Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
~ W O 96106332 2 1 9 7 8 8 5 PC~r~US9S/10599
-- 1 --
SYST~MSFOR TES~NGDNnRAVENOUSPU MS
Field of the Invention
The invention relates to systems and
methods for testing the physical, functional, and
electrical performance of pumps.
Ba~h~l~u..d of the Invention
There are many types and styles of pumps
intended to administer liquids, medications, and
snltltinnc i--LLcv~:luusly. Such pumps (commonly called
"IV pumps") operate in various ways; for example, by
syringe, diaphragm, peristaltic, and fluid ~L eS~U~
action.
Because of their intended use, IV pumps
must meet stringent requirements for accuracy and
safety. IV pumps also require periodic
certification of their physical, functional, and
electrical performance characteristics.
Today, testing and certification of IV
pumps are typically performed by facilities with
trained technical staffs. The pump owner loses use
of the pump during ch i L of the pump to the test
facility, and while the pump facility performs its
services and ships the pump back.
There is a need for a system that a non-
tr~rhn;ci~l person can conveniently use to test and
completely certify IV pump performance on site,
without assistance of often distant test facilities.
Summary of the Invention
The invention provides a system that tests
.: i
W096l06332 2 1 9 7 8 8 5 PCT~S9Sll0599 ~
the performance characteristics of intravenous
pUmpS .
In one ~_ho~ i r L, the system includes a
test station and a controller. The test station
houses two functional Ls. The first
cn-pn"~nt is adapted to be coupled in liquid flow
;cation with an external i--L-~v~ us fluid
pump. The second ~ _ L is adapted to be coupled
electrically to the pump. The controller operates
the test station in two modes. In one mode, the
first _ L is operated to test at least one
specified liquid flow characteristic of the pump. In
the other mode, the second c ~nt is operated to
test at least one specified electrical safety
characteristic of the pump. The controller generates
a first test output regarding the specified liquid
flow characteristic tested. The controller also
generates a second test output regarding the
specified electrical safety characteristic tests. In
this way, the controller integrates not only the
carrying out of the different tests, but the
generation of the test results as well.
In one P~ho~ i r L, the system includes a
test station adapted to be coupled to the pump and
a processing station coupled to the test station.
The proc~;ng station has memory for storing in a
database a desired operating characteristic for the
pump coupled to the test station. The processing
station also includes a controller for operating the
test station to obtain an actual operating
characteristic measured by operating the pump while
coupled to the test station. A comparator in the
processing station compares the a_tual operating
characteristic to the desired operating
characteristic and generates a certification output
~ WO 96106332 2 1 9 7 8 8 5 ~ v~j
-- 3 --
,,
based upon the comparison.
In one t~mho~; ~, the system includes a
container adapted to be coupled in liquid flow
,- ; cation with the pump for receiving liquid
uu~v~y~d by the pump. A weight sensor senses weight
of the container as the pump conveys liquid into the
container. The system also includes a test
controller. The controller ;nrl~ c a first element
that ' the pump to convey liquid under
prescribed conditions. The controller also includes
a second element that monitors changes in weight
sensed by the weight sensor over time and derives
therefrom a flow rate. The controller also includes
a third element for comparing the flow rate to an
outcome expected based upon the prescribed
conditions and for generating an output based upon
the comparison.
In one t~mho~ nt, the system includes a
first element adapted to be coupled to the pump to
measure an actual operating characteristic and
provide an measured output. The system includes a
a second element to compare the measured output to
a desired actual operating characteristic and
provide a scoring output comprising a pass mark when
the comparison meets prescribed criteria and a fail
mark when the comparison fails to meet the precribed
criteria. The system also includes a processor for
sampling test outputs over a set test period. The
yLoces~oL provides a pass-test output only when a
prescribed number of consecutive test outputs
comprise pass marks before the test period ends.
The systems following the various aspects
of the invention, alone or in combination, make it
p~Cc;hle for non-tt~rhn;cAl people to perform testing
and recertification of IV pumps on site at pump
~ 21 9788S
W096/06332 ~ ~JII~
- 4 -
distribution centers and hospitals. The systems
eliminate the need to send IV pumps to sr~ciAli7e~
bio 'ic~l facilities for certification. In this
way, the systems avoid lost time and expense due to
5 ~hi~ping, staging time at the certification
facility, and returning the certified pumps to
illvt:llLuLy .
Other features and advantages of the
inventions are set forth in the following
specification and attached drawings.
srief DescriPtion of the Drawinqs
Fig. 1 is a perspective view of an
integrated system for testing and certifying the
physical, functional and electrical performance of
15 IV pumps, which embodies the features of the
invention;
Fig. 2 is a perspective view of the system
shown in Fig. 1 configured as a testing and
certifying network simultaneously serving multiple
20 test stations;
Fig. 3 is a front right perspective view of
the test station associated with the system shown in
Fig. l;
Fig. 4 is a right side elevation view of
25 the testing station shown in Fig. 3, showing the
interior of the wet chamber, where liquid conveyance
testing is accomplished;
Fig. 5 is a left side elevation view of the
testing station shown in Fig. 3, showing the
interior of the dry chamber, where electrical safety
testing is accomplished;
Fig. 6A is a front elevation view of the
testing station, with the front panel broken away in
sections to further show the interior of the dry
35 chamber where electrical safety testing is
~ W096l06332 2 1 ~ 7 ~ ~ 5 ~ u~
~ ~ ,, .
-accomplished;
Fig. 6B is a schematic view of the first
circuit board housed within the dry chamber, which
carries the _ , Ls for testing the electrical
5 safety of an IV pump;
Fig. 6C is a schematic view of the second
circuit board housed within the dry chamber, which
carries a miuLu~Lu~ssor and other , -nts for
controlling liquid flow and electrical tests upon an
10 IV pump;
Fig. 7 is a front section view of the
integral valve block that serves as the inlet valve
station for the wet chamber of the testing station;
Fig. 8 is side section view of the
15 integral valve block shown in Fig. 7, taken
generally along lines 8-8 in Fig. 7;
Fig. 9 is a top view of the liquid
detection pad housed within the wet chamber of the
testing station;
Fig. 10 is a schematic block view of the
principal elements comprising the host pro~pcs;ng
station, the test station, and the data reporting
station of the system shown in Fig. 1;
Fig. llA is a schematic flow chart showing
the operation of the host station CPU after start up
and during the loading of the host program;
Fig. llB is a schematic flow chart showing
the operation of the host program in implementing a
test and certification procedure;
Fig. llC is a schematic flow chart view
showing the operation of the host program in
generating reports;
Fig. 12 is a representativc excerpt of the
Pump Specification Database that forms a part of the
host CPU;
W096/06332 2 1 9 7 8 8 s pCT~S9S/IOS99 ~
-- 6 --
Fig. 13 is a representative Master Test
Listing Database that forms a part of the host CPUj
Figs. 14A and 14B are representative Test
~atrixes that the host program generates based upon
correlating the Pump Specification Database and the
Master Test Listing Database;
Fig. 15 is a side elevation view of the wet
chamber of the test station, largely in schematic
form, during the p~lLuL~ nce of a flow rate accuracy
test;
Fig. 16A is a side elevation view of the
wet chamber of the test station, largely in
schematic form, during the performance of an
upstream occlusion ~Les~uL~ test;
Fig. 16B is a side elevation view of the
wet chamber of the test station, largely in
schematic form, during the performance of a
downstream occlusion pressure test;
Fig. 17 is a side elevation view of the wet
chamber of the test station, largely in schematic
form, during the draining of the test station after
performance of the liquid conveyance tests;
Fig. 18 is a schematic flow chart showing
the operation of the host program in burst filtering
load cell weight samples to derive an average weight
mea~uL~ ~ for use in determining flow rate
accuracy;
Fig. l9 is a schematic flow chart showing
the operation of the host program in determining
whether the pump undergoing testing meets the
overall flow rate accuracy tests;
Fig. 20A is a schematic flow chart showing
the operation of the host program in determining
whether a pump undergoing testing passes the
upstream occlusion tests;
.,
~ ~ W096J06332 2 1 ~ 7 8 8 5 pcT~s9~/lo~9s
-- 7 --
~Fig. 20B is a schematic flow chart showing
the operation of the host program in determining
whether a pump undergoing testing passes the
downstream o~ln~inn tests;
Fig. 21 is a representative Pump
Certification Report generated by the host program
based upon information containing in the log file
database;
Fig. 22 is a representative Pump Failure
Report generated by the host program based upon
information containing in the log file database;
Fig. 23A is a representative Detailed Test
Result Report generate~ by the host program based
upon information containing in the log file
database, detailing the tests conducted and the
results;
Fig. 23B is a representative Detailed Test
Result Report generated by the host program based
upon information containing in the log file
database, detailing the data collected during the
flow rate accuracy tests for a two channel pump;
Fig. 24A is a visual test menu used in a
preferred implementation of the host program;
Fig. 24B is a help screen for the visual
test menu shown in Fig. 24A, used in a preferred
implementation of the host program;
Fig. 25 is a visual real time display of
the flow rate accuracy test used in a preferred
implementation of the host program;
Fig. 26A is a visual real time display of
the occlusion pressure test used in a preferred
implementation of the host program;
Fig. 26B is a visual real time display of
the occlusion alarm time test used in a preferred
i l~ tation of the host program;
. , .
21 97885
W096/06332 - 8 - r~ ,JII~
Fig. 27 is a visual display of the test
results score card used in a preferred
; 1~ Lation of the host program;
Figs. 28A and B are schematic views of the
L~ carried on the first circuit board (shown
schematically in Fig. 6A) used to test the
electrical safety characteristics of an IV pump.
The invention may be embodied in several
forms without departing from its spirit or essential
characteristics. The scope of the invention is
defined in the appended claims, rather than in the
specific description preceding them. All em-
ho~; L~ that fall within the meaning and range of
equivalency of the claims are therefore intended to
be embraced by the claims.
Description of the Preferred Embodiments
Fig. 1 shows an integrated system 10 for
testing and certifying the physical, functional and
electrical performance of pumps intended to
administer liquids, medications, and solutions
intravenously. Such pumps (commonly called "IV
pumps") operate in various ways; for example, by
syringe, diaphragm, peristaltic, and fluid pressure
action. Because of their intended use, IV pumps
must meet stringent requirements for accuracy and
safety. IV pumps also require periodic
certification of their physical, functional, and
electrical performance characteristics. The system
10 serves just such a purpose.
The system 10 includes a host proc~cc;ng
station 12, a test station 14, and a data reporting
station 16.
As Fig. 1 shows, the stations 12, 14, and
16 are preferably arranged side-by-side as modules
on a work station 18 next to the IV pump 20 that is
~ w096l06332 2 1 q 7 8 8 5 . ~I/L~~v~
to be tested and certified. As Fig. 1 also shows,
the IV pump 20 is supported on a conventional
movable stand and IV pole assembly 22.
As Fig. 1 shows, the test station 14 is
adapted to be coupled electrically to the AC power
cord 174 of the pump 20 (if the pump 20 is AC
powered). The test station 14 carries an AC outlet
plug 144 for this purpose. The test station 14 also
;nr~ Pc a ground probe 142 that, in use, is coupled
to a suitable ground connection on the pump 20.
