Alaris MedSystem III User manual
MedSystemIII
®
Multi-Channel Infusion Pump with
Advanced Dose Rate Calculation
DIRECTIONS FOR USE
INTRODUCTION
BASIC OPERATION
ADVANCED OPERATION
TROUBLESHOOTINGMAINTENANCE
TABLE OF CONTENTS
INTRODUCTION
ABOUT THE PUMP....................................................................... 1
FEATURES.................................................................................... 2
SYSTEM COMPONENTS ............................................................... 4
OPERATIONAL PRECAUTIONS ...................................................... 6
BASIC OPERATION
PREPARING THE INFUSION .......................................................... 9
PREPARING THE ADMINISTRATION SET ........................................ 9
LOADING THE SET ....................................................................... 9
FRONT PANEL OVERVIEW ............................................................ 10
PROGRAMMING PRIMARY INFUSION........................................... 14
MAKING CHANGES WHILE INFUSING .......................................... 15
KVO STATUS................................................................................ 17
ADVANCED OPERATION
SECONDARY MODE .................................................................... 19
PREPARING THE ADMINISTRATION SET ........................................ 19
PROGRAMMING SECONDARY INFUSION...................................... 20
DOSE RATE CALCULATOR (DRC) USING A SPECIFIC DRUG NAME............... 22
DOSE RATE CALCULATOR PROGRAMMING WITH DRUG? ........................... 24
DEVICE........................................................................................ 26
CONFIG....................................................................................... 28
NOTE .......................................................................................... 29
BATLOG....................................................................................... 29
TROUBLESHOOTING
RESPONDING TO AN ADVISORY, ALARM OR FAULT ...................... 31
ALARM RESPONSE KEYS .............................................................. 31
ADVISORIES ................................................................................ 32
ALARMS...................................................................................... 33
FAULT.......................................................................................... 36
WATCHDOG ................................................................................ 36
OTHER CONDITIONS.................................................................... 36
MAINTENANCE
SPECIFICATIONS .......................................................................... 37
CLEANING................................................................................... 38
INSPECTION REQUIREMENTS ....................................................... 41
SERVICE INFORMATION............................................................... 42
WARRANTY................................................................................. 43
GLOSSARY................................................................................... 44
Alaris MedSystem III Directions For Use v
INTRODUCTION
CHAPTER 1 — INTRODUCTION
The MedSystem III®Multi-Channel Infusion Pump —
• three independent fluid delivery systems in the space of one.
• compact size:
- reduces bedside clutter
- simplifies patient transport
• easy to setup and use, yet provides advanced features.
• accurate delivery of a variety of fluids.
• accommodates assorted container types.
• multiple delivery methods:
Intravenous/Intra-arterial/Subcutaneous/Epidural
• Uses administration sets that provide free flow protection.
• Six available Device Types with configurable parameters
(maximum and minimum rates, maximum volumes, baseline
and maximum pressures, and air-in-line thresholds) to
achieve specific clinical applications:
General Purpose
Neonatal
Controller Pressure
Operating Room
General Purpose II
Operating Room II
• Displays infusion status for rate, volume remaining and
volume infused.
• Infusions can be programmed to deliver at a specified rate or
over a specified period of time.
• Secondary mode allows fluids and medications to be
delivered at two different rates, sequentially.
• Dose Rate Calculator (DRC) feature performs the volumetric
rate and/or dose rate calculations.
• With DRC activated, displays infusion status for rate, dosing
regimen and drug name.
• Communications Protocol allows clinical monitoring,
instrument configuration and maintenance.
• Field Maintenance software (FMS) available for Biomed to
configure, service and troubleshoot the pump.
About the Pump
1
CAUTION: With any
multiple or parallel infusions (i.e.,
connection of additional infusion
systems to the MedSystem III pump
and connection to the patient venous
system), air infusion, reverse flow,
and flow interruption are possible.
