CADD-Prizm PCS II Model 6101 Technical Manual Nov 2010

Table of Contents 1. Introduction... 1

6. Safety Features and Fault Detection... 15

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

Hardware Safety Features... 15 Watchdog Timer Circuit... 15 Motor Driver/Motor Watchdog Circuit... 15 Cassette ‘Type’ Sensor Circuit... 16 Latch/Lock Sensor Circuit... 16 Voltage Detector Circuit... 16 Software Safety Features... 17

2. CADD‑Prizm® PCS II Pump... 2 Delivery Modes... 2 Specifications (Nominal)... 4

3. Batteries... 7 Battery Compatibility... 7 DURACELL® Alkaline Battery Life... 7 ULTRALIFE® Lithium Battery Life... 7

4. Construction... 9 5. Theory of Operation... 10 Keyboard Circuitry... 10 Data Memory EEPROM... 10 Battery Backed RAM... 10 Time Base Circuitry... 10 LCD Circuitry... 10 LED Status Indicators... 11 Flash PROM Technology... 11 Gate Array Circuitry... 11 Audible Alarm Circuitry... 11 Watchdog Timer Circuit... 11 Motor Driver/Motor Watchdog Circuit... 11 Power Circuitry... 12 Voltage Reference Circuit... 12 Pumping Mechanism... 13 Pumping Characteristics... 13 Air Detector... 14 Upstream Occlusion Sensor... 14

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 Cleaning and Functional Testing Checklist... 26

For detailed instructions, specifications, warnings, warranties and additional information on operating 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 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 user’s 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

2

1 Introduction The Technical Manual is intended to provide a basic, but limited, understanding of the mechanical and electrical operation of the Smiths Medical CADD-Prizm® PCS II Computerized Ambulatory Drug Delivery pump to persons familiar with this device. The CADD-Prizm® PCS II Operator’s 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® PCS II pump. This technical manual is applicable to the CADD-Prizm® PCS II pump only. IMPORTANT NOTICE CADD-Prizm PCS II 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® PCS II pump must be performed by Smiths Medical or its authorized agents. The manufacturer’s warranty agreement shall become null and void if the pump is not used in accordance with the Operator’s 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 Warranty The limited warranty associated with the CADD-Prizm® PCS II 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 pump’s 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.

1

2 CADD-Prizm® PCS II pump Delivery Modes

PCA Delivery Profile

The 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 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. (See Figure 1.)

The PCA (patient-controlled analgesia) delivery mode is used for therapies that require a continuous rate of infusion, patientcontrolled demand doses or both, such as patient-controlled analgesia. (See Figure 2.)

Indicator Lights Amber Green Display

Polemount Bracket Recess

Keypad

Power jack Data In/Out jack Air Detector Port Cover

‹ ⁄¤ ´ Œ„ Î ÅÍ kj h ® PCS II -Prizm CADD

2000-03-07 D. Zurn «Prizm Rear 3/4 (dark BW)»

Battery compartment

Cassette lock Cassette latch Cassette

Air Detector (optional) Upstream Occlusion Sensor Front View

Rear View

Dosage

Figure 1. Front and back views of the CADD‑Prizm® PCS II pump.

Clinician Bolus (used here as a loading dose) Demand Doses

Time

Figure 2. PCA mode delivery profile.

2

Continuous Rate

Continuous Rate Scroll Ranges Units

Starting

Increment

Milliliters

0.10

0.10

Milligrams & Micrograms

10% of concentration

Mg only Values between 0.01 and 0.5 Mcg only Values between 0.1 and 0.5 Values between 0.5 and 100 Values between 100 and 1000 Values greater than 1000

Maximum 30.00 Concentration x 30

0.01 0.1 0.1 1.0 10.0

Table 1. PCA delivery mode continuous rate scroll ranges.

Milligrams Concentration mg/ml

Micrograms

Demand Dose Clinician Bolus increment max. increment max.

Concentration Demand Dose Clinician Bolus mcg/ml increment max. increment max.

