VP5005 Instruction Manual
VP5005 Instruction Manual
VP5005 Instruction Manual
Volumed µVP5005
0123
Swiss Made
ARCOMED AG
Page
Index numbers 0
1. Introduction 1
2. Specifications 3
3. Operation 4
3.11 Parallel / Multiple Infusions 6
4. Alarm Supervision System 7
5. Special Key Inputs 10
6. Warranty 11
Design Changes
7. Inspection and Maintenance Intervals 12
8. Significance of Trumpet Curves 13
3
11 10 12 13
ML/H TOTAL ML
RATE
16 14
DEFECT
! KVO
ALARM ML INFUSED
ON 2 MIN START
INF
COMPL 18
OFF STOP
17 15 19
9
7
8 26
8
5 6
23 24
22
27
21
25
20
1 Knurled screw
2 Bottle / Plastic container support
3 Drip chamber
4 Empty container detector (ECD)
5 Pump door
6 Door latch
7 Stop-flow lever
8 Tube guides
9 Air detector
10 Rate display
11 Rate keys
12 Volume display
13 Volume keys
14 Infused display
15 Information window
16 Alarm window
17 ON/OFF key
18 START/STOP-key
19 Alarm tone-mute key
20 Mains supply socket
21 Fuses
22 Nurse call
23 Option RS232
24 Input external drop detector
25 Earth potential plug
26 Pressure detector
27 Infusion pole clamp knob
1. Introduction
1.0 General
The Volumed® µVP5005 Volumetric Infusion Pump has been developed using the
latest state-of-the-art technology. The pump has been manufactured and tested to
meet the VDE specification „Safety of Electromedical Apparatus - General
Requirements“ DIN IEC 601 Part 1 or VDE 0750 Part 1/05.82 and the draft German
Standard E VDE 750 Part 232 and Appendix A1. The pump has also been built and
tested to Swiss SEV, German TÜV-PS , UK BSI 5724 and BS800 and French
M.O.H specifications. It has been designed to comply with IEC 60601-2-24.
The Volumed® µVP5005 meets the Medical Device Directive (MDD) requirements
of the EC Guideline 93/42 EEC and is marked CE 0123 (TUV PS Munich,
Germany).
The manufacturer according to MDD is Arcomed AG, Althardstrasse 146, CH 8105
Regensdorf, Zurich, Switzerland. The person responsible for the EC is
Mr. Rob Bradshaw, Arcomedical Infusion Ltd., West Horndon, Essex CM13 3XL, UK.
The Volumed® µVP5005 may be operated only on mains power installed to DIN
57107 VDE 0107 or the appropriate national standards. If the integrity of the mains
power supply protective earth system is in doubt, the pump should be operated on
battery power. Mobile telephones should not be used anywhere near this
equipment.
Every effort has been made to ensure this manual‘s completeness. If there are any
queries with regard to the product‘s use or any ambiguity, you are advised to
contact our Customer Service Department in or the official distributor in your
country.
Switzerland: ARCOMED AG, Althardstr. 146, CH-8105 Regensdorf/Zurich,
Switzerland.
Tel: +41 1 840 47 40, Fax: +41 1 840 06 49
Page 1
1.2 Routine and maintenance procedure
It is advisable to keep the pump clean and to carry out routine maintenance
periodically. A mandatory safety and performance test must be performed every 24
months or after 10’000 hours of use. (see chapter 7). Maintenance carried out
annually ensures optimal performance and prolongs the life of the product.
Should the pump be dropped or damaged in any way, it should be examined by a
suitably qualified service technician or returned to the manufacturer for inspection
and test.
1.2.1 Cleaning, disinfection and storage
CAUTION: The pump must be switched off and disconnected from the mains power
supply before cleaning and disinfecting.
The pump must be kept clean and dry. Remove any spillage immediately. The
pump must not be placed in an autoclave.
The unit is disinfected by wiping over with a cloth which has been damped slightly
with an alcohol-based disinfectant. Take care when cleaning that no liquid enters
the inside of the pump case. Wait at least 30 seconds after disinfecting before
switching the pump on.
1.2.2 Routine maintenance
The following schedule is suggested:
1) Clean the pump after each infusion.
2) Every 4-8 months (according to usage) check if all alarm systems are operative,
inspect mains cord and mains connections and perform routine self test,
calibration* and battery check.
3) Please refer to the chapter 8 for further details.
*Use an established test procedure or refer to the maintenance manual for advice.