Please consult the “Overall
Problem/Solution Matrix” contained
in DIN/VDE Standard 0753 in such
cases.
WARNING: The use of
positive displacement infusion devices
ported together with gravity flow
infusion systems into a common IV
site may impede the flow of common
“gravity only” systems affecting their
performance (hospital personnel
must ensure the performance of the
common IV site is satisfactory under
these circumstances).
WARNING: The pump is
designed to stop fluid flow under
alarm conditions other than the Low
Battery and KVO. Periodic patient
monitoring must be performed to
ensure infusion is proceeding as
expected.
WARNING: The
MedSystem III is a positive pressure
delivery system capable of developing
positive fluid pressures to overcome
widely varying resistances to flow. It
is neither designed nor intended to
detect infiltrations and will not alarm
under infiltration conditions.
WARNING: Hospital
personnel must ensure the
compatibility of the drugs as well as
the performance of each pump as
part of the overall infusion. Potential
hazards include drug interactions,
inaccurate delivery rates, inaccurate
pressure alarms, and nuisance alarms.
CAUTION: Only systems
that have been qualified to
International Standard IEC 60601-1
should be connected to the
Communications Receptacle, and the
connection should ONLY be
performed by qualified personnel.
The selection, testing, and use of host
computer hardware and software, in
conjunction with the MedSystem III
pump is strictly the responsibility of
the purchaser.
INTRODUCTION
Multi-channel Fluid Delivery System
The instrument combines three independent infusion channels
in an unparalleled small size.
Lightweight/portable
The pump with pole clamp weighs just over 5 pounds and is
easy to transport.
Unique, rotating pole clamp
The Pump may be attached to a variety of surfaces.
Dose Rate Calculator (DRC)
The pump calculates a volumetric or dose rate based on values
entered for patient weight, drug concentration (drug amount
and diluent volume) and dosing parameters.
Six Device Types available
General Purpose, Neonatal, Controller Pressure, Operating
Room, General Purpose II, and Operating Room II.
Free-flow Protection
The IVAC 28 and 25 Series Administration Sets contain a
cassette that provides protection from free-flow conditions. To
remove the cassette from the pump, the cassette’s slide clamp
is pulled to full extension, occluding the tubing and preventing
fluid from flowing.
Features
2
A: Stopped
DRUG? Wt ---- KG= 0.0 LB
A:Conc ------- mg/---- ml
A:Dose ------- mcg/kg/min
A:Rate ------- ml/h
A:VR 1 ml (Vol Rem)
A:VI 0 ml DI 0.0 mg
Press Select to choose line
Select
Clear
INTRODUCTION
Monitoring System
The instrument continuously monitors pump conditions and
alerts with adjustable audio tones and visual messages.
Data Monitoring
The pump can be configured to communicate with a remote
computer, such as a centralized patient monitoring nurses
station. The COMM receptacle is compatible with RS-232
cabling. A communications manual that describes the
programming and hardware involved is available.
Field Maintenance Software (FMS)
The pump can be modified to accommodate specialized clinical
applications. The Device Type parameters, occlusion limit, and
air-in-line threshold can be reconfigured with the optional FMS
software.
Secondary Mode
Allows the user to program two different rates of infusion to
run sequentially.
Full Range of Delivery Rates
Rates from 0.1 to 999 milliliters an hour.
Battery Capacity
A fully-charged battery provides 6 to 8 hours of operating time
with rates at 125 ml/h per channel.
3
A: Infusing Secondary
A: Secondary Rate 100 ml/h
A: Sec VolRem (VR) 100 ml
A: Sec Time(TR) 1 hr
A: Sec VolInf(VI) 1 ml
since 12:37p 01 Feb 02
Stop Affects Secondary
Select
Fast
INTRODUCTION
System Components
Slide
Clamp
Pressure
Dome
Piston
Tubing
Collar
Lower Assembly
3 Cassette Holders
Pump Latch Mechanism
Drives the cassette piston to move
fluid through the tubing.
