Alaris Signature Gold - Service Manual
Alaris Signature Gold - Service Manual
Alaris Signature Gold - Service Manual
GOLD
Infusion System DFU.
The Signature Edition
GOLD Infusion
System includes:
Single-Channel, Models 7130/7131
Dual-Channel, Models 7230/7231
AccuSlide
Flow Regulator
administration sets
The Signature Edition
GOLD Infusion
System series includes the following
configurations:
7130B, 7130D, 7130E
7131A, 7131B
7230B, 7230D, 7230E
7231A, 7231B
Chapter 1 GENERAL INFORMATION
1-1
Do not use sharp objects (pens, pencils, etc.)
to activate switches, as this will damage the
keypad.
Any attempt to service an ALARIS Medical
Systems instrument by anyone other than an
authorized ALARIS Medical Systems Service
Representative while the instrument is under
warranty may invalidate the warranty.
CAUTION
CAUTION
Signature Edition
IV sets.
Maximum Time to Alarm:
NOTE: When the occlusion alarm pressure limit is set to the
maximum threshold setting, the maximum infusion pressure
generated into a hard occlusion at 25 mL/h is 11.63.9 psi. Testing
was performed using IV set Model 72003, at 684F (202C).
Memory: 4.06 and higher: Maintains infusion perimeters indefinitely until the
instrument is reprogrammed.
2.78: Interrupted secondary or advanced operating modes retain special
program settings up to 6 hours. Resistance/pressure trending
information is retained for 6 hours.
Mode of Operation: Continuous
Number of Instruments
per Pole: 3 (713X), 2 (723X), single pole, weighted base, 5 legs.
Time to Detect
Downstream
Occlusion (minutes)
Monitoring Options
Pressure
Resistance and
High Resistance
Threshold Settings
25
mmHg
600
mmHg
100%
25 mmHg
100%
25 mmHg
1 mL/h
Maximum 2 75 2 7
Typical 0.6 30 0.6 4
25 mL/h
Maximum 1 25 1 3
Typical 0.1 1 1.0 1
GENERAL INFORMATION
1-6
Signature Edition
GOLD Infusion System has been assessed and complies with the following
Technical Standards: IEC 60601-1 / BS 5724, including amendments A1 and A2; IEC 60601-2-24; CISPR
11, Group 1, Class B Emissions; IEC 60601-1-2.
Infusion rate range:
0.1 to 999.9 mL/h
Head height: 24 1 in.
(61 2.5 cm)
Environment temperature:
688F (204C)
Back pressure: 0 psi.
Test solution: distilled water Set Model: 72003
Needle: 18 gauge Minimum collection volume: 6 mL
GENERAL INFORMATION
1-7
Signature Edition
SYSTEM
(DMS)
The following is general information
regarding the Dynamic Monitoring
System.
In order for fluid to move through the
administration set, a pressure difference
(gradient) must exist. In a gravity setup, this
is done by head height. In a pump, the
instrument will develop pressure to
overcome downstream effects on fluid flow.
The fundamental concept behind the
Dynamic Monitoring
System provides
a means to measure the mechanical
properties of the downstream flow path.
Figure 1-3. Resistance Graph
Pressure =
Effect when a force is against a restriction.
Resistance =
Caused when impediment to fluid flow
occurs.
Resistance = Change in Pressure (P)
Change in Flow ( F)
Refer to Figure 1-4 "Pressure and Resistance
Graph".
GENERAL INFORMATION
1-14
Signature Edition
SYSTEM
(DMS) (Continued)
Features include:
Alarm setting is based on dynamic
system impedance (pressure changes,
not absolute pressure).
Detection of complete occlusions.
Reduced nuisance alarms by minimizing
artifact effects such as head height and
patient movement.
AutoRestartPlus feature allows
instrument to automatically continue
operation if an occlusion is cleared within
self-check period (40 seconds). A
warning tone and Checking Line
message will occur for up to 40 seconds.
The feature can be turned off (set
restarts to zero), or number of restarts
may be set from 1 to 9.
NOTES:
The restart counter is reset whenever
Run/Hold is pressed, the instrument or
channel is turned off or an alarm occurs.
