This document and the subject matter disclosed herein are proprietary information.
Hospira retains all the exclusive rights of dissemination, reproduction, manufacture, and sale.
Any party using this document accepts it in confidence, and agrees not to duplicate it in whole
or in part nor disclose it to others without the written consent of Hospira.
430-600203-003 (Rev. 07/05)GemStar
®
Change History
Part NumberDescription of Change
430-600203-001
(Rev. 04/00)
430-600203-002
(Rev. 12/02)
430-600203-A02
(Rev. 08/03)
430-600203-003
(Rev. 06/05)
Original issue
Second issue
Change Page issue
Updated cover and
copyright pages
Updated change history
Updated equipment
needed for Operation Test
in Section 5
Third issue
Incorporated Hospira
name change and updated
to current style
Updated cover, copyright,
and back page
Updated Section 1
and Section 4
Updated to include
EMC/IEC requirements
Added Appendix
Remove
and Destroy
Pages
cover
i to ii
5-19 to 5-20
Insert
Change
Pages
cover
i to ii
5-19 to 5-20
Technical Service Manual i430-600203-003 (Rev. 07/05)
Specific instructions for operating the device are contained in the GemStarOperating Manual. Provision is made for the inclusion of the system operating manual
in Section 3 of this manual.
®
System
Note: The terms “infuser” and “device” are used interchangeably throughout
the manual.
Note: Figures are rendered as graphic representations to approximate actual product.
Therefore, figures may not exactly reflect the product.
Technical Service Manual1 - 1430-600203-003 (Rev. 07/05)
SECTION 1 INTRODUCTION
1.2
CONVENTIONS
The conventions listed in Table 1-1 are used throughout this manual.
Table 1-1. Conventions
ConventionUseExample
ItalicReference to a section, figure,
table, or publication
[ALL CAPS]KeysPress [YES/ENTER]
ALL CAPSDisplay messagesThe infuser displays
BoldEmphasisCAUTION: Use proper ESD grounding
Throughout this manual, warnings, cautions, and notes are used to emphasize important
information as follows:
WARNING:
CAUTION: A CAUTION usually appears in front of a procedure or statement.
It contains information that could prevent hardware failure, irreversible damage
to equipment, or loss of data.
A WARNING CONTAINS SPECIAL SAFETY EMPHASIS AND MUST
BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING
MAY RESULT IN PATIENT INJURY AND BE LIFE-THREATENING.
(see Section 6.1, Technical Assistance)
to continue.
END OF INFUSION
techniques when handling
components.
Note: A note highlights information that helps explain a concept or procedure.
1.3
ACRONYMS AND ABBREVIATIONS
This section contains the acronyms and abbreviations that appear in the text of this
manual.
Technical Service Manual1 - 3430-600203-003 (Rev. 07/05)
SECTION 1 INTRODUCTION
V Volts
Volts alternating current
V
AC
V
Collector voltage supply
CC
V
Volts direct current
DC
V
VTBI Volume to be infused
Primary power source
PWR
V
Volts root mean squared
rms
µA Microampere
µs Microsecond
1.4
USER QUALIFICATION
The infuser is intended for use at the direction or under the supervision of licensed
physicians or certified healthcare professionals who are trained in the use of the infuser
and the administration of parenteral fluids or drugs. Training should emphasize
preventing related IV complications, including appropriate precautions to prevent
accidental infusion of air.
1.5
ARTIFACTS
Non-hazardous, low level electrical potentials are commonly observed when fluids are
administered using infusion devices. These potentials are well within accepted safety
standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG,
and EEG machines. These artifacts vary at a rate that is associated with the infusion rate.
If the monitoring machine is not operating correctly or has loose or defective connections
to its sensing electrodes, these artifacts may be accentuated so as to simulate actual
physiological signals. To determine if the abnormality in the monitoring equipment
is caused by the infuser instead of some other source in the environment, set the device
so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates
that it was probably caused by the electronic noise generated by the infuser. Proper setup
and maintenance of the monitoring equipment should eliminate the artifact. Refer to the
appropriate monitoring system documentation for setup and maintenance instructions.
