Alaris MedSystem III User manual

Download

MedSystemIII

Multi-Channel Infusion Pump with

Advanced Dose Rate Calculation

DIRECTIONS FOR USE

INTRODUCTION

BASIC OPERATION

ADVANCED OPERATION

TROUBLESHOOTINGMAINTENANCE

TABLE OF CONTENTS

INTRODUCTION

ABOUT THE PUMP....................................................................... 1

FEATURES.................................................................................... 2

SYSTEM COMPONENTS ............................................................... 4

OPERATIONAL PRECAUTIONS ...................................................... 6

BASIC OPERATION

PREPARING THE INFUSION .......................................................... 9

PREPARING THE ADMINISTRATION SET ........................................ 9

LOADING THE SET ....................................................................... 9

FRONT PANEL OVERVIEW ............................................................ 10

PROGRAMMING PRIMARY INFUSION........................................... 14

MAKING CHANGES WHILE INFUSING .......................................... 15

KVO STATUS................................................................................ 17

ADVANCED OPERATION

SECONDARY MODE .................................................................... 19

PREPARING THE ADMINISTRATION SET ........................................ 19

PROGRAMMING SECONDARY INFUSION...................................... 20

DOSE RATE CALCULATOR (DRC) USING A SPECIFIC DRUG NAME............... 22

DOSE RATE CALCULATOR PROGRAMMING WITH DRUG? ........................... 24

DEVICE........................................................................................ 26

CONFIG....................................................................................... 28

NOTE .......................................................................................... 29

BATLOG....................................................................................... 29

TROUBLESHOOTING

RESPONDING TO AN ADVISORY, ALARM OR FAULT ...................... 31

ALARM RESPONSE KEYS .............................................................. 31

ADVISORIES ................................................................................ 32

ALARMS...................................................................................... 33

FAULT.......................................................................................... 36

WATCHDOG ................................................................................ 36

OTHER CONDITIONS.................................................................... 36

MAINTENANCE

SPECIFICATIONS .......................................................................... 37

CLEANING................................................................................... 38

INSPECTION REQUIREMENTS ....................................................... 41

SERVICE INFORMATION............................................................... 42

WARRANTY................................................................................. 43

GLOSSARY................................................................................... 44

Alaris MedSystem III Directions For Use v

INTRODUCTION

CHAPTER 1 — INTRODUCTION

The MedSystem III®Multi-Channel Infusion Pump —

• three independent fluid delivery systems in the space of one.

• compact size:

- reduces bedside clutter

- simplifies patient transport

• easy to setup and use, yet provides advanced features.

• accurate delivery of a variety of fluids.

• accommodates assorted container types.

• multiple delivery methods: Intravenous/Intra-arterial/Subcutaneous/Epidural

• Uses administration sets that provide free flow protection.

• Six available Device Types with configurable parameters

(maximum and minimum rates, maximum volumes, baseline and maximum pressures, and air-in-line thresholds) to achieve specific clinical applications:

General Purpose Neonatal Controller Pressure Operating Room General Purpose II Operating Room II

• Displays infusion status for rate, volume remaining and

volume infused.

• Infusions can be programmed to deliver at a specified rate or

over a specified period of time.

• Secondary mode allows fluids and medications to be

delivered at two different rates, sequentially.

• Dose Rate Calculator (DRC) feature performs the volumetric

rate and/or dose rate calculations.

• With DRC activated, displays infusion status for rate, dosing

regimen and drug name.

• Communications Protocol allows clinical monitoring,

instrument configuration and maintenance.

• Field Maintenance software (FMS) available for Biomed to

configure, service and troubleshoot the pump.

About the Pump

CAUTION: With any

multiple or parallel infusions (i.e., connection of additional infusion systems to the MedSystem III pump and connection to the patient venous system), air infusion, reverse flow, and flow interruption are possible. Please consult the “Overall Problem/Solution Matrix” contained in DIN/VDE Standard 0753 in such cases.

WARNING: The use of

positive displacement infusion devices ported together with gravity flow infusion systems into a common IV site may impede the flow of common “gravity only” systems affecting their performance (hospital personnel must ensure the performance of the common IV site is satisfactory under these circumstances).

WARNING: The pump is

designed to stop fluid flow under alarm conditions other than the Low Battery and KVO. Periodic patient monitoring must be performed to ensure infusion is proceeding as expected.

WARNING: The

MedSystem III is a positive pressure delivery system capable of developing positive fluid pressures to overcome widely varying resistances to flow. It is neither designed nor intended to detect infiltrations and will not alarm under infiltration conditions.

WARNING: Hospital

personnel must ensure the compatibility of the drugs as well as the performance of each pump as part of the overall infusion. Potential hazards include drug interactions, inaccurate delivery rates, inaccurate pressure alarms, and nuisance alarms.

CAUTION: Only systems

that have been qualified to International Standard IEC 60601-1 should be connected to the Communications Receptacle, and the connection should ONLY be performed by qualified personnel. The selection, testing, and use of host computer hardware and software, in conjunction with the MedSystem III pump is strictly the responsibility of the purchaser.

INTRODUCTION

Multi-channel Fluid Delivery System

The instrument combines three independent infusion channels in an unparalleled small size.

Lightweight/portable

The pump with pole clamp weighs just over 5 pounds and is easy to transport.

Unique, rotating pole clamp

The Pump may be attached to a variety of surfaces.

Dose Rate Calculator (DRC)

The pump calculates a volumetric or dose rate based on values entered for patient weight, drug concentration (drug amount and diluent volume) and dosing parameters.

Six Device Types available

General Purpose, Neonatal, Controller Pressure, Operating Room, General Purpose II, and Operating Room II.

Free-flow Protection

The IVAC 28 and 25 Series Administration Sets contain a cassette that provides protection from free-flow conditions. To remove the cassette from the pump, the cassette’s slide clamp is pulled to full extension, occluding the tubing and preventing fluid from flowing.

Features

A: Stopped

DRUG? Wt ---- KG= 0.0 LB

A:Conc ------- mg/---- ml A:Dose ------- mcg/kg/min A:Rate ------- ml/h A:VR 1 ml (Vol Rem) A:VI 0 ml DI 0.0 mg Press Select to choose line

Select

Clear

INTRODUCTION

Monitoring System

The instrument continuously monitors pump conditions and alerts with adjustable audio tones and visual messages.

Data Monitoring

The pump can be configured to communicate with a remote computer, such as a centralized patient monitoring nurses station. The COMM receptacle is compatible with RS-232 cabling. A communications manual that describes the programming and hardware involved is available.

Field Maintenance Software (FMS)

The pump can be modified to accommodate specialized clinical applications. The Device Type parameters, occlusion limit, and air-in-line threshold can be reconfigured with the optional FMS software.

Secondary Mode

Allows the user to program two different rates of infusion to run sequentially.

Full Range of Delivery Rates

Rates from 0.1 to 999 milliliters an hour.

Battery Capacity

A fully-charged battery provides 6 to 8 hours of operating time with rates at 125 ml/h per channel.

A: Infusing Secondary

A: Secondary Rate 100 ml/h A: Sec VolRem (VR) 100 ml

A: Sec Time(TR) 1 hr A: Sec VolInf(VI) 1 ml

since 12:37p 01 Feb 02

Stop Affects Secondary

Select

Fast

INTRODUCTION

System Components

Slide Clamp

Pressure Dome

Piston

Tubing Collar

Lower Assembly

3 Cassette Holders

Pump Latch Mechanism

Drives the cassette piston to move fluid through the tubing.

Air-in-Line Sensor

Detects bubbles of air during infusion.

Tubing Collar Recess

Holds tubing collar in place.

Front Panel

Instrument Keys

Display Screen

Softkey Pads

Channel Indicator Lights

Green:

• Steady - infusing on AC power

• Flashing - infusing on battery power

Red:

• Slow flashing - Advisory

• Rapid flashing - Alert

Channel Select Keys

Cassette

Portion of administration set, inserts into cassette holder.

INTRODUCTION

AC Adapter Power Cord 120V/60 Hz three-pronged

grounded adapter with 4 pin locking connector, standard on Model 2863.

Connector Panel

External Power

External power receptacle connects with power cord.

Plug Symbol

Green light on indicates AC power is connected; batteries are charging.

COMM

Communications line receptacle connects with RS-232.

NOT E:

When inserting or removing connectors to the receptacles, avoid excessive force or twisting.

Container Hook

One hook on each side of the instrument.

Rotating Latch

Allows clamp to spin 360° and position at every 90°.

Adjustable Pole Clamp

Jaw with clutch feature, mounts pump to a pole or bedside.

Attaching Pole Clamp

To attach the pole clamp, position the clamp jaw over the mounting surface and turn the knob until the clamp is tightened and the pump feels secure. When the knob is as tight as possible, continued turning will make it click and spin freely without over-tightening.

