the schools [1.1 ml:<5 % U T (> 95 % dip in U T ) for 0,5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (> 95 % dip in U T ) for 5 sec <5 % U T (> 95 % dip in U T ) for 0,5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (> 95 % dip in U T ) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. If the user of the Pump requires continued operation during power mains interruptions, it is recommended that the Pump be powered from an uninterruptible power supply or a battery. Power frequency 50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 400 A/m (IEC 60601-2-24) Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: U T is the a.c. mains voltage prior to application of the test level. Electromagnetic immunity declaration The Pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Pump should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz 10 Vrms Recommended separation distance d=0.27*P 1/2 Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2,5 GHz 10 V/m d=0.27*P 1/2 80MHz to 800 MHz d=0.54*P 1/2 800MHz to 2,5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 : These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pump is used exceeds the applicable RF compliance level above, the Pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Pump. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Recommended separation distances between portable and mobile RF communications equipment and the Pump The Pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pump as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter Separation distance according to frequency of transmitter m W 150 kHz to 80 MHz d=0.27*P 1/2 80 MHz to 800 MHz d=0.27*P 1/2 800 MHz to 2,5 GHz d=0.54*P 1/2 0.01 0.03 0.03 0.05 0.1 0.09 0.09 0.17 1 0.27 0.27 0.54 10 0.85 0.85 1.7 100 2.7 2.7 5.4 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watchdog timer circuit, motor driver and motor watchdog circuits, and a voltage detector circuit. Each safety circuit performs a unique function to insure the overall safety of the device. Watchdog Timer Circuit The microprocessor must send an appropriate signal to the watchdog circuit at least once per second. If the microprocessor does not, the watchdog circuit will time out and shut down the pump controller. Watchdog timer circuitry is provided to monitor the status of the microprocessor and disable the motor and enable the audible alarm if the microprocessor fails to function properly. The microprocessor must strobe the watchdog circuit at least once every second in order to prevent the watchdog from performing its reset function. The reset output from the watchdog circuit is a pulse output. This acts to jump startˮ the microprocessor. This unique feature allows the microprocessor to test the watchdog circuit on every power-up. By setting a flag in the memory and not strobing the watchdog, the microprocessor can force a watchdog time-out. After being reset, the microprocessor checks the status flag to see if this was a time-out test. If so, the microprocessor continues normal power-up activities. If the reset occurred when the microprocessor was not expecting it, the microprocessor traps the event, sounds the audible alarm and displays an error message on the LCD. Motor Driver/Motor Watchdog Circuit Motor drive circuitry is composed of a series of power FET transistors, passive components, and 2 voltage comparators. Built into the motor drive circuitry is an RC timer which times how long the motor runs each time it is turned on. If the motor runs for more than an average of 3 seconds, the circuit will time out and disable the motor. A unique feature of this circuit is that control lines to and from the microprocessor circuit allow the microprocessor to perform a complete functional test of the motor drive circuit without running the motor. The microprocessor performs this test function every several minutes to assure its continued functionality. An input from the watchdog circuit prevents motor operation if the watchdog timer expires. The software verifies this function during the watchdog test described above. Voltage Detector Circuit Low voltage detection is performed by part of the watchdog circuit and by the microprocessor via software. Three low voltage levels are detected. The first 2 levels are detected by software and the third by hardware. The first level to be reached is the low battery warning threshold which occurs when the battery voltage decays to a nominal value of 2.4 volts when the motor is off or 1.8 volts when the motor is active. An analog to digital converter (ADC) built into the microprocessor allows the microprocessor, via software, to monitor the battery voltage. At the low battery warning threshold, the microprocessor enables a periodic series of beeps and displays a low battery warning message on the LCD. As the voltage operating the motor reaches a nominal value of 4.75 volts, the software disables delivery, places a battery depleted message on the LCD, and enables a constant two tone audible alarm. When the battery voltage decays to a nominal value of 1.0 volts, a hardware reset circuit is triggered which places the microprocessor in reset. This prevents ambiguous microprocessor operation when the battery voltage continues to decay. The hardware reset continues until the battery is completely discharged or until it is removed. Once the pump controller goes into low battery shutdown, only replacing the depleted batteries with new ones will clear the condition. Software Safety Features Hardware-related Software Safety Features Program Memory Check At power up and at regular intervals thereafter, the program memory is tested by calculating a cyclic redundancy code (CRC) on the program and then comparing it with the CRC stored with the program. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. RAM Memory Check At power up, the random access memory is checked. A series of bit patterns is written to and read from each address in the RAM. If the read data is different from the written data, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Motor Circuit Check At power up and at regular intervals thereafter, the motor circuit is checked to ensure that no power is being applied to the motor unless the motor is actually on. If the software detects power being applied to the motor at any other time, it will sound a continuous two-tone audible alarm and will no longer attempt to deliver medication. During every pump activation, the software checks to see whether the motor completes one activation. If the motor fails to turn, or fails to complete a cycle, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Keyboard Encoder Check Every time the software receives data from the keyboard encoder, it is checked. If the data is not a valid key press, the software will disregard the key press. The keyboard is designed with redundant switches for , , and . The software must detect that both switches are activated before taking any action. Data Handling Software Safety Features Data Stored in RAM Before use, data associated with delivery and stored in RAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Data Stored in EEPROM Before use, data associated with delivery and stored in EEPROM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Data Stored in NOVRAM Before use, data associated with delivery and stored in NOVRAM is tested by calculating a CRC on the data and then comparing it with the CRC stored with the data. If the stored and calculated CRCs do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Data Used in Calculations Calculations on data used in some way to control the delivery of medication are performed redundantly. The two calculated values are then compared. If the two values do not match, the software will display a system fault screen, turn on a continuous two-tone audible alarm, and stop all medication delivery. Timer Data Registers The data in the real time clock is checked at regular intervals. If the data is not reasonable, the software will turn on a continuous two-tone audible alarm and stop all medication delivery. Annual Functional Inspection Smiths Medical recommends annual functional inspections and tests on the CADD-Legacy 1400 pump. Contact Smiths Medical to coordinate return and inspection of the pump. CAUTION: CADD-Legacy 1400 pumps are sealed units. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD-Legacy 1400 pumps must be performed by Smiths Medical or its authorized agents. Collect Separately This product contains electronic and other components (such as batteries) that may contain materials which, if disposed of with general household waste, could be damaging to the environment. In accordance with Directive 2002/96/EC Waste Electrical and Electronic Equipment, Smiths Medical requires that residents of the European Union return this product for proper disposal at the end of its useful life. If you are unsure of the proper disposal method, contact your local distributor for specific disposal instructions. WARNING: There are potential health hazards associated with improper disposal of batteries, electronics, and contaminated (used) reservoirs and extension sets. Dispose of used batteries, reservoirs, extension sets and other used accessories, or a pump that has reached the end of its useful life, in an environmentally safe manner, and according to any regulations that may apply. Limited Warranty Smiths Medical ASD, Inc. (the Manufacturer ) warrants to the Original Purchaser that the infusion pump (the Pump ), not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with this Operator s Manual, for a period of one year from the actual date of sale to the Original Purchaser. THERE ARE NO OTHER WARRANTIES. This warranty does not cover normal wear and tear and maintenance items, and specifically excludes batteries, administration sets, extension sets or any other accessory items or equipment used with the Pump. Subject to the conditions of and upon compliance with this Limited Warranty, the Manufacturer will repair or replace at its option without charge (except for a minimal charge for postage and handling) any Pump (not including accessories) which is defective if a claim is made during such one-year period. The following conditions, procedures, and limitations apply to the Manufacturer s obligation under this warranty: A. Parties Covered by this Warranty: This warranty extends only to the Original Purchaser of the Pump. This warranty does not extend to subsequent purchasers. The Original Purchaser may be a patient, medical personnel, a hospital, or institution which purchases the Pump for treatment of patients. The Original Purchaser should retain the invoice or sales receipt as proof as to the actual date of purchase. B. Warranty Performance Procedure : Notice of the claimed defect must be made in writing or by telephone to the Manufacturer as follows: Smiths Medical ASD, Inc. 1265 Grey Fox Road, St. Paul MN 55112 USA, 1 800.258.5361 (USA) . Notice to the Manufacturer must include date of purchase, model and serial number, and a description of the claimed defect in sufficient