0.1 0.2 0.3 0.4 0.5

0.01 0.02 0.03 0.04 0.05

0.99 1.98 2.97 3.96 4.95

0.01 0.02 0.03 0.04 0.05

2 4 6 8 10

1 2 3 4 5

0.05 0.10 0.15 0.20 0.25

9.9 19.8 29.7 39.6 49.5

0.05 0.10 0.15 0.20 0.25

20 40 60 80 100

1 2 3

0.05 0.10 0.15

9.9 19.8 29.7

0.05 0.10 0.15

20 40 60

6 7 8

0.30 0.35 0.40

59.4 69.3 79.2

0.30 0.35 0.40

120 140 160

4 5 6

0.20 0.25 0.30

39.6 49.5 59.4

0.20 0.25 0.30

80 100 120

9 10 11

0.45 0.50 0.55

89.1 99.0 108.9

0.45 0.50 0.55

180 200 220

7 8 9

0.35 0.40 0.45

69.3 79.2 89.1

0.35 0.40 0.45

140 160 180

12 13 14

0.60 0.65 0.70

118.8 128.7 138.6

0.60 0.65 0.70

240 260 280

10 11 12

0.50 0.55 0.60

99.0 108.9 118.8

0.50 0.55 0.60

200 220 240

15 20 25

0.75 1.00 1.25

148.5 198.0 247.5

0.75 1.00 1.25

300 400 500

13 14 15

0.65 0.70 0.75

128.7 138.6 148.5

0.65 0.70 0.75

260 280 300

30 35 40

1.50 1.75 2.00

297.0 346.5 396.0

1.50 1.75 2.00

600 700 800

20 25 30

1.00 1.25 1.50

198.0 247.5 297.0

1.00 1.25 1.50

400 500 600

45 50 55

2.25 2.50 2.75

445.5 495.0 544.5

2.25 2.50 2.75

900 1000 1100

35 40 45

1.75 2.00 2.25

346.5 396.0 445.5

1.75 2.00 2.25

700 800 900

60 65 70

3.00 3.25 3.50

594.0 643.5 693.0

3.00 3.25 3.50

1200 1300 1400

50 55 60

2.50 2.75 3.00

495.0 544.5 594.0

2.50 2.75 3.00

1000 1100 1200

75 80 85

3.75 4.00 4.25

742.5 792.0 841.5

3.75 4.00 4.25

1500 1600 1700

65 70 75

3.25 3.50 3.75

643.5 693.0 742.5

3.25 3.50 3.75

1300 1400 1500

90 95 100

4.50 4.75 5.00

891.0 940.5 990.0

4.50 4.75 5.00

1800 1900 2000

80 85 90

4.00 4.25 4.50

792.0 841.5 891.0

4.00 4.25 4.50

1600 1700 1800

95 100

4.75 5.00

940.5 990.0

4.75 5.00

1900 2000

200 300 400 500

10.00 15.00 20.00 25.00

1980.0 2970.0 3960.0 4950.0

10.00 4000 15.00 6000 20.00 8000 25.00 10000

Table 2. Demand dose, clinician bolus scroll ranges, milligrams

Table 3. Demand dose, clinician bolus scroll ranges, micrograms

Milliliters Demand Dose Clinician Bolus increment max. increment max.

0.05

9.9*

0.05

20

Table 4. PCA delivery mode Demand dose, clinician bolus scroll ranges, milliliters

*The maximum Demand Dose is 20 with software revision E or higher.

3

Specifications (Nominal) General Pump Specifications Resolution CADD™ medication cassette reservoir or CADD® administration set, 0.050 ml per pump stroke nominal Size  4.4 cm x 10.4 cm x 14.1 cm [1.7 in x 4.1 in x 5.6 in] excluding cassette or other accessories Weight  568 g [20 oz.] including 9 volt battery and empty 100 ml CADD™ medication cassette reservoir, excluding other accessories Pump Alarms  Low battery power; depleted battery power; external power source low, faulty, depleted; pump stopped; pump fault; low reservoir volume; high delivery pressure; air in line; Air Detector faulty or detached (only with the use of the optional Air Detector); Air Detector Port Cover detached; delivery too slow; key stuck; cassette detached or unlocked; print failure, epidural cassette not used.

System Operating Temperature  +2°C to 40°C (36°F to 104°F) System Storage Temperature -20°C to 60°C (-4°F to 140°F) Power Pack Charging Temperature +10°C to 35°C (50°F to 95°F) System DeliveryAccuracy  ± 6% (nominal) System Definition System is defined as a CADD-Prizm® PCS II pump with an attached CADD™ medication cassette reservoir and CADD® extension set with integral anti-siphon valve, or an attached CADD® administration set with integral or add-on anti-siphon valve.

Delivery Specifications Reservoir Volume  1 to 9999 or Not In Use; programmable in 1 ml increments, displayed in 0.1 ml increments. Default: 1 ml

Bolus Volume at Occlu­sion Alarm Pressure 0.050 ml resolution administration sets/CADD™ medication cassette Reservoirs <0.25 ml

Units*  Milliliters (ml), milligrams (mg), micrograms (mcg). Default: milligrams

Power Sources  9 volt alkaline or lithium battery such as ­ DURA­CELL® Alkaline MN 1604 or ULTRALIFE® Lithium U9VL; CADD® External Power Source (EPS) Power Pack reorder number 21-3801; AC Adapter. The expected life of a 9 volt battery is 12 hours at 100 ml/hour, or approximately 5 days at 10 ml/day (nominal). This estimate is based on laboratory tests conducted at room temperature using a new battery. Actual battery life will vary depending on the brand of battery, 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.

