Arcomed Volumed uVP7000 Premium User manual

Maintenance Manual
Volumed®µVP7000
Swiss Made
2 MIN
DEFECT
RATE ML/H
ON
INF
COMPL
OFF
RATE
STOP
START
KVO
VOLUME ML
BOLUS
volumed
µVP7000
OPTION
ARCOMED AG
8105 Regensdorf / Zürich
(an ISO 9001 company)
Important
This manual is exclusively intended for authorized personnel who have been
instructed by Arcomed AG in the maintenance and repair of the Infusion Pump
indicated above.
Arcomed AG shall assume no liability for tampering by unauthorized persons.
Caution: The manufacturer reserves the right to improve the specifications of
this product without prior notice.
Edition 02/03 -VA-TM-7000-E

Contents
Page
Index numbers 0
1. Introduction 1
1.2.2 Service Intervals 2
2. Specifications 3
3. Operation 4
3.18 Parallel / Multiple Infusions 10
4. Alarm Supervision System 11
5. Warranty 13
Design Changes 13
6. Inspection and Maintenance Intervals 14
7. Significance of Trumpet Curves 15
8. Technical description 17
9. Trouble shooting 21
10. Replacement of parts 22
11. Spare parts list 7000 23
Annex A Drawings
Annex B Schematics
Annex C Component layout

Index Numbers
1Administration set
2Drip chamber
3Stop flow clamp (internal or robson clamp)
4Empty container detector (ECD)
5Door
6Door latch
7On / OFF key
8Rate display
9Volume display
10 Start / Stop key
11 Tube guides
12 Pumping-peristaltic
13 Occlusion detector
14 Stop flow device
15 Air detector
16 Rate keys
17 Volume keys
18 Option key, Alarm tone-mute key
19 Prime / Bolus key
20 Alphanumeric LCD display
21 Alarm window
22 Information window
23 Mains supply socket
24 Fuses
25 Connector nurse call
26 Connector empty container detector (ECD)
27 External power supply (12 DC)
28 Infra red interface
29 Pole clamp
30 Carrying handle

18 19 10
9
16 8
713
volumed
µVP7000
VOLUME MLRATE ML/H
KVORATE
arcomed ag
OFF
ON
INF
COMPL DEFECT
OPTION
2 MIN
STOP
START
BOLUS
Volumed µVP7000
Front view
22
6
21 20
30
12
11
4
5
6
1
2
11 3
7
15
14
11
6

Volumed µVP7000
Rear view
30
28272625
29
23
24
25

1. Introduction
1.0 Introduction
The Volumed® µVP7000 Volumetric Infusion Pump has been developed using
the latest state-of-the-art technology. This microprocessor-controlled volumetric
pump operates by pumping the infusate using a peristaltic system. The sterility of
the infusate is not affected. The pump is designed to infuse drugs or other
infusates into the patient by controlled means under pressure.
The Volumed µVP7000 meets the performance requirements of the MDA (UK) for
neonatal and high risk infusions. It can be used in both stationary and
transportable applications as it has a battery life up to 6 hours duration.
Applications include neonatology, intensive and cardiac care, paediatrics,
gynaecology and osbstetrics, surgery and general medicine. It can also be used
in ambulances or for laboratory use. For infusions with very small rates and small
volumes it is recommended to use a syringe pump such as the Syramed®
µSP6000 as the the remaining volume in the administration set can become
significant compared to the infused volume.
The Volumed µVP7000 meets the Medical Device Directive (MDD) requirements
of the EC Guideline 93/42 EEC and is marked CE.
Classification: Class IIb
The manufacturer according to MDD is Arcomed AG, Althardstrasse 146, CH
8105 Regensdorf, Zurich, Switzerland. Responsible for the EC is Arcomedical
Infusion Ltd., West Horndon, EssexCM133XS,UK.
The Volumed µVP7000 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.
1.1 Mounting the pump
Check the pump and accompanying accessories for damage when unpacking.
The pump must not be operated if damaged. Should the pump be damaged
contact our Service Department.
Permitted mounting: positioned on a flat horizontal surface or pole mounted on
an infusion stand or rail mounted.
The pump should normally be operated from a mains power supply. The internal
batteries will automatically operate the pump in the event of a power failure.
CAUTION: This pump is not designed for use in areas where there is an
explosion hazard. Environmental requirements as per IEC601-1-2 must be
observed. Do not operate this pump in an environment with high levels of
electromagnetic radiation such as surgical diathermy or mobile telephones. For
further information contact the official distributor in your country or the Customer
Service Department in Switzerland:
Switzerland: a r c o m e d a g, Althardstr. 146, CH-8105 Regensdorf
Tel. [phone]’47’40, Fax. [phone]’06’49
United Kingdom: Arcomedical Infusion Ltd., 5g West Horndon Industrial
Estate, West Horndon, Essex CM13 3X
Page 1

