C-me VET-PRO VIP 2000 User manual

VET-PRO
VIP 2000
Veterinary Infusion Pump
Operator's Manual
EDITION March 2013
Ref.: 100-090XV
Manufacturer:
Caesarea Medical Electronics Ltd.
23 Staufenburg st.
72805 Lichtenstein, Germany
T: [phone]
E: [e-mail]
W: www.cme-infusion.com

VET-PRO operator’s manual
2
LIMITED WARRANTY
The VET-PRO Infusion Pump has been carefully manufactured from the highest quality
components.
Caesarea Medical Electronics Ltd. (CME) guarantees the pump against defects in material and
workmanship for twelve (12) months from date of purchase by the original purchaser.
CME’s obligation, or that of its designated representative under this Limited Warranty, shall be
limited, at CME’s option, or that of its designated representative, to repairing or replacing
pumps, which upon examination, are found to be defective in material or workmanship. The
repair or replacement of any product under this Limited Warranty shall not extend the above-
mentioned Warranty period.
All repairs under this Limited Warranty should be undertaken only by qualified, trained service
personnel. In the event that a pump is found to be defective during the warranty period, the
purchaser shall notify CME or its designated representative within thirty (30) days after such
defect is discovered.
The defective pump should be sent immediately to CME or its designated representative for
inspection, repair or replacement. Shipping costs are the purchaser’s responsibility.
Material returned to CME or its designated representative should be properly packaged using
CME shipping cartons and inserts. Inadequate packaging may result in severe pump damage.
This Limited Warranty shall not apply to defects or damage caused, wholly or in part, by
negligence, spilled fluids, dropping of the pump, misuse, abuse, improper installation or
alteration by anyone other than qualified, trained personnel; or to damage resulting from
inadequate packaging in shipping the pump to CME or its designated representative.
If, after inspection, CME or its designated representative is unable to identify a problem, CME
or its designated representative reserves the right to invoice purchaser for such inspection.
This Limited Warranty is the sole and entire warranty pertaining to CME’s products and is in
lieu of and excludes all other warranties of any nature whatsoever, whether stated, or implied or
arising by operation of law, trade, usage or course of dealing, including but not limited to,
warranties of merchantability and warranties of fitness for a particular purpose. Purchaser
expressly agrees that the remedies granted to it under this limited warranty are purchaser’s sole
and exclusive remedies with respect to any claim of purchaser arising under this Limited
Warranty.
Managing Director

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Contents
LIMITED WARRANTY............................................................................................ 2
INTRODUCTION....................................................................................................... 5
GLOSSARY................................................................................................................. 6
SAFETY PRECAUTIONS......................................................................................... 7
SPECIFICATIONS..................................................................................................... 9
TECHNICAL DESCRIPTION................................................................................ 11
VET-PRO –WITH DOOR OPEN ........................................................................... 16
THE CHARGER....................................................................................................... 17
UNPACKING............................................................................................................ 18
LOADING THE ADMINISTRATION SET .......................................................... 18
FLUSH OPERATION .............................................................................................. 19
VET-PRO - OPERATION ....................................................................................... 20
PUMP OPERATION TEST..................................................................................... 20
AIR IN LINE - ALARM TEST................................................................................ 21
DOOR OPEN - ALARM TEST............................................................................... 22
DOWN OCCLUSION - ALARM TEST................................................................. 23
CHARGE INDICATOR TEST................................................................................ 23
PROGRAMS.............................................................................................................. 24
CHANGING CURRENT PROGRAM.................................................................... 25
PRESSURE SETTING............................................................................................. 27
BASIC OPERATION ............................................................................................... 28
CONTINUOUS PROGRAM.................................................................................... 29
25 STEPS PROTOCOL............................................................................................ 32
TPN PROGRAM....................................................................................................... 34
INTERMITTENT PROGRAM ............................................................................... 37
PCA PROGRAM –WITH PROTOCOLS............................................................ 40
HISTORY .................................................................................................................. 46
INFO MODE ............................................................................................................. 47
PROGRAM DELAY................................................................................................. 49
PROGRAM COMPLETED..................................................................................... 50
CHANGING THE FLUID CONTAINER.............................................................. 51
LOCKING.................................................................................................................. 52
HOW TO LOCK....................................................................................................... 53
BATTERY OPERATION ........................................................................................ 55

