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Related Manuals for Sutter CURIS flow
Summary of Contents for Sutter CURIS flow
- Page 1 INSTRUCTIONS FOR USE CURIS flow Irrigation pump ® REF 350950...
- Page 3 Read carefully before use and retain for future reference!
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Page 4: Table Of Contents
® CURIS flow Instructions for Use Table of contents EXPLANATION OF SYMBOLS AND ABBREVIATIONS ..............1 SYSTEM DESCRIPTION ........................3 Function and meaning of the display and control elements ..........3 Intended use ........................... 5 2.2.1 Purpose ........................... 5 2.2.2 Contraindications ...................... -
Page 5: Explanation Of Symbols And Abbreviations
1 Explanation of symbols and abbreviations Warning, attention Note Temperature limit Relative humidity limit Air pressure limit Medical device Compliant with Regulation 2017/745/EU (MDR) Sale restricted to attending physicians (USA) Disposal notice (WEEE symbol) Manufacturer Manufacturing date Catalog number Serial number Observe the instructions for use Potential equalization / PA... - Page 6 Alternating current Ampere/meter Centimeter dB(A) Assessed sound pressure level Electromagnetic compatibility Electrostatic discharge Gigahertz Hectopascal High frequency Hertz Kilogram Kilohertz Kilovolt Meter Milliampere Milliliter max. Maximum Megahertz Minute Millimeter Potential equalization Radio frequency Volt Volt-ampere Effective value eff. Volt/meter Watts...
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Page 7: System Description
2 System description The CURIS flow is an irrigation pump for the supply of isotonic saline solution to the surgical area ® with the integrated peristaltic pump, an insertable irrigation tubing and a bipolar irrigation instrument. The selected flow setting is displayed on the irrigation pump and can be changed using a control element. - Page 8 Back of the device: Connection socket For the optional CURIS flow one-pedal footswitch with push-button (REF: 360115) ® Mains cable connection socket PE connection for electric potential equalization To establish a potential equalization connection in rooms where potential equalization is required Type plate Bottom of the device:...
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Page 9: Intended Use
2.2 Intended use 2.2.1 Purpose The Sutter irrigation pump is indicated to provide sterile isotonic saline solution for improved procedural site visualization. 2.2.2 Contraindications No contraindications that apply to the product directly are known at this time. The safety measures... -
Page 10: Potential Equalization Connection
3.2 Potential equalization connection Potential equalization is a connection of device housings with good electrical conductivity. It is intended to ensure that the devices consistently maintain the same electrical potential, even in case of an electrical defect. For optional potential equalization, use the potential equalization connection (11). Push the potential equalization cable on firmly until it snaps into place. -
Page 11: Inserting The Bipolar Cord And Tubing Set
Failure to comply can result in user injury! NOTE Sutter recommends using compatible bipolar cord / tubing sets or irrigation tubing. Using other bipolar cord / tubing sets or irrigation tubing may cause deviating fluid volumes (excess or short dosing of the irrigation fluid) and failure of the irrigation pump. -
Page 12: Operation
4. Priming the tubing set: Switch on the device with the power switch on the front of the device (1). Release the clamp on the irrigation tubing and then start priming using one of the following two methods (4a or 4b). a. -
Page 13: Additional Operating Functions
The CURIS flow Irrigation pump offers the possibility to select 20 flow settings from ® 0 to 20. When the recommended bipolar cord / tubing set or irrigation tubing is used, these correspond to 0 to 20 ml/min. Check the selected flow setting before each use and adjust if required. NOTE In principle, select the lowest flow setting for the required irrigation and increase the flow rate if needed. -
Page 14: Decommissioning
4.2 Decommissioning No special measures are required to take the device out of operation. Turn the device off with the power switch on the front of the device (1). Subsequently, open the lock lever of the rotary pump (8) and remove the inserted tubing set. -
Page 15: Cleaning And Disinfection
For troubleshooting see below table or turn off the irrigation pump with the power switch (1) on the front of the device, check all connections, and turn the device back on with the power switch. If the LED status indicator (5) still lights up red, contact your Sutter representative or the manufacturer. - Page 16 (1). Device is defective, service case. Internal power supply defective Contact your Sutter representative or the manufacturer Flow setting control Replace rotary encoder. element (3) has no Rotary encoder is defective...
- Page 17 / used. tubing set or irrigation tubing Replace rotary pump rollers. The rollers located in the rotary Contact your Sutter representative pump (7) must be replaced or the manufacturer CURIS® flow one-pedal footswitch cable is not or not...
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Page 18: Maintenance And Repair
The product may only be repaired by the manufacturer or persons/organizations authorized by the manufacturer. Otherwise the warranty and any possible additional liability claims against the manufacturer are voided. Contact your Sutter representative or the manufacturer for repair or replacement. Warning Unauthorized changes can cause malfunctions or failure of the irrigation pump. -
Page 19: Transportation And Packaging
Never use cleaning agents that may attack the plastic surfaces, such as instrument cleaners, scouring cleaning agents, or cleaners containing solvents. Technical data – CURIS® flow one-pedal footswitch with push-button IEC 60601-1 Standards IEC 60529 Class Class I according to Regulation 2017/745/EU Material Pedals made of break-proof, self-extinguishing thermoplastic material, cast aluminum housing... -
Page 20: Claims For Damages
9.3 Returns Use the original packaging to return a device to Sutter or a Sutter service center. If this is not available, packaging that properly protects the device being returned is mandatory. In case of improper packaging, liability rests exclusively with the sender. The following accompanying documents must be included: •... -
Page 21: Technical Information
10 Technical information 10.1 Technical data, standards, certification Mains connection 100 - 240 V; 50 / 60 Hz Power consumption Max. 30 VA Protection class Type CF (Cardiac Floating); defibrillator safe Protection level IP21 (protection against finger contact/foreign objects larger than 12 mm. Protection against vertically dripping water) Classification acc. -
Page 22: Electromagnetic Emissions
10.2.1 Electromagnetic emissions Measurement of emitted Compliance Electromagnetic environment guidelines interference The emission of electromagnetic energy by the High-frequency emitted CURIS flow Irrigation pump while fulfilling its ® interference according to Group 1 intended function is unavoidable. Nearby electronic CISPR 11 equipment may be affected. - Page 23 0 % U 0 % U connecting the CURIS flow ® Irrigation pump to an uninterruptible (100 % drop in U (100 % drop in U power supply or a battery. for 1 period for 1 period at 0 degree at 0 degree 70 % U 70 % U...
- Page 24 Interference Test level Compliance level Electromagnetic environment – resistance tests according to guidelines IEC 60601 385 MHz 385 MHz Portable and mobile radio devices Pulse modulation Pulse modulation should not be used closer to the 18 Hz 18 Hz CURIS flow Irrigation pump, ®...
- Page 25 Interference resistance Test level Compliance level Electromagnetic environment/ tests/standard according to guidelines IEC 60601 Portable and mobile radio devices Conducted HF interference should not be used closer to the 150 kHz to 80 MHz according to 150 kHz to 80 MHz CURIS flow Irrigation pump, including ®...
- Page 27 +49 (0) 7641 96256-0 Fax: +49 (0) 7641 96256-30 E-mail: info@sutter-med.de www.sutter-med.de Only for US: Distributed by: Sutter Medical Technologies USA 3159 Royal Drive, Suite 340 Alpharetta, GA 30022 - USA Office phone: +1 678–336–9353 Fax number: +1 470–308–3155 E-mail: info@sutter-usa.com...
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