Accumate 2300 Volumetric Infusion Pump

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Accumate® 2300Volumetric Infusion Pump

Operating Manualwww.wooyoungmed.com

2

Important

This Operating Manual is for clinician

use only.

Do not permit patients to have access

to this Operating Manual.

Please read the entire Operating

Manual before operating the Accumate®

2300 volumetric infusion pump.

Failure to properly follow warnings,

cautions and instructions could result in

death or serious injury to the patient.

3

Warnings

If the pump is used to deliver life-sustaining medication, an additional pump must be available.

Prior to use, always check the audible and visual alarms.

The pump is not to be used for delivery of blood or cellular blood products.

Do not use this pump on mains power if the integrity of the protective earth system is suspect.

To prevent a possible explosion hazard do not use this pump in presence of inflammable anesthetic gases.

Do not use this pump in close proximity to equipment such as surgical diathermy with generates high levels of RFI.

Do not permit the use of mobile telephones in wards where this pump is in use.

If the pump is dropped or hit, inspect the pump for damage. Do not use a pump that is damaged or not functioning properly. Contact Customer Service to return a pump for service.

Do not permit this pump to used if standing in a pool of liquid.

System delivery inaccuracies may occur as a result of back pressure or fluid resistance, which depends upon drug viscosity, catheter size, and extension set tubing.

4

Warnings

Always read and follow the manual that accompany the source container and IV administration sets you are using. Carefully follow the manual for loading, removing, and reloading the set, as well as recommended set change intervals.

Change pumping section on tubing every 24 hours. Do not use tubing for more than 72 hours.

Always check pump data prior to starting infusion.

After starting an infusion, make sure drops are falling in the drip chamber. If no drops are falling, make sure the roller clamp is open. If the roller clamp is open and still no drops are falling, replace and dispose of the set.

The air detector cannot recognize the introduction of air at 3-way stopcocks, infusion ports, and other lines/tubes below the pump.

To avoid mechanical or electronic damage, do not steam autoclave or immerse the pump in any fluids or cleaning solutions. Always disconnect electrical power cord from outlet before cleaning to prevent electrical shock.

5

Cautions

Do not operate the pump at temperatures below +10◦C(50 ◦F) or above 40◦C(104◦F) and humidity levels below 30% or above 85%.

Do not store the pump at temperatures below +5◦C(41 ◦F) or above 40◦C(104◦F) and humidity levels below 10% or above 90%. Do not store the pump with the Administration Set attached.

Do not store the pump for prolonged periods with the battery installed (above 3months).

Do not immerse the pump in cleaning fluid or water or allow solution to soak into the pump, accumulate on the key pad, or enter the battery compartment.

Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners.

Do not use the pump to therapeutic levels of ionizing radiation.

Do not use the pump directly to ultrasound.

Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment.

Do not use the pump near ECG equipment.

Do not sterilize the pump.

All service and repair of the Accumate® 2300 pumps must be performed by Woo Young Medical or its authorized agents.

6

Table of Contents

In t roduct ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Features of the Accumate® 2300 – Front View & Key Pad .................................................................8

– Controls and Indicators .................................................................9

– Re a r V ie w . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 0

Directions for Operation– Preparation of the IV-set ..............................................................12

– Turning ON the Power - Rear ............................................................13

– Turning ON the Power - Front ...........................................................14

– Insertion of the IV-set ................................................................15

– Setting the Flow Rate and Delivery Limit ...........................................17

– Clearing the Volume Delivered ..........................................................18

– Operating the Pump .............................................................18

– Purge Infusion (stop mode) ...............................................................19

– Bolus Infusion (start mode) ...............................................................19

– T i t ra t ion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

– Data Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

– Adjust Sound ...... .... .. ... ... .. ... ... .. ... ... .... .. ... ... .. ... ... .. ... ... .... 22

– Occlusion Level ................................................................ 23

– Near End of Infusion ............................................................24

– End of Infusion ................................................................... 25

Alarms and Troubleshooting .....................................................26

Specif ications ..... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .... ... . 28

Maintenance– Routine Maintenance Procedures ....................................................30

– Cleaning and Storage ..................................................................31

– Replacing the AC fuses ...................................................................32

– Battery operation ................................................................. 33

Occlusion Pressure Limits ........................................................34

Start-up & Trumpet Curves ......................................................35

Warranty ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Service and Packaging ............................................. 39

Contact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

7

Introduction

The Accumate® 2300 volumetric infusion pump is a fully

featured infusion pump suitable for critical care and

generation applications.

The Advantages

High precision.

