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

Continuous and PCA Delivery Battery Life
(Max Delivery Rate PCA Mode 30 ml/hr)

Note Results are without air detector.

Rate Life Volume

10 ml/hr 86 hrs 860 ml
30 ml/hr 37 hrs 1110 ml
50 ml/hr 26 hrs 1300 ml
100 ml/hr 13 hrs 1300 ml
200 ml/hr 14 hrs 2800 ml
350 ml/hr 7 hrs 2450 ml

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

Rate Life Volume

0.4 ml/hr 212 hrs 85 ml

10 ml/hr 161 hrs 1610 ml
30 ml/hr 79 hrs 2370 ml
50 ml/hr 60 hrs 3000 ml
100 ml/hr 30 hrs 3000 ml
200 ml/hr 32 hrs 6400 ml
350 ml/hr 17 hrs 5950 ml

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

Rate Life Volume
100 ml/hr 64 hrs 6400 ml

200 ml/hr 67 hrs 13400 ml
350 ml/hr 39 hrs 13650 ml

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

0.4 ml/hr 120 hrs 48 ml

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

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.

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.

Time Base Circuitry

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.

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.

10

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 power‑
up. 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 power‑
up 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

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 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.

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

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.

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 Reference Circuit

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.

Voltage CADD® Pump Status
Trip Point*

>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

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:

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.

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).

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:

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

Rate Volume
(ml/hr) Resolution (ml)

Cassette or 0 ‑ 3 0.050
Admin Set 3.1 ‑ 125 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.

CamshaftMotor

Pump Housing

Expulsor

Occlusion Sensor

Cassette Hinge

Pump Tubing

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

Lock Button

Latch Button

Pressure Plate

Inlet Valve

Outlet Valve

13

Air Detector

The air detector is designed to detect air in
the outlet tubing fluid path. The air detector is
detachable if not needed. The CADD‑Prizm

®

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

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.

Theory of Operation

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.

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.

14

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 power‑
up. 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 power‑
up 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.

LCD DISPLAY

PROGRAM

MEMORY

MB

REFERENCE

CPU/IO/

DATA

MEMORY

MB

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

GATE ARRAY

WATCHDOG

KEYBOARD

AUDIBLE

ALARM

VOLTAGE

MOTOR

WATCHDOG

MOTOR

DRIVER

VOLTAGE

DETECTOR

SENSORS

REAL-TIME

CLOCK

15

Cassette ‘Type’ Sensor 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
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.

®

PCS II pump

Voltage Detector Circuit

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

Program Memory Check

At power up and at regular intervals
thereafter, the program memory is tested
by calculating a Cyclic Redundancy Code
(CRC) on the program and then comparing it
with the CRC stored with the program. 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

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 two‑
tone audible alarm and stop all drug delivery.

Motor Circuit Check

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.

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 Handling
Software Safety Features

Data Stored in RAM

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.

Data Stored in EEPROM

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.

Data Stored in NOVRAM

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.

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

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

C A D D - P R I Z M 61XX
lec XXXXX
sn XXXXXXXX 0351-01X
XXXX-X

Serial number

Pump model number

Software revision level

Order of Error Code Events

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.

18

8 Cleaning and Inspection Procedures

Inspection Recommendation

Smiths Medical recommends annual functional
inspection on the CADD‑Prizm
pump. The following inspection and testing
procedures should be performed annually to
verify function and accuracy.

NOTE

Persons performing the following tests and
procedures should be familiar with the Smiths
Medical CADD-Prizm

®

PCS II pump. Please
read the Operator’s Manual supplied with the
pump before proceeding.

WARNING

®

CADD

pumps are sealed units. A broken or
damaged seal will, therefore, be considered
conclusive evidence that the pump has been
misused and/or altered, which voids any and
all warranties. All service and repair of CADD
pumps must be performed by Smiths Medical
or its authorized agents.

®

PCS II

®

Cleaning

CAUTION

• Do not immerse the pump in cleaning fluid or

water. Do not allow solution to soak into the
pump, accumulate on the keypad, or enter
the battery compartment.

• Do not allow solution to enter the data in-out

jack or the power jack. Make sure the jack
covers are closed before cleaning.

