baxter Flo-Gard 6301 User manual

Operator's Manual
Flo-Gard® 6301
Dual Channel Volumetric
Infusion Pump

Table of Contents
Introduction..............................................................................................1
Physical Description...............................................................................3
Operating Instructions..........................................................................10
Precautions ......................................................................................10
Loading the Pumps...........................................................................11
Starting a Primary Infusion ...............................................................15
Starting a Secondary Infusion...........................................................18
Using Volume-Time Programming....................................................19
Changing the Flow Rate While the Pump Is Running.......................21
The OPTIONS Key ...........................................................................22
Using the Programmed Delivery Profile Feature........................22
Computer Control.......................................................................25
Computer Monitoring..................................................................26
Locking the Front Panel....................................................................26
Battery Powered Operation ..............................................................27
FLOW CHECK Information Display..................................................27
Cleaning and Storage ...........................................................................28
Alerts and Alarms .................................................................................29
Technical Specifications ......................................................................34
Configurable Options............................................................................36
Warranty and Service Information.......................................................41
Warranty ...........................................................................................41
Service Information ..........................................................................42
7-19-B1-564 i

Change record
7-19-01-564
Original issue: 7/92
Rev. A: 9/92
Rev. B: 05/93
Page Revision
Front cover 0
iB
ii B
1–4 0
5A
6–8 0
9A
10–14 B
15 0
16–17 B
18-30 0
31–32 B
33 0
34 A
35–38 0
39–42 B
Back cover B
A zero in the “Revision” column indicates original issue.
ii 7-19-B1-564

Introduction
The lo-Gard®6301 Dual Channel Volumetric Infusion
Pump from Baxter can deliver a wide variety of fluids over
a broad range of infusion rates. The device's features in-
clude:
•Uses only standard Baxter®solution administration
sets.
•Two separate pump channels allow it to do the work
of two conventional pumps, resulting in space sav-
ings.
•Configurable settings allow the device to be custom-
tailored to best suit the hospital's needs.
•Computer control capability allows remote control
or monitoring of the device via a standard RS-232C
interface.
•Infuses a wide variety of fluids, including blood and
fat emulsions.
•Suitable for use in epidural administration.
•Safety clamp automatically occludes the tubing
when the pump door is opened.
•Occlusion sensors detect both upstream and down-
stream restrictions. Sensitivity of the downstream
occlusion sensor is selectable through the device's
configuration.
•low check display shows resistance to flow.
•Ultrasonic air-in-line detectors. Sensitivity of the
air detectors is selectable through the device's con-
figuration.
•Each pump channel features a Programmed Deliv-
ery Profile that enables programming of up to 10 se-
quential infusion programs for situations where
ramping of medications are indicated.
7-19-B1-564 1

•Slide clamp loading option provides flow shut-off
when I.V. set is removed from the pump.
•Locking control panel helps prevent patient tamper-
ing.
•Each pump channel features an independent secon-
dary medication program. The channel automati-
cally switches over to the primary program upon
completion.
•Volume-Time programming automatically calcu-
lates flow rate.
•Automatic self-test routine checks for proper func-
tion before use.
•ive-hour memory retains infusion data after
power-off.
•Easily replaceable fuse, battery, and power cord.
•Access to test points and internal program simpli-
fies servicing and software upgrades.
•Device can be configured to display a hospital area
designator, such as “
ONCOLOGY ”or“ CARDIAC
ICU
,” upon power-up.
2 7-19-B1-564

Physical Description
Items 1 through 9 are associated with Pump 1 and are de-
scribed below. The controls associated with Pump 2 are
identical and function in exactly the same manner. Items 10
through 28 are common to the operation of both pumps. All
front panel items are shown in igure 1.
Front Panel
ITEM FUNCTION
1. Pump 1 ON
OFF/CHARGE key Turns Pump 1 on and off. The internal battery charger re-
mains on regardless of the ON OFF/CHARGE key as long as
the device is plugged in.
2. Pump 1 door
latch Opens and closes pump door for I.V. set loading and removal.
3. Pump 1 STOP key Stops Pump 1 until further instructions are given. The mes-
sage
STOPPED appears when the key is pressed. An alert
sounds if Pump 1 is stopped for more than two minutes.
Clears all programming alerts while pump is running.
4. PUMP 1 key and
indicator Allows keypad and other controls common to both pumps to
accept data for Pump 1 programming. Yellow LED lights to in-
dicate that Pump 1 is selected.
5. Pump 1 main dis
play Shows rate, volume to be infused (VTBI), and total volume in-
fused for Pump 1 primary and secondary infusion programs.
The decimal point is displayed as an underscore (example:
99_9).
6. Pump 1 message
display Shows all Pump 1 messages and messages that apply to the
device as a whole.
7. Pump 1 ALARM
LED Red LED that blinks on and off during a Pump 1 or general
alarm, accompanied by a message display and a repeated se-
quence of three tones. An alarm indicates that Pump 1 or the
device as a whole requires immediate attention.
8. Pump 1 PUMPING
LED Green LED which is constantly lit while Pump 1 is pumping.
9. Pump 1 ALERT
LED Yellow LED which lights during Pump 1 and general alerts,
accompanied by a message display and a repeated single tone.
An alert indicates that Pump 1 or the device as a whole needs
timely attention.
7-19-B1-564 3

