Flowtron ACS800 Instructions for Use Manual
Contents
1. to the left of Show Patient Hours indicates that the total therapy time is shown in the bottom right of the LCD screen during therapy To change this setting use the up and down buttons to make sure the Show Patient Hours option is selected and then press the tick button to toggle the option on or off The text Hours Run 00001 indicates the current value of the Patient Hours Meter To clear the elapsed time showing in the Patient Hours Meter for example when therapy is started on a new patient use the up and down buttons to select the Clear Patient Hours option Press the tick button TWICE to clear the Hours Run to 00000 The Patient Hours Meter on the LCD screen will show Oh during therapy 1f selected You must press the tick button twice e To exit and return to the Standby screen select and confirm Exit To change another option select and confirm Back and the Options menu is displayed 18 3 To select a new Language e On the Options menu select and confirm Language and the Language screen is displayed Language ES Espanol FR Francais DE Deutsch IT Italiano V V A e The tick on the left side of the screen shows that the language is currently set to English e Use the up and down buttons to select the new language e g FR2. e Gangrene Recent skin graft e Dermatitis e On untreated infected leg wounds IS Ifyouareunsure of any contraindications refer to the patient s physician before using the device Cautions 1 Proper garment application and connection to the pump is essential Garments should be positioned in such a way that there is no potential for sustained pressure points on the skin and underlying tissues Lower limb positioning in relation to the garment and tubing should also be considered particularly in a patient that is unconscious cannot feel or has reduced sensation and or ability to move their leg s While using the system the patient s skin should be inspected frequently and regularly paying particular attention to bony prominences such as the malleolus and heel It is recommended that these checks should be performed not less than every hour if the patient cannot feel or has reduced sensation and or ability to move their leg s in all other patients perform these checks not less than every 6 hours Clinical judgement is required to determine if the patient s skin condition requires additional protective measures or if the therapy should be discontinued and an alternative modality used Garments should be removed immediately if the patient experiences tingling numbness or pain and the physician notified When used for DVT prevention continuous external pneumatic compression is recommended until the patient
3. 10 After a few seconds the following screen is displayed showing Battery OK B Battery OK SS ARJOHUNTLEIGH GETINGE GROUP Running Diagnostics IS If the text at the top of the screen says Low Battery then you must connect mains power before you can start therapy e At the end of the diagnostic test the following screen is displayed showing the Hours Run at the top the software version of the pump at the bottom and ACS800 Tri Pulse below Flowtron Hours Run 145 Flowtron ACS800 Tri Pulse Version XX XXXX XXX I The Hours Run value displayed on this screen is for service use only and is different to the Patient Hours Meter displayed during therapy Refer to Controls Alarms and Indicators on page 6 for the Patient Hours Meter Standby Screens The No Garments Standby screen is then displayed Mains power Battery connected icon Indication Options There are two leg icons with no garments attached and the text Attach garments at the top of the screen this indicates that no garments are currently connected to either tubeset I There is no text above the Start Stop button until at least one garment is connected to a tubeset Apply the prescribed ArjoHuntleigh garment s to the patient by following the instructions included in the garment packaging 11 I Garments are for single patient use only Do n
4. 45 mmHg 3 Mains power indications The pump is connected to the mains power supply The pump is not connected to the mains power supply but is powered by the internal battery only 4 Battery indication e When the pump is connected to the mains power supply then ee If the battery is fully charged the indicator will be static and show full ee Ifthe battery is not fully charged the indicator will scroll from empty to full to indicate that the pump is being charged e When the pump is NOT connected to the mains power supply then the indicator is static and shows the charge remaining in the battery Battery Empty Battery 1 3 Full Battery 2 3 Full Battery Full I The battery has a service life of 5 years 600 charge cycles It is not user replaceable and must be replaced as part of the service procedure 5 Patient Hours Meter if this is selected the total therapy time is shown in hours Refer to Changing Options on page 16 to select and or clear the Patient Hours Meter e This is the pump run time since the Patient Hours Meter was last cleared e The factory default is to NOT show the Patient Hours Meter on the LCD screen 6 Warning and alarm indications refer to Troubleshooting on page 23 LED Indicators on the There are two sets of LED indicators on the front case of Front Case the pump Their status is as follows LED Colours Pump Status Warnings Alarm
