Deltec CADD-Prizm PCSII 6101 Technical Manual
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Deltec CADD-Prizm PCSII 6101 Technical Manual

Ambulatory infusion pump
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M O D E L 6 1 0 1
Deltec
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Summary of Contents for Deltec CADD-Prizm PCSII 6101

  • Page 1 M O D E L 6 1 0 1 Deltec...
  • Page 2 The issue date of this Technical Manual is included for the user’s information. In the event one year has elapsed between the issue date and product use, the user should contact Deltec, Inc. to see if a later revision of this manual is available.

  • Page 3: Table Of Contents

    Table of Contents 1. Introduction ..........1 6. Safety Features and Fault Detection ..16 Limited Warranty ........... 1 Hardware Safety Features ......16 Exposure to Radiation or Magnetic Resonance Watchdog Timer Circuit ......16 Imaging (MRI) ..........1 Motor Driver/Motor Watchdog Circuit ..17 Cassette ‘Type’...

  • Page 4: Introduction

    All recommendations, information and litera- ® on the CADD-Prizm PCS II pump. ture supplied by Deltec with respect to the This technical manual is applicable to the ® CADD product line are believed to be accu- CADD-Prizm ®...

  • Page 5: Delivery Modes

    ® 2 CADD-Prizm Pump Delivery Modes ® The Deltec CADD-Prizm PCS II pump provides measured drug therapy to patients. CADD-Prizm ® PCS II pumps are indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusion. Epidural administration is...
  • Page 6 PCA Delivery Profile Clinician Bolus The PCA (patient-controlled analgesia) delivery Continuous Rate (used here as a loading dose) Demand Doses mode is used for therapies that require a continuous rate of infusion, patient-controlled demand doses or both, such as patient- controlled analgesia.
  • Page 7 Continuous Rate Scroll Ranges Units Starting Increment Maximum Milliliters 0.10 0.10 30.00 Milligrams & 10% of Mg only: Values between 0.01 and 0.5: 0.01 Concentration Micrograms concentration Mcg only: Values between 0.1 and 0.5: x 30 Values between 0.5 and 100: Values between 100 and 1000: Values greater than 1000: 10.0...

  • Page 8: Specifications (Nominal)

    maintain the clock time. This battery must Specifications (Nominal) be replaced by the manufacturer. The internal battery has an expected life of 5 General Pump Specifications years. Resolution System Operating Temperature ® Medication Cassette Reservoir or CADD +2°C to 40°C (36°F to 104°F) Administration Set, 0.050 ml per pump stroke nominal System Storage Temperature...
  • Page 9 Demand Dose Time 0 to 9.9 ml* 00:00 to 23:59 Delivery rate (Continuous Rate + Demand Air Detector Dose): programmable from 40 to 125 ml/hr. Turned On or Turned Off. Default: On Default: 0 ml (See Table 2, 3 & 4 for Scroll ranges) Biomed Toolbox Specifications *The Maximum Demand Dose is 20 with...
  • Page 10 • Patient Review. Default: Off Remote Dose Cord • Pain Scale (subjective pain scale rating of Deltec provides a Remote Dose Cord for the 0 to 10 in increments of 1). Default: On PCA delivery mode. The push button switch is •...

  • Page 11: Batteries

    30% of its normal capacity. particular battery selected, battery shelf life, and temperature conditions. Deltec’s testing Alkaline batteries do not need to be stored in a indicates a large variability in battery life.
  • Page 12 Continuous and PCA Delivery Battery Life (Max Delivery Rate PCA Mode 30 ml/hr) Note: Results are without air detector. 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...

  • Page 13: Construction

    4 Construction The custom Liquid Crystal Display (LCD), also The pump’s housing is made of a special high located on the front housing, shows the pump impact plastic designed to reduce interference from electromagnetic fields and to dissipate status and programmed settings. The dot matrix display consists of 21 character col- electrostatic discharge.

  • Page 14: Theory Of Operation

    5 Theory of Operation ies. These batteries are designed to provide a Keyboard Circuitry minimum of five years of memory retention ® The CADD-Prizm PCS II pump is controlled during normal pump usage. Whenever the by a microprocessor. The actions of the micro- microprocessor uses data from the RAM, the processor are controlled by a program, which data is checked for validity.

  • Page 15: Led Status Indicators

    high frequency sound at a rate of 0.8 and 2 LED Status Indicators Hz. Low battery voltage detection and watch- An amber and a green Light Emitting Diode dog timer circuitry also have the ability to (LED) are provided under the pump’s front enable the audible alarm via the Gate Array.

  • Page 16: Power Circuitry

    detector. An infrared light source is mounted Voltage Reference Circuit so that its light beam illuminates the infrared A voltage reference circuit provides a constant detector. An opaque flag is mounted concentri- DC voltage to the microprocessor Analog to cally to the camshaft and rotates with it be- Digital Converter (ADC).

