Instruction/ maintenance manual of the product 6 1 0 1 Deltech Fitness
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33 T E C H N I C A L M A N U A L C A D D - P r i z m ® A M B U L A T O R Y I N F U S I O N P U M P MODEL 6101 Deltec MODEL 6100 This online version diff er s fr om the printed version. Certain information that is not intended f or patients has been removed.
32 For detailed instructions, specifications, warnings, warranties and additional information on operat- ing CADD ® pumps, please refer to the Operator ’ s Manual supplied with the product. If you have additional comments or questions concerning the operation of CADD ® pumps, please call this num- ber: (800) 426-2448 .
34 T able of Contents 1. Introduction ............................................. 1 Limited Warranty ........................................... 1 Exposure to Radiation or Magnetic Resonance Imaging (MRI) ............................................
1 1 Introduction The T echnical Manual is intended to provide a basic, but limited, understanding of the mechanical and electrical operation of the Deltec CADD-Prizm ® Computerized Ambulatory Drug Delivery pump to persons familiar with this device.
2 Pantone 653 Dk Blue Pantone 654 Extra Dk Pantone 519 Purple NO AIR DETECTOR INSTALLED ST ART STOP Y N LOCK DOSE NEXT ENTER OPTIONS ? Power Data In/Out 2 CADD-Prizm ® Pump Figure 1.
3 Figure 2. PCA mode delivery profile. Clinician Bolus (used here as a loading dose) Demand Doses Continuous Rate Time Dosage Figure 3. Continuous mode delivery profile. Figure 4. Intermittent mode delivery profile. Figure 5. TPN mode delivery profile.
4 Concentration Demand Dose Clinician Bolus mg/ml increment max. increment max. 0.1 0.01 0.99 0.01 2 0.2 0.02 1.98 0.02 4 0.3 0.03 2.97 0.03 6 0.4 0.04 3.96 0.04 8 0.5 0.05 4.95 0.05 10 1 0.05 9.9 0.05 20 2 0.10 19.8 1.10 40 3 0.15 29.7 1.15 60 4 0.20 39.
5 Specifications (Nominal) General Pump Specifications Resolution Medicaton Cassette reservoir or CADD ® administration set, 0.050 ml/pump stroke nominal CADD-Prizm ® high volume administration set, 0.100 ml/pump stroke nominal Size 4.4 cm x 10.4 cm x 14.
6 Given 0 to 99999.99 in 0.01 unit increments Clinician Bolus 0.1 ml to 20.00 ml (or mg or mcg equiva- lent) (See T ables 2, 3 and 4 for scroll ranges) Delivery rate (Continuous Rate + Clinician Bolus.
7 Options Specifications Immediate T aper -Down (TPN) 0 to time remaining in the infusion period, in 10 minute increments (defaults to the currently programmed T aper -Down) AutoLock Not In Use, LL1 o.
8 Battery Compatibility Recommended Batteries Nine-volt alkaline or lithium batteries are recommended for use in the CADD-Prizm ® pump. Carbon-zinc, mercury , nickel-cadmium, or zinc-air 9-volt batteries should not be used. Battery Life The CADD-Prizm ® pump has been designed to provide optimal battery life.
9 Rate Life Volume 0.4 ml/hr 120 hrs 48 ml 10 ml/hr 86 hrs 860 ml 30 ml/hr 37 hrs 1110 ml 50 ml/hr 26 hrs 1300 ml 100 ml/hr 13 hrs 1300 ml 200 ml/hr 14 hrs 2800 ml 350 ml/hr 7 hrs 2450 ml Rate Life Volume 0.
10 Intermittent Delivery Battery Life Note: Results are without air detector . TPN Delivery Battery Life Note: Results are without air detector . Volume Duration Cycle KVO Life Volume 23.5 1:00 hr 5:00 hr 0.2 ml/hr 117 hrs 477 ml 61 1:00 hr 6:00 hr 0.
11 4 Construction The pump ’ s housing is made of a special high impact plastic designed to reduce interference from electromagnetic fields and to dissipate electrostatic discharge. It is composed of two sections: the base and cover housing. The pump housing is sealed to ensure that the pump is water resistant.
12 5 Theory of Operation Keyboard Circuitry The CADD-Prizm ® pump is controlled by a microprocessor . The actions of the micropro- cessor are controlled by a program, which is contained in the memory . Commands are issued to the microprocessor from the user via the nine keys on the key- board and the Remote Dose cord.