Concentration Mg/ml: 0.1 to 0.5 mg/ml in increments of 0.1 1 to 15 mg/ml in increments of 1 mg/ml 20 to 100 mg/ml in increments of 5 mg/ml Default: 100 mg/ml Mcg/ml: 1 to 15 mcg/ml in increments of 1 mcg/ml 15 to 95 mcg/ml in increments of 5 mcg/ml 100 to 500 mcg/ml in increments of 100 mcg/ml. Default: 500 mcg/ml Continuous Rate 0 to 30 ml/hr (or the mg or mcg equivalent). Default: 0 mg/hr (See Table 1 for Scroll ranges)

* If programmed to be part of pump programming screens in Biomed Toolbox.

4

Demand Dose  0 to 9.9 ml* Delivery rate (Continuous Rate + Demand Dose) programmable from 40 to 125 ml/hr. Default: 0 ml (See Table 2, 3 & 4 for Scroll ranges) *The Maximum Demand Dose is 20 with software revision E or higher. Demand Dose Lockout  5 minutes to 24 hours in the following increments: • 1 minute for values between 1 and 20 minutes • 5 minutes between 20 minutes and 24 hours Default: 5 min Set Delivery Limit 0.5 ml to 1000 ml (or the mg or mcg equivalent), or “No Limit”: 0.01 from 0.01 to 0.1 0.1 from 0.1 to 100 1.0 from 100 to 1000 10.0 from 1000 to 10000 100.0 from 10000 to 100000 1000.0 from 100000 and up Default: 0.5 ml or mcg or mg equivalent

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. Default: maximum program limits. Dosing Limit* Delivery Limit, a Maximum Doses per Hour, or neither. Default: Neither Key Beeps On or Off. Default: On Res Vol Trip Point 1 to 999 ml in increments of 1 ml, or “Standard.” Default: Standard

Given  0 to 99999.99 in 0.01 unit increments.

Res Vol Empty Alarm* Single or Insistent alarm. Default: Single

Clinician Bolus  0.1 ml to 20.00 ml (or mg or mcg equivalent) Delivery rate (Continuous Rate + Clinician Bolus): 125 ml/hr nominal (See tables 2, 3 & 4 for Scroll ranges)

Pump Stopped Alarm* Beep or Two-tone alarm. Default: Beep

High Pressure Alarm  18 ± 9 psi [1.24 ± 0.62 bar] Air Detector Alarm Single bubble greater than 0.100 ml

Options Specifications Lock Level LL0, LL1, LL2. Default: LL2 Epidural Mode On or Off. Default: Off Units*  Milliliters (ml), milligrams (mg), micrograms (mcg). Default: milligrams

AutoLock  Not In Use, LL1 Key/Code, LL2 Key/Code, LL1 No Key or LL2 No Key. Default: Not In Use PM (Preventive Maintenance) Reminder 1 to 24 months in 1 month increments, or “Not In Use.” Default: Not In Use Custom Lock Level Code 001 to 899 (excluding preset code) in increments of 1. Default: 061 Units Selection* Program units to appear in the Programming Units screens. Default: All Programming Units Units Location Options, Program or Biomed Toolbox. Default: Programming screens

* If programmed to be part of Options settings in the Biomed Toolbox.

5

Date Format  US Standard (mm/dd/yy) or European Standard (dd/mm/yy). Default: U.S. Standard Custom Main Display Display: • Res Vol or Continuous Rate • Power Source Always or Low 9 volt battery only Default: Res Vol and Low 9V Auto Review* Select the automatic program review feature during the pump’s power-up sequence. Default: On • Dose Counters (0 to 999 Given and/or Attempted). Default: On • Given. Default: On • Doses Hour By Hour (up to 48 hours in increments of 1 hour). Default: Off • Patient Review. Default: Off • Pain Scale (subjective pain scale rating of 0 to 10 in increments of 1). Default: On • Pain Scale Log (0 to 500 entries). Default: On • Delivery Log (0 to 500 events). Default: Off • Event Log (0 to 500 events). Default: Off • New Patient Marker. Default: On New Patient Marker* Reports/No Clear, Power-up/No Clear, Reports/Clear, Power-up/Clear Default: Reports/No Clear Air Detector Required  Required or Not Required. Default: Not Required