5. Degree of protection against electric shock Class II Double Insulated with Functional Earth Type BF Degree of protection against liquid ingress IPXO No protection Mode of operation SYMBOLS The operator must read this document Instructions for Use before use Note This symbol is blue on the product label Continuous Run Standby Note Pump is not isolated from mains power supply Do not dispose of in the domestic refuse Refer to this document Instructions for Use for a description of the product classification 3rd Edition Manufacturer This symbol is accompanied by the name and the address of the manufacturer With respect to electric shock fire and mechanical hazards only in accordance with CAN CSA C22 2 No 60601 1 2008 MEDICAL EQUIPMENT Y C US 25EA CAN CSA C22 2 No 60601 1 2008 ENVIRONMENTAL INFORMATION Condition Operating Temperature Range 10 C to 40 C 50 F to 104 F Refer to this document Instructions for Use for a description of the product classification 2nd Edition Double Insulated Relative Humidity 30 to 75 non condensing Atmospheric Pressure 700 hPa to 1060 hPa Storage and Transport Long Term 10 C to 40 C 50 F to 104 F 20 to 95 non condensing 700 hPa to 1060 hPa Storage and Transport Short Term I normal operating conditions before
6. Fran ais IES The list of languages depends on the territory but is typically EN English ES Espanol FR Francais DE Deutch IT Italiano NL Nederlands PT Portugu s SV Svenska NO Norsk DA Dansk Language Y EN English ES Espanol FR Francais DE Deutsc IT Italiano V V A e Press the tick button to confirm that French has been selected e A second confirmation screen is displayed with Just the new language French displayed Language FR Frangais Back Exit V V A 19 e Press the tick button to confirm the change of language to French e The screen now displays the Options menu in the new language French Options Volume alarme audio Compteur patient Langue Sortie VCO A To exit and return to the Standby screen select and confirm Sortie Settings Adjustment The pump is configured to give the recommended therapy for each garment type and does not require any direct setting by the clinician or nurse If the physician requires different therapy settings for uniform DVT calf and calf amp thigh garments then limited changes can be made to the pump pressure by accessing a Service screen on the pump Contact your local ArjoHuntleigh sales office for details IS The pump pressures for Foot garments and Tri Pulse calf and calf amp thigh garments are fixed and cannot be changed I The pressure range and fact
7. removed while the pump is in the Run state it shows that garment 1 has been removed Screen B now alternates with screen C Garment unplugged Connect garment Reconnect or replace the garment The warning or alarm will be cleared if the garment is reconnected or replaced 24 Description and Corrective Action Battery Low These Battery Low warning and alarm will only be activated when the pump is operating from just the battery the mains power is disconnected When any of these Battery Low warning or alarm screens are activated connect the pump to the mains power supply to recharge the battery and continue therapy If the pump is in Standby The warning will be activated when the remaining charge in the battery is less than 15 Screen A alternates with screen B Therapy can not be started There is an audible tone when the Start button is pressed Pressing Mute will silence the audible tone Connect the mains power supply to the pump to clear the warning and start therapy If the pump is in the Run state The warning will be activated when the remaining charge in the battery is less than 15 There is an audible tone and screen C alternates with screen D Therapy can continue Pressing Mute will silence the audible tone Connect the mains power supply to the pump to clear the warning and continue therapy e When the remaining charge is less than 10 the full alarm is activated Screen E altern
8. up and down arrows To confirm the new menu item press the button below the tick e To exit and return to the Standby screen select and confirm Exit on the menu 1 To change the Audio Alarm Volume setting On the Options menu select and confirm Audio Alarm Volume and the Audio Alarm Volume screen is displayed Audio Alarm Volume Y Set Volume High Set Volume Low Back Exit V V A The tick on the left side of the screen shows that the alarm is currently set to High Volume Use the up and down buttons to select the new volume setting Press the tick button to confirm the new volume The tick now shows the new setting To exit and return to the Standby screen select and confirm Exit To change another option select and confirm Back and the Options menu is displayed 2 The Patient Hours Meter settings When selected the Patient Hours Meter shows the total therapy time at the bottom right of the LCD screen during therapy I This is the elapsed time since the Patient Hours Meter was last cleared using these commands 17 To change the settings e On the Options menu select and confirm Patient Hours Meter and the Patient Hours Meter screen is displayed Patient Hours Meter J Show Patient Hours Clear Patient Hours Back Exit Hours Run 00001 V CoO A e A tick
9. 0 344 64 08 85 E mail info nl arjohuntleigh com NEW ZEALAND ArjoHuntleigh Ltd 41 Vestey Drive Mount Wellington NZ AUCKLAND 1060 Tel 64 0 9 573 5344 Free Call 0800 000 151 Fax 64 0 9 573 5384 E mail nz info ArjoHuntleigh com NORGE ArjoHuntleigh Norway AS Olaf Helsets vei 5 N 0694 OSLO Tel 47 22 08 00 50 Faks 47 22 08 00 51 E mail no kundeservice arjohuntleigh com www arjohuntleigh com OSTERREICH ArjoHuntleigh GmbH Dorrstrasse 85 AT 6020 INNSBRUCK Tel 43 0 512 204 160 0 Fax 43 0 512 204 160 75 POLSKA ArjoHuntleigh Polska Sp z 0 0 ul Ks Piotra Wawrzyniaka 2 PL 62 052 KOMORNIKI Poznan Tel 48 61 662 15 50 Fax 48 61 662 15 90 E mail arjo arjohuntleigh com PORTUGAL ArjoHuntleigh em Portugal MAQUET Portugal Lda Distribudor Exclusivo Rua Poeta Bocage n 2 2G PT 1600 233 Lisboa Tel 351 214 189 815 Fax 351 214 177 413 E mail Portugal arjohuntleigh com SUISSE SCHWEIZ ArjoHuntleigh AG Fabrikstrasse 8 Postfach CH 4614 HAGENDORF T l Tel 41 0 61 337 97 77 Fax 41 0 61 311 97 42 SUOMI Oy Vestek AB Martinkuja 4 FI 02270 ESPOO Puh 358 9 8870 120 E mail info vestek fi SVERIGE ARJO Scandinavia AB Hans Michelsensgatan 10 SE 211 20 MALMO Tel 46 0 10 494 7760 Fax 46 0 10 494 7761 E mail kundservice arjohuntleigh com UNITED KINGDOM ArjoHuntleigh UK ArjoHuntleigh House Houghton Hall Park Houghton Regis UK DUNST
