MedSystem III Directions for Use

ADVANCED OPERATION SECONDARY MODE ... PREPARING THE ADMINISTRATION SET ... PROGRAMMING SECONDARY INFUSION... DOSE RATE CALCULATOR (DRC) USING A SPECIFIC DRUG NAME... DOSE RATE CALCULATOR PROGRAMMING WITH DRUG?... DEVICE... CONFIG... NOTE ... BATLOG... TROUBLESHOOTING RESPONDING TO AN ADVISORY, ALARM OR FAULT ... ALARM RESPONSE KEYS ... ADVISORIES ... ALARMS... FAULT... WATCHDOG ... OTHER CONDITIONS...

9 9 9 10 14 15 17 19 19 20 22 24 26 28 29 29 31 31 32 33 36 36 36

BASIC OPERATION

1 2 4 6

ADVANCED OPERATION

ABOUT THE PUMP... FEATURES... SYSTEM COMPONENTS ... OPERATIONAL PRECAUTIONS ... BASIC OPERATION PREPARING THE INFUSION ... PREPARING THE ADMINISTRATION SET ... LOADING THE SET ... FRONT PANEL OVERVIEW ... PROGRAMMING PRIMARY INFUSION... MAKING CHANGES WHILE INFUSING ... KVO STATUS...

TROUBLESHOOTING

INTRODUCTION

INTRODUCTION

TABLE OF CONTENTS

SPECIFICATIONS ... CLEANING ... INSPECTION REQUIREMENTS ... SERVICE INFORMATION ... WARRANTY ... GLOSSARY...

Alaris MedSystem III Directions For Use

37 38 41 42 43 44

v

MAINTENANCE

MAINTENANCE

CAUTION:

W ith 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.

About the Pump 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.

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INTRODUCTION

CHAPTER 1 - INTRODUCTION

INTRODUCTION

Features 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.

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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 Clear Select

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. A:

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

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 Fast Select

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.

3

INTRODUCTION

System Components 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. Pressure Dome

Slide Clamp

Piston

Tubing Collar

Lower Assembly

3 Cassette Holders

Air-in-Line Sensor Detects bubbles of air during infusion. 4

Tubing Collar Recess Holds tubing collar in place.

Pump Latch Mechanism Drives the cassette piston to move fluid through the tubing.

INTRODUCTION

Connector Panel External Power External power receptacle connects with power cord.

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

AC Adapter Power Cord 1 2 0 V/ 6 0 H z three- p r o n g e d grounded adapter with 4 pin locking connector, standard on Model 2863.

COMM Communications line receptacle connects with RS-232. NOTE: 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.

5

INTRODUCTION

Operational Precautions Patient Precautions 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 without a ‘Y’ connector or injection port, for epidural infusions. The pump‘s secondary mode must not 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.

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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.

User Precautions 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.

WARNING: When the

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

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BASIC OPERATION Preparing the Infusion 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.

Connect the container to the IV set.

Pressure Dome

BASIC OPERATION

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.

Slide Clamp

Preparing the Administration 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.

Tubing Collar Clear portion of cassette

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

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

to turn pump on.

A

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. A A

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Front Panel Overview Instrument Control Keys ON/OFF Recharge Key

BASIC OPERATION

Turns the pump on and off.

Channel Control Key

STANDARD DISPLAY Key

START/STOP Key

MORE OPTIONS Key

Starts or stops infusion Allows the user to display additional softkey on selected channel. functions.

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

Standard Display Page Status Line Displays infusion status (Infusing; Stopped; Standby; KVO; ALARM; FAULT; SERVICE) for each channel. NOTE: Status 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 is pressed during infusion. Cntrst – (Contrast) Brightens or dims display. GP II – When pressed, indicates full name of selected Device Type on the prompt line. NOTE: Additional softkey prompts are displayed by pressing More Options.

Softkey Pads (4) 10

ON/OFF

STANDARD DISPLAY ®

MORE OPTIONS

START STOP

MedSystem III® DLE

Stopped

Standby

Standby

125

25

95

ml/h VR: 996.2 VI: 12.8

ml/h VR: 138.8 VI: 26.9

ml/h VR: 93.2 VI: 16.8

Start affects channel C STNDBY

A

Cntrst

GP

B

C

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

BASIC OPERATION

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.

