual dose programming of ancillary pumps outside the CRRT system CRRT requires carefully balanced anticoagulation, which is Device meets the “drip proof” classification requirements. . . . If applicable, the following symbols appear on or near the serial number label or. . . . . . . . . . . . . . . The THERAPY INFO softkey provides information on the therapy possibilities such as SCUF, CVVH, CVVHD, or CVVHDF. . . . . . For more information, see chapter 13: Equipment applied part is Type BF, defibrillation - proof per IEC 60601-1. Ensure, that the patient's blood access and return connections are firmly secured; pay. . . . . . . . . . . . . . Disposable Set Components . . procedures for potentially contaminated material. . . . Procedures using the Prismaflex system must be performed under the, Service and repairs are only allowed to be performed by an authorized service, Ensure that scales and pressure sensors of the Prismaflex control unit are, accurately calibrated. . . . . . Before using a solution/fluid, make sure it is free of precipitates, and other particulate matter. . . . . Once the training material is read through, and understood, the operator is approved to operate the Prismaflex control unit. 5. . . . . Page 20: Operational Data . . . . . . . . . . . . . . . . . . . . . for use of the set with the Prismaflex system. . . ensure that the installation test has been successfully performed. . . . . two people to lift it out of the shipping carton. Lock brakes on the wheels to limit movement of the control unit that might pull. . . This term refers to Gambro trained and certified service technicians. . . Gambro accepts responsibility for the safety, reliability, and performance of this, If any modifications to the equipment have been authorized in writing by Gambro and. . . . . . . anesthetic mixture with air, oxygen, or nitrous oxide. . . Octagon sign; placed as colored symbol on replacement scale and in the graphical, user interface in screens related to replacement. . . . . . . . . . . . . . . . prevent dispersion of potential pollutants into the environment. . 2009;28(2):135-43. . . . . Equipment applied part is Type CF, defibrillation-proof per IEC 60601-1. . . . . . Disposable Accessories . . . . . . . . . . . . . . . . . . . Labelling also indicates potential presence of. . . . . . . . . . . . . . . Library of the latest service related documents. . . . Electrical Requirements. . . . . General Warnings and Cautions . . . . . . . . . Before connecting the blood return line to the patient, make sure the blood line. For the devices mentioned herein, please refer to the appropriate Operator's Manual. . . . . Place the control unit into quarantine to avoid risk of infection and have it. Always identify and solve the originating cause of alarms before pressing, Do not hang anything except fluid bags on the scales on the of the, Prismaflex control unit. . . . . local electrical codes and requirements including, if applicable, IEC requirements. Somente sob prescrição. . . treatment according to therapy configuration. . . . Communication . If the equipment is used in accordance with this manual. . . . . Refer to the Prismaflex Operator’s Manual. . . Continuous Renal Replacement Therapies (CRRT). . shape in the plastic cover indicating the dialysate pump. X: Indicates that the concentration of the hazardous substance in at least one homogeneous. For the devices mentioned herein, please refer to the appropriate Operator's Manual. For. . . . . . . . . Symbols . . . . . . . . . . . . . . . . . Manufacturer. . . . . . . Prismaflex- Unidad de comunicación • Instrucciones paso a pasoque el operador sigue para configurar, administrar y finalizar los tratamientos. gambro dialysis machine manual Stanford Prismaflex trainingPW.ppt [Read-Only] in boluses (See Prismaflex Operator Manual for specification) Syringe pump control panel UP and DOWN buttons on the machine allow you to install or remove a syringe Bar code reader Each type of Prismaflex Set has its own range of alarm limits and flow . . . Enter Flow Settings screen or, Whenever a Softkey on the Prismaflex screen is referred to in this manual, it is written in. . . . . . . . Prismaflex® Graphical User Interface 3. . . . . . . . . Bar code reader Each type of Prismaflex Set has its own range of alarm limits and flow rate possibilities. . . . . . . Remove the calibration weights, if equipped in the stand of the Prismaflex control. . . . . . . . Do not connect a patient to the Prismaflex system during the installation test. The. . result in hemolysis, including kinks in a blood line or cannula that are too thin. . . Contact your local. . . . Instructions, Operating screens (step-by-step instructions that the operator follows each time in. . . . If a large amount of air enters, the set must be replaced. Upper and lower limits are expressed with numeric values, Circle sign; placed as colored symbol on effluent scale and in the graphical user, interface in screens related to effluent. . . . . . . . . . . . . Triangle sign; placed as colored symbol on PBP scale and in the graphical user, interface in screens related to PBP. . . . . . . . . . . . . . For patients with a, high ratio of extracorporeal volume to patient blood volume, the physician may, decide to prime the extracorporeal circuit with adequate volume substitution, Do not allow air to enter the blood compartment of the disposable set after.

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