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Vitalograph asma-1 4000 Quick Start Manual

Vitalograph asma-1 4000 Quick Start Manual

For healthcare professionals. child.
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Guide for Healthcare
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Summary of Contents for Vitalograph asma-1 4000

  • Page 1 asma-1 Child Guide for Healthcare Professionals...
  • Page 2 Testing Subject Insert mouthpiece and switch on Blow 3 times = Bad blow View values for parameters FEV.₅, FEV.₇₅, FEV₁ and PEF...
  • Page 3 Best blow PEF +/- 5%; FEV₁ +/- 3% EN ISO 23747:2009 Specifies accuracy: ± 10% PEF Resistance to flow: < 0.35 kPa/L/s Vitalograph Childrens Respiratory Monitor V.₅, Accuracy: ± 5% PEF ± 3% FEV₁, .₅,.₇₅ Resistance to flow: < 0.15kPa/L/s...
  • Page 4 Review History Switch on Hold for 3 seconds Review history Return...
  • Page 5: Delete History

    Delete History Switch on Hold for 10 seconds Cleaning and Disinfecting: The outer surfaces should be cleaned every week, more often if necessary. The use of an ordinary alcohol wipe is recommended, with special attention to the mouthpiece area. www.vitalograph.co.uk...
  • Page 6: Regulatory Notices

    Regulatory Notices Warnings and Advisory Notices: Note: Please read all this information before using this Vitalograph device. A full set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk. • This Vitalograph device is intended to measure lung function, primarily for...
  • Page 7 • Before use, ensure that the batteries do not exceed their shelf life, as indicated on the batteries. • Store in a clean dry place. • Cleaning & disinfecting: The outer surfaces should be cleaned every week, more often if necessary. The use of an ordinary alcohol wipe is recommended, with special attention to the mouthpiece area.
  • Page 8: Warranty

    Community. Such marking is indicative that the Vitalograph device meets or exceeds the referenced technical standards. The Vitalograph device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any...
  • Page 9 The Vitalograph device is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
  • Page 10 Technical Specifications Material: PC/ABS Accuracy: Better than ± 3% (FEV₁ & FEV₆), ± 10% (PEF) Flow Impedance (as applicable): Better than 0.15kPa/L/s at 14L/s Measurement Range: PEF: 25 - 840 L/min BTPS : 0 - 9.99 L BTPS : 0 - 9.99 L BTPS 0.75 : 0 - 9.99 L BTPS Safety &...
  • Page 11 Recommended separation distances between portable and mobile RF communication equipment and the system The Vitalograph device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic...
  • Page 12 Note 1: at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: these guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 13: Declaration Of Conformity

    Declaration of Conformity Product: Vitalograph Model 4000 Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards: • European Medical Devices Directive {MDD} 93/42/EEC. This device, classified...
  • Page 14 • EN ISO 13485: 2003. Medical devices. Quality management systems. Requirements for regulatory purposes. Certifying Body {for 93/42/EEC and CMDR}: British Standards Institute {BSI}. Certificate Nos. CE 00772, MD 82182, FM 83550. Signed on behalf of Vitalograph (Ireland) Ltd. B. R. Garbe. Group Managing Director...
  • Page 16 Tel: (913) 730 3200 Fax: (913) 730 3232 e-mail: vitcs@vitalograph.com www.vitalograph.com Vitalograph (Ireland) Ltd. Gort Road Business Park Ennis Co Clare Ireland Tel: (065) 6864100 Fax: (065) 6829289 e-mail: sales@vitalograph.ie www.vitalograph.ie Vitalograph® and asma-1™ are trademarks or registered trademarks of Vitalograph Ltd. PRINT REF: 07583_2...