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Rx Only. Refer to m
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For the safe
manufacturer
D
ter’s S
Master
and proper u
rs' full Prescri
DESK RE
SIGMS
r DrugVe
use of this de
ibing Informa
EFEREN
A SpeSysteg Librersion
evice, refer to
ation for Dobu
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fusion
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or’s manual.
n
USMP/361/14‐0079 09/14 Page 2 of 47
The SIGMA Spectrum Infusion Pump is a Smart Pump. A Smart Pump system has software that allows your facility to create drug libraries with dose limits that can alert users to potential programming errors commonly referred to as DERS (Dose Error Reduction System). The Master Drug Library is intended to be used for the controlled administration of drugs, blood, blood products, and mixtures for required patient therapy. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, epidural or irrigation of fluid space.
The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas. Reference Guide for:
SIGMA Spectrum Infusion System Master Drug Library (MDL) Software. The Master Drug Library (MDL) is a MICROSOFT WINDOWS computer‐based software program that is used to configure a facility‐specific Drug Library. The software generates a Drug Library file that is transferred to a SIGMA Spectrum Infusion Pump. The development of a Drug Library is the first step in implementing a Dose Error Reduction System (DERS) to be used with the SIGMA Spectrum Infusion Pump.
See Master Drug Library User Manual for complete instructions including all Warnings and Cautions.
USMP/361/14‐0079 09/14 Page 3 of 47
Contents Main Display Screen ......................................................................................................................... 4 Creating a New Drug Library ............................................................................................................ 6 Configuring Care Area ...................................................................................................................... 7 Add new Continuous Drug ............................................................................................................... 9
Fixed Concentration ......................................................................................................... 10 Variable Concentration .................................................................................................... 11 mL mode concentration ................................................................................................... 12 Standard Concentration ................................................................................................... 13 Primary Only, Multi‐step .................................................................................................. 14 Cyclic TPN ......................................................................................................................... 15
Add new Amount/Time Drug ......................................................................................................... 16 Fixed Concentration ......................................................................................................... 16 Variable Concentration .................................................................................................... 17 mL mode concentration ................................................................................................... 18 Standard Concentration ................................................................................................... 19 BSA Dose Mode ................................................................................................................ 20 Line Flush ......................................................................................................................... 21
Drug Configurations ....................................................................................................................... 22 Continuous Drugs ............................................................................................................. 23 Amount/Time Drugs ......................................................................................................... 25
Clinical Advisories ........................................................................................................................... 26 Applying Clinical Advisory to Drug ................................................................................... 27
Modifiers ........................................................................................................................................ 29 Assigning Modifiers .......................................................................................................... 29
Master List ...................................................................................................................................... 33 Clinical Advisory Master List ............................................................................................ 33 Modifier Master List ......................................................................................................... 34
Managing Drug Setup ..................................................................................................................... 35 Copy Drug Setup .............................................................................................................. 35 Unlink Drug Setup ............................................................................................................ 36 Delete Drug Setup ............................................................................................................ 36
Managing Care Areas ..................................................................................................................... 37 Copy Care Area ................................................................................................................. 37 Delete Care Area .............................................................................................................. 38 Rename Care Area ........................................................................................................... 39
Pump Configurations ...................................................................................................................... 39 Keypad Lock Code ............................................................................................................ 39 Wireless Options .............................................................................................................. 40
Reports ........................................................................................................................................... 41 Drug Library Report .......................................................................................................... 41 Audit Report ..................................................................................................................... 42
Create File for Pump ....................................................................................................................... 43 Transferring Drug Library to Pump – IrDA method ........................................................................ 45 Appendix A – Parameters/Settings ................................................................................................ 47
as
US
M
T
To
Care AreUp to 32 Care
Dru
Up to 5000 Drugs for entir
L
Displays list ofssociated with thArea highlighted
Care Ar
MenTo
Linked Drug
C
SMP/361/14‐00
Main Displa
he Master D
• Securit• Creatio• Up to • Assign• Config• Suppo• Suppo• Standa
oolbar icons
Applies
ea List Areas
ug List
unique e Drug Library
f drugs e Care
d in the rea List
nu Bar oolbar
Drug Library
Refer
g icon
Open Drug L
C
79 09/14
ay Screen
Drug Library
ty roles to deon of up to 325000 unique ment of up toguration of uprt for up to 5rt for up to 4ard and custo
s to Continuou
y Name
to manufacturers’ fu
Library
Save Drug Libra
Del
(MDL) softw
esignate full o2 Care Areasdrugs per Dro five modifiep to five conce00 modifiers
400 clinical adomized report
us Drugs only
Clinical Adviso
ull Prescribing Inform
ary Add new d
lete concentration
ware feature
or limited acce
ug Library ers per drugentrations pe dvisories ting
Drug Namory
mation for Amiodaron
rug
n Configure Dr
Generate D& File fo
AT
es the follow
ess to a Drug
er drug or mo
Applies to Am
meDelivery
ne Injection
rug
rug Report or Pump
Open Files ffold
Lib
wing:
Library
odifier
mount/Time D
DruPar
DruConUp Dru
ModUp
y Mode
for Pump er
brary Information
MDL Help me
Drugs Only
ug rameters
ug ncentrations to 5 per
ug or Modifier
difiers to 5 per Drug
enu
Page 4 of 47
USMP/361/14‐0079 09/14 Page 5 of 47
Master Drug Library Administrators (MDLAs) should verify the correct Drug Library is installed when deploying the Drug Library to Pumps. Before implementation, clinical users at each facility must thoroughly test and validate their Drug Library per their facility's procedure to ensure configuration and workflow reflects clinical practice.