10. 49 13 84 87 E mail dk_kundeservice arjohuntleigh com DEUTSCHLAND ArjoHuntleigh GmbH Peter Sander Strasse 10 DE 55252 MAINZ KASTEL Tel 49 0 6134 186 0 Fax 49 0 6134 186 160 E mail info de arjohuntleigh com EAAAAA C Psimitis Co Ltd Dimitriou Andr 59 GR 16121 KAISARIANI ATTIKIS TnA 21 0724 36 68 g 21 0721 55 53 Rev 13 03 2014 ESPA A ArjoHuntleigh Ib rica S L Ctra de Rub 88 1 planta A1 08173 Sant Cugat del Vall s ES BARCELONA 08173 Tel 34 93 583 11 20 Fax 34 93 583 11 22 E mail info es arjohuntleigh com FRANCE ArjoHuntleigh SAS 2 Avenue Alcide de Gasperi CS 70133 FR 59436 RONCQ CEDEX T l 33 0 3 20 28 13 13 Fax 33 0 3 20 28 13 14 E mail info france arjohuntleigh com HONG KONG ArjoHuntleigh Hong Kong Ltd 1510 17 15 F Tower 2 Kowloon Commerce Centre 51 Kwai Cheong Road Kwai Chung HONG KONG Tel 852 2207 6363 Fax 852 2207 6368 INTERNATIONAL ArjoHuntleigh International Ltd ArjoHuntleigh House Houghton Hall Park 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 IT 00133 ROMA 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
11. ABLE LU5 5XF Tel 44 0 1582 745 700 Fax 44 0 1582 745 745 E mail sales admin arjohuntleigh com USA ArjoHuntleigh Inc 2349 W Lake Street Suite 250 US Addison IL 60101 Tel 1 630 307 2756 Free 1 800 323 1245 Institutional Free 1 800 868 0441 Home Care Fax 1 630 307 6195 E mail us info arjohuntleigh com ARJOHUNTLEIGH GETINGE GROUP www arjohuntleigh com ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malm SWEDEN 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 513943EN_01 04 2014
12. ARJOHUNTLEIGH GETINGE GROUP FLOWTRON ACS800 TRI PULSE INSTRUCTIONS FOR USE C 0086 with people in mind Contents General Safety 12 svik AL aaa ON ili Introduction gt A e a E 1 About this Manual 1 intended USE vals ba a ya te l a ae al 1 About Flowtron ACS800 Tri Pulse o aaa k k k r k a a 1 Pump Front View uisssss nsa Risks med aaa aaa aaa aaa aa 2 Pump Rear VIS WE S ronie as er a aaa bacano 2 Clinical Applications ici e A EA AA AAA eee eed 3 INGIGATIONS 5 2 A A AS ee Ak 3 ContraindicationS 000 ee eee 3 GALAS Tis a ee ate eae oa 4 Guidelines and Recommendations sss nsa sala a 5 Controls Alarms and Indicators 0 00 cece eee eee eee 6 Control Panel With Typical LCD Screen View in Run Mode 6 LED Indicators on the Front Case sss suas k k 9 Operation oir AAA 10 GONG 6 ts 3 ccscee ce et ae eh ie eid diate ed Boe Bi Cafe hcg eae E A TENG 10 Start UP gee Soe sl sa Sack Stare Me eas Rett r 10 Standby SClEGNS inundada adas rasa 11 Starting Therapy isaer ASS A II AA Ei wana 13 Stopping Therapy cn eta da o a 15 SWitching Off the PUMD tide dues resins ropa ewes beet 16 PAVERS 2 a ha acne Sie Seeds cae nds tae a Bad a a RE 16 Changing OplOns 22 lt 2 2202 B ki ES dl E a dde 16 Settings AGIUSHMENE se ipyre Hedges Ga Gadd peta ele a 20 Decontamination oi A NA nana 21 Routine Maintenance 2 00
13. CS800 Tri Pulse This manual is your introduction to the Flowtron ACS800 Tri Pulse system which is a Flowtron ACS800 pump enabled for use with both Tri Pulse and uniform DVT garments Refer to Accessories on page 29 for a list of the garments which can be used 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 areference for day to day routines and as a guide to maintenance If you have any difficulties in setting up or using the system contact your local ArjoHuntleigh sales office listed at the end of this manual The intended use of this product is to prevent Deep Vein Thrombosis DVT The garments are single patient use only It is not for use in the home healthcare environment The Flowtron ACS800 Tri Pulse system should be used as part of a prescribed plan of care refer to Indications on page 3 The application of external pneumatic compression has two effects e Augments venous blood flow velocity thereby reducing stasis e Enhances fibrinolytic activity to reduce the risk of early clot formation The system comprises a pump that can be used in conjunction with an extensive range of ArjoHuntleigh inflatable garments including foot calf and calf amp thigh versions The pump automatically adjusts to the correct therapy profile depending upon which garment type foot uniform DVT calf or calf amp thigh or
14. Tri Pulse calf or calf amp thigh is connected The tubeset is integral to the system and cannot be disconnected from the pump The mains power supply is the primary power source for the pump The pump incorporates an internal battery pack which is a secondary power source to back up the pump in the event of failure or disconnection accidentally or deliberately from the mains power supply The system is intended for use ONLY in Professional Healthcare Facilities e g hospitals or physicians offices A full technical description of the Flowtron ACS800 Tri Pulse system can be found in the Service Manual part number SER0020 available from your local ArjoHuntleigh sales office Pump Front View LCD Screen and Controls Integral Carry Handle Integral Tubesets LED Indicator Tubeset 1 Blue Button Tubeset 2 Garment Orange Button Connectors Pump Rear View Swing out Tubeset 1 Bed Hooks Integral Tubesets Mains Power Cord Tubeset 2 2 Clinical Applications Indications Contraindications Uniform DVT Calf Calf amp Thigh and Tri Pulse Calf Calf amp Thigh Garments Foot Garments The intended use of the Flowtron ACS800 Tri Pulse system is to help prevent Deep Vein Thrombosis DVT The system should be combined with an individualised monitoring programme These systems represent one aspect of a DVT strategy if the patient s condition changes the