430-600203-003 (Rev. 07/05)1 - 4GemStar
®
1.6 ELECTROMAGNETIC COMPATIBILITY
1.6
ELECTROMAGNETIC COMPATIBILITY
The GemStar® is compliant with IEC/EN 60601-1-2 (2001), and has been tested and found
to comply with electromagnetic compatibility (EMC) limits for the Medical Device Directive
93/42/EEC (EN 55011 Class B and EN 60601-1-2:2001). These limits are designed to
provide reasonable protection against harmful interference in a typical medical installation
(see the system operating manual).
CAUTION: Portable and mobile RF communications equipment, such as cellular
telephones, two-way radios, Bluetooth
proximity to the infuser may affect or degrade performance of the device. Operation
of the infuser under such conditions should be avoided.
There is a shared responsibility between manufacturers, customers, and users to assure
that medical equipment and systems are designed and operated as intended. Medical
electrical equipment requires special precautions regarding electromagnetic compatibility.
The electromagnetic environment should be managed to permit the infuser to perform as
intended without disturbing other equipment. The infuser should not be used adjacent to
or stacked with other equipment. If the device must be used adjacent to or stacked with
other equipment, monitor the equipment to assure there is no electromagnetic
interference, and verify normal infuser operation.
®
devices, and microwave ovens in close
1.7
INSTRUMENT INSTALLATION
PROCEDURE
CAUTION: Infuser damage may occur unless proper care is exercised during
unpacking and installation.
CAUTION: Do not place the infuser in service if it fails the self test.
The instrument installation procedure consists of unpacking, inspection, and self test.
1.7.1
UNPACKING
Inspect the shipping container as detailed in Section 1.7.2. Use care when unpacking the
infuser. Retain the packing slip and save all packing material in the event it is necessary
to return the infuser to the factory. Verify the shipping container contains a copy of the
system operating manual.
Technical Service Manual1 - 5430-600203-003 (Rev. 07/05)
SECTION 1 INTRODUCTION
1.7.2
INSPECTION
Inspect the shipping container for damage. Should any damage be found, contact the
delivering carrier immediately.
CAUTION: Inspect the infuser for evidence of damage. Do not use the device if it
appears to be damaged. Should damage be found, contact Hospira (see Section 6.1,Technical Assistance).
Inspect the infuser periodically for signs of defects. Also inspect the infuser after repair
or during cleaning. Replace any damaged or defective external parts.
1.7.3
SELF TEST
CAUTION: Do not place the infuser in service if the self test fails.
At power-on, the infuser immediately enters an initialization mode and performs the
following self tests:
-RAM test
- ROM checksum calculation
- Motor control test
- Stuck key test
- PIC watchdog test
- CONFIG register test
- Battery voltage test
- Power loss completion test
- CRC verifications on all RAM areas protected by CRCs
- CRC on calibration data stored in the EEPROM
- Calibration data verification
The initialization mode completes in approximately 30 seconds. During this time the
infuser displays a message that the self tests are being performed. If any test fails,
the infuser alarms.
Note: The device does not infuse during the initialization mode.
After successful completion of the initialization mode, if there is not a current program
in the infuser, the device enters programming mode so the user can enter a new program.
If a program is already in the infuser, the user may:
- Use the current program. The infuser enters stop mode after the program is reviewed.
- Enter a new program. The infuser enters programming mode, then enters stop mode
after the program is reviewed.
Note: If the infuser has been powered-off for less than five minutes, a program
review is not required.
See Figure 1-1 for an illustration of the infuser.
430-600203-003 (Rev. 07/05)1 - 6GemStar
®
1.8 OVERVIEW
1.8
OVERVIEW
The following sections describe therapy options, differences between therapies, safety
features, power sources, and basic operation of the infuser.
