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EC Authorized Representative

Smiths Medical International Ltd.

TN25 4BF, UK
Phone +44 (0) 1233 722100

Smiths Medical ASD, Inc.

St. Paul, MN 55112, USA
Phone 1‑214‑618‑0218
Toll‑Free USA 1‑800‑258‑5361

THE DETAILS GIVEN IN THIS LEAFLET ARE CORRECT AT THE TIME OF GOING TO PRESS. THE COMPANY RESERVES THE RIGHT TO IMPROVE THE EQUIPMENT SHOWN.

CADD, CADD‑Prizm and the Smiths Medical and CADD design marks are trademarks of Smiths Medical. The symbol ®

indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries.

Product(s) described may not be licensed or available for sale in Canada or other countries outside of the United States.

Smiths Medical Canada Ltd.

Markham, Ontario, Canada, L3R 4Y8
Phone 905‑477‑2000
Toll‑Free 1‑800‑387‑4346

www.smiths‑medical.com

Smiths Medical is part of the global technology business Smiths Group plc.

Содержание 6101

Страница 1: ...1 CADD Prizm PCS II Ambulatory Infusion Pump Model 6101 Technical Manual ...

Страница 2: ...Circuit 16 Voltage Detector Circuit 16 Software Safety Features 17 7 Hardware and Software Fault Detection 18 Overview 18 Order of Error Code Events 18 8 Cleaning and Inspection Procedures 19 Inspection Recommendation 19 Cleaning 19 Visual Inspection 19 Mechanical Inspection 19 9 Testing Procedures 20 Functional Testing 20 Air Detector Test if Applicable 22 Occlusion Tests 23 Accuracy Testing 24 C...

Страница 3: ...ed warranty of merchantability or fitness for use Smiths Medical further disclaims responsibility for the suitability of the system for a particular medical treatment or for any medical complications resulting from the use of the system 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 ma...

Страница 4: ... profile Clinician Bolus used here as a loading dose Demand Doses Continuous Rate Time Dosage PCA Delivery Profile The PCA patient controlled analgesia delivery mode is used for therapies that require a continuous rate of infusion patient controlled demand doses or both such as patient controlled analgesia See Figure 2 Figure 1 Front and back views of the CADD Prizm PCS II pump Rear View Front Vie...

Страница 5: ...1 50 600 35 1 75 346 5 1 75 700 40 2 00 396 0 2 00 800 45 2 25 445 5 2 25 900 50 2 50 495 0 2 50 1000 55 2 75 544 5 2 75 1100 60 3 00 594 0 3 00 1200 65 3 25 643 5 3 25 1300 70 3 50 693 0 3 50 1400 75 3 75 742 5 3 75 1500 80 4 00 792 0 4 00 1600 85 4 25 841 5 4 25 1700 90 4 50 891 0 4 50 1800 95 4 75 940 5 4 75 1900 100 5 00 990 0 5 00 2000 Table 2 Demand dose clinician bolus scroll ranges milligr...

Страница 6: ... shelf life temperature conditions delivery rate and frequency of screen display backlighting and printing It is recommended that a new 9 volt battery be kept available for replacement if necessary An internal battery powers the clock When it is depleted it cannot reliably maintain the clock time This battery must be replaced by the manufacturer The internal battery has an expected life of 5 years...

Страница 7: ...ms mg micrograms mcg Default milligrams Time 0000 to 2359 Air Detector Turned On or Turned Off Default On Biomed Toolbox Specifications Custom Concentrations All individual mg or mcg concentration settings may be enabled or disabled at least one concentration must be enabled Default All On Program Limits Maximum program limits may be programmed for Demand Dose Continuous Rate and Clinician Bolus D...

Страница 8: ... appears 2 Press the ENTER key twice 3 Scroll to 911 4 Press the OPTIONS key Compatible Reservoirs and Administration Sets 50 ml or 100 ml CADD medication cassette reservoir used with the CADD extension set with anti siphon valve CADD administration set with integral anti siphon valve with or without bag spike allows use of flexible plastic bag or sterile vial with injector CADD administration set...

Страница 9: ...horter if the battery is stored above room temperature An alkaline battery stored at 43 C 110 F will be down to approximately 80 of its capacity within one year 3 Batteries Recommended storage conditions are 10 C to 25 C 50 F to 77 F with no more than 65 relative humidity noncondensing The following tables are based on laboratory tests conducted at room temperature using fresh DURACELL alkaline ba...

Страница 10: ...r 212 hrs 85 ml 10 ml hr 161 hrs 1610 ml 30 ml hr 79 hrs 2370 ml 50 ml hr 60 hrs 3000 ml 100 ml hr 30 hrs 3000 ml 200 ml hr 32 hrs 6400 ml 350 ml hr 17 hrs 5950 ml Table 5 9 volt Lithium type batteries used with theCADD Prizm PCS II pump ContinuousandPCADeliveryBatteryLife MaxDeliveryRatePCAMode30ml hr Note Results are without air detector Table 6 EPS System used with the CADD Prizm PCS II pump Ra...

Страница 11: ...The keyboard keys are sensed by the pump s microprocessor The custom Liquid Crystal Display LCD also located on the front housing shows the pump status and programmed settings The dot matrix display consists of 21 character columns with 4 rows of characters and is selected by the pump s microprocessor according to status conditions and keyboard entries The microprocessor and other circuitry which ...

Страница 12: ...designed to provide a minimum of five years of memory retention during normal pump usage Whenever the microprocessor uses data from the RAM the data is checked for validity Time Base Circuitry An accurate 3 6864 MHz timebase is provided by a quartz crystal The 3 6864 MHz signal is connected to the microprocessor where it is frequency divided to access the program memory at a cycle rate of 921 kHz ...