15. a ee btt 22 Flowtron ACS800 Tri Pulse System 2 0 eee 22 PMD AR hs Sh cea NA 22 SShlal FADSIS gt e ee cnet sate a anti Seta ober male ict ida aes 22 Troubleshooting isa ee gos Ose Ee che E 23 NA ea Se oe ed ie oe ee eee A a ce 29 Technical Specification IS ys okie He Pee A AAA 30 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 e EN60601 1 1990 A13 1996 and IEC 60601 1 1988 A2 1995 e UL60601 1 and CAN CSA C22 2 No 601 1 M90 e EN60601 1 2006 and IEC 60601 1 2005 e 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 e 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 e 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 e 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 e Disconnec
16. ates with screen F Therapy is suspended and the alarm tone can not be muted Connect the mains power supply to the pump to clear the alarm and restart therapy 25 Description and Corrective Action Hardware Fail This alarm is activated if the pump detects an internal fault The spanner symbol is permanently displayed Therapy is suspended Switch off the pump Call the service engineer Faulty Tubeset The Faulty Tubeset warning and alarm are activated if the pump detects a fault in the tubeset Faulty Tubeset For both conditions e Switch off the pump e Call the service engineer If the pump is in Standby when the faulty tubeset is detected e A warning is activated Screen A alternates with screen B and shows a faulty tubeset 1 Therapy can not be started If the pump is in the Run state when the faulty tubeset is detected An alarm is activated Screen C alternates with screen D and shows a faulty tubeset 1 Therapy can continue When the operator next stops the pump and puts it into Standby the alarm reverts back to the warning in which screen A alternates with screen B and shows a faulty tubeset 1 Therapy can not be restarted 26 Description and Corrective Action Setup Required The Setup Required warning and alarm are activated if the pump detects a fault in the tubeset For both conditions e Switch off the pump e Call the service engineer If the pump is
17. azard The adjacent LED indicator shows the pump status LED Colour Mains Power Pump Status Extinguished Disconnected Off Amber Connected Off Amber Connected or disconnected Standby Green Connected or disconnected Run To switch off the pump press and hold the On Off button for approximately 2 seconds until the LCD screen goes blank and then release If you switch off the pump and then press the On Off button to power it back up e Ifthe mains power is disconnected the pump runs the diagnostic tests and then goes into Standby Ifthe mains power remains connected the pump goes into Standby and does not run diagnostic tests Start Stop Button This has the following functions depending on the text or icon displayed above the button To start or stop therapy e To confirm the option selected in the Options menu When the pump is in Standby press the Start Stop button to put the pump into the Run mode and start therapy the LED indicator adjacent to the On Off button will change to green and the LEDs on the front case will be illuminated green To stop the therapy and put the pump into Standby press and hold the Start Stop button for approximately 2 seconds until the Standby screen is displayed and then release the button The LED indicator adjacent to the On Off button changes to amber and the LEDs on the front case are extinguished Up and Down These have the following functions depending on the S
18. e Portable and mobile radio frequency RF communications equipment e g mobile cell phones can affect medical electrical equipment iii e If this equipment needs to be used adjacent to other electrical equipment normal operation must be checked before use e For detailed EMC information contact ArjoHuntleigh service personnel Expected Service Life The pump 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 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 2014 iv 1 Introduction About this Manual Intended Use About Flowtron A
19. elect Buttons text or icon displayed above the buttons To select the Options menu To move up and down the Options menu To mute certain audible alarm conditions LCD Screen This displays the pump operating mode and status 1 Foot uniform DVT calf or calf amp thigh or Tri Pulse calf or calf amp thigh therapy indications These show what garment type is connected to each tubeset and when each garment is being inflated Uniform Tri Pulse Foot DVT Calf or Tri Pulse Calf or Calf Garment Calf amp Thigh amp Thigh Garment Garment e All therapy indications are initially shown as grey to indicate they are deflated e A therapy indication changes to black to show it is inflating e The therapy indication reverts to grey when it starts to deflate The garment connector on the end of each tubeset has a push button which is colour coded and has a number marked on it blue 1 or orange 2 The numbers corresponds with the 1 and 2 on the right side of the LCD screen Where the tubesets enter the side of the pump the top tubeset is marked 1 2 Pressure indication this is the inflation pressure applied to the garment as follows e Foot garment 130 mmHg e Uniform DVT calf and calf amp thigh The pressure is adjustable between 35 65 mmHg To be adjusted only by authorised personnel The pump will default to the last pressure set e Tri Pulse calf and calf amp thigh garments