1.8.1
THERAPIES
The GemStar® offers the following seven types of therapy:
- Pain Management
- Total Parenteral Nutrition (TPN)
- Intermittent
-Weight Dosed
-Continuous
- mL/hr Only
-Variable Time
Note: The availability of these programs may vary, depending upon the configuration
of the infuser in use.
1.8.2
CONFIGURATION DIFFERENCES
The infuser is shipped from the factory with one of the configurations described
in Table 1-2. The infuser configuration is easily identified by the end cap color.
Table 1-2. Configuration List Numbers
Therapies13000 (Blue)13100 (Gray)13150 (Yellow)
Pain Management
TPN
Intermittent
Weight Dosed
Continuous
mL/hr Only
Variable Time
Technical Service Manual1 - 7430-600203-003 (Rev. 07/05)
SECTION 1 INTRODUCTION
1.8.3
SAFETY FEATURES
Table 1-3 describes the special safety features of the GemStar®.
Table 1-3. Safety Features
Safety FeatureDescription
Proximal occlusion detectionStrain gauge
Distal occlusion detectionStrain gauge
Settings: low, medium, and high sensitivity
Air-in-line detectionUltrasonic settings: 0.5 mL, 2 mL, and Off
Motor monitoring circuitRedundant and independent monitoring
systems
Motor parameter monitoringMotor encoder and camshaft flag monitored
by optical sensor
Self testsInitialization and self test at power-on
Continuous self tests during operation
1.8.4
POWER SOURCES
The infuser can be powered by two internal AA disposable batteries, an external
rechargeable battery pack, AC mains adaptor, or docking station. External supply voltage
must not exceed 3.3 V
Install two fresh, disposable AA batteries for backup power when using an external power
source. The infuser will continue to operate on backup power if the external power
source fails.
CAUTION: To assure proper operation when using internal batteries, always
replace both batteries with fresh, disposable AA batteries when a change is required.
Use of rechargeable batteries in the battery compartment is not recommended.
CAUTION: Always connect to a grounded AC outlet when using the AC adaptor.
Use only an AC adaptor specifically labeled for use with the GemStar
battery pack. During charging, if the battery pack becomes hot to the touch,
immediately disconnect from AC power and contact Hospira Technical Support
Operations.
CAUTION: Do not touch exposed connectors on the bottom of the infuser. Exposed
connectors are susceptible to electrostatic discharge (ESD) damage.
DC
.
®
to charge the
430-600203-003 (Rev. 07/05)1 - 8GemStar
®
1.8 OVERVIEW
1.8.5
OPERATION
The infuser is microprocessor-based and is programmed using a 23-key keypad on
the front of the device (see Figure 1-1). The 16-character-by-4-line backlight display
indicates the status of the infuser.
The infuser has up to seven therapies available, depending on its configuration. Delivery
rates and bolus dosage amounts are programmed in one of three units of measure:
milliliters (mL), milligrams (mg), or micrograms (mcg). A loading dose is programmable for
immediate delivery or delayed delivery. Bolus doses can be programmed to begin delivery
on-demand.
To program the infuser, the operator selects the following:
- Therapy type
- Delivery type: volume delivery (mL) or mass delivery (mg or mcg)
- Concentration (only if mass delivery is selected)
- Delivery rate
- Loading dose, if desired
- Bolus dose, if desired
- Total amount to be delivered: volume to be infused (VTBI)
If mass delivery is selected, the infuser automatically converts mg or mcg to the closest
number of tenths-of-mL. The amount of fluid delivered is shown on the display.
When a bolus is programmed, a minimum lockout time between boluses must also
be programmed. In addition to the lockout time, the operator can also program the
maximum total volume that can be delivered in a selected period.
The infuser contains a time-of-day clock and event history storage capability. The program
settings, significant events that take place while a protocol is running, and the associated
time and date, can be reviewed on the display. The event history can be printed to a
compatible printer or downloaded as an ASCII text file to a computer with the use of the
GemStar
For specific instructions regarding infuser operation and optional system components,
refer to the system operating manual.