Circuits, calibration instructions and component list etc. will be made available to
appropriately qualified technical personnel.
1.3 Description of Symbols
external empty
container detector
nurse call
Page 2
2. Specifications µVP5005
Classification IIb
CE certificate number G5 00 11 13006 008
Flow rate range (Option) 1 - 600 ml/h (999 ml/h)
(Micro-pump) (0.1 - 99.9 ml/h)
Resolution (Micro-pump) 1 ml/h (0.1 ml/h)
Deviation in flow-rate with
3101P series administration set typ. +/- 5%
Max. overinfusion (Mech./electr. Defect) 0.5 ml
„KVO“ vein open rate (Micro-pump) 3 ml/h (0.3 ml/h) or set rate if less
Infusion pressure min. 60 kPa / 450 mmHg / 0.6 bar
Infusion pressure max. 150-250 kPa / 1125-1875 mmHg / 1.5-2.5 bar
(according to IV set)
Pressure alarm-limit (Option) adjustable 0-999 mbar / mmHg
Air detection ultrasonic
Sensitivity typ. 100 µl, adjustable from 50 to 250 µl
Battery operation, charged (1.2Ah) > 3h
Unit charging time OFF/ON 15 h / 20 h
Supply connection 230/240 VAC +10%-15%, 50-60 Hz
Input current 80 mA
Mains fuses (F1,F2) 250 mAT/IEC127/III/ SEV 1064
Classification of electrical safety Class I / Type CF
Leakage current < 40 µA
Protection against ingress of liquids IPX1, drip-proof
Equipotential bolt DIN 42801
Nurse call
Potential-free contact switch 24 V/ 0,2 A
Dimensions with ext. Empty Bag Detector (WxHxD) 160x240x210 mm
Dimensions with int. Empty Bag Detector (WxHxD) 190x240x210 mm
Casing High impact ABS plastic
Weight 3,9 kgs
Temperature range Operating/Storage 15°C - 35°C / 0°C- 40°C
Permits. rel. humidity max. 85%, no vapor deposit
Max. storage time 3 months without charging
Safety testing IEC 60601-1
IEC 60601-2-24
IEC 60601-1-2 EMC
Time to alarm after occlusion (3101P)
Page 3
3. Operation
An illustration of the front panel of the Volumed µVP5005 together with a full
explanation of reference numbers is to be found at the beginning of this
Maintenance Manual.
Caution:
Use only IV administration sets or Arcomed approved equivalent.
(20 drops/ml, PVC-standard - IV - set: type 3/4mm, Shore-hardness: Shore A, 78)
The performance data depend on the IV-line / pump system. The use of a IV-line
has to be in accordance with the technical adjustment of the pump.
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.
In accordance with the norm E VDE 750 Part 232 and Appendix A1, the IV-set
should be replaced every 24 hours. The IV-sets are for single use only (BS 5724).
3.1. Preparation / Insertion of the IV-set
a) If the unit is mounted on a floor stand, care must be taken to ensure that it is fixed
at a height not exceeding 1.2 m above floor level, in order to ensure stability. The
unit can also be placed on a flat surface.
b) With the aid of the knurled screw (1) on the back of the unit, the bottle/container
holder (2) can be adjusted so that the drip chamber (3) is held firm by slotting it
into the empty container detector (4). Make sure that there are no large ribs or
joints in the passage of the empty container detector and that fallen drops are
detected by the drop-detector‘s light-barrier.
c) Carefully purge the infusion set, without allowing any air bubbles to enter, until
the drip chamber (3) is 1/4 to 1/3 full. If air has entered, repeat purge-procedure.
d) Close the tubing roller clamp.
e) Open the pump chamber door (5) by raising the door latch (6).
f) Press back the red handled „stop-flow“ lever (7) until it is inside the recess.
g) Starting with the left side, insert the IV set into the tube guides (8). Ensure that the
flow direction of the pump from the left to the right is respected. Insert the tubing
carefully in the air detector (9) from top to bottom in the direction of the arrow.
Ensure there is a loop between the pump door outlet and the air detector.
h) Close pump door (5).
i) Open tubing roller clamp. Check that there is no „free-flow“.
Plug the power supply cable into the back of the pump and connect it to an AC
power supply outlet unless battery operation is required. The AC operation
power indicator (15) will light up and battery charging will commence. If not,
check power cable and both fuses (24).
