Instruction for Use
48 Pages
Preview
Page 1
Instructions for use
Movita/Movita lift
WARNING To properly use this medical device, read and comply with these instructions for use.
Ceiling supply unit
Typographical conventions 1
Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.
z 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®
is a trademark owned by Dräger. – Incidin® –
Dismozon®
–
STABURAGS® Terralin®
–
are trademarks of other manufacturers.
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Instructions for use Movita/Movita lift
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 Movita/Movita lift
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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 Movita/Movita lift
Contents
Contents For your safety and that of your patients. . .
6
General safety information... Product-specific safety information...
6 9
List of accessories...
45
Application... 10 Intended use... 10 Versions... 11 Overview... 12 Ceiling supply unit... 12 Abbreviations... 13 Symbols... 13 Definitions of the maximum load... 15 Assembly and preparation... 16 Positioning and connecting devices... 16 Operation... 20 Releasing the locking brakes... 20 Positioning the ceiling supply unit... 22 Movita lift: Electrically-operated height adjustment... 25 Movita lift: Media column with device mounting 27 Lighting (optional)... 29 Troubleshooting... 30 Fault – Cause – Remedy... 30 Movita lift: Emergency operation of the system 31 Cleaning, disinfection, and sterilization... 32 Reprocessing methods... 32 Reprocessing list... 33 Maintenance... 34 Disposal... 36 Disposal of the medical device... 36 Technical data... 37 EMC Declaration... 37 Product characteristics... 42
Instructions for use Movita
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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 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.
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Maintenance 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 Movita/Movita lift
For your safety and that of your patients
Accessories
Connection to other devices
WARNING Risk due to incompatible accessories
Device combinations approved by Dräger meet the requirements of the following standards:
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.
–
IEC 60601-1 Medical electrical equipment Part 1: General requirements for safety –
IEC 60601-1-1 Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems
–
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests
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 Movita/Movita lift
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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.
CAUTION Risk of device failure
Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. 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.
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 instructions for use and assembly instructions.
Functional safety The essential performance of supply units consists in: –
Power supply for medical devices
–
Supply of medical gases to medical devices
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Scavening of anesthetic gases (optional)
Training Information on electromagnetic compatibility
Training for users is available from the Dräger organization responsible, see www.draeger.com.
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 in accordance with the EMC information provided on page 37. Portable and mobile RF communications equipment can affect medical electrical equipment.
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Instructions for use Movita/Movita lift
For your safety and that of your patients
Product-specific safety information WARNING Components that have been subsequently installed on the medical device must correspond to all regulatory or technical requirements and approvals. The operator of the healthcare facility is responsible for choosing the appropriate components. Dräger assumes no warranty and no liability for parts from third-party manufacturers or the functionality of third-party manufacturers' products.
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 Danger of personal injury and/or equipment damage
If the above are not complied with, the correct functioning of the medical device may be compromised.
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.
WARNING Risk of electric shock
CAUTION Risk of equipment damage or personal injury
The device housing must not be opened.
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.
Only experts may carry out subsequent installation.
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.
Avoid collisions when positioning the support arm. NOTE Certifications depend on market-specific terminal units (e.g., gas terminal units and power sockets). NOTE The CSA mark is only valid for devices equipped with components for the North American market.
Do not place objects on the support arm.
Instructions for use Movita/Movita lift
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Application
Application
Intended use Movita ceiling supply units are used in rooms serving medical purposes. They provide –
location for equipment used in diagnostics, therapy, or for surgery
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and their simple positioning in the room in up to three dimensions
–
passing through media such as –
medical gases
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vacuum
–
electricity
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data (such as telephone, nurse call, PC networks).
They are the basis for ergonomic workplace layout in operating rooms, intensive care units and emergency units. –
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Separate unit functionality, or in combination with other Dräger ceiling supply units from the Agila, Movita, and Forta series or surgical lights.
Instructions for use Movita/Movita lift
Application
Versions The Movita ceiling supply unit is available in the following 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. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.
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 version or double-arm version (D) with electric height adjustment in two versions: –
Movita lift
–
Movita lift express
It is permanently installed and always ready to use.
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.
A
–
The Movita 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.
