biodex PULMONEX II Operation Manual
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biodex PULMONEX II Operation Manual

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PULMONEX II DOUBLE-TRAP
XENON SYSTEM
OPERATION MANUAL
132-503
B
IODEX
Biodex Medical Systems, Inc.
20 Ramsey Road, Shirley, New Y ork, 11967-4704, Tel: 800-224-6339 (Int'l 631-924-9000), Fax: 631-924-9241, Email: info@biodex.com, www.biodex.com
FN: 07-151 Rev E 7/15

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  • Page 1 PULMONEX II DOUBLE-TRAP XENON SYSTEM OPERATION MANUAL 132-503 IODEX Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New Y ork, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: info@biodex.com, www.biodex.com FN: 07-151 Rev E 7/15...
  • Page 2 Pulmonex II Xenon System This manual covers operation procedures for the following product: 132-503 Xenon System, Pulmonex II, Double-trap, 115 VaC PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 3: Table Of Contents

    Hose Set Up ..........................8 Manual Trap Test (Without Monitor) ..................10 Chapter 5: TROUBLESHOOTING ....................11 APPENDIX A - SPECIFICATIONS ....................14 APPENDIX B - CONFORMANCE TO STANDARDS ............... 15 APPENDIX C - SCHEMATICS ..................... 19 PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 4: Definition Of Symbols

    “Off” Power Earth (ground) Alternating Current Fuse USB Connector/Cable Waste in Electrical Equipment Date of Manufacture Type B Applied Part CE Mark CE Mark for products with EC Certificate Certified for Safety by ETL Intertek PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 5: Before Proceeding

    CAUTION: Some patients are sensitive to Oxygen. Consult a physician before using Oxygen. If the physician prefers, substitute room air for Oxygen. ATTENTION: Certains patients réagissent à l’oxygène. Se référer à un médecin avant d’utiliser de l’oxygène. Utiliser l’air ambiant quand indiqué. PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 6 5th percentile female, 20-65 years of age to 95th percentile male, 20-65 years of age Product Certifications and Classifications The Pulmonex II Xenon System has received the following certifications, and falls within the following classifications: 60601-1 to CAN/CSA C22.2 No. 601-1-M90, EN 60601-1.

  • Page 7: Important Safety Information

    This product should be used only as specified in the operation manual. The Biodex Pulmonex Xenon System is designed for use in a patient environment. Biodex Pulmonex Xenon System est conçu à l'utilisation dans un environnement patient.
  • Page 8 ATTENTION: Ce produit est destiné pour rester dans un endroit pendant l'opération. Le produit est fourni avec les roues pour le réendroit. Une fois placé, retenez les roulettes se bloquant pour garantir la stabilité. VIII PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 9: Warranty

    CONSEQUENTIAL OR INDIRECT DAMAGES INCLUDING LOSS OF USE, SALES, PROFITS OR BUSINESS INTERRUPTION. B. This warranty does not apply if the product, as determined by BIODEX MEDICAL SYSTEMS, INC., is defective due to abuse, misuse, modification or service performed by other than a BIODEX MEDICAL SYSTEMS, INC.

  • Page 10: Service Support

    Check to see that the problem occurs more than once. Refer to the instruction manual and operations procedure. If you still think you have a service problem, call BIODEX MEDICAL SYSTEMS, INC., Service Department at (800) 224-6339 and select radiology product service as prompted.

  • Page 11: Chapter 1: Introduction

    1. Introduction Intended Use The Pulmonex II Xenon System was designed for the safe delivery and trapping of Xe-133 to a patient. It is shielded for patient and operator safety. The design features are intended to provide maximum, reliable test results.

  • Page 12: Chapter 2: Setup Procedure

    Open the top door. The Pulmonex II can use either of two different style Drierite cartridges. A refillable plastic cartridge is shipped with your unit and is located on the right side of the compartment.
  • Page 13 Bedside. As a safety precaution you can connect a hose from your room vent to the exhaust port located just below the overhang on the patient side of the Pulmonex II. Do not leave this connected all the time. It will shorten the life of the traps.

