Drager Vyana User manual

1
Instructions for use
Vyana
WARNING Ceiling supply unit
Toproperlyusethismedicaldevice,the
user mustobtaina fullunderstandingof
theperformance characteristics ofthis
medicaldevice prior tousebycarefully
reading these Instructions for Use.

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.
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 additional information intended to avoid
inconvenience during operation.

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Contents
Contents
For your safety and that of your patients.
.. 5
General safety information . . . . . . . . . . . . . .
.. 5
Product-specific safety information. . . . . . . .
… . 8
Application . . . . . . . . . . . . . . . . . . . . . . . ..
.. 9
Intended use. . . . . . . . . . . . . . . . . . . . . . . ..
.. 9
Description . . . . . . . . . . . . . . . . . . . . . . .. .
. . .
.. 9
Version ………….. . . . . . . . . . . . . . . . . . . ..
.. 10
Overview. . . . . . . . . . . . . . . . . . . . . . . . . ..
. . 12
Abbreviations . . . . . . . . . . . . . . . . . . . . . . ..
.. 13
Symbols . . . . . . . . . . . . . . . . . . . . . . .. .
. . .
.. 13
Location of information label. . . . . . . . . . .. .
. . . . . . . . . . . . . . .
.. 14
Definitions of the maximum load . . . . . . . . .
.. 15
Assembly and preparation . . . . . . . . . . . .
.. 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 toxicorhazardous substancesor
elements. . . . . . . . . . . . . . . . . . . . . . . . . .. .
. .29
Technical data.. . . . .. . . . .. . . . . .. . . . ..
. .30
Arm length,movement and raising area . .
. .32
Declaration of Hazardous Substance .. .
32

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List of accessories. . . . . . . . . . . . . . . . . . .
. .33
Spare Part list. . . . . . . . . . . . . . . . . . .
. .34

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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.
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 for all patient population.

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For your safety and that of your patients
General safety information
The following WARNING and CAUTION
statements apply togeneral operation of the medical
device.
WARNING and CAUTION statements specific to
subsystems or particular features of the medical
device appear in the respective sections of these
instructions for use or in the instructions for use of
another product being used with this device.
Strictly follow these instructions for use
WARNING
Any use of the medical device requires full
understanding and strict observation of all
sections of these instructions for use. The
medical device is only to be used for the pur-
pose specified under "Intended use" on page
9.
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device
labels. Failure to observe these safety
information statements constitutes a use of the
medical device that isinconsistent 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 where combustible or
explosive gas mixtures are likely to occur.
WARNING
The medical device must be inspected and
serviced regularly by professionals who pos-
sess the required qualifications due to their
training and experience. Repair of the medical
device must also be performed by trained per-
sonnel with additional product-specific
DrägerService training.
Dräger recommends that a service contract is
obtained with DrägerService and that all repairs
are performed by DrägerService. Dräger further
recommends that only authentic Dräger repair
parts are used for maintenance.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
See chapter "Maintenance" on page 26.

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Accessories
WARNING
Only the accessories indicated in the chapter
"List of Accessories" on page no 31 have been
tested and approved for use with the medical
device.
Therefore, it is strongly recommended that
only these accessories are used in conjunc-
tion with the medical device. Otherwise, the
correct functioning of the medical device may
be compromised.
WARNING
If you push out the upper smaller pole of the
infusion pole too far, it may fall off under load.
Connected devices
WARNING
Risk of electric shock and of device malfunc-
tion
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use may
compromise the correct functioning of the
medical device. Before operating any combi-
nation of devices, refer to and strictly comply
with the instructions for use for all connected
devices and device combinations.
Safe connection with other electrical
equipment
Connection to other devices
Device combinations approved by Dräger (see
instructionsfor 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;
Requirements and tests
–IEC 60601-1-6 (EN 60601-1-6)
Medical electrical equipment –Part 1-6: General
requirements for safety –Collateral standard:
Usability
If Dräger devices are connected to other Dräger
devices or third-party devices and the resulting
combination is not approved by Dräger, the correct
functioning of the devices may be compromised.
The owner is responsible for ensuring that the
resulting system meets the requirements of the
applicable standards.
Strictly observe assembly instructions and instruc-
tions for use for each networked device.
CAUTION
Risk of patient injury
Electrical connections to equipment not listed in
these instructions for use or these assembly
instructions must only be made when approved
by each respective manufacturer.

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

For your safety and that of your patient
9
Product-specific safety information
CAUTION
The general state of the device and internal cables and
hoses has to be checked for damages.
For proper function of thedevice it must be examined
carefully before use.
Functional safety
This device does not have any Essential Performance
features as defined by IEC 60601-1-2, because there is no
active electronic equipment in the device.
For that reason there are no effects concerning electrical
irradiation and radiation.
WARNING
Components that have been subsequently installed on
the medical device must correspond to all regulatory or
technical requirements and approvals.
The customer must make the right choice. Dräger
assumes no warranty and no liability forpartsfromthird-
party manufacturers or the functionality of third-party
manufacturers' products.
Only trained personnel may carry out subsequent
installation.
Iftheabovearenotcomplied with,thecorrectfunctioning
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 oxygenated areas.
NOTE
Certifications depend on market-specific components
(e. g. gas terminal units and power sockets).
CAUTION
Danger of personal injury and/or equipment damage
The supply unit must be in flawless operation condition.
Damage of the system can cause objects (defective gas
terminal units and power sockets, loose paint particles,
adhesive labels, etc.) to fall down into the operation field
and compromise the supply to the patient or the connected
devices.
CAUTION
Risk of equipment damage or personal injury
If a light is attached directly under a support arm of asupply
unit, the light will move when the support arm is positioned.
It may collide with people or objects as a result of this.
Avoid collisions when positioning the support arm.

For your safety and that of your patient
10
Application
Intended use
Vyana ceiling supply unit with arm system are intended to
be used for the following application.
Applications
−For simple positioning of devices in room in up to
two dimensions.
−For supplying medical devices with electrical
power and with medical gases and vacuum.
−For provision of indirect floor light.
−For communication and data transmission.
−For ergonomic positioning of medical equipment
onto the rail system.
They are the basis for ergonomic workplace layout in
operating rooms, intensive care units, and emergency units.
Description
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° radially.
The Vyana ceiling supply unit with arm system is
customizable, in accordance with customer wishes,
wherein the number of gasoutlets, electricalsockets, data
(network) points and telephone sockets can be selected.
It can be supplemented with accessories that are listed in
page no. 27. It is available in 4 standard colours - RAL
1003, RAL 9006, RAL 9016 and RAL 5024. Other than
these, other RAL colours can also be offered on request.
CAUTION
Install accessories to the basic device in accordance
withthe instructions for use of the basic device. Make
sure that there is a safe connection to the basic
device system.