Air-in-Line Sensor
Detects bubbles of air during
infusion.
Tubing Collar Recess
Holds tubing collar in place.
Front Panel
Instrument Keys
Display Screen
Softkey Pads
Channel Indicator Lights
Green:
• Steady - infusing on AC
power
• Flashing - infusing on
battery power
Red:
• Slow flashing - Advisory
• Rapid flashing - Alert
Channel Select Keys
Cassette
Portion of administration set,
inserts into cassette holder.
4
INTRODUCTION
AC Adapter Power Cord
120V/60 Hz three-pronged
grounded adapter with 4 pin
locking connector, standard on
Model 2863.
Connector Panel
External Power
External power receptacle connects with power cord.
Plug Symbol
Green light on indicates AC
power is connected; batteries are
charging.
COMM
Communications line receptacle
connects with RS-232.
NOT E:
When inserting or
removing connectors to the
receptacles, avoid excessive
force or twisting.
Container Hook
One hook on each side of the
instrument.
Rotating Latch
Allows clamp to spin 360° and
position at every 90°.
Adjustable Pole Clamp
Jaw with clutch feature, mounts
pump to a pole or bedside.
Attaching Pole Clamp
To attach the pole clamp,
position the clamp jaw over the
mounting surface and turn the
knob until the clamp is tightened
and the pump feels secure.
When the knob is as tight as
possible, continued turning will
make it click and spin freely
without over-tightening.
5
INTRODUCTION
To avoid possible injury to the patient, observe the following
precautions:
Epidural Administration
The MedSystem III pump can be used for epidural administration of
anesthetic and analgesic drugs. This application is only appropriate
when using anesthetic and analgesic drugs labeled for continuous
epidural administration and catheters intended specifically for
epidural use. Use only an IVAC 28 or 25 series set
wwiitthhoouutt
a ‘Y’
connector or injection port, for epidural infusions. The pump‘s
secondary mode must
nnoott
be used when the pump is being used for
epidural administration of anesthetic and analgesic drugs.
- Epidural administration of anesthetic drugs — Use indwelling
catheters specifically indicated for short-term (96 hours or less)
anesthetic epidural drug delivery.
- Epidural administration of analgesic drugs — Use indwelling
catheters specifically indicated for either short-term or long-term
analgesic epidural drug delivery.
Administration Sets
• Use only IVAC 28 and 25 Series Administration Sets. The use
of other sets will cause improper pump operation.
• Do not use the set if damaged.
• Do not insert a cassette into a channel with a Service status.
• Remove any cassettes from channel(s) requiring service.
• Ensure the cassette is properly installed before starting
infusions.
Electromagnetic and Radio Frequencies
Operating the pump near equipment which radiates high-energy
electromagnetic and radio frequencies (electrosurgical/cauterizing
equipment, portable radios, cellular telephones, etc.) may cause false
alarm conditions. If this happens, reposition the pump away from the
source of interference; or turn off the pump and manually regulate
the flow with the administration set regulating clamp.
Operational Precautions
Patient Precautions
WARNING:Epidural
administration of drugs other than
those indicated for epidural use
could result in serious injury to the
patient.
WARNING: It is strongly
recommended that the infusion
pump source container and
administration set used for epidural
drug delivery be clearly
differentiated from those used for
other types of administration.
6
INTRODUCTION
Artifacts
It is normal for intravenous infusion devices to produce nonhazardous currents when infusing electrolytes. These currents vary at
a rate proportional to the infusion device flow rate. When the ECG
monitoring system is not functioning under optimal conditions, these
currents may appear as artifacts, simulating actual ECG readings. To
determine if ECG abnormalities are caused by patient condition or the
ECG equipment, place the infusion device on hold. If the ECG
readings become normal, the ECG equipment requires attention.
Proper setup of the ECG equipment should eliminate these artifacts.
Reference the appropriate ECG monitoring system documentation for
instructions on setup and maintenance.