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LOW BATTERY....................................................................................................... 55
END BATTERY....................................................................................................... 55
CLEANING AND STORAGE................................................................................. 56
ALARMS CONDITIONS......................................................................................... 57
ALARMS.................................................................................................................... 57
TROUBLESHOOTING............................................................................................ 58
SHOW SETTING...................................................................................................... 60
ADJUST SETTING................................................................................................... 62

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Introduction
This Manual Provides directions for the setup and operation of the VET-PRO
Pump
VET-PRO Features

Small, light and compact pump.

Multi Programs:
CONTINUOUS
Continuous program.
Infusion Rate: 0.1 to 1200 ml/hr.
Volume: 0.1 to 9999 ml.
User can design a specific protocol, for drug
delivery, which contains up to 25 steps.
Infusion Rate: 0.1 to 1200 ml/hr.
Volume: up to 9999ml., For each step.
Accumulated Volume for all steps –up to 10
liters.
Rate Taper program, with programmable up
and down times
INTERMITTENT
A set Dose delivered in set intervals. Between
Intervals the pump will allow a base rate or
KVO.
PCA
Patient Control Analgesia, continuous delivery
plus /or programmed boluses.
Bolus Rate: 0.1-1000 ml/h

Highly accurate fluid delivery.

Operated with a customized safe administration set

Rechargeable internal battery

Can be latched into a Charger, which is mounted on an IV pole

A.B.S. Anti-Bolus System

Silent operation
25 STEPS
TPN

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Glossary
Terms used in manual:

Note:
Essential operating procedure or condition.

Caution:
A precaution which, if not followed, could result in extensive
damage to the equipment.

Warning
A precaution, which, if not followed, can result in personal
injury or loss of life.

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Safety Precautions

Warning

To avoid possible personal injury or loss of life, observe the following:
Note: Read the entire Operation Manual before using the pump, since the
text includes important precautions.

Disconnect the Charger from the mains, prior to opening the casing.
Voltage present on internal components may cause severe shock or death
on contact. Only trained service personnel should open the pump cover.

Before servicing pumps connected to mains via the Charger - remove
rings, watches, and other jewelry, which may present a shock / burn
hazard.

To prevent a fire hazard, replace blown fuses on the Charger only with
fuses of the same type and rating (see fuse values on the Charger PCB).

The equipment is not suitable for use in the presence of flammable gases
–e.g. air/oxygen/nitrous oxide mixture.

Watch your fingers / nails when opening the pump door.
To avoid possible injury to patient, observe the following:

Warning
Battery charging is enabled as long as the charger cord is
connected to the mains and the pump is in the charger.
Switching the pump off does not disconnect it from the
mains. In order to disconnect from the mains, take the
charger cable out of the mains. In order to disconnect pump
from the mains, take it out of the charger.
Note:
To avoid battery damage do not leave the pump battery in a
temperature more than 500C

Make sure the pump is attached securely to the Charger, which is
connected snugly to an IV pole.

If the pump is dropped, return the pump for inspection by qualified
service personnel.

Before operation, verify that administration set tubing is not kinked or
occluded.
!

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
This pump should be operated only with the IV set that the pump is
calibrated for.
Use of incorrect administration sets may impair the operation of the
pump and the accuracy of the infusion.
Warning:
The BodySet is not suitable to use with Taxol.
Note:
The maximum volume that may be infused under SINGLE FAULT
CONDITION is 0.1 ml
CAUTION
To avoid possible damage to the equipment, observe the
following:

Do not immerse the pump in liquids.

