Drager Vyana Скачать руководство пользователя страница 8 | Manualshive

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Drager Vyana Скачать руководство пользователя страница 8

For your safety and that of your patient

8

Note

Any serious incident that has occurred to the
medical device shall be reported to the
manufacturer.

Patient safety

The  design  of  the  medical  device,  the  accompanying
documentation,  and  the  labeling  on  the  medical  device  are
based on the assumption that the purchase and the use of
the medical device are restricted to trained professionals, and
that certain inherent characteristics of the medical device are
known to the trained user. Instructions and WARNING and
CAUTION  statements  are  therefore  largely  limited  to  the
specifics of the Dräger medical device.

These  instructions  for  use  do  not  contain  references  to
various  hazards  which  are  obvious  to  professionals  who
operate  this  medical  device  as  well  as  references  to  the
consequences  of  medical  device misuse, and to potentially
adverse  effects  in  patients  with  different  underlying  diseases.
Medical device modification or misuse can be dangerous.

Information on electromagnetic
compatibility

General information on electromagnetic compatibility (EMC)
according to international EMC standard IEC 60601-1-2:

Medical electrical equipment is subject to special
precautionary

measures

concerning

electromagnetic

compatibility (EMC) and must be installed and put into
operation.

Portable and mobile RF communications equipment can
affect medical electrical equipment.

Installing accessories

CAUTION

Install accessories to the basic device in accor-
dance with the instructions for use of the basic
device. Make sure that there is a safe connection to
the basic device system.

Strictly observe assembly instructions and instructions for
use.

CAUTION

Risk of patient injury

Height adjustment of accessories shall be
carried out at no load condition.

Training

Training for users is available from the Dräger organization
responsible, see

www.draeger.com

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Содержание Vyana

Страница 1: ...na WARNING Ceiling supply unit 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 ...

Страница 2: ...sult in death or serious injury Abbreviations and symbols For explanations refer to sections Abbreviations and Symbols in chapter Overview 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 NOTE A NOTE provides addit...

Страница 3: ... 17 Positioning and connecting devices 17 Operation 20 Releasing the locking brakes 20 Positioning the ceiling supply unit 21 Positioning the single arm ceiling supply unit 21 Assembly procedure for accessories on ceiling supply unit 22 Troubleshooting 24 Fault Cause Remedy 24 Cleaning disinfection and sterilization 25 Reprocessing list 26 Maintenance 27 Disposal 28 Table of toxic or hazardous sub...

Страница 4: ...4 List of accessories 33 Spare Part list 34 ...

Страница 5: ...oduct Users Users are persons who utilize the product in accordance with its intended use Service personnel Service personnel responsible for the installation reprocessing and maintenance must be trained in the applicable processes Experts Experts responsible for repair and complex maintenance must have the necessary knowledge and experience on the product Patients This product can be considered f...

Страница 6: ... that is inconsistent with its intended use WARNING To avoid the risk of electric shock the equipment must only be connected to a supply mains with protective earth Maintenance Safety inspections The medical device must be subject to regular safety checks See chapter Maintenance Not for use in areas of explosion hazard WARNING This medical device is neither approved nor certified for use in areas ...

Страница 7: ...es Device combinations approved by Dräger see instructions for use of the individual devices meet the requirements of the following standards IEC 60601 1 EN 60601 1 3rd Edition Medical electrical equipment Part 1 General requirements for safety IEC 60601 1 2 EN 60601 1 2 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Requirem...

Страница 8: ...o potentially adverse effects in patients with different underlying diseases Medical device modification or misuse can be dangerous Information on electromagnetic compatibility General information on electromagnetic compatibility EMC according to international EMC standard IEC 60601 1 2 Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibili...

Страница 9: ...e correct functioning of the medical device may be compromised WARNING Danger of electric shock The device housing must not be opened WARNING Increased fire risk Gas terminal units must not come into contact with oil grease or flammable liquids WARNING The electrical connections from the hospital wiring to the terminal strip must be made by a qualified electrician WARNING Do not use this device in...

