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Table of Contents
Summary of Contents for Drager Vyana
- Page 1 Instructions for use Vyana Ceiling supply unit WARNING To properly use this medical device, the user must obtain a full understanding of the performance characteristics of this medical device prior to use by carefully reading these Instructions for Use.
- Page 2 Trademarks Trademark Trademark owner DrägerService® Dräger Microzid® Schülke & Mayr Acryl-des® Schülke & Mayr 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...
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Page 3: Table Of Contents
Contents Contents For your safety and that of your patients. General safety information ....… . 8 Product-specific safety information..Application . - Page 4 List of accessories.....33 Spare Part list....
- Page 5 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 6: For Your Safety And That Of Your Patients
For your safety and that of your patients General safety information following WARNING CAUTION Maintenance statements apply to general operation of the medical device. WARNING and CAUTION statements specific to WARNING subsystems or particular features of the medical device appear in the respective sections of these The medical device must be inspected and instructions for use or in the instructions for use of serviced regularly by professionals who pos-... - Page 7 Accessories Connection to other devices WARNING Device combinations approved by Dräger (see instructions for use of the individual devices) meet the Only the accessories indicated in the chapter requirements of the following standards: "List of Accessories" on page no 31 have been tested and approved for use with the medical –...
- Page 8 For your safety and that of your patient Patient safety Installing accessories The design of the medical device, the accompanying CAUTION documentation, and the labeling on the medical device are Install accessories to the basic device in accor- based on the assumption that the purchase and the use of dance with the instructions for use of the basic the medical device are restricted to trained professionals, and device.
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Page 9: Product-Specific Safety Information
For your safety and that of your patient Product-specific safety information WARNING NOTE Components that have been subsequently installed on Certifications depend on market-specific components the medical device must correspond to all regulatory or (e. g. gas terminal units and power sockets). technical requirements and approvals. -
Page 10: Application
The Vyana Ceiling supply unit with arm system is a ceiling suspended supply unit which is permanently installed and always ready to use. It can be rotated by 330° by its own axis as well as can be positioned 330°... -
Page 11: Version
For your safety and that of your patient Version Vyana ceilling supply unit is available in the following WARNING version: Risk due to incompatible accessories A. Rigid Pendant Unit Dräger has tested only the compatibility of accessories B. Single Arm System listed in page no 31 as list of accessories. - Page 12 For your safety and that of your patient WARNING Only the accessories indicated in the chapter "List of Luminaires: Accessories" on page no 31 have been tested and approved for use with the medical device. The luminaires used in the device are: Therefore, it is strongly recommended that only these 1.
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Page 13: Overview
For your safety and that of your patient Overview An example of use 330˚ Degree 330˚ Degree H – Shelf assembly A – Pre fixture assembly I – Shelf & Drawer assembly B – Canopy (Hood) J – LED down light C –... -
Page 14: Abbreviations
For your safety and that of your patient Abbreviation Abbreviation Explanation Abbreviation Explanation for the EMC declaration Abbreviation Explanation AGSS Anesthetic gas scavenging system CISPR Comité International Spécial des Perturbations Pressurized medicinal air Radioélectriques (International Special Committee on Radio Interference) Ceiling supply unit DSSS Direct - Sequence Spread Spectrum, spread... -
Page 15: Location Of Information Label
For your safety and that of your patient Location of information labels Vyana Rigid Pendant and Single arm system Labels Rating plate Media column: The rating plate is on the upper front side of the media column between the front rails. - Page 16 For your safety and that of your patient Accessories Labels Shelf assembly and Shelf & Drawer Assembly. Information label Information label for maximum load of shelf is on front side. Information label for maximum load of medical rail is on the side of shelf.
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Page 17: Definitions Of The Maximum Load
For your safety and that of your patient Definitions of the maximum load For Dräger supply units System Parts Load description Definition Position Arm System Maximum load Maximum load on the end Capacity Of the arm system Head Maximum load Maximum load can be put Capacity on the media column... -
Page 18: Assembly And Preparation
For your safety and that of your patient Assembly and preparation Positioning and connecting devices Connecting the devices to an electricity supply CAUTION CAUTION Danger of overloading the supply unit Risk of patient injury Do not exceed the maximum load for the supply unit and individual devices when positioning the intended Electrical connections to equipment not listed in these devices. - Page 19 For your safety and that of your patient Parking position 1 Connect mains plug (A) of the devices to the power sockets of the media column. 1 Press probe into the terminal unit until it engages the first time (parking position). Connecting the probe for medical gas supply Operating position 2 Press probe until it engages the second time.
