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VELA ventilator Med One Group
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ii Service Manual VELA Ventilator Systems, 2008 Cardinal Health. All rights reserved No part of this document may be reproduced stored or transmitted in any form or by any means. without the written permission of Cardinal Health except as specifically permitted under the copyright laws of the United. States of America, VELA is a registered trademark of the Cardinal Health group of companies Other brands and their products are. trademarks of their respective holders and should be noted as such. USA Authorized European Representative, Cardinal Health Cardinal Health Germany 234 GmbH. Respiratory Technologies Leibnizstrasse 7, 1100 Bird Center Drive 97204 Hoechberg. Palm Springs California 92262 8099 Germany, Telephone 800 231 2466 Telephone 49 931 4972 0.
1 714 283 2228 Fax 49 931 4972 423, Fax 1 714 283 8493. cardinalhealth com, Literature number L2859 101 Revision B. L2859 101 Rev B, VELA Ventilator Systems Service Manual iii. Revision History, Date Revision Pages Changes, September 2006 A NA NA. May 2008 B 2 10 20 23 25 27 37 Updated for VELA Coldfire 2. 40 42 44 46 57 60 63 66, Throughout the document Changed VIASYS Healthcare to.
Cardinal Health and Cardinal, Health Respiratory Technologies. Changed Vela to VELA, viii Updated Intended Use Notice. and IEC Classification to remove, references to infant ventilation. 4 Remove optional from the first, sentence of Oxygen Blending. 65 Removed the Caution, statements regarding non, operational ports.
L2859 101 Rev B, iv Service Manual VELA Ventilator Systems. THE VELA ventilator systems are warranted to be free from defects in material and workmanship and to meet the. published specifications for two 2 years or 8 000 hours whichever occurs first The turbine only is warranted to be free. from defects in material or workmanship for five 5 years or 40 000 hours whichever occurs first. The liability of Cardinal Health referred to as the Company under this warranty is limited to replacing repairing or issuing. credit at the discretion of the Company for parts that become defective or fail to meet published specifications during the. warranty period the Company will not be liable under this warranty unless A the Company is promptly notified in writing. by Buyer upon discovery of defects or failure to meet published specifications B the defective unit or part is returned to. the Company transportation charges prepaid by Buyer C the defective unit or part is received by the Company for. adjustment no later than four weeks following the last day of the warranty period and D the Company s examination of. such unit or part shall disclose to its satisfaction that such defects or failures have not been caused by misuse neglect. improper installation unauthorized repair alteration or accident. Any authorization of the Company for repair or alteration by the Buyer must be in writing to prevent voiding the warranty. In no event shall the Company be liable to the Buyer for loss of profits loss of use consequential damage or damages of. any kind based upon a claim for breach of warranty other than the purchase price of any defective product covered. The Company warranties as herein and above set forth shall not be enlarged diminished or affected by and no obligation. or liability shall arise or grow out of the rendering of technical advice or service by the Company or its agents in. connection with the Buyer s order of the products furnished hereunder. Limitation of Liabilities, This warranty does not cover normal maintenance such as cleaning adjustment or lubrication and updating of equipment. parts This warranty shall be void and shall not apply if the equipment is used with accessories or parts not manufactured. by the Company or authorized for use in writing by the Company or if the equipment is not maintained in accordance with. the prescribed schedule of maintenance, The warranty stated above shall extend for a period of TWO 2 years from date of shipment or 8 000 hours of use. whichever occurs first with the following exceptions. 1 Components for monitoring of physical variables such as temperature pressure or flow are warranted for ninety. 90 days from date of receipt, 2 Elastomeric components and other parts or components subject to deterioration over which the Company has no. control are warranted for sixty 60 days from date of receipt. 3 Internal batteries are warranted for ninety 90 days from the date of receipt. 4 The turbine only is warranted to be free from defects in material or workmanship for five 5 years or 40 000 hours. whichever occurs first, The foregoing is in lieu of any warranty expressed or implied including without limitation any warranty of.
merchantability except as to title and can be amended only in writing by a duly authorized representative of the. L2859 101 Rev B, VELA Ventilator Systems Service Manual v. Revision History iii, Warranty iv, Notices vii, EMC Notice vii. MRI Notice vii, Intended Use Notice vii, Regulatory Notice vii. IEC Classification vii, Declaration of Conformity Notice viii. Safety Information ix, Warnings ix, Cautions x, Equipment Symbols xi.