Clean solution spills on the pump immediately. Use a damp
cloth or sponge. A cleaning disinfectant may be used. Wipe
thoroughly with a dry cloth.

Do not clean pump with chemicals such as Xylene, Acetone or
similar solvents. These chemicals cause damage to plastic
components and paint.
Warning:
Any adjustments, maintenance, or repair of the uncovered
pump while connected to the power should be avoided. If
necessary, these repairs should be carried out by skilled
technicians who are aware of the hazards involved.
Warning:
The pump should be operated within a temperature range of
15C to 35C. and at up to 85% humidity
Warning:
Do not operate the pump near high-energy radio-frequency
emitting equipment, such as electro-surgical cauterizing
equipment, and cellular telephones. False alarm signals may
occur.

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Specifications
Pumping Mechanism:
Piston Mechanism
Flow Rate:
PCA: 0 to 100 ml/hr in 0.1ml increments
All other programs: 0.1 to 1200 ml/hr in 0.1ml or
1 ml increments.
Total Infused Volume:
PCA: 0.1 to 1,000 ml.
Continuous, TPN, Intermittent: 0.1-9999 ml
25 Steps: 0.1 to 9999 ml. for each step
Accumulated volume for all steps- up to 10 liters.
Total Time Setting
100 hours
Accuracy:
±5 %.
KVO rate:
0.1 to 5 ml/hr. (to be set)
Air Sensor:
Ultrasonic, adjustable air bubble size
Maximum Pressure:
0.7 bar or 10 psi Adjustable (high/normal/low)
Power Supply:
110-240 VAC, 50/60 Hz. 20 W
Battery:
Li-Ion 7.2V, 1800mA. (Rechargeable)
Battery Operation at 125 ml/hr
15 hours
Battery Charging:
Automatic when latched into the Charger
connected to an AC power source (4 hours)
Alarms:
End Program
Low & End Battery
Air in line
Down Occlusion
Door Open
Pump Unattended
Internal Malfunction
Locking state
Missing Key
Dimensions:
112 x 89 x 32mm. (L x w x h).
Symbol
Attention (Consult accompanying documents)

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Classification
Type CF Equipment
(degree of protection against electrical shock)
Housing:
ABS (fire retardant)
Weight
280 gr. without battery
390 gr. with battery
Electrical Safety
Complies with:
EN 60601-1 (Medical Electrical Equipment
Safety), IEC 60601-2-24 (Infusion pumps and
controllers),
IEC 60601-1-4 (Programmable Electrical Medical
System), UL 2601- 1 and CAN/CSA C22.2 No
601.1.
Standards
Manufactured in accordance to ISO 9001:2000
and ISO 13485:2003
CE marked (In accordance with the Medical
Devices Directive 93/42/EEC)
EMC
The BodyGuard Infusion System is designed to
be in compliance with EN 60601-1 (safety) and
IEC 601-1-2 (EMC).
Environmental Specifications
Non Operating Conditions (Transportation and
Storage):
Temperature: -25oC to 50oC (-13oF to + 122oF)
Humidity: 5 % to 100% R.H., non-condensing
Air pressure: 48kPa to 110kPa
Operating Conditions:
(The system may not meet all performance
specifications if operated outside of the following
conditions)
Temperature: +15oC to +45oC
(+59oF to + 113oF)
Humidity: 20 % to 90% R.H. at +40 oC, non-
condensing Air pressure: 70kPa to 110kPa