As Fig. 1 also shows, the test station 14
is adapted to be connected in liquid flow
communication with the ~;cpOs~hle fluid
administration set 168 of the IV pump 20. The test
station 14 carries a female luer connector 64 for
this purpose, which mates with a conventional male
luer commonly carried on the distal end of fluid
administration sets 168.
The host processing station 12 includes a
central mi~L~lo~pccing unit (CPU) 24. The CPU 24
is linked to the test station 14 by a conventional
serial connection cable 32 (using, for example, a
conventionaI RS-232 interface).
The host processing station 12 also
includes an interactive interface 154 for the
operator. The interface 154 includes a display
screen 26 (for example, a graphics display monitor
or CRT), keyboard 28, and a mouse 30.
As will be described in greater detail
later, the host CPU 24 executes a resident host
program 160 (see Figs. 10 and llA/B/C). Through the
host program 160, the CPU 24 generates and then
~ s an integrated test and certification pro-
cedure (which will also be referred to as a test
matrix 162, as Figs. 14A/B show). The host program
21 97~3~5
W096/0633~ r~l/u~,J , ~
-- 10 --
,
160 preferably customizes the test matrix 162
according to specifications of the particular IV
pump that is tested. For this purpose, the host CPU
24 retains pump specifications in an onboard
specification database 156 (see Fig. 12). The test
matrix 162 integrates a battery of visual physical
tests, liquid flow and ~L~S~UL~ tests, and
electrical safety tests for the pump 20 into one
consolidated test and certification procedure.
In the illustrated and preferred
~ho~i- L, the integrated test and certification
procedure includes a series of physical inspection
tests performed on the pump 20 by the operator under
the prompting and control of the host proyram 160.
The integrated test and certification ~L uced~L ~ also
includes a series of flow rate accuracy tests,
Occlllcinn ~UL~S~ULe tests, and (for AC powered pumps)
electrical safety tests performed on the pump 20 by
the test station 14 under the control of the host
CPU 24 with assistance from the operator, when
prompted by the host program 160.
In the illustrated and preferred ' ~;r L
(as will also be described later in greater detail),
the host program 160 uses a graphical interface to
display test status information and operator prompts
on the display screen 26 as the test procedure
progresses. The host interface allows the operator
to interact by entering n~s and r~cpnn~;ng to
interface prompts, using the keyboard 28 or mouse
30. In this way, the host program leads the
U~L~UL in a logical, stepwise fashion through the
integrated test and certification procedure.
The automated and user-friendly nature of
the interface makes possible the use of the system
10 by non-technical people to perform testing and
~ W09610633~ 2t q7885 ~l/U~
recertification of IV pumps on site at pump
distribution centers and hospitals. The system 10
eliminates the need to send IV pumps to sppriAl i 7P~
bio - 'ic~l facilities for certification. In this
way, the system 10 avoids lost time and expense due
to shipping, staging time at the certification
facility, and returning the certified pumps to
inventory.
In the illu~LL~ted and preferred P~hn~i- t
(as will be described later in greater detail), the
host CPU 24 also retains a log file database 164 for
each IV pump tested (see Fig. llB). The log file
database 164 identifies each pump tested by make,
model, and an unique alpha-numeric designation. The
log file database 164 holds the historical results
of each test and certification procedure conducted
for each individual IV pump. The log file database
164 provides full A~u Lation for generating a
diverse number of performance and tests reports for
management, certification, and failure diagnosis
~oses .
A conventional parallel or serial
connection cable 34 links the data reporting station
16 to the host CPU 24. In the illustrated and
preferred r-ho~ nt (as Fig. 1 shows), the
reporting station 16 is a dot matrix or laser
printer. The host program 160 draws from the log
file database 164 to transmit to the printer 16 the
processed~test and certification results. The
printer 16 prints these reports in easily
understood, preformatted reports (see Figs. 22 to
23). As Fig. 2 shows, the host processing station
12 preferable employs conventional real-time multi-
tasking. This allows the host processing station 12
to allocate CPU cycles to different application
- 21 978~
W096l06332 PCT~S95/10599
- 12 -
tasks and simultaneously control multiple test
stations 14 in a test and calibration network ll.
The illustrated '~'i- L in Fig. 2 shows,
by way of example, the host processing station 12
simultaneously controlling up to four test stations,
designated 14(1); 14(2); 14(3~; and 14(4), each
associated with an individual IV pump, respectively
designated 20(1); 20t2); 20(3); and 20(4). Of
course, the host processing station 12 could be
conditioned to simultaneously control more test
stations 14, if desired.
The principal ~ mpon-nts of the system 10
will now be individually discussed in greater
detail.
I. THE T~ST STATION
As Fig. 3 best shows, the test station 14
includes a compact housing 36 , which can be made
from formed metal or molded plastic material. The
test station 14 integrates within the housing 36 the
testing of both electrical safety and liquid
col-v~yd~,ce characteristics of the IV pump 20.
~ ore particularly, the test station 14
physically isolates these two very different test
functions by internally compartmentalizing the
housing by a dividing plate 38. The dividing plate
38 creates two side-by-side chambers 40 and 42
within the test station 14.
One chamber 40 occupies the right front side of
the housing 36. This chamber 40 ~also shown in side
view in Fig. 4) is dedicated to the h~n~l ;ng of
liquid ~u--v~y~d by the IV pump 20. In the
illustrated and preferred _~hoS;l nt shown in Fig.
4, this chamber 40 holds the , -nts that perform
~ liquid flow rate and liquid pressure occlusion tests
on IV pumps. For this reason, the chamber 40 will
.
~ W096l06332 2 1 9 7 8 8 ~ F~l/u ~
.~ ,~
also be called the "wet chamber."
The other chamber 42 orcl~r;Pc the left front
side of the housing 36. This chamber 42 (also shown
in front and side views in Figs. 5 and 6) is
5 dedicated to the hAnAl ;ng of high voltage electrical
flow to and from AC power IV pumps 20. In the
illustrated and preferred : _~ir L shown in Figs.
5 and 6, this chamber 42 holds ~ L~ Ls for
hAn~l;ng electrical output to perform a range of
10 electrical safety tests for AC power IV pumps. For
this reason, the chamber 42 will be also called the
"dry chamber."
The dividing plate 38 shields the electrical
crmrnnents in the dry chamber 42 from exposure to
15 liquid handled in the wet chamber 40. The dividing
plate 38 thereby isolates within the test station
housing 36 all high voltage electrical ~ L~
from all liquid hAn~l ing , ~ntS.
A. The Wet Chamber
The wet chamber 40 (see Fig. 4) contains a
conventional load cell 44 housed within a bracket 46
mounted to the dividing plate 38. A representative
load cell 44 that can be used for this purpose is
manufactured by HBM Incorporated, Marlboro,
25 MAcsA~h~lcetts (Model No. LPX-2XX109).
The load cell 44 supports a liquid collection
bottle 48. Preferably, the interior volume of the
bottle 48 is sufficiently large to collect liquid
during flow accuracy mea~uL~ Ls without filling.
30 For most test ~uL~oses~ a bottle 48 with a volume of
about 250 cc should be adequate. Still, as will be
described in greater detail later, the test station
14 can be operated to drain the bottle 48, if
required, during a given test procedure, and the
35 test ~LuceduL~ resumed with an emptied bottle 48.
W096l06332 2 1 ~ 7 8 8 5 ~ J~
The wet chamber 40 also contains an inlet valve
station 50 and a drain valve station 52 mounted to
the dividing plate 38. First and second solenoids 54
and 56 are, in turn, carried by the valve stations
50 and 52. Under the direction of the host program,
the host CPU 24 ;~ Lly ~ tes the solenoids
54 and 54 to control fluid flow through the
respective valve stations 50 and 52 to carry out
flow accuracy and occlusion ~L~ULe tests.
The inlet valve station 50 is configured as a
two way valve and includes three branches 58, 60,
and 62. The first branch 58 communicates with the
female luer 64 mounted on the front panel 66 of the
test station housing 36. A m-ale luer ~not shown)
carried at the distal end of the IV pump tubing 168
makes an interference fit within the female luer 64
to connect the pump tubing 168 to the valve station
50. The inlet valve station 50 is therefore
directly subject to pumping ~L~S~uL~ applied by the
associated IV pump.
The second branch 60 of the inlet valve station
communicates with a conventional pressure
L,~..sduc~ 70, which is also carried within the wet
chamber 40. The third branch 62 of the inlet valve
station 50 - irates with a first length 72 of
flexible tubing extending within the wet chamber 40.
The flexible tubing 72 is preferably made of an
inert flexible plastic material, like plasticized
polyvinylchloride.
The first solenoid 54 controls the pl ~S~UL ized
fluid flow through the inlet valve station 50, under
the direction of the host program, from the female
luer 64 (via the first branch 58~ either to the
~L~s~uLe transducer 70 (via the second branch 56) or
to the first tubing 72 (via the third branch 62).
-
~ w096l06332 2 1 ~ 7 8 8 5 1 ~"~ j
- 15 -
P
The first solenoid 54 is normally spring biased to
open liquid flow between the first branch 58 (from
the female luer 64), the second branch 56 (to the
pLe ~ULe LL~ilSdUCeL 70), and the third branch 62 (to
5the first tubing 72). In this condition, pLes~uLized
liquid flows, following the path of least
rPcictAnre, through the inlet valve station 50 from
the female luer 64 to the drain valve station 52.
The first solenoid 56 can be activated, under
10the control of the host program ;n~PrPn~ont of
activation of the second solenoid 56, to close
liquid flow between the first branch 58 (from the
female luer 64~ and the third branch 62 (to the
first tubing 72, leading to the drain valve station
1552). This condition ~hAnnPlc all pressurized liquid
flow from the first branch 58 into the second branch
60. The resulting increase in p~eS~ULe in the second
branch 60 is ~Ptectod by the pLes~uLe trAncd~lcPr 70.
A representative commercially available
20solenoid that can serve as the first solenoid 54 is
made of NR Research Inc., Northboro, Massachusetts
(Model Number HP225T021).
The drain valve station 52 is configured as a
three way valve and also includes first, second, and
25third branches 74, 76, and 78. The first branch 74
;cates with the first tubing 72 leading from
the inlet valve station 50. The second branch 76
;~ates with a second length 80 of tubing
extending within the wet chamber 40, which is also
30preferably plasticized polyvinylchloride plastic
material. The second tubing 80 leads in an iso-
radial path from the drain valve station 52 to the
collection bottle 48. The third branch 78
- communicates ~ith a drain tube 82 for the wet
35chamber 40. The drain tube 82 exits the wet
W096/06332 2 1 ~7 8 85 I ~1IU~ LV~
chamber 40 through an opening 84 in the bottom panel
86 of the test station housing 36. The drain tube
82 is also preferably plasticized polyvinylchloride
plastic material.
A second solenoid 56 controls fluid flow
through the drain valve station 52, under the
direction of the host program, from the first tubing
72 (via the first branch 74) either to the
collection bottle 48 (via the second branch 76 and
tubing 80) or to drain tube 82 (via the third branch
78).
The second solenoid 56 is normally spring
biased to open liquid flow between the first branch
74 (from the first tubing 72), and the second branch
76 (to the second tubing 80 leading to the
collection bottle 48), while closing liquid flow
through the third branch 78 (to the drain tube 82).
