510933us 01

Download as pdf or txt
Download as pdf or txt
You are on page 1of 28

FLOWTRON HYDROVEN 3

Instructions for Use

40 60
20 80
mmH
g
100

120

0086

...with people in mind


Contents
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
About Flowtron Hydroven 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Clinical Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Clinical Treatment Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Garment and Insert Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Garment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Selecting the correct Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Applying the Garment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Pump Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Flowtron Hydroven 3 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Flowtron Hydroven 3 Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Serial Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Service Returns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Garments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Inserts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Technical Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

(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

Indications Intermittent Pneumatic Compression (IPC) is effective


in the treatment of the following clinical conditions,
when combined with an individualised monitoring
programme:
• Edema.
• Dependent (including secondary to
cerebrovascular incident, pregnancy or paralysis).
• Traumatic (post-surgical or injury).
• Lymphedema.
• Primary and secondary (including post surgery,
radio or chemotherapy).
• Chronic venous insufficiency.
• Post phlebotic syndrome.
• Acute and chronic wounds including venous leg
ulcers and post-surgical wounds.
IPC may also be beneficial in the management of:
• Fixed flexion deformity.
• Arthritic conditions.
• Lower limb pain due to trauma or surgery.
• Lipedema.
Selection should be based upon a holistic assessment of
the patients' individual care needs.
 These systems represent one aspect of a treatment
strategy; if the patient's condition changes the
overall therapy regimen should be reviewed by the
prescribing clinician.
 The above are guidelines only and should not
replace clinical judgement.

Contraindications IPC should NOT be used in the following


circumstances:
• Known or suspected deep vein thrombosis (DVT),
pulmonary embolism, thrombophlebitis.
• Acute infections of the skin such as cellulitis.
• Untreated, infected wounds.

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.

Cautions IPC should be used with care in patients with the


following symptoms or conditions:
• Peripheral neuropathy, pain or numbness in the limb.
• Undiagnosed, untreated or infected wounds, fragile
skin, grafts or dermatological conditions that may be
aggravated by the garment.
• Extreme limb deformity which may practically
impede the correct application of the garment.
Warning • Therapy should be interrupted and physician notified
if pain, tingling or numbness of the limb occurs
during, or as a result of therapy.
• In the event of a power failure, or fault whereby the
garment remains inflated, remove the garment.
• Patients must not walk or stand when wearing leg
garments.

3
3. Clinical Treatment Guide

An initial pressure setting of 40 mmHg is suggested at the commencement of


treatment. It may be necessary to start at a lower level of pressure dependant on the
patient’s tolerance.

The pressure can be gradually increased over time, until the required pressure is
reached. The upper treatment pressure range is generally 60-70 mmHg.

A single treatment session is usually 20-30 minutes.


 The above settings and timings are guidelines, and should not be used as a
substitute for clinical judgement and experience.
 Loss of mains power will halt therapy.

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

Hydroven 3 Garment Hydroven 1 Garment

 For Hydroven 1 garments, when an insert is not in use, the bung can be used
as a quick air release.

Selecting the correct Garment


1. Select the type of garment depending on treatment
type:
• 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.
2. Measure the circumference of the largest part of the
limb, and the length in cm/inch from the heel to the
upper thigh for a full leg garment, heel to knee for
half leg garment, from shoulder to finger tips for
full arm garment, and from elbow to finger tips for
half arm garment. Refer to “Accessories” on
page 14 to order the correct size garment.
Shoulder Circumference
Knee Hand Circumference
Circumference

Half Leg Garment Full Arm Garment

5
Applying the Garment

Quick air release bung

Tubing to pump Tubing to pump

Leg Garment Arm Garment

 Before fitting the garment ensure all quick air


release bungs are closed, as this will effect the
efficiency of the garment.

1. If a larger circumference is required, fit a matching


length insert piece before applying to the limb. If
appropriate, a primary dressing or stockinette may
be used underneath the garments.
2. Undo the zip on the garment.
3. If a garment insert is fitted to the garment, fully
fasten one of the zips between the garment and
insert, leaving the other unfastened.
4. Before applying the garment (and insert, if fitted) to
the limb, zip up the first 150 mm (6”) of the
unfastened garment zip. Put the garment (and
insert) onto the limb and fully fasten the zip. Make
sure that the quick air release bung is secured.
5. Make sure the patient is in a comfortable position
with the limb supported or elevated as necessary.
6. Check that the insert piece connecting tube is not
kinked and is attached to the garment using the
lower outlet bung as shown below.

6
Leg Garment Arm Garment
With Insert Fitted With Insert Fitted

7. Attach the garment tubing to the pump ensuring a


“click” is heard from each snap-lock connector.
8. If only one garment is to be used, attach the
garment to either port on the pump. The system will
automatically identify that only one garment is to
be used.
 Ensure that the all zips are fully done up on the
garment before switching the pump on.

9. Switch on the pump and adjust the pressure control


accordingly.

Caution

Do not apply the garment to the limb unless it is partially zipped, as


you may damage the garment zip.
Do not apply or remove the garment while it is attached to the pump
and the pump is in operation, as you may damage the garment zip.
Do not stand or walk while leg garments are fitted.