Dropping/Jarring
If a pump is dropped or severely jarred, it should be immediately
taken out of service and inspected by qualified service personnel to
ensure proper function prior to reuse.
To ensure proper performance of the pump and to reduce potential
injury to the operator, observe the following precautions:
• The power cord must be connected to a properly grounded,
3-wire receptacle (“Hospital Use” or “Hospital Grade”)
• Avoid excessive force or twisting of detachable power cords,
when inserting or removing connector terminals.
• Use power cord indoors only.
• Disconnect AC and battery power when performing
maintenance.
• Do not use the pump in the presence of flammable
anesthetics.
• Do not open the instrument case. The case should only be
opened by qualified service personnel using proper
grounding techniques.
• Do not stack instruments on top of each other.
User Precautions
WARNING: When the
case is opened, an electrical shock
hazard exists which can result in
serious injury to persons and
instrument component damage.
7
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BASIC OPERATION
9
BASIC OPERATION
Prepare solution container in accordance with the manufacturers’
instructions.
• A syringe can be used as the container for the IV fluid to be
infused. Syringe sizes from 20cc to 60cc of the B-D and Monoject
®
brands can be used.
NOTE:
The IVAC Model 8631A Syringe Holder is available as an
accessory that provides a convenient place to hold syringes while they
are being used as containers for IV fluid. The Syringe Holder is designed
to be easily installed and removed from the top of the pump and to
support up to three syringes. Do not use the Syringe Holder as a handle
to carry the pump.
Connect the container to the IV set.
Prime the IVAC 28 or 25 Series administration set in accordance with
Administration Set Directions for Use.
It is important to prime the set properly to eliminate air bubbles.
Ensure the cassette slide clamp is pushed in completely so tubing is not
occluded.
Invert the cassette so tubing is up. Slowly open the regulating clamp
and establish fluid flow to fully prime the set. Gently tap the cassette
and ‘Y’ sites as necessary to remove all air. Gently massage the pressure
dome to ensure no air bubbles are trapped.
Close regulating clamp before inserting and removing the cassette to
reduce the risk of free flow.
Press to turn pump on.
With tubing down, use a 45 degree, upward motion to insert cassette
into channel.
Push on clear portion of cassette until completely seated. Then push in
slide clamp flush with entire cassette.
Pull down gently on tubing collar. Press with thumb to seat tubing
collar in recess beneath cassette.
NOTE: Three beeps sound when inserted properly.
Preparing the Infusion
Loading the Set
Preparing the Administration Set
WARNING: An open
regulating clamp and slide
clamp can cause a freeflow condition and may
result in serious injury to
the patient.
Pressure Dome
Slide
Clamp
Tubing Collar
Clear portion of cassette
A
A
A
10
BASIC OPERATION
Status Line
Displays infusion status
(Infusing; Stopped; Standby;
KVO; ALARM; FAULT; SERVICE)
for each channel.
NOTE:
S
tatus line in selected
channel is highlighted.
Infusion Rate
Volume Remaining
Volume Infused
Prompt Line
Displays messages that prompt
the user to make programming
choices and/or take appropriate
actions.
Softkeys Prompts
Displays function of specific
softkey.
STNDBY – Appears in softkey
information line
when
is
pressed during
infusion.
Cntrst – (Contrast) Brightens
or dims display.
GP II – When pressed, indi-
cates full name of
selected Device
Type on the
prompt line.
NOT E:
Additional softkey
prompts are displayed by
pressing More Options.
Softkey Pads (4)
Front Panel Overview
Instrument Control Keys
ON/OFF Recharge Key
Turns the pump on and
off.
STANDARD DISPLAY Key
Allows the user to
display Standard Display
page to view infusion
settings for all channels.
MORE OPTIONS Key
Allows the user to
display additional softkey
functions.
START/STOP Key
Starts or stops infusion
on selected channel.
