Dräger Agila User manual

Instructions for use
Agila
Ceiling supply units
WARNING
To properly use this medical device,
read and comply with these
instructions for use.

2Instructions for use Agila
Typographical conventions
1Consecutive 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.
ALetters in illustrations denote elements referred
to in the text.
Trademarks
–Agila
®
–Movita
®
– DrägerService®
–Polaris
®
are trademarks owned by Dräger.
– Dismozon pur/plus®
– STABURAGS®
– Terralin®
– Actichlor®
–BruTab6S
®
– Dispatch®
– Buraton®
– Mikrozid®
–Perform
®
– acryl-des®
– Descogen®
– Dismozon®
–Mikrobac
®
– Korsolex®
– Neodisher Mediclean®
– Klorsept®
– Oxycide®
– Virkon®
are trademarks of other manufacturers.
Abbreviations and symbols
For explanations refer to sections "Abbreviations"
and "Symbols" in chapter "Overview".

Instructions for use Agila 3
Safety information definitions
Definition of target groups
For this product, users, service personnel, and
experts are defined as target groups.
These target groups 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.
The product must be used, installed, reprocessed,
maintained, or repaired exclusively by defined
target groups.
Users
Users are persons who use the product in
accordance with its intended use.
Service personnel
Service personnel are persons who are responsible
for the maintenance of the product.
Service personnel are persons who reprocess or
maintain the medical device and are authorized to
install accessories.
Experts
Experts are persons who perform repair or complex
maintenance work on the product.
Experts must have the necessary knowledge and
experience with complex maintenance work on the
product.
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.
NOTE
A NOTE provides additional information intended
to avoid inconvenience during operation.

Contents
4Instructions for use Agila
Contents
For your safety and that of your patients . . 5
General safety information . . . . . . . . . . . . . . . . 5
Product-specific safety information . . . . . . . . . 8
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Ceiling supply unit . . . . . . . . . . . . . . . . . . . . . . 12
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Definitions of the load descriptions. . . . . . . . . . 17
Assembly and preparation . . . . . . . . . . . . . . 18
Positioning and connecting devices . . . . . . . . . 18
Connecting IACS components (optional) . . . . . 22
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Releasing the locking brakes . . . . . . . . . . . . . . 24
Positioning the ceiling supply unit . . . . . . . . . . 25
Agila lift: Electrically-operated height
adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Agila Easylift: Height adjustment using gas
spring strut . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Lighting (optional). . . . . . . . . . . . . . . . . . . . . . . 33
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 34
Fault – Cause – Remedy . . . . . . . . . . . . . . . . . 34
Agila lift: Emergency operation of the
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Agila Easylift: Setting the movability of the
spring arm . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Agila Easylift: Setting the end positions of
the spring arm . . . . . . . . . . . . . . . . . . . . . . . . . 37
Cleaning, disinfection, and sterilization. . . . 39
Reprocessing methods . . . . . . . . . . . . . . . . . . 39
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 41
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Disposal of medical devices . . . . . . . . . . . . . . 44
Technical data . . . . . . . . . . . . . . . . . . . . . . . . 45
Product characteristics . . . . . . . . . . . . . . . . . . 45
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . 46
Data exchange and interfaces . . . . . . . . . . . . 48
Arm lengths, swivel and lifting ranges . . . . . . . 54
Maximum load . . . . . . . . . . . . . . . . . . . . . . . . 55
Load distribution on the Agila equipment
pole . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Load distribution on the Agila rack . . . . . . . . . 60
List of accessories . . . . . . . . . . . . . . . . . . . . 63

Instructions for use Agila 5
For your safety and that of your patients
For your safety and that of your patients
General safety information
The following WARNING and CAUTION
statements apply to general 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 medical
device.
Strictly follow these instructions for use
Service
WARNING
Risk of incorrect operation and of incorrect
use
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
purpose specified under "Intended use" on
page 10.
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 is inconsistent with its
intended use.
WARNING
Risk of medical device failure and of patient
injury
The medical device must be inspected and
serviced regularly by service personnel.
Repair and complex maintenance carried out
on the medical device must be performed by
experts.
If the above is not complied with, medical
device failure and patient injury may occur.
Observe chapter "Maintenance".
Dräger recommends that a service contract is
obtained with DrägerService and that all
repairs are performed by DrägerService. For
maintenance Dräger recommends the use of
authentic Dräger repair parts.
WARNING
Risk of electric shock and of device malfunction
Service activities may only be carried out by
specialized service personnel.
WARNING
Risk of electric shock and of device malfunction
The electrical connection of the on-site supply
lines to the electrical terminals of the supply unit
must be carried out by a qualified electrician.