INTRODUCTION

To avoid possible injury to the patient, observe the following precautions:

Epidural Administration

The MedSystem III pump can be used for epidural administration of anesthetic and analgesic drugs. This application is only appropriate when using anesthetic and analgesic drugs labeled for continuous epidural administration and catheters intended specifically for epidural use. Use only an IVAC 28 or 25 series set

wwiitthhoouutt

a ‘Y’ connector or injection port, for epidural infusions. The pump‘s secondary mode must

nnoott

be used when the pump is being used for

epidural administration of anesthetic and analgesic drugs.

- Epidural administration of anesthetic drugs — Use indwelling catheters specifically indicated for short-term (96 hours or less) anesthetic epidural drug delivery.

- Epidural administration of analgesic drugs — Use indwelling catheters specifically indicated for either short-term or long-term analgesic epidural drug delivery.

Administration Sets

• Use only IVAC 28 and 25 Series Administration Sets. The use of other sets will cause improper pump operation.

• Do not use the set if damaged.

• Do not insert a cassette into a channel with a Service status.

• Remove any cassettes from channel(s) requiring service.

• Ensure the cassette is properly installed before starting infusions.

Electromagnetic and Radio Frequencies

Operating the pump near equipment which radiates high-energy electromagnetic and radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular telephones, etc.) may cause false alarm conditions. If this happens, reposition the pump away from the source of interference; or turn off the pump and manually regulate the flow with the administration set regulating clamp.

Operational Precautions

Patient Precautions

WARNING:Epidural

administration of drugs other than those indicated for epidural use could result in serious injury to the patient.

WARNING: It is strongly

recommended that the infusion pump source container and administration set used for epidural drug delivery be clearly differentiated from those used for other types of administration.

INTRODUCTION

Artifacts

It is normal for intravenous infusion devices to produce nonhazardous currents when infusing electrolytes. These currents vary at a rate proportional to the infusion device flow rate. When the ECG monitoring system is not functioning under optimal conditions, these currents may appear as artifacts, simulating actual ECG readings. To determine if ECG abnormalities are caused by patient condition or the ECG equipment, place the infusion device on hold. If the ECG readings become normal, the ECG equipment requires attention. Proper setup of the ECG equipment should eliminate these artifacts. Reference the appropriate ECG monitoring system documentation for instructions on setup and maintenance.

Dropping/Jarring

If a pump is dropped or severely jarred, it should be immediately taken out of service and inspected by qualified service personnel to ensure proper function prior to reuse.

To ensure proper performance of the pump and to reduce potential injury to the operator, observe the following precautions:

• The power cord must be connected to a properly grounded, 3-wire receptacle (“Hospital Use” or “Hospital Grade”)

• Avoid excessive force or twisting of detachable power cords, when inserting or removing connector terminals.

• Use power cord indoors only.

• Disconnect AC and battery power when performing maintenance.

• Do not use the pump in the presence of flammable anesthetics.

• Do not open the instrument case. The case should only be opened by qualified service personnel using proper grounding techniques.

• Do not stack instruments on top of each other.

User Precautions

WARNING: When the

case is opened, an electrical shock hazard exists which can result in serious injury to persons and instrument component damage.

THERE IS

PRINTING

ON THIS

PAGE

BASIC OPERATION

Prepare solution container in accordance with the manufacturers’ instructions.

• A syringe can be used as the container for the IV fluid to be infused. Syringe sizes from 20cc to 60cc of the B-D and Monoject

brands can be used.

NOTE:

The IVAC Model 8631A Syringe Holder is available as an accessory that provides a convenient place to hold syringes while they are being used as containers for IV fluid. The Syringe Holder is designed to be easily installed and removed from the top of the pump and to support up to three syringes. Do not use the Syringe Holder as a handle to carry the pump.

Connect the container to the IV set.

Prime the IVAC 28 or 25 Series administration set in accordance with Administration Set Directions for Use.

It is important to prime the set properly to eliminate air bubbles. Ensure the cassette slide clamp is pushed in completely so tubing is not

occluded. Invert the cassette so tubing is up. Slowly open the regulating clamp

and establish fluid flow to fully prime the set. Gently tap the cassette and ‘Y’ sites as necessary to remove all air. Gently massage the pressure dome to ensure no air bubbles are trapped.

Close regulating clamp before inserting and removing the cassette to reduce the risk of free flow.

Press to turn pump on.

With tubing down, use a 45 degree, upward motion to insert cassette into channel.

Push on clear portion of cassette until completely seated. Then push in slide clamp flush with entire cassette.

Pull down gently on tubing collar. Press with thumb to seat tubing collar in recess beneath cassette.

NOTE: Three beeps sound when inserted properly.

Preparing the Infusion

Loading the Set

Preparing the Administration Set

WARNING: An open

regulating clamp and slide clamp can cause a freeflow condition and may result in serious injury to the patient.

Pressure Dome

Slide Clamp

Tubing Collar

Clear portion of cassette

BASIC OPERATION

Status Line

Displays infusion status

(Infusing; Stopped; Standby; KVO; ALARM; FAULT; SERVICE)

for each channel.

NOTE:

tatus line in selected

channel is highlighted.

Infusion Rate

Volume Remaining

Volume Infused

Prompt Line

Displays messages that prompt the user to make programming choices and/or take appropriate actions.

Softkeys Prompts

Displays function of specific softkey.

STNDBY – Appears in softkey

information line when

pressed during infusion.

Cntrst – (Contrast) Brightens

or dims display.

GP II – When pressed, indi-

cates full name of selected Device Type on the prompt line.

NOT E:

Additional softkey prompts are displayed by pressing More Options.

Softkey Pads (4)

Front Panel Overview

Instrument Control Keys

ON/OFF Recharge Key

Turns the pump on and off.

STANDARD DISPLAY Key

Allows the user to display Standard Display page to view infusion settings for all channels.

MORE OPTIONS Key

Allows the user to display additional softkey functions.

START/STOP Key

Starts or stops infusion on selected channel.

Channel Control Key

Standard Display Page

ON/OFF

STANDARD DISPLAY

OPTIONS

START

STOP

Stopped

125

VR: 996.2 VI: 12.8

Start affects channel C

STNDBY Cntrst GP

ml/h

MedSystem III® DLE

Standby

ml/h VR: 138.8 VI: 26.9

Standby

ml/h

VR: 93.2

VI: 16.8

BASIC OPERATION

Selected channel is indicated by the letter displayed at the beginning of the first five lines.

Status Line

Displays infusion status for selected channel.

Infusion Rate

Volume Remaining

Time Remaining

Volume Infused Date/Time

Displays when volume infused was last cleared and infusion began.

Prompt Line

Displays messages that prompt the user to make programming choices and/or take appropriate action.

Soft Key Prompts

Displays function of specific softkey.

Select – Moves highlight bar

through the programmable infusion parameters.

↑↑

– Increases highlighted value.

↓↓

– Decreases highlighted value.

Fast

↑↑

– Increases highlighted

value at greater increments.

Fast

↓↓

– Decreases highlighted

value at greater increments.

Programming Page

ON/OFF

STANDARD DISPLAY

OPTIONS

MedSystem III® DLE

A: Stopped

A: Primary Rate 25 ml/h A: Pri VolRem (VR) 250 ml

A: Pri Time(TR) 10h 00m A: Pri VolInf (VI) 10 ml

since 12:37p 01 Feb 02

Press Select to choose line

Select Fast

START

STOP

BASIC OPERATION

Press .

• Instrument information page is momentarily displayed.

• Continuing to hold down ON/OFF key will keep the information on the display.

• When the ON/OFF key is released, the Standard Display page is displayed.

Press and hold .

• Display disappears.

• Pump is turned off.

Press .

• Standard Display page is displayed.

With the Standard Display page displayed:

Press

once.

•

TotVol, Device, Config, and Note softkeys appear.

Press again.

•

Batlog and DemoWd softkeys appear.

Press , , or .

• Selected channel programming page is displayed.

With programming page displayed: Press

Select to choose value to change.

• Value is highlighted.

Scroll through values using

↑↑

, ↓↓, FAST↑↑, or FAST↓↓.

•

↑↑

and FAST↑↑increases highlighted values in single or multiple

increments.

To turn pump on

To activate additional Standard Display softkey prompts

To turn pump off

To view infusion settings for all active channels

To select channel and display Programming Pages

To program infusion

BASIC OPERATION

• ↓↓and FAST↓↓decreases highlighted values in single or multiple increments.

• Pressing

↑↑

or ↓↓changes direction of the FAST↑↑or FAST

↓↓

• Highlight remains flashing until Enter is pressed. If Enter is not

pressed, the entry incomplete advisory will sound.

Press

Enter to accept new value.

