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DHS - User Manual Air Plus 2.indd

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1. Audible alarm will resume after 20 minutes if cause of failure not resolved D Pressure Buttons Soft Medium amp Firm Press buttons to increase or decrease pressure setting The Soft Medium amp Firm settings allow comfort to the user without clinical compromise The green LEDs illuminate to indicate which of the three settings is operational E Dynamic Function Button Press Dynamic Mode for alternative cells cyclically inflating and deflating Static Mode will automatically revert to Alternation Mode after one hour for patient safety Upon power up the system automatically reverts back to the dynamic mode operating at the previous pressure setting for patient safety Static Mode will automatically revert to Alternation Mode after one hour for patient safety F Static Function Button Press to facilitate static mode for clinical procedure patient transfer purposes After 20 minutes the system automatically reverts back to the previous pressure setting for patient safety Press Static Mode for all cells to be fully inflated with no dynamic alternation Static Mode will automatically revert to Alternation Mode after one hour for patient safety G Control Unit Lock Unlock Button Press for at least two seconds to lock the Control Unit settings a beep sounds and the amber LED illuminates to indicate system is locked When locked only the Alarm Mute and Lock Unlock buttons remain operational P
2. top cover upper surface either by spraying or by hand application 2 Ensure the surface is completely covered with the disinfectant and remains in contact with the surface according to manufacturer s instructions 3 Remove disinfectant and rinse thoroughly 4 Allowtoair dry before use Handle The exterior of the Handle can be periodically wiped using a cloth a dampened with authorised cleaning and disinfection solutions Control Unit A Ensure the Control Unit is disconnected from the mains electricity supply before cleaning A Do not spray disinfectant directly on to the Control Unit or immerse the Control Unit in any type of liquid This could result in a severe electrical hazard as this equipment has no protection against ingress of water A This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Wipe down Control Unit with warm water containing detergent or authorised cleaning and disinfection solution and dry thoroughly before use A In case of notifiable diseases clean and disinfect systems following eventually special procedures revised and published by the local health care authorities The transport should take place in special plastic bags only 13 14 MAINTENANCE Air Filter Replacement 1 Switch off the power supply to the Control Unit 2 Disconnect the power lead and air hoses 3 Place the Control Un
3. RF disturbances are controlled The customer or the user of the system can help prevent electromagneticinterference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters andthe system as recommended below according tothe maximum output power of the communications equipment Rated maximum Separation distance according to frequency of output power of transmitter m transmitter W 150KHzto 80 MHz 80 MHzto 800 MHz 800 MHzto 2 5 GHz d 1 167P d 1 167P d 2 333VP Fortransmitters rated ata maximum output power notlisted above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P isthe maximum output power rating of the transmitter in watts W according to thetransmitter manufacturer NOTE 1 At80MHzand800Mbkz the separation distance forthe higher frequency range applies NOTE2 Theseguidelines may notapplyinall situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people
4. or lowering the pressure ensure the system is working effectively by performing a bottoming out test Bottoming Out Test When altering the pressure setting ensure the patient is not bottoming out insufficiently supported by the air cells and therefore coming in contact with bed base 1 Ensure system is in alternation mode but is not undergoing an alternation 2 With the patient lying in a supine position unzip top cover just past sacral bottom region 3 Slide your hand along a deflated cell under the patients sacral area bottom The inner static cell will remain inflated but your hand should slide easily between patient and base 4 Ifahand can pass under patient then the patient is adequately suspended and pressure can be lowered 5 Repeat Bottoming Out test after pressure has been lowered In the event of a system malfunction the alarm will activate and pressure LEDs will flash Establishing Pressure inclined patient When moving the patient to a sitting or more upright position pressure may need to be increased to a medium or firm setting in order to provide added support and to avoid bottoming out A Itis important to return to the original pressure setting when the patient returns to the supine position A Wait a minimum of 12 minutes between pressure adjustment and patient assessment as it may take a cycle for the system to adjust CPR Function Rapid deflation of th