Default:ing the Lock Level Code & Clinician Bolus Code The standard Lock Level Code (061) can be changed to a customized code using the Biomed Toolbox Custom Lock Code feature. See the Operator’s Manual supplied with the pump for instructions on customizing the Lock Level Code. If it becomes necessary to change a customized code back to the standard Lock Level Code, do the following: 1. Press the OPTIONS key until the Lock Level screen 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 with add on anti-siphon valve and bag spike (allows for gravity priming before attaching the add on anti-siphon valve)

Remote Dose Cord Smiths Medical provides a Remote Dose Cord for the PCA delivery mode. The push button switch is a Single Pole Double Throw (SPDT). When the Remote Dose Cord is attached to the pump, the patient may press the Remote Dose button to receive a Demand Dose. The clinician may use the Remote Dose button to deliver a clinician bolus. For easy access, the Remote Dose cord may be fastened to the patient’s clothing or bedsheet with the attached clip. NOTE To detach the Remote Dose cord from the pump, grasp the Remote Dose cord connector and pull back using a straight, steady motion. Do not twist or turn the connector, or use any instrument to remove it. For additional specifications refer to the Operator’s Manual provided with the product.

Note The CADD-Sentry® Medication Software programming mode must be used to change a customized code back to the standard lock level code with CADD-Prizm® PCS II pumps with software revision E or higher. * If programmed to be part of pump programming screens in Biomed Toolbox.

6

3 Batteries Battery Compatibility Recommended Batteries Nine-volt alkaline or lithium batteries are recommended for use in the CADD-Prizm® PCS II pump. Carbon-zinc, mercury, nickelcadmium, or zinc-air 9-volt batteries should not be used. Battery Life The CADD-Prizm® PCS II pump has been designed to provide optimal battery life. The expected battery life in the CADD-Prizm® PCS II pump depends on the following factors: • Programmed delivery rate • Operating temperatures • Frequency of display backlighting • Frequency of printing • Battery type and brand • Battery age

DURACELL® Alkaline Battery Life The following tables may be used to predict typical alkaline battery life at different delivery rates when an alkaline battery is used in the CADD-Prizm® PCS II pump. As expected, battery life decreases as the delivery rate increases. These tables are based on laboratory tests using fresh DURACELL® alkaline batteries in CADD-Prizm® PCS II pumps while the pumps were operating at room temperature. Actual battery life may be significantly shorter depending on the operating temperature and the storage conditions of the battery.

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 batteries and a CADD® administration set. Actual battery life will vary depending on the brand of battery, battery shelf life and temperature conditions.

ULTRALIFE® Lithium Battery Life The following tables may be used to predict typical lithium battery life at different delivery rates when a lithium battery is used in the CADD-Prizm® PCS II pump. As expected, battery life decreases as the delivery rate increases. These tables are based on laboratory tests using fresh ULTRALIFE® lithium batteries in CADD-Prizm® PCS II pumps while the pumps were operating at room temperature. Actual battery life may be significantly shorter depending on the operating temperature and the storage conditions of the battery. Lithium battery life is dependent upon the temperature and relative humidity of storage. Recommended storage conditions are less than 20°C (68°F) with a desiccant to ensure less than 10% relative humidity. The following tables are based on laboratory tests conducted at room temperature using fresh ULTRALIFE® lithium batteries and a CADD® administration set. Actual battery life depends upon the brand of battery selected, the particular battery selected, battery shelf life, and temperature conditions. Smiths Medical’s testing indicates a large variability in battery life.

Battery life is shortened significantly at very low operating temperatures. For example, at 0°C (32°F), an alkaline battery will yield approximately 30% of its normal capacity. Alkaline batteries do not need to be stored in a refrigerator. After four years of storage at 21°C (70°F), an alkaline battery retains approximately 86% of its original capacity. Battery life will be shorter 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.

7

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 10 ml/hr 30 ml/hr 50 ml/hr 100 ml/hr 200 ml/hr 350 ml/hr

120 hrs 86 hrs 37 hrs 26 hrs 13 hrs 14 hrs 7 hrs

48 ml 860 ml 1110 ml 1300 ml 1300 ml 2800 ml 2450 ml

Table 4. 9-volt Alkaline-type batteries used with the CADD-Prizm® PCS II pump. Rate

Life

Volume

0.4 ml/hr 10 ml/hr 30 ml/hr 50 ml/hr 100 ml/hr 200 ml/hr 350 ml/hr

212 hrs 161 hrs 79 hrs 60 hrs 30 hrs 32 hrs 17 hrs

85 ml 1610 ml 2370 ml 3000 ml 3000 ml 6400 ml 5950 ml

Table 5. 9-volt Lithium-type batteries used with theCADD-Prizm® PCS II pump. Rate

Life

Volume

100 ml/hr 200 ml/hr 350 ml/hr

64 hrs 67 hrs 39 hrs

6400 ml 13400 ml 13650 ml

Table 6. EPS System used with the CADD-Prizm® PCS II pump.

