Model 2001i Operations Manual Sw Ver 2.0

TABLE OF CONTENTS Page SECTION 1

INTRODUCTION .........................................................................

1-2

SECTION 2

GENERAL SPECIFICATIONS ...................................................

3-4

SECTION 3

GENERAL DESCRIPTION/DIAGRAM ....................................... 5-7

SECTION 4

OPERATING INSTRUCTIONS ................................................... 8-l 5

SECTION 5

INFUSION MODES ....................................................................

16-41

BODY-WEIGHTMODE ...................................... 17-23 MASS MODE ..................................................... 24-29 CONTINUOUSMODE ........................................ 30-36 VOLUMWIMEMODE ....................................... 37-41 SECTION 6

BOLUS .........................................................................................

42

SECTION 7

CHANGERATE ..........................................................................

43

SECTION 8

PRIME .........................................................................................

44

SECTION 9

STANDBY TIME ..........................................................................

45-46

SECTION 10

ALARMS/ALERTS .......................................................................

47-53

SECTION 11

BATTERY POWER .....................................................................

54

SECTION 12

BATTERY VOLTAGE ..................................................................

55

SECTION 13

IV POLE CLAMP/ACCESSORIES ............................................. 56-58

SECTION 14

PRECAUTIONS ..........................................................................

59-6 1

SECTION 15

CLEANING ..................................................................................

62

SECTION 16

SERVICE AND LIMITED WARRANTY ...................................... 63-64

SECTION 17

CUSTOM PROGRAM MODE ......................................................

65-67

SECTION 18

USER BANKS .............................................................................

68-75

APPENDIX 1

FLOW RATES .............................................................................

76

APPENDIX 2

DEFINITIONS .............................................................................

77-78

APPENDIX 3

USE OF THE [email protected] LUER LOCK SYRINGE IN THE OPERATION MODE ....................................................................

79

APPENDIX 4

LOCKOUT ...................................................................................

80

APPENDIX 5

PUMP I.D ....................................................................................

80

P/N g-61-201 Oi-O-1

Model 20 1 Oi Operations Manual

Page i

SECTION I: Introduction The Medfusion 201 Oi Syringe Pump offers flexibility for a variety of clinical needs, settings and applications. The pump may be utilized whenever meticulous low volume drug or fluid injections using a syringe are required in the hospital. All medications should be delivered in accordance with their approved drug labeling. The pumps may be field customized for specific applications. A choice of 15 modes of delivery are available as follows: Body Weight Mode (uglkglmin, ugIkg/HR, MG/kg/min, MG/kg/HR), Mass Mode (ug/min, ug/HR, MG/min, MG/HR, mU/min, mU/HR, U/min, UIHR), Continuous Mode (ml/min, ml/HR) and Volume Over Time Mode (dose volume/delivery time). In addition, the pump has the capability to store up to 64 user regimens/protocols. A bolus may be programmed then changed or administered at any time prior to or during drug delivery. The Medfusion 201 Oi Syringe Pump can be programmed for four types of infusion. Each infusion mode is listed below and explained in “Section 5: Infusion Modes” of this manual. IMPORTANT: Clinical discretion should guide the use of this syringe pump and associated disposables. Considerations should include, but not be limited to, the medication or fluid to be administered, its stability, its compatibility, and its pharmacologic response to environmental conditions. Consult with the syringe manufacturer, medical literature, drug package inserts and other available sources for additional information on syringe/medication interactions. 8 0 CAUTION ii

In consideration of how syringe pumps operate, clinicians should consider use of appropriate syringe, tubing, and in-line devices for the given application and the drug being infused. Certain factors enhance multiple characteristics of syringe pump infusion such as time to detect an occlusion, visual verification of volume delivered, continuity of flow, time to reach the set rate. Following are considerations requiring discretion by clinicians using syringe pumps. (Typically, this is most important with continuous injections of short half-life drugs.) a. Select the smallest syringe size appropriate for the intended application. Friction within the syringe (between the plunger rubber tip and the barrel) can affect the continuity of flow and the time required to attain the set infusion rate; the plunger tip expands and relaxes throughout the infusion, particularly with larger syringes at slower rates. The best case is to use smaller syringes at higher rates. b. Do not use a 60 cc syringe for rates of 2.0 cc/hour or less. Such use is generally not recommended when using a syringe pump.

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Model 20 I Oi Operations Manual

Page 1

Introduction c. Connect the syringe pump tubing at the closest point to the patient for more predictable and accurate delivery of the fluid. d. Use small internal diameter, high durometer (hardness) tubing and no in-line devices for best results at low rates.

8 AUTION: 0 EFC Federal (USA) law restricts this device to the sale by or on the order of a physician.

n !

I

WARNING:

manual, including the Carefully read the entire contents of this “PRECAUTIONS SECTION”, before attempting to use your Medfusion 201 Oi III

Syringe Pump, and verify that the SOFTWARE VERSION of the pump and manuals are in agreement.

The Model 201 Oi has four infusion modes: body-weight, mass mode, continuous and volume over time. 1.

Sody Weight Mode where mass units (e.g.: mg or mcg) are delivered per weight (e.g.: kg) per time (e.g.: minute or hour). Rates for this mode would be programmed in mg per kilogram per minute or per hour and mcg per kilogram per minute or hour.

2.

Mass Modewhere mass units (e.g.: mg, ug, mu, U) are delivered per time (e.g.: minutes or hours).

3.

Continuous Modewhere volume (e.g.: ml) is delivered per time (e.g.: minutes or hours). Rates for this example would be programmed in ml per hour or ml per minute.

4.

Volume Over Time Modewhere the total delivery volume in ml and the desired delivery time in hours and minutes are programmed individually.

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Model 20 1 Oi Operations Manual

P/N 9-61-2OlOi-O-1

SECTION 2: General Specifications Overall Size

Power

4.5” wide x 3.0” high x 7.5” long

AC Adapter DC Internal rechargeable batteries

Weight 2.5 pounds

Recharge Time No longer than 16 hours with the pump turned off.

Accuracy +/-

3% excluding syringe variations Infusion Modes

(may be field customized)

Battery Capacity At 25”C, a 16 hour charge will operate the

pump for approximately 10 hours at 5.0 ml/hr with a 60 ml syringe.

Body Weight Modes: ug/kg/min Crg/kg/HR

MG/kg/min MG/kg/HR Mass Modes: ug/min l-Jg/HR MG/min MG/HR mU/min mU/HR U/min UMR Continuous Mode: ml/min ml/HR Volume Over Time Mode: volume/time

Alarms/Alerts

*Near Empty (5 to 60 minutes) *Empty *Dose Volume Delivered l Bolus Complete l Bolus Delivery *Occlusion System Malfunction *Low Battery *Depleted Battery Syringe Pops Out *Invalid Size *Invalid Number Check Clutch *Alarm Temporary Delay: 2 or 60 minutes *Alarm Audio Volume: Soft or Loud *Load Syringe Plunger Status Alerts (Visual, Non Audible)

Stop/Program Flow Rate 0.01 to 378.0 ml/HR

dependent on syringe size selected (See Appendix 1) Bolus Delivery

In Body Weight, Mass and Continuous Modes P/N 9-61-201 Oi-C-1

*Deliver *Battery In Use

*Battery Charging *Battery Depleted *Priming Standby Mode *Back Light

Model 20 1 Oi Operations Manual

Page 3

SECTION 2: GENERAL SPECIFICATIONS CONTINUED... Total Delivered

. from 0.0000 from 0.00 from 0.0000 l

l

to 9999.9999 MG to 9999.99 ml to 9999.9999 u

Syringe Options/Sizes

l Becton-Dickinson (B-D*): l Monoject* (Mono): l Terumo (Teru): l Becton-Dickinson Glass(BD-G): l Abboject* (Abot):

1,3,5,10,20,30,60 ml 1,3,6,12,20,35,60 ml 1,3,5,10,20,30,60 ml 1,3,5,10 ml 50 ml

* The following are trademarks: B-D (by Becton Dickinson and Company), Monoject (by Sherwood Medical), and Abboject (by Abbott Laboratories). Please note the folio wing: *Automatically senses syringe size (except B-m ICC Luer Lock Syringe, See Appendix 3). *All syringes will fill to their maximum stated volume.

