Related Manuals for Dräger Gemina DUO
Summary of Contents for Dräger Gemina DUO
- Page 1 Instructions for use GeminaDUO Wall supply unit WARNING To properly use this medical device, read and comply with these instructions for use.
- 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.
- 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.
- Page 4 Target groups Duties of the operating organization Service personnel Task Requirement The tasks described in this document specify the requirements that have to be met by each Installation Specialist knowledge in respective target group. electrical engineering and Basic service mechanics The operating organization of this product must activities ensure the following:...
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Page 5: Table Of Contents
Contents Contents Safety-related information ....Reprocessing......37 General safety information . - Page 6 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 7: Safety-Related Information
Safety-related information Safety-related information General safety information Service The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING WARNING and CAUTION statements specific to Risk if service is not performed regularly subsystems or particular features of the medical If service is not performed regularly, device appear in the respective sections of these malfunctions may occur, which can result in... - Page 8 Safety-related information Accessories Safe connection with other electrical equipment WARNING WARNING Risk due to incompatible accessories Risk of patient injury The use of incompatible accessories may adversely affect the functional integrity of the Electrical connections to equipment not listed product. Personal injury and property damage in these instructions for use or these may occur as a consequence.
- Page 9 Safety-related information Patient safety Electromagnetic compatibility (EMC) The design of the medical device, the Medical electrical equipment is subject to special accompanying documentation, and the labeling on precautionary measures concerning the medical device are based on the assumption electromagnetic compatibility. During installation that the purchase and the use of the medical device and before initial operation, follow the information in are restricted to persons familiar with the most...
- Page 10 Safety-related information Storing the instructions for use WARNING Risk due to electromagnetic disturbance CAUTION Wireless communication devices (e.g., Risk of incorrect use cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical Instructions for use must be kept accessible to the devices) emit electromagnetic radiation.
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Page 11: Product-Specific Safety Information
Safety-related information Product-specific safety information WARNING WARNING Risk of personal injury and equipment Risk of personal injury and equipment damage damage The complete system must meet all regulatory The supply unit must be in flawless operation or technical requirements and approvals after condition. - Page 12 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 13: Overview
Overview Overview Front view (example of use) A Media column on the right Infusion pole for syringe pumps and volumetric infusion pumps B Media column on the left J Indirect ceiling light on the media column C Night light on the media column (optional) (optional) D Compact rail (optional) K Shelf, e.g., for monitor... -
Page 14: Side View (Example Of Use)
Overview Side view (example of use) Infusion side on the left and ventilation H Emergency call socket for connecting a remote control side on the right Telephone socket TAE 6F A Gas terminal unit or vacuum terminal unit B Network connection C Potential equalization socket D Power socket E Monitor port... -
Page 15: Abbreviations
Overview Abbreviations Abbreviation Explanation Abbreviation Explanation AGSS Anesthetic gas scavenging system Electromagnetic compatibility Medical compressed air Electrostatic Discharge CISPR Comité International Spécial des IACS Infinity Acute Care System Perturbations Radioélectriques, International Electrotechnical International Special Committee on Commission Radio Interference International Organization for Canadian Standards Association Standardization Deutsches Institut für Normung... - Page 16 Overview Location of information labels Device versions with CSA mark (USA and Canada) Rating plate Caution label for respective circuit C A caution label for the respective circuit is A The rating plate is located at the bottom right on located on each installation plate, see the media column.