US
C
E
SMP/361/14‐00
Creating a N
Select
Enter
1
2
3
Enter Care
79 09/14
New Drug
t File > New
Drug Libra
Area(s) an
Library
w
ary File Na
d click <Add
ame and clic
d>
ck <Save> tto continue
4
Page 6 of 47
US
C Se
C SMP/361/14‐00
Click <
Configuring
Select
elect
Care Area >
4
1
2
79 09/14
<Apply> to
g Care Area
t the desired
> Configure
save the Ca
a
d Care Are
e Care Are
are Areas en
a from the C
ea
ntered
Care Area lis
st
3
Page 7 of 47
US
SMP/361/14‐00
3
4
Downstre
HIGH MEDIUM LOW Priming VDefault vathe volumtubing. Only appliduring init
79 09/14
eam Occlusion P
131 kPa ±6289 kPa ±41 k41 kPa ±27 k
Volume (range 0alue is blank. Adjme (mL) used to m
icable for Amoutial programmin
Pressure Default
2 kPa (19 psi ±9 pkPa (13 psi ±6 pskPa (6 psi ±4 psi)
0.5 mL – 30 mL)just parametersmanually prime
nt/Time primarng and IV set loa
Enter Wwhere
Check
Value
Selec
Entepara
Click the C
Weigh 0.1 kg
BSA Li0.1 m
Setting
psi) si) )
based on the IV
ry infusions ad and
Weight ande applicable
Require We Confirma
ct Settings
er and/or seameters an
<OK> to saCare Area co
ht Limit Range g – 500 kg
imit Range m2 – 4 m2
back ye
Pump thi
Adjust Aand
primi(
Critic
cefTRIAXo2 grams/50 m
Pump pr
d BSA limit
Weight/BSAation, if req
tab
elect desirnd settings
ave and comonfiguration
edites no
will not infuses amount !
Amount, VTBI,d Time forng volume ?(15 mL)
al Care Adult
onemL
rogramming
ts,
A quired
ed s
mplete n
Page 8 of 47
US
A
Cod
SMP/361/14‐00
Add new Co
ontinuous: Tiscontinued o
Select
Enter
1
2
79 09/14
ontinuous
he IV therapyor the volume
t the desired
OR
Clic
Drug Nam
Drug
y continues toe to be infuse
d Care Area,
ck on the
me in the hig
o infuse at a sd has been co
, then select
icon on t
ghlighted fie
set dose rate ompleted
t Drug > Ad
the toolbar
eld
DruUp
Firsalp
until the infu
dd Drug
ug Name to 20 character
st 2 characters mhabetic.
usion is
rs allowed.
must be
3
Page 9 of 47
US
C
SMP/361/14‐00
Fixed
Selec
3
79 09/14
d Concentr
ct and ente
P
ration
er parame
ump Screen
ters
Cl
se
Bolus anDose
Soft Limi
lick <Apply
elect Continuo
e
nd Loading e option
it Alert H
y> to save
ous
select Del
enter concentr
select Dose M
enter Dose Lim
Hard Limit Alert
livery Bag
ration
Mode
mits
Page 10 of 47
US
C
SMP/361/14‐00
Varia
Select
Pump Scr
Variable cduring pu
Concentr
4
79 09/14
able Conce
t Variable i
reens
concentratioump program
ration Limits m
5
Cucopr
Dr
entration
in the conce
n drugs requming.
may be config
00 mg/250 mL
g/0 mL
ursor to the desiredoncentration andress OK
Critical Care Adult
rug X
0
entration fie
ire the clinicia
gured in the D
t
clear
500 mg/250 m
250 mg/
Cursor to the concentrationpress OK
Critical
Drug X
25
Bolus and LoDose opt
eld
an to enter th
Drug Library,
mL
mL
desiredn and
Care Adult
0
clear
Cucopr
Dr
52
se
oadingtion
he Drug Amo
if applicable.
ursor to the desiredoncentration andress OK
Critical Care Adult
rug X
500 mg/250 mL250 mg/250 mL
CONFIRM CONC
Is Drug X250 mg/250 mL
the correct drug?
noyes
elect Variable
select conc
enter conc
select Dose
enter Dose
ount and Volu
.
t
c units
limits
Mode
Limits
Page 11 of 4
ume
7
US
C
SMP/361/14‐00
mL m
Select
Pump
The mdeliver
Cr
Drug X
Cursor tconcentpress O
mL/hr m500 mgVariabl
5 C
79 09/14
mode conce
mL mode
p Screens
L mode is usered using volu
itical Care Adult
to the desiredtration and
OK
modeg/250 mLe
back
entration
in the conce
ed for drugs tume flow rate
Critical Care
Drug X
Cursor to the desirconcentration and press OK
mL/hr mode500 mg/250 mLVariable
back
ntration field
that do not rees.