5. CONTENTS Important Notice Before operating this medical equipment it is important to read this manual and understand the operating instructions and safety precautions Failure to do so could result in patient injury and or damage to the product If you have any questions please see contact information on cover CE SAFETY PRECAUTIONS iscssscssscsssesossassscsseussvecssscasens 3 PRO DUG OVERVIEW vanari 4 ttl Ai OM isssccassssssenscosssstsssisbsiaserastectesasesaventeasnse 5 Unpacking amp INSPeCtiON sssssssssssssssssssssssssssssss 5 Installation Guide wesc see cover OPERATION osataan 6 Control Unit Panel sssi 6 Alarm FUNCTIONS sessssentesscazscesisssrscuscncdssunreussaacets 7 Mattress FUNCTION sssrinin 8 Removal amp Transport Function sses 9 TROUBLESHOOTING ssscsossssssssssessscssisesessassoessasanse 10 GLE AINIIING irssi 12 MAINTENANCE ss sccsscsnssssssccesssseseasieccecoasscasconiiessctes 14 WARRANTY INFORMATION sssesscessssseeceeseeee 15 TECHNICAL SPECIFICATIONS sssssees see cover SAFETY PRECAUTIONS In General Control Unit A Do not use this equipment in the presence of flammable anesthetics Explosions could result A Bed frames used with the systems can vary greatly depending on the specific health care setting i e hospitals nursing homes home care etc It is the responsibility of the caregiver to take the necessary precautions to ensure the safety of the patient This
6. System providing pressure application and release to patients with or vulnerable to pressure ulcers It is designed to replace an existing mattress and can be used on both standard and profiling bed frames Mattress This system includes a static head cell s to provide static pillow support for optimum user comfort while air pressure in the other cells is alternated over a 10 12 minute cycle This provides regular periods of pressure reduction to aid blood and lymphatic flow to vulnerable tissue Control Unit The Control Unit provides the air supply to the Mattress Itis controlled via a touch panel with integrated digital display The Alarm sounds when pressure fails or power is interrupted Alarm Mute silence the alarm for maximum of 20 minutes the alarm resumes if cause of failure is not resolved The Alarm will sound for up to two hours following an interruption to power The Control Unit includes a back up power battery for the alarm This battery is continuously re charged will last the life time of the product Buttons onthe control panel adjust the three comfort level settings The Alarm LED indictor and Alarm Mute completes the profile The visible and audible alarm functions has a number of indications depending on the cause of the failure The mains supply to the Control Unit can be easily disconnected and is designed to detach if tugged too firmly protecting the internal wirin
7. arked with the following symbol NOTE 1 At80MHzand800Mbz the higher frequency range applies NOTE2 Theseguidelines may notapplyinall 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 Span system is used exceeds the applicable RF compliance level above the system should be observed to verify normal operation Ifabnormal performance is observed additional measures may be necessary suchas reorienting or relocating the system b Over the frequency range 150 kHzto 80 MHz field strengths should be less than 3 V m 19 20 Technical specification Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for ME EQUIPMENT or ME SYSTEM that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the MAT PRO PLUS PUMP Alternating Control Unit The MAT PRO PLUS PUMP is intended for usein an electromagnetic environmentin which radiated
8. b with authorised cleaning and disinfection solutions Dry thoroughly with a soft cloth before refastening A Do not machine wash or dry the Air Cells or Mattress base A Do not disassemble the Mattress unless cleaning is required If cleaning or disinfecting is required do not disconnect the pipes from individual Air Cells CLEANING Top Cover A Refer to the top cover wash tag for cleaning instructions If there are visible signs of body fluids and or substances present the top cover should be washed Top covers can be machine washed up to 95 C using authorised cleaning and disinfection solutions To establish the amount of disinfectant to use determine the amount of water in the washer and then follow the manufacturers instructions for dilution Soak the top cover in the disinfectant during the wash cycle Rinse well in clean water and dry thoroughly before use A Do not dry the top cover using too high a heat cycle see Dartex technical recommendations up to 95 C Air dry if possible or select a n appropriate heat dry cycle within limits as above If there are no visible signs of body fluids and or substances on the top cover the top cover should be sanitized and rinsed with fresh water accordingly If there are no visible signs of body fluids and or substances on the top cover the top cover should be sanitized 1 Apply an intermediate level authorised cleaning and disinfection solution to the