• Highlight moves to next programmable value if channel status is

Stopped or Standby.

• If status is

Infusing, highlight remains on selected value.

To recall a previous value after a new value is introduced but not entered, press .

• Recall soft key appears.

Press

Recall.

• Number returns to previous value.

Press .

• Infusion starts or stops immediately, unless the channel’s programming is incomplete, or if an advisory, alarm, or fault condition exists on selected channel.

•

ALARM is displayed in affected channel status line.

• Alarm condition is displayed on the Standard Display of the affected channel.

Press affected channel , , or .

• Alarm Information page is displayed for that channel.

With the programming page displayed:

Press .

Press

2°Sec to access Secondary page.

Press

CalcOn to access Dose Rate Calculation page.

Press .

Press

CalcOff to discontinue use of the Dose Rate Calculator.

To access alarm information

To activate additional Programming Page softkeys

See the TROUBLESHOOTING section of this manual for more alarm information.

See the ADVANCED OPERATION section of this manual for information on the use of the Dose Rate Calculator function.

BASIC OPERATION

Press , , or .

• Programming Page is displayed.

• Rate is highlighted.

Press

Select if current rate is desired

Press

↑↑

, ↓↓, FAST↑↑, or FAST

↓↓

to change Rate.

• Value flashes.

Press

Enterto confirm.

• Highlight moves to volume remaining (VR)

Press

Select if current VR is desired

Press

↑↑

, ↓↓, FAST↑↑, or FAST

↓↓

to change VR.

• Value flashes.

Press

Enter to confirm.

• Primary time remaining (TR) is calculated automatically, based on VR and Rate.

• Highlight moves to volume infused (VI).

Press

Select if current VI is desired

Press

Clear to reset volume infused to zero.

• Date and time are cleared.

•

Clear softkey switches to Recall.

Pressing

Recall softkey recalls previous VI value.

Press

Enter to confirm.

THEN

Open regulating clamp on administration set.

Press to begin infusion.

• Channel starts infusing.

• Current date and time are entered.

• Green infusion light on channel key stays lit.

• Display reverts to Standard Display page after one minute.

Verify solution flow.

Press .

Verify settings.

Programming Primary Infusion

To set primary rate

To set primary volume remaining (VR)

To clear primary volume infused (VI)

A: Stopped

A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml

A: Pri Time(TR) 05h 00m

A: Pri VolInf(VI) 1 ml

since 12:37p 01 Feb 02

Press Select to choose line

Select

A: Stopped A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml A: Pri Time(TR) 05h 00m

A: Pri VolInf(VI) 1 ml Press Select to choose line

Select

A: Stopped A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml A: Pri Time(TR) 05h 00m

A: Pri VolInf(VI) 800 ml Press Select to choose line

Select

A: Stopped A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml A: Pri Time(TR) 05h 00m

A: Pri VolInf(VI) 0 ml Press Enter or Recall

Enter

since 12:37p 01 Feb 02

Press Select to choose line

Select

since 12:37p 01 Feb 02

since -----

Fast

Clear

Recall

Fast

BASIC OPERATION

Press , , or .

• Programming Page is displayed.

• Rate is highlighted.

Press

↑↑

, ↓↓, FAST↑↑, or FAST

↓↓

to change Rate

• Value flashes.

Press

Enter to confirm.

• New rate begins infusing immediately.

Press , , or .

• Programming Page is displayed.

• Rate is highlighted.

Press

Select to highlight VR.

Press

↑↑

, ↓↓, FAST↑↑, or FAST

↓↓

to change VR.

• Value flashes.

Press

Enter to confirm.

• Infusion continues with new volume remaining.

Press , , or .

• Programming Page is displayed.

• Rate is highlighted.

Press

Select to highlight VI.

Press

Clear then Enter to reset volume infused to zero.

• Date and time are cleared.

•

Clear softkey switches to Recall.

Pressing

Recall softkey recalls previous VI value.

Press

Enter to confirm.

• Infusion continues with volume infused reset to zero.

• Current date and time are entered.

Making Changes While Infusing

To titrate or change primary rate during infusion

To change volume remaining during infusion

To clear volume infused during infusion

NOTE: When the channel VI is cleared, that volume is not subtracted from the volume on the TotVol page.

BASIC OPERATION

Press .

• Standard Display page is displayed.

Press .

•

TotVol, Device, Config and Note softkeys appear.

Press

TotVol softkey.

• Total Volume page is displayed

• VI for each channel and total pump VI values are highlighted.

Press

ClrTotto reset volume infused to zero.

• Date and time are cleared.

Press

Enter to accept clearing of all values.

Press

RECALL to return the previous Total VI .

Press appropriate channel , , or .

Press to stop infusion.

Press .

• Standard Display page is displayed.

Press

Stndby.

Press appropriate channel , , or .

Press to start infusion.

Press if Standard Display page not already displayed.

Press .

•

TotVol, Device, Config and Note softkeys appear.

Press

Config softkey.

• The first of five Instrument Settings pages is displayed.

Press

Select to move the highlight to Setup Line Option.

Press

↑↑

or ↓↓to choose Yes.

•

↑↑

and ↓↓will not be displayed if pump is infusing.

Press

Enter to enable programming option.

Press channel , , or .

To start an infusion from Standby status

To set up an infusion by Rate/Volume or Volume/Time

To place a channel on Standby during infusion

NOTE: When a channel is Stopped for two minutes with a cassette in place, a Channel Not In Use advisory sounds. When a channel is on Standby, the advisory does not sound.

NOTE: Infusing channel should always be stopped prior to removing cassette.

Programming Option

To simultaneously clear Total Volume Infused for all channels

Stopped Stopped Stopped

TotVI A TotVI B TotVI C

Pri 20 Pri 20 Pri 20 Sec 0 Sec 0 Sec 0 = 20 = 20 = 20

Total VI = 60 ml

since 03:25p 10 Feb 02

Press ClrTot to clear TotVI

Stopped Stopped Stopped

TotVI A TotVI B TotVI C Pri 0 Pri 0 Pri 0

Sec 0 Sec 0 Sec 0 = 0 = 0 = 0

Total VI = 0 ml

since -----

Press Enter or Recall

Enter

Stopped

100

ml/h

VR: 450

VI: 50

Start affects channel A

STNDBY Cntrst GP II

ClrTot

Recall

Instrument Settings (1 of 5)

* Audio Volume: highest

Sec Complete Advisory: No Setup Line Option No

Time: am/pm 02:16p 01 Jul 02

Press Stnd Display to Exit

Select

NextPg

BASIC OPERATION

With a channel infusing at KVO rate:

• Green light on channel key remains on.

• Red light on channel key flashes .

• Two toned advisory sounds.

Press appropriate channel , , or twice.

• VR is highlighted.

Press

REPEAT to recall previous VR.

Press

↑↑

, ↓↓, FAST↑↑, and FAST↓↓to change VR.

• Value flashes.

Press

Enterto confirm.

Press to resume infusion and stop KVO rate.

NOTE: If current infusion rate is set below KVO rate, channel will infuse at the lower rate.

To resume infusion when VR=0 (KVO)

KVO Status

Press if channel is infusing.

Press

Select to move highlight to

Setup:Select VR and Time.

OORR

Setup: Select VR and Rate

If highlighted choice is not desired, use arrow softkeys to change setup choice.

• Choice flashes.

Press

Enter to accept .

• Highight moves to top of page.

NOTE: Rate will highlight but cannot be changed if Volume/Time option is active. Time remaining selection will highlight but cannot be changed if Rate/Volume option active.

A: Stopped A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml A: Pri Time(TR) 05h 00m A: Pri VolInf(VI) 1 ml

since 02:16p 01 Jul 02

Setup: Select VR and Time Press Select to choose line

Select

A: Stopped A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 500 ml A: Pri Time(TR) 05h 00m

A: Pri VolInf(VI) 1 ml

since 02:16p 01 Jul 02

Setup: Select VR and Rate

Press Enter or Recall

Enter

Recall

KVO

100

Infusion Complete VR = 0

Alarm Info: Press A

Cntrst GP II

A: KVO 3.0 ml/h A: Primary Rate 100 ml/h

A: Pri VolRem (VR) 0 ml A: Pri Time (TR) ---A: Pri VolInf (VI) 100 ml

since 12:37p 01 Feb 02

Press Select to choose line

Select

REPEAT

THERE IS

PRINTING

ON THIS

PAGE

ADVANCED OPERATION

This option allows two different rates of infusion to be administered sequentially. When secondary volume remaining reaches zero, primary infusion resumes automatically.

To avoid the possibility of sympathetic flow during secondary delivery of intermittent medications, set up the administration set as recommended below.

• Use a 16 gauge needle to attach secondary set to primary upper ‘Y’ site, below a check valve.

