Alaris Medical Systems imed Gemini PC-1 User manual

MEDICAL SYSTEMS
dx ALARIS'
m Ur :
imeci Gemn Pc-1*
VOLUMETRIC INFUSION PUMP/CONTROLLER
MAINTENANCE MANUAL

PC-1
WARNINGS, CAUTIONS AND NOTICES
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A PHYSICIAN.
USE ONLY HOSPITAL GRADE POWER SUPPLY CORD TO INSURE
PROPER GROUNDING. GROUNDING RELIABILITY CAN ONLY BE
ACHIEVED BY CONNECTION TO A RECEPTACLE MARKED "HOSPITAL
GRADE".
DANGER: EXPLOSION HAZARD, DO NOT USE IN THE PRESENCE OF
FLAMMABLE ANESTHETICS. © 7
WARNING: TO PREVENT UNRESTRICTED FLOW, CLOSE CLAMP WHEN
FLO-STOP IS OPEN.
REMOVE COVER OR BACK. REFER SERVICING TO '
CAUTION: TO REDUCE RISK OF ELECTRICAL SHOCK, DO NOT
QUALIFIED SERVICE PERSONNEL.
WARNING: REPLACE FUSE AS MARKED.
CAUTION: | BEFORE CONNECTING "REFER TO MANUAL"
|
NOTE
TO MAXIMIZE THE SERVICE LIFE OF THE INSTALLED BATTERY, IT IS RECOMMENDED
THAT THIS INSTRUMENT BE STORED AND OPERATED IN AN ENVIRONMENT THAT IS
TEMPERATURE CONTROLLED BETWEEN 68°F (20°C) AND 77°F (25°C).
WARNING
IN THE EVENT THE INSTRUMENT IS DROPPED AT ANY TIME, IT MUST BE CHECKED BY A
BIOMEDICAL TECHNICIAN PRIOR TO USE FOR PATIENT CARE.

PC-1
WARNING AND CAUTION NOTICES em
WARNING: TO PREVENT UNRESTRICTED FLOW, CLOSE ROLLER CLAMP WHEN FLO-STOP®
MECHANISM IS OPEN.
/ | CAUTION: REFER TO MANUAL
TYPE CF (Equipment useable for direct cardiac applications)
CLASS 1
ALTERNATING CURRENT
- REPLACE FUSE ONLY WITH SAME TYPE AND RATING
| EQUIPOTENTIAL GROUND POINT: IF THE INTEGRITY OF THE EQUIPOTENTIAL
(CY EARTH CONNECTION OR HOSPITAL EARTH SYSTEM IS IN QUESTION, OPERATE
THE INSTRUMENT USING INTERNAL BATTERY POWER.
IPX1 DRIP PROOF
WARNING
tf the PC-1 pump/controtler is dropped at any time, have the
instrument checked by the Biomedical Department prior to further
use.
一
iv

PC-1
NOTICE
Product design and/or specifications are subject to None of the information contained herein may be
change without notice. The information contained duplicated nor may it be utilized in any manner
in this manual is current as of the date of issue. other than for the repair and maintenance of
ALARIS Medical infusion pump/controllers and the
This publication contains ALARIS Medical component parts thereof. Any unauthorized use of
Systems,” Inc. ("ALARIS Medical") proprietary the information contained herein may subject the
data provided solely for the use of technical user to substantial liability.
personnel in repairing ALARIS Medical infusion
pump/controllers.
This manual may not, in whole or in part, be copied, photocopied, reproduced, translated, or converted to
any electronic or machine-readable form without prior written consent of ALARIS Medical Systems, Inc.
ALARIS Medical Systems, inc. Copyright 2000 ALARIS Medical Systems, Inc. All Rights Reserved
10221 Wateridge Circle Printed in USA
[phone]
San Diego, CA 92121 USA
U.S. Patents 4,617,014; 4,689,043; 4,690,673; 4,725,205; 4,728,265; 4,836,752; 4,909,710;
4,920,336; 4,954,046; 4,859,927; 5,219,330; D305, 151; D308,946; D312,879, AU 646,216;
580,184; 586,594; 590,179; 601,664; 607,112; 622,088; 604,477. CA 1,235,033; 1,258,212;
1,300,977; 1,280,647; 1,296,791; 2,020,926; 1,238,832. AT 0,225,158. BE 0,225,158. FR
0,225,158; 283,614; 315,312; 0,431,726; 0,238,277. GB 0,225,158; 283,614; 315,312;
0,431,726; 0,238,277. NL 0,225,158; 283,614. IT 0,225,158; 283,614. SE 0,225,158; 283,614.
CH 0,225,158. DE P3686558.3; P3772,556.9; 3871721T2; P6908208; P3774598. TW
UM52721.
JP ###1754470%.###1 8 16872##%##1902387%:
###19671685,8##17931195;##*173039585.
Other US and Foreign Patents Issued and Pending.
IMED®, Gemini PC-1®, Flo-Stop®, VersaTaper®, AutoTaper®, are registered trademarks of ALARIS
Medical Systems™.