  • Page 14: Chapter 3: Performing A Study

    NOTE: even after the Power Switch is set to the ON position, power will not be evident until the Timer has been turned ON. Place the Pulmonex II as close to the patient as possible and set the pointer on the master control handle to “Start” position #1.
  • Page 15 NOTE: If the motors are running too fast it may be difficult for the patient to breathe in. When the washout is complete, remove the patient from the system. Allow the system to run for a few more seconds or until both bags are empty. PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 16: Chapter 4: Maintenance

    4 to insure the integrity of the breathing bags and system. NOTE: Biodex recommends that the (two) breathing bags (130-610) be changed every three years. Breathing bags should be inspected periodically for signs of deterioration such as swelling, tackiness, or cracking.

  • Page 17: Maximizing Charcoal Trap Efficiency

    Monitor the trap air flow blower motor. It should be set at a maximum of 50-60 and only in- creased when a patient needs assistance during washout. Change the moisture absorber after every study! NOTE: Do not leave the Pulmonex II in position #3 when not in use. Charcoal Trap Replacement Procedure To Replace the Charcoal Trap: Remove the right side trap.

  • Page 18: Leak Test

    Leak Test The following procedures are a simple yet effective means of testing the delivery and breathing portion of the Pulmonex II system for leaks. Tests A and C should be done with the Pulmonex II turned OFF. Test A (Be sure Pulmonex is turned OFF.)

  • Page 19: Hose Set Up

    Hans Rudolph Valve - attach so that air flows in on the left and out on the right; green dot sticker faces up. Bacteria filter Face mask or mouthpiece placed directly onto the filter - you may add an injection adapter between the filter and mask or mouthpiece. Figure 11. Pulmonex Tubing Setup PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 20: Manual Trap Test (Without Monitor)

    Exhaust Concentration = r (2 x 10 µCi/cm = (2.5 x 10 ) (4 x 10 µCi/cm ) = 1 x 10 µCi/cm * MPC Xe-133 controlled areas should not exceed 1 x 10 µCi/cm PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 21: Chapter 5: Troubleshooting

    Biodex Medical Systems System leaks See leak test Patient hose set not set up properly Correct Hans Rudolf Valve and hoses for proper directional flow Is camera set for xenon? Set camera for xenon PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 22 Blowers not running Check power or replace blower Breathing bags crimped Uncrimp bags Charcoal has settled in lead cartridge Remove cartridge, turn upside down and shake gently, then replace cartridge PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 23 Charcoal has settled Shake cartridge gently to loosen charcoal OXYGEN HOSE COMES OFF Input pressure too high Adjust input pressure to not greater than 8 psi No clamp for hose at input fitting Install clamp PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 24: Appendix A - Specifications

    Certifications: ETL and cETL listed to UL 60601-1 to CAN/CSA C22.2 No. 601-1- M90, EN 60601-1 Warranty: one year parts and labor Authorized European Community Representative: Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 25: Appendix B - Conformance To Standards

    The list in Table 1.2 includes all accessory cables supplied with the Pulmonex for which the manufacturer of this equipment claims compliance to EN 60601-1-2 when used with the Pulmonex. Cable description Part no. Cable length Power Cable Biodex # 945-110-e730 10ft Table 1.2. Pulmonex cable PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 26 RF emissions Class B The Pulmonex is suitable for use in all establishments other EN 55011 than domestic and those directly connected to the public low-voltage power supply network supplying buildings used for domestic purposes. PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 27 Pulmonex should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pulmonex . Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m. PULMONEX II DOUBLE TRAP XENON SYSTEM...
  • Page 28 Do not expose the equipment to a temperature change of more than 5° F (3° C) per hour. limits of low and high operating temperature ranges are 59° to 86° F (15° C to 30° C). PULMONEX II DOUBLE TRAP XENON SYSTEM...

  • Page 29: Appendix C - Schematics

    C. Appendix C - Schematics PULMONEX II DOUBLE TRAP XENON SYSTEM...
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  • Page 36 IODEX MADE IN Biodex Medical Systems, Inc. 20 Ramsey Road, Shirley, New Y ork, 11967-4704, Tel: 800-224-6339 (Int’l 631-924-9000), Fax: 631-924-9241, Email: info@biodex.com, www.biodex.com U . S . A .  ...

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