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Model 20 1 Oi Operations Manual

P/N g-61-201 Oi-O-1

SECTION 3: General Description/ Diagram

Syringe Plunger Retainler

LCD (Liquid Crystal

Syringe Clamp (Clear)

I On/Off Switch

P/N g-61-201 Oi-O-1

-Syringe Saddle

Model 201 Oi Operations Manual

Page 5

SECTION 3: GENERAL DESCRIPTION/DIAGRAM CONTINUED... Rate Keys BE

These keys will move in increments of 50 counts regardless of decimal point location. Press both simultaneously during stop to zero all numbers. These keys will move in increments of 1 count regardless of decimal point location.

Rate Keys

Press both simultaneously to zero all numbers. NOTE:

Protocol

Holding down any rate key continuously will cause it to move faster than a single key press.

Used to scroll through different screens of user ID’s and modes. Used in conjunction with stop key to access Data Bank. Used prior to operation to access User Bank “A”.

Decimal Shift

Allows user to shift decimal point for concentration, bolus and dose in certain modes.

stop/ Program

Used to stop infusion or bolus delivery. Used in conjunction with protocol key to access user bank.

Deliver

Used to start delivery or initiate bolus. Used to stop bolus delivery.

Select

Enter

Page 6

q q

Used to simplify screen by removing the displays for Weight and Concentration in Body Weight Mode or Mass Mode. Used to select choices (i.e., acts as “NO” answer for certain selections or to toggle between “YES” and “NO”). Used to enter or confirm selections. Used to temporarily display in ml/hour instead of weight or mass. Model 20 1 Oi Operations Manual

P/N g-61-201 Oi-O-l

SECTION 3: GENERAL DESCRIPTION/DIAGRAM CONTINUED... Silence Alarm

Allows audio silencing of alarm for 2 to 60 minutes. (depending on what was programmed in Custom Programming)

Reset Total

Allows user to reset total volume to zero in stop mode.

Delivered

Allows user to reset total volume to zero when concentration changed or ID changed. Allows for programming of bolus during stop or delivery.

Bolus

Allows for delivery of bolus when used in conjunction with deliver key. Prime

q b

P/N 9-61-201 Oi-O-l

Used as a “clear” function to clear user name in the Data Banks. Used to lock pump so that settings cannot be changed.

Lockout

Pump Power Switch

Used to purge fluid through line and to remove mechanical slack.

[el

Allows for stopping and starting only.

ir!!El

Used to turn the pump ON and OFF.

Model 20 1 Oi Operations Manual

SECTION 4: Operating Instructions STEP 1:

SYRINGE LOADING

STEP 1A:

Pinch and hold together the CLUTCH LEVER (releases the clutch) and pull the SYRINGE DRIVER outward until it reaches the end of its track.

STEP 1B:

pull

Grasp the clear SYRINGE CLAMP, pull upward allowing room for the syringe in the SYRINGE SADDLE.

STEP 1C:

Insert the syringe, plunger end first.

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Model 20 1 Oi Operations Manual

P/N 9-61-201 Oi-O-1

SECTION 4: OPERATING INSTRUCTIONS CONTINUED...

1C continued:

NOTE: To be certain that the syringe is properly placed in the

pump, make sure the graduations/ numbers on the syringe face UP.

STEP 1D:

The clear syringe clamp must secure the syringe tabs within the syringe clamp groove. Syringe tabs can be rotated slightly. Finger tabs should be parallel in relation to the clamp as shown: syringe tabs parallel to clamp

If not properly engaged, the pump may alarm after it has been in the deliver mode for a period of time.

For all size syringes, be sure the finger tabs of the syringe engage the syringe clamp groove (retainer) and the syringe saddle.

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SECTION 4: OPERATING INSTRUCTIONS CONTINUED... STEP 1E:

Pinch together the CLUTCH LEVER and move the SYRINGE DRIVER forward until the SYRINGE DRIVER contacts the plunger end of the DISPOSABLE SYRINGE.

m

IMPORTANT:

Make sure the CLUTCH LEVER snaps into its fully extended operating position.

STEP 1F:

Insert the end of the SYRINGE PLUNGER into the SYRINGE PLUNGER RETAINER thus holding it in place. The SYRINGE PLUNGER may need to be lifted to load.

n !

WARNING: Failure to secure the syringe plunger to the plunger retainer

may result in siphoning, causing overdelivery.

n8 0

CAUTION:

The plunger must be in contact with the driver to begin immediate delivery. A gap could lead to a delay in delivery. Use the prime function to eliminate any gap.

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Model 20 1 Oi Operations Manual

P/N 9-61-201 Oi-O-1

SECTION 4: OPERATING INSTRUCTIONS CONTINUED... STEP 1G: REMOVING THE SYRINGE: Plunger Retainer

To remove syringe from pump: Lift up the clear syringe clamp and remove the empty syringe as shown.

(I1F

IMPORTANT:

Be sure to lift the syringe plunger out of the plunger retainer (groove) before pulling the syringe out.

n !

WARNING:

Failure to follow proper syringe removal procedures could cause damage to your pump, which may result in inaccurate drug delivery.

STEP 1H:

OPTIONAL Loading Abbot Pre-Filled Syringe

l

.

\

Plunger Holder Cup

! n

Securely attach the plunger holder cup provided by Abbott to the end of the syringe plunger. (Glue or tape must be utilized to securely attach the plunger holder cup). Place the end of the cup into the plunger retainer as described in STEPS 1 E and 1 F.

WARNING:

Proper syringe loading and plunger holder cup placement is essential for proper delivery and actuation of the empty and near empty alarms. Improper use or the lack of use of the plunger holder cup may result in inaccuracy with ramifications that are drug dependent. Failure to secure the plunger holder cup to the syringe may result in siphoning, causing over-delivery. P/N g-61-201 Oi-0-l

Model 20 1 Oi Operations Manual

Page 11

SECTION 4: OPERATING INSTRUCTIONS CONTINUED... STEP 2:

TURNING THE PUMP “ON”; REVIEWING THE CUSTOM PROGRAMMED FEATURES AND PUMP SELF TEST

STEP 2A:

The main power switch is located on the end of the pump. Switch it to its “on” position (i.e., 0 = Off, 1 = On).