7
5. Operation

Pump Description

3
2

Flowtron Hydroven 3 Pump

Control
Description Function
Number

1 On/Off Switch Operation of this switch starts or stops the


system
2 Pressure Control Knob Rotates clockwise to increase and
counterclockwise to decrease pressure (user
range 30 - 100 mmHg)
3 Tube Connectors For garment attachment (snap-lock)
4 Pressure Gauge Indicates delivery pressure to garment (mmHg)
5 Carry Handle For easy handling of pump

 If the operation or performance of the pump changes during use, refer to


“Troubleshooting” on page 13 of this IFU before calling a service engineer
or contacting your local ArjoHuntleigh sales office.

8
Caution

Do not apply or remove the garment while it is attached to the pump


and the pump is in operation, as you may damage the garment zip.

Operation The pump should be placed securely on a flat surface.


Before starting the pump ensure that the garments are
properly applied, the zips are secured and the garment
connecting tubes are attached to the pump outlet ports via
snap-lock connectors.
 Make sure the system has been arranged so that the
power cable and garment hoses do not pose a trip or
strangulation hazard.
Ensure that the pressure level is set at minimum i.e. the
knob (2) is fully rotated in a counterclockwise direction.
Switch On Connect the pump to the mains power supply using the
power cable provided. Turn the mains power switch (1)
to the on (I) position.
To Set the Garment While the garment is inflating, rotate the pressure control
Pressure knob (2) slowly clockwise until the required pressure is
displayed on the gauge (4).
The garments will take approximately three cycles to fully
inflate. Check and adjust as necessary after three inflation
cycles.
 It might be necessary to start at a lower pressure
level dependant on the patient’s tolerance.
Compression should not cause any discomfort or
pain to the patient.

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.

The Flowtron Hydroven 3 system should be routinely decontaminated between


patients and at regular intervals while in use; as is good practice for all reusable
medical devices.

WARNING

Remove the electrical supply to the pump by disconnecting the


mains power cord from the mains power supply before cleaning.
Protective clothing should always be worn when carrying out
decontamination procedures.

Caution

Do not use Phenol-based solutions or abrasive compounds or pads


during the decontamination process as these will damage the
surface coating. Avoid immersing electrical parts in water during
the cleaning process. Do not spray cleaning solutions directly onto
the pump. Do not immerse the tubeset in water.

To clean Clean all exposed surfaces and remove any organic


debris by wiping with a cloth moistened with a simple
(neutral) detergent and water.
Do not allow water or cleaning solutions to collect on
the surface of the pump.
Chemical Disinfection We recommend a chlorine-releasing agent, such as
sodium hypochlorite, at a strength of 1,000ppm
available chlorine (this may vary from 250ppm to
10,000ppm depending on local policy and
contamination status).
Wipe all cleaned surfaces with the solution, then wipe
using a cloth moistened with water and dry thoroughly.
Alcohol based disinfectants (strength 70%) may be used
as an alternative.
Ensure the product is dry before storage.

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.

Fault Check Remedy

Pump does not Is power switch on? Check switch.


power up
Is power cord plugged in Check connections.
correctly?

Fuse Blown Call Service Engineer


Pump operates but Blockage in garment Ensure that the tube airway is
garment will not supply tube. clear.
inflate.
Garment not correctly fitted Check connections.
to pump.

Pressure control set too Increase pressure control.


low.

Air leak in garment. Check garment. Replace if


defective.

Service Returns If for any reason your Flowtron Hydroven 3 is being


returned, please:
1. Clean the product following the instructions in
section “Decontamination” on page 10.
2. Enclose a covering letter explaining the reasons for
the return, with documentation (including an
appropriate decontamination certificate if possible).
3. To prevent damage in transport please pack the
pump in a suitably robust box.
 If the trouble shooting procedures do not return the
system to normal performance, stop using the
system immediately and call the service engineer.

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

HYDROVEN 1 LEG GARMENTS

Order Code Type Length (L) Circumference (W)

5101L50 Half Leg 19.7" (50cm) 24" (61cm)

5101L66 Full Leg 26" (66cm) 25.2" (64cm)

5101L71 Full Leg 28" (71cm) 26" (66cm)

5101L76 Full Leg 29.9" (76cm) 28” (72cm)

5101L84 Full Leg 33.1" (84cm) 28" (72cm)

5101L92 Full Leg 36.2" (92cm) 28" (72cm)

HYDROVEN 1 ARM GARMENTS

Order Code Type Length (L) Circumference Circumference


Hand (H) Shoulder (S)

5101A51 Half Arm 20.1" (51cm) 17.3" (44cm) 22" (56cm)

5101A68 Full Arm 26.8" (68cm) 17.3" (44cm) 24.4" (62cm)

5101A78 Full Arm 30.7" (78cm) 17.3" (44cm) 24.4" (62cm)

HYDROVEN 3 LEG GARMENTS

Order Code Type Length (L) Circumference (W)

