ZOLL Infusion Dynamics Power Infuser M100B-3A User manual

POWER
INFUSER
®
Operating
Instructions
Model M100B-3A
Infusion Dynamics
A Division of ZOLL Medical Corporation
5209 Militia Hill Road
Plymouth Meeting, PA 19462 USA
1 [phone] or 1 [phone]
FAX [phone]
www.infusiondynamics.com
RESTRICTED DEVICE: Federal law (USA) restricts this
device to sale by or on the order of a physician.
EC Authorized Representative: ZOLL International
Holding BV, PO Box 52, 6669 ZH Dodewaard,
The Netherlands. ([phone].
0197
EN

Contents
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . .2
Features & Warnings . . . . . . . . . . . . . . . . . . .3
Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Normal Operation . . . . . . . . . . . . . . . . . . . . .9
Troubleshooting . . . . . . . . . . . . . . . . . . . . . .13
Maintenance & Service . . . . . . . . . . . . . . . .16
Effect of Catheter on Max Flow Rate . . . . .19
Effect of IV Bag Elevation on Flow Rates ..20
Specifications . . . . . . . . . . . . . . . . . . . . . . . .21
Components . . . . . . . . . . . . . . . . . . . . . . . . .24
Power Infuser M100B-3A Operating Instructions
Re: Pump Part No. 0040-0013 (NSN 6515-01-499-5112)
Document No. 0080-0220 rev C 4/2005

2
Intended Use
The Power Infuser®Model M100B-3A is
intended to support primary intravenous fluid
resuscitation therapy to rapidly restore
intravascular volume and blood pressure in
patients with clinical shock, hypotension, and
hypoperfusion states as a result of hemorrhag-
ic blood loss, occult hemorrhage, neurogenic
shock and septic shock.
The device is intended for use by medical,
paramedical and EMT personnel in the field
and in pre-hospital and hospital environments.
When used with the Crystalloid/Colloid
Cartridge the device is intended to deliver
crystalloid and colloid resuscitative fluids
only. It is not intended to support the infu-
sion of blood or blood products.
When used with the Blood Cartridge the
device is intended to deliver crystalloid
and colloid resuscitative fluids, whole
blood and packed red blood cells.
The device is not intended to support the
delivery of any pharmaceutical or other med-
ications.

3
Features & Warnings
This is a unique infusion pump. Please make
a note of these features, as you may need to
change your infusion procedures.
High Flow Rates. The Power Infuser will
infuse IV fluids at rates up to 6 liters per hour
with no IV bag elevation. The pump has rate
settings of 0.2, 1, 2, 4 and 6 liters per hour.
This pump is not designed for low flows.
Do not use it to administer medications.
Automated Bolus. When set to BOLUS the
pump will infuse approximately 250 ccs in
2.5 minutes, then switch to standby.
Use a catheter that is large enough for
these high flow rates. See chart on p19.
Free Flow. Fluids can free flow through the
pump cartridge at all times in the forward
direction only. When the bag is elevated
above the patient the flow rate due to gravity
will be added to that generated by the pump.
The free flow rate is approximately 0.75
lph per foot of elevation when infusing
saline through an 18ga peripheral IV

4
catheter. This feature can add flexibility
in the way you use the pump. For exam-
ple, use gravity to generate a low keep-
vein-open rate or continue fluid delivery
when the pump is disconnected. However,
be aware that free flow can cause the
actual flow rate to be higher than the set
rate, particularly at the low settings.
In the event of a pump failure or unin-
tended free flow, the maximum volume of
fluid that can be infused will be deter-
mined by the volume remaining in the IV
bag (typically 1 liter maximum).
Air Elimination (crystalloid/colloid car-
tridge only). Filters in the crystalloid/colloid
pump cartridge will vent air from the IV line
once the cartridge has been primed.
Do not use blood or blood products with
the Crystalloid/Colloid Cartridge—the 1.2
micron filter will clog.
These membranes are not included in the
Blood Cartridge. When using the Blood
Cartridge, PURGE ALL AIR when prim-
ing and before starting the infusion.