NOTE:

Make sure the AC adaptor cord is plugged into an electrical outlet (unless battery power is required). When “ON”, the LCD displays the following information: Line 1: Software Version, Pump ID Line 2: NE - Near Empty Alarm

(10 min. was programmed in Custom Programming) Bol- Bolus feature was custom programmed. VL - A Volume Limit was custom programmed. V - Voltage of Battery at 8.4. (which indicates a full charge) Line 3: ALARM - (Soft or Loud can be chosen). 2 MIN - (Temporary alarm delay either 2

(NE18 B0i

uL

U=8.4)

(_laarm=Loud ZHIN Nonei

min.or 1 hour). ALARM DELETED - Choice of none, #l or

#l and #2 alarms. Line 4:System Test STEP 3:

PROGRAMMING (INITIAL POWER-UP)

NOTE:

The program key ‘LED” blinks and a slow intermittent beep (#l) sounds to indicate the Program Mode unless deactivated in Custom Programming. (The alarm temporarily silences by pressing the SILENCE ALARM key once). Program or function changes occur only in the STOP/ PROGRAM Mode. A single audio peck indicates a valid key press (occurs even when the audio is silenced).

Page 12

Model 20 1 Oi Operations Manual

System

Test

)

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SECTION 4: OPERATING INSTRUCTIONS CONTINUED... STEP 3A:

If more than one syringe manufacturer is chosen in the custom program mode the bottom line displays: “Select Mfger:” Use SELECT key to choose syringe manufacturer. Use ENTER to confirm choice.

NOTE:

If only one syringe manufacturer is custom programmed, the pump automatically advances to STEP 38.

STEP 3B:

The first line of the LCD displays the most recent mode programmed. Press ENTER to confirm this mode or press PROTOCOL to select from modes setup in custom programming. If more than 8 modes were setup, the PROTOCOL key toggles between the screens, beginning with any programmed user modes.

NOTE:

If the user modes have been previously custom programmed more screens will exist. (See Section 18: User Banks). Use SELECT key to choose desired mode. Use ENTER key to confirm choice.

STEP 3C:

The mode chosen appears in the right upper corner. If the syringe is not loaded, load it per instructions.

NOTE:

In this case ug/‘kg/min was chosen. The LCD displays “LOAD SYRINGE, PRESS ENTER”. Press ENTER key to confirm the syringe size.

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’

Page 13

SECTION 4: OPERATING INSTRUCTIONS CONTINUED...

STEP 3D:

CONCENTRATION ENTRY

Use the RATE SELECTION KEY(s) 0 to select the appropriate numerical value for concentration.

q q q

NOTE:

The decimal point may be moved by pressing the decimal shift key prior to numerical entry However, it may not be moved if in User Bank ‘A” or lb’!

NOTE:

If decimal shift is pressed after numbers have been programmed the numbers will all change to zero.

Press ENTER to confirm concentration.

STEP 3E:

WEIGHT ENTRY

Use the RATE SELECTION KEY(s) 6 0 to select the appropriate numerical value for weight.

q

NOTE:

q

The decimal point cannot be shifted for weight and the minimum allowable entry is 000.1 and the maximum is 250.0 kg. Use ENTER key to confirm weight.

Page 14

Model 201 Oi Operations Manual

P/N 9-6 f-201 Oi-O-f

SECTION 4: OPERATING INSTRUCTIONS CONTINUED... BOLUS ENTRY

STEP 3F:

Use the RATE SELECTION KEY(S) to select the appropriate numerical value for the bolus amount.

q q q q

NOTE:

The Decimal point may be moved by pressing decimal shift key prior to numerical entry. If it is moved after the numerical entry, the entry will be automatically reset to zero. However, the decimal point may not be moved if in User Bank ‘A” or “b”.

Bolus Bolus Bolus iBolus

= = =

Bolus =

iseepg/kg

Press ENTER to confirm the bolus amount. NOTE:

If no bolus is desired, enter value as zero.

NOTE:

If bolus was not selected in the Custom Program Mode it willnot be offered here.

STEP 3G:

RATE

Use the RATE SELECTION KEY(S) E to select the appropriate numerical value for rate. Press ENTER key to confirm rate.

q q q

NOTE:

Decimal point may be moved by pressing decimal shift key prior to numerical entry. If it is moved after the numerical entry the entry will be automatically reset to zero. However, the decimal point may not be moved in User Bank ‘A” or ‘lb”.

eee.e pg/kg/min= eeee pg/kg/min= 8.888 &kg/min= 88.88

I

P/N g-61-201 Oi-O-l

Model 201 Oi Operations Manual

&kg/min=128.8

I

Page 15

SECTION 5: INFUSION MODES (BODY- WEIGHT) Body Weight Mode Introduction The Body Weight Mode requires entries for concentration in mg/ml, weight in kg and dose. Additionally a bolus amount may be programmed. Body Weight Mode includes:

uglkglmin IJSlkglHR mg/kg/min mg/kg/HR

Any or all of these will be available depending on which were chosen in Custom Programming. STEP 1:

PROGRAMMING SYRINGE MANUFACTURER

NOTE:

If a single syringe manufacturer is custom programmed, the pump automatically advances to the mode screen.

STEP 1A:

Press SELECT key until the desired syringe manufacturer appears, then press ENTER to confirm.

The choices may be any combination of the following: BD MONO TERU BD-G

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ABOT

WARNING:

Verify that the syringe manufacturer on the LCD is the same as the syringe in use. Failure to use the listed manufacturer could result in inaccurate delivery. The pump cannot automatically identify syringe manufacturer.

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SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED... STEP 2:

SELECT MODE

STEP 2A:

If the pump has been previously programmed the initial screen shows the last mode or the name programmed. If the current identification (see Appendix 2: Definitions) is satisfactory, press ENTER. If not press the PROTOCOL key to find the name or mode desired. Continued pressing of PROTOCOL reviews all ID’s and modes available.

STEP 2B:

The Body Weight Mode appears on the first modescreen. Select from up to four of the Body Weight Modes (depending how many were chosen in Custom Programming).

NOTE:

The mode screens appear in sequence after the customized user bank screens. Use the SELECT key to move the “flashing” cursor next to the mode chosen, then press ENTER to confirm.

STEP 3:

PROGRAMMING SYRINGE SIZE

The fourth line of the LCD alternately flashes: “Load Syringe - Press enter”. If the syringe is not already loaded onto the pump, load per instruction (See Section 4: Operating Instructions).

n !

Load Syringe/

Once the syringe is properly loaded, press the ENTER key. The pump will automatically enter the syringe size and advance to the next programmable item, unless use of the [email protected] luer lock syringe was selected in custom programming, in which case the operator must select syringe size (i.e., lee or 3cc). (See Appendix 3). WARNING:

Always confirm that the syringe size stated on the LCD agrees with the size of the syringe loaded on the pump. Failure to select the correct syringe size will result in inaccurate delivery. Page 18

Model 20 1 Oi Operations A&nual

P/N 9-61-2OlOi-O-1

SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED,...

n !

WARNING:

If the [email protected] luer lock option was selected in custom programming, the operator must select the appropriate syringe size (i.e., 1 cc or 3cc). The pump cannot distinguish between these syringe sizes. STEP 4:

PROGRAMMING THE CONCENTRATION

STEP 4A:

DECIMAL SHIFT If the decimal point is located appropriately, skip to STEP 4B. If the decimal needs to be

moved, use the decimal shift key to move it to an appropriate location. NOTE:

Concentration is always programmed in MG/ ml regardless of decimal location.

= ee.ee HG/ml = 888.8 HG/ml 8888 HG/ml = Et.Eml

HG/ml >

To program a concentration, press the RATE SELECTION KEY(S) E beneath the flashing numerals.

STEP 48:

q q q

Press ENTER to confirm the desired concentration.

STEP 5:

PROGRAMMING WEIGHT To program a weight, press the RATE

SELECTION KEY(S) E the flashing numerals.

q q q

beneath

Press ENTER key to confirm the desired weight.