PC-1
PREFACE
This manual contains operation and maintenance
instructions for the IMEDº GEMINI PC-1º
Volumetric Infusion Pump/Controller (“PC-1").
The information provided herein is intended for
use by technical personnel responsible for
servicing this product. The material is divided into
six sections and is presented as follows: Section
1 - Descriptive Information; Section 2 -
Preparation for Use; Section 3 - Operating
Instructions; Section 4 - Functional Description
and Schematic. Diagrams; Section 5 -
Maintenance Instructions; Section. 6 - Parts Lists
and Assembly Drawings; Section 7 - Calibration
and Preventive Maintenance.
Additional copies of this manual may be obtained
by contacting ALARIS Medical's Customer
Service Department.
This manual supersedes PC-1 Maintenance
Manuals 1310-9251-00 and 1310-9261-00 and
1310-9261-00 and PC-1 International
Addendum P/N 1310-9028-00.
The features of the 220V model of the PC-1
pump/controller have been incorporated into this
manual. Text or graphics that are related
exclusively to the 220V model are identified with *
a EM symbol.
In addition, some features are for the 110V
model of the PC-1 pump/controlier only and are
identified with a symbol.
vi

PC-1
TABLE OF CONTENTS
SECTION 1 - DESCRIPTION
ーー
©
NO
UP
Wh
+
introduction .......... ーー 1-1
Operating Characteristics -
Operating Condifion enveree
User Interface ...............,.....,............,,.....,.........
Physical Description ................................ 0. eee
Product History ...................................
Operating Specifications ` ・
Accessories .ee
SECTION 2 - PREPARATION FOR USE
2.1 Iniroduclon eee enn -- 2-1
2.2 Pre-Operational Mechanical Inspection ......:.................,.,.,....... 2-1
2.3 OperationalPerformanceCheck ........................................ 23
2.3.1 Pre-operationalCheckBatteyCharge ................................... 2-3
232 Pre-operational Electrical Inspectiion .. enene 2-3
2.3.2.1 Electrical Leakage Test ......................,..... P 2-3
2.3.2.2 Electrical Ground Test ...........................,..........,......... 2-3
2.8.3 Abbreviated Operational Performance Test ............................... 2-3
2.3.3.1 Тез! Ведийетет$ ............... ω ων εννοώ νοκ εννεενε ον ενω νοκ ώ ο ων 2-3
2.3.3.2 TestProcedures............................. 1 e lisa 2-4
SECTION 3 - OPERATION
8.1 Introduction .............. Z ο κώνο νο ον 3-1
3.2 Controls and Indicators ..........,.........,,....,..........,.,...,... 3-1
3.3 Operating Conditions .............. rr 3-9
3.3.1 NormalandComputerOperation........................................ 3-9
3.3.1.1 Ритр апа СогигоНег Модез ........... i 3-9
3.3.1.2 VersaTaper*/AutoTaper® Mode Operation ................................ 3-17
3.3.1.3 Battery Powered Operation ..................... i 3-23
3.3.2 Maintenance/Diagnostic Mode ..............,...............,......... 3-24
3.4 Operator Information Display and Alarm Response Procedures .....,......... 3-25
3.5 Audio Alert Sysiem k 3-25
SECTION 4 - PRINCIPLES OF OPERATION
4.1
42
4.2.1
4.2.1.1
421.2
42.2
4.2.2.1
4.2.2.2
4.3
4.3.1
4.3.2
jntroduciion .. ee n 4-1
Mechanical Operation ................,.................,...,..4...2 41
Physical Description ............... a 41
Pumping Mechanism .......................,....,.......,...,...,... 4-1
Strain Beam (Pressure Transducer) ...........,..........,.........,.... 4-1
Functional Operation .......................... .. . 1... laa 4-1
Pumping Mechanism .............................. 0. 00 cence eeae 41
Strain Beam (Pressure Transducer) .................................... 4-5
Electrical/Electronic Operation . ................................:.,..... 4-5
Functional Description ......................,,,.....,,....,..,..... 4-5
Functional Operation ............................ 2... 아이다 4-8

