B. Braun Vista basic Manual de usuario

Vista™basic

950787 Rev 6/02

Instructions for Use

Rx Only

WARRANTY

Vista™basic Instructions for Use 1/25

950787 Rev 6/02

WARRRANTY

B. Braun provides 24 months

warranty as of the date of delivery

for every Vista™basic Infusion

Pump. This includes the repair or

replacement of damaged parts as

a result of design/manufacturing

errors or material defects.

Modifications or repairs to the unit

by the owner or third parties

invalidate the warranty.

The warranty does not cover the

elimination of faults attributable to

incorrect/inexpert handling,

normal wear and tear, or

rechargeable batteries.

The CE mark confirms compliance

with the “Council Directive on

Medical Products 93/42/EEC”

dated the 14th of June, 1993.

B. Braun Melsungen AG

RESPONSIBILITY OF

MANUFACTURER

Manufacturer, assembly, and

installation personnel or instructors

can only be held responsible for any

effects on device safety, reliability,

and performance if

♦Installation, expansion work,

readjustments, modifications, or

repairs are carried out by

personnel authorized by the

above,

♦The electrical wiring for AC power

satisfies the requirements of VDE

0100, 0107, and/or the IEC

publications, or regional and/or

national variations,

♦The device is operated in line with

the Instructions for Use, and

♦Regular technical inspections

(Preventative Maintenance) are

carried out every 2 years as

outlined in the Service Manual.

INSPECTION ON DELIVERY

Despite careful packaging, the risk

of transport damage cannot be

entirely excluded. Upon delivery,

please check that nothing is

missing. Do not use a damaged

device! If the device is damaged,

contact the Service Department.

See “Maintenance, Storage, &

Service.”

Packaging: The pump packaging is

reusable.

Package Contents: Vista basic

Infusion Pump, drop sensor, power

cable, pole clamp, Instructions for

Use.

Vista™basic Contents

Vista™basic Instructions for Use 2/25

950787 Rev 6/02

CONTENTS

Warranty..................................................................................... 1

Warnings & Cautions.................................................................. 3

Introduction ................................................................................ 5

Preparing the Infusion ................................................................ 7

Continuous Mode ....................................................................... 8

Options: Piggyback.......................................................................... 11

Ramp/Taper Mode ............................................................ 12

Program Mode ............................................................ 14

Delay A Mode ................................................................... 15

Dosage Calculation........................................................... 16

Bolus Mode, Interval Bolus (Intermittent Mode)................ 17

Total Infused, Standby ................................................. 18

Occlusion Pressure, Drop Sensor, Battery ....................... 19

Data Lock, Contrast Selection .......................................... 20

Adjust Clock, Loudness .................................................... 21

Alarms ........................................................................................ 22

AC, 12V, Battery, & CC Interface ............................................... 23

Maintenance, Storage, & Service............................................... 24

Specifications ............................................................................. 25

The Vista basic is a volumetric infusion

pump intended to provide accurate and

continuous flow of parenteral and

enteral fluids.

Qualified medical staff should decide

how the device should be used based

on its features and specifications.

For more details, please read the

Instructions for Use.

Rx only.

WARNINGS & CAUTIONS

Vista™basic Instructions for Use 3/25

950787 Rev 6/02

The following should be observed to avoid patient/user injury. This Instructions

for Use manual contains detailed instructions and warnings on the use of the

Vista™basic Infusion Pump. Please read it completely prior to using this device.

This manual is intended to reinforce the teaching given to the user by a trained

health care professional or an authorized B. Braun representative.

WARNINGS

♦B. Braun will assume no

responsibility for incidents which

may occur if the product is not used

in accordance with product labeling.

♦Make sure the pump is stable, either

fastened securely to the IV pole or

resting on a flat surface.

♦Prior to use, always check the

audible and visual alarms (and staff

call, where applicable).

♦Connection of pump tubing to the

patient should only be made after

the tubing is loaded and the unit is

turned on. Disconnect tubing from

patient when changing solution

containers to avoid the danger of

incorrect dosage.

