PneumaPress® Manual
Contents
1. initial use Caution is recommended when using manual pressure settings Leg over 50mmHG Foot over 140mmHg 3 4 CONTROLLER VIEWS 3 5 TECHNICAL DATA Specifications and Dimensions TEST DESCRIPTIONS STANDARD AC voltage 100 240V 50 60Hz Power consumption 25W 38VA Air power consumption Below 5W Noise level Above 2KV Operation noise level Below 60dB Max pressure level 140mmHg Pump weight 2kg Pump size 200 W x 165 D x 190 H mm 3 6 PRODUCTS LABEL 1 COPYRIGHT 2 LABEL Caution Medical Equipment Europe Certification Mark Manufacturer Mark Serial Number Date of Manufacture LOT Number Service Supplier Mark 7977 4 1 PACKAGE PneumaPress DVT 2600 box consists of the following PneumaPress DVT 2600 Air connecting hose tubing AC cable plug Operations manual Cuff s are ordered separately and can be ordered in various sizes 4 2 INSPECTION OF BOX Caution Do not open boxes by using sharp implements Ensure content matches above list Check power cable is correct for your locality and use 4 3 PRODUCTS OR PACKAGING DEFECTS Please contact your representative if products are found to be damaged or items are missing from the packaging 4 4 PLEASE NOTE 1 Damage caused by the user during the opening of the packaging is not covered by the warranty Please take care 2 Please ensure PneumaPress is stored sa2. Connect the equipment into an outlet a different circuit Consult the manufacturer or technician for help 2 7 WEEE MARKING This marking shown on the product or 15 literature indicates that it should not be disposed of with other household waste at the end of its working life To prevent possible harm to the environment or human health from uncontrolled waste disposal please separate this trom other types of waste and recycle it responsibly to promote the sustainable reuse of material resources Business users should contact their supplier and check the items and conditions of the purchase contract This product should not be mixed with other commercial waste disposal 3 Product Description 3 1 SUMMARY AND SPECIFICATIONS Composition The pump Air connecting hose tubing AC cable plug Specification Model DVT 2600 Weight 2 Kg only body Dimension 190 W x 200 D x 162 H mm Power consumption 35 Fuse Apply inside the inlet socket F 3 15AL 250V Place Indoors Ambient temperature amp humidity 40 below 60 Power source 100 240 50 60Hz The information label sticker of DVT 2600 is attached on rear of a controller Operating Principle The pump will deliver air to the cuff s and sequentially pressurise them Cuff s with 3 air chambers will be pressurised from the 1st chamber nearest
3. Product Manufactured in Korea GANDWN PP 0308 1 114
4. To charge the batteries please ensure PneumaPress is plugged in and the power switch is on The amount of power the batteries can deliver will vary according to a battery s condition and the settings of the device Regular battery charging time is approximately 4 hours Maximum running time is up to 8 hours E Operation indicator This LED indicator shows the status and type of cuff s applied following the self test application It also shows if one or two legs are being compressed and to which leg different 5 are being used i e leg and foot A moving LED shows pump in operation following self check application im ey The operation indicator below displays the variety of cuff types which may used Please note if there is cuff applied to the pump an error code be displayed aw oe Left leg feet wo legs amp Right foot Right leq Left leg Left foot Right Operating Mode The pump is able to provide two levels of therapy For the UK PneumaPress is only marketed to provide DVT VTE prophylaxis Diagram 1 1 DVT OPERATING MODE In DVT mode the pump pressurises the cuff s see diagram 1 If different cuff s 37 have been selected pressure is applied to foot cuff first then the leg cuff s Interval time will start after both legs cuft s have been pressurised 2 ERROR DESCRIPTION If there Is an error with the pump t
5. to the foot to the 3rd chamber Once the chambers are pressurised the pump will provide an interval period for vein refilling before the pump starts to pressurise the chambers again These cycles will be repeated throughout the time the unit is in use Intended Use This product is a medical device to help reduce the risk of DVT VTE formation by increasing the flow of blood in the venous circulation the legs back to the heart Please use this product under the guidance of medical staff and in line with your hospital s DVT VTE policy System features The Self Test Function On start up the pump initiates an automatic check of the cuff connection and the type of cuff applied The controller also detects any abnormal pressures encountered during regular operation Manual Setting Program The pump is designed to allow custom pressure values to be delivered to the patient 3 2 THE FUNCTIONS O LCD Foot pressure display button Control Buttons Leg pressure Interval START STOP button button button button 1 START STOP This button is used to start or stop the compression cycles If an error occurs the pump automatically stops To restart cycles press once 2 MODE In the UK PneumaPress is only marketed to provide DVT VTE prophylaxis The mode button does have a use use in DVT mode only 3 LEG PRESSURE This button is used to set the required pressure to be delivered t