13 LED Status Indicators An amber and a green Light Emitting Diode (LED) are provided under the pump ’ s front panel overlay to provide pump status to the user . Under software control, the LEDs can either flash at a low duty cycle or be on con- tinuously .
14 detector . An infrared light source is mounted so that its light beam illuminates the infrared detector . An opaque flag is mounted concentri- cally to the camshaft and rotates with it be- tween the infrared light source and detector .
15 When the microprocessor commands the mecha- nism to pump, the camshaft begins to rotate, thus controlling the following pump cycle: 1. The inlet valve closes. 2. In synchrony with the expulsor moving down to compress the tubing, the outlet valve opens, expelling 0.
16 Air Detector The air detector is designed to detect air in the outlet tubing fluid path. The air detector is detachable if not needed. The CADD-Prizm ® pump automatically detects the presence of the air detector and will automatically turn the sensor on when powered up in LL0.
17 6 Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watch- dog timer circuit, motor driver and motor watchdog circuits, cassette ‘ type ’ sensor circuit, latch/lock sensor circuit, and a voltage detector circuit.
18 Motor Driver/Motor W atchdog Circuit Motor drive circuitry is composed of a series of power FET transistors, passive components, and two 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.
19 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.
20 Overview If the CADD-Prizm ® pump displays an error code, a hardware or software fault has been detected by the microprocessor , and the pump should be returned for servicing.
21 8 Cleaning and Inspection Procedures Use any of the following solutions to clean the pump and accessories: • Soap solution • Benzalkonium chloride concentrate (0.
22 Mechanical Inspection • Press each key on the keyboard. Each key should have a distinctive dome feeling. The keys should not feel flat. • Attach the battery door .
23 • Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot. The display should show “ Cassette Locked. ” • Unlock the device by inserting a key into the lock and turning clockwise until the mark lines up with the open dot.
24 • Remove the 50- or 100-ml reservoir and attach a CADD ® administration set to the pump. Latch the cassette to the pump. The display should show “ Admin Set Latched. ” • Lock the device by inserting a key into the lock and turning counterclockwise until the mark lines up with the solid dot.
25 NOTE: The remaining testing procedures should be performed using a 50- or 100-ml Medication Cassette reservoir containing fluid and a primed extension set with anti-siphon valve or a primed CADD ® administration set with anti-siphon valve. Starting/Stopping the Pump • Check the STOP/ST ART key by pressing it.
26 • Press the ENTER key . The display should now show 0/0. MG GIVEN Mode Check • Press the NEXT key to advance to the Milligrams Given screen. The display should now show 2.0 mg, if the DOSE key and Remote Dose cord were tested. If only the DOSE key was tested, the display will show 1.
27 NOTE: The pressure from the source must be zero when the cassette is attached. 3. Assemble the apparatus as shown in Figure 9. 4. Connect the Medication Cassette ™ reser - voir outlet tube to the metered pressure source. NOTE: Do not use a CADD ® extension set with anti-siphon valve.
28 Procedure 1. Spike an appropriate standard I.V . bag. 2. Prime the entire fluid path. 3. Program the pump to deliver a continuous rate of 20 ml/hr . 4. Start the pump. 5. Clamp the tubing halfway between the fluid reservoir and the pump. 6. The pump should alarm within three activa- tions after clamping the tubing.
29 11. If the accuracy error percentage is greater than ± 6%, repeat the test with a new reservoir . If the pump fails a second time, call Deltec ’ s Customer Service Department. EXAMPLE: Predelivery Weight: 61.1 g Postdelivery Weight: - 41.6 g Weight of Amount Delivered: 19.
30 Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery V olume Error Error Percentage V olume V olume 20 ml 19.5 ml -0.5 ml -0.5/20.0 ml =-0.025 -0.025 x 100 = ± 2.5% Table 15. Volumetric percentage calculation delivery volume. This is the inaccuracy volume .
31 CADD-Prizm ® Pump Cleaning and Functional T esting Checklist The following checklist is provided as a guide only to assist in establishing documentation of cleaning and functional testing for the CADD-Prizm ® pump. If service is provided, fill out this sheet and return it with the device.
35 ISO 9001 Registered CADD, CADD-Prizm and Medication Cassette reservoir design are Deltec, Inc. trademarks. DURACELL is a DURACELL Inc. trademark. ULTRALIFE is a ULTRALIFE Batteries, Inc. trademark. LEMO is a LEMO USA INC. trademark. SaniCloth is a PDI trademark.
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