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SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED... STEP 6:

PROGRAMMING A BOLUS

c=ie.eenc/mi

If BOLUS does not appear on the LCD, it was not custom programmed, skip to STEP 7. STEP 6A:

7e.ekg

DECIMAL SHIFT If the decimal point is located appropriately, skip to Step 6B. If the decimal needs to be moved, use the decimal shift key to move it to an appropriate location.

I

Bolus =

eeeepg/kg

1

See tabbed section ‘BOLUS” for detailed information on programming, delivering and reprogramming bolus doses. STEP 6B:

To program a bolus, press the RATE SELECTION KEY(S) E e 13 beneath the flashing numbers. The LCD automatically advances.

q

Bolus =

seem/kg

I

Press ENTER to confirm. STEP 7:

PROGRAMMING RATE

STEP 7A:

DECIMAL SHIFT

If the decimal point is located appropriately, skip to STEP 78. If the decimal needs to be moved, press the DECIMAL SHIFT key to move it to an appropriate location.

Rate= eeeepg/kg/min Rate= e.eee&kg/min Rate= ee.eepg/kg/min

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Model 20 1 Oi Operations Manual

P/N 9-61-2OlOi-O-l

SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED... STEP 7B:

PROGRAMMING RATE To program a RATE, press the RATE

q

q q

SELECTION KEY(S) E beneath the flashing numerals. NOTE:

located

Continuously pressing the RATE SELECTION KEY(S) E E pI automatically advances the number.

q

Press ENTER to confirm the desired rate. NOTE:

Programming is complete when the display is solid (not flashing). The operator should PRIME to remove any mechanical slack before commencing delivery.

NOTE:

INVALID NUMBER displays on the LCD when an invalid rate en try occurs followed by an appropriate rate programmable for the syringe selected.

STEP 8:

PRIMING

I

For important detailed information on priming olease see tabbed section “PRIME”.

STEP 9:

DELIVERY

STEP 9A:

INITIATING DELIVERY

Press the DELIVER key to begin the infusion. The LCD will not flash and the green LED DELIVER light begins to blink. In the DELIVERY MODE all keys are inactive for programming except the ALARM ON/OFF key, the BOLUS and the RATE SELECTION key(s).

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SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED... STEP 9B:

DELIVERY-VIEW MUHR AND SIMPLIFY SCREEN C=lf3.ElOHGhl

7e.ekg

VIEW:

While delivering the operator can temporarily display the TOTAL DELIVERED in ml and the RATE in ml per hour by pressing and releasing the ENTER key. The ml conversion can also be viewed in STOP/PROGRAM by pressing the ENTER key.

NOTE:

SIMPLIFY:

Press the SELECT key while delivering to simplify the screen. Another press of SELECT will make the full screen reappear (not shown). STEP 9C:

q

m

CHANGING THE RATE

The operator may change the infusion RATE by two methods: See tabbed section “CHANGE RATE” for detailed information on same.

STEP 10:

BOLUS PROGRAMMING

See tabbed section ‘BOLUS” for detailed information on programming, delivering and reprogramming bolus doses. STEP 11:

STOP DELIVERY Press the STOP/PROGRAM key to stop the infusion. The STOP/PROGRAM LED blinks and a slow intermittent #l audio alarm sounds, unless it has been deleted in Custom Programming (See Section 10: Alarms/Alerts).

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P/N 9-61:2OlOi-O-l

SECTION 5: INFUSION MODES (BODY- WEIGHT) CONTINUED,.. NOTE:

Alarms (e.g.: occlusion, depleted battery, load syringe plunger, syringe pops out, etc.) interrupt delivery. Correct the alarm and press the DELIVER key to resume.

STEP 12:

END OF DELIVERY

When the syringe empties, an EMPTY ALARM occurs (Type 2 Alarm unless deleted in Custom Programming). (See Section 10: Alarms/Alerts). STEP 13:

PROGRAMMING STANDBY TIME

The Standby Mode allows temporary suspension of an infusion while retaining all pertinent data (e.g.: rate, total delivered, syringe size, syringe manufacturer, etc.) See tabbed section “STANDBY MODE” for detailed information on programming and cancelling standby time.

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SECTION 5: INFUSION MODES (MASS MODE) \

Mass Mode Introduction The Mass Modes allow for programming a concentration value, weight and a dose. The pump then calculates the volume (i.e., rate). Additionally a bolus amount may be programmed. Mass Modes include: pg/min [email protected] mg/HR mg/min Units/min Units/HR Milliunits/HR Milliunits/min Any or all of these modes will be available depending on which were chosen in custom programming. STEP 1:

PROGRAMMING SYRINGE MANUFACTURER

NOTE:

If a single syringe manufacturer is custom programmed, the pump automatically advances to mode screen.

STEP 1A:

Press SELECT key until the desired syringe manufacturer appears, then press ENTER to confirm. Choices may be any combination of the following:

n !

[email protected] MONO TERU BD-G ABOT WARNING

Verify that the syringe manufacturer on the LCD is the same as the syringe in use. Failure to use the listed manufacturer could result in inaccurate delivery. The pump cannot automatically identify syringe manufacturer.

STEP 2:

SELECT MODE

STEP 2A:

If the pump has been previously programmed the initial screen shows the last mode programmed or the name.

Page 24

Model 20 1 Oi Operations Manual

ID=m/kg/min Use <enter> to keep Use <protocol> to Select New I.D. P/N 9-61-20101-O-l

SECTION 5: INFUSION MODES (MASS MODE) CONTINUED... If the current ID is satisfactory, press ENTER. If not, press the PROTOCOL key to find the name or mode desired. Continued pressing gf the PROTOCOL key reviews all ID’s and modes available. STEP 2B:

The Mass Mode appears on either the first or second mode screen (depending on how many modes were chosen in Custom Programming). Up to 8 Mass Modes may be selected.

NOTE:

The mode screens appear in sequence after the customized User Bank screens. Use the SELECT key to move the flashing cursor next to the mode chosen then press ENTER to confirm.

STEP 3:

PROGRAMMING SYRINGE SIZE The fourth line of the LCD alternately flashes: “Load Syringe - Press enter”. If the syringe is not already loaded onto the pump, load per instructions (See Section 4: Operating Instructions).

n

Load Syringe/ Press enter

Once the syringe is properly loaded, press the ENTER key. The pump will automatically enter the syringe size and advance to the next programmable item, unless use of the [email protected] luer lock syringe was selected in custom programming, in which case the operator must select syringe size (i.e., 1 cc or 3cc). (See Appendix 3)

!

WARNING Always confirm that the syringe size stated on the LCD

agrees with the size of the syringe loaded on the pump. Failure to select the correct syringe size will result in inaccurate delivery.

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Model 20 1 Oi Operations Manual

Page 25

SECTION 5: INFUSION MODES (MASS MODE) CONTINUED...

! WARNING n If the [email protected] luer lock option was selected in custom programming, the operator must select the appropriate syringe size (i.e., 1 cc or 3cc). The pump cannot distinguish between these syringe sizes. STEP 4:

PROGRAMMING THE CONCENTRATION

STEP 4A:

DECIMAL SHIFT If the decimal point is located appropriately, skip to 48. If the decimal needs to be moved, press the DECIMAL SHIFT key to move it to an appropriate location. Concentration is always programmed as MG/ ml regardless of decimal location.

NOTE:

Cont. Cont. Cont. : Cont.