Chapter 1 Introduction 1, General Instructions 1, Recommended Tools Equipment 1. Recommended Maintenance Schedules 2, Chapter 2 Theory of Operation 3. General Device Description 3, Pneumatic System Overview 3. Oxygen Blending System 4, Electronic Overview 4, Chapter 3 Disassembly and Assembly 9. General Instructions and Warnings 9, Required Tools 9.
Disassembly and Reassembly Procedures 10, Right Panel Containing the Power PCB P N 16351A 12. Front Panel P N 16345A S N AHT07499 Below 13, Main PCB P N 52300A S N AHT07499 Below 15. Main PCB P N 52850A S N AHT07500 Above 15, Flow Sensor Receptacle assembly P N 16106 16. Exhalation Valve Assembly P N 16417A 16, Blender Assembly P N 16358A 17. Turbine and Muffler Assembly P N 16350 18, Turbine reorder P N 16349A 18.
Inlet Filter Screen P N 21575 18, Oxygen Sensor P N 16101 19. Rear Panel P N 16346 S N AHT07499 Below 19, Rear Panel P N 16559 S N AHT07500 Above 19. Fan and Filter Assembly P N 16256 20, Manifold Base Assembly P N 16348 21. L2859 101 Rev B, vi Service Manual VELA Ventilator Systems. Chapter 4 Software Download Procedure 23, Software Download 23.
Ventilator Upgrade Procedure 26, Chapter 5 One Year P M Procedure 27. Contents of PM kit P N 11416 27, General Instructions and Warnings 27. Required Tools 28, Procedure 29, Chapter 6 Calibration Procedure 37. Calibration 37, Calibration and Test Kit 38, Chapter 7 Operational Verification Procedure 43. 1 0 UVT Functions Screen 43, 2 0 Performance Test 44.
Operational Verification Procedure Checklist 49, Chapter 8 Troubleshooting Codes Messages 51. UVT Test Troubleshooting 51, Delivered Volumes Test Troubleshooting 52. Monitored Volume Test Troubleshooting 52, FiO2 Performance Test Troubleshooting 53. Battery Performance Test Troubleshooting 53, Chapter 9 Frequently Asked Questions 55. Chapter 10 Maintenance and Cleaning 59, Cleaning Sterilization 59.
Cleaning 59, Sterilization 60, Other Accessories 61. Recommended Periodic Maintenance 61, Chapter 11 Specifications 63. Oxygen Supply 63, Electrical Supply 63, Data Input Output 64. Atmospheric Environmental Specifications 66, Physical Dimensions 66. Appendix A Contact and Ordering Information 67, Appendix B Reordering Instructions 69.
Appendix C Schematics Diagrams 71, L2859 101 Rev B. VELA Ventilator Systems Service Manual vii, EMC Notice. This equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with the. instructions in this manual electromagnetic interference may result The equipment has been tested and found to comply. with the limits set forth in EN60601 1 2 for Medical Products These limits provide reasonable protection against. electromagnetic interference when operated in the intended use environments described in this manual. The ventilator has been tested to conform to the following specifications. MIL STD 461D 1993 MIL STD 462D 1993 EN55011 1991 IEC 1000 4 2 1994 IEC 1000 4 3 1994 IEC 1000 4 4 1994. IEC 1000 4 5 1994 QUASI STATIC 1993, This ventilator is also designed and manufactured to comply with the safety requirements of IEC 601 1 IEC 601 2 12. CAN CSA C22 2 No 601 1 M90 and UL 2601 1, MRI Notice. This equipment contains electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the ventilator in a MRI environment or in the vicinity of high frequency surgical diathermy equipment. defibrillators or short wave therapy equipment Electromagnetic interference could disrupt the operation of the ventilator. Intended Use Notice, The Vela Ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who.
