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11. Technical Specification

PUMP

Model:

Flowtron Universal

Part Numbers:

507001
507009AU

UK

Australia

Pressure Range:

Calf/Thigh: 40 mmHg ± 5 mmHg
Foot: 130 mmHg ± 10 mmHg

Supply Voltage:

100-230 V

Supply Frequency:

50-60Hz

Power Input:

38-77 VA

Size:

230 x 270 x 150 mm

Weight:

3.9 kg

Case Material:

Fire Retardant ABS Plastic

Plug Fuse Rating:

5A to BS1362 (UK ONLY)

Degree of protection
against electric shock:

Mains Connected: Class II, Double Insulated with Functional Earth
Type BF

Mains Not Connected: Internally Powered

Degree of protection
against liquid ingress:

IPX0 - No protection

Mode of operation:

Continuous

PUMP SYMBOLS

The operator must read 
this document 
(Instructions for Use) 
before use.
Note: This symbol is blue 
on the product label.

Run/Standby. 
Note: Unit is not 
isolated from 
mains supply.

Do not dispose of in 
domestic refuse

With respect to electric 
shock, fire and 
mechanical hazards only 
in accordance with CAN/
CSA-C22.2 No. 60601.1 
(2008).
MEDICAL EQUIPMENT

Double Insulated

Type BF

Refer to this document 
(Instructions for Use) for 
a description of the 
product classification (3rd 
Edition).

SN:

Serial Number

Ref:

Model number

Refer to this document 
(Instructions for Use) for 
a description of the 
product classification 
(2nd Edition).

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

i

Summary of Contents for FLOWTRON UNIVERSAL

Page 1: ...FLOWTRON UNIVERSAL Instructions for Use with people in mind 0086 ...

Page 2: ......

Page 3: ...nded Checks 7 To Use One Garment 7 To Use Different Garments on Each Limb 8 Settings Adjustment 9 Options 10 Battery Operation 12 Connecting the Battery Pack 12 Battery Pack in Use 12 Battery Storage and Disposal 13 Checking the Status of the Battery 14 Recharging the Battery Pack 15 Alternative Method of Charging 15 Decontamination 16 Routine Maintenance 17 Flowtron Universal System 17 Flowtron U...

Page 4: ... ii ...

Page 5: ...ot 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 The Flowtron Universal system is NOT intended for use in the Home Healthcare Environment e g private d...

Page 6: ...rformance Portable and mobile radio frequency RF communications equipment e g mobile cell phones can affect medical electrical equipment 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 Universal has an expected service life of...

Page 7: ...nts are single use only It is not for use in the home healthcare environment The Flowtron Universal system should be used as part of a prescribed plan of care refer to Indications on page 2 About Flowtron Universal The pump automatically adjusts to the correct therapy profile depending upon which garment type foot calf or thigh length is connected An optional battery pack is available which allows...

Page 8: ...plications are included in the packaging of every garment The type of garment used on an individual patient must be specified by a physician Contraindications DVT Calf Thigh Garments The Flowtron Universal system when used with the DVT Calf Thigh Garments should not be used in the following conditions 1 Severe arteriosclerosis or other ischaemic vascular diseases 2 Severe congestive cardiac failur...

Page 9: ...hould be taken when placing the garments on any deformed leg or foot or on legs with significant oedema 3 Garments should be removed immediately if the patient experiences tingling numbness or pain and the physician notified 4 When used for DVT prevention continuous external pneumatic compression is recommended until the patient is fully ambulatory Uninterrupted use of the Flowtron Universal syste...

Page 10: ...y checked to ensure continued proper fit and application in addition to assessing the condition of the skin Where appropriate patients should be instructed in the proper use of the system the purpose of therapy and that any problems should be reported to the nursing staff Loss of mains power will halt therapy DVT prophylaxis The Flowtron Universal system should be applied to the patient pre operat...

Page 11: ...efer to Troubleshooting on page 18 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office Plug the pump into an electrical outlet Make sure system has been arranged so that the power cable and garment hoses do not pose a trip or strangulation hazard Standby Mode The pump will first go through a self test routine and then remain in until required for use R...

Page 12: ...s and ensure the connectors click into place Check that the connection and garment type are confirmed correctly on the display Typical garment options and therapy parameters TO START press and hold the green RUN button on the pump The green power indicators will illuminate and therapy will begin Garment Type LCD Display Inflation Pressure mmHg Inflation Hold seconds Cycle seconds Foot garments e g...

Page 13: ...that there are no kinks in the pump hoses and garment tubing Check that the pump hoses and connectors do not cause the patient any discomfort Regularly check that the garments remain correctly fitted to the patient To Use One Garment When the pump is in standby see Standby Mode on page 5 connect one garment to either pump hose connector The display will confirm that only one garment is connected I...

Page 14: ...rescribed by the patient s physician Connect the garments to either tubing outlet and the correct therapy cycle will be administered Check on the display panel to confirm the garment types connected The system is not designed to be used with different garment types e g foot and calf thigh on the same limb ...