Tel. [phone]’81’04’32 Fax. [phone]’81’19’67
The technical manual and the list of spares and used materials can be requested
from Arcomed.
1.2.1 Cleaning and disinfection
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. Use only disinfectant that are
compliant with:
- ABS, POM, stainless steel, PVC, aluminum, silicone
Please check with your supplier of disinfectant.
1.2.2 Annual safety check
Battery power is provided by a nickel metal hydride (NiMH) battery which must be
checked annually. Battery condition is checked by connecting the pump to the
mains power supply for 15 hours in a switched off condition so that the battery
may be fully charged. Disconnect the mains power supply and switch the pump
on using battery power. Determine the operating time when the low battery alarm
activates. This should be at least 3 hours - if not the battery must be replaced.
Repeated charging and discharging may in certain circumstances cause
degeneration of the battery (memory effect).
Used batteries must be disposed of in an environmentally friendly manner or
returned to the manufacturer.
Safety checks (see chapter 6) may be performed only by qualified staff.
1.3. Key to symbols
The pictograms and symbols shown on the reverse of the pump have the
following meanings or functions:
Empty bag detector
Nurse Call
12 VDC External 12 VDC supply
IR Interface RS232
(Infrared Interface)
IPX 1
CF (cardiac floating) part
CAUTION: consult accompanying
documents
Drip-proof
class II double insulated
!
Page 2

2. Specifications
CE Mark A23 02 04 07000 01
Classification IIb
Software revision 1.xx
Flow rate range (ml/h) 0.1 - 999.0 ml/h, increments: 0.1 ml/h
Volume range (ml) 0.1 - 9999.9 ml, increments: 0.1 ml
Deviation in flow-rate with
8101P series administration set typ. +/- 3% (Silicone insert)
Deviation in flow-rate with
3101P series administration set typ. +/- 5% (PVC line)
Overinfusion in case of electrical 1.5 ml max.
or mechanical defect
Keep vein open rate (KVO) 3.0 ml/h, adjustable
Bolus rate, Prime rate 1000 ml/h, adjustable
Infusion pressure min. 60 kPa / 450 mmHg / 0.6 bar
Infusion pressure max. 120-250 kPa / 900-1875 mmHg
1.5-2.5 bar (according to IV set)
Alarm pressure limit 0 - 999 mbar/mmHg
Bolus volume after occlusion Automatic bolus reduction (see also 3.9)
Time to alarm after occlusion Depending on rate, pressure limit setting
and set, see also table below.
Air detection ultrasonic
Sensitivity typ. 100 µl, adjustable from 50 to 250 µl
Cumulated 15 min adjustable from
500 to 5000 µl
Battery operation time (1.85Ah) 3 - 5 hrs (dependent on rate and mode)
Charging time 15 hours/20 hours
Supply voltage 230 VAC+10%-15%, 50/60 Hz
External power supply (optional) 12 VDC
Input power 9.3 VA
Mains fuse T200 mA/IEC127/III/SEV 1064
Type of protection against electric shock Class II
Protection against ingress of liquids IPX 1, drip proof
Leakage current < 40µA
Radio interference CE-Class A
Nurse call, potential-free 24V/0.2A
contact switch
Degree of protection against electric shock CF (cardiac floating)
Dimensions 245x90x180 mm (WxHxD)
Housing ABS plastic, UL listed
Weight 2.6 kg (approx.)
Page 3