  • Page 17: Pumping Characteristics

    When the microprocessor commands the mecha- causes the pump mechanism to deliver 0.05 ml nism to pump, the camshaft begins to rotate, fluid “pulses” timed according to the desired thus controlling the following pump cycle: rate. At rates higher than 3 ml/hr, 2 pulses in succession will be given.

  • Page 18: Air Detector

    Theory of Operation Air Detector The air detector consists of sensor electronics The air detector is designed to detect air in the and two ultrasonic transducers positioned on outlet tubing fluid path. The air detector is opposite sides of the tubing. One transducer acts detachable if not needed.

  • Page 19: Safety Features And Fault Detection

    6 Safety Features and Fault Detection microprocessor fails to function properly. The Hardware Safety Features microprocessor must strobe the watchdog Key hardware safety features include a watch- circuit at least once every second in order to dog timer circuit, motor driver and motor prevent the watchdog from performing its reset watchdog circuits, cassette ‘type’...

  • Page 20: Motor Driver/Motor Watchdog Circuit

    Latch/Lock Sensor Circuit Motor Driver/Motor Watchdog Circuit Latch and Lock sensors allow the microproces- Motor drive circuitry is composed of a series of sor to detect the positions of the latch and lock power FET transistors, passive components, buttons. This prevents attempted fluid delivery and two voltage comparators.

  • Page 21: Software Safety Features

    Data Handling Software Safety Features Software Safety Features Data Stored in RAM Hardware-related Software Safety Features Before use, data associated with delivery and stored in RAM is tested by calculating a CRC Program Memory Check on the data and then comparing it with the At power up and at regular intervals thereafter, CRC stored with the data.

  • Page 22: Hardware And Software Fault Detection

    7 Hardware and Software Fault Detection Overview Order of Error Code Events If the CADD-Prizm ® pump displays an error 1. There is a continuous two-tone audible code, a hardware or software fault has been alarm, a continuous amber indicator light, detected by the microprocessor, and the pump and the display will read should be returned for servicing.

  • Page 23: Cleaning And Inspection Procedures

    Allow the pump to dry all warranties. All service and repair of completely before use. CADD ® pumps must be performed by Deltec or its authorized agents. Visual Inspection Cleaning • Visually inspect the pump for any damage to...

  • Page 24: Mechanical Inspection

    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. The battery door should fit snugly in place when it is closed on the pump.

  • Page 25: Testing Procedures

    9 Testing Procedures Functional Testing If the Epidural mode is NOT turned on in the Options Menu: The Power-up Check, Latch/Lock Check and Cassette Sensor Check using a Reservoir Latched VIEW to continue Medication Cassette reservoir or CADD ® administration set can be performed with the pump in any of the four delivery modes.
  • Page 26 Motor and Gear Train Check mark lines up with the solid dot. The display should show “Cassette Locked.” • Attach either a 50- or 100-ml Medication Cassette reservoir or CADD ® administration set • Unlock the cassette. The display should to the pump.
  • Page 27 • After RUNNING appears on the display, • To stop the device, press the STOP/START press the Remote Dose Cord button and key. When the message “Stop the Pump?” note the time. The pump should beep twice appears, press YES. STOPPED appears in the and begin to deliver.

  • Page 28: Air Detector Test (If Applicable)

    • Close the door making sure the tubing does Equipment needed not get pinched or kinked. 50- or 100-ml Medication Cassette reservoir containing water. • Start the pump. • The pump should respond with a continuous Procedure two-tone alarm and the display should read: 1.

  • Page 29: Accuracy Testing

    Procedure Equipment needed 1. Insert a battery and wait for the pump to • CADD ® administration set with anti-siphon power up. valve. 2. Attach a Medication Cassette reservoir to the • Tubing clamp (slide clamp or hemostat) pump. Latch and lock the cassette. Procedure 1.
  • Page 30 Equipment needed 9. Find the difference between the volume of the amount delivered and the intended delivery • 50- or 100-ml Medication Cassette reservoir. volume. This is the inaccuracy volume. • 50- or 60-ml syringe. 10.Divide the inaccuracy volume by the intended ®...
  • Page 31 ± 6%, repeat the test with a new • 50- or 100-ml Medication Cassette reservoir reservoir. If the pump fails a second time, • 50- or 60-ml syringe call Deltec’s Customer Service Department. • CADD ® extension set with anti-siphon valve EXAMPLE: •...
  • Page 32 ±6%, repeat the test with a new intended delivery volume and multiply by 100. This is the accuracy error percentage. reservoir. If the pump fails a second time, (See Table 15.) call Deltec’s Customer Service Department. Intended Actual Inaccuracy Accuracy...

  • Page 33: Cleaning And Functional Testing Checklist

    CADD-Prizm ® Pump Cleaning and Functional Testing 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.
  • Page 34 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. ISO 9001 Registered SaniCloth is a PDI trademark. The products described are covered by one or more of the following U.S. Patent Nos., 4,559,038; 4,565,542;...

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