Note: The power supply must include a reliable earth connection for safety. An
earth terminal is provided on the back of the unit (25) for connection to an
independent protective earth system if necessary. If the integrity of the protective
earth system is in doubt, always operate the pump from its internal battery
supply.
k) Press ON/OFF key ( ) (17). The audible alarm beeps once together with
the indication < ! > in the alarm window (16). The software version number
(µVP5005, rx.xx) and the configuration of the pump (µVP5005, c.xxx) light up
briefly.
Page 4
3.2. Rate (Ml/h)
Set the desired rate with the Up/Down keys (11) in the rate display(10). Keys with
arrow up increase the rate, those with arrow down decrease the rate in single steps.
3.3. Total volume (TOTAL ML)
After setting the rate, use the Up/Down keys (13) in the total ml display (12) to set
the total volume to be infused. When the Volumed® µVP-5005 reaches the preset
total volume the pump goes into infusion complete (indication window), gives an
audible alarm and the rate will be switched to the KVO rate.
If no total volume is desired, the pump can be started directly after setting the rate.
If you want to use one of the following variants, please contact our Customer
Service Department or contact the approved ARCOMED distributor for your country
(see also point 1.1).
a) Reset the Ml Infused
Reset of the Ml Infused after every Start/Stop.
b) SBS (Step by step) or titration
If the volume is increased after reaching the preset total volume, only the
difference between the new and old values is infused when the pump is
restarted. Volume infused can be either accumulated or not.
c) Storage of the last set ml/h rate and total ml.
d) Display of time infused and or drops infused.
e) Adjustment of the audible alarm volume level.
3.5. START/STOP
Once the rate is set, the pump can be started with the START/STOP key (18). At
every fallen drop the drop lamp in the indication window (15) lights up.
In the Ml Infused display (14) the actual volume is indicated. This indication is not
influenced by starting/stopping the pump, however it is reset after the total volume is
reached and the pump is restarted again. Also turning off/on the pump resets the
volume infused.
The audible alarm can be suppressed for 2 minutes by using the alarm tone-mute
key (19). After two minutes the audible alarm will automatically restart if the pump is
still in alarm condition.
Page 5
3.8. ON/OFF ( ) -Key
To turn On/Off the pump the ON/Off key (17) is used. This resets the rate ml/h, total
ml and infused ml values to zero. The ON/OFF key has to be held down for more
than 1 second to turn off the pump. This prevents the pump from being turned off
accidentally.
This switch is not a mains isolating switch, and the battery charging circuit is always
connected to the mains (stand-by).
3.14. Environment
Used IV set are dangerous and must be discharged according to the local
regulations. Used batteries must be recycled or returned to the supplier. A list of the
used materials can be obtained form our service department.
Page 6
4. Alarm supervision system
4.1. Alarm causes
During the operation of the unit, the built-in supervision system continually checks
that the pump is operating correctly. In the event of a malfunction, the infusion is
immediately suspended and the alarm is activated. This is signaled by the lighting
up of the 'ALARM' display (15) with the corresponding alarm symbols continuously
illuminated in red and by an intermittent audible alarm. At the same time, the nurse
call system will be activated. If there is no 'Occlusion' or 'Air alarm', the KVO rate is
activated.
- if the infusion tubing is not inserted or is incorrectly inserted in the air detector (4).
- if the rate is not set (0 ml/h).
- if there is an occlusion or the door is open (alarm through optional pressure
sensor).
During operation, the Volumed 5005 switches on the audible alarm and 'KVO'
operation if:
- handling operations are performed on the rate or total input keys (11 and 13)
- the 'Start/Stop' (18) key is actuated
- the infused quantity has reached the preset total volume value. During operation
the Volumed® µVP 5005 emits an audible alarm and goes into the 'Stop' mode if:
- a deficit/excess total number of mls are detected in relation to the ml/h rate
- the liquid level in the drip chamber is too high
- the tubing roller clamp has not been opened
- the infusion bottle or plastic container is empty
- the charge state of the battery can no longer guarantee continuous infusion
- the pressure in the tubing exceeds the maximum permissible value
- the infusion tubing contains air bubbles
- the infusion PVC tubing is not fitted correctly in the air detector
- the door is open.
After rectifying the cause of the alarm or acknowledging the rate change, the alarm
condition is cancelled and infusion resumed by pressing the START/STOP key
(18).
Page 7
4.4. Battery Alarm
The unit can be connected to an external call system by means of the connection
socket (22) on the rear of the unit. For each alarm, the nurse call is thus transferred
to the call station. This does not affect either the optical alarm display of the pump
or the audible alarm system.
