Braun 950787 User Manual

Vista™ basic
Instructions for Use
950787 Rev H 02/03
Rx Only
The CE mark confirms compliance with the “Council Directive on Medical Products 93/42/EEC” dated the 14
th
of June, 1993.
B. Braun Melsungen AG
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.”
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.
Packaging: The pump packaging is reusable.
Package Contents: Vista basic Infusion Pump, drop sensor, power cable, pole clamp, Instructions for Use.
Vista™ basic Instructions for Use 1/25 950787 Rev H 02/03
Vista™ basic Contents
CONTENTS
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.
Vista™ basic Instructions for Use 2/25 950787 Rev H 02/03
WARNINGS & CAUTIONS
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.
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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
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.
Vista™ basic Instructions for Use 4/25 950787 Rev H 02/03
INTRODUCTION
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
Alarm Light
Lights up during an alarm. Display will also show flashing AAA.
A.
Infusing Light
Indicates pump is infusing
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Handle for carrying
Clear Key
Resets a value to zero
INTRODUCTION
y
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) Ke Alarm Silence Key
Silences alarm tone for 2 minutes
START/STOP Key
Vista™ basic Instructions for Use 6/25 950787 Rev H 02/03
PREPARING THE INFUSION
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.
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Continuous Mode
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.
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.
NO
Begins in Continuous Mode with all data cleared.
Press the green key below your answer.
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
Vista™ basic Instructions for Use 8/25 950787 Rev H 02/03
Returns to the beginning of the last program with all data retained.
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.
NO
YES
NO
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