Instructions for Use
48 Pages
Preview
Page 1
Instructions for Use
Ponta C/H/E/S
WARNING To properly use this medical device, the user must obtain a full understanding of the performance characteristics of this medical device prior to use by carefully reading these Instructions for Use.
Intensive care supply units
Trademarks –
Ponta®
–
Incidin®
–
DrägerService®
–
Dismozon® Terralin®
are trademarks owned by Dräger.
–
are trademarks of other manufacturers.
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".
2
Instructions for Use Ponta C/H/E/S
Table of Contents
Table of Contents For Your Safety and that of Your Patients . .
4
General safety information... Product-specific safety information...
4 7
Application...
8
Intended Use... Versions...
8 9
Overview... 10 Supply unit... 10 Shuttle... 14 Lighting... 16 Abbreviations... 18 Symbols... 18 Definitions of the maximum load... 20 Assembly and preparation... 21 Positioning and connecting devices... 21 Operation... 23 Sliding the racks... 23 Rotating the rack... 25 Lighting... 29 Troubleshooting... 32 Fault – Cause – Remedy... 32 Changing the bulbs... 33 Cleaning, Disinfection and Sterilization... 35 Care... 35 Reprocessing list... 36 Maintenance... 37 Disposal... 38 Disposal of the Medical Device... 38 Technical Data... 39 EMC declaration... 39 Product Characteristics... 43 List of accessories... 46 Instructions for Use Ponta® C/H/E/S
3
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 any other product being used with this device.
Strictly follow these Instructions for Use WARNING 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 8. 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.
Maintenance WARNING The medical device must be inspected and serviced regularly by professionals who possess the required qualifications due to their training and experience. Repair of the medical device must also be performed by trained personnel with additional product-specific DrägerService training. Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. Dräger further recommends that only authentic Dräger repair parts are used for maintenance. If the above are not complied with, the correct functioning of the medical device may be compromised. See chapter "Maintenance" on page 37.
Safety inspections The medical device must be subject to regular safety checks. See chapter "Maintenance".
Not for use in areas of explosion hazard WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.
4
Instructions for Use Ponta C/H/E/S
For Your Safety and that of Your Patients
Accessories
Connection to other devices
WARNING Only the accessories indicated on the G 15 600 list of accessories (1st edition or higher) have been tested and approved for use with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised.
Device combinations approved by Dräger (see Instructions for Use of the individual devices) meet the requirements of the following standards:
Connected devices
–
IEC 60601-1 (EN 60601-1, 2nd Edition) Medical electrical equipment Part 1: General requirements for safety
–
IEC 60601-1-1 (EN 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 (EN 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests
–
IEC 60601-1-4 (EN 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems
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 correct functioning 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.
Safe connection with other electrical equipment CAUTION Risk of patient injury
If Dräger devices are connected to other Dräger devices or third-party devices and the resulting combination is not approved by Dräger, the correct functioning of the devices may be compromised. The owner is responsible for ensuring that the resulting system meets the requirements of the applicable standards. Strictly observe Assembly Instructions and Instructions for Use for each networked device.
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 Ponta C/H/E/S
5
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 trained professionals, and that certain inherent characteristics of the medical device are known to the trained user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These Instructions for Use do not contain references to various hazards which are obvious to professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous.
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. Strictly observe Assembly Instructions and Instructions for Use.
Training Training for users is available from the Dräger organization responsible, see www.draeger.com.
Information on Electromagnetic Compatibility 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 39. Portable and mobile RF communications equipment can affect medical electrical equipment.
6
Instructions for Use Ponta C/H/E/S
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 customer must make the right choice. Dräger assumes no warranty and no liability for parts from third-party manufacturers or the functionality of third-party manufacturers' products. Only trained personnel may carry out subsequent installation.
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.
NOTE Certifications depend on market-specific components (e.g. gas terminal units and power sockets).
WARNING Danger of overheating The supply beam can overheat if objects are placed on the supply beam in the area of the light fittings.
The supply unit must be in flawless operation condition. Damage of 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.
NOTE According to this, the CSA mark is only valid for devices equipped with components for the North American market.
Do not place objects on the supply beam. WARNING Danger of electric shock. The device housing must not be opened.
Functional safety This device does not have any Essential Performance features as defined by IEC 60601-1-2.
WARNING Increased fire risk. Gas terminal units must not come into contact with oil, grease or flammable liquids. CAUTION Danger of personal injury and/or equipment damage Whenever positioning the shuttle and devices attached to this, take care not to injure persons or damage objects. Move the shuttle carefully.