• Do not expose the open air detector port area

of the pump or the connector opening on the
air detector to foreign material, moisture
or cleaning fluids. If an air detector is not
installed on the pump, make sure the air
detector port cover is securely attached
before cleaning.

• Do not clean the pump with acetone, other

plastic solvents, or abrasive cleaners.

Use any of the following solutions to clean the
pump and accessories:

• Soap solution

• Benzalkonium chloride concentrate (0.13%)

• Glutaral concentrate, USP (2%)

• 20 percent solution of household bleach (one

part household bleach to four parts water–

1.2% Sodium HypoChlorite or 12,000 ppm)

• Alcohol, USP (93%)

• Isopropyl Alcohol, USP (99%)

• PDI – Super Sani‑Cloth

• Mada Medical – MadaCide

®

1. Dampen a soft, lint‑free cloth with
cleaning solution. Apply the solution to
exterior surface of the pump or accessory.
Do not allow the solution to soak into the
pump or accessory.

2. Wipe the entire surface dry with another
soft, lint‑free cloth. Allow the pump to dry
completely before use.

Visual Inspection

• Visually inspect the pump for any damage to

the LCD, occlusion sensor seals, valves and
expulsor, reservoir hinge area, latch, lock,
cassette sensors (3), keyboard, indicator
lights, power jack, data in/out jack, air
detector port cover or air detector, and
housing. If any damage is noted, the pump
should be returned for service.

• Check the battery door for proper operation.

It should not be broken or damaged. The
mating tabs on the pump housing should not
be broken or damaged.

• Examine the battery compartment for

damage. If the battery contacts appear
corroded, clean them with a cotton swab
and isopropyl alcohol. If the battery contacts
appear to be bent or pushed in, straightening
may be possible with a small screwdriver or
other suitable tool. Care must be taken so as
not to damage the pump housing or to incur
further damage to the contacts.

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.

• Attach either a 50‑ or 100‑ml CADD

medication cassette reservoir or a CADD
administration set to the pump. Check
for smooth operation and a definite “feel”
when the latch pulls the reservoir or
administration set firmly against the bottom
of the pump. The mark on the latch should
be aligned with the solid dot.

• Lock the device by inserting a key into the

lock and turn counterclockwise until the
mark lines up with the solid dot.

• Gently twist and pull on the cassette to make

sure it is firmly attached.

NOTE

In the PCA delivery mode, the cassette must
be locked in order to start the pump.

™

®

19

9 Testing Procedures

Functional Testing

The Power‑up Check, Latch/Lock Check
and Cassette Sensor Check using a CADD
medication cassette reservoir or CADD
administration set can be performed with the
pump in any of the four delivery modes.

™

®

Power-up Check

• Insert a battery in the pump and observe the
LCD during power up.

Error code

C A D D - P R I Z M 61XX
lec XXXXX
sn XXXXXXXX 0351-01X
XXXX-X

The number values may vary depending on the
current mode and software revision.

Serial number

Pump model number

Software revision level

• If “lec XXXXX” (last error code with 5 digit
number) appears on the display prior to the
pump reviewing the current program settings,
the pump has experienced an electrical or
mechanical fault and should be returned for
service. If no error message is immediately
shown, the pump has powered up normally.
The pump should sequentially display all of
the programmed values. The words “Self
Test Complete” should appear, then the text
“Power Up Successful” with six audible beeps.
Continue with the Latch/Lock check.

Latch/Lock Check

• Attach a 50‑ or 100‑ml CADD™
medication cassette reservoir or a CADD
administration set to the pump. The mark
on the latch should be aligned with the
solid dot. The display should show that the
reservoir or administration set is latched.
See Table 13.

• Lock the device by inserting a key into the
lock and turning counterclockwise until the
mark lines up with the solid dot. The display
should show “Cassette Locked.”

• Unlock the device by inserting a key into
the lock and turning clockwise until the
mark lines up with the open dot. The display
should show “Cassette Unlocked.”

• Unlatch the reservoir by inserting a coin into
the latch slot and turning clockwise until the

20

®

If the Epidural mode is NOT turned on in the
Options Menu

Reservoir Latched VIEW to continue

Admin set Latched Upstream Sensor On.