By pressing the alarm tone-mute key (19) the audible alarm can be muted for a
period of 2 minutes. After the muting time has elapsed, the alarm again sounds until
the cause has been eliminated.
In order to be able to determine quickly the cause of the alarm, the alarm situations
are indicated by illuminated pictograms in the alarm window (16):
Occlusion
Battery discharged Rate changed
RATE
!
Air bubble alarm KVO Keep vein open
DEFECT
ALARM
Page 8
4.8. General indications and their meaning
Infusion complete
Mains supply on
INF
Drops falling
Battery supply on COMPL
Page 9
5. Special key inputs for auxiliary displays
Display test and recall of the last values:
Hold the Start/Stop key (18) while turning on the pump. Check whether all displays
light up in the correct sequence (..6789).
In this Display test mode, last ml/h, total ml, ml infused and the pressure limit (option
pressure-transducer) of the last infusion will be recalled and displayed.
Display of the software version number:
Hold the „Total 1000ml down“ key while turning on the pump. The software version
number (µVP5005, r1.xx) is displayed. After about 10 seconds the pump switches to
normal operation.
Display of the configuration:
Hold the „Total 100ml down“ key while turning on the pump. The configuration
(µVP5005, c.xxx) is displayed. After about 10 seconds the pump switches to normal
operation.
Display of the pump serial number:
Hold the „Total 10ml down“ key while turning on the pump. The pump serial number
(P.nr. xx.xx xxxx) is displayed. After about 10 seconds the pump switches to normal
operation.
Display of the hospital inventory number:
Hold the „Total 1ml down“ key while turning on the pump. The hospital inventory
number (no xxxx) is displayed. After about 10 seconds the pump switches to normal
operation.
Micro-pumping-mode:
Hold the „Rate1ml down“ key while turning on the pump. The pump switches to the
micro pump mode. Rates can be set from 0.1 to 99.9 ml/h and the total volume to be
infused from 0.1 to 999.9 ml. Carefully watch the decimal point in the 3 displays.
Otherwise the pump operates exactly the same as the standard version 1 to 999
ml/h.
Attention: When turned off in the micro pump mode, the µVP5005 automatically
reverts to its standard version when switched on again, unless permanently
configured through the software code access.
Pressure display mode (option):
Press audible alarm 2 min suppression key (19) once while the pump is running.
Line pressure in mbar or mmHg will be displayed for 20 sec in the ml infused
display (14). By pressing the same key twice in quick succession, not only will the
pressure in mbar or mmHg be displayed in the ml infused display (14), but the
pressure level will also be displayed in the total ml display (12). During this 20 sec
time period, the pressure level can be adjusted below or above the preset 800 mbar
or mmHg to a maximum of 999 or a minimum to suit the displayed in line pressure.
Remember the lower the pressure level, the lower the bolus occlusion on release
and the quicker the time to alarm. As soon as the line pressure exceeds the
prescribed pressure level, the pump will go into occlusion alarm in the alarm
window (16). An audible alarm will also be triggered. Once the occlusion has been
released, the visual occlusion symbol will flash, and both the general alarm !
and audible alarm will continue until the START/STOP key (18) has been pressed.
Caution: Do not open the door if the system is under pressure!
Page 10
6. Warranty
ARCOMED AG offers a 12-month warranty on every Volumed 5005 unit, effective
from the date of delivery.
The warranty covers the repair and replacement of faulty parts due to manufacturing
or material defects. This warranty is rendered null and void if the unit is tampered
with by unauthorized persons and if the inspection/maintenance intervals are not
observed.
This warranty does not cover the elimination of problems caused by incorrect
operation, inappropriate handling or normal wear and tear.
The supplier only accepts responsibility for the safety, functional reliability and
performance of the unit providing that:
- assembly, extension work, resetting, modification or repair work has been carried
out by personnel specifically authorized by him,
- the electrical system at the operating site meets the IEC requirements, and the unit
is operated in accordance with these instructions for use.
CAUTION:
The Volumed® µVP5005 may only be used with accessories, expendable parts and
consumable items which have been authorized by ARCOMED AG as being
approved as being safe.
The information provided in this manual applies to the currently prevailing situation
and is given in good faith. We reserve the right to make modifications which may be
in the interest of technical progress.
NOTE: When ordering spares, always state the model, serial number and where
applicable the color of the unit in question.