5.5.3.4a Charger Adapter CCA Removal (Instruments with Dual State Charger
Modification Kit installed) . ............................................ 5-39
5.5.3.5 Power Supply Board Removal ......,.................................. 5-39
5.5.3.6 Pole Clamp Assembly Removal and Disassembly (Figure 6-18) .............. 5-40
5.5.3.7 Removal of the Power Cord Strap (Figure 6-1c) ........................... 5-40
5.5.3.8 GroundingStudRemoval:....................................... 5-40
5.6 Reassembiy ........ erre se 5-40
SECTION 6 - ILLUSTRATED PARTS BREAKDOWN
6.1 Introduction eee. 6-1
SECTION 7 - CALIBRATION AND PREVENTIVE MAINTENANCE
7.1 Introduction に に に に に に に に に ーー に ーー トト に に に トト トト トー トー トト トト トト トト て レレ トト トレ トト トト トー トレ レー ッッ ここ 7-1
7.2
Preventive Maintenance .....................,...................,..,. 71
73 Calibration Procedures .....,........................,.........,...,.. 7-1
7.3.1 Strain Beam Calibration.................................. 0... 7-1
7.3.1.4 Calibration Equipment Requirements ..............,..................... 7-1
7.3.1.2 Calibration Procedures ............................................... 7-2
7.3.2 AllDetectorCalibration.................................... ... 0... 7-3
7.4 Comprehensive Operational Performance Test ............................ 7-4
7.4.1 Electrical Inspection ....... EE と と と と と と に ez 7-4
7.4.1.1 Electrical Leakage Test .. eee eee 7-4
7.4.1.2 Electrical Ground Test ...........................,.............,...... 7-4
7.4.4.3 Dielectric Test (Optional) .................................. 0... 00 7-4
7.4.1.4 Battery Voltage Check .............................,................. 7-4
7.4.1.5 Battery Care and Maintenance ..........................,,..,,......... 7-4
7.4.2 Qualitative Operational Performance Test ................................ 7-5
7421 Operational PerformanceTest.............................. Lon 75
7.4.2.2 VTBI Display Validity Check ....................,...................... 7-5
7.4.3 Quantitative Operational Performance Test ............................... 7-5
7.4.3.1 Equipment Requirements ............................. 0.00 κ νο ος ον 7-5
7.4.3.2 Initialization Setup .................... ーー 7-5
7.4.3.3 Pump Mode Tests ......................................,............ 7-7
WARRANTY
NOTES
SALES AND SERVICE OFFICES
TECHNICAL SERVICE MANUAL SUPPLEMENTS

PC-1
Figure
1-2
2-1
2-2
2-3
2-4
3-1
3-1а
3-2
4-1
4-2
4-2а
4-3
4-4а
4-5
4-6
4-7
4-8
4-8а
4-9
4-10
4-11
4-12
4-12а
4-12b
4-12b
4-12c
4-126
4-13
4-14
4-15
4-16
417
4-18a
4-18b
4-18¢
4-18d
4-19
4-20
4-20a
4-20b
4-20c
4-20c
4-21
4-22
4-22a
LIST OF FIGURES
Title
Page
IMED® Gemini PC-1° Volumetric Infusion Pump/Controller. ................... xiii
Audio Characteristics. ............................. 0.1.0111 1-8
PC-1 Front and Rear Operating Features. .................. eee eee 2-2
Communications Emulator Plug. .........,....,............. ーー 2-4
Aïir-In-Line Simulator. .....................................,,....,.28. 2-8
PC-1 Test Data Sheet. し ーー ュ に に に に に に に に レー に に に に ーー に ーー トト トト トー て トト て て ーー スーーー ト ーー 2-9
PC-1 Front Panel Controis and Indicators. ..............,......,......... 3-2
PG-1 Titration Front Panel Controlsandindicators.......................... 3-3
PC-1 Rear Panel Controls and Indicators. ............................... 3-4
PC-1 Pumping Mechanism ................................,..,,...., 42
Functional Block Diagram [v2.x/5.xx/6.xx] ............. se 4-3
Functional Block Diagram [V7.xx] eee en 4-4
CrossSectionofStranBeamAssembiy................................. 4-5
PC-1 Interconnect Diagram 0 e. 4-6
PC-1 (220V) interconnect Diagram κκ κος 4-7
Microprocessor TimingWaveforms ..................................... 4-8
Power ON/OFF, Auto Power On and Sensor Signal Functional Schematic
№2.хх/5.хх/б.хх] ..-.- ーー 4-10
5 Volt Protected Circuit Functional Schematic [v2200520/8.xx] ............... 4-11
+12 Volt Power Supply Functional Schematic [V2.xx/5.xx/6.xx] . ..........,.... 4-14
Charger Adapter Board Schematic (with Mod.Kit installed) .................. 4-14
System Reset Functional Schematic [v2.xx/5.xx/6.xx] ...................... 4-16
Stator Polarity Change as a Function of Phase Excitation. ................... 4-37
Relationship of Stator and Rotor Teeth with the A Phase Energized. .......... 4-17
Battery Charger Functional Schematic (without Dual State Charger). .......... 4-19
Battery Charger Functional Schematic Pwr Sup Brd (Dual State Charger). .... 4-21
Power Supply CCA [v7.xx] (Sheet 1) ..... 本 4-23
Power Supply CCA [V7.xx] (Sheet 2) ...........,............,........,.. 4-25
Power Supply CCA with Crowbar/Timer (PC-1CE V8.xx) (Sheet 1). ........... 4-27
Power Supply CCA with Crowbar/Timer (PC-1CE V8.xx) (Sheet 2). ........... 4-29
Pumping Mechanism Functional Schematic [V2.xx/5.x%/6.xx] ................ 4-31
input Signal Pulses and Change in Phase Excitation of Unipolar Drive. ........ 4-32
Strain Beam Functional Schematic [V2.x4\5.2046.xx] . ..................,.... 4-33
AlL Detector Cross Section ..........,............,.......,........... 4-34
Slide Clamp Detector Cross Section ............................ ーー 4-35
Hybrid AlU/SCDBoardSchematic...................................... 4-35
ALSCD PCB Sechemag kenene 4-36
AIL/SCD Schematic ...............,,..............,....,..,....,2. 4-36
AIL/SCD PCB Schematic ................,......................,..... 4-37
PC-1 Audio Subsystem [V2.x45.x4u6.xx] . …............................... 4-39
Display CCA Schernatic IM2.xyv5 ーー 4-41
Display GCA Schematic [V6.xx] ..................... k 4-43
Display CCA Schematic [V7.XX] enke nnesnenes 4-45
Display CCA Schematic [PC-1CE v8.xx] (Sheet 1) ................,,.....: 4-47
Display CCA Schematic [PC-1CE v8.xx] (Sheet 2) ........................ 4-49
Communicatons Interface Functional Schematic .......................... 4-51
ECD Schematiic .. rr rr 4-53
ECD (Universal) Schematic ...............................,,........., 4-54