VIEW to continue

If the Epidural mode is turned on in the
Options Menu

Reservoir Latched Is epidural reservoir

attached

Press YES or NO

Admin set Latched Upstream Sensor On.

Is epidural admin set

attached?

<Press YES or NO>

• Select Yes

Table 13.

mark lines up with the open dot. The display
should show “Cassette Unlatched / Close
Clamp to Prevent Free Flow.”

Cassette Sensor Check

• Attach a 50‑ or 100‑ml CADD™ medication
cassette reservoir to the pump. Latch the
cassette to the pump. The display should
show “Reservoir latched.”

NOTE The message displayed depends on

the type of reservoir or administration set
attached. See Table 13.

• Lock the device by inserting a key into the
lock and turning counterclockwise until the
mark lines up with the solid dot. The display
should show “Cassette Locked.”

• Unlock the cassette. The display should show
“Cassette Unlocked.” Unlatch the cassette.
The display should show “Cassette Unlatched /
Close Clamp To Prevent Free Flow.”

• Remove the 50‑ or 100‑ml reservoir and
attach a CADD
pump. Latch the cassette to the pump. The
display should show “Admin Set Latched.”
(See table 13)

• Lock the device by inserting a key into the
lock and turning counterclockwise until the
mark lines up with the solid dot. The display
should show “Cassette Locked.”

®

administration set to the

• Unlock the cassette. The display should
show “Cassette Unlocked.” Unlatch the
Administration Set. The display should
show “Cassette Unlatched/Close Clamp To
Prevent Free Flow.”

The following three checks (LCD, motor and
gear train, and Reservoir Volume is Zero alarm)
should be performed in the sequence shown.

LCD Check

• Remove and reinsert the battery. After a few
seconds, the LCD will display all off pixels
(dots) followed by all on pixels. Examine the
LCD for missing dark or light pixels.

• Program the pump to the following
parameters:

Units Milligrams
Concentration 1.0 mg/ml
Continuous Rate 30.0 mg/hr
Demand Dose 0.0 mg
4 Hour Delivery Limit No Limit
Reservoir Volume 2.0 ml

• Press the VIEW/SILENCE key until units is
displayed on the LCD. Press the YES or NO
key until milligrams is displayed and press
the ENTER key. Select the Concentration of

1.0 mg and press the ENTER key. Select the
Continuous Rate of 30.0 mg/hr, then press
the ENTER key. Select the Demand Dose of

0.0 mg, then press the ENTER key. Select
the 4 hour limit to “No Limit”, then press
the ENTER key. Select the Reservoir Volume
of 2.0 ml, then press the ENTER key.

Motor and Gear Train Check

• Attach either a 50‑ or 100‑ml CADD™
medication cassette reservoir or CADD
administration set to the pump. Latch and
lock the cassette.

• Press the PRIME/BOLUS key. Press and
hold the YES key. The pump should begin
to prime. While priming the pump, listen to
the motor for excessive noise or grinding
sounds. Then press the VIEW/SILENCE key
until the Reservoir Volume screen appears.
The reservoir volume should show 1.0 ml.

®

Reservoir Volume is Zero Alarm Check

• Press the PRIME/BOLUS key. Press and hold
the YES key. The pump should prime ten
double activations and then stop. The pump
will alarm and display “Reservoir Volume is
Zero.” Press the VIEW/SILENCE key.

• Reprogram the reservoir volume to 1.0 ml.
Press the VIEW/SILENCE key until Reservoir
Volume is displayed on the LCD. Press the
YES or NO key until 1.0 ml is displayed. Then
press the ENTER key.

NOTE

The remaining testing procedures should
be performed using a 50- or 100-ml CADD

™

medication cassette reservoir containing fluid
and a primed extension set with anti-siphon

®

valve or a primed CADD

administration set

with anti-siphon valve.

Starting/Stopping the Pump

• Check the STOP/START key by pressing it.
“Start the Pump?” should be displayed.
Press the YES key. The display should show
“Starting Pump” followed by a review of the
programmed parameters. The main screen
should appear with “RUNNING” in the
display, and the green LED indicator light
should blink every 3 seconds.