detail to allow the Manufacturer to determine and facilitate any repairs which may be necessary. AUTHORIZATION MUST BE OBTAINED PRIOR TO RETURNING THE PUMP. If authorized, the Pump must be properly and carefully packaged and returned to the Manufacturer, postage prepaid. Any loss or damage during shipment is at the risk of the sender. C. Conditions of Warranty : The warranty is void if the Pump has been 1) repaired by someone other than the Manufacturer or its authorized agent; 2) altered so that its stability or reliability is affected; 3) misused; or, 4) damaged by negligence or accident. Misuse includes, but is not limited to, use not in compliance with the Operator s Manual or use with nonapproved accessories. The Pump is a sealed unit, and the fact that the seal has been broken will be considered conclusive evidence that the Pump has been altered or misused. Removal or damage to the Pump s serial number will invalidate this warranty. D. Limitations and Exclusions : Repair or replacement of the Pump or any component part thereof is the EXCLUSIVE remedy offered by the Manufacturer. The following exclusions and limitations shall apply: No agent, representative, or employee of the Manufacturer has authority to bind the Manufacturer to any representation or warranty, expressed or implied. THERE IS NO WARRANTY OF MERCHANTABILITY OR FITNESS OR USE OF THE PUMP FOR ANY PARTICULAR PURPOSE. The Pump can only be used under the supervision of medical personnel whose skill and judgment determine the suitability of the Pump for any particular medical treatment. All recommendations, information, and descriptive literature supplied by the Manufacturer or its agents are believed to be accurate and reliable, but do not constitute warranties. E. Computer Program License: The Pump is intended to be used in conjunction with a particular Licensed Computer Program supplied by Manufacturer and use of any other program or unauthorized modification of a Licensed Computer Program shall void Manufacturer s warranty as set forth above. The Original Purchaser and any users authorized by the Original Purchaser are hereby granted a nonexclusive, nontransferable license to use the Licensed Computer Program only in conjunction with the single Pump supplied by Manufacturer. The Licensed Computer Program is supplied only in machine-readable object code form and is based upon Manufacturer s proprietary confidential information. No rights are granted under this license or otherwise to decompile, produce humanly readable copies of, reverse engineer, modify or create any derivative works based upon the Licensed Computer Program. All other terms and conditions of this Limited Warranty shall apply to the Licensed Computer Program. The Manufacturer disclaims responsibility for the suitability of the Pump for any particular medical treatment or for any medical complications resulting from the use of the Pump. The Manufacturer shall not be responsible for any incidental damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the Pump. This warranty gives the Original Purchaser specific legal rights, and the Original Purchaser may have other legal rights which may vary from state to state. Index A AC adapter accessory jack accuracy tests AC indicator light arrow keys B batteries, AA installing battery compartment battery contacts, cleaning battery, internal clock battery life biomed functions extra dose lockout morning dose lockout specifications upstream occlusion sensor on/off biomed functions code C cassette latch cleaning pump continuous rate programming D downstream occlusion sensor E ECG equipment, interference with electromagnetic emissions and immunity declarations extra dose Lockout programming starting stopping extra dose key G given clearing K keypad, keys L latch, cassette lock level changing lock level code M magnetic resonance imaging main screen medication cassette reservoir attaching removing morning dose Lockout starting stopping P power jack power-up priming programming programming, general programming screens R radiation, exposure to reservoir volume programming resetting S safety features hardware software security codes biomed functions code lock level code service due software version specifications biomed functions delivery general standards starting pump stopping pump symbols system definition T turning pump on/off U ultrasound, vii upstream occlusion sensor W warnings and cautions warranty Appendix A Pump Programming Quick Reference for Healthcare Providers This quick reference provides for step-by-step directions for several of the common pump programming tasks performed with the CADD-Legacy 1400 pump. Additional pump information including warnings, cautions and more information on pump operations is located in the referenced sections of the pump Operator s Manual. Please refer to the full prescribing information for Duopa (carbidopa and levodopa) enteral suspension for indications and usage, contraindications, warnings, precautions, and adverse reactions. Begin programming the pump by: Attaching a medication cassette reservoir Turning on the pump For instruction on attaching a medication cassette reservoir, see Section 2 , Pump Setup and Programming. You will need the following items to complete these steps: Pump Medication cassette reservoir Changing to Lock Level 0 (LL0) Lock level 0 (LL0) allows the health care provider to adjust settings so they are appropriate for the patient. For more information on lock levels descriptions, see Section 1 , General Description . For more information on