In this condition, the drain valve station 52
directs liquid from the inlet valve station 50 to
the collection bottle 48. sy sensing with the load
cell 44 the change in weight of the bottle 48 over
time, and knowing the specific gravity of the liquid
being CUIIV~Y~d, the host program 160 derives a flow
rate calculation gravimetrically.
The second solenoid 56 can be activated, under
the control of the host program 160, independent of
activation of the first solenoid 54, to open liquid
flow between the second branch 76 (from the second
tubing 80 leading from the collection bottle 48) and
the third branch 78 (to the drain tube 82). This
allows liquid in the bottle 48 to drain by gravity
esauL~ through the drain tube 82. If the IV pump
20 is still operating and the first solenoid 54 is
not activated, pressurized liquid flowing from the
inlet valve station 50 will also follow the path of
.,
~ W096106332 2 1 9 7 ~ 8 5 1 ~-~u~ ~iv~.
-- 17 --
least resistance through the drain tube 82.
A representative commercially available
solenoid that can serve as the first solenoid is
made of NR Research Inc., Northboro, Massarhllcettc
tModel Number 648T031).
In the illustrated and preferred Pmho~i - L
(see Fiqs. 7 and 8), the inlet valve station 50
minimi7Pc the number of high ~LeS~ULe, leak-prone
connections by concol;~Ated them into integral valve
block 88 attached to the dividing plate 38. The
valve block is made of an inert plastic material
that makes leak resistant threaded connections, like
Teflon plastic. The block 88 contains drilled
interior p~qsageways that comprise the first,
second, and third branches 58, 60, and 62, already
described. The first branch pACcAgpway 58 joins the
second branch passageway 60, and together they join
an orifice 90 that enters a preformed valve seat 92
on the block 88. The second branch pAcSA~ y 60
joins a second orifice 94 that also enters the valve
seat 92. The first solenoid 54 is mounted to the
block 88 overlying the valve seat 92. In its
normally biased, inactivated position, the first
solenoid 54 is withdrawn from the valve seat 92.
This allows liquid flow through the valve seat 92
between the orifices 90 and 92, through the first
and second branch passageways ~8/60 into the third
branch passageway 62. When activated, the first
solenoid 54 seats inside the value seat 92, blocking
the orifices 90 and 92 and thereby blocking the
liquid flow between them. The pressurized flow
thereby collects in the second branch passageway 56
for ~LeS~ULe detection by the pressure trAnc~llcpr
70.
The first, second, and third branch passageways
W096l06332 2 1 9 7 8 ~5 PCT~S95110599 ~
- 18 -
58, 60, and 62 include internally threaded ports 96
that mate with threaded connectors 98 on the female
luer 64, the pressure tr~nc~ r 70, and the first
tubing 72. Consolidated, secure, and leakproof
conveyance of liquid through the valve station block
88 results.
While not shown, a similar integral block
construction could be used to form the drain valve
station 52, or to consolidate the inlet and drain
valve stations 50 and 52 into a single valve block.
In the illustrated and preferred Pm~oAi- ~
(see Fig. 4), the wet chamber 40 includes a liquid
spill detection element 100. The element 100 detects
the leakage of liquid within the wet chamber 40.
The leakage, if not detected, could adversely impact
the accuracy of the flow rate calculations.
The spill detection element 100 can be
uul~Ll~uLed in various ways. In the illustrated and
preferred ~mhoA i - L ( see Fig. 9), the spill
detection element 100 comprises pad 102 of
electrically non-conducting material mounted on the
bottom panel 86 of the wet chamber 40. Various non-
conducting materials can be used. In the illustrated
and preferred ~mhoAi~ L, the pad 102 is made of a
polyester material.
First and second circuits 104 and 106 of
electrically conducting material, like copper, are
applied by coating or by etching or by ; mheAA; ng
thin wires on the pad 102 (see Fig. 9). The first
and second circuits 104 and 106 form an array of
spaced apart fingers 108, which are nested in an
alternating pattern on the pad 102.
The first and second circuits 104 and 106 are
normally insulated from each other by the pad
material between the alternating fingers 108, so
' 2 1 97885
~ WO 96106332 . .~ J/1C.~
-- 19 --
,~ ,.
that the first and second circuits 104 and 106
normally conduct no current between them. The
presence of one or more liquid droplets on the pad
102 SpAnning across the alternating fingers 108
electrically connects the first and second circuits
104 and 106 to conduct current and ill ;nAte an LED
110 on the front panel 66 of the test station
housing 36 (see Fig. 3). When illuminated, the LED
110 alerts the operator to the leakaye of liquid
within the wet chamber 40.
When the pad 102 senses liquid leakage, a
siynal is also relayed to the host CPU 24 indicatiny
the problem. The host CPU 26 also displays a
"liquid leakage" message on the screen 26 (and
preferably also sounds an audible alarm) to alert
the operator.
As Figs. 3 and 4 show, the riyht side of the
test station housiny 36 includes a door 112 mounted
on a piano hinye 114. The door 112 opens and closes
to provide access to the wet chamber~ 40. A
conventional maynetic release latch 116 (see Fiy. 4)
normally holds the access door 112 closed duriny
use.
In the illustrated and preferred '~ t (as
Fiy. 4 shows), the interior of the access door 112
includes a bracket 118 that carries weiyhts
(desiynated Wl and W2 in Fig. 4) of predetermined
size. Upon prompting by the host program 160, the
operator opens the access door 112 and places one or
more of the weiyhts Wl/W2 upon the collection bottle
48 to calibrate the load cell 44. The details of
this calibration process governed by the host
proyram 160 will be described later.
In a preferred PmhQ~; 8 ~ the test station
housiny 36 includes a conventional proximity sensor
2lq788~ ~
Wos6l06332 PCT~S95110599
- 20 -
120 (see Fig. 4) to sense when the access door 112
is opened. The host program 160 appropriately
prompts the operator with an "Open Door" indication
in response to a signal relayed to it from the
proximity sensor 120. Upon receiving an "Open Door"
signal from the sensor 120, the host CPU 24
preferably also aborts any tests involving
Ls in the wet chamber 40. Upon closing the
access door 112, the host CPU 24 restarts an aborted
test from the beginning.
It should be realized that flow accuracy
measuL~ ~s could be accomplished in ways different
than gravimetrically. For example, the wet chamber
40 could include a fixed volume capillary tube and
photocPnc~rs to measure flow rates volumetrically.
Because the capillary tube becomes partially or
totally occluded by bacterial growth or liquid
residue within it, volumetric systems are prone to
inaccuracies and results that are not uniformly
repeatable, For this reason, the gravimetric method
for measuring flow rates is preferred.
B. The Dry Chamber
Please refer now to Figs. 5 and 6A/B/C. The dry
chamber 42 houses on three integrated circuit boards
122, 124, and 124 the numerous ~nts that
assist in the acquisition and processing of
electrical data by the test station 14, as well as
the - ;~ation of this data to the host CPU 24.
A left side panel 128 closes the dry chamber 42,
protecting the boards 122, 124, and 126 from direct
access and exposure to the outside environment. As
before stated, the dividing panel 38 protects the
boards 122, 124, and 126 from unirtended contact
with liquid in the wet chamber 40, and vice-versa.
Spacers 130 attach the first circuit board 122
~ ~ 9 7 ~ 8~ v~ ~
os6/06332
- 21 -
,~
to the dividing panel 38 (see Fig. 6A). The first
circuit board 122 (shown schematically in block form
in Fig. 6B~carries the various relays and electrical
- 68 needed to check internal and external
5electrical leakage in the IV pump 20 with normal and
reverse polarities, with and without ground, and
with and without AC power applied. Further details
of the elcctrical - - -nts 68 and their operation
will be described later.
10The first circuit board 122 ;ncln~Pc a low
voltage AC (115V) power supply PSl. This power
supply PSl powers the relays and electrical
- Ls 68 on the board 122, the solenoids 50 and
52 in the wet chamber 40, and the serial port
15interface 188 between the host CPU 32 and the test
station mi~Luplocessor 132 (mounted on the second
circuit board 124).
The second circuit board 124 is attached by
additional spacers 130 to the first circuit board
20122 in the dry chamber 42 (see Fig. 6A). The second
circuit board 124 (shown schematically in block form
in Fig. 6C) carries a mi~LupLucessor 132 (for
example, a type 8032B~) for implemented tasks under
the control of the host CPU 24. The second circuit
25board 124 includes the serial interface 188 (for
example, a type MAX232~ through which the host CPU
32 and test station mi~Lu~lucessor 132 communicate.
The second circuit board 124 also includes a
static RAM block 176 (for example, a type 6264) for
30use by the microprocessor 132. The board 124 also
carries a battery backed RAM block 178 (for example,
a type 2816) for retaining information pertaininq to
the use and maintenance of the test station 12,
which will be described in greater detail later. The
board 124 also ;nc~ P~ a p~O~L hle R0~ block 180
W096/06332 2 1 ~ 7 8 85 PCT~59~10~s ~
- 22 -
(for example, a type 27C64). The ROM block 180
contains ;~e~Pd software that the host software
160 programs to instruct the miuLu~ULoc~ssor 132 to
carry out prescribed test and certification
~)L UUt:llUL 1::5 .
The second circuit board 124 carries the low
voltage DC power (5 V) supply PS2 for the Ls
on the second circuit board 124. As will be
described in greater detail later, optical-isolation
elements 198 carried on the first board 122
electrically isolate the low voltage r Ls on
the second board 124 from the high voltage
electrical components 68 on the first board 122 and
the solenoids 50/52. The control signals from the
test station microprocessor 132 are rh~nnPle~
through the optical-isolators and decoded by
decoders 202 before being sent to the drivers 204
for the relays 68 on the first board 122.
Likewise, optical-isolation elements 198 on the
~ 20 second board 124 electrically isolate the serial
port interface 188 from its power supply PSl carried
on the first board 122.
The static RAM block 176, battery backed RAM
block 178, and the ROM block 180 communicate with
the microprocessor 132 via an address bus 182 and a
data bus 184. Implementing the program in ;~P~e~
software, the test station mi~Lu~Lucessor 132
transmits control signals through an I/O buss 186
(for example, a type 82C55) to activate the first
and second solenoids 54/56 and the electrical
, ~nts 68 on the first circuit board 122, as
well as receive data signals from the electrical
_ ents 68, the pressure tr~ncducPr 70, and the
load cell 44. The second circuit board 124 carries
an analog-to-digital ~A-to-D) converter 190 (for
r PCI'IUS95110599
W096/06332 2 1 9 7 8 8 ~
~ 23 --
example, a type ICL7135) that converts the analog
signals of the pressure transducer 70, the load cell
44, and the electrical components 68 on the first
board 122 to digital signals for processing by the
host CPU 24. The analog signals are conditioned and
amplified by conventional front end conditioning
circuits 192 on the second board 124. The
conditioned analog signals are also preferably
channeled through an analog multiplexer 194 (for
example, a type 4051), which selects the analog
signal to be converted by the converter 190. The
digital output of the A-to-D converter 190 passes
through a decoder 196, if necessary to assure
compatibility with the microprocessor bus 186. The
digital output is transmitted by the microp~ocessor
132 to the host CPU 32 for processing.
