CADD-Legacy® Ambulatory Infusion Pumps

CADD-Legacy
Ambulatory Infusion Pumps
®
CADD-Legacy 1
CADD-Legacy PCA
CADD-Legacy PLUS
®
®
®
Technical Manual
Table of Contents
1.Introduction................................................ 1
Limited Warranty............................................... 1
Exposing CADD® Pumps to Radiation, Ultrasound, or MRI or use near ECG equipment...... 1
6. Safety Features and Fault Detection....... 16
Hardware Safety Features.............................. 16
Software Safety Features................................ 18
7. Hardware and Software Fault Detection.... 19
2.CADD‑Legacy® Pump
Delivery Modes.................................................. 2
Specifications (Nominal)................................... 5
Compatible Medication Cassette Reservoirs
and CADD® Administration Sets....................... 7
Remote Dose Cord............................................ 7
Overview.......................................................... 19
Order of Error Code Events............................. 19
8. Cleaning and Inspection Procedures...... 20
Inspection Recommendation.......................... 20
Cleaning.......................................................... 20
Battery Contact Cleaning................................ 20
Visual Inspection............................................. 20
Mechanical Inspection.................................... 21
3.Batteries.................................................... 8
Battery Compatibility........................................ 8
DURACELL® Alkaline Battery Life.................... 8
9. Testing Procedures.................................. 22
4.Construction............................................ 11
Testing Recommendation............................... 22
Changing to Lock Level 0 (LL0)....................... 22
5. Theory of Operation................................. 12
Keyboard Circuitry........................................... 12
Data Memory in Real Time Clock RAM........... 12
EEPROM.......................................................... 12
Battery Backed RAM....................................... 12
Time Base Circuitry......................................... 12
LCD Circuitry................................................... 12
LED Indicator................................................... 12
Flash PROM Technology................................. 12
Audible Alarm Circuitry................................... 13
Watchdog Timer Circuit.................................. 13
Motor Drive/Motor Watchdog Circuit.............. 13
Power Circuitry............................................... 13
Voltage Reference Circuit............................... 14
Pumping Mechanism...................................... 14
Pumping Characteristics................................ 14
Air Detector..................................................... 15
Downstream Occlusion Sensor....................... 15
Upstream Occlusion Sensor........................... 15
Cassette Attachment Detection...................... 15
CADD-Legacy® PCA Pump...................... 22
Air Detector Test.......................................... 24
Upstream Occlusion Sensor Test................ 24
Occlusion Pressure Range Tests................. 24
Accuracy Testing.......................................... 25
CADD-Legacy® 1 Pump........................... 28
Air Detector Test.......................................... 29
Upstream Occlusion Sensor Test................ 29
Occlusion Pressure Range Tests................. 29
Accuracy Testing.......................................... 30
CADD-Legacy® PLUS Pump.................... 33
Air Detector Test.......................................... 34
Upstream Occlusion Sensor Test................ 34
Occlusion Pressure Range Tests................. 34
Accuracy Testing.......................................... 35
Cleaning and Functional Testing
Checklist.................................................. 38
For detailed instructions, specifications, warnings, warranties, and additional information on
operating CADD® pumps, please refer to the Operator’s Manual supplied with the product. If you
have additional comments or questions concerning the operation of CADD® pumps, please call
this number: 1-800-258-5361. Our staff is available to help you twenty-four hours a day with the
programming and operation of CADD® pump infusion systems.
The issue date of this Technical Manual is included on the back cover 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: January 2011
1Introduction
This Technical Manual is intended to provide an
understanding of the mechanical and electrical
operation of the CADD-Legacy® PCA,
CADD-Legacy® 1, and CADD-Legacy® PLUS
Computerized Ambulatory Drug Delivery
pumps to persons familiar with these devices.
The CADD-Legacy® PCA, CADD-Legacy® 1,
and CADD-Legacy® PLUS pump Operator’s
Manuals should be used in conjunction with this
publication for complete information.
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.
This manual also outlines cleaning and functional
testing procedures that can be performed on the
CADD-Legacy® PCA, CADD-Legacy® 1, and
CADD-Legacy® PLUS pumps.
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.
WARNING
This Technical Manual must be used by
Bio-medical technicians only. Do not permit
patients to have access to this manual.
Do not disclose to the patient the pump’s
security codes or any other information that
would allow the patient complete access to
all programming and operating functions.
Improper programming could result in death or
serious injury to the patient.
IMPORTANT NOTICE
CADD-Legacy® PCA, CADD-Legacy® 1, and
CADD-Legacy® PLUS pump operations and
safety features are based on a microcomputer
design. Inadequate servicing or tampering with
the safety features of the pumps may seriously
affect performance and safety.
For that reason, All servicing and repair of the
CADD-Legacy® 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-Legacy® PCA, CADD-Legacy® 1, and
CADD-Legacy® PLUS pumps can be found
in the product literature supplied with the
product when originally purchased, which
is incorporated herein by reference. Smiths
Medical specifically disclaims any other
warranty, whether express, implied or
statutory, including, without limitation, any
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)
CAUTION
• Do not expose the pump to therapeutic levels
of ionizing radiation as permanent damage
to the pump’s electronic circuitry may occur.
The best procedure to follow is to remove the
pump from the patient during therapeutic
radiation sessions. If the pump must remain
in the vicinity during a therapy session, it
should be shielded, and its ability to function
properly should be confirmed following
treatment.
• Do not expose the pump directly to
ultrasound, as permanent damage to the
pump’s electronic circuitry may occur.
• Do not use the pump in the vicinity of
magnetic resonance imaging (MRI)
equipment as magnetic fields 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.
• Do not use the pump near ECG equipment as
the pump may interfere with the operation
of the equipment. Monitor ECG equipment
carefully when using this pump.
1
2CADD-Legacy® Pump
Delivery Modes
The CADD-Legacy® ambulatory drug delivery
pump provides measured drug therapy to
patients in hospital or outpatient settings.
The CADD-Legacy® pump is indicated for
intravenous, intra-arterial, subcutaneous,
intraperi-toneal, epidural space, or
subarachnoid space infusion.
Epidural administration is limited to use with
indwelling catheters for short term delivery
of anesthetics and short or long term delivery
of analgesics. Subarachnoid administration
is limited to use with indwelling catheters for
short-term delivery of analgesics.
The CADD-Legacy® PCA pump may be
programmed to deliver medication in one
of three ways: 1) continuous rate only, 2)
patient-activated Dose only and 3)
continuous rate and patient-activated Dose.
(See figure 1.)
The CADD-Legacy® PLUS pump may be
programmed to deliver in one of two modes:
(1) Continuous, (2) Intermittent.
(See figures 2 and 3.)
The CADD-Legacy® 1 pump operates in
continuous mode. (See figure 2.)
Figure 4 shows a diagram of the
CADD-Legacy® pump.
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.
Figure 1. PCA mode delivery profile.
Continuous Mode Delivery Profile
The Continuous delivery mode allows
the infusion of drug at a constant,
programmed rate.
Figure 2. Continuous mode delivery profile.
Dose Cycle
Dose
Volume
Dose
Starts
in
Dose
Dose
Duration
Duration
Time
Intermittent Delivery
Figure 3. Intermittent mode delivery profile.
2
Intermittent Mode Delivery Profile
The Intermittent delivery mode allows the
infusion of a specific volume of drug at
regular programmed intervals.
Threaded
Mounting
Hole
Display
Power Jack
Power Jack
Symbol
Accessory
Jack
Accessory
Jack Symbol
AC Indicator
Light
Battery
Compartment
Air Detector
®
Cassette Lock
Keypad
Dose key on
CADD-Legacy® PCA
Front View
Cassette
CADD-Legacy® PCA
Cassette Lock
Rear View
Figure 4. Front and Rear views of the CADD-Legacy® Pump. Features are identical on all CADD-Legacy® pumps except as illustrated for
the CADD-Legacy® PCA pump.
3
PCA Delivery Mode Scroll Ranges
Units
Starting
Increment
ML
0.10
All values:
0.10
50.00
MG
10% of
Concentration
Values between 0.01 and 0.5:
Values between 0.50 and 100.0:
Values between 100.0 and 1000.0:
Values greater than 1000.0:
0.01
0.10
1.00
10.0
Concentration
x 50
10% of
Concentration
Values between 0.1 and 100:
Values between 100 and 1000:
Values greater than 1000:
0.10
1.00
10.00
Concentration
x 50
MCG
Maximum
Table 1. PCA delivery mode: continuous rate scroll ranges.
Milligrams
Concentration
mg/mL
0.1
0.2
0.3
0.4
0.5
1
2
3
4
5
10
15
20
25
30
35
40
45
50
55
60
65
70
75
80
85
90
95
100
Demand Dose Clinician Bolus
increment max. increment max.
0.01 0.99
0.02 1.98
0.03 2.97
0.04 3.96
0.05 4.95
0.05 9.9
0.10 19.8
0.15 29.7
0.20 39.6
0.25 49.5
0.50 99.0
0.75 148.5
1.00 198.0
1.25 247.5
1.50 297.0
1.75 346.5
2.00 396.0
2.25 445.5
2.50 495.0
2.75 544.5
3.00 594.0
3.25 643.5
3.50 693.0
3.75 742.5
4.00 792.0
4.25 841.5
4.50 891.0
4.75 940.5
5.00 990.0
0.01
2
0.02
4
0.03
6
0.04
8
0.05 10
0.05 20
0.10 40
0.15 60
0.20 80
0.25 100
0.50 200
0.75 300
1.00 400
1.25 500
1.50 600
1.75 700
2.00 800
2.25 900
2.50 1000
2.75 1100
3.00 1200
3.25 1300
3.50 1400
3.75 1500
4.00 1600
4.25 1700
4.50 1800
4.75 1900
5.00 2000
Table 2. Demand Dose, clinician bolus scroll ranges, milligrams
Milliliters
demand Dose Clinician Bolus
incrementmax.
incrementmax.
0.05
9.90.05
20
Table 4. Demand Dose, clinician bolus scroll ranges, milliliters
4
Micrograms
Concentration
mg/mL
Demand Dose
Clinician Bolus
increment max. increment max.