= BB.BEl HG/ml = 8Ele.e HG/ml

=

eet3f3 HG/ml

= 8.Elt38 HG/ml

To program a CONCENTRATION, press the RATE SELECTION KEY(S) E beneath the flashing numerals.

STEP 4B:

q q q

Press ENTER to confirm desired concentration.

STEP 5:

PROGRAMMING A BOLUS

If Bolus does not appear on the LCD it was not custom programmed, the pump automatically skips to STEP 6. STEP 5A:

DECIMAL SHIFT

If the decimal point is located appropriately program bolus amount. If the decimal needs to be moved, use the DECIMAL SHIFT key to move it to an appropriate location.

Page

26

Model 20 1 Oi Operations Manual

P/N 9-61-20101-0-l

SECTION 5: INFUSION MODES (MASS MODE) CONTINUED.... STEP 5B:

To program a bolus, press the RATE SELECTION KEY(S) E E 0 beneath the flashing numerals. Press ENTER to confirm the desired bolus. The LCD automatically advances.

q

C= 1.88HGhl

See the tabbed section “BOLUS” for detailed delivering and reprogramming bolus doses. STEP 6: STEP 6A:

PROGRAMMING A RATE DECIMAL SHIFT

C= l.eeHG/ml

If the decimal point is located appropriately, skip to STEP 6B. If the decimal needs to be moved, use the decimal shift key to move it to an appropriate location. STEP 6B:

PROGRAMMING THE RATE To program a RATE, press the RATE SELECTION KEY(S) E located beneath the flashing numerals.

q q q

NOTE:

i

Continuously pressing the RATE SELECTION KEY(S) automatically advances the number. Press ENTER to confirm the desired rate.

NOTE:

Programming is complete when the display is solid (not flashing). The operator should PRIME to remove any mechanical slack before commencing DELIVERY:

NOTE:

INVALID NUMBER displays on the LCD when an invalid rate entry occurs followed by an appropriate rate programmable for the syringe selected.

STEP 7:

PRIMING

For important detailed information on priming, please see tabbed section “PRIME”.

P/N 9-61-2OlOi-O-l

Model 20 1 Oi Operations Manual

Page 27

SECTION 5: INFUSION MODES (MASS MODE) CONTINUED...

STEP 8:

DELIVERY

STEP 8A:

INITIATING DELIVERY

Press the DELIVER key to begin the infusion. The LCD will not flash and the green LED DELIVER light begins to blink. In the DELIVERY MODE, all keys are inactive except the SILENCE ALARM key, the STOP/ PROGRAM key, the BOLUS and the SELECT, ENTER and the RATE SELECTION KEY(S). STEP 88:

DELIVERY-VIEW MUHR AND SIMPLIFY SCREEN VIEW

While delivering the operator can temporarily display the TOTAL DELIVERED in ml and the RATE in ml per hour by pressing and releasing the ENTER key. NOTE:

The ml conversion can also be viewed in STOP/PROGRAM by pressing the ENTER key SIMPLIFY

Press the SELECT key while delivering to simplify the screen. Another press of SELECT will make the full screen reappear (not shown). STEP 8C:

CHANGING THE RATE

The operator can change the infusion for detailed information on same.

Page 28

Model 20 1 Oi Operations Manual

P/N 9-61-201Oi-O-l

SECTION 5: INFUSION MODES (MASS MODE) CONTINUED...

BOLUS PROGRAMMING

STEP 9:

“BOLUS” for detailed information on programmmg, delivering and reprogramming bolus doses. STOP DELIVERY

STEP 10:

Press the STOP/PROGRAM key to stop the infusion. The STOP/PROGRAM LED blinks and a slow intermittent #l audio alarm sounds, unless it was deleted in Custom Programming (See Section 10: Alarms/ Alerts). NOTE:

Alarms (e.g.: occlusion, depleted battery, load syringe plunger, syringe pops out, etc.) interrupt delivery. Correct the alarm and press the DELIVER key to resume.

STEP 11:

END OF DELIVERY

When the syringe empties, an EMPTY ALARM occurs (Type 2 Alarm unless deleted in Custom Programming). STEP 12:

PROGRAMMING STANDBY TIME

The Standby mode allows temporary suspension of an infusion while retaining all pertinent data (e.g.: rate, total delivered, syringe size, syringe manufacturer, etc.). See tabbed section “STANDBY MODE” for detailed information on programming and cancelling standby time.

P/N 9-61-2OlOi-O-l

Model 20 1 Oi Operations Manual

Page 29

SECTION 5: INFUSION MODES (CONTINUOUS MODE) Continuous Mode Introduction The Continuous Modes allow programming of a volume limit (if custom programmed) and a rate. Additionally a bolus amount may be programmed. Continuous Mode includes:

ml/min ml/HR

One or both of these modes will be available depending on which were chosen in custom programming. STEP 1:

PROGRAMMING SYRINGE MANUFACTURER

NOTE:

If a single syringe manufacturer is custom programmed, the pump automatically advances to the mode screen.

STEP 1A:

Press the SELECT key until the desired syringe manufacturer appears, then press ENTER to confirm. Choices may be any combination of the following: B-D Mono Teru BD-G Abot

! WARNING: n

Verify that the syringe manufacturer on the LCD is the same as the syringe in use. Failure to use the listed manufacturer could result in inaccurate delivery. The pump cannot automatically identify syringe manufacturer. STEP 2:

SELECT MODE

STEP 2A:

If the pump has been previously programmed

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Model 20 1 Oi Operations Manual

P/N 9-61-20101-0-l

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED... the initial screen shows the last mode programmed or the name: If the current ID is satisfactory, press ENTER. If not, press the PROTOCOL key to find name or mode desired. Continued pressing of the PROTOCOL key reviews all ID’s and modes available. STEP 2B:

The Continuous modes appear either on the first or second modescreen depending on how many modes were chosen in custom programming. You may select from 2 Continuous Modes.

NOTE:

The mode screen appears in sequence after the customized User Bank Screens.

Use <enter> to keep

Use the SELECT key to move the flashing cursor next to the mode chosen, then press ENTER to confirm. PROGRAMMING SYRINGE SIZE

STEP 3:

The fourth line of the LCD alternately flashes: “Load Syringe - Press enter”. If the syringe is not already loaded onto the pump, load per instructions (See Section 4: Operating Ins true tions).

I

-_

_- __

Load Syringe/ Press enter

Once the syringe is properly loaded, press the ENTER key. The pump will automatically enter the syringe size and advance to the next programmable item, unless use of the [email protected] luer lock syringe was selected in custom programming in which case the operator must select syringe size (i.e., 1 cc or 3cc). (See Appendix 3).

P/N g-61-201 Oi-O-1

Model 201 Oi Operations Manual

Page 31

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED...

n !

WARNING: Always confirm that the syringe size stated on the LCD

agrees with the size of the syringe loaded on the pump. Failure to select the correct syringe size will result in inaccurate delivery.

n !

WARNING:

If the [email protected] luer lock option was selected in custom programming the operator must select the appropriate syringe size (i.e., 1 cc or 3cc). The pump cannot distinguish between these syringe sizes.

STEP 4:

VOLUME LIMIT

If volume limit does not appear on the LCD, it was not custom programmed, the pump automatically skips to STEP 5. The volume limit (VL) allows delivery of a preprogrammed fluid volume from any size syringe. The pump stops automatically when the VL is reached. Program the VL with the RATE SELECTION KEY(S) E

q q

0. Continuously pressing

the RATE SELECTION KEY(S) E

q

0

q

automatically advances the number. Press ENTER to confirm the desired VL. The LCD automatically advances. NOTE:

If the VL is inappropriate for the syringe capacity’ the LCD will display INVALID NUMBER and show an appropriate VL programmable for the syringe selected.