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Page 17: Definitions Of The Load Descriptions
Overview Definitions of the load descriptions for Dräger supply units System parts Load description Definition Position Media column Maximum load Maximum load that can be applied to the media column. Racks Payload Maximum load minus the weight of racks/shelves. Shelves Instructions for use GeminaDUO... - Page 18 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 19: Application
Application Application Intended use Medical wall supply unit for intensive care and – Mounting Dräger workstation components postoperative areas for – Providing additional facilities, e.g., – Ergonomic positioning and organization of communications interfaces, connections for medical devices and accessories central patient monitoring, telephone –... -
Page 20: Variants
Application Variants The configuration of the care place is generally The care place configuration is available in three chosen to meet customer needs. different variants: – 1 media column per bed – 1 media column with media supply on both sides for 2 beds –... -
Page 21: Assembly And Preparation
Assembly and preparation Assembly and preparation Height adjustment of the shelf holder The shelf holder is mounted on the 38 mm 1 Loosen the M6 x 16 hexagon socket screws (B) (1.50 in) Ø support pole on the media column. on the shelf holder (A) by 2 turns. -
Page 22: Fitting The Compact Rail (Optional)
Assembly and preparation Fitting the compact rail (optional) The compact rail is used for mounting e.g., infusion 1 Place both compact rail halves (A) + (B) around holders and is mounted on the 38 mm (1.50 in) Ø the support pole (C) and screw them together at support pole of the media column. -
Page 23: Connecting The Electrical Devices
Assembly and preparation Connecting the electrical devices 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 CIRCUIT 1 CIRCUIT 2 by each respective manufacturer. Device combinations must comply with the requirements of these instructions for use, see CIRCUIT 3... -
Page 24: Laying Cables And Hoses (Cable Management)
Assembly and preparation Laying cables and hoses (cable management) WARNING Risk of electric shock Electric shock may result if damaged cables are put in the cable organizer. Make sure that damaged cables are not put in the cable organizer. WARNING Risk of electric shock Electric shock may result if single-insulated cables are put in the cable organizer. -
Page 25: Connecting Gas Probes For The Gas Supply (Applies Only To Dräger Din Terminal Units)
Assembly and preparation Connecting gas probes for the gas supply (applies only to Dräger DIN terminal units) WARNING Increased fire risk Terminal units must not come into contact with oil, grease or flammable liquids. CAUTION Risk of device malfunction Also observe the respective manufacturer's instructions when using the gas terminal units. -
Page 26: Connecting The Probe For The Anesthetic Gas Scavenging (Optional)
Assembly and preparation Connecting the probe for the anesthetic gas scavenging (optional) 1 Push the probe (A) until it engages. If the indicator (B) turns green, the anesthetic gas scavenging is functional. Connecting the probe for the AIR motor (optional) ... -
Page 27: Connecting Iacs Components (Optional)
Assembly and preparation Connecting IACS components (optional) Connecting IACS components to the Interfaces IACS system cable Information on the interfaces can be found in the instructions for use for the corresponding CAUTION IACS component. Risk of incorrect use When medical displays or patient monitors from a Information labels third-party manufacturer are used with the IACS system, the corresponding instructions for use... - Page 28 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 29: Operation
Operation Operation WARNING CAUTION Risk of touch voltages on the patient The supply unit must be checked for proper operation before each use. Touch voltages on the patient may arise if the patient and a conductive interface are touched at the same time. Avoid touching the patient and the conductive interface at the same time. -
Page 30: Adjusting The Shelf
Operation Adjusting the shelf Adjusting the height of the shelf The shelf for mounting monitors is fitted to the 38 mm (1.50 in) Ø support pole on the media column. 1 Unload the shelf. 2 Adjust the height of the shelf holder, see "Height adjustment of the shelf holder"... -
Page 31: Removing The Cable Support (Optional)
Operation Removing the cable support (optional) CAUTION Risk of injury When removing the cable support, make sure that your thumbs do not hit against the support pole. Two-sided cable support To release the cable support, pull the upper edge of the cable support (A) towards your body with both hands and simultaneously press your thumbs against the middle part. -
Page 32: Lighting (Optional)
Operation Lighting (optional) Indirect ceiling light and night light WARNING Danger of overheating The supply unit can be equipped with an indirect The supply unit can overheat if objects are ceiling light (A) and a night light (B), depending on placed in the area of the light fittings. - Page 33 Operation Switching the lighting on and off with the switch Switching the lighting on and off with the touch (optional) dimmer (optional) 1 To turn on the lighting, operate the switch (A). 1 To turn on the lighting, press the touch dimmer (B) briefly.
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Page 34: Noise Display (Optional)
Operation Noise Display (optional) The Noise Display indicates in color the current noise level at the installation location. Thus the Noise Display aids the detection and regulation of noise pollution. – The Noise Display may only be operated beyond the reach of patients. –... -
Page 35: Troubleshooting
Troubleshooting Troubleshooting NOTE For more information on troubleshooting fixtures for other installed devices, please see the respective instructions for use. Fault – Cause – Remedy Fault Cause Remedy Insufficient gas supply, hissing Compressed gas is escaping Have the gas supply checked by sound. - Page 36 Troubleshooting Replacing the LED bulb in the upper or 8 Perform a functional test. lower end cap Do not touch the light element when doing this. 9 Disconnect the system from the power supply. The disassembly/assembly of the upper end cap is described in this section.