• To stop the device, press the STOP/START
key. When the message “Stop the Pump?”
appears, press YES. STOPPED appears in
the display and the amber LED indicator
light blinks.

Activation Timing Check

• Check the activation timing by programming
the pump with the following values:

Units Milligrams
Concentration 1.0 mg/ml
Continuous Rate 30.0 mg/hr
Demand Dose 0.0 mg
Delivery Limit No Limit
Reservoir Volume 1.0 ml

• Press the STOP/START key. Press the YES
key. “Starting Pump” should appear on the
display. The pump should sequentially
display all of the programmed values. Start a
timer at the first motor activation.

• Count the activations. One activation should
occur every twelve seconds. Approximately
one minute fifty seconds (150) and ten
activations later, the RES VOL alarm should
occur. The display should show “Reservoir
Volume is Zero”.

21

Remote Dose Cord Check

• Check the Remote Dose Cord button
operation by programming the pump with
the following values:

Units Milligrams
Concentration 1.0 mg/ml
Continuous Rate 0.0 mg/hr
Demand Dose 1.0 mg
Demand Dose Lockout 0 hrs 5 min
Delivery Limit No Limit
Reservoir Volume 10.0 ml
Dose Counters 0/0 (Press the
ENTER key to clear
in the Reports
menu)
Milligrams Given 0.00 mg (Press the
ENTER key to clear
in the Reports
menu)

• Press the STOP/START key. Press the YES
key. The pump should sequentially display
all of the programmed values.

• After RUNNING appears on the display,
press the Remote Dose Cord button and
note the time. The pump should beep twice
and begin to deliver. Count the number of
pump activations. The pump should make
ten double activations. After ten double
activations, the display should show a
reservoir volume of 9.0 ml. Press the Remote
Dose Cord button two more times within the
next 5 minutes. The pump should not deliver
and the message “Dose Not Delivered Dose
Locked Out” should be displayed.

Doses Given and Doses Attempted Check

• Stop the pump by pressing the STOP/START
key, then the YES key. Press the REPORTS
key to advance to the Dose Counters report.
The display should show 1/3. (If the above
steps have not been followed exactly,
different values may appear.)

• Press the ENTER key. The display should
now show 0/0.

MG GIVEN Report Check

• Press the REPORTS key to advance to the
Milligrams Given report. The display should
now show 1.0 mg if the Remote Dose cord
was tested. (If the above steps have not been
followed exactly, different values may appear.)

• Press the ENTER key. The display should
now show 0.0 mg.

Air Detector Test (if applicable)

This test will verify the function of the optional
air detector. To perform this test, the
CADD‑Prizm

®

PCS II pump must have an air
detector installed and the air detector must
be turned on. The previous program from
the DOSE key check can be used to perform
this test.

• Attach an empty CADD

cassette reservoir or CADD

™

medication

®

administration

set to the pump.

• Latch and lock the set to the pump.

• Open the air detector door and thread the

tubing through the groove.

• Close the door making sure the tubing does

not get pinched or kinked.

• Start the pump.

• The pump should respond with a continuous

two‑tone alarm and the display should read
Air in line detected, Pump will not run VIEW
to silence,

• Press VIEW/SILENCE to silence the alarm,

™

and remove the CADD
reservoir or CADD

• Now attach a CADD

medication cassette

®

administration set.

™

medication cassette
reservoir containing fluid and a primed
extension set with anti‑siphon valve, or

®

a primed CADD

administration set with
anti‑siphon valve to the pump. Make certain
there is no air in the fluid path.

• Latch and lock the set to the pump.

• Open the air detector door and thread the
tubing through the groove.

• Close the door making sure the tubing does
not get punched or kinked.

• Start the pump.

• Deliver a demand dose. (NOTE five minutes
must have passed since the delivery of the
last demand dose.)

• The pump should deliver the dose without
an air detection alarm.

Occlusion Accuracy Tests

This manual provides two testing options for
the Occlusion Pressure Range Test and the
Accuracy Test. Only one option needs to be
performed. It is not necessary to perform
both Option 1 and Option 2.

22

Downstream Occlusion Pressure Range
Test (Option 1)

Description

Pressure is generated by activating the
pumping mechanism with an attached filled,
clamped CADD
The pump is started and a Demand Dose is
given until the high pressure alarm sounds.