1 0.05 9.9
2
0.10 19.8
3
0.15 29.7
4
0.20 39.6
5
0.25 49.5
10
0.50 99.0
15
0.75 148.5
20
1.00 198.0
25
1.25 247.5
30
1.50 297.0
35
1.75 346.5
40
2.00 396.0
45
2.25 445.5
50
2.50 495.0
55
2.75 544.5
60
3.00 594.0
65
3.25 643.5
70
3.50 693.0
75
3.75 742.5
80
4.00 792.0
85
4.25 841.5
90
4.50 891.0
95
4.75 940.5
100
5.00 990.0
200
10.00 1980.0
300
15.00 2970.0
400
20.00 3960.0
500
25.00 4950.0
0.05 20
0.10 40
0.15 60
0.20 80
0.25 100
0.50 200
0.75 300
1.00 400
1.25 500
1.50 600
1.75 700
2.00 800
2.25 900
2.50 1000
2.75 1100
3.00 1200
3.25 1300
3.50 1400
3.75 1500
4.00 1600
4.25 1700
4.50 1800
4.75 1900
5.00 2000
10.00 4000
15.00 6000
20.00 8000
25.00 10000
Table 3. Demand Dose, clinician bolus scroll ranges, micrograms
Specifications (Nominal)
General Pump Specifications
Resolution
CADD™ medication cassette reservoir or
CADD® administration set, 0.050 mL/pump
stroke nominal
Size
4.1 cm x 9.5 cm x 11.2 cm (1.6 in x 3.8 in x 4.4 in)
excluding cassette or other accessories
Weight 391 g (13.8 oz.) including 2 AA batteries, empty
100-mL medication cassette reservoir, and air
detector, excluding other accessories
Air Detector Alarm Single bubble
Low sensitivity = greater than 0.250 mL
High sensitivity = greater than 0.100 mL
Multi-bubble = 1.0 mL nominal
Delivery Mode Specifications
CADD-Legacy® PCA Pump
Reservoir Volume
1 to 9999 or Not In Use; programmable
in 1 mL increments, displayed in 0.1 mL
increments
Default: 1 mL
Pump Alarms Low battery power; depleted battery power;
battery dislodged; pump stopped; pump fault;
low reservoir volume; high delivery pressure;
air in line; disposable not attached when run
attempted; motor locked; upstream occlusion;
reservoir volume empty; program incomplete;
remote Dose cord removed; key stuck;
disposable detached, power removed, value not
saved.
Units
Milliliters (mL), milligrams (mg),
micrograms (mcg)
Default: milligrams
Bolus Volume at Occlusion Alarm Pressure
0.050 mL resolution sets/reservoirs:
< 0.15 mL
Continuous Rate 0 to 50 mL/hr (or the mg or mcg equivalent)
(See Table 1 for scroll ranges)
Power Sources Two AA alkaline batteries such as DURA­CELL®
or EVEREADY Energizer®; AC adapter.
Demand Dose 0 to 9.9 mL in 0.05 mL increments (or the mg
or mcg equivalent)
(See Tables 2 and 3 for scroll ranges)
Delivery rate (continuous rate + demand
Dose): 125 mL/hr nominal
An internal battery powers the clock. When it is
depleted, it cannot reliably maintain the clock
time. This battery must be replaced by Smiths
Medical The internal battery has an expected
life of 5 years.
System Operating Temperature*
+2°C to 40°C (35°F to 104°F)
System Storage Temperature* -20°C to 60°C (-4°F to 140°F)
System Delivery Accuracy* ± 6% (nominal)
High Pressure Alarm
26 (±14) psi, 1.79 (± 0.97) bar
Concentration
Mg/mL: 0.1, 0.2, 0.3, 0.4, 0.5, 1, 2, 3, 4, 5, 10,
15, ... 95, 100 (Default: 100 mg/mL)
Mcg/mL: 1, 2, 3, 4, 5, 10, 15, ...95, 100, 200,
300, 400, 500 (Default: 500 mcg/mL)
Dose Lockout
5 minutes to 24 hours in the following
increments:
1 minute for values between 5 and 20 minutes
5 minutes between 20 minutes and 24 hours
Default: 24 hours
Doses Per Hour
1 to 12 doses in 1 dose increments (will also
be limited by the demand dose Lockout value)
Default: 1 dose/hr
Doses Given
0 to 999
*System is defined as a CADD-Legacy® pump with an attached medication cassette reservoir and CADD® extension set with
integral anti-siphon valve, or an attached CADD® administration set with integral or add-on anti-siphon valve.
5
Doses Attempted
0 to 999
Given
0 to 99999.95 in 0.05 unit increments or
0 to 99999.99 in 0.01 unit increments
(increments converted to current units based
on concentration)
Clinician Bolus 0.05 mL to 20.00 mL (or mg or mcg
equivalent) (See Tables 1, 2 and 3 for scroll
ranges)
Delivery rate (continuous rate + clinician
bolus): 125 mL/hr nominal
CADD-Legacy® 1 Pump
Continuous Delivery Mode Specifications
Reservoir Volume
1 to 9999 or Not In Use; programmable
in 1 mL increments, displayed in 0.1 mL
increments
Default: 1 mL
Continuous Rate
1 to 3000 mL/24 hr in increments of
1 mL/24hr
Default: 0 mL/24hr
Given
0 to 99999.95 in 0.05 mL increments
CADD-Legacy® PLUS Pump
Intermittent Delivery Mode Specifications
Reservoir Volume
1 to 9999 or Not In Use; programmable
in 1 mL increments, displayed in 0.1 mL
increments
Default: 1 mL
Dose Volume
0.1 to 1000.0 mL in increments of 0.1
Default: 0.0 mL
Dose Duration
1 minute to 24 hours in the following
increments:
1 minute from 00:01 to 00:10
5 minutes from 00:10 to 24:00
Default: 30 minutes
6
Dose Cycle
10 minutes to 96 hours in 5 minute
increments
Default: 4 hours
KVO Rate
0 to 125.0 mL/hr in increments of 0.1 mL/hr
Default: 0 mL/hr
Dose Starts in
Immediate or 1 minute to 96 hours in the
following increments:
00:01 from 00:00 to 00:10
00:05 from 00:10 to 96:00
Default: Immediate
Continuous Delivery Mode Specifications
Reservoir Volume
1 to 9999 or Not In Use; programmable
in 1 mL increments, displayed in 0.1 mL
increments
Default: 1 mL
Continuous Rate
0.1 mL/hr to 125.0 mL/hr in increments of
0.1 mL/hr
Default: 0.0 mL/hr
Given
0 to 99999.95 in 0.05 mL increments
Biomed Functions Specifications
Air Detector Status Off
On- low
On- high
Default: On-high
Upstream Occlusion Status
Off
On
Default: On
Delivery Mode (CADD-Legacy® PLUS only)
Continuous
Intermittent
Default: Intermittent
Compatible CADD™ Medication Cassette
Reservoirs and CADD® 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 CADD-Legacy® PCA pump which is an
extension of the Dose key. The push button is a
Single Pole Double Throw (SPDT) switch which
operates in the same manner as the Dose key.
When the remote dose cord is attached to the
pump, the patient may press either the remote
Dose button or the Dose key to receive a demand
dose. The clinician may also use either the
remote Dose button or the Dose key to deliver
a clinician-activated bolus. For easy access, the
remote dose cord may be fastened to the patient’s
clothing or bedsheet with the attached clip.
There is an alarm/function present in the
CADD-Legacy® PCA pump. If the remote dose
cord is removed, the display shows a message
“Remote Dose Removed”. The pump sounds an
audible alarm until the Next key is pressed to
acknowledge the alarm.
NOTE
To detach the remote DOSE cord from the pump,
grasp the remote DOSE cord connector and pull
back using a straight, steady motion.
7
3Batteries
Battery Compatibility
Recommended Batteries
Two AA alkaline batteries are recommended for
use in the CADD-Legacy® pumps. Carbon-zinc,
mercury, nickel-cadmium, nickel-metal-hydride,
or zinc-air AA batteries should not be used.
Battery Life
The CADD-Legacy® pumps have been designed
to provide optimal battery life. The expected
battery life in the CADD-Legacy® pumps
depends on the following factors:
• Programmed delivery rate
• Operating temperatures
• Battery type and brand
• Battery age
DURACELL® Alkaline Battery Life
Battery life is shortened significantly at very
low operating temperatures. For example,
at 0°C (32°F), an alkaline battery will yield
approximately 30% of its normal capacity.
Alkaline batteries do not need to be stored in a
refrigerator. After four years of storage at 21°C
(70°F), an alkaline battery retains approximately
86% of its original capacity. Battery life will
be shorter if the battery is stored above room
temperature. An alkaline battery stored at 43°C
(110°F) will be down to approximately 80% of its
capacity within one year.
Recommended storage conditions are 10°C
to 25°C (50°F to 77°F) with no more than 65%
relative humidity noncondensing.
The following table may be used to predict
typical alkaline battery life at different delivery
rates when alkaline batteries are used in
the CADD-Legacy® pump. As expected,
battery life decreases as the delivery rate
increases. This table is based on laboratory
tests using fresh DURACELL® alkaline
batteries in CADD-Legacy® 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.
8
Continuous Delivery Battery Life with Alkaline Batteries
Rate
Life
0.4 mL/hr
4 mL/hr
10 mL/hr
15 mL/hr
30 mL/hr
75 mL/hr
125 mL/hr
Volume
338 hrs
178 hrs
112 hrs
96 hrs
53 hrs
18 hrs
15 hrs
135 mL
712 mL
1120 mL
1440 mL
1590 mL
1350 mL
1875 mL
Table 5. Two AA alkaline-type batteries used with the CADD-Legacy® pumps.
Intermittent Delivery Battery Life with Alkaline Batteries
Dose Volume
Duration
Dose Cycle
KVO
23.5 mL
1:00 hr
5:00 hr
0.2 mL/hr
61 mL
1:00 hr
6:00 hr
0.2 mL/hr
125 mL
1:00 hr
6:00 hr
0.2 mL/hr
®
Table 6. Two AA alkaline-type batteries used with the CADD-Legacy pumps.
Life
Volume
193 hr
120 hr
65 hr
915 mL
1224 mL
1356 mL
135
120
Rate (mL/hr)
105
90
75
60
45
30
15
0
10
20
30
40
50
Hours
60
70
80
90
100
Figure 5. Operating time to low battery alarm using alkaline batteries.
18
16
Rate (mL/hr)
14
12
10
8
6
4
2
0
50
100
150
200
Hours
250
300
350
Figure 6. Operating time to low battery alarm using alkaline batteries.