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Page 37: Reprocessing
Reprocessing Reprocessing Information on reprocessing Instructions for reprocessing are based on WARNING internationally accepted guidelines, e.g., standard Risk of fire ISO 17664. Do not use any flammable cleaning agents in the vicinity of the terminal units or power Safety information sockets. -
Page 38: Classifications For Reprocessing
Reprocessing Classifications for reprocessing Classification of medical devices Medical devices and their components are classified according to the way they are used and the resulting risk. Classification Explanation Non-critical Components that come only into contact with skin that is intact Semi-critical Components that carry breathing gas or come into contact with mucous membranes or pathologically altered skin... -
Page 39: Reprocessing Methods
Reprocessing Reprocessing methods Validated reprocessing procedures At the time of product-specific validation, the following reprocessing procedures showed good material compatibility and effectiveness: Procedure Agent Manufacturer Concentration Contact time ® Surface disinfection with Dismozon plus Bode Chemie 1.6 % 15 min cleaning ®... - Page 40 Reprocessing Disinfectants The manufacturers of the surface disinfectants have verified at least the following spectra of activity: Use disinfectants that are nationally approved and are suitable for the particular reprocessing – Bactericidal procedure. – Yeasticidal – Virucidal or virucidal against enveloped viruses Surface disinfectant Observe the specifications of the surface At the time of the test, the surface disinfectants...
- Page 41 Reprocessing Surface disinfection with cleaning WARNING Risk due to penetrating liquid Penetrating liquid may cause the following: – Damage to the device – Electric shock – Device malfunctions Ensure that no liquid penetrates the device. 1 Remove soiling immediately. Use a cloth dampened with disinfectant to remove soiling.
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Page 43: Maintenance
Maintenance Maintenance Overview This chapter describes the maintenance measures required to maintain the proper functioning of the medical device. Maintenance measures must be performed by the personnel responsible. WARNING Risk if service is not performed regularly Wear and material fatigue of the components may lead to device failure and malfunctions. - Page 44 Maintenance Definitions of service terminology Concept Definition Service All measures (inspection, maintenance, repair) intended to maintain or restore the functional integrity of a product Inspection Measures intended to determine and assess the current state of a product Maintenance Regular specified measures intended to maintain the functional integrity of a product Repair Measures intended to restore the functional integrity of a product after a failure...
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Page 45: Inspection
Maintenance Inspection Regular inspections must be carried out according to the following specifications and at the specified intervals. Technical documentation is available on request. WARNING Risk of electric shock Before carrying out any work, disconnect all electrical connections from the power supplies. -
Page 46: Maintenance
Maintenance Maintenance WARNING Risk of electric shock Before carrying out any work, disconnect all electrical connections from the power supplies. Table of maintenance intervals Component Interval Task Personnel responsible Dräger gas terminal Every 6 years Replacement of the Specialized service personnel units O-ring and flat sealing ring wearing parts, see... -
Page 47: Repair
Maintenance Repair WARNING Dräger recommends that all repairs are performed by DrägerService and that only authentic Dräger repair parts are used. Instructions for use GeminaDUO... - Page 48 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 49: Disposal
Disposal Disposal Disposing of medical devices At the end of its service life: Consult the relevant waste disposal company for appropriate disposal. Observe the applicable laws and regulations. For countries subject to the EU Directive 2002/96/EC This device is subject to EU Directive 2002/96/EC (WEEE). - Page 50 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 51: Technical Data
Technical data Technical data EMC declaration General information by Dräger, it must be ensured that this device functions correctly in the desired arrangement before use. The instructions for use for the other This device was tested for electromagnetic devices must be followed. compatibility using accessories from the list of accessories. - Page 52 Technical data Immunity against Test level and required electromagnetic environment Electrostatic discharge (ESD) (IEC 61000-4-2) Contact discharge: ±8 kV Air discharge: ±15 kV Fast transient electrical disturbances (bursts) Power cable: ±2 kV (IEC 61000-4-4) Longer signal input lines/output lines: ±1 kV Impulse voltages (surges) (IEC 61000-4-5) Voltage, external conductor –...