Equipment needed

50‑ or 100‑ml CADD
reservoir containing water

™

medication cassette reservoir.

™

medication cassette

• Pressure regulator, 30 psi

• 50 or 100 ml CADD

™

medication cassette

reservoir containing water

Procedure

1. Insert a battery and wait for the pump to
power up.

2. Attach a CADD

™

medication cassette

reservoir to the pump. Latch and lock
the cassette.

NOTE

The pressure from the source must be zero
when the cassette is attached.

Procedure

1. Insert a battery and wait for the pump to
power up.

2. Attach a CADD

™

medication cassette
reservoir containing water to the pump.
Latch and lock the cassette.

3. Prime the CADD

™

medication cassette
reservoir tubing. The tubing should be
filled with fluid to the end of the luer lock
connector. The system must be free from
air bubbles for this test.

4. Close the slide clamp on the distal end
of the tubing near the female luer of the

™

CADD

medication cassette reservoir.

5. Program the pump to the following
parameters:

Units Milligrams
Concentration 1.0 mg/ml
Continuous Rate 0.0 mg/hr
Demand Dose 1.0 mg
Demand Dose Lockout 0 hrs 5 min
Delivery Limit No Limit
Reservoir Volume 10.0 ml

6. Start the pump. When the pump is running,
activate a Demand Dose, noting when the
high pressure alarm is activated.

7. The pump should alarm when the pump
delivers between 1 and 2 activations.

Downstream Occlusion Pressure Range
Test (Option 2)

Description

An adjustable metered pressure source is
connected to the CADD
reservoir tubing. The pressure is slowly
increased until the high pressure alarm sounds.

Equipment needed

• Pressure gauge, 30 psi ± 1 psi

• Pressure vessel, partially filled with water

™

medication cassette

3. Assemble the apparatus as shown in Figure 9.

4. Connect the CADD

™

medication cassette

reservoir outlet tube to the metered
pressure source.

6/5/96 D. Zurn, Occlusion Set-up Prizm 6/96

30

PSI

Pressure GaugeRegulator

Figure 9. Occlusion test set‑up.

NOTE

Do not use a CADD

®

extension set with

anti-siphon valve.

5. Start the pump and run at 30 ml/hr.

6. Slowly increase the back pressure, noting
when the high pressure alarm is activated.
NOTE The pressure may be increased
rapidly to 8 psi, after which the pressure
should be increased at 3 psi/min or less
until the alarm sounds.

7. The high pressure alarm should sound
between 9 and 27 psi (18±9 psi).

Upstream Occlusion Sensor Test

Description

The tubing between the fluid reservoir and the
pump is occluded while the pump is running
until the occlusion alarm sounds.

Equipment needed

• CADD

• Tubing clamp (slide clamp or hemostat)

Procedure

1. Spike an appropriate standard I.V. bag

2. Prime the entire fluid path

®

administration set with

anti‑siphon valve

23

3. Program the pump to deliver a continuous
rate of 30 ml/hr

4. Start the pump

5. Clamp the tubing halfway between the
fluid reservoir and the pump

6. The pump should alarm within three
activations after clamping the tubing

NOTE

Make sure the upstream occlusion sensor is
turned on in the Biomed Toolbox.

Accuracy Testing

Accuracy testing may be performed in
any delivery mode. This manual shows an
example of delivery accuracy testing with the
pump in the PCA delivery mode.

Gravimetric Accuracy Testing (Option 1)

Description

A CADD
partially filled with water and weighed. The
reservoir is then attached to the pump and
the pump is set to deliver a certain amount
of water. The reservoir is then removed and
weighed again. The amount of water delivered
is compared to the amount that the pump
should have delivered.

Nominal system accuracy is given in the
technical specifications section for the pump.
That is, under the test conditions described
below, the accuracy of the pump and reservoir
will be nominal with a 90% confidence level.
The nominal test conditions are as follows
degassed water at 25 ± 5°C without
back pressure.