Page 11
7. Inspection and maintenance intervals Volumetric Infusionpump
Volumed ® µVP5005 (according MDD)
Visual Check
Housing Physical damage
External emty container detector (ECD) (Easy Clip) Physical damage
or Internal empty container detector (ECD) ( especially spring ) Physical damage
Door, door latch Clean, function
Stop-flow lever Clean, function
Cover for peristaltic blades Physical damage
Inscriptions, display Readable, damage
Display - LED Function, display test
Mains plug, fuses Damaged, values
Air in line Physical damage
Functional checks
The rates of the fuses must comply with the rates recommended by arcomed (producer):
Conventional transformer 230V :100 mAT/250V, toroid transformer 230V: 250 mAT/250V,
toroid transformer 115V: 500mA T/250V ( IEC127/III/SEV 1064).
Caution: After any work on the pump (e. g. adjustment of programming, change of parts, any opening of
the pump) this inspection must be made and all checks must be documented with the serial number of the
pump. * depending on set.
Serial Number: Remarks: Date /Signature:
Page 12
8. Significance of trumpet curves for practical use
Trumpet curves indicate for 5 different observation windows the maximum and minimum
mean values of the flow rate in ratio to the preset flow rate.
Known therefore is the discrepancy per time-window. For optimal use of the infusion pump
Volumed® µVP5005, the trumpet curve is an important factor in deciding whether the pump
can be used with the prescribed drug.
Volatile drugs with short therapheutic half life demand high accuracy.
For a drug where the plasma-half life is e.g. 1 min. discrepancy of the flow rate of 15% per
minute would mean the same discrepancy for the plasma level. Therefore, a predictable
constant impact of the drug would not be guaranteed.
Example:
Intraveinous infused Insulin has a therapheutic half life of 15 minutes. A flow deviation of ±
15% within 40 minutes would have at least the same (rather twice as much) influence on
deviation of the plasma level and therefore on its impact.
It is important to know that the deviation in a short observation window depends strongly on
the preset rate. The Volumed® µVP5005 has at a rate of 25 ml/h a deviation smaller than
±2% in a observation window of 2 minutes.With 5 ml/h the deviation in the same
observation window is ± 4%, within 5 minutes it is 2%. Mean deviations are within ±5%
(see also following table).
Page 13
Weight [mg]: Flow: ø Flow: ø Error[%]: Time:
37.5
25.0
12.5
0.0
0:00 0:10 0:20 0:30 0:40 0:50 1:00 1:10 1:20 1:30 1:40 1:50 2:00
Trumpet Curve:
10.0
2 Min (max):
5.0 2.04
2 Min (min):
0.0 -2.46
5 Min (max):
-5.0 1.04
5 Min (min):
-10.0 -1.01
0:00 0:10 0:20 0:30
Typical trumpet curve Volumed® µVP5005 at 5 ml/h
Page 15
Notes:
Page 16
Special Keys
Volumed® µVP5000/5005
1) Start up - keys:
Hold indicated key while switching on pump
Micro Pump
Starts Micro Pump 0.1 ml/h ... 99,9 ml/h
ML/H TOTAL ML
RATE
DEFECT
! KVO
ALARM ML INFUSED
ON 2 MIN START
INF Display Test
COMPL
OFF STOP Memory Key
Recalls previous setting
2) In Use
RATE
Will display a relative pressure
DEFECT
! KVO
(=working pressure) between
pump and patient.
ALARM ML INFUSED e.g. P 20 to 35
ON 2 MIN START
INF
COMPL
OFF STOP
Pressure
Recall of
- Pressure (mmHg)
Double Click
- Setting of the pressure limit
in the TOTAL ML window
Condensed instructions for use
Volumed ® µ V P 5 0 0 5
(Volumetric Pump)
Connect 3101 P series Arcomed Administration set or
Arcomed approved equivalent to fluid container.
Fill the drip chamber 1/4 to 1/3 full.
Release roller clamp and prime all air from the
downstream line.
Close roller clamp.
Insert drip chamber into drop detector and secure
using the retaining spring.
Open pump door and depress stop flow lever.
Correctly install the IV set into the pumping chamber
and close door. Insert the tubing carefully in the air
detector from top to bottom in the direction of the
arrow.
ON
Connect infusion line to patient.
Switch on unit (ON/OFF).
OFF
Set required delivery rate.
START
Set required total volume to be delivered
(optional).
STOP
Release roller clamp.
ON
Press START/STOP key to begin infusion.
To switch off unit (power), press ON/OFF
key and hold for about 1 second. OFF