Front Panel
ITEM FUNCTION
10. BACK LIGHT key Backlights the displays when pressed. Pressing the key again
turns the backlight off. If the device is operating on battery
power, the backlight remains on for 60 seconds when the
BACK LIGHT key is pressed.
11. SILENCE key Temporarily silences an audible alarm or alert for two min-
utes, unless another alarm or alert occurs on either pump
within the two-minute silence period. All messages remain
displayed.
12. NEXT legend Lights when theTOT VOL STATUS key is functioning as the
NEXT key.
13. TOT VOL/STATUS
key Displays total volume delivered for each pump. The key is also
used to advance to the next step when programming a delivery
profile. (See NEXT legend, item 12 above.)
14. CLEAR TOT VOL
key Resets the total volume delivered by the selected pump to zero
if pressed when the pump is stopped.
15. TIME key Enters the time over which an infusion is to take place during
Volume-Time programming.
16. PRI RATE key Allows programming of the primary infusion rate for the se-
lected pump.
17. PRI VTBI key Allows programming of the primary VTBI for the selected
pump.
18. PRI START key Starts the primary infusion for the selected pump.
19. Plug icon Always lit while the device is plugged in and the battery is
charging.
20. MONITOR legend Lights when the device is being queried by the computer dur-
ing computer monitoring.
21. Battery icon Lights when the device is operating on battery power.
22. COMPUTER CON
TROL legend Lights when the device is being controlled by a remote com-
puter.
23. CLR key Clears any programming values currently being entered.
24. SEC START key Starts the delivery of the secondary infusion for the selected
pump.
4 7-19-B1-564

Front Panel
ITEM FUNCTION
25. SEC VTBI key Allows programming of the secondary VTBI for the selected
pump.
26. SEC RATE key Allows programming of the secondary infusion rate for the se-
lected pump.
27. Numerical keypad Programming values and decimal point are entered with these
keys.
28. OPTIONS key Allows the device to enter an enabled optional mode. These
may include the Programmed elivery Profile (P P) or Com-
puter Control modes. If Programmed elivery Profile and/or
Computer control is available, the OPTIONS key is lit.
7-19-B1-564 5
Rev. A
P MPING
ALERT
PRI
START
7
8 9
45
6
12
3
0
.
CLR
ALARM
PRI
VTBI
PRI
RATE
SEC
RATE SEC VTBI SEC
START COMP TER
CONTROL
MONITOR
P
S
H
®
P
S
H
P MPING
ALERT ALARM
P MP
1
P MP
2
CLEAR
TOT VOL
STOP
TIME
BACK
LIGH T
ON
OFF
CHARGE
STOP
OPTIO NS
TOT VOL
STAT S
NEXT
VOL METRIC INF SION P MPD AL CHANNEL
Flo-Gard® 6301
SILENCE
CHARGE
ON
OFF
1
2
3
4
5
6
78910 11 12 13 14 15
16
17
18
19
20
21
22
23
24
25
26
28
27
Figure 1. Front View

igure 2 shows Pump 2 only. Pump 1 has identical features,
which function in the same manner.
Pump Head Features
ITEM FUNCTION
1. Upstream occlusion sensor Detects a tubing restriction upstream of the
pump.
2. Pumping fingers The linear peristaltic pump mechanism consists
of cam-driven pumping fingers which succes-
sively manipulate the tubing against the back-
plate, resulting in fluid movement in a
downward direction.
3. Downstream occlusion
sensor Detects tubing restrictions downstream of the
pump. The sensitivity level can be adjusted to
suit the needs of the hospital through the de-
vice's configuration.
4. Air sensor Detects air bubbles in the tubing. The sensitivity
is adjustable via the device's configuration.
5. Safety clamp Prevents accidental fluid flow by automatically
occluding the tubing whenever the pump door is
opened.
6. Slide clamp slot The slide clamp loading option is selectable
through the configuration. When the slide clamp
loading option is enabled, the I.V. set's slide
clamp must be inserted into this slot. The opera-
tor must push the slide clamp into the slot to oc-
clude the tubing before the I.V. set can be
removed from the pump.
7. Slide clamp spring retainer If your hospital has not selected the slide clamp
loading option, this spring retainer is inserted
into the slide clamp slot, preventing the insertion
of the slide clamp.
6 7-19-B1-564