The second circuit board 124 also includes a
watchdog 200 that alerts the operator should the
mi~L~Lsr~csor 132 fail during use. The details of
the watchdog 200 will be described later.
The third circuit board 126 drives LED's
exposed on the front panel 66 of the test station
housing 36. The number and function of the LED's
can vary. The illustrated and preferred embodiment
provides five LED's (see Fig. 3 as well).
A status LED 134 identifies the test station 14
by a number 1 to 4 (when multiple test stations are
being used), and blinks when tests are underway.
The moisture detection LED 110 (already
described) illuminates when the spill detection
element 100 in the wet chamber 40 senses liquid
leakage.
A communication fault LED 136 illuminates when
the communication link between the host processing
station 12 and the test station 14 breaks down.
2 1 97885
Wos6/o~32 PCT~S9s/l~99
- 24 -
A device fault LED 138 illuminates when general
electrical or logic failures in the test station
circuitry are sensed.
A test power LED 140 illuminates when the
outlet plug 144 of the test station 14 receives
power.
Cables 142 lead around the dividing panel 38
between the dry and wet chambers 40 and 42 to
electrically connect the first and second solenoids
54/56, the pressure transducer 70, the load cell 44,
the spill detection element 100, and the proximity
sensor 120 to the circuit boards 122, 124, and 126.
Additional cables 142 also electrically connect a
test station power plug 144 (mounted to the front
panel 66 of the test station housing 36~ and a
ground probe 146 to the circuit boards 122, 124, and
126. In routinq the electrical cables 142, high
voltage lines are kept separate from low voltage
lines.
Two resistance studs (designated Sl and S2)
mounted on the dividing panel 38 extend into the wet
chamber 40 (see Figs. 4 and 6). The studs Sl and S2
are electrically connected to the boards 122, 124,
and 126 in the dry chamber 42 to present different,
known resistance values for conducting periodic
ground resistance calibration at the prompting of
the host CPU 24. The particularities of these
calibration tests will be described later.
C. Start Vp and Safety Checks
Preferably, the operator allows the test
station 14 to warm up for a predetermined time (e.g.
5 minutes) before use. This warm up period allows
the load cell 44 and other electrical components to
stabilize before use.
The status LED 134 preferably displays a "-"
6l06332 ~ 7 ~ U~/ ' /5
- 25 -
,:s ,~*
indication or the like during the warm up period.
After the warm up period, the status LED 134
displays the test station number. The displayed test
station number is constant when the test station is
on line but not being used to conduct a test. The
displayed test station number blinks when the test
station is on line and conducting a test, as
previously described.
During power up, the test station
mi~Lu~lucessor 132 runs a prescribed series of self
tests during warm up to assure that communications
with the host processing station 12 exists and that
no general electrical or logic failures are present
in the test station circuitry, including using
checksum for battery backed RAM data. The test
station miuLu,uLucessor 132 illuminates the device
fault LED 138 when general electrical or logic
failures in the test station circuitry are sensed.
The test station miuLu~Locessor 132 also
preferably includes a watchdog 200, as previously
~;ec-lc~P~. The watchdog 200 automatically
interrupts operation of the test station 12 and
initiates a power up routine after a given time-out
period (for example 1.5 seconds), unless the
watchdog receives a specified flag signal from the
;mhe~Pd software on the second board 124, which
resets the time-out period. When the miuLuyLoce~so~
132 is functioning properly, the watchdog 200
per;n~;r~lly receives the flag signal (for example,
once every 0.5 second) to prevent its timing out.
When the miuLu~Locessor 132 fails, the absence of
the flag signal allows the watchdog 200 to time-out,
initiating a power up routine to initiate the series
- of self-tests to identify the electrical or logic
failure.
. , ,
=
Wog6/06332 2 1 9 7 8 8 5 . ~ ,t .~ ~
- 26 -
The test station mi~LupLuces~oL 132 also
illt-m;n~tes the i~ation fault LED 136 should
;cation with the host station 12 fail to be
detected. The LED 136 goes off whenever
;cation occurs between the test station
mi~Lu~Luuessor 132 and the host CPU 24. Likewise,
if ;~ation is garbled, causing frequent
tr~n~;Ccinnc and retransmissions, the LED 135 will
flicker.
In addition, the host CPU 24 sends a periodic
"heartbeat" signal to the test station
microprocessor 132. The "heartbeat" signal causes
the test station microprocessor 132 to transmit an
elapsed test time signal. If the microprocessor 132
does not respond to the "heartbeat" signal, the host
CPU 24 alerts the operator that communication with
the test station 12 has broken down.
II. T~E XOST PROCESSING ST~TION
A. The ~ost CPU
The host CPU 24 acts as the master of the
system 10, initiating all of the control functions.
The test station mi~Lu~Luces~ol 132 is slaved to the
host CPU 24, as is the data reporting station 16,
which respond to the control functions that the CPU
24 initiates. The host CPU 24 communicates with the
test station mi~LuyLocessor 132 and the data
reporting station 16, as previously described. In
this way, the host CPU 24 coordinates overall con-
trol functions for the system 10.
As Fig. 10 schematically shows, the host CPU 24
~; ;cates with a mass storage device 148 (e.g.,
a hard drive) and an extended static RAM 150.
Preferable, the RA~ 150 ;nclll~Pc a battery backup
152. The user interactive interface 154 (already
described) also communicates with the host CPU 24.
~ w096l06332 ~ 2 1 q 7 8 8 5 PCT~595~1~599
- 27 -
~ .
The mass storage device 148 retains in non-
volatile memory the databases and data processing
intollig~nre to perform and process the intended
test and certification p.uc~duLes. In the
illustrated and preferred r~o~ L (as Fig. 10
shows), the host CPU 24 retains in hard drive
memory:
tl) a specification database 156 (see also
Fig. 12), which contains the current physical,
functional, and performance specifications of all
makes and models of IV pumps that the system 10 is
intended to test and certify, which are provided by
or derived from the manufacturer's product
specifications.
(2) a master test list database 158 (see
also Fig. 13), which contains all visual, flow rate,
occlusion, and electrical safety tests that the
system 10 is capable of performing.
(3) the executable host program 160, which
generates and implements the test matrix 162 (see
Figs. 14A and B) based upon the unique
specifications for the make and model of the IV pump
identified for testing by the system 10.
(4) a log file database 164 dc Ling by
make, model, and unique identification designation,
each pump tested by the system 10 and the results of
each test and certification procedures conducted by
the system 10 for each IV pump.
(5) a usage database 166 documenting usage
of the host proc~C;ng station and each test station
it controls. Usage information can include, for
example, the total number of automated test
se~u~.,ces completed by the host sta-ion 12; and the
total number of test and certification procedures
performed by each test station 14, classified
21 978~5
W096l0633~ PCT~S95/l~Sg9
- 28 -
according to test type.
The test station mi~Lu~Locessor 132 also
retains usage information specifically relating to
the test station in battery-backed RAM in the
; ' software of the test station microprocessor
132. This information can be retrieved by the
operator upon demand through the host CPU 32.
Representative examples of test station-specific
usage information include the total times the test
station 12 has been powered up; recent (e.g., the
last twenty) test station error alarms; and recent
(e.g., the last twenty) test station recalibrations
performed by the operator tas will be described
later).
In the illustrated and preferred Pmho~ir~nt~
the host CPU 24 comprises a conventional 486-series
mi~LupIucessoL (33 Mhz or more), with a hard drive
148 having a mass storage capacity of at least 200
mB and RAM 150 of at least 4 mB.
B. Host Station Start Up
In readying the system 10 for use (as Fig. 1
shows), the operator supplies power to the host
processing station 12, test station 14, and data
reporting station 16.
As Fig. llA shows, like the test station
microprocessor 132, the host CPU 24 conducts, upon
start up, conventional initialization and critical
data integrity checks (designated in Fig. llA as the
initialization routine) to verify that its pLocessor
and associated electrical - -nPnts are working,
;n~ ;ng a checksum for battery backed RAM data.
If these power-up tests fail, the host CPU 24
enters a shutdown mode. otherwisel the CPU 24 loads
the host program 160.
Upon execution, the host program 160 prompts
~ WO 96106332 ' ~ ~1 9 7 ~ 8 5
-- 29 --
the operator to log on by verifying the correct date
and time and identifying him or him or herself.
Password protection could be implemented at this
initial stage of the host program 160 to prevent
unauthorized persons from using the system 10.
As Fig. llA further shows, after log on, the
host program prompts the operator to select among
ta) Conducting a Test and Calibration Procedure; (b)
Generating a Report; or t3) Exiting the Host
Program.
C. Conducting a Test and Certification
P~ VCL l1UL ~:
(1) Pump Identification
As Fig. llB shows, at the outset of each test
and certification yLucedu.~, the host program 160
requires the operator to identify by make, model,
and unique identification number the IV pump 20 to
be tested. The operator ~ onds by supplying an
alpha-numeric designation unique to each IV pump
tested by the system 10.
~ The designation can comprise the serial number
assigned by the manufacturer of the IV pump.
Alternatively, the designation can comprise an
alpha-numeric sequence assigned by the user or
distributor of the IV, or by the operator of the
system 10.
The alpha-numeric designation is initially
entered by the operator, upon prompting by the host
program, by the keyboard 28. Alternatively, the
designation can be entered by s~nni ng the
designation affixed in bar code form on a label
- attached to the pump. Once entered, the host CPU 24
retains the alpha-numeric designation in a file in
- the log file database 164. Thereafter, the operator
can use the mouse 30 or keyboard 28 to open and
- 2197885 PCr~Us9sllos99
W096l0~32
- 30 -
scroll through pump identification windows displayed
by the host program, which present those pumps
recorded in the log file datAhA-cP 164. The operator
can select one of the pumps using the mouse 30 or
the keyboard 28.
The log file database 164 automatically
generated by the host program 160 creates a
historical record of all test and certification
procedures conducted on the IV pump by the system
10, together with the detailed results of each
procedure. The log file database 164 holds the log
files for each IV pump, uniquely identified by its
assigned alpha-numeric designation, thereby
documenting the performance records and Pass/Fail
diagnoses for all IV pumps tested by the system 10.
It is from the log file database 164 that the host
~ram compiles the performance and tests reports.
The automatic maintenance by the host program
of the log file database 164 during each test and
calibration procedure, coupled with the associated
ability to generate reports both at the end of each
test and certification procedure and on demand,
constitutes an invaluable resource and management
tool for the operator. Further details concerning
these reports and the execution of host program in
creating them will be described later.
~2) Generating the Test ~atrix
As Fig. llB shows, upon identifying the make,
model, and alpha-numeric designation of the pump 20,
the host program 160 creates and executes the test
and certification procedure for the identified IV
pump. The procedure first draws upon and
consolidates information within the pump
specification database 156 and the master test
listing database 158 to create a test matrix 162 for
~ W O 96/06332 2 1 9 7 8 8 5 P~r~US95/10599
- 31 -
the pump to be tested.
tA) Pump Specification Database
Fig. 12 is a representative excerpt from the
specification database 156, listing the
5specifications for certain makes and models of
commercially used IV pumps. As Fig. 12 shows, the
specification database includes not only the
functional and performance specifications for the
pumps, but also the manufacturers' specifications
10regarding flow rate accuracy and onclucinn pressure.
Fig. 12 shows that the specifications can differ
significantly among different makes and models of
pumps.