♦Ensure there are no kinks in the

tubing.

♦Always read and follow the

instructions that accompany the

source container and IV

administration sets you are using.

Carefully follow the instructions for

loading, removing, and reloading the

set, as well as the recommended set

change intervals.

♦Change pumping section on tubing

every 24 hours. Do not use tubing

for more than 72 hours or per

current facility protocol.

♦Always check pump data prior to

starting infusion.

♦Do not operate this device in

environments where there is an

explosion hazard! A possible

explosion hazard exists if the pump

is used in the presence of

flammable anesthetics.

♦The EMC-limits (Electro-magnetic

compatibility) according to IEC/EN

60601-1-2 and IEC/EN 60601-2-24

are maintained. If the equipment is

operated near other equipment

which may cause high levels of

interference (e.g. HF surgical

equipment, nuclear spin tomography

units, mobile telephones, etc.)

maintain the recommended

protective distances for these

devices. Under certain conditions,

malfunctions may occur which lead

to a device alarm with permanent

alarm tone. Interference may occur

e.g. at electro-magnetic fields > 10

[V/m] resp. electro-magnetic

discharges > [8 kV].

♦Monitoring of the patient and

infusion status is necessary to

ensure the infusion is being

delivered as anticipated. The Vista

basic has been designed to stop

fluid flow to the patient under certain

alarm conditions. Also, prior to

starting an infusion, verify that no

drops are falling in the drip chamber

and the programmed information is

correct.

WARNINGS & CAUTIONS

Vista™basic Instructions for Use 4/25

950787 Rev 6/02

♦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.

♦See section entitled “Drop Sensor”

for additional information on using

the device without a drop sensor.

♦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.

CAUTIONS

♦Rx only.

♦Do not attempt to infuse two fluids

simultaneously using the Vista™

basic.

♦Variations in pressure, e.g. caused

by change in level of fluid container,

may affect the accuracy of the

device.

♦If several pieces of infusion

equipment are connected together,

it is possible there may be mutual

influence. Possible incompatibilities

can be found in the instructions for

use for the drug or for the other

appliances.

♦Use only equipment, accessories,

parts, and disposables that are

intended for use with the Vista

basic.

♦Do not clean, disinfect, or sterilize

any part of the device by autoclaving

or with ethylene oxide gas. Doing

so may damage the device and void

the warranty. Only external parts of

the pump should be disinfected.

See “Maintenance, Storage, &

Service” for suggested cleaning

solutions.

♦Technical specifications are not

guaranteed with any other tubing

than that approved for use with the

Vista basic.

♦Any analog and digital components

connected must demonstrate that

they meet EN specifications (i.e. EN

60950 for data processing

equipment and EN 60601 for

electrical medical equipment).

♦Only an authorized system

configuration technician responsible

for meeting the specifications of

standard EN 60601-1-1 may

connect additional devices to the

signal inputs or outputs.

SAFETY STANDARD

The Vista basic meets all safety

standards for medical electrical devices,

corresponding to IEC 60601-1 and IEC

60601-2-4.

NOTE: IEC 60601-1 corresponds to

European Standard EN 60601.

INTRODUCTION

Vista™basic Instructions for Use 5/25

950787 Rev 6/02

Handle for carrying

Display

All essential information is

displayed in plain language.

Green background lighting

illuminates only when

connected to AC power, or, in

battery operation, only when a

key is pressed.

Keyboard

Allows data entry

Clear Key

Resets a

value to

zero

Alarm Light

Lights up during an alarm.

Display will also show

flashing AAA.A.

Infusing Light

Indicates pump is infusing

INTRODUCTION

Vista™basic Instructions for Use 6/25

950787 Rev 6/02

Door Open Button

Aluminum Case

Easy upkeep, drip proof, and

resistant to disinfectants

Function Keys

Allow choices of YES, NO, OK,

INFO, OPTS, etc.