• Prepare the secondary IV container according to your institution’s policy.

• Suspend secondary solution container at

least 8 inches above primary solution container.

• Press , , or to select channel.

WARNING: Setting a secondary rate over 275

ml/h may result in sympathetic flow with the primary container.

Secondary Mode

Preparing the Administration Set and Container

START

STANDARD

ON/OFF

OPTIONS

STOP

DISPLAY

DLE

BCA

ADVANCED OPERATION

Press , , or .

• Primary programming page is displayed.

Press . Press 2º Sec softkey.

• Secondary programming page is displayed.

Press Select to highlight secondary VR, if necessary. Press REPEAT to enter the last VR selected.

Press ↑↑,

↓↓

, Fast ↑↑or Fast

↓↓

to change VR.

• Value flashes.

Press Enter to confirm.

• Secondary time remaining (TR) is calculated automatically, based on VR and Rate.

• Highlight moves to secondary volume infused (VI).

Press Select if current VI is desired

Press Clear to reset volume infused to zero.

• Date and time are cleared.

• Clear softkey switches to Recall.

Pressing Recall softkey recalls previous VI value. Press Enter to confirm.

Press Select if current rate is desired

Press ↑↑,

↓↓

, Fast ↑↑or Fast

↓↓

to change Rate.

• Value flashes.

Press Enter to confirm.

THEN

Open regulating clamp on secondary administration set.

Press to begin infusion.

• Four tones sound if primary infusion is in progress.

• Pump starts infusing at secondary rate.

• Current date and time are entered.

Programming Secondary Infusion

To set secondary rate

To set secondary volume remaining(VR)

To clear secondary volume infused(VI)

NOTE: Secondary programming page is reverse highlighted.

A: Infusing

A: Primary Rate 50 ml/h A: Pri VolRem (VR) 450 ml

A: Pri Time(TR) 09h 00m A: Pri VolInf(VI) 50 ml

since 12:37p 01 Feb 02

Press Select to choose line

2° Sec

A: Infusing

A: Secondary Rate 100 ml/h

A: Sec VolRem (VR) 0 ml A: Sec Time(TR) -----

A: Sec VolInf(VI) 200 ml

since 12:37p 01 Feb 98

Stop Affects Secondary

Select

CalcOn

Repeat

ADVANCED OPERATION

• Display reverts to Standard Display page after one minute.

Press . Verify settings.

Verify solution flow from secondary container.

Press , , or .

• Secondary programming page is displayed.

• Rate is highlighted.

Press ↑↑,

↓↓

, Fast ↑↑or Fast

↓↓

to change rate.

• Value flashes.

Press Enter to confirm.

• New rate begins infusing immediately.

Press , , or .

• Secondary programming page is displayed.

Press .

• 1ººPri and CalcOn softkeys appear.

Press 1ººPri softkey.

• Primary programming page is displayed.

Press Select to highlight value(s) to change. Press ↑↑,

↓↓

, Fast ↑↑or Fast

↓↓

to change value(s).

Press Enter to confirm.

Close regulating clamp on secondary infusion set.

Press , , or .

• Secondary programming page is displayed.

Press .

• 1ººPri and CalcOn softkeys appear.

Press 1ººPri softkey.

• Primary programming page is displayed.

Press to begin primary infusion and stop secondary infusion.

• Four tones will sound.

• Infusion starts at primary rate.

To titrate or change secondary rate during infusion

To review or change primary value(s) during secondary infusion

To start primary infusion before secondary completes

WARNING: Pressing

would result in the remaining secondary medication being delivered at the primary rate.

NOTE: Channel display on the Standard Display is reverse highlighted.

Infusing

Secondary

100

ml/h VR = 91 VI = 9

Stop affects channel A

Cntrst GP II

Press , , or .

• Primary programming page is displayed.

If infusing, press to stop infusion.

Press .

• 2

ºº

Sec and CalcOn softkeys appear.

Press CalcOn.

• Dose Rate Calculator programming page is displayed.

• Drug? is highlighted.

Scroll using arrow softkeys to display alphabetized, abbreviated, generic drug names.

• ↓↓moves A to Z.

• ↑↑moves Z to A.

e.g. Dopamine___ mg/___ml and ___mcg/kg/min

Lidocaine___ Gm/ml and ___ mg/min

Press Enter when desired drug name is highlighted.

• Highlight moves to Wt.

Choose patient’s kilogram weight using the arrow softkeys. Press Enter when desired weight is displayed.

• Highlight moves to Conc.

Choose

concentration

using the

arrow softkeys.

Press Enter when desired concentration is displayed.

• Highlight moves to value for diluent volume.

Choose

diluent volume

using the

arrow softkeys.

Press Enter when desired volume is displayed.

• VR is automatically set when the diluent volume value is enteredbut can be changed if desired.

• Highlight moves to Dose.

ADVANCED OPERATION

With this feature, the instrument calculates a volumetric or dose rate based on values entered for patient weight, drug concentration (drug amount and diluent volume) and dosing parameters. If a dose is entered, the volumetric rate is calculated. If a volumetric rate is entered, the dose is calculated.

Dose Rate Calculator (DRC) Programming using a specific drug name

WARNING:

Ensure correct entry of all drug calculation infusion parameters. Consult the drug manufacturer’s labeling for information concerning appropriate administration guidelines and

dosages.

Programming Drug

Programming Weight

Programming Concentration

NOTE

Pressing , ,or at any time during DRC set-up, returns the highlight to the top of the page.

NOTE:

Dose Rate programming page will not display if channel is infusing. If infusing in secondary mode, switch to primary mode and stop infusion before proceeding.

NOTE

: Changing drug name clears previous values and changes drug concentration and dose rate parameters to parameters appropriate for the selected drug.

A: Stopped

DRUG? Wt ---- KG= 0.0 LB

A:Conc ------- mg/---- ml

A:Dose ------- mcg/kg/min A:Rate ------- ml/h A:VR 1 ml (Vol Rem) A:VI 0 ml DI 0.0 mg Press Select to choose line

Select

Clear

A: Stopped

DOPAMINE Wt 70.0 KG=154.3LB

A:Conc 400 mg/ 250 ml

A:Dose 5.0 mcg/kg/min A:Rate 13.1 ml/h A:VR 250 ml (Vol Rem) A:VI 0 ml DI 0.0 mg Press Select to choose line

Select

Fast

ADVANCED OPERATION

Programming Dose

NOTE: Calculated rates for infusion are fractional and will be displayed as a fraction on the Standard Display even if Device Type is set for whole numbers.

Choose

dose

using the

arrow softkeys.

Press Enter when desired dose is displayed.

• Volumetric rate is automatically calculated.

• Highlight moves to Rate.

Choose

rate value

using the

arrow softkeys if dose rate is not desired.

Press Enter when desired volumetric rate is displayed.

• When rate is changed, dose value is automatically calculated.

• Highlight moves to VR.

Change

VR value using the arrow softkeys.

Press Enter when desired VR is displayed.

• Highlight moves to VI.

Press Clear then Enter to reset volume infused to zero.

• Highlight moves to DI.

Press Clear then Enter to reset dose infused to zero. Open regulating clamp.

Press to begin infusing.

• Channel starts infusion.

• Display switches to Standard Display page after 1 minute. DRC parameters are displayed.

Verify fluid flow.

Press . Verify settings.

Press , , or .

• Dose Rate Calculator programming page is displayed.

• Dose value is highlighted.

Press Select to scroll through values that can be changed. When highlight is on value to be changed (Dose, Rate, VR, VI, DI), use

arrow softkeys until desired value is displayed

• When dose is changed, rate is automatically recalculated.

• When rate is changed, dose is automatically recalculated.

When highlight is on value for VI or DI, Clear softkey becomes active. Pressing the Clear softkey changes the value to 0.0.

Press Enter after each value change to accept the new value.

• New rate begins infusing immediately.

Press .

• Verify settings.

Changing DRC values while infusing

Changing Volumetric Rate

Changing Volume Remaining

Clearing the Volume Infused(VI) and Dose Infused(DI)

NOTE: Stop infusion to make changes to the drug name, weight, or concentration.

Infusing

ml/h

5.0

mcg/k/mn

DOPAMINE

Stop affects channel A

Cntrst GP II

ADVANCED OPERATION

Dose Rate Calculator Programming with DRUG?

NOTE:

Dose Rate programming page will not display if channel is infusing. If infusing in secondary mode, switch to primary mode and stop infusion before proceeding.

Programming Weight

Programming Concentration

Programming Dose

rug concentration

parameters

m, mg, mcg, mMol, mEq, mUn, and Un

Dose parameters

measure —

Gm, mg, mcg, Ng, mMol, mEq, mUn, or Un

weight —

time —

min, hr, or day

The Drug? selection can be used to calculate a drug not listed in the pump or for an alternative dosing regimen.

