Agila and Agila CC lift express Instructions for Use Edition 7 April 2017

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.

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Instructions for use Agila CC/Agila CC lift express

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

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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 CC/Agila CC lift express

Contents

Contents For your safety and that of your patients. . .

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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

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.

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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.

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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

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

Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

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.

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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

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.

11

Application

B

C

D

001

A

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Instructions for use Agila CC/Agila CC lift express

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

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Instructions for use Agila CC/Agila CC lift express

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.

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Position

Instructions for use Agila CC/Agila CC lift express

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.

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.

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.

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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

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.

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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