7-19-B1-564 7
Figure 2. Pump 2 With Door Open
1
3
4
5
2
6
7

The following items are located on the rear of the device
and are shown in igure 3.
Rear Panel Features
ITEM FUNCTION
1. I.V. pole clamp Secures the device to the I.V. pole.
2. Power cord strap Stores the power cord.
3. Audio speakers or generation of alarm and alert tones.
4. Battery compartment Allows easy access to the battery. ( or use by
authorized service personnel only.)
5. Fuse use compartment is located behind the power
cord cover.
6. Power cord Supplies AC power when plugged into a
hospital-grade earth-grounded outlet. Remov-
able by authorized service personel only.
7. PANEL LOCK switch Disables all front panel keys except BACK
LIGHT and TOT VOL/STATUS when pressed.
8. COMMUNICATIONS PORT Standard RS-232C port that allows the device to
communicate with a computer and provides the
nurse call signal when enabled.
9. VOLUME knob Adjusts volume of alert and alarm tones. The
tones cannot be turned completely off.
8 7-19-B1-564

7-19-B1-564 9
Rev. A
PANEL LOCK
VOLUME
COMMUNICATIONS
PORT
(PUSH)
13
4
5
6
7
8
2
9
Figure 3. Rear View

Operating Instructions
Precautions
General
•DANGER—Poss ble explos on hazard f used
n the presence of flammable anesthet cs.
•Operate device from 115 V, 60 Hz, hospital-grade
earth-grounded outlet only.
•Though the factory-supplied configuration settings
are suitable for most therapies, the operator and
hospital professionals should verify that the device's
settings are appropriate for their clinical applica-
tions.
•Use only with standard Baxter®soft tubing admini-
stration sets with an “s” designation.
•Read and understand this manual before using this
device.
•When infusing fluid through a central line catheter,
Baxter recommends that sets with a Luer lock
adapter be used.
•If using a filter set, use only filters which are suit-
able for use with infusion pumps. Read and follow
instructions of the filter to be used.
•To use the automatic piggyback function, use only
Continu- lo®sets from Baxter as the primary line
with a compatible secondary set for the secondary
line.
•As with all medical electronic equipment, care must
be exercised to avoid exposing this device to power-
ful sources of electromagnetic interference. This de-
vice design has been tested to the requirements of
10 7-19-B1-564

MDS–201–004, and applicable portions of
MIL–STD–461C, which are voluntary test guide-
lines for electromagnetic susceptibility and emis-
sions. This device was not found to be adversely
affected by the susceptibility tests in these specifica-
tions, and will perform safely. The device's emis-
sions were also found to be acceptable.
Epidural Administration
•Epidural administration of anesthetics is limited to
short-term infusion (not to exceed 96 hours) with in-
dwelling catheters specifically indicated for short-
term anesthetic epidural drug delivery.
•Epidural administration of analgesics is limited to
use with indwelling catheters specifically indicated
for either short-term or long-term analgesic
epidural drug delivery.
•To prevent infusion of drugs that are not indicated
for epidural use, do not use administration sets that
incorporate injection sites during epidural delivery.
•It is strongly recommended that pumps used for
epidural drug delivery be clearly differentiated from
pumps used for other routes of administration.
•WARNING—Ep dural adm n strat on of drugs
other than those nd cated for ep dural use
could result n ser ous njury to the pat ent.
Loading the Pumps
1. Plug the device in. Plug power cord into a 115 V, 60 Hz
grounded outlet, unless temporary bat-
tery power is required. The plug icon
lights whenever the device is plugged in.
When the device is not plugged in and is
on battery power, the battery icon lights.
7-19-B1-564 11

Note: The procedure for preparing and loading the admini-
stration set (steps 2 through 9) is the same for Pump 1
and Pump 2.
2. Prepare solution. Prepare fluid container and administra-
tion set according to the directions ac-
companying the products. Prime the set.
Ensure all air is expelled from the set.
3. Close set regulating
clamp.
4. Open pump door. Raise pump door latch to horizontal po-
sition and pull door open.
5. Load the I.V. set. a. Press SAFETY CLAMP to open position.
b. If your hosp tal has enabled the
sl de clamp load ng feature,in-
sert the slide clamp on the I.V. set
fully into the slot, so that it is flush
with the pump housing. (See igure
4.) If the slide clamp loading feature
is not enabled, a black spring re-
tainer occupies the slide clamp slot
and the slide clamp cannot be in-
serted. Proceed to step c.
Note: During an emergency, in the alert
mode, the pump can be operated ithout
inserting the slide clamp. An alert tone
sounds until the slide clamp is inserted or
SILENCE is pressed. In the alarm mode (soft-
are versions later than 1.08), the pump
ill NOT start and an alarm tone ill
sound if the slide clamp is not loaded.
12 7-19-B1-564
Figure 4. I.V. Set
Loading Diagram
Slide clamp
in slot

