Related Manuals for COOK Medical K-MAR5200-US
Summary of Contents for COOK Medical K-MAR5200-US
- Page 1 VACUUM PUMP Vacuum Pump User Manual Please familiarise yourself with the safety instructions before using the device. Federal Law(USA) restricts this device to use by or on the order of a physician. M E D I C A L...
- Page 3 For more detailed information about disposal of this product, please contact your directive (2002/96/EC). local city o ce or Cook Medical Representative. © COOK 2017 Document No: IFU-MAR52_US-1 Service address: Please refer to your local Cook Medical distributor for details of your nearest authorised service agent.
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Page 4: Table Of Contents
Vacuum Pump Instructions for Use Table of Contents EXPLANATION OF PICTOGRAMS ..........................5 HOW TO USE THIS MANUAL . -
Page 5: Explanation Of Pictograms
Vacuum Pump Instructions for Use Explanation of Pictograms The following pictograms appear on the Vacuum Pump and the Disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) Before connection, read the manual! EC REP EC Representative Refer to IFU – Mandatory Catalogue Code Standby/On Serial Number Degree of enclosure protection from... -
Page 6: Safety Instructions
Vacuum Pump Instructions for Use 1. Safety Instructions This manual describes the operation and intended use of the Vacuum Pump and the disposables. WARNING: Please familiarise It is essential to use this document to familiarise yourself with the functions and the operation of the Vacuum Pump yourself with the safety instructions before use. -
Page 7: Installation And Set-Up
Vacuum Pump Instructions for Use 3. Installation and Set-up An installation and set-up checklist has been included at the end of this section (see §4). This may be used to help ensure correct preparation. IMPORTANT NOTE: It is important to retain packaging for future use. -
Page 8: Front Of The Device
Vacuum Pump Instructions for Use 3.3 Front of the Device Standby Indicator Indicates the powered on state, Green = Active, Orange = Standby. Standby Touch-Pad Toggles the device between Active and Standby State. Vacuum Display Displays the measured vacuum. Vacuum Adjust Indicators Indicates Set-Point adjustment. Vacuum Adjust Touch-Pad Decrease, Press to decrease the Vacuum Set-Point. -
Page 9: Supply Voltage Selection
Vacuum Pump Instructions for Use 3.5 Supply Voltage Selection WARNING: ELECTRIC SHOCK The Vacuum Pump can operate on the voltage range 100 – 240 VAC, 50 – 60 Hz. No fuse selection is required. HAZARD. Determine if the available If the voltage is changed, it may be necessary to replace the Power Cord to an appropriately rated Power Cord. voltage corresponds to your device. -
Page 10: Activating The Device
Vacuum Pump Instructions for Use 3.10 Activating the Device WARNING: ELECTRIC SHOCK • Connect the Power Cord to the Power Inlet. The Standby Indicator should light up. HAZARD. Internal circuitry is energised • The Vacuum Pump will either be in the standby mode or active mode depending on the last state the device was whenever the Vacuum Pump is in when mains power was disconnected. -
Page 11: Set Foot Pedal
Vacuum Pump Instructions for Use 3.13.3 Set Foot Pedal Function IMPORTANT NOTE: This To change the setting. keystroke must be entered correctly to change the Foot Pedal Function. Ensure that the Vacuum Pump is in standby mode by using the Standby Touch-Pad. If the Vacuum display does not indicate Press the following sequence of Touch-Pads on the front panel to enter set Foot Pedal Function mode where Latching or Non-Latching Mode, retry... -
Page 12: Pre-Operation Test
Vacuum Pump Instructions for Use 3.16 Pre-Operation Test WARNING: ELECTRIC SHOCK • Connect the Foot Pedal and the disposable Vacuum Line with Hydrophobic Filter (K-DVLF-240) to the Vacuum Pump. HAZARD. Internal circuitry is energised • Switch the device on. whenever the Vacuum Pump is connected to mains power irrespective •... -
Page 13: Operation Of The Device
Vacuum Pump Instructions for Use 5. Operation of the Device This section provides general information about the use of the Vacuum Pump. Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must IMPORTANT NOTE: To ensure decide on the speci c technique and procedure that will accomplish the desired clinical e ect. -
Page 14: Service And Maintenance
Vacuum Pump Instructions for Use 6. Service and Maintenance To preserve the Vacuum Pump and ensure its proper functioning, proper service, maintenance and storage must be provided for. To protect the patient from infection, all disposables that come into contact with human tissue (eg. IMPORTANT NOTE: To test tubes and tubing) must be sterile. -
Page 15: Inspection By An Authorised Service Agent
Vacuum Pump Instructions for Use 6.3 Inspection by an Authorised Service Agent WARNING: No user serviceable parts inside! Inspections at least once a year For ongoing operational safety of the device, an authorised service agent must maintain the Vacuum Pump annually as per SMA30001. The service agent will assess the operational functionality of the vacuum system. -
Page 16: Technical Data
Vacuum Pump Instructions for Use 8. Technical Data Classi cation according to IEC 60601-1 Type of protection against electric shock: Class I equipment Degree of protection against electric shock: Type B Degree of protection against harmful ingress of solids and water: IP41 Speci cations Power Supply:... - Page 17 Vacuum Pump Instructions for Use Guidance and manufacturer’s declaration – electromagnetic emissions The Vacuum Pump is intended for use in the electromagnetic environment specified below. The customer or the end user of the Vacuum Pump should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance...
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Page 18: Troubleshooting
Vacuum Pump Instructions for Use Recommended separation distance between portable and mobile RF communications equipment and the Vacuum Pump The Vacuum Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Vacuum Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Vacuum Pump as recommended below, according to the maximum output power of the communications equipment. -
Page 19: Limited Warranty
Vacuum Pump Instructions for Use 10. Limited Warranty COOK AUSTRALIA warrants to the purchasers of this device that at time of manufacture, the product was prepared and tested in accordance with good manufacturing practices and guidelines speci ed by the Australian Therapeutic Goods Administration or relevant competent authority. In the event of product failure under normal use, due to defects in material or workmanship, within a period of one (1) year from the date of purchase, the product will be repaired, or at Cook’s option, replaced, at no charge. -
Page 20: Index
Vacuum Pump Instructions for Use 11. Index About the K–MAR–5200....................6 Non-Latching Foot Pedal Function ................10 Activating the Device ..................... 10 Alarm Indicator ........................ 17 Operation of the Device ....................13 Aspiration Line ........................9 Original Disposables ....................6, 15 Authorised Service Agents ..................15 Patient Tube Connection ....................8 Biannual Functionality Testing ................... - Page 24 Americas: EDI – www.cookmedical.com/edi.do Phone: +1 812.339.2235, 800.457.4500, Fax: 800.554.8335 E-mail: orders@cookmedical.com Manufacturer WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 Brandl Street, Brisbane Technology Park, Eight Mile Plains, Brisbane M E D I C A L QLD 4113, AUSTRALIA © COOK 10/2017 IFU-MAR52_US-1...
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