Smiths Medical CADD-Prizm PCS II, 6101 Technical Manual

CADD-Prizm® PCS II
Ambulatory Infusion Pump

Model 6101

Technical Manual

1

Table of Contents

1. Introduction ............................................... 1

Limited Warranty ..............................................1

Exposure to Radiation or Magnetic Resonance

Imaging (MRI) ................................................... 1

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

6. Safety Features and Fault Detection ...... 15

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

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
have additional comments or questions concerning the operation of CADD

®

pumps, please refer to the Operator’s Manual supplied with the product. If you

®

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
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.

®

PCS II pump can be found

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

Clinician Bolus

(used here as a loading dose)

Demand Doses

Continuous Rate

Time

Dosage

Delivery Modes

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.)

Indicator Lights

Amber

Display

Keypad

Green

⁄ ¤ ‹

Power jack

Data In/Out jack

Π㠫
Å Í Î

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.)

Polemount

Bracket Recess

2000-03-07 D. Zurn

«Prizm Rear 3/4 (dark BW)»

Battery

compartment

Air Detector

Port Cover

Air Detector

(optional)

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

Figure 2. PCA mode delivery profile.

h k j

®

CADD-Prizm

Upstream Occlusion Sensor

PCS II

Cassette lock

Cassette latch

Cassette

Rear ViewFront View

2

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 0.1 x 30
Values between 0.5 and 100 0.1
Values between 100 and 1000 1.0
Values greater than 1000 10.0

Table 1. PCA delivery mode continuous rate scroll ranges.

Milligrams

Concentration

mg/ml

Demand Dose
increment max.

Clinician Bolus
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 0.10 40
3 0.15 29.7 0.15 60

4 0.20 39.6 0.20 80
5 0.25 49.5 0.25 100
6 0.30 59.4 0.30 120

7 0.35 69.3 0.35 140
8 0.40 79.2 0.40 160
9 0.45 89.1 0.45 180

10 0.50 99.0 0.50 200
11 0.55 108.9 0.55 220
12 0.60 118.8 0.60 240

13 0.65 128.7 0.65 260
14 0.70 138.6 0.70 280
15 0.75 148.5 0.75 300

20 1.00 198.0 1.00 400
25 1.25 247.5 1.25 500
30 1.50 297.0 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,
milligrams

Micrograms

Concentration

mcg/ml

Demand Dose
increment max.

Clinician Bolus
increment max.

1 0.05 9.9 0.05 20
2 0.10 19.8 0.10 40
3 0.15 29.7 0.15 60
4 0.20 39.6 0.20 80
5 0.25 49.5 0.25 100

6 0.30 59.4 0.30 120
7 0.35 69.3 0.35 140
8 0.40 79.2 0.40 160

9 0.45 89.1 0.45 180
10 0.50 99.0 0.50 200
11 0.55 108.9 0.55 220

12 0.60 118.8 0.60 240
13 0.65 128.7 0.65 260
14 0.70 138.6 0.70 280

15 0.75 148.5 0.75 300
20 1.00 198.0 1.00 400
25 1.25 247.5 1.25 500

30 1.50 297.0 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

200 10.00 1980.0 10.00 4000
300 15.00 2970.0 15.00 6000
400 20.00 3960.0 20.00 8000
500 25.00 4950.0 25.00 10000

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
or CADD
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
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.

medication cassette reservoir

®

administration set, 0.050 ml

™

medication cassette reservoir,

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
pump with an attached CADD
cassette reservoir and CADD

™

®

®

PCS II

medication

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 Occlu sion Alarm

Pressure 0.050 ml resolution
administration sets/CADD

™

medication

cassette Reservoirs <0.25 ml

Power Sources

9 volt alkaline or lithium battery such as
DURA CELL
Lithium U9VL; CADD

®

Alkaline MN 1604 or ULTRALIFE®

®

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.

Units*

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

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.

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)

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

Res Vol Empty Alarm*

Single or Insistent alarm. Default: Single

Pump Stopped Alarm*

Beep or Two‑tone alarm. Default: Beep

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, nickel‑
cadmium, 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
battery life decreases as the delivery rate
increases. These tables are based on
laboratory tests using fresh DURACELL
alkaline batteries in CADD‑Prizm
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.

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.

®

PCS II pump. As expected,

®

PCS II

®

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
life decreases as the delivery rate increases.
These tables are based on laboratory tests
using fresh ULTRALIFE
CADD‑Prizm
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

®

CADD
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.

®

PCS II pump. As expected, battery

®

®

PCS II pumps while the pumps

®

lithium batteries and a

lithium batteries in

administration set. Actual battery life

7