9
Continuous Delivery Battery Life with Lithium Batteries
Rate
Life
0.4 mL/hr
4 mL/hr
10 mL/hr
15 mL/hr
30 mL/hr
75 mL/hr
125 mL/hr
Volume
413 hrs
307 hrs
190 hrs
163 hrs
90 hrs
33 hrs
22 hrs
165 mL
1228 mL
1900 mL
2445 mL
2700 mL
2475 mL
2750 mL
Table 7. Two AA lithium-type batteries used with the CADD-Legacy® pumps.
Intermittent Delivery Battery Life with Lithium Batteries
Dose Volume
Duration
Dose Cycle
KVO
23.5 mL
1:00 hr
5:00 hr
0.2 mL/hr
61 mL
1:00 hr
6:00 hr
0.2 mL/hr
125 mL
1:00 hr
6:00 hr
0.2 mL/hr
®
Table 8. Two AA lithium-type batteries used with the CADD-Legacy pumps.
Life
Volume
300 hrs
185 hrs
125 hrs
1458 mL
1911 mL
2625 mL
135
120
Rate (mL/hr)
105
90
75
60
45
30
15
0
20
40
80
60
100
Hours
120
140
160
180
200
Figure 7. Dual-stroke operating time on lithium batteries.
18
16
Rate (mL/hr)
14
12
10
8
6
4
2
0
50
100
150
200
Figure 8. Single-stroke operating time on lithium batteries.
10
250
Hours
300
350
400
450
4Construction
The pump’s housing is made of a special high
impact plastic. It is composed of two sections:
the rear and front housing. The pump housing
is sealed to ensure that the pump is water
resistant. The battery compartment is not
water resistant.
NOTE
The CADD-Legacy® ambulatory infusion
pump is water resistant, but not waterproof.
The pump is “splashproof” and is
characterized by the IEC code of IPX4.
The battery compartment is accessed through
a removable door on the rear housing. Within
the battery compartment is space for the
batteries and the four battery contacts.
On CADD-Legacy® pumps the 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 must be secured in place
by inserting a coin (or key if using the
CADD-Legacy® PCA pump) in the slot on the
pump’s locking button, pushing the button
in and turning the button one-quarter turn
counter-clockwise.
NOTE
The medication cassette reservoir and
the administration set are intended for
single use only.
The keyboard, located on the front housing, is
composed of eight membrane switches (nine
membrane switches on the CADD-Legacy®
PCA pump) 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 Liquid Crystal Display (LCD), also located
on the front housing, shows the pump status
and programmed settings. The dot matrix
display consists of 16 character columns with
2 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 a printed
circuit board. The board contains the Central
Processing Unit (CPU), motor driver circuitry,
and other circuitry. The circuitry is designed
to reduce susceptibility to interference from
electromagnetic fields and to dissipate
electrostatic discharge.
The LCD controller is mounted on the LCD
using chip on glass technology.
The pumping mechanism subassembly
contains the motor, gear train, camshaft,
valves, expulsor, sensing disk, infrared
light source, infrared detector, occlusion
sensors, disposable sensor, and cassette
locking button. Via the motor driver circuitry,
the pump’s microprocessor controls motor
rotation.
Two external port connectors are utilized for
remote dose and external power input. The
accessory jack is used for attachment of the
remote dose cord (CADD-Legacy® PCA pump
only) and interface cable. The remote dose
cord enables the patient to use either of two
options to begin a demand dose when using
the PCA delivery mode: (1) the Remote Dose
button; or (2) the Dose key.
The second port allows connection to an
AC adapter.
The keyboard is connected to the printed
circuit board via a flex circuit tail. Discrete
wires connect the pumping mechanism,
motor, and sensors to the printed
circuit board.
The accessory jack in conjunction with the
interface cable allows download of events
using the CADD-DIPLOMAT® software.
11
5 Theory of Operation
Keyboard Circuitry
Battery Backed RAM
The CADD-Legacy pumps are 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 eight keys on the keyboard
(nine keys and remote dose cord on
CADD-Legacy® PCA pump). The keys on the
keyboard are arranged in a 3x3 matrix which
feeds into the keyboard encoder. A key closure
applies a ground to the associated input of
the keyboard encoder. Key debounce circuitry
resident in the keyboard encoder 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
keyboard encoder.
The remote dose cord button (CADD-Legacy®
PCA pump only) consists of an SPDT switch with
one switch output going to the microprocessor
and the other going to the keyboard encoder.
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 cord button is pressed, both signal
lines change to the alternate logic state. This
redundancy prevents a single line failure from
starting a dose delivery.
The ON/OFF button allows the pump to be
placed in a very low power mode by turning off
all sensors and LCD, but some battery energy
is still used by the electronics. To maximize
battery life, remove the batteries when pump is
not in use.
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 a printed
circuit board-mounted lithium battery. This
battery provides 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.
®
Data Memory in Real Time Clock RAM
Many settings of the pump’s delivery and
record-keeping parameters are stored by
the microprocessor in a battery backed RAM
in the real time clock. Data to and from the
memory is presented serially. Whenever the
microprocessor uses data from the real time
clock, the data is checked for validity.
EEPROM
Data describing the current delivery protocol
is stored in an EEPROM included in the
microprocessor. Whenever this data is used, it
is checked for validity.
12
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 CADD-Legacy® pumps feature a 2 line by
16 character Liquid Crystal Display (LCD). The
characters on this dot matrix display are formed
by a matrix of 5 by 7 dots. It is reflective only, with
a black on silver appearance, with no backlight.
The display includes a controller chip mounted
directly on the glass capable of interfacing
with 4 and 8 bit systems to display 92 kinds of
characters, numerals, symbols, and special
characters under control of a built in character
generator ROM. A RAM is also included to
make other special characters possible.
LED Indicator
A green Light Emitting Diode (LED) is provided
under the pump’s front panel overlay to
provide pump power status to the user. When
this LED is lit, it indicates that an AC adapter
is being used to power the pump.
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. Several layers of
redundancy in the programming system
prevent accidental erasing or modification of
the PROM.
Audible Alarm Circuitry
Audible alarm circuitry consists of two piezo
electric disks and an independent oscillator.
The disks flex or bend in resonance with the
output of the oscillator. The piezo disks are
mounted to the pump housing to enhance
sound level.
The microprocessor controls the audible
alarm by selecting the alarm control line for
more than 0.5 seconds. The oscillator which
drives the piezo disks 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.
When the microprocessor selects the audible
alarm, the 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 microprocessor.
The audible alarm circuitry is backed up by a
super capacitor. The super capacitor provides
energy for the alarm in the instance where all
power is lost while pump is in the RUN mode.
There is enough energy in the super capacitor
to drive the audible alarm for 3 minutes when
the pump has been in the RUN mode for 2
minutes or longer.
Watchdog Timer Circuit
Watchdog timer circuitry is provided to
monitor the status of the microprocessor. If
the microprocessor fails to function properly,
the watchdog circuit issues a reset signal
which disables the motor and enables the
audible alarm. To assure proper function, 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 verifies the
watchdog’s ability to disable the motor and
then continues normal power-up activities.
If a reset occurs when the microprocessor is
not expecting it, the microprocessor traps the
event, sounds the audible alarm and displays
an error message on the LCD.
Motor Drive/Motor Watchdog Circuit
The 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 drive 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 four 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.
Power Circuitry
Power for the pump is normally supplied by two
AA alkaline batteries, two AA lithium batteries,
or an 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
13
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 power from the two AA batteries is boosted
to +5VDC. This 5V is used to power the motor
and a 3.3V linear regulator. The linear regulator
provides power to all the other circuitry including
the microprocessor.
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
To deliver the amount of drug specified by the
parameter settings, the pump’s microprocessor
causes the pump mechanism to deliver fluid
“pulses” timed according to the desired rate. At
rates of 15 mL/hr or less the microprocessor
delivers a single pulse to the motor circuit
causing a half revolution of the camshaft and
fluid delivery in 0.05 mL increments. At rates
greater than 15 mL/hr the microprocessor
delivers two back to back pulses to the motor
circuit causing a full revolution of the camshaft
and fluid delivery in 0.1 mL increments.
Thus, to deliver 20 mL/hr, for example, the
microprocessor solves these equations:
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 3.3-volt power supply. Variations
in the 3.3-volt supply left undetected can result
in inaccuracy in the low battery alarm set points
and variations in other calculated values. (Also
refer to Voltage Detector Circuit description on
page 17.)
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
Pumping Mechanism
The pumping mechanism is linear peristaltic
with two active valves and an expulsor. 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 9.)
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 toward the patient.
3. The outlet valve closes.
NOTE
At rates 15 ≤ mL/hr the pump delivers 0.05
mL per stroke. This allows a more continuous
delivery at low rates.
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.
Air Detector
Motor
Camshaft
Pump Housing
Expulsor
Occlusion Sensor
Lock Cassette
Cassette Hinge
Pump Tubing
Figure 9. A simulated pumping mechanism in a CADD-Legacy® pump.
14
Upstream Sensor
Pressure Plate
Inlet Valve
Outlet Valve
The air detector is designed to detect air in the
outlet tubing fluid path. The air detector can be set
to On-high sensitivity, On-low sensitivity, or Off by
accessing Biomed Functions. When the On-high
sensitivity setting is selected the pump will detect
a single bubble greater than 0.100 mL. When the
On-low sensitivity setting is selected the pump will
detect a single bubble greater than 0.250 mL.
Multi-bubble Sensing
The air detector is also designed to sense if
an accumulation of more than 1 mL of air has
passed through the outlet tubing path in the last
15 minutes. This feature is active anytime the air
detector is on.
The air detector is compatible with all of the
medication cassette reservoirs and CADD®
administration sets indicated for use with the
CADD-Legacy® pump, and all pump accessories.
It is powered directly from the pump and no
additional power is required.
Theory of Operation
The air detector consists of sensor electronics and
two ultrasonic transducers positioned on opposite
sides of the fluid path. 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.
Downstream Occlusion Sensor
The downstream occlusion sensor is designed to
detect excessive pressure in the outlet tubing.
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 179.3 kPa ± 96.5 kPa, 1.79 (±
0.97) bar, or 26 (±14) psi, the occlusion sensor
trips, whereupon the microprocessor stops the
pump mechanism and issues visual and audible
alarms. Thus the maximum pressure which can be
developed is 276 kPa (2.76 bar, 40 psi).
Construction
The downstream occlusion sensor consists of
a membrane switch located on the bottom of
the pump Next to the outlet valve. The switch is
fastened to the housing with an adhesive to ensure
that the overall assembly is water resistant.