When infusion is started, the resistance
may be other than 0%, depending on
solution viscosity, catheter/tubing size and
filters.
Resistance Alert provides an early
warning of slow or gradual changes in
resistance of IV line/site. Resistance Alert
marker can be set from 5 to 100%. It
allows resistance to be monitored and
provides a tone every 30 seconds if
percent resistance exceeds resistance
alert mark.
Resistance display may be turned off. If
off, system continues to monitor
downstream resistance and alarm
appropriately.
Figure 1-4. Pressure and Resistance Graph
Pressure rise is quite small with site
complication, especially with low flow rates.
Resistance rises dramatically with site
complication.
OCCLUSION
P
R
E
S
S
U
R
E
m
m
H
g
IN PRESSURE
TIME
0
300
600
OCCLUSION
IN PRESSURE
TIME
F
L
U
I
D
O
H
M
S
m
m
H
g
/
L
i
t
e
r
/
H
r
100%
0
50%
75%
GENERAL INFORMATION
Signature Edition
GOLD
Infusion System DFU.
2.3 CONFIGURABLE OPTIONS AND
DEFAULTS
A hospital/facility biomedical technician has
the capability to set all configuration
parameters to their startup defaults in a
single operation. The terms "configuration
parameters" and "programmable features"
are interchangeable and have the same
meaning. Refer to the applicable Signature
Edition
Safety
Software must be loaded to set Profiles
to On. For the Guardrails
Safety
Software to function, Profiles and Dose
Rate must be On.
When Profiles is turned on, the
configuration mode will have limited
access. Access will be limited to
Regional Settings, Profiles, Computer
Link and Optional Features, due to the
data set overriding the configuration
settings as part of the Guardrails
Safety Software.
CHECKOUT AND CONFIGURATION
Software Versions 4.06 and 4.08
Signature Edition
System
Features
The Signature Edition
Infusion System
incorporates the Dynamic Monitoring
System
Features (Continued)
If resistance measurements initiate the
Checking Line condition, the channel
will continue infusing in order to
determine if the measured flow
resistance has changed. In Resistance
monitoring mode, if the measured flow
resistance falls to any value below 100%,
the channel will resume normal operating
conditions automatically (excluding High
Resistance monitoring mode).
In resistance monitoring modes, pressure
measurements initiate the Checking
Line period when the pressure exceeds
the limit. If the pressure falls to less than
one third of the configured limit with 40
seconds, normal flow resumes.
In pressure monitoring mode, the
Checking Line period is caused by
pressure exceeding the alarm limit. If the
pressure falls to less than one third of the
alarm limit within 40 seconds, normal
flow resumes.
Qualified service personnel can turn off this
feature (set restarts to zero), or program
from 1 to 9 restarts.
In High Resistance monitoring mode,
restarts do not occur for resistance
measurements.
After the programmed number of restarts
has occurred, the channel will immediately
alarm OCCLUSION DOWNSTREAM, if
pressure or flow resistance conditions
indicate an occlusion. The programmed
number of restarts become available again
when RUN/HOLD or the run soft key is
pressed.
NOTE: The restart counter is reset whenever
RUN/HOLD is pressed, the instrument or
channel is turned off or an alarm occurs.
Trend Graphs
Trend graphs display downstream pressure
or flow resistance over time (up to 12
hours).
In Pressure, Resistance, and High
Resistance monitoring modes, the trend
graph displays the flow pattern over time.
Downstream occlusions, which occur in the
Pressure or Resistance modes, will be
indicated by a vertical tick mark at the top of
the trend screen.
Trend graphs of fifteen minutes, one hour,
four hours and twelve hours are available
during normal operation.
1. On C4 page, press Monitoring Options
soft key.
CHECKOUT AND CONFIGURATION
Software Versions 4.06 and 4.08
Signature Edition
System
Features (Continued)
2. Press Mode soft key to select for editing.
Press again to cycle between Hi Resist,
Resist and Pressure.
3. Press Restarts soft key. Use numeric
keypad to enter number of restarts, from
"0" (which turns feature off) to "9", then
press Enter.
4. Press Trends soft key to select for
editing. Press again to cycle between
On and Off.