STEP 5:

PROGRAMMING A BOLUS

If a bolus does not appear on the LCD it was not custom programmed, the pump automatically skips to STEP 6. Page 32

Model 20 1 Oi Operations Manual

uL=25.eeml

P/N 9-61-2OlOi-O-1

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED... STEP 5A:

DECIMAL SHIFT

If the decimal point is located appropriately, program the bolus amount. If the decimal needs to be moved, press the DECIMAL SHIFT key to move it to an appropriate location. STEP 5B:

PROGRAMMING A BOLUS Bolus = eee.eml

BONUS =

To program the BOLUS AMOUNT press the RATE SELECTION KEY(S) E E beneath the flashing numerals.

q q

eeeeml

Bolus = e.eeeml Bolus = ee.eeml

Press ENTER to confirm the desired BOLUS. The LCD automatically advances. STEP 6:

PROGRAMMING A RATE

STEP 6A:

DECIMAL SHIFT

If the decimal point is located appropriately skip to 6B. If the decimal needs to be moved press the DECIMAL SHIFT key to move it to an appropriate location. STEP 6B:

I

uL=25.8eml B=l

.eeml

ml/ldR

=

ea.88

I

PROGRAMMING THE RATE

To program a RATE, press the RATE beneath the flashing numerals. NOTE:

Continuously pressing the RATE selection key automatically advances the number.

Press ENTER to confirm the desired rate. NOTE:

Programming is complete when the display is solid (not flashing). The operator should PRIME to remove any mechanical slack before commencing delivery

P/N 9-61-2OlOi-O-l

Model 20 1 Oi Operations Manual

Page 33

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED... NOTE:

INVALID NUMBER displays on the LCD when an invalid rate entry occurs followed by an appropriate rate programmable for the syringe selected.

: 0 CAUTION: n The rate does not reset to 0 when the syringe size is changed. STEP 7:

PRIMING

For important detailed information on priming, please see tabbed section “PRIME”.

STEP 8:

DELIVERY

STEP 8A:

INITIATING DELIVERY

Press the DELIVER key to begin the infusion. The LCD will not flash and the green LED DELIVER light begins to blink. In the DELIVERY MODE, all keys are inactive except the SILENCE ALARM key, the STOP/ PROGRAM key, the SELECT key, the BOLUS key and the RATE SELECTION KEY(S). STEP 8B:

RUNNING VOLUME (ONLY IF VL IS PROGRAMMED)

The running volume (RV) in hundredths of a ml is displays on the LCD.

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Model 20 1 Oi Operations Manual

P/N 9-61-201Oi-O-1

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED... NOTE:

The RV records volume delivered since the last VL reset. By comparing the RV to the VL, one can determine how much more fluid must be delivered before reaching the VL. The RV is reset to zero when any of the following occur: change in syringe size, empty alarm, reprogramming the VL, when the VL is reached and when prime is used.

NOTE:

The RV is not reset to 0 when the total volume delivered is reset, however.

STEP 88:

CHANGING THE RATE

The operator can change the infusion rate by two methods. See tabbed section “CHANGE RATE” for detailed information on same. BOLUS PROGRAMMING

STEP 9:

See tabbed section ‘BOLUS” for detailed information on programming, delivering and reprogramming bolus doses. STEP 10:

STOP DELIVERY Press the STOP/PROGRAM key to stop the infusion. The STOP/PROGRAM LED blinks and a slow intermittent #l audio alarm sounds, unless deleted in Custom

Programming (See Section IO: Alarms/ Alerts). NOTE:

Alarms (e.g.: occlusion, depleted battery, load syringe plunger, syringe pops out, etc.) interrupt delivery. Correct the alarm and press the DELIVER key to resume.

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Model 20 1 Oi Operations Manual

Page 35

SECTION 5: INFUSION MODES (CONTINUOUS MODE) CONTINUED...

STEP 11:

END OF DELIVERY When the syringe empties, an EMPTY ALARM occurs (Type 2 Alarm unless deleted in Custom Programming). (See Section 70: Alarms/Alerts)

STEP 12:

PROGRAMMING STANDBY TIME

The STANDBY MODE allows temporary suspension of an infusion while retaining all pertinent data (e.g.: rate, total delivered, syringe size, syringe manufacturer, etc.). See tabbed section, “STANDBY MODE” for detailed information on programming and cancelling standby time.

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Model 20 1 Oi Operations Manual

P/N 9-61;2OlOi-O-l

SECTION 5: INFUSION MODES (VOLUMEITIME MODE) Volume/lime Mode Introduction The VOLUME/TIME mode requires entry of two infusion parameters --the desired DOSE VOLUME (DV) and the desired DELIVERY TIME (DT). This mode is most useful in delivery of a single dose. The rate in ml per hour calculates automatically. The DOSE VOLUME becomes the VOLUME STEP 1:

PROGRAMMING SYRINGE MANUFACTURER

NOTE:

If a single syringe manufacturer is custom programmed, the pump automatically advances to the mode screen.

STEP 1A:

Press the SELECT key until the desired syringe manufacturer appears, then press ENTER to confirm.

n !

Choices may be any combination of the following: B D MONO TERU BD-G ABOT WARNING:

Verify that the syringe manufacturer on the LCD is the same as the syringe in use. Failure to use the listed manufacturer could result in inaccurate delivery. The pump cannot automatically identify syringe manufacturer. STEP 2:

SELECT MODE

STEP 2A:

If the pump has been previously programmed the initial screen shows the last mode programmed or the name: If the current ID is satisfactory, press ENTER. If not, press PROTOCOL to find name or mode desired. Continued pressing of the PROTOCOL key reviews all ID’s and modes available.

P/N 9-61-20101-0-l

Model 20 1 Oi Operations Manual

Page 37

SECTION 5: INFUSION MODES (VOLUME/TIME MODE) CONTINUED... STEP 28:

The Volume Over Time (V/T) appears on the first or second modescreen depending on how many modes were chosen in Custom Programming. Use the SELECT key to move the flashing cursor next to V/J, then press ENTER to confirm.

STEP 3:

PROGRAMMING SYRINGE SIZE

Ymin ~&kg/HR NG/kg/HR

WHR ml/min ml/HR

1

The fourth line of the LCD alternately flashes “Load Syringe - Press enter”. If the syringe is not already loaded onto the pump, load per instructions (See Section 4: Operating Ins true tions).

n n !

Once the syringe is properly loaded, press the ENTER key. The pump will automatically enter the syringe size and advance to the next programmable item unless use of the [email protected] luer lock syringe was selected in Custom Programming in which case, the operator must select syringe size (i.e., 1 cc or 3cc). (See Appendix 3). WARNING:

Always confirm that the syringe size stated on the LCD agrees with the size of the syringe loaded on the pump. Failure to select the correct syringe size will result in inaccurate delivery.

!

WARNING:

If the [email protected] luer lock option was selected in Custom Programming, the operator must select the appropriate syringe size (i.e. ICC or 3cc). The pump cannot distinguish between these two syringe sizes.

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Model 20 1 Oi Operations Manual

P/N 9-61-2OlOi-O-l

SECTION 5: INFUSION MODES (VOLUMEITIME MODE) CONTINUED... PROGRAMMING DOSE VOLUME (DV)

STEP 4:

Press the appropriate RATE SELECTION KEY(S) E E to program a DOSE VOLUME (DV).

q q

NOTE:

Continuously pressing the RATE SELECTION KEY(S) E E 0 automatically advances the number.