Theory of Operation
The membrane switch is in contact with the
outlet tubing when a cassette is installed. Tubing
expansion caused by a downstream occlusion
results in closure of the membrane switch. Switch
closure sends a logic low to the microprocessor
indicating a downstream occlusion.
Upstream Occlusion Sensor
The upstream occlusion sensor detects an
occlusion in the inlet tubing which would
prevent or restrict the flow of fluid to the pump.
Construction
The upstream occlusion sensor consists of a strain
gauge sensor located on the bottom of the pump
Next to the inlet valve. The sensor is fastened to
the housing with an adhesive to ensure that the
overall assembly is water resistant.
Theory of Operation
When a cassette is installed on the pump, the inlet
tubing is in contact with the sensor. In order to
conserve battery power, the upstream occlusion
sensor circuit is only activated while the motor
circuitry is enabled. Pressure on the sensor is read
just prior to the motor starting and after the end
of the motor stroke. The microprocessor uses an
average of the pressure exerted by the unoccluded
tubing to establish a baseline pressure. If the
tubing pressure at the end of a motor stroke is
below the baseline pressure, the upstream tubing
is occluded.
Cassette Attachment Detection
The pump uses the upstream occlusion sensor
and cassette present sensor to verify the presence
of a cassette. If an infusion is started by pressing
STOP/START when there is no cassette installed
or if a cassette is improperly seated, the pump will
initiate a visual and audible alarm.
Theory of Operation
During manufacture of the pump, upstream
occlusion sensor readings are recorded for no
cassette installed and typical cassette installed.
These readings are used to calculate threshold
levels for cassette detection. When a cassette is
first attached to the pump, the new sensor reading
must be above the calculated threshold level.
Additional readings are taken periodically while
the pump is in use. If the sensor readings drop
below the threshold when the motor is off, or
the cassette present sensor circuit does not
sense the presence of a cassette, the cassette is
considered removed.
15
6 Safety Features and Fault Detection
Hardware Safety Features
reset, the microprocessor checks the status
flag to see if this was a time-out test. If so,
the microprocessor verifies the watchdog’s
ability to disable the motor and then 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.
Key hardware safety features include a
watchdog timer circuit, motor drive and motor
watchdog circuits, cassette present sensor
circuit, and a voltage detector circuit. Each
safety circuit performs a unique function to
insure the overall safety of the device. (See
Figure 10.)
Watchdog Timer Circuit
Motor Drive/Motor Watchdog 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.
▼
▼
▼
REAL-TIME
CLOCK
▼
WATCHDOG
▼
▼
▼
▼
▼
▼▼▼
16
MOTOR
WATCHDOG
POWER
INPUT
▼
KEYBOARD
Figure 10. CADD-Legacy® pump hardware block diagram.
MOTOR
DRIVE
▼
CPU/IO
▼▼▼
▼
DATA
MEMORY
VOLTAGE
MONITOR
▼
LCD DISPLAY
▼
PROGRAM
MEMORY
AUDIBLE
ALARM
▼
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 watchdog circuit is a pulse output. This
acts to “jump start” the microprocessor. This
unique feature allows the microprocessor
to test the watchdog circuit on every powerup. By setting a flag in memory and not
strobing the watchdog, the microprocessor
can force a watchdog time-out. After being
▼
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 from the microprocessor can 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.
SENSORS
Voltage
Trip Point
Voltage
Trip Point
Source
≥ 2.4 V
Battery
Running/not running
No alarm
< 2.4 V
Battery
Not running
Audible alarm (3 beeps every 5 minutes); Low Bat
message appears†
< 1.8 V
Battery
Running
Audible alarm (3 beeps every 5 minutes); Low Bat
message appears†
< 4.75 V
5 volt supply
motor voltage
Running
Battery Depleted message appears††
< 1.0 V
Battery
Running/not running
Hardware reset occurs; Pump continues to indicate
depleted battery condition
Motor Status
CADD-Legacy® Pump Status
Table 9. CADD-Legacy® pump low battery conditions.
Cassette Present Sensor Circuit
The cassette present sensor system consists
of a switch on the pump mechanism that
interfaces to the attached cassette and
associated circuitry. This switch senses the
presence of a cassette.
When a cassette is latched to the pump, the
cassette presses against the switch in the
pump mechanism. Electronic circuitry on
the circuit board detects this and reports
the information to the microprocessor. This
system acts as a safety feature to detect a
damaged or detached cassette. If, during
operation, the microprocessor detects the
switch open, the pump will enable audible and
visual alarms and stop delivery.
Redundancy with the upstream occlusion
sensor 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.
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 (low battery and battery depleted)
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
2.4 volts when motor is off or 1.8 volts when
motor is active. An Analog to Digital Converter
(ADC) built into the microprocessor allows the
microprocessor, via software, to monitor the
battery voltage and motor voltage.
At the low battery warning threshold, the
microprocessor enables a periodic series
of beeps and displays a “Low Bat” warning
message on the LCD.
The second level is the battery depleted
warning threshold. As the voltage operating
the motor reaches a nominal value of 4.75
volts, the software disables delivery, places a
“Battery Depleted” message on the LCD, and
enables a continuous two tone audible alarm.
The third level is a hardware reset which
is reached when the battery voltage decays
to a nominal value of 1.0 volt. At this point
a hardware reset circuit is triggered which
places the microprocessor in reset. This
prevents ambiguous microprocessor
operation as the battery voltage continues
to decay. The hardware reset continues until
the battery is completely discharged or until
it is removed. A hardware reset can only be
cleared by replacing the old batteries with two
fresh ones.
†
The pump emits 3 beeps every 5 minutes, and the
message “Low Bat” 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 “Battery Depleted” appears on the
display, the battery power is too low to operate the pump
and pump operation has stopped.
††
17
Software Safety Features
Data Handling Software Safety Features
Hardware-related 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 display a system fault screen, turn on a
continuous two-tone audible alarm, and stop
all drug delivery.
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 display a
system fault screen, turn on a continuous twotone 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 display a system fault screen,
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 display a system fault screen,
turn on a continuous two-tone audible alarm,
and stop all drug delivery.
Keypad Encoder Check
Key presses are routed to the microprocessor
via a keypad encoder. Every time the software
receives data from the keypad encoder, it is
checked. If the data is not a valid key press, the
software disregards it.
The keypad contains a redundant switch in
the Stop/Start key, Prime key, and Dose
key (CADD-Legacy® PCA). The redundant
switch in each of these keys is routed to the
microprocessor via an I/O chip.
The microprocessor must see a valid signal
simultaneously from the redundant switch and
the normal switch (routed through the keypad
encoder) before it will start infusing.
18
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 display a system fault screen, 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 display a system fault screen, 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 display a system fault
screen, turn on a continuous two-tone audible
alarm, and stop all drug delivery.
Timer Data Registers
The data in the timer real time clock is
checked at regular intervals. If the data is
not reasonable, the software will turn on a
continuous two-tone audible alarm and stop
all drug delivery.
7 Hardware and Software Fault Detection
Overview
If the CADD-Legacy® pump displays an error
code, a hardware or software fault has been
detected by the microprocessor, and the
pump should be returned for servicing.
Error Code
Range
Description
1010-1040
Software Application Errors
When hardware or software faults are
detected by the microprocessor, pump
operation stops and a continuous two-tone
audible alarm will be activated. An error
message will be displayed on the LCD. On
the Next power up, the error code will again
be displayed. 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.)
1110-1160
Software Control Errors
1210-1270
CRC Errors
1310-1340
Real Time Clock Errors
1410-1450
Standard Delivery
Calculation Errors
1510-1530
Air Detector System Errors
1610-1670
CPU Test Errors
1710-1720
Miscellaneous Hardware
Errors
Order of Error Code Events
1810-1872
Motor Errors
1. There is a continuous two-tone audible
alarm and the display will read
Table 10. CADD-Legacy® pump error codes.
Error Detected
E(XXXX)
NOTE
“XXXX” is a 4-digit code.
2. To silence the error code alarm, remove
the batteries.
3. At each subsequent power up the pump
will display the initial power up screen and
then the following screen:
LEC XXXX
Thus there is always a display of the
“Last Error Code (LEC)” detected by the
microprocessor.
19
8 Cleaning and Inspection Procedures
Inspection Recommendation
CAUTION
Smiths Medical recommends annual
functional inspection on the CADD-Legacy® 1,
CADD-Legacy® PLUS, and CADD-Legacy® PCA
pumps. The following inspection procedures
should be performed annually to verify
function and accuracy.
• 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. Moisture build-up
inside the pump may damage the pump.
NOTE
Persons performing the following tests
and procedures should be familiar with the
Smiths Medical CADD-Legacy® pump. Please
read the Operator’s Manual supplied with the
pump before proceeding.
WARNING
CADD-Legacy® 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-Legacy® pumps
must be performed by Smiths Medical or its
authorized agents.
Cleaning
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
• 70% Chlorohexine
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.
20
• Do not clean the pump with acetone, other
plastic solvents, or abrasive cleaners, as
damage to the pump may occur.
Battery Contact Cleaning
Pump battery contact cleaning can be performed
easily using a clean cotton swab wetted with
isopropyl alcohol or by using a pre-moistened
alcohol swab. Use a minimum of 70%
concentration by volume isopropyl alcohol. Do not
use alcohol formulation that has other additives
besides alcohol and water.
• Using a cotton swab wetted with alcohol or the
pre-moistened alcohol swab, rub with medium
pressure over the entire contact surface a
minimum of ten back and forth cycles (twenty
total wipes over the contact).
• Select a fresh surface of the swab and repeat
the cleaning process on the second battery
contact. Dispose of the swab when finished.
• Using a second alcohol wetted swab, rub over
each contact surface again a minimum of four
back and forth cycles (eight total wipes over
the contact). Allow the contacts to dry for a
few minutes.
Visual Inspection
• Visually inspect the pump for any damage to
the LCD, occlusion sensor seals, valves and
expulsor, cassette hinge area, cassette lock,
cassette sensor, keypad, indicator light, power
jack, accessory jack, 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 battery
door 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 as instructed on page 20. 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 not to damage the pump housing or to
incur further damage to the contacts.
Mechanical Inspection
• Press each key on the keypad. 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-mL or 100-mL medication
cassette reservoir or a CADD® administration
set to the pump. Using a coin (key for the
CADD-Legacy® PCA pump), turn the lock 1/4
turn counter-clockwise. Check for smooth
operation and a definite feel when the lock
pulls the cassette firmLy against the bottom
of the pump. The slot on the cassette lock
should be aligned with the “LOCKED”
indicator on the side of the pump.