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Technical Description
The following details outline the safety checks designed into the VET-PRO
infusion pump, to minimize the possibility of under / over infusions.
Anti-Bolus Function
The anti-bolus function is designed to reduce the bolus that may occur upon the
release of an occlusion following a downstream occlusion alarm. Upon the
detection of a downstream occlusion, the alarm is activated and the pump returns
the IV set line pressure to neutral within 15 seconds. Neutral line pressure is
achieved by the reverse operation of the pumping mechanism, and measurement of
the IV set line pressure through the in-line pressure detection system. This feature
prevents an inadvertent fluid bolus to the patient, which may occur upon the release
of an occlusion, caused by a downstream clamp.
Air-in-Line Accumulation
To improve the detection of air in the IV administration set, the VET-PRO
Infusion Pump utilizes an air-in-line accumulation detection system in addition to
the standard single bubble detection. This feature monitors the volume of air that
passes through the IV administration set by accumulating the volume of individual
bubbles over a moving 0.5 milliliter window. The limit is configurable. Although
an individual bubble may not exceed the pre-programmed threshold, the cumulative
volume of bubbles in a 0.5 milliliter volume may exceed that limit and initiate an
air-in-line alarm. This accumulation feature is particularly useful with infusions for
patients who are highly sensitive to air (i.e. infants, neonates, children) or when
infusing products that create significant volumes of small air bubbles

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Trumpet and Flow Rate
In VET-PRO, as with all infusion systems, the action of the pumping
mechanism and variations cause short –term fluctuations in rate accuracy.
The following curves show typical performance of the system in two ways:
1. The accuracy of fluid delivery over various time periods is measured
(Trumpet curves).
2. The delay in onset of fluid flow when infusion commences (Start up
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 fluctuation has little 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 clinical impact depending on the shelf-life of the drug
being infused and the degree of intravascular integration, the clinical effect
cannot be determined from the trumpet curves alone.
The Start-up curves represent continuous flow versus operating time for two
hours 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 according to IEC 601-2-24 standard.

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Start-Up Graph at 1.0 ml/h (Initial Period)
Using BodySet
Time (minutes)
Trumpet Graph at 1.0 ml/h (Initial Period)
Using BodySet
Overall Mean Error = -0.1% Max Rate Error = 8%
Trumpet Graph at 1.0 ml/h (After 4 Hours)
Using BodySet

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Overall Mean Error = -1.1% Max Rate Error = 6%
VET-PRO Front View
No.
Description
Function
1.
Display
Displays: Selected Infusion Rate, Total Time,
Time Delay, Volume To BeInfused and
Volume Infused.
2.
START/ OK Key
START
OK
Starts pump operation and delivery.
Confirms selection and setting.
3.
STOP/NO key
STOP
NO
Silences an alarm condition and pauses
operation.
Zeroes the displayed value during setting
Press to return to previous screen
4.
Numeric Keyboard
Used to set the RATE, TIME limit and VTBI.
Dial the required number.
Pressing NO will erase the last digit.
Rate: 125 ml /h
Press OK for Volume
2
5
8
7
3
0
4
5
6
9
01

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5.
Arrow keys
20
Enable scrolling through options.
6.
Syringe key
Pressing Syringe key during data setting:
Enable Flushing procedure.
Flushing default volume: 4 ml.
Pressing Syringe key during PCA program
operation:
Enable bolus procedure.
7.
On / Off key
Turns the pump on and off.
To turn the pump on press until the
self- test screen appears
To turn the pump off press until the
OFF Graph is all black and a beep is
sounded.
8.
Operation LED
Green Indicator: Lights during system self-test
An intermittent green light indicates infusion
delivery.
Red Indicator: Indicates an alarm state with a
continuous red light Lights when the pump is
in a stand-by mode during programming.
.
9.
Door Latch
Opens the pump door.
Lift to open the door.
10.
Info key
i
Pressing Info key supplies information about
the pump and its programs (see info mode
chapter).
FLUSH 2 ml
0 4
B Volume, ml.
O
L
U
0 2.8 5

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VET-PRO –with door open
No.
Description
Function
1.
Latch holder
Holds the door closed when latch is in vertical
position.
2.
Pressure sensor
Detects downstream tubing restriction and
occlusion. Alarm level can be adjusted to suit
patient needs.
3.
Tubing Guide
Guide the administration set
4.
Pressing Plate
Connected to the door by 2 springs.
5.
Pump door
Covers the pressing plate.
6.
Air sensor –front
Ultrasonic air detector, which is mounted on the
front housing.
7.
Air sensor - door
Mounted on the door.
2
1
3
4
5
6
7

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The Charger
IV Set Requirements
The VET-PRO pump should be operated only with the IV sets that the
pump has been calibrated for.