The specification database 156 can be
15periodically updated to remain current.
(B) Master Test Listing Database
Fig. 13 shows a listing of a representative
master consolidated test database 158 retained by
the host CPU 24. The host program 160 is capable of
20prompting the operator and directing the test
station microprocessor 132 to implement all the
tests in the master test database 158 according to
prescribed criteria, as will be described later.
(C) The Test Matrix
25Still, not all tests contained in the master
cnn~oli~ted test database 158 are applicable to all
IV pumps. For example, as Fig. 12 shows, many IV
pumps conduct liquid using only one pump channel,
while other pumps have two pump ch~nn~l c.
30Therefore, the testing of a second pump channel
found in the master database 158 (see Tests 27, 28,
and 29) is simply not applicable to these pumps. As
another example, pumps that are not AC powered do
- not require the electrical safety tests listed in
35the master database 158.
21 9788~
W096/06332 ~ ~J
- 32 -
Therefore, before proc~DAing with testing a
given IV pump identified by the operator, the host
program 160 correlates the information contained in
the master c~ncoli~ted test database 158 based upon
the information contained in the specification
database 156 for the pump identified for testing.
This correlation generates the test matrix 162 (see
Figs. 14A and 8) for the identified IV pump.
Figs. 14A and B show representative text
matrixes 162 for the IV pumps contained in the
specification database 156 shown in Fig. 12, based
upon the master test database 158 shown in Fig. 13.
The pump-specific test matrix 162 takes into
account the particular functional and performance
characteristics of the identified IV pump set forth
in the specification database 156. The matrix 162
selects from the master consolidated test database
158 only those tests that can or should be performed
on the identified pump during the test and
calibration ~Locedu.e (see Fig. 14A). The test
matrix 162 also takes into account the accuracy flow
rate and occlusion flow rate and pressure data set
forth in the specification database 156 for
identified pump (see Fig. 14B).
Guided by the test matrix 162 for the
particular IV pump identified for testing, the host
program 160 proceeds with the test and calibration
uoedu-e. As Fig. llB shows, the ~L~cedu-e advances
through visual inspection tests, flow rate accuracy
tests, occlusion pressure tests, and electrical
safety tests set forth in the pump-specific test
matrix 162. The host program 160 also uses the flow
rate accuracy and occlusion flow rate and y~es~u-~
information specified for that IV pump in the test
matrix 162 in setting up and evaluating the flow
WO 96106332 2 1 9 7 8 8 5 PCI~/[J59~i/10~99
-- 33 --
,~ ~ i
rate accuracy tests and occlusion pressure tests.
The host program 160 also draws upon information in
the test matrix 162 to re ' the flow rate for
.~nAn~ti nj the accuracy tests, as well as the number
of flow rate samples that should be taken during the
test period.
A given IV pump receives an overall PASS result
for the test and calibration procedure only if it
receives a PASS result for every visual inspection
test, every flow rate accuracy test, every occlusion
pressure test, and every electrical safety test
contained in its test matrix 162. Otherwise, the IV
pump receives an overall FAIL result for the test
and calibration procedure.
The overall nature of the individual tests on
the master list database 158 that are implemented by
the host program 160 in the illustrated and
preferred ~~hoAir L will now be discussed in
greater detail.
~3) Conducting Visual Inspection
Tests
The host program 160 carries out visual
inspection tests by prompting the operator to
operate and/or visually inspect certain physical or
functional aspects of the IV pump that are
acc-~ccihle or visible to the operator.
~he particular aspects of the IV pump
identified for operation or inspection in the test
matrix 162 during the visual inspection tests can
vary according to the particular specifications of
the pump. The following is a l~r es~"Lative listing
of typical visual inspection tests and the
associated representative prompts that the host
~ program can use:
Unit Clean
, ~, ,; ,: , ,
21 97885
Wos6/o6332
- 34 -
Host Program Prompt:
Ensure the pump is clean of all spilled
fluids and other dirt or grime. Check for
solution stains in corners and connections
between case halves and/or other
;~,e-- 1 i f'e. .
Loose c ,enL (Vibration) Check
Host Program Prompt:
Listen for loose , , -nts moving around
the inside of the pump while turning the
pump upside down and sideways.
During Flow Rate Accuracy testing, check
for excessive vibration or other noises
emanating from the pump.
Kev~ad h DisPlav Window (Visual Check)
Host Program Prompt:
Check for cuts, cracks, or holes in the
keypad or display window. Check for fluid
on the inside of the display window.
Ensure that any scuffs or other marks on
the display window do not interfere with
the correct reading of the display.
Case Assemblv
Host Program Prompt:
Visually inspect the pump case for missing
or damaged parts including any cosmetic
defects.
Batterv Door Ins~ection
Host Program Prompt:
The battery door should slide upward to
reveal the battery compartment. Verify
some resistance at the start of opening
and smooth operation once started. Ensure
that the battery diagram symbol with the
+ and - symbols is firmly in place.
WO 96/06332 2 1 ~ 7 ~ ~ 5 PCT/U595/10599
Ensure that the battery contact pads are
firmly in place.
Latch Assemblv Ins~ections
Host Program Prompt:
Verify smooth operation for the Channel A
latch and the Channel B latch. In opening
a latch, it should move in an ~L" shape by
sliding down and then back. To close the
latch, slide down, forward and then up.
The small tab on the latch assembly should
overlap the small tab on the
administration set cartage and hold the
cartridge in place.
Power U~ On Batterv
Host Program Prompt:
Install both batteries. Tone alarm will
beep and the LCD will display:
UNIT SELF TEST
IN PROGRESS
At the completion of the self-test, the
display will then show the results of the
last program entered and 4STOP."
Ensure all LCD segments are visible.
Press the [DISPLAY] key. Verify that
ba~klight is illuminated.
Verify that the pump powers on with one
battery in either battery position. Shake
pump to verify continued battery operation.
Try each battery position one at a time.
Kev~ad Functionality
Host Program Prompt:
. ,
21 97885
W O 96106332 Pl~rnUS9S/10599
- 36 -
Activate each key to ensure it correctly
responds and operates. Ensure correct
information is displayed with each key
activation. Inspect for excessive wear of
keys.
Prime Buttons FunctionalitY
Host Program Prompt:
Place pump in priming mode. Depress
~PRIMF] button followed by pressing and
holding the A channel button... Ensure the
Channel A motor turns and set priming
function is initiated and properly
completed. Depress [PRIME] button
followed by pressing and holding the B
channel button..... Ensure the Channel B
motor turns and set priming function is
initiated and properly completed.
Bolus Button Functionalitv
Host Program Prompt:
Place pump in bolus delivery mode.
Depress bolus button. Ensure bolus
delivery is initiated and properly
completed.
Remote Bolus Cord Functionality
Host Program Prompt:
Attach Remote Bolus Cord to pump. Verify
that display does not change while plug is
being inserted. Place pump in bolus
delivery mode. Depress remote bolus
button. Ensure bolus delivery is initiated
and properly completed.
Air In Line Detectors
~ W0 96106332 2 1 9 7 8 ~ 5 }~
-- 37 --
.~ .
Host Program Prompt:
Visually inspect for excessive wear or
damaged parts on the air detector
transmitter and receiver for both Channel
A and Channel B.
Verify that the air alarm is not defeated.
To verify, ensure that each channel is
~L~yL i. Press the [DISPLAY] key and
note that:
"AIR IN LINE *A~
~ALAR~ ON"
and
~AIR IN LINE *B~
~ALARM ON"
is displayed on the screen.
Enter air bubble into administration set
above the pump 'An;r- for Channel A. Air
bubble size must be greater than 50 to 100
microliters. Ensure air bubble is detected
and that the air alarm is properly,indicated
by ~AIR" in the display and is a , ni~d by
a beeping tone alarm.
Clear the alarm. Enter air bubble into
administration set above the pump r- ' ~nir~
for Channel B. Air bubble size must be
greater than 50 to 100 microliters. Ensure
air bubble is detected and that the air
alarm is properly indicated by "AIR" in the
display and is a~ , n i ~ by a beeping tone
alarm.
Memorv Check
,Host Program Prompt:
Remove batteries from pump for 15 seconds.
~ Display should go blank.
Reinstall batteries.
~ , :
W 0 96/06332 ~ 2 1 9 7 8 85 PC~r~US9S/10599 ~
- 38 -
Following completion of the pump self-
test, press the [DISPLAY] key and verify
that the previous program is displayed.
proPer Labels
Host Program Prompt:
Visually inspect to ensure no labels are
damaged beyond use or exhibit excessive
wear.
Visually inspect to ensure the pump has
attached to it all appropriate product
labels in the correct locations. At
minimum, this is to include:
Name Plate Label
Side Logo Label
Operating Instructions Label
Warranty Void Label
Bolus Label
Final Visual InsPection
Host Program Prompt:
Visually inspect the pump to ensure no
scratches, blemishes or other physical
damage has occurred during the course of
testing or was otherwise not noted during
previous inspections.
Ensure all required labels are present
with technician initials and dates where
appropriate.
If appropriate, attach recertification
label.
Documentation ComPlete
Host Program Prompt:
Ensure all required recertification
documents are present.
Ensure all required recertification
documents are correctly and completely
WO 96106332 2 1 9 7 ~ ~ 5 ~ u~ ~
-- 39 --
.~,, ~' .
filled in.
Ensure signatures are in appropriate
areas.
Power U~ on AC Power
Host Program Prompt:
Plug the pump power plug into the power
receptacle on the Test Station. Connect the ground
probe to a chassis grounded conductive part. Turn
the pump power switch on.
In addition to a visual prompt, the host
program 160 may also include a graphic display of
information to instruct the operator in performing
the visual test.
The operator responds to the host program's
prompts individually for each visual test item by
indicating compliance (PASS) or lack of compliance
(FAIL), using either the keyboard 28 or clicking the
mouse 30 to enter information. Preferably, the host
program 160 does not proceed with other tests
categories on the test matrix 162 until the operator
has appropriately responded to all the visual
inspection prompts.
A preferred implementation of the host
program 160 (see Fig. 24A) includes a VISUAL TEST
MENU which displays the visual tests and provides
Fail and Pass Buttons. The operator makes the
selections, as appropriate, by clicking the mouse.
This preferred implementation also provides
a Detail Button (as Fig. 24A shows), which the
operator can click to open a help window (see Fig.
24A). The help window (which Fig. 24B shows for the
Pole Clamp Test) explains to the operator the how
the visual and functional inspection should be
carried out for the particular test. The Host
Program Prompts, listed above, are found in the help
W096/06332 2 1 97885 PCT~S95/10599 ~
- 40 -
windows for their respective test items.
Only if all selected visual inspection test
items receive a PASS response does the host program
160 register a PASS result for the overall visual
inspection test. Otherwise, the host program
registers a FAIL result.