Microprocessor Interface Schematic [V2.xx/5.xx/6.xx] (Sheet 1) .............. 4-55
Microprocessor Interface Schematic [v2.xx/5.xx/6.xx] (Sheet 2) .............. 4-57
Microprocessor Interface Schematic [V2.xx/5.xx/6.xx] (Sheet 3) .............. 4-59
Logic CCA Schematic [v7.xx] (Sheet 1) ................................. 4-61
Logic CCA Schematic [V7.xx] (Sheet 2) ................................. 4-63
Logic CCA Schematic [v7.xx] (Sheet 3) ................................. 4-65
Logic/Analog CCA Schematic [PC-1CE v8.xx] (Sheet 1) .................... 4-67
Logic/Analog CCA Schematic [PC-1CE v8.xx] (Sheet 2) ...:................ 4-69
Logic/Analog CCA Schematic [PC-1CE v8.xx] (Sheet 3) .................... 4-71
Parts Identification PC-1 Final Assembly
Parts Identification PC-1 Final Assembly
Parts Identification PC-1 Final Assembly
Parts Identification Front Case Assembly
Parts Identification Front Case Assembly
Parts Identification Front Case Assembly
Parts Identification Door Assembly ......,..............................
Parts Identification Logic CCA [V7.xx] ...........,....:.....,............
Parts Identification Logic CCA [V8.13] ........................,...........
Parts Identification Display Circuit Card Assembly [V7.xx] ................... 6-23
Parts identification Display Circuit Assembly [V8.13] ....................... 6-24
Parts Identification Rear CaseAssembiy ................................ 6-26
Parts Identification Power Supply CCA [V7.xxX] 0.0002. o 6-32
Parts Identification Power Supply CCA [V8.13] ............................ 6-33
Universal Test Station Setup ........................................., 7-10
Air-In-Line Simulator ーー 7-11
PC-1 Test Data Sheet ................,....,...................,..... 7-12
xi

PC-1
LIST OF TABLES
Table Title
Page
1-1 Product History .............. ーー 1-5
1-2 Operating Requirements ....... 本 1-6
1-3 Performance Specifications ..............................,.... ーー 1-6
1-4. Accessories eee n 1-9
3-1
PC-1 Controls and indicators я изн зените 3-5
3-2 PC-1 Status/Alarm Displays ............. ーー k 3-26
4-1 RS-232-C Communications Data Port Signal Definitions . ..........,............, 4-32
5-1 (o TroubleshootinyaultisolationGuilde......................... ーー 5-10
5-2 PC-1 Error Log Codes (V2.xx, V5.xx, V6.xx, and V6.3X/4x) ....................... 5-14
5-2а PC-ErmorlogCodes(V7X)........................ eee 5-21
5-2b PC-tErorlogCodes(V8XxX)....................... 1... resen 5-29
5-2z PC-1 Maintenance Mode Error Codes (v5.xx/v6.xx/V7.xx/v8.xx) .................,. 5-35
5-3 TableoflorgueValues.................................... 0. een 5-41
6-1 Parts List - PC-1 Final Assembly .. iii 6-2
6-1a ' Parts List - PC-1 Final Assembly ....................,.,............,...,..,. 6-3
6-2 Parts List - Front Case Assembly ....................,.....,......,,........ 6-8
6-3 Partslist-DoorAssembiy .............................. 0.00. ea 6-13
6-4 Parts List - Logic Circuit Card Assembly [v7.xx & subsequent] ...........,........ 6-15
6-5 Parts List - Display Circuit Card Assembly [v7.xx & subsequent] ........:.......... 6-21
6-6 Parts List - Rear Case Assembly. ..............................,............ 6-25
6-7 Parts List - Power Supply Circuit Card Assembly for [V7.xx & subsequent] . .......... 6-27
xii