9. e Mattress may be required for emergency treatment or to decommission the system Firmly pull the Rapid Release CPR Handle from the side of the Control Unit to rapidly deflate the entire system To re inflate the system after the Rapid Release CPR Handle has been removed replace as such ensuring all sealing connectors are firmly attached and restart the Control Unit Wait for the Mattress system to gain optimal pressure Perform a Bottoming Out test after inflating the mattress following rapid deflation Mattress replacement Overlay Function The mattress body of the Air Pro Plus can be used as a mattress replacement system or as an overlay system The standard delivery status is as a mattress replacement system To use the Air Pro Plus as an overlay system zip off the bottom part of the mattress body which holds the foam base Once the bottom part is removed the mattress body can be placed ona standard hospital mattress before patient use OPERATION Transport Function 1 Before patient transport switch modes from alternating to static and wait for 10 12 minutes for cells to inflate to maximum pressure 2 Turn off the Control Unit 3 Remove the mattress connection from the Control Unit Allow air to escape for a few seconds before sealing with the attached transport cap see picture on cover This will soften the Mattress surface for pressure relief and comfort Air can be seal in the system for 30 hour
10. er supply or abattery Power frequency magnetic fields should beatlevels characteristic ofatypical location inatypical commercial or hospital environment Technical specification Declaration electromagnetic immunity for ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPPORTING Guidance and manufacture s declaration electromagnetic immunity The MAT PRO PLUS PUMP is intended for use in the electromagnetic environment specified below The customer orthe user of the system should ensure that it is used in such an environment Conducted Immunity IEC60601 Compliance Electromagnetic environment guidance test testlevel level Portable and mobile RF communications equipment RF 150kHzto should be used noclosertoany partoftheCT515 IEC61000 80MHz including cables than the recommended separation 46 distance calculated fromthe equation applicable tothe frequency of thetransmitter Recommended separation distance d 1 167P Radiated 3V m d 1 167VP 80 MHzto 800 MHz 80MHzto IEC 61000 2 5GHz 4 3 Where Pis the maximum output power rating of the d 2 333VP 800 MHzto 2 5 GHz transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distancein meters m Field strengths from fixed RF transmitters as determined byanelectromagneticsite survey should belessthan the compliance levelineachfrequencyrange Interference may occurinthe vicinity of equipment m
11. g of the unit Should this occur the alternation sequence is suspended and the Mattress cells remain inflated and or deflated based on the current cycle The Power Down Alarm will sound See picture on inside cover INSTALLATION Unpacking amp Inspection see cover A It is recommended that all packing materials and instructions be kept in the carry bag provided in the event the product has to be shipped to Direct Healthcare or an authorised local Direct Healthcare distributor Please see contact information on cover Carefully remove the Control Unit Mattress Replacement and accessories from the shipping cartons Inspect all items for any damage that may have occurred during shipping Any damage or missing components should be reported to Direct Healthcare or an authorised local Direct Healthcare distributor as soon as possible Please see contact information on cover OPERATION Control Unit Panel see inside cover A Power Button Turns system power on and off by pressing the Power button for at least two seconds B Alarm LED A B amp C One of these red light flashes and an audible alarm sounds to alert when Control Unit or Mattress Replacement pressure fails The alarm has three different signals to indicate the cause of the failure see over The audible alarm also sounds when power is switched off press Alarm Mute to silence C Alarm Mute Button Silences the audible alarm on off