Instructions for Use Ponta C/H/E/S
7
Application
Application
Intended Use Ponta C/H/E/S Medical supply units for intensive care and postoperative areas for –
Ergonomic positioning and organization of medical devices and accessories
–
Supply of medical devices with power, medical gases and vacuum
–
Mounting of Dräger workstation components (WSC)
–
Preparation of additional equipment, such as connections for central patient monitoring, telephone, etc.
–
Integration of lighting systems such as indirect room lighting, reading/examinations lights, night light, etc.
Medical devices are supplied with power or medical gases via a supply beam fastened to the ceiling. The medical devices are positioned/placed in rotating and sliding racks in the supply beam Ponta; media is supplied via terminals that are integrated in either the supply beam or in the media column/head. In this way, each workspace can be optimally adapted to the respective requirement.
8
Instructions for Use Ponta C/H/E/S
Application
Versions WARNING Only the accessories indicated on the G 15 600 list of accessories (1st edition or higher) have been tested and approved for use with the medical device. Therefore, it is strongly recommended that only these accessories are used in conjunction with the medical device. Otherwise, the correct functioning of the medical device may be compromised. WARNING Components that have been subsequently installed on the medical device must correspond to all regulatory or technical requirements and approvals. The customer must make the right choice. Dräger assumes no warranty and no liability for parts from third-party manufacturers or the functionality of third-party manufacturers' products. Only trained personnel may carry out subsequent installation. If the above are not complied with, the correct functioning of the medical device may be compromised. 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.
–
Shuttle with media column or media head; media head can be combined with rack or pole
–
Shuttle with pivoting arm and media column or media head; media head can be combined with rack or pole
–
Media supply in media column or media head; additional equipment possible in the supply beam.
Ponta E –
Shuttles with racks or pole
–
Shuttles with media column or media head; media head can be combined with rack or pole; media supply in media column or media head; additional equipment possible in the supply beam.
Ponta S –
Shuttles with racks or pole
–
Shuttle with pivoting arm and media column or media head; media head can be combined with rack or pole
–
Media supply in media column or media head; additional equipment possible in the supply beam.
The supply unit Ponta can be supplemented with accessories that are shown in the G 15 600 accessory list.
The supply unit Ponta can be supplied in four different versions: Ponta C –
Shuttles with racks or pole; media supply in the supply beam
Ponta H –
Shuttles with racks or pole
Instructions for Use Ponta C/H/E/S
9
Overview
Overview
Supply unit
Ponta C
B GH A
F
I
B
J
C
D
A
B GH
C
A J
I
F
K
E
001
L A Supply beam B Spacer tube C Shuttle D Pole E Racks F Gas terminal units and power sockets G Indirect ceiling light (optional biodynamic light or RGB light) H Night light (optional) I
Reading and examination light (optional)
J
Rating plate
K Control panel for RGB light (optional) L Remote control for RGB light (optional)
10
Instructions for Use Ponta C/H/E/S
Overview
Ponta H
B
I
A
J K
L
A
M
C G
H
J K
C H
L
C H
G
M
I
G O F
D E N B
I
L
A
J K
A
M
C
P
J K
H O
H
I C
M
L
D E
P
A Supply beam B Spacer tube C Shuttle D Media head with rack E Media column F Media head with pole G Pivoting arm H Media feed hoses I
002
N J
Indirect ceiling light (optional biodynamic light or RGB light)
K Night light (optional) L Reading and examination light (optional) M Rating plate N Floor light (optional) O Control panel for RGB light (optional) P Remote control for RGB light (optional)
Gas terminal units and power sockets
Instructions for Use Ponta C/H/E/S
11
Overview
Ponta E NOTE The supply beam system allows any combination of the shuttles for the E and S version.
G
B
J
H I
A K
C
C
A
G K
H I C M
D
J
F N
E
003
L A Supply beam B Spacer tube C Shuttle D Media head with rack E Media column F Media head with pole G Gas terminal units and power sockets H Indirect ceiling light (optional biodynamic light or RGB light) I
Night light (optional)
J
Reading and examination light (optional)
K Rating plate L Floor light (optional) M Control panel for RGB light (optional) N Remote control for RGB light (optional)
12
Instructions for Use Ponta C/H/E/S
Overview
Ponta S NOTE The supply beam system allows any combination of the shuttles for the E and S version.