Press , , or .

• Primary programming page is displayed.

Press if channel is infusing.

Press .

• 2º Sec and CalcOn softkeys appear.

Press CalcOn.

• Dose Rate Calculator programming page is displayed.

• Drug? is highlighted.

Press Select.

• Highlight moves to Wt.

Choose

patient’s KG weight using arrow softkeys.

Press Enter when desired weight is displayed.

• Highlight moves to Conc.

Choose

concentration using arrow softkeys.

Press Enter when desired concentration is displayed.

• Highlight moves to concentration parameters.

Choose

desired concentration parameters using arrow softkeys.

Press Enter when desired parameter is displayed.

• Highlight moves to value for diluent volume.

Choose

diluent volume value using arrow softkeys.

Press Enter when desired volume is displayed.

• VR is automatically set when the diluent volume is entered, but can be changed if desired.

• Highlight moves to Dose parameters.

Choose dose parameters (measure/weight/time) using arrow softkeys. Press Enter when each desired dose parameter is displayed.

• Highlight moves to next parameter each time Enter is pressed.

• Highlight moves to Dosewhen Enter is pressed to accept time value.

Choose

dose using arrow softkeys.

Press Enter.

• Highlight moves to Rate parameters.

A: Stopped

DRUG? Wt ---- KG= 0.0 LB

A:Conc ------- mg/---- ml A:Dose ------- mcg/kg/min A:Rate ------- ml/h

A:VR 1 ml (Vol Rem) A:VI 0 ml DI 0.0 mg

Press Select to choose line

Select

Clear

ADVANCED OPERATION

Choose

volumetric rate using arrow softkeys if dose calculation is not desired.

Press Enter when desired rate is displayed.

• When rate is changed, dose is automatically calculated.

• Highlight moves to VR.

Choose

VR value using the arrow softkeys.

Press Enter when desired VR is displayed.

• Highlight moves to VI.

Press Clearthen Enter to change VI value to 0.

• Highlight moves to DI.

Press Clear then Enter to change DI value to 0. Open regulating clamp.

Press to begin infusion.

• Channel starts infusing.

• Display switches to Standard Display page after 1 minute. DRC parameters are displayed.

Verify fluid flow. Press .

Verify settings.

Press , , or .

• Dose Rate Calculator programming page is displayed.

Press to stop if infusing.

Press . Press CalcOff.

• Display reverts to primary programming page.

• Volumetric rate, volume remaining and volume infused from DRC is carried over to the primary programming page.

Discontinuing DRC option

Changing Volume Remaining

Clearing Volume Infused (VI) or Dose Infused (DI)

Facts about DRC

Changing Volumetric Rate

• Drug name, patient weight, or drug concentration

cannot be changed while infusing. Changes to patient weight or concentration will recalculate volumetric rate but maintain dose rate.

• All drug names are generic and abbreviated if the name contains more than eight letters.

• Weight can only be entered in Kg’s but is displayed in

Kg’s

and

Lbs. Weight units can be switched to grams

by pressing

↓↓

to value of 1Kg then repress

↓↓

. A two

tone advisory sounds.

• If dose measurement parameters and concentration measurement parameters are unrelated, a volumetric rate will not calculate. Attempts to start will display a prompt message:

Verify all dose settings.

• When a drug amount is 10,000 or greater, a Kis used to replace 000th (i.e. 10,000=10K; 12,000 = 12K).

• If a recalculated dose results in a rate outside the rate ranges, a prompt message is displayed:

Rate too

High,reenter value or Rate too Low,reenter value.

• If a recalculated rate results in a dose outside the dose

range, the channel will infuse at the entered rate but the dose will display the minimum or maximum allowable limit: (i.e. <0.1 or >999k).

• Secondary option cannot be used when the Dose Rate Calculator is enabled.

• If instrument is off for more than five minutes, the DRC mode will revert to the primary mode.

A: Stopped

DOPAMINE Wt 70.0 KG=154.3LB

A:Conc 400 mg/ 250 ml A:Dose 5.0 mcg/kg/min

A:Rate 13.1 ml/h A:VR 250 ml (Vol Rem) A:VI 0 ml DI 0.0 mg

Press Select to choose line

CalcOff

ADVANCED OPERATION

There are six Device Types with preset parameters that accommodate specific clinical applications. They are:

General Purpose Neonatal Controller Pressure

When setting up the pump, select the device type that best suits your clinical needs.

The abbreviated name of the Device Type appears as a softkey on the Standard Display page. Pressing the softkey displays the device type on the prompt line.

Maximum rate, maximum volume, pressure and air-in-line threshold are configured at the factory. See Table 1 for a complete listing of preset parameters. Refer to the config softkey section following Table 1 for programmable and configurable parameters. These parameters can be modified to meet the institution’s specific requirements using the optional FMS software.

Press .

• TotVol, Device, Config and Note softkeys appear.

Press Device softkey.

• The currently selected Device Type has an asterisk and is highlighted.

Press Select to move the highlight through the list. Press Enter when the desired device is highlighted.

If preset values are compatible with the newly selected device type,

• An asterisk appears next to the device name.

If channel is not infusing when device type is changed and preset values are not compatible with the newly selected device type,

• The display switches to a notification screen.

• Incompatible Channel(s) indicated.

• Choice is given to continue.

If Yes,

• Incompatible values are cleared.

• Display reverts to Standard Display Page.

• New Device Type becomes active.

If No,

• Display reverts to Change Device Type page.

Device

NOTE: The Device Type programming selection affects all three channels. It is not possible to program different Device Types for a channel independently.

To change Device Type

Operating Room General Purpose II Operating Room II

Stopped

100

ml/h

VR: 450 VI: 50

Device: General Purpose II

STNDBY

Cntrst

GP II

Infusing

100

ml/h

VR: 450

VI: 50

Stop affects channel A

TotVol Device Config Note

Change Device Type

General Purpose Neonatal Controller Pressure Operating Room

* General Purpose II

Operating Room II Press Stnd Display to Exit

Select

Enter

ADVANCED OPERATION

If channel is infusing when device type is changed and preset values are not compatible with the newly selected device type,

• The display switches to the notification screen.

• Incompatible Channel(s) is indicated.

• Choice is given to continue.

If No,

• Display reverts to Change Device Type page for user to select another device type.

If Yes,

• The pump will alarm.

• Infusion will stop on affected channel.

• Display reverts to Standard Display with Alarm indicated in affected channel.

Press affected channel , , or

Follow instructions displayed.

Table 1

Occlusion Detection Method

Occlusion Alarm Setting

Maximum Pressure

Air-in-line Alarm Threshold

KVO Rate* Rate Range Maximum VR

Setting Pump Not In

Use Advisory ALL Setting

for VR

Baseline

Baseline 5 psi

15 psi

500 µl

3 ml/h

1 —999 ml/h

9999 ml

Yes

N/A

Baseline

Baseline+3 psi

15 psi

50 µl

1.0 ml/h

0.1—99.9 ml/h

9999 ml

Yes

N/A

Absolute

Threshold

Absolute 3 ft H2O

3 ft H2O

500 µl

3 ml/h

1 — 299 ml/h

9999 ml

Yes

N/A

Baseline

Baseline+5 psi

15 psi

500 µl

3 ml/h

1 —999 ml/h

9999 ml

Option

Baseline

Baseline+5 psi

15 psi

500 µl

3.0 ml/h

0.1—999 ml/h

9999 ml

Yes

N/A

Baseline

Baseline+5 psi

15 psi

500 µl

3.0 ml/h

0.1—999 ml/h

9999 ml

Option

Default General

Neonatal

Controller Operating General Operating

Parameter Purpose Pressure Room Purpose II Room II

* Channel will infuse at the KVO rate shown in table or at the current infusion rate,

whichever is lower.

NOTE: Values shown in table can be modified to meet the institution’s requirements using optional FMS software. To review actual default parameters on a MedSystem III pump, select a Device Type and refer to Instrument Settings pages 2 through 5. An asterisk appears beside settings which are not factory default.

ALARM

-----

Rate/Vol Settings Cleared

Alarm Info: Press channel A

CANCEL QUIET

ADVANCED OPERATION

Config

(Configuration)

The Config option allows the user to view and/or change some instrument settings. There are five pages in this option. Items shown on page 1 can be changed by user (see Table 2). Pages 2 - 5 can only be changed by qualified personnel using the optional FMS software .

Press .

• TotVol, Device, Config and Note softkeys appear.

Press Config softkey.

• The first of five Instrument Settings pages is displayed.

• An asterisk indicates options that have been changed from factory settings.

Pressing Select moves the highlight through the list . Press ↑↑and ↓↓to change a highlighted setting.