PC-1
に D το
τν =
Integer Keypad
απ
|
|
Em
Fractional Keypad
B =
l
Titration Keypad
Figure 1-1 IMED® GEMINI PC-1® Volumetric Infusion Pump/Controller
xiii

PC-1
SECTION 1 - DESCRIPTION
1.1 INTRODUCTION
This section includes general operating
characteristics, physical description and operating
specifications for the IMED® GEMINI PC-1®
Volumetric Infusion Pump/Controller ("PC-1").
1.2 OPERATING CHARACTERISTICS
The PC-1 instrument is a single channel volumetric
infusion pump/controller used for the administration
of intravenous drugs and fluids. The instrument can
be operated as either a Pump or Controller. A
lockout feature is incorporated which allows the
instrument to be preset as either a Pump or
Controller. Secondary (piggyback) infusions can be
administered using infusion parameters
independent of the Primary infusion. An Empty
Container Detector (ECD) is available, as an option
(All except PC-1CE v8.xx 220V), to permit infusing
ihe eniire contents of an IV solution container. The
instrument is compatible with remote computer
operation when the communication option is
installed. An integral maintenance mode is
‘ incorporated to monitor instrument performance,
identify and document instrument malfunctions and
assist technical personnel in troubleshooting and
repair.
Fractional Keypad/Series V5.xx & Subsequent
Software `
A VersaTaper® Mode is incorporated to facilitate
administration of !V fluids that require non-linear
delivery (rate and/or VTBI) during the period of
medication. Twenty, manually input, independent
steps (rate and VTBI combinations) are available to
set up a tapered infusion program.
Titration Keypad/Series V7.xx & Sub. Software
An AutoTaper“ Mode is incorporated to automate
infusion setup and delivery of ramp-up/taper-down
cyclic parenteral nutrition applications.
The PC-1 pumping mechanism employs linear
peristaltic action to deliver a continuous flow of
infusion products reliably, accurately and safely. In
the controller mode, the instrument will deliver fluid
at a pressure equal to the pressure created by the
head height of the IV solution container +12 inches
(30 cm). In the pump mode, the instrument delivers
fluid at a pressure up to a maximum of 10 +2 psi
(69 +14 kPa; 517 +103 mmHg). Above these
pressures, the instrument will occlude.
Integer Keypad/Series V2.xx Software
infusion rate is selectable between 1 and 999 mL/hr
in 1 mL/hr increments. Volume to be infused (VTBI)
is selectable between 1 and 9999 mL in 1 mL
increments. When an infusion is complete, the
instrument automatically switches to the KVO rate
of 1 mL/hr.
Fractional Keypad/Series V5.xx & Sub. Software
infusion rate and VTB! are dependent on the
selected instrument operating mode - Micro, Macro
or Universal. Available parameters are as follows:
MICRO (mic) - Rate is selectable between 0.1 and
99.9 mU/hr in 0.1 mL/hr increments; VTBl is
selectable between 0.1 and 999.9 mL in 0.1 mL
increments.
MACRO (mac) - Rate is selectable between 1 and
999 mL/hr in 1 mL/hr increments; VTBI is selectable
between 1 and 9999 mL in 1 mL increments.
UNIVERSAL (mic/mac) - Rate is selectable in 0.1
mL/hr increments between 0.1 and 99.9 and in 1
mi/nr increments between 100 and 999 mL/hr; VTBI
is selectable in 0.1 mL increments between 0.1 and
999.9, when the Rate is fractional, and otherwise in
1 mL increments between 1 and 9999 mL.
When an infusion is complete, the instrument
automatically switches to a KVO rate of 1 mL/hr for
delivery rates >1 mL/hr or a rate equal to the set
delivery rate for rates <1.0 mL/hr.