NOTE:

The pump may be programmed to deliver a volume of 0.05 ml with the stipulation that the calculated rate must be equal to or greater than the minimum allowable rate for the chosen syringe size.

Dose u01 .=ee .ee ml

q

Press ENTER to confirm the desired DV. The LCD automatically advances. STEP 5:

PROGRAMMING DELIVERY TIME (DT) Press the appropriate RATE SELECTION KEY(S) E to program a delivery time (DT) in Hours:Minutes.

q q q

NOTE:

Continuously pressing the RATE selection key automatically advances the number.

NOTE:

Entriesdone with the e ore will

DWl5.eeml

will move in single minutes and roll over to hours when they exceed 60 minutes. Press ENTER to confirm the desired DT. The LCD automatically advances. NOTE:

Invalid Number displays on the LCD when an invalid entry occurs. The maximum (or minimum) valid infusion time appears for the D V selected.

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Model 20 1 Oi Operations Manual

Page 39

SECTION 5: INFUSION MODES (VOLUME/TIME MODE) CONTINUED... The pump automatically calculates the rate and all information on the LCD is solid (not flashing). The operator should PRIME to remove any mechanical slack before commencing delivery. STEP 6:

PRIMING

tailed information on priming, tabbed section “PRIME”.

STEP 7:

DELIVERY Press the DELIVER key to begin the infusion. The LCD will not flash and the green LED

DELIVER light begins to blink. The RUNNING VOLUME (RV) appears on the LCD when delivery begins. In the DELIVERY MODE, all keys are inactive for programming except the ALARM ON/OFF key and the STOP/PROGRAM key. STEP 8:

RUNNING VOLUME The RV in hundredths of a ml will be displayed

on the LCD.

.eeml

NOTE:

The RV records how much of the DOSE VOLUME (e.g.: VOLUME LIMIT) has been delivered. The RV is reset to zero when any of the following events occur: change in syringe size, empty alarm, reprogram the DV, the DV is reached and when PRIME is used.

STEP 9:

STOP/END DELIVERY

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Model 20 1 Oi Operations Manual

DT=el:3e

P/N 9-61-201Oi-O-1

SECTION 5: INFUSION MODES (VOLUMEITIME MODE) CONTINUED... STEP 9A:

STOP DELIVERY

Press the STOP/PROGRAM key to stop the infusion. The STOP/PROGRAM LED blinks and a slow intermittent #l audio alarm sounds unless deleted in Custom Programming (See Section 10: Alarms/Alerts). NOTE:

Alarms (e.g.: occlusion, depleted battery, load syringe plunger, syringe pops out, etc.) interrupt delivery. Correct the alarm and press the DELIVER key to resume. The remaining DV is given at the proper rate.

STEP 9B:

END OF DELIVERY When the DV is reached, the Type 2 alarm sounds unless disabled in Custom Programming. The LCD says “DOSE VOL. DELIVERED” “PRESS ENTER” and the STOP/PROGRAM LED blinks indicating delivery cessation. To silence the audio alarm, press the SILENCE ALARM key (See Section 10: Alarms/Alerts).

NOTE:

The DV only equals the TOTAL DELIVERED readout during the administration of the first infusion. To continue the infusion, press DELIVER. The RUNNING VOLUME resets to zero (RV=O.OO ml) and another dose can be given. For example, if two DV amounts are delivered, the TOTAL DELIVERED amount will equal twice the DV amount.

STEP 10:

PROGRAMMING STANDBY TIME

mki5.eeml

DT=el:3e

The STANDBY MODE allows temporary suspension of an infusion while retaining all pertinent data (e.g.: rate, total delivered, syringe size, syringe manufacturer, etc.) See tabbed section “STANDBY MODE” for detailed information on programming and cancelling STANDBY TIME. P/N 9-61-20101-O-l

Model 20 1 Oi Operations Manual

Page 41

SECTION 6: Bolus 1 Bolus Delivery 1 To administer a bolus, the pump may be delivering or paused.

D D D D

Press BOLUS, then DELIVER. The BOLUS delivered is continuously updated on the LCD and the bolus deliver LED is lit. At the end of bolus delivery there will be 2 short beeps. If bolus was given during non-delivery, the pump will return to nondelivery after the bolus is complete. If a bolus was given during delivery, the pump will resume delivery when the bolus is completed. Reprogramming A Bolus:

During delivery or while paused, press the BOLUS key. Bolus amount will flash.

I

BoIus= 1500 mcg/kg

I

Change BOLUS to desired amount and

(a> (b)

Press ENTER to store. or Press DELIVER to immediately deliver. Interrupting A Bolus:

Bolus delivery may be interrupted at any time by one of two methods: Press STOP. This will stop bolus as well as stopping previous rate. Press DELIVER. This will stop bolus and resume or start programmed rate. Temporarily Deprogramming

A Bolus:

During delivery, press BOLUS then change amount to zero. Then press ENTER. During STOP or programming, press BOLUS button then press any two rate keys

simultaneously to change to zero. Then press ENTER. Note: Page 42

Bolus may be recalled at any time by pressing BOLUS as long as bolus delivery was chosen in Custom Program Mode. Model 20 1 Oi Operations Manual

P/N 9-61-20101-0-l

SECTION 7: Change Rate The operator can change the infusion rate by two methods:

1.

STOP THE PUMP D

Press STOP/PROGRAM.

D

Press the RATE SELECTION KEY(S) to start rate flashing: program a new rate.

D

Press the ENTER key.

D

Press the DELIVER key.

EEEO

OR 2.

DON’T STOP THE PUMP

D

Press any RATE SELECTION KEY(S) and when rate flashes, press RATE key to readjust existing rate to new rate.

D

Press ENTER to change to the newly programmed rate.

EEEO

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Model 20 1 Oi Operations Manual

,Page 43

SECTION 8: Prime

Press and hold the PRIME key to purge air from the administration set. The LCD states “PRIME VOL OO.OOML” and the pump runs at its fastest rate. After approximately 16 seconds elapses, a continuous Type 3 Alarm sounds. However, the pump continues to prime when the key is held down (See Section 10: Alarms/Alerts).

Prime Vok 00.00 ml

The amount delivered while priming is NOT counted by the TOTAL DELIVERED counter. However, the priming amount is shown on the prime volume counter. The PRIME function only activates when the pump is in the STOP/PROGRAM MODE and all other functions are entered (e.g.: Syringe Manufacturer, Syringe Size, Bolus Amount and Rate).

:il 0

Prime Vok 00.30ml

CAUTION: The prime function should be utilized when placing a newly filled syringe

on the pump or when attaching an infusion set. Priming will displace the air in the set with the infusate and removes mechanical slack before starting delivery. This assures that the syringe driver and plunger are in contact. ! WARNING: Do not operate the pump in the prime function while connected to the n patient. This could cause over-delivery of infusate or an infusion of air purged from the set. NOTE: When priming, the occlusion alarm may occur if a small bore Mini-volTM extension set is used. Intermittently press and release the PRIME key (versus pressing and holding it continuously) to alleviate this problem.