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Page 53: Product Characteristics
Technical data Product characteristics Mechanical data Length of media column 1500 mm (59.06 in) Usable length of the 1300 mm (51.18 in) 38 mm (1.5 in) Ø support pole Weight of the media column 50 kg (110.23 lb) including media supply (no accessories) Total weight of wall supply unit 200 kg (440.92 lb) - Page 54 Technical data Color Media column White, NCS-S-0500 N Installation plate Aluminum-colored, anodized White, NCS-S-0500 N Dräger munsell blue or conforming to the Color-Line concept Ambient conditions During operation Temperature +10 °C to +40 °C (+50 °F to +104 °F) Atmospheric pressure 700 hPa to 1060 hPa (10.2 psi to 15.4 psi) Relative humidity 5 % to 95 % (non-condensing)
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Page 55: Data Exchange And Interfaces
Technical data Data exchange and interfaces Video connection BNC connector Socket conforming to IEC 61169-8 Pin assignment Inner conductor: Signal Outer conductor: Ground, shielding Signal SDI/HD-SDI Serial, digital video signals conforming to SMPTE 292M over a coaxial cable (75 Ω) Output voltage 800 mV (±10 %) (–48 mV ÷... - Page 56 Technical data Video connection S-Video connector Mini DIN S-Video socket (HICON S-VHS) Pin assignment 1 Y ground 2 C ground 3 Luminance (Y) 4 Chrominance (C) Signal S-Video Analog video signals (Y-C Component Video) Output voltage NTSC Setup 53.57 mV 714.29 mV (peak luma, 100 % white) 626.70 mVpp (75 % color bars) 835.60 mVpp (100 % color bars)
- Page 57 Technical data Video connection VGA connector DE-15/HD-15 socket Pin assignment 1 Red (analog) 2 Green or monochrome (analog) 3 Blue (analog) 4 Not used 5 Ground for DDC (digital) 6 Ground for Red (analog) 7 Ground for Green 8 Ground for Blue (analog) (analog) 9 Not used 10 Ground for...
- Page 58 Technical data Video connection DVI connector Standard DVI socket Pin assignment 20 19 Data (Link1) Shielding Data (Link2) Plug & Play Clock Analog 1 Data 2- 2 Data 2+ 3 Shielding for Data 2 and 4 4 Data 4- 5 Data 4+ 6 DDC clock 7 DDC data 8 Vsync...
- Page 59 Technical data Video connection HDMI connector Socket Type A Pin assignment 19 17 15 13 11 18 16 14 12 10 1 Data 2+ 2 Shielding for Data 2 3 Data 2- 4 Data 1+ 5 Shielding for Data 1 6 Data 1- 7 Data 0+ 8 Shielding for Data 0...
- Page 60 Technical data Audio port Cinch connector Pin assignment Inner conductor: Signal Outer conductor: Ground, shielding Signal Audio signal Stereo, analog audio frequency signal Maximum output voltage 30 V Maximum output current Power <10 W Data connection RJ45 connector Socket conforming to EIA/TIA-568A/B Pin assignment 1 2 3 4 5 6 7 8 1 TD+...
- Page 61 Technical data Telecommunications port TAE connector Telephone socket with a/b interface of type NTA Pin assignment 1 Line a 2 Line b 3 Not used 4 Ground 5 Looped-through line b 6 Looped-through line a Signal Telecommunications Analog audio frequency signals (e.g., frequency band from 300 Hz to 3400 Hz for a full-duplex speech channel) Output voltage 60 V (50 V to 72 V)
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Page 62: Maximum Load
Technical data Maximum load Load center on the media column WARNING Risk of overloading the device The maximum load depends on the configuration of the supply unit. The values specified in the instructions for use are maximum values. The device-specific maximum load is specified on the information label on the device. -
Page 63: List Of Accessories
List of accessories List of accessories WARNING Risk due to incompatible accessories The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. Use only compatible accessories. The accessories compatible with this product are listed in the current list of accessories for supply units (G15600) and in the list of... - Page 64 This page has been left blank intentionally. Instructions for use GeminaDUO...
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Page 65: Index
Index Index Abbreviations ......15 Media column ......13 Adjusting the height of the shelf . - Page 66 Index Video connection ....55, 56, 57 WEEE ....... . 49 Instructions for use GeminaDUO...
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- Page 68 Directive 93/42/EEC concerning medical devices Manufacturer Drägerwerk AG & Co. KGaA Moislinger Allee 53 – 55 D-23542 Lübeck Germany +49 451 8 82-0 +49 451 8 82-20 80 http://www.draeger.com 9510101 – GA 6936.260 en © Drägerwerk AG & Co. KGaA Edition: 1 –...
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