c. Load the tubing through the guide
channel from bottom to top as shown
in igure 4.
d. Ensure that the I.V. tubing is loaded
straight through the pump mecha-
nism tubing guides and safety
clamp.
e. Ensure that the tubing is touching
the pumping fingers before closing
the pump door.
6. Close pump door. If resistance is felt when closing the
door, check for a misloaded I.V. set.
7. Open set regulating
clamp completely.
a. Verify that no drops are falling in
drip chamber. If flow is observed,
close regulating clamp, recheck I.V.
set loading, and verify that the
proper administration set is being
used.
b. If flow is again observed, do not use
the pump. Have it inspected by serv-
ice personnel.
Note: Al ays close the administration set regulating
clamp(s) before opening pump door and removing set.
8. Attach set to I.V. access
site.
9. Turn pump(s) on by
pressing appropriate
ON/OFF CHARGE key(s).
Verify that the following
self-test occurs when you
turn on the first pump:
a. All segments of the Pump 1 and
Pump 2 message displays appear
momentarily. All segments of the
main display of the powered-on
pump appear momentarily.
b. Three separate audible tones sound.
7-19-B1-564 13

c. If a Hospital Area Designator (HAD)
has been programmed into the de-
vice, it is displayed for three seconds
in the Pump 1 message display.
d. The occlusion detection level is mo-
mentarily displayed in the Pump 1
message display (
LEVEL 1, 2, or 3 ),
followed by
AUDIBLE SWITCHOVER
if the Audible Switchover option is
enabled.
e. If Auto Restart and low Check are
both enabled,
AUTO RESTART ap-
pears for one second in the Pump 1
message display.
f. If the device is plugged into an AC
outlet, the plug icon is lit. If the de-
vice is operating on battery power,
the battery icon is lit.
g. If the message
INSERT SLIDE
CLAMP
appears when you close the
door, the slide clamp loading option is
enabled. Close the I.V. set's regulat-
ing clamp, open the door, and insert
the I.V. set's compatible slide clamp
fully into the slide clamp slot located
below the safety clamp. Close the door
and open the regulating clamp.
10. Set VOLUME knob on the
rear of the device to the
desired level.
14 7-19-B1-564

Starting a Primary Infusion
Note: The procedures for programming Pump 1 and Pump 2
are identical.
1. Select the pump you
wish to program.
Press PUMP 1 or PUMP 2 as appropriate.
The yellow LED on the PUMP key lights
to indicate that the pump is selected.
2. Set primary flow rate. a. Press PRI RATE.
b. Program desired flow rate (in
mL/hr) on keypad. Zero cannot be
entered as the first digit.
c. A selected flow rate higher than the
allowable maximum results in the
message
Hi appearing in the PRI
RATE display. To correct a mistake,
press CLR or PRI RATE again and re-
enter correct rate. The flow rate is
displayed in the main display of the
selected pump.
3. Set primary volume to
be infused.
a. Press PRI VTBI.
b. Program desired VTBI (in mL) on
keypad. Set VTBI equal to the
amount of fluid in the container or
less if desired.
c. To correct a mistake, press CLR or
PRI VTBI again and re-enter the cor-
rect VTBI. The VTBI is displayed in
the main display of the selected
pump.
4. Review infusion settings
and/or read total volume
infused.
Press TOT VOL/STATUS key.
VOLUME IN
FUSED
is displayed first, followed by
RATE and VTBI .
7-19-B1-564 15

5. If necessary, reset the
volume previously in-
fused on the selected
pump to zero.
Press the CLEAR TOT VOL key.
Note: Al ays verify programmed information prior to start-
ing the selected pump.
6. Start the pump. a. Press PRI START. The green
PUMP
ING
LED lights and a moving bar
appears next to the appropriate flow
rate setting.
b. If the alarm (software versions later
than 1.08) or the alert tone sounds
with the message
INSERT SLIDE
CLAMP
when you press PRI START,
the slide clamp loading option is en-
abled and the slide clamp has not
been loaded into the slide clamp slot.
Close the I.V. set's regulating clamp,
open the door, and insert the I.V.
set's slide clamp into the slide clamp
slot located below the safety clamp.
Close the door, then open the regu-
lating clamp.
c. Confirm flow by checking for drops
in the I.V. set drip chamber.
d. If Auto Restart is enabled and low
Check is not enabled,
AUTO RE
START
is displayed in the Pump 1
message display.
e. If you wish to program the other
pump, press its ON OFF/CHARGE key
and repeat steps 1 through 6.
7. To stop an infusion bef-
ore it is complete:
a. Press the appropriate STOP key.
16 7-19-B1-564