6. EUMAPRESS DVT 2600 ACCESSORIES PRODUCT SIZE LENGTH OF LENGTH OF CALF THIGH NHS CODE CUFF CALF SECTION CIRCUMFERENCE CIRCUMFERENCE o D 5 DS011 26 40cm 50 76cm EGD 7614 DS012 Med 61cm 63 5cm 37 51cm 53 81cm EGD 7615 DS013 5 _ 56 87cm ECD 7616 X DS014 45 84cm 56 102 EGD 7617 LENGTH OF CALF CIRCUMFERENCE PRODUCT SIZE CODE CUFF mea 33m CALF EGD 7618 EGD 7619 EGD 7620 EGD 7621 PRODUCT CODE 05031 FOOT 9 jS 74 PRODUCT 05041 LENGTH OF CALF SECTION CALF CIRCUMFERENCE FOOT CIRCUMFERENCE Up to 36cm FOOT CIRCUMFERENCE NHS CODES EGD 7622 NHS CODES 27 46cm Upto28cm EGD 7623 Cuff usage and caution TWO CUFFS amp PUMP Two connectable hoses Two Same cults Twa different PRODUCT r d CODE i m DVT 2600 4 gufi 1 12 3 CUFF USAGE AND CAUTION Do turn on power switch before applying 5 to a patient Connect the tubing hose after the cuff s are applied to the patient Turn the power on after connecting the hose s to the air socket at rear of PheumaPress to ensure self check Do not operate with patient standing or sitting down There could a risk of malfunction of PneumaPress and cuff s The manufacturer recommends using basic pressure settings
7. Pneuma 9 User Manual Intermittent Pneumatic Compression System To ensure safe use of this device it is essential Mechanical that you read and fully prophylaxis for the understand the information prevention of Deep contained within this Vein Thrombosis manual Caution Federal USA and European Union law restricts this device to sale distribution and N MEDICAL 0473 use by or on the order of a physician 1 Introduction 1 1 OVERVIEW OF THE SYSTEM Thank you for choosing PneumaPress DVT 2600 The product is a pneumatic compression system which is used to improve the blood circulation for patients with reduced mobility therefore reducing the risk of DVT VTE formation The product range comprises of a pump connecting tubing and disposable cuff s The pump has digital sensors to check the cuff connections output and power supply If an error code shows during the initial operation check the error code sticker on top of the controller and action as advised This user manual contains information on how to use and maintain 5 Please read this manual to ensure you use this product correctly 2 Clinical Information 2 1 RANGE OF APPLICATION AND EFFECT OF USE Air from the pump is delivered to the cuff s via 3 air chambers in the thigh calf and boot styles The air will sequentially pressurise the chambers from 1st to 3rd This applies pressure to the legs and the
8. cycle time When the START STOP button 15 pressed the default setting of 48 sec is shown and can be changed with each depression of the button 6022824860 sec Upon completion of pressurisation to each chamber the pump has an interval period to allow time for the vein to refill with blood before the pump restarts to pressurise the chambers again These cycles will be repeated during the operating time set or until discontinued It is not possible to change these settings whilst the pump 15 in operation 6 LCD DISPLAY SCREEN A Battery status indicator PneumaPress DVT 2600 is equipped with back up battery pack An LED indicator is used to represent the charge status of the battery as per diagram below B AC power indicator AC power indicator LED is used to show mains power 15 attached and in use If not shown please check status of mains supply C Battery charging indicator Indicates whether batteries are charging Indication of the battery charge level will not be displayed when the unit is off The indicator for battery charging will be displayed only when the batteries are not fully charged Battery fully charged Power plugged Battery is 50 charged Battery needs to be recharged is charging Cut af battery The batteries require PheumaPress to be switched on for charging Warranty period for the batteries will be 6 months after the date of purchasing D Battery charging
9. ect the cuffs in the correct hose s to the pump and cuff s sequence 6 2 OTHER RELATED PROBLEMS Weak air injection Air hose damage Ensure hose s are correctly Air socket damage inserted Internal defect Power on but not Internal defect Return to hospital maintenance operating or supplier The user is responsible for any defect that occurs through careless use even during the warranty period 16 7 Maintenance DEVICE Use PneumaPress indoors in the temperature range of 0 40 C and under humidity of 90 Outside of these parameters there is a fire risk Keep PneumaPress away from heating equipment or direct sunlight Fire risk Do not use PneumaPress in high humidity places such as bathrooms or saunas etc Fire electric shock risk Do not fold or bend air hose s Do not tamper or attempt to repair PneumaPress contact your representative Fire electric shock risk Keep the device in a clean place and protect from dust Disposable cuff s for single patient use only Store cuff s tubing away from water or dust Inflate cuff s only when fitted to limb as this may cause problems to the sensors or pump Caution should be used when using sharp implements near to cuff s and tubing BATTERY Avoid dropping Prevent from being soaked in liquid Do not touch any fluid leaking from the battery pack Do not open the cover of the battery pack or tamper with it i