Max. storage period 3 months without charging
Permitted temperature range 15°C - 35°C / 0°C- 40°C
(operation/storage)
Permitted relative humidity 20-90% max. (no vapor deposit)
Atmospheric pressure 500-1000 hPa
Safety certification DIN IEC 601 Part 1
EN55011 Radio interference
IEC60601-1-2 Susceptibility
IEC60601-2-24
Operating modes Continual, manual bolus, automatic bolus, priming.
Labeling of the pump 12 alpha numeric caracters.
Configured through IR interface.
History Up to 1500 data logs with real time stamps.
Read out and printout through IR interface and PC.
Time to alarm after occlusion (PVC set), volume of bolus without bolus reduction:
1.0 bar 500 mbar 100 mbar
1 ml/h >60 min 45 min 8 min
20 ml/h 3.5 min 100 sec 20 sec
100 ml/h 50 sec 25 sec 5 sec
999 ml/h 6 sec 2.5 sec 0.5 sec
Bolus 0.9 ml 0.45 ml 0.09 ml
Pressure
Rate
Page 4

3. Operation
The figures in brackets refer to the illustrations of front and rear views shown in
the appendices.
CAUTION: Use only approved disposable adiministration sets!
(cf. leaflet "Accessories and Consumables")
The performance of the pump depends on both pump and administration set. The
volumed must only be used with the sets the pump has been calibrated to. The
functional safety of the pump cannot be guaranteed if non-approved IV sets are
used. The safety of the patient may be compromised as a result.
Disposable IV sets are for single-use only. Single-use needles carry an infection
hazard and must be disposed of in accordance with local guidelines. The IV-set
should be replaced every 24 hours.
3.1. Preparation and loading of the administration set
a) If the pump is to be operated on an infusion stand, care must be taken that the
pump is not positioned more than 1.4m above the ground to ensure stability.
Ideally use an "Arco Luxe" or "Arco Standard" infusion stand. If several pumps
are mounted one above the other the maximum permitted height from the floor
must be observed and measures taken to prevent instability. The pump
may be fixed to the infusion stand by means of the pole clamp (29) on the rear
of the unit.
b) Slot the drip chamber (2) 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 (1), without allowing any air bubbles to
enter, until the drip chamber (2) is 1/4 to 1/3 full. If air has entered, repeat
purge-procedure.
d) Close the tubing roller clamp.
e) Open the pump door (5) by pulling the latch (6).
f) Pump with Robson Clamp:
Position the Robson clamp (3) on the tubing. In case of a silicon insert
tubing, position the Robson clamp just left of the silicone segment. Close the
Robson clamp. Hold the tubing with your right hand with your thumb
positioned on the Robson clamp. Starting with the left side, insert the IV set
into the left tube guide (11). Ensure that the flow direction of the pump from
the left to the right is respected and the tubing is in a straight line. Put the
Robson clamp with your thumb into the Stop Flow device (14) and insert
the remaining tubing onto the right tube guide (11).
Pump with internal clamp:
Starting with the left side, insert the IV set into the left and right tube guides
(11). Ensure that the flow direction of the pump from the left to the right is
respected and the tubing is in a straight line. In case of a silicon insert tubing
verify the correct position of the silicon insert as shown in the front view of this
manual.
g) Close the door (5) and push the latch (6) firmly against the pump. Open the
tubing roller clamp.Page 5