• Select softkey changes to Enter and NextPg softkey changes to Recall when a setting is changed.

Press Enter to accept new setting

Press Recall to recall previous setting.

Press to exit Instrument Settings page.

able 2

Option Choices Description

Audio Volume: low

medium

high

highest

Sec Complete Advisory: Yes

Setup Line Option: No

Yes

Time: 24 hr

am/pm

Hour/minutes

00:00-23:59

Day 1-31

Month Jan-Dec

Years

00-99

To access Instrument Settings information

A tone accompanies each level to aid in determining volume choice. If an alarm is ignored, the volume will ramp to the highest audio unless disabled by FMS.

Pump sounds two tones and displays advisory when secondary VR = 0.

Enables infusion to be set up as rate/volume or volume/time. Stop infusion before modifying this line option.

Allows pump to be set with a 12 or 24 hour clock.

}

Each item can be adjusted when highlighted

Infusing

100

ml/h

VR: 450

VI: 50

Stop affects channel A

TotVol Device Config Note

Instrument Settings ( 1 of 5 )

*Audio Volume: low *Sec Complete Advisory: Yes

Setup Line Option: No

Time: am/pm 9:56a 01 Feb 02 Press Stnd Display to Exit

Select

NextPg

ADVANCED OPERATION

The Note soft key accesses the Special Note Message page. When note is programmed, it appears when the pump is turned on.

Press .

• TotVol, Device, Config and Note softkeys appear.

Press Note softkey.

• Note information is displayed.

• If no information has been programmed on the note page, there

will be a two tone advisory and the message There is no Special Note will display on the prompt line.

The BatLog softkey accesses the Battery History Log page. This page is provided for the Biomedical Engineering staff to review and record battery history data.

Press .

Press twice.

• BatLog and DemoWD softkeys appear.

Press BatLog softkey.

• The Battery History page is displayed.

Display switches to Standard Display page after 1 minute

Press to exit Battery History page.

NNoottee

BBaattLLoogg

(Battery History Log)

To access Note(s)

To access Battery History Log

Infusing

100

ml/h

VR: 450

VI: 50

Stop affects channel A

TotVol Device Config Note

Infusing

100

ml/h

VR: 450

VI: 50

There is no Special Note

TotVol Device Config Note

Infusing

100

ml/h

VR: 450

VI: 50

Stop affects channel A

BatLog DemoWD

THERE IS

PRINTING

ON THIS

PAGE

NOTE: Channel’s VR and VI calculations are updated with each press of ClrAir softkey.

NOTE: A  appears on S tandard Display page to indicate CONFIRM has been pressed.

TROUBLESHOOTING

Use this troubleshooting information in conjunction with appropriate hospital procedures.

Press

QUIET.

• Audio tone stops.

• Red light flashes on affected channel.

Press affected channel , , or

• Alarm Information page is displayed. Take appropriate action(s) indicated on the display. Press to resume infusion.

silences Advisories, Alarms, and Faults for two minutes. Softkey is accessible during alarm status.

clears alarm and advisory messages and stops tone. Use when alarm or advisory condition cannot be corrected or user chooses not to correct.

moves air bubbles past air-in-line sensor. Each press of the ClrAir softkey displaces 0.2 ml of air and fluid. Three beeps indicate when air bubble is no longer in front of the air-in-line sensor.

is present during Check Fluid Side alarms. Allows infusion tocontinue if no upstream occlusion is found and fluid is flowing in drip chamber.

resets resumable fault conditions. Used when attempting to re-establish normal operation of a channel.

disables use of affected channel. Servicing of the pump is required before channel can be used.

SERVICE

RETRY

CONFIRM

ClrAir

CANCEL

QUIET

To respond to an advisory, alarm, or fault message

Alarm Response Keys

TROUBLESHOOTING

Check Air Sensor

At installation of cassette:

a) air is detected in tubing; b) tubing collar is not prop-

erly seated;

c) air sensor is dirty or

damaged.

• Verify tubing collar is fully seated in air sensor recess.

• Verify tubing in air sensor recess is not damaged, twisted or dirty.

• Press ClrAir on channel's Alarm Information page. Three beeps indicate air bubble is no longer in front of air sensor.

• If air is still present, remove cassette and manually clear air according to hospital policy.

• If no air is present, clean air sensor recess as directed in cleaning instructions.

Infusion Complete VR=0

VR has counted down to zero. Channel is infusing at KVO rate.

• Enter new VR or, if same volume is desired, press REPEAT.

• Press Enter.

• Press to resume primary infusion rate.

Low Battery

30 minutes or less battery power remaining.

• Connect AC adapter power cord to pump.

• Plug into wall outlet.

Channel Not In Use

Two minutes have elapsed since cassette was installed or infusion was stopped.

• Remove cassette,

• Press to start infusion,

• Press

STNDBY to place channel on Standby.

T wo beeps, slow flashing red light on infusing channel’s channel key; infusion continues.

CORRECTIVE ACTION

Advisories

TROUBLESHOOTING

Air In Line

Air detected in fluid pathway during infusion, or air sensor is dirty.

• Verify tubing collar is fully seated in air sensor recess.

• Verify tubing in air sensor recess is not damaged, twisted or dirty.

• Press ClrAir softkey on channel's Alarm Information page. Three beeps indicate air bubble is no longer in front of air sensor.

NOTE: Each press of the ClrAir softkey displaces 0.2 ml of air and fluid and updates channel’s VR and VI calculations.

• If air is still present, remove cassette and manually clear air according to hospital policy.

• If no significant air is present, clean air sensor recess as directed in cleaning instructions.

• Set up pump at, or slightly below, IV site to minimize formation of micro bubbles.

• Press to resume infusion.

Air In Lower Tubing

Air bubbles detected in fluid pathway with a total volume exceeding the air in line threshold setting.

Possible outgassing and/or leaks in administration set.

• Check administration set for leaks.

• Check lower tubing for multiple small air bubbles.

• Press ClrAir softkey on channel's Alarm Information page. Three beeps indicate air bubble is no longer in front of air sensor.

NOTE: Each press of the ClrAir softkey displaces 0.2 ml of air and

fluid and updates channel’s VR and VI calculations.

• If air is present, clear air according to hospital policy.

• Set up pump at or slightly below, IV site to minimize formation of micro bubbles.

• If no significant air is present, press to resume infusion.

Battery Depleted

Insufficient battery power. The pump will shut down in 5 minutes.

• Connect AC adapter power cord to pump and plug into wall outlet.

• Press to resume infusion(s).

CORRECTIVE ACTION

Four rapid-beeps, infusion stops, rapidly flashing red light on channel key .

Alarms

• Check tubing between container and pump for a closed regulating clamp, closed vent (with unvented container), kinked tubing, empty syringe, or any restriction to flow.

• If NO occlusion is present, press CONFIRM.

• Press to resume infusion.

• Verify fluid is flowing in drip chamber.

• A  appears on standard display to indicate Confirm has been

pressed.

TROUBLESHOOTING

Cassette Not Latched

Cassette is partially disengaged or latching mechanism is dirty.

ALARMS (continued)

Four rapid-beeps audio, rapid-flashing red light and infusion stops.

• Push cassette completely in. Ensure slide clamp is flush with entire cassette. Press to resume infusion.

• If condition continues, try cassette in a different channel. Replace administration set if alarm recurs.

• Clean lower assembly according to Cleaning Instruction described in MAINTENANCE section of this document.

Cassette Removed

Cassette is removed from holder while channel is infusing.

• Reinstall cassette, and press to resume infusion. OR

• Press CANCEL.

Check Fluid Side

Possible upstream restrictions to flow.

Cassette Jammed

Cassette piston is difficult to move or piston sleeve is loose.

• Remove cassette, check placement of soft, plastic piston sleeve and reposition, if necessary.

• If condition continues, try cassette in a different channel.

• Replace administration set if alarm recurs or if piston does not move freely.

• If Alarm recurs with several cassettes, channel may need service.

CORRECTIVE ACTION

INCORRECT

CORRECT

TROUBLESHOOTING

Faulty Cassette

Cassette may be damaged or inoperable. Possible disfunction of cassette sensor located in holder.

• Reinsert cassette in another channel.

• If alarm recurs in second channel, replace administration set.

• If alarm recurs with two cassettes in the same channel, press

SERVICE and contact qualified service personnel.

Fluid-Side Occluded

Upstream restriction to flow.

• Check tubing between container and pump for a closed regulating clamp, closed vent (with unvented container), kinked tubing, empty syringe, or any restriction to flow.

• Clear occlusion.

• Press to resume infusion.

Patient-Side Occluded

Downstream restriction to flow.

• Check tubing between pump and patient for kinks, closed clamps, closed stopcocks, clogged filters, site problems, etc.

• Clear occlusion or change infusion site.

• Press to resume infusion.