• Gently twist and pull on the cassette to make
sure it is firmLy attached.
21
9 Testing Procedures
Testing Recommendation
To Access Biomed Functions Loop
Smiths Medical recommends annual functional
testing on the CADD-Legacy® pumps. The
following testing procedures should be
performed annually to verify function and
accuracy.
1.Press LOCK. The current lock level will appear.
2.Press LOCK or ENTER/CLEAR. “CODE 0”
will appear.
3.Press ´ or Î until the Biomed function
code “163” appears (Lock Code +100). Then
press LOCK or ENTER/CLEAR.
NOTE
To perform the following functional tests the
pump must be in Lock Level 0.
Changing to Lock Level 0 (LL0)
Before programming the pump, make sure the
lock level is 0. LL0 allows the operator to access
all programming and operating functions.
1. Make sure the pump is stopped. Press LOCK.
The current lock level will appear. (If the lock
level is already LL0, press NEXT to exit.)
2.Press ´ or Î until “LL0” appears.
3. Press LOCK again or ENTER/CLEAR.
“Code 0” will appear.
4.Press ´ or Î until the Lock Level Code
“63” appears for CADD-Legacy® PCA,
“64” for CADD-Legacy® 1 or
“65” for CADD-Legacy® PLUS.
5. Press LOCK or ENTER/CLEAR to set the new
lock level.
CADD-Legacy® PCA Pump
Power-up Check
• Insert batteries or press ON/OFF and
observe the LCD during power up. The first
screen will display the serial number, model
number, and software number with revision
level. The second screen will display 32
character blocks. (If “LEC” and four digits
appear prior to the pump displaying the 32
character blocks, 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 will then sequentially
display all of the programmed values and
beep at each screen. After all screens are
displayed, successful power up is indicated
with six audible beeps and the “STOPPED”
screen displayed. Continue with the Lock
check.
22
Air Detector ON/OFF
1.Press Next until “Air Detector” appears.
2.Use ´ or Î to select “Off.”
3.Press ENTER/CLEAR to enter the change.
Lock Check
• Attach a 50- or 100-mL CADD™ medication
cassette reservoir or a CADD® administration
set to the pump. The mark on the cassette
lock button should be aligned with the
“Locked” symbol.
Cassette Sensor Check
• Unlock the cassette by inserting a key into the
lock and turning clockwise.
• The pump should issue an audible alarm
and the display should read “No Disposable
Clamp Tubing”.
• Press STOP/START or NEXT to silence the
alarm. Press and hold ON/OFF to turn the
pump off.
The following three checks (LCD, Motor and
Gear Train, and reservoir volume Empty
Alarm Check) should be performed in the
sequence shown.
LCD Check
• With the pump turned off, press ON/OFF. The
second screen that the pump displays will
consist of 32 blocks of characters. Examine
the LCD to verify that there are no missing
dark pixels in the character blocks.
Motor and Gear Train Check
• Program the reservoir volume to 2.0 mL.
• Attach either a 50- or 100-mL CADD™
medication cassette reservoir or CADD®
administration set to the pump. Lock the
cassette.
• Press and hold PRIME until three series of
dashes appear. Release PRIME. Press and
hold PRIME. While priming the pump, listen
to the motor for excessive noise or grinding
Testing Procedures - CADD-Legacy® PCA pump continued
sounds. Count the number of pump
activations. The pump should prime ten
double activations and then stop. Press NEXT
to return to main menu.
Reservoir Volume Empty Alarm Check
• Program the reservoir volume to 1.0 mL.
Press NEXT until reservoir volume is
displayed on the LCD. Press ´ or Î
until 1.0 mL is displayed. Then press
ENTER/CLEAR.
• Press and hold PRIME until three series
of dashes appear. Release PRIME. Press
and hold PRIME. The pump should prime ten
double activations and then stop. The pump
will alarm and display “Reservoir Volume
Empty.” Press NEXT.
Starting/Stopping the Pump
• Program the pump with the following values:
Reservoir Volume 1.0 mL
UnitsMilliliters
Continuous Rate 50 mL/hr
Demand Dose
0.00 mL
Given
0.00 (Press ENTER/CLEAR)
• Program the Air Detector Off.
• Press and hold STOP/START. “Starting”
appears followed by three sets of dashes,
each accompanied by a beep. A review of
the programmed parameters then appears.
The main screen should appear with
“RUN” in the display.
• To stop the device, press and hold
STOP/START. “Stopping” appears followed
by three sets of dashes that disappear one
at a time, each accompanied by a beep. The
main screen should appear with “STOPPED”
in the display.
Activation Timing Check
• Reprogram the reservoir volume to 1.0 and
clear the Given screen.
• Press and hold STOP/START until three
dashes disappear from 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 six seconds. Approximately
sixty-six seconds and ten activations later,
the reservoir volume alarm should occur.
The display should show “Reservoir Volume
Empty.”
Dose Key Check
(CADD-Legacy® PCA pump only)
• Check the DOSE key operation by
programming the pump with the following
values:
Reservoir Volume 10.0 mL
UnitsMilliliters
Continuous Rate 0.0 mL/hr
Demand Dose
1.00 mL
Dose Lockout
00 hrs 5 min
Doses Per Hour 12
Doses Given
0 Doses (Press ENTER/CLEAR to clear)
Doses Attempted 0 Doses (Press ENTER/CLEAR to clear)
Given
0.00 mL (Press ENTER/CLEAR to clear)
• Press and hold STOP/START. The pump
should sequentially display all of the
programmed values.
• After “RUN” appears on the display, press
DOSE 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 DOSE two
more times within the Next 5 minutes. The
pump should not deliver.
Remote Dose Cord Check
(CADD-Legacy® PCA pump only)
• Wait 5 minutes after the dose given above;
then, instead of pressing DOSE, press the
button on the remote Dose cord. The pump
should make ten double activations. After
ten double activations, the display should
show areservoir volume of 8.0 mL. Press
the remote dose cord button two more times
within the Next 5 minutes. The pump should
not deliver.
Doses Given and Doses Attempted Check
(CADD-Legacy® PCA pump only)
• Stop the pump by pressing and holding
STOP/START. Use NEXT to advance to the
Doses Given screen. The screen should
show 2. Use NEXT to advance to the Doses
Attempted screen. The display should show
6. If the above steps have not been followed
exactly, different values may appear.)
23
Testing Procedures - CADD-Legacy® PCA pump continued
Given Mode Check
• Press NEXT to advance to the Given screen.
The display should now show 2.00 mL. (If
the above steps have not been followed
exactly, a different value may appear.)
• Press the ENTER/CLEAR key. The display
should now show 0.00 mL.
Air Detector Test
This test will verify the function of the air
detector. To perform this test, 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™ medication cassette
reservoir or CADD® administration set to
the pump.
• Secure it using the lock button.
• Thread the tubing through the air detector
groove.
• Start the pump.
• The pump should respond with a continuous
two-tone alarm and the display should
read: “Air In Line Detected”
• Press NEXT or STOP/START to silence the
alarm, and remove the medication cassette
reservoir or CADD® administration set.
• Now attach a CADD medication cassette
reservoir containing fluid, or a primed CADD®
administration set to the pump. Make certain
there is no air in the fluid path.
™
• Secure it using the lock button.
• Thread the tubing through the air detector
groove.
• 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.
Upstream Occlusion Sensor Test
• Verify that the Upstream Occlusion Sensor
is turned on. (See page 22, To Access
Biomed Functions Loop.)
• Obtain a CADD® administration set with bag
spike and anti-siphon valve. Also obtain a
clamp (slide clamp or hemostat).
24
• Insert the CADD® administration set spike
into an appropriate, standard IV bag filled
with water. Attach the cassette to the pump.
Prime the entire fluid path.
• Program the pump to deliver a continuous
maximum rate. Press and hold STOP/START
to start the pump.
• Clamp the tubing halfway between the IV bag
and the pump. The pump should alarm within
three activations after clamping the tubing.
Occlusion Pressure Range Tests
Occlusion Pressure Range Test I
Description
Pressure is generated by activating the
pumping mechanism with an attached filled,
clamped medication cassette reservoir. The
pump is started and a demand dose is given
until the high pressure alarm sounds.
Equipment Needed
50- or 100-mL CADD™ medication cassette
reservoir containing distilled water
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir
containing water to the pump. Lock the
cassette.
3. Prime the 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
medication cassette reservoir.
5. Program the pump to the following
parameters:
Reservoir Volume 10.0 mL
UnitsMilliliters
Continuous Rate 0.00 mL/hr
Demand Dose 1.00 mL
Dose Lockout
00 hrs 5 min
Doses Per Hour 12
Dose Given
0 (Press ENTER/CLEAR to clear)
Dose Attempts
0 (Press ENTER/CLEAR to clear)
Milligrams Given 0.00 mL (Press ENTER/
CLEAR to clear)
Testing Procedures - CADD-Legacy® PCA pump continued
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.
Occlusion Pressure Range Test II
Description
An adjustable metered pressure source is
connected to the medication cassette reservoir
tubing. The pressure is slowly increased until
the high pressure alarm sounds.
Equipment Needed
• Pressure gauge, 40 psi ± 1 psi
(2.76 bar ± 0.07 bar)
• Pressure vessel, partially filled with water
• Pressure regulator, 40 psi (2.76 bar ± 0.07 bar)
• 50- or 100-mL CADD™ medication cassette
reservoir containing water
CAUTION
At the completion of the test, the pressure
must be reduced to zero before detaching
the cassette from the pump; otherwise, the
cassette may rupture. Safety glasses should be
worn while conducting or observing this test.
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir to
the pump. Lock the cassette.
NOTE
The pressure from the source must be zero
when the cassette is attached.
3. Assemble the apparatus as shown in Figure 11.
4. Connect the medication cassette
reservoir outlet tube to the metered
pressure source.
NOTE
Do not use a CADD® extension set with
anti-siphon valve.
1998-11-22 D. Zurn
«Lgc Occlusion Setup»
40
PSI
Regulator
Pressure Gauge
Figure 11. Occlusion test set-up.
5. Program the pump for a continuous rate of
50 mL/hr. Press STOP/START.
6. Slowly increase the back pressure, noting
when the high pressure alarm is activated.