Страница 13: ...e feature allows the microprocessor to test the watchdog circuit on every power up By setting a flag in 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...

Страница 14: ...rs continuous alarm 5 25 5 95V Hardware reset occurs Pump continues to indicate depleted battery condition Voltage ranges are due to component tolerances Actual trip values are guaranteed to be non overlapping Power Circuitry Power for the pump is normally supplied by a 9 volt alkaline battery 9 volt lithium battery or AC adapter These types of batteries have a fairly low internal resistance over ...

Страница 15: ... cycle is completed Pumping Characteristics If the fluid path to the patient becomes blocked the pump tubing will expand as pumping occurs When there has been an amount of inflation corresponding to 124 62 kPa 1 24 0 62 bar 18 9 psi the occlusion analog sensor trips whereupon the microprocessor stops the pump mechanism and issues visual and audible alarms Thus the maximum pressure which can be dev...

Страница 16: ...ngle base compartment with a detachable door It is sealed against the pump housing to ensure the overall assembly is water resistant The air detector is mounted to the pump housing with two screws and electrically connected with a ten pin connector Theory of Operation The air detector consists of sensor electronics and two ultrasonic transducers positioned on opposite sides of the tubing One trans...

Страница 17: ...ag in 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 me...

Страница 18: ...d delivery and enable audible and visual alarms if the set is unlatched during fluid delivery Opposing infrared transmitters and receivers on both the latch and lock buttons allow the microprocessor to detect their open and closed positions Additional circuitry allows these sensors to be turned on and off by the microprocessor to conserve battery power Additionally control of sensor power allows t...

Страница 19: ...ftware will turn on a continuous two tone audible alarm and stop all drug delivery The DOSE key has two independent signal lines to prevent single fault failures 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 calc...

Страница 20: ...e Events 1 There is a continuous two tone audible alarm a continuous amber indicator light and the display will read NOTE XXXXX is a 5 digit code 2 To silence the error code alarm remove the battery 3 At the next power up the last error code lec will be visible on the display The microprocessor will also record an error code in the Event Log The description Error Detected along with five digits wi...

Страница 21: ...to the lock and turn counterclockwise until the mark lines up with the solid dot Gently twist and pull on the cassette to make sure it is firmly attached NOTE In the PCA delivery mode the cassette must be locked in order to start the pump Inspection Recommendation Smiths Medical recommends annual functional inspection on the CADD Prizm PCS II pump The following inspection and testing procedures sh...

Страница 22: ... Unlocked Unlatch the reservoir by inserting a coin into the latch slot and turning clockwise until the 9 Testing Procedures C A D D P R I Z M 61XX lec XXXXX sn XXXXXXXX 0351 01X XXXX X Software revision level Error code Pump model number Serial number If the Epidural mode is NOT turned on in the Options Menu Reservoir Latched VIEW to continue Admin set Latched Upstream Sensor On VIEW to continue ...

Страница 23: ...rm Check Press the PRIME BOLUS key Press and hold the YES key The pump should prime ten double activations and then stop The pump will alarm and display Reservoir Volume is Zero Press the VIEW SILENCE key Reprogram the reservoir volume to 1 0 ml Press the VIEW SILENCE key until Reservoir Volume is displayed on the LCD Press the YES or NO key until 1 0 ml is displayed Then press the ENTER key NOTE ...

Страница 24: ... exactly different values may appear Press the ENTER key The display should now show 0 0 mg Air Detector Test if applicable This test will verify the function of the optional air detector To perform this test the CADD Prizm PCS II pump must have an air detector installed and the air detector must be turned on The previous program from the DOSE key check can be used to perform this test Attach an e...

Страница 25: ...ctivations Downstream Occlusion Pressure Range Test Option 2 Description An adjustable metered pressure source is connected to the CADD medication cassette reservoir tubing The pressure is slowly increased until the high pressure alarm sounds Equipment needed Pressure gauge 30 psi 1 psi Pressure vessel partially filled with water Pressure regulator 30 psi 50 or 100 ml CADD medication cassette rese...

Страница 26: ...et luer lock connector 3 Secure the clamp as close to the extension set luer lock connector as possible This should assure a minimum water loss from the tubing when the syringe is removed 4 Weigh the entire reservoir extension set assembly and record the weight This is the pre delivery weight This weight includes the empty CADD medication cassette reservoir extension set and weight of the water 5 ...

Страница 27: ...ansfer the water into a CADD medication cassette reservoir 2 Remove any air from the CADD medication cassette reservoir by aspirating the air with the syringe Attach the CADD extension set with anti siphon valve Prime the tubing so it is filled with fluid to the end of the extension set luer lock connector 3 Attach the end of the extension set to the fluid collection device 4 Attach the CADD medic...

Страница 28: ...y Compartment III Mechanical Inspection Keyboard Cassette Latch Battery Door Cassette Lock IV Functional Inspection Power up RES VOL Alarm Dose Given Attempted Latch Lock Stop Start MG Given Cassette Sensor Activation Timing Air Detector LCD Remote Dose Cord Printer Tests Motor Gear Train V Occlusion Tests Only need to perform 1 or 2 not both Downstream Option 1 Activations Before Alarm_ _________...

Страница 29: ...iths Medical and CADD design marks are trademarks of Smiths Medical The symbol indicates the trademark is registered in the U S Patent and Trademark Office and certain other countries 2010 Smiths Medical All rights reserved 11t 10 IN19779 Product s described may not be licensed or available for sale in Canada or other countries outside of the United States Smiths Medical Canada Ltd Markham Ontario...

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