20. ent Up to 89cm 35 FOOT GARMENTS Order Type Shoe Size Therapy Code Foot Garment Regular UK Men Women up to size 7 Uniform US Women up to size 9 US Men up to size 7 EURO up to size 40 FG100S Foot Garment Regular UK Men Women up to size 7 Uniform Sterile US Women up to size 9 US Men up to size 7 EURO up to size 40 Foot Garment Large UK Men Women size 7 or above Uniform US Women size 91 2 or above US Men size 7Y2 or above EURO size 41 or above FG200S Foot Garment Large UK Men Women size 712 or above Uniform Sterile US Women size 91 or above US Men size 7Y2 or above EURO size 41 or above Sequential Sequential 29 9 Technical Specification Model Flowtron ACS800 Tri Pulse Part Numbers 513101 UK 513103 US 513109AU Australia 5131010R UK Operating Room with longer tubeset 5131030R US Operating Room with longer tubeset Pressure Range Foot Garment 130 10 mmHg Uniform DVT Calf and Calf amp Thigh Garments Range 35 65 5 mmHg Factory Default 40 5 mmHg Tri Pulse Calf and Calf 8 Thigh Garments 45 5 mmHg Supply Voltage 100 230 V Supply Frequency 50 60 Hz Power Input 10 60 VA Size 335 x 210 x 130 mm 13 2 x 8 3 x 5 1 in Weight 3 9 kg 8 6 Ib Case Material Flame Retardant ABS Plastic Mains Power Plug Fuse Rating 5A to BS1362 UK ONLY
21. in Standby when the faulty tubeset is detected e A warning is activated Screen A alternates with screen B and shows a faulty tubeset 1 Therapy can not be started Setup required Setup required If the pump is in the Run state when the faulty tubeset is detected An alarm is activated Screen C alternates with screen D and shows a faulty tubeset 1 Therapy can continue When the operator next stops the pump and puts it into Standby the alarm reverts back to the warning in which screen A alternates with screen B and shows a Faulty faulty tubeset 1 Therapy can not be restarted Setup required Service Required The spanner icon appears at the lower left side of the screen to indicate that the pump requires service attention This will normally occur after the preset service interval has expired Therapy can continue until service is available Call the service engineer Service Spanner icon 27 Condition Description and Corrective Action This alarm is activated when the temperature inside the pump exceeds 55 C Pump too hot is displayed at the top of the standard Run screen screen A and an audible alarm sounds Therapy can continue Make sure the pump is connected to mains power if this alarm is activated and check that the ventilation holes on the pump rear case are not covered or blocked Pump Too Hot When the temperature inside the pump R kol exceeds 60 C the f
22. ing 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 Rated maximum output power of transmitter W Separation distance 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 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 31 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 IEC 60601 Test Compliance Electromagnetic environ
23. is fully ambulatory Uninterrupted use of the system is encouraged The system should be USED WITH CAUTION on patients with e Insensitive extremities e Diabetes e Impaired circulation e Fragile or impaired skin I These are guidelines only and should not replace clinical judgement and experience Guidelines and Recommendations General Recommendations DVT Prophylaxis While using the system the patient s limbs should be checked not less than every six hours and more often if the patient has known circulatory or skin problems or is diabetic Note Many patients are at risk for pressure ulcers on the heel Use of the foot garments does not negate the necessity for heel protection and proper skin care Clinical judgment should be used to determine if the patient s skin condition requires additional measures or if the treatment should be discontinued and alternative modalities used ArjoHuntleigh does not recommend the use of compression stockings with its system If these are ordered by the physician the clinician should ensure that the compression stockings are properly measured applied and worn by the patient Any compression stocking used should be routinely 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 rep
24. is shown in the bottom right of the screen Patient Hours Meter Foot garment 1 is inflated to 130 mmHg with a ramp up and hold time of 3 seconds The foot garment indicator is black while it is inflated The foot garment is deflated to zero Both garment indicators are grey Foot garment 2 is then inflated to 130 mmHg with a ramp up and hold time of 3 seconds The foot garment indicator is black while it is inflated 14 Stopping Therapy 5 The foot garment is deflated to zero Both garment indicators are grey 6 This cycle of alternate garment inflations repeats from step 2 above until the therapy is stopped If calf or calf amp thigh garments are attached to the pump then each of these garments is inflated to 40 mmHg uniform DVT or 45 mmHg Tri Pulse with a ramp up and hold time of 12 seconds If a foot garment uniform DVT calf or calf amp thigh or Tri Pulse calf or calf amp thigh garment are attached to the pump then since the inflate and hold times for a foot garment are shorter than for a calf or calf amp thigh garment there is a modified inflation sequence the foot garment is always inflated twice in succession and then the uniform DVT calf or calf amp thigh or Tri Pulse calf or calf amp thigh garment is inflated as follows I The first garment to be inflated is always garment 1 1 Inflate the foot garment to 130 mmHg 2 Deflate the foot garmen