Adult
red Cursor concenpress O
Cr
Drug X
500 mg250 mg
C
t
Bolus andDose o
d
equire a conc
to the desiredntration andOK
ritical Care Adult
/250 mL/250 mL
CONFIRM CONC
Is Drug XmL/hr mode
the correct drug?
noyes
se
sel
d Loading option
centration val
Primary Bag
Drug X
clearprogram
Rate mL/hr
VTBI mL
Time hr:min
Total given mL
Critical Care
elect mL mode
lect Dose Mod
enter limits
ue and are
g
clear rate
0
000:00
0
e Adult
e
de
Page 12 of 47
US
C
SMP/361/14‐00
Stand
Enter C
Pump
ConceDiluenvolum
Crit
Drug X
Cursor toconcentrpress OK
mL/hr m5 mg/mL500 mg/Variable
6
79 09/14
dard Conce
Concentra
p Screens
ntrations cannt Volume vae of 1 mL.
tical Care Adult
o the desiredration and K
modeL/250 mLe
back
entration
ation value
n be entered alues entered.
Critical Care A
Drug X
Cursor to the desireconcentration and press OK
mL/hr mode5 mg/mL500 mg/250 mLVariable
back
e in concentr
as a Standard. Standard co
Adult
ed Cursor tconcentpress OK
Cri
Drug X
500 mg/2250 mg/2
CO
th
Bolus anDose
ation field
d Concentratincentration i
to the desiredration andK
tical Care Adult
250 mL250 mL
ONFIRM CONC
Is Drug X5 mg/mL
he correct drug?
noyes
e
se
e
nd Loading option
ion with no Ds any drug am
Primary Bag
Drug X
clearprogram
Rate mL/hr
VTBI mL
Time hr:min
Total given mL
5 mg/mL
Patient Weight kg
Dose mcg/kg/min
Critical Care A
enter conc valu
elect Dose Mod
nter Dose limi
Drug Amountmount with a
clear weight
0250
00:00
0
00
Adult
ue
de
its
Page 13 of 4
or
7
US
C
SMP/361/14‐00
Prim
Select
Pump
Step 1 pr
Multi‐individmust b
Drug Z
clearprogram
Rate mL/hr
VTBI mL
Time hr:m
Total given
20 grams/2
Patient WeDose mL/k
1 2 3
Critical Car
7
79 09/14
ary Only, M
t Primary O
Screens
rogramming
‐step mode adual infusion be within the
clear weight
r 00
in 00:00
n mL 0
00 mL
eight kg 0kg/hr 0.5
3 4 5 6 7 8 9 10
re Adult
Multi‐step
Only, Mult
Step 1 complete
llows the drurate steps. AuDrug Library
p
ti‐step Deliv
Step 2 pr
g to be progrutomatic trandefined dose
very Bag
rogramming
rammed on thnsition occurse rate limit.
Select Prima
Step 3 programm
he Pump withs between ea
ary Only, Multi
Complete allparameters
ming
h up to 10 ch step. Each
i‐step
Page 14 of 4
h step
7
US
PPr
RU
Cyauthin
T
cpro
Pr
To
VT
C
SMP/361/14‐00
Cyclic
Select
ump Screensrogramming scree
UN screens
yclic TPN delutomatic ramhe delivery ranfusion. Cycli
TPN
clearogram
rog Time hr:min
otal given mL
TBI mL
Critical Care Adul
8
79 09/14
c TPN
t mL mode
s ens
ivers TPN (Tomp‐up infusioate at the staric TPN is only
clear VTBI
00:00
0
0
lt
TPN
clearprogram
Prog Time h
Total given m
VTBI mL
Critica
Press OK t
e Concentrat
otal Parenteran rate to a mrt of an infusiy available wh
clear time
r:min 12:00
mL 0
1000
l Care Adult
12hrs 00mins
to confirm time
tion, then se
al Nutrition) oain rate befoon and decrehen configuri
elect Cyclic
over a prescriore tapering deases the delivng a Continu
se
s
E
Ram10 raconsthe ttime MainThe rate80%time Tape10 tastepsremathe ttime
TPN Dose
bed period odown. This prvery rate at t
uous Infusion
elect mL mode
select Cyclic TP
nter volume li
Enter time lim
mp Up amp‐up steps sisting of 10% oftotal infusion e
n Step main delivery accounts for of the infusion
e
er Down aper‐down s for the aining 10% of total infusion e
Mode
f time in an rocess increasthe end of the Drug.
e
PN
imits
mits
f
Page 15 of 4
ses e
7
US
A Aov
A
SMP/361/14‐00
Add new A
Amount/Timever a set dura
Fixed
Select
Selec
Pump
AmouAmoun
1 AT
79 09/14
mount/Tim
e: An IV drug tation of time
d Concentr
t desired Ca
ct and ent
Screens
Prog
nt Limits andnt/Time deliv
me Infusio
therapy presc
ration
re Area, the
er parame
gramming screens
d Dose Modevery mode.
Max
on Drug
cribed as a to
en select Dru
eters
s
options do n
s
Line Flush vol
otal dose amo
ug > Add D
not apply for F
select Amount
en
ume
ount complet
Drug
Fixed Concen
t/Time
select Delive
nter concentra
enter Time Duration Limi
tely administe
ntration drugs
ry Bag
tion
ts
Page 16 of 4
ered
s for
7
US
A
SMP/361/14‐00
Varia
Select
Pump
VariabVolum
Dose M
Conce
Line Flin the 20
2 AT
79 09/14
able Conce
t Variable i
Screens
ble concentrame during pum
Mode option
ntration Limi
lush ‐ The LinIV container
entration
in the conce
ation drugs remp programm
s include Non
its may be co
e Flush featuat the compl
entration fie
equire the clinming.
