ZOLL Power Infuser

Operator’s GuideModel M100B-3A

9650-0068-01 Rev. FNovember, 2008

ZOLL and Power Infuser are registered trademarks of ZOLL Medical Corporation.

Copyright 2008 by ZOLL Medical Corporation. All rights reserved.

ContentsIntended 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

ZOLL Power Infuser, Model M100B-3A, Part No. 8700-0600-01

(NSN 6515-01-499-5112)

ZOLL Power Infuser Operator’s Guide, 9650-0068-01 Rev. F

2

Intended UseThe ZOLL Power Infuser ® Model M100B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure inpatients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.

The device is intended for use by medical,paramedical and EMT personnel in the fieldand in pre-hospital and hospital environments.

When used with the Crystalloid/ColloidCartridge the device is intended to delivercrystalloid and colloid resuscitative fluidsonly. It is not intended to support the infusion of blood or blood products.

When used with the Blood Cartridge thedevice is intended to deliver crystalloidand colloid resuscitative fluids, wholeblood and packed red blood cells.

The device is not intended to support thedelivery of any pharmaceutical or other medications.

3

Features & WarningsThis is a unique infusion pump. Please makea note of these features, as you may need tochange your infusion procedures.

High Flow Rates. The Power Infuser willinfuse IV fluids at rates up to 6 liters per hourwith no IV bag elevation. The pump has ratesettings 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 thepump will infuse approximately 250 cc in 2.5 minutes, then switch to standby.

Use a catheter that is large enough forthese high flow rates. See chart on p. 19.

Free Flow. Fluids can free flow through thepump cartridge at all times in the forwarddirection only. When the bag is elevatedabove the patient the flow rate due to gravitywill be added to that generated by the pump.

The free flow rate is approximately 0.75lph per foot of elevation when infusingsaline through an 18ga peripheral IV

4

catheter. This feature can add flexibilityin the way you use the pump. For exam-ple, use gravity to generate a low keep-vein-open rate or continue fluid deliverywhen the pump is disconnected. However,be aware that free flow can cause theactual flow rate to be higher than the setrate, particularly at the low settings.

In the event of a pump failure or unin-tended free flow, the maximum volume offluid that can be infused will be deter-mined by the volume remaining in the IVbag (typically 1 liter maximum).

Air Elimination (crystalloid/colloid car-tridge only). Filters in the crystalloid/colloidpump cartridge will vent air from the IV lineonce the cartridge has been primed.

Do not use blood or blood products withthe Crystalloid/Colloid Cartridge—the 1.2micron filter will clog.

These membranes are not included in theBlood Cartridge. When using the BloodCartridge, PURGE ALL AIR when prim-ing and before starting the infusion.

5

Air Detection. If the pump detects air exitingthe cartridge it will stop pumping and signalthe air alarm.

When using the Crystalloid/ColloidCartridge this should only happen if thecartridge has not been fully primed. Theair alarm can also be triggered if the car-tridge becomes dislodged from the pump,if the IV solution does not have anysaline content, or during the 10-20 sec-ond adjustment period when a primedcartridge is first attached to the pump orwhen switching from saline to bloodthrough the same IV line.

Occlusion Detection. If the pump detectsexcessive resistance to flow on the patientside, the occ alarm will be triggered and thepump will stop.

An upstream occlusion or an empty IVbag will not trigger any alarms on thepump. The pump motor will continue torun but fluid flow will stop. Ensure thatupstream roller clamps are wide open toachieve maximum flow rates, and moni-tor the bag level as needed.

Long Battery Life. Six standard AAA sizealkaline batteries will run the pump forapproximately 8 hours at 6 liters per hour,longer at lower rates.

When the battery can no longer sustainthe set rate, the batt alarm will flicker butthe pump will continue to operate, oftenfor another hour or more. When the bat-tery is very low, the pump motor will stalland all the alarm lights will turn on andwill not clear when the start/stop button ispressed. Battery lifetime decreases whencold.

Discard used batteries properly. Mayexplode or leak if recharged, insertedimproperly, disposed of in fire or mixedwith different battery types.

To operate under AC power, first turnbattery on/off switch to the off position.Use only power adapters supplied byZOLL Medical Corporation (p. 24) -- use ofan unregulated power supply, or any sup-ply delivering > 15 VDC, may cause permanent damage to the Power Infuser.

6

Remove batteries before storage, especial-ly at elevated temperatures.

Under extreme circumstances (lowhumidity, synthetic-covered floors) elec-trostatic discharges to the Power Infusermay cause it to alarm and interrupt fluiddelivery. Press start/stop to reset alarmsand again to resume flow.

Type BF (body floating) applied partcomplying with IEC 60601-1.

Return to a collection site intended forwaste electrical and electronic equip-ment (WEEE). Do not dispose of inunsorted trash.

7

8

Start/stop button. Press to reset alarms and start or stop pump. Hold down to pump continuously and override alarms.

Flow rate selectorliters/hourBOL=250 ccbolus

Alarmsair air exiting

cartridgeocc patient-side

occlusion batt low battery

Pump statusstandbyon (0.2 lph)on (1-6 lph)

Controls

On/off switchfor battery power

Cartridgerelease

9

Normal OperationSetup and PrimeConnect bag, cartridge and IV setsusing standard IV bag spike withLuer connectors. When infusingblood products with the Bloodcartridge, always use an IV setthat is designed for blood productsand contains an appropriate screen.

Install cartridge: hold at an angle and engagetab on the side of the cartridge;swing over rocker until the 2pegs on the cartridge snapinto the slots in the pump.Turn pump on for batteryoperation or connect option-al power adapter.

Hold down start/stop toprime entire IV set. Tapcartridge to remove airbubbles. Stop pump.