In Pressure mode, graph displays in
mmHg.
Trend data is lost when:
graph information is cleared
instrument is off for more than
12 hours
Trend data is maintained when:
rate is changed
battery is depleted
Trend data is scaled (by 3 times or
1/3, as applicable) when cycling
between Resistance and Hi
Resistance modes.
5. Press ok to accept changes and return to
beginning of C4 page.
6. Precision Flow: Selecting Pressure
Mode and running below 50 mL/h will
place instrument into Precision Flow
Mode.
Precision Flow addresses both flow
resolution (parts or pulses per mL) and
flow continuity (time between pulses).
The instrument will divide each mL into
3600 parts and equally space these parts
into a virtually continuous delivery. With
Precision Flow, the longest time between
a part/pulse at 0.1 mL/h is 10 seconds.
As the rate increases, this time will
become shorter.
NOTE: Resistance measurement is
restarted at 0% when:
RUN/HOLD is pressed to put on hold
and again to start.
Dose ends in Multi-Dose mode.
Checking Line message appears.
Checking Line alert applies to pressure,
resistance and upstream occlusion, with
one tone at the beginning and a flashing
popup display (on for 4 seconds, off for
6 seconds).
2.4.12 Setting Audio Volume
The volume settings determine which range
of audio volume is available. For example,
"Low" may be too low, therefore "Med Hi"
would be chosen. A transition tone, if
enabled, will sound upon completion of a
secondary VTBI, step in multi-step mode,
dose beginning and ending in multi-dose
mode, and completion of a loading dose in
loading-dose mode.
The speaker volumes are approximately:
Low = 60 dB, Med = 65 dB, and Hi = 70 dB
at one meter.
CHECKOUT AND CONFIGURATION
Software Versions 4.06 and 4.08
2A-12
Signature Edition
Safety Software
data sets will NOT be transferred.
Connect a standard 9-pin Null Modem
RS-232 cable (ALARIS P/N 133450) to the
RS-232 ports on the instruments.
NOTE: Instrument software versions 4.06
and 4.08 use same "Rev.01.24" and can be
used to learn/teach one instrument to the
next.
CHECKOUT AND CONFIGURATION
Software Versions 4.06 and 4.08
Signature Edition
Instrument ID/Serial #
Config Name
(Instr Label)
Location
Regional Settings
Air-In-Line:
Threshold
Reset
Accumulator
l l l l l
Profiles
Dose Rate Calculator Generic Dose Rate Calculator only
Maximum Rate mL/h mL/h mL/h mL/h mL/h mL/h
Computer Link:
Mode
Baud Rate
Parity
Optional Modes:
Loading Dose
Dose Rate
Multi-Step
Multi-Dose
Optional Features
Panel Lock
VTBI
Multi-Dose Alert
KVO Rate mL/h mL/h mL/h mL/h mL/h mL/h
Table 2-1. Record of Configured Instruments
--- Table Continued on Next Page ---
CHECKOUT AND CONFIGURATION
Software Versions 4.06 and 4.08
Signature Edition
GOLD Infusion
System DFU.
2.3 CONFIGURABLE OPTIONS AND
DEFAULTS
A hospital/facility biomedical technician has
the capability to set all configuration
parameters to their startup defaults in a
single operation. The terms "configuration
parameters" and "programmable features"
are interchangeable and have the same
meaning. Refer to the applicable Signature
Edition
System
Features
The Signature Edition
Infusion System
incorporates the Dynamic Monitoring
Instrument ID/Serial #
Config Name
(Instr Label)
Location
Language
Air-In-Line:
Threshold
Reset
Accumulator
l l l l l
Dose Rate Drugs (See Table 2-4 Drug List )
Maximum Rate mL/h mL/h mL/h mL/h mL/h mL/h
Computer Link:
Mode
Baud Rate
Parity
Optional Modes:
Loading Dose
Dose Rate
Multi-Step
Multi-Dose
Optional Features
Panel Lock
VTBI
Multi-Dose Alert
KVO Rate mL/h mL/h mL/h mL/h mL/h mL/h
Table 2-3. Record of Configured Instruments
--- Table Continued on Next Page ---
Software Version 2.78
CHECKOUT AND CONFIGURATION
Signature Edition
GOLD
Infusion System remains in good operating
condition, regular and preventive
maintenance inspections are required.
