2008T Preventive Maintenance Procedures

1 2008T HEMODIALYSIS SYSTEM Preventive Maintenance Procedures Part Number 508033 Rev. O Page ii 2008T Preventive Maintenance Procedures P/N 508033 Rev. O FRESENIUS MEDICAL CARE NORTH AMERICA 800-227-2572 Fresenius Medical Care North America 920 Winter St. Waltham, MA 02451 Manufactured by: Fresenius USA, Inc. 4040 Nelson Avenue Concord, CA 94520 Page iii 2008T Preventive Maintenance Procedures P/N 508033 Rev. O 2008T HEMODIALYSIS SYSTEM Preventive Maintenance Procedures Part Number 508033 Rev. O INCLUDING Preventive Maintenance CHECKLISTS SIX (6) MONTH AND ANNUAL/4000 HOUR Copyright 2008 2020 Fresenius Medical Care. All Rights Reserved. Page iv 2008T Preventive Maintenance Procedures P/N 508033 Rev. O 2008T Preventive Maintenance Procedures This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates ( Fresenius Medical Care ). The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius Medical Care.

2 Fresenius Medical Care, the triangle logo, 2008, BlueStar, bibag and DIASAFE are trademarks of Fresenius Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the property of their respective owners. Caution: US Federal law restricts this device to sale only by or on the order of a physician. Frequency, duration, and parameters of treatment are to be determined by the prescribing physician. Installation, Maintenance , calibration and other technical information may be found in the 2008T Technician s Manual, P/N 490130. Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare parts manual for the model 2008T and other information may be found on our web site at Indications for Use: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing 20kg and 40 kg).

3 This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing 40 kg. The 2008T Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid. Conventions Symbol Description Warning! A warning is a statement that identifies conditions or actions that could result in personal injury or loss of life. Warnings found in this manual outside of this section are designated with the warning symbol. Shock Hazard: A shock hazard warning refers to a risk of a possibly severe electrical shock due to improper use or handling of the equipment. Caution: A caution is a statement that identifies conditions or actions that could result in damage to the machine. Note: Notes are advisory comments or recommendations regarding practices or Procedures . Page v 2008T Preventive Maintenance Procedures P/N 508033 Rev.

4 O Preventive Maintenance Procedures TABLE OF CONTENTS INTRODUCTION .. 1 SUPPLIES NEEDED .. 2 TEST EQUIPMENT NEEDED .. 3 OPERATING MODES .. 4 FRONT PANEL CONTROLS .. 5 MEASURING FLUID VOLUMES .. 7 SIX (6) MONTH Preventive Maintenance .. 8 FILTERS .. 10 PRE-UF PUMP FILTER .. 10 UF PUMP CHECK 11 HIGH VOLTAGE AC CONNECTIONS .. 11 UF PUMP .. 12 CONDUCTIVITY .. 12 TEMPERATURE .. 13 ALARM OPERATION AND PRESSURE HOLDING TESTS .. 14 VERIFY PH .. 16 POWER FAILURE ALARM .. 16 FINAL CHECKS .. 17 ANNUAL (4000 HOUR) Preventive Maintenance .. 18 FILTERS AND 18 PRE-UF PUMP FILTER .. 19 UF PUMP CHECK 19 DIAPHRAGM PUMPS .. 19 HEATER ELEMENT .. 20 HIGH VOLTAGE AC CONNECTIONS .. 20 DEAERATION MOTOR BRUSHES .. 21 INLET WATER PRESSURE REGULATOR .. 22 ONLINE CLEARANCE TEST (IF APPLICABLE) .. 23 DEAERATION AND LOADING 26 FLOW RELIEF 27 CONCENTRATE (ACID) AND BICARBONATE PUMPS .. 28 UF PUMP .. 28 CONDUCTIVITY .. 28 TEMPERATURE.

5 28 VOLT HI LO DETECT .. 28 BLOOD LEAK AND DIMNESS .. 29 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE .. 30 DIALYSATE FLOW .. 33 HEPARIN PUMP .. 33 BLOOD PUMP .. 36 LEVEL DETECTOR .. 38 ALARM OPERATION AND PRESSURE HOLDING TESTS .. 40 VERIFY PH .. 40 RINSE CHECKS .. 41 POWER FAILURE ALARM AND BATTERY REPLACEMENT .. 42 BLOOD PRESSURE MODULE .. 43 INSPECT DIALYSATE LINES .. 47 FINAL CHECKS .. 47 REBUILDING THE DIAPHRAGM PUMPS .. 48 REBUILDING THE ULTRAFILTRATION PUMP .. 48 REBUILDING THE CONCENTRATE (ACID) AND BICARBONATE PUMPS .. 51 TESTING CONCENTRATE (ACID) AND BICARBONATE PUMPS .. 53 Preventive Maintenance CHECKLIST SIX (6) MONTH .. 56 Preventive Maintenance CHECKLIST ANNUAL/4000 HOUR .. 58 Page vi 2008T Preventive Maintenance Procedures P/N 508033 Rev. O General Warnings Refer to the General Warning section in the 2008T Hemodialysis Machine Operator s Manual (P/N 490122) for a complete listing of general warnings. Warning!

