510933us 01
510933us 01
510933us 01
40 60
20 80
mmH
g
100
120
0086
(i)
(ii)
GENERAL SAFETY
Before you connect the system pump to a mains socket, read carefully all the installation
instructions contained within this manual.
The system has been designed to comply with regulatory safety standards including:
• EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995
• UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90
• EN60601-1:2006 and IEC 60601-1:2005
• AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008)
Safety Warnings
• It is the responsibility of the care giver to ensure that the user can use this product
safely.
• Make sure that the mains power cable and tubeset or air hoses are positioned to
avoid causing a trip or other hazard, and are clear of moving bed mechanisms or
other possible entrapment areas.
• Electrical equipment may be hazardous if misused. There are no user-serviceable
parts inside the pump. The pump's case must only be removed by authorised
technical personnel. No modification of this equipment is allowed.
• The mains power socket/plug must be accessible at all times. To disconnect the
pump completely from the electricity supply, remove the plug from the mains
power socket.
• Disconnect the pump from the mains power socket before cleaning and inspecting.
• Keep the pump away from sources of liquids and do not immerse in water.
• Do not use the pump in the presence of uncontained flammable liquids or gasses.
• Only the pump and garment/insert combination as indicated by ArjoHuntleigh
should be used. The correct function of the product cannot be guaranteed if
incorrect pump and garment combinations are used.
Caution (applicable to the USA market only)
• US Federal law restricts this device to sale by or on the order of a physician.
Precautions
For your own safety and the safety of the equipment, always take the following precautions:
• Do not expose the system to naked flames, such as cigarettes, etc.
• Do not store the system in direct sunlight.
• Do not use phenol-based solutions to clean the system.
• Make sure the system is clean and dry prior to use or storage.
• Pets and children must be supervised in the vicinity of the system.
Electromagnetic Compatibility (EMC)
This product complies with the requirements of applicable EMC Standards. Medical electrical
equipment needs special precautions regarding EMC and needs to be installed in accordance
with the following instructions:
• The use of accessories not specified by the manufacturer may result in increased
emissions by, or decreased immunity of, the equipment, affecting its performance.
• Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell
phones) can affect medical electrical equipment.
(iii)
• If this equipment needs to be used adjacent to other electrical equipment, normal
operation must be checked before use.
• For detailed EMC information contact ArjoHuntleigh service personnel.
Expected Service Life
The Flowtron® Hydroven 3 has an expected service life of seven years. To maintain the
condition of the pump have the pump serviced regularly according to the schedule
recommended by your ArjoHuntleigh distributor.
Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse
the Flowtron Hydroven 3 system. Failure to observe this caution could result in injury, or in
extreme cases, death.
Environmental Protection
Incorrect disposal of this equipment and its component parts, particularly batteries or other
electrical components, may produce substances that are hazardous to the environment. To
minimise these hazards, contact ArjoHuntleigh for information on correct disposal.
Design Policy and Copyright
® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. As our policy is
one of continuous improvement, we reserve the right to modify designs without prior notice.
The content of this publication may not be copied either whole or in part without the consent
of ArjoHuntleigh.
© ArjoHuntleigh 2012
(iv)
1. Introduction
About this Manual This manual is your introduction to the Flowtron®
Hydroven 3 system.
You must read and fully understand this manual before
using the system.
Use this manual to initially set up the system, and keep
it as a reference for day-to-day routines and as a guide to
maintenance.
If you have any difficulties in setting-up or using the
Flowtron Hydroven 3 system, contact your local
ArjoHuntleigh sales office, listed at the end of this
manual.
Intended Use The intended use of this product is to manage the list of
clinical conditions detailed in the “Indications” (refer to
page 2).
The Flowtron Hydroven 3 system should be used as part
of a prescribed plan of care detailed in the “Indications”
(refer to page 2).
About Flowtron The pump supplies air via connecting tubes to an
Hydroven 3 inflatable garment allowing the application of controlled
pressure to gently compress the limb. This action assists
in increasing the return of blood, excess fluids, improves
venous stasis and encourages the reabsorption of waste
products.