12. ge ESD IEC61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge lEC61000 4 5 Voltage dips shortinterruptions andvoltage variations on power supply inputlines EC61000 4 11 Powerfrequency 50Hz magnetic field IEC 61000 4 8 NOTE IEC 60601 testlevel 6kV contact 8kVair 2 kV for power supplylines 1kVline s to line s lt 5 U gt 95 dip in U for0 5 cycle 40 U 60 dip inU for5 cycles 70 U 30 dipin UT for25 cycles lt 5 U E gt 95 dipinU for5 sec Compliance level 6kV contact 8kVair 2kV for power supply lines 1kVdifferential mode lt 5 U gt 95 dipin U for0 5 cycle 40 U 60 dip inU for5 cycles 70 U 30 dip inU for 25 cycles lt 5 U gt 95 dipinU for5 sec U isthea c mains voltage priorto application of the test level Electromagnetic environment guidance Floors should be wood concrete orceramictile If floor are covered with synthetic material the relative humidity should be atleast 30 Mains power quality should be that of atypical commercial or hospital environment Mains power quality should be that ofatypical commercial or hospital environment Mains power quality should be that of atypical commercial or hospital environment Ifthe user of the Span system requires continued operation during power mains interruptions itis recommended thatthe system be powered from an uninterruptible pow
13. includes but is not limited to the appropriate use of side rails to prevent falls and or patient entrapment A Minimize articles between the system surface and patient and secure bed sheets loosely so as not to affect the alternating cell movement A the manufacturer does not require such preventive inspections by other persons A the user must check that the equipment functions safely and see that it is in proper working condition before being used Ano special skills or training of the operator is required there is no restriction on the location or the environment A significant risks of reciprocal interference may be posed by the presence of the system during specific investigations or treatments Potential electromagnetic or other interference bewteen the system and other device may occur if interference is suspected move equipiment from sensitive devices or contact the manufacturer A preventive inspection and calibration is not required Ano not modify this equipment without authorization of the manufacturer A Manufacturer will provide circuit diagrams component part lists descriptions to assist to service personnel in parts repair Arre mattress is treated as the applied part A Uunplug the control unit from the mains power supply to disconnect the power A the control unit is tested and approved according to ISO EN 60601 1 rev 2 amp EMC A Only plug into a grounded power receptacle and use the powe
14. it on a flat surface with back panel uppermost place soft cloth under unit to prevent scratches 4 Carefully remove air filter cover remove and discard the filter material and fit new filter there may bea small locking screw use a small Phillips Head screwdriver to remove 5 Refit the air filter cover to the Control Unit The Control Unit is now ready for re connection A Good filter maintenance is critical to maintain your system in optimal operating condition Failure to keep the filters clean will result in system downtime and increase repair costs It is recommended that the air filter be replaced annually Replacement air filters are available from an authorised local Direct Healthcare distributor Please see contact information on cover Fuse Replacement 1 Switch off the power supply to the Control Unit 2 Remove the power cord from the electrical socket on the side of the base of the Control Unit 3 Inserta small Flat Head screwdriver into the groove and turn anti clockwise quarter turn 4 Remove the blown fuse from the fuse holder clip and discard 5 Insert anew fuse into the plug Push against the force of the spring and turn clockwise with the screwdriver quarter turn A Ensure the replacement of fuses is carried out accordance with local legislation WARRANTY INFORMATION This product is produced to perform in accordance with established specifications starting from
15. otect clothing use plastic apron face mask and gloves Infection Control and routine cleaning must be carried out in accordance with your local Infection Control Policy It is suggested that all disinfection be done with a high grade disinfectant in accordance with manufacturer s instructions A Use authorised cleaning and disinfection solutions only A The working table and the system must be cleaned and disinfected A Concentration and exposure time of the solutions must be noted A The top cover seams are sealed to prevent moisture ingress and bacterial growth in the seam stitching A Do not use high temperature autoclave or use Phenolic based products for cleaning A It is recommended the system is cleaned between patients and approximately every two weeks if in constant use A Refer to the cleaning and disinfection information for the Air Pro Plus system for additional guidance A In case of questions in hygiene please contact an authorised local Direct Healthcare distributor Mattress Base Wipe down the outside shell with authorised cleaning and disinfection solutions ensuring that all surfaces come in contact with the disinfectant Rinse off well with a clean damp cloth and air dry Should Air Cells require disinfecting disconnect Air Cells from the base by unfastening the press studs at each end and disconnecting air pipes from main air hoses before sliding each cell out from the cell straps Swa