Pumping Latch Closed

Pumping latch jaw located to right of air sensor is closed or broken.

ALARMS (continued)

Four rapid-beeps audio, rapid-flashing red light and infusion stops.

INCORRECT

Rate/V ol Settings Cleared

Rates and/or volumes are incompatible with newly selected Device Type.

• Re-enter settings as required.

• Press to resume infusion.

CORRECTIVE ACTION

CORRECT

CORRECTIVE ACTION

CORRECT

Air Sensor Pumping

Latch Jaw

• Using only your finger, push down pumping latch jaw until it snaps

open.

• If pumping latch jaw is visibly broken, press SERVICE and contact qualified service personnel.

CAUTION:

Never use a blunt instrument to open a closed pumping latch.

INCORRECT

TROUBLESHOOTING

Screen is too light or dark to read, with pump on.

• Press

• Press Cntrst softkey to change screen contrast.

Pump Shut Off: Low Power Pump had shut down after a Battery Depleted alarm had not been corrected.

• If power cord has been detached from pump, reconnect terminal end to pump’s EXTERNAL POWER receptacle.

• Plug AC adapter power cord into electrical outlet.

• next to EXTERNAL POWER receptacle is lit green when

power cord is properly attached.

Channel Out of Order

Safety checks built into software have detected a faulty channel.

Fault Number

Safety checks built into software have detected a fault condition.

Numeric message, Europeansiren, rapid-flashing red light, infusion stops.

CORRECTIVE ACTION for resumable faults, only.

• Press affected channel , , or

• Follow instructions on channel's Alarm Information page.

• Press RETRY to clear Fault.

• If Fault recurs, press SERVICE and contact qualified service

personnel.

Blank screen, continuous-tone red and green lights continuous, all infusions stop.

Blank Screen Safety checks built into

software have detected an instrument error condition.

Attempt to reset pump:

• Turn pump off, then on again.

• Press to resume each channel that had been infusing.

• If Watchdog alarm recurs or pump cannot be turned on, replace pump and notify qualified service personnel.

CORRECTIVE ACTION

Fault

Watchdog

Other Conditions

MAINTENANCE

Specifications

STANDARDS UL 544

CSA C22.2, No. 125

CASE MATERIAL Impact resistant polycarbonate/ABS alloy

DIMENSIONS Height 7.875 inches (20.00 centimeters)

Width 6 inches (15.24 centimeters) Depth 2.10 inches (5.33 centimeters)

WEIGHT Approximately 5.1 pounds (2.32 kilograms) includes Pole Clamp.

AIR-IN-LINE (

OCCLUSION PRESSURE (

DEFAULT) 500 µl except for Neonatal which is 50µl

DEFAULT) 15 psi except for Controller pressure device which is 3 ft H

OPERATING TEMPERATURE 50-104° Fahrenheit (10° - 40° Celsius)

STORAGE TEMPERATURE <95° Fahrenheit (<35° Celsius) for optimum battery life.

MAXIMUM STORAGE 131° Fahrenheit (55° Celsius)

TEMPERATURE

RATE RANGE 0.1 - 999 milliliter per hour (each channel)

VOLUME RANGE 0.1 - 9999 milliliter (each channel)

KVO RATE RANGE 0.1 - 20.0 milliliter per hour

* NOTE: 60601-2-24, under the following conditions: Head Height: 30”; Test Solution: Distilled Water; Environmental: Ambient temperature; Back Pressure: 18 gauge needle; IV Set: Model 28034.

SYSTEM ACCURACY 1.0 - 999 ml/hr ±5% with a standard deviation of 1.96 under

Long-term accuracy specified, per IEC

specified conditions. *

0.1 - 0.9 ml/hr ±10% with a standard deviation of 1.96.

ADMINISTRATION SETS Use only IVAC MedSystem III Administration Sets.

POWER CONSUMPTION 6 watts AC power. Use only IVAC MedSystem III AC Adapter, Model 1555 or

1550.

BATTERIES Main – Rechargeable NiCd Battery Pack

NOTE:

Use only approved ALARIS Medical Systems

Battery Packs.

Memory Back-up – Nonrechargeable Lithium

NOTE:

Replacement of both the main and memory backup batteries must be performed by qualified service technicians.

all channels running at 125 milliliter per hour and backlighting usage of 2 minutes per hour.

The main battery retains 80% of its capacity after 500 charging cycles, and retains 90% of its capacity after 3 months of continuous AC charging.

AC ADAPTER & CORD LENGTH Model 1555, 7.5 VDC @ 1A with 10ft. (3.05 meter) cord.

Model 1550, 8.5 VDC @ 750mA with 8.5ft. (2.59 meter) cord.

AC ADAPTER CONNECTOR 4 pin locking connector is standard on Model 2863. Detachable

connector is standard on Model 2860.

FUSES 3 amp fast-blow internal

GROUND CONTINUITY Maximum 0.1 ohm

LEAKAGE CURRENT Maximum 100 microamps

BATTERY CHARGE A fully charged battery has a minimum of 6 hours running time with

MAINTENANCE

Clean the pump regularly to maintain proper working order and optimum performance.

WARNING: To avoid electrical hazard, always disconnect AC

adapter power cord from the wall outlet before cleaning the instrument.

CAUTIONS:

• DO NOT SPRAY cleaning solutions onto instrument housing or immerse the instrument. Fluid leakage into the instrument can cause damage. Apply cleaning solutions to a cloth then apply to instrument for cleaning.

• Do not clean the instrument before inspecting the condition of the housing for damage that could allow fluid to enter the case interior.

• Do not invert the instrument when cleaning or rinsing, to prevent fluids from possibly leaking into the instrument.

• Do not steam, autoclave, or EtO gas sterilize the instrument.

• Do not use pressurized air to dry the mechanisms after cleaning. Pressurized air force could move fluid past moisture seals and fluid leakage into the instrument can cause damage.

• Do not use organic solvents, ammonia, ammonium- based agents, isopropyl alcohol, and/or abrasive cleansers for cleaning.

• Do not use sharp or metallic tools to remove residue.

Instrument exterior and pumping mechanism area

, use:

• Mild, non-abrasive, non-staining solution (e.g., commercially available, alcohol-free, dish washing liquid, well diluted with warm water.)

Instrument exterior

, use:

• Mild, non-abrasive, non-staining, standard hospital disinfectant (e.g., warm water with 10% bleach.)

NOTE:

After cleaning with a bleach solution, rinse thoroughly with

water.

Instrument Exterior

• Routinely clean the exterior surfaces of the instrument, using a cloth dampened with the appropriate cleaning

Cleaning

Before Cleaning

MAINTENANCE

To Clean

solution, as specified in the “Cleaning Solutions” section.

• Rinse with a cloth dampened with water.

• Wipe dry with a clean cloth or allow to air dry.

Lower Housing Removal to Access Pumping Mechanisms

• To access the pumping mechanisms, remove the lower housing by simultaneously depressing the four black release tabs and pulling straight down.

Slide Link and Pumping Mechanism

• Place the instrument in the upright position.

• Clean the slide link and pump latch mechanism using small soft-bristled brush (or lint-free swab), dampened with the appropriate cleaning solution, as specified in the “Cleaning Solutions” section. If dried residue is difficult to remove, or the slide link or pump latch sticks, spray the cleaning solution on the residue and allow it to soak until it can be more easily removed.

• After removing residue, rinse with a lint-free swab dampened with water. Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab.

• Dry with a lint-free swab or cloth, or allow to air dry.

ir-in-line Sensor

NOTE

: Air-in-line alarms may occur when dried residue builds up in the

air-in-line sensor tubing recess.

• Inspect the air-in-line sensor module to ensure that there is no separation or breakage of the glued seams.

NOTE:

Defective air-in-line sensor modules must be replaced before

using the instrument.

• Place the instrument in the upright position.

• Clean the tubing recess (using a downward motion) with a lint-free swab dampened with the appropriate cleaning solution, as specified in the “Cleaning Solutions” section.

CAUTION: Use of abrasives or abrasive cleaners on the air-in-

line sensor recess may cause false Air-in-line or Check Air Sensor alarms.

• Rinse with a lint-free swab dampened with water.

• Dry with a lint-free swab or allow to air dry.

SLIDE LINK ASSY

PUMP LATCH

AIR SENSOR

MAINTENANCE

Optomodule

WARNING: When cleaning the optomodule, use EXTREME

CARE to avoid damage to valve actuators. Damage or breakage of the actuator tips could cause an uncontrolled flow condition.

CAUTION: Do not use isopropyl alcohol or chlorine water on

the optomodule.

• Place the instrument in the upright position.

• Gently clean the optomodule using a lint-free swab dampened with the appropriate cleaning solution, as specified in the “Cleaning Solutions” section. The cleaning solution may be sprayed on difficult to remove residue to help wet and soften the residue for easier removal.