5103L50 Half Leg 19.7" (50cm) 24" (61cm)

5103L66 Full Leg 26" (66cm) 25.2" (64cm)

5103L71 Full Leg 28" (71cm) 26" (66cm)

5103L76 Full Leg 29.9" (76cm) 28" (72cm)

5103L84 Full Leg 33.1" (84cm) 28" (72cm)

5103L92 Full Leg 36.2" (92cm) 28" (72cm)

HYDROVEN 3 ARM GARMENTS

Order Code Type Length (L) Circumference Circumference


Hand (H) Shoulder (S)

5103A68 Full Arm 26.8" (68cm) 17.3" (44cm) 24.4" (62cm)

5103A78 Full Arm 30.7" (78cm) 17.3" (44cm) 24.4" (62cm)

14
Inserts

HYDROVEN INSERT PIECES


(To Fit Hydroven 1 and Hydroven 3 Garments)

Order Code Type Length (L) Added Circumference Added Circumference


Wide End Narrow End

510LI50 Half Leg 19.7" (50cm) 7.5" (19cm) 5.5" (14cm)

510LI66 Full Leg 26" (66cm) 7.5" (19cm) 5.5" (14cm)

510LI71 Full Leg 28" (71cm) 7.5" (19cm) 5.5" (14cm)

510LI76 Full Leg 29.9" 7.5" (19cm) 5.5" (14cm)


(76cm)

510LI84 Full Leg 33.1" (84cm) 7.5" (19cm) 5.5" (14cm)

510LI92 Full Leg 36.2" (92cm) 7.5" (19cm) 5.5" (14cm)

510AI68 Full Arm 26.8" (68cm) 6.7" (17cm) 4.7" (12cm)

510AI78 Full Arm 30.7" (78cm) 6.7" (17cm) 4.7" (12cm)

15
10. Technical Specification

Pump
Model: Flowtron Hydroven 3

Part Numbers: 510003

Pressure Range: 30 - 100 mmHg ± 5%

Supply Voltage: 120 V

Supply Frequency: 60 Hz

Power Input: 14 VA

Size: 10.6 x 5.9 x 4.1” (270 x 150 x 105 mm)

Weight: 5.3 lb (2.4 kg)

Case Material: Fire Retardant ABS Plastic

Pump Fuse Rating: F500 mAH 250V

Degree of protection Class II, Double Insulated


against electric shock:
Type BF

Degree of protection
against liquid ingress: IPX0 - No protection

Mode of operation: Continuous

ENVIRONMENTAL INFORMATION
Condition Temperature Range Relative Humidity Atmospheric Pressure

Operating +10 °C to +40 °C 30% to 75% 700 hPa to 1060 hPa


(+50 °F to +104 °F) (non-condensing)

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).

Refer to this document


Power (Instructions for Use) for

i
I
Connects to the Double Insulated a description of the
(On)
mains supply product classification
(3rd Edition).

The operator must read


this document
(Instructions for Use)
Fuse Type BF
before use.
Note: This symbol is blue
on the product label.

With respect to electric


shock, fire and
mechanical hazards only
Ref: Model Number SN: Serial Number in accordance with CAN/
CSA-C22.2 No. 60601.1
(2008).
MEDICAL EQUIPMENT

Manufacturer: This
symbol is accompanied
by the name and the
address of the
manufacturer.

CLEANING SYMBOLS

Do not iron Do Not Tumble Dry

Do not Dry Clean Wipe surface with damp cloth

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.

Emissions Test Compliance Electromagnetic environment - guidance

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.

RF emissions Class A The pump is suitable for use in all establishments


other than domestic and those directly connected
CISPR - 11 to the public low-voltage power supply network
that supplies buildings used for domestic
Harmonic emissions Class A purposes.

Voltage fluctuations/ Complies


flicker emissions

IEC 61000-3-2

Recommended separation distances between portable


and mobile RF communications equipment and the pump
The pump is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the pump can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the pump as recommended below, according to the maximum output power of the
communications equipment.

Separation distance according to frequency of transmitter


Rated maximum m
output power of
transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W
d = 1.2√P d = 1.2√P d = 2.3√P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 2.8 3.8 7.3

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.

Immunity Test IEC 60601 Test Compliance Electromagnetic environment - guidance


Level Level

Portable and mobile RF communications


equipment should be used no closer to any
part of the pump, including cables, that the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3V d = 1.2√P


IEC 61000-4-6 150 kHz to 80 MHz
d = 1.2√P 80 MHz to 800 MHz

Radiated RF 3 V/m 3 V/m d = 2.3√P 800 MHz to 2.5 GHz


IEC 61000-4-3 80 MHz to 2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in metres
(m).

Field strengths from fixed RF transmitters, as


determined by an electromagnetic site survey
a, should be less than the compliance level in

each frequency range.b

Interference may occur in the vicinity of


equipment marked with the following symbol:

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

ArjoHuntleigh AB Place barcode over this box.


Verkstadsvägen 5 Place document No and date below this box.
241 38 Eslöv
SWEDEN 510933US_01: 09/2012

You might also like