The pump operates on an automatically timed cycle of
3 minutes, 90 seconds inflation followed by 90 seconds
deflation. Variable pressure output ranges from
30-100 mmHg. The garments are inflated alternately.
The Flowtron Hydroven 3 system operates two types of
garments:
• Hydroven 1 garments have a single chamber and
provide uniform compression.
• Hydroven 3 garments have three chambers providing
graduated segmental compression, inflating distally
to proximally.
Optional garment inserts can be used to increase the
circumference of the standard arm and leg garments.
A full technical description of the Flowtron Hydroven 3
system can be found in the Service Manual, part No.
SER0014, available from your local ArjoHuntleigh
sales office.
1
2. Clinical Application
2
• Decompensated / severe congestive cardiac failure,
pulmonary edema associated with significant limb
edema or any condition where an increase of fluid to
the heart may be detrimental.
• Severe arteriosclerosis or other ischaemic vascular
disease.
• Active metastatic disease affecting the limb.
If you are uncertain whether you have any of the
above conditions please consult a physician before
use.
3
3. Clinical Treatment Guide
The pressure can be gradually increased over time, until the required pressure is
reached. The upper treatment pressure range is generally 60-70 mmHg.
4
4. Garment and Insert Information
Garment Description
Zip Ring Pull Zip Ring Pull
Quick Air
Release Bung
Tubing Connector
(To Pump) Tubing Connector
(To Pump)
Garment Garment
Bung/Connector Bung/Connector
For Insert Tubing For Insert Tubing
For Hydroven 1 garments, when an insert is not in use, the bung can be used
as a quick air release.
5
Applying the Garment
6
Leg Garment Arm Garment
With Insert Fitted With Insert Fitted
Caution
7
5. Operation
Pump Description
3
2
Control
Description Function
Number
8
Caution
Shut Down Turn the power switch (1) to the off (O) position.
Turning the power off will stop the patient therapy.
If it is required to completely isolate the pump from
the mains power, remove the plug from the mains
power socket.
To Remove the Garment Make sure the pump power switch is in the off (O)
position, disconnect the tubes from the pump by releasing
the snap-lock connectors (3), and release the quick air
release bung on the garment.
Only open the zip after the garment is completely deflated.
9
6. Decontamination
The following processes are recommended, but should be adapted to comply with
the local or national guidelines (Decontamination of Medical Devices) which may
apply within the Healthcare Facility or the country of use. If you are uncertain, you
should seek advice from your local Infection Control Specialist.
WARNING
Caution
10
If an alternative disinfectant is selected from the wide
variety available, we recommend that suitability for use
is confirmed with the chemical supplier prior to use.
To Clean and Sterilise Wipe down garments using a neutral detergent or soap
Garments powder at 40°C (104°F). Dry thoroughly.
After cleaning gas sterilisation is possible, however:
• Do not exceed 51°C (120°F).
• Do not autoclave.
11
7. Routine Maintenance
Flowtron Hydroven 3 System
Maintenance The equipment has been designed to be maintenance-
free between service periods.
Servicing ArjoHuntleigh will make available on request service
manuals, component parts lists and other information
necessary for ArjoHuntleigh trained personnel to repair
the system.
Service Period ArjoHuntleigh recommend that the Flowtron
Hydroven 3 pump is serviced every 12 months by an
ArjoHuntleigh authorised service agent.
Flowtron Hydroven 3 Pump
General Care, Check all electrical connections and power cable for
Maintenance and signs of excessive wear.
Inspection Check the tubeset and connectors for any damage.
In the event of the pump being subjected to abnormal
treatment, e.g. immersed in water or dropped, the unit
must be returned to an authorised service centre.
Serial Labels The serial number for the pump is on the label on the
back of the pump case. Quote this serial number when
requesting service.
12
8. Troubleshooting
If you should encounter a problem, please follow the fault finding guide below. If the
fault cannot be rectified, please refer to Service.
13
9. Accessories
To order garments, please contact your distributor quoting the appropriate codes as
shown below:
Refer to diagrams on page 5 of this manual.
