Instructions for Use
54 Pages
Preview
Page 1
Instructions for use
Agila/Agila lift/Agila Easylift
WARNING To properly use this medical device, read and comply with these instructions for use.
Ceiling supply units
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
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Agila® Movita®
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Forta®
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DrägerService® Sola®
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Polaris®
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are trademarks owned by Dräger. – Incidin® –
Dismozon®
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STABURAGS® Terralin®
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are trademarks of other manufacturers.
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Instructions for use Agila/Agila lift/Agila Easylift
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/Agila lift/Agila Easylift
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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.
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Instructions for use Agila/Agila lift/Agila Easylift
Contents
Contents For your safety and that of your patients. . .
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Technical data...
45
General safety information... Product-specific safety information...
6 9
EMC declaration... Product characteristics...
45 48
Application... 11
List of accessories...
53
Intended use... 11 Versions... 12 Overview... 13 Ceiling supply unit... 13 Abbreviations... 14 Symbols... 15 Definitions of the load descriptions... 17 Assembly and preparation... 18 Positioning and connecting devices... 18 Operation... 22 Releasing the locking brakes... Positioning the ceiling supply unit... Agila lift: Electrically-operated height adjustment... Agila Easylift: Height adjustment using gas spring strut... Lighting (optional)...
23 25 29 31 34
Troubleshooting... 35 Fault – Cause – Remedy... 35 Agila lift: Emergency operation of the system . 36 Agila Easylift: Setting the movability of the spring arm... 37 Agila Easylift: Setting the end positions of the spring arm... 38 Cleaning, disinfection, and sterilization... 40 Reprocessing methods... 40 Reprocessing list... 41 Maintenance... 42 Disposal... 44 Disposal of medical devices... 44 Instructions for use Agila/Agila lift/Agila Easylift
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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.
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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.
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.
Instructions for use Agila/Agila lift/Agila Easylift
For your safety and that of your patients
Accessories
Connection to other devices
WARNING Risk due to incompatible accessories
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
Dräger has tested only the compatibility of accessories listed in the current ist 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 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.
Safe connection with other electrical equipment 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.
Instructions for use Agila/Agila lift/Agila Easylift
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For your safety and that of your patients
Patient safety
Installing accessories
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.
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.
Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.
Strictly observe instructions for use and assembly instructions.
The instructions for use do not contain any information on the following points:
Training
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Risks that are obvious to users
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Consequences of obvious improper use of the medical device
Training for users is available from the Dräger organization responsible, see www.draeger.com.
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Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous.
Electromagnetic compatibility (EMC)
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 following section: "EMC Declaration" (page 45). Mobile high-frequency communication equipment can affect medical electrical equipment.
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Instructions for use Agila/Agila lift/Agila Easylift
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.
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.
Only experts may carry out subsequent installation.
CAUTION Risk of device malfunctions
If the above are not complied with, the correct functioning of the medical device may be compromised.
To properly use the supply unit, read and comply with the instructions for use for the respective display.
WARNING Risk of electric shock
CAUTION Danger of personal injury and/or equipment damage
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.
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.
Do not place objects on the support arm.
Instructions for use Agila/Agila lift/Agila Easylift
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For your safety and that of your patients
NOTE The certifications for terminal units (e.g., gas terminal units and power sockets) are marketspecific. NOTE The CSA mark is only valid for devices equipped with components for the North American market.
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Instructions for use Agila/Agila lift/Agila Easylift
Application
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
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simple positioning of devices in the room in up to three dimensions
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passing through media such as –
medical gases
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vacuum
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electricity
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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, Movita, and Forta series or surgical lights.
Instructions for use Agila/Agila lift/Agila Easylift
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Application
Versions WARNING Risk due to incompatible accessories Dräger has tested only the compatibility of accessories listed in the current ist of accessories G15600. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.
The Agila ceiling supply unit is available in the following versions: –
Version without support arm (A)
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Single-arm version (B)
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Double-arm version (C)
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Single-arm or double-arm version (D) with electric height adjustment in two versions:
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.
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Agila lift
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Agila lift express
Single-arm or double-arm version (E) with manually adjustable spring arm: –
Agila Easylift
It is permanently installed and always ready to use. The Agila 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 G15600.
