Dräger Prana W Instructions For Use Manual

Dräger Prana W Instructions For Use Manual

Bed head units for medical applications

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Instructions for Use
Prana W
WARNING
For a full understanding of the
performance characteristics
of this device, the user shall
carefully read these
Instructions before use of the
device.
Bed Head Units for medical
applications

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Summary of Contents for Dräger Prana W

  • Page 1 Instructions for Use Prana W Bed Head Units for medical WARNING For a full understanding of the applications performance characteristics of this device, the user shall carefully read these Instructions before use of the device.
  • Page 2 Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions. • Bullet points indicate individual actions or different options for action. – Dashes indicate the listing of data, options, or objects. (A) Letters in parentheses refer to elements in the related illustration.
  • Page 3 Safety information definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.
  • Page 4 Definition of target groups Users, service personnel and experts must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product. Users Users are persons who utilize the product in accordance with its intended use.
  • Page 5: Table Of Contents

    Contents General Safety information ... . . General safety information ....7 Product-specific safety instructions ..Application and Overview .
  • Page 6 This page was intentionally left blank.
  • Page 7: General Safety Information

    General safety information Maintenance The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING WARNING and CAUTION statements specific to Risk of medical device failure and of patient subsystems or particular features of the medical injury device appear in the respective sections of these A regular inspection of gas –...
  • Page 8 Connected devices WARNING Risk of electric shock and of device malfunction Any connected devices or device combinations not complying with the requirements mentioned in these instructions for use can compromise the correct functioning of the medical device and lead to an electric shock. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device...
  • Page 9: Product-Specific Safety Instructions

    Product-specific safety instructions Patient safety The design of the medical device, the Note: accompanying documentation, and the labeling on Any serious incident that has occurred to the the medical device are based on the assumption medical device shall be reported to the that the purchase and the use of the medical device manufacturer.
  • Page 10 Putting into operation for the first time WARNING WARNING! Risk of injury to the patient or user due to The electrical connections from the hospital malfunction of the bed head unit wiring to the terminal strip must be made by a Before putting the bed head unit into operation qualified electrician.
  • Page 11: Application And Overview

    Both these variants are customizable units wherein the number of Gas outlets, electrical sockets, data (network) points and telephone sockets can be selected. All variants are available in 4 standard RAL colours - RAL 1003, RAL 9006, RAL 9016, RAL 5024. Prana W can also have colours other than these on request.
  • Page 12: Variants

    Fig 3- Prana W (Double Duct) Fig 4- Prana W (Triple Duct)
  • Page 13 Vent holes: Front profiles shown in fig.2, 3 and 4 have vent holes that provide sufficient venting to atmosphere. WARNING! Do not cover or clog the vent openings e.g. with clothes, towels, newspapers etc.
  • Page 14: Abbreviations

    Abbreviations Abbreviation Explanation Abbreviations for the EMC declaration Oxygen Medical compressed air CISPR Comité International Spécial des Vacuum Perturbations Radioélectriques Bed Head Unit Electromagnetic compatibility Deutsches Institut für Normung High frequency (German Institute for Standardization) International Organization for European Economic Community Standardization UMDNS Universal Medical Device...
  • Page 15: Putting The Device Into Operation

    Putting the device into operation WARNING! WARNING! O2 and nitrous oxide are easily flammable Each use of the Terminal unit gases. requires full understanding and strict Increased fire hazard! observation of all sections of Do not bring terminal units and connectors for instructions for use –...
  • Page 16: Acceptance And Handover

    Acceptance and handover Delivery Final Test Inspect delivery (acc. to acceptance protocol) Check the shipping crate for The acceptance test includes: damage Ensure that the delivery Gas-type inspection is complete: Instructions for Use / Inspection of electrical circuits (also for Installation Instructions emergency power outlets, if applicable) Ground continuity test...
  • Page 17: Cleaning And Disinfection

    Cleaning/ Disinfection Safety information WARNING! Electrical mains! CAUTION Risk of electric shock. Risk of fire Do not open the housing during cleaning Do not use any flammable cleaning agents in process. the vicinity of the terminal units or power sockets. WARNING! Penetration of liquids can influence the WARNING...
  • Page 18 The manual disinfection of device surfaces was tested with various agents. At the time of testing, the following disinfectants showed good material compatibility and effectiveness: 1. Quaternary ammonium compounds 1.1 Mikrozid® sensitive liquid 1) 1.2 Mikrozid® alcohol free liquid 1) 1.3 Mikrozid®...
  • Page 19: Maintenance

    Maintenance Preventive maintenance WARNING The medical device must be inspected and Maintenance measures must be performed by serviced regularly by trained technical the personnel responsible. personnel. The medical device must also be put into operation by trained technical Expected Service Life personnel.
  • Page 20: Disposal

    Disposal Disposal of the medical device When disposing of the medical device: • Consult the relevant waste disposal company for appropriate disposal. • Observe the applicable laws and regulations. For countries subject to the EU Directive 2002/96/EC This device is subject to EU Directive 2002/96/EC (WEEE).
  • Page 21: Technical Data

    Technical Data Prana W (Single Duct) Prana W (Double Duct) Prana W (Triple Duct ) Size Rows of outlets Length Any length upto 3 mtrs. Outlet spacing At least 200mm between gas terminals units (for flammable or oxidizing gases) and electrical outlets.
  • Page 22 Technical Data Order list Gas supply Operating pressure Medical gases 400 kPa to 500 kPa ≤60 kPa absolute Vacuum Power supply =16 A, 220-240 V (FL) 50/60 Hz Ambient conditions Operating Temperature +15 °C to +40 °C (+59 °F to +104 °F) Transport and storage -10°C to + 60°C (14 °F to +140 °F)
  • Page 23: Order List

    Order List Order list Part Name/Description Part Number Spare and wear parts 2P00486 Norisys 13A universal socket white 2P00487 Norisys 6 A Switch White 2P00490 16/6 Amps Indian Socket 2P00336 DIN Duct (BHP & SU) Mount Terminal Unit structural block O2 2P00338 DIN Duct (BHP &...
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  • Page 25 Prana W – Bed Head Unit Regulation (EU) 2017/745 concerning Medical Devices Compliance to Following Standards ISO 11197, EN 60601-1 Manufacturer Draeger India Pvt. Ltd. 10th Floor, Commerz II, International Business park, Oberoi Garden City, Off Western Express Highway, Goregoan (East), Mumbai – 400 063.

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