Table of Contents
Related Manuals for Dräger Prana S
Summary of Contents for Dräger Prana S
- Page 1 Instructions for Use Prana S and Prana V WARNING Bed Head Units for medical For a full understanding of the performance characteristics applications 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.
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Page 5: Table Of Contents
Contents For your safety and that of your patients . . . 7 General safety information ....7 Product-specific safety instructions ..9 Application and Overview . - Page 6 This page was intentionally left blank.
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Page 7: For Your Safety And That Of Your Patients
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 NOTE Risk of electric shock and of device The medical electrical equipment used malfunction with this device should comply with EMI/EMC requirements of the standard connected devices device combinations not complying with the IEC 60601-1-2. requirements mentioned these instructions for use can compromise the correct functioning of the medical device...
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Page 9: Product-Specific Safety Instructions
Product-specific safety instructions Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical Note: device are based on the assumption that the Any serious incident that has occurred to the purchase and the use of the medical device are restricted to persons familiar with the most important medical device shall be reported to the inherent characteristics of the medical device. - 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.
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Page 11: Application And Overview
Application and Overview Intended use Prana S and Prana V– Bed Head Unit for medical Applications For supplying medical devices with medical gases. For supplying medical devices with electrical power. For provision of reading light, indirect light and night light. -
Page 12: Variants
Prana V (Single Duct) Versions The Prana S, Prana V wall supply is available in the following versions: Prana (Single Duct) Prana S (Double Duct) Prana V (Single Duct) Prana V (Double Duct) These variants are customizable units wherein the number of Gas outlets, electrical sockets, data (network) points and telephone sockets can be selected. - Page 13 Vent holes: Luminaires: The side covers have holes that provide sufficient The luminaires used in the device are: venting to atmosphere. 1. Philips 4ft T5 Astra line LED batten. 2. Philips 2ft T5 Astra line LED batten. 3. Philips 1ft T5 Astra line LED batten. WARNING! Electronic components and luminaires that comply with the requirements of IEC 60601-...
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Page 14: Abbreviations
Abbreviations Abbreviation Explanation Abbreviations for the EMC declaration Oxygen CISPR Comité International Spécial des Nitrous Oxide Perturbations Radioélectriques Medical compressed air Electromagnetic compatibility Vacuum High frequency Bed Head Unit International Organization for Deutsches Institut für Normung Standardization (German Institute for Standardization) UMDNS Universal Medical Device European Economic Community... -
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®...
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Page 19: Maintenance
Maintenance WARNING Expected Service Life The medical device must be inspected and Expected service life is 20 years assuming serviced regularly by trained technical service and maintenance has been performed personnel. The medical device must also be according manufacturers requirements. put into operation by trained technical 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 Prana S, Prana V (Single duct) Prana S, Prana V (Double duct) Size LED Lighting Night Light, Indirect light & Reading light. Medical Rail Size and shape as per ISO19054, available in 300mm or 600mm lengths Medical rail load...
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Page 22: Technical Data
Technical Data 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: Declaration Of Hazardous Substance
Declaration of hazardous substances in accordance with Regulation CLP 1272/2008 Appendix VI Part 3 Certain materials of this product contain the following substances in a proportion exceeding 0.1 % by mass: – Lead (CAS no. 7439-92-1) This product is safe to use for patients who are sensitive to the indicated substances. Dräger is aware of the following residual risks: –... -
Page 24: Order List
Order List Part Name/Description Part Number Spare and wear parts Finished light cover Profile 1 – 1mtr 2P00481 Finished light cover Profile 6 – 1mtr 2P00482 2P00546 Finished light cover Profile 1 - 1.2 mtr 2P00547 Finished light cover Profile 6 - 1.2 mtr 2P00548 Finished light cover Profile 1 - 1.5 mtr 2P00549... - Page 25 This page was intentionally left blank.
- Page 26 Prana S, Prana V– Bed Head Unit Regulation (EU) 2017/745 concerning Medical Devices Compliance to Following Standards ISO 11197, IEC 60601-1 Manufacturer Draeger India Pvt. Ltd. 10th Floor, Commerz II, International Business park, Oberoi Garden City, Off Western Express Highway, Goregoan (East), Mumbai –...
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