In a preferred implementation, the VISUAL
TEST MENU lists only those tests that can be
accomplished before the pump 20 is either
electrically coupled to or placed in liquid flow
;cation with the test station 14. Tests that
are not ~pPnd~nt upon connection to the test
station 12 include, for example, Test Numbers 1 to
8 and 11 to 21 in the master test listing database
shown in Fig. 13. These tests are preferably
performed at the outset of the test and calibration
~IUC~dUL~, with prompting by the host program 160,
while the pump 20 is free of attachment to the test
station 14. Because of this, after completing all
required tests, the operator can exit the VISUAL
TEST ~ENU without completing any of the re-~ining
tests in the test matrix 162. The host program 160
nevertheless est~hl iCh~c and retains in the log file
database 164 for that pump the results of the
completed visual tests. At a later time, the
operator can enter the host program 162 and resume
the test and certification pLuu~dul~ for that pump,
skipping the visual tests already performed. In
this way, an operator having a limited number of
available test stations can conduct simultaneously
the functional/visual tests on one pump (without
att~, t to a test station) while another pump
(attached to a test station) undergoes testing.
~4) Conducting Liguid conveyance
Tests
~ wos6l06332 2 ~ 9 7885 PCT~S95~10599
- 41 -
To conduct flow rate accuracy tests and
occltlCion ~l~S~ULe tests, the pump 20 must be
coupled in liquid flow ~ ;cation with the test
station 14, as well as must be electrically coupled
to the test station 14.
The host program 160 prompts the operator to
install a primed d; qposAhle administration set 168
intended for the IV pump Z0. In carrying out this
instruction (see Fig. 1), the operator connects the
proximal end of the set 168 to a full solution bag
170 5l~Cr~nd~d above the pump 20 for gravity flow.
The operator connects the male luer at the distal
end of the set 168 to the female luer 64 on the
front panel 66 of the test station housing 36. The
operator also readies the drain tube 82 by routing
it from the test station 14 to a suitable drain
receptacle 172. Preferable, the operator is
prompted to prime the set using about 2 mL of
liquid.
If the pump 20 is AC powered, the operator
will also be prompted to connect the AC power cord
174 of the IV pump 20 to the power outlet 144 on the
front panel 66 of the test station housing 36 (see
the Power Up on AC Power Test, described above). At
the same time, the operator will further be prompted
to connect the ground continuity probe 146 of the
test station 14 to a suitable connection site on the
IV pump 20, such as a ground lug or to the handle or
the IV pole on the stand 22 carrying the IV pump 20.
(a) ~est Station Verification
As Fig. llB shows, at some point before
beginn;ng a prescribed liquid conveyance test, the
host program 160 preferably verifies that the first
~ and second solenoids 54 and 56 in the wet chamber 40
of the test station 14 are functional, not leaking,
~. . . .
21 97885
W096/06332 PCT~S9S/10599
- 42 -
and ready for operation.
With the first solenoid 54 and second
5~1Pnn;~c 56 in their unactivated position (as Fig.
15 generally showsj, the host program 160 prompts
the operator to turn on the pump 20 to convey fluid
into the wet chamber 40. If the load cell 44 does
not sense the expected increase in weight of the
bottle 48, either the first or second solenoids
54/56, or both, are ~L- ' to have failed in their
activated positions.
The host program 160 can direct the test
station microprocessor 132 to supply trouble
shooting information to identify the failure mode
and prompt the operator accordingly. For example,
with minimal pressure sensed by the ~leS~uL~
trAncducPr 70, the host program 160 deduces the
second solenoid 56 as the source of failure. With
high ~L~S~UL~ sensed by the pressure transducer 70,
the host program 160 deduces the first solenoid 54
as the source of failure.
With the first solenoid 54 in its activated
position (as Fig. 16B generally shows), the ~es~uLe
transducer 70 should sense an increase in pressure.
If the ~l~s~uLe trAncd~cPr 70 does not sense this
expected ~L~s~uLe increase, the host program 160
deduces that the first solenoid 54 has failed in its
unactivated position and prompts the operator
accordingly.
When the second solenoid 56 is in its
activated position (as Fig. 17 generally shows),
liquid should drain from the collection bottle 48,
and the load cell 44 should sense a decrease in
weight. If the load cell 44 does not sense this
PYppcrp~ decrease, the host program 160 deduces that
the second solenoid 56 has failed in its unactivated
~ W096~06332 2 1 97 885 P ~ J/J~
-- 43 --
:i Y
position and prompts the operator accordingly.
If~either solenoid 54 or 56 has failed in a
leaky condition, the spill detector element 100 will
sense the ~r esellce of liquid. The test station
mi~Lu,uLUuessor 132 senses this condition and relays
a "liquid leakage" signal to the host program 160,
which alerts the operator.
When these threshold functionality tests
indicate the rPA~inpcs of the test station 14, the
host program 160 proceeds stepwise through the
applicable flow rate accuracy tests and occlusion
pressure tests.
~b~ Flow Rate Accuracy Tests
The host program 160 carries out the flow
rate accuracy tests by operating the pump 20 to
convey liquid of a known specific gravity to the
collection bottle 48 in the wet chamber 40, while
monitoring the change in weight sensed by the load
cell 44 over time.
More particularly, as Fig. 15 shows, with
the IV pump 20 operating, the host program 160
directs the test station mi~LupLocea~uL 132 to
retain the first and second solenoids 54/56 in their
normal, unactivated conditions. Liquid conveyed by
the IV pump 20 flows through the inlet and drain
valve stations 50 and 52 into the collection bottle.
The test station mi~lu~Lucesso~ 132 converts the
analog weight signals received from the load cell 44
during sU~cPccive prescribed sample periods to
digital weight signals. The digital weight signal
from one sample period are compared to the weight
signal for a preceding sample period. By assessing
the change in weight between the sample periods, and
knowing the specific gravity of the liquid being
~u"v~y~d, the host CPU 24 gravimetrically calculates
2 1 9788~
Wos6/~332
- 44 -
a flow rate at the end of successive sample periods
during the test period.
The host program 160 defaults to a
lec 'ed flow rate, an overall test period for
the accuracy test, and a ~c~ ed weight sample
period within the test period. The host program 160
selects these based upon the particular
specifications for accuracy of the IV pump 20
undergoing testing, as set f orth in the test matrix
162 generated for the pump 20. The selected test and
sample periods take into account the flow conditions
encountered during normal use of the particular
pump.
For example, one pump (like a Pharmacia
DeltecTM Model CADD-5800) operates at relatively a
low flow rate of 20mL/hr in normal use. Another
pump (like a Pharmacia DeltecTM Model CADD-5101~F)
operates at a relatively high flow rate of 299 mL/hr
in normal use. The host program 160 requires longer
test and sampling periods for lower flow rates, to
thereby preserve a high degree of accuracy
tPreferably less than 1~) during testing.
Therefore, the preselected test and sample periods
for the lower flow rate pump are longer than the
sPlP~tPd test and sample periods for the higher flow
rate pump. Likewise, the selected test and sample
periods for the lower flow rate pump are longer than
the s~lPcted test and sample periods for the higher
flow rate pump.
Still, the host program 160 preferably
allows, within a reasonably prudent range of
acceptable test and sample periods, the operator to
change the selected test and/or sample period in
his/her discretion.
The host program 160 also defaults to the
W096/06332 ~ 9 ~ PCT~S95/10599
- 45 -
specific gravity of water as the liquid to be used
for the flow rate tests. The host program 160 also
allows the operator to select another liquid (for
~ example, a TPN solution) and alter the specific
gravity according.
- Under the direction of the host program 160,
the host CPU 24 processes the changes in the digital
weight signals during successive sample periods to
gravimetrically calculate the flow rates
periodically throughout the test period.
In the illustrated and preferred e-~ nt
(see Fig. 18), the host CPU 24 uses a "data burst"
~technique to filter multiple digital weight samples
over each sample period. More particularly, the
host CPU 24 takes a prescribed number (n) of digital
weight samples (a "data burst" of n data samples, or
SAMPLE(J), where J = l to n) during each sample
period. Preferably, the bursts are clustered at the
end of the sample period. For example, given a
sample period of about 1 minute, the data burst of
five samples is begun at about the 58th second of
the period. After the five data samples within the
burst are taken (at about 0.5 seconds per data
sample), a new sample period is initiated.
The host CPU 24 then calculates an average
(BURSTAVE) and a standard deviation (8URSTsTD) of the
n samples in the burst. The CPU 24 then compares
each of the n samples (SAMPLE (J), for J = 1 to n)
and rejects a SAMPLE(J) when the absolute value of
BURSTAVE - SAMPLE(J)> SET, where SET = k * BURSTs7D, k
being a preselected value. In the preferred
':';r-pt, k is 1.5.
Upon rejecting one or more SAMPLE(J) within
the burst based upon this criteria, the CPU 24 again
calculates BURSTAVE and BURS~7D for the r~-ining
,, ,
21 97885
PCT~S9s/1~99
Wo ~/06332 ~
- 46 -
samples within the burst (J now equalling 1 to the
value of n minus the number of samples rejected).
The CPU 24 again reviews the remaining samples to
determine whether each meet the selected standard
deviation variance. The CPU 24 continues to reject
samples that fall outside the standard deviation
variance and recalculate a new BURST~VE and BURS~D
for the remainder of the samples, until all samples
remaining the burst meet the standard deviation
variance criteria. BURST~ after such processing is
then used as the weight for calculating flow rate at
the end of each sample periods.
The CPU 24 compares the actual flow rate
data derived during the test period to prescribed
flow rate criteria. The prescribed fl~w rate
criteria are selected based upon the flow rate
accuracy specified by the manufacturer for the
particular pump undergoing testing, which is set
forth in the test matrix 162 (see Fig. 14B). Based
upon this comparison, the CPU 24 determines whether
or not the processed actual flow rate data meets the
criteria established by the manufacturer.
In the preferred embodiment (see Fig. 19),
the CPU 24 makes this determination based upon the
overall accuracy of the IV pump during the test
period. More particularly, to meet the established
criteria, the CPU 24 requires that a prescribed
number of flow rates sampled at consecutive sample
periods during the test period fall within the
manufacture's specified range of accuracy during the
test period. The host program selects the prescribed
number of consecutive samples based upon the set
flow rate during the test period.
Still, the host program 160 allows, within
a window of acceptable values, the operator to
~ 21 9788~
W096/0633~ : .~"~
- 47 -
~. ,
change the, number of flow rate samples required in
his/her discretion.
If'the specified number of consecutive flow
rates sampled during the test period fall within the
range of flow rates specified in the test matrix
162, the host program 160 registers a PASS result.
Otherwise, the host program 160 registers a FAI~
result.
In a, preferred implementation, the host
program graphically displays the flow rate accuracy
test in real time as the test proceeds. Fig. 25
shows a representative graphical display. The
graphical display shows time on the horizontal axis
and percent above and below the accuracy flow rate
set by the test matrix on the vertical axis. The
manufacturer's specified range of accuracy (in
percentage), as also set by the test matrix, is
bounded by horizontal lines extending above and
below the zero percent axis. In Fig. 25, the
specified range of accuracy is plus/minus 5~.
The graphical display in Fig. 25 plots the
interval average as well as the overall average as
a function of time. Fig. 25 shows an 0verall
average of + 1.3% for the test period. The overall
average is also continuously gr~phic~lly displayed
as a floating icon on the right hand side of the
display throughout the test period. In Fig. 25, the
pump achieved a PASS result.