®
serial printer cable.
Technical Service Manual1 - 9430-600203-003 (Rev. 07/05)
SECTION 1 INTRODUCTION
BOLUS (BUTTON)
TOP CAP
GRIP
KEYPAD
SILENCE
1
4
7
PURGE
TOP VIEW
START
STOP
2
5
3
6
89
0
NOHELP
POWER
ON/OFF
BACK-UP
CHANGE
OPTIONS
YES
ENTER
CASSETTE EJECT
BUTTON
TOP CAP
BEZEL DISPLAY WINDOW
BEZEL ASSEMBLY
BOTTOM CAP
FRONT VIEW
BATTERY DOOR RECESS
BATTERY DOOR VOID LABEL
BATTERY DOOR
BATTERY PACK CONNECTOR
3 VDCBOLUS
BOTTOM VIEW
AC POWER CONNECTOR
DATAPORT CONNECTOR
BOLUS CONNECTOR
CONNECTOR LABEL
BOTTOM CAP
04K02001
Figure 1-1. Illustration of the Infuser
430-600203-003 (Rev. 07/05)1 - 10GemStar
®
Section 2
WARRANTY
Subject to the terms and conditions herein, Hospira, Inc., herein referred to as Hospira,
warrants that the product shall conform to Hospira's standard specifications and be free
from defects in material and workmanship under normal use and service for a period of
one year after purchase. Hospira makes no other warranties, express or implied, as to
merchantability, fitness for a particular purpose, or any other matter.
Purchaser's exclusive remedy shall be, at Hospira's option, the repair or replacement
of the product. In no event shall Hospira's liability arising out of any cause whatsoever
(whether such cause be based in contract, negligence, strict liability, other tort,
or otherwise) exceed the price of such product, and in no event shall Hospira be liable for
incidental, consequential, or special damages or losses or for lost business, revenues,
or profits. Warranty product returned to Hospira must be properly packaged and sent
freight prepaid.
The foregoing warranty shall be void in the event the product has been misused, damaged,
altered, or used other than in accordance with product manuals so as, in Hospira's
judgment, to affect its stability or reliability, or in the event the serial or lot number has
been altered, effaced, or removed.
The foregoing warranty shall also be void in the event any person, including the Purchaser,
performs or attempts to perform any major repair or other service on the product without
having been trained by an authorized representative of Hospira and using Hospira
documentation and approved spare parts. For purposes of the preceding sentence,
“major repair or other service” means any repair or service other than the replacement
of accessory items such as batteries, flow detectors, detachable AC power cords, and
patient pendants.
In providing any parts for repair or service of the product, Hospira shall have no
responsibility or liability for the actions or inactions of the person performing such repair
or service, regardless of whether such person has been trained to perform such repair
or service. It is understood and acknowledged that any person other than a Hospira
representative performing repair or service is not an authorized agent of Hospira.
Technical Service Manual2 - 1430-600203-003 (Rev. 07/05)
SECTION 2 WARRANTY
This page intentionally left blank.
430-600203-003 (Rev. 07/05)2 - 2GemStar
®
Section 3
SYSTEM OPERATING MANUAL
A copy of the system operating manual is included with every GemStar® infuser.
Insert a copy here for convenient reference. If a copy of the system operating manual is not
available, contact Hospira (see Section 6.1, Technical Assistance).
Technical Service Manual3 - 1430-600203-003 (Rev. 07/05)
SECTION 3 SYSTEM OPERATING MANUAL
This page intentionally left blank.
430-600203-003 (Rev. 07/05)3 - 2GemStar
®
Section 4
THEORY OF OPERATION
This section describes the theory of operation for the GemStar®. The theory of operation
details the electro-mechanical and cassette systems. Related drawings are provided
in Section 9.
4.1
ELECTRO-MECHANICAL SYSTEMS
The following sections describe the functions and electronic circuitry of the infuser.
