Agila and Agila CC lift express Instructions for Use Edition 7 April 2017.pdf
Page 1
Instructions for use
Agila CC/Agila CC lift express
WARNING
To properly use this medical device,
read and comply with these instructions for use.
Ceiling supply units
Page 2
Typographical conventions
1
Consecutive 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.
A
Letters in illustrations denote elements
referred to in the text.
Trademarks
–
–
DrägerService®
Agila CC®
are trademarks owned by Dräger.
– Incidin®
–
Dismozon®
are trademarks of other manufacturers.
2
Instructions for use Agila CC/Agila CC lift express
Page 3
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 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.
Abbreviations and symbols
For explanations refer to sections "Abbreviations"
and "Symbols" in chapter "Overview".
Instructions for use Agila CC/Agila CC lift express
3
Page 4
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.
4
Instructions for use Agila CC/Agila CC lift express
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Contents
Contents
For your safety and that of your patients. . .
7
General safety information . . . . . . . . . . . . . . . . 7
Product-specific safety information. . . . . . . . . . 10
Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Versions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Definitions of the load descriptions. . . . . . . . . . 16
Assembly and preparation . . . . . . . . . . . . . . 17
Positioning and connecting devices . . . . . . . . . 17
Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Releasing the locking brakes . . . . . . . . . . . . . . 21
Positioning the ceiling supply unit. . . . . . . . . . . 22
Agila CC lift express: Electrically-operated height
adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 27
Fault – Cause – Remedy . . . . . . . . . . . . . . . . . 27
Agila CC lift express: Emergency operation of the
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Cleaning, disinfection, and sterilization. . . . 29
Reprocessing methods. . . . . . . . . . . . . . . . . . . 29
Reprocessing list . . . . . . . . . . . . . . . . . . . . . . . 30
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Table of toxic or hazardous substances or elements
34
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . 35
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . . 35
Product characteristics . . . . . . . . . . . . . . . . . . . 38
List of accessories . . . . . . . . . . . . . . . . . . . . . 41
Instructions for use Agila CC/Agila CC lift express
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Instructions for use Agila CC/Agila CC lift express
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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
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 11.
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.
CAUTION
Observe and follow all additional instructions for
use before using the devices and connections of
the media supply unit.
Instructions for use Agila CC/Agila CC lift express
Service
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.
Safety checks
The medical device must be subject to regular
safety checks. See chapter "Maintenance".
Not for use in areas of explosion hazard
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
7
Page 8
For your safety and that of your patients
Accessories
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of
accessories listed in the current list of accessories G15600. 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.
Connected devices
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 may
compromise the functional integrity of the
medical device. Before operating any combination of devices, refer to and strictly comply
with the instructions for use for all connected
devices and device combinations.
WARNING
Risk of electric shock and of device malfunction
Any connected devices or device combinations not complying with the requirements
mentioned in the accompanying documents
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.
8
Safe connection with other electrical
equipment
WARNING
Electrical connections to equipment not mentioned in these instructions for use should
only be made following consultation with the
manufacturers of the equipment. The system
must meet the requirements of IEC 606011:2012 and IEC 60601-1-2:2014.
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.
Connection to other devices
WARNING
Device combinations approved by Dräger
meet the requirements of the following standards:
– 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 CC/Agila CC lift express
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For your safety and that of your patients
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.
Installing accessories
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.
Strictly observe assembly instructions and instructions for use.
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)
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.
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 EMC information provided on
page 35.
Mobile high-frequency communication equipment
can affect medical electrical equipment.
Instructions for use Agila CC/Agila CC lift express
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For your safety and that of your patients
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 functional integrity 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
Risk of personal injury and/or damage to the
device
The supply unit must be in flawless operation
condition. Damage to the arm system can
cause objects (faulty 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.
10
WARNING
Risk of fire or explosion.
Do not block the air vent slots.
WARNING
The values given in these instructions for use
are to be checked against the values labeled
on the device and that the maximum load
labeling on the device is the correct value.
CAUTION
Risk of device malfunctions
To properly use the supply unit, read and comply
with the instructions for use for the respective display.
CAUTION
Risk of personal injury and/or damage to the
device
Whenever positioning the supply unit, take care
not to injure persons or damage objects.