Purge, automatic & manual bolus capability.

Easy to operate in only three steps.

– Power On > Select (rate, total, VTBI) > Start

Easy to read, large display.

History function.

– Historical data of infusion records.

(warnings, settings, starts and stops of infusion, etc.)

Micro-infusion for neonatal and high risk application.

None dedicated sets, available from various manufacturers.

Programmable, ultrasonic air bubble detector.

Multi-position clamp for vertical or horizontal fixation to poles.

SAFETY STANDARD

The Accumate® 2300 meets all safety standards for medical electrical devices, corresponding to IEC 60601-1 and IEC 60601-2-24.

8

Features of the Accumate® 2300

-Front View & Key Pad

a

b

c

d

e

fg h

ij

k

l

m

n

opqr

s

t uv

w

x

y

9

Controls and Indicators

NO. Name Function

a Handle To handle for carrying

b Name Plate To display the pump model and name

c Display All essential information is displayed (flow rate,

delivery limit, volume delivered, alarms

information)

d Locker To lock pump door

e Key Pad To set infusion data

f Finger To squeeze the tube with the spring housing by

peristaltic motion

g Occlusion

Sensor

To detect the downstream occlusion of the tube

h Clamp Lever To prevent free flow when the pump door is

opened

i Spring

Housing

To squeeze the tube with the peristaltic fingers

j Door Handle To lock pump door with locker

k Door To protect the tubing set when running

l Door Magnet To detect whether the door is open or not

m Bubble Sensor To detect air in the tube

n LED To indicates pump is infusing or lights up during

an alarm (normal : green, malfunction : red)

10

Controls and Indicators

NO. Name Function

o Volume

Delivered

Displays Volume Delivered (VTBI:Volume To

Be Infused)

p Delivery Limit Displays delivery limit or alarms information

q Flow Rate Displays flow rate (infusion rate)

r SELECT

/SILENCE

To select setting mode (flow rate, delivery limit,

volume delivered)

/ To silence alarm for 2minutes

s BATTERY

LEVEL

To display the charging status of internal

rechargeable battery

t EXTERNAL

POWER

To inform whether the external power is

connected or not

u PURGE To access PURGE or BOLUS key

v POWER

ON/OFF

Press once to switch the pump ON. Press and

hold down for 2 seconds to switch the pump

OFF

w START To start the infusion

x STOP

/CLEAR

To stop the infusion

/To clear the value when setting data

y UP/DOWN To increase or decrease of value shown on

display

11

Features of the Accumate® 2300

-Rear View

a

b

c

d

e

f g h i

j

k

l

NO. Name Function

a Multi-position Clamp To fix the pump to vertical pole stand or horizontal bar of bed

b Rear Support To support to pole stand

c Drop Sensor Port To connect the drop sensor with the pump

d Nurse Call/ Comm. Port To connect the nurse call jack or communication cable

e Front Panel Lock Switch To lock the front key pad

f 12V DC Jack To supply the power of 12V in ambulance car

g Protective Ground To connect the protective earth line

h Spec Plate To inform the product information

i AC Outlet/Fuse Socket To connect the AC 90~245V main power cord where the 1.25A fuse is

j Rechargeable Battery To hold the NIMH rechargeable battery

k Power Switch To switch the main power

l Clamp Knob To fix the clamp

12

Direction for Operation

Preparation of the IV-set

– Check for cleanliness, completeness, and

damage. If unit appears damaged, do not use it.

– Check the IV administration sets. If other IV

administration sets are used, the operating safety

of the pump can no longer be guaranteed.

Patient safety may, as a result, be compromised.

• Recommended IV-set

– BD(BECTON DICKINSON) :A122

– KV(KOREA VACCINE) :143T/243T

– Carefully purge the infusion set, without allowing

any air bubbles to enter, until the drip chamber is

to 1/3 full. If air has entered, repeat purge-

procedure.

– Close the tubing roller clamp.

1/3

chamber

close

13


Turning ON the Power - Rear

Attach the pump to an IV

pole by turning the knob

on pole clamp.

Plug the pump's power

cord into an electrical

outlet.

Turn ON the MAIN POWER

switch. MAIN POWER switch

must be ON to charge the

battery.

14


Turning ON the Power - Front

Check whether the AC

power LED is turned on.

External Power LED display

will light.

Press the POWER ON key

on the front panel.When turning the pump OFF, the

pump must be at STOP mode in

order for the POWER key to respond.

Wait the self test

procedure.

Check the previously

used data.

15


Insertion of the IV-set

Completely insert the IV-set

into the BUBBLE SENSOR.