16. r and press the alarm mute button Disconnect the air hoses to reduce pressure reconnect when pressure has decreased Check for twists in the air hoses between Mattress and Control Unit Switch on power Other checks to consider as below Alarm LED Any audible alarm Alternating Mode Failure no alternation Reset the alarm turn off Power and press the Alarm Mute button Disconnect the air hoses to reduce pressure reconnect when pressure has decreased Alarm LED Any audible alarm Power down Press the Alarm Mute button to silence the audible alarm Check the power cable is firmly plugged into the mains outlet and the Control Unit and check the mains power is switched on Check the Control Unit fuse 1 AMP fuses can be released using a screwdriver to push and turn Patient is sinking or bottoming out whilst lying flat on the Mattress Replacement The pressure may be set too low for the patient s weight Increase the pressure setting by pressing up the Pressure arrow To check effective system performance conduct a bottoming out test as described on page 8 A Ifthe problem is not resolved please contact Direct Healthcare or an authorised local distributor See contact information on cover 11 12 CLEANING Before the cleaning and disinfection procedure please use hygienic hand disinfection with an alcoholic skin disinfectant To pr
17. r cord supplied with the system A Exposure of the electronic Control Unit to any liquid while itis plugged in could result in a severe electrical hazard A Only use fuses that have the same specified rating Using fuses with higher ratings could result in damage and or injury See Technical Specifications on cover A the electronic Control Unit is a precision electronic product Use care when handling or transporting Dropping or other sudden impacts may result in damage to the unit A Do not open the Control Unit risk of electrical shock Do not attempt to repair or service the Control Unit Repairs and service should be conducted by an authorised local distributor See contact information on cover If the Control Unit is not functioning properly or has been damaged unplug the unit and take it out of service immediately See contact information on cover for repair and service information A Do not place any objects or items such as blankets on or over the Control Unit A the power cord to the Control Unit should be positioned to avoid a tripping hazard and or damage to the cord It is recommended to place the cord under the bed frame and attach it to an electrical outlet by the head of the bed Ado not position the system so that it is difficult to operate the disconnection device PRODUCT OVERVIEW Alternating Mattress System see cover Dyna Form Air Pro Plus is an Alternating Mattress Replacement
18. ress again for at least two seconds to unlock beep sounds and amber LED turns off A the Control Unit will automatically unlock in the event of a power failure OPERATION Alarm Function The red Alarm LED A B or C flashes and an audible alert sounds to indicate the control unit or mattress pressure has failed The LED will remain illuminated until appropriate pressure is restored The audible alarm can be silenced by pressing the Alarm Mute button The system has three different alarm signals identified by illumination sequences The signals and corresponding Pressure Setting LED displays are illustrated below E A B C Display Alarm Signal A High pressure The system cannot reach the set pressure within 8 oo minutes The system pressure is to high ABC A Low pressure The system cannot reach the set pressure within 8 eae minutes The system pressure is to low A BC L Mains Failure Power unit has no power feed eee A BC If alarm activates and the system fails to inflate or loses pressure refer to Troubleshooting on following pages OPERATION Mattress Function Establishing Pressure supine patient With the patient lying supine on their back face upwards use the Pressure arrows to cycle through the eight available pressure settings Based on patient weight and comfort requirements establish the best setting for effective alternation support and comfort Before changing