A
B
C
D
001
E
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Instructions for use Agila/Agila lift/Agila Easylift
Overview
Overview
Ceiling supply unit An example of use l
Agila double-arm
A B
D
C
Agila lift
E
F
G A B
C H
Agila Easylift
E J
I A B
C
E L 002
K A Main bearing
G Media head/media column
B First support arm
H Drive unit
C Intermediate bearing
I
Movable lifting arm
D Second support arm
J
Joint coupling
E Spacer tube
K Movable spring arm
F Rotating bearing of the media head/media column
L Joint coupling
Instructions for use Agila/Agila lift/Agila Easylift
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Overview
Abbreviations Abbreviation Explanation AGSS
Anesthetic gas scavenging system
AIR
Medical compressed air
CSU
Ceiling supply unit
DIN
Deutsches Institut für Normung (German Institute for Standardization)
Abbreviations for the EMC declaration Abbreviation Explanation CISPR
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
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Instructions for use Agila/Agila lift/Agila Easylift
Overview
Symbols Symbol
Description
Symbol
Warning of hazardous electric voltage
For device versions with CSA mark (USA and Canada) Caution label
Do not lean against the device CIRCUIT 1
Disposal information
Description
Identification label for the respective circuit of the power sockets
Warning! Strictly follow these instructions for use Manufacturer Date of manufacture
XXXX Caution! Caution! max. XX kg
Observe the maximum load Potential equalization
This applies to Sola lights that are fastened under a support arm. Avoid collisions with people or objects
Polaris
This applies to Polaris lights that are fastened under a support arm. Avoid collisions with people or objects
Instructions for use Agila/Agila lift/Agila Easylift
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Overview
Location of information labels
Information label for service technician (optional) D This information label is applicable only for the Agila Easylift ceiling supply unit: Note for service technicians: Loaded with 5.5 kg
B A
Sola
033
E Polaris
Rating plate 047
A Media column: The rating plate is located on the upper front side of the media column between the front rails.
Caution label for Sola lights or Polaris lights E This applies to Sola lights or Polaris lights that are fastened under a support arm. When the support arm with the light is positioned, the light moves with the support arm and can cause collisions with people or objects. The label is next to the control panel.
A Media head: The rating plate is located on the top of the media head. Information label for maximum load B An information label for maximum load is located on the spacer tube above the media head/media column.
For device versions with CSA mark (USA and Canada)
D
F CIRCUIT 1
G
CIRCUIT 2
CIRCUIT 3
CIRCUIT 4
036
C
032
Caution label for respective circuit
Caution label C An information label stating that the instructions for use must be observed is located above the handle on the media head/media column. For more details see "Agila Easylift: Height adjustment using gas spring strut" on page 31. 16
F A caution label for the respective circuit is located on each installation plate, see "Assembly and preparation" on page 18. Identification label for the respective circuit of the power sockets G An identification label for the respective circuit is located on each power circuit (numbered sequentially from 1 to N).
Instructions for use Agila/Agila lift/Agila Easylift
Overview
Definitions of the load descriptions for Dräger supply units System parts Arm system
Media head
Load description Maximum load capacity
Definition Position Maximum load on the end of the arm system.
Maximum lift capacity
Maximum load on the end of the arm system which is still safe for height adjustment.
Maximum load
Maximum load that can be put on the media head/column.
Payload
Maximum load minus the weight of racks/shelves.
Media column
Racks Shelves
Instructions for use Agila/Agila lift/Agila Easylift
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Assembly and preparation
Assembly and preparation
Positioning and connecting devices WARNING Danger of damage to 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.
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.
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 Danger of overloading the ceiling supply unit Do not exceed the maximum load for the supply unit and individual devices when positioning the intended devices. The maximum load is based on the customerspecific assembly of the supply unit. CAUTION Incorrect positioning of accessories If accessories get close to the control panel of the ceiling supply unit, the keys may be actuated unintentionally. This may lead to a movement of the ceiling supply unit and therefore to damages to the surrounding or connected devices. Make sure that accessories do not get close to the control panel of the ceiling supply unit.
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Instructions for use Agila/Agila lift/Agila Easylift
Assembly and preparation
Connecting the devices to an electricity supply
A
WARNING Risk of electric shock
B
Electrical devices must only be connected to ceiling supply units with protective grounding.
If a connected device 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. 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. Device combinations must comply with the requirements of these instructions for use, see "Connection to other devices" on page 7.
005
WARNING Risk of device malfunction 1
Connect the device mains plug (A) 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.
2
Connect the potential equalization cable (B) to the associated potential equalization socket. The potential equalization cable must meet the requirements of the IEC 60601-1 standard. The potential equalization connection must be made in order that all metallic conducting surfaces are at the same potential.
CAUTION Risk of device malfunction Do not connect any power socket strips to the power sockets of the ceiling supply unit.
Instructions for use Agila/Agila lift/Agila Easylift
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Assembly and preparation
Connecting the probe for medical gas supply WARNING Increased fire risk
A
Gas terminal units must not come into contact with oil, grease or flammable liquids.
B
NOTE The following instructions apply only to Dräger DIN gas terminal units.
Interrupting the gas supply
007
CAUTION Also observe the respective manufacturer's instructions when using the gas terminal units.
A Apply light pressure to the release bushing. The probe will return to the park position. Fully disconnecting the plug B Push the release bushing with more force and at the same time remove the probe from the gas terminal unit.
A
Connecting the probe for the AGSS (optional)
B 006
B
Park position A Push the probe into the gas terminal unit until it engages for the first time (park position).
A
Operating position
008
B Push the probe in until it engages for the second time. 1
Push the probe (A) in until it engages.
The indicator (B) turns green and the anesthetic gas scavenging is working.
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Instructions for use Agila/Agila lift/Agila Easylift