- Page 20 For your safety and that of your patient Connecting the probe for the AGSS (optional) Connecting the probe for the AIR motor (optional) Press probe (A) until it snaps into place. • The indicator (B) turns green, the anesthetic gas scavenging is functional.
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Page 21: Operation
For your safety and that of your patient Operation Releasing the locking brakes CAUTION Danger of personal injury and/or equipment damage CAUTION The supply unit must be in flawless operation condition. Damage of the arm system can cause objects Danger of personal injury and/or equipment dam- (defective gas terminal units and power sockets, loose paint particles, adhesive labels, etc.) to fall down into the operation field and compromise the... -
Page 22: Positioning The Ceiling Supply Unit
For your safety and that of your patient Positioning the single arm ceiling supply Positioning the ceiling supply unit unit and Head. WARNING Ensure that the supply lines can move freely Equipment could be pulled off the shelf or cables and hoses may become damaged or pinched. -
Page 23: Assembly Procedure For Accessories On Ceiling Supply Unit
Swivel Arm and keep it aside. aside. Move the whole assembly into the veridical medical Move the whole assembly into the veridical medical rail on the Vyana column at desired height as shown. rail on the Vyana column at desired height as shown. NOTE: slide... - Page 24 The information on the secondary product label is as shown below. Unwrap the IV Pole assembly (Part no: 2P00884) comes along with Vyana packaging box. A – Description of accessories Adjust the stopper which is Pre mounted on the IV pole at desired length by loosening the set screw.
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Page 25: Troubleshooting
For your safety and that of your patient Troubleshooting Fault – Cause – Remedy WARNING NOTE Repair and maintenance of the medical device must be For more information on troubleshooting fixtures for carried out by trained technical personnel. other installed devices, please see the respective instructions for use. -
Page 26: Cleaning, Disinfection, And Sterilization
For your safety and that of your patient Cleaning, disinfection, and sterilization WARNING! CAUTION Risk of fire Electrical mains! Do not use any flammable cleaning agents in Risk of electric shock. the vicinity of the terminal units or power Do not open the housing during cleaning sockets. -
Page 27: Reprocessing List
For your safety and that of your patient 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®... -
Page 28: Maintenance
For your safety and that of your patient Maintenance WARNING CAUTION The medical device must be inspected and Before first being put into operation and after exchanging serviced regularly by trained technical per- compressed gas hoses in medical supply units, the following sonnel. -
Page 29: Disposal
For your safety and that of your patient 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 2012/19/EU (WEEE). -
Page 30: Table Of Toxic Or Hazardous Substances Or Elements
For your safety and that of your patient Table of toxic or hazardous substances or elements Component name Toxic or hazardous substances or elements PBDE Wiring harnesses, valves Metal parts Plastic parts 0: Indicates that this toxic or hazardous substance contained in all of the homogeneous materials used for this component is below the limit requirement in SJ/T 11363-2006. -
Page 31: Technical Data
For your safety and that of your patient Technical data Product characteristics Ceiling mounting Ambient conditions Suspended ceiling upto 1200 mm Depth During operation Mounting on concrete with heavy duty anchors Temperature +10 °C to +40 °C Structural ceiling (other construction also (+50 °F to +104 °F) Possible) –... -
Page 32: Arm Length,Movement And Raising Area
For your safety and that of your patient Arm lengths, movement and raising areas Single arm system Head A – Length of support arm for single arm ceiling supply unit B – Length of distant tube (short) for single arm system C –... - Page 33 For your safety and that of your patient List of accessories WARNING Only use authorized accessories listed in this chapter. Otherwise, the correct function- ing of the device may be compromised. Part name Part no. Shelf assembly 2P00815 Shelf with drawer assembly 2P00862 IV pole assembly 2P00884...
- Page 34 For your safety and that of your patient Part Name/Description Part Number Spare and wear parts SU Hose(EPDM), O2 – 2.5mtr 2P00833 SU Hose(EPDM), O2 – 0.5mtr 2P00834 SU Hose(EPDM), Air – 2.5mtr 2P00835 SU Hose(EPDM), Air – 0.5mtr 2P00836 SU Hose(EPDM), VAC –...
- Page 35 For your safety and that of your patient This page was intentionally left blank.
- Page 36 For your safety and that of your patient Vyana – Ceiling Supply 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 –...
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