For your safety and that of your patients
6Instructions for use Agila
Not for use in areas of explosion hazard
Accessories
Connected devices
Safe connection with other electrical
equipment
Connection to other devices
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 persons familiar with the most
important inherent characteristics of the medical
device.
Instructions and WARNING and CAUTION
statements are therefore largely limited to the
specifics of the Dräger medical device.
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
WARNING
Risk due to incompatible accessories
The use of incompatible accessories may ad-
versely affect the functional integrity of the
product. Personal injury and property damage
may occur as a consequence.
Use only compatible accessories. The
accessories compatible with this product are
listed in the current list of accessories for
supply unit
s.
WARNING
Risk of electric shock and of device
malfunction
Any connected devices or device
combinations not complying with the
requirements mentioned in these instructions
for use can compromise the correct
functioning of the medical device and lead to
an electric shock. Before operating the
medical device, strictly comply with the
instructions for use of all connected devices
or device combinations.
WARNING
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.
The system must meet the requirements of
IEC 60601-1:2012 and IEC 60601-1-2:2014
(general requirements for the safety of
medical electrical equipment).
WARNING
Device combinations approved byDräger
meet the requirements of the following
standards (if applicable):
– IEC 60601-1
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-2
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic
compatibility; Requirements and tests

Instructions for use Agila 7
For your safety and that of your patients
The instructions for use do not contain any
information on the following points:
– Risks that are obvious to users
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with
different underlying diseases
Medical device modification or misuse can be
dangerous.
Electromagnetic compatibility (EMC)
Medical electrical equipment is subject to special
precautionary measures concerning
electromagnetic compatibility. Observe the EMC
information during installation and initial operation.
For further information, see the following section:
"EMC declaration" (page 46).
Mobile high-frequency communication equipment
can affect medical electrical equipment.
Installing accessories
Strictly observe instructions for use and assembly
instructions.
Training
Training for users is available from the Dräger
organization responsible, see www.draeger.com.
Installation information
Contact information for assembly personnel is
available from DrägerService.
The assembly instructions are available to the
organization operating the healthcare facility.
WARNING
Risk of device malfunction
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.

For your safety and that of your patients
8Instructions for use Agila
Product-specific safety information
WARNING
Components that have been subsequently
installed on the medical device must comply
with all regulatory or technical requirements
and certifications and are the responsibility of
the organization operating the healthcare
facility.
Dräger assumes no warranty and no liability
for parts from third-party manufacturers or the
functionality of third-party manufacturers'
products.
Only experts may carry out subsequent
installation.
If the above are not complied with, the correct
functioning of the medical device may be
compromised.
WARNING
Risk 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
Danger of overheating
The support arm can overheat if objects are
placed on the support arm in the area of the
light fittings.
Do not place objects on the support arm.
WARNING
Danger of personal injury and/or equipment
damage
The supply unit must be in flawless operation
condition. Damage to the arm 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 device malfunctions
To properly use the supply unit, read and comply
with the instructions for use for the respective
display.
CAUTION
Danger of personal injury and/or equipment
damage
Whenever positioning the supply unit, take care
not to injure persons or damage objects.
Move the supply unit carefully.
CAUTION
Risk of equipment damage or personal injury
If a light is attached directly under a support arm
of a supply 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.

Instructions for use Agila 9
For your safety and that of your patients
WARNING
Risk of injury to the patient and damage to the
device
The mounting rail is only approved for GH3 and
GH3+ patient lifting modules from Guldmann
GmbH. Consequently, only these may be installed
on the mounting rail.
Otherwise, the correct functioning of the medical
device may be compromised.
NOTE
The certifications for terminal units (e.g., gas
terminal units and power sockets) are market-
specific.
NOTE
The CSA mark is only valid for devices equipped
with components for the North American market.

Application
10 Instructions for use Agila
Application
Intended use
The Agila ceiling supply unit is used in rooms
serving medical purposes.
It provides
– location for equipment used in diagnostics,
therapy, or for surgery
– simple positioning of devices in the room in up
to three dimensions
– passing through media such as
– medical gases
–vacuum
– electricity
– data (such as telephone, nurse call,
PC networks).
It is the basis for ergonomic workplace layout in
operating rooms, intensive care units, and
emergency units:
– As a stand-alone unit or in combination with
other Dräger ceiling supply units from the Agila
and Movita series or surgical lights.