8

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. The battery compartment is not water resistant. NOTE The CADD-Prizm® PCS II ambulatory infusion pump is water resistant, but not waterproof. The battery compartment is accessed through a removable door on the side of the base housing. Within the battery compartment is space for the battery and the two battery contacts. The CADD™ medication cassette reservoir or the administration set is attached to the bottom of the pump by inserting the two hooks on the cassette into the mating hinge pins on the pump. The pump and the reservoir or the administration set are then placed in an upright position on a firm, flat surface. The reservoir or the administration set can be latched in place by inserting a coin in the slot on the pump’s latching button, pushing the button in, and turning the button one-quarter turn counterclockwise. The reservoir or the administration set is locked into place by inserting a key into the pump’s lock and turning the lock one-quarter turn counterclockwise. NOTE The cassette lock must be unlocked before attempting to unlatch the disposable. NOTE The CADD™ medication cassette reservoir and the administration set are intended for single use only. The keyboard, located on the front housing, is composed of nine membrane switches and is sealed against moisture. All of the keys contain domes to provide a tactile feel when the key is pressed. 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 control the pump are located on two printed circuit boards. The microprocessor board contains the Central Processing Unit (CPU) and its associated circuitry, motor driver circuitry, and other miscellaneous circuitry. The LCD board contains the Liquid Crystal Display with its associated circuitry, and the backlight module with its associated circuitry. The pumping mechanism subassembly contains the motor, gear train, camshaft, valves, expulsor, sensing disk, infrared light source, infrared detector, occlusion sensor, cassette sensors, lock and latch. Via the motor driver circuitry, the pump’s microprocessor controls motor rotation. Two external port connectors are utilized for communication and external power input. One of these connectors, the data in/out jack, is used for attachment of the Remote Dose cord. This enables the patient to use the Remote Dose cord to begin a Demand Dose. This jack can also be connected via an interface cable to an external PC to view reports or to a printer to print reports. The second port is for external power connection. This port, the power jack, can receive input from either an AC adapter or the External Power Source rechargeable power pack. Connections between the printed circuit boards are designed for ease of manufacturing and serviceability. The keyboard is connected to the microprocessor board via a flex circuit tail. Flexible circuitry and discrete wires connect the pumping mechanism, motor, and sensors to the printed circuit boards.

9

5 Theory of Operation Keyboard Circuitry

Time Base Circuitry

The CADD-Prizm PCS II pump is controlled by a microprocessor. The actions of the microprocessor are controlled by a program, which is contained in the memory.

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.

®

Commands are issued to the microprocessor from the user via the nine keys on the keyboard and the Remote Dose cord. The keys on the keyboard feed individually into the Gate Array on the microprocessor board. A key closure applies a ground to the associated input of the Gate Array. Key debounce circuitry resident in the Gate Array provides a clean output signal to the microprocessor for the duration of the key closure. The microprocessor reads keyboard status by accessing special memory locations in the Gate Array. The Remote Dose button consists of an SPDT switch with its own dedicated input to the microprocessor circuitry. The switch has a common input line and two output signal lines. The two signal lines are complementary such that one line is always logic high and the other is always low. When the Remote Dose button is pressed, both signal lines change to the alternate logic state. This redundancy prevents a single line failure from starting a dose delivery.

Data Memory EEPROM Many settings of the pump’s delivery and record keeping parameters are stored by the microprocessor in an Electrically Erasable Programmable Read Only Memory (EEPROM). Data to and from the memory is presented serially. Whenever the microprocessor uses data from the EEPROM, the data is checked for validity.

Battery Backed RAM Additional settings of the pump’s delivery and record keeping parameters are stored in a battery backed Random Access Memory (RAM). Battery backup is provided by two printed circuit board-mounted lithium batteries. These batteries are 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. 10

In addition, an accurate 32.768 kHz timebase is provided by a second quartz crystal. The 32.768 kHz signal is used for the real time clock.