n Weight‐Bas
onfigured in th
ure on the pumletion of an A
Max Line Flus
eld
nician to ente
sed, Weight‐B
he Drug Libra
mp allows deAmount/Time
sele
sh volume
er the Drug A
Based and BS
ary, if applicab
elivery of any e infusion. Se
ect Variable
select conc un
enter conc li
select Dose M
enter limit
mount and
SA
ble.
residual volue Line Flush, p
nits
mits
Mode
ts
Page 17 of 4
ume page
7
US
A
SMP/361/14‐00
mL m
Select
Pump
The mdeliver
Dose M
3 AT
79 09/14
mode conce
mL mode
Screens
L mode is user a volume ba
Mode option
entration
in the conce
Enter Amount val
ed for drugs tased amount
s include Non
ntration field
lue (mL) VTBI po
that do not ret over set tim
n Weight‐Bas
Max Line Flu
d
opulates automatic
equire a concme duration.
sed, and Weig
sele
se
sh volume
cally
centration val
ght‐Based
ect mL mode
elect Dose Mod
enter Limits
ue. This is us
de
Page 18 of 4
sed to
7
US
A
SMP/361/14‐00
Stand
Enter C
Pump
For drVolum
Duringbased
Amou
4 AT
79 09/14
dard Conce
Concentra
Screens
ugs where thme are availab
g pump progron the stand
nt limits can
entration
ation value
Enter Amount va
e concentratble.
ramming, clinard concentr
be defined o
e in concentr
alue VTBI i
ion is fixed, h
nician enters tration value.
r Dose limits
Max Line Flush
ation field
s calculated
however no sp
the Amount.
for weight‐b
e
se
h volume
pecified Drug
The VTBI is
based and BSA
enter conc valu
elect Dose Mo
enter limits
g Amount and
auto‐calculat
A based dose
ue
de
Page 19 of 4
d
ted
e
7
US
A
SMP/361/14‐00
BSA D
Select
Pump
BSA baStanda
5 AT
79 09/14
Dose Mod
t Variable i
Screens
ased dose moard concentra
e
in the conce
odes are onlyation or Varia
entration fie
y available witable concentr
eld
th Amount/Tration.
S
co
e
Time program
elect Variable enter standardncentration va
enter conc limi
select BSA
enter limits
mming with
or d alue
its
Page 20 of 47
USMP/361/14‐0079 09/14 Page 21 of 47
Line Flush The Line Flush feature allows delivery of any residual fluid volume in the IV container of a primary or secondary Amount/Time infusion at the end of an infusion. The Max Volume Limit per Line Flush allows a user to configure the maximum volume of fluid allowed per line flush.
The clinician may repeat the Line Flush function up to 3 times on the pump. Line Flush infuses at the same rate as the last programmed infusion rate.
Pump Screens
Primary infusion complete Line Flush option Enter residual volume Line Flush running
Secondary Infusion complete Line Flush option Enter residual volume Line Flush running
Critical Care Adult
1 mL/hr KVO
Press STOP
INFUSION COMPLETE
Critical Care Adult
1 mL/hr KVO
Press STOP
INFUSION COMPLETE
silence
1 mL/hr KVO
clearprogrambolus review options clearprogrambolus review/
program options
20 grams/200 mL
30 g/ mL
clear
LINE FLUSH
Would you liketo flush the
PRIMARY line?
noyes
silence
SECONDARYCOMPLETE
Critical Care Adult
Infusing at1 mL/hr KVO
Press STOP
US
D DCItan
SMP/361/14‐00
Drug Config
rug Configuraoncentrationt is recommennd values sho
Select
Select
1
2
79 09/14
gurations
ations are set. The MDL snded that theould be custo
t the desired
t Drug > Co
ttings which moftware provese be reviewomized where
d Drug and
onfigure D
may be custovides default vwed for all dre appropriate
d Concentr
rug
mized for eacvalues for Druugs and conce.
ration
ch individual ug Configuratcentrations in
Drug and tion settings. n the Drug Lib
3
Page 22 of 4
brary
7
US
C
SMP/361/14‐00
Cont
Error Enter
Note: • • • •
3 C
Pump
79 09/14
inuous Dru
Prevention desired Sing
Settings mayCurrent druAll concentAll drugs in(set at 500
Screen
ugs
gle Step Rat
y be applied toug and concetrations for th the Drug Lib
0% in Anesthe
te Change –
o: ntration he drug rary esia and OR
SingfeatuDosegreaavaildrug
DefaConf The autodecrpercup toincredecr
Infusion R
Care Areas)
le‐Step Rate Chaure is designed te or Rate increaster than intendelable for Contings.
ault setting is 10figurable range
Infusion Rate Deomatically adjustrease of the progcentage. The deco 99% of the proease percentagerease cannot be
Rate Increa
ange to prevent any se or decrease ed. This is only uous infusion
01% 20% ‐ 500%
ecrease field ts to a fixed 50%grammed increacrease will adjusogrammed e. The 50% changed.