5
Air Detection. If the pump detects air exiting
the cartridge it will stop pumping and signal
the air alarm.
When using the Crystalloid/Colloid
Cartridge this should only happen if the
cartridge has not been fully primed. The
air alarm can also be triggered if the car-
tridge becomes dislodged from the pump,
if the IV solution does not have any
saline content, or during the 10-20 sec-
ond adjustment period when a primed
cartridge is first attached to the pump or
when switching from saline to blood
through the same IV line.
Occlusion Detection. If the pump detects
excessive resistance to flow on the patient
side, the occ alarm will be triggered and the
pump will stop.
An upstream occlusion or an empty IV
bag will not trigger any alarms on the
pump. The pump motor will continue to
run but fluid flow will stop. Ensure that
upstream roller clamps are wide open to
achieve maximum flow rates, and moni-
tor the bag level as needed.

Long Battery Life. Six standard AAA size
alkaline batteries will run the pump for
approximately 8 hours at 6 liters per hour,
longer at lower rates.
When the battery can no longer sustain
the set rate, the batt alarm will flicker but
the pump will continue to operate, often
for another hour or more. When the bat-
tery is very low, the pump motor will stall
and all the alarm lights will turn on and
will not clear when the start/stop button is
pressed. Battery lifetime decreases when
cold.
Discard used batteries properly. May
explode or leak if recharged, inserted
improperly, disposed of in fire or mixed
with different battery types.
To operate under AC power, first turn
battery on/off switch to the off position.
Use only power adapters supplied by
Infusion Dynamics (p24)—use of an
unregulated power supply, or any supply
delivering >15VDC, may cause perma-
nent damage to the Power Infuser.
6

Under extreme circumstances (low
humidity, synthetic-covered floors) elec-
trostatic discharges to the Power Infuser
may cause it to alarm and interrupt fluid
delivery. Press start/stop to reset alarms
and again to resume flow.
Type BF (body floating) applied part
complying with IEC 60601-1.
7

8
Start/stop button
Press to reset alarms
and start or stop
pump. Hold down to
pump continuously
and override alarms.
Flow rate
selector
liters/hour
BOL=250cc
bolus
Alarms
air air exiting
cartridge
occ patient-side
occlusion
batt low battery
Pump status
standby
on (0.2 lph)
on (1-6 lph)
Controls
On/off switch
for battery power
Cartridge
release

9
Normal Operation
Setup and Prime
Connect bag, cartridge and IV sets
using standard IV bag spike with
Luer connectors. When infusing
blood products with the Blood
cartridge, always use an IV set
that is designed for blood products
and contains an appropriate screen.
Install cartridge: hold at an angle and engage
tab on the side of the cartridge;
swing over rocker until the 2
pegs on the cartridge snap
into the slots in the pump.
Turn pump on for battery
operation or connect option-
al power adapter.
Hold down start/stop to
prime entire IV set. Tap
cartridge to remove air
bubbles. Stop pump.
Air elimination membranes in the
Crystalloid/Colloid Cartridge will not
function until the cartridge is primed and
on off

10
the filter is completely wet. Air that is
trapped in the cartridge tubing may
reduce flow rates. Air bubbles that are
not cleared from the top of the filter dur-
ing priming may release later, triggering
the air alarm.
When using the Blood Cartridge, remove
all air from the system. Note: There is no
automatic air elimination system provided
in the Blood Cartridge design.
Attach IV set to patient catheter.
Recommended: 18ga 1-2in for
crystalloid, 16ga 1-2in for
colloid or whole blood;
14ga for warmed
packed cells. See
chart on p19.
Infuse IV Fluids
Set flow rate.
Numbered settings
(liters/hour) run con-
tinuously until
stopped. BOLUS
infuses approximately
250cc in 2.5 min
BOLUS
6
4
2
1
0.2
liters/hour

250cc in 2.5 minutes and then stops automati-
cally.
These settings are approximate and are
based on IV bag level with patient, crys-
talloid infusate and an 18ga peripheral
IV catheter. If IV bag is raised above
patient, fluids will free flow and rate will
be greater than setting. See p19 for
catheter size and fluid viscosity effects on
flow rates. Fully open all IV set clamps to
achieve maximum flow rates.
Press start/stop to begin infusion.
Change IV Bag
Monitor fluid level in
IV bag. Press start/stop to
pause pump.
Close clamp on IV set.
Change IV bag.
Open clamp on IV set. Press
start/stop to resume infusion.
11