Garments
14
Inserts
15
10. Technical Specification
Pump
Model: Flowtron Hydroven 3
Supply Frequency: 60 Hz
Power Input: 14 VA
Degree of protection
against liquid ingress: IPX0 - No protection
ENVIRONMENTAL INFORMATION
Condition Temperature Range Relative Humidity Atmospheric Pressure
Storage and Transport +10 °C to +40 °C 20% to 95% 700 hPa to 1060 hPa
(Long Term) (+50 °F to +104 °F) (non-condensing)
Storage and Transport -20 °C to +50 °C 20% to 95% 500 hPa to 1060 hPa
(Short Term) (-4 °F to +122 °F) (non-condensing)
If the pump is stored in conditions outside of the “Operating” ranges, it should be allowed
time to stabilise at normal operating conditions before use.
16
Symbols
Refer to this document
Power (Instructions for Use) for
O Do not dispose of in
Disconnects from the a description of the
(Off) domestic refuse
mains supply product classification
(2nd Edition).
i
I
Connects to the Double Insulated a description of the
(On)
mains supply product classification
(3rd Edition).
Manufacturer: This
symbol is accompanied
by the name and the
address of the
manufacturer.
CLEANING SYMBOLS
Do Not Use Phenol-based cleaning Use solution diluted to 1000 ppm of Available
Solutions Chlorine
17
Guidance and manufacturer’s declaration - electromagnetic emissions
The pump is intended for use in the electromagnetic environment specified below. The customer or the
user of the pump should assure that it is used in such an environment.
RF emissions Group 1 The pump uses RF energy only for its internal
function. therefore, its RF emissions are very low
CISPR - 11 and are not likely to cause any interference in
nearby electronic equipment.
IEC 61000-3-2
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
18
Guidance and manufacturer’s declaration - electromagnetic immunity
The pump is intended for use in the electromagnetic environment specified below. The customer or the
user of the pump should assure that it is used in such an environment.
Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field
strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the pump is used exceeds the applicable RF compliance level above, the pump should
be observed to verify normal operation. If abnormal operation is observed, additional measures may be
necessary, such as reorientating or relocating the pump.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
19
20
AUSTRALIA FAR EAST PORTUGAL
ArjoHuntleigh Pty Ltd ARJO Far East Limited ArjoHuntleigh em Portugal:
78, Forsyth street Unit 3A, 4/F., Block B Hoi Luen MAQUET Portugal, Lda.
O’Connor Industrial Centre (Distribudor Exclusivo)
AU-6163 Western Australia 55 Hoi Yuen Road, Rua Poeta Bocage n.º 2 - 2G
Tel: +61 89337 4111 Kwun Tong, Kowloon 1600-233 Lisboa, Portugal
Free: +1 800 072 040 HONG KONG Tel: +351 214 189 815
Fax: + 61 89337 9077 Tel: +852 2508 9553 Fax: +351 214 177 413
Fax: +852 2508 1416 E-mail: [email protected]
BELGIQUE / BELGIË
ArjoHuntleigh NV/SA FRANCE SUISSE / SCHWEIZ
Evenbroekveld 16 ArjoHuntleigh SAS ArjoHuntleigh AG
B-9420 ERPE-MERE 2 Avenue Alcide de Gasperi Fabrikstrasse 8
Tél/Tel: +32 (0) 53 60 73 80 BP 133 Postfach
Fax: +32 (0) 53 60 73 81 59436 RONCQ CEDEX 4614 Hägendorf,