~c) Occl~qion P,ess~e Test3
The host program 160 carrieS out the
occl-lqinn pressure tests by prompting the operator
to simulate an upstream occlusion lbetween the
solution bag 170 and the IV pump 20) and by
operating the test station 12 to simulate a
downstream occlusion (between the pump 20 and the
L~
Wos6/06332 2 1 9 7 8 g5 PCT~S9~1059 ~
- 48 -
patient~. The IV pump 20 must pass both upstream
and downstream occlusion tests to pass the overall
occlusion ~S~ULe tests.
~ a~,aam Occ~-~Qion Tcst
In carrying out the u~a-L~d-~ oc~ cinn tests
(see Figs. 16A and 20A), the host program 160
prompts the operator to clamp the upstream tubing
168 close while the IV pump is operating, thereby
simulating an upstream occlll~in~ (see Fig. 16A).
The operator is prompted to notify the host program
160, either by using the mouse 30 or the keyboard
28, when the occlusion alarm of the pump 20 sounds.
The host program 160 measures the time
interval between the simulated upstream occlusion
TOCCLL~E and the timcA~A~ at which the operator
indicates the alarm has sounded (see Fig. 20A). The
host program 160 compares the measured time interval
TAL~ -TOCCLWE to a prescribed time period TSE~ that the
host program 160 sets according to the
manu$acturer's specification for the IV pump. If the
measured time period falls within the specified time
period, the host program 160 registers a PASS
result. Otherwise, the host program 160 registers
a FAIL result.
~ii) Downstream occlusion Test
In carrying out the downstream occlusion
tests (see Figs. 16B and 20B), the host program 160
prompts the user to operate the pump 20 at a
specified flow rate to convey liquid to the
collection bottle 48 in the wet chamber. The host
program directs the test station microprocessor 132
to activate the first solenoid 54. In this condition
(see Fig. 16B), liquid conveyed by the IV pump 20
cannot flow beyond the inlet valve station 50,
thereby simulating a downstream occlusion. The
~ wos6l06332 2 1 9 7 8 8 5 r~.,u~
operator is prompted to notify the host processing
station, either by using the mouse 30 or the
keyboard 28, when the ocr]u~inn alarm of the pump 20
sounds.
During the simulated downstream occlusion,
liquid pressure builds in the second branch 60 of
the inlet valve station 50, as Fig. 16B shows. The
pressure trAncd~ 70 senses the increasing
pl~S~UL~. The test station mi~,v~lvcessor 132
converts the analog pressure signals received from
the ~L~S~UL~ trAncr~ r 70 to digital signals, which
are sent to the host CPU 24.
During the downstream occlusion, the host
program 160 continuously monitors the y,es~u,~
sensed by the ~L~s~ule trAn~d~c~r ~~ PSENSE- The host
program 160 continuously compares the measured
P - ~S~UL~ PSENSE to a prescribed maximum ~L~sauLe PHAXSET
that the host program 160 sets. PHAXSET can be s y
the host program 160 according to the manufacturer's
specification for the given IV pump, or it can be
set by the host program 160 at a generic value (e.g.
~ 36 PSIG) applicable to IV pumps in general. If any
pressure reading PSENSE sensed during the test
interval set by the host program 160 exceeds the
maximum set for the pump PHAXSET' the host program 160
immediately registers a FAIL result.
If the measured sensed pressure PSENSE does
not exceed the specified minimum pressure PHAXSET
during the test interval, the host program 160
prompts the operator to indicate whether the pump
occlusion alarm sounded during the test interval.
- If the operator provides input that the occlusion
pump alarm did sound during the test period, the
. host program 160 registers a PASS result. However,
if the operator occlusion pump alarm does not go off
W096l06332 2 1 9 7 ~ 83
- 50 -
during the test period, the host program 160
registeres a FAIL result, even when the measured
~ ~ULe PSEUSE does not exceed the specified
minimum pressure PMAXSET during the test interval.
In a preferred implementation, the host
program 160 consolidates the time and pressure
sensing aspects of the test in an intuitive
graphical display, which is presented in real time
as the tests proceed.
Fig. 26A shows a representative graphical
display during the upstream occlusion test. The
display depicts a digital timer that begins at TSET
and counts down to zero. The operator clicks the
PASS button as soon as the occlusion alarm sounds.
If the PASS button is clicked before the time runs
out on the timer, the pump receives a PASS result
for the downstream occlusion test. Fig. 26A shows a
count-down timer originally set at 5:00 minutes.
Fig. 26A shows that the occlusion alarm sounded
within six seconds, the digital timer having counted
down in real time from 5:00 minutes (TSET) to 4:54
minutes.
Fig. 26B shows a companion display for the
downstream occlusion test. The companion display
depicts a pressure gauge showing the instantaneous,
sensed ~LeS~L~ during the test interval. Fig. 26B
shows this sensed pressure to be 30 PSIG, less than
the PSET of 36 PSIG. The display also shows that the
ocrl-l~io~ alarm sounded during the test interval, as
the operator has checked the Pass button next to the
gauge.
Figs. 26A/B show the pump to have passed
both the upstream and downstream segments of
occlusion pressure test.
If the host program 160 registers a PASS
21 97885
WO 96106332
-- 51 --
result for both the upstream and the downstream
ocr~ inn tests, the host program 160 registers an
overall PASS result for the occlusion pLes~u-e
tests. If the host program registers a FAIL result
for either the upstream occlusion test or the
downstream occlusion test, the host program 160
registers an overall FAIL result for the occlusion
P~ ~S~L ~ tests.
Vpon completing the occlusion pressure
tests~ the host program 160 directs the test station
mi~L~Lucessor 132 to deactivate the first solenoid
54 to relieve the simulated downstream occlusion.
~d) Test Station Drain
At some point after completing all liguid
conveyance tests using the test station 14, the host
program 160 directs the operator to turn off and
~ L the IV pump 20 from the test station 14.
The host program 160 directs the test station
mi~Lu~Lucessor 132 to activate the second solenoid
56. In this condition (see Fig. 17), liquid
collected in the bottle 48 drains through the drain
tube 82 into the receptacle 172 provided.
In a preferred Pmho~; nt, the host program
160 uses the load cell 44 to monitor the total
volume of liquid entering the bottle 48 during the
liquid cul,v~y~rlce tests. During subsequent drainage
of the bottle, the host program 160 uses the load
cell 160 to monitor the volume of liquid that drains
from the bottle 48. The host program 160 compares
the volume of liquid that entered the bottle 48
during the tests with the volume of liquid drained
from the bottle 48 after the tests. If the two
volumes do not compare, the host program 160
generates an alert, prompting the operator to open
the access door 112 to the wet chamber 40 and check
-; .
~ .
w096/06332 2 1 9 7 8 8~ ,L~J IC59~
- 52 -
the bottle 48 for residual liquid.
Furthermore, the host program 160 can sense
when the bottle 48 fills during a given liquid
conveyance test by comparing the total volume of
liquid entering the bottle 48 to a preest~hli~hD~
value ~L L ~ ; ng to the safe liquid capacity of
the bottle 48. In this situation, the host program
160 suspends the ongoing test and directs the test
station microprocessor 132 to activate the second
solenoid 56 to drain the bottle 48. Following
drainage, the host program 160 resumes the suspended
liquid conveyance test.
(4) Electrical Safety Tests
The host program 160 carries out the
electrical safety tests, if required by the test
matrix 162 ~see Fig. 11), by directing the test
station microprocessor 132 to operate the relays on
the first circuit board 122 in the dry chamber 42.
The test station mi~Loploces~oL 132 registers a
series of measurements that test ground continuity,
leakage current, and other electrical safety
functions ll -n~D~ or required by UL and/or AAMI.
The test station microprocessor 132
transfers these electrical measurements to the host
CPU 24. The host program 160 compares these
measured values to prescribed values set by the host
program 160 based upon UL or AAMI standards.
The particular electrical aspects of the IV
pump 20 identified for mea~uL~ 3- t during the
electrical safety tests can vary according to the
particular specifications of the pump 20. In the
preferred Dmho~ nt, the aspects that the host
program 160 includes during the electrical safety
tests include:
1. Internal Leakage; AC Off; Reverse
~ W096/06332 ~ 2 1 ~7 8 8 5 PCT~Sg~/loS99
- 53 -
Polarity; No Ground.
2. Internal Leakage; AC Off; Reverse
Polarity; With Ground.
3. Internal Leakage; AC On; Reverse
Polarity; No Ground.
4. Internal Leakage; AC On; Reverse
Polarity; With Ground.
5. Internal Leakage; AC Off; Normal
Polarity; No Ground.
6. Internal Leakage; AC Off; Normal
Polarity; With Ground.
7. Internal Leakage; AC On; Normal
Polarity; No Ground.
8. Internal Leakage; AC On; Normal
Polarity; With Ground.
9. External Leakage; AC Off; Reverse
Polarity; No Ground.
10. External Leakage; AC Off; Reverse
Polarity; With Ground.
11. External Leakage; AC On; Reverse
Polarity; No Ground.
12. External Leakage; AC On; Reverse
Polarity; With Ground.
13. External Leakage; AC Off; Normal
Polarity; No Ground.
14. External Leakage; AC Off; Normal
Polarity; With Ground.
15. External Leakage; AC On; Normal
Polarity; No Ground.
16. External Leakage; AC On; Normal
Polarity; With Ground.
17. Ground Wire Resistance.
If a given measured electrisal value meets
the specified value, the host program 160 registers
a PASS result for that measured electrical value.
. , .
W096/06332 2 ~ 9 7 g ~ 5 1 ~ JII ,~
Otherwise, the host program 160 registers a FAIL
result.
If the host program 160 registers a PASS
result for all measured electrical values, the host
program 160 registers an overall PASS result for the
electrical safety tests. If the host program 160
registers a FAIL result for any one measured
electrical value, the host program 160 registers an
overall FAIL result for the electrical safety tests.
The particular construction, arrangement,
and operation of electrical -I--~s 68 on the
first circuit board 122 to carry out the electrical
safety tests can vary. Figs. 28A and 28B shows a
preferred e-~o~i t.
Fig. 28A shows the relay control signals
generated by the test station mi~ Lo~ssor 132 are
communicated as a digital, eight bit binary code.
The code is first channeled in groups of two through
four optical isolation devices 204(1); 204(2~;
204(3); and 204(4). The devices 204(1)-(4) each
comprises a type HCPL2731 optical isolation device.
Each device converts the received bits of digital
code into light signals emitted by associated LED
sources 206, which are received by sensors 208. The
details of this are shown only for device 204(1),
although all devices 204(1) to (4) are identically
constructed.
The light signals are decoded by two
decoders 208(1) and (2), which are type 74L5138 and
74L5158 decoders, respectively. The decoded signals
are then transmitted to a type UDN2395A relay driver
210. Based upon the (now processed and decoded)
eight bit code it receives, the driver 210 activates
one or more selected relays, which are shown in Fig.
28B.
~ Wos6/0633~ 2 l 9 7 8 8 5
- 55 -
~ ,~
~There are nine relays on the first circuit
board 122, identified in Fig. 28B as RY1 to RY9.
The relays RYl to RY9 are each mr-hAnic~lly linked
to one or more switch element5, numbering fifteen
and designated Sl to S15 in Fig. 28B. The linkage
between a relay and a switch or switches is shown by
dotted lines in Fig. 28B.
As Fig. 28B shows:
Relay RY1 is linked to switch S11.
Relay RY2 is linked to switch S12.