Equipment needed

• 50‑ or 100‑ml CADD

• 50‑ or 60‑ml syringe

• CADD

• A balance accurate to 0.1 g

• 40 ml of room temperature water

™

medication cassette reservoir is

reservoir

®

extension set with anti‑siphon valve

™

medication cassette

Procedure

1. Fill the 50‑ or 60‑ml syringe with 40 ml of
water. Transfer the water into a

™

CADD

2. Remove any air from the CADD

medication cassette reservoir.

™

Medication
Cassette reservoir by aspirating the air with
the syringe. Attach the CADD® extension set
with anti‑siphon valve. Prime the tubing so it is
filled with fluid to the end of the extension set
luer lock connector.

3. Secure the clamp as close to the extension set
luer lock connector as possible. This should
assure a minimum water loss from the tubing
when the syringe is removed.

4. Weigh the entire reservoir/extension set
assembly and record the weight. This is the
pre‑delivery weight. (This weight includes the
empty CADD

™

medication cassette reservoir,

extension set, and weight of the water.)

5. Attach the CADD

™

medication cassette
reservoir to the pump. Program the reservoir
volume to 20 ml. Now press the ENTER key.
This value is the intended delivery volume.
(One ml of water at 20°C weighs 1 gram.) Open
the clamp.

6. With the pump in Lock Level 0, program a
continuous rate of 0 ml/hr and a dose of 1.0 ml
(but do not deliver a Demand Dose). Start the
pump and deliver a clinician bolus of 20 ml.

7. Again, secure the clamp as close as possible

to the end of the extension set luer lock
connector. Remove the CADD

™

medication
cassette reservoir from the pump and weigh
the entire reservoir/extension set assembly.
This is the postdelivery weight.

8. Calculate the difference in weight between the
predelivery weight and the postdelivery weight.

This is the weight of the amount delivered.

9. Find the difference between the volume of the
amount delivered and the intended delivery
volume. This is the inaccuracy volume.

10. Divide the inaccuracy volume by the intended
delivery volume and multiply by 100. This is
the accuracy error percentage (See Table 14).

11. If the accuracy error percentage is greater

than ± 6%, repeat the test with a new reservoir.
If the pump fails a second time, call Smiths
Medical’s Customer Service Department.

Pre- Post Weight of Intended Inaccuracy Accuracy Accuracy
Delivery Delivery Amount Delivery Volume Error Error Percentage

Weight Weight Delivered Volume

61.1 g 41.6 g 19.5 g = 19.5 ml 20 ml ‑0.5 ml ‑0.5 ml ÷ 20.0 ml = ‑0.025 x 100 = ‑2.5%
‑0.025

Table 14. Gravimetric percentage calculation

24

EXAMPLE

Predelivery Weight 61.1 g
Postdelivery Weight ‑ 41.6 g

Weight of Amount Delivered 19.5 g

= 19.5 ml

Volume of Amount Delivered 19.5 ml
Intended Delivery Volume ‑ 20.0 ml

Inaccuracy Volume – 0.5 ml

Inaccuracy Volume – 0.5 ml
Intended Delivery Volume ÷ 20.0 ml

Accuracy Error -0.025 ml

Accuracy Error ‑0.025
x 100.00

Accuracy Error Percentage –2.5%

Volumetric Accuracy Testing (Option 2)

Description

A predetermined amount of water is delivered
into a collection device such as a burette or
graduated cylinder. The amount of water
delivered is compared to the amount that the
pump should have delivered.

Nominal system accuracy is given in the
technical specifications section for the pump.
That is, under the test conditions described
below, the accuracy of the pump and reservoir
will be nominal with a 90% confidence level. The
nominal test conditions are as follows degassed
water at 25 ± 5°C without back pressure.

Equipment needed

• 50‑ or 100‑ml CADD
reservoir

• 50‑ or 60‑ml syringe

• CADD

®

extension set with anti‑siphon valve

• A fluid collection device such as a burette or
a class A 25 ml capacity graduated cylinder

• 40 ml of room temperature water

™

medication cassette

Procedure

1. Fill the 50‑ or 60‑ml syringe with 40 ml of
water. Transfer the water into a

™

CADD

2. Remove any air from the CADD

medication cassette reservoir.

™

medication
cassette reservoir by aspirating the air with
the syringe. Attach the CADD® extension set
with anti‑siphon valve. Prime the tubing so it
is filled with fluid to the end of the extension
set luer lock connector.