NOTE
The pressure may be increased rapidly to
8 psi (0.55 bar), after which the pressure
should be increased at 3 psi/min (0.21 bar/
min) or less until the alarm sounds.
7. The high pressure alarm should sound
within 1.79 (±0.97) bar, or 26 (±14) psi.
Accuracy Testing
Gravimetric Accuracy Testing
Description
A medication cassette reservoir is partially
filled with water and weighed. The cassette
is then attached to the pump and the pump is
set to deliver a certain amount of water. The
cassette 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
medication cassette 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™ medication
cassette reservoir
• 50- or 60-mL syringe
• CADD® extension set with anti-siphon valve
• A balance accurate to 0.1 g
• 40 mL of room temperature water
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
2. Remove any air from the 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
CADD® extension set luer lock connector.
25
Testing Procedures - CADD-Legacy® PCA pump continued
3. Weigh the entire CADD™ medication
cassette reservoir/CADD® extension set
assembly and record the weight. This is the
pre-delivery weight. (This weight includes
the empty medication cassette reservoir,
CADD® extension set, and weight of
the water.)
Example
4. Attach the medication cassette reservoir
to the pump. Program the reservoir volume
to 20 mL. Now press ENTER/CLEAR. This
value is the intended delivery volume.
Remove the slide clamp.
Volume of Amount Delivered 19.5 mL
Intended Delivery Volume – 20.0 mL
Inaccuracy Volume
-0.5 mL
5. With the pump in Lock Level 0, program
a continuous rate of 50 mL/hr. Start the
pump and deliver 20 mL.
6. Again, secure the slide clamp as close as
possible to end of the CADD® extension
set luer lock connector. Remove the
medication cassette reservoir from the
pump and weigh the entire medication
cassette reservoir/CADD® extension set
assembly. This is the post-delivery weight.
7. Calculate the difference in weight
between the pre-delivery weight and the
post-delivery weight. This is the weight of
the amount delivered. (1 mL of water at
20° weighs 1 gram.)
8. Find the difference between the volume
of the amount delivered and the intended
delivery volume. This is the inaccuracy
volume.
9. Divide the inaccuracy volume by the
intended delivery volume and multiply by
100. This is the accuracy error percentage.
(See Table 11.)
10.If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
Pre-
Post-
Delivery Delivery
Weight Weight
Pre-delivery Weight
61.1 g
Post-delivery Weight
– 41.6 g
Weight of Amount Delivered 19.5 g
= 19.5 mL
Inaccuracy Volume
-0.5 mL
Intended Delivery Volume ÷ 20.0 mL
Accuracy Error
-0.025
x 100.00
Accuracy Error Percentage = -2.5%
Volumetric Accuracy Testing
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
medication cassette 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™ medication
cassette 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
Weight of
Intended Inaccuracy
Amount
Delivery Volume
Delivered Volume
61.1 g
41.6 g
19.5 g = 19.5 mL
20 mL
-0.5 mL
Table 11. Gravimetric percentage calculation
26
Accuracy
Error
Accuracy
Error Percentage
-0.5 mL ÷ 20.0 mL =
-0.025
-0.025 x 100 = -2.5%
Testing Procedures - CADD-Legacy® PCA pump continued
NOTE
The test procedure calls for the use of a
CADD™ medication cassette reservoir and a
CADD® extension set with anti-siphon valve.
An IV bag and CADD® administration set with
integral or add-on anti-siphon valve can
be substituted for the medication cassette
reservoir and CADD® extension set with
anti-siphon valve.
9. If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
Example
Actual Delivery Volume
Intended Delivery Volume
Inaccuracy Volume
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
19.5 mL
– 20.0 mL
= -0.5 mL
Inaccuracy Volume
-0.5 mL
Intended Delivery Volume ÷ 20.0 mL
Accuracy Error
-0.025
x 100.00
Accuracy Error Percentage = -2.5%
2. Remove any air from the 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
CADD® extension set luer lock connector.
3. Insert the end of the CADD® extension set
into the fluid collection device.
4. Attach the medication cassette reservoir to
the pump. Program the reservoir volume
to 20 mL. This is the intended delivery
volume. Remove all clamps.
5. Program a continuous rate of 50 mL/hr.
Start the pump and deliver 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 12.)
Intended ActualInaccuracy
Delivery
Delivery
Volume
Volume
Volume
20 mL
19.5 mL
-0.5 mL
Accuracy
Error
-0.5 mL ÷ 20.0 mL = -0.025
Accuracy
Error Percentage
-0.025 x 100 = -2.5%
Table 12. Volumetric percentage calculation
27
CADD-Legacy® 1 Pump
Power-up Check
• Insert batteries or press ON/OFF and
observe the LCD during power up. The first
screen will display the serial number, model
number, and software number with revision
level. The second screen will display
32 character blocks. (If “LEC” and four
digits appear prior to the pump displaying
the 32 character blocks, 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 will then sequentially display all of the
programmed values and beep at each screen.
After all screens are displayed, successful
power up is indicated with six audible beeps
and the “STOPPED” screen displayed.
Continue with the Lock check.
To Access Biomed Functions Loop
1.Press LOCK. The current lock level will appear.
2.Press LOCK or ENTER/CLEAR. “CODE 0”
will appear.
3.Press ´ or Î until the Biomed function
code “164” appears (Lock Code +100). Then
press LOCK or ENTER/CLEAR.
Air Detector ON/OFF
1.Press Next until “Air Detector” appears.
2.Use ´ or Î to select “Off.”
3.Press ENTER/CLEAR to enter the change.
Lock Check
• Attach a 50- or 100-mL CADD™ medication
cassette reservoir or a CADD® administration
set to the pump. The slot on the cassette lock
button should be aligned with the “Locked”
symbol.
Cassette Sensor Check
• Unlock the cassette by inserting a coin into
the latch and turning clockwise.
• The pump should issue an audible alarm
and the display should read “No Disposable
Clamp Tubing”.
• Press STOP/START or NEXT to silence the
alarm. Press and hold ON/OFF to turn the
pump off. The following three checks (LCD,
Motor and Gear Train, and Reservoir Volume
Empty Alarm Check) should be performed in
the sequence shown.
28
LCD Check
• With the pump turned off, press ON/OFF.
The second screen that the pump displays
will consist of 32 blocks of characters.
Examine the LCD to verify that there are no
missing dark pixels in the character blocks.
Motor and Gear Train Check
• Program the Lock Level to LL0. Program
the reservoir volume to 2.0 mL.
• Attach either a 50- or 100-mL CADD™
medication cassette reservoir or CADD®
administration set to the pump. Lock the
cassette.
• Press and hold PRIME until three series
of dashes appear. Release PRIME. Press
and hold PRIME. While priming the pump,
listen to the motor for excessive noise or
grinding sounds. Count the number of
pump activations. The pump should prime
ten double activations and then stop. Press
NEXT to return to the main menu.
Reservoir Volume Empty Alarm Check
• Program the reservoir volume to 1.0 mL.
• Press and hold PRIME until three series of
dashes appear. Release PRIME. Press and
hold PRIME. The pump should prime ten
double activations and then stop. The pump
will alarm and display “Reservoir Volume
Empty.” Press NEXT.
Starting/Stopping the Pump
• Program the pump with the following values:
Reservoir Volume 1.0 mL
Rate 3000 mL/24hrs
Given 0.0 mL (press
ENTER/CLEAR to clear)
• Program the Air Detector Off.
• Press and hold STOP/START. “Starting”
appears followed by three sets of dashes,
each accompanied by a beep. A review of
the programmed parameters then appears.
The main screen should appear with “RUN”
in the display.
• To stop the device, press and hold
STOP/START. “Stopping” appears followed
by three sets of dashes that disappear
one at a time, each accompanied by a
beep. The main screen should appear with
“STOPPED” in the display.
Testing Procedures - CADD-Legacy® 1 pump continued
Activation Timing Check
• Reprogram the reservoir volume to 1.0 and
clear the Given screen.
• Press and hold STOP/START until three
dashes disappear from 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 three seconds. Approximately
twenty-seven seconds and ten activations
later, the reservoir volume alarm should
occur. The display should show “Reservoir
Volume Empty.”
Given Mode Check
• Press NEXT to advance to the Given screen.
The display should now show 1.00 mL. (If
the above steps have not been followed
exactly, a different value may appear.)
• Press the ENTER/CLEAR key. The display
should now show 0.00 mL.
Air Detector Test
This test will verify the function of the air
detector. To perform this test, the air detector
must be turned on. The previous program
from the activation timing check can be used
to perform this test.
• Attach an empty CADD™ medication cassette
Reservoir or CADD® administration set to
the pump.
• Secure it using the lock button.
• Thread the tubing through the air
detector groove.
• Start the pump.
• The pump should respond with a continuous
two-tone alarm and the display should
read: “Air In Line Detected”
• Press NEXT or STOP/START to silence the
alarm, and remove the medication cassette
reservoir or CADD® administration set.
• Now attach a medication cassette
reservoir containing fluid or a primed CADD®
administration set to the pump. Make certain
there is no air in the fluid path.
• Secure it using the lock button.
• Thread the tubing through the air
detector groove.
• Program the reservoir volume to 1.0 mL.
Start the pump.
• The pump should deliver without an air
detection alarm.
Upstream Occlusion Sensor Test
• Verify that the Upstream Occlusion Sensor
is turned on. (See page 28, To Access
Biomed Functions Loop.)
• Obtain a CADD® administration set with bag
spike and anti-siphon valve. Also obtain a
clamp (slide clamp or hemostat).
• Insert the CADD® administration set spike
into an appropriate, standard IV bag filled
with water. Attach the cassette to the pump.
Prime the entire fluid path.
• Program the pump to deliver a continuous
maximum rate. Press and hold STOP/START
to start the pump.
• Clamp the tubing halfway between the IV bag
and the pump. The pump should alarm within
three activations after clamping the tubing.
Occlusion Pressure Range Tests
Occlusion Pressure Range Test I
Description
Pressure is generated by activating the
pumping mechanism with an attached filled,
clamped medication cassette reservoir. The
pump is started and a demand Dose is given
until the high pressure alarm sounds.
Equipment needed
50- or 100-mL CADD™ medication cassette
reservoir containing distilled water.
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir
containing water to the pump. Lock the
cassette.
3. Prime the 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.
29
Testing Procedures - CADD-Legacy® 1 pump continued
4. Close the slide clamp on the distal end of
the tubing near the female luer of the
medication cassette reservoir.