ON/OFF

(

Power

)

Alarm Silence Key

Silences alarm tone for 2

minutes

START/STOP Ke

PREPARING THE INFUSION

Vista™basic Instructions for Use 7/25

950787 Rev 6/02

Prepare the Pump

1. Check for cleanliness, completeness, and damage. If unit appears

damaged, do not use it.

2. Attach the pump to an IV pole by turning the knob on the pole clamp

clockwise, or place the pump on a flat, stable surface.

3. Plug the pump’s power cord into an electrical outlet.

Turn on the Pump

1. Press (ON/OFF).

2. Listen for 3 loud beeps.

3. Check screen for completeness of all pixels on the display. The Alarm ()

and Infusing (6) lights will blink once.

Load the Set

1. Prepare the solution container and prime the administration set according to

the instructions provided on the set package. Close the roller clamp.

2. Check that the drip chamber is about 1/3 full

and there is no air in the set.

3. Open the pump door by pressing the Door

Open Button on the top right corner of the

pump.

4. Push and hold open the clamp at the top of

the fluid path.

5. Insert tubing in clamp and release clamp.

6. Thread the tubing down the fluid path, making

sure the tubing is pressed into the Air-in-Line

detector at the bottom of the fluid path. The

roller clamp should be below the pump.

7. Close the door and open the roller clamp.

Check that no drops are falling in the drip

chamber.

8. Place drop sensor on drip chamber (optional).

9. Connect set to patient site.

Turning off the Pump

1. Press to stop the infusion.

2. Close the roller clamp.

3. Press and hold for 2 seconds.

Continuous Mode

Vista™basic Instructions for Use 8/25

950787 Rev 6/02

When the pump is turned on, it may display: Tubing Type VISTA Pump Set

Confirm you are using a Vista™ Pump Set, then press YES.

The pump may then display: Is This a New Therapy?

YES

Begins in Continuous Mode with all

data cleared.

Returns to the beginning of the last

program with all data retained.

The pump may then display: Prime Set?

YES

Press YES to begin priming set.

•Press STOP to end priming.

•Press EXIT to begin Continuous

Mode.

Begins in Continuous Mode with all

data cleared.

Press the green key below your

answer.

YES

Press YES to begin priming set.

•Press STOP to end priming.

•Press EXIT to return to the

beginning of the last program with

all data retained.

Returns to the beginning of the last

program with all data retained.

CONTINUOUS MODE

This section explains how to program a Continuous Mode infusion. For

directions on how to program other Modes and Options, refer to those sections

later in this manual.

There are three ways to enter infusion data in Continuous Mode:

RATE and VTBD (Volume To Be Delivered)

1. Enter rate in ml/hr.

2. Press VTBD (Volume To Be Delivered).

3. Enter bag volume in ml.

4. Press OK. (To leave screen without saving changes, press EXIT.)

5. Press to begin the infusion. Check for drops in the drip chamber.

Continuous Mode

Vista™basic Instructions for Use 9/25

950787 Rev 6/02

VTBD and TIME

1. Press VTBD.

2. Enter bag volume in ml.

3. Press OK. (To leave screen without saving changes, press EXIT.)

4. Press TIME.

5. Enter infusion time in hours and minutes.

NOTE: For a 2 hour infusion, enter 2, 0, 0. The pump will show: Time: 02h00m

6. Press OK. (To leave screen without saving changes, press EXIT.) The

pump calculates the rate and asks: Accept Rate?

7. Press OK.

8. Press to begin the infusion. Check for drops in the drip chamber.

RATE and TIME

1. Enter rate in ml/hr.

2. Press TIME.

3. Enter infusion time in hours and minutes.

4. Press OK. (To leave screen without saving changes, press EXIT.)

5. Press to begin the infusion. Check for drops in the drip chamber.

To Change the Rate

1. Press to stop the infusion.

2. Press . The display will reset to 000.0 ml/h.

3. Enter a new rate.

4. Press to begin the infusion. Check for drops in the drip chamber.

To Change the Rate While Infusing

1. Enter a new rate.

2. Press OK.

NOTE:If the OK key is not pressed within 10 seconds of the change, the infusion will

continue at the old rate.

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