novos Easypuff User Manual

Infant resuscitation device

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Easypuff
Infant Resuscitation Device
User Manual
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Summary of Contents for novos Easypuff

  • Page 1 Easypuff Infant Resuscitation Device User Manual...
  • Page 2 This document contains information on which NOVOS assumes the property rights. The information may not be reproduced in whole or in part unless authorized in writing by NOVOS. These information are the property of NOVOS, for its intended use only.
  • Page 3: Table Of Contents

    NOVOS Easypuff™ User Manual Table of Contents Safety Information ............................1 1.1. User Obligations for Patient Safety ........................ 1 1.1.1. Patient Monitoring ..........................1 1.2. Limitation of Liabilities ........................... 1 1.3. Usage Restrictions ............................1 1.3.1. Warnings on Possible Physiological Effects ..................... 2 1.3.2.
  • Page 4 NOVOS Easypuff™ User Manual Symbols This symbol is used to warn the users of the device against possible risk or injury. Warnings are instructions that, if not followed, could result in fatal or serious injury to a user, engineer, patient, or other person, or could result in improper treatment.
  • Page 5 NOVOS Easypuff™ User Manual Operation temperature and humidity range Storage temperature and humidity range Upright Direction of the Package Easily Fragile, Handle With Care Protect from moisture and rain NVS.S9.KK17/Rev04/04.12.2020...
  • Page 6: Labels On The Device

    NOVOS Easypuff™ User Manual Labels on the Device Device ID Label Technical Service Warning Outer Box Label NVS.S9.KK17/Rev04/04.12.2020...
  • Page 7: Safety Information

    Circumstances that void the warranty, negligence that may occur independently of NOVOS, product violation, etc. limit the liability of NOVOS regardless of whether it was the fault of NOVOS and regardless of the manner in which the fault occurred. NOVOS shall not assume any liability for compensation for damages arising from or related to the products and for the buyer's liabilities to third parties;...
  • Page 8: Warnings On Possible Physiological Effects

    The device is connected only to the air, oxygen or a mixture of air and oxygen with adjustable gas flow. Make sure that the Easypuff device is at a distance from the baby that the patient circuit can easily reach and resuscitation can be performed easily.
  • Page 9: Warranty

    As a result of evaluations, NOVOS or the authorized factory center must confirm that the warranty conditions cover this defect. Written notice of the failure of the device or part must be received by NOVOS or authorized factory center 2 weeks before the end of the warranty period.
  • Page 10: Product Description

    The Easypuff is a baby breathing device where the user can determine the exact amount of air/oxygen mixture pressure that is transferred to the baby's lung.
  • Page 11: Controls And Indicators

    NOVOS Easypuff™ User Manual 2.5. Controls and Indicators Handle Manometer calibration hole Manometer PIP Adjustment Button Maximum Pressure Relief Head & Control T-Piece patient circuit control Button Gas inlet connector Ventouse NVS.S9.KK17/Rev04/04.12.2020...
  • Page 12 NOVOS Easypuff™ User Manual Easypuff Tube Slot (optional) Transport Trolley (optional) Wire Basket (optional) IV Pole (Optional) T-Piece patient circuit Blender (optional) Mask Vacuum Unit (Optional) Test Lung NVS.S9.KK17/Rev04/04.12.2020...
  • Page 13: Preparation

    NOVOS Easypuff™ User Manual 3.Preparation The following procedure must be followed before each use to ensure the correct operation of the device. Check the manometer. The manometer should show zero when there is no gas flow. If not, the manometer needs calibration (see the Service manual).
  • Page 14: Oxygen Concentration

    NOVOS Easypuff™ User Manual It is recommended to set the total flow to 8 l/min. If a flow meter system is used, make sure that the air/oxygen mixture does not exceed 15 l/min. For example, setting both the oxygen and air flows at 4 L/min will give a total flow rate of 8 L/min.
  • Page 15 NOVOS Easypuff™ User Manual When connecting the gas supply to Easypuff, please be careful not to damage the gas inlet. A slight force will be enough to properly insert the connector. Attach T-Piece Circuit • Connect the test balloon to the T-Piece Circuit, then connect the circuit to the gas outlet port.
  • Page 16 NOVOS Easypuff™ User Manual Check flow settings. • Set the gas supply at the desired flow rate between 5-15 l/min. • 8 l/min is the recommended flow rate. Note: Make sure that the oxygen concentration of the Oxygen/Air supply is monitored using the oxygen analyzer or using the preset oxygen/Air flow rate chart.
  • Page 17 NOVOS Easypuff™ User Manual *PEEP: Positive end-expiratory pressure ** PIP: Peak inspiratory pressure • Remove the protective cap and adjust the maximum pressure control knob to set the desired maximum pressure. Note: The factory setting for the Maximum Pressure Discharge is 40 cmH2O [mbar].
  • Page 18 NOVOS Easypuff™ User Manual PIP (Peak Inspiratory Pressure) indicates the maximum pressure during breathing. It is not evaluated according to the weight of the baby, but according to the rise and fall of the chest. It is adjusted by closing the PEEP head and turning the PIP control knob counterclockwise until the desired PIP value is set.
  • Page 19: Operating

    NOVOS Easypuff™ User Manual 4.Operating • Adjust the gas supply and oxygen concentration at the desired flow rate (5-15l/min). The device should only be used after the correct pressure is set. Do not use the device on the patient before making sure that the pressure is set.
  • Page 20: Routine Cleaning And Maintenance

    Clean the case of the device with a dry soapy cloth and soapy water. Rinse and dry. You can also wipe the exterior surfaces with isopropyl alcohol. 5.2. Maintenance Under normal conditions of use, Easypuff requires minimal service and maintenance. It is recommended to calibrate the manometer once a year. 5.3. Disposal of Device When the device has reached the end of its service life, dispose of the device according to the local waste disposal regulations in accordance with the medical waste regulation.
  • Page 21: Troubleshooting

    NOVOS Easypuff™ User Manual 6. Troubleshooting 6.1. Fast Troubleshooting Guide Problem Solution  Check that the flow rate is between 8-10 lpm.  Check the lung test for possible damage. PIP and PEEP  Check the lung test, T-Piece circuit and gas supply line.
  • Page 22: Annexes

    NOVOS Easypuff™ User Manual 7. Annexes 7.1. Technical Specifications 7.1.1. Dimensions and Weight Height 26 cm Width 20 cm Depth 13 cm 1.5 kg Weight 7.1.2. General Properties Manometer Range -20 / 80 cmH₂O Maximum Pressure Up to 5 - 70 cmH₂O Peak Pressure (PIP) 0-70 cmH₂O @ 8 l/min...
  • Page 23: Compatibility

    NOVOS Easypuff™ User Manual 7.2. Compatibility Document Acceptance Document Name / Title Published Date Institution/ Organization TS EN ISO 15223-1 / Medical devices - Symbols to be used in medical device 12/9/2016 labels, labeling and information to be conveyed- Part 1: General...
  • Page 24: Compliance Directive

    Compliance with the revised directive became mandatory on 21 March 2010. 1984 7.3. Trademark Registrations Easypuff™ is a commercial product of Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi. 7.4. Manufacturer Novos Tıbbi Cihazlar Sanayi ve Ticaret İthalat ve İhracat Limited Şirketi Address: İvedikosb Mahallesi 1518 Cad.

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