4.1.1
CPU SYSTEM
The central processing unit (CPU) system consists of the following components:
❏ CPU: controls infuser operation
❏ Memory
- RAM: stores temporary therapy program data; stores ROM program during
software updates
- ROM: stores the operating program
❏ Field programmable gate array (FPGA): provides auxiliary logic functions to operate
the infuser
®
See Figure 4-1, GemStar
4.1.1.1
Block Diagram, and Figure 4-2, Board Connector References.
CPU
The CPU (U2) is a Motorola MC68L11K1 8-bit processor powered by 3.3 VDC. It operates
at 2 MHz using a self-contained buffer and crystal Y1. The clock is divided by four to
provide a 500 kHz bus clock (E-clock). Capacitors C9 and C11 provide the proper loading
of the crystal.
The CPU provides the following:
- Separate data, address, and extended
address lines
- On-chip EEPROM for non-volatile
configuration status
- Serial UART port
- Serial peripheral port
- 4-channel, 8-bit pulse-width
modulated output
- Non-maskable and maskable
interrupt inputs
Technical Service Manual4 - 1430-600203-003 (Rev. 07/05)
- General purpose input and output
lines (I/O)
SECTION 4 THEORY OF OPERATION
Audio
Driver
Backup Power
U7
ROM
512K x 8
(29BV040)
FLASH MEM
D
XA
CS
A
R/W
U8
32K x 8
D
CS
SRAM
A
LED
LED
(Red)
Alarm
Power
(Yellow)
Bolus Jack
Interface
U9
FPGA
A
D
CS / IRQCS/IRQ
R/WR/W
Keypad
LED Drive
/Shaft IRQ
Encoder Signal
Digital Port I/O
CS
E-CLK
Bolus Switch
/TOD IRQ
/RST/RST
U10
DRIVER
BACKLIGHT
CS
IRQ
/TOD
CLOCK
D
CS
A
EL Backlight
CS
DISPLAY
D
E-CLK
A0
/RST
R/W
Backup Power
U3
XA
TIME-OF-DAY
Y2
Address Bus
Data Bus
XA(13..18)
Bus
Ext Addr
Digital Ports
Y201
U105
U201
+5V
+5V
DC-DC
PIC
BEEPER
Power Select
12C508
WD Fault
U202
WDT PIC
+3.3V
U108
Switch
12C508
WDTri
-5V
-5V
DC-DC
To motor drive
Y1
/RST
SUPERVISOR
+3.3V
VPWR
Backup Power
WDTri
g
Backup Battery
RAMCS
/XIRQ
RAMCS1
U1
MICRO-P
g
+5V
VPWR
+3.3V
PWM3
/XIRQ
RAMCS1
Ext-Addr
CS Flash
g
WDTri
U2
68L11K1
SDI
Microcontroller
E-CLK
A/D Input
A/D Input Ports
Digital Ports
U109
+3.3V
DC-DC
BT201
Battery
Lithium
Air
Ultrasonic
Piezo
Air Transmit
Circuit
U101, U102,
U103, U104
AA
Internal
Batteries
Power Sensing
Proximal
Pressure
Pressure
Proximal
Circuit
Sensor
Distal
Circuit
Pressure
MOTOR DRIVE
Motor
Addr
Digital I/O
and
CIRCUIT
Data
PW1
D/C-D/C
CONVERTER
WD Fault
Motor
/Shaft IRQ
SCI
Encoder
Motor Encoder Signals
Output Shaft Encoder Signals
RS232
INTERFACE
LT1331
Connector
Distal
Ext
Power
Signal
Ext_Pwr
Sensor
Pressure
Piezo
Air Receive
Drive
Mechanics
Output
Shaft
Encoder
Serial Data
Figure 4-1. GemStar® Block Diagram
430-600203-003 (Rev. 07/05)4 - 2GemStar
04K02010
®
000
TOP BOARD
CPU, MEMORY, RTC, SERIAL PORT
4.1 ELECTRO-MECHANICAL SYSTEMS
J1
DISPLAY
CHASSIS GROUND
CONTACT
BATTERY SPRING
BATTERY CONTACT
MOTOR
J101
J104
J108
J106
J2
J102
J105
J3
J103
100
MIDDLE BOARD
MOTOR CONTROL,
POWER CONVERSION
J4
J110
J109
J107
PUMP BOTTOM
EXTERNAL CONNECTOR
KEYPAD
AIR
RECEIVER
AIR
TRANSMITTER
J203
J204
J205
200
BOTTOM BOARD
J207
J206
AUDIBLE BEEPER
PRESSURE SENSOR, AIR SENSOR
PROXIMAL
PRESSURE
DISTAL
PRESSURE
J201
J202
04K02002
Figure 4-2. Board Connector References
Technical Service Manual4 - 3430-600203-003 (Rev. 07/05)
SECTION 4 THEORY OF OPERATION
4.1.1.2
MEMORY
The operating program is stored in a 512K x 8 flash ROM (U7) that can be reprogrammed
with software updates.
