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

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.
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.

6
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.

7
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.

For your safety and that of your patient
11
Version
Vyana ceilling supply unit is available in the following
version:
A. Rigid Pendant Unit
B. Single Arm System
C. Vyana Head
It is permanetly installed and always ready to use.
The Vyana ceiling supply unit is assembled in a
modular system in accordance with customer wishes
and can be supplemented with accessoreis that are
indicated in the chapter “List of asccessoreis” 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
Install accessories to the basic device in accordance with the
instructions for use of the basic device. Make sure that there is
a safe connection to the basic device system.
Rigid Pendant Unit Single Arm System Vyana Head

For your safety and that of your patient
12
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 conjunction with the medical
device. Otherwise, the correct functioning of the
medical device may be compromised.
WARNING
Components that have been subsequently installed
onthemedicaldevicemustcorrespondtoallregulatory
or technical requirements and 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 device are:
1. LED down light 3 Watt
However, Luminaries are not available in Head
variant.
WARNING!
Electronic components and luminaires that comply
with the requirements of IEC 60601-1-2 should be
used to avoid any electromagnetic interference with
other devices.
Draeger further recommends the use of above
enlisted luminaires only.

For your safety and that of your patient
13
Overview
An example 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

For your safety and that of your patient
14
Abbreviation
Abbreviation Explanation
AGSS Anesthetic gas scavenging system
AIR Pressurized medicinal air
CSU Ceiling supply unit
DIN Deutsches Institut für Normung
(German Institute for Standardization)
WSC Workstation components
Abbreviation Explanation for the EMC declaration
Abbreviation Explanation
CISPR Comité International Spécial des Perturbations
Radioélectriques (International Special
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 Description
Degree of protection -
Protected against solid
foreign objects of
Ø 12.5 mm and greater.
Manufacturer
Observe the maximum load
Observe individual and total load
of the supply beam
Contains Hazardous
substance (CMR)
Medical Device
IP2X

For your safety and that of your patient
15
Location of information labels
Vyana Rigid Pendant and Single arm system Labels
Rating plate
A Media column: The rating plate is on the upper front side of the
media column between the front rails.
Information label
B Information label for maximum load is on the distant tube above the
media head/media column
C Information label that indicates “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 the media head/media column
C Information label that indicates “Follow
Instruction for use”. In Case of Single arm,
D Electrical hazard Label
E Pressure information Label
A
B
C
D
A
C
E
B
D
E

For your safety and that of your patient
16
Accessories Labels
Shelf assembly and Shelf & Drawer Assembly.
Information label
E Information label for maximum load of shelf is on front side.
F Information label for maximum load of medical rail is on the 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 Monitor arm is on the
side of monitor arm base.
E
G
F
J

For your safety and that of your patient
17
Definitions of the maximum load
For Dräger supply units
System Parts
Load 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

For your safety and that of your patient
18
Connecting the devices to an electricity supply
Positioning and connecting devices
CAUTION
Danger of overloading the supply unit
Do not exceed the maximum load for the supply unit
and individual devices when positioning the intended
devices.
The maximum load for the ceiling supply unit is
specified on the loading information labels, see
"Technical data" on page 29 and "Information label"
on page 14.
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.
CAUTION
Danger of device malfunctions
Electrical equipments shall be connected to the supply unit
considering maximum electrical load of the device. Any kind
of ME Equipment that will get the power from the supply unit
through multiple sockets must comply with the requirements
of respective applicable harmonized standards.
If a connected device trips the on-site automatic circuit
breaker of the respective circuit, all other connected devices in
the samecircuit 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.
•Position the devices symmetrically on the rack. The
load on the rack must be even
Device combinations must correspond to the
requirements of these instructions for use; see
"Connection to other devices" on page 16.
CAUTION
Danger of damage to devices or injury due to the
ceiling supply unit rotating on its own.
If extreme changes to the load situation of the ceiling
supply unit occur during operation (pertains only to
ceiling supply units equipped exclusively with a friction
brake), the ceiling supply unit may rotate on its own.
After any extreme change to the load situation, the
friction brake systems of the ceiling supply unit must be
readjusted (according to the assembly instructions)
by trained DrägerService employees.
NOTE
If therack is loaded asymmetrically, the rack can
rotate on its own.

For your safety and that of your patient
19
A
005
1
2
006
1 Connect mains plug (A) of the devices to the power sockets
of the media column.
Connecting the probe for medical gas supply
WARNING
Increased fire risk
Gas terminal units must not come into contact with oil,
grease, or flammable liquids.
CAUTION
Before using the terminal units also observe 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 out the plug connection completely
4 Push release bushing in with more force and at the same
time remove probe from the terminal unit.
007
3
4

For your safety and that of your patient
20
Connecting theprobe fortheAGSS(optional)
1 Press probe (A) until it snaps into place.
• The indicator (B) turns green, the anesthetic gas
scavenging is functional.
Connecting theprobeforthe AIR motor
(optional)
1. Press probe (A) until it snaps into place
B
A
A