Move the supply unit carefully.
CAUTION
Do not use any flammable cleaners in the vicinity
of the power sockets.
CAUTION
Before use inspect the device and check it carefully.
NOTE
The certifications for terminal units (e.g., gas terminal units and power sockets) are market-specific.
Instructions for use Agila CC/Agila CC lift express
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Application
Application
Intended use
The Agila CC/Agila CC lift express 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 3 dimensions
–
Passing through media such as
–
Medical gases
–
Vacuum
–
Electricity
–
Data (such as 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.
WARNING
Risk of electric shock
To avoid the risk of an electric shock, this
device must only be connected to a grounded
power socket.
Versions
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of
accessories listed in the current list of accessories G 15 600. 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.
Instructions for use Agila CC/Agila CC lift express
The Agila CC/Agila CC lift express ceiling supply
unit is available in the following versions:
–
Single-arm version (A)
–
Double-arm version (B)
–
Fix (without arm system) (C)
–
Single-arm or double-arm version (D) with electric height adjustment (Agila CC lift express)
It is permanently installed and always ready to use.
The Agila CC/Agila CC lift express ceiling supply
unit is assembled in a modular system, in accordance with customer wishes, and can be supplemented with accessories that are listed in the list of
accessories G 15 600.
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Page 12
Application
B
C
D
001
A
12
Instructions for use Agila CC/Agila CC lift express
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Overview
Overview
Examples of use:
l
Agila CC double-arm
A
B
D
C
E
F
G
Agila CC lift express
A
C
H
E
I
J
002
B
A Ceiling bearing
B First support arm
C Intermediate bearing
D Second support arm
E Distance tube
F Rotating bearing of the media head/media column
G Media head/media column
H Drive unit
I
Movable lift arm
J
Joint coupling
Instructions for use Agila CC/Agila CC lift express
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Overview
Abbreviations
Abbreviation Explanation
Abbreviations for the EMC declaration
AGSS
Anesthetic gas scavenging system
Abbreviation Explanation
AIR
Medical compressed air
CISPR
CSU
Ceiling supply unit
DIN
Deutsches Institut für Normung
(German Institute for Standardization)
Comité International Spécial des
Perturbations Radioélectriques
(International Special Committee
on Radio Interference)
DSSS
Direct-Sequence Spread Spectrum, modulation technique for signal transmission in
telecommunications
EMC
Electromagnetic compatibility
FHSS
Frequency-Hopping Spread Spectrum, modulation technique for signal transmission in
telecommunications
HF
High frequency
Symbols
Symbol
Description
Symbol
Warning of hazardous electric
voltage
Do not lean against the device
XXXX
Caution!
max. XX kg
Observe the maximum load
max. xx kg
Observe the individual and total
load of the device
Σ kg max.
STOP
Manufacturer
Date of manufacture
Caution!
Disposal information
Warning! Strictly follow these
instructions for use
Description
Locking of the lift system of the
ceiling supply unit
RoHS marking
14
Instructions for use Agila CC/Agila CC lift express
Page 15
Overview
Location of information labels
B
033
A
Rating plate
A Media column: The rating plate is on the upper
front of the media column between the front
rails.
A Media head: The rating plate is on the top of the
media head.
Information label
B An information label for maximum load is on the
distance tube above the media head/media column.
Instructions for use Agila CC/Agila CC lift express
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Overview
Definitions of the load descriptions
for Dräger supply units
System parts
Load description
Definition
Arm system
Maximum load
capacity
Maximum load on the end of the arm
system.
Media head/
Media column
Maximum load
Maximum load that can be put on the
media head/media column.
Racks/Shelves
Payload
Maximum load minus the weight of
racks/shelves.
16
Position
Instructions for use Agila CC/Agila CC lift express
Page 17
Assembly and preparation
Assembly and preparation
Positioning and connecting devices
WARNING
Risk of damage to the devices or personal
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 arm systems of the ceiling supply
unit must be readjusted by experts according
to the assembly instructions.
CAUTION
If the rack is loaded asymmetrically, the rack can
rotate on its own.
Place the additional devices on the rack below
the media head or 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.