PC-1
This version of the PC-1 pump/controller
incorporates a feature that allows the instrument to
be preset in either the Micro (mic), Macro (mac) or
Universal (mic/mac) mode.
Rate Titration Keypad/Series v7.xx E
The Rate Titration feature allows the rate to be’
increased or decreased 1 mL/hr (MACRO mode) or
0.04 mL/hr (MICRO mode) with each press of the
or (© control, then press START to accept the
new rate. Greater rate changes can be achieved by
pressing and holding the appropriate BB controls
until the desired rate is obtained, then press START
to accept the new rate.
The PC-1 pump/controller does not require any pre-
operational warm up. An internally mounted battery
provides normal operation for a limited period to
enable use when AC power is not available or the
external power source is interrupted.
The PC-1 pump/controller's user interface consists
of a front panel tactile keypad and the rear panel
Audio Control potentiometer. Tamper resistant
operation is provided through the requirement to
utilize a prescribed key press sequence to enter or
change infusion parameters. Basic operating
instructions are printed on the right side of the
instrument case. Functional control is provided by a
16 bit microprocessor using a stored program that
includes a diagnostic routine that monitors pump
performance, provides audio and visual signals to
ensure proper sequencing of normal operations and
initiates an alarm in the event a software or
hardware malfunction is detected.
_ Sufficient disposable configurations are available to
provide the user with a full range of set-up
combinations (see Section 1.7). The Flo-Stop® on
the GEMINI administration set's pumping segment
prevents free flow in the event the tubing set is
removed from the instrument following initial
installation. Free flow, as a result of deliberate
operator action, is possible when using the set to
perform a gravity infusion in accordance with the
instructions provided in the set package.
1.3 OPERATING CONDITION
The PC-1 pump/controller can be operated
independently (Normal Operation) or, when
configured with a communication data port, as a
computer controlled device (Computer Operation).
Normal operation includes the Controller and Pump
modes plus the Maintenance mode. Computer
operation includes the Monitor and Computer
Control modes.
NORMAL OPERATION —.
SETUP MODE V7.xx and subsequent software
The Titration keypad instruments utilize the Setup
Mode (refer to Section 2.3.3.2) to configure the
instrument for specific infusion regimes, language
selection and communication (serial port)
parameters.
CONTROLLER MODE
In the CONTROLLER mode, the PC-1
pump/controller is programmed to control the
infusion of a specific volume of IV solution. The
instrument senses and responds to container height
and patient-side pressure in a manner similar to a
gravity infusion. The instrument's pressure sensor
measures the hydrostatic pressure from the fluid
container and compares that pressure against distal
tubing in-line pressure. When in-line pressure
exceeds pump input pressure, an occlusion
condition exists and an alarm is initiated. Actual
delivery pressure is directly proportional to
container height; increasing container height raises
and decreasing the height reduces occlusion
pressure. Controller mode occlusion pressure
tolerance is +12 inches (30.54 cm) from the fluid
container height. Transient surges in patient-side
pressure above the occlusion threshold of <60
seconds duration will produce a LOW FLOW
condition which stops the infusion while the
pressure is above the occlusion threshold. Pressure
transients above the occlusion threshold for periods
longer than 60 seconds duration or cumulative time
required to compensate for volumeiric deficiency in
excess of 30 minutes will initiate an occlusion
alarm.
À
ペー
ジ

PC-1
Roe
PUMP MODE
In the PUMP made of operation, the instrument
employs a preset occlusion pressure limit of 10 +2
psi (69 +14 kPa; 517 +103 mmHg) predicated on a
nominal container height of 24 inches (61 cm) and
a delivery rate >30 mL/nr. For delivery rates <30
mL/hr, the occlusion pressure is rate-dependent to
ensure timely detection of occlusion conditions. Any
transient distal in-line pressure above this limit will
generate a patient-side occlusion alarm.
Software Release V6.xx and Subsequent
These instruments can be locked into a rate-
independent (10 psi) occlusion pressure mode. This
mode will result in significantly increased time-to-
occlusion for rates <30 mL/hr.
Software Release v8.13 only
These instruments can be locked into a rate-
independent (517 mmHg) occlusion pressure
mode. This mode will result in significantly
increased time-to-occlusion for rates <30 mL/hr.
MAINTENANCE/DIAGNOSTIC MODE
Integer/Fractional Keypad Instruments
The Maintenance mode is intended solely for use
by biomedical technicians to perform servicing and
maintenance actions and must NEVER be used
when the PC-1 pump/controller is connected to a
patient. The maintenance mode provides
biomedical service personnel access to the closed
loop diagnostic test routines and allows the
pumping mechanism to be operated unencumbered
by stoppages resulting from alarm and maifunction
conditions. Specific sub-routines are incorporated in
the maintenance test sequence to permit
configuring the instrument for non-English language
and computer operation (see Section 5.3 for
detailed operation).
Titration Keypad Instruments
The Diagnostic mode provides biomedical service
personnel access to the closed loop diagnostic
routines, allows the pumping mechanism to be
operated uninterrupted by stoppages resulting from
alarm conditions and maintains a log of the 24 most
recent error codes (see Section 5.3 for detailed
operation).
COMPUTER OPERATION
Fractional/Titration Keypads with Software
Release V6.xx and Subsequent ONLY
MONITOR MODE
The Monitor mode allows a host computer to
monitor infusion status and instrument
performance. Monitor mode is enabled when a host
computer is connected to the PC-1 pump/controller
through the Communications Data Port (RS-232-C)
and the Monitor indicator is illuminated.
COMPUTER CONTROL
The Computer Control mode allows an infusion,
once set up, to be controlled and monitored by a
host computer installation. Computer controlled
operation is selected by actuating the COMPUTER
CONTROL/MONITOR switch after Monitor mode
has been established. Computer controlled
operation is confirmed by the computer control
indicator presentation changing from flashing to a
steady illumination.
1.4 USER INTERFACE
The front Control! and Display panel incorporates a
tactile keypad for operator use in programming an
infusion. Delivery mode (if not locked), Rate and
Volume to be Infused are each selected for Primary
infusions. A SEC/PIGGYBACK (Secondary) key
permits independent selection of Rate and VTBI for
a sequential secondary infusion. Separate registers
are provided to accumulate Total and Secondary
volume infused quantities. Fhe PAUSE/STOP
control allows an infusion to be "paused" and then
resumed or stopped. Rate and VTBI infusion
parameters for the Primary or Secondary are
displayed digitally in the respective displays. The
operator information display presents visual
prompts, advisories, alarms and/or malfunctions
messages as appropriate to assist the operation in
programming and operating the instrument.
Fractional Keypad/Series V5.xx & Sub. Software
The 0.1, 10, 100, VTBI, Vi, PC and
CLEAR/SILENCE keys have a secondary function
during instrument power up to enable or clear