Страница 10: ...eiling 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 radially The Vyana ceiling supply unit with arm system is customizable in accordance with customer wishes wherein the number of gas outlets electrical sockets data network points and telephone sockets ...

Страница 11: ...on the page 31 WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in page no 31 as list of accessories If other incompatible accessories are used there is a risk of patient injury due to medical device failure Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories CAUTION In...

Страница 12: ...nd approvals The customer must make the right choice Dräger assumes no warranty and no liability for parts from third party manufacturers or the functionality of third party manufacturers products Only trained personnel may carry out subsequent installation If the above are not complied with the correct functioning of the medical device may be compromised Luminaires The luminaires used in the devi...

Страница 13: ...xample of use 330 Degree 330 Degree A Pre fixture assembly B Canopy Hood C Ceiling bearing assembly D Arm assembly E Distant tube short F Media column G IV pole Swivel arm assembly H Shelf assembly I Shelf Drawer assembly J LED down light A B C D E F H I G J ...

Страница 14: ...ial Committee on Radio Interference DSSS Direct Sequence Spread Spectrum spread spectrum EMC Electromagnetic compatibility FHSS Frequency Hopping Spread Spectrum frequency hopping HF High Frequency Symbols Symbol Description Date of Manufacture Warning Strictly follow these Instructions for use General warning sign Warning Electricity Do not lean against the device Alternating Current Symbol Descr...

Страница 15: ...tes Follow Instruction for use D Electrical hazard Label E Pressure information Label All label positions for Rigid Pendant unit and single arm system are same Vyana Head Labels Rating plate A Distant tube The rating plate is on the lower front side of the media distant tube as shown in the picture for Vyana Head Information label B Information label for maximum load is on the distant tube above t...

Страница 16: ... side of shelf G Information label for maximum load of Drawer is on the top side of drawer Swivel Arm assembly and IV pole Assembly Information label H Information label for maximum load of swivel arm is on the side of swivel arm I Information label for maximum load of IV pole is on the height adjusting knob side Monitor Arm assembly Information label J Information label for maximum load of Monito...

Страница 17: ...d description Definition Position Arm System Head Maximum load Capacity Maximum load Capacity Maximum load on the end Of the arm system Maximum load can be put on the media column Media column Maximum load Maximum load can be put on the media column Racks shelves Net load Maximum load minus the weight of rack shelves ...

Страница 18: ...vice trips the on site automatic circuit breaker of the respective circuit all other connected devices in the same circuit will also no longer be supplied with current WARNING Don t place objects below the panel covering the floor lights and vent openings Assembly and preparation Place the additional devices on the rack mounted on the media column Do not exceed the maximum load in doing so Positio...

Страница 19: ...erve the respective manufacturer s instructions NOTE The following instructions only apply to Dräger DIN terminal units Parking position 1 Press probe into the terminal unit until it engages the first time parking position Operating position 2 Press probe until it engages the second time Stopping the gas supply 3 Apply slight pressure to release bushing probe will return to parking position Taking...

Страница 20: ...necting the probe for the AGSS optional 1 Press probe A until it snaps into place The indicator B turns green the anesthetic gas scavenging is functional Connecting the probe for the AIR motor optional 1 Press probe A until it snaps into place B A A ...

Страница 21: ...ger of personal injury and or equipment damage Components in the ceiling supply unit may overheat if the ventilation slots in the ceiling supply unit are covered Make sure that the ventilation slots are not covered NOTE Full load current specified in IfU Releasing the locking brakes CAUTION Danger of personal injury and or equipment dam age Fully equipped heavily laden ceiling supply units require...

Страница 22: ...ION Danger of personal injury and or equipment damage Whenever positioning the supply unit take care not to injure persons or damage objects Rotate the supply unit carefully While positioning ensure that the supply unit does not collide with other people supply units or surgical lights as well as walls and other objects Grasp the handle on the media column with both hands firmly to rotate the devi...

Страница 23: ... while holding the assembly at desired height 5 Tight 6 M6 screw inside C clamp on both sides to secure the assembly at the desired height 6 Tight the two socket set screw M4 after the mounting the accessories to the vertical rail B Shelf 400mm_assembly 1 Mounting of Shelf 400mm_assembly Part No 2P00815 to the Vertical rail is exactly same as Shelf and drawer assembly as mentioned above C Swivel A...