B
C
002
D
Instructions for use Movita/Movita lift
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Overview
Overview
Ceiling supply unit An example of use
Example Movita double-arm
A
C
B
D
E J I
Example Movita lift
F H 003
G
A Main bearing
F Drive unit
B First support arm
G Movable lifting arm
C Intermediate bearing
H Joint coupling
D Second support arm
I
Media head/media column
E Spacer tube
J
Rotating bearing of the media head/media column
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Instructions for use Movita/Movita lift
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
Comité International Spécial des Perturbations Radioélectriques
DIN
Deutsches Institut für Normung (German Institute for Standardization)
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
This applies to Sola lights that are fastened under a support arm. Avoid collisions with people or objects
Disposal information
Warning! Strictly follow these Instructions for Use Manufacturer
Polaris
Date of manufacture
STOP
XXXX Caution!
max. XX kg
Locking of the lift system of the ceiling supply unit
Description Caution label
Observe the maximum load
CIRCUIT 1
Instructions for use Movita/Movita lift
This applies to Polaris lights that are fastened under a support arm. Avoid collisions with people or objects
For device versions with CSA mark (countries USA and Canada) Symbol
Caution!
Description
Identification label for the respective circuit of the power sockets 13
Overview
Location of information labels
For device versions with CSA mark (countries USA and Canada)
B
D
A
E
CIRCUIT 2
CIRCUIT 3
CIRCUIT 4
031
CIRCUIT 1
004
Caution label for respective circuit
Rating plate A Media column: The rating plate is located on the upper front side of the media column between the front rails.
D A caution label for the respective circuit is located on each installation plate, see "Assembly and preparation" on page 16. Identification label for the respective circuit of the power sockets E An identification label for the respective circuit is located on each power circuit (numbered sequentially from 1 to N).
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.
Sola
C
046
Polaris
Caution label for Sola lights or Polaris lights C This applies to Sola lights or Polaris lights that are fastened under a support arm. When positioning the support arms with the light, the light moves with it and can cause collisions with people or objects. The label is next to the control panel.
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Instructions for use Movita/Movita lift
Overview
Definitions of the maximum load for Dräger supply units System parts
Load description
Definition
Arm system
Maximum load capacity
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 head Media column
Racks Shelves
Instructions for use Movita/Movita lift
Position
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Assembly and preparation
Assembly and preparation
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 is based on the customerspecific assembly of the supply unit.
NOTE If the rack is loaded asymmetrically, the rack can rotate on its own. z 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. z Position the devices symmetrically on the rack. The load on the rack must be even.
CAUTION 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. 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 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 Movita/Movita lift
Assembly and preparation
Connecting the devices to an electricity supply
Connecting the probe for medical gas supply
CAUTION Risk of patient injury
WARNING Increased fire risk
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.
Gas terminal units must not come into contact with oil, grease or flammable liquids. CAUTION Also observe the respective manufacturer's instructions when using the gas terminal units.
Device combinations must correspond to the requirements of these instructions for use, see "Connection to other devices" on page 7.
NOTE The following instructions only apply to Dräger gas terminal units corresponding with the DIN standard.
CAUTION Risk of electric malfunction Do not connect any power socket strips to the power sockets of the ceiling supply unit. CAUTION Danger of device malfunctions
A
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.
006
B B
Park position
A
A Press the probe into the gas terminal unit until it engages for the first time (park position). Operating position
005
B Press the probe until it engages for the second time. 1
Connect the device mains plug (A) to the power sockets of the media head/media column.
2
Connect the potential equalization cable (B) to the potential equalization socket.
Instructions for use Movita/Movita lift
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Assembly and preparation
Connecting the probe for the AGSS (optional)
A
B
B 007
A
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.
008
Interrupting the gas supply
1
Press the probe (A) until it engages.
z If the indicator (B) turns green, the anesthetic gas scavenging is functional.
Connecting the probe for the AIR motor (optional)
009
A
1
18
Press the probe (A) until it engages.
Instructions for use Movita/Movita lift
Assembly and preparation
Connecting the cable remote control (optional)
C D B
010
A
The cable remote control is available for ceiling supply units. 1
Plug connector (A) into the receptacle. Make sure that the key of the connector goes into the groove of the receptacle.
2
Rotate the knurled screw (B) clockwise = The connector is locked in place.
z Hang the cable remote control (C) on the rail (D).
Instructions for use Movita/Movita lift
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Operation
Operation CAUTION Danger of personal injury and/or equipment damage!
The supply unit is installed as a fixed unit and is therefore always ready for operation.
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.
Releasing the locking brakes CAUTION Danger of personal injury and/or equipment damage 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 cannot be stopped with the locking brake. The bearings of the arm systems are equipped with friction or pneumatic brakes.
Friction brakes z Arm systems with friction brakes can be positioned without further preparation, see "Positioning the ceiling supply unit" on page 22.
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Pneumatic brake 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. z For arm systems with pneumatic brakes, the brake must be released using keys. The keys are installed in the media head or media column. Alternatively, for the media column, the brake keys can be integrated in a shelf or in a cable remote control.
Instructions for use Movita/Movita lift