10. ed long term use 5 3 STOPPING THE DEVICE DURING OPERATION Do not use PneumaPress if the patient demonstrates any of the following symptoms Oedema of the foot calf or leg Difficulty breathing Patient complains that the compression Is too strong Patient complains of serious during use of the device Temporary numbness or irritation caused by the cuff 54 RECOMMENDATION The PneumaPress DVT 2600 15 a medical device and must only used as prophylaxis the prevention of DVT VTE formation and under the guidance of medical staff and as per the Hospital DVT VTE policy Patients often feel that the compressions become weaker as time goes by but this is due to them becoming accustomed to the compression 6 Troubleshooting 6 1 TROUBLESHOOTING No electric power Check the plug is inserted correctly error Power on but not Power supply error Turn off and on at PneumaPress operating power switch Check cable is plugged in securely Noisy during Position of pump Check that that the pump is standing operation hanging correctly and not lying flat Ensure there is nothing covering the device No air coming out of Hose connection error Ensure hose s are correctly inserted the hose s or into pump and cuff s hose is bent or kinked Ensure all tubing and hoses lie straight Air is not inflating the Connection error Stop the operation and reconn
11. fely away from dust and humidity after each use 3 Ensure PneumaPress is unplugged from the mains supply when not in use or being charged 14 4 5 ENVIRONMENTAL CONDITIONS FOR TRANSPORT AND STORAGE Temperature Operating Relative humidity 10 90 Condition Atmospheric pressure hPa 700 1060 Temperature 20 60 Transport and Storage Relative humidity ______0 90 ____ Atmospheric pressure hPa 500 1060 5 Product Use Procedure 5 1 BEFORE USING THIS DEVICE Only use PneumaPress under the direction of medical staff and as per your hospital s DVT VTE policy Do not operate this device unless you have been trained to do so 5 2 SETTING UP AND USING THE DEVICE Place the PneumaPress on a hard flat surface or hang using the bed hanger Connect to a suitable power supply Ensure the cuffs are the correct size and securely fitted to the patient Connect the applied 5 to pump using connecting hose s Turn on the power switch at the rear of the pump The pump will automatically self test checking the cuff s attached Operate the pump by pressing START STOP button to use the device s basic settings or the previously saved patient settings OR Change the settings for the Mode Pressure and Interval time as previously described in section 3 2 The Functions 8 Press the START STOP button to stop the controller operating Note PneumaPress is not recommend
12. he error mode will start with an alarm The pump will stop and return to a waiting mode Once the error Is corrected the pump will restart when the user presses START STOP 10 Error Mode Vent error H A Pressure in cuff doesn t ventilate No cuff s connected Device error Low pressure error _ AC cord plug error 30 under pressure Power problem when following 5 using AC power consecutive checks High pressure error Battery power error Power problem when AC power off and using battery 30 over pressure following 5 consecutive checks 1 CODE 10 Cuff connection error During power on the pump performs an automatic one cycle calibration to detect cuff type s being used and confirm they are fitted to limb s If the pump fails to detect the cuff s error code 10 will be displayed with an alarm sound 1 Check the pump and cuff s to ensure the tubing is correctly fitted 2 Check that each cuff is fitted correctly the patient s leg 2 CODE 21 Low pressure error If pressures lower than 30 of the set value are detected more than 5 times during operation error code 21 will be displayed 1 Check the pump and 5 to ensure the tubing is correctly fitted 2 Check that each cuff is fitted correctly on the patient s leg Check whether there is any leakage from a connected cuff 4 Disconnect the cuff and tubing check air is being p
13. n any way explosion risk Dispose of the battery properly according to local regulations The warranty period for the battery is 6 months after the date of purchase Mame FRONT_COVER KNOB_BUTTON 2 PARTS ASSEMBLY DIAGRAM SUB ASM FRAME 3 PARTS ASSEMBLY DIAGRAM SUB ASM REAR 18 E 24 UBBER_HOSE_ELBOW ______ RUBBER_HOSE_PRESSURE 70mm 2 10 4 PARTS ASSEMBLY DIAGRAM SUB DVT 2600 4 WARRANTY Thank you purchasing and using PnuemaPress We constantly strive to improve the quality of our products and the support provided to our customers Note In the following cases we are not able to repair our device free of charge even during the warranty period 1 Damage caused by a strong impact 2 Unauthorised user repair or arbitrary part replacement 3 Use of the device in unauthorised situations 4 Used against manufacturer s manual instructions Pump 1 year N A Disposable item 19 Intermittent Pneumatic Compression System Manufactured G N Medical Maydwell Avenue off Stane Street Slinfold Horsham West Sussex United Kingdom RH13 OGN Tel 44 0 845 263 8908 Email medsales gandn com Website www gandn com