25. mal performance stop using the system immediately and call the service engineer Condition Description and Corrective Action Low Pressure Garment leak The warning is activated after 4 inflation cycles and shows a leak in garment 1 or its tube Screen A alternates with the standard Run screen The warning changes to an alarm after 10 inflation cycles and shows a leak in garment 1 or its tube Screen A alternates with screen B Examine the garment and tubeset for leaks The warning or alarm will be cleared if the leak is repaired 23 Condition Description and Corrective Action Blocked Garment Kinked Tube Kinked tube The warning is activated after 3 inflation cycles and shows a blocked garment 1 or kinked tube Screens A and B alternate with the standard Run screen Blocked garment The warning changes to an alarm after 10 Check garment inflation cycles and shows a blocked garment 1 or kinked tube Screen C alternates with screens A and B Examine the garment and tubeset for kinks or blockages The warning or alarm will be cleared if the kink or blockage is repaired This warning is activated after 1 inflation cycle if the pump detects that a garment has been removed while the pump is in the Run state it shows that garment 1 has been removed Screen A alternates with screen B The warning changes to an alarm after 10 inflation cycles if the pump continues to detect that a garment has been
26. ment guidance Test 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 d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz Radiated RF 3 V m d 2 3VP 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 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol CY 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 2 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 enviro
27. nment 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 gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 32 AUSTRALIA ArjoHuntleigh Pty Ltd 78 Forsyth Street O Connor AU 6163 Western Australia Tel 61 89337 4111 Free 1 800 072 040 Fax 61 89337 9077 BELGIQUE BELGI ArjoHuntleigh NV SA Evenbroekveld 16 BE 9420 ERPE MERE T l Tel 32 0 53 60 73 80 Fax 32 0 53 60 73 81 E mail info arjohuntleigh be BRASIL Maquet do Brasil Equipamentos M dicos Ltda Rua Tenente Alberto Spicciati 200 Barra Funda 01140 130 S O PAULO SP BRASIL Fone 55 11 2608 7400 Fax 55 11 2608 7410 CANADA ArjoHuntleigh 90 Matheson Boulevard West Suite 300 CA MISSISSAUGA ON L5R 3R3 Tel T l 1 905 238 7880 Free 1 800 665 4831 Institutional Free 1 800 868 0441 Home Care Fax 1 905 238 7881 E mail info canada arjohuntleigh com CESK REPUBLIKA ArjoHuntleigh s r o Hlinky 118 CZ 603 00 BRNO Tel 420 549 254 252 Fax 420 541 213 550 DANMARK ArjoHuntleigh A S Vassingeradvej 52 DK 3540 LYNGE Tel 45 49 13 84 86 Fax 45
28. o an authorised service centre The serial number for the pump is on the label on the back of the pump case Quote this serial number when requesting service 22 7 Troubleshooting On detection of a fault condition the pump provides a visual only warning followed by an audible and visual alarm if the fault is not cleared Warning Conditions The visual only warning is a fault message on the LCD screen The LED indications remain unchanged and there is no audible alarm except Battery Low warning The warning can be cleared by either e Checking and rectifying the fault on the system or e Pressing the button below Stop to put the pump into Standby Alarm Conditions If the fault is not cleared then the warning is replaced by an audible and visual alarm which consists of e A fault message on the LCD screen e The LED indicators on the front of the pump change to red and start flashing e An audible alarm will sound which increases in pitch if the alarm is ignored The alarm can be cleared by either e Checking and rectifying the fault on the system or e Pressing the button below Stop to put the pump into Standby IS For simplicity the following screens except Battery Low Hardware Fail and Pump Too Hot show a fault detected on garment 1 similar fault messages are displayed if the fault is detected on garment 2 or both garments IS If the trouble shooting procedures do not return the system to nor
29. orted to the nursing staff The system should be applied to the patient pre operatively prior to the induction of anaesthesia The system should be used continuously for no less than 72 hours post operatively or until the patient becomes fully ambulatory If the garment cannot be applied to the operative limb during surgery it may be applied to the limb once the patient reaches the recovery unit In the non surgical patient the system should be initiated immediately the risk of DVT formation is identified 3 Controls Alarms and Indicators Control Panel With Typical LCD Screen View in Run Mode Garment Type and Therapy Indicator the possible garment types are detailed in LCD Screen section below Mains Power Indicator Battery Indicator LED Indicator Pressure vicer coord ee pe On Off Button ad y O PA 2h Patient Hours Meter LCD screen a Start Stop Therapy Down Select Button Start Stop Button Up Select Button On Off Button Press the On Off button to power up the pump from its and LED Indicator unpowered state and put it into Standby refer to Standby Screens on page 11 IS Connecting the pump to the mains power supply will automatically power up the pump from its unpowered state and put it into Standby without having to press the On Off button Make sure the system has been arranged so that the power cable and garment hoses do not pose a trip or strangulation h
30. ory default pressure for the uniform DVT calf and calf amp thigh garments are detailed in the Technical Specification on page 30 20 5 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 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 cable 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