Relay RY3 is linked in tandem to switches
S5 and 56.
Relay RY4 is linked in tandem to switches
S13 and S14.
Relay RY5 is linked in tandem to switches
S9 and S10.
Relay RY6 is linked to switch S15.
Relay RY7 is linked in tandem to switches
S3 and S4.
Relay RY8 is linked in tandem to switches
Sl and S2.
Relay RY9 is linked in tandem to switches
S7 and S8.
Voltage from the power source PS1 enters the
switched circuit shown in Fig. 28B through terminal
TB1, pin 1 (AC Hot); pin 2 (AC Ground); and pin 3
(AC Low), which are controlled by switches S13 (AC
Hot) and 514 (AC Low). The three prong pump plug
outlet 144 (on the front panel 66 of the test
station 12) communicates with the switched circuit
through terminal TBl, pins 4, 5, and 6, which are
controlled by S6; S5; and S11, respectively. Switch
S10 is common to all pins 1 to 6 on terminal TB1.
~ The external ground probe 142 of the test station is
~ -~L~d at terminal J2, pin 2, which is controlled
, ~.
~19~885
W096/06332
- 56 -
by switch 59. The ~, ;ning switches further direct
current flow to carry out the various electrical
tests desired.
As configured in Fig. 28B, relay RY1
controls the open grid. Relay RY2 controls power
on/off. Relay RY3 controls reverse polarity. Relay
RY4 controls power on activate. switch RY5 controls
the selection between resistance and leakage
testing. Switch RY6 control internal (test station)
and external (pump) electrical testing. Switch RY7
controls the leakage signal. Switch RY8 controls
the yround resistance signal. Switch RY9 controls
the line voltage signal.
The relay driver 210 provides signals to
activate the relays RY1 to RY9 alone or in groups to
conduct the various electrical safety tests as
follows:
TST RY RY RY RY RYRY RY RY RY
2 3 4 S 6 7 8 9
I X
2 X X X
3 X X X X
4 X X X X
X X X X X
6 X X X X
7 X X X X X
8 X X X X X
9 X X X X X . X
X X X X
11 X X X X X
12 X X X X X
21 97885
P~ J555110599
Wos6l06332
- 57 -
l3 x x x x x x
14 x x x x x
lS x x x x x x
l6 x x x x x x
517 x x x x x x x
l8 x x
19 X X
x
2l
KeY to Tests bY Test Number
1. Ground Resistance
2. External Leakage, AC on, Normal
Polarity, Normal Ground.
3. External Leakage, AC on, Normal
Polarity, Open Ground.
4. External Leakage, AC off, Normal
Polarity, Normal Ground.
~ 5. External Leakage, AC off, Normal
Polarity, Open Ground.
6. External Leakage, AC on, Reverse
Polarity, Normal Ground.
7. External Leakage, AC on, Reverse
Polarity, Open Ground.
8. External Leakage, AC off, Reverse
Polarity, Normal Ground.
9. External Leakage, AC off, Reverse
Polarity, Open Ground.
10. Internal Leakage, AC on, Normal
- 30 Polarity, Normal Ground.
11. Internal Leakage, AC on, Normal
Polarity, Open Ground.
12. Internal Leakage, AC off, Normal
21 978~
W096l06332 PCT~S95ll0599
- 58 -
Polarity, Normal Ground.
13. Internal Leakage, AC off, Normal
Polarity, Open Ground.
14. Internal Leakage, AC on, Reverse
Polarity, Normal Ground.
15. Internal Leakage, AC on, Reverse
Polarity, Open Ground.
16. Internal Leakage, AC off, Reverse
Polarity, Normal Ground.
17. Internal Leakage, AC off, Reverse
Polarity, Open Ground.
18. Flow Rate Testing, AC to outlet 144
on.
19. Pressure Testing, AC to outlet 144
on.
20. AC line check, AC to outlet 144 off.
21. Ground to Neutral Line Check.
In the above table, a given relay with an
open box (without an "X") indicates that the switch
or switches associated with the relay are in the
position shown in Fig. 28B. A given relay with a
filled box (with an "X") indicates that the relay is
activated and the switch or switches associated with
the relay occupy the alternative position shown in
Fig. 28B.
~5) The Score Card
In a preferred implementation, the host
program 160 provides a graphical scorecard (see Fig.
27) presenting the PASS/FAIL results for each
category of test and the overall PASS/FAIL result.
In Fig. 27, a check mark indicates a PASS result,
while an "X" indicates a FAIL result. By clicking
on a given test category, the host program displays
the detailed test information for that category.
By ~ king the Print button, the host
-
~ WO 96/0633~ 2 1 9 7 ~ ~ 5 PCT/US9~i/10599
-- 5 9
program 160 generates either Pump Certification
Report (see Fig. 21) (if the pump received an
overall PASS result) or a Pump Failure Report (see
Fig. 22) (if the pump received an overall FAIL
result, as the pump in Fig. 27 did). The host
program 160 also generates and prints the Detailed
Test Result Report (Figs. 23A/B).
C. Test Station Calibration
As Fig. llB shows, the host program 160
periodically prompts the operator to calibrate
certain liquid mea~ L and electrical c _ne"Ls
of the test station 14. The period of time between
these calibrations can vary. It is presently
believed that host-prompted calibration of the test
station 14 should occur every day of use.
The ~( ~nts in the test station 14
selected for periodic calibration can vary. In the
illustrated and preferred ~mho~lir t, the load cell
44, the ground probe 146, and electrical components
of the test station 14 are periodically recalibrated
at the prompting of the host program 160.
~ ~1) Load Cell Ree~lihration
To carry out a recalibration of the load
cell 44, the host program 160 prompts the operator
to open the access door 112 to the wet chamber 40.
The host program 160 directs the test station
mi~.~Lucessor 132 to transmit the load cell reading
with the bottle 48 empty.
The host program 160 then prompts the
operator to remove weight Wl from the bracket 118 on
the door and place it on the empty bottle 48. In
the illustrated and preferred embodiment, this
weight Wl is 100 gr. The host program 160 directs
: the test station microprocessor 132 to transmit the
load cell reading with the 100 gr weight present on
i 21 97885
W096/06~2 ~ PCT~S95/10599
- 60 -
the empty bottle 48.
The host program 160 then prompts the
operator to place the other weight W2 from the door
bracket 118 and place it on the first weight Wl on
empty bottle 48. In the illustrated and preferred
~ L, this second weight W2 is 25 gr. The host
program 160 directs the test station miuLu~-ocessuL
132 to transmit the load cell reading with the 125
gr weight present on the empty bottle 48.
The host program 160 linearly interpolates
the load cell readings for the three weight values
-- zero, or tare weight, for the empty bottle 48;
the 100 gr weight on the bottle 48; and the 125 gr
weight on the bottle 48. The host program 160 uses
the zero (tare) weight and 100 gr readings, along
with the assumption of a linear output among all
three readings, to mathematically adjust the load
cell readings during subsequent tests.
The host program 160 preferably establishes
a range for calibrated weight readings. Should the
calibration weight readings fall outside the
es~hl;~h~d range, the host program 160 prompts the
operator that the load cell 44 requires servicing.
Upon completi~g load cell recalibration, the
host program 160 prompts the operator to return the
weights W1 and W2 to the door bracket 118.
Before conducting any subsequent flow rate
accuracy tests (described above), the host program
160 queries the test station microprocessor 132 to
sense the tare weight to ensure that the collection
bottle is in place on the load cell 44 and the
calibration weights W1 and W2 have been removed.
t2) Electrical Safety Tests
With the access door 112 to the wet chamber
40 open, the host program 160 prompts the operator
2 1 q 7 8 85 Pcr/usgsllo599
W096l06332
-
- 61 -
to connect the ground continuity probe 146 to a
selected one of the resistance studs Sl mounted in
the wet chamber 40 on the dividing plate 38. One
stud S1 has a known resistance of zero ohms, while
the other stud S2 has a known resistance of a
different value (e.g., 1 ohm).
The host program 160 directs the test
station microprocessor 132 to perform a ground
resistance test using the known resistance of the
stud S1 to which the ground probe 146 is attached.
The host program 160 directs the test station
microprocessor 132 to perform a ground resistance
test. The microprocessor 132 should output a ground
resistance value of zero ohm.
The host program 160 then prompts the
operator to connect the ground probe 146 to the
other stud S2. Again, the host program 160 directs
the test station microprocessor 132 to perform a
ground resistance test. The microprocessor 132
should output a ground resistance value of one ohm.
If either output does not match the expected
resistance value, the host CPU 32 alerts the
operator that calibration of the test station by a
service technician is required.
When the test station calibration tests are
successfully completed, the host program 160 prompts
the operator to disconnect the ground continuity
probe 146 from the test studs S1 and S2 and to close
the access door 112 to the wet chamber 40.
III. THE DATA R~irOK~l~lG STATION
The host CPU 24 processes the acquired raw
data and the PASS/FAIL results for each IV pump
tested. The CPU 24 stores this information in the
log file database 164. The host CPU 24 also
3~ transmits this processed data to the data reporting
21 978ûs
WO g6,06332
PCT/US95/1059g
- 62 -
station 16 for printing the in form of reports.
A. The Pump Pass/Failure Report
If the IV pump receives a PASS result in all
applicable visual inspection tests, flow rate
accuracy tests, occlusion pressure tests, and
electrical safety tests, the host CPU 24 generates
and sends to the data reporting station from
printing a Certification Report for the IV pump in
the form shown in Fig. 21. As Fig. 21 shows, the
Certification Report includes a preprinted label
that can be attached;to the IV pump indicating its
certification and that date of certification.
If the IV pump receives a FAIL result in
some or all applicable visual inspection tests, flow
rate accuracy tests, occlusion pressure tests, and
electrical safety tests, the host CPU 24 generates
and sends to the data reporting station a Pump
Failure Report for the IV pump in the form shown in
Fig. 22.
B. The Detailed Test Result Report
Both the Certification Report and the Pump
Failure Report are accompanied by the Detailed Test
Results Report in the form shown in Figs. 23(a) to
(d). The Detailed Test Results Report lists for
each applicable visual inspection tests, flow rate
accuracy tests, occlusion pressure tests, and
electrical safety tests, the PASS/FAIL results, with
the associated raw data supporting the result. when
appropriate.
For an IV pump receiving the Pump Failure
Report, a review of the associated Detailed Test
Results Report pinpoints the areas where performance
failed to meet established criteria. It therefore
simplifies subsequent trouble shooting and repair by
an qualified service representative.
~ WO96l0633~ 2 1 9 7 8 8 5 A ~ I / ~ ~ tt A C ~ ~
- 63 -
.,
C. Consolidated Database RePorts
The log file database 164 is a relational
database. It offers the operator the flexibility of
generating a diverse number of reports, presenting
the data in the database 164 in different ways.
By way of example (see Fig. llC), the host
program 162 can generate various types of
certification reports, in letter, listing, summary,
or ~PtA;lPd form. Also by way of example, the host
program 162 can generate various types of database
reports, such as all or any selected part of the
pump log files, e.g., individually, by manufacturer,
or by alpha-numeric designation.
Drawing upon the host usage database 166 in
the same manner, the host program 160 can generate
diverse types of accounting reports relating to the
use and performance of the system lO.
Various features of the invention are set
forth in the following claims.