14. o leg cuff s When the START STOP button is pressed the basic leg pressure will automatically be shown LEG CALF BOOT CUFF 40mmHg It is not possible to change these settings whilst the pump 15 in operation The basic pressure is set as 40 mmHg and pressure setting will changed by 10mmHg with each depression of the button 40 250 260 220 230 40 The LCD screen will remain turned off if the user does not apply the cuff as the controller automatically selects the cuff when the START STOP button Is selected The pump has an automatic gradient pressure application that is applied into each chamber of a cuff sequentially 5 mmHG For 5 with three chambers such as leg calt boot if 40mmHG is set pressure will be delivered as 35 40 45mmHG to the three chambers 4 FOOT PRESSURE This button Is used to set the required pressure to be delivered to a foot cuff When the START STOP button is pressed the basic foot pressure will automatically be shown FOOT CUFF 120 It is not possible to change these settings whilst the pump is in operation The basic pressure is set as 120mmHg and the pressure setting will be changed by 10mmHg with each depression of the button 120 130 140 120 The LCD screen will switch off if the user does not apply a cuff because the pump selects the cuff automatically when START STOP 15 pressed 5 INTERVAL This button 15 used to set the interval
15. resentative Use the device with a suitable AC power cord observing the electronic standards tor each local region Fire and electric shock are possible CLAUSE 5 Type of protection against electric shock Class 1 Equipment Degree of protection against electric shock Not classified BF applied parts Classify according to the degree of protection against ingress of water IPXO ordinary equipment This equipment is not suitable for use in the presence of flammable anaesthetics or oxygen Mode of operation continuous operation INFORMATION REGARDING POTENTIAL ELECTROMAGNETIC OR OTHER INTERFERENCE This equipment has been tested and found to comply with the limits for medical devices EC EN 60601 1 2 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and 1 not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particular installation If this equipment does cause interference to other devices which can be determined by turning the equipment off and on The user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment
16. umped from the air outlets on the pump UJ 3 CODE 22 High pressure error If pressures higher than 30 of the set value are detected more than 5 times during operation error code 22 will be displayed 1 Check whether the tubing is bent 2 Check if there is something blocking the tubing 3 Check the pump air output sockets for blockages CODE 31 Ventilation error If air has not ventilated deflated under 20mm Hg during the INTERVAL TIME error code 31 will be displayed 1 Check the inner solenoid valve Exchange the valve 5 CODE 32 Pump error During the initial self detection test if the pump is not operating normally error code 32 will be displayed 1 Check pump operation after opening cover of the pump 2 Check the wire connection in the pump 6 CODE 33 System error This error indicates serious damage to the inner pump Please call your local representative 7 CODE 41 Power supply error Code 41 15 displayed if the power supply from the outer AC Is causing a problem Please call your local representative 8 CODE 42 Code 42 15 displayed when there 15 a problem with the power supply generated by the inner batteries Please call your local representative 3 3 SYSTEM DESCRIPTION Main Compositions 1 PNEUMAPRESS DVT 2600 PUMP Voltage and AC power 100 240 50 60Hz Power consumption 25W 35VA Output 2 Pressure range LEG 20 60mmbHg FOOT 120 140mmHg 2 PN
17. veins within them forcing blood up towards the heart Please use this product as prescribed by medical staff and as per your Hospital Trust DVT VTE policy and only once you have undertaken training in 15 use 2 2 CONTRA INDICATIONS PneumaPress DVT 2600 system is not recommended for use with the 3 following conditions Pre existing deep vein thrombosis phlebothrombosis or pulmonary embolism Presumptive evidence of congestive heart failure Inflammatory phlebitis process Severe arteriosclerosis or other ischemic vascular disease Decompensated cardiac insufficiency Carcinoma metastasis in the affected extremity Where lymphatic return is undesirable Severe arteriosclerosis or active infection 2 3 2 6 PRECAUTIONS If any pain or oedema occurs during use of the device cease therapy and seek medical advice Use with caution on patients with recently fitted prosthesis Assess skin integrity frequently during use in patients with diabetes or vascular disease In the unlikely event of electric shock whilst using the device remove device from power source and disconnect unit from patient Manual settings should be adjusted under the advice of a medical practitioner WARNINGS Manual settings should be adjusted under the advice of a medical practitioner Do not attempt to repair a faulty device or replace broken tubing connectors as abnormal inflation of the cuff may occur Contact your local rep
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