PC-1
discrete delivery mode selections available on
these versions of the PC-1 pump/controller.
Titration Keypad/Series V7.xx & Sub. Software
The keypad adds the rate titration controls & and
E which enable the user to quickly increase or
decrease the rate parameter. A tamper resistance
feature is enabled in the SETUP mode and
implemented using the push actuation of the Audio/
Tamper Resistance Control on the rear panel.
The requirement to properly install the
administration set's integral Flo-Stop before the
door will close and latch prevents inadvertent "free
flow," inhibits premature operation of the pump and
prohibits use of an unauthorized set. The Door
Open and Air-in-Line sensors are provided to stop
pump operation if either of these conditions occur
during an infusion. A strain relief fitting is provided
in the instrument's handle support to prevent
kinking of the proximal tubing.
The rear panel of the PC-1 pump/controller is
configured with an audio volume contro! and an
ECD connection (ECD connection - All except
PC-1CE v8.xx 220V). A RS-232-C data port
connector is incorporated on the power supply
board for the Fractional Keypad instruments.
Software releases V6.xx and subsequent enable
the PC-1 pump/controller for computer controlled
operation.
IMED® GEMINI Series disposable administration
sets are required for use with the GEMINI family of
Infusion Pump/Controllers. Sufficient set types are
available to support a broad range of infusion types
and configurations.
1.5 PHYSICAL DESCRIPTION
The PC-1 instrument has the following physical
characteristics:
Height: 10.8 inches (27.5 cm)
Width: 8.4 inches (21.3 cm) w/pole clamp
Depth: 6.5 inches (16.5 cm) w/pole clamp
Weight: 11.1 pounds (5.1 kg)
The PC-1 instrument consists of two major
assemblies: the front and rear case.
FRONT CASE
The front case assembly consists of a high-impact,
injection molded, plastic case/insert assembly with
an Electro-Static Discharge (ESD) coating, which
houses and supports the pumping chamber access
door, the peristaltic pumping mechanism, pressure
transducer (strain beam), Air-in-line and slide clamp
detectors, the multi-card assembly, keypad and
front case ESD components.
REAR CASE
The rear case assembly consists of a die-cast
aluminum shell which mounts and supports intern-
ally the battery, transformer, power supply board
(with sonalert), ECD connector (except PC-1CE
v8.xx 220V), audio control potentiometer and RS-
232-C connector) and power entry module. The
exterior of the rear case supports the pole clamp,
ECD storage fitting, power cord retention strap and
power cord retainer.
only. The exterior of the rear case supports
the 220V AC power entry module plus the.
equipotentiality grounding point. The power entry
module includes fuses for. both input leads and a
220V AC power interrupt switch (where applicable).
1.6 PRODUCT HISTORY
The initial release of the Gemini PC-1° Infusion
Pump/Controller was in October 1988. Since that
time a number of changes have occurred. The initial
release PC-1 is an “Integer” Infusion Pump/
Controller, it delivers fluids in whole number
increments only. The next iteration of PC-1
delivered fluid in whole and fractional increments
and incorporated “VersaTaper® an intravenous
feeding algorithm. Then the PC-1 was updated to
interface with the RS-232 bus. The last major
change incorporated “Rate Titration” keys which
allows the user to increase/decrease the rate by
small increments with a minimum number of key
presses. This model also incorporated AutoTaper®
which is a predefined intravenous feeding
algorithm. These instruments can be identified by
their keypads, The Keypad without a fractional key
is the “Integer” model. The Keypad with a fractional
key is the “Fractional” model. The Keypad with 1 /
keys is the “Titration/Fractional” model. Refer to
Table 1-1 for product history.
1-4

