Model 2001i Operations Manual Sw Ver 2.0

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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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.

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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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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

*Deliver *Battery In Use

dependent on syringe size selected (See Appendix 1)

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

Bolus Delivery

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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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SECTION 3: General Description/ Diagram

Syringe Plunger Retainler

LCD (Liquid Crystal

Syringe Clamp (Clear)

I On/Off Switch

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-Syringe Saddle

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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

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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

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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

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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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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.

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

may result in siphoning, causing overdelivery.

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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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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.

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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

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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

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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).

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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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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.

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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

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&kg/min=128.8

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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).

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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 B-D@ 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

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

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WARNING:

If the B-D@ 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

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

c=ie.eenc/mi

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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