5. Program the pump to the following
parameters:
Reservoir Volume 10.0 mL
Continuous Rate 3000.0 mL/24hr
Given
0.0 mL (Press ENTER/
CLEAR to clear)
6. Start the pump. When the pump is running, note
when the high pressure alarm is activated.
7. The pump should alarm when the pump
delivers between 1 and 2 activations.
Occlusion Pressure Range Test II
Description
An adjustable metered pressure source is
connected to the medication cassette reservoir
tubing. The pressure is slowly increased until
the high pressure alarm sounds.
Equipment Needed
• Pressure gauge, 40 psi ± 1 psi
(2.76 bar ± 0.07 bar).
• Pressure vessel, partially filled with water.
• Pressure regulator, 40 psi (2.76 bar ± 0.07 bar).
• 50- or 100-mL CADD™ medication cassette
reservoir containing water.
CAUTION
At the completion of the test, the pressure
must be reduced to zero before detaching
the cassette from the pump; otherwise, the
cassette may rupture. Safety glasses should be
worn while conducting or observing this test.
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir to
the pump. Lock the cassette.
NOTE
The pressure from the source must be zero
when the cassette is attached.
30
1998-11-22 D. Zurn
«Lgc Occlusion Setup»
40
PSI
Regulator
Pressure Gauge
Figure 12 . Occlusion test set-up.
3. Assemble the apparatus as shown in
Figure 12.
4. Connect the medication cassette reservoir
outlet tube to the metered pressure source.
NOTE
Do not use a CADD® extension set with
anti-siphon valve.
5. Program the pump for a continuous rate of
3000 mL/24hr. Press STOP/START.
6. Slowly increase the back pressure, noting
when the high pressure alarm is activated.
NOTE
The pressure may be increased rapidly to
8 psi (0.55 bar), after which the pressure
should be increased at 3 psi/min
(0.21 bar/min) or less until the alarm sounds.
7. The high pressure alarm should sound
within 1.79 (±0.97) bar, or 26 (±14) psi.
Accuracy Testing
Gravimetric Accuracy Testing
Description
A medication cassette reservoir is partially
filled with water and weighed. The cassette
is then attached to the pump and the pump is
set to deliver a certain amount of water. The
cassette 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
medication cassette 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.
Testing Procedures - CADD-Legacy® 1 pump continued
Equipment Needed
• 50- or 100-mL CADD™ medication
cassette reservoir
• 50- or 60-mL syringe
• CADD® extension set with anti-siphon valve
• A balance accurate to 0.1 g
• 40 mL of room temperature water
8. Find the difference between the
volume of the amount delivered and
the intended delivery volume. This is the
inaccuracy volume.
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
10.If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
2. Remove any air from the 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 CADD®
extension set luer lock connector.
3. Weigh the entire medication cassette
reservoir/CADD® extension set assembly and
record the weight. This is the
pre-delivery weight. (This weight includes the
empty medication cassette reservoir, CADD®
extension set, and weight of the water.)
4. Attach the medication cassette reservoir to the
pump. Program the reservoir volume to 20 mL.
Now press ENTER/CLEAR. This value is the
intended delivery volume. Remove the slide
clamp.
9. Divide the inaccuracy volume by the
intended delivery volume and multiply by
100. This is the accuracy error percentage.
(See Table 13.)
Example
Pre-delivery Weight
Post-delivery Weight
61.1 g
– 41.6 g
Weight of Amount Delivered
19.5 g
= 19.5 mL
Volume of Amount Delivered
Intended Delivery Volume
19.5 mL
– 20.0 mL
Inaccuracy Volume
= -0.5 mL
Inaccuracy Volume
Intended Delivery Volume
-0.5 mL
÷ 20.0 mL
Accuracy Error
-0.025
x 100.00
Accuracy Error Percentage
= -2.5%
5. With the pump in Lock Level 0, program a
continuous rate of 3000 mL/24hr. Start the
pump and deliver 20 mL.
Volumetric Accuracy Testing
6. Again, secure the slide clamp as close as
possible to end of the CADD® extension set
luer lock connector. Remove the medication
cassette reservoir from the pump and weigh
the entire medication cassette reservoir/
CADD® extension set assembly. This is the
post-delivery weight.
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.
7. Calculate the difference in weight between the
pre-delivery weight and the post-delivery weight.
This is the weight of the amount delivered. (One
mL of water at 20°C weighs 1 gram.)
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
Pre-
Post-
Weight of
Delivery Delivery Amount
Weight Weight Delivered
Intended Inaccuracy
Delivery Volume
Volume
Accuracy
Error
Accuracy
Error Percentage
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 13. Gravimetric percentage calculation
31
Testing Procedures - CADD-Legacy® 1 pump continued
medication cassette 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.
5. Program a continuous rate of
3000 mL/24hr. Start the pump and
deliver 20 mL.
Equipment Needed
• 50- or 100-mL CADD™ medication
cassette 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
NOTE
The test procedure calls for the use of a
medication cassette reservoir and a CADD®
extension set with anti-siphon valve. An
IV bag and CADD® administration set with
integral or add-on anti-siphon valve can
be substituted for the medication cassette
reservoir and CADD® extension set with
anti-siphon valve.
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 14.)
9. If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
Example
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
2. Remove any air from the 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 CADD® extension set luer
lock connector.
Actual Delivery Volume
Intended Delivery Volume
19.5 mL
– 20.0 mL
Inaccuracy Volume
= -0.5 mL
Inaccuracy Volume
Intended Delivery Volume
-0.5 mL
÷ 20.0 mL
Accuracy Error
= -0.025
x 100.00
Accuracy Error Percentage
= -2.5%
3. Insert the end of the CADD® extension set
into the fluid collection device.
4. Attach the medication cassette reservoir to
the pump. Program the reservoir volume
to 20 mL. This is the intended delivery
volume. Remove all clamps.
Intended ActualInaccuracy
Delivery
Delivery
Volume
Volume
Volume
20 mL
19.5 mL
Table 14. Volumetric percentage calculation
32
-0.5 mL
Accuracy
Error
-0.5 mL ÷ 20.0 mL =-0.025
Accuracy
Error Percentage
-0.025 x 100 = -2.5%
CADD-Legacy® PLUS Pump
Power-up Check
• Insert batteries or press ON/OFF and
observe the LCD during power up. The
first screen will display the serial number,
model number, and software number
with revision level. The second screen
will display 32 character blocks. (If “LEC”
and four digits appear prior to the pump
displaying the 32 character blocks, 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 will then sequentially display all
of the programmed values and beep at each
screen. After all screens are displayed,
successful power up is indicated with six
audible beeps and the “STOPPED” screen
displayed. Continue with the Lock check.
• Press STOP/START or NEXT to silence the
alarm. Press and hold ON/OFF to turn the
pump off.
The following three checks (LCD, Motor and Gear
Train, and Reservoir Volume Empty Alarm Check)
should be performed in the sequence shown.
LCD Check
• With the pump turned off, press ON/OFF. The
second screen that the pump displays will
consist of 32 blocks of characters. Examine
the LCD to verify that there are no missing
dark pixels in the character blocks.
Motor and Gear Train Check
• Program the reservoir volume to 2.0.
• Program Biomed to Continuous Mode.
To Access Biomed Functions Loop
• Attach either a 50- or 100-mL CADD™
medication cassette reservoir or CADD®
administration set to the pump. Lock the
cassette.
1.Press LOCK. The current lock level
will appear.
2.Press LOCK or ENTER/CLEAR. “CODE 0”
will appear.
3.Press ´ or Î until the biomed function
code “165” appears (Lock Code +100). Then
press LOCK or ENTER/CLEAR.
• Press and hold PRIME until three series
of dashes appear. Release PRIME. Press
and hold PRIME. While priming the pump,
listen to the motor for excessive noise or
grinding sounds. Count the number of pump
activations. The pump should prime ten
double activations and then stop. Press NEXT
to return to the main menu.
Air Detector ON/OFF
1.Press Next until “Air Detector” appears.
2.Use ´ or Î to select “Off.”
3.Press ENTER/CLEAR to enter the change.
Changing Delivery Modes
1.Press Next until “Delivery Mode” appears.
2.Press ´ or Î to select “Continuous”.
3.Press ENTER/CLEAR to enter the change.
Lock Check
• Attach a 50- or 100-mL CADD™ medication
cassette reservoir or a CADD® administration
set to the pump. The slot on the cassette lock
button should be aligned with the “Locked”
symbol.
Cassette Sensor Check
• Unlock the cassette by inserting a coin into
the lock and turning clockwise.
• The pump should issue an audible alarm
and the display should read “No Disposable
Clamp Tubing”.
Reservoir Volume Empty Alarm Check
• Program the reservoir volume to 1.0 mL.
• Press and hold PRIME until three series of
dashes appear. Release PRIME. Press and
hold PRIME. The pump should prime ten
double activations and then stop. The pump
will alarm and display “Reservoir Volume
Empty.” Press NEXT.
Starting/Stopping the Pump
• Program the pump with the following values:
Reservoir Volume 1.0 mL
Rate 125 mL/hr
Given
0.0 mL (press ENTER/
CLEAR to clear)
• Program the Air Detector Off.
• Press and hold STOP/START. “Starting”
appears followed by three sets of dashes,
each accompanied by a beep. A review of the
programmed parameters then appears. The
main screen should appear with “RUN” in
the display.
33
Testing Procedures - CADD-Legacy® PLUS pump continued
• To stop the device, press and hold
STOP/START. “Stopping” appears followed
by three sets of dashes that disappear
one at a time, each accompanied by a
beep. The main screen should appear with
“STOPPED” in the display.
Activation Timing Check
• Reprogram the reservoir volume to 1.0 and
clear the Given screen.
• Press and hold STOP/START until three
dashes disappear from 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 three seconds. Approximately
twenty-seven seconds and ten activations
later, the reservoir volume alarm should
occur. The display should show “Reservoir
Volume Empty.”
Given Mode Check
• Press NEXT to advance to the Given screen.
The display should now show 1.00 mL. (If
the above steps have not been followed
exactly, a different value may appear.)
• Press the ENTER/CLEAR key. The display
should now show 0.00 mL.
Air Detector Test
This test will verify the function of the air
detector. To perform this test, the air detector
must be turned on. The previous program
from the Activation Timing Check can be used
to perform this test.
• Attach an empty CADD™ medication cassette
reservoir or CADD® administration set to
the pump.
• Secure it using the lock button.
• Thread the tubing through the air
detector groove.
• Start the pump.