Insert the IV-set chamber

into the IV bottle/bag. Fill 1/3

of the chamber. Take cautions to avoid any air bubbles.

Open the door by pulling

the DOOR HANDLE.

Push the CLAMP LEVER to right

to open. Place the IV-set into

the clamp. This is a safety feature that

prevents free flow when the door is opened

during infusion.

16


Insert the IV-set in the occlusion

guide.

Check if the IV-set is

straightforward.

Close the door by pushing

the tightly DOOR HANDLE.

The roller clamp should be below

the pump. Open the roller clamp

to be ready to infuse. Check that no drops are falling in the drip

chamber.

CAUTION : Make sure that IV tube is NOT loosely fastened into the internal

chamber of the pump. It should be straightforward.

17


Setting the Flow Rate and Delivery Limit

Press the SELECT key.

The digits in the LED digital

display will blink in 7seconds.

Use the UP(▲) DOWN(▼) keys to

set the desired rate of infusion.The rate of infusion can be set

from 0.1 to 999.9ml/hr.





set the desired volume to be

infused. The volume to be infused can be

set from 0.1 to 9,999ml.

18


Clearing the Volume Delivered

Operating the Pump




Press the STOP/CLR key.

Press the START key.

Check the three LED turned

on sequentially.

19


Purge Infusion (stop mode)

Bolus Infusion (start mode)

Press and hold the PURGE key

when the pump is not infusion. Press and hold the PURGE key until fluid

flows and the purging of the IV-set is complete.

CAUTION : PURGE will infuse at the rate of 999.9ml/hr.The volume used during purging will be displayed, but it is

not added to the volume delivered.

The pump will not purge if the lock has been enabled.

Press the PURGE key when the

pump is infusion.PURGE will infuse at the rate of 999.9ml/hr.

The feature allows a bolus to be given during

an infusion.

Enter the amount of bolus to

be given in ml and Press the

START key. The amount of bolus

can be set from 1.0 to 99.9ml.

20


Titration (To change the flow rate while infusing)





set the desired rate of infusion.The rate of infusion can be set

from 0.1 to 999.9ml/hr.

Press the START key.

CAUTION : The pump will not titration if the lock has been enabled.

21


Data Lock (This features prevents unauthorized

use by locking out all key except SILENCE key.)

Turn ON [KEY LOCK] button

to lock the key pad on the

front panel.

Press the any key and

check the displayed in '----'.

Check the set up and pump

status again.

22


Adjust Sound (This feature allows the volume of

the alarm tone to be changed)



front panel.

Press and hold the SELECT

key and UP(▲) /DOWN(▼)

keys to increase or decrease

the sound level.

Select the volume of the alarm

tone to be changed.

caution : The volume of the alarm to change can be set from

1(45dB/1m) to 5(65dB/1m)

23


Occlusion Level (The pressure at which a

downstream occlusion alarm will be triggered

varied. The higher the pressure limit, the less

sensitive the pump is changes in fluid

resistance.)



front panel.


key and UP(▲)/DOWN(▼) keys

to increase or decrease the

occlusion level.

Select the occlusion level

to be changed.

caution : The occlusion level to change can be set low(7± 2psi),

center(11± 3psi), or high(15± 3psi).

24


Near End of Infusion (Sets the near end of

infusion warning time, as time left to End of

Infusion.)



front panel.


key and UP(▲)/DOWN(▼) keys

to increase or decrease.

Select the near end of infusion

to be changed.

caution : The end of infusion to change can be set from 0(no set)

to 15minutes.

25


End of Infusion (The pump has reached the end

of the infusion)

In certain conditions the Accumate® 2300

automatically switches to the KVO (Keep-Vein-

Open) rate. The KVO-rate is set to 1.0ml/hr.

However, if the flow-rate set by the user is lower

than 1.0ml/hr, the KVO-rate is equal to flow-rate.

This alarm occurs 5 minutes

before infusion is completed.

Press the SILENCE key.

This alarm occurs when infusion

is completed. (KVO : Keep Vein

Open)

Press the STOP key to reset.

26

Alarms and Troubleshooting

Alarms are indicated by a combination of an

audible alarm, flashing alarm indicator and

abbreviated message in the display.

First press the SILENCE key to silence the

alarm for a maximum of 2 minutes, then check

the display for an alarm message. Press the

STOP key to cancel the alarm message.

If the infusion has stopped, rectify the cause of

the alarm then press the START key resume

the infusion.