End Infusion
Push to release cartridge.
Gravity-driven infusion
can continue with the
cartridge in-line.
After use, dispose of
cartridge and tubing sets in accordance
with applicable regulations.
Turn off pump or unplug power adapter.
on off
12

13
Troubleshooting
Problem:“air” indicator illuminated and unit
continues to alarm.
Solution:
(a) Unit may have detected air as fluid exits
the pump. If air bubble present extract air
before resuming flow. Press start/stop to
resume infusion.
(b) Check if cartridge has disconnected from
pump. Re-insert cartridge as described on p9.
Press start/stop to resume infusion.
(c) Fluid being delivered does not have ade-
quate salinity. Fluid must have a salinity
level greater than 0.15%. Press start/stop to
resume infusion.
(d) Pump circuitry is adjusting to the IV fluid.
This problem will correct itself 10-20 seconds
after pump has been turned on and a primed
air

cartridge has been installed or when switching
from IV fluid to blood products in the same
IV line. Press start/stop to resume infusion.
When using the crystalloid/colloid car-
tridge, condition (a) should only occur if
the IV set has not been properly primed
(p8). Under normal operation the car-
tridge should vent air entering the pump.
Problem: “occ” indicator illuminated and unit
continues to alarm.
Solution:
(a) Flow has become restricted between pump
and patient. Check that clamps are open and
that lines are not kinked.
(b) Confirm that IV catheter is of adequate
size (see p19) and properly positioned in vein.
When infusing saline or Ringer’s Lactate,
an 18ga peripheral IV catheter is
occ
14

recommended. When infusing blood or
blood products, use of a 14ga or 16ga
peripheral catheter is recommended. See
p19 for more information.
batt
Problem: “batt” indicator illuminated and unit
continues to alarm.
Solution:
(a) Batteries are low. Replace batteries (p16)
or connect optional power adapter.
Standard AAA alkaline batteries are rec-
ommended. Use only power adapters sup-
plied by Infusion Dynamics.
15

16
Maintenance &
Service
Change
Batteries
To open battery
tray, turn lock
counter-clock-
wise and pull
out.
Insert six
AAA batteries.
Orientation
noted on tray
rails.
To close
tray, push in
fully and turn
lock clockwise to secure.
1
2

17
Routine Maintenance
After each use, clean dirt
and salt solutions from
the top of the pump
by flushing with
water and drying
thoroughly. Salt solu-
tions can defeat the
pump’s air detection system
and salt crystals can damage the
pump’s seals. Clean foreign matter from
under the pump rocker to prevent jamming.
Do not allow water or IV fluids
to enter the battery compart-
ment.
Do not manipulate the
pump rocker with your fin-
ger—it can damage the
mechanism.
Annual performance testing is recommended
for organizations that wish to test the pump
on a periodic basis to ensure that it is calibrat-
ed and functioning to specifications. Contact
Infusion Dynamics for a copy of the End-
User Performance Test Procedure (0080-
0226).
keep clean

18
Service
Please report any pump malfunctions to the
company immediately. If a pump requires fac-
tory service, first contact Infusion Dynamics
to receive a Returned Material Authorization
number (RMA), then return the device to:
Infusion Dynamics
5209 Militia Hill Road
Plymouth Meeting PA 19462-1216
USA
TEL: [phone] or 1 [phone]

19
+20% +15% +0% -25%†
Crystalloid Colloid +0% -5% -20%† Crystalloid Colloid Whole blood Packed RBCs
+25% +20% +10% -25%†
+15% +10% -15%†
+10% -10% -35%†
-5% -25%†
Cartridge IV Fluid
Peripheral IV Catheter (Ga) equivalent central venous catheter lumen
14 12 16 14 18 16 20 18 22 20
Crystalloid/ Colloid Cartridge (PN 0040-0050) Blood Cartridge (PN 0040-0051)
Recommended Do not use *Effect of catheter size less at lower rates
† May trip occlusion alarm; use larger catheter if this occurs
Effect of Catheter Size on Max Flow Rate % difference, actual v. set flow rate @ 6*