• The pump should respond with a continuous
two-tone alarm and the display should
read: “Air in Line Detected”
• Press NEXT or STOP/START to silence the
alarm, and remove the medication cassette
reservoir or CADD® administration set.
34
• Now attach a medication cassette
reservoir containing fluid, or a primed
CADD® administration set to the pump. Make
certain there is no air in the fluid path.
• Secure it using the lock button.
• Thread the tubing through the air detector
groove.
• Program the reservoir volume to 1.0 mL.
Start the pump.
• The pump should deliver without an air
detection alarm.
Upstream Occlusion Sensor Test
• Verify that the Upstream Occlusion Sensor
is turned on. (See page 33, To Access
Biomed Functions Loop.)
• Obtain a CADD® administration set with bag
spike and anti-siphon valve. Also obtain a
clamp (slide clamp or hemostat).
• Insert the CADD® administration set spike
into an appropriate, standard IV bag filled
with water. Attach the cassette to the pump.
Prime the entire fluid path.
• Program the pump to deliver a
continuous maximum rate. Press and hold
STOP/START to start the pump.
• Clamp the tubing halfway between the
IV bag and the pump. The pump should
alarm within three activations after
clamping the tubing.
Occlusion Pressure Range Tests
Occlusion Pressure Range Test I
Description
Pressure is generated by activating the pumping
mechanism with an attached filled, clamped
medication cassette reservoir. The pump is
started until the high pressure alarm sounds.
Equipment needed
50- or 100-mL CADD™ medication cassette
reservoir containing distilled water
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir
containing water to the pump. Lock the
cassette.
Testing Procedures - CADD-Legacy® PLUS pump continued
3. Prime the 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.
3. Assemble the apparatus as shown in
Figure 13.
4. Close the slide clamp on the distal end of
the tubing near the female luer of the
medication cassette reservoir.
NOTE
Do not use a CADD® extension set with
anti-siphon valve.
5. Program the pump to the following
parameters:
5. Program the pump for a continuous rate of
125 mL/hr. Press STOP/START.
Reservoir Volume
Continuous Rate
Given
10.0 mL
125.0 mL/hr
0.0 mL (Press ENTER/
CLEAR to clear)
6. Start the pump. When the pump is running,
note when the high pressure alarm is activated.
7. The pump should alarm when the pump
delivers between 1 and 2 activations.
Occlusion Pressure Range Test II
Description
An adjustable metered pressure source is
connected to the medication cassette reservoir
tubing. The pressure is slowly increased until
the high pressure alarm sounds.
Equipment Needed
• Pressure gauge, 40 psi ± 1 psi (2.76 bar ±
0.07 bar)
• Pressure vessel, partially filled with water
• Pressure regulator, 40 psi (2.76 bar ± 0.07 bar)
• 50- or 100-mL CADD™ medication cassette
reservoir containing water
CAUTION
At the completion of the test, the pressure
must be reduced to zero before detaching
the cassette from the pump; otherwise, the
cassette may rupture. Safety glasses should be
worn while conducting or observing this test.
Procedure
1. Insert two AA batteries and wait for the
pump to power up.
2. Attach a medication cassette reservoir to
the pump. Lock the cassette.
NOTE
The pressure from the source must be zero
when the cassette is attached.
4. Connect the medication cassette reservoir
outlet tube to the metered pressure source.
6. Slowly increase the back pressure, noting
when the high pressure alarm is activated.
NOTE
The pressure may be increased rapidly
to 8 psi (0.55 bar), after which the
pressure should be increased at 3 psi/min
(0.21 bar/min) or less until the alarm sounds.
7. The high pressure alarm should sound
within 1.79 (±0.97) bar, or 26 (±14) psi.
Accuracy Testing
Gravimetric Accuracy Testing
Description
A medication cassette reservoir is partially
filled with water and weighed. The cassette
is then attached to the pump and the pump is
set to deliver a certain amount of water. The
cassette 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 medication casssette 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.
1998-11-22 D. Zurn
«Lgc Occlusion Setup»
40
PSI
Regulator
Pressure Gauge
Figure 13. Occlusion test set-up.
35
Testing Procedures - CADD-Legacy® PLUS pump continued
Equipment Needed
• 50- or 100-mL CADD™ medication
cassette reservoir
• 50- or 60-mL syringe
• CADD® extension set with anti-siphon valve
• A balance accurate to 0.1 g
• 40 mL of room temperature water
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
2. Remove any air from the 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
CADD® extension set luer lock connector.
3. Weigh the entire medication cassette
reservoir/CADD® extension set assembly
and record the weight. This is the
pre-delivery weight. (This weight
includes the empty medication cassette
reservoir, CADD® extension set, and
weight of the water.)
4. Attach the medication cassette reservoir to
the pump. Program the reservoir volume
to 20 mL. Now press ENTER/CLEAR. This
value is the intended delivery volume.
Remove the slide clamp.
5. With the pump in Lock Level 0, program
a continuous rate of 125 mL/hr. Start the
pump and deliver 20 mL.
6. Again, secure the slide clamp as close as
possible to end of the CADD® extension
set luer lock connector. Remove the
medication cassette reservoir from the
pump and weigh the entire medication
cassette reservoir/CADD® extension set
assembly. This is the post-delivery weight.
7. Calculate the difference in weight between
the pre-delivery weight and the postdelivery weight. This is the weight of the
amount delivered. (One mL of water at
20°C weighs 1 gram.)
8. Find the difference between the volume
of the amount delivered and the intended
delivery volume. This is the inaccuracy
volume.
9. Divide the inaccuracy volume by the
intended delivery volume and multiply by
100. This is the accuracy error percentage.
(See Table 15.)
10.If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
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
Intended Delivery Volume
Inaccuracy Volume
19.5 mL
– 20.0 mL
= -0.5 mL
Inaccuracy Volume
-0.5 mL
Intended Delivery Volume
÷ 20.0 mL
Accuracy Error
= -0.025
x 100.00
Accuracy Error Percentage = -2.5%
Pre-
Post-
Weight of
IntendedInaccuracy
Accuracy
Accuracy
Delivery
DeliveryAmountDelivery
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 15. Gravimetric percentage calculation
36
Testing Procedures - CADD-Legacy® PLUS pump continued
Volumetric Accuracy Testing
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
CADD® extension set luer lock connector.
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.
3. Insert the end of the CADD® extension set
into the fluid collection device.
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
medication cassette 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.
5. Program a continuous rate of 125 mL/hr.
Start the pump and deliver 20 mL.
4. Attach the medication cassette reservoir to
the pump. Program the reservoir volume
to 20 mL. This is the intended delivery
volume. Remove all clamps.
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.
Equipment Needed
• 50- or 100-mL CADD™ medication
cassette 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
8. Divide the inaccuracy volume by the
intended delivery volume and multiply by
100. This is the accuracy error percentage.
(See table 16.)
9. If the accuracy error percentage is greater
than ± 6%, repeat the test with a new
medication cassette reservoir. If the pump
fails a second time, call Smiths Medical’s
Customer Service.
NOTE
The test procedure calls for the use of a
medication cassette reservoir and a CADD®
extension set with anti-siphon valve. An
IV bag and CADD® administration set with
integral or add-on anti-siphon valve can
be substituted for the medication cassette
reservoir and CADD® extension set with
anti-siphon valve.
Example
Actual Delivery Volume
Intended Delivery Volume
Inaccuracy Volume
Procedure
1. Fill the 50- or 60-mL syringe with 40 mL of
water. Transfer the water into a medication
cassette reservoir.
Inaccuracy Volume
-0.5 mL
Intended Delivery Volume
÷ 20.0 mL
Accuracy Error
= -0.025
x 100.00
Accuracy Error Percentage = -2.5%
2. Remove any air from the medication
cassette reservoir by aspirating the air with
Intended ActualInaccuracy
Delivery
Delivery
Volume
Volume
Volume
20 mL
19.5 mL
-0.5 mL
19.5 mL
– 20.0 mL
= -0.5 mL
Accuracy
Error
-0.5 mL ÷ 20.0 mL =-0.025
Accuracy
Error Percentage
-0.025 x 100 = -2.5%
Table 16. Volumetric percentage calculation
37
CADD-Legacy® 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-Legacy® pump. If service is required, fill out this sheet and return it with the device.
Serial #________________ Reference Number________________________ Date________________________
(Refer to the Technical Manual procedures.)
I. Cleaning Completed
M Yes II. Visual Inspection
M LCD
M Occlusion Sensor Seals
M Valves and Expulsor
M Cassette Hinge Area
M Cassette Lock
M
M
M
M
III. Mechanical Inspection
M Keypad
M Battery Door
IV. Functional Inspection
M Power-up
M Cassette Lock
M Cassette Sensor M LCD
M Motor/Gear Train
M No
Cassette Sensor
Keypad Indicator Light
Power Jack
M
M
M
M
M
Accessory Jack
Air Detector
Pump Housing
Battery Door
Battery Compartment
M Cassette Lock
M
M
M
M
M
Reservoir Volume Empty Alarm M Dose Given/Attempted (PCA)
Starting/Stopping
M MG Given/Given
Activation Timing
M Air Detector
Dose key (PCA)
remote Dose cord (PCA)
V. Downstream Occlusion Pressure Range Tests
Test 1: Activations Before Alarm______________
Test 2: High Pressure Alarm At_______________ psi
VI. Accuracy Testing
Volumetric Accuracy Test
Intended Delivery
Volume
Actual Inaccuracy
Delivery
Volume
Volume
Accuracy
Accuracy
Error
Error
Percentage
mL mL mL %
Gravimetric Accuracy Test
Pre-DeliveryPost-Delivery Amount
Intended
Inaccuracy Accuracy Accuracy
Weights Weight Delivered Delivery Volume Error Error
Volume
38
g
g
mL
mL mL
%
39
40
41
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.
Smiths Medical Canada Ltd.
St. Paul, MN 55112, USA
Phone: 1-214-618-0218
Toll-Free USA: 1-800-258-5361
Markham, Ontario, Canada, L3R 4Y8
Phone: 905-477-2000
Toll-Free: 1-800-387-4346
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‑Legacy, the CADD Medicaton Cassette Reservoir 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. All other names and marks mentioned are the trade names, trademarks, or service marks of
their respective owners. ©2011 Smiths Medical. All rights reserved. 1/11 IN19876
EC Authorized Representative
Smiths Medical International Ltd.
TN25 4BF, UK
Phone: +44 (0) 1233 722100
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