19. s as a transport feature If the patient is responsive check comfort level based on current pressure and adjust accordingly A Always perform a bottoming out test see page 8 to ensure the patient is adequately supported and not touching bed base System Removal 1 Turn off the Control Unit by pressing the Power button for at least two seconds and unplug the power cable Remove the Rapid Release Handle from the Control Unit Place Control Unit and power cable on top of the Mattress and detach Mattress from the bed frame Once air has been released from all cells roll up the Mattress and return all items to Carry Bag for safe keeping A Prior to re starting the system ensure the Rapid Release Handle is firmly connected to the Control Unit 10 TROUBLESHOOTING Alarm Fault Control Unit does not operate no display lights illuminate Cause The Control Unit may not be attached toa power source or a fuse may need replacing Solution 1 Check the Control Unit is connected to mains power outlet with the correct voltage 2 Check the Control Unit is switched on Switch off and unplug the unit before restarting 3 Check the mains plug fuse 3 AMP then check both Control Unit fuses 1 AMP fuses can be released using a screwdriver to push and turn A Do not try to open the Control Unit Opening the unit could cause personal injury or equipment damage A Ensure the replacement of fu
20. ses is carried out accordance with local legislation Alarm LED C audible alarm Mains failure Other see above plus gt 1 Reset the alarm turn off power and press the alarm mute button 2 Check the handle is intact ensuring all four sealing connectors are firmly fitted to the control unit and the air hoses Check the CPR tag is attached and all sealing connectors are firmly secure 3 Check all air hoses along the inside of the mattress each should be firmly connected Check each air cell is securely attached to its connecting air pipe 4 Check all cells pipes and hoses for any air leakage 5 Switch on power Alarm LED B audible alarm Pressure too low 1 Reset the alarm turn off power and press the alarm mute button 2 Check the handle is intact ensuring all four sealing connectors are firmly fitted to the control unit and the air hoses Check the CPR tag is attached and all sealing connectors are firmly secure 3 Check all air hoses along the inside of the mattress each should be firmly connected Check each air cell is securely attached to its connecting air pipe 4 Check all cells pipes and hoses for any air leakage 5 Check that the air filter cover is correctly secured and the air filter is clean 6 Switch on power TROUBLESHOOTING Alarm Fault Alarm LED A audible alarm A eoo ABC Cause Pressure too high Solution Reset the alarm turn off powe
21. t is necessary Operating Instruction e Dz DISPOSAL Do not dispose of this product as unsorted municipal waste Technical specification Declaration electromagnetic emissions for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacture s declaration electromagnetic emission The MAT PRO PLUS PUMP is intended for usein the electromagnetic environment specified below The customer orthe user ofthe system should ensure thatitis used in suchan environment Compliance Emission test RF emissions CISPR11 RF emission CISPR11 Harmonic emissions 1EC61000 3 2 Voltage fluctuations flicker emissions 1EC61000 3 3 Electromagnetic environment guidance The system uses RF energy only forits internal function Therefore its RF emissions are very lowandarenotlikely tocauseany interferencein nearby electronic equipment Thesystem is suitable for use inallestablishments including domesticestablishments and those directly connectedto the publiclow voltage power supply network that supplies buildings used for domestic purposes 17 18 Technical specification Declaration electromagnetic immunity Guidance and manufacture s declaration electromagnetic immunity The MAT PRO PLUS PUMP is intended for use in the electromagnetic environment specified below The customer orthe user of the system should ensure that itis used in such an environment Immunity test Electrostatic dischar
22. the date the product is shipped For warranty period see Technical Specification on cover During the warranty period repairs and replacement will be made on products that are not performing in accordance with established specifications unless the problem failure is due to e customer damage negligence and or misuse e unauthorised repairs Items not covered under warranty include but are not limited to stains punctures cuts damages to electrical cords rips or tears dents and or lost missing parts Neither the company See contact information oncover its distributors officers directors employees or agents shall be liable for consequential or other damages including but no limited to personal injury loss or any other expense directly or indirectly arising from the use of its products The sole remedy for breach of the limited warranty granted herein shall be repair or replacement of the products If you have any questions see contact information on cover 15 16 Technical specification Definition of Symbols Used The following symbols may appear in this manual on the Control Unit or on its accessories Some of the symbols represent standards and compliances associated with the Control Unit and its use A Caution Consult accompanying documents O Class Il equipment goal Manufacturer SN Serial number Type B applied part Collection of such waste separately for special treatmen

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