3. Attach the end of the extension set to the fluid
collection device.

4. Attach the CADD

™

medication cassette

reservoir to the pump. Program the reservoir
volume to 20 ml. This is the intended delivery
volume. Open all clamps.

5. Program a continuous rate of 0.0 ml/hr and a
Demand Dose of 1.0 ml (but do not deliver a
Demand Dose). Start the pump and deliver a
clinician bolus of 20 ml.

6. When delivery is complete, record the volume
of fluid delivered. This is the actual delivery.

7. Find the difference between the volume of the
amount delivered and the intended delivery
volume. This is the inaccuracy volume.

8. Divide the inaccuracy volume by the
intended delivery volume and multiply by 100.
This is the accuracy error percentage.
(See Table 15.)

9. If the accuracy error percentage is greater
than ±6%, repeat the test with a new
reservoir. If the pump fails a second time,

call Smiths Medical’s Customer Service
Department.

Intended Actual Inaccuracy Accuracy Accuracy
Delivery Delivery Volume Error Error Percentage

Volume Volume

20 ml 19.5 ml ‑0.5 ml ‑0.5/20.0 ml =‑0.025 ‑0.025 x 100 = ±2.5%

Table 15. Volumetric percentage calculation

25

CADD-Prizm® PCS II 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® PCS II pump. If service is provided, fill out
this sheet and return it with the device.

Serial # _______________ Reference Number _______________________ Date _______________________

(Refer to the Technical Manual procedures.)

I. Cleaning Completed  Yes  No

II. Visual Inspection

 LCD  Lock  Data In/Out Jack
 Occlusion Sensor Seals  Cassette Sensors (3)  Air Detector or Port Cover
 Valves and Expulsors  Keyboard  Pump Housing
 Reservoir Hinge Area  Indicator Light  Battery Door
 Latch  Power Jack  Battery Compartment

III. Mechanical Inspection

 Keyboard  Cassette Latch
 Battery Door  Cassette Lock

IV. Functional Inspection

 Power‑up  RES VOL Alarm  Dose Given / Attempted
 Latch / Lock  Stop / Start  MG Given
 Cassette Sensor  Activation Timing  Air Detector
 LCD  Remote Dose Cord  Printer Tests
 Motor / Gear Train

V. Occlusion Tests (Only need to perform 1 or 2; not both)
Downstream Option 1 Activations Before Alarm ___________
Downstream Option 2 High Pressure Alarm At ____________ psi

Upstream Occlusion Sensor Test
Pass ________Fail __________

VI. Accuracy Testing (Only need to perform 1 or 2; not both)

Volumetric Accuaracy Test

Intended Actual Inaccuracy Accuracy Accuracy
Delivery Delivery Volume Error Error
Volume Volume Percentage

ml ml ml %

Gravimetric Accuracy Test

Pre-Delivery Post-Delivery Amount Intended Inaccuracy Accuracy Accuracy
Weights Weight Delivered Delivery Volume Error Error
Volume

g g ml ml ml %

26

THE DETAILS GIVEN IN THIS LEAFLET ARE CORRECT AT THE TIME OF GOING TO PRESS. THE COMPANY RESERVES THE RIGHT TO IMPROVE THE EQUIPMENT SHOWN.

Smiths Medical ASD, Inc.

St. Paul, MN 55112, USA
Phone 1‑214‑618‑0218
Toll‑Free USA 1‑800‑258‑5361

Smiths Medical Canada Ltd.

Markham, Ontario, Canada, L3R 4Y8
Phone 905‑477‑2000
Toll‑Free 1‑800‑387‑4346

EC Authorized Representative

Smiths Medical International Ltd.

TN25 4BF, UK
Phone [phone]

www.smiths‑medical.com

Smiths Medical is part of the global technology business Smiths Group plc.

Product(s) described may not be licensed or available for sale in Canada or other countries outside of the United States.

CADD, CADD‑Prizm and the Smiths Medical and CADD design marks are trademarks of Smiths Medical. The symbol ®
indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries.
©2010 Smiths Medical. All rights reserved. 11t/10 IN19779