ase %
% ase st
Page 23 of 47
US
C
SMP/361/14‐00
Alarm
Selectparam
4 C
79 09/14
ms
t the desire meter
settings for
each
Audio LeApplies Air In LinOcclusioClamp CComplet
Bag NeaThis alarinfusiondrug hasprogram
CompleAn audiorequire of a secobolus doavailableContinu
UpstreaAllows tUpstreaprogramavailableperformupstreashould ndrugs wundetecthat of fupstreaOnly useSuspensobserve
evel Alarm to the followingne; Max Air Deteon; DownstreamClosed; KVO; Bagtion
ar Empty Alarm rm is available fon drug. Alarm tons less than 30 mmmed volume re
tion Alarm o tone will sounacknowledgemeondary infusion,ose. The Complee for a drug thatous infusion wit
am Occlusion Alathe clinician to sam Occlusion Alammed infusion. e after a Check F
med on the seconm occlusion alarnot be used whewhere the risk of cted upstream oflow interruptionm occlusion alare Upstream Occsion after the opes positive line fl
g alarms: Inactivected; Upstream
m Occlusion; Slideg Near Empty;
or any Continuone will sound wh
minutes of emaining
d, but does not ent at the comp, loading dose oetion Alarm is not is specified for th cyclic TPN
arm Suspensionuspend the arm for the curreThis option is Flow confirmationd consecutive rm. This suspensen delivering critflow stoppage d
occlusions outwen due to false rms. lusion Alarm perator visually ow.
Page 24 of 4
ity; m e
ous hen a
letion r ot
n
ently
on is
sion tical due to eighs
7
US
A
SMP/361/14‐00
Infusi
Enter/
Amo
Alarm
Selectparam
4 C
1 AT
79 09/14
on Options
/select desir
unt/Time
ms
t desired setmeter
re settings f
Drugs
ttings for ea
for each para
ach
KVOTherangspePrimAt tinfuKVOin thinfuAt tinfuthe
DelThemay12 hdur
AudAppAir OccClamCom
BagNot
ComAn reqof abol
UpsAlloUpsproavaperups
ameter
O Rate (Keep Vee KVO rate may bging from 0.5 – ecific Drug and Cmary Infusions.the completion usion, the PumpO Rate configurehe Drug Library usion rate, whichthe completion ousion program, tfixed KVO Rate
ayed Run e start of a progry be delayed frohours. The delaring initial pump
dio Level Alarmplies to the folloIn Line; Max Airclusion; Downstrmp Closed; KVOmpletion
g Near Empty Alt available for Am
mpletion Alarmaudio tone will suire acknowledga secondary infuus dose
stream Occlusioows the clinicianstream Occlusioogrammed infusiailable after a Chrformed on the sstream occlusion
ein Open) be configured, 50 mL/hr for a
Concentration fo
of a primary p will infuse at thed per drug or the current hever is lower. of a secondary the Pump will ruof 1 mL/hr.
rammed infusionom 1 minute up ay time is entere programming.
owing alarms: Inar Detected; Upstream Occlusion;O; Bag Near Empt
larm (primary omount/Time dru
sound, but doesgement at the cusion, loading do
on Alarm Suspenn to suspend then Alarm for the ion. This optionheck Flow confirmsecond consecutn alarm.
r
he
un at
n to ed
activity; tream ; Slide ty;
nly) ugs
s not ompletion ose or
nsion e currently is mation is tive
Page 25 of 47
US
C CdinA
A
SMP/361/14‐00
Infusi
Enter/
Clinical Adv
linical advisorug is selectenformation pr Clinical Advis
Select
2 AT
1
79 09/14
on Options
/select desir
visories
ries are facilitd on the Pumrior to prograsory may be a
t Master Li
red settings
ty‐defined temp. These briemming a druapplied to on
ist > Clinica
for each pa
ext descriptioef text descripg. e or more dr
al Advisor
KVOThe rangspecPrimAt thinfuKVOin thinfus
DelaThe may12 hduri
arameter
ons that appeptions may b
ugs.
ies
O Rate (Keep VeiKVO rate may bging from 0.5 – 5cific Drug and Comary Infusions. he completion osion, the Pump
O Rate configuredhe Drug Library osion rate, which
ayed Run start of a progray be delayed fromhours. The delayng initial pump
ar in a pop‐ue used to pro
in Open) be configured, 50 mL/hr for a oncentration for
of a primary will infuse at thed per drug or the current hever is lower.
ammed infusionm 1 minute up ty time is enteredprogramming.
p window whovide addition
r
e
n to d
2
Page 26 of 4
hen a nal
7
US
SMP/361/14‐00
Enter
Enter provid
Click <
Click <List
Apply Select
2
3
79 09/14
the desired
the contentded (2)
<Add> (3) to
<Apply to
ying Clinic
t symbo
d Clinical Ad
t for the Clin
o add this to
Master Lis
cal Advisor
ol to the left
dvisory Na
nical Advisor
o the Clinica
st> (4) to sa
ry to Drug
t of the Drug
ame in the
ry in the Ad
al Advisory l
ave the Clinic
g Name
C
c
C
A
New Name
dvisory Con
ist
cal Advisory
Clinical AdvisorMaximum of 40clinical advisorie
Clinical AdvisoryUp to 20 characlength
Advisory ContenUp to 200 chara
field (1)
ntent space
y to the Mas
ies 00 es
y Name ters in
nt acters
4
Page 27 of 4
e
ster
7
US
SMP/361/14‐00
Select
Cont
The sy
This in
You m
4
5
79 09/14
t the desired
ent
Clic
ymbol chang
ndicates a C
may view thi
d Clinical A
ck <Apply>
ges to
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is Clinical Ad
Pump S
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> to apply th
a paper cli
sory has bee
dvisory by cl
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om the list,
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ip with a pie
en applied to
licking on th
and review
dvisory to t
ece of paper
o this Drug
his symbol a
the Adviso
his Drug
r.