Regular inspections must be performed by
hospital/facility before each use.
Preventive maintenance inspections should
be performed once a year in accordance
with ALARIS Medical Systems requirements
and guidelines. A maintenance reminder will
occur after 52 weeks, unless the feature has
been changed to select a different time
interval or has been disabled. These
inspections are also intended to complement
the intent of J CAHO requirements.
Use Table 3-1, "PM Inspections," to record
the completion of preventive maintenance
inspections.
3.2 PREVENTIVE MAINTENANCE
INSPECTIONS
A message can be set through the
diagnostics mode which automatically
reminds the user when preventive
maintenance inspections are due. Refer to
"Setting Preventive Maintenance Interval"
section in the Troubleshooting chapter.
3.2.1 Regular Inspection
Regular inspections consist of a visual
inspection for damage and cleanliness, and
performing the procedure described in the
Start-Up section of the Directions for Use
(DFU), before each usage of the instrument.
Failure to perform regular and preventive
maintenance inspections may result in improper
instrument operation.
WARNING
Signature Edition
Feature,
the rate is varied during operation. For this
reason, ALARIS Medical Systems does not
recommend using automatic testers to
check rate accuracy. Generally, these
devices collect small samples and may
cause results to be incorrect, even though
the instrument is accurate.
It is recommended, with the initial use of the
80VCS set on each instrument, to perform
rate calibration first, to save time.
Do not use the Model 80VCS Calibration
Set for more than 15 rate calibration and
post calibration rate accuracy verifications
(count one use for both calibration and
verification of the same instrument).
CAUTION
Figure 3-1. Rate Accuracy Test Setup
Table or
Bench
Equipment
Stand
Burette
Clamp
Burette
(50 mL)
Tubing
IV Tubing
Used Fluid
Receptacle
Three-
Way
Stopcock
80VCS
Rate Cal Set
Instrument Stand
30 +2 inches
Signature Edition
Flow Regulator
clamp on 80VCS Calibration Set and
then insert spike into solution container.
2. Open AccuSlide
GOLD
Infusion System.
A thorough familiarization with the function
and operation of the mechanical assemblies
and electrical circuits of the pump will enable
repair and calibration to be accomplished
more efficiently (refer to Principles of
Operation chapter).
The circuit boards used in the instrument
are fitted with surface mount devices and
are deemed nonfield repairable. Therefore,
ALARIS Medical Systems requires that all
circuit boards be returned to an authorized
ALARIS Medical Systems Service Center
CAUTION
NAME MANUFACTURER MODEL NUMBER APPLICATION
Electrical Safety Tester BIO-TEK 260*
Used to test AC wiring and pump
grounding.
IV Infusion Set IVAC 80 VCS Rate accuracy test
Nurse Call Cable IVAC 136111 Nurse call option
Pressure Cal Set IVAC 70ISS Pressure verification and calibration
Pressure Gauge
(-400 to +750mmHg)
Dresser Industries:
203-406-3115
(Heise) BIO-TEK:
802-655-4040
PTE1/901M1*
DPM III*
Pressure verification and calibration
Burette 50mL, 0.1mL
increment
Fisher Scientific
Keynex
Class A or B*
113 Sec A*
Rate calibration and verification
RS-232 (9-pin, Null modem) IVAC 133450*
Connects between 2 instruments to
download configuration.
Silicon Tubing IVAC 303109* Pressure calibration setup
T-Fitting IVAC 313815* Pressure calibration setup
NiCad Battery Optomizer
Alexander Batteries
800-577-2539
Model 2006*
2003*
Test and condition batteries (optional)
Hand-Held Vacuum Any Any Main board assembly cleaning
Table 5-1. Test Equipment
WARNING
* or equivalent
CMOS devices are sensitive to static electrical
charges and may be damaged during repair if
the repair activity is not performed in an
electrostatic discharge (ESD) protected
environment, using approved ESD protective
procedures, including personnel grounding, or
the instrument could be damaged.