Warning:
Do not operate the pump with any administration set, other
than what it has been calibrated for as doing so will cause the
rate and flow measurements to be incorrect.
No.
Description
Function
1.
Display
Display infusion data
2.
Release Handle
Push to release the pump from the Charger.

Note:
The pump is protected against overcharging. In order to keep
your battery fully charged, connect the pump to the mains via the
Charger whenever it is used at home.
1
2

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Unpacking
1.
Carefully remove the pump and Charger from the box.
2.
Make sure no items were damaged during shipment
3.
Make sure you have the following items:

VET-PRO Infusion Pump

Charger

Battery Pack

Operator’s Manual
If any items are missing or damaged, contact your VET-PRO supplier.
Loading the Administration Set

Note:
Follow the Instructions supplied with the individual
administration set.
Use of any administration set, other than the IV set that the
pump is calibrated for, may impair the operation of the pump
and the accuracy of the Infusion.
1.
Lift the door latch to open the pump door.
2.
Insert the IV tubing into the tubing guide, following the direction flow label
located above the tubing slot. Insert the tubing from left to right, and avoid
stretching or pulling the tubing. Check key is located in correct position.
3.
Close the pump door. Press on the door to close firmly, ensure that the latch
is correctly applied.

Note:
Ensure that the tubing is inserted completely into the pumping
channel.

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Flush Function (Priming)
Flush Function is used:
1.
Before starting a program (see instruction below);
2.
After the air in line alarm, as follows:
Press STOP/NO key to mute the alarm. Disconnect IV tubing from
patient; press the SYRINGE key to push air bubbles through.
When flushing is completed press START/OK key to resume program.
Flush operation
1.
Switch on the pump using the ON/OFF key. (Press until the self-test screen
appears). After a short self-test, the pump will display the program setting and
status followed by the last setting rate.
2.
Press the SYRINGE key to flush the
administration set.
ENSURE THE SET IS NOT CONNECTED
TO THE PATIENT !!
FLUSH
Press OK to start
3.
Press the START/OK key to start flushing.
4.
The display will show a graph indicating the flush
operation.
FLUSH 2 ml
0 4
5.
Once the flushing is completed, the display will change back to the previous
screen the pump was in, before flushing.
5.
To stop flushing, press the STOP/NO key.

Note:
The flushing rate can be adjusted, in “adjust setting”
options, up to 1200 ml/h. The default is 600 ml/hr. During
flushing the air in line alarm is disabled.

Warning
Always disconnect IV tubing from patient before starting
flushing procedure.

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VET-PRO - Operation
Before attaching the VET-PRO to a patient, run the following tests to verify that all
indicators and alarms work properly.
When an alarm is activated the following will occur:
1.
An alarm message will appear on the display.
2.
An audible alarm will be sounded.
3.
Infusion will cease.
Pump Operation Test
1.
Click the pump into a Charger connected to AC power.
Verify that the CHARGE indicator is on (on charger).
2.
Load an administration set in the pump (as described on page 21).
3.
Switch on the pump using the ON/OFF key (press until the
self-test screen appears).
4.
The pump will display "Self Test" followed by the program selected and its
status. During the self-test a long beep will be performed. This procedure
verifies that the pump’s acoustic and visual features are working properly.
After overview, the display will show the last rate setting.
5.
Press the SYRINGE key to flush the
administration set.
FLUSH
Press OK to start
6.
Press the START/OK key to start flushing.
7.
The display will show a graph indicating the
flushing operation.
FLUSH 2 ml
0 4
8.
When flushing is completed, wait without
pressing any key. Verify that when two
minutes have passed without any key being
pressed an audible alarm is activated and a
“Pump Unattended” message appears on the
display.
Pump Unattended
Press start key
9.
Press the START/OK key to silence the alarm.