LCD Circuitry The high-impedance, low-power, special drive signals for the liquid crystal display are provided by the LCD-drivers. Each alpha or numeric character on the LCD is formed by darkening combinations of dots. Commands to display dots are issued via data bus commands to the LCD-drivers by the microprocessor. The LCD circuit also contains a power supply which provides bias voltage to the LCD panel. This voltage controls the relative brightness of the characters. Additional circuitry allows the microprocessor to disable the LCD when not in use in order to conserve battery power. A two brightness level LCD backlight is provided to improve LCD viewing under low light conditions. When the microprocessor enables the LCD, it also enables the low brightness backlight. Low brightness is used to conserve battery power. If the AC adapter is connected, the microprocessor will enable the high brightness backlight since this does not consume power from the battery. The backlight automatically shuts off when the LCD is turned off.

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 continuously. A flashing indicator typically indicates a normal mode of operation and a steady “on” indicator typically indicates a fault condition.

Flash PROM Technology Program memory for the pump is stored in Flash Programmable Read Only Memory (Flash PROM). This type of memory allows modification of the contents without physically removing the device from the circuit board. Under certain circumstances, the program can also be downloaded through the I/O port on the side of the pump. Several layers of redundancy in the programming system prevent accidental erasing or modification of the PROM.

to test the watchdog circuit on every powerup. 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 powerup 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.

Gate Array Circuitry

Motor Driver/Motor Watchdog Circuit

The Gate Array contains circuitry which controls memory address decoding, keyboard debounce, Light Emitting Diode (LED) indicator status, LCD command buffering, Battery Backed RAM interface, and miscellaneous signal line buffering functions.

Audible Alarm Circuitry Audible alarm circuitry consists of a piezo electric disk and independent oscillator. The disk flexes or bends in resonance with the output of the oscillator. The piezo disk is mounted to the pump housing to enhance sound level. The oscillator which drives the piezo disk is capable of providing two driving frequencies. The low frequency is in the range of 700 to 1500 Hz and the high frequency is in the range of 1600 to 2500 Hz. The microprocessor controls the audible alarm via control lines from the Gate Array. When the microprocessor selects both the low and high frequency control lines, the audible alarm enters a warble mode where it oscillates between the low and high frequency sound at a rate of 0.8 and 2 Hz. Low battery voltage detection and watchdog timer circuitry also have the ability to enable the audible alarm via the Gate Array.

Watchdog Timer Circuit 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 start” the microprocessor. This unique feature allows the microprocessor

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. If the motor runs for more than an average of 4 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. Rotation of the motor is sensed by the microprocessor via an infrared-sensitive photo detector. An infrared light source is mounted so that its light beam illuminates the infrared detector. An opaque flag is mounted concentrically to the camshaft and rotates with it between the infrared light source and detector. When the flag interrupts the light beam, the output of the detector is sensed by the microprocessor via an input port bit. Power to the infrared LED light source is controlled by the motor driver circuit and is off when the motor is not running to conserve battery life. In the microprocessor software, multiple checks are made on motion of the camshaft. When the motor is commanded to start, the infrared sensor must show that half a revolution has occurred within five seconds and that the motor has stopped when half a rotation was completed. In addition, no camshaft rotation can take place when the motor has not been commanded to run. 11

Power Circuitry

Voltage Reference Circuit

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 their discharge range, which will keep power supply noise low. Other types of batteries, such as carbon-zinc, exhibit high internal resistance, especially near depletion. A voltage drop across the internal resistance occurs when current is drawn by the motor during pump activations. This current is demanded in short pulses when the motor is first turned on and generates large spikes in the battery voltage. This noise can cause the low battery detection circuit to shut down the pump.

A voltage reference circuit provides a constant DC voltage to the microprocessor Analog to Digital Converter (ADC). By reading this input and comparing the value to a predetermined range, the microprocessor can validate the accuracy of the 5-volt power supply. Variations in the 5-volt supply left undetected can result in inaccuracy in the low battery alarm set points and variations in other calculated values.

The motor driver circuit power is taken directly from the battery, but the microprocessor and its associated circuitry requires closely regulated and filtered 5-volt power which is supplied from the micropower voltage regulator. This regulator will supply 5-volt power until its input voltage is approximately 5.3 volts. After that point, the output of the regulator will follow the input voltage down.

Voltage Trip Point*

CADD® Pump Status

>7.0V

No alarm

6.4–7.0V*

Transition to low battery condition; battery low message appears; 3 beeps every 5 min.†

6.0–6.6V*

Transition to depleted battery condition; battery depleted message appears; 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. Table 12. CADD-Prizm® PCS II pump low battery conditions. † The pump emits 3 beeps every 5 minutes, and the message “9 Volt Battery Low” appears on the pump’s display, indicating that the battery power is low, but the pump is operable. †† The pump emits a continuous, variable-tone alarm, and the message “9 Volt Battery Depleted” appears on the display, the battery power is too low to operate the pump, and pump operation has stopped.