Страница 24: ...ole at desired length by loosening the set screw 9 Loosen the knob at the end of Swivel arm and insert the IV pole 10 Slide the IV pole down till it touches the stopper on the Swivel arm 11 Tight the Knob at the end of Swivel arm to secure IV pole at desired position as shown Secondary product label The information on the secondary product label is as shown below A Description of accessories B Par...

Страница 25: ...intenance power supply to connected inside the ceiling supply unit or DrägerService to check the Equipment electrical supply Take care of patient and connected consuming devices WARNING Repair and maintenance of the medical device must be carried out by trained technical personnel Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerS...

Страница 26: ...to terminals can impair the function of the device and endanger the patient Only clean parts with a damp cloth and disinfect the surface Do not allow any fluids to get in Manual cleaning Perform manual cleaning and disinfection by following below steps 1 Remove soiling immediately by using a cloth 2 Clean vent openings with moist cloth 3 Perform wipe disinfection with a cloth damped with disinfect...

Страница 27: ...f the profiles of RPU as well as its components with a cloth moistened with disinfectant Do not allow any fluid to penetrate the terminal units and electrical components DRAEGER does not take on a responsibility for the use of other disinfectants Visual inspection Check all items for damage and external signs of wear such as cracking embrittlement or pronounced hardening and residual dirt Reproces...

Страница 28: ...ollowing tests amongst others are to be carried out in accordance with DIN EN ISO 7396 2 Leakage test Test for flow Pressure drop test Along with above tests to ensure safety from electrical hazards ground continuity test and leakage current test should be performed If this test is not passed the medical device must not be put into operation Functionality test and visual inspection of the whole su...

Страница 29: ...2012 19 EU WEEE In order to comply with its registration according to this directive this device may not be disposed of at municipal collection points for waste electrical and electronic equipment Dräger has authorized a company to collect and dispose of this device To initiate collection or for further information visit Dräger on the Internet at www draeger com Use the Search function with the ke...

Страница 30: ...ned in at least one of the homogeneous mate rials used for this component is above the limit requirement in SJ T 11363 2006 NOTE The indication of an environmental pro tection use period on the product label refers to the period during which the toxic or hazardous substances or elements contained in the product will not leak or mutate under normal operating conditions so that the use of such produ...

Страница 31: ...dering All accessories Max Length of arm System A mentioned On page30 1000 mm Max Length of distant Tube mentioned on Page no 30 1000 mm Max Load on Shelf 50 kg Including medical rails Max load on individual 5 kg Medical rails on shelf Max Load on drawer 7 kg Max Load on IV pole 13 5 kg Max Load on swivel arm 15 kg Ambient conditions During operation Temperature 10 C to 40 C 50 F to 104 F Relative...

Страница 32: ...single arm system C Swivel range 330 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 No...

Страница 33: ...y 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 Swivel arm assembly 2P00885 Monitor Arm Assembly 2P00655 ...

Страница 34: ...uide ring Norisys 13A universal socket white Norisys 6 A Switch White 16 6 Amps Indian Socket DIN Duct BHP SU Mount Terminal Unit structural block O2 DIN Duct BHP SU Mount Terminal Unit structural block AIR400 DIN Duct BHP SU Mount Terminal Unit structural block VAC BS Duct mount structural block O2 BS Duct mount structural block N2O BS Duct mount structural block Air 400 BS Duct mount structural ...

Страница 35: ...For your safety and that of your patient 35 This page was intentionally left blank ...

Страница 36: ...onal Business park Oberoi Garden City Off Western Express Highway Goregoan East Mumbai 400 063 INDIA Production Facility Draeger India Pvt Ltd Bldg Shed no 4 5 and 1 Deodal village Vasai Taluka Dist Palghar 401208 INDIA Drägerwerk AG Co KGaA Moislinger Allee 53 55 23542 Lübeck Germany 2P00822 IfU 326820 001 en Draeger India Pvt Ltd Edition 7 2022 04 Draeger reserves the right to make modifications...

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