B I J
G
K C
A L
G L
I J
K
C H
A
C
H
K H N F
D
O
E 004
M A Supply beam B Spacer tube C Shuttle D Media head with rack E Media column F Media head with pole G Gas terminal units and power sockets H Pivoting arm I
Indirect ceiling light (optional biodynamic light or RGB light)
J
Night light (optional)
K Reading and examination light (optional) L Rating plate M Floor light (optional) N Control panel for RGB light (optional) O Remote control for RGB light (optional)
Instructions for Use Ponta C/H/E/S
13
Overview
Shuttle
Ponta C
Ponta H
D
A Guide handle/media rail B Rotary knob for mechanical rotation brake
B
A
C
005
A B C
D E
C Rotary knob for mechanical linear brake D Roller track
D E
006
F
A Roller track B Guide handle/media rail C Media feed hoses D Keypad for pneumatic braking system of the shuttle and the pivoting arm (positioned at the media head or at the media column) E Key for linear brake (shuttle) and column bearing/head bearing (optional) F Key for rotation brake (pivoting arm) and column bearing/head bearing (optional)
14
Instructions for Use Ponta C/H/E/S
Overview
Ponta E
Ponta S
E
A
F
B
A C
D
D
A Guide handle/media rail B Roller track C Keypad for pneumatic braking system of the shuttle (positioned at the media head or at the media column) D Key for linear brake (shuttle) and column bearing/head bearing (optional) E Media channel
C D E 008
007
C
B
A Guide handle/media rail B Roller track C Keypad for pneumatic braking system of the shuttle and the pivoting arm (positioned at the media head or at the media column) D Key for linear brake (shuttle) and column bearing/head bearing E Key for rotation brake (pivoting arm) and column bearing/head bearing (optional) F Media channel
Instructions for Use Ponta C/H/E/S
15
Overview
Lighting A Supply beam B Indirect ceiling light (optional biodynamic light or RGB light) C Night light (optional) D Reading and examination light (optional)
C
B
Control panel for RGB light (optional)
A B
B A
E D B
B 035
C A Display B Function keys F1, F2, F3, F4
D
C Connect key D Jog wheel E Central key
009
A
16
Instructions for Use Ponta C/H/E/S
Overview
Remote control for RGB light (optional)
A
B C
C
D ON 2
3
4
036
1
DIP
A Infra-red transmitter B Display C Function keys D DIP switches in the battery compartment
Instructions for Use Ponta C/H/E/S
17
Overview
Abbreviations Abbreviation Explanation AGSS
Anesthetic gas scavenging system
Abbreviations for the EMC declaration
AIR
Pressurized medicinal air
Abbreviation Explanation
CSU
Ceiling supply unit
CISPR
DIN
Deutsches Institut für Normung (German Institute for Standardization)
Comité International Spécial des Perturbations Radioélectriques (International Special Committee on Radio Interference)
WSC
Workstation component
DSSS
Direct-Sequence Spread Spectrum, spread spectrum
EMC
Electromagnetic compatibility
FHSS
Frequency-Hopping Spread Spectrum, frequency hopping spread procedure
HF
High frequency
Symbols Symbol
Description
Symbol
Attention label is valid only for supply units with CSA mark (for USA and Canada). On each installation plate, an attention label for the respective circuit is attached, see "Assembly and preparation" on page 21.
Disposal information
Observe the Instructions for Use
Year of manufacture
max. XX kg
max. xx kg
Σ kg max.
18
Observe the maximum load
Description
CIRCUIT 1
Identification label for the respective circuit of the power sockets
Observe the individual and total load of the supply beam
Instructions for Use Ponta C/H/E/S
Overview
Location of information labels
A
A
032
D CIRCUIT 1
E
CIRCUIT 1 030
Supply beam rating plate A The rating plate is on the supply beam.
C
B
C
Attention label D Is valid only for ceiling supply units with CSA mark (for USA and Canada). On each installation plate, an attention label for the respective circuit is attached, see "Assembly and preparation" on page 21.
B
C
Identification label of the power socket circuits
B
033
E Is valid only for ceiling supply units with CSA mark (for USA and Canada). For each power socket, an identification label for the respective circuit is attached (numbered sequentially 1 to N).
Shuttle rating plate B The rating plate of the shuttle is on the media column or on the media head. Information label C The information label for maximum load is on the media head or media column spacer tube.
Instructions for Use Ponta C/H/E/S
19
Overview
Definitions of the maximum load for Dräger supply units System parts
Load description
Definition
Spacer tube
Maximum payload
Maximum load that can be put on the spacer tube.
Supply beam with shuttle
Maximum load
Maximum load that can be put on the shuttle.
Media column
Maximum load
Maximum load that can be put on the media head or on the media column.
Net load
Maximum load less the weight of the racks or shelves; usable for devices.
Media head
Racks Shelves
20
Position
Instructions for Use Ponta C/H/E/S