31. ot use the garments on a different patient after treatment Connect the garment s to the pump by pushing the garment connector firmly into the pump tubeset connector until it clicks The pump LCD screen will show which garments are connected to each tubeset connector the garment connector with the blue push button is 1 and the one with the orange push button is 2 If any pump options Audio Alarm Volume Patient Hours Meter or Language need to be changed they must be changed before the patient therapy is started Refer to Changing Options on page 16 The following six screens show typical Standby screens with different garment configurations Options Foot Garment Uniform DVT Calf or Calf amp Thigh Connected to Tubeset 1 Garment Connected to Tubeset 1 Sa Two Uniform DVT Calf or Calf amp Foot and Uniform DVT Calf or Thigh Garments Connected Calf amp Thigh Garments Connected iC Pulse Tri Pulse Calf or Calf amp Thigh Foot and Tri Pulse Calf or Calf amp Thigh Garment Connected to Tubeset 1 Garments Connected 12 Starting Therapy Make sure the garment s are fitted correctly to the patient and the pump Make sure any pump options have been changed if necessary I If the pump is to be positioned under a bed make sure it is placed horizontally with the bed hooks underneath to prevent damage to the pump While the pump is in Standby the LEDs on the fron
32. overall therapy regimen should be reviewed by the prescribing clinician The above are guidelines only and should not replace clinical judgement Depending on the garment type used other clinical applications are also appropriate The FG foot garment in particular has a wide range of clinical applications Full details for clinical applications are included in the packaging of every garment The type of garment used on an individual patient must be specified by a physician The system when used with the uniform DVT calf calf amp thigh and Tri Pulse calf calf amp thigh garments should not be used in the following conditions 1 Severe arteriosclerosis or other ischemic vascular diseases 2 Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental 3 Known or suspected acute deep vein thrombosis thrombophlebitis or pulmonary embolism 4 Any local condition in which the garments would interfere including e Gangrene e Recent skin graft e Dermatitis e On untreated infected leg wounds The system when used with the foot garments should not be used in the following conditions 1 Severe congestive cardiac failure or any condition where an increase of fluid to the heart may be detrimental 2 Known or suspected acute deep vein thrombosis thrombophlebitis or pulmonary embolism 3 Any local condition in which the garments would interfere including
33. r and extinguished if the mains power is disconnected On detection of a fault condition the pump provides a visual only warning followed by an audible and visual alarm if the fault is not cleared 1 The visual only warning is a fault message on the LCD screen The LED indications remain unchanged and there is no audible alarm 2 Ifthe fault is not cleared then the warning is replaced by an audible and visual alarm which consists of e A fault message on the LCD screen The LED indicators on the front of the pump change to red and start flashing e An audible alarm will sound which increases in pitch and intensity if the alarm is ignored The warning and alarm can be cleared by either e Checking and rectifying the fault on the system or e Pressing the button below Stop to put the pump into Standby Refer to Section 7 Page 23 Troubleshooting for the alarms their possible causes and their remedies To change the pump operating options the pump must be in Standby If the pump is in Run mode press and hold the button below Stop for 2 seconds to put the pump into Standby 16 On the Standby screen press the button below Options and the Options menu is displayed Options Audio Alarm Volume Patient Hours Meter Language Exit V V A The border around an item indicates the currently selected item To select a new menu item press the buttons below the
34. s Extinguished Off or Standby e No fault detected SERI Bun e Warning only detected Fault detected with full audible and visual alarm Red Flashing Run 4 Operation General These instructions cover the day to day operation of the system Other operations such as maintenance and repair should only be carried out by suitably qualified personnel Refer to Controls Alarms and Indicators on page 6 for a description of the controls indicators and LCD screen I If the operation or performance of the pump changes during use refer to Troubleshooting on page 23 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office Start Up To switch on the pump do one of the following e Connect the pump to the mains power supply using the power cable provided The pump will power up automatically and start running a diagnostic test and display the following screen ARJOHUNTLEIGH Progress GETINGE GROUP Bar Running Diagnostics e If operating from just the battery disconnected from the mains power supply press the On Off button The pump will power up and start running the diagnostic test and display the following screen Note the Checking Battery text and the Mains power not connected icon at the top of the screen Checking Battery ARJOHUNTLEIGH GETINGE GROUP Mains power not connected icon Running Diagnostics
35. 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 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 Caution Garments are single patient use and hence cannot be cleaned or reused 21 6 Routine Maintenance Flowtron ACS800 Tri Pulse System Maintenance Servicing Service Period Pump General Care Maintenance and Inspection Serial Labels The equipment has been designed to be maintenance free between service periods ArjoHuntleigh will make available on request service manuals component parts lists and other information necessary for ArjoHuntleigh trained personnel to repair the system ArjoHuntleigh recommend that the pump is serviced every 12 months by an ArjoHuntleigh authorised service agent 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 returned t