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Model 20 1 Oi Operations Manual

P/N 9-61-2OlOi-O-1

SECT/ON 9: Standby Time PROGRAMMING STANDBY TIME ! WARNING: n If any alarms are deleted in the Custom Program Mode, the STOP/PROGRAM audio alarm may be disabled, therefore an audio alarm will not occur when the STANDBY TIME elapses in the STANDBY MODE. The STANDBY MODE allows temporary suspension of an infusion while retaining all pertinent data (e.g. rate, total delivered, syringe size, syringe manufacturer, etc.). The STANDBY TIMER delays the occurrences of the STOP/ PROGRAM audio alarm by the time programmed. Press the STOP/PROGRAM key to stop the infusion. The pump must be in the STOP/PROGRAM mode. Press at the same time the STOP/PROGRAM and ENTER keys then release both. <sel>l<ent>:Stand-by

The last line of the LCD will appear as shown. Press the ENTER key. The LCD displays “STBY Time = 00:00”. STBY Time= 0O:OO

Program the desired STANDBY TIME in hours and minutes (e.g. 03:30 for three hours and thirty minutes) with the RATE keys.

STBY Time= 03:30

NOTE:

Time entries in minutes that equal or exceed 60 [i.e., 00:60 to 00:99] are converted to hours lie., 01:OO to 01:39]. The time entry then must be confirmed by pressing the ENTER key. STBY Time= 03:30

Press ENTER to start the timer. The LCD states “STBY Time = 03:30”. The time shown on the LCD will begin to count down. NOTE:

When the STANDBY TIME elapses, ‘STBY TIME = 0O:OO” disappears from the screen, the STOP/PROGRAM audio alarm sounds and the previously programmed rate reappears.

P/N 9-6l-201Oi-O-1

Model 20 1 Oi Operations Manual

1 STBY Time= I

0O:OO 1 I

.Page 45

SECTION 9: STANDBY TIME CONTINUED.. Press the DELIVER key to begin delivery.

1 CANCELLING THE STANDBY TIME 1 Press the STOP/PROGRAM key to return the pump to the previously programmed setting. Press the DELIVER key to begin delivery.

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Model 20 1 Oi Operations Manual

P/N 9-61-201Oi-O-1

SECTION IO: Alarms/Alerts INTRODUCTION

A.

The pump incorporates a series of ALARMS which are depicted in this section.

_ ALARMS nearempty empty bolus delivery

NOTE:

B.

Review Section 3 - General Description for specifics on how the SILENCE ALARM key functions. PROCEDURE FOR CORRECTING OCCLUSION ALARM

occlusion sys. malfunction low battery depleted battery battery in use battery charging

Troubleshoot by first checking for:

I

1. 2.

Kinks in tubing. Stop cocks and clamps which are turned off thus prohibiting flow.

3. 4. 5.

Clotted IV catheter or needle. Something preventing movement of the Syringe Driver. Make sure syringe is not empty.

Press the DELIVER key to restart the infusion once the occlusion is relieved/ corrected. NOTE:

a !

The pump STOPS INFUSING if an occlusion alarm occurs.

WARNING:

When an occlusion occurs and is corrected, there is a risk of infusing the pressurized buildup of infusate. To avoid inadvertent BOLUS, relieve the pressure before restarting the infusion. C.

PROCEDURE FOR SYSTEM MALFUNCTION

This alarm indicates that something has disrupted the operation of the microprocessor. Failures, which would activate this alarm, are some over and under deliveries and electrical component failures. ! WARNING: n If this alarm occurs, record any operating data such as TOTAL VOLUME DELIVERED, RATE, SYRINGE MANUFACTURER, SYRINGE SIZE, etc. Once the pump is turned off, this information is not retained. Remove the pump from service and consult the manufacturer.

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Page 47

SECTION IO: ALARMS/ALERTS CONTINUED... D.

NEAR EMPTY ALARM

Under most conditions, the NEAR EMPTY ALARM automatically sounds 3 beeps 5 to 60 minutes (dependent upon Custom Programmed Option) before the syringe becomes physically empty unless Type 1 alarms are deleted in Custom Programming. The pump continues to deliver after the NEAR EMPTY ALARM sounds. However, be aware of the following: If a volume limit is programmed and is less than the fluid in the syringe, the volume limit alarm will sound at the appropriate point and the infusion will stop. If a volume limit is programmed to be larger than the fluid remaining, a NEAR EMPTY alarm and EMPTY ALARM will sound at the end of the syringe. No Volume Limit Alarm will sound. If a volume limit value just slightly less than the volume of fluid in the syringe is programmed as a volume limit, the near empty alarm will sound, then the volume limit alarm may sound. E.

EMPTY ALARM

The EMPTY ALARM’s actuation point is determined by a mathematical formula based on the Syringe Manufacturer and Syringe Size. Whenever an EMPTY ALARM sounds (Alarm #/2), the operator should visually verify that the syringe in use is EMPTY. The operator must decide to terminate the infusion or replace the syringe with a new supply of infusate. NOTE:

The pump stops delivering when the EMPTY ALARM SOUNDS. The audio #2 alarm may be temporarily silenced by pressing the SILENCE ALARM key. The Type 2 alarms may be deleted in Custom Programming. If the syringe has any fluid remaining to deliver, restart the infusion by pressing the DELIVER key. The NEAR EMPTY ALARM will sound and when the syringe is empty you will receive a second EMPTY ALARM.

NOTE:

That the RV is reset but the total volume delivered is cumulative.

F.

SYRINGE POPS OUT

This alarm occurs if the syringe is disturbed during the infusion. A type 3 (i.e., continuous alarm) sounds and the fourth line of the LCD alternates between “PRESS ENTER” and “SYRINGE POPS OUT!“.

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P/N 9-61-2OlOi-O-1

SECTION 70: ALARMS/ALERTS CONTINUED... To correct press the ENTER key: Confirm that thesyringe is loaded properly.

Then press ENTER again to verify syringe size. Press DELIVER to continue the infusion. The audio alarm is temporarily silenced by pressing the SILENCE ALARM key. G.

CHECK CLUTCH If the clutch is manually disengaged for a period of time or the drive is manually moved during delivery a “CHECK CLUTCH” alarm results. A type 3 (i.e., continuous alarm) sounds and the fourth line of the LCD alternates between “PRESS ENTER” and “CHECK CLUTCH”!! Make sure the clutch is fully engaged and that the syringe is properly loaded. Press ENTER to confirm clutch check and then press DELIVER to continue the infusion. The audio alarm is temporarily silenced by pressing the SILENCE ALARM key.

H.

INVALID SIZE

This alarm occurs if the syringe loaded on the pump is not the size which is stored in the pump. In addition, please note that the pump cannot always distinguish between the same size syringe for different manufacturers. To correct, confirm that the syringe manufacturer programmed is the same as the syringe being utilized. Also verify that the area between the syringe barrel and SYRINGE CLAMP is kept clear of labels, etc. and that the syringe finger tabs are oriented as described in this manual. INVALID NUMBER

This LCD message occurs with entry of a parameter which cannot be accepted by the computer. Two beeps sound and the first valid number is displayed (for example, a rate too fast for the syringe selected, a volume limit greater than the volume of the syringe selected, the time between doses is less than or equal to the delivery time, in V/T where the desired delivery time is too fast for the volume chosen, etc.). J.

LOW BATTERY The low battery alarm occurs approximately 30 minutes before battery depletion at rates under 5 ml/HR or less. The low battery LED lights and two beeps occur intermittently every 15 seconds. The audio alarm may be permanently silenced by pressing the SILENCE ALARM key once. The LED will remain on.

P/N 9-61-201 Oi-O-1

Model 20 1 Oi Operations Manual

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