CADD-Prizm Ambulatory Infusion · PDF file2 CADD-Prizm® Pump Figure 1. Front and back...

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Transcript of CADD-Prizm Ambulatory Infusion · PDF file2 CADD-Prizm® Pump Figure 1. Front and back...

CADD-PrizmAmbulatory Infusion PumpModel 6100 and Model 6101

Technical Manual

Table of Contents

1. Introduction ............................................... 1Limited Warranty ..............................................1Exposure to Radiation or Magnetic Resonance Imaging (MRI) ...................................................1

2. CADD-Prizm Pump ................................. 2Delivery Modes .................................................3Specifications (Nominal) ..................................5

3. Batteries ................................................... 8Battery Compatibility .......................................8DURACELL Alkaline Battery Life ...................8ULTRALIFE Lithium Battery Life ....................8

4. Construction ........................................... 10

5. Theory of Operation ................................ 11Keyboard Circuitry .......................................... 11Data Memory EEPROM .................................. 11Battery Backed RAM ...................................... 11Time Base Circuitry ........................................ 11LCD Circuitry .................................................. 11LED Status Indicators .................................... 11Flash PROM Technology ................................ 12Gate Array Circuitry ........................................ 12Audible Alarm Circuitry .................................. 12Watchdog Timer Circuit ................................. 12Motor Driver/Motor Watchdog Circuit ........... 12Power Circuitry............................................... 13Voltage Reference Circuit............................... 13Pumping Mechanism ..................................... 14Pumping Characteristics ............................... 14Air Detector .................................................... 15Upstream Occlusion Sensor .......................... 15

6. Safety Features and Fault Detection ...... 16Hardware Safety Features ............................. 16Watchdog Timer Circuit ................................. 16Motor Driver/Motor Watchdog Circuit ........... 16Cassette Type Sensor Circuit ....................... 17Latch/Lock Sensor Circuit ............................. 17Voltage Detector Circuit ................................. 17Software Safety Features ............................... 18

7. Hardware and Software Fault Detection 19Overview ......................................................... 19 Order of Error Code Events ............................ 19

8. Cleaning and Inspection Procedures...... 20Inspection Recommendation ......................... 20Cleaning ......................................................... 20Visual Inspection ............................................ 20Mechanical Inspection ................................... 21

9. Testing Procedures ................................. 22Functional Testing .......................................... 22Air Detector Test (if Applicable) ..................... 25Occlusion Tests .............................................. 25Accuracy Testing ............................................ 26Cleaning and Functional Testing Checklist ... 29

For detailed instructions, specifications, warnings, warranties and additional information on operating CADD pumps, please refer to the Operators Manual supplied with the product. If you have additional comments or questions concerning the operation of CADD pumps, please call this number: 1-800-258-5361. Our staff is available to help you 24 hours a day with the programming and operation of CADD pump infusion systems.The issue date of this Technical Manual is included for the users information. In the event one year has elapsed between the issue date and product use, the user should contact Smiths Medical to see if a later revision of this manual is available. Issue Date: November 2010

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1 Introduction

The Technical Manual is intended to provide a basic, but limited, understanding of the mechanical and electrical operation of the CADD-Prizm Computerized Ambulatory Drug Delivery pump to persons familiar with this device. The CADD-Prizm Operators Manual should be used in conjunction with this publication for complete information.This manual also outlines cleaning and functional testing procedures that can be performed on the CADD-Prizm pump.This technical manual is applicable to both the CADD-Prizm PCS and CADD-Prizm VIP pumps. For information on the CADD-Prizm PCS pump refer to the information regarding the CADD-Prizm VIP PCA application in this manual. Testing procedures in the back of this manual are intended to be performed with the pump in the PCA delivery mode.

IMPORTANT NOTICECADD-Prizm pump operations and safety features are based on a microcomputer design. Inadequate servicing or tampering with the safety features of the pump may seriously affect performance and safety.For that reason, All servicing and repair of the CADD-Prizm pump must be performed by Smiths Medical or its authorized agents.The manufacturers warranty agreement shall become null and void if the pump is not used in accordance with the Operators Manual and Instructions for Use for the pump accessories; or, the pump is serviced by persons other than Smiths Medical or those authorized by Smiths Medical.

Limited WarrantyThe limited warranty associated with the CADD-Prizm pump can be found in the product literature supplied with the product when originally purchased, which is incorporated herein by reference. Smiths Medical specifically disclaims any other warranty, whether express, implied or statutory, including, without limitation, any implied 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 malfunction of the system.If you wish to receive additional information about the extent of the warranty on these products, please contact your Smiths Medical representative or call Customer Service at 1-800-258-5361.All recommendations, information and literature supplied by Smiths Medical with respect to the CADD product line are believed to be accurate and reliable, but do not constitute warranties. No agent, representative, or employee of Smiths Medical has authority to bind Smiths Medical to any representation or warranty, expressed or implied.

Exposure to Radiation or Magnetic Resonance Imaging (MRI)CAUTIONS

1 The pump SHOULD NOT BE DIRECTLY IRRADIATED by therapeutic levels of ionizing radiation because of the risk of permanent damage to the pumps electronic circuitry. The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation. If the pump must remain in the vicinity during a diagnostic or therapy session, it should be shielded, and its ability to function properly should be confirmed following treatment.

2 Magnetic fields produced by magnetic resonance imaging (MRI) equipment may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures and keep it at a safe distance from magnetic energy.

2

2 CADD-Prizm Pump

Figure 1. Front and back views of the CADD-Prizm pump.

Delivery ModesThe CADD-Prizm pump provides measured drug therapy to patients in hospital or outpatient settings. The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusion. Epidural administration is limited to short-term infusion of anesthetics and either long- or short-term infusion of analgesics. Subarachnoid administration is limited to short-term infusion of analgesics. The pumps flexibility allows it to be used in a variety of

settings. The CADD-Prizm VIP (Variable Infusion Profile) pump may be programmed to deliver medication in one of four delivery modes: (1) PCA (patient-controlled analgesia) (2) Continuous (3) Intermittent and (4) TPN (total parenteral nutrition) (See Figures 2 through 5). The CADD-Prizm PCS (Pain Control System) pump may be programmed to provide patient-controlled analgesia therapy. Figure 1 shows a diagram of the CADD-Prizm pump.

Pantone 653 Dk Blue

Pantone 654 Extra Dk

Pantone 519 Purple

NO AIRDETECTORINSTALLED

STARTSTOP

YNLO

CK

DOSE

NEXT

ENTEROPTION

S

?

PowerData In/Out

Amber Green

Display

Keypad

Power Jack

Data In/Out Jack

Air Detector Port Cover

Air Detector (optional)

Polemount Bracket Recess

Battery Compartment

Cassette Lock

Cassette

Cassette Latch

Upsteam Occlusion Sensor (Model 6101 only)

Rear ViewFront View

Indicator Lights

3

Figure 2. PCA mode delivery profile.

Clinician Bolus(used here as a loading dose)

Demand DosesContinuous Rate

Time

Dos

age

Figure 3. Continuous mode delivery profile.

Figure 4. Intermittent mode delivery profile.

Figure 5. TPN mode delivery profile.

PCA Delivery ProfileThe 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.

Continuous Mode Delivery ProfileThe Continuous delivery mode allows the infusion of drug at a constant, programmed rate.

Intermittent Mode Deliv