Note: The program cannot be modified without special tools and protocols.
A 32K x 8 low-power static RAM (U8) is used to store the following data:
- Specific patient delivery protocols
-User options
- History records
- Operating program during Flash ROM programming
When the infuser is powered off, an on-board lithium battery provides power
to the RAM chip.
4.1.1.3
FPGA
The FPGA (U9) is a specially programmed IC that incorporates auxiliary logic for the
infuser. The FPGA provides the following:
-Input/output mapping
- Keypad interface
- Buffering and control of interrupt signals
- Additional logic interfaces for the infuser
- Motor encoder logic
The FPGA interfaces to the CPU through the address and data bus.
4.1.2
CPU SUPERVISORY FUNCTIONS
A MAX793R supervisory IC (U1) provides a secondary check for proper CPU functioning
and monitors the following:
- Primary power source (V
- 3.3 volt power supply (V
- Battery backup switch over
- Power-on and brownout reset
4.1.2.1
SUPPLY MONITORING
PWR
CC
)
)
Whenever the 3.3 V power supply (VCC) drops below a safe system operating voltage
of 2.6 V
watchdog circuitry to sound an alarm. U1 also monitors the primary power (V
provides early detection of loss of primary power to the infuser. If V
power fail input (PFI) voltage of approximately 1.3 V
be expected. When this happens, U1 interrupts program execution with a non-maskable
interrupt via signal /PFO. This interrupt signals the microprocessor to execute
a power-down routine that gracefully stops the motor, saves current data, and powers off
the infuser.
430-600203-003 (Rev. 07/05)4 - 4GemStar
, U1 generates a system reset (/RST) that stops the computer and forces the
DC
drops below the
, imminent loss of 3.3 VCC power can
DC
PWR
PWR
) and
®
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.2.2
POWER-ON RESET
During power-on or other reset conditions, the supervisory circuit holds the system in
reset for 140 ms after V
starting normal operation. During reset conditions, the reset signal interfaces with all
circuitry to assure conditions are held in a safe operational state (e.g., motor stopped).
4.1.2.3
reaches 2.6 VDC to assure the system has stable power prior to
CC
MEMORY AND TIME RETENTION
Whenever all power sources are disconnected from the infuser, an internal 3.0 V lithium
battery (BT201) provides power to retain memory and real-time clock operation.
The lithium battery provides approximately three years of backup power from the time
of infuser assembly. U1 monitors power, and whenever the supervisory circuit detects that
the logic power is low (approximately 2.6 V
appropriate circuits. A series 100 Ω resistor (R227) is used to measure the lithium current
during off conditions. Voltage across R227 is normally less than 0.6 V
4.1.2.4
), it switches the lithium battery power to the
DC
(6 µA).
DC
WATCHDOG FUNCTION
U1 has a built-in secondary watchdog detection circuit (WDT) that provides a secondary
check for proper CPU operation. The primary watchdog circuit is implemented using two
programmable integrated circuit (PIC) microcontrollers on the bottom board
(see Section 4.1.2.6, WDT PIC/Beeper PIC/Beeper Driver).