E-mail: [email protected] Tél: +33 (0) 3 20 28 13 13 Tél/Tel: +41 (0) 61 337 97 77
Fax: +33 (0) 3 20 28 13 14 Fax: +41 (0) 61 311 97 42
CANADA E-mail: [email protected]
ArjoHuntleigh Canada Inc. SUOMI
1575 South Gateway Road INTERNATIONAL ArjoHuntleigh OY
Unit “C” ArjoHuntleigh International Ltd. Vanha Porvoontie 229
MISSISSAUGA, ON, L4W 5J1 ArjoHuntleigh House FI-01380 VANTAA
Tel/Tél: +1 905 238 7880 Houghton Hall Park Puh: +358 9 4730 4320
Free: +1 800 665 4831 Institutional Houghton Regis Faksi: +358 9 4730 4999
Free: +1 800 868 0441 Home Care UK-DUNSTABLE LU5 5XF
Fax: +1 905 238 7881 Tel: +44 (0) 1582 745 800 SVERIGE
E-mail: [email protected] Fax: +44 (0) 1582 745 866 ARJO Scandinavia AB
E-mail: Verkstadsvägen 5
ČESKÁ REPUBLIKA [email protected] Box 61
ARJO Hospital Equipment s.r.o. SE-241 21 ESLÖV
Hlinky 118 ITALIA Tel: +46 (0) 413 645 00
CZ- 603 00 BRNO ArjoHuntleigh S.p.A. Fax: +46 (0) 413 645 83
Tel: +420 549 254 252 Via di Tor Vergata 432 E-mail: [email protected]
Fax: +420 541 213 550 00133 ROMA - ITALIA
Tel: +39 (0) 6 87426211 UNITED KINGDOM
DANMARK Fax: +39 (0) 6 87426222 ArjoHuntleigh UK
ArjoHuntleigh A/S E-mail: [email protected] ArjoHuntleigh House
Vassingerødvej 52 Houghton Hall Park
DK-3540 LYNGE NEDERLAND Houghton Regis
Tel: +45 49 13 84 86 ArjoHuntleigh Nederland BV UK-DUNSTABLE LU5 5XF
Fax: +45 49 13 84 87 Biezenwei 21 Tel: +44 (0) 1582 745 700
E-mail: [email protected] 4004 MB TIEL Fax: +44 (0) 1582 745 745
Postbus 6116 E-mail: [email protected]
DEUTSCHLAND 4000 HC TIEL
ArjoHuntleigh GmbH Tel: +31 (0) 344 64 08 00 USA
Peter-Sander-Strasse 10 Fax: +31 (0) 344 64 08 85 ArjoHuntleigh Inc.
D-55252 MAINZ-KASTEL E-mail: [email protected] 2349 W Lake Street Suite 250
Tel: +49 (0) 6134 186 0 Addison, IL 60101
Fax: +49 (0) 6134 186 160 NORGE Tel: +1 630 307 2756
E-mail: [email protected] ArjoHuntleigh Norway AS Free: +1 800 323 1245 Institutional
Ryenstubben 2 Free: +1 800 868 0441 Home Care
ΕΛΛΑΔΑ NO-0679 OSLO Fax: +1 630 307 6195
C. Psimitis Co Ltd Tel: +47 22 08 00 50 E-mail: [email protected]
Dimitriou Andr. 59 Faks: +47 22 08 00 51
GR-16121 KAISARIANI ATTIKIS E-mail: [email protected] ÖSTERREICH
Τηλ: 21 0724 36 68 ArjoHuntleigh GmbH
Φάξ: 21 0721 55 53 POLSKA Dörrstrasse 85
ArjoHuntleigh Polska Sp. z o.o. AT-6020 INNSBRUCK
ESPAÑA ul. Ks Piotra Wawrzyniaka 2 Tel: +43 (0) 512 204 160 0
ArjoHuntleigh Ibérica S.L. PL 62-052 KOMORNIKI (Poznan) Fax: +43 (0) 512 204 160 75
Ctra. de Rubí, 88 1ª planta - A1 Tel: +48 61 662 15 50
08173 Sant Cugat del Vallés Fax: +48 61 662 15 90
ES- BARCELONA 08173 E-mail: [email protected]
Tel: +34 93 583 11 20
Fax: +34 93 583 11 22
E-mail: [email protected]
www.arjohuntleigh.com
GETINGE GROUP is a leading global provider of products and
systems that contribute to quality enhancement and cost efficiency
within healthcare and life sciences. We operate under the three
brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh
focuses on patient mobility and wound management solutions.
GETINGE provides solutions for infection control within healthcare
and contamination prevention within life sciences. MAQUET
specializes in solutions, therapies and products for surgical
interventions and intensive care.
www.arjohuntleigh.com