Signature Edition
Flow
Regulator
clamp (open)
AccuSlide
Flow
Regulator clamp
(closed)
2 Segment
2 Segment
of RTV
Place X cut here
(on backside)
Dome (on
backside)
5.3 TEST AND CALIBRATION (Continued)
5.3.7 Hard Pressure Cal Procedure
NOTE: When performing the Hard Pressure
Calibration, take care not to press downward
on the transducer. The pot is a one-turn,
surface-mount pot with a rivet in the middle.
Use a small screwdriver or scribe to push
sideways on the two slots in the pot. If the
Count = value is 0 or 4095, this could
indicate a bad transducer and necessitate
replacement of the mechanism.
1. Ensure warm-up of 1 hour minimum.
2. Leave instrument on and connected to
AC power and battery.
3. Follow procedure to disassemble
instrument.
NOTE: There is one case screw inside the
battery compartment.
4. Do not disconnect any cables. Adjust
pole clamp so knob is facing downward.
Lay front case on desk/bench top.
5. Locate pot under motor and on backside
of transducer (Figure 5-38).
6. Evaluate sensor in D6 Pressure
Calibration page (see Troubleshooting
chapter), as follows:
a. Press lower left soft key 4 times to see
Count = value.
b. If Count = value is between 875 and
1275, go to start of Pressure Cal
screen. Verify Sensor = reading is
between -80 and +30 mmHg after set
is removed (repeat for other channel if
necessary). If not, perform soft
pressure calibration.
c. If Count = value is less than 875 or
more than 1275, perform hard cal for
this channel.
7. Adjust transducer pot for a Count = value
of 117525 counts.
8. Once transducer is adjusted for proper
reading, press ok to accept value.
9. Close instrument by setting bottom of
front case onto rear case, using case
bosses for alignment. For a dual channel
instrument, route long ground wire into
corner of case boss. Ensure ground
wires do not rub against mechanism.
10. Check for proper routing of cables.
11. Close case by following pattern and
tightening procedure outlined earlier in
this chapter.
12. Wait 30 minutes for transducer to warm
up again and check that compensated
value is still in range, as noted earlier.
13. Perform soft pressure cal procedure
(after 30-minute warm-up) as follows:
a. Install 70ISS Press Cal Set.
CORRECTIVE MAINTENANCE
5-45
Figure 5-38. Transducer Pot
Signature Edition
GOLD Infusion
System Directions for Use (DFU).
Chapter 6 TROUBLESHOOTING
6-1
Use extreme caution in servicing the
instrument when connected to AC power.
Hazardous voltages are present when AC
power is connected, regardless of the setting
of the power switch.
WARNING
Before disconnecting the battery,
disassembling, troubleshooting or testing the
instrument, record the alarm history. Refer to
Viewing Alarm or Event History (Event Log)
section of this chapter.
CAUTION
Table 6-1. Technical Troubleshooting Guide
This table contains information for troubleshooting possible technical problems. The steps in the
Remedy column are listed in the sequence in which the specified actions are to be taken.
Before making a final diagnosis, visually inspect the instrument for damage. Pay particular attention
to the power cord and plug. Verify the instrument is electrically safe by performing the Ground Current
Leakage and Ground Resistance tests (refer to the applicable Signature Edition
GOLD Infusion
System DFU).
PROBLEM REMEDY
Accuracy Verification
Fails
1. Try new 80VCS Rate Cal set and repeat test a second time.
2. Check for mechanical damage and proper loading of administration
sets.
3. Perform Rate Calibration.
4. Replace mechanism.
5. Return to factory.
Air-in-Line 1. Air in set. Remove air or press RESET to move air through line.
2. Change AIL setting.
3. Clean AIL transducer/receiver.
4. Check connector.
5. Replace AIL transmitter.
6. Replace AIL receiver.
7. Return to factory.
Signature Edition
GOLD
Infusion System Directions for Use (DFU)
for directions on viewing software
version.
Part number.
Part description, as provided in parts list.
For labels, specify required language.
ILLUSTRATED PARTS BREAKDOWN
7-2
Signature Edition
, AccuSlide
, Dynamic Monitoring
, Guardrails