2008T Calibration Procedures - Fresenius Medical Care

1 2008T HEMODIALYSIS SYSTEM Calibration Procedures Part Number 508032 Rev. H 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 REGIONAL EQUIPMENT SPECIALIST: _____ Page i 2008T Calibration Procedures P/N 508032 Rev. H 2008T HEMODIALYSIS SYSTEM Calibration Procedures Part Number 508032 Rev. H Copyright 2008 2019 Fresenius Medical Care, All Rights Reserved Page ii 2008T Calibration Procedures P/N 508032 Rev. H 2008T Calibration 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, 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.

3 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). 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.

4 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 iii 2008T Calibration Procedures P/N 508032 Rev. H Calibration Procedures TABLE OF CONTENTS INTRODUCTION .. 1 TEST EQUIPMENT AND SUPPLIES NEEDED .. 2 OPERATING MODES .. 3 FRONT PANEL CONTROLS .. 6 MEASURING FLUID VOLUMES .. 8 CALIBRATE IF REPLACED .. 9 SERVICE MODE CALIBRATIONS .. 10 TOUCH SCREEN Calibration .. 10 HYDRAULIC Calibration Procedures .. 11 DEAERATION AND LOADING PRESSURE Calibration .. 12 FLOW PRESSURE 17 BALANCE CHAMBER VOLUME Calibration .. 18 ACID (CONCENTRATE) PUMP VOLUME Calibration .. 20 BICARBONATE PUMP VOLUME Calibration .. 22 UF PUMP VOLUME Calibration .

5 24 SENSOR Calibration Procedures .. 27 ARTERIAL PRESSURE Calibration .. 28 VENOUS PRESSURE Calibration .. 34 DIALYSATE PRESSURE Calibration .. 37 TEMPERATURE SENSOR Calibration .. 39 POST TEMPERATURE SENSOR Calibration .. 41 TEMPERATURE CONTROL Calibration .. 43 TEMPERATURE CONTROL Calibration (METHOD 1) .. 44 TEMPERATURE CONTROL Calibration (METHOD 2) .. 47 BLOOD LEAK Calibration .. 50 CONDUCTIVITY CELLS Calibration .. 52 DIALYSATE CELLS Calibration .. 53 BICARBONATE CONDUCTIVITY CELL Calibration .. 55 CONDUCTIVITY CONFIRMATION CELL Calibration .. 56 MAINTENANCE Calibration Procedures .. 58 SET TIME & DATE .. 59 VOLTAGE DETECTION Calibration .. 60 ARTERIAL PUMP RATE .. 63 VENOUS PUMP RATE .. 64 Calibration Procedures NOT PERFORMED IN SERVICE MODE.

6 65 INLET WATER PRESSURE REGULATOR Calibration .. 65 LEVEL DETECTOR Calibration .. 67 BLOOD PUMP Calibration .. 69 Page iv 2008T Calibration Procedures P/N 508032 Rev. H 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! 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.

7 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! 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.

8 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! 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.

9 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 Functional board software version or later. Page 1 2008T Calibration Procedures P/N 508032 Rev. H INTRODUCTION Calibration involves doing two things. One is making mechanical adjustments, both to the hydraulics and to the electronics. The other part of Calibration is storing data in the electronic memory in the machine. The machine uses an EEPROM, which stores Calibration data until it is purposely erased and replaced with new data.

10 To store new data in the EEPROM, the machine is operated in Service Mode as described in Section Service Mode also shows important data that is needed to make some of the mechanical adjustments. Perform the Calibration Procedures only when needed following repairs, or if the machine fails the performance tests included in the preventive Maintenance Procedures . Do not re-calibrate the machine routinely to verify normal operation. Instead, use the performance tests included in the preventive Maintenance Procedures to ensure the machine is working properly. If the machine behaves erratically during Calibration , perform the preventive Maintenance Procedures . Clogged filters, leaky O-rings and similar items routinely corrected during preventive Maintenance are a common cause of intermittent problems.