Channel Control Key
Standard Display Page
ON/OFF
STANDARD
DISPLAY
MORE
OPTIONS
START
STOP
Stopped
125
VR: 996.2
VI: 12.8
Start affects channel C
STNDBY Cntrst GP
®
ml/h
MedSystem III® DLE
Standby
25
ml/h
VR: 138.8
VI: 26.9
A
B
Standby
95
ml/h
VR: 93.2
VI: 16.8
C
BASIC OPERATION
11
Selected channel is indicated by
the letter displayed at the
beginning of the first five lines.
Status Line
Displays infusion status for selected channel.
Infusion Rate
Volume Remaining
Time Remaining
Volume Infused
Date/Time
Displays when volume infused
was last cleared and infusion
began.
Prompt Line
Displays messages that prompt
the user to make programming
choices and/or take appropriate
action.
Soft Key Prompts
Displays function of specific
softkey.
Select – Moves highlight bar
through the
programmable
infusion
parameters.
↑↑
– Increases highlighted value.
↓↓
– Decreases highlighted value.
Fast
↑↑
– Increases highlighted
value at greater
increments.
Fast
↓↓
– Decreases highlighted
value at greater
increments.
Programming Page
ON/OFF
®
STANDARD
DISPLAY
MORE
OPTIONS
MedSystem III® DLE
A: Stopped
A: Primary Rate 25 ml/h
A: Pri VolRem (VR) 250 ml
A: Pri Time(TR) 10h 00m
A: Pri VolInf (VI) 10 ml
since 12:37p 01 Feb 02
Press Select to choose line
Select Fast
A
B
C
START
STOP
12
BASIC OPERATION
Press .
• Instrument information page is momentarily displayed.
• Continuing to hold down ON/OFF key will keep the information
on the display.
• When the ON/OFF key is released, the Standard Display page is
displayed.
Press and hold .
• Display disappears.
• Pump is turned off.
Press .
• Standard Display page is displayed.
With the Standard Display page displayed:
Press
,
once.
•
TotVol, Device, Config, and Note softkeys appear.
Press again.
•
Batlog and DemoWd softkeys appear.
Press , , or .
• Selected channel programming page is displayed.
With programming page displayed:
Press
Select to choose value to change.
• Value is highlighted.
Scroll through values using
↑↑
, ↓↓, FAST↑↑, or FAST↓↓.
•
↑↑
and FAST↑↑increases highlighted values in single or multiple
increments.
To turn pump on
To activate additional Standard Display softkey prompts
To turn pump off
To view infusion settings for all active channels
To select channel and display Programming Pages
To program infusion
BASIC OPERATION
13
• ↓↓and FAST↓↓decreases highlighted values in single or multiple
increments.
• Pressing
↑↑
or ↓↓changes direction of the FAST↑↑or FAST
↓↓
• Highlight remains flashing until Enter is pressed. If Enter is not
pressed, the entry incomplete advisory will sound.
Press
Enter to accept new value.
• Highlight moves to next programmable value if channel status is
Stopped or Standby.
• If status is
Infusing, highlight remains on selected value.
To recall a previous value after a new value is introduced but not
entered, press .
• Recall soft key appears.
Press
Recall.
• Number returns to previous value.
Press .
• Infusion starts or stops immediately, unless the channel’s
programming is incomplete, or if an advisory, alarm, or fault
condition exists on selected channel.
•
ALARM is displayed in affected channel status line.
• Alarm condition is displayed on the Standard Display of the
affected channel.
Press affected channel , , or .
• Alarm Information page is displayed for that channel.
With the programming page displayed:
Press .
Press
2°Sec to access Secondary page.
Press
CalcOn to access Dose Rate Calculation page.
Press .
Press
CalcOff to discontinue use of the Dose Rate Calculator.
To access alarm information
To activate additional Programming Page softkeys
See the TROUBLESHOOTING section
of this manual for more alarm
information.
See the ADVANCED OPERATION
section of this manual for
information on the use of the Dose
Rate Calculator function.
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