require mechanical ventilation The ventilator is a restricted medical device intended for use by qualified trained. personnel under the direction of a physician Specifically the ventilator is applicable for adult and pediatric patients. weighing at least 10 kg 22 lbs who require the following general types of ventilation support as prescribed by an. attending physician, Positive pressure ventilation. Assist Control SIMV or CPAP modes of ventilation, The ventilator is suitable for use in institutional and transport settings It is not intended for use as an emergency medical. transport ventilator or for homecare applications, Regulatory Notice. Federal law restricts the sale of this device except by or on order of a physician. IEC Classification, Type of Equipment Medical Equipment Class 1 type B. Adult Pediatric Lung Ventilator, L2859 101 Rev B, viii Service Manual VELA Ventilator Systems.
Declaration of Conformity Notice, This medical equipment complies with the Medical Device Directive. 93 42 EEC and the following Technical Standards to which Conformity is. EN60601 1 2, ISO 13485 2003, EU Notified Body, BSI Reg No 0086. Trade names, If you have a question regarding the Declaration of Conformity for this product please contact Cardinal Health. Respiratory Technologies at the number given in Appendix A. L2859 101 Rev B, VELA Ventilator Systems Service Manual ix. Safety Information, Please review the following safety information prior to operating the ventilator Attempting to operate the ventilator.
without fully understanding its features and functions may result in unsafe operating conditions. Warnings and Cautions which are general to the use of the ventilator under all circumstances are included in this section. Some Warnings and Cautions are also inserted within the manual where they are most meaningful. Notes are also located throughout the manual to provide additional information related to specific features. If you have a question regarding the installation set up operation or maintenance of the ventilator contact VASYS. Healthcare Customer Care as shown in Appendix A Contact Ordering Information. WARNINGS identify conditions or practices that could result in serious adverse reactions or potential safety hazards. CAUTIONS identify conditions or practices that could result in damage to the ventilator or other equipment. NOTES identify supplemental information to help you better understand how the ventilator works. Warnings and Cautions appear throughout this manual where they are relevant The Warnings and Cautions listed here. apply generally any time you operate the ventilator. The VELA Ventilator is intended for use by a trained practitioner under the direction of a qualified physician. When the ventilator is connected to a patient a trained health care professional should be in attendance at all. times to react to an alarm or other indications of a problem. Alarm loudness must be set above ambient sound in order to be heard. Always have an alternate means of ventilation available whenever the ventilator is in use. The operator should not touch the electrical connectors of the ventilator or accessories and the patient. simultaneously, Due to possible explosion hazard the ventilator should not be used in the presence of flammable anesthetics. An audible alarm indicates an anomalous condition and should never go unheeded. Anti static or electrically conductive hoses or tubing should not be used within the patient circuit. If a mechanical or electrical problem is recognized while running the Operational Verification Tests or while. operating the ventilator the ventilator must be removed from use and referred to qualified personnel for. servicing Using an inoperative ventilator may result in patient injury. When a low gas supply alarm occurs the oxygen concentration delivered to the patient will differ from that set on. the O2 control setting, A source gas failure will change the FIO2 and may result in patient injury. The functioning of this equipment may be adversely affected by the operation of other equipment nearby such. as high frequency surgical diathermy equipment defibrillators short wave therapy equipment walkie talkies. or cellular phones, Do not block or restrict the Oxygen bleed port located on the instrument back panel Equipment malfunction. may result, L2859 101 Rev B, x Service Manual VELA Ventilator Systems. Electric shock hazard Do not remove any of the ventilator covers or panels Refer all servicing to an authorized. VELA Ventilator Systems Service Manual iii L2859 101 Rev B Revision History Date Revision Pages Changes September 2006 A NA NA May 2008 B 2 10 20 23 25 27 37 40 42 44 46 57 60 63 66 69 92 Updated for VELA Coldfire 2 Throughout the document Changed VIASYS Healthcare to Cardinal Health and Cardinal Health Respiratory Technologies Changed Vela to VELA viii Updated

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