6 Never perform Maintenance when a patient is connected to the machine. If possible, remove the machine from the treatment area when it is being serviced. Label the machine to ensure it is not accidentally returned to clinical use before the service work is completed. Always fully test the machine when Maintenance is completed. Confirm dialysate conductivity and pH level before returning the machine to clinical use. Shock Hazard: Refer servicing to qualified personnel. The electrical source must be 120 volts, 60 Hz, single phase. The outlet must be a three-conductor type with a hospital-grade receptacle and a ground fault interrupter. Test the polarity and ground integrity before installation and ensure it is maintained thereafter. Failure to do so may result in electrical shock to the operator or patient Warning! Calibration Procedures must be performed using primary standards or by using standards that are regularly calibrated in a program traceable to the National Institute of Standards and Technology (National Bureau of Standards) Warning!

7 Calibrate the Level Detector module for the model of venous line being used. During calibration ensure the filter inside the drip chamber is below the sensor heads. Also verify that the venous clamp fully occludes the line when closed. Improper functioning of the level detector may be caused by a clot of blood. Warning! Failure to install, operate and maintain this equipment according to the manufacturer s instructions may cause injury or death to the patient or the operator. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. Substitution of a component different from that supplied may result in measurement errors. Warning! Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Warning!

8 Only Original Equipment Manufacturer (OEM) Fresenius Medical Care parts should be used in the repair or upgrade of the Fresenius Medical Care 2008T Hemodialysis System. Although, parts may look similar to parts in various vendor catalogs or brick and mortar stores the 2008T Hemodialysis System uses parts that have been specified and tested in accordance to ANSI/AAMI/ISO guidelines. The use of non-OEM parts will void your warranty and may cause patient harm. Note: This document is written for the 2008T Hemodialysis Systems using software versions or later. Page 1 2008T Preventive Maintenance Procedures P/N 508033 Rev. O INTRODUCTION Preventive Maintenance for the 2008T Hemodialysis System is simple and straightforward. Scheduled Maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows: Machines without Extended Life Pump Components3 Six (6) months Annually or after 4000 hours of operation Machines with Extended Life Pump Components3 Six (6) months Annually or after 4000 hours of operation Concentrate (acid), Bicarbonate & UF Pumps with extended life components3 are rebuilt every 2 years or after 8000 hours of operation.

9 2008T BlueStar Premium Machines 2008T BlueStar Premium machine are equipped with extended life components3 and can be identified by the 2008T BlueStar logo (shown below) on the keyboard. Six (6) months Annually or after 4000 hours of operation Concentrate (acid), Bicarbonate & UF Pumps with extended life components3 are rebuilt every 2 years or after 8000 hours of operation. The Maintenance Procedures have been devised to require a minimum of time while ensuring that the machine is maintained in optimum operating condition. Included in the Preventive Maintenance Procedures are tests to verify normal machine operation. Should the machine fail to pass any of these tests, repair or re-calibrate as needed, then repeat the tests until the specifications are met before returning the machine to service. Checklists are provided in the back of this manual to record the work done. Make copies of these checklists as needed. Your initials on the checklist certifies that each procedure has been completed and that the machine is performing according to the specifications given.

10 3 Refer to Sections and on how to recognize extended life pump components. Page 2 2008T Preventive Maintenance Procedures P/N 508033 Rev. O SUPPLIES NEEDED A number of small parts must be available to perform the Preventive Maintenance (PM). Kits are available that include the necessary parts needed, except for the 9-Volt battery that must be replaced annually. An NEDA 1604AC heavy-duty (alkaline type) battery is required. Machines without Extended Life Pump Components3 o 2008T Annual PM Kit (part number 191108) Machines with Extended Life Pump Components3 o 2008T BlueStar Premium One Year PM Kit (part number 191175) o 2008T BlueStar Premium Two Year PM Kit (part number 191174) 2008T BlueStar Premium1 Machines 2008T BlueStar Premium One Year PM Kit (part number 191175) 2008T BlueStar Premium Two Year PM Kit (part number 191174) Note: The 2008T BlueStar Premium Two Year PM Kit includes all of the items in the 2008T BlueStar Premium One Year PM Kit along with the necessary extended life components3 to rebuild the concentrate (acid), bicarbonate and UF pumps every 2 years or 8000 hours.