PC-1
1.7 OPERATING SPECIFICATIONS 1.8 ACCESSORIES
The PC-1 Operating Specifications are The accessories approved for use with the PC-1
subordinated into Operating Requirements and pump/controller are listed in Table 1-4.
Performance Specifications which are delineated in
Tables 1-2 and 1-3, respectively.
Table 1-1. Product History
Model History
Integer PC-1 ・ Initial release of product Software version 2.xx.
Fractional PC-1 ・ Fractional rate, VersaTaper® introduced Software version 5.xx.
Fractional PC-1 ・ RS-232 interface enhanced 10psi mode introduced. Software version 6.xx.
Titration/Fractional + Rate Titration, Tamper mode and AutoTaper® introduced. This unit has a
Configuration Setup Mode that can be accessed by holding the “Volume
Infused” key at Power Up. Software version 7.xx.
International PC-1 * This unit was developed to meet international requirements. Software
version 8.xx.
n Matrix:
Revision # PC-1
X
Revision “A” - Initial Revision
Revision “B"- Software Upgrade for International Units to enhance operation.
Revision “C"- Software Upgrade to change “PSI” to “mm/hg”.
Revision “D” - Mandatory Upgrade to incorporate “Crowbar” circuit for 2.xx units. This circuit will cause the line fuse to blow if the
battery is in an overcharge condition.
Revision “E"- Not used.
Revision “F”- Mandatory Upgrade to incorporate “Crowbar” circuit for 5.xx and 6.xx units. This circuit will cause the line fuse to
blow if the battery is in an overcharge condition.
Note’: xx = a number associated with a particular software version, i.e., 2.xx could be 2.09 or 2.13 or 2.16 etc.
Notez: All PG-1's have a Maintenance or Diagnostic Mode. To access this mode: hold in the Computer key at Power Up; press
the “Computer” button to step through; press the “Start” button to access each function...
CAUTION: The “Fractional” and “integer” Pumping Mechanisms are not interchangeable.

PC-1
Table 1-2. Operating Requirements ui
Parameter Specification
Power Required: Non-Dual State Charger instruments
90-132 VAC, current draw 0.2 Amps maximum (25 watts), 0.1 Amps
nominal (12 watts), fused at 0.4A, 50-60 Hz, 3 wire, Single 4
Dual State Charger Instruments
90-132 VAC, current draw 0.3 Amps maximum (35 watts), 0.1 Amps
nominal (12 watts), fused at 0.5A, 50-60 Hz, 3 wire single d
ED 180-264V AC 0.15 Amps nominal, Fused at 0.315 A, 50-60 Hz, 3 wire,
Single 中
Battery: Sealed Lead-acid, 6 VDC, 7.2 Amp-Hr
Operating Temperature Range: 40°F (5°C) to 104°F (40°C)
Operating Humidity Range: 0% to 95% Relative Humidity, non-condensing
Storage/Transport Temperature: . -40°F (-40°C) to 158°F (70°C)
Storage/Transport Humidity: 0% to 95% Relative Humidity, non-condensing
Table 1-3. Performance Specifications
Parameter Specification
Operating Principle: Linear Peristaltic
Operating Range: }
Pump and Controller modes: . .
Integer Keypad/Series V2.xx Software
Rate: 1-999 mL/hr in 1 mL/hr increments (CONTROLLER Mode maximum
recommended rate is 500 mL/hr)
Volume-to-be-Infused: . 1-9999 mL or ALL (with external ECD)
Keep Vein Open (KVO) Rate: 1 mU/hr
Fractional/Titration Keypad/Series V5.xx & Subsequent Software
Rate: MICRO: 0.1-99.9 mL/hr in 0.1 mL/hr increments
MACRO: 1-999 ml/hr in 1 mL/hr increments
UNIVERSAL: 0.1-99.9 mL/hr in.0.1 mL/hr increments; 100-999
mL/hr in 1 mi/hr increments
(CONTROLLER Mode maximum recommended rate is 500 mL/hr)
Volume-to-be-infused: MICRO: 0.1-999.9 mL in.0.1 mL increments
MACRO: 41-9999 mL in 1 mL increments
UNIVERSAL: 0.1-999.9 mL in 0.1 mL increments; 1000-9999 mL in
1 mL increments
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