During normal operation, the CPU provides a one-second timing signal (WDTRIG) to the
supervisory circuit indicating proper operation. If the WDTRIG signal is greater than
approximately 1.6 seconds, the supervisory circuit will generate a system reset and stop
all infuser operations.
Each of the following signals are driven low during system reset:
- Motor on (MOTORON)
- Motor drive enable (MOTDRVEN)
- Motor speed control (MOTSPCTL)
4.1.2.5
CPU ERROR CHECKING/WATCHDOG CIRCUITRY
The CPU is the primary error detection and checking component. When error conditions
exist, the CPU generates an alarm, warning, or other action appropriate to the conditions.
For example, it stops delivery when out-of-tolerance conditions are sensed.
The watchdog (U202) PIC has been designed to monitor the CPU for error-free operation.
The CPU toggles the logic state of the watchdog trigger (WDTRIG). If the CPU becomes
unstable, this signal will either not be generated or will have incorrect timing. The PIC
processors monitor the WDTRIG signal for the correct timing. Whenever this signal is out
of tolerance (1 sec ± 25%), U202 stops the motor (using the WDFLT signal) and sounds
an alarm independent of the CPU.
Technical Service Manual4 - 5430-600203-003 (Rev. 07/05)
SECTION 4 THEORY OF OPERATION
4.1.2.6
WDT PIC/BEEPER PIC/BEEPER DRIVER
The watchdog WDT PIC (U202) is clocked from an external 32 kHz oscillator and crystal
Y201 independent of the CPU clock. It monitors the WDTRIG signal for correct timing
(change of state once a second). If either clock is in error or if the WDTRIG from the CPU
is incorrect, the watchdog fault signal (WDFLT) goes low. This causes the beeper PIC (U201)
to generate an audible alarm and the motor servo switching current source (U102) to stop
the motor. When the infuser is turned off during normal power-down, the power-on
(POWERON) signal from the CPU inhibits a WDTRIG fault while the power supply supercap
discharges.
The beeper PIC (U201) can sound the beeper from the following two independent sources:
- Watchdog fault (WDFLT) signal from the WDT PIC (U202)
- Beeper control signal (BEEPCTL) from the CPU (U2)
When there is a watchdog fault, the WDFLT signal is activated and has the highest priority.
When this happens, the motor turns off and the infuser stops. This causes the beeper PIC
to produce an audible tone every five seconds.
The beeper PIC uses an internal 4 MHz oscillator and generates a predefined frequency
and duty cycle for WDFLT faults. The CPU sends the BEEPCTL signal to generate audio
output, such as audible operator alarms or keypad feedback. The beeper PIC passes the
BEEPCTL signal frequency and duty cycle to the beeper. This allows different tones,
duration, and volumes.
If the 3.3 V
CPUs are reset. R201, R202, R203, D204, and Q203 (brownout detector) provide
a reset-generator, which nominally trips at 2.1 V
When power losses occur, such as an accidental disconnection of the AC adapter with no
battery backup, two .047 F capacitors (supercaps) maintain the 3.3 V supply for
approximately 10 seconds. This allows the CPU to execute an orderly shutdown, and
provides enough power to the watchdog circuit to sound an audible alarm every five
seconds after power loss (at least three audible beeps).
supply drops below the minimum PIC operating level of 2.5 VDC, the PIC
CC
.
DC
4.1.3
DISPLAY MODULE/BACKLIGHT
The display module is a 64-by-128 dot matrix LCD array with control and memory
circuitry. The CPU and FPGA generate the display control signals. Since the display
consumes only 1 mA, it is powered from a logic gate (U4A) that goes low when powered
off. This allows the display to clear within seconds after power-off.
Note: Display contrast can be factory adjusted.
An electroluminescent (EL) backlight illuminates the display. The CPU turns on the
backlight drive circuit (U10) when a key is pressed or when AC mains power is applied.