changing the lock level, see Section 2 , Pump Setup and Programming. **Text Omitted** Pump Programming Settings Program the pump settings to customize the medication delivery inputs for the patient. For more information see Section 2 , Pump Setup and Programming. NOTE: Ensure that the pump is in lock level 0 (LL0) and appears on the screen. Press Check for on the screen. NOTE: Not in Use is the default setting for the reservoir volume. The reservoir volume feature is not required for use, but is available at provider discretion. Press again. Check for on the screen. Press or to select the desired continuous rate. Press Pump Status: The continuous rate is now set. Press Check for on the screen. Press or to select the extra dose amount. Press Pump Status: The extra dose amount is now set. Press Check for on the screen Press if you wish to clear the amount given. Press NOTE: To change a setting again, press NEXT until the appropriate screen appears. Press or to adjust the setting, then press to confirm. Changing Lockout Times Program the dose lockout times to customize medication delivery inputs for each patient. Lockout times will determine how often a patient can deliver a morning dose and an extra dose. These values should be determined during titration. For more information on Duopa titration, refer to the full prescribing information for Duopa (carbidopa and levodopa) enteral suspension. The biomed functions allow the health care provider access to the extra dose lockout and morning dose lockout settings. For more information about biomed functions, see Section 4 , Biomed Functions. NOTE: Ensure that the pump is in lock level 0 (LL0) and is on the screen. When entering a new lockout value, any lockout time previously in effect will be cleared. **Text Omitted** Programming the Morning Dose Program the morning dose to customize medication delivery for the patient. For more information, see Section 2 , Pump Setup and Programming. CAUTION: Review programming screens when complete to make sure desired programming has been entered. Check to make sure unintended changes were not made to the morning dose, continuous rate, or extra dose volume. If unintended changes were made, go to the appropriate screen and program the desired value. The pump must be running with a cassette attached and in LL0 or LL1. Start the pump, if necessary and confirm the lock level settings. NOTE: In LL0, programming in the full range is possible. In LL1, you can program up to the LL0 value. Press should appear on the screen. Press or to select the desired morning dose volume. Press to store the morning dose volume. Setting the Lock Level For patient use, the pump must be set to lock level 2 (LL2) or lock level 1 (LL1). For more information on lock levels descriptions, see Section 1 , General Description . For more information on changing the lock level, see Section 2 , Pump Setup and Programming. **Text Omitted** Manufacturer: Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA Tel: 1 800 258 5361 (USA), +1 614 210 7300 www.smiths-medical.com CADD, CADD-Legacy, and Smiths Medical design mark are trademarks of Smiths Medical. The symbol indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners. 2015 Smiths Medical. All rights reserved. 2015-01 40-6756-01C NDC 0074 3012 07 Duopa carbidopa and levodopa enteral suspension 4.63 mg / 20 mg per mL 7 Cassettes (100 mL each) Each mL contains 5 mg of carbidopa monohydrate (equivalent to 4.63 mg of carbidopa anhydrous) and 20 mg of levodopa. Pharmacist: Store frozen. Thaw in refrigerator prior to dispensing. See package insert for full prescribing information. Store in the refrigerator between 36 -46 F (2 -8 C). Protect from light. Store cassettes in the carton until use. THIS PACKAGE NOT INTENDED FOR HOUSEHOLDS WITH YOUNG CHILDREN Rx only abbvie Duopa carbidopa and levodopa suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0074-3012 Route of Administration ENTERAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Levodopa (Levodopa) Levodopa 20 mg in 1 mL Carbidopa (Carbidopa Anhydrous) Carbidopa Anhydrous 4.63 mg in 1 mL Inactive Ingredients Ingredient Name Strength Carboxymethylcellulose Sodium Water Packaging # Item Code Package Description 1 NDC:0074-3012-07 7 CARTRIDGE in 1 CARTON 1 100 mL in 1 CARTRIDGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA203952 01/15/2015 Labeler - AbbVie Inc. (078458370) Revised: 09/2016 AbbVie Inc. Next Interactions Print this page Add to My Med List More about Duopa (carbidopa / levodopa) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: dopaminergic antiparkinsonism agents Consumer resources Duopa Duopa (Advanced Reading) Professional resources Levodopa/Carbidopa (AHFS Monograph) Carbidopa and Levodopa Tablets (FDA) Other brands: Sinemet , Rytary , Sinemet CR , Parcopa Related treatment guides Parkinson's Disease ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer AbbVie Inc. Drug Class Dopaminergic antiparkinsonism agents Related Drugs dopaminergic antiparkinsonism agents ropinirole , carbidopa , pramipexole , Sinemet , Requip , carbidopa / levodopa Parkinson's Disease Exelon , ropinirole , pramipexole , Sinemet , Requip , benztropine , carbidopa / levodopa , Mirapex , amantadine , rivastigmine , Azilect , Cogentin , selegiline , trihexyphenidyl , bromocriptine , entacapone , Neupro , Rytary , rasagiline , Stalevo , Artane , carbidopa / entacapone / levodopa , Comtan , belladonna , More... Duopa Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } to enclose
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