MORE OPTIONS

STANDARD DISPLAY

ON/OFF

START STOP

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

A

Fast

B

C

↑ – Increases highlighted value. ↓ – Decreases highlighted value. Fast ↑ – Increases highlighted value at increments.

Fast

greater

↓ – Decreases highlighted value at increments.

greater

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To turn pump on Press

.

BASIC OPERATION

• 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.

To turn pump off Press and hold . • Display disappears. • Pump is turned off.

To view infusion settings for all active channels Press

.

• Standard Display page is displayed.

To activate additional Standard Display softkey prompts With the Standard Display page displayed: Press

, once.

• TotVol, Device, Config , and Note softkeys appear. Press

again.

• Batlog and DemoWd softkeys appear.

To select channel and display Programming Pages Press , , or . • Selected channel programming page is displayed.

To program infusion 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.

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

To access alarm information • 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.

To activate additional Programming Page softkeys With the programming page displayed: See the ADVANCED OPERATION section of this manual for information on the use of the Dose Rate Calculator function.

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.

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BASIC OPERATION

Press Enter to accept new value.

Programming Primary Infusion

BASIC OPERATION

To set primary rate Press , , or . • Programming Page is displayed. • Rate is highlighted. Press Select if current rate is desired OR Press ↑, ↓, FAST ↑, or FAST ↓ to change Rate. • Value flashes. Press Enter to confirm. • Highlight moves to volume remaining (VR)

A:

Stopped A: Stopped A: Primary Rate Rate 100 ml/h A: Primary 100 ml/h A: Pri VolRem (VR) 500 A: Pri VolRem (VR)ml500 ml A: Pri Time(TR) A: Pri Time(TR)05h 00m 05h 00m A: Pri VolInf(VI) A: Pri VolInf(VI) 1 ml 1 ml since 12:37p 01 Feb01 02Feb 02 since 12:37p Press Select to choose line line Press Select to choose Fast Fast Select Select

To set primary volume remaining (VR) Press Select if current VR is desired OR 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).

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 Fast Select

To clear primary volume infused (VI) Press Select if current VI is desired OR 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.

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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 since 12:37p 01 Feb 02 Press Select to choose line Clear 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 since ----Press Enter or Recall Recall Enter

Making Changes While Infusing To titrate or change primary rate during infusion Press

,

, or

.

BASIC OPERATION

• 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.

To change volume remaining during infusion 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.

To clear volume infused during infusion 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. OR Press Enter to confirm. • Infusion continues with volume infused reset to zero. • Current date and time are entered.

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

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To simultaneously clear Total Volume Infused for all channels Press

.

Stopped

• Standard Display page is displayed. Press

.

• TotVol, Device, Config and Note softkeys appear.

BASIC OPERATION

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. OR Press RECALL to return the previous Total VI .

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 ClrTot Stopped

Stopped

TotVI A TotVI B Pri 0 Pri 0 Sec 0 Sec 0 = 0 = 0 Total VI = 0 since ----Press Enter or Recall Enter

Stopped TotVI C Pri 0 Sec 0 = 0 ml Recall

To place a channel on Standby during infusion Press appropriate channel Press

,

, or

Stopped

.

100

to stop infusion.

ml/h VR: 450 VI: 50

Press . • Standard Display page is displayed. Press Stndby.

Start affects channel A STNDBY

To start an infusion from Standby status Press appropriate channel Press

,

, or

.

to start infusion.

Programming Option To set up an infusion by Rate/Volume or Volume/Time 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 16

,

, or

.

Cntrst

GP II

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. 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 NextPg Select

if channel is infusing.

Press Select to move highlight to Setup:Select VR and Time. OR 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.

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

BASIC OPERATION

Press

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 Recall Enter

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.

KVO Status To resume infusion when VR=0 (KVO) 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

,

KVO

100 , or

twice.

• VR is highlighted. Press REPEAT to recall previous VR. OR Press ↑, ↓, FAST ↑, and FAST ↓to change VR. • Value flashes. Press Enter to 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.

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 REPEAT Select

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