12

Pumping Mechanism

To deliver the amount of drug specified by the parameter settings, the pump’s microprocessor causes the pump mechanism to deliver 0.05 ml fluid “pulses” timed according to the desired rate. At rates higher than 3 ml/hr, 2 pulses in succession will be given. Thus, to deliver 20 ml/hr, for example, the microprocessor solves these equations:

The pumping mechanism is linear peristaltic with two active valves. Pumping occurs when the expulsor presses on the reservoir pump tubing in sequence with the inlet and outlet valves. At rest, the outlet valve is pressing down fully on the tubing and the expulsor and inlet valve are retracted. (See Figure 7.) When the microprocessor commands the mechanism to pump, the camshaft begins to rotate, thus controlling the following pump cycle:

Mechanism activations per hr:

1. The inlet valve closes. 2. In synchrony with the expulsor moving down to compress the tubing, the outlet valve opens, expelling 0.050 ml of fluid. 3. The outlet valve closes. 4. The inlet valve opens as the expulsor is retracted, causing fluid from the reservoir to again fill the pump tubing segment. 5. The camshaft rotation stops after half a revolution and the cycle is completed.

= 200

= 20 ml per hr/0.1 ml per activation

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 developed is 186 kPa (1.86 bar, 27 psi).

Motor

= 20/0.1 Time (seconds) between activations: = 3600 sec per hr/number of activations per hr = 3600/200 = 18

Cassette or Admin Set

Rate (ml/hr) 0 - 3 3.1 - 125

Volume Resolution (ml) 0.050 0.100

The microprocessor uses its timer circuits to accurately time the 18 seconds (in this example) between mechanism activations. The timebase accuracy is ultimately determined by the 3.6864 MHz quartz crystal oscillator.

Camshaft

Pump Housing Expulsor Occlusion Sensor

Lock Button Latch Button

Cassette Hinge Pump Tubing Pressure Plate Inlet Valve Outlet Valve

Figure 7. A simulated pumping mechanism in a CADD-Prizm® PCS II pump.

13

Air Detector

Theory of Operation

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® PCS II pump automatically detects the presence of the air detector and will automatically turn the sensor on when powered up in LL0.

The air detector consists of sensor electronics and two ultrasonic transducers positioned on opposite sides of the tubing. One transducer acts as an acoustic transmitter and the other as an acoustic receiver. Air detection occurs when air in the fluid path causes a reduction in the signal level to the receiver. When the signal is interrupted for a preset length of time, the sensing circuitry sends a signal to the microprocessor indicating air in the fluid path. To maximize the reliability of the system and to reduce false alarms, the transmitted signal is swept over a frequency range. This accommodates varying resonance frequencies of the transducer and reduces sensitivity to tubing tolerances and other mechanical variations.

When the optional air detector is installed, the Biomed Toolbox feature allows the air detector to be “required” or “not required.” When the air detector is not required, it can be “turned on” or “turned off” using the Options menu. When the air detector is required, the option for turning the air detector on or off will not be available. When the air detector is turned on, the pump will detect the presence of air in the outlet tubing fluid path. If the air detector settings are “not required” and “turned off,” it will Default: to “turned on” each time the pump powers up in Lock Level 0. The air detector is compatible with all of the reservoirs and sets indicated for use with the CADD-Prizm® PCS II pump, and all pump accessories. It is powered directly from the CADD-Prizm® PCS II pump and no additional power is required.

Specifications The air detector will alarm when it senses a single air bubble greater than 100 microliters (0.1 milliliters.)

Construction The air detector housing is made of a special high impact plastic and has a metalized film coating on the inside surface to reduce interference from electromagnetic fields. The air detector is composed of a single 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.

14

Upstream Occlusion Sensor Theory of Operation The upstream occlusion sensor is a strain gauge device capable of detecting pressure changes in the disposable tubing set. This is accomplished by using a loading ball or sphere located on the bottom of the pump. This loading ball contacts the pump tubing when a tubing set is attached to the pump. Under normal operation, the pump tube pushes outward and applies a specified force on the sensor. When an upstream occlusion is present, the upstream tubing collapses pulling away from the sensor reducing the force on the sensor. It is this change of the force that indicates an upstream occlusion.

6 Safety Features and Fault Detection Hardware Safety Features Key hardware safety features include a watchdog timer circuit, motor driver and motor watchdog circuits, cassette ‘type’ sensor circuit, latch/lock sensor circuit, and a voltage detector circuit. Each safety circuit performs a unique function to insure the overall safety of the device. (See Figure 8.)

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 start” the microprocessor. This unique feature allows the microprocessor to test the watchdog circuit on every powerup. 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 powerup 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 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. If the motor runs for more than an average of 4 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.