36. t 3 Repeat the inflation of the foot garment to 130 mmHg Deflate the foot garment Inflate the uniform DVT calf or calf amp thigh garment to 40 mmHg or the Tri Pulse calf or calf amp thigh garment to 45 mmHg 6 Deflate the uniform DVT calf or calf amp thigh garment or Tri Pulse calf or calf amp thigh garment v 7 This cycle of garment inflations repeats from step 1 above until the therapy is stopped To stop the therapy and put the pump into Standby press and hold the Start Stop button for approximately 2 seconds until the Standby screen is displayed refer to Standby Screens on page 11 and then release it The LED indicator by the On Off button changes to amber and the LEDs on the front case are extinguished 15 Switching Off the Pump Alarms Changing Options If the pump stays in Standby then 1 After 5 minutes the LCD display backlight is dimmed 2 After a further 15 minutes 20 minutes total the pump automatically switches off I The LED indicator will remain amber if the pump is connected to the mains power and extinguished if the mains power is disconnected 1 Make sure the therapy is stopped and the pump is in Standby refer to Stopping Therapy on page 15 2 Press and hold the On Off button for approximately 2 seconds until the LCD screen goes blank and then release it IS The LED indicator will remain amber if the pump is connected to the mains powe
37. t case remain extinguished Press the button below Start to start the therapy The LEDs on the front case change to static green It is recommended that the following checks are carried out at the start of and throughout the therapy Check the LCD screen icons to confirm that the correct type of garment s have been connected During garment inflation check the LCD screen to confirm that there are no fault messages displayed and that the correct pressure is being supplied The supplied inflation pressures for the different garments are e Foot garment 130 mmHg Uniform DVT calf and calf amp thigh garments 40 mmHg Tri Pulse calf and calf amp thigh garments 45 mmHg ES Initial inflation cycles up to 10 may not show the correct inflation pressure This is to be expected Check that there are no kinks in the pump tubesets Check that the pump tubesets and connectors do not cause the patient any discomfort Regularly check that the garments remain correctly fitted to the patient The pump will inflate and deflate each garment in turn as follows starting with garment 1 IS The following example shows two foot garments 1 fitted to the pump Both garments are initially deflated The garment pressure is displayed on the left side of the screen If the Patient Hours Meter is selected in the Options menu refer to Changing Options on 13 page 16 the total elapsed time in hours
38. t 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 e Do not use the pump in the presence of uncontained flammable liquids or gasses e 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 e The Flowtron ACS800 Tri Pulse system is NOT intended for use in the Home Healthcare Environment e g private dwellings or nursing homes 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 e Do not expose the system to open flames such as cigarettes etc e Do not store the system in direct sunlight e Do not use phenol based solutions to clean the system e Make sure the system is clean and dry prior to use or storage 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 e The use of accessories not specified by the manufacturer may result in increased emissions by or decreased immunity of the equipment affecting its performance
39. ull alarm is activated pe ener Screen B is permanently displayed and an audible alarm sounds Therapy is suspended Switch off the pump and allow pump to cool D Then switch back on and continue therapy If either alarm continues switch off the pump and call the service engineer 28 8 Accessories The Flowtron ACS800 Tri Pulse pump should only be used with the following garments CALF GARMENTS Order Type Calf Therapy Code Circumference DVT10 DVT10 Standard Calf Garment Up to 43 cm 17 Uniform DVT10S DVT10S Standard Calf Garment Sterile Up to 43 cm 17 L501 M L501 M Standard Calf Garment Up to 43 cm 17 DVT20 DVT20 Large Calf Garment Up to 58 cm 23 Uniform DVT60 DVT60 Extra Large Calf Garment Up to 71 cm 28 Uniform DVT60L DVT60L Bariatric Calf Garment Up to 81 cm 32 Uniform TRP10 TRP10 Regular Calf Garment Up to 43 cm 17 Sequential TRP20 TRP20 Large Calf Garment Up to 58 cm 23 Sequential TRP6OL TRP6OL Bariatric Calf Garment Up to 81cm 32 Sequential Uniform Uniform CALF amp THIGH GARMENTS Type Thigh Therapy Circumference DVT30 DVT30 Standard Thigh Garment Up to 71cm 28 Uniform DVT30S DVT30S Standard Thigh Garment Sterile Up to 71cm 28 Uniform L503 M L503 M Standard Thigh Garment Up to 71cm 28 Uniform DVT40 DVT40 Large Thigh Garment Up to 89cm 35 Uniform TRP30 TRP30 Regular Thigh Garment Up to 71cm 28 TRP40 TRP40 Large Thigh Garm
40. use 20 C to 50 C 4 F to 122 F 20 to 95 500 hPa to 1060 hPa If the pump is stored in conditions outside of the Operating ranges it should be allowed time to stabilise at 30 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 its internal function therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies The pump is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 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 maintain
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