Air elimination membranes in theCrystalloid/Colloid Cartridge will notfunction until the cartridge is primed and

on off

10

the filter is completely wet. Air that istrapped in the cartridge tubing mayreduce flow rates. Air bubbles that arenot cleared from the top of the filter dur-ing priming may release later, triggeringthe air alarm.

When using the Blood Cartridge, removeall air from the system. Note: There is noautomatic air elimination system providedin the Blood Cartridge design.

Attach IV set to patient catheter.

Recommended: 18 ga 1-2 in. for crystalloid, 16 ga 1-2 in. for colloid or whole blood;14 ga for warmed packed cells. Seechart on p. 19.

Infuse IV FluidsSet flow rate.Numbered settings(liters/hour) run con-tinuously untilstopped. BOLUSinfuses approximately

250 cc in. 2.5 min.

BOLUS6

4

2

10. 2

liters/hour

250 cc in 2.5 minutes and then stops automatically.

These settings are approximate and arebased on IV bag level with patient, crys-talloid infusate and an 18ga peripheralIV catheter. If IV bag is raised abovepatient, fluids will free flow and rate willbe greater than setting. See p. 19 for catheter size and fluid viscosity effects onflow rates. Fully open all IV set clamps toachieve maximum flow rates.

Press start/stop to begin infusion.

Change IV Bag

Monitor fluid level inIV bag. Press start/stop topause pump.

Close clamp on IV set. Change IV bag.

Open clamp on IV set. Pressstart/stop to resume infusion.

11

End Infusio n

Push to release cartridge.

Gravity-driven infusioncan continue with thecartridge in-line.

After use, dispose ofcartridge and tubing sets in accordancewith applicable regulations.

Turn off pump or unplug power adapter.

on off

12

13

Troubleshooting

Problem: “air” indicator illuminated and unitcontinues to alarm.

Solution:

(a) Unit may have detected air as fluid exitsthe pump. If air bubble present extract airbefore resuming flow. Press start/stop toresume infusion.

(b) Check if cartridge has disconnected frompump. 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 salinitylevel greater than 0.15%. Press start/stop toresume infusion.

(d) Pump circuitry is adjusting to the IV fluid.This problem will correct itself 10-20 secondsafter pump has been turned on and a primed

air

cartridge has been installed or when switchingfrom IV fluid to blood products in the sameIV line. Press start/stop to resume infusion.

When using the crystalloid/colloid car-tridge, condition (a) should only occur ifthe IV set has not been properly primed(p. 8). Under normal operation the car- tridge should vent air entering the pump.

Problem: “occ” indicator illuminated and unitcontinues to alarm.

Solution:

(a) Flow has become restricted between pumpand patient. Check that clamps are open andthat lines are not kinked.

(b) Confirm that IV catheter is of adequatesize (see p. 19) and properly positioned in vein.

When infusing saline or Ringer’s Lactate,an 18 ga peripheral IV catheter is

occ

14

recommended. When infusing blood orblood products, use of a 14 ga or 16 ga peripheral catheter is recommended. See p. 19 for more information.

batt

Problem: “batt” indicator illuminated and unitcontinues to alarm.

Solution:

(a) Batteries are low. Replace batteries (p. 16) or connect optional power adapter.

Standard AAA alkaline batteries are rec-ommended. Use only power adapters sup-plied by ZOLL Medical Corporation.

15

16

Maintenance &Service

ChangeBatteriesTo open batterytray, turn lockcounter-clock-wise and pullout.

Insert sixAAA batteries.

Orientationnoted on trayrails.

To closetray, push infully and turnlock clockwise to secure.

1

2

17

Routine MaintenanceAfter each use, clean dirtand salt solutions fromthe top of the pumpby flushing withwater and dryingthoroughly. Salt solu-tions can defeat thepump’s air detection systemand salt crystals can damage thepump’s seals. Clean foreign matter fromunder the pump rocker to prevent jamming.Do not allow water or IV fluidsto enter the battery compart-ment.

Do not manipulate thepump rocker with your fin-ger—it can damage themechanism.

Annual performance testing is recommendedfor organizations that wish to test the pumpon a periodic basis to ensure that it is calibrat-ed and functioning to specifications. ContactZOLL Medical Corporation for a copy of theEnd-User Performance Test Procedure (9652-0103-01).

keep clean

18

ServicePlease report any pump malfunctions to thecompany immediately. If a pump requires fac-tory service, first contact ZOLL MedicalCorporation to receive a Returned MaterialAuthorization number (RMA), then return thedevice to:

ZOLL Medical Corporation269 Mill RoadChelmsford MA 01824USATEL: 1 (800) 348-9011 or 1 (978) 421-9655

19

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ComponentsThe following components are available separately (see www.zoll.com for more

Crystalloid/colloid pump cartridges for thePower Infuser. Includes 18 inch pump-to-patient tubing set. Sterile, single use only. Box of 10.

ZOLL Part No. 8700-0601-01 NSN: 6515-01-466-1488

Blood pump cartridges for the Power Infuser.Includes 18 inch pump-to-patient tubing set. Sterile, single use only. Box of 10.

ZOLL Part No. 8700-0602-01 NSN: 6515-01-543-5684

AC/DC power adaptor for the Power Infuser.Wall-mounted.

US-type plug, 120VAC/12VDCZOLL Part No. 8700-0603-01 NSN: 6515-01-466-1481

CEE 7/7 plug, 100-240VAC/12VDC ZOLL Part No. 8700-0603-12

IV pole clamp for the Power Infuser. Includes IV bag holder and adjusts for horizontal or verticalmounting.

ZOLL Part No. 8700-0604-01 NSN: 6515-01-466-1481

24

information):