t any time
Page 28 of 4
ory
7
US
M Aw
Th
SMP/361/14‐00
Modifiers
modifier is awhen it has dis
he maximum
• A drug• A mod• All con
or Am• A drug
Amoun
Assig
CompModif
Click <
1
2
79 09/14
facility‐definstinctive uses
number of m
g must use a mdifier can havencentrations fount/Time). g can use a grnt/Time infus
gning Mod
plete the entfier
<Modifier>
ned text descs, dose modes
modifiers per
minimum of te up to five cofor a single m
oup of modifsions
ifiers
try for conce
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criptor used ts, concentrat
Drug Library
two modifieroncentration
modifier must
fiers that may
entration(s)
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o differentiations, limits, o
is 500
rs but no mors defined. have the sam
y have both C
that will be
te drug theraor configurati
re than five.
me infusion ty
Continuous in
e assigned to
apies on the Pon settings
ype (Continuo
fusions and
o the first
3
Page 29 of 4
Pump
ous
7
US
SMP/361/14‐00
Click <
Enter
Repea
The A
Select M
Select clickin
3
4
5
79 09/14
<New> to e
desired Mo
at above ste
Available Mo
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the desired Mg on the Mod
enter desired
odifier name
eps 3 and 4 u
odifiers list n
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lick <Add>
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ew>
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er names ha
iers entered
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ve been ent
d
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Page 30 of 4
tered
7
US
SMP/361/14‐00
Revie
To re‐
<Up>
Enter
6
7
8
79 09/14
w sort orde
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Once Mod
r concentrat
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difier
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e list will be centration(s)
First Modifiecompleted
lick <Next> tooncentrations hird Modifier
nd then clic
ply>
er d
9
o setup for the
Page 31 of 4
ck the
7
US
SMP/361/14‐00
Modif
Pump
Select Dr
RUN Scre
Drug A
Cursor to drug and
Criti
9
79 09/14
fiers setup c
Screens
rug
een
the desired press OK
ical Care Adult
completed
Select Modifier
Drug A
Cursor to the desireddrug modifier andpress OK
Rapid LoadSlow LoadMaintenance
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Critical Care A
d
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Modifier LisClick on eacto view concentratifor each modifier
st ch
ions
Page 32 of 47
US
M ThtwM
SMP/361/14‐00
Master List
he Master Liswo items can Master List allo
Clinic
Select1
# oC
79 09/14
t
st menu contabe added to ows you to cr
cal Advisor
t Master Li
of Drugs usingClinical Adviso
Clinic
ains the optiothe Drug Librreate, delete
ry Master
ist > Clinica
g the ory
cal Advisory as
ons to access rary prior to cor rename m
List
al Advisor
ssigned to thes
modifiers anconfiguring Camodifiers and
ies
Clinical Ad
se drugs
nd clinical advare Areas or dclinical adviso
dvisory conten
visories. Thesdrug setups. ories.
nt
Page 33 of 4
se The
7
US
SMP/361/14‐00
Mod
Select2
79 09/14
ifier Maste
t Master Li
er List
ist > Modif
Modifierthe follo
fiers
r assigned to owing drugs
# of Drugs usiModifie
ing the er
Page 34 of 47
US
M
WmWU
SMP/361/14‐00
Managing D
Copy
When the Comodifiers andWhen copyinUnlinked.
• If Linkedrug innot inc
• If UnliAny chUnlink
Highli
1
79 09/14
Drug Setup
y Drug Setu
py Drug featd concentratg a drug to a
ed, the drugsn one Care Arcrease the dr
nked, the druhanges to a drked drugs incr
ight the Dru
Select desCare A
p
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g to copy, se
stination rea(s)
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y the same limed to all Care he Library.
e different limre Area will ng count of th
elect Drug
drug setup is
he drugs can
mits and confAreas the dru
mits and confignot affect thee Drug Librar
> Copy Dru
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s copied, thi
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figurations. Anug is linked to
gurations bete drug(s) in otry.
ug Setup
k <Add>
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y>
s includes a
as Linked or
ny changes too. Linked drug
tween Care Ather Care Are
Page 35 of 4
ll the
o a gs do
Areas. as.
7
US
TdWth
WtoTis
1
SMP/361/14‐00
Unlin
he Unlink Drifferent betw
When a drug he drug coun
Highli
Delet
When a drug o the drug. he drug can s linked.
1
Dialog boxregarding
Click <OK>
79 09/14
nk Drug Se
rug Setup feween Care Ais unlinked,nt for the Dr
ight the Dru
te Drug Se
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x provides infounlinking dru
> to unlink
etup
eature is useAreas. drug(s) will rug Library
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etup
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ormation g.
d when limit
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select Drug
udes all the m
rrent Care A
ts and confi
from the un
g > Unlink
modifiers an
Area or all th
igurations n
nlinking, whi
Drug Setu
nd concentra
he Care Area
eed to be
ch will incre
up
ations assign
as that the d
Page 36 of 4
ase
ned
drug
7
US
M
ACT
SMP/361/14‐00
Highli
Managing C
Copy
All the drugs onfigurationhe drugs are
• If Linkto a dLinked
• If UnliconfigLibrar
1
Delete fr
Dele
79 09/14
ight the Dru
Care Areas
y Care Area
from an exisn settings aree either copi
ked, the drugrug in one Cd drugs do ninked, the dgured indepery.