430-600203-003 (Rev. 07/05)4 - 6GemStar
®
4.1 ELECTRO-MECHANICAL SYSTEMS
4.1.4
KEYPAD/LEDS
A 23-key keypad receives operator input. One of these keys is used for power on/off
(see Section 4.1.9, Infuser On/Off Control). Each of the other keys is at a distinct junction
of an array of four columns and six rows, strobed by the FPGA approximately every 30
milliseconds. Pressing a key connects a row to a column. As the FPGA energizes each row,
the columns are monitored and the FPGA determines which key has been pressed.
A software routine eliminates noise (debounce) when the keys are pressed.
Two signal LEDs are mounted on the keypad and driven under software control, via FPGA
outputs. The yellow LED illuminates when AC mains power is connected to the infuser.
The red LED illuminates during an alarm condition, and is accompanied by an audible
alarm and a display message, when applicable.
4.1.5
BOLUS SWITCHES
Patients can request a bolus dose for pain management and variable time protocols.
The bolus switch (SW101) is located on the top of the infuser and is protected by a rubber
end cap. The bolus switch signal (logic low) is buffered, inverted (U4C), and passed to the
FPGA (U9-11) as the bolus request (BOLUSREQ) signal. The bolus request is latched by
the FPGA and passed to the CPU as an interrupt.
An external (remote) bolus pendant can be connected to the bolus connector on the bottom
of the infuser. The remote bolus pendant is wired in parallel with SW101. There is no
distinction between the infuser bolus switch and the remote bolus switch. The buffering
provided for the bolus request signal (U4C) allows for electrostatic discharge (ESD)
rejection.
4.1.6
TIME-OF-DAY CLOCK
The infuser has a separate time-of-day clock (U3). The time is displayed at power-on
and can be reset by the operator. This clock is used to provide the following:
- Schedule deliveries
- Record infuser history and event timing
- Generate a precise one-second CPU interrupt for timing functions
The internal lithium battery (BT201) powers the clock when no other power source
is present.
Technical Service Manual4 - 7430-600203-003 (Rev. 07/05)
SECTION 4 THEORY OF OPERATION
4.1.7
POWER INPUT SENSING/SELECTION CIRCUITRY
The infuser can be powered by two internal disposable AA batteries, or an external power
source connected to the 3.3 V connector on the bottom of the infuser (see Figure 4-3,
Power Input). Power is applied to the internal voltage-power (V
or disconnected when the infuser is powered on or off (see Section 4.1.9).
) line, which is connected
PWR
Battery power connects to V
through a fuse (F101) and a field effect transistor (FET)
PWR
switch (Q110 A and B) controlled by comparator U110. The FET switch has an intrinsic
forward diode, which allows sufficient battery current for the infuser to power-on when
only batteries are present.
External power (EXTPWR) connects to V
through an isolation diode D106. Comparator
PWR
U110 senses the external voltage and automatically switches to external power when the
external voltage (EXTPWR) is greater than approximately 1.8 V. When this happens,
transistors Q106 and Q104 turn off the FET switch (Q110 A and B) to disconnect the
internal batteries. The MAX965 (U110) has its own internal reference voltage at U110-6
of 1.235 V, which it uses to measure the switching point.
The external supply source may be from a DC supply connected to AC mains power or from
an external battery. If the source is derived from AC mains power, a separate signal line
is pulled high (to 3 volts). On external battery power, the signal line is low. The CPU
monitors this signal line through the multiplexer (U106-4) and the A/D converter.
The CPU uses this information when monitoring the external voltage to display
appropriate messages (e.g., ON BATTERIES; LOW BATTERIES) or to turn on the power
LED. The CPU monitors power source voltages. The internal (battery) and external voltages
are connected to the CPU A/D input port through the multiplexer, MUX U106 (U106-13
and U106-15).
430-600203-003 (Rev. 07/05)4 - 8GemStar
®
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