Page 15: ...mended therapy for each garment type and does not require any setting by the clinician or nurse If the physician requires different therapy settings limited changes can be made through a service link Contact your local ArjoHuntleigh Sales Representative for details ...

Page 16: ...s to highlight Audio Alarm Volume 3 Press the button to display the volume setting controls 4 Use buttons to select either high or low volume setting 5 Press the button to confirm 6 The selected volume setting will remain in place during subsequent uses of the pump Patient Hours Meter 1 Press the function button adjacent to 2 Use the arrow buttons to highlight Patient Hours Meter 3 Press the butto...

Page 17: ...o confirm 4 Use the arrow buttons to scroll through the available languages 5 Press the button to confirm 6 Press the button again to confirm 7 Use the arrow buttons to highlight Exit Note the word Exit will be displayed in language selected 8 Press the button to confirm ...

Page 18: ... pack Connecting the Battery Pack From the front of the pump engage the pack on the runners and slide into place until a click is heard To remove the pack depress the latch at the rear of the unit and slide pack forward and out Battery Pack in Use The battery pack will automatically take over powering the pump whenever the mains power cord is removed from the wall outlet Reset Status Latch Battery...

Page 19: ...f the charge remaining the battery symbol will flash and the remaining charge will be displayed as a percentage Recharge the battery as soon as possible Then when the battery has 1 charge the audible alarm will sound and the pump will stop running Recharge the battery Battery Storage and Disposal If the device is not to be used for an extended period charge refer to Recharging the Battery Pack on ...

Page 20: ...ck OK Battery Pack needs recycling Battery Pack Fault 30 80 Charge 30 Charge Press Reset Status Latch Jack Socket Polarity LED 1 LED 2 Battery Status Green Green The Battery Pack is OK It has 80 charge Green Green The Battery Pack is OK It has between 30 80 charge Green The Battery Pack is OK It has 30 charge Red Green The Battery Pack needs recycling It has between 30 80 charge Red The Battery Pa...

Page 21: ...attery is charging Alternative Method of Charging Alternatively the battery pack can be recharged away from the pump by plugging it into the battery charger as shown below Avoid charging the battery near source of heat or in direct sunlight Red Green The Battery Pack needs recycling The Battery is charging Red The Battery has a fault The Battery has a fault Caution Only ArjoHuntleigh approved batt...

Page 22: ... 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 If an alternative disinfectant is selected from the wide variety available we recommend that suitability...

Page 23: ...owtron Universal pump is serviced every 12 months by an ArjoHuntleigh authorised service agent Flowtron Universal Pump General Care Maintenance and Inspection Check all electrical connections and power cable for signs of excessive wear 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 ret...

Page 24: ...f Recommended Checks To confirm that the fault has corrected watch the display for approximately one minute If the fault has not been corrected a fault message will flash during that time In addition the pump will refuse to start if it does not recognize the attached garment If the trouble shooting procedures do not return the system to normal performance stop using the system immediately and call...

Page 25: ...cm 28 DVT30S DVT30S Standard Thigh Garment Sterile Up to 71cm 28 L503 M L503 M Standard Thigh Garment Up to 71cm 28 DVT40 DVT40 Large Thigh Garment Up to 89cm 35 FOOT GARMENTS Order Code Type Shoe Size FG100 Foot Garment Regular UK Men Women up to size 7 US Women up to size 9 US Men up to size 7 EURO up to size 40 FG100S Foot Garment Regular Sterile UK Men Women up to size 7 US Women up to size 9 ...

Page 26: ...PX0 No protection Mode of operation Continuous PUMP SYMBOLS The operator must read this document Instructions for Use before use Note This symbol is blue on the product label Run Standby Note Unit is not isolated from mains supply Do not dispose of in domestic refuse With respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 No 60601 1 2008 MEDICAL EQUIPMENT D...

Page 27: ... dispose of in domestic refuse Recycle 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 CISPR 11 Group 1 The pump uses RF energy only for...

Page 28: ... 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 an...

Page 29: ...tance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz 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 transmi...

Page 30: ...24 ...

Page 31: ... Houghton Regis UK DUNSTABLE LU5 5XF Tel 44 0 1582 745 800 Fax 44 0 1582 745 866 E mail international ArjoHuntleigh com ITALIA ArjoHuntleigh S p A Via di Tor Vergata 432 00133 ROMA ITALIA Tel 39 0 6 87426211 Fax 39 0 6 87426222 E mail Italy promo arjohuntleigh com NEDERLAND ArjoHuntleigh Nederland BV Biezenwei 21 4004 MB TIEL Postbus 6116 4000 HC TIEL Tel 31 0 344 64 08 00 Fax 31 0 344 64 08 85 E ...

Page 32: ...eigh 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 Verkstadsvägen 5 241 38 Eslöv SWEDEN 507933EN_...

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