Connecting the devices to an electricity
supply
CAUTION
Risk of overloading the ceiling supply unit
WARNING
Risk of electric shock
Do not exceed the maximum load for the ceiling
supply unit and individual devices when positioning the intended devices.
Electrical devices must only be connected to
ceiling supply units with protective grounding.
The maximum load is based on the customerspecific assembly of the ceiling supply unit, see
"Technical data" on page 35 and "Information
label" on page 15.
WARNING
Risk of device malfunctions
CAUTION
Incorrect positioning of accessories
If a connected device trips the on-site circuit
breaker of the respective circuit, all other connected devices in the same circuit will also no
longer be supplied with current.
If accessories get close to the control panel of the
ceiling supply unit, the keys may be actuated
unintentionally.
CAUTION
Risk of patient injury
This may lead to a movement of the ceiling supply
unit and therefore to damages to the surrounding
or connected devices.
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.
Make sure that accessories do not get close to the
control panel of the ceiling supply unit.
Instructions for use Agila CC/Agila CC lift express
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Assembly and preparation
Device combinations must correspond to the
requirements of these instructions for use, see
"Connection to other devices" on page 8.
NOTE
The following instructions only apply to Dräger DIN
gas terminal units.
CAUTION
Risk of device malfunction
Do not connect any power socket strips to the
power sockets of the ceiling supply unit.
A
B
006
A
Park position
005
A Press probe into the terminal unit until it
engages the first time (park position).
1
Connect power plug (A) of the devices to the
power sockets of the media head/media column.
Connected power plugs must not be covered by
workspace components such as shelves or
drawers.
Operating position
B Press probe until it engages the second time.
A
Connecting the probe for medical gas
supply
Gas terminal units must not come into contact
with oil, grease, or flammable liquids.
CAUTION
Observe the respective manufacturer's instructions when using the gas terminal units.
18
B
Stopping the gas supply
A Apply slight pressure to release bushing, probe
returns to park position.
Taking out the plug connection completely
Instructions for use Agila CC/Agila CC lift express
007
WARNING
Increased risk of fire
Page 19
Assembly and preparation
B Push release bushing in with more force and at
the same time remove probe from the terminal
unit.
Connecting the probe for the AGSS
(optional)
B
008
A
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)
009
A
1
Press probe (A) until it snaps into place.
Instructions for use Agila CC/Agila CC lift express
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Operation
Operation
WARNING
Risk of touch voltages on the patient
Touch voltages on the patient may arise if the
patient and the LAN interface are touched at
the same time.
Avoid touching the patient and the LAN interface at the same time.
WARNING
Risk of personal injury and/or damage to the
device
The supply unit must be in flawless operation
condition. Damage to the arm system can
cause objects (faulty 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.
WARNING
Risk of personal injury
If the supply unit is not locked by a brake it
may rotate if leaned against, and the patient
may be disconnected.
No persons may lean against the supply unit.
WARNING
Risk of patient disconnection
If friction brake of column is not set correctly
and an anesthesia or ventilation device is connected the column may pivot.
20
WARNING
Risk of device damage due to condensate formation
Guarantee ambient conditions during operation. Do not turn off air condition even when
operations do not take place e.g. during night
or at weekends.
WARNING
The supply unit must be checked for proper
operation before each use.
WARNING
Risk of personal injury and/or damage to the
device
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.
Control panel blocking
A ceiling supply unit can be fitted with more than
one control panel, but a ceiling supply unit can only
ever be operated from one control panel at a time.
When a control panel is actuated, all other control
panels are blocked for 5 seconds. After these
5 seconds have elapsed, the ceiling supply unit can
once more be operated from any control panel.
Instructions for use Agila CC/Agila CC lift express
Page 21
Operation
Releasing the locking brakes
WARNING
Risk of personal injury and/or damage to the
device
Fully equipped (= heavily laden) ceiling supply
units require high braking forces due to the
inertia of the weight. The braking force must
be applied by the user because the ceiling
supply unit may not be stopped with the locking brake.
NOTE
To release the pneumatic brake on a bearing, it is
necessary to press the key that is labeled with the
corresponding bearing.
A
The bearings on the arm systems are always fitted
with friction brakes. Additionally, pneumatic brakes
may also be present.