om current Ca
te from all linkCare Areas
g to delete,
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sting Care Ae also copieed as Linked
gs have exacCare Area arenot increase rugs are notendently. Un
are Area
ked
select Drug
rea may be cd from the sd or Unlinke
ctly the same applied to the drug cout associated nlinked drug
g > Delete
copied to a source Care ed
e limits and all Care Areunt of the Dwith other C
gs increase th
Drug Setu
new Care ArArea.
configuratioeas the drug Drug Library. Care Areas ahe drug cou
up
rea. Care Ar
ons. Any chais linked to.
and can be nt of the Dr
Page 37 of 4
rea
anges
ug
7
US
SMP/361/14‐00
Highli
Linked mode Drug count r
Delet
Highli
1
Select Ca
1
79 09/14
ight the Care
e remains the sa
te Care Ar
ight Care Are
are Area to cop
e Area to co
ame
ea
ea to delete
py
opy, select C
Unlinke Drug co
e, select Car
Cl
E
Care Area >
ed mode ount increases
re Area > D
ick <OK> to co
nter New Care
> Copy Car
s
Delete Care
onfirm deletion
e Area to recei
Clicka
New
re Area
e Area
n
ive copy
k <Add> to add to Care Area List
Page 38 of 47
US
P ThLi
SMP/361/14‐00
Rena
Highli
Pump Conf
he Pump conibrary is deplo
Keyp
Select
Default
1
1
79 09/14
ame Care A
ight the Care
figurations
figurations apoyed to the S
pad Lock Co
t File > Pum
t code is 429
unchecus
Area
e Area, selec
s
pply to the enIGMA Spectr
ode
mp Configu
eck to enter tom code
ct Care Are
En
ntire facility aum Infusion P
urations
ea > Renam
nter New Nam
and should bePump
Enter cust
me Care A
me, click <Appl
e reviewed be
tom code in Cu
rea
y>
efore the Dru
urrent Code fie
Page 39 of 4
ug
eld
7
US
ThtonP
Ba
Bnbp Cinco
SMP/361/14‐00
Wire
he Wireless Oo turn On or Oetwork to chump modes t
• Clinica• AC Sle• Batter
attery Sleep M
attery Sleep ot connectedelow 25%, at eriodically co
isco Locationnformation toonfigured tim
79 09/14
less Optio
Options tab coOff. These tweck for and trthat have thre
al / Biomed Mep Mode ry Sleep Mode
Mode options
Mode: The Pd. The Pump rwhich point
onnect to the
n Services: Tho a Cisco Locame interval wh
ons
ontains the Bo options afferansfer Drug ee configured
Mode (Pump O(Pump O
e (Pump O
ump enters Bremains in Bathe Pump shunetwork at th
e Pump periotion System. henever the P
attery Sleep ect the intervLibrary updad time interva
ON) OFF, Pump onOFF, Pump on
Ba
Battery Sleep attery Sleep Muts down. Whhe configured
odically reporThe Pump loPump is powe
Mode and Cival in which tates or reportals to choose
n AC) n Battery)
attery and Cisc
Mode when Mode until thehile in Batteryd time interva
rts its locationcation informered On or co
isco Locationhe Pump cont its location.from
co Location Se
powered Offe battery chay Sleep Modeal.
n as well as thmation is repoonnected to A
n Services optnnects to the There are th
rvices
f and AC powarge level is ate, the Pump w
he Pump statorted at the AC power.
Page 40 of 4
tions
ree
wer is t or will
us
7
US
R
RreC
SMP/361/14‐00
Reports Drug
eports are geeport can inclare Areas tha
Select
Standa
StandAll
•
Drug/F•
Concen•
Config•
79 09/14
Library Reenerated to relude all Care Aat are have lin
t Tools > G
ard Report
dard Report –
Includes all iAdvisories re
/Fluids Report of allconfiguratio(Amount/Tim
ntration LimiReport of allDrugs with V
gurations Report of all
eport eview drugs aAreas, or onenked drugs
Generate D
– Clinical Va
information froeport
l drugs that arens. Drugs are lme or Continuoits l drugs that areVariable Conce
l drugs and the
and configurae specific Care
Drug Repor
alidation typ
om Drugs/Fluid
e not Variable isted by Care Aous). Drug con
e configured asentrations and
e drug configur
ations in the De Area. Additi
rt and File
pes
ds, Concentrat
for the Care AArea then catenfigurations are
s a Variable coConcentration
rations.
Drug Library. ionally the re
for Pump
tion Limits and
Areas and their egorized by drue not included
oncentration. Tn Limits
Report Focus Option to genreport for All CAreas or speciArea Option to showthat are linked
Report Type Standard Repo• All • Drugs/Flu• ConcentrLimits
• Configura
The focus of port can inclu
d Configuration
respective ug type in this report
The report inclu
erate Care ific Care
w drugs d
ort
uids ration
ations
Page 41 of 4
the ude
ns and
udes
7
US
Add
SMP/361/14‐00
Adviso•
Audit
n audit reporate and timeescription of
Select
Audit R
Select CustReport
79 09/14
ories Report of all
Cus
Cus
t Report
rt is a list of ch of the changthe action pe
t Tools > G
Report displa
tom t
l drugs that ha
stom Report
stomize repo
hanges madege, the user loerformed.