• After removing residue, gently rinse with a lint-free swab dampened with water. Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab.

• Gently dry with a lint-free swab or allow to air dry.

alve Actuator

WARNING: Care must be taken when cleaning the vicinity of

the valve actuators to avoid damage and breakage of the actuator tips. Damage or breakage of the actuator tips could cause an uncontrolled flow condition.

CAUTION: Do not use isopropyl alcohol to clean the valve

actuators.

• Gently clean the valve actuator and actuator seal area using a lint-free swab dampened with the appropriate cleaning solution, as specified in the “Cleaning Solutions” section. The cleaning solution may be sprayed on difficult to remove residue to help wet and soften the residue for easier removal.

• After removing the residue, gently rinse using a lint-free swab dampened with water. Water may be sprayed on the cleaned surfaces to rinse areas that are difficult to reach with a swab.

• Gently dry with a lint-free swab or allow to air dry.

• After cleaning, inspect the exposed tips of the valve actuators. A broken tip may be supported by the actuator seal and not appear defective. Lightly attempt to push the tips of the valve actuators from side to side with a dry lint-free swab. If a tip is not rigid, then it is broken and must be replaced before using the instrument.

OPTOMODULE

NOTE

: Use extra-diluted, non-

alcohol cleaning solution.

NOTE

: A broken valve actuator tip may be supported by the actuator seal and may not appear defective.

WARNING: Damage to the

valve actuators can cause an uncontrolled flow condition. Do not clean with sharp or hard tools. Only clean with a non-abrasive, lintfree swab.

VALVE ACTUATOR

MAINTENANCE

To ensure the pump remains in good operating condition, both regular and periodic inspections are required. Any instrument that does not meet listed specifications should be serviced.

Regular inspections consist of performing the procedures described in the Basic Operation and Cleaning sections of this manual before use of the pump. Regular inspections are not covered under any contract or agreement offered by Alaris Medical Systems, and must be performed by the user.

When programming infusions verify the display:

Is complete and not blurred;

Reads the same as described in this manual;

Responds with the intended function for that key press.

Periodic inspections must be performed every 12 months. A service agreement may be obtained from Alaris Medical Systems, for the performance of all required periodic inspections.

The periodic inspections must be performed in accordance with Alaris Medical Systems requirements and guidelines. Customers within the United States and Canada should note that these inspections are also intended to complement the intent of Joint Commission on the Accreditation of Healthcare Organizations requirements.

Inspection Requirements

WARNING: Failure to

perform these inspections may result in improper instrument operation.

NOTE

: Detailed instructions for performing periodic inspections and maintenance can be found in the Technical Service Manual for the IVAC MedSystem III Multi-Channel Infusion Pump and in supplemental service bulletins.

MAINTENANCE

Service Information

If the instrument fails to respond as described in this manual and the cause cannot be determined, do not use the instrument. Contact qualified service personnel.

Within the United States, application and service information may be obtained by writing to the ALARIS Medical Systems Customer Service Department at:

ALARIS Medical Systems ATTN: Customer Service 10221 Wateridge Circle San Diego, California 92121

Within the United States and Canada, a toll-free telephone number has been set up for your convenience.

For information or assistance, or to arrange for the return of an instrument for repair, call:

In the United States - (800) 854-7128 In Canada - (905) 507-1131

For clinical or technical support, call:

(800) 854-7128

Outside the United States and Canada, service information, applications, and manuals may be obtained by contacting your local ALARIS Medical Systems Service Department or distribution center.

When submitting a request for service, include:

• a description of the difficulty experienced

• instrument settings

• administration set model and lot number

• solution used

• message displayed at the time of difficulty

If it is necessary to return the instrument for service, obtain a return authorization prior to shipment. Carefully package the instrument (preferably in the original packaging), reference the return authorization information, and return it to the appropriate service or distribution center. ALARIS Medical Systems cannot assume any responsibility for loss of or damage to instruments while in transit to ALARIS Medical Systems.

ALARIS Medical Systems Inc., (hereinafter referred to as ALARIS Medical Systems) warrants that:

A. Each new ALARIS Medical Systems instrument (excluding the battery) is free

from defects in material and workmanship under normal use and service for a period of one (1) year from the date of delivery by ALARIS Medical Systems to the original purchaser.

B. The battery and each new accessory are free from defects in material and

workmanship under normal use and service for a period of ninety (90) days from the date of delivery by ALARIS Medical Systems to the original purchaser.

If any product requires service during the applicable warranty period, the purchaser should communicate directly with ALARIS Medical Systems headquarters (San Diego, CA) to determine the appropriate repair facility. Except as provided otherwise in this warranty, repair or replacement will be carried out at ALARIS Medical Systems’ expense. The product requiring service should be returned promptly, properly packaged and postage prepaid by purchaser. Loss or damage in return shipment to the repair facility shall be at purchaser's risk.

In no event shall ALARIS Medical Systems be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any ALARIS Medical Systems product. This warranty shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and ALARIS Medical Systems shall not be responsible for, any loss or damage arising in connection with the purchase or use of any ALARIS Medical Systems product which has been:

(a) repaired by anyone other than an authorized ALARIS Medical Systems service

representative;

(b) altered in any way so as to affect, in ALARIS Medical Systems judgment,

the product's stability or reliability;

duct's serial or lot number altered, effaced or removed;

(d) improperly maintained or used in any manner other than in accordance

with the written instructions furnished by ALARIS Medical Systems.

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of ALARIS Medical Systems, and ALARIS Medical Systems does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of ALARIS Medical Systems any other liability in connection with the sale or use of ALARIS Medical Systems products.

ALARIS MEDICAL SYSTEMS DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

See packing inserts for international warranty, if applicable.

WARRANTY

1° Pri Primary infusion

2° Sec Secondary infusion

a am

AAMI American Association of Medical Instrumentation

ABS acrylonitrile-butadiene-styrene

AC alternating current (electrical power)

ANSI American National Standards Institute

BatLog Battery History Log

Calc Calculator

CalcOff Dose Rate Calculator Off

CalcOn Dose Rate Calculator On

ClrAir Clear Air

Cntrst Contrast

COMM Communications Port

Conc Concentration

Config Configuration

CP Controller Pressure

CSA Canadian Standards Association

DemoWD Demonstrate Watchdog

DI Dose Infused

ECRI Emergency Care Research Institute (ECRI, Plymouth Meeting, PA)

ECG Electro-cardiogram

ES Electro-static

FMS Field Maintenance Software

Gm gram

GP General Purpose

GP II General Purpose II

h hour

in. inch

I.D. identification

IEC International Electrical Code

Inf infused

IV intravenous

JCAHO Joint Commission on the Accreditation of Health Care Organizations

K 1,000 for numbers 10,000 or greater

KG; kg kilogram

KVO keep vein open

LB; lb pound

mcg microgram

mEq milliequivalent

mg milligram

min; mn minute

Sub Head

GLOSSARY

Abbreviations, Acronyms, Units of Measure

ml milliliter

mMol millimole

mUn milliUnit

µl microliter

N/A not applicable

Neontl Neonatal

NextPg Next Page

ng Nanogram

NiCd nickel-cadmium

OR Operating Room

OR II Operating Room II

p pm

Pri Primary

psi pounds per square inch

Sec Secondary

Stnd Disp Standard Display

STNDBY Standby

TotVol Total Volume

TR time remaining

UL Underwriters Laboratories, Inc.

Un unit

VI volume infused

Vol volume

VolRem volume remaining

VR volume remaining

Wt weight

Symbols

Refer to accompany documents for complete instructions.

Canadian Standards Association

Underwriters Laboratories

Plug

Direct Current

Flammable Anesthetics DANGER: Explosion risk if used with flammable anesthetics.

CITECH certification mark

___

----

THERE IS

PRINTING

ON THIS

PAGE

Corporate Office: 10221 Wateridge Circle San Diego, California 92121-2733

Mail:

P.O. Box 85335

San Diego, California 92186-5335

Alaris MedSystem III User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

INTRODUCTION

About the Pump

Features

System Components

Operational Precautions

BASIC OPERATION

Preparing the Infusion

Loading the Set

Preparing the Administration Set

Front Panel Overview

Programming Primary Infusion

Making Changes While Infusing

KVO Status

ADVANCED OPERATION

Secondary Mode

Preparing the Administration Set and Container

Programming Secondary Infusion

Dose Rate Calculator Programming with DRUG?

Device

Config

Press Note softkey.

Press BatLog softkey.

TROUBLESHOOTING

Alarm Response Keys

Advisories

Alarms

Fault

Watchdog

Other Conditions

MAINTENANCE

Specifications

Cleaning

Inspection Requirements

Service Information

WARRANTY

GLOSSARY