AUDIBLE ALARM LCD DISPLAY PROGRAM MEMORY MB DATA MEMORY

CPU/IO/ GATE ARRAY

MB KEYBOARD

VOLTAGE REFERENCE MOTOR DRIVER

WATCHDOG

MOTOR WATCHDOG

VOLTAGE DETECTOR SENSORS

REAL-TIME CLOCK

Figure 8. CADD-Prizm® PCS II pump hardware block diagram.

15

Cassette ‘Type’ Sensor Circuit

Voltage Detector Circuit

The cassette ‘Type’ sensor system consists of three pins protruding from the button of the pump mechanism that interface to the attached administration set and associated circuitry. Each type of administration set designed to work with the CADD-Prizm® PCS II pump contains a unique ‘code’ programmed into the set via nubs molded into the plastic. When a set is latched to the pump, the nubs press against the pins in the pump mechanism in a pattern unique to that set type. Optical detectors and electronic circuitry on the circuit board encode this pattern and report the information to the microprocessor. This feature allows automatic rate selection dependent on the type of set attached. This system also acts as a safety feature to detect a damaged or detached set. If, during operation, the microprocessor detects all pins extended, the pump will enable audible and visual alarms and stop delivery. Redundancy in the pattern prevents single fault failures from causing over or under delivery of fluid. Additional circuitry allows these sensors to be turned on and off by the microprocessor to conserve battery power. Additionally, control of sensor power allows the microprocessor to test the sensor inputs in both the powered and unpowered states, thus allowing detection of sensor fault conditions. Care should be taken not to damage these sensor pins.

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 two 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 6.8 volts. 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 battery voltage reaches a nominal value of 6.3 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 5.6 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 old battery with a fresh one will clear the condition.

Latch/Lock Sensor Circuit Latch and Lock sensors allow the microprocessor to detect the positions of the latch and lock buttons. This prevents attempted fluid delivery when the set is not correctly latched to the pump. In addition, it allows the microprocessor to stop fluid 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 the microprocessor to test the sensor inputs in both the powered and unpowered states, thus allowing detection of sensor fault conditions.

16

Software Safety Features Hardware-related Software Safety Features

Data Handling Software Safety Features

Program Memory Check

Data Stored in RAM

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 turn on a continuous two-tone audible alarm and stop all drug delivery.

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 turn on a continuous two-tone audible alarm and stop all drug delivery.

RAM Memory Check

Data Stored in EEPROM

At power up, the random access memory is checked. A particular bit pattern is written to and read from each address in the RAM. If the read data is different from the written data, the software will turn on a continuous twotone audible alarm and stop all drug delivery.

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 turn on a continuous two-tone audible alarm and stop all drug delivery.

Motor Circuit Check

Data Stored in NOVRAM

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 turn on a continuous two-tone audible alarm and stop all drug delivery.

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 turn on a continuous two-tone audible alarm and stop all drug delivery.

Keyboard Encoder Check Every time the software receives data from the keyboard encoder, it is checked. If the data is not of the proper form, the software 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 Used in Calculations Calculations on data used in some way to control the delivery of drug are performed redundantly. The two calculated values are then compared. If the two values do not match, the software will turn on a continuous two-tone audible alarm and stop all drug delivery. Timer Data Registers The data stored in the timer control register is checked at regular intervals. If the data is not correct, the software will turn on a continuous two-tone audible alarm and stop all drug delivery.

17

7 Hardware and Software Fault Detection Overview

Order of Error Code Events

If the CADD-Prizm PCS II pump displays an error code, a hardware or software fault has been detected by the microprocessor, and the pump should be returned for servicing. ®

When hardware or software faults are detected by the microprocessor, pump operation stops and a continuous, audible alarm will be activated as well as the amber warning LED. An error message will be displayed. On the next power up, the error code will again be displayed with the software level (see illustration below). If the error detected was a data fault, the pump will be in Lock Level 2, and all other programmed functions will have Default: values. (See the pump’s Operator’s Manual for specific Defaults.)

Error code

Pump model number

C A D D - P R I Z M lec XXXXX sn XXXXXXXX

61XX

Serial number

18

0351-01X XXXX-X Software revision level

1. There is a continuous two-tone audible alarm, a continuous amber indicator light, and the display will read:

Error Detected E(XXXXX) 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 will appear in the LCD in the Event Log. These five digits will remain in memory and will appear on the Event Log record until 500 data writes have occurred or until the mode has been changed. (See “Testing Procedures” starting on page 23 of this manual for detailed instructions regarding the power-up check.) Thus, there is always a record of the last internal fault detected by the microprocessor.