Generate A
ayed in the de
ve an assigned
ort by checkin
e to the Drug ogged into the
Audit Repo
efault web bro
d Clinical Advis
ng or uncheck
Library. Infoe PC who ma
rt
owser
sory.
king paramet
rmation that de the chang
ters
is included isge and a
Page 42 of 4
s the
7
US
C Threth
SMP/361/14‐00
Create File
he Create Fileeviewed and he Sigma Spec
Select1
Create F
Select
1
2
79 09/14
for Pump
e for Pump fuvalidated. Tctrum pump.
t Tools > G
Select File for Pump
t Report to Geand validate
unction requirThe Binary Dr
Generate D
enerate
res the user trug Library (B
Drug Repor
to confirm thaBDL) file is the
rt and File
Select 3
at the Drug Lie file that will
for Pump
Generate Rep
ibrary has be be transferre
port
2
Page 43 of 4
een ed to
7
US
SMP/361/14‐00
The Dweb bDrug L
Retur
2
3
Create1
Confreviewe
Drche
2
3
79 09/14
Drug Library browser. Library Repo
n to the Dru
e File for PumSele
Create File
firm that you haed and validaterug Library byecking the bo
enter Reviewer Nam
and Title(s
Report is ge
ort may be u
ug Report
mp option is enaect
e for Pump
ave ed the y x
me(s) s)
enerated as
used to REV
Paramete
Confirmation
abled
SeCrea
4
a html file a
VIEW and VA
ers screen
Screen
electate BDL
and display i
ALIDATE the
in the defau
Drug Librar
Page 44 of 4
ult
ry
7
US
T
Se
Se
1
U
Cse
e
2
SMP/361/14‐00
The B
The BC:\SIG It is natype eFor ex When(SDS) C:\SIG
Transferrin
Prepa
elect Options M
elect Drug Librar
. Drug Library
PDATE SOFTWARE
Cursor to the desiredelection and push OK
exit
. Pump Software
4
1
79 09/14
Binary Drug
inary Drug LGMA\Maste
amed with textension. xample, Hos
n a Binary Dris saved to tGMA\Maste
g Drug Lib
are the Pump
enu Select B
ry Pump is
K
UPDATE
exit
Ready to
g Library (B
Library (BDL)er Drug Libra
he Drug Libr
pitalABC_20
rug Library (Bthe archive fer Drug Libra
brary to Pu
p to receive
Biomed Options
s ready to receiv
DRUG LIB
o receive
BASIConly
BDL) file is
) is saved to ary\Data\Fil
rary name, d
0140228_v3
BDL) file is cfolder: ary\Data\Ar
ump – IrDA
the Drug Li
s Enter passwo
ve
Ensure suusing a v
s now create
the followinles For Pump
date and ver
3.BDL
reated, a co
rchive
A method
brary file (B
ord Sele
uccessful connvalidated IrDA
BIOM
exit
Cursselec
1. Sen
2. Ca
3. Pu
4. Pu5. Up
6. Ne
ed
ng default fop
rsion numbe
opy of the Dr
BDL file)
ect Update Softw
nection betwedevice
MED OPTIONS
or to the desiredction and push OK
nsor Configuration
libration
mp Settings
mp Testingpdate Software
etwork Configuration
older:
er and a BDL
rug Library fi
ware
een PC and pum
2
Page 45 of 4
file
ile
mp
7
US
SMP/361/14‐00
On th
Select
2
79 09/14
e PC
t File > Ope
The Window
Select the deExample: Ri
Transfer pro
en ‘Files fo
ws Explorer win
esired BDL fileght‐click file, s
ogress is displa
or Pump’ F
ndow appears
and initiate trselect Send to
ayed on the pu
Folder
displaying con
ransfer > A nearby com
ump
ntents of the Fi
mputer
les for Pump f
Page 46 of 4
folder
7
USMP/361/14‐0079 09/14 Page 47 of 47
Appendix A – Parameters/Settings
Parameter Information Care Area 32Care Area Name 20 characters Drug Records 5000 Drug Name 20 characters Clinical Advisories 400 Clinical Advisory content 200 characters Modifier Name 20 characters Modifiers 500
Continuous Drugs Amount/Time Drugs Delivery Bag Primary or Secondary
Primary Only, Secondary Not Allowed Primary Only, Secondary Allowed Secondary Only Primary Only, Multi‐step
Primary or Secondary Primary Only, Secondary Not Allowed Secondary Only
Concentration Units g/mL mg/mL mcg/mL Units/mL mUnits/mL mEq/mL ng/mL mmol/mL
g/mL mg/mL mcg/mL Units/mL mEq/mL mmol/mL
Dose Modes (based on concentration units selected)
mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr, mg/kg/hr, mg/min, mg/kg/min, mg/kg/day, mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min, mcg/kg/day, ng/min, ng/kg/min, Units/hr, Units/kg/hr, Units/min, Units/kg/min, mUnits/min, mUnits/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr.
Non weight‐based mL, mg, Units, g, mcg, mEq, mmol
Weight‐based mL/kg, mg/kg, Units/kg, g/kg, mcg/kg mEq/kg, mmol/kg
BSA‐based mg/m2, Units/m2, g/m2, mcg/m2
Bolus/Loading Dose Units
Non weight‐based mL, g, mg, mcg, Units, mUnits, mEq, ng, mmol
Weight‐based mL/kg, mg/kg, mcg/kg, Units/kg, mUnits/kg, ng/kg, mEq/kg, mmol/kg
N/A
Rx Only. For the safe and proper use of this device, refer to the appropriate operator’s manuals. Baxter and SIGMA Spectrum are trademarks of Baxter International Inc. Any other trademarks, product brands or images appearing herein are the property of their respective owners.
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