052
B
Friction brakes
Arm systems with friction brakes can be positioned without further preparation, see "Positioning the ceiling supply unit" on page 22.
At the ceiling bearing
1
Hold down key (A) and move the arm system
and media column/media head (optional) at the
same time.
Pneumatic brakes
2
Bring the arm system and media column/media
head (optional) into the desired position, see
"Positioning the ceiling supply unit" on page 22.
Only release the key (A) once the system has
come to a standstill. The arm system is locked
again.
CAUTION
Damage to the pneumatic brake
Systems with a pneumatic brake must not be
turned with the locking brake engaged. The brake
can be damaged as a result.
The system must not be moved without the brake
being released and the key may only be released
after the system has come to a standstill. Movements of the support arm may only be braked by
hand.
For arm systems with a pneumatic brake, the
brake must be released using the keys.
The keys are installed in the media head or media
column.
Instructions for use Agila CC/Agila CC lift express
At the intermediate bearing
1
Hold down key (B) and move the arm system
and media column/media head (optional) at the
same time.
2
Bring the arm system and media column/media
head (optional) into the desired position, see
"Positioning the ceiling supply unit" on page 22.
Only release the key (B) once the system has
come to a standstill. The arm system is locked
again.
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Page 22
Operation
Positioning the ceiling supply unit
To move the media column (A), grasp it with
both hands on the sides or on the shelves (if
present).
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. This causes an interruption of supply to the patient.
If necessary, disconnect supply line, reposition, and reconnect.
A
A
CAUTION
Risk of personal injury and/or damage to the
device
Do not move/position the equipment or the equipment cart over people or life-support systems.
043
B
B
To move the media head (B), grasp it with both
hands on the sides or on the rack (C).
CAUTION
Risk of personal injury and/or damage to the
device
Positioning the single-arm ceiling
supply unit
Whenever positioning the supply unit, take care
not to injure persons or damage objects.
Move the supply unit carefully.
A
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.
011
019
B
22
Instructions for use Agila CC/Agila CC lift express
Page 23
Operation
1
Positioning the double-arm ceiling
supply unit
Turn the media head/media column (A) parallel
to the support arm (B).
A
B
020
B
Turn the support arm (B) until it comes to the
desired position.
013
2
On double-arm ceiling supply units, the ceiling
bearing (A) is adjusted to be stiffer than the intermediate bearing (B). This gives better control when
positioning the ceiling supply unit.
A
A
021
B
Turn the media head/media column (A) to the
desired position.
014
3
1
Turn the media head/media column (A) at right
angles to the second support arm (B).
A
B
022
C
Adjust the media head/media column (A).
015
4
Instructions for use Agila CC/Agila CC lift express
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Operation
2
Turn the second support arm (B) until it is perpendicular to the first support arm (C).
Adjust the media head/media column (A).
C
016
D
5
3
Rotate the first support arm (C) around the ceiling bearing (D) until it reaches the desired position.
017_1
B
4
Turn the second support arm (B) back again.
018
A
24
Instructions for use Agila CC/Agila CC lift express
Page 25
Operation
Agila CC lift express: Electrically-operated height adjustment
CAUTION
Risk of damage to objects
A
Ceiling supply units, especially lift systems, can
collide with other ceiling supply units, associated
surgical lights, or room walls as a result of brisk or
careless operation.
B
This can cause devices placed on the shelves
(e.g. monitors) to be clamped under the lift arm.
Because of this, damage to the arm system can
result, which in an extreme case can lead to parts
of the arm system breaking.
A
B
053
CAUTION
Risk of damage to objects
To prevent collisions, be careful when operating
the height adjustment above or below equipment.
The ceiling supply unit continues moving for up to
2 cm.
Keep a safe distance.
CAUTION
Risk of personal injury and/or damage to the
device
Do not move/position the equipment or the equipment cart over people or life-support systems.
The keys for height adjustment are either on the
control panel on the media head or media column.
Instructions for use Agila CC/Agila CC lift express
Moving the media column/media head
upwards
1
Push the Up Arrow key (A) and release it in the
desired position.
Moving the media column/media head
downwards
2
Push the Down Arrow key (B) and release it in
the desired position.
At the top and bottom limit positions, the lifting
motor switches off automatically.
25