27

Alarms and Troubleshooting

Alarm

Indication &

Sound

Possible Cause Action

Air-in-line

Air

bb-bb-bb

Air bubble air-in-line sensor

IV tube not properly inserted

into the Bubble Sensor

Remove the air from the tube

Completely insert the IV

tube into the Bubble Sensor

Door Open

OPEn

bb-bb-bb

Door opened during infusion Close the door

Occlusion

OccL

bb-bb-bb

Downstream tubing kinked

Filter blocked

Closed roller clamp

IV positional or infiltrated

Catheter or vein too small

Occlusion limit too low

Correct kinks

Correct blocked filter

Open roller clamp

Check IV site

Increase occlusion limit

Drive Error

Err

bb-bb-bb

Motor malfunction

Mechanical error

Request A/S

Request A/S

Low battery

BAtt

b-b-b

30 minutes until battery is fully

discharged

Connect pump to AC

power

End of infusion

End, conP

b-b-b

Programmed infusion is

complete

Stop infusion and reset

No Good

ng-?

silence

Self-Test NG

Internal Malfunction

Request A/S

28

Specifications

Name Volumetric Infusion Pump

Model Accumate® 2300

Pumping System Linear peristaltic

Flow Rate Range 0.1-999.9ml/hr (0.1ml/hr increments)

Delivery Limit Range0.1-999.9ml (0.1 ml increments), 1,000-9,999ml(1ml

increments)

Total Volume Equals to the upper limit of the delivery limit range

Purge Rate Range Equals to the upper limit of the flow-rate range

Accuracy +/- 5% nominal

KVO( Keep-Vein-

Open)0.1-5.0ml/hr(0.1ml/hr increments)

Adjustable occlusion[5.8-17.4psi(3 level : low, center, high)

Adjustable alarm volume (level up or down)

Infusion completed

Alarms Low battery(30 min. before infusion stop)

Battery depleted(3 min. before power off)

Air-in-line

Door open

Drive error

Near End of Infusion

Others

Titration while running

Self testing (System check)

One key bolus

Front panel lock

29

Specifications

EMS DC 12V

Electrical Safety Class I, Type BF

Dimensions 140(W)*225(H)*140(D)mm

Weight Approximately 2.5Kg

Power Requirements AC 90-245V, 50/60Hz

Battery Built-in rechargeable dc 12V(NI-MH 2.3Ah)

Battery Operation Ca. 4hr @ 100ml/hr

Battery Charging

Time7hrs

Operation Conditions 10-40℃(Relative humidity 30-85%)

Storage Conditions 5-40℃(Relative humidity 10-90%)

Accessories AC power cord for 220V, Operating manual

Warranty 2 years from the date of delivery

Options RS-485, nurse call, drop sensor

CAUTION : Specifications are subject to change without

notice.

30

Maintenance

Routine Maintenance Procedures

To ensure that pump remains in good operating

condition, it is important to keep it clean and carry out

routine maintenance procedures described below. All

servicing should only be performed by a qualified

service engineer with reference to the Technical

Service Manual for this product.

– As required

Thoroughly clean external surfaces of the pump

before and after prolonged period of storage.

– At least once per year

Inspect AC power supply plug and cable for

damage. Perform functional tests as outlined in

the Technical Service Manual. Operate the pump

on battery power until the battery low alarm then

charge the battery to confirm battery operation

and charging.

31

Maintenance

Cleaning and Storage

Before the transfer of the pump to a new patient and periodically during the use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant/detergent solution.

Disinfectants which are known to be corrosive to metals must not be used. Concentrated Isopropyl alcohol based cleaners will degrade plastic parts.

The IV-set and extension lines are disposable single use items and should be discarded after use according to their manufacturers' instructions.

If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packing for protection.

Once every 3 months during storage, carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged.

Caution : Before cleaning always switch OFF disconnect from the AC power supply. Never allow liquid to enter the casing and excess fluid build up on the pump. Do not steam autoclave, ethylene oxide sterilize or immerse this pump in any fluid. Keep the pump plugged into electrical power during storage.

32

Maintenance

Replacing the AC fuses

If the pump continually illuminates the battery

indicator and the AC power indicator light does not

illuminate when the pump is connected to the AC

power supply and switched ON, suspect that either

the power supply fuse in the AC plug or the internal

fuses have blown.

First check the power supply fuse in the AC mains

plug. If the AC power indicator light does not

illuminate remove the pump from service.

It is recommended that only a qualified service

engineer replaces the AC fuses. For further

information regarding the replacement of internal AC

fuses refer to the Technical Service Manual.

33

Maintenance

Battery Operation

The internal rechargeable battery allows continued

operation when the AC power is unavailable, for

example during patient transfer or AC power failure.

A fully charged battery will provide over 4 hours of

operation at typical infusion rates.

A low battery alert is activated approximately 30

minutes before the battery depleted alarm.

The battery is maintenance free, sealed Nickel Metal

Hydride and requires no routine servicing. However,

to achieve optimum operation, ensure that the battery

is fully recharged after full discharge, before storage,

and at regular 3 month intervals during storage.

Charge retention will eventually degrade. Where

retention is critical the internal battery should be

replaced every 3 years.

It is recommended that only a qualified service

engineer replaces the Battery. For further information

regarding the replacement of batteries refer to the

Technical Service Manual.

34

Occlusion Pressure Limits

Time to alarm following occlusion is achieved in less

than 5minutes at rates of 25ml/hr and higher by the

appropriate selection of occlusion levels.

The following graphs show the typical values for time

to alarm and bolus volume that can be expected in

the event of an occlusion when the IV-set (KV 243T)

is selected.

Time to Alarm - 25ml/hr

0

2

4

6

8

10

12

14

16

0 1:00 2:00 3:00 4:00min : sec

Occ

lusi

on

Le

vel(

psi

)

Bolus Volume

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Occlusion Level(psi)

ml

35

Start-up Curves

& Trumpet Curves

In this pump, as with all infusion systems, the action

of the pumping mechanism and variations in

individual IV-sets cause short-term fluctuations in

rate accuracy.

The following curves show typical performance of the

system in two ways : 1) the delay in onset of fluid

flow when infusion commences (start-up curves)...

and 2) the accuracy of fluid delivery over various time

periods is measured (trumpet curves).

The start-up curves represent continuous flow versus

operating time from the start of the infusion. They

exhibit the delay in onset of delivery due to

mechanical compliance and provide a visual

representation of uniformity. Trumpet curves are

derived from the second hour of this data. Tests

performed per IEC60601-2-24 standard.

36

Start-up Curves

& Trumpet Curves

Trumpet curves are named for their characteristic

shape. They display discrete data averaged over

particular time periods or 'observation windows', not

continuous data versus operating time. Over long

observation windows, short term fluctuations have ㅣlittle effect on accuracy as represented by the flat

part of the curve. As the observation window is

reduced, short term fluctuations have greater effects

as represented by the "mouth" of the trumpet.

Knowledge of system accuracy over various

observation windows may be of interest when certain

drugs are being administered. Short term fluctuations

in rate accuracy may have impact depending on the

half-life of the drug being infused, therefore the

clinical effect cannot be determined from the trumpet

curves alone.

Caution : Start-up and trumpet curves may not be

indicative of operation under negative pressure.

37

Start-up Curves

& Trumpet Curves

Start-up (25ml/hr)

05

1015

2025

30

17s 2

m5m

9m

13m

17m

31m

Time

Rate

(m

l/hr)

Trumpet Curve (25ml/hr)

-15.00%

-10.00%

-5.00%

0.00%

5.00%

10.00%

15.00%

17s 1m 5m 11m 19m 31m

Observation Window(mins)

Error

(%)

38

Warranty

Woo Young Medical Co., Ltd. offers a 24-month

warranty on every Accumate® 2300 unit (except

for the battery), effective from the date of

delivery.

The battery is free from defects in material and

workmanship under normal use and service for

a period one hundred eighty(180) days from the

date of delivery by Woo Young Medical to the

original purchaser.

This includes the repair or replacement of

damaged parts as a result of design/

manufacturing errors or material defects.

This warranty do not apply if Accumate® 2300

has been altered, misused, or repaired by

persons not authorized by Woo Young Medical.

The warranty do not cover the elimination of

problems caused by incorrect operation,

inappropriate handling normal wear and tear.

39

Service & Packaging

Service

– If the pump fails to respond to the operating or

troubleshooting procedures listed in this manual

and the cause cannot be determined, discontinue

use and forward it to an authorized Woo Young

Medical's agency.

– With each complaint, please include pump serial

number and full description of difficulty, including

all setting, types of fluids, time, and alarm

messages.

– Return IV-set used if possible.

– Woo Young Medical cannot assume

responsibility for loss or damage to returned

pumps while they are in transit.

Packaging

– The pump packaging is reusable.

– Package Contents : Accumate® 2300 Infusion

Pump, power cable, operation manual

Accumate 2300 Volumetric Infusion Pump

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Transcript of Accumate 2300 Volumetric Infusion Pump